In the past decade, quality of life ... REPORTS... Quality of Life and Symptom Measures in Oncology: An Overview

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1 ... REPORTS... Quality of Life and Symptom Measures in Oncology: An Overview Mehul K. Soni, PharmD; and David Cella, PhD Abstract Improving quality of life (QOL) in oncology patients is an important therapeutic goal, and most treatment decisions are heavily influenced by their effect on QOL. Although measuring QOL has been a significant challenge because of a lack of consensus on the definition of QOL, research in this field has advanced rapidly. Numerous instruments now exist for measuring QOL and symptom burden, ranging from general health status measures to considerably more focused symptom measures. QOL measures have been routinely incorporated in clinical trials, and their use in clinical settings is strongly encouraged because their value in cancer patient management is now established. These measures also have a potential impact in the managed care environment because they provide information on patient satisfaction and quality of care provided. This article clarifies the definition of QOL, provides a brief overview of several useful measurement instruments, and addresses some common concerns encountered in measuring QOL in cancer patients. In addition, potential uses of such measures are explored and their value in various settings, including managed care, is highlighted. (Am J Manag Care. 2002;8:S560-S573) In the past decade, quality of life (QOL) has gained tremendous importance in oncology. 1-5 Survival as a sole end point of treatment evaluation is no longer sufficient; QOL is also a vital outcome for cancer patients. Measuring QOL in a valid, reliable way presents a significant challenge because of the lack of consensus on how QOL is defined. 6-8 Numerous QOL and symptom assessment tools exist to capture such information, although the potential of these tools in the managed care setting is not fully realized This article is intended to clarify the definition of QOL; review commonly used measures in oncology; summarize the potential uses of these measures in various settings, including managed care; and address some challenges encountered in measuring QOL. Quality of Life Defined In 1948, the World Health Organization defined health as not only the absence of disease or illness, but also the presence of physical, mental, and social well-being. 15 Following that lead, today s concept of QOL encompasses the effect of an illness on a patient s physical, psychological, and social well-being as perceived by that patient. An individual s general QOL is affected by many factors in addition to those that are health-related, such as financial status, job satisfaction, and living conditions. When put into a health context as the duration or severity of morbidity accumulates, these factors influence QOL, and are often referred to as healthrelated QOL. For patients who are extremely ill, the illness can be all-consuming to the point where QOL is synonymous with health-related QOL. 2 When a minor health condition interferes with an individual s functioning for a few days or weeks, QOL is not perceived to be affected very much by health status. Therefore, measuring health-related QOL S560 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

2 Quality of Life and Symptom Measures in Oncology: An Overview is most relevant when health is expected to exert significant impact on daily functioning and well-being. Measuring QOL in Cancer Patients QOL is a well-accepted outcome measure for cancer patients in clinical trials. Many instruments have been developed to capture important QOL issues to assess impact of treatments on patient well-being and improve patient care. QOL instruments measure various aspects of QOL and commonly include physical, psychological, and social domains. These domains are subdivided into a number of questions, referred to as items. QOL measurement instruments available today range from generic to general cancer-specific to site-specific symptom measures (Table 1). Generic instruments, such as the Medical Outcomes Study 36- Item Short-Form Health Survey (SF-36) assess broad concerns related to various domains of QOL General cancer-specific measures focus on broad, yet clinically relevant, issues and a few symptoms. Hundreds of instruments are available to measure QOL for cancer patients, although a few of these are used quite often. Examples of general cancerspecific measures include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-Items (EORTC-QLQ-C30) 19,20 and the Functional Assessment of Cancer Therapy-General Scale (FACT-G). 21 Both, the EORTC-QLQ-C30 and FACT-G measurement systems offer a modular approach, which entails a general core questionnaire to assess overall QOL and is supplemented by a site-specific symptom module or subscale to address additional concerns specific to that cancer population. Site-specific symptom measures include, for example, breast cancer, lung cancer, and colorectal cancer supplements that specifically focus on symptoms patients with these types of cancers commonly experience. Useful general cancer-specific and site-specific symptom measures are briefly discussed below. QOL and Symptom Measures in Oncology Generic QOL Instruments. The SF-36 is a 36-item, widely used generic health questionnaire (Table 2) It measures 8 QOL dimensions: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, vitality, bodily pain, emotional health, and general health. In addition to the 8 dimension score, 2 higher-order summary scores, Physical Component Summary and Mental Component Summary, can also be calculated to assist in comparison. Higher scores on the SF-36 indicate improved QOL. The SF-36 is extensively validated and is widely used in various outpatient settings to measure functional status. 22 The Sickness Impact Profile (SIP) is a 136-item, generic health status measure that evaluates impact of disease on physical and emotional functioning. 23,24 SIP measures physical and psychosocial domains as everyday activities in 12 categories: sleep and rest, emotional behavior, body care and movement, home management, mobility, social interaction, ambulation, alertness behavior, communication, work, recreation and pastimes, and eating. Responses are dichotomous (yes/no), and scoring is based on the number and type of items given higher scores, which represent greater dysfunction. The validity, reliability, and responsiveness of SIP have been established in a healthy population as well as in cancer patients. 25 General Cancer-Specific QOL Instruments. Questionnaires that were originally developed or validated using cancer patients are often referred to as cancerspecific, distinguishing them from the more general health status assessment of instruments such as the SF-36 or SIP. However, many of these cancer-specific questionnaires are multidimensional and have more recently been validated in populations other than cancer patients. Thus, they may more accurately be considered general chronic illness questionnaires. Some examples follow. VOL. 8, NO. 18, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S561

3 REPORTS 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 used 36-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 descriptive functional, family/social dichotomous profile of changes in a person s behavior associated with sickness Higher scores indicate greater dysfunction Cancer-Specific QOL Questionnaires European Organization for Research General cancer Physical, functional, 30 items; Widely used and Treatment of Cancer Quality of cognitive, social, Likert-type/ Modular approach Life Questionnaire Core 30-Items emotional, global dichotomous supplemented by site- (EORTC-QLQ-C30) rating specific modules Higher global scale scores and lower symptom scores indicate better functioning and lower symptom distress Functional Assessment of Cancer General cancer Physical, functional 27 items; Widely used Therapy-General Scale (FACT-G) family, emotional, Likert-type Modular approach supplesocial, global rating mented by site-specific or symptom-specific subscales Higher scores indicate improved QOL Cancer Rehabilitation Evaluation General cancer Physical, psychosocial, 139 items; Comprehensive System (CARES) marital, medical inter- Likert-type Focuses on important action, sexual clinical issues amenable to rehabilitation Useful in generating complete problem list Higher scores indicate greater symptom distress and 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-36 Quality of Life Questionnaire social, symptoms, and SDS global rating Modular approach supplemented by sitespecific modules (colon and prostate) (Continued) S562 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

4 Quality of Life and Symptom Measures in Oncology: An Overview 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-QLQand Treatment of Cancer Quality of C30 core questionnaire Life Questionnaire Site-Specific 5 site-specific gabscales (eg, Modules breast, lung, ovarian) Validation of other modules under way Functional Assessment of Cancer Symptom measure Site-specific symptoms Likert-type For use with FACT-G Therapy Site-Specific Subscales Scale 12 cancer site-specific subscales (eg, breast, lung, prostate) 4 treatment-specific subscales (eg, taxanes, bone marrow transplant) 8 symptom-specific subscales (eg, anorexia/cachexia, diarrhea, fatigue) Symptom Distress Scale (SDS) Symptom measure 11 symptoms (nausea, 13 items; Designed as a general appetite, insomnia, Likert-type cancer measure to control pain, fatigue, outlook, symptom distress bowel pattern, concen- Useful in identifying tration, 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 Health Survey (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 Limited If 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. VOL. 8, NO. 18, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S563

5 REPORTS The EORTC-QLQ-C30 is a general 30- item questionnaire (Table 3). 19,20 This instrument, specifically designed for cancer patients, evaluates 5 QOL domains (physical, role, cognitive, emotional, and social), several symptoms (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite, constipation, and diarrhea), and global health/qol. All questions dealing with functional scales and symptom domains are rated on a 4-point Likerttype scale ranging from not at all to very much, and the global scale is a numerical 7-point Likert-type scale representing a continuum from very poor to excellent. High functioning and global scale scores and low symptom scores reflect better functioning and lower symptom distress, respectively. EORTC-QLQ-C30 has demonstrated good reliability and validity in various large, international cancer populations and is available in many other languages. 26 The FACT-G is a 27-item self-report instrument designed to measure QOL for all cancer patients (Table 4). 21 The core questionnaire evaluates 4 QOL domains: physical, social/family, emotional, and functional. Response categories for all items of FACT-G range from 0 (not at all) to 4 (very much). Higher scores are associated with increased satisfaction with QOL. FACT-G is tested and validated in large, international patient samples and is available in many languages The Functional Living Index Cancer (FLIC) is a 22-item, self-reported general cancer QOL questionnaire. 34 Dimensions of QOL assessed by FLIC include physical role, and social, mental, and general health perceptions, as well as measurement of some symptoms, such as pain and nausea. Responses are measured on a linear scale with 7 equidistant marks ranging from 1 (not at all) to 7 (a great deal). Subscale scores are derived for 7 domains: role, sociability, emotional, current health, hardship, nausea, and pain, with higher total score representing better QOL. The validity and reliability of FLIC is established in various cancer populations The Cancer Rehabilitation Evaluation System (CARES) is a relatively longer, more comprehensive, self-administered 139-item cancer-specific questionnaire. 42 It measures 5 domains of QOL: physical, Table 3. Sample Questions From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-Item Survey (EORTC-QLQ-C30) Not A Quite Very During the past week: At All Little A Bit Much Were you limited in doing either your work or other daily activities? Were you limited in pursuing your hobbies or other leisure time activities? Were you short of breath? Have you had pain? Did you need to rest? Have you had trouble sleeping? Have you felt weak? Have you lacked appetite? Have you felt nauseated? Have you vomited? Source: References 19, 20. Reprinted with permission from EORTC Quality of Life Group. S564 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

6 Quality of Life and Symptom Measures in Oncology: An Overview Table 4. Emotional Well-Being Subscale of the Functional Assessment of Cancer Therapy- General Scale (Fact-G) Not A Little Quite Very Emotional Well-Being: At All Bit Somewhat a Bit Much I feel sad I am satisfied with how I am coping with my illness I am losing hope in the fight against my illness I feel nervous I worry about dying I worry that my condition will get worse Source: Reprinted with permission from DF Cella. 21 psychosocial, marital, medical interaction, and sexual. All items are measured on a 4-point Likert-type scale ranging from 0 (not at all/no problem) to 4 (very much/severe problem), with a higher total score representing greater symptom distress and lower QOL. The CARES is a valuable tool, especially in cancer rehabilitation settings, to generate a complete patient problem list. 43,44 At times, some organizations such as the Southwest Oncology Group (SWOG) use a battery approach to measuring QOL. This entails selecting brief instruments or sets of questions to address specific concepts of interest in a given clinical trial or clinical application study. The SWOG Quality of Life Questionnaire is an example of a cancerspecific QOL assessment that separately measures physical, emotional, and social functioning, symptoms, and global QOL. 45 The physical, emotional, and social functioning are measured using items from the SF-36 questionnaire. It measures items adapted from the Symptom Distress Scale (SDS) to assess general symptoms common to all types of cancer, such as nausea, appetite, insomnia, and pain, as well as other treatment-specific symptoms, which depends on the nature of the protocol, on a 5-point response categorical scale. It includes a 31-item, global QOL questionnaire that is scored on 5-point categories scale ranging from extremely unpleasant to normal (no change). Three additional items are added to measure the effect of comorbid conditions. Such an approach involving custom tailoring QOL measures to meet the needs of the cancer population have been used for example in SWOG prostate cancer trials Symptom-Specific Measures. Site-specific modules available for EORTC-QLQ- C30 include breast, 49 head and neck, oesophageal, 53 ovarian, 54 and lung 55 cancers. These modules specifically focus on commonly experienced site-specific symptoms. For example, the EORTC-QLQ-Lung Cancer 13-item (LC13), shown in Table 5A, is a module supplementing the C30 core questionnaire designed to assess impact of treatment on symptoms specifically relevant to lung cancer patients. The responses in the LC13 are measured on a 4-point Likert-type scale ranging from not at all to very much. 55 The last item dealing with pain medication has dichotomous response categories (yes/no). Higher symptom scores represent increased symptom distress. Site-specific subscales available for FACT-G include breast, 56 bone marrow transplant, 31 brain, 33 colorectal, 57 cervical, head and neck, 58 lung, 27 (Table 5B), ovarian, 59 and prostate 60 cancers. These subscales are generally added to the core questionnaire, resulting in a composite VOL. 8, NO. 18, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S565

7 REPORTS Table 5A. European Organization for Research and Treatment of Cancer Quality of Life Quesstionnaire Lung Cancer 13-Item Module (EORTC-QLQ-LC13) Not A Quite Very During the past week: At All Little A Bit Much How much did you cough? Did you cough up blood? Were you short of breath when you rested? Were you short of breath when you walked? Were you short of breath when you climbed stairs? Have you had a sore mouth or tongue? Have you had trouble swallowing? Have you had tingling hands or feet? Have you had hair loss? Have you had pain in your chest? Have you had pain in your arm or shoulder? Have you had pain in other parts of your body? If yes, where Did you take any medicine for pain? 1. No 2. Yes If yes, how much did it help? Source: Reference 55. Table 5B. Lung Cancer-Specific Items From Functional Assessment of Cancer Therapy- Lung (FACT-L) Not A Little Quite Very Additional Concerns: At All Bit Somewhat a Bit Much I have been short of breath I am losing weight My thinking is clear I have been coughing I am bothered by hair loss I have a good appetite I feel tightness in my chest Breathing is easy for me Have you ever smoked? No Yes If yes: I regret my smoking Source: Reference 27. S566 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

8 Quality of Life and Symptom Measures in Oncology: An Overview Figure. Sample Items From the Symptom Distress Scale (SDS) Nausea (1) 1 I seldom if ever have nausea 2 I have nausea once in a while 3 I have nausea fairly often 4 I have nausea half the time at least 5 I have nausea continually Nausea (2) 1 When I do have nausea, it is very mild 2 When I do have nausea, it is mildly distressing 3 When I have nausea, I feel pretty sick 4 When I have nausea, I usually feel very sick 5 When I have nausea, I am as sick as I could possibly be Appetite 1 I have my normal appetite and enjoy good food 2 My appetite is usually, but not always, pretty good 3 I don't really enjoy my food 4 I have to force myself to eat my food 5 I cannot stand the thought of food Insomnia 1 I sleep as well as I always have 2 I occasionally have trouble getting to sleep and staying asleep 3 I frequently have trouble getting to sleep 4 I have difficulty getting to sleep and staying asleep almost every night 5 It is almost impossible for me to get a decent night's sleep Pain (1) 1 I almost never have pain 2 I have pain once in a while 3 I have pain several times a week 4 I am usually in some degree of pain 5 I am in some degree of pain almost constantly Pain (2) 1 When I do have pain, it is very mild 2 When I do have pain, it is mildly distressing 3 When I do have pain, it is usually fairly intense 4 The pain I have is very intense 5 The pain I have is almost unbearable Source: Reference 61. general and site-specific QOL measure. For example, 9 lung cancer-specific items (LCS) are added to FACT-G, resulting in a 36-item questionnaire referred to as FACT-Lung. 27 Symptoms covered by the lung cancer module include dyspnea, weight loss, clarity of thinking, cough, hair loss, appetite, tightness in chest, breathing difficulty, and an optional regret from smoking item. Similar to FACT-G, items on LCS are measured on a 4-point Likerttype scale ranging from not at all to very much, with higher scores representing lesser symptom distress. The SDS is a 13-item self-reported symptom measure that was developed for use with cancer patients (Figure). 61 It assesses the severity level of 11 common cancer symptoms, including nausea, appetite, insomnia, pain, fatigue, bowel pattern, concentration, appearance, outlook, breathing, cough, and frequency of nausea and pain. Higher score on the SDS indicate greater or more frequent symptom distress. The SDS has been extensively validated in various cancer populations and is a commonly used symptom distress measure. Measurement Issues Commonly Encountered in QOL Research If collected properly, QOL data can be useful. Important issues in collecting this data include using appropriate tools, deriving assessments in a timely manner, and producing results that are easily interpreted. Researchers and clinicians have raised several issues that should VOL. 8, NO. 18, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S567

9 REPORTS Table 6. Important Concerns Encountered in Quality 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 be addressed before QOL data collection. 11,62-65 These issues are summarized in Table 6. Measurements of QOL to be used for data collection must be suitable for the intended purpose. Because general measures focus on broader QOL issues, they lack sensitivity to specific changes in the impact of cancer for individual patients. Therefore, such measures allow for group comparisons as well as help assess overall impact of disease and treatment on QOL. Disease-specific tools focus on detailed symptom assessment and are responsive to changes in important concerns relevant to the patient group being studied, although these measures do not easily allow for comparisons between groups. Neither approach has been proved superior to the other. A more complete approach is to combine both types of measures to capture overall QOL of patients without compromising the sensitivity to changes in disease-specific issues. A modular approach, which utilizes a generic core questionnaire assessing broader QOL concepts and is supplemented with shorter disease-specific and symptom-specific measures, has become more practical. Such a system allows researchers to ensure that all QOL domains that could potentially be impacted by an intervention are measured along with any changes in disease-specific symptoms. QOL should be measured at appropriate time intervals and with appropriate frequency to capture necessary changes. Symptom-specific measures are short and can be helpful in frequently tracking the short-term, such as weekly, changes in QOL related to acute adverse effects of chemotherapy or radiation. Site-specific questionnaires are moderate in length and could be given less frequently, perhaps monthly, than symptom measures to track broader QOL issues pertaining to the disease and the treatment. Longer, general cancer-specific instruments may be more appropriate for quarterly assessment of overall QOL in a treated population. QOL measurement generates massive amounts of data. Combining or presenting a large dataset in a concise, interpretable way can be difficult. Therefore, QOL tools should allow for easy interpretation and comparison of data. For example, the FACT-G measurement system allows for combining physical and functional status scores with their respective supplemental symptom measures to derive Trial Outcome Index (TOI), a single score measure that can be useful in comparing overall physical well-being and symptom status, which can be useful in comparing 2 treatment modalities in a clinical trial. 27 Interpreting the difference in QOL scores can be difficult. Identifying a minimum clinically important difference (MCID), which is a change in score that affects a treatment decision, is important. A few QOL instruments have an estimated and validated MCID. For example, the MCID for FACT-G has been shown to be about 5 to 6 points in cancer patients in various stages. 66 MCID for the LCS and the TOI has been validated in advanced non small-cell lung cancer and is reported to be 2 to 3 points and 5 to 6 points, respectively. 28 Identifying a meaningful change in score can play a role in dose adjustment and treatment modification. Studies are under way to establish MCID for other general cancer-specific as well as site-specific symptom measures. How the Scales Have Been Used in Various Settings QOL questionnaire and symptom measure scores are subjective measures performed by the patients themselves and are a useful patient-reported outcome in research, clinical trials, clinical practice, S568 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

10 Quality of Life and Symptom Measures in Oncology: An Overview and managed care. Their uses range from patient-focused, such as understanding how patients value QOL and identifying important QOL issues in cancer patients, to organization-focused, such as improving patient management within a physician group practice and managed care organization (MCO). These uses are briefly summarized in Table 7. QOL Research. QOL and symptom measures have been extensively studied in research trials for validation purposes and to evaluate the impact of cancer or a treatment on QOL of patients. Instruments have been tested in patients with various types of cancer to establish their reproducibility, validity, responsiveness, and interpretability. Such research provides insight into how QOL is valued and reported by patients. QOL questionnaires are continuously refined to reduce patient burden, to be more user-friendly, and to enhance their application in clinical settings. Clinical Trials. QOL instruments have been used in clinical trials to understand important QOL issues in cross-sectional as well as longitudinal assessment of groups. Comparisons of QOL and symptom measure scores between a diseased population and a healthy population could provide insight into areas of concern of the diseased population. Such comparisons could be valuable in understanding the QOL impact profile of a disease and help predict utilization of other medical services within the healthcare system. For example, QOL assessments in advanced lung cancer patients have revealed that psychological and emotional issues are highly prevalent in this population, often requiring referral to psychotherapists for appropriate management of such issues. 67 With QOL becoming an important end point of evaluation, it is increasingly measured in clinical trials. Cross-sectional and longitudinal QOL score comparisons between a new treatment group and a comparator group help investigators better understand the impact of a novel treatment on patient well-being. Such comparisons are valuable, and often necessary, if a new treatment offers survival benefits at the expense of adverse effect on patient QOL. Longitudinal QOL data comparisons may help clinicians better explain the long-term consequences of placing patients on such a treatment as well as help patients make informed treatment decisions. QOL and patient-reported symptoms have, in part, contributed to approval of new anti-cancer agents. Both quality, as well as quantity, of life provide a more detailed picture of how a novel agent will affect a cancer patient. The Food and Drug Administration increasingly demands QOL data as a measure of treatment efficacy along with traditional survival benefits. For example, gemcitabine for patients with pancreatic carcinoma refractory to fluorouracil and mitoxantrone for Table 7. Use of Quality of Life Questionnaires and Symptom Measures in Various Settings Quality of Life Research Clinical Trials Clinical Practice Managed Care Organizations Establish validity, reliability, and responsiveness of an instrument Better understand how patients report and value quality of life Identify quality of life issues in a disease population Identify quality of life associated with a new treatment Contribute to approval of a new treatment Identify quality of life concerns from a patient s perspective Help focus physician-patient interaction on concerns important to the patients Assist in treatment decision-making Help predict morbidity and mortality Identify strengths and areas of improvement within a clinical pathway Improve quality of care and patient satisfaction 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 VOL. 8, NO. 18, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S569

11 REPORTS hormone-refractory prostate cancer 70 were approved in part because of their effect on improvement of disease-related symptoms. Clinical Practice. QOL and symptom measures have been shown to be useful in clinical practice. QOL tools may help clinicians better understand patient concerns. Physicians, nurses, and family members often underestimate the QOL impact on the patients and are poor proxies for such evaluations. 71 Symptom measures can help clinicians understand the prevalence and severity of symptoms and their impact on QOL from the patient s perspective. Such tools may help improve communication between the clinician and the patient. 72,73 A systematic QOL and symptom evaluation increases the probability of covering more areas of patient concern. Pilot studies evaluating the usefulness of computerized QOL assessments performed in the physician s waiting room before seeing the physician have shown that such tools can concisely summarize important patient concerns and help clinicians explore these issues in depth during the visit. The conversation between physicians and patients can be directed to focus on important QOL issues, making the physician-patient interaction more meaningful for both parties. QOL and symptom measure data have been useful in treatment decision-making These measures allow physicians to track the prevalence and severity of disease-related as well as treatment-related symptoms. Together with other clinical data, such as tumor size and presence of metastases, QOL data can help physicians decide when to modify dosage or switch to less toxic agents and when to treat advanced cancer patients with palliative rather than curative intent. QOL and symptom measures may help predict patient survival Worsening of QOL despite appropriate and aggressive palliative care may be indicative of worsening of clinical or psychological status. For example, patients with advanced non small-cell lung cancer demonstrating symptom improvement on the LCS experienced longer progression-free survival and overall survival than those who did not experience symptom improvement. 75,76 Providers can use such data in combination with other clinical indicators to make more reliable prognosis estimation and better prepare the patient and family members for upcoming consequences. Although this area of research is still in its infancy, as the use of QOL tools increases, such associations will become more apparent. Managed Care. QOL measurement may be useful in managed care settings because it provides information on patient satisfaction as well as the quality of medical services provided. 80,81 Physician groups may collect disease-specific QOL and symptom data from their patients to identify strengths and areas of improvement within their clinical pathways. Physicians may use general health status measures to compare a patient s QOL with national norms to evaluate the quality of care and patient satisfaction with their services. An MCO can use a treatment s profile of impact on QOL in making formulary decisions. 82 Symptom measures assist providers in making treatment decisions and may supplement other indicators, such as adherence to prescribing guidelines and therapeutic monitoring to evaluate provider performance. They can also identify opportunities for academic detailing. For example, learning opportunities regarding symptom management can be provided when a patient s symptoms exceed a predetermined threshold score. MCOs can use such information to improve the care offered to their enrollees and monitor patient satisfaction. An MCO may offer incentives to their physicians for incorporating such assessments in their routine practice. Employers may request such data from various MCOs to compare the quality of care their enrollees receive and incorporate such comparisons in making contract decisions. S570 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 2002

12 Quality of Life and Symptom Measures in Oncology: An Overview Conclusion QOL is an integral part of cancer patient management, although measuring QOL is a difficult task. Numerous instruments are available for measuring QOL and symptom burden, including general health status measures as well as considerably more focused symptom measures. The increasing number of such measures available makes recognition of brief, valid, and reliable instruments difficult for those less familiar with them. Some instruments use a modular approach, which includes a core questionnaire to assess general QOL concerns and a supplemental disease-specific symptom module to provide a targeted assessment of a patient s well-being. Such assessments have been very useful in QOL research, clinical trials, and clinical practice, and can be of great value in managed care. Their potential uses range from institution-specific, such as improving quality of care and patient satisfaction within a practice setting, to organization-specific, such as assisting in formulary decisionmaking, evaluating physician performance, and identifying opportunities for academic detailing.... REFERENCES Tannock IF. Treating the patient, not just the cancer. N Engl J Med. 1987;317: Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993;118: Lehman AF. Measuring quality of life in a reformed health system. Health Aff. 1995;14: Coates A, Gebski V, Bishop JF, et al. Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Engl J Med. 1987;317: Testa MA, Simonson DC. Assessment of quality-oflife outcomes. N Engl J Med. 1996;334: Padilla GV, Ferrell B, Grant MM, et al. Defining the content domain of quality of life for cancer patients with pain. Cancer Nurs. 1990;13: Cohen SR, Mount BM, MacDonald N. Defining quality of life. Eur J Cancer. 1996;32A: Costantini M, Mencaglia E, Giulio PD, et al. Cancer patients as experts in defining quality of life domains. A multicentre survey by the Italian Group for the Evaluation of Outcomes in Oncology (IGEO). Qual Life Res. 2000;9: Coons SJ, Rao S, Keininger DL, et al. A comparative review of generic quality-of-life instruments. Pharmacoeconomics. 2000;17: Lohr KN, Aaronson NK, Alonso J, et al. Evaluating quality-of-life and health status instruments: development of scientific review criteria. Clin Ther. 1996;18: Cella DF, Bonomi AE. Measuring quality of life: 1995 update. Oncology. 1995;9: Anderson RT, Aaronson NK, Bullinger M, et al. A review of the progress towards developing healthrelated quality-of-life instruments for international clinical studies and outcomes research. Pharmacoeconomics. 1996;10: Ringash J, Bezjak A. A structured review of quality of life instruments for head and neck cancer patients. Head Neck. 2001;23: Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986;134: World Health Organization. Constitution of the World Health Organization. Geneva, Switzerland: WHO Basic Documents; Ware JE Jr, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30: McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31: McHorney CA, Ware JE Jr, Lu JF, et al. The MOS 36-Item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32: Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85: Aaronson NK, Bullinger M, Ahmedzai S. A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results Cancer Res. 1988;111: Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11: Stewart AL, Hays RD, Ware JE Jr. The MOS Short-Form General Health Survey. Reliability and validity in a patient population. Med Care. 1988;26: Bergner M, Bobbitt RA, Pollard WE, et al. The sickness impact profile: validation of a health status measure. Med Care. 1976;14: Bergner M, Bobbitt RA, Carter WB, et al. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981;19: De Bruin AF, de Witte LP, Stevens F, et al. Sickness Impact Profile: the state of the art of a generic functional status measure. Soc Sci Med. 1992;35: Osoba D, Zee B, Pater J, et al. Psychometric properties and responsiveness of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, VOL. 8, NO. 18, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S571

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