Quality of Life and Symptom Measures in Oncology: An Overview€¦ · (QOL) has gained tremendous...

S560 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

In the past decade, quality of life(QOL) has gained tremendous impor-tance in oncology.1-5 Survival as a sole

end point of treatment evaluation is nolonger sufficient; QOL is also a vital out-come for cancer patients. Measuring QOLin a valid, reliable way presents a signifi-cant challenge because of the lack of con-sensus on how QOL is defined.6-8

Numerous QOL and symptom assessmenttools exist to capture such information,although the potential of these tools inthe managed care setting is not fully real-ized.9-14 This article is intended to clarifythe definition of QOL; review commonlyused measures in oncology; summarizethe potential uses of these measures invarious settings, including managed care;and address some challenges encounteredin measuring QOL.

Quality of Life Defined

In 1948, the World Health Organizationdefined health as not only the absence ofdisease or illness, but also the presence ofphysical, mental, and social well-being.15

Following that lead, today’s concept ofQOL encompasses the effect of an illnesson a patient’s physical, psychological, andsocial well-being as perceived by thatpatient. An individual’s general QOL isaffected by many factors in addition tothose that are health-related, such asfinancial status, job satisfaction, and livingconditions. When put into a health con-text as the duration or severity of morbid-ity accumulates, these factors influenceQOL, and are often referred to as health-related QOL. For patients who areextremely ill, the illness can be all-con-suming to the point where QOL is syn-onymous with health-related QOL.2 Whena minor health condition interferes withan individual’s functioning for a few daysor weeks, QOL is not perceived to beaffected very much by health status.Therefore, measuring health-related QOL

AbstractImproving quality of life (QOL) in oncology

patients is an important therapeutic goal, and mosttreatment decisions are heavily influenced by theireffect on QOL. Although measuring QOL has beena significant challenge because of a lack of con-sensus on the definition of QOL, research in thisfield has advanced rapidly. Numerous instrumentsnow exist for measuring QOL and symptom bur-den, ranging from general health status measuresto considerably more focused symptom measures.QOL measures have been routinely incorporatedin clinical trials, and their use in clinical settings isstrongly encouraged because their value in cancerpatient management is now established. Thesemeasures also have a potential impact in the man-aged care environment because they provideinformation on patient satisfaction and quality ofcare provided. This article clarifies the definitionof QOL, provides a brief overview of several use-ful measurement instruments, and addresses somecommon concerns encountered in measuringQOL in cancer patients. In addition, potentialuses of such measures are explored and theirvalue in various settings, including managed care,is highlighted.

(Am J Manag Care. 2002;8:S560-S573)

Quality of Life and Symptom Measures in Oncology: An Overview

Mehul K. Soni, PharmD; and David Cella, PhD

. . . REPORTS . . .

is most relevant when health is expectedto exert significant impact on daily func-tioning and well-being.

Measuring QOL in Cancer Patients

QOL is a well-accepted outcome mea-sure for cancer patients in clinical trials.Many instruments have been developed tocapture important QOL issues to assessimpact of treatments on patient well-beingand improve patient care. QOL instru-ments measure various aspects of QOLand commonly include physical, psycho-logical, and social domains. These domainsare subdivided into a number of questions,referred to as items.

QOL measurement instruments avail-able today range from generic to generalcancer-specific to site-specific symptommeasures (Table 1). Generic instruments,such as the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)assess broad concerns related to variousdomains of QOL.16-18 General cancer-spe-cific measures focus on broad, yet clini-cally relevant, issues and a fewsymptoms. Hundreds of instruments areavailable to measure QOL for cancerpatients, although a few of these are usedquite often. Examples of general cancer-specific measures include the EuropeanOrganization for Research and Treatmentof Cancer Quality of Life Questionnaire“Core” 30-Items (EORTC-QLQ-C30)19,20

and the Functional Assessment of CancerTherapy-General Scale (FACT-G).21 Both,the EORTC-QLQ-C30 and FACT-G meas-urement systems offer a modularapproach, which entails a general corequestionnaire to assess overall QOL andis supplemented by a site-specific symp-tom module or subscale to address addi-tional concerns specific to that cancerpopulation. Site-specific symptom meas-ures include, for example, breast can-cer, lung cancer, and colorectal cancersupplements that specifically focus onsymptoms patients with these types ofcancers commonly experience. Usefulgeneral cancer-specific and site-specif-ic symptom measures are briefly dis-cussed below.

QOL and Symptom Measures in Oncology

Generic QOL Instruments. The SF-36is a 36-item, widely used generic healthquestionnaire (Table 2).16-18 It measures 8QOL dimensions: physical functioning,social functioning, role limitations dueto physical problems, role limitationsdue to emotional problems, vitality,bodily pain, emotional health, and gen-eral health. In addition to the 8 dimen-sion score, 2 higher-order summaryscores, Physical Component Summaryand Mental Component Summary, canalso be calculated to assist in comparison.Higher scores on the SF-36 indicateimproved QOL. The SF-36 is extensivelyvalidated and is widely used in variousoutpatient settings to measure functionalstatus.22

The Sickness Impact Profile (SIP) is a136-item, generic health status measurethat evaluates impact of disease on physi-cal and emotional functioning.23,24 SIPmeasures physical and psychosocialdomains as everyday activities in 12categories: sleep and rest, emotionalbehavior, body care and movement, homemanagement, mobility, social interaction,ambulation, alertness behavior, communi-cation, work, recreation and pastimes,and eating. Responses are dichotomous(yes/no), and scoring is based on the num-ber and type of items given higher scores,which represent greater dysfunction. Thevalidity, reliability, and responsiveness ofSIP have been established in a healthypopulation as well as in cancer patients.25

General Cancer-Specific QOL Instru-ments. Questionnaires that were original-ly developed or validated using cancerpatients are often referred to as cancer-specific, distinguishing them from themore general health status assessment ofinstruments such as the SF-36 or SIP.However, many of these cancer-specificquestionnaires are multidimensional andhave more recently been validated in pop-ulations other than cancer patients. Thus,they may more accurately be consideredgeneral chronic illness questionnaires.Some examples follow.

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Table 1. Selected Quality of Life Questionnaire/Symptom Measures Useful in Oncology

Population QOL Dimensions Item Format Comments

Generic Health Status Measures Medical Outcomes Study General illness Physical, emotional, 36 items; • Widely used36-Item Short-Form Health Survey functional, social, Likert-type/ • 8 subscale scores and(SF-36) general health dichotomous 2 underlying dimensions

(physical and mental health) useful for group comparison

• Higher scores indicate improved QOL

Sickness Impact Profile (SIP) General illness Physical, emotional, 136 items; • Provides a descriptivefunctional, family/social dichotomous profile of changes in a

person’s behavior associated with sickness

• Higher scores indicate greater dysfunction

Cancer-Specific QOL QuestionnairesEuropean Organization for Research General cancer Physical, functional, 30 items; • Widely usedand Treatment of Cancer Quality of cognitive, social, Likert-type/ • Modular approachLife Questionnaire “Core” 30-Items emotional, global dichotomous supplemented by site-(EORTC-QLQ-C30) rating specific modules

• Higher global scale scoresand lower symptom scores indicate better functioning and lower symptom distress

Functional Assessment of Cancer General cancer Physical, functional 27 items; • Widely usedTherapy-General Scale (FACT-G) family, emotional, Likert-type • Modular approach supple-

social, global rating mented by site-specific orsymptom-specific subscales

• Higher scores indicateimproved QOL

Cancer Rehabilitation Evaluation General cancer Physical, psychosocial, 139 items; • ComprehensiveSystem (CARES) marital, medical inter- Likert-type • Focuses on important

action, sexual clinical issues amenableto rehabilitation

• Useful in generating complete problem list

• Higher scores indicate greater symptom distressand worsening QOL

Functional Living Index-Cancer General cancer Physical, social, 22 items; • Provides a single score for(FLIC) mental, general health Likert-type/ comparison

analog • Useful in outpatient settings• Higher total scores indicate

improved QOL

Southwestern Oncology Group General cancer Physical, emotional, Categorical • Combines items from SF-36Quality of Life Questionnaire social, symptoms, and SDS

global rating • Modular approachsupplemented by site-specific modules (colonand prostate)

(Continued)



Table 1. Selected Quality of Life Questionnaire/Symptom Measures Useful in Oncology (continued)

Population QOL Dimensions Item Format Comments

Symptom-Specific Scales European Organization for Research Symptom measure Site-specific symptoms Likert-type • For use with EORTC-QLQ-and Treatment of Cancer Quality of C30 core questionnaireLife Questionnaire—Site-Specific • 5 site-specific gabscales (eg,Modules breast, lung, ovarian)

• Validation of other modulesunder way

Functional Assessment of Cancer Symptom measure Site-specific symptoms Likert-type • For use with FACT-GTherapy—Site-Specific Subscales Scale

• 12 cancer site-specificsubscales (eg, breast, lung,prostate)

• 4 treatment-specific subscales (eg, taxanes, bonemarrow transplant)

• 8 symptom-specific subscales(eg, anorexia/cachexia,diarrhea, fatigue)

Symptom Distress Scale (SDS) Symptom measure 11 symptoms (nausea, 13 items; • Designed as a generalappetite, insomnia, Likert-type cancer measure to controlpain, fatigue, outlook, symptom distressbowel pattern, concen- • Useful in identifyingtration, appearance, symptom affecting QOL cough, breathing) • Higher scores indicate

geater symptom distress

QOL indicates quality of life.

Table 2. Physical Functioning Scale of the Medical Outcomes Study 36-Item Short-Form HealthSurvey (SF-36)

The following items are about activities you might do during Yes, Yes, No,a typical day. Does your health now limit you in these activities? Limited Limited Not LimitedIf so, how much? (Mark one circle on each line.) A Lot A Little At All

Vigorous activities, such as running, lifting heavy objects, ❍ ❍ ❍

participating in strenuous sports.

Moderate activities, such as moving a table, pushing a vacuum ❍ ❍ ❍

cleaner, bowling, or playing golf.

Lifting or carrying groceries. ❍ ❍ ❍

Climbing several flights of stairs. ❍ ❍ ❍

Climbing one flight of stairs. ❍ ❍ ❍

Bending, kneeling, or stooping. ❍ ❍ ❍

Walking more than a mile. ❍ ❍ ❍

Walking several blocks. ❍ ❍ ❍

Walking one block. ❍ ❍ ❍

Bathing or dressing yourself. ❍ ❍ ❍

Source: References 16, 17, 18. Reprinted with permission from QualityMetric Incorporated. SF-36® Health Survey ©1988,2002 by Medical Outcomes Trust and Quality Metric Incorporated. All rights reserved.SF-36® is a registered trademark of the Medical Outcomes Trust.


REPORTS

The EORTC-QLQ-C30 is a general 30-item questionnaire (Table 3).19,20 Thisinstrument, specifically designed for can-cer patients, evaluates 5 QOL domains(physical, role, cognitive, emotional, andsocial), several symptoms (fatigue, pain,nausea and vomiting, dyspnea, sleep distur-bance, appetite, constipation, and diar-rhea), and global health/QOL. All questionsdealing with functional scales and symp-tom domains are rated on a 4-point Likert-type scale ranging from ‘not at all’ to ‘verymuch,’ and the global scale is a numerical7-point Likert-type scale representing acontinuum from ‘very poor’ to ‘excellent.’High functioning and global scale scoresand low symptom scores reflect betterfunctioning and lower symptom distress,respectively. EORTC-QLQ-C30 has demon-strated good reliability and validity in var-ious large, international cancer populationsand is available in many other languages.26

The FACT-G is a 27-item self-reportinstrument designed to measure QOL forall cancer patients (Table 4).21 The corequestionnaire evaluates 4 QOL domains:physical, social/family, emotional, andfunctional. Response categories for all

items of FACT-G range from 0 (not at all)to 4 (very much). Higher scores are asso-ciated with increased satisfaction withQOL. FACT-G is tested and validated inlarge, international patient samples and isavailable in many languages.27-33

The Functional Living Index–Cancer(FLIC) is a 22-item, self-reported generalcancer QOL questionnaire.34 Dimensionsof QOL assessed by FLIC include physicalrole, and social, mental, and generalhealth perceptions, as well as measure-ment of some symptoms, such as painand nausea. Responses are measured ona linear scale with 7 equidistant marksranging from 1 (not at all) to 7 (a greatdeal). Subscale scores are derived for7 domains: role, sociability, emotional,current health, hardship, nausea, andpain, with higher total score representingbetter QOL. The validity and reliability ofFLIC is established in various cancerpopulations.34-41

The Cancer Rehabilitation EvaluationSystem (CARES) is a relatively longer,more comprehensive, self-administered139-item cancer-specific questionnaire.42

It measures 5 domains of QOL: physical,

Table 3. Sample Questions From the European Organization for Research and Treatmentof Cancer Quality of Life Questionnaire “Core” 30-Item Survey (EORTC-QLQ-C30)

Not A Quite VeryDuring the past week: At All Little A Bit Much

Were you limited in doing either your work 1 2 3 4or other daily activities?

Were you limited in pursuing your hobbies 1 2 3 4or other leisure time activities?

Were you short of breath? 1 2 3 4

Have you had pain? 1 2 3 4

Did you need to rest? 1 2 3 4

Have you had trouble sleeping? 1 2 3 4

Have you felt weak? 1 2 3 4

Have you lacked appetite? 1 2 3 4

Have you felt nauseated? 1 2 3 4

Have you vomited? 1 2 3 4

Source: References 19, 20. Reprinted with permission from EORTC Quality of Life Group.

psychosocial, marital, medical interac-tion, and sexual. All items are measuredon a 4-point Likert-type scale rangingfrom 0 (not at all/no problem) to 4 (verymuch/severe problem), with a higher totalscore representing greater symptom dis-tress and lower QOL. The CARES is avaluable tool, especially in cancer rehabil-itation settings, to generate a completepatient problem list.43,44

At times, some organizations such asthe Southwest Oncology Group (SWOG)use a battery approach to measuring QOL.This entails selecting brief instruments orsets of questions to address specific conceptsof interest in a given clinical trial or clinicalapplication study. The SWOG Quality of LifeQuestionnaire is an example of a cancer-specific QOL assessment that separatelymeasures physical, emotional, and socialfunctioning, symptoms, and global QOL.45

The physical, emotional, and social func-tioning are measured using items from theSF-36 questionnaire. It measures itemsadapted from the Symptom Distress Scale(SDS) to assess general symptoms com-mon to all types of cancer, such as nausea,appetite, insomnia, and pain, as well asother treatment-specific symptoms, whichdepends on the nature of the protocol, ona 5-point response categorical scale. Itincludes a 31-item, global QOL question-naire that is scored on 5-point categoriesscale ranging from extremely unpleasant

to normal (no change). Three additionalitems are added to measure the effect ofcomorbid conditions. Such an approachinvolving custom tailoring QOL measuresto meet the needs of the cancer popula-tion have been used for example inSWOG prostate cancer trials.46-48

Symptom-Specific Measures. Site-spe-cific modules available for EORTC-QLQ-C30 include breast,49 head and neck,50-52

oesophageal,53 ovarian,54 and lung55 can-cers. These modules specifically focus oncommonly experienced site-specific symp-toms. For example, the EORTC-QLQ-LungCancer 13-item (LC13), shown in Table 5A,is a module supplementing the C30 corequestionnaire designed to assess impact oftreatment on symptoms specifically rele-vant to lung cancer patients. The responsesin the LC13 are measured on a 4-pointLikert-type scale ranging from “not at all”to “very much.”55 The last item dealingwith pain medication has dichotomousresponse categories (yes/no). Higher symp-tom scores represent increased symptomdistress.

Site-specific subscales available forFACT-G include breast,56 bone marrowtransplant,31 brain,33 colorectal,57 cervical,head and neck,58 lung,27 (Table 5B), ovar-ian,59 and prostate60 cancers. These sub-scales are generally added to the corequestionnaire, resulting in a composite



Table 4. Emotional Well-Being Subscale of the Functional Assessment of Cancer Therapy-General Scale (Fact-G)

Not A Little Quite VeryEmotional Well-Being: At All Bit Somewhat a Bit Much

I feel sad 0 1 2 3 4

I am satisfied with how I am coping with my illness 0 1 2 3 4

I am losing hope in the fight against my illness 0 1 2 3 4

I feel nervous 0 1 2 3 4

I worry about dying 0 1 2 3 4

I worry that my condition will get worse 0 1 2 3 4

Source: Reprinted with permission from DF Cella.21


REPORTS

Table 5A. European Organization for Research and Treatment of Cancer Quality of LifeQuesstionnaire—Lung Cancer 13-Item Module (EORTC-QLQ-LC13)

Not A Quite VeryDuring the past week: At All Little A Bit Much

How much did you cough? 1 2 3 4

Did you cough up blood? 1 2 3 4

Were you short of breath when you rested? 1 2 3 4

Were you short of breath when you walked? 1 2 3 4

Were you short of breath when you climbed stairs? 1 2 3 4

Have you had a sore mouth or tongue? 1 2 3 4

Have you had trouble swallowing? 1 2 3 4

Have you had tingling hands or feet? 1 2 3 4

Have you had hair loss? 1 2 3 4

Have you had pain in your chest? 1 2 3 4

Have you had pain in your arm or shoulder? 1 2 3 4

Have you had pain in other parts of your body? 1 2 3 4

If yes, where _________________________________

Did you take any medicine for pain?

1. No 2. Yes

If yes, how much did it help? 1 2 3 4

Source: Reference 55.

Table 5B. Lung Cancer-Specific Items From Functional Assessment of Cancer Therapy-Lung (FACT-L)

Not A Little Quite VeryAdditional Concerns: At All Bit Somewhat a Bit Much

I have been short of breath 0 1 2 3 4

I am losing weight 0 1 2 3 4

My thinking is clear 0 1 2 3 4

I have been coughing 0 1 2 3 4

I am bothered by hair loss 0 1 2 3 4

I have a good appetite 0 1 2 3 4

I feel tightness in my chest 0 1 2 3 4

Breathing is easy for me 0 1 2 3 4

Have you ever smoked?No _______ Yes _______ If yes:

I regret my smoking 0 1 2 3 4




general and site-specific QOL measure.For example, 9 lung cancer-specific items(LCS) are added to FACT-G, resulting in a36-item questionnaire referred to asFACT-Lung.27 Symptoms covered by thelung cancer module include dyspnea,weight loss, clarity of thinking, cough, hairloss, appetite, tightness in chest, breathingdifficulty, and an optional “regret fromsmoking” item. Similar to FACT-G, itemson LCS are measured on a 4-point Likert-type scale ranging from “not at all” to“very much,” with higher scores repre-senting lesser symptom distress.

The SDS is a 13-item self-reportedsymptom measure that was developed foruse with cancer patients (Figure).61 Itassesses the severity level of 11 commoncancer symptoms, including nausea,

appetite, insomnia, pain, fatigue, bowelpattern, concentration, appearance, out-look, breathing, cough, and frequency ofnausea and pain. Higher score on the SDSindicate greater or more frequent symp-tom distress. The SDS has been extensive-ly validated in various cancer populationsand is a commonly used symptom distressmeasure.

Measurement Issues CommonlyEncountered in QOL Research

If collected properly, QOL data can beuseful. Important issues in collecting thisdata include using appropriate tools,deriving assessments in a timely manner,and producing results that are easilyinterpreted. Researchers and clinicianshave raised several issues that should

Figure. Sample Items From the Symptom Distress Scale (SDS)

Nausea (1)

1I seldom if ever

have nausea

2I have nausea

once in a while

3I have nauseafairly often

4I have nausea

half the time at least

5I have nauseacontinually

Nausea (2)

1When I do have

nausea, it is very mild

2When I do have nausea, it is mildly

distressing

3When I have nausea, I feelpretty sick

4When I have

nausea, I usuallyfeel very sick

5When I have

nausea, I am as sick as I could possibly be

Appetite

1I have my normal appetite and enjoy

good food

2My appetite is

usually, but not always,pretty good

3I don't really

enjoy my food

4I have to force myself

to eat my food

5I cannot stand thethought of food

Insomnia1

I sleep as well asI always have

2I occasionally have

trouble getting to sleepand staying asleep

3I frequently have trouble

getting to sleep

4I have difficulty getting to sleep and staying asleep

almost every night

5It is almost impossible

for me to get a decent night's sleep

Pain (1)1

I almost neverhave pain

2I have pain

once in a while

3I have pain

several times a week

4I am usually in

some degree of pain

5I am in some degree

of pain almostconstantly

Pain (2)1

When I do have pain, it is very mild

2When I do have pain, it is mildly distressing

3When I do have pain, it is usually fairly intense

4The pain I haveis very intense

5The pain I have

is almost unbearable



REPORTS

be addressed before QOL data collec-tion.11,62-65 These issues are summarized inTable 6.

Measurements of QOL to be used fordata collection must be suitable for theintended purpose. Because general mea-sures focus on broader QOL issues, theylack sensitivity to specific changes in theimpact of cancer for individual patients.Therefore, such measures allow for groupcomparisons as well as help assess overallimpact of disease and treatment on QOL.Disease-specific tools focus on detailedsymptom assessment and are responsiveto changes in important concerns relevantto the patient group being studied,although these measures do not easilyallow for comparisons between groups.Neither approach has been proved superi-or to the other. A more complete approachis to combine both types of measures tocapture overall QOL of patients withoutcompromising the sensitivity to changesin disease-specific issues. A modularapproach, which utilizes a generic corequestionnaire assessing broader QOL con-cepts and is supplemented with shorterdisease-specific and symptom-specificmeasures, has become more practical.Such a system allows researchers toensure that all QOL domains that couldpotentially be impacted by an interven-tion are measured along with any changesin disease-specific symptoms.

QOL should be measured at appropri-ate time intervals and with appropriatefrequency to capture necessary changes.Symptom-specific measures are short andcan be helpful in frequently tracking theshort-term, such as weekly, changes in

QOL related to acute adverse effects ofchemotherapy or radiation. Site-specificquestionnaires are moderate in length andcould be given less frequently, perhapsmonthly, than symptom measures to trackbroader QOL issues pertaining to the dis-ease and the treatment. Longer, generalcancer-specific instruments may be moreappropriate for quarterly assessment ofoverall QOL in a treated population.

QOL measurement generates massiveamounts of data. Combining or presentinga large dataset in a concise, interpretableway can be difficult. Therefore, QOL toolsshould allow for easy interpretation andcomparison of data. For example, theFACT-G measurement system allows forcombining physical and functional statusscores with their respective supplementalsymptom measures to derive TrialOutcome Index (TOI), a single scoremeasure that can be useful in comparingoverall physical well-being and symptomstatus, which can be useful in comparing2 treatment modalities in a clinicaltrial.27

Interpreting the difference in QOLscores can be difficult. Identifying a mini-mum clinically important difference(MCID), which is a change in score thataffects a treatment decision, is important.A few QOL instruments have an estimatedand validated MCID. For example, theMCID for FACT-G has been shown to beabout 5 to 6 points in cancer patients invarious stages.66 MCID for the LCS and theTOI has been validated in advancednon–small-cell lung cancer and is reportedto be 2 to 3 points and 5 to 6 points,respectively.28 Identifying a meaningfulchange in score can play a role in doseadjustment and treatment modification.Studies are under way to establish MCIDfor other general cancer-specific as well assite-specific symptom measures.

How the Scales Have Been Used in Various Settings

QOL questionnaire and symptommeasure scores are subjective measuresperformed by the patients themselves andare a useful patient-reported outcome inresearch, clinical trials, clinical practice,

Table 6. Important Concerns Encountered inQuality of Life Measurement

1. Selection of an appropriate tool

2. Frequency and timing of measurement

3. Ease of data interpretation and comparison

4. Identifying the minimum clinically important difference


and managed care. Their uses range frompatient-focused, such as understandinghow patients value QOL and identifyingimportant QOL issues in cancer patients,to organization-focused, such as improv-ing patient management within a physi-cian group practice and managed careorganization (MCO). These uses arebriefly summarized in Table 7.

QOL Research. QOL and symptommeasures have been extensively studied inresearch trials for validation purposes andto evaluate the impact of cancer or a treat-ment on QOL of patients. Instruments havebeen tested in patients with various typesof cancer to establish their reproducibility,validity, responsiveness, and interpretabili-ty. Such research provides insight into howQOL is valued and reported by patients.QOL questionnaires are continuouslyrefined to reduce patient burden, to bemore user-friendly, and to enhance theirapplication in clinical settings.

Clinical Trials. QOL instruments havebeen used in clinical trials to understandimportant QOL issues in cross-sectionalas well as longitudinal assessment ofgroups. Comparisons of QOL and symp-tom measure scores between a diseasedpopulation and a healthy population couldprovide insight into areas of concern ofthe diseased population. Such compar-isons could be valuable in understandingthe QOL impact profile of a disease andhelp predict utilization of other medicalservices within the healthcare system. Forexample, QOL assessments in advancedlung cancer patients have revealed thatpsychological and emotional issues arehighly prevalent in this population, oftenrequiring referral to psychotherapists forappropriate management of such issues.67

With QOL becoming an important endpoint of evaluation, it is increasinglymeasured in clinical trials. Cross-sectionaland longitudinal QOL score comparisonsbetween a new treatment group and acomparator group help investigators bet-ter understand the impact of a novel treat-ment on patient well-being. Suchcomparisons are valuable, and often nec-

essary, if a new treatment offers survivalbenefits at the expense of adverse effecton patient QOL. Longitudinal QOL datacomparisons may help clinicians betterexplain the long-term consequences ofplacing patients on such a treatment aswell as help patients make informed treat-ment decisions.

QOL and patient-reported symptomshave, in part, contributed to approval ofnew anti-cancer agents. Both quality, aswell as quantity, of life provide a moredetailed picture of how a novel agent willaffect a cancer patient. The Food and DrugAdministration increasingly demands QOLdata as a measure of treatment efficacyalong with traditional survival benefits.For example, gemcitabine for patientswith pancreatic carcinoma refractory tofluorouracil68-69 and mitoxantrone for


Table 7. Use of Quality of Life Questionnaires and SymptomMeasures in Various Settings

Quality of Life Research Establish validity, reliability, and responsive-ness of an instrument

Better understand how patients report andvalue quality of life

Clinical Trials Identify quality of life issues in a diseasepopulation

Identify quality of life associated with a newtreatment

Contribute to approval of a new treatment

Clinical Practice Identify quality of life concerns from apatient’s perspective

Help focus physician-patient interaction onconcerns important to the patients

Assist in treatment decision-making

Help predict morbidity and mortality

Managed Care Identify strengths and areas of improvementOrganizations within a clinical pathway

Improve quality of care and patient satisfac-tion within a practice setting

Assist in formulary decisions

Evaluate physician performance

Identify strengths and opportunities for academic detailing of physicians

Assist employers in MCO contract decisions


hormone-refractory prostate cancer70

were approved in part because of theireffect on improvement of disease-relatedsymptoms.

Clinical Practice. QOL and symptommeasures have been shown to be useful inclinical practice. QOL tools may help cli-nicians better understand patient con-cerns. Physicians, nurses, and familymembers often underestimate the QOLimpact on the patients and are poor prox-ies for such evaluations.71 Symptom mea-sures can help clinicians understand theprevalence and severity of symptoms andtheir impact on QOL from the patient’sperspective. Such tools may help improvecommunication between the clinician andthe patient.72,73 A systematic QOL andsymptom evaluation increases the proba-bility of covering more areas of patientconcern. Pilot studies evaluating the use-fulness of computerized QOL assessmentsperformed in the physician’s waiting roombefore seeing the physician have shownthat such tools can concisely summarizeimportant patient concerns and help clini-cians explore these issues in depth duringthe visit. The conversation between physi-cians and patients can be directed to focuson important QOL issues, making thephysician-patient interaction more mean-ingful for both parties.

QOL and symptom measure data havebeen useful in treatment decision-mak-ing.74-76 These measures allow physiciansto track the prevalence and severity of dis-ease-related as well as treatment-relatedsymptoms. Together with other clinicaldata, such as tumor size and presence ofmetastases, QOL data can help physiciansdecide when to modify dosage or switch toless toxic agents and when to treatadvanced cancer patients with palliativerather than curative intent.

QOL and symptom measures may helppredict patient survival.77-79 Worsening ofQOL despite appropriate and aggressivepalliative care may be indicative ofworsening of clinical or psychologicalstatus. For example, patients withadvanced non–small-cell lung cancer

demonstrating symptom improvementon the LCS experienced longer progres-sion-free survival and overall survivalthan those who did not experience symp-tom improvement.75,76 Providers can usesuch data in combination with other clin-ical indicators to make more reliableprognosis estimation and better preparethe patient and family members forupcoming consequences. Although thisarea of research is still in its infancy, asthe use of QOL tools increases, such asso-ciations will become more apparent.

Managed Care. QOL measurementmay be useful in managed care settingsbecause it provides information on patientsatisfaction as well as the quality ofmedical services provided.80,81 Physiciangroups may collect disease-specific QOLand symptom data from their patients toidentify strengths and areas of improve-ment within their clinical pathways.Physicians may use general health statusmeasures to compare a patient’s QOLwith national norms to evaluate the quali-ty of care and patient satisfaction withtheir services.

An MCO can use a treatment’s profileof impact on QOL in making formularydecisions.82 Symptom measures assistproviders in making treatment decisionsand may supplement other indicators,such as adherence to prescribing guide-lines and therapeutic monitoring to evalu-ate provider performance. They can alsoidentify opportunities for academicdetailing. For example, learning opportu-nities regarding symptom managementcan be provided when a patient’s symp-toms exceed a predetermined thresholdscore. MCOs can use such information toimprove the care offered to theirenrollees and monitor patient satisfac-tion. An MCO may offer incentives totheir physicians for incorporating suchassessments in their routine practice.Employers may request such data fromvarious MCOs to compare the quality ofcare their enrollees receive and incorpo-rate such comparisons in making con-tract decisions.

REPORTS


Conclusion

QOL is an integral part of cancerpatient management, although measuringQOL is a difficult task. Numerous instru-ments are available for measuring QOLand symptom burden, including generalhealth status measures as well as consid-erably more focused symptom measures.The increasing number of such measuresavailable makes recognition of brief, valid,and reliable instruments difficult for thoseless familiar with them. Some instru-ments use a modular approach, whichincludes a core questionnaire to assessgeneral QOL concerns and a supplemen-tal disease-specific symptom module toprovide a targeted assessment of apatient’s well-being. Such assessmentshave been very useful in QOL research,clinical trials, and clinical practice, andcan be of great value in managed care.Their potential uses range from institu-tion-specific, such as improving quality ofcare and patient satisfaction within apractice setting, to organization-specific,such as assisting in formulary decision-making, evaluating physician perform-ance, and identifying opportunities foracademic detailing.

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