The Impact of Road Traffic Injury in North India: A Mixed ...BMJ Open: first published as 10.1136/bmjopen-2015-008884 on 19 August 2015. Downloaded from . For peer review only Page

For peer review only

The Impact of Road Traffic Injury in North India: A Mixed Methods Study Protocol

Journal: BMJ Open

Manuscript ID: bmjopen-2015-008884

Article Type: Protocol

Date Submitted by the Author: 25-May-2015

Complete List of Authors: Jagnoor, Jagnoor; The George Institute for Global Health, Injury Division Prinja, Shankar; Post Graduate Institute of Medical Education and Research, School of Public health Lakshmi, PVM; Post Graduate Institute of Medical Education and Research, School of Public health Aggarwal, Sameer; Post Graduate Institute of Medical Education and Research, School of Public health Gabbe, Belinda; Monash University, Epidemiology and Preventive Medicine

Ivers, Rebecca; The George Institute for Global Health, Injury Division

<b>Primary Subject Heading</b>:

Public health

Secondary Subject Heading: Epidemiology, Research methods

Keywords: Injury, Health related quality of life, Economic Impact, Low and middle income countries

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Authors: J Jagnoor,1 S Prinja,

2 PVM Lakshmi,

2 S Aggarwal,

2 BJ Gabbe,

3 RQ Ivers

1

Jagnoor Jagnoor 1 The George Institute for Global Health

PO Box M201 Missenden Road

Emal:[email protected]

*Shankar Prinja (corresponding author) Email: [email protected] 2Post Graduate Institute of Medical Education and Research

Sector 12, Chandigarh India

2PVM Lakshmi

Email: [email protected] 2Sameer Aggarwal

Email: [email protected] 3Belinda Gabbe

Epidemiology & Preventative Medicine Monash Medical School Building The Alfred Hospital, Victoria, Australia Email: [email protected] 1Rebecca Q Ivers

Email: [email protected]

Keywords: Health related quality of life, social impact, economic impact, injuries, India

Word count: 2570

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ABSTRACT

Background: Road traffic injuries are a large and growing public health burden, especially in low-income and

middle-income countries where 90% of the world's deaths due to road traffic injuries are estimated to occur.

India is one of the fastest growing economies, with rapid motorization and increasing road traffic burden.

However there are limited data addressing the problem of non-fatal road traffic injuries with data of poor quality,

non-representative, difficult to access, and encompassing limited number of relevant variables. This study aims

to determine the outcomes of road traffic injuries on function, health-related quality-of-life, social impact and

economic cost of road traffic crashes in an urban setting in India

Methods/design: This prospective observational study will recruit nearly 1500 participants, who are injured in

a road traffic crash admitted to hospital for >24 hours at any of the three participating hospitals in Chandigarh,

India. Face-to-face baseline interviews will be conducted with telephone interviews. At 1, 2, 4 and 12 months

post-injury, participants will be interviewed again. Standardized tools will be used to collect data on health and

social outcomes and the economic impact of road traffic crashes.

Discussion: This study will provide the first comprehensive estimates on outcomes of serious road traffic

injury in India, including economic and social costs and the impact on individuals and families. The study will

contribute considerable information to enable debate about societal context, culture and injury impact of traffic

crashes.

STRENGTHS

• First estimates of outcomes of serious road traffic injury in India, including economic and social costs

and the impact on individuals and families.

• Uses validated tools at regular intervals for comprehensive estimates

LIMITATIONS

• Systems cost will not be generated through this research work

• Quality of life of cares would not be comprehensively captured using the protocol

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BACKGROUND

The World Health Organisation (WHO) estimates that over 1.2 million people die each year on the world’s

roads, and between 20 and 50 million fall victim to non-fatal injuries.[1] The WHO projects that, unless

immediate action is taken, traffic crashes will increase from the ninth to the fifth leading cause of death by 2030,

and will then cause around 2.4 million deaths per year.[1] Road traffic injuries are also projected to rise to the

third leading cause of disability adjusted life years (DALYs) lost worldwide by 2020.[2] The burden of traffic

crashes, in terms of both mortality and morbidity, is increasing fastest in developing countries, due to rapid

motorization associated with economic growth.[3,4]

The situation is particularly acute in India, a nation of more than one billion people with one of the fastest

growing economies in the world. This economic growth has also meant a rapidly increasing number of

vehicles sold every year (around six million) and one of the highest reported mortality rates from road traffic

injuries in the world.[5] Road traffic fatalities in India increased by about 5% per year from 1980 to 2000 and

then by about 8% per year to reach 105,725 in 2006 with the fatality rate increasing from 36 /million persons in

1980 to 95 /million persons in 2006.[6] Non-fatal injury is more common consequence of road crashes than

death, and injuries sustained are often severe. The incidence of RTI remains poorly measured in India, though

the number of people injured in road traffic crashes in 2006 was estimated to exceed 450,000. Cautious

interpretation is necessary, as previous studies have found traffic crashes to be underreported in India by 5%

for deaths and more than 50% for serious injuries.[7]

Weak estimates, or none, of morbidity due to road traffic crashes is a common problem in low- and middle-

income countries, where data sources are often of poor quality, non-representative, difficult to access, and

contain a limited number of relevant variables.[8]

A review of four studies in India estimated the cost of traffic crashes in the country to be between 0.29 and

0.69 percent of GDP, and identified a number of limitations related to the methods used.[9]

At least two studies

used rudimentary methods of cost analysis which omitted many components of the cost of traffic crashes. The

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studies were each for a single locality, had small sample sizes, focused mainly on direct costs, and did not

take into account impact on families or estimate injury burden. A study by Reddy et al [10] examined both

direct and indirect costs related to traffic crashes based on interviews with victims and their families instead of

relying on secondary data. However, this study shared limitations of the previous studies on cost of traffic

crashes in India including small sample size (148 crashes), the localized nature and the lack of estimates

related to disability mainly due to the cross-sectional nature of the study. More importantly, each of these

previous studies adopted a patient perspective in estimating the economic cost. None of the previous study

estimated the health system cost of delivering treatment for RTI patients. Since, the curative care for injury

patients at public sector hospitals is highly subsidized by the Government, patient’s costs does not value the

true cost of the gamut of resources which are spent on patient care.

As reviewed above, the gaps in knowledge, results both in under- estimation and limited understanding of the

burden of injury, limiting the capacity to inform policy development and capacity building for medical

management, rehabilitation and support services. Given the potentially catastrophic effects of injuries on families

and communities in such settings, particularly those of low socioeconomic status, there is a need to study non-

fatal outcomes in LMIC settings in order to inform the public health response to RTI.[11]

AIMS

The aims of this study are to describe:

1. The impact of road traffic injuries on function and health-related quality-of-life (HRQoL) in urban settings

in India,

2. The social impact of road traffic injuries on victims and their families including their participation

and utilization of health and social services; and

3. The economic cost of road traffic injuries using the human capital approach, including direct and

indirect costs to individuals and their families.

METHODS/DESIGN

This is a prospective observational study.

Study settings: Participants will be recruited from RTI patients admitted to hospital Chandigarh (Advanced

Trauma Centre, Post- Graduate Institute of Medical Education and Research), and two secondary care public

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sector hospitals in Chandigarh and Panchkula during a 4 month period beginning in April 2014.

The study involves recruitment of patients of all ages admitted to hospital for at 24 hours due to a RTI. All types

of road users injured as a result of a traffic crash will be eligible for participation. Eligible participants will be

identified by trained research staff located in emergency departments; staff will also review admissions registers

daily. The research staff will explain the study and consent process and invite participation. For participants who

are unable to give informed consent due to injury, consent will be sought from a proxy (relative or carer) and

consent will be sought from the patient when he or she is able to give or withdraw it. For children aged less than

18 years, consent will be sought from the carer/guardian, and from the child to the extent of the child’s

capabilities from the age of seven years up to the age of 18 years as per Indian Council of Medical Research

ethical guidelines.[12]

Approximately 1500 patients from the three hospital sites will be approached to join the study over the 4 month

period. Stratification for follow-up will be determined by the prevalence of key variables of interest in baseline

data (road user group, severity of injury, age, gender and socioeconomic status) to ensure the study has

sufficient power to describe with precision measures of function, health related quality of life and cost in the

longitudinal sample across these factors. The sample size calculations are for 90% power, to detect independent

effects of about 5% of the size of the variable in multiple linear regression analysis. These calculations are based

on experience from the pilot study.

Recruitment Procedures and follow up: All baseline interviews will be administered face to face at the

hospital and subsequent interviews will be conducted by telephone. Trained staff will conduct telephone interview

to collect data from the injured (or a proxy where appropriate) at standardized time points over the first 12-

months (1, 2, 4 and 12 months), selected based on the recommendations of a previous injury outcomes study

consensus paper.[13] If the participant dies during follow-up, his or her family will be asked to complete the final

interview at 12 months to ascertain impact of RTI related mortality. Patient recruitment and follow-up will be

conducted by appropriately qualified and trained research assistants.

Where possible, the following information will be collected for patients who do not consent to the follow-up

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study: sex, age, place of injury and type of injury to establish any biases in the participating sample.

Measures

Baseline interview: The interview administered in hospital to participants will collect demographic information

as well as information related to the circumstances of traffic crashes. Data will (where possible) be collected

directly from participants or their carers. Items include age, gender, education, occupation, household income

and consumption expenditure, road user type and vehicle counterpart, use of alcohol and other drugs in the

hours prior to the injury, use of safety devices at the time of the crash, setting of accident, road type, and time of

day. Pre-injury HRQoL, the use of health and social services in the 4 weeks prior to the injury and contact

information for follow-up interviews will also be obtained. The trained research assistants at each site will

extract data from the medical records on date and time of injury, type of injury, anatomical site of the body, co-

morbidities, length of the hospital admission as well as diagnosis and treatment procedures, and will score

injury severity according to the Abbreviated Injury Scale (AIS 2005-Update 2008).

Follow-up interviews: Subsequent follow-up interviews post hospital discharge will include measures of

quality of life, functioning and disability, economic costs and social impact.

Quality of life, functioning and disability: To measure health-related quality of life we will use the EQ-5D, the

Pediatric Quality of Life Inventory (PedsQL) and the WHODAS II, which have been translated into Hindi.

Functioning will be measured according to the Glasgow Outcome Scale – Extended (GOSE), and its pediatric

version (KOSCHI). These instruments were selected because they cover most important dimensions of quality

of life, function and disability as defined by the International Classification of Functioning (ICF), are applicable to

a broad range of injuries and age groups and have been recommended as being valid and appropriate

measures of the impact of injury.[13-16] The EQ-5D will be used to produce a single utility score between < 0

and 1 based on individual’s responses to questions on the impact of road traffic injuries on their lives. The

pediatric measures will be completed by the parents, as well as children aged from 5 years and above, as there

are differences in HRQoL reported by parents and children after injury.[17]

Economic costs: The economic impact of RTI will be measured by the human capital approach. The study

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will seek to quantify both direct costs of road traffic injury (out–of-pocket costs) and indirect costs. A review

of cost of illness studies identified six most common categories of direct medical costs including emergency

department/hospital services, outpatient physician services, drugs, diagnostic procedures/laboratory tests,

other healthcare services and ancillary personnel.[18] In addition to these elements, cost of injury studies

also included as part of direct costs, ambulance/transport costs, home care, nursing home and other long

term care as well as vocational rehabilitation and insurance administration costs.[19,20] Direct non-

healthcare costs including those associated with police attendance and investigation of crashes, other legal

and coroners costs, vehicle and other property damage costs as well as other general costs associated with

travel delays and fire and other emergency services costs will also be included.[21]

Taking into consideration the common cost items included in previous studies as well the context of traffic

crashes in India, we will collect data from participants and their families using standardized questionnaires on

out-of-pocket direct costs associated with a RTI during pre-hospital care: transportation to the hospital; hospital

facility and services, diagnostic procedure/laboratory tests, surgery, inpatient physician visits, medication, in

hospital rehabilitation, equipment; post-hospital costs: rehabilitation, medication, home care and other related

costs. In addition to direct costs incurred by victims, we will also collect information on costs incurred by

victim’s relatives/caretakers. These include accommodation during victim’s hospitalization transportation as

well as other costs specified by respondents. Costs of legal fees relating to the crash and of vehicle

replacement or repair will also be included. Information on compensation (insurance or legal) paid to the

participant or to his/her family because of the RTI will also be collected. This will include information on

whether claims were accepted and on timeliness of payment or reimbursement.

This study will rely on interviews with injured people and their family to obtain detailed direct medical costs.

Recent work has highlighted the important need to validate out-of-pocket expenditure and the lack of a gold

standard for measures of these costs[22] and the difficulties in validating such costs.[23] To ensure maximum

accuracy, we will utilize a short recall period (time since previous interview), standardized questionnaires will be

developed to collect information during interviews. Receipts, hospital and insurance cost records will also be

sourced where available from participants to validate reported costs.

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Finally, the health system costs of providing treatment and care will be collected. An economic costing will be

undertaken using bottom-up costing methods. Cost centres, i.e. service and support centres will be identified. All

resources spent on provision of care over a period of one year will be enlisted. Information on price of these

resources will be obtained from suitable sources. In case the same is not available, a market survey to assess

the price will be undertaken.

Indirect costs: To estimate indirect costs for RTI for participants, the human capital approach will be applied,

using lost working days and occupation rates.[24] To calculate the indirect costs attributable to morbidity,

income loss and the working day loss of both the victims and their relatives/carers during the hospitalization

and follow-up period will be collected.

Social impact: Impact of RTI on families, and their changed circumstances including work and caring roles, will

be assessed at each follow-up. Additionally, we will conduct 15 semi-structured face-to-face interviews from

each site and based on saturation of themes additional 5 interviews might be considered.[25] These interviews

will explore issues related to patients’ experiences post-crash including impact of the traffic crash on their life

and that of their family, access to health care and other services as well as other factors that impact on

recovery. This is a chiefly qualitative aspect of the project.

Table 1: Data collected at baseline and follow-up

BASELINE (Face to face)

Socio-demographic Age, sex, place of birth, primary language, education, marital status

Employment Employment status, occupation, household income

Health BMI ( height and weight), history of chronic illness

Lifestyle habits Smoking status and alcohol consumption

Circumstances of Crash Road user type, Role of the injured and use of any preventive measure

like helmet, seatbelt use, road type, time of the day

Quality of life, disability

and functioning

Likert scale for overall health, PedsQL, EQ5D3L , 4 weeks prior to crash

and at baseline. History of any disability, World Health Organisation

Disability Assessment Schedule II (12-item version) (WHODAS II). GOSE

and Koschi.

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Data management and analysis: Data will be entered into an electronic database by study staff in

Chandigarh. Logic and range checks will be used in the data entry process to minimize data entry errors and

identify missing data or problems with completed data. The electronic database will be stored on a “firewall-

protected” local network server.

Data will be analyzed in order to describe the burden, the associated disability and length of time for recovery,

as well as the economic cost of injurious road traffic crashes. Descriptive analyses will be performed to estimate

the outcomes of traffic crashes in terms of health, social and economic consequences, including catastrophic

health expenditure.

Multivariate modeling will also be undertaken to explore the role of demographic, injury and health care related

factors in predicting the health and socio-economic impact of hospitalized RTI, as well as mixed effects

Injury Type of injury and associated hospitalisation, AIS score

Work Return to work, modified duties, hours

Cost Direct and indirect costs such as medical costs, drugs, diagnostics,

transportation, legal costs, property damage and compensation.

Separate assessment of health system costs will be undertaken

1, 2, 4 and 12 months follow up (telephone interviews)

Health related quality of

life

Likert scale for overall health, EQ5D3L and SF12.

Health Care Utilisation Days of hospitalisation, rehabilitation and home care


and functioning




and Koschi.

Disability and functioning History of any disability, World Health Organisation Disability Assessment

Schedule II (WHODAS II).



Social Impact at 12 months follow up (10% of the sample)

In depth interview Exploring issues related to access to health care, impact on carer,

insurance, advice seeking ( health and compensation), social life, impact

on work, perception of recovery, impact of injury general view

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regression models to examine recovery, predictors of recovery, predictors of catastrophic health expenditure

and other outcomes. Estimates of duration of disability, and disability weights, for each injury health state will

be calculated from the EQ-5D.

Cost data will be analyzed using standard methods. Capital costs will be annualized after discounting of the life

of the capital item. Joint costs will be apportioned for injury care by using appropriate statistics. OOP expenditure

will be analyzed to assess its mean value and dispersion. Financial hardship will be assessed by analyzing the

extent of catastrophic health expenditures, at 40% threshold of non-food household expenditure. Poverty impact

of RTI will be estimated by computing the poverty headcount increase and poverty gap as a result of OOP

expenditure. Finally the private OOP expenditure will be analyzed using an equity lens, by computing

concentration curves and concentration index. This will provide a snapshot of vertical equity in financing care for

RTI.

Qualitative interviews on social impact will be transcribed and analyzed thematically using content analysis.

Detailed information on the victim’s personal experience and factors influencing injury outcomes will be

explored.[25]

OUTCOMES AND SIGNIFICANCE

The proposed study will provide the first comprehensive estimates of outcomes of serious road traffic injury in

India, including economic and social costs and the impact on individuals and families. The study will contribute

considerable information to enable debate about societal context, culture and injury impact of traffic crashes. The

result will contribute to the required evidence for generating future investments in RTI prevention and document

non-fatal outcomes in low and middle income country settings in order to inform investment prioritization.[26]

Ethical approvals: The study has been approved by Institute’s Ethics Committee, Post Graduate Institute of

Medical Education and Research along with administrative approvals from hospital sites.

Funding Agency: The study has been funded by the Road Traffic Injury Research Network through a peer review

process, Agreement number 10/2013 in kind support to the study has been provided by School of Public Health,

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Post Graduate Institute of Medical Education and Research.

REFERENCES

1. World Health Organization. Global status report on road safety: time for action. Geneva, World Health

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2. Nantulya VM, Reich MR. The neglected epidemic: road traffic injuries in developing countries developing

countries. BMJ 2002;324:1139-1141.

3. Garg N, Hyder AA. Road traffic injuries in India: A review of the literature. Scand J Public Health 2006;34:100-

109.

4. Moniruzzaman S, Andersson R. Economic development as a determinant of injury mortality - a longitudinal

approach. Soc Sci Med 2008;66(8):1699-1708.

5. Garg N, Hyder AA. Exploring the relationship between development and road traffic injuries: a case study from

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6. Mohan D, Tsimhoni O, Sivak M. Flannagan MJ. Road Safety in India: Challenges and

Opportunities. Michigan: Transportation Research Institute, The University of Michigan, 2009.

7. Gururaj G. Road traffic deaths, injuries and disabilities in India: Current scenario. Natl Med J India

2008;21(1):14-20.

8. Bhalla K, Naghavi M, Shahraz S, Bartels D, and Murray CJ. Building national estimates of the burden of road

traffic injuries in developing countries from all available data sources: Iran. Inj Prev 2009;15:150-6.

9. Mohan D. The Road Ahead: Traffic Injuries and Fatalities in India. Delhi: Indian Institute of

Technology, Transportation Research and Injury Prevention Programme, 2004.

10. Reddy G, Negandhi H, Singh D, Singh AJ. Extent and determinants of cost of road traffic injuries in an Indian

city. Indian J Med Sci 2009;63:549-56.

11. Ameratunga S, Hijar M, Norton R. Road-traffic injuries: confronting disparities to address a global health

problem. Lancet 2006; 367:1533-1540.

12. Indian Council of Medical Research (ICMR). Ethical guidelines for biomedical research on human

participants. ICMR, New Delhi, 2006.

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13. Van Beeck EF, Larsen CF, Lyons RA, Meerding WJ, Mulder S, Essink-Bot ML. Guidelines for the Conduction

of Follow-up Studies Measuring Injury-Related Disability. J Trauma 2007; 62(2):534-550.

14. Lyons RA. Measuring quality of life after injury. Inj Prev 2010; 16(3):145-6.

15. Polinder S, Haagsm JA, Bonsel G, Essink-Bot M, Toet H, van Beeck EF. The measurement of long-term

health-related quality of life after injury: comparison of EQ-5D and the health utilities index. Inj Prev 2010;16:147-

153.

16. Gabbe BJ, Simpson PM, Sutherland AM, Palmer CS, Williamson OD, Butt W, et al. Functional and health-

related quality of life outcomes after pediatric trauma. The Journal of Trauma and Acute Care Surgery.

2011;70(6):1532-8.

17. Gabbe B, Sutherland A, Hart M, et al. Population-based capture of long-term functional and quality of life

outcomes after major trauma - the experiences of the Victorian State Trauma Registry. J Trauma. 2010; 69(3):

532-536.

18. Akobundu E, Ju J, Blatt L, Mullins CD. Cost-of-illness studies: a review of current methods.

Pharmacoeconomics 2006;24(9):869-90.

19. Corso P, Finkelstein E, Miller T, Fiebelkorn I, Zaloshnja E. Incidence and lifetime costs of injuries in the

United States. Inj Prev 2006; 12(4):212-218.

20. Meerding WJ, Mulder S, Van Beeck EF. Incidence and costs of injuries in The Netherlands. Eur J Public

Health 2006;16(3):272-278.

21. Connelly LB, Supangan R. The economic costs of road traffic crashes: Australia, states and territories. Accid

Anal Prev 2006;38(6):1087-93.

22. García-Altés A, Pérez K. The economic cost of road traffic crashes in an urban setting. Inj Prev 2007;13:65-

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23. Lu C, Chin B, Lic G, Murray CJL. Limitations of methods for measuring out-of-pocket and catastrophic

private health expenditures. Bull World Health Organ 2009;87:238–244.

24. Xu K, Evans DB, Kawabata K, Zeramdini R, Klavus J, Murray CJL. Household catastrophic health

expenditure: a multi-country analysis. Lancet 2003; 362:111–17.

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26. Ivers R, Bhandari M, Norton R. A call to research: Documenting the non-fatal outcomes of injury. Injury

2014;45(6):921.

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and

related documents*

Section/item ItemNo

Description

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions,

and, if applicable, trial acronym

Trial registration 2a Trial identifier and registry name. If not yet registered, name of

intended registry

2b All items from the World Health Organization Trial Registration Data

Set

Protocol version 3 Date and version identifier

Funding 4 Sources and types of financial, material, and other support

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors

5b Name and contact information for the trial sponsor

5c Role of study sponsor and funders, if any, in study design; collection,

management, analysis, and interpretation of data; writing of the report;

and the decision to submit the report for publication, including whether

they will have ultimate authority over any of these activities

5d Composition, roles, and responsibilities of the coordinating centre,

steering committee, endpoint adjudication committee, data

management team, and other individuals or groups overseeing the

trial, if applicable (see Item 21a for data monitoring committee)

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the

trial, including summary of relevant studies (published and

unpublished) examining benefits and harms for each intervention

6b Explanation for choice of comparators

Objectives 7 Specific objectives or hypotheses

Trial design 8 Description of trial design including type of trial (eg, parallel group,

crossover, factorial, single group), allocation ratio, and framework (eg,

superiority, equivalence, noninferiority, exploratory)

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2

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital)

and list of countries where data will be collected. Reference to where

list of study sites can be obtained

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility

criteria for study centres and individuals who will perform the

interventions (eg, surgeons, psychotherapists)

Interventions 11a Interventions for each group with sufficient detail to allow replication,

including how and when they will be administered

11b Criteria for discontinuing or modifying allocated interventions for a

given trial participant (eg, drug dose change in response to harms,

participant request, or improving/worsening disease)

11c Strategies to improve adherence to intervention protocols, and any

procedures for monitoring adherence (eg, drug tablet return,

laboratory tests)

11d Relevant concomitant care and interventions that are permitted or

prohibited during the trial

Outcomes 12 Primary, secondary, and other outcomes, including the specific

measurement variable (eg, systolic blood pressure), analysis metric

(eg, change from baseline, final value, time to event), method of

aggregation (eg, median, proportion), and time point for each

outcome. Explanation of the clinical relevance of chosen efficacy and

harm outcomes is strongly recommended

Participant

timeline

13 Time schedule of enrolment, interventions (including any run-ins and

washouts), assessments, and visits for participants. A schematic

diagram is highly recommended (see Figure)

Sample size 14 Estimated number of participants needed to achieve study objectives

and how it was determined, including clinical and statistical

assumptions supporting any sample size calculations

Recruitment 15 Strategies for achieving adequate participant enrolment to reach

target sample size

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-

generated random numbers), and list of any factors for stratification.

To reduce predictability of a random sequence, details of any planned

restriction (eg, blocking) should be provided in a separate document

that is unavailable to those who enrol participants or assign

interventions

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3

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central

telephone; sequentially numbered, opaque, sealed envelopes),

describing any steps to conceal the sequence until interventions are

assigned

Implementation 16c Who will generate the allocation sequence, who will enrol participants,

and who will assign participants to interventions

Blinding

(masking)

17a Who will be blinded after assignment to interventions (eg, trial

participants, care providers, outcome assessors, data analysts), and

how

17b If blinded, circumstances under which unblinding is permissible, and

procedure for revealing a participant’s allocated intervention during

the trial

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other

trial data, including any related processes to promote data quality (eg,

duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with

their reliability and validity, if known. Reference to where data

collection forms can be found, if not in the protocol

18b Plans to promote participant retention and complete follow-up,

including list of any outcome data to be collected for participants who

discontinue or deviate from intervention protocols

Data

management

19 Plans for data entry, coding, security, and storage, including any

related processes to promote data quality (eg, double data entry;

range checks for data values). Reference to where details of data

management procedures can be found, if not in the protocol

Statistical

methods

20a Statistical methods for analysing primary and secondary outcomes.

Reference to where other details of the statistical analysis plan can be

found, if not in the protocol

20b Methods for any additional analyses (eg, subgroup and adjusted

analyses)

20c Definition of analysis population relating to protocol non-adherence

(eg, as randomised analysis), and any statistical methods to handle

missing data (eg, multiple imputation)

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role

and reporting structure; statement of whether it is independent from

the sponsor and competing interests; and reference to where further

details about its charter can be found, if not in the protocol.

Alternatively, an explanation of why a DMC is not needed

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4

21b Description of any interim analyses and stopping guidelines, including

who will have access to these interim results and make the final

decision to terminate the trial

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and

spontaneously reported adverse events and other unintended effects

of trial interventions or trial conduct

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and

whether the process will be independent from investigators and the

sponsor

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board

(REC/IRB) approval

Protocol

amendments

25 Plans for communicating important protocol modifications (eg,

changes to eligibility criteria, outcomes, analyses) to relevant parties

(eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

Consent or assent 26a Who will obtain informed consent or assent from potential trial

participants or authorised surrogates, and how (see Item 32)

26b Additional consent provisions for collection and use of participant data

and biological specimens in ancillary studies, if applicable

Confidentiality 27 How personal information about potential and enrolled participants will

be collected, shared, and maintained in order to protect confidentiality

before, during, and after the trial

Declaration of

interests

28 Financial and other competing interests for principal investigators for

the overall trial and each study site

Access to data 29 Statement of who will have access to the final trial dataset, and

disclosure of contractual agreements that limit such access for

investigators

Ancillary and

post-trial care

30 Provisions, if any, for ancillary and post-trial care, and for

compensation to those who suffer harm from trial participation

Dissemination

policy

31a Plans for investigators and sponsor to communicate trial results to

participants, healthcare professionals, the public, and other relevant

groups (eg, via publication, reporting in results databases, or other

data sharing arrangements), including any publication restrictions

31b Authorship eligibility guidelines and any intended use of professional

writers

31c Plans, if any, for granting public access to the full protocol, participant-

level dataset, and statistical code

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5

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to

participants and authorised surrogates

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological

specimens for genetic or molecular analysis in the current trial and for

future use in ancillary studies, if applicable

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013

Explanation & Elaboration for important clarification on the items. Amendments to the

protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT

Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported”

license.

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Journal: BMJ Open

Manuscript ID: bmjopen-2015-008884.R1

Article Type: Protocol

Date Submitted by the Author: 02-Jul-2015

Complete List of Authors: Jagnoor, Jagnoor; The George Institute for Global Health, University of Sydney, Injury Division Prinja, Shankar; Post Graduate Institute of Medical Education and Research, School of Public health Lakshmi, PVM; Post Graduate Institute of Medical Education and Research, School of Public health Aggarwal, Sameer; Post Graduate Institute of Medical Education and Research, School of Public health

Gabbe, Belinda; Monash University, Epidemiology and Preventive Medicine Ivers, Rebecca; The George Institute for Global Health, Injury Division; The George Institute for Global Health, University of Sydney, Injury Division

<b>Primary Subject Heading</b>:

Public health

Secondary Subject Heading: Epidemiology, Research methods

Keywords: Injury, Health related quality of life, Economic Impact, Low and middle income countries


BMJ Open on A

ugust 13, 2021 by guest. Protected by copyright.

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Authors: J Jagnoor,1 S Prinja,

2 PVM Lakshmi,

2 S Aggarwal,

2 BJ Gabbe,

3 RQ Ivers

1

Jagnoor Jagnoor 1 The George Institute for Global Health

PO Box M201 Missenden Road

Emal:[email protected]

*Shankar Prinja (corresponding author) Email: [email protected] 2Post Graduate Institute of Medical Education and Research

Sector 12, Chandigarh India

2PVM Lakshmi

Email: [email protected] 2Sameer Aggarwal

Email: [email protected] 3Belinda Gabbe

Epidemiology & Preventative Medicine Monash Medical School Building The Alfred Hospital, Victoria, Australia Email: [email protected] 1Rebecca Q Ivers

Email: [email protected]

Keywords: Health related quality of life, social impact, economic impact, injuries, India

Word count: 3023

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ABSTRACT

Background: Road traffic injuries are a large and growing public health burden, especially in low-income and

middle-income countries where 90% of the world's deaths due to road traffic injuries are estimated to occur. India

is one of the fastest growing economies, with rapid motorization and increasing road traffic burden. However

there are limited data addressing the problem of non-fatal road traffic injuries with data of poor quality, non-

representative, difficult to access, and encompassing limited number of relevant variables. This study aims to

determine the outcomes of road traffic injuries on function, health-related quality-of-life, social impact and

economic cost of road traffic crashes in an urban setting in India

Methods and analysis: This prospective observational study will recruit nearly 1500 participants, who are

injured in a road traffic crash admitted to hospital for >24 hours at any of the three participating hospitals in

Chandigarh, India. Face-to-face baseline interviews will be conducted with telephone interviews at 1, 2, 4 and 12

months post-injury. Standardized tools will be used to collect data on health and social outcomes and the

economic impact of road traffic crashes. Descriptive analysis and multivariate models would be used to report

outcome data and associations. Qualitative in-depth interview will be analyzed thematically using content

analysis. This study will provide the first comprehensive estimates on outcomes of serious road traffic injury in

India, including economic and social costs and the impact on individuals and families.

Ethics and dissemination: Primary ethics approval was received from Postgraduate Institute for Medical

Education and Research, Institutes Ethics Committee, Chandigarh, India. Results will be disseminated via the

usual scientific forums including peer-reviewed publications and presentations at international conferences.

STRENGTHS

• First estimates of outcomes of serious road traffic injury in India, including economic and social costs and

the impact on individuals and families.

• Uses validated tools at regular intervals for comprehensive estimates

LIMITATIONS

• Systems cost will not be generated through this research work

• Quality of life of cares would not be comprehensively captured using the protocol

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BACKGROUND

The World Health Organisation (WHO) estimates that over 1.2 million people die each year on the world’s roads,

and between 20 and 50 million fall victim to non-fatal injuries.[1] The WHO projects that, unless immediate action

is taken, traffic crashes will increase from the ninth to the fifth leading cause of death by 2030, and will then

cause around 2.4 million deaths per year.[1] Road traffic injuries are also projected to rise to the third leading

cause of disability adjusted life years (DALYs) lost worldwide by 2020.[2] The burden of traffic crashes, in terms

of both mortality and morbidity, is increasing fastest in developing countries, due to rapid motorization

associated with economic growth.[3,4]

The situation is particularly acute in India, a nation of more than one billion people with one of the fastest

growing economies in the world. This economic growth has also meant a rapidly increasing number of vehicles

sold every year (around six million) and one of the highest reported mortality rates from road traffic injuries in

the world.[5] Road traffic fatalities in India increased by about 5% per year from 1980 to 2000 and then by about

8% per year to reach 105,725 in 2006 with the fatality rate increasing from 36 /million persons in 1980 to 95

/million persons in 2006.[6] Non-fatal injury is more common consequence of road crashes than death, and

injuries sustained are often severe. The incidence of RTI remains poorly measured in India, though the number

of people injured in road traffic crashes in 2006 was estimated to exceed 450,000. Cautious interpretation is

necessary, as previous studies have found traffic crashes to be underreported in India by 5% for deaths and

more than 50% for serious injuries.[7]

Weak estimates, or none, of morbidity due to road traffic crashes is a common problem in low- and middle-

income countries, where data sources are often of poor quality, non-representative, difficult to access, and

contain a limited number of relevant variables.[8]

A review of four studies in India estimated the cost of traffic crashes in the country to be between 0.29 and 0.69

percent of GDP, and identified a number of limitations related to the methods used.[9]

At least two studies used

rudimentary methods of cost analysis which omitted many components of the cost of traffic crashes. The

studies were each for a single locality, had small sample sizes, focused mainly on direct costs, and did not take

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into account impact on families or estimate injury burden. A study by Reddy et al [10] examined both direct and

indirect costs related to traffic crashes based on interviews with victims and their families instead of relying on

secondary data. However, this study shared limitations of the previous studies on cost of traffic crashes in India

including small sample size (148 crashes), the localized nature and the lack of estimates related to disability

mainly due to the cross-sectional nature of the study. More importantly, each of these previous studies adopted

a patient perspective in estimating the economic cost. None of the previous study estimated the health system

cost of delivering treatment for RTI patients. Since, the curative care for injury patients at public sector hospitals

is highly subsidized by the Government, patient’s costs does not value the true cost of the gamut of resources

which are spent on patient care.

As reviewed above, the gaps in knowledge, results both in under- estimation and limited understanding of the

burden of injury, limiting the capacity to inform policy development and capacity building for medical management,

rehabilitation and support services. Given the potentially catastrophic effects of injuries on families and

communities in such settings, particularly those of low socioeconomic status, there is a need to study non-fatal

outcomes in LMIC settings in order to inform the public health response to RTI.[11]

AIMS

The aims of this study are to describe:

1. The impact of road traffic injuries on function and health-related quality-of-life (HRQoL) in urban settings

in India,

2. The social impact of road traffic injuries on victims and their families including their participation and

utilization of health and social services; and

3. The economic cost of road traffic injuries using the human capital approach, including direct and

indirect costs to individuals and their families.

METHODS/DESIGN

This is a prospective observational study.

Study settings: Participants will be recruited from RTI patients admitted to hospital Chandigarh (Advanced

Trauma Centre, Post- Graduate Institute of Medical Education and Research), and two secondary care public

sector hospitals in Chandigarh and Panchkula during a 4 month period beginning in April 2014.

The study involves recruitment of patients of all ages admitted to hospital for at 24 hours due to a RTI. All types of

road users injured as a result of a traffic crash will be eligible for participation. Eligible participants will be

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identified by trained research staff located in emergency departments; staff will also review admissions registers

daily. The research staff will explain the study and consent process and invite participation. For participants who

are unable to give informed consent due to injury, consent will be sought from a proxy (relative or carer) and

consent will be sought from the patient when he or she is able to give or withdraw it. For children aged less than

18 years, consent will be sought from the carer/guardian, and from the child to the extent of the child’s capabilities

from the age of seven years up to the age of 18 years as per Indian Council of Medical Research ethical

guidelines.[12]

Approximately 1500 patients from the three hospital sites will be approached to join the study over the 4 month

period. Stratification for follow-up will be determined by the prevalence of key variables of interest in baseline data

(road user group, severity of injury, age, gender and socioeconomic status) to ensure the study has sufficient

power to describe with precision measures of function, health related quality of life and cost in the longitudinal

sample across these factors. The sample size calculations are for 90% power, to detect independent effects of

about 5% of the size of the variable in multiple linear regression analysis. These calculations are based on

experience from the pilot study.

Recruitment Procedures and follow up: All baseline interviews will be administered face to face at the hospital

and subsequent interviews will be conducted by telephone. Trained staff will conduct telephone interview to collect

data from the injured (or a proxy where appropriate) at standardized time points over the first 12-months (1, 2, 4

and 12 months), selected based on the recommendations of a previous injury outcomes study consensus

paper.[13] If the participant dies during follow-up, his or her family will be asked to complete the final interview at

12 months to ascertain impact of RTI related mortality. Patient recruitment and follow-up will be conducted by

appropriately qualified and trained research assistants.

Where possible, the following information will be collected for patients who do not consent to the follow-up

study: sex, age, place of injury and type of injury to establish any biases in the participating sample.

Measures

Baseline interview: The interview administered in hospital to participants will collect demographic information as

well as information related to the circumstances of traffic crashes. Data will (where possible) be collected directly

from participants or their carers. Items include age, gender, education, occupation, household income and

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consumption expenditure, road user type and vehicle counterpart, use of alcohol and other drugs in the hours

prior to the injury, use of safety devices at the time of the crash, setting of accident, road type, and time of day.

Pre-injury HRQoL, the use of health and social services in the 4 weeks prior to the injury and contact information

for follow-up interviews will also be obtained. The trained research assistants at each site will extract data from

the medical records on date and time of injury, type of injury, anatomical site of the body, co-morbidities, length of

the hospital admission as well as diagnosis and treatment procedures, and will score injury severity according to

the Abbreviated Injury Scale (AIS 2005-Update 2008).

Follow-up interviews: Subsequent follow-up interviews post hospital discharge will include measures of quality

of life, functioning and disability, economic costs and social impact. Interviews will be conducted by trained

research staff.

Quality of life, functioning and disability: To measure health-related quality of life we will use the EQ-5D, the

Pediatric Quality of Life Inventory (PedsQL) and the WHODAS II, which have been translated into Hindi.

Functioning will be measured according to the Glasgow Outcome Scale – Extended (GOSE), and its pediatric

version (KOSCHI). These instruments were selected because they cover most important dimensions of quality of

life, function and disability as defined by the International Classification of Functioning (ICF), are applicable to a

broad range of injuries and age groups and have been recommended as being valid and appropriate measures

of the impact of injury.[13-16] The EQ-5D will be used to produce a single utility score between < 0 and 1 based

on individual’s responses to questions on the impact of road traffic injuries on their lives. The pediatric measures

will be completed by the parents, as well as children aged from 5 years and above, as there are differences in

HRQoL reported by parents and children after injury.[17]

Economic costs: The economic impact of RTI will be measured by the human capital approach. The study will

seek to quantify both direct costs of road traffic injury (out–of-pocket costs) and indirect costs. A review of cost

of illness studies identified six most common categories of direct medical costs including emergency

department/hospital services, outpatient physician services, drugs, diagnostic procedures/laboratory tests,

other healthcare services and ancillary personnel.[18] In addition to these elements, cost of injury studies also

included as part of direct costs, ambulance/transport costs, home care, nursing home and other long term care

as well as vocational rehabilitation and insurance administration costs.[19,20] Direct non-healthcare costs

including those associated with police attendance and investigation of crashes, other legal and coroners costs,

vehicle and other property damage costs as well as other general costs associated with travel delays and fire

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and other emergency services costs will also be included.[21]

Taking into consideration the common cost items included in previous studies as well the context of traffic

crashes in India, we will collect data from participants and their families using standardized questionnaires on

out-of-pocket direct costs associated with a RTI during pre-hospital care: transportation to the hospital; hospital

facility and services, diagnostic procedure/laboratory tests, surgery, inpatient physician visits, medication, in

hospital rehabilitation, equipment; post-hospital costs: rehabilitation, medication, home care and other related

costs. In addition to direct costs incurred by victims, we will also collect information on costs incurred by victim’s

relatives/caretakers. These include accommodation during victim’s hospitalization transportation as well as other

costs specified by respondents. Costs of legal fees relating to the crash and of vehicle replacement or repair will

also be included. Information on compensation (insurance or legal) paid to the participant or to his/her family

because of the RTI will also be collected. This will include information on whether claims were accepted and on

timeliness of payment or reimbursement.

This study will rely on interviews with injured people and their family to obtain detailed direct medical costs. Recent

work has highlighted the important need to validate out-of-pocket expenditure and the lack of a gold standard for

measures of these costs[22] and the difficulties in validating such costs.[23] To ensure maximum accuracy, we will

utilize a short recall period (time since previous interview), standardized questionnaires will be developed to collect

information during interviews. Receipts, hospital and insurance cost records will also be sourced where available

from participants to validate reported costs.

Finally, the health system costs of providing treatment and care will be collected. An economic costing will be

undertaken using bottom-up costing methods. Cost centres, i.e. service and support centres will be identified. All

resources spent on provision of care over a period of one year will be enlisted. Information on price of these

resources will be obtained from suitable sources. In case the same is not available, a market survey to assess the

price will be undertaken.

Indirect costs: To estimate indirect costs for RTI for participants, the human capital approach will be applied,

using lost working days and occupation rates.[24] To calculate the indirect costs attributable to morbidity, income

loss and the working day loss of both the victims and their relatives/carers during the hospitalization and follow-

up period will be collected.

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Social impact: Impact of RTI on families, and their changed circumstances including work and caring roles, will

be assessed at each follow-up. Additionally, we will conduct 15 semi-structured face-to-face interviews from

each site and based on saturation of themes additional 5 interviews might be considered.[25] These interviews

will explore issues related to patients’ experiences post-crash including impact of the traffic crash on their life

and that of their family, access to health care, health insurance, and other services as well as other factors that

impact on recovery like return to work, carer responsibilities. This is chiefly a qualitative aspect of the project.

Families of participants who have died during the study period due to their injuries will also be invited to

participate, to ensure the wider impact of fatal injuries is included. For both fatal and non-fatal injuries, the

interviews will also cover any long delay or other negative aspect of compensation processes and their

implications for families and individuals.

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Table 1: Data collected at baseline and follow-up

BASELINE (Face to face)

Socio-demographic Age, sex, place of birth, primary language, education, marital status

Employment Employment status, occupation, household income

Health BMI ( height and weight), history of chronic illness

Lifestyle habits Smoking status and alcohol consumption

Circumstances of Crash Road user type, Role of the injured and use of any preventive measure

like helmet, seatbelt use, road type, time of the day


and functioning




and Koschi.

Injury Type of injury and associated hospitalisation, AIS score

Work Return to work, modified duties, hours



Separate assessment of health system costs will be undertaken

1, 2, 4 and 12 months follow up (telephone interviews)

Health related quality of

life

Likert scale for overall health, EQ5D3L and SF12.

Health Care Utilisation Days of hospitalisation, rehabilitation and home care


and functioning




and Koschi.

Disability and functioning History of any disability, World Health Organisation Disability Assessment

Schedule II (WHODAS II).



Social Impact at 12 months follow up (10% of the sample)

In depth interview Exploring issues related to access to health care, impact on carer,

insurance, advice seeking ( health and compensation), social life, impact

on work, perception of recovery, impact of injury general view

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Data management and analysis: Data will be entered into an electronic database by study staff in

Chandigarh. Logic and range checks will be used in the data entry process to minimize data entry errors and

identify missing data or problems with completed data. The electronic database will be stored on a “firewall-

protected” local network server.

Data will be analyzed in order to describe the burden, the associated disability and length of time for recovery,

as well as the economic cost of injurious road traffic crashes. Descriptive analyses will be performed to estimate

the outcomes of traffic crashes in terms of health, social and economic consequences, including catastrophic

health expenditure.

Multivariate modeling will also be undertaken to explore the role of demographic, injury and health care

related factors in predicting the health and socio-economic impact of hospitalized RTI, as well as mixed

effects regression models to examine recovery, predictors of recovery, predictors of catastrophic health

expenditure and other outcomes. Estimates of duration of disability, and disability weights, for each injury

health state will be calculated from the EQ-5D. The potential will be assessed for extrapolating from findings

at the study sites to generate population-based estimates of years lived with disability (YLD) and Years of life

lost (YLL) due to RTI, and overall DALYs.

Cost data will be analyzed using standard methods. Capital costs will be annualized after discounting of the life

of the capital item. Joint costs will be apportioned for injury care by using appropriate statistics. OOP expenditure

will be analyzed to assess its mean value and dispersion. Financial hardship will be assessed by analyzing the

extent of catastrophic health expenditures, at 40% threshold of non-food household expenditure. Poverty impact

of RTI will be estimated by computing the poverty headcount increase and poverty gap as a result of OOP

expenditure. Finally the private OOP expenditure will be analyzed using an equity lens, by computing

concentration curves and concentration index. This will provide a snapshot of vertical equity in financing care for

RTI.

Qualitative interviews on social impact will be transcribed and analyzed thematically using content analysis,

Frameworks will be identified and coding plan developed to explore interactions. A deductive approach will be

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Page 11 of 13

used to explore similarities or differences in context, person and their interactions; with health, compensation

and related systems, like occupational rehabilitation. Detailed information on the victim’s personal experience

and factors influencing injury outcomes will be explored.[25]

OUTCOMES AND SIGNIFICANCE

The proposed study will provide the first comprehensive estimates of outcomes of serious road traffic injury in

India, including economic and social costs and the impact on individuals and families. The study will contribute

considerable information to enable debate about societal context, culture and injury impact of traffic crashes. The

result will contribute to the required evidence for generating future investments in RTI prevention and document

non-fatal outcomes in low and middle income country settings in order to inform investment prioritization.[26]

Ethical approvals: The study has been approved by Institute’s Ethics Committee, Post Graduate Institute of

Medical Education and Research along with administrative approvals from hospital sites. No incentives will be

provided to the patients for participation in the research, as this is an observational study.

Funding Agency: The study has been funded by the Road Traffic Injury Research Network through a peer review

process, Agreement number 10/2013 in kind support to the study has been provided by School of Public Health,

Post Graduate Institute of Medical Education and Research.

Data sharing statement -No additional data are available for this manuscript.

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Organization, 2009. [www.who.int/violence_injury_prevention/road_safety_status/2009].

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4. Moniruzzaman S, Andersson R. Economic development as a determinant of injury mortality - a longitudinal

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Opportunities. Michigan: Transportation Research Institute, The University of Michigan, 2009.

7. Gururaj G. Road traffic deaths, injuries and disabilities in India: Current scenario. Natl Med J India

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8. Bhalla K, Naghavi M, Shahraz S, Bartels D, and Murray CJ. Building national estimates of the burden of road

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10. Reddy G, Negandhi H, Singh D, Singh AJ. Extent and determinants of cost of road traffic injuries in an Indian

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related quality of life outcomes after pediatric trauma. The Journal of Trauma and Acute Care Surgery.

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17. Gabbe B, Sutherland A, Hart M, et al. Population-based capture of long-term functional and quality of life

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and

related documents*

Section/item ItemNo

Description

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions,

and, if applicable, trial acronym

Trial registration 2a Trial identifier and registry name. If not yet registered, name of

intended registry

2b All items from the World Health Organization Trial Registration Data

Set

Protocol version 3 Date and version identifier

Funding 4 Sources and types of financial, material, and other support

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors

5b Name and contact information for the trial sponsor

5c Role of study sponsor and funders, if any, in study design; collection,

management, analysis, and interpretation of data; writing of the report;

and the decision to submit the report for publication, including whether

they will have ultimate authority over any of these activities

5d Composition, roles, and responsibilities of the coordinating centre,

steering committee, endpoint adjudication committee, data

management team, and other individuals or groups overseeing the

trial, if applicable (see Item 21a for data monitoring committee)

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the

trial, including summary of relevant studies (published and

unpublished) examining benefits and harms for each intervention

6b Explanation for choice of comparators

Objectives 7 Specific objectives or hypotheses

Trial design 8 Description of trial design including type of trial (eg, parallel group,

crossover, factorial, single group), allocation ratio, and framework (eg,

superiority, equivalence, noninferiority, exploratory)

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2

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital)

and list of countries where data will be collected. Reference to where

list of study sites can be obtained

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility

criteria for study centres and individuals who will perform the

interventions (eg, surgeons, psychotherapists)

Interventions 11a Interventions for each group with sufficient detail to allow replication,

including how and when they will be administered

11b Criteria for discontinuing or modifying allocated interventions for a

given trial participant (eg, drug dose change in response to harms,

participant request, or improving/worsening disease)

11c Strategies to improve adherence to intervention protocols, and any

procedures for monitoring adherence (eg, drug tablet return,

laboratory tests)

11d Relevant concomitant care and interventions that are permitted or

prohibited during the trial

Outcomes 12 Primary, secondary, and other outcomes, including the specific

measurement variable (eg, systolic blood pressure), analysis metric

(eg, change from baseline, final value, time to event), method of

aggregation (eg, median, proportion), and time point for each

outcome. Explanation of the clinical relevance of chosen efficacy and

harm outcomes is strongly recommended

Participant

timeline

13 Time schedule of enrolment, interventions (including any run-ins and

washouts), assessments, and visits for participants. A schematic

diagram is highly recommended (see Figure)

Sample size 14 Estimated number of participants needed to achieve study objectives

and how it was determined, including clinical and statistical

assumptions supporting any sample size calculations

Recruitment 15 Strategies for achieving adequate participant enrolment to reach

target sample size

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-

generated random numbers), and list of any factors for stratification.

To reduce predictability of a random sequence, details of any planned

restriction (eg, blocking) should be provided in a separate document

that is unavailable to those who enrol participants or assign

interventions

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3

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central

telephone; sequentially numbered, opaque, sealed envelopes),

describing any steps to conceal the sequence until interventions are

assigned

Implementation 16c Who will generate the allocation sequence, who will enrol participants,

and who will assign participants to interventions

Blinding

(masking)

17a Who will be blinded after assignment to interventions (eg, trial

participants, care providers, outcome assessors, data analysts), and

how

17b If blinded, circumstances under which unblinding is permissible, and

procedure for revealing a participant’s allocated intervention during

the trial

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other

trial data, including any related processes to promote data quality (eg,

duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with

their reliability and validity, if known. Reference to where data

collection forms can be found, if not in the protocol

18b Plans to promote participant retention and complete follow-up,

including list of any outcome data to be collected for participants who

discontinue or deviate from intervention protocols

Data

management

19 Plans for data entry, coding, security, and storage, including any

related processes to promote data quality (eg, double data entry;

range checks for data values). Reference to where details of data

management procedures can be found, if not in the protocol

Statistical

methods

20a Statistical methods for analysing primary and secondary outcomes.

Reference to where other details of the statistical analysis plan can be

found, if not in the protocol

20b Methods for any additional analyses (eg, subgroup and adjusted

analyses)

20c Definition of analysis population relating to protocol non-adherence

(eg, as randomised analysis), and any statistical methods to handle

missing data (eg, multiple imputation)

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role

and reporting structure; statement of whether it is independent from

the sponsor and competing interests; and reference to where further

details about its charter can be found, if not in the protocol.

Alternatively, an explanation of why a DMC is not needed

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4

21b Description of any interim analyses and stopping guidelines, including

who will have access to these interim results and make the final

decision to terminate the trial

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and

spontaneously reported adverse events and other unintended effects

of trial interventions or trial conduct

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and

whether the process will be independent from investigators and the

sponsor

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board

(REC/IRB) approval

Protocol

amendments

25 Plans for communicating important protocol modifications (eg,

changes to eligibility criteria, outcomes, analyses) to relevant parties

(eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

Consent or assent 26a Who will obtain informed consent or assent from potential trial

participants or authorised surrogates, and how (see Item 32)

26b Additional consent provisions for collection and use of participant data

and biological specimens in ancillary studies, if applicable

Confidentiality 27 How personal information about potential and enrolled participants will

be collected, shared, and maintained in order to protect confidentiality

before, during, and after the trial

Declaration of

interests

28 Financial and other competing interests for principal investigators for

the overall trial and each study site

Access to data 29 Statement of who will have access to the final trial dataset, and

disclosure of contractual agreements that limit such access for

investigators

Ancillary and

post-trial care

30 Provisions, if any, for ancillary and post-trial care, and for

compensation to those who suffer harm from trial participation

Dissemination

policy

31a Plans for investigators and sponsor to communicate trial results to

participants, healthcare professionals, the public, and other relevant

groups (eg, via publication, reporting in results databases, or other

data sharing arrangements), including any publication restrictions

31b Authorship eligibility guidelines and any intended use of professional

writers

31c Plans, if any, for granting public access to the full protocol, participant-

level dataset, and statistical code

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Appendices

Informed consent

materials

32 Model consent form and other related documentation given to

participants and authorised surrogates

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological

specimens for genetic or molecular analysis in the current trial and for

future use in ancillary studies, if applicable

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013

Explanation & Elaboration for important clarification on the items. Amendments to the

protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT

Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported”

license.

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Documents

The Impact of Road Traffic Injury in North India: A Mixed ...BMJ Open: first published as 10.1136/bmjopen-2015-008884 on 19 August 2015. Downloaded from . For peer review only Page