With the publication of its 100th paper, the new open access Journal Health and Quality
of Life Outcomes (HQLO), achieves a significant milestone. Launching a journal in
this field was not just a challenge with respect to nomenclature, [1] but also provided
a forum for disseminating research which emphasises the unique contributions as well
as the inter-relationships among determinants of health, provision of care, and outcomes.
So far, prominence (as measured by the number of scientific manuscripts accepted for
publication) has been given mainly to the unique contributions of health-related quality
of life (HRQL). Other determinants like health needs and satisfaction have sporadically
been considered [2-7]. A few additional papers have focused on approaches to detect
ill health. In this editorial we would like to explore the relationship between needs,
satisfaction and quality of life, identify gaps in the current knowledge base, and
encourage future research in these areas.
Clinical approach
The World Health Organisation (WHO) in 1948 defined health as a "a state of complete
physical, mental, and social well being not merely the absence of disease or infirmity"
[8]. While this definition is comprehensive (though rather utopian and ambitious)
it clearly indicates what
should
be the goal of health care intervention. Medical professionals however tend to focus
more narrowly on a medical model of health care -a history and examination- followed
by investigation and treatment, and finally clinical measures of successful outcome.
This approach has been criticised for producing a paternalistic doctor-patient relationship
[9,10]. The relative success of a given health care intervention may differ significantly
from a patient perspective vis-à-vis the health care provider's perspective. When
this occurs we may ask ourselves; Has a health need been met? Was the care process
satisfactory? Has the burden of disease on the patient's quality of life been minimised?
This traditional approach to patient assessment, using clinical and laboratory evaluation,
is largely based on observer ratings by health professionals. In the 'medical model',
there is an optimal level of functioning and everybody below this could be assumed
to suffer ill health. However if these cases are examined carefully, physically-disabled
individuals could be found with better quality of life than individuals with optimal
functioning, as quality of life refers to a broader concept of health than has traditionally
been defined. Modern medicine is slowly beginning to recognise the importance of the
perspective of the patient in health care and more investigations are needed to understand
the importance of the inter-relationships among health needs, satisfaction, and quality
of life.
'Need': conceptually complex
No consensus seems to be exist about the meaning and concept of 'need' in health,
sociology and political literature [11-13]. The ambiguity of the concept of 'needs'
and enormity of the task imposed upon practitioners has made the transition from service-led
to needs-led much harder [14]; this vagueness is more apparent when a specific need
fails to fall neatly into 'health care' or 'social care' domains, each of which is
correlated with the other. Patients with depreciated perception of health status have
more social needs [4], thus meeting social needs may have a direct impact on general
health status, which eventually falls into the health domain, perhaps indicating the
'holistic nature' of needs [14]. For example, cancer patients may have a need to better
understand their diagnosis and the specific prognosis. However, they may feel guilty
about interrupting a busy General Practitioner, and so their needs are not met. This
may raise the patient's level of anxiety, which in turn may worsen their emotional
health status [6,15,16].
Need has a broad spectrum, as the range of human experiences is quite large. The main
focus in Wen and Gustafson's paper [6] was on emotional problems, which despite its
importance in perceived HRQL, consists of just one part of the whole concept- there
are more subscales. Apparently, the physical scale has been ignored in their models,
as are other components of the physical and emotional domains such as quality of sleep,
pain and discomfort, social contacts and overall perception of quality of life perception.
'Need' may have a direct effect on satisfaction with care but the direction of the
relationship is not clear. For example, patients may have a need for more or better
information on some aspect of health. If this need is unmet, it may result in dissatisfaction
with services. Alternatively, the better informed patient tends to have higher expectations
and so be dissatisfied with care [6]. Both of these scenarios directly influence quality
of life [5].
A current definition of need that has been occasionally published in the National
Health Service (NHS) documents indicates that need is the 'capacity to benefit from
health care services'. However this definition may be too restrictive as "legitimate"
patient needs might be limited to those that can be easily addressed within existing
health services and that are considered 'medically necessary', maintaining the medical
model which experience suggests has proven unsatisfactory in meeting patient needs.
The pressure of political self-preservation obliges health decision makers to handle
health issues with no further increase in global health budget, thus they prefer to
manipulate and introduce rather strict and somewhat artificial definitions to justify
shortages in resources devoted to the health sector. Unfortunately using a more restrictive
definition of 'need' masks the larger amount of genuine health needs of the population.
Satisfying all of these desired health needs would, most certainly, require more monetary
resources.
The challenge therefore is to identify and target patients' genuine needs. Mobilising
resources to meet these needs would certainly avoid further expenses, keep patients
satisfied with services, and lead to better quality of life. At the moment, there
is no single definition of genuine health needs precisely within the context of public
health policy, yet it makes sense to describe this inherently complex issue as 'what
patients – and the population as a whole- desire to receive from health care services
to improve overall health'. Even this definition may leave practitioners 'open to
making judgement based on implicit knowledge, rooted in professional training and
values, office culture and assumptive world' [17].
Patient satisfaction surveys
The modern approach to healthcare seeks to engage the attention of both patients and
the public in developing healthcare services and equity of access, but this is not
easy to achieve, requiring time, commitment, political support and cultural change
to overcome barriers to change [18,19]. Improvement in selected aspects of health
care delivery through quality assurance and outcome assessment has been driven by
political expediency. While this is important, a 'bottom up' assessment of patient
satisfaction seems preferable if service improvement is to be translated into outcomes
meaningful to patients, especially improved quality of life [20,21].
Satisfaction can be defined as the extent of an individual's experience compared with
his or her expectations [22]. Patients' satisfaction is related to the extent to which
general health care needs and condition-specific needs are met. Evaluating to what
extent patients are satisfied with health services is clinically relevant, as satisfied
patients are more likely to comply with treatment [23], take an active role in their
own care [24], to continue using medical care services and stay within a health provider
(where there are some choices) and maintain with a specific system [25]. In addition,
health professionals may benefit from satisfaction surveys that identify potential
areas for service improvement and health expenditure may be optimised through patient-guided
planning and evaluation [19].
Critics draw attention to the lack of a standard approach to measuring satisfaction
and of comparative studies [26,27] and so the significance of the results of those
surveys that do exist in the literature is often ignored. There is less controversy
with respect to clinical outcome measures, as health-related quality of life (HRQL)
is not only widely regarded as a robust measure of outcome assessment but also is
extensively used in several clinical areas [28,29].
Patient satisfaction is considered by some to be of dubious benefit in facilitating
the process of clinical care, as patients have no specific clinical expertise and
are -perhaps- readily influenced by non-medical factors; in addition, there are few
reports on the reliability of satisfaction surveys [19,30,31]. Nevertheless, satisfied
patients are more likely to comply with medical treatment and therefore ought to have
a better outcome [23].
The role of health-related quality of life
Reliable (and increasing) evidence exists about the robustness of the predictive value
of patients' perception of their own health status [32,33]. Some HRQL tools are able
to assess post-MI patients' perceived health status and there is a significant correlation
with conventional clinical assessments like the treadmill exercise test [34,35], or
with functional classification such as the New York Heart Association (NYHA) scale
[36]; however reports are inconsistent [37,38]. It is noteworthy that the correlation
coefficient for treadmill-induced angina on tests one day apart was 0.70 [39] and
for patient-reported angina was 0.83 when SAQ was applied three months apart [40].
The shift to the patients' viewpoint, however, is pessimistically asserted to be inevitable
in chronically ill or dying patients as there is no option for further clinical assessment
[41].
There is growing evidence indicating that 'quality of life assessment' can be considered
as adjuvant to clinical and physiological assessments in many chronic conditions,
particularly cancers [42] and coronary artery diseases [43]. This approach is postulated
to be the 'gold standard' in the evaluation of healthcare services and outcome assessment.
The large variety of generic and disease specific instruments can confuse researchers
contemplating the most appropriate tools for quality of life investigation. As a general
rule, however, the combination of generic and disease-specific HRQL questionnaires
provide complementary information [3,44,45].
Relationship of satisfaction, quality of life and health needs
Wen and Gustafson [6] proposed an interesting model of the relationship between health
needs, satisfaction with care and quality of life in cancer patients. Their research
makes a compelling case for us to reassess the concept of needs assessment and better
explore its relationship with outcome measurements, like clinical endpoints, quality
of life, and satisfaction with care. The association of health needs and health-related
quality of life and also satisfaction with health services have been acknowledged
in cancer patients, oral health and cardiac patients in Health and Quality of Life
Outcomes [3-5,7], and a few in other journals [46].
A comprehensive evaluation of health care should ascertain a patient's expressed health
needs [47]. Identification of the needs of individuals (and of the local population),
whether through formal needs assessment or some surrogate, is an essential first step
towards optimising the use of allocated resources.
The correlation between health needs and health-related quality of life scores might
have potential benefits in routine clinical investigation, too, where comprehensive
care is targeted. Administration of appropriate HRQL tools in clinics, surgeries or
health centres may detect areas of health care needs worthy of health professionals'
closer scrutiny. For example, a patient with an impaired Short Form Physical Component
Score [33] or physical dimension (SAQ-Phys) may perhaps be distinguished not only
as being at high risk in terms of clinical end points [48], but also as a vulnerable
patient who might have difficulty accessing health care services, for which extra
care (such as after hours services or ambulance transport) may be required. Similarly
where the satisfaction component in the SAQ yields a lower score, cardiac care teams
must be aware of potential shortcomings in the delivery of care and investigate reasons
for any dissatisfaction; even provision of information about the nature of cardiovascular
disease or its treatment may improve the satisfaction score.
Health-related quality of life tools have the potential to identify specific and general
health needs. First, components of disease-specific HRQL tools are more likely to
be associated with specific health care needs. Second, measuring HRQL provides outstanding
insight towards approaches that may lead to improved quality of care [40]. Third,
the administration of 'off-the-shelf' quality of life tools affords a rapid screening
test to identify both populations and individuals who warrant a more detailed health
needs assessment.
A common critique of quality of life tools in clinical research is that data are 'soft'
and less reliable than traditional clinical assessment or physiological measurement.
Nevertheless, both generic and disease-specific tools can detect subtle clinical changes
quite precisely [40], especially in cardiac disease [49]. Some are concerned that
HRQL tools may not precisely identify the most important problems yet, from an economic
and existential point of view, it is conceded that patients' perception has equal
validity and legitimacy to that of physicians [41]. English language-based quality
of life tools have been tested in a wide range of diseases; overall in clinical practice
and in health service research, they have proven so useful that both generic and disease-specific
tools have been translated into a variety of other languages for wider application.
Basing health care needs on quality of life scores, however, necessarily incorporates
several sources of uncertainty due to factors such as age, sex, social class and individual
patient's health status. In addition, quality of life tools may fail to distinguish
between health problems and the desire to get professional attention [50].
Despite the documented relative merits of HRQL tools in various clinical and research
settings, these tools may not detect individual health needs in depth. For example,
assume a coronary artery patient who has attended in a cardiac rehabilitation session
with an impaired emotional score in the MacNew (Quality of Life after Myocardial Infarction)
or sleep disorder in the Nottingham Health Profile (NHP) questionnaire: can we distinguish
the background reason for this impairment? Is it due to (at worst) heart failure disturbing
depth of sleep or simply because the patient has teen-aged grandchildren who afford
little time for rest? At this stage, an in-depth needs assessment could reveal the
background explanation, which may warrant changes in medical treatment or the provision
of social support. Any comprehensive modelling must include both needs and outcome
assessment to evaluate the whole process of care in individual and population levels.
The optimum approach, perhaps, could be a combination of needs and outcome assessment,
preferably at individual levels [41].
Comments/ Discussion
While a large body of literature exists and continues to expand on generic and condition
specific health-related quality of life assessment theory and applications, and to
a lesser degree patient satisfaction, the inter-relationship between needs, satisfaction,
and quality of life remains ambiguous; there is no consensus over the actual contribution
of these measures in modelling a comprehensive health care arrangement.
As we reflect on the current state of research in these areas, a number of challenges
confront us:
1. Are the current research efforts in the evaluation of health status, needs, satisfaction
and quality of life appropriately balanced?
2. Should research on health status and quality of life be terminated or should the
emphasis on traditional clinical outcomes (such as survival) be reduced? Which should
prevail?
3. To what extent can quality of life be used as a proxy or surrogate for satisfaction
and/or the needs of patients? Just as clinical indicators have been used as surrogates
for quality of life [51], are we in danger of similarly mistaking health need as a
surrogate?
4. What is the evidence for the psychometric properties of the instruments used to
evaluate satisfaction and needs?
5. Have studies of patients' satisfaction been conducted but not published because
of negative results, poor validity and reliability and responsiveness of the instruments
developed (eg high levels of ceiling effect with high levels of satisfaction due to
patients' fear of giving negative evaluations)? Or studies which could not be published
because non-validated instruments were deployed, to assess patient satisfaction, not
only wasting scarce hospital resources but also delaying changes in health service
delivery by local health authorities.
We have addressed these questions to a selected number of researchers (most of them
editorial board members of the Journal or Authors of articles published in HQLO; see
Table 1). Their answers/comments are reported in the following sections and provide
HQLO readers with interesting thoughts about the direction of future studies.
Table 1
Appendix. Authors of the comments
Mark J. Atkinson, PhD
Senior Outcomes Research Scientist
Worldwide Outcomes Research
La Jolla Labs, Pfizer Inc.
San Diego, CA, USA
Anne Brédart, PhD
Unite de Psychiatrie et D'Onco-Psychologie
Institut Curie, Paris Cedex, France
Cinzia Brunelli, ScD
Unit of Psychology
Istituto Nazionale Tumori, Milan, Italy
David Cella, PhD
Professor, Psychiatry and Behavioral Science
Research Professor
Institute for Health Services Research
and Policy Studies
Northwestern University
Director, Center on Outcomes,
Research and Education
Evanston Northwestern Healthcare
Evanston, IL, USA
Anthony Culyer, CBE, BA, Hon DEcon, FRSA, FMedSci
Professor and Chief Scientist
Institute for Work and Health
Toronto, ON, Canada
James T. Fitzgerald, PhD
Department of Medical Education
University of Michigan Medical School
Ann Arbor, MI, USA
Samuel C. "Chris" Haffer, PhD
Director, Medicare Health Outcomes
Survey Program
Centers for Medicare & Medicaid Services
Baltimore, Maryland, USA
Michael E. Hyland, PhD, CPsychol
Professor of Health Psychology
School of Psychology
University of Plymouth, UK
Robert M. Kaplan, PhD
Professor and Chair
Department of Family
and Preventive Medicine
University of California
San Diego, La Jolla, CA, USA
Richard Kravitz, MD, MSPH
Professor and Director
UC Davis Center for
Health Services Research
in Primary Care
Co-Vice Chair for Research
Department of Internal Medicine
Sacramento, CA, USA
Ruth McCorkle, RN, PhD, FAAN
Director of the Center for
Excellence in Chronic Illness Care
School of Nursing, Yale University
New Haven, CT, USA
Stephen P McKenna, PhD
Director of Research
Galen Research, Manchester, UK
Brian Ott, MD
Department of Clinical Neurosciences
Brown Medical School
Providence, Rhode Island, USA
Luis Prieto, PhD
Health Outcomes Research Unit
Lilly, S.A., Madrid, Spain
Ewa Roos, PT, PhD,
Associate Professor
Dept of Orthopedics
Lund University Hospital
Lund, Sweden
Rob Sanson-Fisher, PhD
Professor of Health Behaviour
Faculty of Health
University of Newcastle, Australia
Richard Shikiar, PhD
Senior Research Scientist and COO
MEDTAP International, Inc.
Seattle, WA, USA
Davide Tassinari, MD
Department of Oncology, City Hospital
Rimini, Italy
Andrew Vickers, PhD
Integrative Medicine Service
Memorial Sloan-Kettering Cancer Center
New York, USA
The concept and approaches of needs assessment, satisfaction, and HRQL seems fundamental
to 'good practice', 'quality care', and 'community participation' at a time of greater
patient empowerment. However, resource constraints on one hand and medical expectations
on the other may jeopardise the impact of the patient's perspective.
It is our hope that drawing attention to the importance of the interaction of patients'
health needs, satisfaction and health-related quality of life will stimulate further
research to produce valid and reliable data and perhaps new investigational tools
which take all these non-medical factors into account.
Are the current research efforts in the evaluation of health status, needs, satisfaction
and quality of life appropriately balanced?
My view is that the best, most accurate quality of life data and conclusions should
point to unmet needs and should be closely associated with satisfaction. Therefore,
rather than seeing this as a competition for limited resources, potentially spawning
a short-term feeding frenzy on the nature of these relationships, I view it as a call
for better appreciation for how existing quality of life evaluations point to appropriate
treatment directions and patient satisfaction with care. Recently, several researchers
have turned their focus to such application of existing tools. David Cella
Why is 'balance' needed? And what is an appropriate balance? I find this sort of question
a bit pointless, as researchers will do what researchers do anyway. But the question
lacks explicit criteria in terms of which to discuss the matter. Anthony Culyer
I don't think it is a good idea to dictate which areas of research should be continued
and discontinued. The best research stems from investigator initiation. Robert M.
Kaplan
We need to make our assumptions clear. We, as researchers and clinician, categorise
the world so as to make sense of the world. We divide it into manageable parcels.
One of these parcels is health related quality of life (HRQL); another is patient
satisfaction; and yet another is patient need.
However, these are our interpretations, they are not necessarily what goes on inside
the patient. Consider the following truisms:
1. When patients respond to a questionnaire, they are actually responding to the individual
items of the questionnaire. The researcher then sums those items in one way or another.
2. The patient's response to individual items reflects (a) what the researcher thinks
the item is measuring and (b) many other things as well, some of which the research
may be aware of but others are unknown.
3. Measures of satisfaction reflect items measuring referring specifically to some
defined aspect treatment (the selection is made by the researchers). Measures of HRQL
include a range of emotional and physical aspects (again selected by the researcher)
but typically without referring to the actual treatment received. Both these kinds
of item are highly correlated with trait negative affect (e.g., neuroticism), which
is itself often a component of HRQL scales. There is often some overlap in the wording
of items from different kinds of scale, so not surprisingly satisfaction, HRQL and
personality scales inter-correlate quite highly.
4. Perception of need depends on trait negative affect, as well socially constrained
expectations. If all of your neighbours have donkeys but not cars, then you don't
'need' a car. But if your neighbours all have two cars, then you may be dissatisfied
with one. The idea of 'genuine needs' referred to in the editorial is one of those
fictions – it depends on who decides what is genuine.
5. Perceptions about need have an impact on satisfaction and HRQL – the more you need
the less satisfied you are. People with high self-expectations are more likely to
be depressed. Is it better to be happy and live in a gutter, or unhappy and live in
a palace? Are health professionals encouraging patients to be unhappy palace dwellers
by showing them how much better their health could be?
6. The above shows that outcome is conceptually far more complex than is often thought
and from the patient's perspective, the distinction between satisfaction, HRQL and
needs is by no means straightforward, and furthermore assessment is associated with
value judgements which are often not made explicit.
7. Despite all these problems, my personal view is that the really is no alternative
to questionnaire based assessment of patients satisfaction, HRQL and need. All health
care resource allocation is based on value judgements. We cannot avoid resource allocation,
and we cannot avoid value judgements. Outcome assessment forces us to make these assumptions
a little more explicit. Perhaps if I am making recommendations for the future, it
is that we should make the assumptions on which our scales are based far more explicit
than we do at the moment. Michael E. Hyland
My reflection on this question and above is: how encourage, help communicating, sharing
viewpoints between various specialists (e.g. clinicians, psychometricians,...). There
are still barriers between them and this may cause unproductive research. Clinicians
need to understand the relevance and usefulness of working on "soft" data besides
traditional medical endpoints. This is far to be achieved. Anne Brédart
One area where we do think there is imbalance is that quality of life and health status
instruments are often evaluated cross-sectionally, for example, by comparing scoresbetween
patients with early and late stage disease. There is less researchlooking at the responsiveness
of instruments to change following treatment; in particular, there is insufficient
research on how to develop instruments that are maximally sensitive to change. Andrew
Vickers
I think one needs to have more research on assessing the contribution of general health
and specific disease components to quality of life, and how this contribution varies
between cultures, ethnic groups, genders, and age groups. More research on health
related quality of life as an outcome measure in clinical trials is needed. Pharmaceutical
companies for example are still reluctant to use quality of life as an outcome due
to perceptions that the available measures lack reliability and, to a lesser extent,
validity. There is also reluctance to use clinical indicators as proxies for quality
of life, which I think is justified, given our present state of knowledge. Brian Ott
The issue is not so much balance as continuing to explore the connections between
these concepts and to be explicit about their relationships to one another. Health
status, needs, satisfaction, and quality of life are empirically related. Are they
conceptually distinct? Not yet. As the editorial points out, needs are subjective,
satisfaction is related to "needs", and measures of quality of life should (but rarely
do) incorporate the values of patients rather than investigators. As Sullivan points
out [52], the outcomes movement is changing the physician's job description from a
focus on patients' bodies to a focus on their lives. We better get it right. Richard
Kravitz
The editorial covers a number of different types of health outcome that could be assessed;
health status / health-related quality of life (HRQL), quality of life (QoL), patient
satisfaction and health needs. Each has a different purpose and these different outcomes
are not dependent on each other – though they may be correlated to a greater or lesser
extent [53]. Research into HRQL is more extensive than that into the other outcomes
but it is questionable whether it has reached a particularly high quality in most
cases. Further research is required to improve the assessment of HRQL and into assessment
of the other outcomes. There is no reason why, for example, development work on the
assessment of QoL should be sacrificed to increase efforts to assess patient satisfaction.
However, it seems likely that market forces will govern where research efforts are
directed.
As the different types of outcome are based on different measurement models and have
dissimilar aims, one type of outcome cannot (and should not) be seen as a surrogate
for another. The science of patient-reported outcome measurement has been hindered
by the practice of taking measures of one type of outcome and implying that they assess
a different outcome. Instruments such as the Sickness Impact Profile [54], Nottingham
Health Profile [55] and SF-36 [56] were developed as health status instruments for
use in population surveys (as indicated by their authors). Over the years they have
become commonly referred to as 'QoL' measures, as the need arose to assess this construct
in clinical trials. As a consequence of their widespread use in this context, relatively
few 'true' QoL instruments are now available, limiting our ability to determine the
true overall impact of disease and its treatment on the patient.
Care must also be taken in using the terms 'health needs' and 'needs' interchangeably.
The issue is analogous to that of equating HRQL with QoL. HRQL restricts consideration
to issues that are capable of influence by health services [57] and, consequently,
misses many important aspects of a patient's QoL which may benefit from an improvement
in health status. As defined in the editorial, 'health needs' are also restricted
to ways in which 'health services can improve overall health'. This could lead to
the conclusion that health needs have been satisfied while neglecting the fact that
this has been at the cost of other needs. For example; economic needs may be increased
as a result of paying for treatment, emotional needs may be adversely affected by
certain pharmaceutical treatments or appearance needs may deteriorate following radical
surgery.
A more holistic approach to 'needs' can be taken, following from Hunt & McKenna's
work on needs-based QoL. Proponents of the needs-based approach postulate that life
gains its quality from the ability and capacity of the individual to satisfy their
needs (either inborn or learned during socialisation processes) [58]. Functions such
as employment, hobbies and socialising are important only insofar as they provide
the means by which these needs can be fulfilled. In this approach it is taken as axiomatic
that QoL is high when most human needs (not just health needs) are fulfilled and low
when few needs are being satisfied. Again, focusing only on those needs that can be
influenced by health services will give an incomplete picture of their value to patients.
In order to evaluate the benefits of any service it is essential to have high quality
instruments with good psychometric properties. For most diseases such instruments
are lacking for all types of outcomes listed above. Extensive instrument development
work is required in each of these outcome areas. Consequently, it is too soon to talk
of achieving a 'balance' or reducing efforts into any one particular type of patient-reported
outcome. Stephen P. McKenna
Each of the three broad areas addresses a potentially different and important field.
Many measures of quality-of-life reflect the views and judgements of the experts.
The respondent is asked to indicate whether or not they can perform or feel in a certain
way. Dependent upon the answer a judgement is made usually on statistical basis that
they have what do not have a high quality of life. In Needs analysis the respondent
is often asked for their judgement about whether or not they have a need in a particular
area. This allows the respondent themselves to determine priorities and perceptions
of what assistance they require. It is this area of research which currently requires
more effort on development of both the theoretical and pragmatic aspects of measurement.
Rob Sanson-Fisher
More than balancing current research in the evaluation of health status, needs, satisfaction
and quality of life, the integration of these scientific researches in the assistance
process is, in my opinion, the most important challenge that is currently set to the
health agents. Luis Prieto
Since the mid-1990s there seems to have been an increase in research focusing on health
status, satisfaction, and quality of life as independent concepts. Very little seems
to have focused on needs. Even fewer (if any) efforts have attempted to study the
inter-relationships between health status, needs, satisfaction, and quality of life.
Chris Haffer
Should the research focus on health status and quality of life be reduced or should
the research on traditional clinical outcomes (such as survival) be reduced?
Rather than reducing either, we should continue to strive for combining them in meaningful
ways that each "side" understands and values. David Cella
Why these two alternatives? I would like to see more of both, but especially more
on discriminating between the characteristics of the main Health Related QoL measures,
their empirical significance, and their usefulness to organisations such as NICE.
(Any sensible answer to this question has to begin by asking 'what the research is
for?'). Anthony Culyer
I have read the editorial with interest but also with some confusion. After some thinking
I find my confusion might arise from the fact that in orthopaedics we deal with diseases
that you do not die from (at least not primarily). This applies to your open question
2, research on QOL or survival. That is not applicable to my area, if we do not take
prosthesis survival into account. This is how orthopaedic surgeons have assessed the
success of total joint replacement for years. Generally, assessing QOL in musculoskeletal
disease seem the most appropriate in clinical studies since the correlation between
the patients perspective and impairments such as radiographic status is poor. Ewa
Roos
Which area should "pay" for an increase in the number of studies on needs and satisfaction
assessment? In my opinion, we have too many disease targeted QOL measures. Although
these measures are sometimes sensitive to clinical change in specific populations,
they do not clearly guide us toward overall better outcomes. Robert M. Kaplan
The degree of focus on health status or Health Related Quality of Life (HRQL) measures
compared to more traditional clinical outcomes depends on a number of factors. Typically,
if the disease state and the outcomes of treatment can best be reported by the patient
(e.g., migraine or depression/anxiety), there is a greater dependence on Patient-Reported
Outcomes (PROs) than clinically defined endpoints. A second consideration is whether
achieving a particular clinical endpoint is the primary objective of a medical treatment.
In palliative care, for example, patient comfort and well-being may be favored over
aggressive chemotherapies that might provide a limited extension of life. PROs may
also be given equal weight in situations where the costs of treatment are considered
against the degree to which such treatments provide some larger societal benefit.
In Europe, for example, QALYs are a routine part of formulary decisions and patient
access to competing treatments. In contrast, the market access in the USA is less
centrally determined and to some degree diverse market forces determine medication
availability. Thus a variety of cultural and clinical factors need to be considered
when addressing this question and advances in outcomes research are not by any means
uniform. Mark J. Atkinson
I think there is no white/black answer. Perhaps the question would be: in which contexts
(type, stage of disease, treatment side effects), should health status and QoL studies
be expanded? Anne Brédart
In our view this is not an either / or choice. Both can be measured. Where more thought
and research is required is how to combine results from different types of endpoint.
For example, what if in a clinical trial one group experiences improved survival,
but worse quality of life? What if an intervention affects a clinical outcome, such
as a pain score, but does not appear to have an important effect on quality of life?
Andrew Vickers
This question begs a Solomonic response: both "subjective" measures such as health
status and quality of life and "objective" measures such as morbidity and mortality
are critically informative, but in different ways. Creating a parsimonious set of
generic health measures absent a larger set of disease-specific measures is extremely
seductive but ultimately misguided. The reason is that medical care can extend lives
and improve function but cannot, ultimately, make people happy. Richard Kravitz
It is difficult to make a judgement about this issue without having a clearer idea
about the clinical topic which is being addressed. For example in the area of cancer
control that has not been a clinically significant improvement in mortality for some
types of cancer. Here the research focus should continue to be on health status, perceived
need, and quality-of-life until the interventions exist which will substantively increase
the length of life. When this occurs there will be a need to balance the length of
life with the quality of that experience. Rob Sanson-Fisher
The challenge, again, is in the integration of these two ways of health assessment.
Despite the quality-adjusted life year (QALY) continue to represent the paradigm of
the integration of the biomedical and the psychosocial models, this indicator has
been criticised on technical and ethical grounds. A salient problem relies on the
numerical nature of its constituent parts. The appropriateness of the QALY arithmetical
operation is compromised by the essence of the utility scale: while life-years are
expressed in a ratio scale with a true zero, the utility is an interval scale where
0 is an arbitrary value for death. In order to be able to obtain coherent results,
both scales would have to be expressed in the same units of measurement. The different
nature of these two factors jeopardises the current meaning and interpretation of
QALYs. Further steps in the integration of different health dimensions, like quality
of life and survival, are thus necessary. Luis Prieto
Rather than viewing these research foci as being in competition, I believe it is more
beneficial to view each as complimentary. Both bring unique value to and are essential
in providing effective patient care. In other words, they both measure different components
of the same phenomenon and both are necessary to maximize positive patient outcomes.
James T. Fitzgerald
Although there has been an increase in health related quality of life studies over
the last decade, there remain major gaps in the literature. Decisions about areas
of priorities and the balance of studies must be driven by the research questions
to be answered. There continue to be too many isolated studies, with small samples;
rather than multi-site investigations combining samples using standardized measures
with established protocols. We also need additional studies related to methods, such
as determining the best times to measure quality of life in relation to the critical
events we are trying to capture. Evidence related to ethnically diverse populations
is just beginning to emerge and as our world becomes smaller with the use of increased
technology, these studies will only enrich our interventions.
As our knowledge base grows, clarity will evolve about how HRQL relates to other variables.
It's important we design studies that help to clarify the mechanisms to effect predictors
and outcomes. Clinically, standardized HRQL measures can enhance screening patients
for clinical problems and monitoring them for changes; but overall this process will
not take the place of asking patients what they want and what helps to improve their
health. With the increased opportunities to do collaborative research across continents,
it is a time to increase our efforts to do HRQL research not to reduce them. However,
our studies must be theory driven, well designed, multi-site, and build on our previous
work. Ruth McCorkle
Neither should be reduced. Instead incentives should be provided which would encourage
researchers to undertake studies on the undeserved topics mentioned above. Incentives
could be: financial (providing money to support the work), educational (encouraging
students to undertake dissertations and theses in the areas), or professional (thematic
journal issues dedicated only to publishing research on particular topics). Chris
Haffer
To what extent can quality of life be used as proxy or surrogate for satisfaction
and/or the needs of patients? Is there a danger of making the same mistakes as in
the when clinical indicators were used as surrogates for quality of life?
Yes, this kind of risk always emerges when one tries to use a related concept to estimate
another. David Cella
I would say, not at all to the former and only to the extent that it correlated with
a conceptually correct version might the answer to the second be affirmative. Anthony
Culyer
In orthopedics, measures of satisfaction have been used to determine the outcome of
total joint replacement. I am however concerned about the single question that has
been used. From unpublished data I know that patients reporting to be satisfied with
a total knee replacement may have revision surgery within a year. This is bothering
when considering validity of the satisfaction question. Ewa Roos
I do not think that QOL measures can serve as surrogates for satisfaction and needs.
In fact, it is important to maintain independence. For example, it would be valuable
to demonstrate that satisfaction goes up when outcomes improve. However, evidence
is necessary to demonstrate this relationship. Robert M. Kaplan
Important conceptual and practical distinctions exist between HRQL and treatment satisfaction
(and more broadly, patient satisfaction). As the term suggests, Quality of Life is
typically considered a quality or characteristic of one's life and HRQL is an independently
definable quality or state of one's life (or health). Although such perceptions are
subjectively influenced by disease processes, they are thought to exist somewhat universally
and independently of particular life events and circumstances.
On the surface, measures of patient satisfaction may appear to be just another type
of HRQL or Health Status measure. Indeed, both HRQL and satisfaction constructs are
both strongly influenced by the effects of illness and moderated by the effects of
available treatments. Nevertheless, these classes of PROs differ in some profound
ways. A closer inspection reveals that satisfaction measures are actually composed
of questions asking patients to make judgments or appraisals about a specific set
of treatment-related events and experiences. Treatment/patient satisfaction may be
thought of as an interaction between a set of personal expectations and judgments
and particular experiences associated with current or past treatments. HRQL and Health
Status, on the other hand, are appraisals of a quality or status of one's health,
and thought to exist somewhat independently of specific situational events.
Such a distinction between the two types of measures is more clearly appreciated when
one realizes that HRQL measures may be used prior to starting a treatment at baseline
but that the same cannot be said for treatment satisfaction. Prior to the occurrence
of a treatment event, one cannot assess treatment satisfaction only the expectations
or anticipations towards future treatment events. Moreover, such expectations have
been shown to be relatively weak predictors of patients' later satisfaction with treatment
[59]. Thus treatment satisfaction can be thought of as an experiential appraisal of
the degree to which a current treatment has been able to moderate the impact of illness
without being causing bothersome side effects or be a great inconvenience. Such a
distinction may explain why measures of treatment satisfaction do not seem to be as
strongly associated with patients' emotional states as HRQL measures [60].
Thus satisfaction and HRQL/Health Status measures focus on different, although interrelated,
PRO constructs. Any decision to use one as a proxy for another would be based on a
fair number of assumptions that are not yet well understood. The use of HRQL/Health
Status measures as a proxy for evaluation of patient need may be more easily justified.
A parallel can be drawn between 'patient need' as defined by the authors of this author,
namely, a state of discrepancy from a condition that most healthy persons would be
expected to possess. Mark J. Atkinson
Quality of life is only a moderate proxy of satisfaction with care as the latter,
but not the former, is strongly dependent of the *process* of care, and not just it's
outcome. Patients who experienced an important improvement in quality of life are
likely to be more satisfied that those who do not; however, a patient who responds
dramatically to a treatment my have poor satisfaction if, for example, the clinician
was rude, treatment overly expensive or waiting times too long. Quality of life, satisfaction
and needs are distinct concepts that should largely be measured separately; that said,
it is not always important to measure all three. Andrew Vickers
This question cannot be addressed without a clear conceptual model linking medical
care to physiological and psychological health to quality of life and satisfaction
[61]. Quality of life is not a proxy for satisfaction unless measured using scales
that incorporate patients' own utilities. Richard Kravitz
I really appreciate the discussion you approached in this paper. Several years ago,
physicians tried to treat a disease, supposing that a reduction in the tumoural mass
could improve patients' health status. In this context, complete or partial responses
by the tumour were classified as "response rate", and the response rate was considered
as the main outcome of a treatment.
Unfortunately, it was easy to demonstrate that response rate and overall survival
were not always correlated; response rate was classified as an index of activity and
overall survival as an index of efficacy of a treatment, using response rate as a
surrogate index of efficacy in clinical practice.
Likewise, after the first enthusiastic results of chemotherapy against metastatic
tumours, a plateau in the outcomes was rapidly reached, and all oncologists met a
sort of stalemate in the results of their approaches, regardless the introductions
of new molecules or new schedules. It was the time when the oncologists became aware
of the side effects of chemotherapy, and beyond side effects, the way to overcome
the resistance to chemotherapy and to outcome improvement were considered.
Unfortunately, neither the CSF, nor the other cytoprotectans favoured a significant
improve in the outcomes of treatment of the most part of solid tumours, although it
was evident that chemotherapy could be better tolerated with the use of appropriate
supportive approaches.
When it became evident that an improve in overall survival could not be so easy to
obtain with standard chemotherapy in a large part of solid tumours, the oncologists
reconsidered the problem of the symptoms burden, hypothesising both a possible role
of chemotherapy in the treatment of cancer-related symptoms, and a direct relationship
between response rate and symptoms improve. Two approaches were followed:
• The identification of arbitrary indices to define and assess the clinical benefit
in cancer-related symptoms with chemotherapy;
• The identification of a new field for clinical research, in which quality of life
(or better "health-related quality of life") was defined as an outcome for a medical
approach.
Introducing health-related quality of life raised further problems:
• What was the relationship between health-related quality of life and overall survival
(if any)?
• What was the relationship between symptom relief and quality of life (if any)?
• Did health-related quality of life represent an outcome both in patient's and physician's
points of view?
In this context this paper about patients' needs, satisfaction and quality of life
intervenes approaching some controversial aspects of the problem:
• Are the researches in quality of life, patients' needs or satisfaction adequately
approached in clinical setting? In my opinion the response is no, as we are still
creating in our mind a surrogate index of the needs of patients that is still too
much "physician-related" but too-little "patient-related".
• Can improvement in health-related quality of life be assumed as an index of satisfaction
of the patient? In my opinion the response is no, because it only represents the "health-related"
dimension of quality of life, that could be strictly related to, but shall not be
considered the same of patient satisfaction.
• Are we sure that we have all the instruments to assess the needs and satisfaction
of our patients? I do not know, but I fear for two potential risks that we will be
contented with the easiest solution of some surrogate composite indices of satisfaction
(as occurred with clinical benefit and quality of life in clinical oncology) avoiding
to define better instruments to assess needs and satisfaction, or, worse, that the
needs and satisfaction assessment (or their surrogate indices) will be used as an
instrument for a political or administrative consent, that is so far from- (but unfortunately
even so near to-) the real dimension of patients. Davide Tassinari
The use of the word proxy is in my opinion inappropriate: Quality of life, (Qol) Health
Care Needs (HCN) and Satisfaction (Sat) are all distinct concepts and Qol cannot be
assessed "in the place of" the other two. An attempt to prove this replaceability
was made by measuring the correlation between them [3] the absence of such correlation
would be surprising!!
A sound proof would have been to demonstrate that the contents of the three concepts
are equivalent, but, unfortunately, this is not true also when speaking of different
instruments for quality of life evaluation and is very likely to be false for the
three concepts in examination. Identifying quality of life score cut-offs able to
detect high levels of HCNs or low levels of Sat at an appreciable degree of sensitivity
and specificity would be useful but would not solve the problem to have valid and
reliable instruments for HCNs and Sat assessment. Cinzia Brunelli
Views will vary. However if we assume the needs of patients represent their judgement
about whether or not they wish to receive assistance with a particular area, reflected
an item on questionnaire, then quality-of-life should not be used as a proxy. For
example patients suffering from chronic condition may experience a substantive pain,
not be able to take care of themselves and lack of mobility. For most quality-of-life
scales this would be reflected in a low score. A poor quality-of-life. This maybe
an accurate representation of the respondents experience. However, perceived needs
may reflect what the respondent may wish to have improved. That is, they may indicate
while that they are experiencing considerable pain is not that that they wish assistance
with but how to deal more effectively with the medical system or get help for their
partner. Given this scenario it is clear that quality-of-life should not be used as
a surrogate measure for perceived needs. Rob Sanson-Fisher
This is a question that must be responded with empirical evidence. In my opinion,
there is a likely relationship between the concepts, but the direction and strength
of this association must be ascertained in practice. Luis Prieto
In my recent article [62] I distinguish between satisfaction with medication, treatment
satisfaction, and satisfaction with health delivery. In the article cited above, I
point out that HRQL needs to be distinguished from satisfaction with medication; the
former basically represents the status of a patient on dimensions assumed to of importance,
whereas satisfaction is evaluative in nature. Therefore, I do not think that HRQL
can be used as a proxy for satisfaction. Richard Shikiar
These are testable hypotheses on which research should be encouraged. However, as
we anxiously await the results of the research we should never forget the words of
the philosopher George Santayana, "Those who do not learn from history are doomed
to repeat it". Chris Haffer
What is the evidence for psychometric properties of the instruments used to evaluate
satisfaction and needs?
Regarding satisfaction, the single biggest problem across virtually all of them is
a ceiling effect. We can at least take heart in knowing that most people report being
very satisfied with their care. Regarding needs, this area has seldom moved beyond
the qualitative level, reporting proportions of people having the studied range of
needs. One example of a needs-based (or, more accurately, rehabilitation-based) instrument
in oncology, is the Cancer Rehabilitation Evaluation System (CARES). David Cella
Well, for the latter, it's there in the literature – from Rosser and watts on, through
Torrance and the army of QALY, HYE etc. measurers. As for satisfaction, there's a
huge economic and psychological literature but there's a lot of mystery as to what
'satisfaction' means. Many take it – wrongly – as a synonym for 'utility' – though
not, I think, most utilitarians. Anthony Culyer
I can not give you a conclusion regarding the psychometrics of satisfaction outcomes
in orthopaedics. However, psychometric data on satisfaction measures in total joint
replacement have been reported [63]. Ewa Roos
Standards with which to judge the psychometric properties of various types of PRO
measurement tools have been clearly established for several decades [64] and continue
to be refined [65,66]. All PROs should be held to the same high standards of both
classical and modern measurement theory, and be shown to possess adequate reliability,
validity, and responsiveness to the phenomenon in question.
What is needed in our field is to sharpen the ways in which we conceive of our PRO
constructs [67] and to elucidate the inter-relationships between direct and mediated
causal pathways between such constructs and illness or treatment conditions [2,68].
Too often conceptual distinctness between outcome measures is blurred. This is clearly
evident when instrument content (e.g., appraisals of medication effectiveness or ratings
of disease severity) are indiscriminately mixed together with temporally distinct
constructs in the causal pathway (e.g., the behavioral ramifications of the appraisal).
For example, mixing treatment experience questions with one addressing the "willingness
to recommend to a friend" or, in the case of disease severity ratings, the functional
effects of symptom severity on daily activities. The lack of conceptually coherent
measures precludes elaboration of conceptual frameworks with which to understand our
empirical observations.
As acknowledged in the preceding article, while Quality of Life is broadly conceptualized,
it is most often more narrowly operationalized by disease-specific HRQL measures.
Similarly, patient satisfaction can be broadly thought to refer to all relevant experiences
and processes associated with a healthcare delivery, while treatment satisfaction
typically focuses on events related to a particular medication or surgical treatment.
When designing new PRO tools, the referential scope of our measures is an important
consideration. General and specific measures yield different sorts of information
and perform in differing ways. Narrowly specified PROs tend to be more useful when
the objective is to gain context specific understanding within a particular disease
state. Moreover, such measures also tend to be more responsive to changes in the underlying
cause(s) over time (e.g., disease severity or treatment effects). On the other hand,
more broadly defined PROs are generally phrased and, because of this they allow for
greater diversity in how respondents interpret their meaning. Such instruments allow
for comparisons of diverse patient populations but provide more limited insight into
the underlying reasons for observed differences. Mark J. Atkinson
There has been progress. In the recent past, satisfaction surveys were performed without
any information on the psychometric properties of questionnaires. At present, information
on the validity of these questionnaires is collected. The criterion validity (degree
to which the questionnaire measures the true situation) and responsiveness of these
questionnaires is hard to assess. In many research on patient satisfaction in the
oncology field, it appears that patients are less satisfied with the information provided
compared to other aspects of care. This should lead to prioritise initiatives to improve
information provision at the expense of other care aspects improvement. I think that
further research need to be performed to understand the meaning of these results.
Anne Brédart
Developers of instruments designed to measure patient satisfaction face a paradox.
On the one hand, mean scores are invariably high (i.e., there is a ceiling effect).
On the other hand, huge numbers of patients every year switch doctors and health plans,
do not comply with recommended therapy, sue their doctors (or at least think about
it), and complain to their children about their medical care. We may need to acknowledge
that we are bumping up against a "wall of cognitive dissonance" that creates a theoretical
limit to the value of satisfaction ratings.
Another important and unresolved issue is whether to adjust for patient characteristics
when comparing satisfaction ratings among providers. It is well known that age, ethnicity,
and health status (among other characteristics) influence patients' ratings of satisfaction.
Some organizations have decided to use raw (unadjusted) comparisons based on the argument
that health care organizations and practitioners need to adapt to their own patient
populations and provide whatever is needed to generate satisfaction in the groups
they serve. But this may be a little unfair. In our own primary care clinic at UC
Davis, Russian-speaking patients almost never choose the (properly translated) "excellent"
column when rating their care, while Spanish-speaking patients use it liberally. Physicians
who see many Russian-speaking patients (or other groups with systematically higher
thresholds for satisfaction) have a right to be concerned. Richard Kravitz
Traditionally the determination what constitutes an adequate measure has been grounded
in the psychometric literature. There is some reason to continue the utilisation of
concepts such as test retest reliability, face and content validity. Con current validity
has appeal when similar measures exist but is heavily dependent on the concept that
the existing measures accurately betray the issue under consideration. To compare
a new measure against an existing inappropriate or an accurate measure is obviously
foolhardy and inappropriate. The use of confirmatory factor analysis appears dubious
as strategy for examining the potential usefulness of the scale. The fact that the
items may be statistically related and then delete other items may mean that the most
predictive items are discarded. More importantly it is whether the scale can predict
future behaviour, use of resources or outcomes such as mortality or morbidity. It
is unusual for the development of new scale to be asked to demonstrate its predictive
validity and more difficult to achieve this important goal. It may be timely for those
involved in the construction of questionnaires to consider some of the dimensions
used by epidemiologists when discussing the robustness of a new testing procedure.
Rob Sanson-Fisher
A simple search of the literature shows that there is an emerging emphasis in assessing
the psychometric properties of this type of instruments. In any case, I would like
to challenge the audience of this editorial with more open questions: Is the 'need'
attribute really quantitative? Does it deserve the application of psychometric methods
directed to assign a number to the amount of 'need' that a given patient has? Or the
'need' is it just a dichotomous variable (i.e. need present/need absent) that should
not be defined by the patient itself but by professional health care agents? Luis
Prieto
Through its leadership is standardizing satisfaction instruments and publicly reporting
the results, the U.S. Agency for Healthcare Research and Quality, and the U.S. Centers
for Medicare and Medicaid Services has sponsored research on many aspects of measuring
satisfaction including psychometric properties of the instruments. A good place to
begin a review of the relevant literature is:
Chris Haffer
Have studies of patients' satisfaction been conducted but not published because of
negative results, poor validity, reliability and responsiveness of the instruments
developed (i.e. a high levels of ceiling effect towards high level of satisfaction
due to patients fear of giving negative evaluations)? Or studies which could not be
published because non-validated instruments were deployed, to assess patient satisfaction,
not only wasting scarce hospital resources but also delaying changes in health service
delivery by local health authorities
It's not clear to me that there has been such a publication bias with regard to satisfaction
studies. But to the extent this is true, I don't have the impression it is any more
a problem with satisfaction studies as opposed to others, except for the ceiling effect
issue. The problem people tend to face with satisfaction studies or outcomes, is that
because most patients already have a high degree of satisfaction, it may be difficult
to improve it further when it comes to treatments that affect patient quality of life.
Hospitals in the US can tend to focus on patient conveniences and impressions such
as parking, lobby feel, way-finding and personal services to improve satisfaction
ratings, leaving actual care delivery in the hands of the providers. David Cella
Isn't the premise of this question false? Anthony Culyer
Various problems face those wishing to further our understanding of patient satisfaction.
The most important seems to be a lack of good psychosocial science in the field, which
may in-part be due to a resource-strained healthcare system. At the risk sounding
somewhat repetitive; conceptually, Patient Satisfaction, Satisfaction with Care, and
Treatment Satisfaction should be clearly distinguished from each other both on their
scope measurement (i.e., level of generality-specificity) and on their context of
measurement (e.g., satisfaction with healthcare, care provided by providers, characteristics
of treatment etc.) Without a sound conceptual basis measures will lack coherence,
produce uninterpretable or ambiguous results, and consequently be unable to benefit
current organizational or business processes. This may be why many satisfaction studies
are one-off, and not adopted as a routine assessment of clinical care. Also impeding
substantive advancements are a host of poorly designed and inadequately tested measures,
which are often applied using very weak study designs. These factors make it very
difficult to increase the credibility of such evaluation activities through publication
in reputable peer-reviewed journals. Mark J. Atkinson
Our measures of patient outcomes and satisfaction are variegated and deeply flawed.
Nevertheless, one of the most promising trends in health care today is the collection
and sharing of information about patient outcomes and satisfaction at the hospital
and medical group level. Unlike the uncoordinated efforts of the past, these initiatives
seem to have roused health care executives from a deep slumber. Large measurement
collaborations should be encouraged at the same time that we support more basic work
on instrumentation. Richard Kravitz
There will always be cases where studies of patient satisfaction and other measures
are not published because of their perceived lack of psychometric vigour. It is also
the case that when one is attempting to change the health-care system by presenting
findings which suggested adequate care is being provided to the patient group the
professionals who are being asked to change will often resist using what ever strategies
they can. One of the methods is to criticise the nature of the research or the research
instrument. Consequently, it is reasonable that the instrument such as a patient satisfaction
measure is credible. However, as suggested in my response to question for this may
not necessarily mean the usual criteria that are used by psychometricians. Rob Sanson-Fisher
In the U.S. a number of studies on patients' satisfaction have been conducted and
reported in the peer-reviewed literature. As noted above a good place to begin is:
. Chris Haffer