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Assessing Quality of Life: Measures and Utility J. Ivy Brims md Sharon Wood-Dauphinee Quality-of-life research has included me study of levels of economic, political, social, and psychological wellbeing resuldng from varying governments and economic systems, as wed as policies and public pro- grams related to heath. Schuessler and Fisher (1985) wrote Mat quality- of-life research began in the 1960s wad We Report of the President's Commission on National Goals in the United States. Most specialists agree mat Me term "quality" has Me same meaning as "grade" or "rank," which can range from high to low or best to worst. What elements of life are to be so graded? The Imits of analysis can be as large as a nation. Countries can be racked on Weir economic systems and on me types and amounts spent by governments on social programs reladve to expenditures on industry and the military. At Me level of the individual, the elements can be objective (for example, job, income, shelter, and food) or subjective (happiness, sense of well-being, self- re~ization and Me perceptions of the worth and value of life, and me like). Editors' Note: The authors have supplied information about sources of descriptions of measures and their validity and ~liability. Those especially concerned about such matters may wish to go directly to the section entitled "Strategies Used to Assess Instruments," and then to the section entitled "l~e Sources of Descnp~ve ~fonnation for Quality-of-Iife Measures," which lists Awe key reference WOTICs that provide names, descnpua~s, and properties of a number of standard instruments. Readers may then skip to "Ten Review Fonns for Quality-of-Iife Measures," where sources are listed and rewew forms supplied for some instruments not described in standard works. Ibis chapter contains a special segment that describes utility analysis, a specie econanetnc approach to measures of quality of life. 65

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66 J. I. WILLIAMS AND S. WOOD-DAUPHINEE The best known studies of the quality of life of individuals are Rose of Andrews and Wiley (1976) and Campbell and colleagues (1976, 1980) at We Institute for Social Research at the University of Michigan. Bow teams of ~nves~gators asked questions about the domains of life sadsfac- tion, including wow, marriage, leisure activities, family, housing, and neighborhood. They developed a global measure of sadsfacdon by com- bin~ng the scores in a genes measure. Quality of life series In the health sector are more limited In scope. In the health sciences, We task at hand is to assess We impact of disease and its management, including interventions, on the well-being of the patient. The health states of the Individuals may influence their quality of life without detenn~ng it As Ware (1987) noted "jobs, housing, schools, and the neighborhood are not attributes of an ~ndividual's health, and they are wed outside the purview of We health care system." Heady care researchers have developed numerous measures of quality of life over We past two decades, and several review articles have com- mented on Rose so far available. Their use in assessing the outcome of health care interventions has become popular. As we have seen In Chapter 2, recent studies have reported on the quality of life of men win mild to moderate hypertension undergoing andhypertensive therapy, of women win advanced breast cancer undergoing chemotherapy, and of cancer patients in hospice programs. Although a variety of studies purport to assess quality of life, there is remarkably little agreement about He underlying concepts or theoretical framework Hat He measures represent. These measures may include clinical symptoms (for example, pain, nausea, vomiting), functional dis- ability (Katz Activities of Daily Livings, heals status measures (RAND health status measures, Sickness Impact Profile), and measures of life satisfaction and psychological weD-be~ng. The World Heath Organization (WHO) has defined heady as a "state of complete physical, mental, and social weld-being and not merely He absence of disease or infirmity." Ware (1987) argues that five health concepts are inherent in this definition: physical health, mental health, social fi~nction~ng, role functioning, and general weD-being. He takes a conservative approach to He study of quality of life in He health sciences. Because the goad of health care is to maximize He health component of He quality of life, he suggests Hat He measures be restncted to assessing heals status. Spider (1987) includes He burden of symptoms in his operational decoration of health He would restrict the assessment of the attributes of

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ASSESSING QUALITY OF LIFE 67 heath to those who are definitely sicL He sees lime point In extending me studies of quality of life in health care to me ostensibly healthy, but few writers in the field agree win this point of view. Wenger et al. (1984y, McDowell and Newell ~1987), and Kane and Kane (1981) offer systematic reviews of a number of measures used in qu~ity-of-life studies, including functional disability indices, heady status scales, and measures of life satisfaction. In Weir reviews, these authors discuss He reliability and validity of a number of me measures and Heir uses in heath care studies. We list He ~ns~nents they treat in He section entitled 'bee Sources of Desc~ip~ve Formation for Quality-of- Life Measures." This chapter focuses on measures developed specifically to assess quality of life. ISSUES IN SELECTING QUALITY-OF-LIFE: MEASURES To choose measures for assessing quality of life, researchers need to address seven issues, briefly reviewed below. Disease-Specific Versus Global Assessments Measures may focus on He symptoms, complaints, disabilities, and disruptions in life Hat are specific to He Caracas condition under study. ~deed, He disease-specific approach has been advocated in He study of arthritis, heart disease, and the evaluation of chemotherapy. Altematively, one can assess me quality of life resulting *om He overeat consequences of disease and management on He functional ca- pacities and padents' perception of weB-being. The more global meas- ures cover a number of dimensions urchin a summary score. For ex- ample, the Quality of Life Index developed by Spitzer et al. (1981) includes one item for each of He following dimensions: activities of daily living, pnncipal activities, heath, outlook, and support. Similarly, meas- ures of life satisfaction and general weD-being are global in perspective. Other measures, such as He linear analogue self-assessment scales developed by Pnestman and Baum (1976) or the Breast Cancer Question- naire Levine et al. 1988), are designed so that patients may repeatedly assess Heir symptoms and report Heir physical and emotional responses to adjuvant chemotherapy. The resulting scores show He padents' imme- diate and specific responses to disease and treatment.

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68 J. 1. WIlLIAAiS AND S. WOOD-DAUPHINFF: Clinical Endpoints Versus ~ng-Term Outcomes Fletcher et al. (1988) state that me clinical endpoints commonly used for assessing prognoses include evidence of improvement foBow~ng inter- vention, remission of disease, and recurrence. CI=cal endpoints tradi- tionaDy focus on sets of outcomes that are assessed near Me time of diagnosis and treannent. Long-mnge outcomes can be viewed as Rose mat are important to patients as Hey live win Heir resulting states of heath. Patient Ratings Versus Proxy Assessments Investigators generally prefer Hat patients rate their own quality of life. Proxy assessments are important when patients are unable to respond. In these circumstances, researchers may use quality~f-life measures com- pleted by other persons such as ~ responsible clinician, spouse, close friend, or relative of me padent. Objective Versus Subjective Measures Objective measures are based on variables mat can be observed and recorded by venous testing procedures and assessors. Measures of dis- ease activity, remission of symptoms, presence of side effects, changes in functional capacity, ability to calTy out usual activities, and family and social activities are phenomena that can be observed and recorded. These variables are important determinants of quality of life, and agreement can be reached about changes in status that have occulted. Subjective measures provide oppormnides for individuals to express Heir Noughts, knowledge, attitudes, moods, and feelings. Subjective phenomena may be related to particular diseases or Apes of therapy, or they may be more global. Although researchers and policymakers tend to malce much of He distinction between objective and subjective measures, bow are probably necessary when assessing quality of life, and bow require ~nves~gadons into Heir reliability and validity. It is pethaps supposing Hat He objective measures often are not as weU standardized as He subjective measures; objectivity does not automatically mean mat measures are reliable and valid.

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ASSESSING QUAIdTY OF LIFE Cognitive Functioning 69 Researchers commonly exclude cognitive funchon~ng from considera- tion In studies of qualitr of life. Except for diseases and therapies that obviously diminish mental capacity, investigators usually assume Mat the cognitive abilities of individuals are unaffected by episodes of illness and care. One may test this assumption by including tests of connive funcdon~ng, as did Croog et al. (1986) in their study of antihypenensive medications. Ratings and Utilities As Schuessler arid Fisher (1985) indicate, quality~f-life measures provide ratings or rankings of heady and life. Some assessments attempt to move *om states of health to judgments of ~e worm or value of life win a given state of heals. Lnvestigators' working win concepts and methods developed in economics, are desiring measures of the utilities of heady states, win me typical scores ranging from 0 for "Dead" to ~ for "Normal Heath." By multiplying the utility values by the number of years individuals live win a given health state, survival time can be expressed in Quality Adjusted Life Years (QUAY). Heath economists have used this approach to compare technologies in terms of costs per QALY gained. Not everyone agrees win such an approach, because it tends to diminish He value of a good, but troubled, life. Utility measures move He measurement of quality of life from rank- ings to judgments of word1 and value. This extension of the field of study is controversial; most particularly, me role of utility analysis in quality-of- life research is hotly contested. Timing of the Assessments Measures such as He linear analogue self-assessment scales, the Func- tional Living Index Cancer, and the Breast Cancer Questionnaire are designed for repeated use before, during, and immediately after treatment. The purpose of He repeated measures is to assess padents' short-temn responses dunng the course of therapy. Global assessment measures, such as He Spitzer Quality of Life Index, are designed to reflect the quality of life foBow~ng He impact of disease

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70 J. I. WII1lAMS AND S. WOOD-DAUPHINEE and management or to reflect global changes In assessments over a long period of time. Investigators have used the Spitzer Quality of Life Index for repeated assessments during me course of therapy (Coates et al. 1987, Levine et at. 1988), but the scores tend to be less responsive to short-tenn clinical changes than me disease-specific measures. The basic issue is Me use of quality-of-life measures to assess short- tenn against long-tenn responses to therapy. For example, Levine et al. (1988) stopped taking assessments when patients withdrew from ~eat- ment or relapsed. Conversely, Chubon (1987) used the Life Situation Survey to compare the quality of life of patients in chronic care and rehabilitation programs wad Lose of healthy subjects. There is a problem win repeated self-assessment dunng me course of therapy. Investigators have found it difficult to maintain high self-assess- ment completion rates over seven weeks (Finkelstein et al. 1988, Ragha- van et al. 1988) and were not able to use We assessments because of missing values. Levine et al. (1988) minimized me problem by having nurses interview the patients during clinic visits; this procedure, however, added considerably to We time and costs of the study. If these measures are to be used repeatedly, the time and costs of ma~nta~ng high response rates over multiple assessments must be considered. Summary - Some qualiW-of-life studies ma~ntain one perspective or point of view. Yet it is becoming increasingly common for researchers to employ a mix of perspectives and mesons in assessing qualibr of life. We have re- viewed what is known about the conceptual framework, reliability, valid- id, and uses of specific measures. In any study, several tools may be combined to provide information on various perspectives: subjective and objective, disease-specif~c and global, clinical endpoints and long-term outcomes, and so on. No attempt win be made to sort out the combina- dons of approaches researchers have employed. Examples of multiple approaches to assessing quality of life are given in Chapter 2. STRATEGIES USED TO ASSESS INSTRUMENTS A bewildenng array of terms labels the properties of measures, and researchers in the heath sciences frequency employ strategies for devel- oping and testing measures that differ from Lose used in Me social

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ASSESSING QUALt7Y OFL1FE 71 sciences. To standardize our work, we developed He Review Form for Quality-of-Life Measures. We used the Review Form to gamer biblio- graphic information, Be stated purpose of me measure, its underlying concept framework, and a descriptor of its content and fonnat. As part of this review, we have Died to use terms Cat are consistent wad Pose compiled in the Dictionary of Epidemiology Beast 1988) by the International Epidemiology Association and that are used by writers in epidemiology (Fe~nste~n 1987, McDowell and NeweB 1987) and Be social sciences (Bohmstedt 1981, Kerlinger 1986, NunnaBy 1978~. This section briefly reviews some s~ishcal and over expressions. Reliability Two basic strategies can be used to establish Be reliability of a meas- ure. For those based on subjective ratings of attitudes, perceptions, and sense of weD-being, investigators may assess Be reliability by examining the consistency of patterns of response across me items. Me coefficient alpha (Cronbach 1951) measures the intemal consistency of Be response, based on the average correlation among Be items and the number of items In Be instrument The coefficient assumes that the correlations in Be matrix are all positive, because they represent the same dimension. Val- ues of Cronbach's alpha range from O to I. If Cronbach's alpha is high (for example, 0.80 or higher)' Be responses are consistent, and the sum of Be item responses yields a score for Be underlying dimensions Cat the item represents. S=ed another way, if Be items are adequately sampled *om me domain of quality of life, Be son of Be responses should give a better indication of the quality of life of Be individual than Be response to any one item. A low coefficient alpha would indicate Cat the items did not come from the same conceptual domain or that Be noise in the items was substantial. The items can be divided and placed on altemate forms of the measure; the equivalence of the altemate fonns can be tested by comparing Be alphas. Alternatively, me items on one form can be split into two groups, and coefficients can be computed for each half and compared. Compa- rable coefficients confirm the consistency of the responses. The scores for the split fonns can also be correlated to see how Hey correspond. The Speannan-Brown formula uses this correlation to esti- mate the reliability of a scale containing ad items after adjusting for the presence of twice as many items on the composite scale as in each of He two groups (ZeDer and Cannines 1980~.

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72 J. 1. W7ll~AMS AND S. WOOD-DAUPHINEE Researchers may decide to create a m~dimensional measure of qual- ity of life and Men select items mat represent me dimensions of interest. For example, quality-of-life measures may have items related to condi- tions specific to disease and management (for example, nausea and vomit- ing in response to chemotherapy for cancer), and Were may be additional items related Deco physical functioning, and social and psychological well- being. Factor analysis s~tisticaDy defines a small number of factors or under- lying dimensions that account for a high proportion of the common variance of We items. Exploratoty factor analysis is used to identify and discard items that are not correlated with We factors of interest. Altema- tively, an investigator may use factor analysis to confirm mat items selected to represent a single dimension of quality of life (for example, physical functioning) principally load onto mat factor and correlate weakly with over factors. The factor represents a single dominant dimension or variable when the factor loadings for the items are relatively high 0.60 or higher—and me common variance and the factor loadings cannot be increased by subdividing the items onto additional factors. Factors are not considered stable unless the results can be replicated in a number of samples and study settings. Once a factor is defined as representing a single variable or dimension, We responses for ~e items on each factor are summed to create the factor score. For a measure with a fairly large number of items and a high coefficient alpha, one can use factor analysis to define two or more factors underlying the responses. A measure mat is intemaBy consistent may still not represent a single dimension. Factor analysis is used to define the under- ly~ng dimensions, and the coefficient alpha may men be used to assess the strength of the consistency of the items on We separate factors. The stability of a scale or factor score is assessed by correlating the scores of subjects with the scores obtained in testing at another time. As Bohmstedt (1981) has noted, the test-retest coefficient can be influenced by true changes in scores. The interpretation of We coefficient of stability is not always straightforward. If me variables being considered are sufficiently objective to be evalu- ated by persons over man me patients, it is possible to compare raters' scores. For example, the Quality of Life Index is designed to be com- pleted by the heady professions responsible for me care of We patient and significant others as well as by patients themselves. Interrater agreement indicates the reliability of the scores by different raters on a single occa- sion, and intrarater agreement is We reliability of the scores by the same rater over repeated testings.

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ASSESSING QUAL17Y OF LIFE 73 If the measure is categorical, Cohen's kappa Weiss 1981) is most frequently used to assess the level of agreement beyond Mat expecter! by chance. For mnkings of ordinal measures, Spearman's rho and Kend~l's tau may be used as measures of agreement In addition to kappa. Pearson's product moment correlation is commordy used for comparing quantitative scores of raters. The preferred measure of agreement is We ~ntracIass correladon coeff~- cient. It is particularly useful when Were are Wee or more ratings. It compares the variance between subjects, We variance between raters, and We van ance between times wad We error v an ance. The intraciass corre- lation is reliable if most of We variance in me mode! is accounted for by me van ance between subjects and if me variances by raters and by lime are minimal Weiss 1986~. The measure rests on the analysis of variance and can be use with ordinal as wed as interval data An intraciass correlation coefficient of, for example, 0.80 or higher indicates mat the measure is highly reliable. Scaling refers to We rules for assigning numbers to responses. The scaling determines whether We measure is a nominal, ordinal, interval, or ratio variable. Validity A first step in assessing the validity of a measure is to determine if the content of the items represents the domain or dimension of interest. Face validity is sometimes used to refer to me intuitive appeal of the items; content validity is reserved for me judgments of experts or specialists. When Were exists a v en able extemal to We measure against which me scores can be checked, that v en able can be used as a cr~tenon to judge the measures. For example, the quality-of-life scores should differentiate patients dying of cancer, patients in intensive care, outpatients win chronic diseases, and hearty individuals, even Cough mere may be substantial overlaps in We distributions of scores. Concurrent criterion validity refers to me ability of a measure to differ- entiate between groups at We time the measure is applied. Predictive criterion validity refers to the ability to use these scores to predict future health-related events and states. Quality-of-life measures can be compared win other measures as well. Concepts derived from theory and operationalized into reliable and valid measures are referred to as constructs. The measures under study can be tested against the constructs to determine if We observed relationships are as hypothesized. For example, quality of life should be negatively related

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74 J. I. WIlllAMS AND S. WOOD-DAUPHINEE to measures of pain, anxiety, and depression. Similarly, a measure of quality of life should be positively related to life satisfaction and genes well-being. To judge the sensitivity or responsiveness of a measure, me ~nvestiga- tor should have a sense of how much change in a patient's clinical or func- donal stems would produce a change In their quality-of-life score. Sign~fi- cant clinical changes in the individual may not parallel changes in quality- of-life scores. Alternatively, a relatively small change in clinical levels may result in marked changes in a patient's sense of psychological well- being. Finally, Me practicality of a measure refers to He ease and convenience of administration and interpretation. Practicality is particularly important if a measure is to be used repeatedly. A REVIEW OF SELECTED MEASURES FOR ASSESSING QUALITY OF LIFE We reviewed 10 measures for rating quality of life using the Review Form for Quality-of-Life Measures. The section entitled "Ten Review Forms for Quality-of-Life Measures" presents the completed fonns, and Table 6-1 (see page 76, this volume) provides a summary. The Quality of Life Index (Qua), developed by Spitzer et al. (1981), has been tested In a variety of settings. It is used to assess He physical, psychological, and social functioning of patients. The QL-! yields a score that ranges from a high of 10 to a low of 0. Alternative fonns for completion by He patient, He physician or over health professional, relative, or significant other were developed to determine whether compa- rable ratings could be obtained from several sources. The reliability and validity of the QLl have been demonstrated in a series of studies in Australia, Canada, and He United States win a variety of patients. Chubon (1987), PadiBa et al. (1983), and Ferrans and Powers (1985) developed global measures of quality of life to be completed by patients. Chubon's Life Situation Survey assesses quality of life beyond disease- specific conditions and functional limitations, comparing He responses of patients in chronic care and rehabilitation programs with Hose of healthy subjects. Chubon tested his instrument with prison inmates, hospital patients, mentally retarded aunts, spinal injury patients, and Adversity students. Although He samples have been relatively small, the instn~nent appeared to wow well with all groups, and the differences in mean scores were as predicted. Chubon also found positive changes in me mean scores of patients who completed a program for chronic back pain.

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ASSESSrNG QUAl~TY OF luff 75 PadiBa's Quality of Life Index focused on physical conditions, ac- tivities, and attitudes of the patients. We found no reports of Me measures other than the articles published by the developers of the instruments. PadiDa ong~naBy developed her measure while working with cancer patients. She adapted the measure for use with colostomy patients, adding a number of disease-specific items. Armour the measure was designed to be global, we found no use of We adapted measure across conditions. Ferrans' QuaUity of Life Index focused on We satisfaction of needs; this measure is broader In scope. It taps life satisfaction In areas outside the immediate reach of health care (for example, marriage, education, occu- pation, future retirement), In addition to items related directly to heath. By 1988' results had been reported for healthy graduate students and dialysis padents. Karnofsky and Burchemal (1949) were among the first to develop a measure to assess the ability of cancer padents to perform dally activities. Their measure has been studied extensively and is widely used, although it has been criticized both conceptually and for its measurement proper- ties. The consensus seems to be that it continues to be a useful tool for physicians to use In rating We impact of cancer and cancer treatment on patients' ability to lead normal lives. The Functional Living Index—Cancer DICE is one of the newer instruments. The FLIC contains 22 items pertaining to symptoms and complaints related to cancer treatment, as wed as me impact of disease and management on physical, psychological, and social functioning. The items were tested on 837 patients in Winnipeg and Edmonton, Canada. When the data were factor analyzed, Schipper et at. (1984) found mat the mean factor scores for four padent groups decreased with the extent of disease. The investigators have completed some construct validation exercises. The FLIC is designed to be completed daily by patients. The responsiveness of the scores to changes over time has yet to be estate fished. Selby et al. (1984) have taken another approach to We development of an instrument for cancer patients. They took 18 items from the Sickness Impact Profile and added 12 items based on clinical experiences along with 2 statements for a global rating of quality of life and life satisfaction. The resulting questionnaire is designed to be completed by either physi- cians or padents. Factor analysis has been used to define We dimensions the items represent. The changes in scores reflect response to chemo~er- apy. We found no reports of uses of the instrument by investigators other man Selby and his colleagues.

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ASSESSING QUAl]IY OF LIFE 105 Additionally, when the repeated scores of 96 breast cancer padents on chemotherapy were enter into a regression analysis using Me item assessing the overall quality of life as We dependent van able and the other 31 items as the ~ndependentvar~ables, between 68 percent arid 83 percent of the variation In me global scale was explained. This information was seen as an indication of content validity. Construct: Using quality-of-life data from 96 patients, factor analysis determined five factors Mat made clinical and biological sense for breast cancer. When the items derived from me SIP categories were compared wad me linear analogue scores of me Sip, they correlated sign~ficandy and in me expected direction. Group scores of patients with different levels of clinical seventy differed sign~ficandy, demonstrating mat me ~ns~nent could disdnguish between groups of patients. Sensitivity: The instrument registered the ejects of chemotherapy when me treatment was started. BeD et al. (1985) reported Rat the measure was able to discriminate between high and low doses of chemotherapy. Data from an independent observer were more precise man data from We pa- dents. Practicality: Padents report the instrument to be quick, easy, and accept- able. References and Applications: Bed, D.R., Tannock, I.F., and Boyd, N.F. Quadity of life measurement in breast cancer patients. Bndsh loun~al of Cancer 51~4~:577-580, 1985. Twenty-five breast cancer padents participating in a randomized controlled Dial of chemotherapy were assessed 3 weeks after che- mo~erapy started (just prior to me next dose) and 24 hours later. Scores were obtained from padents and physicians. Bergner, M., Bobbit, R.A., Carter, W.B., and Gilson, B.S. The Sickness em pact Profile: Development and final revision of a heal status measure. Medical Care 19~:787-805, 1981. 9. Review Form for Linear Analogue Self-Assessment Name of Measure: Linear Analogue Self-Assessment (LASA)

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106 Authors: Banm, M., and Priesunan, T.~. J. 1. WIGWAMS AND S. WOOD-DAUPHINEE Primary References: Baum, M., Priesunan, T.~., West, R.R., and [ones, E.M. A comparison of subjective responses In a trial comparing endocnne with cytotoxic treatment in the advanced carcinoma of Me breast. European Joumal of Clinical Oncology (Supplement) 1:223-226, 1980. Priesunan, Ad., and Baum, M. Evaluation of quality of life in padents receiving treatment for advanced breast cancer. Lancet 1~7965~:899- 900, 1976. Purpose: The LASA is used to achieve a more complete picture of patients' subjective responses ~ treatment. Conceptual Framework: The developers vary In me number of items Mat are used in me subjective ratings. For each variable, patients mark a 10-cendmeter line that is anchored at each end win words describing the extremes of Mat symptom. These include: Symptoms and side effects: alopecia, anorexia, appetite, constipa- tion, diarrhea, dyspnea, fatigue, nausea, pain, vomiting, and "other." Anxiety and depression: apprehension, depression, insomnia, irnta- biIity, level of anxiety, mood, and weD-being. Personal relations: decisionmaking, getting along win partners arid others, sexual relationships, and social relationships. Physical performance: ability to perfonn daily activities, employ- ment, level of activist, and social activities. Reliability: Stability: Twenty-nine breast cancer patients completed forms with 10 items. These fonns were completed again 24 hours later at home. The correlation between sums of scores was 0.87. Scalability: Scores are summed across items; means and standard deviations are reported. The LASA was designed for repeated testing (weekly) over the course of treatment Validity: Concurrent: One hundred women with advanced breast cancer were randomly allocated to endocnne or combination cymtoxic therapy. N~nety- two were available for assessment; 51 completed the LANA. Fourteen of Me 25 women in Me endocrine group completed Me LASA for six weeks.

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ASSESSING QUALITY OF LIFE 107 Women In Me cytotox~c group had higher symptom-related scores and higher quality-of-life scores man women in me endocnne group. WeD- being differences reached significance after ~ ~ weeks. Predictive: Nonresponsive patients showed worse depression scores man women responding to t;reannent. Sensitivity: Changes in weekly scores indicate mat me LASA scores reflect clinical changes. Practicality: Generally, patients were able to complete me LASA homes without difficulty. NamraBy, for patients with advanced cancers, Were were marked patient attrition rates caused by deem or Habit to respond. References and Applications: Coates, A., DiDenbeck, C.F., McNeil, D.R, Kaye, S.B., Sims, K., Fox, R.M., Woods, Ah., Milton, G.W., Solomon, I., and TattersaD, M.H. On me receiving end IT. Linear Analogue Self Assessment MASAI in He evaluation of aspects of me quality of life of cancer patients receiving therapy. European Joumal of Cancer and Clinical Oncol- ogy 19~:1633-1637, 1983. One hundred and ten patients (30 with melanoma, 41 with lung cancer, 39 win ovarian cancer) completed 506 LASA fonns. The results were compared with performance states as measure by He Eastem Cooperative Oncology Group (ECOG) and response to therapy. LISA fonns included items for global well-being (for example, wet/-being, mood, appetite) and disease-specific conditions (such as, pain, nausea, vomiting). Bow ECOG scores arid the I,ASA scores for general well-being showed parallel and marked deterioration during He penod of radiotherapy with sub- sequent improvement. Coates, A., Gebski, V., Bishop, I.F., leal, P.N., Woods, Ah., Snyder, R., TattersaB, M.H., Byme, M., Harvey, V., and GiU, G., for He Austra- lian-New Zealand Breast Cancer Tnals Group, Clinical Oncology Society of Australia. Improving He quality of life dunng chemo~er- apy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. New England Joumal of Medicine 317(24):149~1495, 1987. Gough, I.R., Fum~val, C.M., Schilder, L., and Grove, W. Assessment of me quality of life of patients win advanced cancer. European loumal of Cancer and CI~rucal Oncology 19~:1161-1165, 1983.

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108 J. 1. WIlLlAMS AlID 5. WOOD-DAUPHINEE Lanham, R.J., and DiGiannanton~o, A.F. Quality~f-life of cancer pa- tients. Oncology 45(1):1-7, 1988. A linear analogue scale consisting of 10 items, including feeling of well-being, mood, level of physical activity, pain, nausea, appetite, ability to perform work, social activities, level of anxi- ety, and whether treatment is helping, was a~nin~stered to 98 cancer patients over 293 office visits and 137 family practice padents over 137 visits. The differences in mean scores, 6.09 for Me cancer patients and 6.67 for me healthy patients, were statisd- cally significant, but Me investigators expected Me differences to be larger. The group differences for men were statistically sig- rnficant, but Me differences for women were not. Male cancer patients had sign~ficandy lower scores than female cancer pa- tients. The investigators identified work, physical activity, and socialization as special needs for men that should be addressed. Raghavan, D., Gnm~y, R., and Lancaster, L`. Assessment of quality of life in long-tem~ survivors treated by first-line intravenous cisplatin for invasive bladder cancer. Progress in Clinical and Biological Research 260:625-63 1, 1988. Questionnaires were sent to 29 patients by mail. In addition to the LASA, Me investigators included mul~ple-choice questions on physical well-being, symptoms of Me disease, side effects of treatment, functional status, sexual function, social interaction, satisfaction win treatment, and overall quality of life. Although Me patients answered the multiple-choice questions readily, half of them were unable to use Me LASA scales correctly. The highest nonresponse rate was on Me LISA items related to sexual fimction. 10. Review Form for Breast Cancer Chemotherapy Questionnaire Name of Measure: Breast Cancer Chemotherapy Questionnaire (BCQ) Authors: Levme, M.N., Guyatt, G.H., Gent, M., De Pauw, S., Goodyear, M.D., H~niuk, W.M., Arnold, A., Flndlay, B., Skillings, J.R., Bramwell, V.H., et al. Primary Reference: Quality of life in stage I! breast cancer: An instrument for clinical teals. Joumal of Clinical Oncology 6~12~:1798-~10, 1988.

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ASSESSING QUALITY OF l]FE 109 Purpose: In planning their study, Me investigators decided Deco develop a new quesdonna~re to-measure the impact of adjuvant chemotherapy on physical, emotional, and social function of women wad stage ~ breast cancer. Conceptual Framework: The investigators reviewed We available meas- ures of quality of life for cancer patients' but these did not focus on me specific problems of women wad advanced breast cancer faced wad receiving adjuvant therapy. Their god was ~ develop a measure specific to me type of patient and me type of therapy. The items had to tap areas of physical, emotional, and social well-being that were important to me patient, quantifiable, valid, reproducible, responsive, simple, and conven- lent to use. The items were generated Trough a literature review and discussions wad medical oncolog~s~ts, oncology nurses, and stage ~ breast cancer padents. The original 150 items were pamd to 99, and 47 patients receiving adjuv ant chemotherapy were asked to rate me importance of these items on five-point Liken scales. The investigators grouped me items into me areas of consequences of hair loss, emotional dysfunction, physical symptoms, trouble and inconvenience associated USA treatment, fatigue, nausea, and positive weB-being. They furler decided Tat each area Could have a minimum of four items. The final 30 items were selected, by area, in teems of me highest mean ratings of importance. The women responded to items about how Hey had felt during He past two weeks on a sevens nt scale. Reliability: Stability: At each visit, He women were asked if their condition had changed dunng He past two weeks. On the first occasion that no change was reported, me investigators compared the current and last scores on me quality-of-life measures. The mean change scores and standard devia- tions were deemed stable and reliable, but they were not statishcaBy assessed. Scalability: The responses for each item had a score from ~ to 7, and He scores were summed across He 30 items. This score was later sfonned so Hat it ranged from 0 to 10. Validity: Content: The methods used for generating and selecting items assured the face and content validity of He items.

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110 J. I. WI1MAJ`S AND 5. WOOD-DAUPHINEE Construct: The first step was to average Me scores for aB visits for each patient The mean BCQ scores were correlated wad the average SCORES for prudent and physician global Wings and We Kamofsky, RAND emotional, RAND physical, and Spider quality-of-life measures. The correlations ranged from 0.41 to 0.62. An analysis of change scores for a single two-week period showed Nat We global physical and emotional assessments by me patients were more spongy correlated wad the qual- ity-of-life ratings than We global assessments by the physicians. Sensitivity: The women in We two Eminent groups had me same therapy during the first 12 weeks, and We mean scores for women in the two groups were equivalent. For one group the treatment continued for 36 weeks and We other group stopped treannent after 12 weeks. The BCQ and Ka~nofsky scores were significantly lower for We short-te~m group man the Midweek group between weeks 12 and 36. The RAND and Spitzer scores did not vary si~ficandy dunng this period. The scores converged again after 36 weeks, when aB women were off therapy. Practicality: The lime, 30 minutes an interview, and costs of having me forms a~nin~stered by a nursefinterviewer were considerable. The ~nves- tigators have recommended that a self-a~n~rustered version of the ques- tionna~re be tested. Application: In He trial, 418 women were assigned to either 12 weeks or 36 weeks of adjuvant therapy. A nursep~nterviewer administered me BCQ, He RAND Physical Health and Mental Heady Status queshon- natures, and the Spitzer Quality of Life Index. The physician completed the Kamofsky Index. Global ratings of physical and emotional function- ing were provided independency by the physician and He patients. The measures were completed at He beginning and me follow-up visits over a period of 80 weeks. The women stopped completing the measures when there was a recurrence of disease or they refused trea~nent. The patients averaged lO visits and completed approximately 85 percent of the poten- hal assessments. REFERENCES Anderson, J.P., Bush, J.W., and BeIry, C.C. Edemas consistency analy- sis: A method for studying He accuracy of function assessment for health outcome and quality of life evaluation. Joumal of Clinical Epidemiology 41(2):127-137, 1988.

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ASSESSING QUALITY OF LIFE 111 Andrews, F.M., and Witney, S.B. Social Indicators of WeB-Being: American Perspectives of Life Quality. New York, Plenum, 1976. Baum, M., PIiestman, T.~., West, R.R., and [ones, E.M. A compan son of subjective responses in a Dial comparing endocrine win cytotoxic treatment in Me advanced carcinoma of Me bmasL European Journal of Clinics Oncology (Supplement) 1:223-226, 1980. Bell, D.R., Tarmock, I.F., and Boyd, N.F. Quality of life measurement in breast cancer padents. British Journal of Cancer 51(4):577-580, 1985. Bergner, M., Bobbit, R.A., Carter, W.B., and Gilson, B.S. The Sickness Impact Profile: Development and final revision of a heath stems measure. Medical Care 19~8~:787-80S, 1981. Bohrnstedt, G.W. Measurement In Rossi, P.H., Wright, I.D., and Ander- son, A.B., eds. Handbook of Survey Research. New York' Academic Press, 1981. Campbell, A. The Sense of WeD-Being In America: Recent Pattems and Trends. New York, McGraw-HiL, 1980. Campbell, A., Converse, P.E., and Rodgers, W.~. The Quality of Ameri- can Life: Perceptions, Evaluations and Sadsfaccions. New York, RusseB Sage, 1976. Chubon, R.A. Qualitr of life measurement of persons with back prob- lems: Some preliminary findings. loumal of Applied Rehabilitation Counsehing 16:31-34, 1985. Chubon, R.A. Quality of life and persons win end-stage renal disease. Dialysis and Transplantation 15:45~452, 1986. Chubon, R.A. A quality of life racing scale. Evaluation and the Heath Professions 10:~86-200, 1987. Churchill, D.N., Torrance, G.W., Taylor, D.W., Bames, C.C., Ludwin, D., Shimizu, A., and Smith, E.K. Measurement of quality of life In end-stage renal disease: The time ~crade-off approach. Clinical and Investigative Medicine 10~1~:14-20, 1987. Coates, A., Dillenbeck, C.F., McNeil, D.R., Kaye, S.B., Sims, K., Fox, R.M., Woods, R.~., Milton, G.W., Solomon, ]., arid Tattersall, M.H. On the receiving end—II. Linear Analogue Self Assessment ROSA) in the evaluation of aspects of He quality of life of cancer padents receiving therapy. European Journal of Cancer arid Clinical Oncol- ogy 19~11~:1633-1637, 1983. Coates, A., Gebski, V., Bishop, Id., Jeal, PA., Woods, R.L"., Snyder, R., Tattersall, M.H., Byme, M., HaIvey, V., and Gill, G., for He Austra- lian-New Zealand Breast Cancer Tnals Group, Clinical Oncology Society of Australia Improving the quality of life during chemo~er- apy for advanced breast cancer. A comparison of intermittent md

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112 J. 1. WII1"IAMS AND S. WOOD-DAUPHINEE continuous treatment strategies. New England Joumal of Medicine 317(24):1490-1495, 1987. Cronbach, L.~. Coefficient alpha and me intemal structure of tests. Psychometrika 22:293-296, 1951. Croog, S.H., Levine, S., Testa, M.A., Brown, B., Bulpitt, Cal., Jenkins, C.D., Klerman, G.~., and Williams, G.H. The effects of andhy- per~nsive therapy on Me quality of life. New England Journal of Medicine 314(26):1657-1664, 1986. Drummond, M.F., Stoddart, G.~., md Torrance, G.W. Me~ods for Me Economic Evaluation of Health Care Programmes. London, Oxford University Press, 1986. Erickson, P., ed. Bibliography on Health Indexes, Clearinghouse on Health Indexes, National Center for Heath Statistics, HyattsvilBe, Maryland. Feinstein, A.R. ClinImetrics. New Haven, Yale University Press, 1987. Ferns, C.E., and Powers, My. Quality of Life Apex: Development and psychometric properties. Advances in Nursing Science 8~:~-24, 1985. Finkelstein, D.M., Cassileth, B.R., Bonomi, P.D., Horton, I., Ez~inli, E.Z., Carbone, P.P., and Wolter, I.N. A pilot study of the Functional Living Index—Cancer (E;LIC) Scale for the assessment of quality of life for metastatic lung cancer patients. American loum~ of Clinical Oncology 2~6~:630-633, 1988. FIeiss, J.~. Stadshcal Me~ods for Rates and Proportions. 2nd ed. New York, John Wiley & Sons, 1981. FIeiss, Ids. The Design and Analysis of Clinical Experiments. New York, John Wiley & Sons, 1986. Fletcher, R.H., Fletcher, S.W., and Wagner, E.H. Clinical Epidemiology: The Essentials. 2nd ed. Baltimore, Williams and Wilkins, 1988. Ganz, P.A., HaskeH, C.M., Figlin, R.A., La Soto, N., and Siau, I. Estimat- ing the quality of life in a clinical trial of patients with metastatic lung cancer using He Ka~nofsky performance status and He Functional Living Index—Cancer. Cancer 61~4~:849-856, 1988. Cough, I.R., Funeral, C.M., Schilder, L., and Grove, W. Assessment of the quality of life of patients win advanced cancer. European Joumal of Cancer and CI~n~cal Oncology 19~:~161-~165, 1983. Grieco, A., and Long, C.J. Investigation of He Kamofsky Performance Status as a measure of quality of life. Health Psychology 3(2):129- 142, 1984. Holloway, C.A. Decision Making Under Uncertainty: Models and Choices. Englewood Cliffs, New Jersey, Prentice-Hall, Inc., 1979.

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ASSESSING QUAld7Y OF llFE 113 Hutchinson, T.A., Boyd, N.F., Weinstein, A.R, in collaboration win Gonda, A., Hollomby, D., and Rowat B. Scientific problems in clinical scales, as demons~ed In He Karnofsky Index of Perfor- mance Stams. loumal of Chronic Diseases 32~9-10~:661-666, 1979. Kane, R.A., and Kane, Rip. Assessing He Elderly: A Practical Guide to Measurement. Lexington, Massachusetts, D.C. Heap and Company, 1981. Kaplan, R.M., and Bush, I.W. Heal~-related quality of life measurement for evaluation research and policy analysis. Heals Psychology 1:61- 80, 1982. Kaplan, R.M., Adcins, C.J.' and T~mms, R. Validity of a quality of well- being scale as an outcome measure In chronic obst~uc~ve pulmonary disease. Joumal of Chronic Diseases 37~2~:85-95, 1984. Karnofsky, D.A., and Burchem~, I.H. The clinical evaluation of che- motherapeutic agents in cancer. In MacLeod, C.M., ed. Evaluation of Chemotherapeutic Agents in Cancer. New York, Columbia Un~- versityPress, 191-205, 1949. Kerlinger, F.N. Foundations of Behavioral Research. 3rd ed. New York, Holt, Rinehart, and Winston, 1986. Lanham, R.~., and DiGiannanton~o, A.F. Quality-of-life of cancer pa- tients. Oncology 45~11:~-7, 1988. Last, J.M. ed. Dictionary of Epidemiology. 2nd ed. New York, Oxford University Press, 1988. Levine, M.N., Guyatt, G.H., Gent, M., De Pauw, S., Goodyear, M.D., H~yniuk, W.M., Arnold, A., Findlay, B., Skillings, I.R., Bramwell, V.H., et al. Quality of life in stage II breast cancer. An instrument for clinical trials. loumal of Clinical Oncology 6~12~:1798-1810, 1988. McDowell, I., and NeweE, C. Measunng Heals: A Guide to Rating Scales and Questionnaires. New York, Oxford University Press, Inc., 1987. Mor, V. Cancer patients quality of life over He disease course: Lessons from He real world. Joumal of Ch~n~c Diseases 40~6~:S35-544, 1987. Mor, V., Laliberte, L., Moms, ].N., and Wiemann, M. The Kamofsky Performance Status Scale. An examination of its reliability and validity in a research setting. Cancer53~9~:2002-2007, 1984. Morris, J.N., Suissa, S., Sherwood, S., Wright S.M., and Greer, D. Least days: A study of me quality of life of terminally ill cancer patients. loumal of Chronic Diseases 39~:47-62, 1986. NunnaBy, J.C. Psychometric Theo~. 2nd ed. New York, McGraw-Hi0, 1978.

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114 ]. I. ARMS AD S. WOOD-DAUPHINEE PadiDa, G.V., and Grant, M.M.. Quality of life as a cancer nursing out- come variable. Advances In Nursing Science 8~11:45-60, 1985. PadiDa, G.V., Presant, C., Grant, M.M., Metter, G., Lipsett, I., and Heide, F. Quality of life index for patients win cancer. Research in Nursing and Heady 6(3):117-126, 1983. Presant, C.A., Klahr, C., and Hogan, L. Evaluating quality-of-life in oncology patients: Pilot observations. Oncology Nursing Forum 8(3):26-30, 1981. Priesunan, At., and Ballm, M. Evaluation of quality of life in patients receiving treatment for advanced breast cancer. Lancer 1(7965):899- 900, 1976. Raghavan, D., Grundy, R., and Lancaster, L. Assessment of quality of life in long-term survivors treated by first-line intravenous cispladn for invasive bladder cancer. Progress in Clinical and Biological Research 260:625-63 1, 1988. Schag, C.C., Heinnch, R.L., and Ganz, P.A. Kan~ofsly performance status revisited: Reliability, validity, and guidelines. Journal of Clinical Oncology 2~3~:~87-193, 1984. Schipper, H., Clinch, I., McMurray, A., and Levitt, M. Measuling the quality of life of cancer patients: The Functional Living Index Cancer: Development and validation. Journal of Clinical Oncology 2~5~:472483, 1984. Schuessler, K.F., and Fisher, G.A. Quality of life research and sociology. Annual Review of Sociology 11: 129-149, 1985. Selby, P.J., Chapman, J.A., Et~adi-Amoli, J., Dalley, D., and Boyd, N.F. The development of a method for assessing the quality of life of cancer patients. BntishioumalofCancerS0~:13-22, 1984. Smith, G.T., ed. Measunng Heady: Practical Approach. New York, John Wiley & Sons, 1988. Spitzer, W.O. State of science 1986: Quality of life and functional status as target vanables for research. Journal of Chronic Diseases 40~6~:465- 471, 1987. Spitzer, W.O., Dobson, A.J., Hall, J. Chestemlan, E., Levi, J., Shepherd, R., Banista, R.N., and Catchlove, B.R. Measunng the quality of life of cancer padents. A concise QL-index for use by physicians. Jour- nal of Chronic Diseases 34~12~:585-597, 1981. Torrance, G.W. Measurement of heath state utilities for economic am praisal: A review. Joumal of Health Economics 3:1-30, 1986. Torrance, G.W. Utility approach to measuring heal~-related quality of life. Journal of Chronic Diseases 40(6):593-603, 1987.

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ASSESSING QUAL177' OF L]FE 115 Torrance, G.W., Thomas, W.H., and Sackett, D.~. A utility max~mizabon mode] for the evaluation of heady care programs. Heady Services Research 7~2~:~-133, 1972. Torrance, G.W., Boyle, M.H., and Horwood, S.P. Application of multiat- tnbute utility theory to measure social preferences for heady states. Operations Research 30:1043-1069, 1982. van Neumann, I., and Morgenstem, O. Theory of Games and Economic Behavior. 3rd ed. New York, John Wiley ~ Sons, 1953. Ware, JE., Ir. Standards for validating health measures: Definition and content. Journal of Chronic Diseases 40~6~:473480, 1987. Ware, lE., Ir. Scales for measuring general heady perceptions. Heath Services Research I1~14~:396415, 1976. We~nste~n, M.C. Economic assessments of medical practices and tech- nolog~es. Medical Decision Making 1:309-330, 1983. Wenger, N.K., Mauson, M.E., Furberg, C.D., and Elinson, I., eds. Assess- ment of Quality of Life in CI~n~cal Trials of Cardiovascular Thera- pies. New York, Le lacq Publishing, Inc., 1984. Yates, J.W., Chalmer, B., and McKegney, F.P. Evaluation of patients win advanced cancer using the Kamof~y perfonnance status. Can- cer45~:222~2224, 1980. ZeBer, R.A., and Carmines, E.G. Measurement in He Social Sciences. London, Cambridge University Press, 1980.