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OCR for page 7
The Use of Quality-of-Life
Measures in Technology
Assessment
Jennifer Falotico-Taylor,
Mark McClellan, and
Fredenck MosteDer
This chapter contains a set of examples of Me application of quaiity-of-
life measures to specific comparative assessments of medical technolo-
g~es. Rawer Tan representing a comprehensive review of He broad
vaneW of measures described in the literature, these studies illustrate Be
types of issues likely to arise in efforts Deco evaluate quality-of-life as a
component of technology assessments. Such issues include study design
and me Innitations and advantages of specific measures, as wed as me
kinds of information and insights Hey produce. Quality-of-life indicators
have generally been applied to therapies for chronic conditions, for condi-
tions where an increase in length of survive is unlikely, and for condi-
tions wad negative consequences of care that may outweigh its benefits.
Consequently, the studies may be particularly relevant for clinical teals,
drug evaluations, arid other analyses to help guide decisions about altema-
tive technologies and Reagents In these areas.
LITERATURE REVIEWS
Literature reviews of two successive five-year periods show that the
rate of use of quality-of-life measures and He rigor of He me~ods of
study have changed substantially. Najman and Levine (1981) conducted
Acknowledgment: We appreciate the advice of JM. Naiman and the editor of Social Science and
Medicine, Peter McEwan, in guiding us to James G. Hollandswonh's paper, and we are grateful to
HoLlandswonh for providing us win a Republication copy of his paper, thus facilitating our use of
the two reviews to indicate the changing situation.
7
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8
J. FALOTICO-TAYLOR, M. McCl=LIAN, AND F. MOSTFr JAR
~ literature search for uses of quality-of-life measures in technology
assessment from 1975 to 1979. They found 23 published studies on Me
impact of medical care or technology on the quality of life, and only one
was a randomized clinical teal. HoBandswor~'s 1988 update of this
effort found 69 empincaDy based studies from 1980 to 1984, a Refold
increase over me number of papers found by Najman and Levine.
Naj man and Levine criticize the "doubt validity" of He criteria used
to measure quality of life in me studies Hey examined. "Most of the
studies (20 out of 23) (87 percent) use Drily objective indicators" Najman
and Levine note, adding, "Researchers appear to have chosen criteria
arbitrarily with no regard to the issue of relative priority that might be
given to some of the criteria. Nor are the criteria interco~Telated to
determine whether, in some instances, Here have been systematic and
consistent changes in the quality-of-life following medical intervention."
In HoBandsworth's review, 28 out of 69 (41 percent) of the studies
used only objective cntena. Almost 60 percent of recent studies have
included a subjective measure of quality of life compared with 13 percent
in the previous five-year penod. Subjective measures require some form
of evaluation by He patient. Objective measures include clinical meas-
ures, such as survival or He presence of medical complications, as wed as
over concrete data provided by sources over Han He patient. Over half
of the studies identified by Hollandsworth used both objective and subjec-
tive criteria.
Najman and Levine note that almost aD studies In Heir review con-
cluded that the intervention imposed improved quality of life. HoDands-
wor~ concludes that in the current review approximately half of the
studies reported either negative or mixed results. AB but one of the seven
randomized clinical Dials found mixed outcomes or a lack of statistically
significant differences between the groups.
Study Design
In the area of study design, some features have improved and others
have not. Essentially He same proportion (64 percent) of He studies
appealing in the recent five-year period (1980-1984) employed a one-shot
case study design win no control group, as had appeared dunng me
previous five-year period (61 percent). Dunng the same period, however,
Hollandswor~ found that the proportion of randomized clinical trials had
increased from 4 percent to 10 percent.
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USE OF MEASURES IN TECHNOLOGY ASSESSMENT
9
Approximately 65 percent of me studies reviewed during bow five-
year periods used samples drawn from "consecutive patients," those pa-
tients presenting themselves for treatment, or "an survivors," those pa-
tients who have survived for a penod of tune following treatment. Hol-
landswor~, however, reports an increase from 2 to 22 in Me actual
number of studies using matched comparison groups or randomized as-
signment of subjects to treatment conditions. Sample sizes doubled from
an average of 90 to 178 between We first f~ve-year penod and the second.
These reviews document that a wide variety of both established and
nonestablished quality-of-life measures are currently being used to help
give patients a greater voice in appreciating me outcome of medical
interventions. The rise in me number of quality-of-life studies reported in
the literature suggests that these measures are playing an increasingly
important role in bow clinical teals and me evaluation of a variety of
medical interventions for chronic diseases such as hypertension, coronary
disease, renal disease, arthritis, and cancer.
To assist me reader in locating matters of interest in me studies re-
viewed in this chapter, we have provided several aids. Table 2-1 lists the
technologies assessed in each study. At me begs ng of each study, we
have provided a set of keys descnbing He technology or treatment as-
sessed, He patient groupies) involved, diagnosis type, measure category,
and measurers) used to assess quality of life. The descnption of measures
or instruments adds infonnation about He kinds of measures available for
specific purposes. The comments concluding each summary combine He
authors' reflections on their use of quality-of-life measures with our own
and stress He value of these measures, along with some caveats to pro-
spective investigators.
The studies reflect a spectrum of approaches and findings; reviewing
them collectively can provide a sense of He current scope of assessments
of quality of life. In these studies, as well as others we reviewed, we
observed a series of recurrent themes. Many researchers encountered
some difficulties in He execution and analysis of their studies. In part,
Innitations emerge from the continuing development of me measures
themselves; as their refinement continues, more valid and powers con-
elusions should result from Heir application. In part, however, these
limitations also reflect the importance of experimental design in any
clinical trial. Such design issues as randomization, double-bl~nding,
standardized implementation, and consideration of padents who withdraw
are important whether or not quality-of-life measures are employed.
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10
J. FAL~TICO-TAYLOR, M. McCLEllAN, AND F. AlOSTFr~FR
TABLE 2-1 Technologies Exemplified and Instruments Con~ibuhng
to the Assessment
Study Technologies Assessed
Number and Instruments Used
Page
Number
1 Antihypertensive medications
General Well-Being Adjustment Scale
Life Saiisfacion Index
Physical Symptoms Distress Index
Sleep Dysfunction Scale
Positive Symptoms Index from the Bnef Symptom Inventory
Wechsler Memory Scale
Reitan Trail-Malcing Test
Social Participation Index
Sexual Symptoms Distress Index
2 Ar~iiis medications
Health Assessment Questionnaire
Keitel Assessment
Quality of Well-Being Questionnaire
Toronto Activities of Daily Living Questionnaire
McGill Pain Quesiionn~re
Pun Ladder Scale
10 cm Pain Line
Arthritis Categoncal Scale
Arthritis Ladder Scale
Overall Health Ladder Scale, Current
Overall Health Ladder Scale, 6-Day Mean
RAND Current Heals Assessment Measure
10 cm Overall Health Scale, by Patient
10 cm Overall Health Scale, by Physician
Patient Utility Measurement Set
Standard Gamble Questionnaire
Willingness-to-Pay Questionnaire
National Institute of Mental Heals ~MH) Depression
Questionnaire
RAND General Health Perceptions Questionnaire
Adam ant chemotherapy
Perceptions of Emotional Distress and Behavioral Disruption
Altemative chemotherapy regimens in advanced breast cancer
Quality of Life Index (QLI)
Linear Analogue SeIf-Assessment (LAS A)
3
4
14
17
21
Table 2-l continues
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USE OF MEASURES IN T~::HNOLOGY ASSESSMENT
TABLE 2-1 (Condnued)
11
Study Technologies Assessed
Numbs and Instruments lJsed
Page
Number
5 Counseling for stage IV cancer
Cumulative Illness Rating Scale
0
Depression Factor of the Psychiatric Outpatient Mood
Scale (POMS)
Sherwood's Self-Esteem Scale
Cantril's Life Satisfaction Scale
Srole's Alienation Scale
Rotter's Locus of Control Scale
Rapid Disability Rating Scale
Surgery for breast canca
NIMH Center for Epidemiologic Studies Depression
Scale (CES-D)
Body hnage Scale (BIS)
Cardiac ~an~lant and coronary army bypass graft surgery
Nottingham Heals Profile (NHP)
Quality of Life Questionnaire
Cardiac rehabilitation programs
Sickness Impact Profile ASP)
Long-tenn dialysis and renal transplant
Quality-of-life indices
Physical activist indices
Kupfer-Detre System Form 1
Kupfer-Detre System Fonn 2
Renal transplantation and dialysis
Ka~nofi;ly Index
Index of Psychological Affect
Index of Overall Life Satisfaction
Index of Well-Being
Work status
11 Case management and usual and customary services for
calorically mentally ill patients
Social Unction
Affect Balance Scale
Self-Esteem Scale
Cost-benefit analysis
12 Heals insurance payment mecharusms
General Health Rating Index
26
28
30
32
34
36
39
41
~-
NOTE: Page number refers to the page in this chapter where discussion of dais application begins.
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12
Not Reinventing the Whee'
J. FALOTICO-TAYLOR, M. McCL~IAN, AND F. MOSTF' FAIR
Using established quality-of-life measures provides special advantages
to clinical investigators. This approach frees the investigator from "rein-
venting He wheel,' by employing measures of demonstrated validity,
reliability, and relative ease of a~n~rustration. Moreover, using estab-
lished measures facilitates Be comparison and combination of study re-
sults with those obtained by other investigators using He same measures.
In this way, larger sample sizes can be accrued by reladng similar studies,
and a broader range of alternative therapies or patient groups can be
compared. For example, given tile large number of antihypertensive
medications available and He broad variety of patients undergoing ther-
apy, no single experiment can adequately encompass this vanety. Com-
parability of measures makes comparisons across conditions easier, and
some established measures make it possible to compare scores win Pose
of the general population Reliance on established measures can thus
promote more effective technology assessments.
At the same rime, some studies profitably combine established meas-
ures with a [united set of instruments developed by me investigators. This
customized approach may be particularly valuable when assessing a tech-
nology that involves relatively distinctive quality-of-life features in spe-
cial populations. ~ such situations, He investigators can identify the
established measures Hat most closely reflect Heir experimental interests.
They can then supplement these measures with a specific group of items
directly reflecting Heir concerns. For example, elderly patients or ~ndi-
vidu~s from different socioeconomic or cultural backgrounds may re-
quire particular modifications in He content or administration of some
indicators. Similarly, assessments of altemadve surgical procedures for
breast cancer require special emphasis on body image and sexual fimc-
tion.
THE VALUE OF ASSESSING QUALITY OF LIFE AS AN
OUTCOME
Measures of quality of life promote an emphasis on issues of direct
importance to patients that are only indirectly reflected in clinical meas-
ures and interpersonal communication. Consequently, they complement
the more ~adidonal sources of information for evaluating therapies and
choosing appropn ate treatments. For example, quality-of-life indicators
can provide reliable and valid data on the side effects of drugs and on
iatrogenic consequences of procedures. Such data help to distinguish
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USE OF MEASURES IN TECHNOLOGY ASSESSMENT
13
between alte~nadve treannents Hat are equivalent In coccal and other
objective measures.
Combining quality-of-life measures win cI=cal indicators and over
objective outcome data produces a more comprehensive picture of the
technology being assessed. This combination may promote a more so-
phisticated analysis of technologies Man either approach Cone might
permit. For example, studies involving combinations of measures for
end-stage Anal disease patients not only provided more information on
the relative advantages of renal transplants, but also indicated that objec-
tive and subjective cI=cal measures cor'-~;lated poorly in ad expenmen~
groups that is, the padents' subjective experience of disease correlated
poorly win Heir clinical status.
Work Status
Work status as a measure of quality of life requires special comment.
Work status before and following treatment has major interest for society
and for patients. Work status depends on whether or not patients were
employed at He time of Heir treatment, their age, how patients view Heir
work both before and after treannent, the support after treatment, and me
outcome of treannent. We are told by experts that some patients put off
important operations because they fear being discharged from their posi-
dons after treatment. Others are eager to have the treatment, regardless of
He consequences. Because the latter may receive disability payments or
over f~nanci~ support, Hey may be able to sustain themselves without
remn~ng to work or troth partial work, especially if Hey do not find Heir
work gratifying. Social policies in various counties and social units offer
diffenug degrees of support ~ those who retire or are disabled at various
ages, making situations less comparable. Thus, wow status, although it
has important social and economic consequences, has several variables
muddying its resolution; therefore it cannot, without deeper investigation,
be regarded as a very direct measure of the success of therapy or the
quality of life of the padent. Some patients win find their quality of life
reduced if their work is no longer available to them, and others win be
very satisfied.
DIAGNOSIS AN OPEN PROBLEM
None of He studies given in this chapter deals with He unproved
quality of life that accompanies the reduction of uncertainn,r about the
disease state of the patient. Measuring the benefit of such anxiety reduc-
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14
J. FALOTICO-TAYLOR, M. McC:LEUAN, AND F. MOSTF-r FOR
don may be difficult, and no established measures are ava~lablee Herbert
L. Ab`=ns, co-chairman of He Methods Panel of He ~stih~te of Medicine
Council on Heady Care Technology, emphasizes Hat a large proportion
of padent visits to physicians deal win complaints for which no therapy is
available. The complaints themselves may bear heavily on He quality of
He padents' lives. InfoITnation alone may appropnately allay He anxiety
Of the patients and Bus improve their quality of life.
In some areas, diagnosis can be made with a high degree of accuracy,
and appropriate patient management can be undertaken if disease is
present or reassurance may be given if it is not. Signs and symptoms of
brain tumors, gastrointestinal distress, and Impending coronary problems
produce anxiety mat can often be reduced by diagnosis and education.
Even when the news is bad, He resolution of uncertainty and starting an
active management plan may improve the patients' quality of life.
ROLES OF THE EXAMPLES
Finally, these studies coercively indicate that quality-of-life measure-
ments can have a significant impact on the conclusions In clinical technol-
ogy assessments. They can help differentiate among chemotherapy regi-
mens, andhypertensive medications, and many other technologies that
appear similar according to other critena. They can demonstrate the value
of some therapies that do not prolong life for tenninaBy id patients, and
they can help gauge He effectiveness of treannent when no alternative
exists. They can help target the concern of heady providers to those areas
where patients Link their lives are most affected, thereby contributing to
the therapeutic process. For an of these reasons, quality-of-life measures
enable ache assessment of an important additional dimension in He ev~u-
ation of health care inte~vendons.
TWELVE APPLICATIONS OF QUALITY-OF-LIFE MEASURES
TO TECHNOLOGY ASSESSMENT
STUDY 1. ANTIHYPERTENSIVE MEDICATIONS
Croog, S.H., Levine, S., Testa, MA., Brown, B., Bulpitt, C. J., Jenkins,
CD., Klerman, Gl., and Williams, G.H. The effects of antihyperten-
sive therapy on the quality of life. New England Journal of Medicine
314(26):1657-1664, 1986.
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USE OF MEASURE; IN TECHNOLOGY ASSESSMENT
Key
15
Technology Assessed: Relative effects of captopnl,me~yldopa, and
propranolol
Patient Group: Adults
Diagnosis Type: Essential hypertension
Measure Category: Physical, psychological, and social
Measures: General WeU-Being Adjustment Scale, Life Satisfaction In-
dex, Physical Symptoms Distress index, Sleep Dysfunction Scale, Posi-
dve Symptoms Apex *om ~ Bnef Symptom Inventory, Wechsler
Memory Scale, Reitan Trail-Making Test, Social Participation Index,
Sexual Symptoms Distress Index
Description of Measures
General Well-Being Adjusonent Scale. This scale consists of six sub-
scales: anxiety, depression, general health, positive weD-be~ng, self con-
trol, and vitality.
Life Satisfaction Index. This index assesses satisfaction in fourteen areas
including marriage, finances, standard of living, housing, and degree of
social participation.
Physical Symptoms Distress Index. This index evacuees the degree of
distress from symptoms such as lethargy, Mar mouth, loss of sense of
taste, nightmares, and feeling faint or light-headed.
Sleep Dysfunction Scale. This scale measures the frequency of problems
in falling or remaining asleep, early awakening, or awakening bred.
Positive Symptom Index from the Brim Symptom Inventory. This index
measures Me degree of depression, anxiety, hostility, somatization, and
obsessive-compulsiveness.
Wechsler Memory Scale. This scale assesses neuropsychological func-
tion based on one's ability deco reproduce diagram images.
Reitan Trail-MaJcing Test. This test assesses vi-quo-motor speed and
coordination.
Social Participation Index. This index assesses Me degree of par~cipa-
tion in social events.
Sexual Symptoms Distress Index. This index assesses distress in areas
such as sexual desire or impotence.
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16
Purpose of the Study
J. FALOTICO-TAYLOR, M. McCI=l'J, AND F. MOSTLY rFR
Croog et al. compared Me effects of captopril, me~yldopa, and propra-
nolol on Me quality of life of men win mild to moderate essential
hypertension.
Methods
Using a randomized double-blind clinical Dial, Croog et al. assessed
me impact of captopnl, me~yldopa, and propranolo} on the quality of life
of 626 white men, aged 21 to 65, win a diagnosis of mild to moderate
essential hypertension. They used several quality-of-life measures de-
scribed above. A placebo was a~n~ster~ to aD subjects for a one-
month period. This was followed by a six-mon~ active treannent phase,
dunng which padents were randomly assigned to receive one of Me Tree
medications. Bow Me padents and investigators were blinded as to study
assignment Interviews were carried out at me begs ng of the study, and
again at one-, three-, and six-mon~ intervals.
Results and Conclusions
In me captopri] group, ~ percent of padents withdrew following ad-
verse reactions, as did 20 percent of patients in He me~yidopa group and
13 percent of patients in the propranolol group. Patients treated with
capper reported a stadsticaBy significant six-mon~ improvement In
general well-being, work performance, costive functioning, and life
satisfaction. Padents Mated win methyldopa improved only in Me area
of costive functioning, and they worsened in me areas of depression,
work performance, sexual functioning, physical symptoms, and life sads-
faction. Patients Heated wad propr~olol reported improved cognitive
functioning and social participation, but they reported more sexual dys-
function and physical symptoms. Compared wad padents receiving cap-
topril, 20 percent more patients treated with methyidopa and 15 percent
more patients heated win propranolol reported a worsening in general
well-being.
Croog et al. note a close association between withdrawal from therapy
because of adverse reactions and the drug's effect on quality of life. They
suggest that withdrawal may be an index of noncompliance, a serious
problem for physicians treating hypertension because many padents per-
ceive the side effects of the drugs to be more troubling than Weir "seem-
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USE OF MEASURES IN TEf:HNOLOGY ASSESSMENT
17
ingly symptomless disease." The short-term withdrawal rates in this six-
month study may actually underestimate the potential long-term noncom-
pliance rates for patients on antihypertensive medications.
Comments
lithe generalizability of this study is limited by He study population.
For example, me results may not apply to other hypertensive groups, such
as women, Be elderly, lower-income persons, and different ethnic groups.
The study demonstrates mat quality-of-life measures highlight Me iat-
rogen~c effects of drugs that successfully coning blood pressure, but win
differential effects on venous aspects of He physical state, emotional
well-being, sexual and social functioning, and cognitive ability of pa-
tients.
The study is also important because it uses several measurement in~-
ments to reinforce its conclusions, and because it is a major quality-of-
life-oriented clinical trial funded by a pharmaceutical company, thus
indicating the potential role for quality-of-life considerations in bow
clinical decisionmaking and marketing.
STUDY 2. ARTHRITIS MEDICATIONS
Bombardier, C., Ware, J., Russell, 13., Larson, M., Chalmers, A., and
Read, J.L. Auranofin therapy and quality of life in patients with
rheumatoid arthritis. Results of a mulizcenter trial. The American
Journal of Medicine S]~41:565-57S, ·986.
Key
Technology Assessed: Auranof~n therapy
Padent Group: Adults
Diagnosis Type: Rheumatoid arthritis
Measure Category: CJ~iruc~, psychological, functional performance, pain,
global impression, and utility
Measures: Health Assessment Questionnaire; Keite! Assessment; Qual-
ity of Well-Being Questionnaire; Toronto Activities of Daily Living
Questionnaire; McGill Pain Questionnaire; Pain Ladder Scale; loom
Pain Line; Arthritis Categorical Scale; Arthritis Ladder Scale; Overall
Heal Ladder Scale, Current; Overall Health Ladder Scale, 6-Day Mean;
RAND Current Health Assessment Measure; 10-cm Overall Health Scale,
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*
34
J. FALOT7CO-TAYLOR, M. McCl~l1AN, AND F. Af OS7.F~R
calculated by subtracting foDow-up scores from me baseline score, which
yielded a positive (detenorabon), negative (improvement), or no score
change.
Results and Conclusions
Ott et al. found mat patients who participated in me teaching and
counseling program in addidon to He exercise program did si=ficandy
better Can those in the over two groups, particularly in the psychosocial
dimension. Patients In the teaching and counseling group also showed an
increase In the overall SIP score at the six-month foBow-up. In addition,
these patients had higher scores in Me category of eating, which the
investigators attribute to the teaching and counseling sessions mat pro-
vided information on nutrition and diet.
Comments
The investigators note that their ong~nal baseline calculations were
faulty, drawn from subjective recollections by patients at the most im-
paired point of their expenence. The investigators also note that the
exercise program was an individual, unsupervised program with no peer
or counseling support. In spite of these faults' me SIP may be a useful
too! in evaluating the recovery progress of patients with myocardial
infarctions. Targeting me padents' varying rates of recovery on each of
me 12 dimensions measured by the SIP may help clinicians and padents
to speed me recovery process In specific areas and to improve the long-
te~m quality of life.
STUDY 9. LONG-TERM DIALYSIS AND RENAL
TRANSPLANT
Bonney, S., Finkelstein, F.O., L`ytton, B., Schiff, M., awl Steele, T.E.
Treatment of end-stage renal failure in a Reined geographic area.
Archives of Internal Medicine ·38~101:1510-1513, ·978.
Key
Technologies Assessed: Long-tenn dialysis and renal transplantation
Patient Group: Adults on long-tenn hemodialysis or transplant recipients
Diagnosis Type: Renal failure
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USE OF MEASURES IN T=~O~GY ~S~M~
35
Measure Category: Psychological, physical, and social function
Measures: Quality-of-life indices (work status, sexual functioning), physi-
cal activity indices, Kupfer-Detre System Forms ~ and 2
Description of Measures
Quality-of-life indices. These indices included He padents' level of gen-
er~ physical ability, level of sexual function, and current and prior wow
status.
Physical activity. This was classified according to the functional ciassifi-
cabons recommended by Be National Kidney Foundation: Class I,
capable of performing all usual types of physical activity; Class 2, unable
to perform Me most strenuous of usual physical activities; Class 3, mable
to perform usual daily physical activities more man occasionally; and
Class 4, severe limitation of usual physical activity.
Kupfer-Detre System Fonn · Is-. The KDS-~1 evaluates current
psychological status.
Kupfer-Detre System Form 2 ~DS-2~. The KDS-2 elicits data on the
presence or absence of 64 specific physical symptoms.
Purpose of the Study
Bonney et al. determined me impact of long-te~m hemodialysis and
renal transplantation on quality of life.
Methods
Bonney et al. reviewed Be medical records of, and conducted stn~c-
cured interviews with, 129 (95 percent of total) long-term home dialysis
patients, 23 (82 percent of total) hemodialysis unit patients, and 38 (100
percent of total) patients who received renal transplants between 1967 and
1975 in southern Connecticut. The investigators selected this region be-
cause most padents with renal failure were able to receive treatment win
a reasonably uniform level of management
Results and Conclusions
The investigators found that quality of life was lower for dialysis
patients Can for transplant recipients. The dialysis patients were more
likely to be unemployed, to be less physically active, to have less satisfac-
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36
J. FALOTICO-TAYLOR, M. McCl=LIA[J, AND F. MOSTFi1FR
tory sexual relations, and to suffer from depression, organic brain dys-
function (demonstrated by He KDS-~), and numerous physical com-
plaints (demonstrated by Me KDS-2) than padents in the transplant group.
Dialysis padents had a mean depression score similar to those of psychiat-
r~c outpatients. In contrast, depression scores for Be transplant recipients
were comparable to Pose for the general population. Although the trans-
plant patients were generally in better condition physically and mentally
than the dialysis patients, they too exhibited manifestations of impaired
functioning.
Comments
Data on the quality of life of dialysis and renal transplantation patients
may help both patients and physicians consider the impact of these treat-
ments. It may also increase Be awareness of Be difficulties Rat may be
expected with each course of treatment.
STUDY 10. RENAL TRANSPLANTATION AND DIALYSIS
Evans, R.W., Mar~ninen, DO., Garrison, L.P., Jr., Hart, L.G., Blagg,
CR., Gunman, RA., Hull, A.R., anal Lowrie, E.G. The qualiry of life of
patients with end-stage renal disease. New England Journal of
Medicine 31269J:553-559, 1985.
Key
Technology Assessed: Renal transplant versus dialysis Come, in-center,
and pentoneal)
Patient Group: Adults
Diagnosis Type: End-stage renal disease (ESRD)
Measure Category: Physical, role and social function, and global weB-
being
Measures: Ka~nofsky Lndex, Index of Psychological Affect, Index of
Overall Life Satisfaction, Index of WeD-Being, work status
Description of Measures
Karnofsky Index. This is an objective measure of overall physical func-
tion. Scores range from ~ (monbund) to 10 (normal activity).
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USE OF MEASURES IN TECHNOLOGY ASSESSMENT
37
Index of Psychological Affect (lPA). The eight bipolar items of me IPA
descnbe respondents' thoughts about Weir current situation. Responses
are averaged to give an overall score ranging from ~ (completely dissatis-
fied) to 7 (completely satisfied).
index of Overall ~ if e Satisfaction ~OLS). The bipolar items of me TOLS
describe the respondents' overall satisfaction with life. Scoring is similar
to Mat in Me IPA.
index of Well-Being. The Index of WeR-Being consists of a combination
of responses to the IPA and IOLS. It is weighted toward the former.
Scores range from 2.1 (low) to 14.7 Might.
Work status. This measure consists of a response to Me question "Are you
now able to work for pay full time, part time, or not at all?"
Purpose of the Study
The investigators compared Me effectiveness of alternative dialysis
methods for ESRD patients using a range of measures related to both
clinical stems and quality of life.
Methods
Evans et at. compared 859 nonrandomized pahents who underwent
either renal transplantation or dialysis Tome, in-center, or peritoneal).
These patients were surveyed from ~ ~ transplantation and dialysis centers
nationwide. The investigators analyzed sociodemographic and medical
vanables as wed as the objective and subjective measures of quality of
life described above. All data collectors participated in an intensive three-
day training session, although much of the Raining was devoted to medi-
cal record abstraction rawer than a~nin~ster~ng quality-of-life ~nstru-
meets. The investigators maintained routine contacts wid1 each center to
ensure Mat uriifonn procedures were followed. The response rate was
over 90 percent.
Results and Conclusions
Evans et al. found Mat me subjective and objective measures correlated
poorly. They found Mat transplant recipients had Me least functional
impairment; those treated through in-center dialysis were most impaired.
Almost 75 percent of transplant recipients were able to work, compared
with 60 percent of those on home dialysis and much lower proportions of
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38
J. FALOTICO-TAYLOR, M. McCLELIAN, AND F. MOSTF'-'FR
He other groups. Case-mix factors, including age, educational level, and
comorbidity, had substantial effects on these two measures.
With case-mix adjustment, transplant recipients had the most favorable
subjective scores. Younger, more educated, and white patients tended to
report hider quality~f-life scores. In contrast to the objective measures,
Be comorbid conditions studied did not have a significant relation deco
subjective quality-of-life measures.
The investigators also compared their padents with Be general popula-
tion. Labor-force participation rates showed that end-stage renal disease
patients are much less likely to work than is the adult population as a
whole. Compansons of results on He subjective measure to results
obtained by Campbell et al. (1976) for the U.S. population showed that
"padents with ESRD perceive that they have only a slightly lower quality-
of-life Can the general population . . . [but] only transplant recipients have
a subjective quality-of-life that does not differ sign~ficandy from that of
the general population." Thus, even with correction for the differences
among treatment groups, transplant recipients had consistently higher
subjective and objective qualiOr-of-life scores.
Comments
The investigators described some weaknesses in their study, such as
the lack of randomization, substantial case-mix vanation among treat-
ment groups, a lack of analysis of interaction terms, and no longitudinal
data. Nevertheless, the design was strengthened by the training and
monitoring of data collectors to promote unifolIni~r, the use of bow
subjective and objective categories of quality-of-life measures, and the
choice of established measures that allow comparisons with other patient
groups and with He genes population The low correlation between the
objective and subjective indices, observed In a variety of quality-of-life
studies, has implications for their use. Subjective measures reveal Hat
these padents may be experiencing levels of quality of life much closer to
those of the general population Can objective measures might indicate.
Although these results may demonstrate the "psychological adaptability"
of ESRD patients, and possibly that of chronic disease patients more
generally, they also raise policy questions concerning the appropriate
standards for Reagent decisions.
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USE OF MEASURES IN T=HNO~GY ~SESSM~
STUDY 11. CASE MANAGEMENT AND USUAL AND
CUSTOMARY SERVICES FOR CHRONICALLY
MENTALLY ILL PATIENTS
39
Franklin, JO., Solovitz, B., Masson, M., Clemons, JR., and Miller,
G.E. An evaluation of case management. American Journal of
Public Health 77(6):674-678, 1987.
Key
Technology Assessed: Case management versus '`usual and customary"
services for chronically mentally ill patients
Patient Group: Mentally id adults
Diagnosis Type: Mental illness
Measure Category: Mental, role, and social function
Measures: Social function, Affect Balance Scale, Self-Esteem Scale,
Cost-Benefit Analysis
Description of Measures
Social function. A variety of objective and subjective measures were
developed to consider six areas: housing, living arrangements, social
relations, leisure, income, and employment. The objective measures
consisted of quantifiable items in each area; subjective measures were
designed to assess satisfaction with conditions in each area. AddidonaBy,
an "activities of daily living" measure included self-assessments of per-
fom~ance of such activities as cooking, budgeting, and traveling.
Affect Balance Scale. This assessment measure consists of 10 yes or no
items, including a 5-item negative affect scale.
Self-Esteem Scale. This scale includes five statements relating to over
self-esteem, such as "On the whole, ~ am satisfied with myself,' and "I
fee} useless at times."
Cost-Ben~tAruzlysis. This analysis compared quality-of-life and utiliza-
tion results with costs incurred by each padent group.
Purpose of the Study
The investigators compared two methods of delivering management
and support services to chron~caBy mentally iD patien~"usual and cus-
OCR for page 40
40
J. FALOTICO-TAY~R, M. McC~, ID F. MO=FJJF.R
tomary" services and a more directed and systematic "case management"
approach designed to meet We needs of individuad padents.
Methods
Using a randomized, pretest-posttest con~ol-group design, inves~ga-
tors assigned 417 (83 percent) of 500 eligible padents to receive either
case management or non-case management services. The investigators
reinterviewed 63 percent of the padents one year later.
Results and Conclusions
Patients in the case management group were twice as likely to be
readmitted to a mental institution; Hey stayed longer, concur higher
costs, and used more Man Vice as many commuruty-based services as He
patients in the over group. Investigators found few significant differ-
ences in quality-of-life measures between He two groups. They con-
cluded dlat tile expenmental case management approach appeared to
increase costs substantially without demonstrating any important effect
on He quality of life of mental patients. This increase may have resulted
from increased detection and correction of an underutilization of services
in He experimental group. Furthermore, the one-year time span of the
experiment may have been too short to detect significant changes in this
chronically ill population.
Comments
The investigators discuss many speciad considerations required for
perfo~Tning quality-of-life assessments win mentally in padents, such as
difficulties In follow-up. The study also illustrates an outcome contractor to
that anticipated by the researchers. They note that case management is
''un~fomlly favored" by professionals to increase effectiveness of ser-
vices, and they do not advocate any policy conclusions based on their
results. Nonetheless, the report provides an example of He use of quality-
of-life measures in a context directly related to me evaluation of policies
for die delivery of social services, as well as the application of qllality-of-
life measures to a specie patient population.
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USE OF MEASURES IN TECHNOLOGY ASSESSMENT
STUDY 12. HEALTH INSURANCE PAYMENT MECHANISMS
41
Brook, R.H., Ware, J.E., Jr., Rogers, WM., Keeler, E.B., Davies, A.R.,
Donald, Cat., Goldberg, GA., Bohr, K.N., Masthay, P.C., and
Newhouse, ].P. Does free care improve aches' health? Results from
a ran~onuzed controlled trial. New England Journal of Medicine
309(23):1426-1434, 1983.
Key
Technology Assessed: Health insurance paymera mechanisms
Patient Group: General adult population (under age 65)
Diagnosis Type: None
Measure Category: Physical, mental, social, and global
Measures: General Heady Rating Index
Description of Measures
General Health Ratzag Index (GHRI). The GHRI is completed by pa-
tients and consists of He following five categories of items, aD scored on
0-100 scales, with higher scores indicating better performance:
(~) Physical Functioning. The 23 items in this category measure
personal limitations in self-care, mobility, and physical acquires.
(2) Role Functioning. The two role functioning items measure ability
to function at work, school, or home.
(3) Social Contacts. These three items measure contact win friends
and family during He past month or year.
(4) Mental Heady. The 38 mental health items measure anxiety,
depression, behavioral arid emotional control, and psychological weB-
being during the previous monk.
(5) Health Perception. The 22 items in this category measure me
person's perceptions of past, present, and future health; susceptibility to
illness; and health concerns.
Purpose of the Study
Brook et al. evaluated whether groups who had access to more heady
care, Hugh He use of"free" plans in the RAND Health Insurance
Experiment, achieved better health status than groups enrolled in a variety
of cost-sha~ing plans.
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42
Methods
J. F~TICO-TAY~R, M. Mat, ID F. MO=.F' J Fig
A total of 3,958 people, between Me ages of 14 and 61 and tested in six
study centers, were enrobed in the study for Free or five years. AB
Medicare-elig~ble patients (for example, the disabled) were excluded.
Participants were assigned to a variety of insurance plans; only one of
these did not require enrollees to pay a portion of Weir medical bills. No
significant differences between Me groups existed at the time of enroH-
ment.
Results and Conclusions
Only role functioning was sigriificandy improved in Me free plan. No
significant differences were detected among subgroups differing in in-
come and initial heady status, but confidence intervals for these groups
were wider than those for average enrollees.
Comments
The GHRI was developed for use in a large, controlled Dial involving
generally healthy adultse Consequently, it provides a well-tested measure
for analyzing medical services for broad segments of the population,
including individuals who are generally heatedly. Adjusunents may be
necessary for its application to subgroups, such as the poor or elderly,
who may have special quality-of-life considerations.
REFERENCES
Bombardier, C., Ware, J., RusseD, I.J., Larson, M., Chalmers, A., and
Read, J.~. Auranofin therapy and quality of life In patients win
rheumatoid arthritis. Results of a multicenter teal. The American
Joumal of Medicine 81~4~:565-57S, 1986.
Bonney, S., Finkelstein, F.O., Lytton, B., Schiff, M., and Steele, T.E.
Treatment of end-stage renal failure In a defined geographic area.
Archives of Entomb Medicine 138~101:1510-1513, 1978.
Brook, R.H., Ware, I.E., Jr., Rogers, W.H., Keeler, E.B., Davies, A.R.,
Donald, C.A., Goldberg, G.A., Lohr, K.N., Masthay, P.C., and
Newhouse, I.P. Does free care improve adults' health? Results from
OCR for page 43
USE OF MEASURES TV TECHNOLOGY ASSESSMENT
43
a randomized con - Bed trial. New England loumal of Medicine
309~23~:1426-1434, 1983.
Campbell, A., Converse, P.E., and Rodgers, W.L`. The Quality of Ameri-
can Life: Perceptions, Evaluations and Satisfactions. New York,
RusseB Sage Foundation, 1976.
Coates, A., Gebski, V., Bishop, I.F., hem, P.N., Woods, R.~., Snyder, R.,
Tattersall, M.H., Byme, M., Harvey, V., and Gill, G. Improving the
quality of life during chemotherapy for advanced breast cancer. A
comparison of intermittent and continuous treannent strategies. New
England loumal of Medicine 317~24~:149~1495, 1987.
Croog, S.H., Levine, S., Testa, M.A., Brown, B., Bulpiu, C.~., Jenkins,
C.D., Klerman, G.L., and Williams, G.H. The effects of andhy-
pertensive therapy on me quality of life. New England Journal of
Medicine 314(26):1657-1664, 1986.
Evans, R.W., Mann~nen, D.L., Garrison, L.P., Jr., Hart, L.G., Blagg, C.R.,
Gutrnan, R.A., HuB, A.R., and Lowr~e, E.G. The quality of life of
patients win end-stage renal disease. New England Joumal of Medi-
cine 312~9~:553-559, 1985.
Franklin, I.L., Solovitz, B., Masson, M., Clemons, J.R., and MiDer, G.E.
An evaluation of case management. American Journal of Public
Heals 77~6~:674-678, 1987.
Hollandswor~, J.G., Jr. Evaluating the impact of medical treatment on
He quality of life: A 5-year update. Social Science and Medicine
26~4~:4254~, 1988.
Lasry, I.C., Margolese, R.G., Poisson, R., Shibata, H., FIeischer, D.,
Lafleur, D., Legault, S., and Taillefer, S. Depression and body image
following mastectomy and lumpectomy. Joumal of Chronic Diseases
40~6~:529-534, 1987.
Linn, M.W., Linn, B.S., and Harris, R. Effects of counseling for late stage
cancer patients. Cancer 49~5~:1048-1055, 1982.
Meyerowitz, B .W. , Spadcs, F. C. , and Spears, I.K. , Adjuvant chemo~er-
apy for breast carcinoma Cancer 43~5~: ~ 613- ~ 6 ~ ~ , 1979.
Najman, I.M., and Levine, S. Evaluating He impact of medical care and
technologies on He quality of life: A review and critique. Social
Science and Medicine [F] 15~2-3~:107-~15, 1981.
Ott, C.R., Sivarajan, E.S., Newton, K.M., Almes, M.~., Bruce, R.A.,
Bergner, M., and Gilson, B.S. A controlled randomized study of
early cardiac rehabilitation: The Sickness Impact Profile as an assess-
menttool. HeartandLungI2~2~:162-170,1983.
OCR for page 44
44
J. FA~17CO-TAYLOR, M. McOl~AN, AND F. MOST-
Steinberg, M.D., Juliano, M.A., and Wise, L. Psychological outcome of
lumpectomy versus mastectomy In Me Reagent of breast cancer.
American louma1 of Psychiatry 142~:34-39, 1985.
Wallwor3`, I., and Caine, N. A comparison of Me quality of life of cardiac
transplant patients and coronary aneIy bypass graft padents before
and aRer surgery. Quality of Life and Cardiovascular Care 1(7)
September/October:3 1 7-33 1, 1 985.
Representative terms from entire chapter:
overall health
