Thorax 1991;46:671-675

Review

Quality of life measurement for patientsundergoing treatment for lung cancer

R J Fergusson, A Cull

The outlook for most patients with lung can-cer remains bleak, with an overall five yearsurvival rate of less than 10%. Surgery stilloffers the best chance of cure in the smallgroup of patients with resectable lesions. Thelife span of patients with small cell tumourshas been extended by combination chemo-therapy but long term survival is rare. Nearlyall patients are therefore treated withpalliative intent.The outcome of treatment has traditionally

been measured in terms of the extent andduration of tumour response and the patient'ssurvival time. In the absence of majortherapeutic advances in the past decade, dif-ferences between treatments as measured bythese biological indices have been small and ithas become increasingly relevant to comparethe cost (in terms of morbidity) at which anygain is achieved. The psychosocial issuesraised by the disease and its treatment haverecently been comprehensively reviewed.'2

Scales for monitoring toxicity related totreatment3 and performance status" arewidely used but inadequate for assessing somekey aspects of patients' experience-for exam-ple, pain and nausea-that are essentiallysubjective. Furthermore, .clinical experienceshows that patients with apparently similarperformance status and toxicity mayexperience substantially different quality oflife. Although good clinicians consider qualityof life as an important variable, most alsoregard it as a matter of clinical judgement: the"art" as opposed to the "science" ofmedicine. These assessments are unsystematicand subjectively biased and more reprodu-cible methods are required for use in (1)auditing clinical practice, (2) evaluating treat-ment outcome in clinical trials, (3) informeddecision making in the care of individualpatients, (4) justifying needs for supportiveservices, and (5) allocating resources formedical services.

Vigorous research efforts by clinicians andsocial scientists over the past decade haveresulted in a bewildering array of quality oflife measures, but only by sustained collabora-tion can the reliability and validity of theseinstruments be ascertained and commonproblems in data collection and analysis over-come. Those unfamiliar with developments inthis subject may view the task of accumulating"soft" data as cumbersome and time consum-ing, but considerable progress has been made

and many of these qualms can now be dis-pelled. Systematic inquiry has sometimesrevealed quality of life outcomes that were

6counterintuitive.6

What is "quality of life"?The concept of quality of life may be acceptedas a basis for clinical decision making but it isoften used with so comprehensive a meaningthat it defies precise definition. There is nowgeneral agreement7 that quality of life in thecontext of health is a multidimensional con-cept concerned with the impact of physicalsymptoms and side effects of treatment onpatients' functioning and psychosocial well-being. Specific research questions may justifya narrower focus but studies sampling onlyone of these domains cannot adequately reflectthe patient's quality of life. A second point ofconsensus is that the emphasis should beplaced on assessing the subjective experience ofthe person whose quality of life is in question.8

Can quality of life be measured?It follows from this definition that indirectindicators such as time in hospital or days offwork may provide valuable information aboutthe outcome of treatment but are inadequateas measures of quality of life. What is requiredis an instrument that measures relevant symp-toms and side effects and their impact on thepatient's physical functioning, emotionalstate, and social activity. The ideal methodshould be short, easy to administer, and easyto interpret and should have validity,adequate reliability, and responsiveness tochange over time. The choice of a specific testalways depends on the particular questionbeing asked and any one "gold standard" testis unlikely to be applicable to all circumstan-ces. Some generic health measures91' havebeen validated for use with patients sufferingfrom cancer, but several new tools have nowbeen developed specifically for assessingquality of life in these patients. Severalexcellent reviews of available instrumentshave been published recently.'"''" Selection ofa particular method raises several questionsfor consideration.

Performance indices and doctors' ratingsPatients' performance status and the response

Imperial CancerResearch FundMedical OncologyUnit, Western GeneralHospital, EdinburghEH4 2XUR J FergussonA CullReprint requests to:Dr RJ FergussonRespiratory Medicine Unit,City Hospital, EdinburghEH1O 5SB

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Table I Doctors' rating scalesfor quality of life

Domains

Name and Psycho- No ofreference Physical Functional logical Social items Scoring

Kamofsky4 + + 1 0-100WHO3 + + 1 0-4ECOG' + + 1 0-4Carlens" + + 1 +20--2Spitzer" + + + + 5 0-10

ECOG-Eastern Cooperative Oncology Group.

to treatment and its toxic effects are generallyassessed by the physician. Examples ofobserver scales are listed in table 1. TheKarnofsky performance index4 has been in uselongest and is still widely favoured as a prog-nostic indicator, though inter-rater reliabilityis unsatisfactory'4 and is related to theexperience of the assessor.'5 Scores are alsoinfluenced by whether the evaluation is perfor-med at home or in hospital.'6 The WorldHealth Organisation' and Eastern CooperativeOncology Group (ECOG)' scales share manyof the same limitations. Although reliabilitycan be improved by training raters,'7 theseinstruments all neglect psychosocial variablesand to that extent remain unsatisfactory asmeasures of quality of life.The Carlens Vitagram'8 was specifically

developed for use with patients with lungcancer. It is based on a points system thatreflects working capacity and time in hospital aswell as physical symptoms and functionalcapacity. It is therefore a performance index.The Spitzer scale'9 is a quick and easy measurethat addresses a more comprehensive range ofquality of life issues, but it has too few items ineach domain for sensitive scaling.Comparison of doctors and patients' ratings

of the patient's quality of life based on severalof these instruments showed poor agreement,suggesting that physicians could notbuuratelydetermine what patients felt.20 Furthermore,inter-rater reliability between health profes-sionals was poor. Where possible, patients'"self report" measures should be included inthe assessment of quality of life.

Is quality of life assessment by patientsreally feasible?Clinical experience and published data suggestthat the overwhelming majority of patientswith cancer welcome the opportunity to reporttheir experience even within the confines of aformal research study,2' but care should betaken that all the questions are easy to read andinterpret. Visual analogue scales have com-monly been used2224 but they may be difficultfor patients to understand25 and are time con-suming to score. A questionnaire shouldspecify the time period to which the questionsrefer (for example, the past 24 hours, the pastthree days, etc) and it is important to considercarefully how often measures need to berepeated. There may be considerable loss ofcompliance if the cumulative burden on thepatient is too great, particularly when perfor-mance is deteriorating.25 With this in mind theMedical Research Committee has favoured the

diary card developed for use in lung cancer" asa means of obtaining frequently repeatedmeasures of a limited number of variables overtime.The most prevalent problem reported in

conducting quality of life studies has been inobtaining the cooperation of medical staff.78Where it can be shown that questions relevantto the clinician can be addressed by proceduresthat can be accommodated in clinical practicescepticism can be overcome, but some commit-ment is required by a member of staff to ensurethe quality control of the data collected.

Which self report measure should beused?Although the standardised interview conduc-ted by a trained interviewer may yield the bestdata, this is expensive, time consuming, andimpractical for most clinical studies, wherelarge numbers ofpatients may be participating.Attention has largely focused on data collectedby questionnaire and diary card.Measures designed for use across a wide

range of chronic diseases927 are often lengthyand hence unsuitable for studies requiringrepeated testing, particularly amongdebilitated patients. The Psychological Adjust-ment to Illness Scalel' was originally publishedas a semi-structured interview with normativedata for lung cancer patients covering sevenquality of life domains. It is now available as aself report questionnaire with good reliabilityand validity but it has the disadvantage that it iscopyright and expensive to obtain and, incommon with other generic measures, it fails toassess specific physical symptoms or side effects.There has been a great temptation for resear-

chers to develop ad hoc, study specific measureswith the problem that reliability and validitytesting are neglected and cross study compar-isons become impossible. The recommenda-tion at this stage would be to use the bestavailable measure rather than to seek to developa new one. Some of the most widely usedquestionnaires that have been applied toquality of life assessment in patients with lungcancer are shown with brief details in table 2.The Linear Self Assessment System (LASA)28appears to detect change over time but issubject to all the criticisms levelled at visualanalogue scales-that is, it is time consuming toscore, scores suggest a spurious degree ofaccuracy, and in group data patients showingequal changes in scores may not show the sameevidence ofimprovement or deterioration. TheFunctional Living Index-Cancer (FLIC)22 iswidely used but there have been problems withits format, which imposes seven equal intervalson the analogue scale. It is sometimes nowpresented as a seven point scale. It hasrelatively few items referring to symptoms andhas been found somewhat insensitive to changeover time. The Cancer Rehabilitation Evalua-tion System (CARES)29 is a well developed andcomprehensive instrument with a short versionthat is more practical for research purposes. Itfocuses on problems amenable to rehabilitativeeffort and patients can identify areas where they

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Table 2 Multidimensional quality of life measures used with patients with lung cancer

Name and reference No of items andformat Content

Linear Self Assessment System (LASA)n 25 linear analogue Symptoms, physical activity, mood,social interaction

Functional Living Index-Cancer (FLIC)Q 22 linear analogue Symptoms, physical activity, mood,7 intervals social interaction

Career Rehabilitation Evaluation System 139 or 59 4 point scale + Physical, psychosocial, marital, sexual,(CARES)29 yes/no medical, social interactionRotterdam Symptom Checklist (RSCL)'3 38 4 point scale Physical symptoms, psychological

distress, 8 item physical function scaleEORTC core questionnaire and lung cancer 30 + 13 4 point scale + Functional state, symptoms,module3'32 yes/no psychological distress, social

interaction, financial state, global healthand quality of life

EORTC-European Organisation for Research on the Treatment of Cancer

would like to have help. The main obstacle toits use in Britain is its cost. The RotterdamSymptom Checklist (RSCL)"0 is a particularlyclear questionnaire, which is increasinglypopular because it is widely applicable and easyfor patients to complete. It was recommendedby the Medical Research Council's workingparty on the quality of life.'1 Its particularadvantage is its flexibility, which allows extraitems to be incorporated if additional illness ortreatment related variables need to be assessed.

Attention is, however, drawn to the measuredeveloped by the quality of life study group ofthe European Organisation for Research on theTreatment of Cancer (EORTC). Internationalcooperation over several years has resulted in acore questionnaire covering the generic impactof cancer and its treatment3' and a 13 itemmodule"2 of items specifically relevant topatients with lung cancer-for example, cough,dyspnoea, pain, and treatment related sideeffects. This scale has been very carefullydeveloped and promises to be a useful in-strument for measuring quality of life in thesepatients. Full details of the psychometricproperties of the final version of the scale aresoon to be published.

Quality of life measurement in lungcancerBefore we consider the effect of treatment onquality of life it is important to remember thatleft untreated lung cancer has a substantial andprogressive impact on patients' quality of life.Poorer performance and more extensive dis-ease are associated with increased psy-chological distress,33 and depressive illness hasbeen reported more commonly among patientswho did not have active treatment.34There are surprisingly few reports of quality

of life measurements in patients undergoingtreatment for lung cancer. The increasing useof chemotherapy for small cell tumours andmore recently for non-small cell lung cancerhas stimulated most interest in this subject.

CHEMOTHERAPYMany early studies of chemotherapy in smallcell lung cancer included assessment of func-tional performance as an attempt to measure

the quality of life.9"" Most reported an associa-tion between improved scores and response totreatment, though one study'5 suggested thatsubsequent maintenance treatment was accom-panied by a fall in performance scores. Coateset al7 also attempted to assess quality of life bymeans of a linear analogue self assessmentscale, measuring general wellbeing and otherspecific factors (mood, pain, nausea, vomiting,appetite, breathlessness, and physical activity)and showed a good correlation with perfor-mance ratings on the ECOG scale.The intensity of performance scores for

detecting changes in quality of life in lungcancer was highlighted in a recent study'8 thatcompared three different instruments (diarycards, the EORTC questionnaire, and thequality of life index of Spitzer et al) in a smallgroup of patients enrolled in a randomised trialof duration of chemotherapy in small cell lungcancer. The diary cards showed a worsening ofquality of survival as treatment continued,which was not seen with the Karnofsky scores.The comparisons between the three quality oflife instruments showed the appropriate con-vergent and divergent validity and showed thatthe diary cards were more sensitive to shortterm changes.Non-small cell lung cancer is a less

chemosensitive disease, but for the smallproportion of patients who might benefit fromthis form of treatment would seem a rationalchoice as most patients have metastatic diseaseat presentation. In a recent review of the role ofchemotherapy in advanced non-small cell lungcancer'9 Splinter commented that few of the142 published studies attempted to measurequality of life. In most, the response to treat-ment correlated with improvement in physicalperformance, but in others no change was seenand in some40" quality of life as measured byKarnofsky index fell during treatment. Thestudy reported by Bakker et al"' deserves com-ment. It assessed the effects of three drugs(vindesine, cisplatin, and bleomycin) in anuncontrolled group of relatively fit patients.The authors reported a high response rate(48%), with a median survival of 47 weeks inthose responding, but concluded that the fall inperformance duringtreatmentoffsetthe benefitsof treatment.Most studies of chemotherapy in non-small

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cell lung cancer show only a small survivaladvantage in responding patients and very fewhave compared active treatment with the bestsupportive care.39 As only palliation can beexpected there would appear to be a strong casefor including measurements of quality of life inany future studies.

RADIOTHERAPYAlthough radiotherapy is recognised as beingcapable of effectively palliating symptoms inpatients with lung cancer, little is known of itsimpact on other aspects of a patient's life. Intwo studies of combined chemotherapy andradiotherapy in small cell lung cancer3738 theperiods of radiotherapy were associated with adeterioration in the quality of life. Minet et al"randomised 81 patients with inoperable non-small cell lung cancer to receive either radio-therapy plus chemotherapy or radiotherapyalone and used the Karnofsky index to assessthe quality of survival. No difference in scorebetween the groups was seen and there was noactual survival advantage for either treatment.

Similar results were reported by Kaasa et at"and Kaasa and Mastekaasa'4 in a study of 95patients with non-small cell lung cancer ran-domised to receive chemotherapy (cisplatinand etoposide) or radiography (2-8 Gy x 15).Quality of life was assessed with a locallydeveloped questionnaire covering psychosocialwellbeing, disease and treatment related symp-toms, physical function, and everyday activity.The tumour response rate in the radiotherapygroup (42%) was double that in the chemo-therapy arm but overall survival in the twogroups was identical. After two weeks of treat-ment there was a significant drop in perfor-mance for the patients having chemotherapy,presumably reflecting the toxicity of treatment.Subsequently there were no differences inquality of life between the two groups. Ofinterest was the fact that psychosocial well-being correlated closely with disease relatedsymptoms (anorexia, tiredness, pain) butpoorly with treatment related effects (nausea,vomiting, alopecia, dysphagia). Thus patientsrecognised the signs of improvement and wor-sening of their disease and this was reflected intheir wellbeing; but they may have acceptedside effects of treatment as the price to pay for achance of overcoming their cancer, and con-sequently this had less impact on their overallquality of life. Coates et al reported similarresults in patients with small cell lung cancer.'7This important finding perhaps should be

considered when we decide to withhold treat-ments with low activity from patients in thebelief that we are protecting them from harmwhen there is little chance ofbenefit. It emphas-ises three important points: firstly, that qualityof life measures may have a role in decisionsabout treatment options: secondly, that insen-sitive instruments, such as performance status,that only cover certain aspects ofwellbeing maymiss differences in the overall effectiveness oftreatments; and, thirdly, that assessment ofquality of life must include input from thepatient.

SURGERYResection still offers the best chance of cure inpatients with lung cancer, but what is theirquality of survival and can the surgeon provideany palliation for patient found to be unresect-able at thoracotomy? These were the questionsaddressed by the one major report on quality oflife in patients having surgery.45 The authorsused the Carlens Vitagram to assess the qualityof survival. This method has been validated inlung cancer.' The quality of survival in pa-tients cured by resection was excellent. The pa-tients who had an operation but subsequentlydied of the disease did not have a better qualityof survival than non-surgically treated patientswith the same stage of disease. The authorsconcluded that an operation had no palliativeeffect and the possible benefits of "reducing thetumour burden" could be dismissed. Thisimportant finding requires further verificationby the more sophisticated methods now availa-ble for assessing quality of life.

ConclusionsMost patients with lung cancer are treated withpalliative intent, where, by definition, the focusis on the quality rather than merely the dura-tion of survival, yet relatively few studiesreport data on quality of life.

Substantial progress has been made in defin-ing the concept of health related quality of lifeto allow agreement about what is to be assessed.An impressive range of practically usefulmeasures has now been developed for collect-ing data about patients' subjective experienceof disease and treatment in a reliable and validway. Of particular interest is the modularassessment strategy, whereby a genericmeasure for patients with cancer can be sup-plemented by a standardised scale specificallyrelevant to lung cancer.Work is continuing to show how quality

control in collection of data on quality of lifecan best be achieved and to address problemsthat can arise in data analysis in longitudinalstudies where there are problems of attrition.Sufficient progress has been made to suggestthat assessment of quality of life should beincluded in the audit of clinical practice andevaluating treatment outcomes in clinical trials.The data obtained could provide an objectivebasis for informing decision making forindividual patients and for making the case forallocation of appropriate resources to medicaland supportive services.4748

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6 Sugarbaker PH, Barofsky I, Rosenberg SA, Gianola FJ.Quality of life assessment of patients in extremity sarcomaclinical trials. Surgery 1982;91:17-23.

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