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doi:10.1111/anae.12810

Editorial

Quality of Life: changing the face of outcome measurements in

critical care

Born from a concern about the cost

and quality of healthcare, and fur-

ther emphasised by an increasing

awareness of the variability of clini-

cal practice throughout different

jurisdictions, interest in measuring

and evaluating the effect of clinical

interventions has grown consis-

tently over the last two decades.

Measuring effectiveness serves as an

attempt to ensure that healthcare

systems are transparent and

accountable to both those who pay

for them, and those who use them.

While outcome measures continue

to rely heavily on the use of mortal-

ity as a marker of performance,

recent evidence demonstrates that

both the UK and the USA have a

growing interest in measuring

patient function, rather than merely

physiological endpoints [1].

This move towards using func-

tional outcome in performance

© 2014 The Association of Anaesthetists of Great Britain and Ireland 1073

Editorial Anaesthesia 2014, 69, 1065–1077

measurement mirrors the realisation

in many specialties that subjective

measures of health are a worthwhile

adjunct in examining the effects of

treatments and interventions. Initial

clinician concerns regarding their

use as an outcome measure have

eased, as the necessary measure-

ment tools have been repeatedly

validated in areas of medicine

including oncology, rheumatology

and cardiology [2–4]. Indeed, the

strength of these tools of subjective

measurement in assessing the effec-

tiveness of care has also led to the

US Food and Drug Administration’s

decision to use patient reported

outcomes (PROs) in the clinical eval-

uation of technologies [5]. Further

proof of their widespread accep-

tance is evident in clinical oncology,

as formal assessments of quality of

life are now a mandatory require-

ment of most randomised control

trials [6].

Nonetheless, despite increasing

evidence within intensive care that

both the disease process of critical

illness and the treatments provided

to our patients can have a substan-

tial effect on the functional outcome

of those who survive intensive care

[7], randomised controlled trials

continue to focus on outcome mea-

sures of survival, length of stay and

duration of mechanical ventilation.

In the 10 years since Wu and Gao

discussed, in this journal, the merits

of examining long-term outcomes

of critical care, there has been an

increasing emphasis on the effect of

critical illness on functional out-

come, yet their call for the use of

subjective measures as an endpoint

in clinical trials has largely gone

unheeded [8]. Indeed, despite the

growth of PROs as a measure of

effectiveness in medical care, they

are rarely evident in the evaluation

of individual treatments and inter-

ventions within critical care medi-

cine.

This individuality is not unex-

pected. The primary target of inter-

ventions within intensive care is the

prevention of death, and the most

costly of its interventions and tech-

nologies are those that aim to save

lives, rather than improve func-

tional status. This targeted approach

is not without merit. Interventions

that used survival as their only pri-

mary outcome in assessing treat-

ment efficacy are known to have

improved mortality rates within

critical care [9]. However, the

World Health Organization reminds

us that the goal of healthcare is not

merely the prevention of death, but

it must also ‘improve health’ [10].

In response to calls for improve-

ments in quality within intensive

care, and an emphasis on perfor-

mance measurement, the use of

quality indicators is becoming more

widespread. These quality indicators

fall within two of the arms of Don-

ebedian’s model of care – structure

and process [11]. Consensus guide-

lines consider nosocomial infection,

pressure sores and pulmonary

embolism to be significant markers

of the provision of quality care

[12]. Identifying these indicators

represents a significant step on the

pathway to realising that critical

care should be about more than just

the prevention of death. However,

by only examining the ‘process’ and

‘structure’ aspects of care, these

indicators describe the outputs of

healthcare delivery, rather than the

ultimate health outcome. In an era

of resource constraint, this is pre-

dictable. As the unit of delivery of a

service, outputs are easy to measure

in terms of quantity, quality, and

cost, and are a tangible measure of

work performed. However, they rely

heavily on the assumption that

altering these outputs will be associ-

ated with an improved outcome.

Health performance measurement

data examining treatment differ-

ences for myocardial infarction

between Ontario and New York

demonstrated that increased outputs

do not necessarily result in

improved outcomes [13]. A realistic

evaluation of care requires us to

examine the ultimate change in

health status that is attributable to

health interventions, rather than the

degree of intervention itself. There-

fore, to demonstrate improvements

in quality within intensive care

units, we need to include an assess-

ment of changes in both health and

functional outcome.

While the intensive care com-

munity may be aware of the effect

of critical illness on the long-term

outcome of survivors, this is less

likely to be identified by healthcare

providers involved in their post-

hospital care. In addition, the

impact on families, and the resul-

tant societal burden, are often

neglected in the allocation of

resources and support. Patients

discharged from intensive care units

are more likely to be to be unem-

ployed or under-employed than

age-related cohorts, and poor cop-

ing has been reported in 100% of

survivors, and in 100% of their pri-

mary carers [14]. Studies of the

physical, psychological and social

1074 © 2014 The Association of Anaesthetists of Great Britain and Ireland

Anaesthesia 2014, 69, 1065–1077 Editorial

morbidities affecting survivors dem-

onstrate that many are unable to

return to normal care. However,

despite both the burden of disease

and the cost-implications for both

patients and society, clinicians

continue to view impairments of

functional outcome and decreased

quality of life as an unfortunate

complication of the disease pro-

cesses and treatments necessary to

ensure survival. Yet, the evidence

suggests otherwise. Low-cost inter-

ventions can be beneficial in

improving functional outcome; for

example, strict attention to sedative

choice and glycaemic control are

possible means of improving cogni-

tive function without negatively

affecting survival [15, 16].

The failure to include quality of

life as an outcome in critical care

trials is particularly remarkable in

the case of acute respiratory distress

syndrome (ARDS). Albeit a contro-

versial association, the effect of

ARDS-related hypoxaemia on cog-

nitive function was described in the

1990s [17]. While the exact mecha-

nism for the relationship between

ARDS and cognitive function

remains in dispute, what is of sig-

nificance is that despite the aware-

ness of this potential relationship,

cognitive function was not included

as a secondary outcome in subse-

quent ARDS Network (ARDSNet)

trials. More recently, survivors of

the Fluid and Catheter Treatment

Trial (FACTT) were involved in

an adjunct study to examine neuro-

psychological function [18]. The

authors determined that fluid man-

agement is a possible risk factor,

but could not confirm their find-

ings. Further retrospective examina-

tion of survivors of ARDS

demonstrated that higher blood glu-

cose levels predicted both a longer

duration of mechanical ventilation

and a decline in cognitive function

[16]. However, functional status as

an outcome measure has been miss-

ing from the endpoints of the most

renowned trials examining glucose

control over the past 12 years [19,

20].

Examining the effect of delirium

on neurocognitive and neuropsychi-

atric function has demonstrated that

it is associated with cognitive dys-

function one year after discharge

[21]. While recent work has rein-

forced the theory that delirium may

be an unavoidable effect of critical

illness [22], an additional body of

evidence has reported that the pre-

cipitating factors for delirium may

be modified by choice of sedatives,

rehabilitation, noise control and

sleep-promoting interventions [23,

24]. However, even the relatively

recent trials of dexmedetomidine

failed to include long-term cogni-

tion in their measurement of out-

comes [25, 26]. Furthermore, no

plans have been reported to do so

on follow-up analysis.

While trials that focus predomi-

nantly on short-term functional

outcome are no doubt important in

determining the degree of support-

ive care that will be required by

patients on their immediate dis-

charge to ward-based care, or

indeed to their home environment,

emphasising only the effect of

these interventions on short-term

function will not provide us with

the necessary information regard-

ing their ability to cope in the

longer term.

Part of the hesitancy surround-

ing the use of quality of life out-

come measures in the intensive care

population relates to concerns

regarding the subjective nature of

the measurement tools involved.

Clinicians’ fears regarding their use

often focus on a belief that patients

are unable to evaluate their own

health status appropriately. Although

an imperfect science, methods to

examine quality of life have been

validated in both in-hospital

patients and the critical care popu-

lation. In cardiology, quality of life

tools have shown a consistent cor-

relation between patients’ subjective

assessments of their health status

and conventional clinical assess-

ments, including exercise stress tests

and New York Heart Association

(NYHA) assessments [27]. Further-

more, there is a growing consensus

in cardiology and oncology that

quality of life assessments are now

the ‘gold standard’ when used as an

adjunct in the evaluation of health-

care performance [28]. Targeted

Short Forms (SF) have been vali-

dated not only in the assessment of

high-risk patients, but also in the

assessment of patients whose social

circumstances may prevent them

from accessing care [28]. Disease-

specific measurement tools are of

particular interest in intensive care

medicine. These tools are known to

detect subtle clinical changes, and

both utility tools (e.g. EQ5D) and

generic instruments (e.g. SF36) have

been demonstrated as being effec-

tive in discrete evaluation and pre-

diction of illness for intensive care

survivors [29]. These measures

allow a multifaceted approach to

measuring outcome, by combining

© 2014 The Association of Anaesthetists of Great Britain and Ireland 1075

Editorial Anaesthesia 2014, 69, 1065–1077

functional capacity, physiological

capacity, neuropsychiatric condi-

tions, work, economic and social

activity, and a subjective expecta-

tion of illness [30].

Nevertheless, the use of quality

of life indicators is not without

controversy. Nor is the use of these

tools fully validated in the assess-

ment of cost-effectiveness. While

the validity of such a form is reli-

ably confirmed, there less consensus

regarding the timing of the quality

of life assessments [31]. Even

within Europe, differences of opin-

ion exist regarding the optimal time

to assess quality of life. Further dif-

ficulties may arise with the small

size of the critical care population

for comparison. As patients requir-

ing intensive care have different

admission diagnoses and exhibit

varying degrees of disease progres-

sion, both generic outcome mea-

sures and disease-specific measures

are required. However, these gen-

eric measures may be poorly

responsive to changes in disease-

specific conditions [32]. Additional

problems with population size

occur due to loss to follow-up,

which is high in these patients [33].

Furthermore, selection bias within

this follow-up group raises concerns

that those attending discharge clin-

ics may be a group with greater

health needs [34], or that those in

greatest need may be unable to

access follow-up care [33].

The most pressing concern

relates to whether or not patient-

reported outcome measures (PROMs)

may result in a focus on conditions

that are not amenable to interven-

tion. In an era of resource con-

straint, do we risk directing scarce

resources away from those treat-

ments that improve survival?

While appropriate concerns

exist regarding the conceptual and

methodological difficulties inherent

in comparing healthcare delivery,

and in how these results are com-

municated and used, moving

towards greater accountability

within healthcare will depend on

accurate measurement of outcomes,

and a move towards cost-effective

care will require these measure-

ments to take long-term functional

outcomes into account.

In 2010, an examination of the

role of subjective measures as an out-

come within all areas of medicine

demonstrated that around 12% of

industry sponsored trials, and 15%

of non-sponsored trials, involved the

use of PROMs [35]. Ageing popula-

tions and technological advance-

ments will continue to place an

enormous strain on critical care ser-

vices. Healthcare costs continue to

increase globally, with an expecta-

tion that they will reach 50% of

national health expenditure by 2021

in the USA alone [36]. As part of an

effort to control costs, while contin-

uing to deliver care within a respon-

sive health system, governments are

turning towards value-based pricing

as a potential reimbursement policy

in the purchase of pharmaceuticals.

Internationally, chronic disease has

become widely recognised as a sig-

nificant burden, in terms of both

patients’ health status and costs.

Those involved in the allocation of

resources will be under increasing

pressure to ensure that treatments

and interventions will benefit

patients in both the short and long

term. In preparation for this, we

should follow the example of clinical

trials in oncology, and ensure that

quality of life measures are consid-

ered as an outcome along with mor-

tality and length of stay. Rather than

focusing on the difficulties with out-

come measures in critical care, we

should instead be focused on devel-

oping measurement tools that accu-

rately represent our patient

population. If we fail to embrace this,

critical care medicine will become

isolated as other specialties within

medicine move towards value-based

delivery of healthcare.

Competing interestsNo external funding and no com-

peting interests declared.

F. KiernanClinical Lecturer in Anaesthesia andIntensive Care MedicineRoyal College of Surgeons of IrelandDublin, IrelandEmail: fionakiernan@rcsi.ie

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