THE MULTI-LIGAMENT QUALITY OF LIFE QUESTIONNAIRE (ML-QOL): DEVELOPMENT AND

PRELIMINARY TESTING OF MEASUREMENT PROPERTIES IN PATIENTS WITH MULTI-LIGAMENT

KNEE INJURIES

by

Jaskarndip Chahal MD, FRCS(C)

A thesis submitted in conformity with the requirements for the degree of Master’s in Science

Institute of Health Policy, Management and Evaluation University of Toronto

© Copyright by Jaskarndip Chahal 2013

The Multi-ligament Quality of Life Questionnaire (ML-QOL):

Development and Preliminary Testing of Measurement Properties

in Patients with Multi-ligament Knee Injuries

Jaskarndip Chahal

Master’s in Science

Institute of Health Policy, Management and Evaluation University of Toronto

2013

Abstract

Despite the existence of numerous knee-joint specific patient-reported outcome measures, the

content contained within such instruments does not completely capture the spectrum of injury

and impairments experienced by multi-ligament knee injured patients. Based on this

shortcoming, the overall objective of the current study was to develop, and to test the reliability

and validity of a novel disease-specific quality of life instrument for patients with multi-ligament

knee injuries. The World Health Organization’s International Classification of Functioning,

Disability, and Health was used to guide content development. Using a mixed methods approach

(surveys, patient focus groups, expert interviews), the final Multi-ligament Quality of Life

(MLQOL) instrument was comprised of 52 items distributed over 4 domains. This instrument

demonstrated excellent content validity, test-retest reliability, and construct validity. Future

work will evaluate the responsiveness of the MLQOL and will implement its use in randomized

trials.

ii

Acknowledgments

I would like to dedicate this thesis to my grandfather, Bakhshish Singh Bhatti, who passed away

at the age of 98 in April 2011. He was the strongest, most positive and most caring individual I

have ever met and remains a source of inspiration for me and my entire family. I will always

remember him.

This work would not have been possible without the amazing research mentorship provided to

me by my supervisor, Dr. Aileen Davis. From her, I learned the importance of slowing down and

doing the best quality work every time. The idea for this thesis was a direct result of my

interactions with inspiring clinical role models – Drs. Daniel Whelan and Peter MacDonald. As

always, I am thankful for their guidance and collaboration in this endeavour.

And of course, I want to thank my parents and my uncle Ravi who have always motivated me to

work hard, pursue my dreams and do the most that I can do. I also got married while this work

was underway – I am grateful to my wife, Pooran, for her endless love, support, and

encouragement at all times.

iii

Table of Contents

Contents

Acknowledgments ......................................................................................................................... iii

Table of Contents ............................................................................................................................ iv

List of Tables .................................................................................................................................vii

List of Figures ................................................................................................................................. ix

List of Appendices ........................................................................................................................... x

Chapter 1 Introduction ..................................................................................................................... 1

1 Introduction ................................................................................................................................. 1

Chapter 2 Background ..................................................................................................................... 4

2 Background ................................................................................................................................. 4

2.1 Anatomy .............................................................................................................................. 4

2.2 Epidemiology, Mechanism of Injury, and Classification .................................................... 4

2.3 Clinical Presentation ............................................................................................................ 6

2.4 Conceptual Framework ........................................................................................................ 7

2.5 Measurement Properties in the Context of Patient-reported Outcome Measures (PROMs) ............................................................................................................................ 10

2.6 A Critique of Existing Measures in Patients with MLKIs ................................................. 11

2.7 Rationale for the Thesis ..................................................................................................... 15

2.8 Objectives .......................................................................................................................... 18

Chapter 3 Methods ......................................................................................................................... 20

3 Methods .................................................................................................................................... 20

3.1 Design ................................................................................................................................ 20

3.2 Participants ........................................................................................................................ 21

3.2.1 Patients ................................................................................................................... 21

iv

3.2.2 Experts ................................................................................................................... 22

3.3 Procedures.......................................................................................................................... 22

3.3.1 Combined Questionnaire with Existing Items (Phase I) ....................................... 24

3.3.2 Stakeholder Input (Phase II) .................................................................................. 25

3.3.3 Mailed Survey – version 2.0 MLQOL (Phase III) ................................................. 28

3.4 Sample Size Estimate ........................................................................................................ 31

3.5 Ethical Considerations ....................................................................................................... 32

3.6 Data Management .............................................................................................................. 32

Chapter 4 Results ........................................................................................................................... 33

4 Results ....................................................................................................................................... 33

4.1 Item Generation and Item Reduction ................................................................................. 34

4.1.1 Combined Questionnaire with Existing Items (Phase I) ....................................... 34

4.2 Stakeholders Input (Phase II)............................................................................................. 46

4.2.1 Focus Groups ......................................................................................................... 46

4.2.2 Expert Interviews ................................................................................................... 52

4.2.3 Themes Generated During Focus Groups.............................................................. 53

4.2.4 Cognitive Debriefing ............................................................................................. 55

4.3 Mailed Questionnaire, Version 2.0 MLQOL (Phase III) ................................................... 55

4.3.1 Final Item Reduction ............................................................................................. 58

4.3.2 Internal Consistency .............................................................................................. 70

4.3.3 Scoring of the Final MLQOL ................................................................................ 70

4.3.4 Content Validity..................................................................................................... 71

4.3.5 Test-Retest Reliability ........................................................................................... 71

4.3.6 Construct Validity .................................................................................................. 72

Chapter 5 Discussion ..................................................................................................................... 76

5 Discussion ................................................................................................................................. 76

v

5.1 Knowledge Translation ...................................................................................................... 82

5.2 Conclusion ......................................................................................................................... 82

References...................................................................................................................................... 84

Appendix A .................................................................................................................................... 89

Appendix B .................................................................................................................................... 94

Appendix C .................................................................................................................................... 97

Appendix D .................................................................................................................................. 125

Appendix E .................................................................................................................................. 129

Appendix F .................................................................................................................................. 135

Appendix G .................................................................................................................................. 139

Appendix H .................................................................................................................................. 141

Appendix I ................................................................................................................................... 158

Appendix J ................................................................................................................................... 161

Appendix K .................................................................................................................................. 163

Appendix L .................................................................................................................................. 164

Appendix M ................................................................................................................................. 177

Appendix N .................................................................................................................................. 181

Appendix O .................................................................................................................................. 189

vi

List of Tables

Table I Characteristics of 11 commonly used knee outcome instruments

Table II Expected convergent (√) and divergent (blank) relationships between MLQOL

domains and SF-36 subscales.

Table III Demographic and injury-related information for individuals enrolled in phase I of

MLQOL development.

Table IV Items satisfying both a priori inclusion criteria for retention of items from the

consolidated questionnaire

Table V Items satisfying one of the two a priori inclusion criteria for retention of items

from the consolidated questionnaire

Table VI Items satisfying neither of the a priori inclusion criteria for retention of items

from the consolidated questionnaire

Table VII A list of 61 items retained prior to focus groups and expert interviews

Table VIII Focus group characteristics

Table IX Decisions about inclusion of grey zone items based on focus group data

Table X Decisions about inclusion of de novo items generated during focus group sessions

based on focus group data

Table XI de novo items generated during content analysis of audiotape transcripts AFTER

all the focus group sessions

Table XII Items generated from expert interviews

vii

Table XIII Comparison of Responders (R) and Non-responders (NR) to the preliminary

MLQOL (version 2.0))

Table XIV Inter-item Spearman’s Correlations and Adjusted Item to Total Correlations for

the Physical Impairments Domain

Table XV Inter-item Spearman’s Correlations and Adjusted Item to Total Correlations for

the Emotional Impairments Domain

Table XVI Inter-item Spearman’s Correlations and Adjusted Item to Total Correlations for

the Activity Limitations Domain

Table XVII Inter-item Spearman’s Correlations and Adjusted Item to Total Correlations for

the Activity Limitations Domain

Table XVIII Item to total correlations (ITC) after final item reduction

Table XIX Internal Consistency of the MLQOL Domains as measured by Cronbach’s Alpha

Table XX Descriptive Statistics for the MLQOL

Table XXI Test-retest reliability of the MLQOL Domains

Table XXII SF-36 scores for 65 patients with multiligament knee injuries

Table XXIII MLQOL domain scores according to neurological status at the time of injury

Table XXIV Multi-trait Multi-method Matrix - SF36 subscale and MLQOL Domain

Correlations

viii

List of Figures

Figure I Selected domains resulting from an integration of two concepts: (i) quality of life

and (ii) functioning and disability

Figure II Overarching Flow of Questionnaire Development

Figure III An overview of the three phases of development and testing for the MLQOL

Figure IV Flow diagram Outlining Item Generation and Item Reduction

ix

List of Appendices

Appendix A: Data Collection Form

Appendix B: Mailed Information Letter

Appendix C: Preliminary consolidated mailed questionnaire

Appendix D: Focus Group Questions (Surgeons, Patients)

Appendix E: Informed Consent – patients

Appendix F: Informed Consent - surgeons

Appendix G: Cognitive Debriefing Questionnaire

Appendix I: Preliminary MLQOL (v 2.0), Anchor Questions, Tegner Activity Scale, and SF-36

Appendix I: Mailed Information Letter

Appendix J: Patient Eligibility Checklist for Other Participating Centres

Appendix K: Research Ethics Board Approval Copy

Appendix L: Responses to the Mailed Consolidated Questionnaire by Frequency Distribution,

Mean, Median, and Standard Deviation.

Appendix M: Responses to the Preliminary ML-QOL (version 2.0)by Frequency Distribution,

Mean, Median, and Standard Deviation.

Appendix N: Final MLQOL

Appendix O: Altman-Bland Plots for the MLQOL Domains

x

Chapter 1 Introduction

1 Introduction Multi-ligament knee injuries (MLKI) are devastating injuries that involve damage to multiple

intra-articular and peri-articular structures around the knee joint. Due to the significant forces

that are imparted on the knee joint during the injury process, there are a large number of injury

permutations that are possible; these combinations involve damage to ligaments, menisci,

articular cartilage, bone, muscle, and/or surrounding neurovascular structures. The upshot is

that the multi-ligament knee-injured population presents with a constellation of impairments,

concerns, and limitations that differentiates it from patients with routine sports medicine injuries

such as isolated anterior cruciate ligament tears. In turn, the resultant clinical heterogeneity that

defines the MLK injured population also makes it difficult to quantify patient-reported outcomes

using existing knee-joint specific questionnaires since they largely have been developed in the

context of the aforementioned, routine, low energy sports medicine population. The short-term

and long-term sequelae resulting from multi-ligament knee injuries include pain, instability,

weakness, emotional concerns, impaired recreational/social activity, and an overall decline in

quality of life (QOL) [1].

At the present time, there are no disease-specific quality of life instruments that have been

developed for patients with MLKI. Although there are many definitions of QOL published in

the literature, in the context of MLKI, QOL will be defined as “patients’ perceptions of

performance in four areas: physical and occupational function, psychological state, social

interaction, and somatic sensation” [2, 3]. Furthermore, of the currently existing knee-joint

specific instruments, none have been tested for their measurement properties (i.e. reliability,

validity, etc.) in the multi-ligament knee injured population. While one approach is to proceed

1

with the latter endeavour, the North American Knee Dislocation Study Group has stated that the

content contained within existing knee-joint patient-reported outcome measures (PROMs) does

not reflect the spectrum of impairments and concerns that are pertinent to patients with MLKIs.

Furthermore, this study group has stated that clinical phenomena are occurring that are not being

detected by existing knee instruments [4]. For these reasons, the testing of measurement

properties of existing instruments in patients with MLKI is not supported as adequate content

validity is a requisite for reliability and validity testing. Finally, from the perspective of the

United States Food and Drug Administration (FDA), patient input is required for PROMs that

will be used in randomized trials for devices in future research. As new biological therapies

such as stem cells and scaffolds begin to be applied in the context of ligament and joint

reconstruction, the need for a reliable, valid, and responsive PROM in patients with multi-

ligament knee injuries will be important from a regulatory standpoint [5]. Given the

shortcomings in the current scientific literature, the purpose of this thesis is to develop a disease-

specific quality of life instrument for patients with MLKIs, as well as, to determine the

measurement properties of this novel tool.

The following chapters provide a detailed description of the background, methods, results and

discussion that is relevant to the current body of work. Specifically in Chapter 2, there is a

discussion regarding the anatomy of the knee joint along with the epidemiology, classification,

and mechanisms of MLKIs. In addition, chapter 2 provides a narrative review of measurement

properties of PROMs, as well as, a critique of existing measures that have been used to date in

the context of such measurement properties for the multi-ligament knee injured population.

After articulating the specific objectives of the thesis in Chapter 2.8, Chapter 3 provides a

detailed description of the materials and methods, while Chapter 4 describes the results. In

2

Chapter 5, the final discussion places the results in the context of existing literature and

identifies future directions and studies for the Multi-Ligament Quality of Life Questionnaire.

3

Chapter 2 Background

2 Background

2.1 Anatomy Although the multiligament knee injured population is comprised of a heterogeneous group of

patients, the common denominator among this population is damage to at least two of the four

major ligamentous structures and regions that stabilize the knee [6, 7]. These four structures

include the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), posterolateral

corner (PLC) and the medial side of the knee. The PLC is comprised of the lateral collateral

ligament (LCL), popliteus, popliteofibular ligament, iliotibial band and the biceps femoris [8].

The medial side of the knee is divided into the superficial MCL as well as the posteromedial

corner (PMC) which is comprised of the deep medial collateral ligament, posterior oblique

ligament, semimembranosus and its expansions, meniscotibial ligament and the posterior horn

of the medial meniscus [9]. In addition to ligamentous involvement variably associated

pathology in the context of MLKIs includes fractures, cartilage damage (chondral or

osteochondral defects), meniscus tears, as well as, injury to surrounding neurovascular

structures.

2.2 Epidemiology, Mechanism of Injury, and Classification Multi-ligament knee injuries can arise from a knee dislocation which in turn represents

approximately 0.02% of all orthopaedic injuries [4, 6, 10]. The true incidence of multi-ligament

knee injuries, however, is likely underestimated and remains largely unknown because a certain

number of knee dislocations reduce spontaneously before presentation – in other words, the

knee may have undergone a subluxation event at the time of injury and then self-reduced [6].

In these latter cases, the knee is often ‘dislocatable’ with stress testing on examination under

4

anesthesia as opposed to being frankly ‘dislocated’ on initial presentation. Both dislocated and

dislocatable knees are associated with high-grade multi-ligament knee injuries. In regards to

associated injuries, the incidence of popliteal artery injury ranges between 7-48% and injury to

the peroneal nerve is estimated to be 25-40% [6]. Associated fractures occur in 50-60% of cases

while injuries involving the head, chest or abdomen occur in approximately 27% of patients [6].

MLKI’s can result from varying levels of force imparted to the knee joint. ‘High-energy’

injuries are usually caused by motor vehicle accidents, which account for over half of cases.

Sports injuries result from ‘low-energy’ mechanisms and represent slightly less than one third of

cases [10]. There is also an increasing incidence of ultra-low energy mechanisms in the

morbidly obese where knee dislocations can result from simple falls [11]. In this latter

population, there is also an increased incidence of neurovascular injury [11].

The classification scheme proposed by Schenck et al. is an anatomical classification that

assesses the pattern of ligamentous disruption and provides a guide to the nature and severity of

the injury, as well as, the options for treatment [12]. According to Schenck’s classification, KD-

1 is a dislocation in which one of the cruciate ligaments is intact; KD-II is a tear of both cruciate

ligaments with intact collateral ligaments; KD-III is a bicruciate injury with either an associated

posteromedial (KD-IIIM) or posterolateral (KD-IIIL) corner injury; KD-IV is a rupture of all 4

major knee ligaments [7]. KD-V is a knee dislocation associated with a fracture and this

category can be further subdivided according the injuries described in the KD-I to IV

subdivisions [10]. Based on a review of the literature, the most common injury type appears to

be KD-III injuries (69%) with the medial side involved more frequently compared with the

lateral side [10]. With the various ligament and bony injury patterns that are possible, especially

in the context of systemic polytrauma, it is important to emphasize once again that patients who

sustain MLKIs comprise a very heterogeneous group of individuals.

5

2.3 Clinical Presentation In the acute setting, patients with multi-ligament knee injuries are evaluated using the Advanced

Trauma Life Support (ATLS) protocol. Once cleared of any possible associated life-threatening

injuries, the next priority is to ensure the viability of the affected limb. The knee (and

extremity) is examined to look for open wounds and for any obvious deformity or dislocations.

Ultimately, knee reduction is achieved if necessary and confirmed clinically and radiologically.

Furthermore, it is imperative to examine the neurological and vascular status of the lower

extremity. In the absence of a vascular or open injury, patients with MLKIs are generally

managed in a brace. The immediate goals are to decrease swelling, increase quadriceps and

hamstrings strength, and optimize range of motion. However, there is ongoing controversy

regarding operative versus nonoperative management, the timing of surgical intervention, and

when indicated, the type of surgical intervention [4, 13]. Similar to patients with cartilage

pathology of the knee, it is felt by experts that in the acute and subacute period, patients are

generally focused on physical impairments including pain, swelling, decreased motion. As the

latter symptoms improve, instability and decreased ability to participate at pre-injury levels in

various endeavours may become a concern [14, 15].

The effects of MLKI on the lives of affected individuals have been well documented in the

literature, with an emphasis placed on symptoms, as well changes in function and activity. For

example, in an evidence-based review on the operative and nonoperative management of multi-

ligament knee injuries [1], Peskun and Whelan pooled data from 31 retrospective studies and

included 865 knees in 855 patients. At a mean follow-up of approximately five years, the mean

age of patients with multi-ligament knee injuries was 30 years and greater than 80% of patients

were male. Long term sequelae of both the operative and nonoperative cohorts included

residual pain, stiffness, weakness, instability, and a modest rate at which patients were able to

6

return to sports or their former occupation. The morbidity associated with posttraumatic

peroneal nerve palsy was substantial wherein function, neuropathic pain, and overall quality of

life were negatively affected. The ability to have a stable, well-functioning, and pain-free knee

was strongly influenced by the neurologic function of the foot and ankle, as well as, the

presence of other ipsilateral limb injury [14]. In a separate retrospective cohort study, Peskun et

al. demonstrated that peroneal nerve injury recovers in approximately one third of affected

patients [16]. Similarly, residual impairments that can result from vascular injuries include

weakness, cold intolerance and diminished lower extremity strength and function, especially in

the context of fasciotomies and revascularization procedures [11]. Finally, in the setting of

systemic visceral polytrauma and trauma to the appendicular/axial skeleton, the recovery of

multiple body parts and organs can delay and/or affect the recovery, treatment planning, and

prognosis for the knee.

Based on the demographics of the multi-ligament knee injured population, these injuries clearly

affect individuals in their young productive working years – the downstream implications

include physical and emotional symptoms, as well as, alterations in activities and occupational

endeavours [4, 13]. As such, the development of an outcome instrument should consider not

only the acute and subacute periods following MLKI, but should also include the

aforementioned downstream changes experienced by patients.

2.4 Conceptual Framework The domains which are selected in an outcome instrument should arise from a theoretical

framework that represents constructs or areas of relevance to the patients affected by the health

condition. Based on clinical experience and the literature [4, 13], it was thought that MLKIs

would have a significant impact on the lives of individuals from a physical, emotional,

functional and social perspective. As such, two distinct but related frameworks were selected for

7

the purposes of this thesis because they provide a basis for the constructs for inclusion in a QOL

measure for MLKI [2, 3, 17, 18]. As illustrated in Figure I, the concepts of quality of life, as

well as, functioning and disability were integrated in order to create four domains – physical

impairments, emotional impairments, activity limitations, and societal involvement. The

discussion below describes in detail theoretical frameworks and the rationale for how individual

domains were derived.

Figure I Selected domains resulting from an integration of two concepts: (i) quality of life

and (ii) functioning and disability.

ICF: International Classification of Functioning, Disability and Health

First, the World Health Organization’s, International Classification of Functioning, Disability

and Health (ICF), comprises a biopsychosocial model in which functioning and disability is

conceived as a dynamic interaction between health conditions and environmental and personal

factors [19]. Based on the ICF, abnormalities in anatomic structures can lead to associated

impairments as well as activity limitations and participation restrictions[18]. Since multi-

ligament knee injuries are associated with pathology involving numerous anatomic structures

8

(e.g. bones, cartilage, ligaments, nerves, etc.) one would expect many downstream

consequences. According to this model, the term impairment refers to “problems in body

function or structure such as a significant deviation or loss.” Activity limitation refers to

“difficulty in the execution of a task or action by an individual” while participation restrictions

refer to “problems an individual may experience in involvement in life situations [18].” Badley

has refined the ICF classification into four distinct components that emphasize the distinction

between activities and participation. These components are : 1) body structures and function; 2)

acts; 3) tasks; and 4) societal involvement [19]. Impairments such as the knee giving way, the

presence of pain or mechanical symptoms, and emotional symptoms are examples of the

component, ‘body structures and function’. ‘Acts’ refers to the general things a person can do

independent of context or purpose (e.g. Running, walking, pivoting). In contrast, ‘tasks’ refers

to the purposeful things that people do in daily life. Tasks comprise a collection or combination

of various acts and are illustrated by activities of daily living and instrumental activities of daily

living. They also include specific tasks that are carried out as part of particular work, leisure,

sports or social activities. Finally, societal involvement concerns the individual as a player in

culturally or socially recognized areas of human endeavour. This component is not concerned

with the performance of particular or specific tasks but rather with social roles in general such as

employment, parenting, leisure, and social and civic life. For example, the emphasis would be

on employment as a role rather than the nature of a particular job (i.e. being able to work as a

carpenter) [19] .

In regards to the second definition, the term ‘quality of life’ QOL was defined as “patients’

perceptions of performance in four areas: physical and occupational function, psychological

state, social interaction, and somatic sensation” [2, 3]. Quality of life has also been defined as

“a concept encompassing a broad range of physical and psychological characteristics and

9

limitations which describe an individual’s ability to function and derive satisfaction from doing

so [20].

Under the auspices of the aforementioned theoretical frameworks/definitions, any attempt at

measuring disorder-specific quality of life must take into account physical, emotional and social

factors. Furthermore, measuring health-related quality of life is directly related to patient

perception and input rather than surgeon/clinician–based measures. Therefore, the initial

domains selected in the development of the questionnaire in this study were: 1) physical

impairments; 2) emotional impairments; 3) activity limitations (acts and tasks); and, 4) societal

involvement.

2.5 Measurement Properties in the Context of Patient-reported Outcome Measures (PROMs)

The quality and appropriateness of an outcome instrument is intrinsically related to its

measurement properties – these include sensibility, reliability, validity and responsiveness.

First, sensibility refers to an aggregate of properties that make up the “common sense” part of

the instrument, including comprehensibility (e.g. inclusion of all relevant items and omission of

unimportant items) and face and content validity[21]. Content validity refers to whether the

items in a questionnaire address all aspects of function and well-being pertinent to a given

patient population. The content validity of an instrument can also be assessed by obtaining

input from patients and clinician experts, by a qualitative assessment of instrument domains and

items, as well as, by determining floor effects and ceiling effects when administered to a larger

group of patients. Face validity is present when an expert clinician reviews the questions in a

scale and believes that they appear to measure the concept in question [22]. The concept of

reliability refers to the repeatability, or precision of an instrument. It is demonstrated when

repeated administrations of an instrument to stable patients produce consistent results. An

10

instrument’s reliability related to its repeatability can be assessed by calculating test-retest

reliability which, in the case of continuous data, uses an intraclass correlation coefficient (ICC),

representing the ratio of the between-subject variation to the total variation [23]. Acceptable

reliability for a health-related quality of life instrument for use in controlled clinical trials is

generally agreed to be present when the ICC is greater than 0.80 [24, 25]. Acceptable reliability

for tests used to make a decision about an individual is an ICC of 0.90 or greater [25].

Furthermore, internal consistency, an indication of how individual items correlate with one

another and with the overall score, can also be used to assess the internal consistency reliability

of an instrument or its domains. Finally, “a measurement tool is valid if it is measuring what it

is supposed to measure” [26]. Validation is clear when there is a gold standard to which the

results can be compared (i.e. criterion validity) [21]. Since there is no gold standard for

measuring ‘quality of life’, this requires one to demonstrate that a measurement tool “behaves”

in relation to other measures as one would expect if it were measuring quality of life (i.e.

concurrent construct validity) [21]. To evaluate the validity of an instrument as a discriminative

tool, one examines the relationship between scores on the new instrument in relation to pertinent

clinical variables at a single point in time (e.g. hypotheses related to different categories of

disease severity would be an example of known-groups construct validity).

2.6 A Critique of Existing Measures in Patients with MLKIs In 1955, O’Donoghue became the first individual to create a subjective, patient-based functional

outcome measure in the assessment of patients with knee problems [27]. Since that time,

several joint-specific and disease-specific outcome measures that pertain to the knee joint have

been published [22, 28, 29]. Tanner et al. described eleven commonly used measurement tools

for patients with knee symptoms and divided them as five non-disease-specific and six disease-

specific scales [28]. The five general knee instruments include: 1) the American Academy of

11

Orthopaedic Surgeons (AAOS) Sports Knee Rating Scale[30]; 2)The Knee Injury and

Osteoarthritis Outcome Score (KOOS) [31]; 3) the 2000 International Knee Documentation

Committee (IKDC) Standard Evaluation Form [32]; 4) the Activities of Daily Living (ADL) of

the Knee Outcome Survey [33]; and, 5) the Knee Disorders Subjective Form of Visual Analog

Scale (VAS, Hughston Sports Medicine Foundation) [34]. Ligament-specific knee instruments

include: 1) the Cincinnati Knee Ligament Rating Scale [35, 36]; 2) the Revised Hospital for

Special Surgery (HSS) Knee Ligament Rating Form [37]; 3) the Modified Lysholm Knee

Scoring Scale [38]; and 4) the Mohtadi Quality of Life (QOL) Assessment in Anterior Cruciate

Ligament Deficiency [2]. One of the instruments specific for osteoarthritis of the knee is the

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [39]. The

instrument specifically designed for meniscal tears is the Western Ontario Meniscal Evaluation

Tool (WOMET) [21].

Prior to initiating the development of a novel disease-specific outcome instrument for patients

with MLKIs, an a priori analysis of existing items was conducted with respect to face validity

and content validity. Tanner et al. had previously combined the 11 aforementioned knee-joint

specific instruments into a consolidated questionnaire that contained 132 items [28]. Two

investigators involved with the current thesis (JC, AD) placed each of the 132 items in this

consolidated questionnaire into one of the four chosen domains previously identified in the

context of the WHO and QOL frameworks. A qualitative analysis of the items in each domain

demonstrated several interesting findings. First, in the physical impairments domains, there was

a lack of items pertaining to neurological, vascular, and systemic impairments that are

experienced by patients with MLKIs. In the activity limitations domain, there is an emphasis on

sports participation with no or few items related to participation in social roles and, finally, the

existing items did not reflect the profound social and emotional impact MLKI’s can have on the

12

lives of individuals who are supposed to by young, active, and vocationally productive. This

pilot work was used to validate our perception that existing measures do not contain the entire

spectrum of content that is pertinent to patients with MLKIs. Based on such limitations in face

and content validity, the development of an outcome instrument that is pertinent to patients with

multiligament knee injuries was warranted. Table I describes the general characteristics of the

eleven most commonly used knee-joint specific instruments with a focus on the nature of items

and domains contained within these instruments, as well as, a brief analysis of the content of the

existing items as they may pertain to patients with MLKIs.

In addition to the identified missing content of existing outcome measures, none have been

shown to be reliable, valid or responsive in the multiligament knee population. Nevertheless,

they continue to be used in clinical studies measuring outcome. The most commonly utilized

instruments in this population are the Lysholm Knee Scoring Scale and the IKDC. In regards to

the Lysholm Scale, it was originally developed to evaluate patients with ACL injury [40].

However its use has been expanded to several conditions including ACL injury, meniscus tears,

chondral lesions and osteoarthritis [41-43] . The most significant weakness of the Lysholm is

that the overall score is represented entirely by physical symptoms and limitations in simple

activity, without any reference to recreational, work or social limitations. In fact, one half of the

total score is attributable to knee stability and pain. Kocher [44] and Briggs [42] have

demonstrated unacceptable floor and ceiling effects for several of the domains in this measure

and have also shown poor test-retest reliability in regard to the pain, stair climbing and locking

items. Other studies have shown that the Lysholm is an appropriate tool in patients presenting

to a sports clinic with a variety of diagnoses [38, 42-45] with reported ICC values greater than

0.90 for test-retest reliability and moderate to good construct validity. Irrgang [33], however,

13

showed that the Lysholm had low internal consistency (alpha 0,60-0.73) when applied to a

heterogeneous group of patients.

The IKDC was developed in 2001 for patients with a variety of knee disorders including knee

ligament, meniscus, patellofemoral and cartilage disorders. It is important to note that this is a

knee-joint-specific and not a disease-specific scale. There are 18 questions (10 main questions

related to symptoms, plus 8 sub-questions regarding activity limitations due to knee disorders).

Evidence for its validation has been based on comparison to the Short Form-36 in 533 patients

with a variety of knee problems [32]. The IKDC has also been recently validated in patients

sustaining acute patellar dislocations [46] and meniscal injuries [47]. These latter studies have

demonstrated acceptable floor and ceiling effects, test-retest reliability (ICC >0.90) and

adequate construct validity. In regards to using the IKDC domains, the ‘sporting activities’

described are actually limitations in acts and there is a paucity of items related to emotional

impairments, task limitations and societal role limitations. Further study regarding the

measurement properties of the IKDC remains to be conducted in a variety of diagnoses,

including multi-ligament knee injury.

Reviews of relevant outcome studies (in patients with multi-ligament injured knees) that have

utilized both the IKDC and the Lysholm have revealed that there is often a discrepancy in

functional outcome scores between these two measures. For example, in a retrospective series

by Mariani et al. [48], individuals who underwent a repair or reconstruction of their ligamentous

structures had an average Lysholm score of 85 which has been defined as ‘good’. However,

using the IKDC subjective score, only 25% of patients were able to achieve good or excellent

results. Furthermore, there were no individuals in the ligamentous repair group who were able

to return to their pre-injury level of sport. Similarly, others studies have demonstrated that

despite achieving Lysholm scores averaging above 85, a large proportion of individuals are still

14

classified as ‘abnormal’ or ‘severely abnormal’ according to the IKDC [49]. These examples

illustrate how currently available instruments may measure different facets of a patients post-

injury impairment and function. Furthermore, in isolation, the IKDC and Lysholm fail to

comprehensively evaluate the impact of a multi-ligament knee injury on lives of patients with

MLKIs.

2.7 Rationale for the Thesis Based on a recent systematic review, the management of multi-ligament knee injuries remains

controversial [4, 13]. The pattern of ligamentous injury, associated pathologies and variable

mechanisms of injury often make comparisons difficult or preclude comparison completely.

There is still debate about the timing of surgery, the technique of surgical reconstruction and the

selection of the most appropriate graft materials for traumatized tissues [10]. It appears that

outcomes following both operative and non-operative treatment are heterogeneous and in part,

may be due to inadequacy of currently available measurement tools to detect all relevant clinical

phenomena. For example, even though it was shown that repair is inferior to reconstruction in

regards to return to pre-injury activity levels, there was no significant difference in mean

Lysholm scores between the two groups [4]. In reference to the posterolateral corner of the

knee, patients who had a reconstruction had a higher rate of return to pre-injury levels of

sporting activity as well as lower surgical failure rate - yet once again there were no differences

in functional outcomes [4]. Hence, there is an obvious need for a measure for use in patients

with MLKIs that can capture the spectrum of clinical content, impairments, and restrictions that

affects daily functioning and quality of life in this patient population.

Tanner et al. demonstrated that disorder-specific knee instruments are best able to detect the

symptoms, functional and social limitations that are important to patients [28]. As noted above,

no disease-specific instrument exists and existing measures lack relevant content. Both in the

15

context of these findings and due to the fact that knee dislocations affect a variety of intra-

articular and extra-articular structures in close proximity, I have identified a need for the

creation of a reliable, valid, and responsive disease-specific quality of life instrument that can be

applied to patients with multi-ligament knee injuries. This thesis addresses this gap.

Table I Characteristics of 11 commonly used knee outcome instruments.

Instrument Development and General

Characteristics Domains Administration

and Scoring

Item Analysis With Respect to

Domains

Knee-Joint Specific Measures

AAOS Sports Knee Scale

Johanson et al: patients used for sports/knee scale had ligament injuries, meniscal tears, patellofemoral disorders

Marx et al JBJS 2001: wide variety of patients with many diagnoses to test generalizability

23 questions with 5 sections: core section (7Q on stiffness, swelling, pain and function); four sections (4Q each) on locking or catching on activity, giving way on activity, current activity limitation due to the knee, pain on activity due to the knee

PROM

Scoring 0-100

All items are based on physical impairments only

Knee Injury and Osteoarthritis Outcome Scale (KOOS) Developed in 2003 by Roos

Five subscales(questions): pain (9), symptoms (7), ADLs (17), sports and recreation function (5), knee-related QOL (4)

PROM

Scoring: scores normalized to 100 for each subscale; each subscale scored separately. Minimum subscale score 0, max 100. the higher the score, the higher the function

Heavily weighted towards physical impairments and activity limitations

Activities of Daily Living of the Knee Outcome Survey (ADL/KOS)

Developed 1998 by Irrgang for a variety of knee specific disorders

17 questions, 2 sections (symptoms 7, functional disability 10)

PROM

0-100

Heavily weighted towards physical impairments and activity limitations

Knee Disorders Subjective Form of VAS (Hughston Sports Medicine Foundation) Published in 1991 28 questions

PROM

0-100

All items related to physical impairments and

16

Instrument Development and General

Characteristics Domains Administration

and Scoring

Item Analysis With Respect to

Domains activity limitations

International Knee Documentation Committee (IKDC) Subjective Knee Form

Published in 1993, revised in 1994 and 1997

18 questions (relating to physical symptoms, sports activities and ability to function including stairs, squatting, running, and jumping)

PROM

0-100

No items relating to emotional impairments or societal involvement

Knee-Ligament Specific Measures

Cincinatti Knee Ligament Rating Scale Published by Noyes, 1983

Six subscales (points): symptoms (20), daily and sports functional activities (15), physical examination (25), knee stability testing (2), radiographic findings (10), functional testing (10)

CBO, PROM

Scoring: 0-100 (worst to best)

Emphasis towards physical impairments and activity limitations. Physical exam findings also part of total score

Revised HSS Knee Ligament Rating Form

HSS rating system was published in 1988

CBO, PROM

No items relating to emotional impairment or societal involvement

Modified Lysholm Knee rating Scale

Published 1982, modified 1985. Developed for followup evaluation of knee ligament surgery

Knee stability (25), pain (25), locking (15), swelling (10), stair climbing (10), limp (5), use of a support (5), squatting (5)

PROM

Scoring: 0-100 Excellent (95-100) Good (84-94) Fair (65-83) Poor (<65)

Entirely based on physical impairments, minimal activity limitations

Mohtadi QOL Assessment in ACL deficient Knees

Published in 1998; validated for patients with chronic ACL deficiency

32 items with five subscales with each subscale weighted equally; Symptoms and Physical Complaints (4); Work Related Concerns (4); Recreational activities and sports participation or competition (12); Lifestyle (6); social and emotional (5); the overall score of 100 weighs each item equally; subscores within the 5 domains have not been separately validated

PROM

0-100 Visual Analogue ScaleVAS

Good balance between physical impairments, emotional impairments, and activities. Emphasis on sports participation rather than social roles. Lack of content pertaining to neurological and vascular

17

Instrument Development and General

Characteristics Domains Administration

and Scoring

Item Analysis With Respect to

Domains impairments, as well as systemic polytrauma.

Knee Arthritis Specific Measures

WOMAC

Three subscales (questions): pain (5), stiffness (2), physical function (17)

PROM

Scoring Minimum 0 Max 96 for global score; subscales normalized to 1-100. The higher the score the lower the function but frequently switched around

Weighted towards physical impairments and activity limitations.

Knee Meniscus Specific Measures

WOMET Developed in 2007 by Kirkley and Whelan

16 items each weighted equally. Physical symptoms (9); sports . Recreation . Work . Lifestyle (4); emotions (3)

PROM

1-100 Visual Analogue Scale

Narrow scope of physical impairments. Minimal number of items pertaining to emotional impairments and societal involvement.

PROM: patient-reported outcome measure CBO: clinician-based outcome

2.8 Objectives

The overall objective of this thesis was to develop a disease-specific quality-of-life instrument

(MLQOL) for patients with multi-ligament knee injuries, which according to the framework

provided by Kirschner et al., is intended to be descriptive and evaluative in nature [50]; that is,

to describe QOL at a single point in time and to evaluate change over time or in response to an

18

intervention. The specific objectives were to: (1) generate items for the questionnaire using

currently available instruments, as well as patient and expert focus groups; (2) reduce the

number of items; (3) evaluate test-retest reliability of domain scores; and, (4) to evaluate

construct validity of the preliminary questionnaire. In regards to the evaluation of the construct

validity, the following hypotheses were tested: (i) patients with a greater change (preinjury-

current) in Tegner activity level would have lower MLQOL scores across all domains (moderate

correlation); (ii) patient with a lower global knee rating score would have lower scores across all

MLQOL domains (moderate correlation); (iii) patients with greater self-reported difficulty with

sports and recreational activities would have lower scores on the activity limitations subscale

(moderate); (iv) patients with a nerve injury would have lower scores on all MLQOL domains

than those without a nerve injury; (v) the MLQOL physical impairments domain would be

moderately correlated with the physical component score of the SF-36; (vi) the ML-QOL

emotional impairments domain would be moderately correlated with the mental component

score of the SF-36; (vii) the activity limitations subscale in the ML-QOL questionnaire would be

moderately correlated with the physical function domain of the SF-36; and, (viii) the societal

involvement domain in the MLQOL questionnaire would be moderately correlated with the

social function domain of the SF-36.

19

Chapter 3 Methods

3 Methods

3.1 Design

This was a multi-centre study that used mailed surveys, focus groups, and expert interviews to

generate the MLQOL. The work was conducted in 3 phases and the overarching flow of

questionnaire development is presented in Figure II.

Figure II Overarching Flow of Questionnaire Development

20

3.2 Participants

The relevant stakeholders in this study included patients with multi-ligament knee injuries and

expert clinicians (surgeons and physiotherapists) who were routinely involved in the diagnosis

and management of patients with MLKIs. Patients were involved in phases I, II and III of the

current study while experts were involved in phase II only.

3.2.1 Patients

3.2.1.1 Inclusion Criteria

1. Patients from 18-60 years of age with a multi-ligament knee injury as determined by a

clinical and/or radiological examination.

2. Individuals who were at least 6 months from the time of injury whether treated

operatively or nonoperatively.

3. Informed consent

4. Fluent in written and conversational English.

3.2.1.2 Exclusion Criteria

1. Patients with radiographic evidence of osteoarthritis (grade 3 or 4 osteoarthritis

according to the Kellegren and Lawrence system [51]) or inflammatory arthritis at the

time of injury or first-time clinical evaluation.

2. Patients who sustained intracerebral/spinal cord injury at the time of initial presentation.

21

3.2.2 Experts

Members of the North American Knee Dislocation Study Group and local physical therapists in

Toronto were recruited to participate in individual interviews in order to contribute to the item

generation and item reduction phases of this study. The North American Knee Dislocation

Study group was established in 2007 and is comprised of a multinational consortium of

orthopaedic surgeons and researchers whose primary aim is to improve our understanding of the

natural history, treatment and outcomes for patients with MLKIs. The local physical therapists

who were approached in this study worked in close concert with one of the members of the

Knee Dislocation Study Group (DW) and were involved in the assessment and treatment of a

high volume of acute and chronic multi-ligament knee injured patients over the last 5 years.

3.3 Procedures

The MLQOL questionnaire was developed and tested in three phases. Phase I and II involved

an iterative process of item generation and item reduction, as well as, establishment of response

options and MLQOL scoring. Phase III involved a final phase of item reduction within

subscales, followed by testing of reliability and validity.

22

Figure III An overview of the three phases of development and testing for the MLQOL

All eligible patients were identified from pre-existing clinical charts from St. Michael’s Hospital

(Phase I, II, III) and the Pan Am Clinic (Phase III). Information pertaining to patient

demographics, mechanism of injury, and clinical and radiological findings was collected on a

standard data collection form. Specifically, pertinent information included age, sex, date of

injury, mechanism of injury, associated injuries, time from injury to treatment(s), time from

injury to survey completion, Schenck classification, presence of neurological and vascular

injury, operative and nonoperative treatments undertaken, activity level, clinical examination

and radiographic and arthroscopic findings. Further detail regarding the data abstraction form

can be found in Appendix A.

23

3.3.1 Combined Questionnaire with Existing Items (Phase I)

The purpose of phase I was to use items in existing knee-joint specific questionnaires and then

perform a process of item reduction using frequency and importance criteria.

Eligible patients were mailed an information letter outlining study details (Appendix B) as well

as a preliminary consolidated questionnaire (132 items from existing instruments arranged into a

priori domains) attached in Appendix C. Eleven knee-specific instruments have previously

been combined by Tanner et al. [28] with the end result being a questionnaire consisting of 132

items that was developed by combining 222 patient-directed questions. This consolidated

questionnaire was modified by Tanner et al. [28]to remove disease-specific wording, separate

double-barrelled questions into distinct entities, phrase questions in the present tense and score

each item using a six-point Likert scale for data analysis. This questionnaire was also pretested

by Tanner et al. on orthopaedic patients to ensure clarity (eighth grade reading level) and ease of

completion. The items on this consolidated questionnaire were re-arranged in a manner to

reflect the chosen domains in this study (physical impairments, emotional impairments, activity

limitations, societal involvement; see section 2.6 for details). In the current thesis, the Tegner

Activity Scale [38] was also administered as separate questionnaires during phase I in order to

assess activity level.

After the consolidated questionnaire was mailed to eligible patients, a reminder phone call was

made two weeks later to ensure survey receipt, clarity of mailing instructions and to increase

compliance [52].

3.3.1.1 Analysis

In the mailed survey, patients were asked to rate the importance of each item and the frequency

with which that item was experienced using a five-point Likert scale. Items with a mean

24

importance rating (MIR) of > 3.5 and frequency (F) < 30% for the response “never

experienced” were included in the subsequent draft version of the ML-QOL questionnaire.

Items which met only one of the two aforementioned criteria were termed as “grey zone items”

and were carried forward for focus group discussions in a subsequent study phase. Items which

did not meet either criterion were discarded. In the latter two circumstances, clinical judgment

was permitted to ensure that pertinent clinical content was not discarded at too early a stage of

questionnaire development.

3.3.2 Stakeholder Input (Phase II)

In phase II, patient focus groups and expert clinician interviews were conducted. The purpose of

phase II was to perform an iterative process of item generation and reduction by generating de

novo items, discussing grey zone items from phase I, and performing content analysis. In this

phase, scoring options, response options, and the appropriateness of selected domains with

patients and clinician experts were also discussed.

A detailed description of the semi-structured focus groups and interviews which were conducted

with patients and experts is included in Appendix D. Focus group sessions and individual

interviews were conducted using the methodology described by Morgan and Kreuger [53-58].

Open-ended questions were initially asked to investigate the perceptions related to the grey zone

items. Paricipants were also asked which items on the mailed survey were not pertinent to them

and whether any items were confusing or unclear. Furthermore, participants were asked if there

were any impairments, activities or societal role limitations that were not addressed, especially

in relation to possible neurological and/or vascular injury.

25

3.3.2.1 Focus Groups

Patients who completed the ‘consolidated questionnaire’ in phase I were also asked (as part of

the questionnaire) if they would be agreeable to participating in focus groups sessions. Of the

patients who were willing to participate, targeted sampling was performed in order to ensure an

equitable distribution of patients across age groups, sex, mechanism of injury, injury severity

(Schenck Classification), and the presence of individuals with neurovascular involvement and

polytrauma. Written informed consent was obtained from participants prior to the start of each

focus group (Appendix E).

Focus groups were limited to 4-6 subjects in order to allow participants an opportunity to share

their ideas while allowing a diversity of opinions. Focus group discussions were led by a

moderater (JC), were conducted in a closed, well-lit and private conference room during the

evening hours, lasted approximately 60-90 minutes, and were digitally recorded and transcribed

verbatum. An easel was used as a visual aid to describe the theoretical framework and to list

grey zone items, domains, as well as, scoring and response options to stimulate discussion. A

scribe (AD) was present during focus group sessions in order to document newly generated

items that were subsequently rated at the end of each session. Any reference to identifiable

information (e.g. participant’s name, locations) was not transcribed.

Focus groups were conducted until no new themes were raised and hence, saturation was

achieved. At the end of each focus group session, individuals were asked to rate the importance

(5-point Likert Scale) of each grey zone item and any new items generated during that session or

previous sessions.

26

3.3.2.2 Individual Interviews

Individual expert interviews were conducted as opposed to focus groups due to the logistical

issues of timing and lack of geographic proximity among participants. Rather than arranging an

online forum or teleconference, all interviews were conducted by a single investigator (JC) in

person except for one (which was done over the phone). Expert interviews were conducted until

saturation (or no new information) was achieved. Interviews lasted approximately 60 minutes

and were digitally recorded and transcribed verbatum. Any reference to identifiable information

(e.g. participant’s name, locations) was not transcribed. The informed consent process for the

expert interviews is described in Appendix F.

3.3.2.3 Analysis of Focus Groups and Interviews

For the focus group sessions, de novo and grey zone items with a mean importance rating ≥ 3.5

were included in the next draft of the ML-QOL.

Focus group transcripts and interviews were recorded and transcribed verbatim. Text was

analyzed using content analysis using a modified approach to that of Braun and Clarke [59] to

identify new items as well as to gain clarity about including items that had been defined as ‘grey

zone’ based on survey responses, response options and scoring. Two coders (JC and AD)

independently coded all transcripts and then met to reach agreement on new items identified

and then codes and themes related to grey zone items, response options and scoring. Items that

were duplicated, incomprehensible or ambiguous were eliminated. New items were also

screened for value-laden wording, ambiguity, positive and negative wording and length [60].

All remaining items were restructured to an eighth grade reading level. Decisions related to

addition and deletion of items, response options and scoring were taken forward to the

committee for discussion and final consensus decisions. At this point the ‘preliminary ML-

27

QOL’ (version 2.0) was generated based on the item generation and reduction processes utilized

in Phase I and II of the current thesis (Figure III).

3.3.2.4 Response Options

When an instrument is to be used as a discriminative tool (i.e. able to differentiate between

individuals with different levels of a condition) and as an evaluative tool (to assess change over

time or with treatment), the response gradations for each individual item must have a scale of

relatively fine gradation [26, 60, 61]. A 5-category Likert scale as opposed to a visual analogue

scale was selected a priori as it has been shown to more reproducible than a visual analogue

scale [62]. Post-hoc content analysis was used to determine the appropriateness of this response

option, as well as, the most appropriate wording for response to items in the MLQOL. In

regards to the latter, patient’s preferences for various types of response options were explored.

Questions and the response choices available were posed in terms frequency (“how often do you

experience…”), bother (“how much are you bothered by….”), difficulty (“what degree of

difficulty do you have with ….”) and extent (“to what extent are you limited by ….”). Experts

were also asked to select and provide rationale for various response options for the items in the

developed questionnaire.

3.3.3 Mailed Survey – version 2.0 MLQOL (Phase III)

The overall objective of the second mailed survey (Phase III) was to perform a final process of

item reduction in order to generate the final MLQOL. Using the items in this version of the

questionnaire, reliability and validity testing was also performed.

3.3.3.1 Pre-testing of v2.0 MLQOL

Prior to mailing of the preliminary MLQOL (version 2.0), a group of patients were asked to

undergo a process of cognitive debriefing and to give their interpretation of each item in the

28

instrument. This was done in order to ensure clarity and comprehensibility of the items in the

questionnaire. The cognitive debriefing process was continued until no novel

comments/suggested revisions were generated from patients in three consecutive interviews.

Any items that subjects partially or fully misinterpreted were revised. The cognitive debriefing

questionnaire used is described in Appendix G.

3.3.3.2 Final Item Reduction

In phase III, the ‘preliminary MLQOL’ (version 2.0) was mailed to eligible patients (see section

4.2.1) from two tertiary centres in Canada (Appendix H). Along with this questionnaire, an

information letter was also mailed to patients that asked if the participants would be willing to

complete a second questionnaire1-2 weeks later to allow assessment of test-retest reliability

(Appendix I). In addition to the ML-QOL questionnaire, standardized measures to be completed

by all patients included the Tegner Activity Scale and Short Form-36. An eligibility

questionnaire was developed to facilitate patient enrolment and questionnaire tracking at the Pan

Am Clinic (Appendix J).

3.3.3.2.1 Analysis

Using the ‘preliminary ML-QOL’(version 2.0, Figure III), inter-item correlations were

calculated. Items with correlations (within a priori subscales) between 0.3 and 0.7 were

included in the final version of the ML-QOL questionnaire. Item to total correlations, as well

as, Cronbach’s alpha (desired minimal level of 0.80) were calculated to determine the internal

consistency of each subscale in the final version of the MLQOL. Similarly, the items in the

final MLQOL were used to determine the test-retest reliability and construct validity of the

MLQOL domains (Figure III).

29

3.3.3.3 Reliability and Validity Testing

Test-retest reliability was assessed by mailing version 2.0 of the ML-QOL for a second time, 1-

2 weeks later, to consenting and clinically stable patients. A question with a binomial response

option (yes/no) was utilized to determine whether there had been any perceivable change in the

overall status of the knee between the two administrations of the questionnaire during reliability

testing. The specific question asked was: “Has there been a change in the overall condition of

your knee (in regards to symptoms, activities, and social involvement) over the last two weeks?”

Construct validity was assessed by comparing ML-QOL scores on a single administration to the

Short Form-36 and by testing several a priori hypothesized relationships (see Chapter 2.8).

3.3.3.3.1 Analysis

Content validity was assessed by determining floor effects and ceiling effects. Floor and ceiling

effects less than 30% have been considered to be acceptable [42, 43]. An intraclass correlation

coefficient (ICC) (version 2,1 as this is generalizable beyond the tested sample) was calculated

to determine test-retest reliability [23]. In this study, the minimum acceptable level for the ICC

was deemed, a priori, to be 0.80 [24, 25].

Construct validation was tested using a multi-trait multi-method matrix approach [63, 64] and

by testing several a priori hypothesized relationships (see Chapter 3) in which moderate or

strong correlations (i.e. ρ >0.3) were expected [65]. The multi-trait multi-method approach

compares similar traits (ex. physical function, social integration) using two different outcome

measures or methods (ex. ML-QOL versus SF-36); it was hypothesized that average convergent

correlations would be greater than average divergent correlations across MLQOL domains and

SF-36 subscales (Table II).

30

Table II Expected convergent (√) and divergent (blank) relationships between MLQOL

domains and SF-36 subscales.

Bodily

Pain

Role

Physical

Physical

Function

Social

Function

Role

Emotional

General

Health

Mental

Health Vitality

PI √ √ √

EI

√

√ √

AL

√

SI

√

3.4 Sample Size Estimate

In phase I, all eligible patients at the primary institution (St. Michael’s Hospital) for this study

were enrolled –a minimum of 50 patients was anticipated prior to the initiation of the study.

Furthermore, it was estimated that 20-30 patients would be required for phase II of this study

(minimum 3 focus groups with 4-6 participants each until saturation was achieved). A formal

sample size calculation was conducted a priori for phase III of this study. For test-retest

reliability, 47 patients were required [using a one-sided 95% confidence interval, this would

allow for an intra-class correlation coefficient of 0.9 with a lower bound of 0.8] [66]. Construct

validation required 60 patients (across all sites) in order to detect correlations from 0.45 to 0.75

(point estimate 0.7, width of estimate 0.3, alpha 0.05) [67].

31

3.5 Ethical Considerations

Details regarding the informed consent process are included in Appendices B, E, F, and I. Ethics

approval for the study was obtained from all participating centres and universities. A copy of the

ethics approval at the primary institution is included in Appendix K.

3.6 Data Management Each completed questionnaire was manually inspected to ensure proper page ordering,

completion of dates, and that all questions were appropriately completed to avoid missing data.

The de-identified data were entered into a Microsoft® Excel database. The data were then

imported into SAS version 9.2 for statistical analyses.

32

Chapter 4 Results

4 Results

To set the stage for the detailed presentation of the results of the item generation and item

reduction steps, Figure IV provides an overview of the processes and outcome. The results of

reliability and validity testing then follow.

Figure IV Flow Diagram Outlining Item Generation and Item Reduction

33

4.1 Item Generation and Item Reduction

4.1.1 Combined Questionnaire with Existing Items (Phase I)

Ninety-three (n=93) consecutive patients were identified from the multi-ligament knee injury

database at St. Michael’s Hospital (Toronto, ON) . Of these patients, six did not meet the

inclusion criteria; two patients were older than 60 years old, two patients had pre-existing

arthritis and were to be treated with staged total knee arthroplasty, and 2 patients had an

associated closed head injury with incomplete recovery. Of the remaining 87 patients, one

patient was deceased and the other had moved to a different continent. A chart review for

pertinent demographic and injury-related information was performed for the remaining 85

eligible patients. Sixty of the 85 patients (70.6%) returned the preliminary ML-QOL

consolidated instrument.

Of the 60 respondents, the average age for the survey responders was 34.7 years and most were

male (n=45). Mean time from injury to survey completion was 845 (170-2360) days. Using the

Schenck classification, 19 patients were KD I, 2 were KD II, 39 were KD IIIM or IIIIL, and 9

were KD IV. Nineteen patients had a peroneal nerve injury and 5 had a vascular injury.

Twenty-five patients had sports-related injuries and another eighteen had associated fractures.

In regards to treatment status, 44 patients were treated surgically, 6 non-operatively and 10 were

pre-operative. The average Tegner activity level for all responders was 3.93 out of 10. Detailed

demographic information as well as injury details is listed in Table III. There were no

statistically significant or clinically meaningful differences in the demographic and injury-

related variables among responders and non-responders.

34

Table III Demographic and injury-related information for individuals enrolled in phase I of

MLQOL development.

Factor Overall

(n=85)

Responders (R)

(n=60)

Non-responders (NR)

(n=25)

p-value

(R vs. NR)

Age: n=85 mean (SD) [Max-Min]

33.6 (10.4)

[17 – 57]

34.7 (10.9)

[17 – 57]

30.8 (8.8)

[18.0 – 46.0]

0.113

Sex : n (%) 0.181

Male 67 (78.8) 45 (75.0) 22 (88.0)

Female 18 (21.2) 15 (25.0) 3 (12.0)

Time from injury to survey completion in days: n=57 mean (SD) [Max-Min]

844.8 (571.7)

[170.0 – 2360.0]

- -

Time from injury to reconstruction in days: n=58 mean (SD) [Max-Min]

158.7 (253.6) [3.0 – 1600.0]

134.6 (180.3)

[3.0 – 639.0]

216.7 (377.9)

[6.0 – 1600.0]

0.402

Total # Surgeries: n=83 mean (SD) [Max-Min]

1.70 (1.03)

[0 – 5]

1.81 (1.00)

[0.0 – 5.0]

1.44 (1.08)

[0.0 – 5.0]

0.135

Side of Injury: n (%) 0.267

Left 48 (56.5) 33 (55.0) 15 (60.0)

Right 34 (40.0) 26 (43.3) 8 (32.0)

Bilateral 3 (3.5) 1 (1.7) 2 (7.4)

Mechanism of Injury: n(%) 0.722

Ultra LE 5 (6.0) 3 (5.1) 2 (8.0)

LE 33 (39.3) 21 (35.6) 12 (48.0)

HE MVA 14 (16.7) 9 (15.3) 5 (20.0)

35

Factor Overall

(n=85)

Responders (R)

(n=60)

Non-responders (NR)

(n=25)

p-value

(R vs. NR)

HE Motorcycle 16 (19.1) 13 (22.0) 3 (12.0)

HE Ped vs Car 3 (3.6) 3 (5.1) 0 (0.0)

HE sports 5 (6.0) 4 (6.8) 1 (4.0)

Object falls on leg 2 (2.4) 1 (1.7) 1 (4.0)

HE other 6 (7.1) 5 (8.5) 1 (4.0)

Associated Fractures: n (%) 0.167

Yes 22 (26.2) 18 (30.5) 4 (16.0)

No 62 (73.8) 41 (69.5) 21 (84.0)

Associated Head Injury: n(%)

1.000

Yes 1 (1.2) 1 (1.7) 0 (0.0)

No 84 (98.8) 59 (98.3) 25 (100.0)

Vascular Injury: n (%) 0.104

None 79 (92.9) 55 (91.7) 24 (96.0)

Intimal Flap 1 (1.2) 0 (0.0) 1 (4.0)

Transectional 5 (5.9) 5 (8.3) 0 (0.0)

Neurological Injury: n (%) 0.401

None 65 (76.8) 41 (71.9) 22 (88.0)

Laceration 1 (1.2) 1 (1.8) 0 (0.0)

Contusion 16 (19.5) 13 (22.8) 3 (12.0)

Avulsion 2 (2.4) 2 (3.5) 0 (0.0)

Any Neurological Injury: n (%)

22 (25.9) 19(31.7) 3 (12.0) 0.059

36

Factor Overall

(n=85)

Responders (R)

(n=60)

Non-responders (NR)

(n=25)

p-value

(R vs. NR)

Skin Injury: n (%) 0.477

Yes 6 (7.1) 5 (8.3) 1 (4.0)

No 79 (92.9) 55 (91.7) 24 (96.0)

Complications 0.527

None 38 (50.0) 22 (43.1) 16 (64.0)

Infection 2 (2.6) 2 (3.9) 0 (0.0)

Stiffness 27 (35.5) 19 (37.3) 8 (32.0)

Pain 4 (5.3) 3 (5.9) 1 (4.0)

Instability 3 (4.0) 3 (5.9) 0 (0.0)

Mechanical 0 (0.0) 0 (0.0) 0 (0.0)

Revision lig recon 1 (1.3) 1 (2.0) 0 (0.0)

Loose body removal 1 (1.3) 1 (2.0) 0 (0.0)

Schenck Classification: n(%)

0.178

I 19 (22.4) 10 (16.7) 9 (36.0)

II 2 (2.4) 2 (3.3) 0 (0.0)

IIIL 30 (35.3) 25 (41.7) 5 (20.0)

IIIM 21 (24.7) 14 (23.3) 7 (28.0)

IV 13 (15.3) 9 (15.0) 4 (16.0)

Treatment status: n(%) 0.599

Lig. Reconst. 59 (69.4) 39 (65.0) 20 (80.0)

Osteotomy only 1 (1.2) 1 (1.7) 0 (0.0)

Lig. reconst. and 3 (3.5) 3 (5.0) 0 (0.0)

37

Factor Overall

(n=85)

Responders (R)

(n=60)

Non-responders (NR)

(n=25)

p-value

(R vs. NR)

osteotomy

Revision Lig. Reconst. 1 (1.2) 1 (1.7) 0 (0.0)

Nonoperative 9 (10.6) 6 (10.0) 3 (12.0)

Preoperative 12 (14.1) 10 (16.7) 2 (8.0)

TEGNER* n=60:

Mean (SD) [Range]

3.83 (2.29)

[0.0 – 9.0]

HE: High Energy LE: Low Energy Lig. Reconst.: Ligament Reconstruction

The distribution of item responses across the 5-point Likert scale, as well as the descriptive

statistics for the 132 items in the mailed consolidated questionnaire are described in Appendix

L. Sixty-nine of the 132 items in the consolidated questionnaire met both a priori criteria for

item inclusion (Table IV). Forty-two items did not meet either of the two criteria for inclusion

(Table V). Twenty-one items were classified as ‘grey zone’ items in which 8 items satisfied the

mean importance rating criteria alone, while 13 items satisfied the frequency criteria alone

(Table VI). Upon clinical review of the items by the investigators (JC, AD), 12 of the retained

items were discarded due to redundancy (Table IV: items 2, 62, 42a, 51, 100, 101, 102, 103,

106, 107, 107a, 107b). Furthermore, two of the grey zone items (Table V: items 6, 71) and two

of the items that satisfied neither of the a priori frequency or importance criteria (Table VI:

items 9, 10) were retained because it was felt they were clinically relevant and should not be

discarded without further consideration by stakeholders.

The end result was 61 items which were to be included in the second draft of the ML-QOL

questionnaire (Table VII, Figure IV). Based on the a priori selected domains for the MLQOL,

38

22 of the retained items were physical impairments (PI), 15 items were emotional impairments

(EI), 18 items were activity limitations (AL), and 6 items were societal involvement (SI). The

distribution across domains of the 10 items with the highest mean importance ratings included 6

emotional impairments items, 1 physical impairment item, and 3 societal involvement items.

The above 61 items were also considered in relation to the existing knee-specific instruments

from which they originated. Twenty-four items (PI=6 EI=13, AL=2, SI=3) of the Anterior

Cruciate Ligament Quality of Life Questionnaire (ACL-QoL) satisfied the a priori criteria and

this instrument also endorsed the most items within the EI and SI constructs. 21 items (PI=7,

EI=2, AL=11, SI=1) from the Knee Osteoarthritis and Injury Outcome Score (KOOS) satisfied

the criteria and the KOOS had the most items within the PI and AL constructs. The International

Knee Documentation Committee (IKDC) Subjective Knee Form contained 12 items (EI=0,

PI=3, AL=9, SI=0) while the remaining questionnaires contained <11 items satisfying the a

priori criteria with concepts redundant to above. Combining the ACL-QoL and KOOS resulted

in 41/61 items (PI=13, EI=13, AL=12, SI=3) satisfying the inclusion criteria.

After the aforementioned analysis, the ‘grey zone’ items listed in Table V were taken forward to

the focus groups and expert interviews in order to discuss their pertinence, clarity, and whether

or not they should be included in the next draft of the MLQOL.

Table IV Items satisfying both a priori inclusion criteria for retention of items from the

consolidated questionnaire (n=69)

Items with mean importance rating (MIR) > 3.5 AND frequency < 30% for response category 1 (“never experienced”) Physical Impairments Item 1: Your knee hurts. Item 2: Your knee hurts frequently.

39

Item 5: Your knee is stiff. Item 7: Your knee partially gives way (i.e., partial knee collapse; sense of knee slipping; you don’t fall to ground). Item 12: Your knee is weak (i.e., the muscles around your knee don’t feel strong). Item 14: Pivoting or twisting is painful. Item 15: Standing hurts your knee. Item 16: Squatting hurts your knee. Item 17: Bending hurts your knee. Item 22: Walking on uneven terrain hurts your knee Item 23: Going up stairs hurts your knee. Item 24: Going down stairs hurts your knee. Item 25: Activity over 30 minutes hurts your knee. Item 29: Knee pain affects your daily activity level. Item 31: Knee stiffness affects your daily activity level. Item 42a: Your knee hurts after moderate sports Item 35: Knee weakness affects your daily activity level. Item 36: Your knee makes you limp. Item 37a: Knee pain makes it difficult to perform moderate work. Item 37b: Knee pain makes it difficult to perform heavy physical labour. Item 42: Your knee hurts after light sports. Emotional Impairments Item 47: You are often aware or conscious of your knee problem. Item 48: You are apprehensive about your knee. Item 49: Your knee condition is frustrating or discouraging. Item 50: You are troubled with lack of confidence in your knee. Item 51: It is frustrating to have to consider your knee with respect to sports and recreation. Item 52: Your enjoyment of life has been limited by your knee. Item 53: Your knee prevents you from being as competitive as you would like. Item 54: You fear playing contact sports due to your knee. Item 55: You fear reinjuring your knee through activity (including sports or work). Item 56: You fear your knee will give way during sports or recreation. Item 57: You are worried about what will happen to your knee in the future Item 58: It is difficult to psychologically “come to grips” with your knee problem. Item 59: You are concerned about safety issues due to your knee (e.g., carrying small children, working in the yard). Item 60: You are concerned about your time off work or school due to your knee condition. Item 61: You are concerned about environmental conditions (e.g., uneven playing field, hard court or type of gym floor) when participating in sports Item 62: You are concerned that sports or recreational activities may worsen your knee. Activity Limitations Item 64: Pivoting or twisting is difficult. Item 65: Standing is difficult due to your knee. Item 66: Squatting is difficult due to your knee. Item 67: Bending your knee is difficult.

40

Item 69: Kneeling is difficult due to your knee. Item 74: Walking on uneven terrain is difficult due to your knee. Item 75: Going up stairs is difficult due to your knee. Item 76: Going down stairs is difficult due to your knee. Item 77: Bending to pick-up an object on the floor is difficult due to your knee. Item 87: You have modified your lifestyle to avoid activities that are potentially damaging to your knee. Item 88: Your knee limits your daily activity level. Item 89: Your knee makes it difficult to run straight ahead Item 90: Your knee makes it difficult to jump. Item 91: Your knee makes it difficult to quickly change direction (i.e., twisting, pivoting or cutting side to side). Item 92: Your knee makes it difficult to decelerate (i.e., stop quickly). Item 93b: Your knee condition makes you limit heavy physical labour. Societal Involvement Item 93a: Your knee condition makes you limit moderate work. Item 95: You have modified your work duties due to your knee. Item 97: Your knee limits your participation in non-competitive sports or recreation. Item 98: Your knee limits your participation in competitive sports. Item 99: Your knee makes it difficult to participate in your favourite sport or recreational activity. Item 100: Your knee makes it difficult to participate in your second most favourite sport or recreational activity. Item 101: Your knee affects the amount of time you can participate in your pre-injury activities. Item 102: Your sports or recreational performance expectations have changed due to your knee. Item 103: Your knee problem has caused you to change to participation in another activity or sport. Item 104: It is difficult for you to go “full out” (i.e., aggressively) during sports or recreation due to you knee condition Item 105: Your fitness level has decreased due to your knee condition. Item 106: You have to participate in sports or recreational activities with caution. Item 107: Your knee makes you limit participation in light sports. Item 107a: Your knee makes you limit participation in moderate sports. Item 107b: Your knee makes you limit participation in vigorous sports.

41

Table V Items satisfying one of the two a priori inclusion criteria for retention of items

from the consolidated questionnaire (n=21)

Items with mean importance rating (MIR) > 3.5 AND frequency > 30% for response category 1 (“never experienced”) (n=8) Physical Impairments Item 3: Your knee hurts continuously. Item 4: Your knee pain is severe. Item 8: Your knee fully gives way (i.e., your knee collapses and you fall to the ground). Item 34: Knee buckling affects your daily activity level. Item 39b: Your knee gives way during heavy physical labour. Item 39a: Your knee gives way during moderate work. Item 39: Your knee gives way during light duties. Item 44: Your knee gives way during light sports Emotional Impairments Nil Activity Limitations Nil Societal Involvement Nil Items with mean importance rating (MIR) < 3.5 AND frequency < 30% for response category 1 (“never experienced”) (n=13) Physical Impairments Item 6: Your knee swells. Item 11: Your knee grinds or grates. Item 20: Your knee hurts when you rise from a chair. Item 27: You knee is stiff after first wakening in the morning. Item 28: Your knee is stiff after sitting, lying, or resting during the day (i.e., not upon first wakening in the morning). Item 30: Grinding or grating of your knee affects your daily activity level. Item 38b: Heavy physical labour causes your knee to swell. Item 38a: Moderate work causes your knee to swell.

42

Table VI Items satisfying neither of the a priori inclusion criteria for retention of items

from the consolidated questionnaire (n=42)

Items with mean importance rating (MIR) < 3.5 AND frequency > 30% for response category 1 (“never experiened”) Physical Impairments Item 6a: Your knee swells continuously. Item 9: Your knee catches (i.e., hangs up or does not move for seconds or less). Item 10: Your knee locks (i.e., it is stuck in one position for minutes or longer). Item 13: Your knee is numb. Item 19: Sitting position hurts your knee (i.e., sitting with your knee bent). Item 18: Straightening hurts your knee. Item 21: Walking on flat surfaces hurts your knee Item 26: Lying in bed at night hurts your knee. Item 32: Knee swelling affects your daily activity level. Item 33: Knee slipping affects your daily activity level. Item 37: Knee pain makes it difficult to perform light duties. Item 38: Light duties cause your knee to swell. Item 40: Your knee catches during light duties (i.e., hangs up or does not move for seconds or less). Item 40a: Your knee catches during moderate work. Item 40b: Your knee catches during heavy physical labour. Item 41a: Your knee locks during moderate work. Item 41: Your knee locks during light duties (i.e., it is stuck in one position for minutes or longer). Item 41b: Your knee locks during heavy physical labour.

Item 42b: Your knee hurts after vigorous sports. Emotional Impairments Item 63: You are concerned about time off work or school due to treatment of your knee. Activity Limitations Item 71: It is difficult to rise from a chair due to your knee. Item 79: Getting in and/or out of a car is difficult due to your knee. Item 81: Getting in and/or out of the bath/shower is difficult due to your knee. Societal Involvement Nil

43

Item 43: Your knee swells during or after light sports. Item 44a: Your knee gives way during moderate sports. Item 43a: Your knee swells during or after moderate sports. Item 43b: Your knee swells during or after vigorous sports. Item 44b: Your knee gives way during vigorous sports. Item 45b: Your knee catches during vigorous sports. Item 45a: Your knee catches during moderate sports. Item 45: Your knee catches during light sports (i.e., hangs up or does not move for seconds or less). Item 46b: Your knee locks during vigorous sports. Item 46a: Your knee locks during moderate sports. Item 46: Your knee locks during light sports (i.e., it is stuck in one position for minutes or longer). Emotional Impairments nil Activity Limitations Item 68: Straightening your knee is difficult or impossible. Item 70: Sitting is difficult due to your knee Item 72: It is difficult to rise from bed due to your knee. Item 73: Walking on flat surfaces is difficult due to your knee. Item 78: Lying in bed is difficult due to your knee (including turning over and maintaining knee position). Item 80: Going shopping is difficult due to your knee. Item 82: Putting on socks and/or stockings is difficult due to your knee. Item 83: Taking off socks and/or stockings is difficult due to your knee Item 84: Getting on and/or off the toilet is difficult due to your knee Item 85: You need support during walking due to your knee problem (i.e., a cane, crutches, walker, or other person). Item 86: You require a wheelchair due to your knee problem Item 93: Your knee condition makes you limit light duties. Societal Involvement Item 96: Your knee condition has caused you to change jobs.

44

Table VII A list of 61 items retained prior to focus groups and expert interviews

Physical Impairments

Item 42: Your knee hurts after light sports. Item 16: Squatting hurts your knee. Item 5: Your knee is stiff. Item 29: Knee pain affects your daily activity level. Item 12: Your knee is weak (i.e., the muscles around your knee don’t feel strong). Item 36: Your knee makes you limp. Item 7: Your knee partially gives way (i.e., partial knee collapse; sense of knee slipping; you don’t fall to ground). Item 37a: Knee pain makes it difficult to perform moderate work. Item 37b: Knee pain makes it difficult to perform heavy physical labour. Item 25: Activity over 30 minutes hurts your knee. Item 1: Your knee hurts. Item 14: Pivoting or twisting is painful. Item 23: Going up stairs hurts your knee. Item 24: Going down stairs hurts your knee. Item 15: Standing hurts your knee Item 22: Walking on uneven terrain hurts your knee Item 17: Bending hurts your knee. Item 6: Your knee swells. Item 10: Your knee locks (i.e., it is stuck in one position for minutes or longer). Item 9: Your knee catches (i.e., hangs up or does not move for seconds or less). Item 31: Knee stiffness affects your daily activity level.

Item 35: Knee weakness affects your daily activity level.

Emotional Impairments

Item 57: You are worried about what will happen to your knee in the future Item 55: You fear reinjuring your knee through activity (including sports or work). Item 49: Your knee condition is frustrating or discouraging. Item 50: You are troubled with lack of confidence in your knee. Item 48: You are apprehensive about your knee. Item 53: Your knee prevents you from being as competitive as you would like. Item 104: It is difficult for you to go “full out” (i.e., aggressively) during sports or recreation due to you knee condition. Item 54: You fear playing contact sports due to your knee. Item 47: You are often aware or conscious of your knee problem. Item 52: Your enjoyment of life has been limited by your knee. Item 61: You are concerned about environmental conditions (e.g., uneven playing field, hard court or type of gym floor) when participating in sports. Item 59: You are concerned about safety issues due to your knee (e.g., carrying small children, working in the yard). Item 58: It is difficult to psychologically “come to grips” with your knee problem. Item 60: You are concerned about your time off work or school due to your knee condition.

45

Item 56: You fear your knee will give way during sports or recreation.

Activity Limitations

Item 88: Your knee limits your daily activity level. Item 35: Knee weakness affects your daily activity level. Item 69: Kneeling is difficult due to your knee. Item 89: Your knee makes it difficult to run straight ahead. Item 91: Your knee makes it difficult to quickly change direction (i.e., twisting, pivoting or cutting side to side). Item 90: Your knee makes it difficult to jump. Item 93a: Your knee condition makes you limit moderate work. Item 93b: Your knee condition makes you limit heavy physical labour. Item 92: Your knee makes it difficult to decelerate (i.e., stop quickly). Item 66: Squatting is difficult due to your knee. Item 64: Pivoting or twisting is difficult. Item 75: Going up stairs is difficult due to your knee. Item 76: Going down stairs is difficult due to your knee. Item 65: Standing is difficult due to your knee Item 74: Walking on uneven terrain is difficult due to your knee. Item 67: Bending your knee is difficult. Item 77: Bending to pickup an object on the floor is difficult due to your knee. Item 71: It is difficult to rise from a chair due to your knee.

Societal Involvement Item 99: Your knee makes it difficult to participate in your favourite sport or recreational activity. Item 97: Your knee limits your participation in non-competitive sports or recreation. Item 98: Your knee limits your participation in competitive sports. Item 95: You have modified your work duties due to your knee. Item 87: You have modified your lifestyle to avoid activities that are potentially damaging to your knee. Item 105: Your fitness level has decreased due to your knee condition.

4.2 Stakeholders Input (Phase II)

4.2.1 Focus Groups

Table VIII describes the demographic characteristics of focus group participants. Data saturation

was achieved after three focus groups. The three groups included 14 participants whose average

age was 34.9 (range, 20-52; SD 11.1) years. Nine patients had low energy sports-related

46

injuries while 5 patients had high-energy injuries. Using the Schenck classification, the

spectrum of injury was well represented. Five patients also had a nerve injury while one patient

had a vascular injury.

Table IX and X list the grey zone items and de novo items, respectively, which were carried

forward based on content analysis or focus group mean importance ratings (>3.5). Table XI

lists17 de novo items generated from content analysis of transcripts following all focus group

sessions organized into domains.

Table VIII: Focus Group Characteristics

FOCUS GROUP (FG) CHARACTERISTICS

Total FG 1 FG 2 FG 3 Number of Participants 14 5 5 4

Average age [years (sd)] 34.9

(11.1) 30.6

(10.7) 37.4

(9.15) 37.2

(12.5) Mechanism of Injury

Sports 9 3 3 3 High Energy 5 2 2 1 Schenck Classification

I 3 0 1 2 II 1 1 0 0 IIIL 6 4 1 1 IIIM 2 0 2 0 IV 2 0 1 1 Nerve Injury 5 1 0 4 Vascular Injury 1 0 0 1

Table IX: Decisions about inclusion of grey zone items based on focus group data

Fate of Grey Zone Item Mean Importance Rating (MIR)

Item Retained Based on MIR ≥3.5

1. Your knee hurts continuously. 3.9

47

Fate of Grey Zone Item Mean Importance Rating (MIR)

2. Your knee pain is severe 3.9

3. Your knee fully gives way (i.e., your knee collapses and you fall to the ground). 3.8

4. Knee buckling affects your daily activity level. 3.6

5. Your knee gives way with light duties. 3.7

6. Your knee gives way during light sports. 4.2

7. You are concerned about time off work or school due to treatment of your knee. 4.0

Item retained based on post-hoc content analysis irrespective of MIR

8. You knee is stiff after first wakening in the morning. 2.9

9. Your knee is stiff after sitting, lying, or resting during the day (i.e., not upon first wakening in the morning). 3.1

10. Getting in and/or out of the bath/shower is difficult due to your knee 3.4

Item Discarded based on content analysis and MIR

11. Your knee gives way with moderate work. 3.2

12. Your knee gives way with heavy physical labour 3.4

13. Heavy physical labour causes your knee to swell. 2.6

14. Moderate work causes your knee to swell. 2.9

15. Your knee hurts after vigorous sports. 3.3

16. Your knee hurts when you rise from a chair. 3.2

17. Your knee grinds or grates 3.1

48

Fate of Grey Zone Item Mean Importance Rating (MIR)

18. Grinding or grating of your knee affects your daily activity level 3.1

19. Getting in and/or out of a car is difficult due to your knee. 3.2

Table X: Decisions about inclusion of de novo items generated during focus group sessions

based on focus group data

Fate of de novo item Mean Importance Rating (MIR)

Item Retained Based on MIR ≥3.5

1. Other parts of body affected 3.5

2. Fear of falling 3.7

3. Difficulty walking on uneven ground. 4.0

4. Avoiding uneven ground 3.7

5. Trust in knee 4.9

6. Sleeping difficulties secondary to stiffness 4.0

7. Compensating 3.6

8. Apprehension 4.4

9. Long-term goals affected 4.1

10. Independence 4.3

11. Dreams/goals 4.0

12. Pain management (different modalities) 4.0

49

Fate of de novo item Mean Importance Rating (MIR)

13. Managing in crowds 4.3

14. Nerve pain – unpredictability 3.8

15. Pins and needles/electric shock 3.5

Item retained based on post-hoc content analysis irrespective of MIR

16. Self-image 3.3

17. Friends/social network affected 3.3

Item Discarded based on content analysis and MIR

18. Numbness 3.0

19. Tripping/catching your foot 3.4

20. Weather affects your knee 2.7

21. Prolonged sitting stiffness 3.1

22. Stiffness in knee, generally 3.1

23. Chronic pain affects activity 3.4

24. Creepy sensations 3.3

25. Ankle sprains/twisting 3.0

26. Difficulty sitting on the floor 2.8

27. Squatting 3.3

28. Kneeling 3.0

29. Affected financially 3.3

50

Fate of de novo item Mean Importance Rating (MIR)

30. Driving 3.0

Table XI: de novo items generated during content analysis of audiotape transcripts AFTER all

the focus group sessions

PHYSICAL IMPAIRMENTS PAIN 1. Bending of my knee causes pain

INSTABILITY 2. My knee partially gives way (i.e., partial knee collapse; sense of knee slipping;

wobbliness; you don’t fall to ground).

WEAKNESS 3. My knee or leg becomes easily tired (i.e. fatigued) after activity 4. The endurance of my limb has been affected due to my knee injury STIFFNESS 5. I have difficulty going up and down stairs due to the stiffness in my knee 6. My knee feels stiff after sitting down for a long period of time (i.e. car, movie theatre,

sitting in a chair) OTHER 7. My toes catch and hit the floor while walking or running 8. I limited by ankle stiffness or decreased motion EMOTIONAL IMPAIRMENTS (22) SELF IMAGE 9. I have had to redefine myself as a person (i.e. self-image) due to your knee injury 10. I do not feel comfortable wearing shorts, skirts, or tight clothing due to my injury

TRUST (IMMEDIATE APPREHENSION) 11. I am nervous about crowds because I fear possible instability (i.e. collapsing, slipping,

or giving way) of my knee 12. I am apprehensive about participating in group activities or sports due to my knee 13. I do not trust my knee to support me under pressure 14. Using a knee brace increases the extent to which I trust my knee 15. Using an ankle brace (ex. AFO) increases the extent to which I trust my leg MOOD

51

16. I tend to dwell on my injury when I am alone 17. My mood has been affected my knee pain or nerve pain ACTIVITY LIMITATIONS (22) Nil SOCIETAL INVOLVEMENT (9) Nil

4.2.2 Expert Interviews

Interviews were conducted with four surgeons and two physiotherapists – at this point,

saturation was achieved. All four surgeons had been in practice for a minimum of ten years and

each performed at least 10 multiligament knee reconstructions per year. The two

physiotherapists recruited for this study worked in the same practice and had a cohort of over 50

multiligament knee injured patients that they each had treated with focused rehabilitation

programs over the last 5 years. Table XII lists de novo items generated after content analysis of

expert interview transcripts.

Table XII Items generated from expert interviews

NEW ITEMS GENERATED DURING EXPERT INTERVIEWS RATIONALE PROVIDED BY EXPERTS

PHYSICAL IMPAIRMENTS (n=7) Do you have pain in your knee while resting? common Does your knee partially or fully give way (i.e. jerk or kick to the side) when walking on level ground?

lateral instability

Does your knee partially or fully give way when going down stairs? flexion (PCL) instability Does your knee partially or fully give way when pivoting or twisting? rotational instability Do you feel comfortable standing on the affected leg for several minutes? extension loss stiffness

Do you have any loss of sensation or weakness in another joint (ex. ankle) due to your knee injury?

one question for nerve injuries

Have you experienced significant weight loss after your knee injury? decreased appetite/nutrition due to high pain levels early on

EMOTIONAL IMPAIRMENTS (n=4)

52

Do you trust your knee? simpler question related to trust

Are you concerned about your financial well-being due to your knee injury? major factor endorsed by patients

Are you depressed or sad as a result of your knee injury? specify the 'mood' Have you ever considered having your knee amputated or fused? an extreme question to

capture someone doing extremely poorly

ACTIVITY LIMITATIONS (n=2) What degree of difficulty do you have going up stairs and using one leg followed by the other in an alternate fashion?

relates to weakness

What degree of difficulty do you experience while driving due to you knee injury?

getting in/out car difficult and using brake etc for nerve pts

SOCIETAL INVOLVEMENT (n=1) Do you experience problems with sexual intimacy as a result of your knee injury?

Common observation

At the end of all focus groups and expert interviews, new items were generated across each of

our a priori domains that are unique to the multi-ligament knee injured population. These items,

deemed to be important and frequently experienced by the sample in this study, are not

represented in the existing knee-joint specific measures in the literature (Table I).

4.2.3 Themes Generated During Focus Groups

In reviewing the transcripts from the focus groups, the grey zone items and new items identified

(Tables IX-XI) were discussed by participants not only in terms of whether they occurred or not

but also in relation to a number of themes: quality; attribute; associations (e.g. with specified

activities or circumstances); contextual factors and resultant modifications; timing at which

different items were experienced; and response options.

For example, physical impairments such as ‘clicking’ and ‘locking’ were eliminated because

although patients indicated that they did experience them , they were not bothered by them at all

53

(quality, attributes). On a similar vein, when analyzing the responses to the symptom of

“instability”, the different interpretations of this term was apparent under the codes ‘quality’,

and ‘attributes’. Based on the responses provided, instability was a term that could be

experienced physically (i.e. knee gives out) as well as emotionally (i.e. apprehension). Taking

this further, the term apprehension can be experienced differently in terms of ‘timing’. Patients

distinguished between ‘immediate apprehension’ (later rephrased as ’trust’) and ‘future

apprehension’ which incorporates concerns patients have about the future as it relates to their

knee taking into account various contextual factors and modifications (environmental

conditions, financial well-being, safety issues with activities such as working in the yard). Next,

items relating to stiffness were worded based on timing and contextual factors. Based on the

responses provided, participants stated that is was important to ask about when stiffness is

experienced – e.g. in the morning, after prolonged sitting – and the difficulties associated with it

(i.e. sleep, sports/physical activities). Finally, the wording of new items (e.g. neurological

sequelae, nerve pain, trust in knee) was also guided by the responses categorized among the

aforementioned coding themes.

Based on the responses of both patients and experts, the overall gestalt impression was that

impairments should be phrased in terms of frequency and that activity limitations and societal

involvement should be phrased in term of ‘degree of difficulty’ or ‘extent of limitation’. The

appropriateness of our chosen domains was affirmed among patients and experts based on the

content analysis of interview transcripts. Finally, the appropriateness of a 5-point Likert scale

for the MLQOL was also confirmed.

During content analysis, the temporal relevance of different items and domains across the

recovery and rehabilitation period was emphasized by patients. For example, in regards to

various physical impairments, patients indicated that the symptom complex they experienced

54

tended to change over time. After surgery, patients initially tended to experience pain and

swelling. This was later followed by the resolution of these symptoms and the onset of stiffness.

Months later, many patients had improvements in stiffness and had a variable onset of pain.

Using domains as an example, patients indicated that in the short term, physical impairments

and emotional impairments share the highest importance while over the long-term, the activity

limitation and societal involvement domains contained the items that were most important or

relevant in their life. This phenomenon of temporal variation supports the potential for the

MLQOL instrument to be able to detect change in various aspects of disease-specific quality of

life over time.

Based on these findings, a revised version of the MLQOL was created that was submitted to

cognitive debriefing prior to moving to testing of additional measurement properties.

4.2.4 Cognitive Debriefing

After generation of the ‘preliminary MLQOL’, cognitive debriefing was conducted (until

saturation) on a group of eight patients with multi-ligament knee injuries in the outpatient

fracture clinic at St. Michael’s Hospital. This sample was independent and separate in relation

to the patients who participated in all other aspects of the current thesis. One item was

eliminated due to a lack of clarity about what was being asked among parrticipants (n=3) (Table

X, #11; “Your dreams and long-term goals have been impacted by your knee injury”). The

‘preliminary MLQOL’ (version 2.0) is presented in Appendix H.

4.3 Mailed Questionnaire, Version 2.0 MLQOL (Phase III)

Ninety-nine eligible patients were identified from two centres in Canada. Eight-one patients

were from St. Michael’s Hospital (Toronto, ON) and 18 patients were from the Pan Am Clinic

(Winnipeg, MB). Sixty-six of the 99 patients (66.7%) returned the ‘preliminary ML-QOL’ by

55

mail. Of these sixty-six individuals, 39 individuals agreed to participate for the test-retest

reliability portion of this study.

The mean age for version 2.0 MLQOL’ responders (n=66) was 35.0 (range, 17-57) years and

74% (n=49) were male. The average time from injury to survey completion was 1170 (range,

242 – 3913) days. Using the Schenck classification, 12 patients were KD I, 4 were KD II, 43

were KD IIIM or IIIIL, and 7 were KD IV. Thirteen patients had a peroneal nerve injury

(20.2%) and 4 patients (6.1%) had a vascular injury. Twenty-four patients(37.0%) had sports-

related injuries and another 20 individuals (30.8%) had associated fractures. In regards to

treatment status, 51 patients (78.4%) were treated surgically, 6 non-operatively (9.3%) and 8

were pre-operative (12.3%). Detailed demographic information as well as injury details is listed

in Table XVI. There were no significant differences in the demographic and injury-related

variables among survey responders and non-responders. The descriptive statistics and

distribution of responses from the 66 version 2.0 MLQOL responders’ is presented in Appendix

M.

Table XIII Comparison of Responders (R) and Non-responders (NR) to the preliminary

MLQOL (version 2.0)

Factor Overall

(n= 99) Responders (n=66)

Non-responders (n=33)

p-value (R vs. NR)

Age: N=98 mean (SD) [Max-Min]

33.7 (10.3) [17 – 57]

35.0 (10.7) [17 – 57]

31.0 (9.2) [18 – 52]

0.072

Sex : n (%) 0.078 Male 76 (79.2) 49 (74.2) 27 (90.0) Time from injury to survey completion (days): n=63 mean (SD) [Max-Min]

1170.1 (801.01) [242 – 3913]

- -

Time from injury to reconstruction (days):

442.8 (1.0) [3 – 3503]

408.6 (566.4) [3 – 3503]

514.9 (697.1) [7 – 2656]

0.451

56

Factor Overall (n= 99)

Responders (n=66)

Non-responders (n=33)

p-value (R vs. NR)

n=87 mean (SD) [Max-Min] Total # Surgeries: n=93 mean (SD) [Max-Min]

1.74 (1.03) [0 – 5]

1.74 (1.0) [0 – 5]

1.75 (0.9) [0 – 3]

0.959

Side of Injury: n (%) 0.144 Left 54 (56.2) 39 (59.1) 15 (50.0) Right 38 (39.6) 26 (39.4) 12 (40.0) Bilateral 4 (4.2) 1 (1.52) 3 (10.0) Mechanism of Injury: n(%) 0.197 Ultra LE 4 (4.2) 2 (3.1) 2 (6.7) LE 32 (33.7) 22 (33.9) 10 (33.3) HE Motor vehicle accident 19 (20.0) 11 (16.9) 8 (26.7) HE Motorcycle 16 (16.8) 14 (21.5) 2 (6.7) HE Pedestrian vs. Car 3 (3.2) 3 (4.6) 0 (0.0) HE sports 10 (10.5) 8 (12.3) 2 (6.7) Object falls on leg 3 (3.2) 2 (3.1) 1 (3.3) HE other 8 (8.4) 3 (4.6) 5 (16.7) Associated Fractures: n (%)

0.146

Yes 25 (26.3) 20 (30.8) 5 (16.7) No 70 (73.7) 45 (69.2) 25 (83.3) Vascular Injury: n (%) 0.251 No 88 (91.7) 62 (93.9) 26 (86.7) Intimal Flap 1 (1.0) 1 (1.52) 0 (0.0) Transection 7 (7.3) 3 (4.6) 4 (13.3) Neurological Injury: n (%) 0.812 No 65 (76.8) 51 (79.7) 22 (75.9) Laceration 1 (1.1) 1 (1.6) 0 (0.0) Contusion 17 (18.3) 11 (17.2) 6 (20.7) Avulsion 2 (2.2) 1 (1.6) 1 (3.5) Complications 0.521 None 41 (48.2) 25 (43.9) 16 (57.1) Infection 3 (3.5) 2 (3.5) 1 (3.6) Stiffness 29 (34.1) 21 (36.8) 8 (28.6)

57

Factor Overall (n= 99)

Responders (n=66)

Non-responders (n=33)

p-value (R vs. NR)

Pain 5 (5.9) 3 (5.9) 2 (7.1) Instability 3 (3.5) 3 (5.9) 0 (0.0) Mechanical 1 (1.2) 0 (0.0) 1 (3.6) Revision ligament Reconstruction

2 (2.4) 2 (3.5) 0 (0.0)

Schenck Classification†: n(%)

0.474

KDI 20 (20.8) 12 (18.2) 8 (26.6) KD II 6 (6.3) 4 (6.1) 2 (6.7) KD IIIL 33 (34.4) 24 (36.4) 9 (30.0) KD IIIM 24 (25.0) 19 (28.8) 5 (16.7) KD IV 13 (13.5) 7 (10.6) 6 (20.0) Treatment status: n(%) 0.416 Ligament Reconstruction 68 (71.6) 43 (66.2) 25 (83.3) Osteotomy only 3 (3.2) 3 (4.6) 0 (0.0) Ligament reconstruction+ osteotomy

4 (4.2) 3 (4.6) 1 (3.3)

Revision Ligament Reconstruction

2 (2.1) 2 (3.1) 0 (0.0)

Nonoperative 9 (9.5) 6 (9.2) 3 (10.0) Preoperative 9 (9.5) 8 (12.3) 1 (3.3)

Figure Legend:

R: Responders NR: Non-responders HE: High Energy LE: Low Energy † Schenck classification: KD I - dislocation in which one of the cruciate ligaments is intact; KD II tear of both cruciate ligaments with intact collateral ligaments; KD-III is a bicruciate injury with either an associated posteromedial (KD-IIIM) or posterolateral (KD-IIIL) corner injury; KD-IV is a rupture of all 4 major knee ligaments [7].

4.3.1 Final Item Reduction

Inter-item correlations (IIC) and adjusted item to total correlations (ITC) for version 2.0

MLQOL are presented in tables XIV-XVII. Using these values, 16 items were eliminated from

v2.0 MLQOL leaving 54 items. Following this, item-to-total correlations were used to assess

58

grouping of items into domains – 2 items were eliminated during this process which is

highlighted in Table VIII. The rationale for item elimination is described in the sections below.

Ultimately, 52 items remained in the final version of the MLQOL instrument. All decisions

regarding the elimination of items were finalized by a committee (JC, AD, PS, SJ, DW). In the

sections below, all item numbers refer to the questions as listed in Appendix H for version 2.0 of

the MLQOL.

(i) Physical Impairments

Five items were eliminated in the physical impairments domain.

Items 16 and 4 had a correlation of 0.82. Both items relate to discomfort with prolonged

standing. Item 16 was eliminated by consensus.

The IICs for the instability items (e.g. items 7-10) ranged from 0.75 to 0.83. On examining

item to item responses it appeared that each tapped a different component or element of

instability As such all items were retained.

Item 12 had multiple inter-item correlations less than 0.30. For this reason, item 12 was

eliminated.

Items 14 and 15 are both related to the ‘stiffness’ construct. They had an inter-item correlation

of 0.77. Item 14 was eliminated.

Items 23 and 24 are related to the dependency of participants on an ankle and knee brace,

respectively. These items had low inter-item correlations with multiple items and were both

removed from the questionnaire. However, because this information is important, the items

59

will be part of the demographic section of the questionnaire. They will not be included in the

total score of the MLQOL.

60

61

(ii) Emotional Impairments

5 items were eliminated in total.

Items 29 and 30 both pertain to the ‘trust’ construct and have an inter-item correlation of 0.77.

Item 30 was eliminated because of a less favorable response distribution (median=3, skewed

right).

Item 32 and 36 both pertain to safety-related issues and had an inter-item correlation of 0.77.

Item 36 was eliminated because it was also highly correlated with item 34 (ρ=0.72).

Item 33 and Item 34 (ρ=0.75) were both related to future concerns. Item 34 was eliminated.

Items 37 and 38 (ρ=0.75) both related to the consequences of not working or going to school.

Item 38 was eliminated because younger patients did not seem to relate well to ‘financial well-

being’ as older and more established individuals.

Item 41 had high inter-item correlations with item 39 (ρ=0.75), Item 42 (ρ=0.82) and Item 44

(ρ=0.72). Due to this redundancy, item 41 was eliminated.

62

63

(iii) Activity Limitations

Four items were eliminated in total.

Item 48 was eliminated because of high correlations with items 45 (ρ=0.74), 46 (ρ=0.76), 47

(ρ=0.72), 55 (ρ=0.72), and 58 (ρ=0.74).

Item 52 was eliminated because of high correlations with items 50 (ρ=0.71), 51 (ρ=0.76), 53

(ρ=0.76), 56 (ρ=0.79), and 58 (ρ=0.73).

Item 55 was eliminated because of high correlations with items 45 (ρ=0.76), 46 (ρ=0.74), 48

(ρ=0.72), and 60 (ρ=0.78).

Item 56 was eliminated due to high correlations with items 52 (ρ=0.79), 53 (ρ=0.72), and 58

(ρ=0.76).

Although item 58 also had high inter-item correlations with multiple items, it was retained in the

questionnaire because focus group participants stated that it was important to differentiate

different levels of sport and/or physical work. Item 58 represents ‘light sports/physical work’

while Items 59 and 60 represent the moderate and vigorous variety, respectively. Furthermore,

3 of the 5 items with high Spearman’s correlations with item 58 were eliminated as described

above.

Item 57 and 58 (ρ=0.71) pertain to difficulty driving versus difficulty with light sports and/or

physical work, respectively. Neither of these items was deleted due to their content differences.

Item 47 and 45 (ρ=0.74) pertain to jumping versus running straight ahead. Neither was deleted

as per group consensus.

64

65

(iv) Societal Involvement

Two items were eliminated in total.

Item 68 was eliminated due to high Spearman’s correlation with Items 63 (ρ=0.78), 64 (ρ=0.79),

65 (ρ=0.72), 66 (ρ=0.72), 69 (ρ=0.76), and 70 (ρ=0.76).

Item 69 was eliminated due to high Spearman’s correlation with Items 64 (ρ=0.78), 65 (ρ=0.75),

66 (ρ=0.78), 68 (ρ=0.76), and 70 (ρ=0.76).

Despite correlations greater than .70 for certain items [Item 63 and 64 (ρ=0.71); Item 65 and 67

(ρ=0.72)], the items were retained in the final MLQOL since it was felt that these items tapped

into different types of pertinent content.

Table XVII Inter-item Spearman’s Correlations and Adjusted Item to Total Correlations for

the Societal Involvement Domain in the Preliminary MLQOL Q61 Q62 Q63 Q64 Q65 Q66 Q67 Q68 Q69 Q70 Mean Adjusted

ITC Q61 1.00 0.54 0.66 Q62 0.70 1.00 0.53 0.64 Q63 0.38 0.42 1.00 0.59 0.72 Q64 0.57 0.65 0.71 1.00 0.68 0.82 Q65 0.62 0.51 0.52 0.69 1.00 0.65 0.79 Q66 0.55 0.43 0.59 0.67 0.68 1.00 0.62 0.77 Q67 0.43 0.49 0.70 0.61 0.72 0.56 1.00 0.61 0.75 Q68 0.53 0.53 0.78 0.79 0.72 0.72 0.68 1.00 0.70 0.84 Q69 0.58 0.56 0.61 0.78 0.75 0.75 0.64 0.76 1.00 0.69 0.84 Q70 0.52 0.50 0.60 0.66 0.60 0.65 0.63 0.76 0.76 1.00 0.63 0.76

Following the above item reduction process, item to total correlations (ITC) were utilized in

order to assess the grouping of items into their respective domains. In circumstances where an

item’s ITC value was greater for domains to which the item had not been assigned a priori,

66

domain assignment was decided according to content analysis of patient focus group sessions

and by group consensus [JC, AD, PS, SJ, DW]. Such discrepancies and the manner in which

they were resolved is described in detail in Table XVIII. Item 61 and 62 in the societal

involvement domain were deleted as they were more highly correlated with the AL domain.

Additionally, on further examination, they were highly correlated with items 58-60 of the AL

domain. In total, 52 items remained after this process in the final version of the MLQOL

instrument (Appendix N).

Table XVIII Item to total correlations (ITC) after final item reduction

ITEM TO TOTAL CORRELATIONS PI

Domain EI

Domain AL

Domain SI

Domain Discrepancy

in ITC? Resolution

Physical Impairments

Q1 0.73 0.62 0.63 0.69 Q2 0.76 0.60 0.64 0.67 Q3 0.68 0.54 0.64 0.66 Q4 0.70 0.62 0.68 0.65 Q5 0.70 0.59 0.65 0.69 Q6 0.61 0.59 0.52 0.59 Q7 0.59 0.50 0.52 0.54 Q8 0.56 0.53 0.49 0.51 Q9 0.71 0.57 0.56 0.60 Q10 0.69 0.56 0.64 0.62 Q11 0.58 0.56 0.60 0.58 Q13 0.64 0.57 0.70 0.62 PI/AL Keep in PI (focus

groups; symptom in the context of an activity)

Q15 0.54 0.50 0.51 0.57 Q17 0.59 0.65 0.61 0.53 PI/EI Conceptually keep in

PI; similar argument as item 13.

Q18 0.78 0.77 0.83 0.68 PI/AL Similar argument as items 13

Q19 0.69 0.57 0.60 0.66 Q20 0.49 0.52 0.50 0.49 PI/EI Nerve symptoms –

keep in PI. High ITC

67

ITEM TO TOTAL CORRELATIONS PI

Domain EI

Domain AL

Domain SI

Domain Discrepancy

in ITC? Resolution

with EI because emotionally disconcerting symptom.

Q21 0.52 0.46 0.52 0.45 Q22 0.75 0.68 0.73 0.70

Emotional Impairments

Q25 0.61 0.66 0.57 0.72 EI/SI Change in identity may affect societal involvement or social role participation. Conceptually would prefer to keep in EI

Q26 0.41 0.46 0.42 0.41 Q27 0.74 0.76 0.75 0.70 Q28 0.70 0.75 0.61 0.61 Q29 0.70 0.67 0.68 0.66 Q31 0.50 0.50 0.54 0.43 EI/AL Trusting knee to

support under pressure

Q32 0.71 0.71 0.66 0.56 Q33 0.60 0.68 0.60 0.58 Q35 0.62 0.65 0.61 0.56 Q37 0.62 0.61 0.67 0.64 EI/ALL

OTHERS Concern about time off work or school may correlate with all other areas as well (similar to item 44)

Q39 0.64 0.69 0.63 0.64 Q40 0.73 0.77 0.75 0.81 EI/SI Conceptually keep in

EI (enjoyment of life limited)

Q42 0.66 0.72 0.64 0.71 Q43 0.55 0.66 0.55 0.48 Q44 0.69 0.68 0.70 0.72 EI/ALL

OTHERS Conceptually in EI; being sad or depressed may correlate with high scores in all other areas as well

68

ITEM TO TOTAL CORRELATIONS PI

Domain EI

Domain AL

Domain SI

Domain Discrepancy

in ITC? Resolution

Activity Limitations

Q45 0.70 0.72 0.79 0.72 Q46 0.63 0.60 0.71 0.71 Q47 0.72 0.70 0.77 0.76 Q49 0.75 0.64 0.69 0.67 AL/PI Focus groups: it is

clear that there is overlap with difficulty in activity and with symptoms during activity. However it is important to differentiate between the two types of questions.

Q50 0.72 0.70 0.75 0.64 Q51 0.77 0.72 0.71 0.67 AL/PI As in 49 Q53 0.72 0.60 0.70 0.63 AL/PI As in 49 Q54 0.79 0.78 0.78 0.79 Q57 0.71 0.60 0.66 0.66 AL/PI As in 49 Q58 0.75 0.68 0.79 0.73 Q59 0.67 0.65 0.79 0.69 Q60 0.64 0.68 0.72 0.69

Societal Involvement

Q61 0.66 0.68 0.79 0.66 SI/AL Participation in noncomp sports; overlap with all domains. Redundant with items 58-60

Q62 0.61 0.65 0.67 0.65 SI/AL Participation in comp sports. Redundant with items 58-60.

Q63 0.72 0.62 0.64 0.70 Q64 0.79 0.73 0.74 0.80 Q65 0.68 0.66 0.75 0.78 Q66 0.63 0.60 0.67 0.74 Q67 0.69 0.59 0.60 0.75 Q70 0.68 0.61 0.68 0.72

69

4.3.2 Internal Consistency

The internal consistency of all domains in the MLQOL was excellent as indicated by

Cronbach’s Alpha values greater than 0.90. The specific Alpha values for each MLQOL

domain are listed in Table XIX.

Table XIX Internal Consistency of the MLQOL Domains as measured by Cronbach’s Alpha

MLQOL Domain Cronbach Coefficient Alpha

Physical Impairments (19 items) 0.94

Emotional Impairments (15 items) 0.93

Activity Limitations (12 items) 0.94

Societal Involvement (6 items) 0.91

4.3.3 Scoring of the Final MLQOL

The descriptive statistics for the MLQOL scores across domains are described in Table XXII.

For each patient, domain scores were calculated by dividing the sum of individual patient

responses by the total possible score for each domain; this result was then multiplied by one

hundred to give a score ranging from 0-100 where low/high scores represent best/worst

outcomes within the context of each subscale.

The mean domain scores ranged from 49.3 - 57.3 and the associated minimum and maximum

values for each domain ranged from less than 10 and greater than 89, respectively. The standard

deviation for all domains ranged from 20.8-29.0 which may reflect the clinical heterogeneity in

the tested populations.

70

Table XX Descriptive Statistics for the MLQOL

MLQOL Domain N Mean Median Std Dev Min Max

Physical Impairments (19 items) 66 51.4 49.3 20.8 5.3 89.5

Emotional Impairments (15 items) 66 48.4 48.3 23.1 3.3 93.3

Activity Limitations (12 items) 66 55.1 57.3 23.6 8.3 97.9

Societal Involvement (6 items) 66 54.4 52.1 29.0 0 100

4.3.4 Content Validity

The MLQOL domains had adequate content validity according to the measured floor and ceiling

effects. All domains had floor and ceiling effects of 0% except for the societal involvement

domain which demonstrated effects of 1.5% and 3.0%, respectively.

4.3.5 Test-Retest Reliability

Thirty-nine stable patients participated in determining test-retest reliability in Phase III of this

study. The intra-class correlation measurements for the MLQOL domains ranged from 0.88 –

0.91. Table XXI lists individual domain ICC values along with their associated 95% confidence

intervals.

Table XXI Test-retest reliability of the MLQOL Domains

MLQOL Domain ICC Lower 95% Confidence

Limit

Upper 95% Confidence

Limit Physical Impairments (19 items) 0.89 0.80 0.94

Emotional Impairments (15 items) 0.86 0.75 0.93

Activity Limitations (12 items) 0.91 0.83 0.95

Societal Involvement (6 items) 0.88 0.78 0.93

ICC: intra-class correlation coefficient

71

Finally, the reliability for each domain was also assessed using Bland-Altman Plots (Appendix

O). The findings indicate that the mean of the difference scores is close to zero and that scores

are symmetrically distributed above and below this mean difference across the x-axis which

plots the mean score between the two administrations.

4.3.6 Construct Validity

The SF-36 scores for patients who participated in phase III are listed in Table XXII to provide

the reader with data that are necessary for testing the a priori construct validity hypotheses.

Table XXII SF-36 scores for 65 patients with multiligament knee injuries

SF36 Domain N Mean (SD) Median Mininum Maximum

Physical Function 65 62.0 (27.4) 65.0 0.0 100.0

Role Physical 65 64.5 (33.1) 68.8 0.0 100.0

Bodily Pain 65 55.7 (26.3) 52.0 0.0 100.0

General Health 65 66.3 (23.4) 67.0 15.0 100.0

Role Emotional 65 75.0 (30.0) 83.3 0.0 100.0

Social Function 65 74.6 (28.8) 87.5 0.0 100.0

Vitality 65 56.2 (23.5) 62.5 0.0 100.0

Mental Health 65 71.4 (20.6) 75.0 10.0 100.0

PCS 65 36.6 (13.3) 38.8 7.0 56.5

MCS 65 51.0 (12.3) 55.1 11.4 64.0

72

Seven of eight a priori developed hypotheses (see section 3.0) were satisfied. Table XXVII lists

the Spearman’s correlations pertinent to hypothesis i-iii. In the text below, a indicated that

our hypothesis was supported whereas a denotes a hypothesis that was not supported

A priori Hypotheses:

i. Patients with a higher change in Tegner activity level (preinjury – current) would have lower

MLQOL scores across all domains (Spearman correlation coefficient > 0.3).

ΔTegner and PI domain (ρ=-0.28, p value = 0.02)

ΔTegner and EI domain (ρ=-0.27, p value = 0.03)

ΔTegner and AL domain (ρ=-0.41, p value = 0.001)

ΔTegner and SI domain (ρ=-0.34, p value < 0.01)

ii. Patient with a lower global knee rating would have lower scores across all MLQOL domains

(Spearman correlation coefficient > 0.3)

Global Knee Rating and PI domain (ρ=-0.71, p value < 0.0001)

Global Knee Rating and EI domain (ρ=-0.68, p value < 0.0001)

Global Knee Rating and AL domain (ρ=-0.73, p value < 0.0001)

Global Knee Rating and SI domain (ρ=-0.85, p value < 0.0001)

iii. Patients with greater self-reported difficulty with sports and recreation activities (5 point

scale) would have lower scores on the AL subscale (Spearman correlation coefficient< -0.3).

Self-Reported Activity Rating and AL Domain (ρ=-0.77, p value < 0.0001)

73

iv. Patients without a nerve injury would have lower scores on all MLQOL domains than those

with a nerve injury

There were no difference in MLQOL domain scores among patients who had a neurological

injury compared to those who did not (Table XXIII).

Table XXIII MLQOL Domain Scores according to neurological status at the time of inury

Domain Neurological Injury? N Mean 95% CL Mean Std Dev t Value Pr > |t|

PI No 51 52.45 46.81 58.10 20.07

0.64 0.52 Yes 13 47.22 33.90 62.66 23.79

EI No 51 49.80 43.12 56.49 23.76

0.93 0.36 Yes 13 43.08 30.17 55.98 21.35

AL No 51 55.88 49.23 62.54 23.66

0.41 0.69 Yes 13 52.88 38.14 67.63 24.39

SI No 51 54.98 46.88 63.09 28.82

0.38 0.71 Yes 13 51.60 34.39 68.82 28.49

v. The MLQOL physical impairments domain would be moderately correlated with the

physical component summary of the SF-36 (Spearman correlation coefficient > 0.3)

MLQOLPI and SF36PCS (ρ=0.79, p<0.0001)

vi. The ML-QOL emotional impairments domain would be moderately correlated with the

mental component summary of the SF-36 (Spearman correlation coefficient > 0.3)

MLQOLEI and SF36MCS (ρ=0.49, p<0.0001)

vii. The activity limitations subscale in the ML-QOL questionnaire would be moderately

correlated physical function domain of the SF-36 (Spearman correlation coefficient > 0.3)

74

MLQOLAL and SF36PF (ρ=0.78, p<0.0001)

viii. The societal involvement domain in the MLQOL questionnaire would be moderately

correlated with the social function domain of the SF-36 (Spearman correlation coefficient >

0.3)

MLQOLSI and SF36SF (ρ=0.77, p<0.0001)

Finally, in summary, using the multi-trait multi-method approach, expected convergent and

divergent correlations of the MLQOL and SF-36 domains were evaluated (section 3.3.3.3.1,

Table II). The findings demonstrated that the average convergent correlations were greater than

the average divergent correlations for all domains except for emotional impairments. Details of

this analysis are presented in Table XXIV.

Table XXIV Multi-trait Multi-method Matrix - SF36 subscale and MLQOL Domain

Correlations †

Spearman Correlation Coefficients (MLQOL Domains and SF36 subscales)

Average covergent and divergent

correlations within MLQOL domains‡

Prob > |r| under H0: Rho=0

PF RP BP GH RE MH VT SF PCS MCS convergent divergent PI 0.73 0.74 0.72 0.67 0.69 0.56 0.68 0.75 0.79 0.54 0.73 0.67 EI 0.63 0.63 0.60 0.60 0.61 0.52 0.57 0.66 0.66 0.49 0.57 0.62 AL 0.78 0.75 0.77 0.70 0.64 0.53 0.62 0.76 0.84 0.45 0.78 0.68 SI 0.71 0.75 0.71 0.59 0.70 0.57 0.66 0.77 0.76 0.54 0.77 0.67

† highlighted boxes represent expected convergent correlations within a domain

‡average convergent and divergent correlations compared within a domain using the multi-trait multi-method

approach

Note: p-value < 0.001 for all correlations

75

Chapter 5 Discussion

5 Discussion The current body of work has led to the development and testing of a novel a disease-specific

quality of life questionnaire containing 52 items in four domains for patients with multiligament

knee injuries (MLQOL). The MLQOL has addressed gaps in content that are present in existing

knee-joint specific questionnaires and has demonstrated content validity, excellent reliability,

and convergent construct validity in a population of patients with chronic multi-ligament knee

injuries managed with either surgical or nonsurgical care. To the best of our knowledge, the

MLQOL is the only knee-specific outcome instrument that has demonstrated reliability and

validity in this patient population.

The rationale for the development of the MLQOL was based on (i) the lack of content pertinent

to patients with multi-ligament knee injuries in the currently existing knee-joint specific

instruments; (ii) the heterogeneous nature of our target population; and, (iii) the fact that none of

the currently existing knee outcome instruments have been tested for reliability, validity and

responsiveness in the multi-ligament knee injured population. Prior to the initiation of the

MLQOL development process, our a priori allocation of existing items in the literature to our

four domains demonstrated substantial gaps in content as applied to the MLK population.

Specifically, there was a lack of items pertaining to neurovascular and polytraumatic sequelae.

In addition, there was a predilection of existing items toward physical impairments and activity

limitations with less emphasis on emotional impairments and societal involvement. Based on

these shortcomings in the literature, we decided to proceed with the development of the

MLQOL.

76

In order to formally evaluate the clinical content that is pertinent to multi-ligament injured knee

patients, the current study also analyzed the content validity of existing instruments in our

patient population using an established clinimetric approach. From existing items in the

literature, our findings emphasized the importance of social and emotional concerns experienced

by the multiligament knee-injured population. In phase I, the distribution of the 10 items with

the highest mean importance rating across domains included included six emotional impairment

items, one physical impairment item, and three items pertaining to societal involvement.

Furthermore, the frequency and importance ratings in phase I demonstrated that of the currently

existing knee-joint specific questionnaires, the Anterior Cruciate Ligament Quality of Life

(ACL-QoL) Questionnaire and the Knee Injury and Osteoarthritis Outcome Score (KOOS)

contained the content most pertinent to patients with multi-ligament knee injuries. Forty-one of

61 items meeting the a priori inclusion criteria in phase I were represented by these two

questionnaires. The ACL-QoL contained many of the emotional impairment items important to

patients while the KOOS contained many of the activity limitation items important to patients.

Nonetheless, a recent systematic review of outcomes following operative or nonoperative care

of multiligament knee injuries demonstrated that the vast majority of outcome measures that

have been used in clinical studies thus far are represented by the Lysholm Score or the

International Knee Documentation Committee (IKDC) Score [1]. The IKDC and Lysholm do

not contain items within the EI and SI domains and based on the above findings, may not

represent the concerns that are most important to and most often experienced by patients with

multi-ligament knee injuries. .

By retaining pertinent content from existing questionnaires in phase I of this study, we initiated

the MLQOL development process. Given the large number of existing instruments, it was felt

that many of the impairments, activity limitations and restrictions in societal involvement

77

important to our patients could be captured using existing items rather than starting with de novo

item generation for all MLQOL items. Subsequently, focus groups with patients and

individual expert interviews were conducted to generate missing content. New items were

generated in all four domains with a particular emphasis by participants on the psychosocial

impact of multi-ligament knee injuries over time. Furthermore, major symptom complexes were

identified in both the physical impairment and emotional impairment domains. For example, in

the PI domain, content analysis revealed that it was important to have groups of items related to

pain, stiffness, instability, weakness and ‘other’ symptom complexes. For the EI domain,

patients emphasized the importance of self-image, immediate and future apprehension, and

mood.

The temporal relevance of different domains and the symptom complexes within domains across

the recovery and rehabilitation period was also emphasized by patients. In regards to MLQOL

domains, patients indicated that in the short term, physical impairments and emotional

impairments shared the highest importance while over the long-term, the activity limitation and

societal involvement domains contained the items that were most important or relevant in their

life. This phenomenon of temporal variation provides face validity for choosing MLQOL

subscales (versus a single global score) and also suggests that this instrument may be able to

detect change in various aspects of disease-specific quality of life over time.

Item reduction was performed at various phases of the study. During phase I, items were

eliminated if they did not meet the a priori criteria for frequency and importance ratings. During

phase II, items were eliminated both after the completion of focus group sessions and expert

interviews using mean importance ratings and post-hoc content analysis. During phase III, item

reduction was performed by using clinimetric item reduction techniques. While 0.3 and 0.7

were set as the lower and upper boundaries for item inclusion based on inter-item correlations,

78

these limits were not implemented rigidly. There were some cases in which items had inter-item

correlations above 0.7 yet were included in the final draft of the questionnaire. For example,

item 8 in the preliminary MLQOL (giving way on level ground) was initially eliminated from

the questionnaire because it had correlations greater than 0.70 with 3 other instability items. In

this case, we went outside the boundaries of our psychometric/clinimetric limits because

conceptually it made sense to ask about instability in several different ways that are clinically

pertinent. As a result, the content validity was used to guide our judgment about the fate of

some items at the expense of not following our a priori selection criteria too strictly. Future

testing using factor analysis will allow us to determine whether such judgments were correct. As

a final example, items 23 and 24 in the preliminary MLQOL pertained to bracing of the knee

and ankle, respectively. These items had very low correlations with most items. While they

were eliminated from the from the final version of the MLQOL, they are retained in the

demographics section of the instrument as this information is clinically pertinent and provides

information to caregivers in regards to requirements for assistive devices in this patient group.

The clinical heterogeneity that is intrinsic to the multiligament knee population is well

represented in the final version of the MLQOL as indicated by (1) the wide distribution of

domain scores, and (2) mean scores for each domain around 50 (central tendency). The latter

two observations indicated a wide spectrum of representation across PI, EI, AL and SI domain

scores. This is not surprising since patients with all types of injuries (Schenck KD I-IV) and at

various stages of treatment (preoperative, nonoperative, and postoperative) were included.

With more strictly-defined subgroups the heterogeneity should decrease. Theoretically the

amount of variability captured by our instrument suggests that further testing regarding its

potential discriminative validity is warranted.

79

The final version of the MLQOL demonstrated excellent reliability and validity. Specifically,

internal consistency was high across all domains. In regards to content validity, minimal floor

and ceiling effects were observed. For test-retest reliability, ICC values ranged from 0.86 to

0.91 across MLQOL domains. Our results indicate that the MLQOL may be suitable for use in

randomized trials in orthopaedic surgery as reliability was high (greater than 0.80) for all

domains. Construct validity was also excellent as indicated by successful testing of 7 of 8 a

priori hypotheses. Furthermore, the multi-trait multi-method analysis demonstrated that

convergent correlations were greater than divergent correlations for 3 of the 4 domains of the

MLQOL. It is important to note that for construct validity testing, comparisons were not made

against currently existing instruments such as the KOOS or IKDC during this initial testing

phase because these instruments were used to develop the MLQOL itself. This helped avoid

falsely high correlations due to common items. In regards to the single hypothesis which was

not met (i.e. MLQOL scores would be greater among patients without a nerve injury compared

to those with a nerve injury), this may be due to the small number of patients in our sample with

peroneal or tibial nerve palsies. An analysis of raw MLQOL scores suggests that there is much

wider variation in the confidence interval in the nerve group (with respect to both the upper and

lower limit) compared to the non-injured nerve group which suggests the two groups may not be

equal despite the observed p values. Finally, there was significant clinical heterogeneity in the

nerve group itself as some patients wore ankle-foot-orthoses, some had tendon transfers, while

others had a surgical neurolysis alone.

For the Emotional Impairments domain, the multi-trait multi-method analysis demonstrated that

the observed divergent and convergent correlations were reversed in absolute value. Although

this may be explained by systematic deficiencies in the MLQOL Emotional Impairment items or

in the SF-36, this discrepancy may also be related to differences in semantics related to the SF-

80

36 and MLQOL. For instance, the SF-36 asks about mood and emotional concerns ‘in general’

while the MLQOL asks about emotional concern in “relation to your knee’. As a result, while

someone may be doing well in general, their emotional concerns may be different in the context

of their knee and can be more profound. Due to this, I am not surprised that the EI domain was

highly correlated with other MLQOL domains (e.g. activity limitations) because the items

contained ask about different issues “related to you knee”. I feel that our a priori hypotheses

regarding convergent and divergent correlations (EI domain) may have been incorrect but this

certainly requires further investigation. Finally, our MLQOL domains scores were all highly

correlated with one another (0.77-0.88). This emphasized the profound effect that multi-

ligament knee injuries can have on all facets of people’s lives. This is in concert with the

WHO’s ICF which supports a bi-directional inter-relationship between impairments, activity

limitations, and participation restrictions.

The strengths of this study include its methodology in which quantitative and qualitative

techniques were used. Direct input was obtained from patients and experts in order to generate

new content until saturation was achieved. Furthermore, our a priori sample size calculations

ensured that our samples were adequately powered for reliability and validity testing. Finally, I

used patients from with varying levels of injury severity and at different points in the spectrum

of clinical care – hence I feel this instrument can be used for patients with chronic multiligament

injuries, irregardless of the type of treatment that is pursued.

This study also has some limitations. First, the generalizability of the content reflected in the

MLQOL is applicable to MLK injured patients cared for in tertiary care referral centers.

Practically this is likely not an issue given that nearly all of these injuries are treated at such

institutions. Next, selection bias may play a role in this study as the survey non-responder rate in

phases I and III was approximately 30%. Despite this, there were no differences in pertinent

81

demographic and injury related variables between these two groups. There was also an overlap

of samples in phases I and III whereby the majority of patients were recruited from St.

Michael`s Hospital and in Phase III a relatively small sample was available from the Pan Am

Clinic. Additionally, our findings reflect preliminary work in an English speaking population.

The use of the MLQOL for patients in non-English speaking countries will require a separate

validation process. Finally, the relatively small sample size in our study precluded use of

psychometric techniques such as confirmatory factor analysis for item reduction.

Further work on testing the measurement properties of the MLQOL is required. Future

directions include: (1) testing known-groups validity; (2) evaluating responsiveness of the

MLQOL; and, (3) determining the minimal clinical important difference and patient acceptable

symptomatic state of the MLQOL subscales over time.

5.1 Knowledge Translation The MLQOL has been presented at the 2013 American Academy of Orthopaedic Surgeons

Annual Meeting and at the 2013 Annual Meeting of the International Society of Arthroscopy,

Knee Surgery, and Orthopaedic Sports Medicine. The next step will be to publish the results of

this thesis in an open-access journal that is available to both patients and physicians. In order to

optimize dissemination, I will also create a free website where the MLQOL can be accessed

along with scoring instructions. Finally, I will work closely with the North American Knee

Dislocation Study group to implement the use of the MLQOL in new research endeavours that

are initiated.

5.2 Conclusion The Multiligament Quality of Life (MLQOL) instrument is a novel disease-specific quality of

life tool for patients who have sustained multi-ligament injuries of the knee. The MLQOL has

82

demonstrated reliability and validity based on testing to date. Critical next steps prior to its use

in clinical trials and cohort studies are to evaluate its responsiveness and to validate it in

different languages.

83

References 1. Peskun, C.J. and D.B. Whelan, Outcomes of operative and nonoperative treatment of

multiligament knee injuries: an evidence-based review. Sports Med Arthrosc, 2011. 19(2): p. 167-73.

2. Mohtadi, N., Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med, 1998. 26(3): p. 350-9.

3. Schipper, H., J. Clinch, and V. Powell, Definitions and conceptual issues, in Quality of life assessment in clinical trials1990, Raven Press: New York.

4. Levy, B.A., et al., Decision making in the multiligament-injured knee: an evidence-based systematic review. Arthroscopy, 2009. 25(4): p. 430-8.

5. U.S. Department of Health and Human Services Food and Drug Administration, C.o.D.E.a.R.C., Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). . Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009 December 2009 August 12, 2011]; Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.

6. Engebretsen, L., et al., Outcome after knee dislocations: a 2-9 years follow-up of 85 consecutive patients. Knee Surg Sports Traumatol Arthrosc, 2009.

7. Talbot, M., et al., Knee dislocations: experience at the Hopital du Sacre-Coeur de Montreal. Canadian Journal of Surgery, 2004. 47(1): p. 20-4.

8. Seebacher, J.R., et al., The structure of the posterolateral aspect of the knee. J Bone Joint Surg Am, 1982. 64(4): p. 536-41.

9. LaPrade, R.F., et al., The anatomy of the medial part of the knee. J Bone Joint Surg Am, 2007. 89(9): p. 2000-10.

10. Robertson, A., R.W. Nutton, and J.F. Keating, Dislocation of the knee. J Bone Joint Surg Br, 2006. 88(6): p. 706-11.

11. Georgiadis, A.G., et al., Changing presentation of knee dislocation and vascular injury from high-energy trauma to low-energy falls in the morbidly obese. J Vasc Surg, 2013.

12. Schenck, R.C., Jr., The dislocated knee. Instr Course Lect, 1994. 43: p. 127-36.

13. Levy, B.A., et al., Controversies in the treatment of knee dislocations and multiligament reconstruction. J Am Acad Orthop Surg, 2009. 17(4): p. 197-206.

84

14. Kreuz, P.C., et al., Treatment of focal degenerative cartilage defects with polymer-based autologous chondrocyte grafts: four-year clinical results. Arthritis Res Ther, 2009. 11(2): p. R33.

15. Roos, E.M., et al., ICRS recommendation document: patient-reported outcome instruments for use in patients with articular cartilage defecs. Cartilage, 2011. 2(2): p. 122-136.

16. Peskun, C.J., et al., Risk factors for peroneal nerve injury and recovery in knee dislocation. Clin Orthop Relat Res, 2012. 470(3): p. 774-8.

17. World Health Organization, The Constitution of the World Health Organization. Basic Documents1984, Geneva.

18. World Health Organization, International Classification of Functioning, Disability, and Health: ICF2001, Geneva: World Health Organization.

19. Badley, E.M., Enhancing the conceptual clarity of the activity and participation components of the International Classification of Functioning, Disability, and Health. Social Science & Medicine, 2008. 66(11): p. 2335-45.

20. Schipper, H., Quality of life: princples of the clinical paradigm. J Psychosocial Oncology, 1990. 8: p. 171-184.

21. Kirkley, A., S. Griffin, and D. Whelan, The development and validation of a quality of life-measurement tool for patients with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clinical Journal of Sport Medicine, 2007. 17(5): p. 349-56.

22. Marx, R.G., Knee rating scales. Arthroscopy, 2003. 19(10): p. 1103-8.

23. Bartko, J.J., The intraclass correlation coefficient as a measure of reliability. Psychol Rep, 1966. 19(1): p. 3-11.

24. Streiner, D.L. and N. G.R., Health measurement scales: A practical guide to their development and use1989, Oxford: Oxford University Press.

25. Nunnally, J.C., Psychometric theory1978, New York: McGraw-Hill.

26. Guyatt, G., Measuring health-related quality of life: general issues. . Can Respir J, 1997. 4(3): p. 123-130.

27. O'Donoghue, D.H., An analysis of end results of surgical treatment of major injuries to the ligaments of the knee. J Bone Joint Surg Am, 1955. 37-A(1): p. 1-13; passim.

28. Tanner, S.M., et al., Knee-specific quality-of-life instruments: which ones measure symptoms and disabilities most important to patients?[see comment]. American Journal of Sports Medicine, 2007. 35(9): p. 1450-8.

29. Wright, R.W., Knee injury outcomes measures. J Am Acad Orthop Surg, 2009. 17(1): p. 31-9.

85

30. American Academy of Orthopaedic Surgeons, Scoring Algorithms for the Lower Limb: Outcomes Data Collection Instrument: 21998, Rosemont, Illinois: American Academy of Orthopaedic Surgeons.

31. Roos, E.M., et al., Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther, 1998. 28(2): p. 88-96.

32. Irrgang, J.J., et al., Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med, 2001. 29(5): p. 600-13.

33. Irrgang, J.J., et al., Development of a patient-reported measure of function of the knee. J Bone Joint Surg Am, 1998. 80(8): p. 1132-45.

34. Flandry, F., et al., Analysis of subjective knee complaints using visual analog scales. Am J Sports Med, 1991. 19(2): p. 112-8.

35. Noyes, F.R., et al., The symptomatic anterior cruciate-deficient knee. Part II: the results of rehabilitation, activity modification, and counseling on functional disability. J Bone Joint Surg Am, 1983. 65(2): p. 163-74.

36. Noyes, F.R., et al., The symptomatic anterior cruciate-deficient knee. Part I: the long-term functional disability in athletically active individuals. J Bone Joint Surg Am, 1983. 65(2): p. 154-62.

37. Windsor, R.E., et al., The hospital for special surgery knee ligament rating form. Am J Knee Surg, 1988. 1: p. 140-145.

38. Tegner, Y. and J. Lysholm, Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res, 1985(198): p. 43-9.

39. Bellamy, N., et al., Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol, 1988. 15(12): p. 1833-40.

40. Lysholm, J. and J. Gillquist, Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med, 1982. 10(3): p. 150-4.

41. Bengtsson, J., J. Mollborg, and S. Werner, A study for testing the sensitivity and reliability of the Lysholm knee scoring scale. Knee Surg Sports Traumatol Arthrosc, 1996. 4(1): p. 27-31.

42. Briggs, K.K., et al., Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am, 2006. 88(4): p. 698-705.

43. Briggs, K.K., et al., The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med, 2009. 37(5): p. 890-7.

86

44. Kocher, M.S., et al., Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee. J Bone Joint Surg Am, 2004. 86-A(6): p. 1139-45.

45. Marx, R.G., et al., Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am, 2001. 83-A(10): p. 1459-69.

46. Paxton, E.W., et al., The reliability and validity of knee-specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med, 2003. 31(4): p. 487-92.

47. Crawford, K., et al., Reliability, validity, and responsiveness of the IKDC score for meniscus injuries of the knee. Arthroscopy, 2007. 23(8): p. 839-44.

48. Mariani, P.P., et al., Comparison of surgical treatments for knee dislocation. American Journal of Knee Surgery, 1999. 12(4): p. 214-21.

49. Ibrahim, S.A.R., et al., Surgical management of traumatic knee dislocation. Arthroscopy, 2008. 24(2): p. 178-87.

50. Kirshner, B. and G. Guyatt, A methodological framework for assessing health indices. J Chronic Dis, 1985. 38(1): p. 27-36.

51. Kellgren, J. and J. Lawrence, Radiologic assessment of osteoarthritis. Ann Rheum Dis, 1957. 16: p. 494-501.

52. Ziegenfuss, J.Y., et al., Telephone follow-up to a mail survey: when to offer an interview compared to a reminder call. BMC Med Res Methodol, 2012. 12: p. 32.

53. Morgan, D.L., The focus group guidebook. The Focus Group Kit. Vol. 1. 1998, Thousand Oaks: Sage Publications, Inc.

54. Morgan, D.L., Planning Focus Groups. The Focus Group Kit. Vol. 2. 1998, Thousand Oaks: Sage Publications.

55. Krueger, R.A., Developing questions for focus groups. The focus group kit. Vol. 3. 1998, Thousand Oaks: Sage Publications.

56. Krueger, R.A., Moderating focus groups. The focus group kit. Vol. 4. 1998, Thousand Oaks: Sage Publications.

57. Krueger, R.A. and J.A. King, Involving community members in focus groups. The focus group kit. Vol. 5. 1998, Thousand Oaks: Sage Publications.

58. Krueger, R.A., Analyzing and reporting focus group results. The focus group kit. Vol. 6. 1998, Thousand Oaks: Sage Publications.

59. Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative research in psychology, 2006. 3: p. 77-101.

87

60. Kirkley, A. and S. Griffin, Development of disease-specific quality of life measurement tools. Arthroscopy, 2003. 19(10): p. 1121-8.

61. Kirkley, A., et al., The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med, 1998. 26(6): p. 764-72.

62. Guyatt, G.H., et al., A comparison of Likert and visual analogue scales for measuring change in function. J Chronic Dis, 1987. 40(12): p. 1129-33.

63. Raykov, T., Evaluation of convergent and discriminant validity with multitrait-multimethod correlations. Br J Math Stat Psychol, 2011. 64(Pt 1): p. 38-52.

64. Streiner, D.L. and G.R. Norman, Validity, in Health measurement scales. A practical guide to their development and use2008, Oxfor University Press: New York. p. 247-274.

65. McHorney, C.A., J.E. Ware, Jr., and A.E. Raczek, The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care, 1993. 31(3): p. 247-63.

66. Walter, S.D., M. Eliasziw, and A. Donner, Sample size and optimal designs for reliability studies. Stat Med, 1998. 17(1): p. 101-10.

67. Bonett, D.G. and T.A. Wright, sample size requirements for estimating pearson, kendall and spearman correlations. psychometrika, 2000. 65(1): p. 23-28.

88

Appendix A

STUDY ID NUMBER: ______

Age: Gender: Occupation: Date of Injury:

Knee Dislocation Data

Side of injury: Right Left Bilateral

Mechanism of injury (choose one): ultra-low energy low energy (sports) high

energy (motor vehicle accident)

Associated Injuries (list all):

Associated injuries

Vascular:

Injury? Intimal flap/transaction

Treatment? Repair/bypass (synthetic/vein graft)

Recovery? Complete/amputation

Neurological:

Injury? None/laceration/contusion

Complete/incomplete

Motor: Sensory:

Treatment? None/grafting/tendon tr.

Recovery? Complete/incomplete

89

Associated injuries

Fractures (list)

UE:

clavicle

scapula

Shoulder

Humerus

Elbow

Forearms

Wrist

Carpus/hand

LE:

Pelvis

Acetabulum

Hip

Femur

Knee

Tibia

Foot/Ankle

Open wounds Contusions

Skin Injuries

(describe)

Physical Examination Findings:

Grade I Laxity: 0-5mm Grade II Laxity: 5-10mm Grade III Laxity: > 10mm

Lachman test: anterior force applied to tibia with femur fixed and knee flexed 300 :

Anterior Drawer: anterior force applied to tibia with knee flexed 900

Posterior Drawer: posterior force applied to tibia with knee flexed 90o

90

Varus/valgus stress test: opening of lateral and medial joint line with application of adduction

and abduction stress, respectively (with knee flexed 30o)

Exam in Clinic

+/++/+++ (I/II/III)

Exam Under Anesthesia

Arthroscopic Findings

MRI Findings

Reconstructive Treatment And

Techniques

Primary Procedures

Lachman:

AD: I II III

PD: I II III

Varus: I II

III

Valgus: I II

III

Pivot: I II

III

RevPivot: I

II III

Dial I II III

ERDrawer.:

I II III

Slocum: I

II III

Date:

I + D: yes/no

ExFix: yes/no

Zimmer: yes/no

Other:

Reconstructive Procedures

ACL

AD: I II III

Pivot: I II

III

Date:

Fixation: tibia

femur:

91

Exam in Clinic

+/++/+++ (I/II/III)

Exam Under Anesthesia

Arthroscopic Findings

MRI Findings

Reconstructive Treatment And

Techniques

Graft: hams PT

allograft

PCL

PD: I II III

Quads

Active:

Medial

Joint Line:

Dial: 30/90

Date:

Fixation: tibia

femur:

Graft: hams PT

allograft

Transtibial Tibial

Inlay

MCL

Valgus

0: I II III

30: I II III

Date:

Nonop:

Operative:

Repair/Reconstruction

LCL

Varus

0: I II III

30: I II III

Date:

PLC

Dial: 30/90:

RPivot:

ERD:

Date:

Repair:

Reconstruction:

Graft Type:

92

Exam in Clinic

+/++/+++ (I/II/III)

Exam Under Anesthesia

Arthroscopic Findings

MRI Findings

Reconstructive Treatment And

Techniques

Tech:

PMC

Slocum: Date:

Repair:

Reconstruction:

Graft Type:

Tech:

Lateral

Meniscus

McMurray:

Grind:

JLT:

Date:

Menisectomy:

Repair: i/o o/i

all-inside

Medial

Meniscus

McMurray:

Grind:

JLT:

Date:

Menisectomy:

Repair: i/o o/i

all-inside

Osteochondral Date:

Patellar Tendon Date:

Quads Tendon Date:

93

Appendix B

RESEARCH PARTICPANT MAILED INFORMATION LETTER

Study Title:

The Multi-Ligament Quality Of Life Questionnaire (ML-QOL): Development And

Preliminary Statistical Testing In Patients With Multi-Ligament Knee Injuries

Dear potential participant,

You are being asked to consider taking part in a research study because you have a complex

knee injury that involves a tear of several of your knee ligaments. This study is a surgical

resident project (Master’s in Science thesis) conducted by Jaskarndip Chahal under the

supervision of Dr. Daniel Whelan at St. Michael’s Hospital.

This research study is being conducted in order to develop and test a questionnaire that will be

able to measure the impact of your knee injury on your physical, emotional and social well

being – that is, your overall quality of life. By taking 30-45 minutes to complete the enclosed

questionnaire you will assist in providing which impairments and limitations are important to

you.

All information obtained during the study will be held in strict confidence. Taking part in this

research is voluntary. You will have treatment for your condition as you normally would if you

were not participating in this study. If you agree to participate in this research study, please

complete the enclosed questionnaire and return it using the enclosed envelope.

There will be two phases in this study. Your consent to participate in the first part of study is

demonstrated by your voluntary completion and submission of the enclosed questionnaire. We

would appreciate your response to all questions; however, none of the individual questions are

mandatory. Your name or any other identifying information will not be collected on the survey.

No one will be able to identify you or know your answers. A patient ID number will be

assigned to track completion of the questionnaire and for data analysis. A master list linking

this ID number will be maintained during the data collection phase. Once the study has

completed the list will be destroyed and your responses will be deemed anonymized. If you

94

decide not to complete the questionnaire enclosed in the mailed envelope, your decision will not

affect your care in any way or have any untoward consequences for you or your family members

in regards to the care received at St. Michael’s Hospital.

For the second part of this study, please indicate below if, upon completing the enclosed

questionnaire, whether you would be willing to participate in focus groups at St. Michael’s

Hospital for further development of a new patient oriented questionnaire. If you decide to fill

out the questionnaire and not participate in the focus group session, we will still be able to use

the data you provided from the completed questionnaire.

A focus group is a group interview where people talk about a specific topic together. It is lead

by one person (moderator) to keep the discussion on topic and active. In this focus group you

will be asked questions about what is important for you as it related to your knee injury and its

effect on your social, emotional and physical well-being. This will help us gather information

about the unique aspects of your knee injury and how they affect your quality of life. The focus

group interview will last approximately 60 to 90 minutes.

If you have any general questions about the study, please call the co-investigator in this study,

Dr. Jaskarndip Chahal, at (416) 893-1230.

If you have any questions regarding your rights as a research participant in this study, you may

contact the Chair of the St. Michael’s Research Ethics Board, at (416) 864-6060 x2557, during

business hours.

Please mark one of the following with an “X”:

___ I would like to participate in a focus group session.

OR

___ I would not like to participate in a focus group session.

95

Sincerely,

_____________________________________________________

Dr. Daniel Whelan MD, MSc, FRCS(C)

Associate Professor,

Division of Orthopaedics, Department of Surgery

University of Toronto

St. Michael’s Hospital

Toronto, ON

Co-Investigators:

(1) Dr. Jaskarndip (Jas) Chahal, MD; Resident Physician, Division of Orthopaedics, Department

of Surgery, University of Toronto, Toronto, ON

(2) Dr. Aileen Davis, PhD; Senior Scientist, Toronto Western Hospital Research Institute,

Toronto, ON

(3) Dr. Susan Jaglal, PhD; Senior Scientist, Department of Health Policy, Management and

Evaluation, University of Toronto, Toronto, ON

(4) Dr. Peter Smith, PhD; Scientist, Institute of Work and Health, University of Toronto,

Toronto, ON

96

Appendix C

PRELIMINARY CONSOLIDATED MAILED QUESTIONNAIRE

The next set of questions asks you about physical symptoms people sometimes experience related to

their knee.

i) The first part asks you to choose the response that best reflects the FREQUENCY with which you experience each symptom. The responses are “Never”, “Rarely”, “Sometimes”, “Often”, or “Always”. (choose one)

ii) The second part asks you to choose the response that describes the IMPORTANCE of each symptom to you. The responses are “Not Important”, “A Little Important”, “Moderately Important”, “Very Important”, or “Extremely Important”. (choose one)

Please answer BOTH questions for each activity. There are no right or wrong answers.

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

1. Your knee hurts.

1 2 3 4 5 1 2 3 4 5

2. Your knee hurts frequently.

1 2 3 4 5 1 2 3 4 5

3. Your knee hurts continuously.

1 2 3 4 5 1 2 3 4 5

4. Your knee pain is severe. 1 2 3 4 5 1 2 3 4 5

5. Your knee is stiff. 1 2 3 4 5 1 2 3 4 5

6. Your knee swells. 1 2 3 4 5 1 2 3 4 5

6a. Your knee swells continuously

1 2 3 4 5 1 2 3 4 5

97

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

7. Your knee partially gives way (i.e., partial knee collapse; sense of knee slipping; you don’t fall to ground).

1 2 3 4 5 1 2 3 4 5

8. Your knee fully gives way (i.e., your knee collapses and you fall to the ground).

1 2 3 4 5 1 2 3 4 5

9. Your knee catches (i.e., hangs up or does not move for seconds or less).

1 2 3 4 5 1 2 3 4 5

10. Your knee locks (i.e., it is stuck in one position for minutes or longer).

1 2 3 4 5 1 2 3 4 5

11. Your knee grinds or grates.

1 2 3 4 5 1 2 3 4 5

12. Your knee is weak (i.e., the muscles around your knee don’t feel strong).

1 2 3 4 5 1 2 3 4 5

13. Your knee is numb.

1 2 3 4 5 1 2 3 4 5

14. Pivoting or twisting is painful.

1 2 3 4 5 1 2 3 4 5

98

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

15. Standing hurts your knee.

1 2 3 4 5 1 2 3 4 5

16. Squatting hurts your knee.

1 2 3 4 5 1 2 3 4 5

17. Bending hurts your knee.

1 2 3 4 5 1 2 3 4 5

18. Straightening hurts your knee.

1 2 3 4 5 1 2 3 4 5

19. Sitting position hurts your knee (i.e., sitting with your knee bent).

1 2 3 4 5 1 2 3 4 5

20. Your knee hurts when you rise from a chair.

1 2 3 4 5 1 2 3 4 5

21. Walking on flat surfaces hurts your knee.

1 2 3 4 5 1 2 3 4 5

22. Walking on uneven terrain hurts your knee.

1 2 3 4 5 1 2 3 4 5

23. Going up stairs hurts your knee.

1 2 3 4 5 1 2 3 4 5

24. Going down stairs hurts your knee.

1 2 3 4 5 1 2 3 4 5

25. Activity over 30 minutes hurts your knee.

1 2 3 4 5 1 2 3 4 5

26. Lying in bed at night hurts your knee.

1 2 3 4 5 1 2 3 4 5

99

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

27. You knee is stiff after first wakening in the morning.

1 2 3 4 5 1 2 3 4 5

28. Your knee is stiff after sitting, lying, or resting during the day (i.e., not upon first wakening in the morning).

1 2 3 4 5 1 2 3 4 5

29. Knee pain affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

30. Grinding or grating of your knee affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

31. Knee stiffness affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

32. Knee swelling affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

33. Knee slipping affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

34. Knee buckling affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

100

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

35. Knee weakness affects your daily activity level.

1 2 3 4 5 1 2 3 4 5

36. Your knee makes you limp.

1 2 3 4 5 1 2 3 4 5

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t 37. Knee pain

makes it difficult to perform light duties.

1 2 3 4 5 1 2 3 4 5

For the following questions (37 – 41), I would like you to think about the symptoms you have during various kinds of work in or outside of the home. In particular, please think about symptoms related to light, moderate and heavy physical work.

Examples of light duties are cooking, dusting, ironing, raking leaves, and painting walls.

Examples of moderate work are carrying groceries, moving a table or climbing a ladder.

An example of heavy physical labour is lifting heavy objects.

101

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

37a. Knee pain makes it difficult to perform moderate work.

1 2 3 4 5 1 2 3 4 5

37b. Knee pain makes it difficult to perform heavy physical labour.

1 2 3 4 5 1 2 3 4 5

38. Light duties cause your knee to swell.

1 2 3 4 5 1 2 3 4 5

38a. Moderate work causes your knee to swell.

1 2 3 4 5 1 2 3 4 5

38b. Heavy physical labour causes your knee to swell.

1 2 3 4 5 1 2 3 4 5

39. Your knee gives way during light duties.

1 2 3 4 5 1 2 3 4 5

102

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

39a. Your knee gives way during moderate work.

1 2 3 4 5 1 2 3 4 5

39b. Your knee gives way during heavy physical labour.

1 2 3 4 5 1 2 3 4 5

40. Your knee catches during light duties (i.e., hangs up or does not move for seconds or less).

1 2 3 4 5 1 2 3 4 5

40a. Your knee catches during moderate work.

1 2 3 4 5 1 2 3 4 5

40b. Your knee catches during heavy physical labour.

1 2 3 4 5 1 2 3 4 5

103

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

41. Your knee locks during light duties (i.e., it is stuck in one position for minutes or longer).

1 2 3 4 5 1 2 3 4 5

41a. Your knee locks during moderate work.

1 2 3 4 5 1 2 3 4 5

41b. Your knee locks during heavy physical labour.

1 2 3 4 5 1 2 3 4 5

For the following questions (42-46), I would like you to think about the symptoms you have during various kinds of sports. In particular, please think about symptoms related to light, moderate and vigorous sports.

Examples of light sports are bowling, golf, swimming, and recreational bicycling.

Examples of moderate sports are jogging, running, recreational skiing, tennis, and competitive bicycling and weight lifting.

Examples of vigorous sports are football, basketball, gymnastics, soccer, and wrestling.

104

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

42. Your knee hurts after light sports.

1 2 3 4 5 1 2 3 4 5

42a. Your knee hurts after moderate sports.

1 2 3 4 5 1 2 3 4 5

42b. Your knee hurts after vigorous sports.

1 2 3 4 5 1 2 3 4 5

43. Your knee swells during or after light sports.

1 2 3 4 5 1 2 3 4 5

43a. Your knee swells during or after moderate sports.

1 2 3 4 5 1 2 3 4 5

43b. Your knee swells during or after vigorous sports.

1 2 3 4 5 1 2 3 4 5

44. Your knee gives way during light sports.

1 2 3 4 5 1 2 3 4 5

105

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

44a. Your knee gives way during moderate sports.

1 2 3 4 5 1 2 3 4 5

44b. Your knee gives way during vigorous sports.

1 2 3 4 5 1 2 3 4 5

45. Your knee catches during light sports (i.e., hangs up or does not move for seconds or less).

1 2 3 4 5 1 2 3 4 5

45a. Your knee catches during moderate sports.

1 2 3 4 5 1 2 3 4 5

45b. Your knee catches during vigorous sports.

1 2 3 4 5 1 2 3 4 5

106

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

46. Your knee locks during light sports (i.e., it is stuck in one position for minutes or longer).

1 2 3 4 5 1 2 3 4 5

46a. Your knee locks during moderate sports.

1 2 3 4 5 1 2 3 4 5

46b. Your knee locks during vigorous sports.

1 2 3 4 5 1 2 3 4 5

The next set of questions asks you about the feelings people sometimes experience related to their knee.

i) The first part asks you to choose the response that best reflects the FREQUENCY in which you experience each symptom. The responses are “Never”, “Rarely”, “Sometimes”, “Often”, or “Always”. (choose one)

ii) The second part asks you to choose the response that describes the IMPORTANCE of each symptom to you. The responses are “Not Important”, “A Little Important”, “Moderately Important”, “Very Important”, or “Extremely Important”. (choose one)

Please answer BOTH questions for each activity. Remember there are no right or wrong answers.

107

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

47. You are often aware or conscious of your knee problem.

1 2 3 4 5 1 2 3 4 5

48. You are apprehensive about your knee.

1 2 3 4 5 1 2 3 4 5

49. Your knee condition is frustrating or discouraging.

1 2 3 4 5 1 2 3 4 5

50. You are troubled with lack of confidence in your knee.

1 2 3 4 5 1 2 3 4 5

51. It is frustrating to have to consider your knee with respect to sports and recreation.

1 2 3 4 5 1 2 3 4 5

52. Your enjoyment of life has been limited by your knee.

1 2 3 4 5 1 2 3 4 5

53. Your knee prevents you from being as competitive as you would like.

1 2 3 4 5 1 2 3 4 5

54. You fear playing contact sports due to your knee.

1 2 3 4 5 1 2 3 4 5

108

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

55. You fear reinjuring your knee through activity (including sports or work).

1 2 3 4 5 1 2 3 4 5

56. You fear your knee will give way during sports or recreation.

1 2 3 4 5 1 2 3 4 5

57. You are worried about what will happen to your knee in the future.

1 2 3 4 5 1 2 3 4 5

58. It is difficult to psychologically “come to grips” with your knee problem.

1 2 3 4 5 1 2 3 4 5

59. You are concerned about safety issues due to your knee (e.g., carrying small children, working in the yard).

1 2 3 4 5 1 2 3 4 5

60. You are concerned about your time off work or school due to your knee condition.

1 2 n3 4 5 1 2 3 4 5

109

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

61. You are concerned about environmental conditions (e.g., uneven playing field, hard court or type of gym floor) when participating in sports.

1 2 3 4 5 1 2 3 4 5

62. You are concerned that sports or recreational activities may worsen your knee.

1 2 3 4 5 1 2 3 4 5

63. You are concerned about time off work or school due to treatment of your knee.

1 2 3 4 5 1 2 3 4 5

The next set of questions asks you about difficulties people sometimes experience because of their knee with various activities.

i) The first part asks you to choose the response that best reflects the FREQUENCY in which you experience each activity limitation. The responses are “Never”, “Rarely”, “Sometimes”, “Often”, or “Always”. (choose one)

ii) The second part asks you to choose the response that describes the IMPORTANCE of each activity limitation to you. The responses are “Not Important”, “A Little Important”, “Moderately Important”, “Very Important”, or “Extremely Important”. (choose one)

Please answer BOTH questions for each activity. There are no right or wrong answers.

110

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

64. Pivoting or twisting is difficult.

1 2 3 4 5 1 2 3 4 5

65. Standing is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

66. Squatting is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

67. Bending your knee is difficult.

1 2 3 4 5 1 2 3 4 5

68. Straightening your knee is difficult or impossible.

1 2 3 4 5 1 2 3 4 5

69. Kneeling is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

111

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

70. Sitting is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

71. It is difficult to rise from a chair due to your knee.

1 2 3 4 5 1 2 3 4 5

72. It is difficult to rise from bed due to your knee.

1 2 3 4 5 1 2 3 4 5

73. Walking on flat surfaces is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

74. Walking on uneven terrain is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

75. Going up stairs is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

76. Going down stairs is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

112

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

77. Bending to pickup an object on the floor is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

78. Lying in bed is difficult due to your knee (including turning over and maintaining knee position).

1 2 3 4 5 1 2 3 4 5

79. Getting in and/or out of a car is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

80. Going shopping is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

81. Getting in and/or out of the bath/shower is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

82. Putting on socks and/or stockings is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

83. Taking off socks and/or stockings is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

113

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

84. Getting on and/or off the toilet is difficult due to your knee.

1 2 3 4 5 1 2 3 4 5

85. You need support during walking due to your knee problem (i.e., a cane, crutches, walker, or other person).

1 2 3 4 5 1 2 3 4 5

86. You require a wheelchair due to your knee problem.

1 2 3 4 5 1 2 3 4 5

87. You have modified your lifestyle to avoid activities that are potentially damaging to your knee.

1 2 3 4 5 1 2 3 4 5

88. Your knee limits your daily activity level.

1 2 3 4 5 1 2 3 4 5

89. Your knee makes it difficult to run straight ahead.

1 2 3 4 5 1 2 3 4 5

114

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

90. Your knee makes it difficult to jump.

1 2 3 4 5 1 2 3 4 5

91. Your knee makes it difficult to quickly change direction (i.e., twisting, pivoting or cutting side to side).

1 2 3 4 5 1 2 3 4 5

92. Your knee makes it difficult to decelerate (i.e., stop quickly).

1 2 3 4 5 1 2 3 4 5

115

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

93. Your knee condition makes you limit light duties.

1 2 3 4 5 1 2 3 4 5

93a. Your knee condition makes you limit moderate work.

1 2 3 4 5 1 2 3 4 5

93b. Your knee condition makes you limit heavy physical labour.

1 2 3 4 5 1 2 3 4 5

For the following question (93), I would like you to think about the difficulties you have in executing various kinds of work inside or outside of your home. In particular, please think activity limitations as they relate to light, moderate and heavy physical work.

Examples of light duties are cooking, dusting, ironing, raking leaves and painting walls.

Examples of moderate work are carrying groceries, moving a table or climbing a ladder.

An example of heavy physical labour is lifting heavy objects.

116

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

94. Your knee problem interferes with your social activities (including family activities).

1 2 3 4 5 1 2 3 4 5

95. You have modified your work duties due to your knee.

1 2 3 4 5 1 2 3 4 5

96. Your knee condition has caused you to change jobs.

1 2 3 4 5 1 2 3 4 5

I would now like you to think about your social roles and activities and how they may be affected by your knee. By social roles and activities we mean family roles and activities, work, leisure, and social activities.

i) The first part asks you to choose the response that best reflects the FREQUENCY in which you experience each social limitation. The responses are “Never”, “Rarely”, “Sometimes”, “Often”, or “Always”. (choose one)

ii) The second part asks you to choose the response that describes the IMPORTANCE of each social limitation to you. The responses are “Not Important”, “A Little Important”, “Moderately Important”, “Very Important”, or “Extremely Important”. (choose one)

Please answer BOTH questions for each activity. There are no right or wrong answers.

117

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

97. Your knee limits your participation in non-competitive sports or recreation.

1 2 3 4 5 1 2 3 4 5

98. Your knee limits your participation in competitive sports.

1 2 3 4 5 1 2 3 4 5

99. Your knee makes it difficult to participate in your favourite sport or recreational activity.

1 2 3 4 5 1 2 3 4 5

118

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

100. Your knee makes it difficult to participate in your second most favourite sport or recreational activity.

1 2 3 4 5 1 2 3 4 5

101. Your knee affects the amount of time you can participate in your pre-injury activities.

1 2 3 4 5 1 2 3 4 5

102. Your sports or recreational performance expectations have changed due to your knee.

1 2 3 4 5 1 2 3 4 5

119

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

103. Your knee problem has caused you to change to participation in another activity or sport.

1 2 3 4 5 1 2 3 4 5

104. It is difficult for you to go “full out” (i.e., aggressively) during sports or recreation due to you knee condition.

1 2 3 4 5 1 2 3 4 5

105. Your fitness level has decreased due to your knee condition.

1 2 3 4 5 1 2 3 4 5

106. You have to participate in sports or recreational activities with caution.

1 2 3 4 5 1 2 3 4 5

120

FREQUENCY IMPORTANCE

Nev

er

Rar

ely

Som

etim

es

Oft

en

Alw

ays

Not

Impo

rtan

t

A L

ittle

Impo

rtan

t

Mod

erat

ely

Impo

rtan

t

Ver

y

Impo

rtan

t

Ext

rem

ely

Impo

rtan

t

107. Your knee makes you limit participation in light sports.

1 2 3 4 5 1 2 3 4 5

107a. Your knee makes you limit partici-pation in moderate sports.

1 2 3 4 5 1 2 3 4 5

107b. Your knee makes you limit partici-pation in vigorous sports.

1 2 3 4 5 1 2 3 4 5

For the following question (107), I would like you to think about how your participation in various kinds of sports has been affected by your knee. In particular, please think about participation in light, moderate and vigorous sports.

Examples of light sports are bowling, golf, swimming, and recreational bicycling.

Examples of moderate sports are jogging, running, recreational skiing, tennis, and competitive bicycling and weight lifting.

Examples of vigorous sports are football, basketball, gymnastics, soccer, and wrestling.

121

The following scale attempts to determine how active you have been over the last year, specifically by

looking at the type of activities you are able to participate in and how often you are able to do so.

Please checkmark the category that most closely represents your highest activity level during the last

year. (choose one)

10. competitive sports: national or international soccer

9. competitive sports: lower divisions of soccer; ice hockey, wrestling, gymnastics

8. competitive sports: squash or badminton, athletics (jumping, etc.), downhill skiing

7. competitive sports: tennis, athletics (running), motocross, speedway, handball, basketball,

cross-country running recreational sports: soccer, ice hockey, squash, athletics (jumping), cross-country running

6. recreational sports: tennis, badminton, handball, basketball, downhill skiing, jogging at least 5

times weekly

5. work: heavy labour such as construction, forestry recreational sports: jogging on uneven ground at least twice weekly competitive sports: cycling, cross-country skiing

4. work: moderately heavy labour such as truck driving, heavy domestic work recreational sports: jogging on uneven ground at least twice weekly

3. work: light labour such as nursing competitive and recreational sports: swimming, walking in forest possible

2. work: light labour walking on uneven ground possible, but impossible to walk in forest

1. work: sedentary work walking on even ground possible

0. sick leave or disability pension

122

Grade symptoms at the highest activity level at which you think you could function without

significant symptoms, even if you are not actually performing activities at this level.

1. What is the highest level of activity that you can perform without significant knee pain? (choose one)

very strenuous activities like jumping or pivoting as in basketball or soccer

strenuous activities like heavy physical work, skiing, or tennis

moderate activities like moderate physical work, running or jogging

light activities like walking, housework, or yard work

unable to perform any of the above activities due to knee pain

2. What is the highest level of activity you can perform without significant swelling in your knee? (choose one)

very strenuous activities like jumping or pivoting as in basketball or soccer

strenuous activities like heavy physical work, skiing, or tennis

moderate activities like moderate physical work, running or jogging

light activities like walking, housework, or yard work

unable to perform any of the above activities due to knee pain

123

3. What is the highest level of activity you can perform without significant giving way in your knee? (choose one)

very strenuous activities like jumping or pivoting as in basketball or soccer

strenuous activities like heavy physical work, skiing, or tennis

moderate activities like moderate physical work, running or jogging

light activities like walking, housework, or yard work

unable to perform any of the above activities due to knee pain

4. What is the highest level of activity you can participate in on a regular basis? (choose one)

very strenuous activities like jumping or pivoting as in basketball or soccer

strenuous activities like heavy physical work, skiing, or tennis

moderate activities like moderate physical work, running or jogging

light activities like walking, housework, or yard work

unable to perform any of the above activities due to knee pain

124

Appendix D

Focus Group Semi-Structured Focus Group Guide –Patients Prior to starting the formal focus group session, patients will have completed a consolidated questionnaire consisting of 111 items. In this focus group session, patients will be asked to be involved in a discussion about questions where it was unclear how frequent or important some items were. The group will help to come to a decision about whether to include such items in the next draft of the questionnaire.

Background Information

General introduction to process – explain that only one person should speak at a time and do NOT identify themselves before speaking. Thank everyone for attending and have them verbally agree to participate, explain how confidentiality and anonymity will be protected at the point of transcription, etc.

Warm-up and establishing rapport

Brief overview of the focus group study objective.

Show patients a pre-selected list of items where the frequency and importance was unclear from

the original 111 items in the consolidated questionnaire. Emphasize that these have been

selected for further discussion. The group will help decide whether or not to include these in the

questionnaire

Identifying the most relevant items

How well do the remaining questions reflect the impact of your knee injury on your quality of life?

- Which items are the most pertinent?

- Which items are redundant?

- Are there any items that are irrelevant?

- Which activities can you do now that you could not 6 months after your injury?

- Which activities can you still not do now that you could not 6 months after your injury?

125

What is missing from the questionnaire?

What symptoms is this questionnaire missing that relate closely to your knee condition ?

(i) how have other body parts been affected?

(ii) do you experience any numbness in the leg? How about pins and needles? Does your foot fall asleep?

(iii) do you experience any weakness in the foot or leg or knee?

(iv) cold intolerance, claudication (i.e. pain after walking for a fixed time period)?

(v) when do you experience these symptoms?

Repeat questions (i)-(v) in the context of acivity limitations.

Repeat questions (i)-(v) in the context of societal limitations.

Cool-Down Questions

Is there anything else I have not asked that you would like to add?

Semi-Structured Interview Guide – Surgeons and Physiotherapists Two weeks prior to starting the formal focus group session, surgeons will have been mailed a preliminary ML-QOL questionnaire that was modified through the focus group sessions conducted with patients.

Background Information

General introduction to process – explain that only one person should speak at a time and do NOT identify themselves before speaking. Thank everyone for attending and have them verbally agree to participate, explain how confidentiality and anonymity will be protected at the point of transcription, etc.

Warm-up and establishing rapport

Brief overview of the interview objective

Sensibility Assessment (Face and Content Validity)

126

(Oxman and Rowe, 1993)

-Which questions are not clear?

-Are the instructions provided to patients adequate?

-Which questions are likely to lead to confusion?

-Is the amount of time taken to complete the questionnaire reasonable?

-How many of the items are crucial, how many are redundant or unnecessary?

-Note any areas that you think should be included that are not.

-Does a Five-point Likert scale provide enough choice for responses?

-How likely are these questions going to be able to measure the impact of a multiligament

knee injury on the quality of life of affected individuals? How about response to treatment or

time?

-Does the content reflect the symptoms and physical and social limitations experienced by patients? If no, what needs to be added to improve the content validity of this questionnaire?

Identifying the most relevant items

How does questionnaire reflect the concerns experienced by your patients with multi-ligament

knee injuries?

-Which items are the most pertinent?

-Which items are redundant?

-Are there any items that are irrelevant?

-Which items (symptoms, activities, social roles) tend to change the most due to treatment or time?

-Which items have tend to change the least due to treatment or time?

What items are missing?

In your opinion, what items is this questionnaire missing from the various domains that relate

closely your patients with muli-ligament knee injuries?

127

- Other body parts been affected?

- Numbness in the leg?

-Paresthesias?

-Weakness in the foot or leg or knee?

- When are these symptoms experienced and what acts or tasks do they limit?

Cool-Down

Is there anything that was not asked that you would like to add?

128

Appendix E

LETTER OF INFORMATION AND CONSENT TO PARTICIPATE IN A RESEARCH

STUDY (PATIENTS)

Study Title:

The Multi-Ligament Quality Of Life Questionnaire (ML-QOL): Development And

Preliminary Statistical Testing In Patients With Multi-Ligament Knee Injuries

Principal Investigator:

Dr. Daniel Whelan, F.R.C.S. (C.); Associate Professor, Division of Orthopaedics, Department

of Surgery, University of Toronto; St. Michael’s Hospital, Toronto, ON.

(416) 864-6002. Monday to Friday (8:30 - 4:30)

Co-Investigators:

Dr. Jaskarndip (Jas) Chahal; Resident Physician, Division of Orthopaedics, Department of

Surgery, University of Toronto, Toronto, ON

(416) 893-1230: Monday to Friday (8:30 - 4:30)

Dr. Aileen Davis, PhD; Senior Scientist, Toronto Western Research Institute, Toronto, ON

416-603-5800 Ext. 5543: Monday to Friday (8:30 – 4:30)

Dr. Susan Jagal, PhD; Senior Scientist, Department of Health Policy, Management and

Evaluation, University of Toronto, Toronto, ON

Dr. Peter Smith, PhD; Scientist, Institute of Work and Health, University of Toronto, Toronto,

ON

Introduction: This study is a surgical resident project conducted by Jaskarndip Chahal under

the supervision of Dr. Daniel Whelan at St. Michael’s Hospital.

Before agreeing to participate in this research study, it is important that you read and understand

this research consent form. This form provides all the information we think you will need to

know in order to decide whether you wish to participate in the study. If you have any questions

after you read through this form, ask your surgeon or study coordinator. You should not sign

this form until you are sure you understand everything on this form. You may also wish to

129

discuss your participation in this study with your family doctor, a family member, or a close

friend.

Purpose of the Study: You are asked to participate in this research study because you have a

complex knee injury that involves rupture of several knee ligaments. This research study is

being conducted in order to develop and test a questionnaire that will be able to measure the

impact of your knee injury on your physical, emotional and social well being – that is, your

overall quality of life. It is our hope that this endeavor will allow us to measure the symptoms

and disabilities that are important to you in regards to your knee.

In this study we do not use any new treatments and we do not test any new surgical or other

treatment approach. You will be treated according to standard of care at St. Michael’s.

Description of the Study: You will have treatment for your condition as you normally would if

you were not participating in this study. If you consent to participate in this research study, you

will be asked to join in a focus group. A focus group is a group interview where people talk

about a specific topic together. It is lead by one person (moderator) to keep the discussion on

topic and active. In this focus group you will be asked questions about what is important for

you as it related to your knee injury and its effect on your social, emotional and physical well-

being. This will help us gather information about the unique aspects of your knee injury and

how they affect your quality of life. The focus group interview will last approximately 60 to 90

minutes.

The interviews will be recorded. Someone will then listen to that recording and type it. Your

name or other identifying information will not be included when the recording is typed.

Approximately 40 patients will take part in this study at St. Michael’s.

After participating in the focus group sessions, Dr. Whelan and his investigators will use your

input to generate a new clinical questionnaire to evaluate how your knee condition affects

quality of life. Before using this tool in the real world, we need to make sure that it is a reliable

tool and that it is measuring what it is intended to measure – quality of life. In order to do this,

you may be asked to participate in the subsequent phases of this study which will involve filling

a rating questionnaire, group discussions about each item on the new clinical tool. Specifically,

you will be asked to rate the importance of a list of items as they pertain to you and to state how

130

frequently you experience each listed item. If you are selected to be a part of this group, you

will need to undergo a second administration of the modified questionnaire two weeks later

during a clinical visit to test the repeatability of our tool.

Given the amount of time to schedule the focus group sessions, and create a new clinical

questionnaire, it is anticipated that the study will take two years to complete.

Potential Harms (Injury, Discomforts, or Inconvenience): There are no anticipated risks or

discomforts during the course of this study. The focus group sessions will be asking questions

related to your overall health as well as questions specific to your knee condition. On average

the focus group sessions last 60-90 minutes. Should you feel uncomfortable answering some of

the questions, you can choose to not answer them.

Potential Benefits: There may or may not be direct benefit to you from participating in this

study. We hope the information learned from this study will facilitate and improve surgical

outcomes for patients with complex knee ligament injuries the future.

Privacy and Confidentiality: The study investigators are committed to respecting your privacy.

The study investigators will make every effort to keep your study information private and

confidential in accordance with all applicable privacy legislation. The study data will be held

strictly confidential unless disclosure is required by law.

Your voice, when audio-taped, is considered to be identifying personal information. The audio-

recording and study records will be securely stored and handled at all times. You are requested

not to state your name or the names of anyone else or any institutions during the audio-recording

of the interview. However, if this happens, you should know that the audio-taped interview will

be transcribed in such a way that any potentially identifying information is removed or coded.

Written notes may also be taken during the interview. A co-investigator will transcribe (type

out) the interview data in a secure manner.

The audio-tape of the interview will be securely destroyed after the information has been

transcribed and verified to be accurate. All links between your identifying personal information

and study data will be broken after the completion of the data analysis. All other study

information, including the rating questionnaires and transcription will be securely stored until all

data analyses have been performed and the study results have been presented or published. Your

131

study information (data) either in paper forms or electronic files will be kept securely stored at

all times. All study data will be securely disposed of two years after the completion of the

study.

The Research Team will keep all of your answers confidential to the extent permitted by law.

Aside from the research team, no one will listen to your tapes or access your completed

questionnaires (your “study records”) other than St. Michael's Hospital Research Ethics Office

whose access to the study records, including the consent form, will be for the purpose of

monitoring the study.

The results of any research will include information from many people grouped together so that

no one person can be identified. The data provided by you may be used in general terms in

academic publications or presentations. For example, we might use a quote by you and say in

the publication that the quote was from someone with your perspective (e.g. female aged 21).

Your name will not be revealed, and a nick name or a generic description (e.g. surgical patient)

will be used. Any responses, records or personal information that could be linked to you will not

be reported or shared with anyone outside of the research team, unless required by law.

The information collected from you will be used to report the results in journals, conferences

and community presentations.

Participation and Withdrawal:

Participation in any research study is voluntary. If you choose not to participate, you and your

family will continue to have access to customary care at St. Michael’s Hospital. If you decide to

participate in this study you can change your mind without giving a reason, and you may

withdraw from the study at any time without any effect on the care you and your family will

receive at St. Michael’s Hospital.

If you withdraw from the study, the data collected from you up to that time will be used to

maintain the integrity of the study, but no more data on you will be collected.

By agreeing to participate in this study, you are agreeing participate in a focus group sessionat

the present time. However, your participation in this study is conditional upon signing this

132

consent form and authorization to disclose personal health information. If you do not sign this

form, you cannot participate in the study.

Potential Costs/Reimbursements: Participation in this study will not involve any additional

costs to you or your private health care insurer. You will not be paid to take part in the study

however you will be reimbursed (up to $25) for parking or travel expense for each visit required

as part of this study.

Research Ethics Board Contact: If you have any questions regarding your rights as a research

participant in this study, you may contact the Chair of the St. Michael's Research Ethics Board,

at (416) 864-6060 x2557, during business hours.

Study Contact: If you have any general questions about the study, please call the co-

investigator in this study, Dr. Jaskarndip Chahal, at (416) 893-1230.

STATEMENT OF CONSENT

Study Title: The Multi-Ligament Quality Of Life Questionnaire (ML-QOL):

Development And Preliminary Statistical Testing In Patients With Multi-Ligament Knee

Injuries

I acknowledge that the research study described above has been explained to me and that any

questions that I have asked have been answered to my satisfaction. I have been informed of the

alternatives to participation in this study, including the right not to participate and the right to

withdraw without compromising the quality of medical care at St. Michael’s Hospital for me

and for other members of my family. As well, the potential risks, harms, and discomforts have

been explained to me, and I also understand the benefits (if any) of participating in the research

study.

I understand that I have not waived my legal rights nor released the investigators, or involved

institutions, from their legal and professional duties. I know that I may ask now, or in the

future, any questions that I have about the study or the research procedures.

133

I have been assured that those records relating to me, and my care, will be kept confidential and

that no information will be released or printed that would disclose my personal identity without

my permission unless required by law. I have been given sufficient time to read and understand

the above information.

I hereby consent to participate, and I will be given a signed copy of this consent form.

____________________ _______________________ _________________

Name of Participant Signature of Participant Date

I have explained the study to the above Participant, explained to the above Participant the nature

and purpose, the potential benefits, and possible risks associated with participation in this

research study. I have answered all questions that have been raised.

_______________________ __________________________ _____________

Name of Person Obtaining Signature of Person Obtaining Date

Consent Consent

134

Appendix F

LETTER OF INFORMATION AND CONSENT TO PARTICIPATE IN A RESEARCH

STUDY (EXPERTS)

Study Title:

The Multi-Ligament Quality Of Life Questionnaire (ML-QOL): Development And

Preliminary Statistical Testing In Patients With Multi-Ligament Knee Injuries

Principal Investigator:

Dr. Daniel Whelan, F.R.C.S. (C.); Associate Professor, Division of Orthopaedics, Department

of Surgery, University of Toronto; St. Michael’s Hospital, Toronto, ON

(416) 864-6002: Monday to Friday (8:30 - 4:30)

Co-Investigators:

Dr. Jaskarndip (Jas) Chahal; Resident Physician, Division of Orthopaedics, Department of

Surgery, University of Toronto, Toronto, ON

(416) 893-1230: Monday to Friday (8:30 - 4:30)

Dr. Aileen Davis, PhD; Senior Scientist, Toronto Western Research Institute, Toronto, ON

(416) 603-5800 Ext. 5543: Monday to Friday (8:30 – 4:30)

Dr. Susan Jagal, PhD; Senior Scientist, Department of Health Policy, Management and

Evaluation, University of Toronto, Toronto, ON

Dr. Peter Smith, PhD; Scientist, Institute of Work and Health, University of Toronto, Toronto,

ON

Introduction: This study is a surgical resident project conducted by Jaskarndip Chahal under

the supervision of Dr. Daniel Whelan at St. Michael’s Hospital.

This form provides all the information we think you will need to know in order to decide

whether you wish to participate in the study. If you have any questions after you read through

135

this form, please ask one of the available investigators. You should not sign this form until you

are sure you understand everything on this form.

Purpose of the Study: You are asked to participate in this research study because of your

expertise in the diagnosis and treatment of patients with multi-ligament knee injuries. The

ultimate goal of this study is to develop a clinical outcome tool that will measure quality of life

in patients with such injuries.

Description of the Study: If you consent to participate in this research study, you will be asked

to join in a focus group (comprised of approximately XX people) where you will be asked

questions about what is important for you and your patients as they relate to multi-ligament knee

injuries and their effect on an individual’s overall quality of life.

The focus group interview will last approximately 60 to 90 minutes and will be audiotaped and

transcribed for analysis.

After participating in the focus group sessions, Dr. Whelan and his investigators will use your

input for the purposes of item generation and item reduction. Once a draft questionnaire is

completed, it will undergo further testing with patients for final item reduction, and testing of

reliability and construct validity. At a later date, you may be asked to complete a questionnaire

to test the sensibility of the final outcome instrument.

Given the amount of time to schedule the focus group sessions, and create a new clinical

questionnaire, it is anticipated that the study will take two years to complete.

Privacy and Confidentiality: Your confidentiality will be respected, and no information that

discloses your identity will be released or published without your consent unless required by

law. No information will be released or printed that would disclose personal identity. Once the

focus groups have been transcribed from the audiotapes, the audio tapes will be destroyed. The

hard copies of data (transcripts and analytical worksheets/notes) and consent forms will be

shredded XX years after publication. Your consent forms will be stored separately from the data

files (transcripts and analytical worksheets). Only the Principal Investigator and the research

team will have access to the consent forms, transcripts, and analytical worksheets/notes which

will be kept in a locked office in a locked cabinet for a period of XX years.

136

The study investigators will keep all of your answers confidential to the extent permitted by

law. Aside from the research team, no one will listen to your tapes or access your completed

questionnaires (your “study records”) other than St. Michael's Hospital Research Ethics Office

whose access to the study records, including the consent form, will be for the purpose of

monitoring the study.

Potential Harms (Injury, Discomforts, or Inconvenience): There are no anticipated risks or

discomforts during the course of this study. On average the focus group sessions last 60-90

minutes and will be scheduled at a mutually convenient time and location.

Potential Benefits: There may or may not be direct benefit to you from participating in this

study. We hope the information learned from this study will facilitate and improve surgical

outcomes for patients with complex knee ligament injuries the future.

Participation and Withdrawal: Participation in any research study is voluntary. If you choose

not to participate, there will no effect or impact on your employment at St. Michael’s Hospital.

If you decide to participate in this study you can change your mind without giving a reason, and

you may withdraw from the study at any time without any effect on your employment at St.

Michael’s Hospital. Given the nature of focus groups, data acquired up the point of withdrawal

may be aggregated as part of the analysis with no identifying information.

By agreeing to participate in this study, you are agreeing participate in a focus group session at

the present time.

Potential Costs/Reimbursements: You will not be paid to take part in the study however you

will be provided with a parking voucher as well as refreshments during the focus group session.

Research Ethics Board Contact: If you have any questions regarding your rights as a research

participant in this study, you may contact the Chair of the Research Ethics Board, Dr. Julie

Spence, at (416) 864-6060 x2557, during business hours.

Study Contact: If you have any general questions about the study, please call the co-

investigator in this study, Dr. Jaskarndip Chahal, at (416) 893-1230.

137

STATEMENT OF CONSENT

Study Title: The Multi-Ligament Quality Of Life Questionnaire (ML-QOL):

Development And Preliminary Statistical Testing In Patients With Multi-Ligament Knee

Injuries

I acknowledge that the research study described above has been explained to me and that any

questions that I have asked have been answered to my satisfaction. I have been informed of the

alternatives to participation in this study, including the right not to participate and the right to

withdraw without affecting my current and/or future employment or relationships at St.

Michael’s for me and for other members of my family. As well, the potential risks, harms, and

discomforts have been explained to me, and I also understand the benefits (if any) of

participating in the research study.

I understand that I have not waived my legal rights nor released the investigators, or involved

institutions, from their legal and professional duties. I know that I may ask now, or in the

future, any questions that I have about the study or the research procedures.

I have been assured that those records relating to me, and my care, will be kept confidential and

that no information will be released or printed that would disclose my personal identity without

my permission unless required by law. I have been given sufficient time to read and understand

the above information.

____________________ _______________________ _________________

Name of Participant Signature of Participant Date

I have explained the study to the above Participant, explained to the above Participant the nature

and purpose, the potential benefits, and possible risks associated with participation in this

research study. I have answered all questions that have been raised.

_______________________ __________________________ _____________

Name of Person Obtaining Signature of Person Obtaining Date

Consent Consent

138

Appendix G

Cognitive Debriefing Questions for Preliminary MLQOL Instrument

The main cognitive technique employed will be ‘probing’. According to Collins (2003), the probing method involves the interviewer asking specific questions or probes which are designed to elicit how the respondent has gone about answering a question. Compared with the think-aloud technique, this method is interviewer-driven and has a lower burden on the respondent. Standard probes are used to assess response burden (B), comprehension (C), retrieval (R), judgment (J), and response processes (Re). Below is a list of questions that will be posed to respondents in this study. Each participant will be asked to answer the questions below for one or two of the four domains in this questionnaire.

I’d like to ask you some questions about the questions you have just completed.

1. Does this questionnaire fully address the physical symptoms you experience in your knee?

If no, why not? (B)

2. Did you have any difficulty understanding this questionnaire? If yes, why? (C)

3. Are there any questions in particular that you found confusing or unclear in meaning? (C)

4. Are there words that are hard to understand? (C)

5. Did you find this section (ex. Physical impairments) of the questionnaire to be too long? A good length? Too short? If too long what could be removed. If too short, what could we ask more about? (B)

6. Did the wording of the answers you could choose from make sense to you? (Re)

7. Do you have a particular time period in mind when answering these questions? (R)

8. How sure are you of your answer to these questions? (J)

The above questions will be repeated for each of the other three sections (emotional impairments, activity limitations, societal involvement).

9. What is the meaning of the following response options to you? (Re)

- Never/rarely/sometimes/often/always

139

10. On this blank piece of paper, can you please draw how the physical symptoms you

experience fluctuate over time? (Re)

a. Emotional symptoms? b. Activity limitations? c. Societal involvement? d. What is the length of your flare-ups and how important are they to your overall

physical, emotional and social well-being?

11. What time frame should we use as a reference when asking you questions about your knee?

a. “in the last week” ? b. “in the last month”? c. Other?

Let me know if you want to discuss more.

Time (months)

Experience

Time of

Time (weeks)

Experience

Time of

140

Appendix H

Preliminary (version 2.0) MLQOL Questionnaire, Anchor Questions, Tegner Activity

Scale, and SF-36

Preliminary (Version 2.0) MLQOL INSTRUCTIONS: The goal of this survey is to measure how your health has been impacted

by your multiligament knee injury from a physical, emotional and social perspective. This

information will help us keep track of how you feel about your knee over time and after any sort

of treatment you may receive. Please answer every question by circling the number in the

appropriate box, only one number for each question. If you are unsure about how to answer a

question, please give the best answer you can.

P H Y S I C A L I M P A I R M E N T S

This first set of questions asks you about physical symptoms people sometimes experience

related to their knee. Please answer how often you have experienced each question in the last

month. There are no right or wrong answers.

HOW OFTEN DOES YOUR KNEE HURT.…

P A I N Never Rarely Sometimes Often Always

1. After sports and/or physical work? 0 1 2 3 4

2. When bending your knee? 0 1 2 3 4

3. When pivoting or twisting? 0 1 2 3 4

4. With prolonged standing? 0 1 2 3 4

5. While at rest? 0 1 2 3 4

P A I N

Never Rarely Sometimes Often Always

6. Do you experience ‘nerve pain’ (e.g., sharp, radiating pain; vibrations; electric sensation, crawling sensation)?

0 1 2 3 4

141

HOW OFTEN DOES YOUR KNEE GIVE WAY

(e.g., partial knee collapse; sense of knee slipping; wobbliness; you

don’t fall to the ground) …..

I N S T A B I L I T Y Never Rarely Sometimes Often Always

7. With sports and/or physical work)? 0 1 2 3 4

8. When walking on level ground (e.g., jerk or kick to the side)? 0 1 2 3 4

9. When going down stairs? 0 1 2 3 4

10. When twisting or pivoting? 0 1 2 3 4

HOW OFTEN DO YOU EXPERIENCE….

S T I F F N E S S Never Rarely Sometimes Often Always

11. Difficulty with sports and/or physical labour due to stiffness in your knee (e.g., inability to fully bend and/or straighten)?

0 1 2 3 4

12. Knee stiffness after first wakening in the morning? 0 1 2 3 4

13. Difficulty sleeping at night due to the stiffness in your knee? 0 1 2 3 4

14. Difficulty going up or down stairs due to stiffness in your knee?

0 1 2 3 4

15. Stiffness in your knee after sitting down for a long period of time (e.g., in a car, at the movie theatre, in a chair)?

0 1 2 3 4

16. Discomfort standing on your affected leg for several minutes or longer (e.g., leg fatigues)?

0 1 2 3 4

Continues on next page

142

HOW OFTEN…. W E A K N E S S

Never Rarely Sometimes Often Always

17. Does your knee feel weak with sports and/or physical labour (e.g., the muscles around your knee don’t feel strong)?

0 1 2 3 4

18. Does your knee or leg become easily tired after activity (e.g., fatigued)?

0 1 2 3 4

HOW OFTEN…. O T H E R

Never Rarely Sometimes Often Always

19. Do you have discomfort in other parts of your body because you are compensating for your knee injury?

0 1 2 3 4

20. Do you experience pins and needles and/or numbness in your affected leg?

0 1 2 3 4

21. Do you experience weakness in another joint due to your knee injury (e.g., foot or ankle; toes may catch and hit the floor while walking or running)?

0 1 2 3 4

22. Does your knee make you limp? 0 1 2 3 4

The next two questions ask what level or extent you are dependent on two different types of

assistive devices. If you do not use or require such devices please choose the answer, ‘not at

all’.

TO WHAT EXTENT ARE YOU DEPENDENT ON….

A S S I S T I V E D E V I C E S Not at all Slightly Moderately Quite a bit Extremely

23. An ankle brace (e.g., AFO) to support your leg? 0 1 2 3 4

24. A knee brace to support your knee? 0 1 2 3 4

Continues on next page

143

E M O T I O N A L I M P A I R M E N T S

People’s mood and/or emotions are sometimes affected because of their knee. This next set of

questions asks about such changes in mood and emotions. Please answer each question as it has

been experienced in the last month. There are no right or wrong answers.

TO WHAT EXTENT…. S E L F I M A G E

Not at all Slightly Moderately Quite a bit Extremely

25. Have you had to redefine your identity as a person due to your knee injury?

0 1 2 3 4

HOW OFTEN…. T R U S T

( I M M E D I A T E A P P R E H E N S I O N ) Never Rarely Sometimes Often Always

27. Are you troubled with lack of confidence or trust in your knee?

0 1 2 3 4

28. Are you nervous about crowds because you fear possible instability (e.g., collapsing, slipping or giving way) of your knee?

0 1 2 3 4

29. Do you fear your knee will give way during sports or recreation?

0 1 2 3 4

30. Are you apprehensive about participating in group activities or sports due to your knee?

0 1 2 3 4

31. Do you not trust your knee to support you under pressure?

0 1 2 3 4

HOW OFTEN…. S E L F I M A G E

Never Rarely Sometimes Often Always

26. Do you feel uncomfortable wearing shorts, skirts or tight clothing due to your injury?

0 1 2 3 4

144

HOW OFTEN…. T R U S T

( I M M E D I A T E A P P R E H E N S I O N ) Never Rarely Sometimes Often Always

32. Do you fear tripping or falling as a result of your injury?

0 1 2 3 4

HOW OFTEN…. F U T U R E C O N C E R N S

( A P P R E H E N S I O N ) Never Rarely Sometimes Often Always

33. Are you worried about what will happen to your knee in the future?

0 1 2 3 4

34. Do you fear reinjuring your knee through activity (including sports or work)?

0 1 2 3 4

35. Are you concerned about environmental conditions when participating in sports (e.g., uneven playing field, hard court or type of gym floor)?

0 1 2 3 4

36. Are you concerned about safety issues due to your knee (e.g., carrying small children, working in the yard)?

0 1 2 3 4

37. Are you concerned about time off work or school due to treatment of your knee?

0 1 2 3 4

38. Are you concerned about your financial well-being due to your knee injury?

0 1 2 3 4

Continues on next page

145

HOW OFTEN…. M O O D

Never Rarely Sometimes Often Always

39. Do you dwell on your injury when you are alone? 0 1 2 3 4

40. Has your enjoyment of life has been limited by your knee?

0 1 2 3 4

41. Do you find it difficult to psychologically “come to grips” with your knee problem?

0 1 2 3 4

42. Are you frustrated or discouraged by your knee? 0 1 2 3 4

43. Are you aware or conscious of your knee problem? 0 1 2 3 4

44. Are you depressed or sad due to knee pain or nerve pain?

0 1 2 3 4

Continues on next page

146

A C T I V I T Y L I M I T A T I O N S

This next set of questions asks you about the degree of difficulty you experience with simple

and complex activities as related to your knee. Please answer each question as it has been

experienced in the last month. There are no right or wrong answers.

DUE TO YOUR KNEE,

WHAT DEGREE OF DIFFICULTY DO YOU

HAVE….

S I M P L E / C O M P L E X A C T I V I T I E S None Mild Moderate Severe Extreme

45. Running straight ahead? 0 1 2 3 4

46. Quickly changing direction (e.g., twisting, pivoting or cutting side to side)?

0 1 2 3 4

47. Jumping? 0 1 2 3 4

48. Decelerating (e.g., stopping quickly)? 0 1 2 3 4

49. Standing? 0 1 2 3 4

50. Walking on uneven terrain? 0 1 2 3 4

51. Bending to pickup an object on the floor? 0 1 2 3 4

52. Rising from a chair? 0 1 2 3 4

53. Getting in and/or out of the bath/shower? 0 1 2 3 4

54. Managing in crowds? 0 1 2 3 4

55. Going “full out” (e.g., aggressively) during sports or recreation?

0 1 2 3 4

56. Going up and down stairs using one leg followed by the other in an alternate fashion?

0 1 2 3 4

57. Driving? 0 1 2 3 4

Continues on next page

147

Questions 58-60 refer to your ability to participate in various levels of physical work and/or

sports. Examples are provided below for your reference – Please refer to an activity that is most

pertinent to you.

• Light sports: bowling, golf, swimming, recreational biking

• Light physical work: cooking, dusting, ironing, raking leaves, painting walls

• Moderate sports: jogging, running, recreational skiing, tennis, competitive

bicycling/weightlifting

• Moderate physical work: carrying groceries, moving a table, climbing a ladder

• Vigorous sports: football, basketball, gymnastics, soccer, wresting

• Vigorous physical work: lifting heavy objects, construction work

DUE TO YOUR KNEE, WHAT DEGREE OF

DIFFICULTY DO YOU HAVE WITH…

P H Y S I C A L W O R K / S P O R T S None Mild Moderate Severe Extreme

58. Light physical work and/or sports? 0 1 2 3 4

59. Moderate physical work and/or sports? 0 1 2 3 4

60. Heavy physical work and/or sports? 0 1 2 3 4

Continues on next page

148

S O C I E T A L I N V O L V E M E N T

This next set of questions asks you about social limitations people sometimes experience related

to their knee. Please answer each question as it has been experienced in the last month. There

are no right or wrong answers.

TO WHAT EXTENT…. S O C I A L L I M I T A T I O N S

Not at all Slightly Moderately Quite a bit Extremely

61. Does your knee limit your participation in non-competitive sports or recreation?

0 1 2 3 4

62. Does your knee limit your participation in competitive sports?

0 1 2 3 4

63. Have you modified your work duties due to your knee condition?

0 1 2 3 4

64. Have you modified your lifestyle to avoid activities that are potentially damaging to your knee?

0 1 2 3 4

65. Has your fitness level decreased due to your knee condition? 0 1 2 3 4

66. Has your social network (e.g., friends, peers) been affected by your injury?

0 1 2 3 4

67. Have your future plans and long-term goals been impacted by your knee injury?

0 1 2 3 4

68. Has your independence been affected by your knee injury? 0 1 2 3 4

69. Have your leisure activities with your friends/family/significant other been affected by your knee injury?

0 1 2 3 4

70. Do you experience problems with intimacy (e.g., physical, platonic) with others as a result of your knee injury?

0 1 2 3 4

Continues on next page

149

The next two questions ask you give a global rating of how you have been affected by your knee condition.

O V E R A L L I M P R E S S I O N

Not at all Slightly Moderately Quite a bit Extremely

71. Considering all factors, to what extent does your knee affect your life?

0 1 2 3 4

O V E R A L L I M P R E S S I O N None Mild Moderate Severe Extreme

72. What is the overall degree of difficulty you have with sports and occupation related activities?

0 1 2 3 4

Continues on next page

150

The next two questions ask you about how active you have been before your injury (page 10) and over the last week (page 11). Please answer these questions specifically in the context of these two time frames.

Please checkmark the category that most closely represents your highest activity level during

the 12 months prior to your knee injury. (CHOOSE ONE)

10. competitive sports: national or international soccer

9. competitive sports: lower divisions of soccer; ice hockey, wrestling, gymnastics

8. competitive sports: squash or badminton, athletics (jumping, etc.), downhill skiing

7. competitive sports: tennis, athletics (running), motocross, speedway, handball,

basketball, cross-country running

recreational sports: soccer, ice hockey, squash, athletics (jumping), cross-country running

6. recreational sports: tennis, badminton, handball, basketball, downhill skiing, jogging at

least 5 times weekly

5. work: heavy labour such as construction, forestry recreational sports: jogging on uneven ground at least twice weekly competitive sports: cycling, cross-country skiing

4. work: moderately heavy labour such as truck driving, heavy domestic work recreational sports: jogging on uneven ground at least twice weekly

3. work: light labour such as nursing competitive and recreational sports: swimming, walking in forest possible

2. work: light labour walking on uneven ground possible, but impossible to walk in forest

1. work: sedentary work walking on even ground possible

0. sick leave or disability pension

Continues on next page

151

Please checkmark the category that most closely represents your highest activity level

during the last month. (CHOOSE ONE)

10. competitive sports: national or international soccer

9. competitive sports: lower divisions of soccer; ice hockey, wrestling, gymnastics

8. competitive sports: squash or badminton, athletics (jumping, etc.), downhill skiing

7. competitive sports: tennis, athletics (running), motocross, speedway, handball,

basketball, cross-country running

recreational sports: soccer, ice hockey, squash, athletics (jumping), cross-country running

6. recreational sports: tennis, badminton, handball, basketball, downhill skiing, jogging at

least 5 times weekly

5. work: heavy labour such as construction, forestry recreational sports: jogging on uneven ground at least twice weekly competitive sports: cycling, cross-country skiing

4. work: moderately heavy labour such as truck driving, heavy domestic work recreational sports: jogging on uneven ground at least twice weekly

3. work: light labour such as nursing competitive and recreational sports: swimming, walking in forest possible

2. work: light labour walking on uneven ground possible, but impossible to walk in forest

1. work: sedentary work walking on even ground possible

0. sick leave or disability pension

Continues on next page

152

The SF-36 General Quality of Life validated survey

Your Health and Well-Being

This survey asks for your views about your health. This information will help keep track of how you feel and how well you are able to do your usual activities. Thank you for completing this survey!

For each of the following questions, please mark an in the one box that

best describes your answer.

1. In general, would you say your health is:

Excellent Very good Good Fair Poor

1 2 3 4 5

2. Compared to one year ago, how would you rate your health in

general now?

Much better now than one

year ago

Somewhat better

now than one year ago

About the same as

one year ago

Somewhat worse

now than one year ago

Much worse now than one

year ago

1 2 3 4 5

153

3. The following questions are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much?

4. During the past 4 weeks, how much of the time have you had any of the following problems with your work or other regular daily activities as a result of your physical health?

All of the time

Most of the time

Some of the time

A little of the time

None of the time

a Cut down on the amount of time you spent on work or other activities ............................... 1 .............. 2 ............. 3 .............. 4 ............. 5

b Accomplished less than you would like ...................................... 1 .............. 2 ............. 3 .............. 4 ............. 5

c Were limited in the kind of work or other activities ................. 1 .............. 2 ............. 3 .............. 4 ............. 5

Yes, limited

a lot

Yes, limited a little

No, not limited at all

a Vigorous activities, such as running, lifting

heavy objects, participating in strenuous sports .................... 1 ............. 2 ............. 3

b Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf .......................... 1 ............. 2 ............. 3

c Lifting or carrying groceries ................................................. 1 ............. 2 ............. 3

d Climbing several flights of stairs .......................................... 1 ............. 2 ............. 3

e Climbing one flight of stairs ................................................. 1 ............. 2 ............. 3

f Bending, kneeling, or stooping ............................................. 1 ............. 2 ............. 3

g Walking more than a kilometre ............................................. 1 ............. 2 ............. 3

h Walking several hundred metres ........................................... 1 ............. 2 ............. 3

i Walking one hundred metres ................................................ 1 ............. 2 ............. 3

j Bathing or dressing yourself ................................................. 1 ............. 2 ............. 3

154

d Had difficulty performing the the work or other activities (for example, it took extra effort) ......... 1 .............. 2 ............. 3 .............. 4 ............. 5

5. During the past 4 weeks, how much of the time have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?

All of the time

Most of the time

Some of the time

A little of the time

None of the time

a Cut down on the amount of time you spent on work or other activities ............................... 1 .............. 2 ............. 3 .............. 4 ............. 5

b Accomplished less than you would like ...................................... 1 .............. 2 ............. 3 .............. 4 ............. 5

c Did work or other activities less carefully than usual ................ 1 .............. 2 ............. 3 .............. 4 ............. 5 6. During the past 4 weeks, to what extent has your physical health or

emotional problems interfered with your normal social activities with family, friends, neighbors, or groups?

Not at all Slightly Moderately Quite a bit Extremely

1 2 3 4 5

7. How much bodily pain have you had during the past 4 weeks?

None Very mild Mild Moderate Severe Very severe

1 2 3 4 5 6

155

8. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?

Not at all A little bit Moderately Quite a bit Extremely

1 2 3 4 5

9. These questions are about how you feel and how things have been with

you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4 weeks…

All of the time

Most of the time

Some of the time

A little of the time

None of the time

a Did you feel full of life? ................ 1 .............. 2 .............. 3 .............. 4 .............. 5

b Have you been very nervous? ....... 1 .............. 2 .............. 3 .............. 4 .............. 5

c Have you felt so down in the dumps that nothing could cheer you up? ................................ 1 .............. 2 .............. 3 .............. 4 .............. 5

d Have you felt calm and peaceful? ....................................... 1 .............. 2 .............. 3 .............. 4 .............. 5

e Did you have a lot of energy? ....... 1 .............. 2 .............. 3 .............. 4 .............. 5

f Have you felt downhearted and depressed? .............................. 1 .............. 2 .............. 3 .............. 4 .............. 5

g Did you feel worn out? .................. 1 .............. 2 .............. 3 .............. 4 .............. 5

h Have you been happy? .................. 1 .............. 2 .............. 3 .............. 4 .............. 5

i Did you feel tired? ......................... 1 .............. 2 .............. 3 .............. 4 .............. 5

156

10. During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?

All of the time

Most of the time

Some of the time

A little of the time

None of the time

1 2 3 4 5

11. How TRUE or FALSE is each of the following statements for you?

Definitely true

Mostly true

Don’t know

Mostly false

Definitely false

a I seem to get sick a little

easier than other people................. 1 .............. 2 .............. 3 .............. 4 .............. 5

b I am as healthy as anybody I know ............................. 1 .............. 2 ............. 3 .............. 4 ............. 5

c I expect my health to get worse ....................................... 1 .............. 2 ............. 3 .............. 4 ............. 5

d My health is excellent ................... 1 .............. 2 ............. 3 .............. 4 ............. 5

THANK YOU !

157

Appendix I RESEARCH PARTICPANT INFORMATION LETTER

Study Title: The Multi-Ligament Quality of Life Questionnaire (ML-QOL): Development

and Preliminary Statistical Testing in Patients with Multi-Ligament Knee Injuries

Dear potential participant,

You are being asked to consider taking part in a research study because you have a complex knee

injury that involves a tear of several of your knee ligaments. This study is a surgical resident

project (Master’s in Science thesis) conducted by Jaskarndip Chahal under the supervision of Dr.

Daniel Whelan at St. Michael’s Hospital.

This research study is being conducted in order to develop and test a questionnaire that will be able

to measure the impact of your knee injury on your physical, emotional and social well being – that

is, your overall quality of life. The enclosed questions have been put together by patients with knee

injuries such as yours. We are attempting to measure the impact of your knee injury on your

health from a global perspective. There are two parts which remain to be completed prior to the

development of the final questionnaire (see below). By taking 30-45 minutes to complete the

enclosed questionnaire you will assist in the development of the final version of the ‘multiligament

quality of life questionnaire’.

All information obtained during the study will be held in strict confidence. Taking part in this

research is voluntary. You will have treatment for your condition as you normally would if you were

not participating in this study. If you agree to participate in this research study, please complete

the enclosed questionnaire and return it using the enclosed envelope. If you choose not to

participate, you and your family will continue to have standard care or access to customary care at

St. Michael’s Hospital. If you decide to participate in this study you can change your mind without

giving a reason, and you may withdraw from the study at any time without any effect on the care

you and your family will receive at St. Michael’s Hospital. Any responses received up to the point of

withdrawal will still be used in the analyses.

The first part of study is demonstrated by your voluntary completion and submission of the

enclosed questionnaire. We would appreciate your response to all questions; however, none of the

individual questions are mandatory. Your name or any other identifying information will not be

collected on the survey. No one will be able to identify you or know your answers. A patient ID

number will be assigned to track completion of the questionnaire and for data analysis. A master

158

list linking this ID number will be maintained during the data collection phase. Once the study has

completed the list will be destroyed and your responses will be deemed anonymized.

For the second part of this study, we will be mailing out the questionnaire one final time in order

to test how reliable or ‘repeatable’ this questionnaire is. Please indicate below if, upon completing

the enclosed questionnaire, whether you would be willing to do so one more time approximately

one-two weeks after returning the current questionnaire. If you decide to fill out the questionnaire

and not participate in the second survey, we will still be able to use the data you provided from the

current completed questionnaire.

The results of this study may be presented at conferences, seminars or other public forums, and

published in journals, but no information will be used in these presentations that would disclose

your identity as a study participant. No information from this study will be released or printed that

would disclose your personal identity without your permission. Although your treating

physician/surgeon has identified you as a potential participant, he will have no knowledge of your

individual answers. Your responses will be kept strictly confidential throughout the data collection,

analysis, and publication phases of the study.

As a token of our appreciation for your consideration and potential participation in this study, we

have included a gift certificate from Tim Horton’s at a value of $10. Please kindly accept this on our

behalf.

If you have any general questions about the study, please call the co-investigator in this study, Dr.

Jaskarndip Chahal, at (416) 893-1230. If you have any questions regarding your rights as a

research participant in this study, you may contact the Chair of the St. Michael’s Research Ethics

Board, at (416) 864-6060 x2557, during business hours.

Please mark one of the following with an “X”:

___ I would like to participate in the second questionnaire mailout in 1-2 weeks.

OR

___ I would not like to participate in the second questionnaire mailout in 1-2 weeks.

159

Sincerely,

_____________________________________________________

Dr. Daniel Whelan MD, MSc, FRCS(C)

Associate Professor,

Division of Orthopaedics, Department of Surgery

University of Toronto

St. Michael’s Hospital

Toronto, ON

Co-Investigators:

(1) Dr. Jaskarndip (Jas) Chahal, MD; Resident Physician, Division of Orthopaedics, Department of

Surgery, University of Toronto, Toronto, ON

(2) Dr. Aileen Davis, PhD; Senior Scientist, Toronto Western Hospital Research Institute, Toronto,

ON

(3) Dr. Susan Jaglal, PhD; Senior Scientist, Department of Health Policy, Management and

Evaluation, University of Toronto, Toronto, ON

(4) Dr. Peter Smith, PhD; Scientist, Institute of Work and Health, University of Toronto, Toronto,

ON

160

Appendix J

ML-QOL SCREENING QUESTIONNAIRE

FOR DETERMINING PARTICIPANT ELIGIBILITY BASED ON CHART/DATABASE

REVIEW

Unique ID Number: ______

Date (dd/mm/yyyy): ______

Respondent’s Age: _______ (If less than 16, older than 60, EXCLUDE)

Gender: Male Female

1. Does this patient have one of the following multiligament knee injury patterns? If yes, please circle the appropriate choice. If no, EXCLUDE.

a. ACL + PCL torn only b. ACL + PCL + POSTEROLATERAL CORNER (ex. lateral collateral ligament,

popliteus tendon) torn c. ACL + PCL + POSTEROMEDIAL CORNER (ex. medial collateral ligament,

semimembranosus) torn d. ACL + PCL + POSTEROLATERAL CORNER + POSTEROMEDIAL

CORNER torn

2. Is the patient at least 6 months from the date of injury? If no, EXCLUDE.

No Yes

3. If this patient had multiple systemic injuries at the time of presentation, was the documented

Injury Severity Score >15? If yes, EXCLUDE.

No Yes

4. Does this patient have radiographic evidence of osteoarthritis (> grade 2 osteoarthritic changes

according to the Kellgren and Lawrence grading system) or inflammatory arthritis at the time of

injury or first-time clinical evaluation? If yes, EXCLUDE.

No Yes

161

If a Kellgren Lawrence grade cannot be assigned, please describe the findings from the initial knee xray by the radiologist. Patients to pre-existing moderate to severe osteoarthritis should be EXCLUDED. ______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________

5. Did this patient sustain an intracerebral/spinal cord injury at the time of initial presentation? If

yes, EXCLUDE.

No Yes

BASED ON THE AFORMENTIONED QUESTIONS, IS THIS PATIENTS

ELIGIBLE FOR ENROLLMENT IN THE CURRENT STUDY?

No Yes

Date 1st Questionnaire Mailed (dd/mm/yyyy): __________

Date 1st Questionnaire Received (dd/mm/yyyy): __________

Date Questionnaire Mailed for 2nd time if patient consents to test-retest phase (dd/mm/yyyy): ______________

Date 2nd Questionnaire Mailed received (dd/mm/yyyy): ______________

Initials of Research Assistant (RA): ______ Email for RA: ______ Phone

Number

162

Appendix K

163

Appendix L

Responses to the Mailed Preliminary Consolidated Questionnaire by Frequency Distribution,

Mean, Median, and Standard Deviation.

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF1 0 (0.0) 15 (25.0) 23 (38.3) 13 (21.7) 9 (15.0) 3.27 3.0 1.01

QI1 2 (3.3) 10 (16.7) 14 (23.3) 20 (33.3) 14 (23.3) 3.57 4.0 1.13

QF2 9 (15.0) 16 (26.7) 14 (23.3) 11 (18.3) 10 (16.7) 2.95 3.0 1.32

QI2 4 (6.7) 6 (10.0) 13 (21.7) 28 (46.7) 9 (15.0) 3.53 4.0 1.08

QF3 19 (31.7) 19 (31.7) 9 (15.0) 7 (11.7) 6 (10.0) 2.37 2.0 1.31

QI3 6 (10.0) 4 (6.7) 9 (15.0) 21 (35.0) 20 (33.3) 3.75 4.0 1.27

QF4 20 (33.9) 18 (30.5) 15 (25.4) 5 (8.5) 1 (1.7) 2.14 2.0 1.04

QI4 5 (8.3) 6 (10.0) 6 (10.0) 24 (40.0) 19 (31.7) 3.77 4.0 1.24

QF5 5 (8.3) 8 (13.3) 16 (26.7) 23 (38.3) 8 (13.3) 3.35 4.0 1.13

QI5 4 (6.8) 7 (11.9) 16 (27.1) 18 (30.5) 14 (23.7) 3.53 4.0 1.18

QF6 10 (16.7) 19 (31.7) 15 (25.0) 6 (10.0) 10 (16.7) 2.78 3.0 1.32

QI6 5 (8.3) 12 (20.0) 11 (18.3) 17 (28.3) 15 (25.0) 3.42 4.0 1.29

QF6a 29 (48.3) 9 (15.0) 11 (18.3) 5 (8.3) 6 (10.0) 2.17 2.0 1.38

QI6a 7 (11.9) 10 (17.0) 12 (20.3) 15 (25.4) 15 (25.4) 3.36 4.0 1.35

QF7 17 (28.8) 16 (27.1) 15 (25.4) 8 (13.6) 3 (5.1) 2.39 2.0 1.19

QI7 4 (6.8) 6 (10.2) 6 (10.2) 21 (35.6) 22 (37.3) 3.86 4.0 1.22

QF8 48 (80.0) 7 (11.7) 3 (5.0) 2 (3.3) 0 (0.0) 1.32 1.0 0.72

QI8 9 (15.0) 2 (3.3) 5 (8.3) 10 (16.7) 34 (56.7) 3.97 5.0 1.47

164

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF9 36 (60.0) 12 (20.0) 10 (16.7) 2 (3.3) 0 (0.0) 1.63 1.0 0.88

QI9 17 (28.3) 5 (8.3) 10 (16.7) 16 (26.7) 12 (20.0) 3.02 3.0 1.52

QF10 43 (72.9) 12 (20.3) 2 (3.4) 2 (3.4) 0 (0.0) 1.37 1.0 0.72

QI10 19 (32.2) 3 (5.1) 6 (10.2) 17 (28.8) 14 (23.7) 3.07 4.0 1.62

QF11 11 (18.6) 10 (17.0) 19 (32.2) 8 (13.6) 11 (18.6) 2.97 3.0 1.35

QI11 9 (15.3) 7 (11.9) 10 (17.0) 18 (30.5) 15 (25.4) 3.39 4.0 1.39

QF12 6 (10.0) 12 (20.0) 12 (20.0) 17 (28.3) 13 (21.7) 3.32 3.5 1.30

QI12 4 (6.8) 2 (3.4) 7 (11.9) 23 (39.0) 23 (39.0) 4.00 4.0 1.13

QF13 27 (45.8) 6 (10.2) 4 (6.8) 10 (17.0) 12 (20.3) 2.56 2.0 1.66

QI13 12 (20.3) 13 (22.0) 12 (20.3) 8 (13.6) 14 (23.7) 2.98 3.0 1.47

QF14 7 (11.7) 15 (25.0) 20 (33.3) 8 (13.3) 10 (16.7) 2.98 3.0 1.24

QI14 5 (8.3) 3 (5.0) 15 (25.0) 20 (33.3) 17 (28.3) 3.68 4.0 1.19

QF15 14 (23.3) 13 (21.7) 17 (28.3) 10 (16.7) 6 (10.0) 2.68 3.0 1.28

QI15 8 (13.3) 3 (5.0) 15 (25.0) 16 (26.7) 18 (30.0) 3.55 4.0 1.33

QF16 4 (6.7) 7 (11.7) 17 (28.3) 14 (23.3) 18 (30.0) 3.58 4.0 1.23

QI16 4 (6.7) 1 (1.7) 13 (21.7) 24 (40.0) 18 (30.0) 3.85 4.0 1.09

QF17 10 (16.7) 9 (15.0) 21 (35.0) 12 (20.0) 8 (13.3) 2.98 3.0 1.26

QI17 5 (8.3) 1 (1.7) 16 (26.7) 23 (38.3) 15 (25.0) 3.70 4.0 1.12

QF18 18 (30.0) 13 (21.7) 16 (26.7) 10 (16.7) 3 (5.0) 2.45 2.0 1.23

QI18 8 (13.3) 7 (11.7) 13 (21.7) 22 (36.7) 10 (16.7) 3.32 4.0 1.27

QF19 22 (37.3) 13 (22.0) 15 (25.4) 6 (10.2) 3 (5.1) 2.24 2.0 1.21

165

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QI19 8 (13.6) 7 (11.9) 17 (28.8) 17 (28.8) 10 (17.0) 3.24 3.0 1.26

QF20 8 (13.3) 20 (33.3) 18 (30.0) 8 (13.3) 6 (10.0) 2.73 3.0 1.16

QI20 7 (11.7) 8 (13.3) 15 (25.0) 21 (35.0) 9 (15.0) 3.28 3.5 1.22

QF21 21 (35.0) 18 (30.0) 14 (23.3) 5 (8.3) 2 (3.3) 2.15 2.0 1.10

QI21 11 (18.3) 4 (6.7) 12 (20.0) 18 (30.0) 15 (25.0) 3.37 4.0 1.41

QF22 6 (10.0) 21 (35.0) 11 (18.3) 12 (20.0) 10 (16.7) 2.98 3.0 1.28

QI22 4 (6.7) 7 (11.7) 15 (25.0) 20 (33.3) 14 (23.3) 3.55 4.0 1.17

QF23 7 (11.7) 16 (26.7) 14 (23.3) 12 (20.0) 11 (18.3) 3.07 3.0 1.30

QI23 6 (10.0) 5 (8.3) 13 (21.7) 16 (26.7) 20 (33.3) 3.65 4.0 1.30

QF24 9 (15.3) 12 (20.3) 19 (32.2) 9 (15.3) 10 (17.0) 2.98 3.0 1.29

QI24 7 (11.9) 6 (10.2) 11 (18.6) 16 (27.1) 19 (32.2) 3.58 4.0 1.35

QF25 3 (5.0) 13 (21.7) 22 (36.7) 13 (21.7) 9 (15.0) 3.20 3.0 1.10

QI25 4 (6.7) 1 (1.7) 13 (21.7) 18 (30.0) 24 (40.0) 3.95 4.0 1.14

QF26 25 (41.7) 15 (25.0) 9 (15.0) 8 (13.3) 3 (5.0) 2.15 2.0 1.25

QI26 12 (20.0) 8 (13.3) 10 (16.7) 17 (28.3) 13 (21.7) 3.18 3.5 1.44

QF27 8 (13.3) 13 (21.7) 12 (20.0) 15 (25.0) 12 (20.0) 3.17 3.0 1.34

QI27 6 (10.0) 8 (13.3) 23 (38.3) 13 (21.7) 10 (16.7) 3.22 3.0 1.18

QF28 7 (11.7) 11 (18.3) 17 (28.3) 17 (28.3) 8 (13.3) 3.13 3.0 1.21

QI28 7 (11.7) 5 (8.3) 20 (33.3) 17 (28.3) 11 (18.3) 3.33 3.0 1.22

QF29 11 (18.3) 12 (20.0) 11 (18.3) 10 (16.7) 16 (26.7) 3.13 3.0 1.48

QI29 7 (11.7) 2 (3.3) 5 (8.3) 16 (26.7) 30 (50.0) 4.00 4.5 1.34

166

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF30 14 (23.3) 20 (33.3) 11 (18.3) 8 (13.3) 7 (11.7) 2.57 2.0 1.31

QI30 11 (18.3) 4 (6.7) 12 (20.0) 15 (25.0) 18 (30.0) 3.42 4.0 1.45

QF31 13 (21.7) 12 (20.0) 13 (21.7) 11 (18.3) 11 (18.3) 2.92 3.0 1.42

QI31 6 (10.0) 10 (16.7) 8 (13.3) 19 (31.7) 17 (28.3) 3.52 4.0 1.33

QF32 24 (40.0) 14 (23.3) 13 (21.7) 6 (10.0) 3 (5.0) 2.17 2.0 1.21

QI32 12 (20.0) 9 (15.0) 11 (18.3) 16 (26.7) 12 (20.0) 3.12 3.0 1.43

QF33 23 (38.3) 14 (23.3) 10 (16.7) 8 (13.3) 5 (8.3) 2.30 2.0 1.33

QI33 11 (18.3) 4 (6.7) 9 (15.0) 19 (31.7) 17 (28.3) 3.45 4.0 1.44

QF34 25 (41.7) 12 (20.0) 14 (23.3) 4 (6.7) 5 (8.3) 2.20 2.0 1.29

QI34 10 (16.7) 4 (6.7) 9 (15.0) 14 (23.3) 23 (38.3) 3.60 4.0 1.48

QF35 14 (23.3) 4 (6.7) 14 (23.3) 14 (23.3) 14 (23.3) 3.17 3.0 1.47

QI35 7 (11.7) 3 (5.0) 6 (10.0) 18 (30.0) 26 (43.3) 3.88 4.0 1.34

QF36 9 (15.0) 9 (15.0) 20 (33.3) 7 (11.7) 15 (25.0) 3.17 3.0 1.37

QI36 6 (10.0) 2 (3.3) 11 (18.3) 15 (25.0) 26 (43.3) 3.88 4.0 1.29

QF37 20 (33.3) 16 (26.7) 18 (30.0) 4 (6.7) 2 (3.3) 2.20 2.0 1.09

QI37 8 (13.3) 8 (13.3) 9 (15.0) 23 (38.3) 12 (20.0) 3.38 4.0 1.32

QF37a 12 (20.0) 9 (15.0) 18 (30.0) 13 (21.7) 8 (13.3) 2.93 3.0 1.31

QI37a 6 (10.0) 3 (5.0) 9 (15.0) 23 (38.3) 19 (31.7) 3.77 4.0 1.24

QF37b 4 (6.7) 6 (10.0) 16 (26.7) 9 (15.0) 25 (41.7) 3.75 4.0 1.28

QI37b 6 (10.0) 4 (6.7) 9 (15.0) 17 (28.3) 24 (40.0) 3.82 4.0 1.31

QF38 25 (41.7) 13 (21.7) 11 (18.3) 5 (8.3) 6 (10.0) 2.23 2.0 1.35

167

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QI38 12 (20.0) 8 (13.3) 13 (21.7) 14 (23.3) 13 (21.7) 3.13 3.0 1.43

QF38a 17 (28.3) 13 (21.7) 12 (20.0) 11 (18.3) 7 (11.7) 2.63 2.5 1.38

QI38a 11 (18.3) 4 (6.7) 14 (23.3) 17 (28.3) 14 (23.3) 3.32 4.0 1.40

QF38b 11 (18.3) 10 (16.7) 13 (21.7) 7 (11.7) 19 (31.7) 3.22 3.0 1.51

QI38b 9 (15.0) 5 (8.3) 14 (23.3) 16 (26.7) 16 (26.7) 3.42 4.0 1.37

QF39 25 (41.7) 20 (33.3) 13 (21.7) 2 (3.3) 0 (0.0) 1.87 2.0 0.87

QI39 9 (15.0) 2 (3.3) 14 (23.3) 18 (30.0) 17 (28.3) 3.53 4.0 1.35

QF39a 20 (33.3) 16 (26.7) 15 (25.0) 8 (13.3) 1 (1.7) 2.23 2.0 1.11

QI39a 7 (11.9) 3 (5.1) 15 (25.4) 19 (32.2) 15 (25.4) 3.54 4.0 1.26

QF39b 20 (33.9) 11 (18.6) 13 (22.0) 7 (11.9) 8 (13.6) 2.53 2.0 1.42

QI39b 9 (15.3) 0 (0.0) 13 (22.0) 18 (30.5) 19 (32.2) 3.64 4.0 1.35

QF40 36 (60.0) 15 (25.0) 8 (13.3) 1 (1.7) 0 (0.0) 1.57 1.0 0.79

QI40 16 (26.7) 5 (8.3) 14 (23.3) 10 (16.7) 15 (25.0) 3.05 3.0 1.53

QF40a 35 (58.3) 13 (21.7) 7 (11.7) 5 (8.3) 0 (0.0) 1.70 1.0 0.98

QI40a 15 (25.0) 4 (6.7) 15 (25.0) 12 (20.0) 14 (23.3) 3.10 3.0 1.49

QF40b 35 (58.3) 10 (16.7) 6 (10.0) 6 (10.0) 3 (5.0) 1.87 1.0 1.24

QI40b 15 (25.0) 4 (6.7) 13 (21.7) 13 (21.7) 15 (25.0) 3.15 3.0 1.52

QF41 45 (75.0) 10 (16.7) 5 (8.3) 0 (0.0) 0 (0.0) 1.33 1.0 0.63

QI41 21 (35.0) 5 (8.3) 9 (15.0) 12 (20.0) 13 (21.7) 2.85 3.0 1.60

QF41a 45 (75.0) 6 (10.0) 7 (11.7) 2 (3.3) 0 (0.0) 1.43 1.0 0.83

QI41a 19 (31.7) 5 (8.3) 12 (20.0) 12 (20.0) 12 (20.0) 2.88 3.0 1.54

168

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF41b 44 (73.3) 7 (11.7) 4 (6.7) 4 (6.7) 1 (1.7) 1.52 1.0 1.00

QI41b 19 (32.2) 5 (8.5) 7 (11.9) 15 (25.4) 13 (22.0) 2.97 3.0 1.60

QF42 12 (20.3) 11 (18.6) 15 (25.4) 11 (18.6) 10 (17.0) 2.93 3.0 1.38

QI42 10 (16.7) 2 (3.3) 7 (11.7) 18 (30.0) 23 (38.3) 3.70 4.0 1.44

QF42a 10 (17.0) 10 (17.0) 7 (11.9) 16 (27.1) 16 (27.1) 3.31 4.0 1.47

QI42a 9 (15.0) 4 (6.7) 8 (13.3) 16 (26.7) 23 (38.3) 3.67 4.0 1.43

QF42b 14 (25.0) 3 (5.4) 7 (12.5) 7 (12.5) 25 (44.6) 3.46 4.0 1.67

QI42b 13 (22.4) 6 (10.3) 6 (10.3) 9 (15.5) 24 (41.4) 3.43 4.0 1.63

QF43 21 (35.0) 13 (21.7) 7 (11.7) 11 (18.3) 8 (13.3) 2.53 2.0 1.47

QI43 11 (18.3) 7 (11.7) 10 (16.7) 12 (20.0) 20 (33.3) 3.38 4.0 1.51

QF43a 20 (33.3) 5 (8.3) 13 (21.7) 13 (21.7) 9 (15.0) 2.77 3.0 1.49

QI43a 11 (18.3) 7 (11.7) 11 (18.3) 13 (21.7) 18 (30.0) 3.33 4.0 1.48

QF43b 20 (34.5) 6 (10.3) 7 (12.1) 7 (12.1) 18 (31.0) 2.95 3.0 1.70

QI43b 14 (24.1) 6 (10.3) 7 (12.1) 12 (20.7) 19 (32.8) 3.28 4.0 1.60

QF44 26 (44.1) 18 (30.5) 8 (13.6) 3 (5.1) 4 (6.8) 2.00 2.0 1.19

QI44 12 (20.0) 3 (5.0) 9 (15.0) 14 (23.3) 22 (36.7) 3.52 4.0 1.52

QF44a 27 (45.8) 12 (20.3) 7 (11.9) 10 (17.0) 3 (5.1) 2.15 2.0 1.31

QI44a 15 (25.0) 4 (6.7) 6 (10.0) 16 (26.7) 19 (31.7) 3.33 4.0 1.59

QF44b 28 (49.1) 7 (12.3) 7 (12.3) 5 (8.8) 10 (17.5) 2.33 2.0 1.57

QI44b 19 (32.2) 4 (6.8) 3 (5.1) 13 (22.0) 20 (33.9) 3.19 4.0 1.72

QF45 39 (65.0) 8 (13.3) 7 (11.7) 4 (6.7) 2 (3.3) 1.70 1.0 1.12

169

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QI45 20 (33.3) 6 (10.0) 8 (13.3) 11 (18.3) 15 (25.0) 2.92 3.0 1.63

QF45a 38 (63.3) 8 (13.3) 5 (8.3) 7 (11.7) 2 (3.3) 1.78 1.0 1.21

QI45a 20 (33.9) 3 (5.1) 9 (15.3) 11 (18.6) 16 (27.1) 3.00 3.0 1.65

QF45b 37 (61.7) 11 (18.3) 3 (5.0) 1 (1.7) 8 (13.3) 1.87 1.0 1.40

QI45b 23 (38.3) 5 (8.3) 6 (10.0) 11 (18.3) 15 (25.0) 2.83 3.0 1.68

QF46 45 (75.0) 8 (13.3) 3 (5.0) 3 (5.0) 1 (1.7) 1.45 1.0 0.93

QI46 23 (38.3) 6 (10.0) 6 (10.0) 13 (21.7) 12 (20.0) 2.75 3.0 1.62

QF46a 46 (76.7) 5 (8.3) 2 (3.3) 5 (8.3) 2 (3.3) 1.53 1.0 1.11

QI46a 23 (38.3) 4 (6.7) 8 (13.3) 13 (21.7) 12 (20.0) 2.78 3.0 1.62

QF46b 45 (75.0) 7 (11.7) 0 (0.0) 3 (5.0) 5 (8.3) 1.60 1.0 1.25

QI46b 25 (41.7) 5 (8.3) 6 (10.0) 10 (16.7) 14 (23.3) 2.72 2.5 1.68

QF47 0 (0.0) 2 (3.3) 2 (3.3) 12 (20.0) 44 (73.3) 4.63 5.0 0.71

QI47 0 (0.0) 4 (6.7) 8 (13.3) 17 (28.3) 31 (51.7) 4.25 5.0 0.93

QF48 0 (0.0) 3 (5.0) 7 (11.7) 21 (35.0) 29 (48.3) 4.27 4.0 0.86

QI48 0 (0.0) 5 (8.3) 6 (10.0) 24 (40.0) 25 (41.7) 4.15 4.0 0.92

QF49 2 (3.4) 5 (8.5) 15 (25.4) 15 (25.4) 22 (37.3) 3.85 4.0 1.13

QI49 4 (6.9) 4 (6.9) 9 (15.5) 12 (20.7) 29 (50.0) 4.00 4.5 1.26

QF50 3 (5.0) 10 (16.7) 14 (23.3) 19 (31.7) 14 (23.3) 3.52 4.0 1.17

QI50 4 (6.7) 4 (6.7) 9 (15.0) 17 (28.3) 26 (43.3) 3.95 4.0 1.21

QF51 1 (1.7) 2 (3.4) 7 (11.9) 14 (23.7) 35 (59.3) 4.36 5.0 0.94

QI51 1 (1.7) 2 (3.3) 11 (18.3) 14 (23.3) 32 (53.3) 4.23 5.0 0.98

170

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF52 4 (6.7) 10 (16.7) 11 (18.3) 14 (23.3) 21 (35.0) 3.63 4.0 1.30

QI52 4 (6.7) 2 (3.3) 3 (5.0) 18 (30.0) 33 (55.0) 4.23 5.0 1.14

QF53 1 (1.7) 2 (3.3) 7 (11.7) 11 (18.3) 39 (65.0) 4.42 5.0 0.94

QI53 2 (3.3) 2 (3.3) 10 (16.7) 12 (20.0) 34 (56.7) 4.23 5.0 1.06

QF54 2 (3.3) 1 (1.7) 4 (6.7) 5 (8.3) 48 (80.0) 4.60 5.0 0.94

QI54 4 (6.7) 4 (6.7) 6 (10.0) 14 (23.3) 32 (53.3) 4.10 5.0 1.23

QF55 2 (3.3) 0 (0.0) 8 (13.3) 11 (18.3) 39 (65.0) 4.42 5.0 0.96

QI55 1 (1.7) 2 (3.3) 4 (6.7) 18 (30.0) 35 (58.3) 4.40 5.0 0.89

QF56 4 (6.8) 2 (3.4) 11 (18.6) 14 (23.7) 28 (47.5) 4.02 4.0 1.20

QI56 3 (5.1) 4 (6.8) 7 (11.9) 13 (22.0) 32 (54.2) 4.14 5.0 1.18

QF57 1 (1.7) 3 (5.0) 9 (15.0) 14 (23.3) 33 (55.0) 4.25 5.0 1.00

QI57 1 (1.7) 1 (1.7) 6 (10.0) 14 (23.3) 38 (63.3) 4.45 5.0 0.87

QF58 10 (16.7) 14 (23.3) 15 (25.0) 13 (21.7) 8 (13.3) 2.92 3.0 1.29

QI58 10 (16.7) 6 (10.0) 7 (11.7) 16 (26.7) 21 (35.0) 3.53 4.0 1.48

QF59 13 (21.7) 8 (13.3) 13 (21.7) 11 (18.3) 15 (25.0) 3.12 3.0 1.49

QI59 7 (11.7) 8 (13.3) 9 (15.0) 18 (30.0) 18 (30.0) 3.53 4.0 1.36

QF60 10 (16.7) 11 (18.3) 10 (16.7) 11 (18.3) 18 (30.0) 3.27 3.0 1.48

QI60 9 (15.0) 6 (10.0) 11 (18.3) 11 (18.3) 23 (38.3) 3.55 4.0 1.47

QF61 3 (5.1) 10 (17.0) 13 (22.0) 9 (15.3) 24 (40.7) 3.69 4.0 1.30

QI61 6 (10.2) 5 (8.5) 9 (15.3) 15 (25.4) 24 (40.7) 3.78 4.0 1.34

QF62 3 (5.0) 9 (15.0) 14 (23.3) 15 (25.0) 19 (31.7) 3.63 4.0 1.22

171

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QI62 2 (3.3) 8 (13.3) 6 (10.0) 17 (28.3) 27 (45.0) 3.98 4.0 1.19

QF63 9 (15.0) 14 (23.3) 9 (15.0) 13 (21.7) 15 (25.0) 3.18 3.0 1.43

QI63 8 (13.6) 7 (11.9) 11 (18.6) 15 (25.4) 18 (30.5) 3.47 4.0 1.39

QF64 3 (5.1) 12 (20.3) 16 (27.1) 15 (25.4) 13 (22.0) 3.39 3.0 1.19

QI64 6 (10.2) 3 (5.1) 11 (18.6) 24 (40.7) 15 (25.4) 3.66 4.0 1.21

QF65 10 (16.7) 17 (28.3) 16 (26.7) 12 (20.0) 5 (8.3) 2.75 3.0 1.20

QI65 4 (6.7) 8 (13.3) 10 (16.7) 16 (26.7) 22 (36.7) 3.73 4.0 1.27

QF66 1 (1.7) 10 (17.0) 12 (20.3) 14 (23.7) 22 (37.3) 3.78 4.0 1.18

QI66 3 (5.0) 6 (10.0) 13 (21.7) 22 (36.7) 16 (26.7) 3.70 4.0 1.12

QF67 8 (13.3) 17 (28.3) 12 (20.0) 11 (18.3) 12 (20.0) 3.03 3.0 1.35

QI67 7 (11.7) 8 (13.3) 8 (13.3) 20 (33.3) 17 (28.3) 3.53 4.0 1.35

QF68 23 (38.3) 12 (20.0) 15 (25.0) 5 (8.3) 5 (8.3) 2.28 2.0 1.29

QI68 9 (15.0) 4 (6.7) 13 (21.7) 17 (28.3) 17 (28.3) 3.48 4.0 1.37

QF69 2 (3.3) 4 (6.7) 11 (18.3) 9 (15.0) 34 (56.7) 4.15 5.0 1.15

QI69 0 (0.0) 4 (6.7) 10 (16.7) 25 (41.7) 21 (35.0) 4.05 4.0 0.89

QF70 22 (36.7) 15 (25.0) 13 (21.7) 8 (13.3) 2 (3.3) 2.22 2.0 1.18

QI70 11 (18.6) 8 (13.6) 5 (8.5) 19 (32.2) 16 (27.1) 3.36 4.0 1.48

QF71 15 (25.0) 16 (26.7) 13 (21.7) 11 (18.3) 5 (8.3) 2.58 2.0 1.28

QI71 9 (15.0) 7 (11.7) 9 (15.0) 18 (30.0) 17 (28.3) 3.45 4.0 1.41

QF72 22 (36.7) 17 (28.3) 8 (13.3) 8 (13.3) 5 (8.3) 2.28 2.0 1.32

QI72 13 (22.0) 5 (8.5) 10 (17.0) 17 (28.8) 14 (23.7) 3.24 4.0 1.48

172

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF73 23 (38.3) 13 (21.7) 15 (25.0) 7 (11.7) 2 (3.3) 2.20 2.0 1.18

QI73 9 (15.0) 6 (10.0) 12 (20.0) 15 (25.0) 18 (30.0) 3.45 4.0 1.41

QF74 8 (13.3) 13 (21.7) 14 (23.3) 13 (21.7) 12 (20.0) 3.13 3.0 1.33

QI74 4 (6.7) 4 (6.7) 12 (20.0) 19 (31.7) 21 (35.0) 3.82 4.0 1.19

QF75 9 (15.0) 11 (18.3) 10 (16.7) 18 (30.0) 12 (20.0) 3.22 3.5 1.37

QI75 6 (10.0) 2 (3.3) 9 (15.0) 18 (30.0) 25 (41.7) 3.90 4.0 1.27

QF76 8 (13.3) 10 (16.7) 16 (26.7) 11 (18.3) 15 (25.0) 3.25 3.0 1.36

QI76 6 (10.0) 1 (1.7) 12 (20.0) 18 (30.0) 23 (38.3) 3.85 4.0 1.25

QF77 9 (15.0) 13 (21.7) 15 (25.0) 11 (18.3) 12 (20.0) 3.07 3.0 1.35

QI77 6 (10.2) 8 (13.6) 13 (22.0) 14 (23.7) 18 (30.5) 3.51 4.0 1.33

QF78 24 (40.0) 10 (16.7) 14 (23.3) 8 (13.3) 4 (6.7) 2.30 2.0 1.31

QI78 15 (25.0) 4 (6.7) 9 (15.0) 16 (26.7) 16 (26.7) 3.23 4.0 1.54

QF79 10 (16.7) 13 (21.7) 16 (26.7) 11 (18.3) 10 (16.7) 2.97 3.0 1.33

QI79 8 (13.3) 9 (15.0) 15 (25.0) 12 (20.0) 16 (26.7) 3.32 3.0 1.37

QF80 21 (35.0) 12 (20.0) 11 (18.3) 9 (15.0) 7 (11.7) 2.48 2.0 1.41

QI80 13 (21.7) 11 (18.3) 10 (16.7) 13 (21.7) 13 (21.7) 3.03 3.0 1.47

QF81 17 (28.3) 16 (26.7) 12 (20.0) 4 (6.7) 11 (18.3) 2.60 2.0 1.44

QI81 11 (18.3) 9 (15.0) 12 (20.0) 15 (25.0) 13 (21.7) 3.17 3.0 1.42

QF82 20 (33.3) 14 (23.3) 15 (25.0) 3 (5.0) 8 (13.3) 2.42 2.0 1.36

QI82 13 (21.7) 12 (20.0) 15 (25.0) 10 (16.7) 10 (16.7) 2.87 3.0 1.38

QF83 20 (33.3) 14 (23.3) 17 (28.3) 3 (5.0) 6 (10.0) 2.35 2.0 1.27

173

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QI83 13 (21.7) 11 (18.3) 16 (26.7) 11 (18.3) 9 (15.0) 2.87 3.0 1.36

QF84 23 (38.3) 18 (30.0) 12 (20.0) 2 (3.3) 5 (8.3) 2.13 2.0 1.21

QI84 12 (20.0) 14 (23.3) 9 (15.0) 13 (21.7) 12 (20.0) 2.98 3.0 1.44

QF85 36 (60.0) 7 (11.7) 9 (15.0) 5 (8.3) 3 (5.0) 1.87 1.0 1.24

QI85 16 (26.7) 4 (6.7) 10 (16.7) 13 (21.7) 17 (28.3) 3.18 3.5 1.58

QF86 49 (81.7) 8 (13.3) 0 (0.0) 2 (3.3) 1 (1.7) 1.30 1.0 0.79

QI86 25 (41.7) 3 (5.0) 9 (15.0) 5 (8.3) 18 (30.0) 2.80 3.0 1.73

QF87 3 (5.1) 5 (8.5) 14 (23.7) 13 (22.0) 24 (40.7) 3.85 4.0 1.20

QI87 3 (5.0) 4 (6.7) 10 (16.7) 15 (25.0) 28 (46.7) 4.02 4.0 1.17

QF88 5 (8.3) 9 (15.0) 14 (23.3) 9 (15.0) 23 (38.3) 3.60 4.0 1.36

QI88 3 (5.1) 4 (6.8) 8 (13.6) 14 (23.7) 30 (50.9) 4.08 5.0 1.18

QF89 8 (13.3) 6 (10.0) 7 (11.7) 5 (8.3) 34 (56.7) 3.85 5.0 1.52

QI89 4 (6.7) 6 (10.0) 7 (11.7) 12 (20.0) 31 (51.7) 4.00 5.0 1.29

QF90 2 (3.3) 6 (10.0) 11 (18.3) 11 (18.3) 30 (50.0) 4.02 4.5 1.19

QI90 3 (5.0) 5 (8.3) 10 (16.7) 19 (31.7) 23 (38.3) 3.90 4.0 1.16

QF91 2 (3.3) 5 (8.3) 10 (16.7) 10 (16.7) 33 (55.0) 4.12 5.0 1.17

QI91 3 (5.0) 3 (5.0) 11 (18.3) 17 (28.3) 26 (43.3) 4.00 4.0 1.13

QF92 4 (6.7) 9 (15.0) 13 (21.7) 11 (18.3) 23 (38.3) 3.67 4.0 1.31

QI92 6 (10.0) 4 (6.7) 10 (16.7) 19 (31.7) 21 (35.0) 3.75 4.0 1.28

QF93 22 (36.7) 11 (18.3) 16 (26.7) 8 (13.3) 3 (5.0) 2.32 2.0 1.24

QI93 10 (16.7) 7 (11.7) 8 (13.3) 19 (31.7) 16 (26.7) 3.40 4.0 1.43

174

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QF93a 13 (21.7) 13 (21.7) 12 (20.0) 12 (20.0) 10 (16.7) 2.88 3.0 1.40

QI93a 7 (11.7) 6 (10.0) 9 (15.0) 19 (31.7) 19 (31.7) 3.62 4.0 1.34

QF93b 5 (8.3) 7 (11.7) 11 (18.3) 12 (20.0) 25 (41.7) 3.75 4.0 1.34

QI93b 7 (11.7) 5 (8.3) 8 (13.3) 14 (23.3) 26 (43.3) 3.78 4.0 1.39

QF94 11 (18.3) 12 (20.0) 12 (20.0) 16 (26.7) 9 (15.0) 3.00 3.0 1.35

QI94 5 (8.3) 3 (5.0) 6 (10.0) 24 (40.0) 22 (36.7) 3.92 4.0 1.20

QF95 17 (28.3) 7 (11.7) 9 (15.0) 8 (13.3) 19 (31.7) 3.08 3.0 1.64

QI95 9 (15.0) 3 (5.0) 8 (13.3) 15 (25.0) 25 (41.7) 3.73 4.0 1.44

QF96 37 (62.7) 3 (5.1) 5 (8.5) 2 (3.4) 12 (20.3) 2.14 1.0 1.64

QI96 20 (33.9) 2 (3.4) 7 (11.9) 9 (15.3) 21 (35.6) 3.15 4.0 1.73

QF97 4 (6.7) 6 (10.0) 13 (21.7) 11 (18.3) 26 (43.3) 3.82 4.0 1.28

QI97 2 (3.3) 4 (6.7) 6 (10.0) 18 (30.0) 30 (50.0) 4.17 4.5 1.08

QF98 3 (5.0) 2 (3.3) 6 (10.0) 6 (10.0) 43 (71.7) 4.40 5.0 1.12

QI98 4 (6.7) 5 (8.3) 8 (13.3) 15 (25.0) 28 (46.7) 3.97 4.0 1.25

QF99 1 (1.7) 2 (3.3) 6 (10.0) 12 (20.0) 39 (65.0) 4.43 5.0 0.93

QI99 1 (1.7) 2 (3.3) 5 (8.3) 18 (30.0) 34 (56.7) 4.37 5.0 0.90

QF100 2 (3.3) 4 (6.7) 9 (15.0) 10 (16.7) 35 (58.3) 4.20 5.0 1.13

QI100 2 (3.3) 3 (5.0) 11 (18.3) 15 (25.0) 29 (48.3) 4.10 4.0 1.08

QF101 1 (1.7) 5 (8.3) 6 (10.0) 15 (25.0) 33 (55.0) 4.23 5.0 1.05

QI101 1 (1.7) 3 (5.0) 8 (13.3) 15 (25.0) 33 (55.0) 4.27 5.0 0.99

QF102 1 (1.7) 0 (0.0) 9 (15.0) 11 (18.3) 39 (65.0) 4.45 5.0 0.87

175

Category n (%)

Item 1 2 3 4 5 Mean Median SD

QI102 0 (0.0) 7 (11.7) 8 (13.3) 14 (23.3) 31 (51.7) 4.15 5.0 1.05

QF103 7 (11.7) 1 (1.7) 16 (26.7) 10 (16.7) 26 (43.3) 3.78 4.0 1.34

QI103 3 (5.0) 7 (11.7) 10 (16.7) 15 (25.0) 25 (41.7) 3.87 4.0 1.23

QF104 3 (5.0) 2 (3.3) 3 (5.0) 7 (11.7) 45 (75.0) 4.48 5.0 1.08

QI104 3 (5.0) 6 (10.0) 4 (6.7) 17 (28.3) 30 (50.0) 4.08 4.5 1.20

QF105 3 (5.0) 8 (13.3) 7 (11.7) 6 (10.0) 36 (60.0) 4.07 5.0 1.31

QI105 1 (1.7) 3 (5.0) 8 (13.3) 14 (23.3) 34 (56.7) 4.28 5.0 0.99

QF106 3 (5.0) 3 (5.0) 6 (10.0) 6 (10.0) 42 (70.0) 4.35 5.0 1.16

QI106 4 (6.7) 2 (3.3) 9 (15.0) 16 (26.7) 29 (48.3) 4.07 4.0 1.18

QF107 8 (13.3) 16 (26.7) 13 (21.7) 7 (11.7) 16 (26.7) 3.12 3.0 1.42

QI107 4 (6.7) 3 (5.0) 10 (16.7) 17 (28.3) 26 (43.3) 3.97 4.0 1.19

QF107a 3 (5.0) 5 (8.3) 10 (16.7) 14 (23.3) 28 (46.7) 3.98 4.0 1.20

QI107a 4 (6.7) 5 (8.3) 8 (13.3) 17 (28.3) 26 (43.3) 3.93 4.0 1.23

QF107b 3 (5.0) 2 (3.3) 4 (6.7) 6 (10.0) 45 (75.0) 4.47 5.0 1.10

QI107b 7 (11.7) 7 (11.7) 8 (13.3) 13 (21.7) 25 (41.7) 3.70 4.0 1.42

Q108 6 (10.0) 4 (6.7) 16 (26.7) 31 (51.7) 3 (5.0) 3.35 4.0 1.04

Q109 3 (5.0) 6 (10.0) 17 (28.3) 29 (48.3) 5 (8.3) 3.45 4.0 0.96

Q110 11 (18.3) 3 (5.0) 14 (23.3) 30 (50.0) 2 (3.3) 3.15 4.0 1.19

Q111 5 (8.3) 3 (5.0) 13 (21.7) 38 (63.3) 1 (1.7) 3.45 4.0 0.95

Q: Question F: frequency item I: importance item

176

Appendix M

RESPONSE OPTION CHOSEN Item N

Miss 0

(%) 1

(%) 2

(%) 3

(%) 4

(%) Mean Std

Dev Median

Q1 0 1 (1.52)

8 (12.12)

18 (27.27)

22 (33.3)

17 (25.76)

2.7 1.04 3

Q2 0 2 (3.03)

15 (22.73)

25 (37.88)

17 (25.76)

7 (10.61)

2.18 1.01 2

Q3 0 2 (3.03)

14 (21.21)

23 (34.85)

16 (24.24)

11 (16.67)

2.3 1.08 2

Q4 0 5 (7.58)

7 (10.61)

23 (34.85)

14 (21.21)

17 (25.76)

2.47 1.21 2

Q5 0 13 (19.7)

25 (37.88)

19 (28.79)

8 (12.12)

1 (1.52)

1.38 0.99 1

Q6 0 11 (16.67)

20 (30.3)

18 (27.27)

11 (16.67)

6 (9.09)

1.71 1.2 2

Q7 0 15 (22.73)

16 (24.24)

18 (27.27)

14 (21.21)

3 (4.55)

1.61 1.19 2

Q8 0 24 (36.36)

18 (27.27)

16 (24.24)

5 (7.58)

3 (4.55)

1.17 1.14 1

Q9 0 22 (33.33)

23 (34.85)

10 (15.15)

7 (10.61)

4 (6.06)

1.21 1.2 1

Q10 0 15 (22.73)

18 (27.27)

15 (22.73)

13 (19.7)

5 (7.58)

1.62 1.25 1.5

Q11 0 4 (6.06)

15 (22.73)

12 (18.18)

16 (24.24)

19 (28.79)

2.47 1.29 3

Q12 0 9 (13.64)

18 (27.27)

12 (18.18)

15 (22.73)

12 (18.18)

2.05 1.34 2

Q13 0 25 (37.88)

20 (30.3)

12 (18.18)

5 (7.58)

4 (6.06)

1.14 1.19 1

Q14 0 14 (21.21)

15 (22.73)

16 (24.24)

10 (15.15)

11 (16.67)

1.83 1.38 2

Q15 0 3 (4.55)

11 (16.67)

18 (27.27)

17 (25.76)

17 (25.76)

2.52 1.18 3

Q16 0 6 (9.09)

17 (25.76)

18 (27.27)

13 (19.7)

12 (18.18)

2.12 1.25 2

Q17 0 6 (9.09)

9 (13.64)

15 (22.73)

24 (36.36)

12 (18.18)

2.41 1.2 3

Q18 0 4 (6.06)

11 (16.67)

18 (27.27)

19 (28.79)

14 (21.21)

2.42 1.18 2.5

177

RESPONSE OPTION CHOSEN Item N

Miss 0

(%) 1

(%) 2

(%) 3

(%) 4

(%) Mean Std

Dev Median

Q19 0 9 (13.64)

11 (16.67)

20 (30.3)

10 (15.15)

16 (24.24)

2.2 1.35 2

Q20 0 22 (33.33)

12 (18.18)

13 (19.7)

10 (15.15)

9 (13.64)

1.58 1.44 1

Q21 0 19 (28.79)

6 (9.09)

22 (33.33)

8 (12.12)

11 (16.67)

1.79 1.42 2

Q22 0 12 (18.18)

11 (16.67)

17 (25.76)

10 (15.15)

16 (24.24)

2.11 1.43 2

Q23 0 55 (83.33)

3 (4.55)

0 (0.0)

2 (3.03)

6 (9.09)

0.5 1.24 0

Q24 0 20 (30.3)

16 (24.24)

13 (19.7)

9 (13.64)

8 (12.12)

1.53 1.37 1

Q25 1 17 (26.15)

9 (13.85)

12 (18.46)

13 (20.0)

14 (21.54)

1.97 1.51 2

Q26 1 35 (53.85)

10 (15.38)

5 (7.69)

9 (13.85)

6 (9.23)

1.09 1.42 0

Q27 1 4 (6.15)

14 (21.54)

18 (27.69)

16 (24.62)

13 (20.0)

2.31 1.2 2

Q28 1 26 (40.0)

13 (20.0)

12 (18.46)

12 (18.46)

2 (3.08)

1.25 1.25 1

Q29 1 4 (6.15)

8 (12.31)

24 (36.92)

13 (20.0)

16 (24.62)

2.45 1.17 2

Q30 2 7 (10.94)

4 (6.25)

14 (21.88)

11 (17.19)

28 (43.75)

2.77 1.37 3

Q31 1 7 (10.77)

17 (26.15)

13 (20.0)

13 (20.0)

15 (23.08)

2.18 1.35 2

Q32 1 15 (23.08)

10 (15.38)

13 (20.0)

10 (15.38)

17 (26.15)

2.06 1.52 2

Q33 0 2 (3.03)

5 (7.58)

19 (28.79)

17 (25.76)

23 (34.85)

2.82 1.09 3

Q34 0 1 (1.52)

7 10.61)

16 (24.24)

19 (28.79)

23 (34.85)

2.85 1.07 3

Q35 3 5 (7.94)

9 (14.29)

10 (15.87)

14 (22.22)

25 (39.68)

2.71 1.34 3

Q36 1 15 (23.08)

10 (15.38)

13 (20.0)

8 (12.31)

19 (29.23)

2.09 1.55 2

Q37 1 15 (23.08)

14 (21.54)

12 (18.46)

12 (18.46)

12 (18.46)

1.88 1.44 2

Q38 0 16 (24.24)

11 (16.67)

10 (15.15)

8 (12.12)

21 (31.82)

2.11 1.6 2

178

RESPONSE OPTION CHOSEN Item N

Miss 0

(%) 1

(%) 2

(%) 3

(%) 4

(%) Mean Std

Dev Median

Q39 0 14 (21.21)

22 (33.33)

12 (18.18)

15 (22.73)

3 (4.55)

1.56 1.19 1

Q40 0 7 (10.61)

15 (22.73)

14 (21.21)

16 (24.24)

14 (21.21)

2.23 1.31 2

Q41 0 20 (30.30)

16 (24.24)

13 (19.70)

12 (18.18)

5 (7.58)

1.48 1.3 1

Q42 0 10 (15.15)

12 (18.18)

15 (22.73)

16 (24.24)

13 (19.70)

2.15 1.35 2

Q43 0 0 (0.0)

7 (10.61)

8 (12.12)

14 (21.21)

37 (56.06)

3.23 1.03 4

Q44 0 24 (36.36)

12 (18.18)

16 (24.24)

6 (9.09)

8 (12.12)

1.42 1.38 1

Q45 2 9 (14.06)

11 (17.19)

14 (21.88)

9 (14.06)

21 (32.81)

2.34 1.45 2

Q46 2 2 (3.13)

11 (17.19)

9 (14.06)

20 (31.25)

22 (34.38)

2.77 1.19 3

Q47 1 8 (12.31)

10 (15.38)

15 (23.08)

13 (20.0)

19 (29.23)

2.38 1.38 2

Q48 1 1 (1.54)

19 (29.29)

19 (29.29)

15 (23.08)

11 (16.92)

2.25 1.1 2

Q49 1 23 (35.38)

19 (29.23)

13 (20.0)

7 (10.77)

3 (4.62)

1.2 1.18 1

Q50 1 11 (16.92)

16 (24.62)

22 (33.85)

9 (13.85)

7 (10.77)

1.77 1.21 2

Q51 0 20 (30.30)

11 (16.67)

20 (30.30)

9 (13.64)

6 (9.09)

1.55 1.3 2

Q52 0 18 (27.27)

21 (31.82)

19 (28.79)

5 (7.58)

3 (4.55)

1.3 1.1 1

Q53 0 25 (37.88)

16 (24.24)

18 (27.27)

4 (6.06)

3 (4.55)

1.15 1.14 1

Q54 0 19 (28.79)

22 (33.33)

18 (27.27)

4 (6.06)

3 (4.55)

1.24 1.08 1

Q55 4 3 (4.84)

6 (9.68)

9 (14.52)

8 (12.90)

36 (58.06)

3.1 1.25 4

Q56 0 16 (24.24)

20 (30.30)

12 (18.18)

8 (12.12)

10 (15.15)

1.64 1.38 1

Q57 0 36 (54.55)

15 (22.73)

10 (15.15)

2 (3.03)

3 (4.55)

0.8 1.1 0

Q58 0 22 (33.33)

19 (28.79)

17 (25.76)

5 (7.58)

3 (3.55)

1.21 1.13 1

179

RESPONSE OPTION CHOSEN Item N

Miss 0

(%) 1

(%) 2

(%) 3

(%) 4

(%) Mean Std

Dev Median

Q59 0 7 (10.61)

12 (18.18)

18 (27.27)

19 (28.79)

10 (15.15)

2.2 1.22 2

Q60 1 1 (1.54)

7 (10.77)

8 (12.31)

10 (15.38)

39 (60.0)

3.22 1.12 4

Q61 0 17 (25.76)

13 (19.70)

7 (10.61)

14 (21.21)

15 (22.73)

1.95 1.54 2

Q62 0 3 (4.55)

9 (13.64)

6 (9.09)

10 (15.15)

38 (57.58)

3.08 1.28 4

Q63 1 19 (29.23)

13 (20.0)

10 (15.38)

12 (18.46)

11 (16.92)

1.74 1.48 2

Q64 0 8 (12.12)

9 (13.64)

12 (18.18)

20 (30.30)

17 (25.76)

2.44 1.34 3

Q65 0 9 (13.64)

11 (16.67)

12 (18.18)

17 (25.76)

17 (25.76)

2.33 1.38 3

Q66 0 30 (45.45)

9 (13.64)

12 (18.18)

11 (16.67)

4 (6.06)

1.24 1.35 1

Q67 0 14 (21.21)

12 (18.18)

9 (13.64)

13 (19.70)

18 (27.27)

2.14 1.53 2

Q68 0 27 (40.91)

13 (19.70)

13 (19.70)

7 (10.61)

6 (9.09)

1.27 1.34 1

Q69 0 16 (24.24)

17 (25.76)

8 (12.12)

14 (21.21)

11 (16.67)

1.8 1.45 1.5

Q70 0 33 (50.0)

11 (16.67)

10 (15.15)

7 (10.61)

5 (7.58)

1.09 1.33 0.5

180

Appendix N

ML-QOL Questionnaire INSTRUCTIONS: The goal of this survey is to measure how your health has been impacted

by your multiligament knee injury from a physical, emotional and social perspective. This

information will help us keep track of how you feel about your knee over time and after any sort

of treatment you may receive. Please answer every question by circling the number in the

appropriate box, selecting only one number for each question. If you are unsure about how to

answer a question, please give the best answer you can.

P H Y S I C A L I M P A I R M E N T S

This first set of questions asks you about physical symptoms people sometimes experience

related to their knee. Please answer how often you have experienced each question in the last

month. There are no right or wrong answers.

HOW OFTEN DOES YOUR KNEE HURT.…

P A I N Never Rarely Sometimes Often Always

1. After sports and/or physical work? 0 1 2 3 4

2. When bending your knee? 0 1 2 3 4

3. When pivoting or twisting? 0 1 2 3 4

4. With prolonged standing? 0 1 2 3 4

5. While at rest? 0 1 2 3 4

P A I N

Never Rarely Sometimes Often Always

6. Do you experience ‘nerve pain’ (e.g., sharp, radiating pain; vibrations; electric sensation, crawling sensation)?

0 1 2 3 4

Continues on next page

181

HOW OFTEN DOES YOUR KNEE GIVE WAY (e.g., partial knee collapse; sense of knee

slipping; wobbliness; you don’t fall to the ground) …..

I N S T A B I L I T Y Never Rarely Sometimes Often Always

7. With sports and/or physical work? 0 1 2 3 4

8. When walking on level ground (e.g., jerk or kick to the side?

0 1 2 3 4

9. When going down stairs? 0 1 2 3 4

10. When twisting or pivoting? 0 1 2 3 4

HOW OFTEN DO YOU EXPERIENCE….

S T I F F N E S S Never Rarely Sometimes Often Always

11. Difficulty with sports and/or physical labour due to stiffness in your knee (e.g., inability to fully bend and/or straighten)?

0 1 2 3 4

12. Difficulty sleeping at night due to the stiffness in your knee?

0 1 2 3 4

13. Stiffness in your knee after sitting down for a long period of time (e.g., in a car, at the movie theatre, in a chair)?

0 1 2 3 4

Continues on next page

182

HOW OFTEN…. W E A K N E S S

Never Rarely Sometimes Often Always

14. Does your knee feel weak with sports and/or physical labour (e.g., the muscles around your knee don’t feel strong)?

0 1 2 3 4

15. Does your knee or leg become easily tired after activity (e.g., fatigued)?

0 1 2 3 4

Continues on next page

HOW OFTEN…. O T H E R

Never Rarely Sometimes Often Always

16. Do you have discomfort in other parts of your body because you are compensating for your knee injury?

0 1 2 3 4

17. Do you experience pins and needles and/or numbness in your affected leg?

0 1 2 3 4

18. Do you experience weakness in another joint due to your knee injury (e.g., foot or ankle; toes may catch and hit the floor while walking or running)?

0 1 2 3 4

19. Does your knee make you limp? 0 1 2 3 4

183

E M O T I O N A L I M P A I R M E N T S

People’s mood and/or emotions are sometimes affected because of their knee. This next set of

questions asks about such changes in mood and emotions. Please answer each question as it has

been experienced in the last month. There are no right or wrong answers.

TO WHAT EXTENT…. S E L F I M A G E

Not at all Slightly Moderately Quite a bit Extremely

20. Have you had to redefine your identity as a person due to your knee injury?

0 1 2 3 4

HOW OFTEN…. S E L F I M A G E

Never Rarely Sometimes Often Always

21. Do you feel uncomfortable wearing shorts, skirts or tight clothing due to your injury?

0 1 2 3 4

HOW OFTEN…. T R U S T

( I M M E D I A T E A P P R E H E N S I O N ) Never Rarely Sometimes Often Always

22. Are you troubled with lack of confidence or trust in your knee?

0 1 2 3 4

23. Are you nervous about crowds because you fear possible instability (e.g., collapsing, slipping or giving way) of your knee?

0 1 2 3 4

24. Do you fear your knee will give way during sports or recreation?

0 1 2 3 4

25. Do you not trust your knee to support you under pressure?

0 1 2 3 4

26. Do you fear tripping or falling as a result of your injury?

0 1 2 3 4

184

HOW OFTEN…. F U T U R E C O N C E R N S

( F U T U R E A P P R E H E N S I O N ) Never Rarely Sometimes Often Always

27. Are you worried about what will happen to your knee in the future?

0 1 2 3 4

28. Are you concerned about environmental conditions when participating in sports (e.g., uneven playing field, hard court or type of gym floor)?

0 1 2 3 4

29. Are you concerned about time off work or school due to treatment of your knee?

0 1 2 3 4

HOW OFTEN…. M O O D

Never Rarely Sometimes Often Always

30. Do you dwell on your injury when you are alone? 0 1 2 3 4

31. Has your enjoyment of life has been limited by your knee?

0 1 2 3 4

32. Are you frustrated or discouraged by your knee? 0 1 2 3 4

33. Are you aware or conscious of your knee problem? 0 1 2 3 4

34. Are you depressed or sad due to knee pain or nerve pain?

0 1 2 3 4

Continues on next page

185

A C T I V I T Y L I M I T A T I O N S

This next set of questions asks you about the degree of difficulty you experience with simple

and complex activities as related to your knee. Please answer each question as it has been

experienced in the last month. There are no right or wrong answers.

DUE TO YOUR KNEE,

WHAT DEGREE OF DIFFICULTY DO YOU

HAVE….

S I M P L E / C O M P L E X A C T I V I T I E S None Mild Moderate Severe Extreme

35. Running straight ahead? 0 1 2 3 4

36. Quickly changing direction (e.g., twisting, pivoting or cutting side to side)?

0 1 2 3 4

37. Jumping? 0 1 2 3 4

38. Standing? 0 1 2 3 4

39. Walking on uneven terrain? 0 1 2 3 4

40. Bending to pickup an object on the floor? 0 1 2 3 4

41. Getting in and/or out of the bath/shower? 0 1 2 3 4

42. Managing in crowds? 0 1 2 3 4

43. Driving? 0 1 2 3 4

Continues on next page

186

Questions 44-46 refer to your ability to participate in various levels of physical work and/or

sports. Examples are provided below for your reference – Please refer to an activity that is most

pertinent to you.

• Light sports: bowling, golf, swimming, recreational biking

• Light physical work: cooking, dusting, ironing, raking leaves, painting walls

• Moderate sports: jogging, running, recreational skiing, tennis, competitive

bicycling/weightlifting

• Moderate physical work: carrying groceries, moving a table, climbing a ladder

• Vigorous sports: football, basketball, gymnastics, soccer, wresting, hockey, lacrosse

• Vigorous physical work: lifting heavy objects, construction work

DUE TO YOUR KNEE,

WHAT DEGREE OF DIFFICULTY DO YOU

HAVE WITH…

P H Y S I C A L W O R K / S P O R T S None Mild Moderate Severe Extreme

44. Light physical work and/or sports? 0 1 2 3 4

45. Moderate physical work and/or sports? 0 1 2 3 4

46. Heavy physical work and/or sports? 0 1 2 3 4

Continues on next page

187

S O C I E T A L I N V O L V E M E N T

This next set of questions asks you about social limitations people sometimes experience related

to their knee. Please answer each question as it has been experienced in the last month. There

are no right or wrong answers.

TO WHAT EXTENT…. S O C I A L L I M I T A T I O N S

Not at all Slightly Moderately Quite a bit Extremely

47. Have you modified your work duties due to your knee condition?

0 1 2 3 4

48. Have you modified your lifestyle to avoid activities that are potentially damaging to your knee?

0 1 2 3 4

49. Has your fitness level decreased due to your knee condition?

0 1 2 3 4

50. Has your social network (e.g., friends, peers) been affected by your injury?

0 1 2 3 4

51. Have your future plans and long-term goals been impacted by your knee injury?

0 1 2 3 4

52. Do you experience problems with intimacy (e.g., physical, platonic) with others as a result of your knee injury?

0 1 2 3 4

THE END

188

Appendix O

Altman-Bland Plots for the 4 domains of the MLQOL

Using this methodology, the y-axis represents the difference in scores in the test and re-test

situation (39 participants in phase III). The x-axis represents the average test score of the test

and re-test scenarios.

Bland-Altman Plot for the Physical Impairments Domain

diff

-70-60-50-40-30-20-10

010203040506070

mean

10 20 30 40 50 60 70 80 90

189

Bland-Altman Plot for the Emotional Impairments Domain

diff

-70-60-50-40-30-20-10

010203040506070

mean

0 10 20 30 40 50 60 70 80 90 100

Bland-Altman Plot for the Activity Limitations Domain

diff

-70-60-50-40-30-20-10

010203040506070

mean

0 10 20 30 40 50 60 70 80 90 100

190

Bland-Altman Plot for the Societal Involvement Domain

diff

-70-60-50-40-30-20-10

010203040506070

mean

0 10 20 30 40 50 60 70 80 90 100

191