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QUALITY OF LIFE Can one have quality of life while dying? If you asked the general population, many would certainly answer no. The public now fears that their dying will be marred by pain, suffering, and a limited quality of life. To the contrary, for some dying has been the “best year” of one’s life. The guiding principle at the heart of the palliative care intervention is the notion of quality of life (Cohen 1995). Over the past two decades, numerous instruments have been developed to measure health related quality of life. Increasingly, it has been recognized that mortality provides a limited measurement of the outcomes of cancer treatment. Both European and American cancer clinical trial organizations have developed “quality of life” instruments to assess the outcomes of cancer interventions. The aim of this briefing book is to review those instruments that measure outcomes of medical care at the end of life. For simplicity, we have focused on the last month, a time period which has been shown in cancer patients to be the time of greatest symptom burden and decline in function. As Dr. Anita Stewart has outlined, additional domains are needed to measure quality of life at the end of life. Spirituality and transcendence has been long neglected. For dying, the degree which this domain is addressed may greatly impact on the patients quality of life. Eric Cassell noted that “Transcendence is probably the most powerful way in which one is restored to wholeness…” when faced with a serious illness or life-defining illness. In this section, we review instruments developed to measure quality of life. Many of these same measures are reviewed under other domains when questions are applicable to that domain (e.g,. symptoms are measured in the McGill Quality of Life Questionnaire, so we reviewed instruments under both domains). Literature Review A literature review of the Medline database was conducted. Using the search terms measurement, instrument, quality of life and (terminal care or palliative care), we found a total of 131 articles published between 1983 to 2000. In addition, we selected references from the methods section of those articles pulled, and an online catalogue was searched for relevant books. I. Potential instruments Based on the review of these 131 articles, we found 41 potential instruments for consideration which are listed below. ADRQL Alzheimer's Disease-Related Quality of Life (Rabins et al 1999) - is an instrument which measures social interaction, awareness of self, enjoyment of activities, feelings and mood and response to surroundings (validation work in progress). AQEL Assessment of Quality of Life at the End of Life instrument (Axelsson, 1999) – this is a 22 item questionnaire measuring the physical, psychological, social, existential, and global aspects of quality of life. CARES-SF (Schag 1991) - a 59 item scale which measures rehabilitation and quality of life in patients with cancer. This has been modified to the HIV Overview of Problems Evaluation Systems (HOPES, Schag 1992) Chronic Respiratory Disease Questionnaire (Guyatt 1987) - a 20 item disease specific quality of life scale developed for measuring outcomes of clinical trials for patients with COPD. COH City of Hope Quality of Life (Ferrell 1995) - a 38 item ordinal scale representing the four domains of quality of life including physical well being, psychological well being, social well being and spiritual well being has been employed in a study (Juarex et al. 1999) which looked at the impact of cultural diversity on cancer pain management. Also available is a 41-item Cancer Specific version of the COH. COOP Charts (Nelson 1996) – a series of charts that features drawings to quickly screen patients in an outpatient setting. Daily Diary Card-QOL (Gower 1995) - a self-administered card for use in cancer clinical trials that has been shown to demonstrate short-term changes in quality of life related to symptoms induced by chemotherapy. EORTC QOL-30 (Aaronson 1993) - this instrument is composed of modules to assess quality of life for specific cancers in clinical trials. The current instrument is 30 items with physical function, role function, cognitive function, emotional function, social function, symptoms, and financial impact. A computerized version of this instrument was employed in a study which compared paper and computer touch-screen questionnaires (Velikova et al 1999). (See "Review of Potential Instruments" below for a list and description of disease-specific EORTC quality of life instruments.) EuroQol Quality of Life Scale (EuroQol 1990) - a measure that covers five dimensions—mobility, self-care, role (or main) activity, family and leisure activities, pain and mood—and expresses health status as a single index score. FACT-G (Cella 1993) – a 33 item scale developed to measure quality of life in patients undergoing cancer treatment. (See "Review of Potential Instruments" below for a list and description of disease-specific FACT quality of life instruments.) Ferrans and Powers Quality of Life Index (Ferrans 1985) - a two section, 68 question instrument that measures both satisfaction with, and importance of, multiple domains. FLIC (Finkelstein 1988) – a 22 item instrument which measures quality of life in the following domains: physical/occupational function, psychological state, sociability, and somatic discomfort. This scale was originally proposed as an adjunct measure to cancer clinical trials. HAT-QoL HIV/AIDS-Targeted Quality of Life (Holmes and Shea, 1999) – this 30 item questionnaire evaluates overall function, disclosure worries, health worries, financial worries, HIV mastery, and life satisfaction. The Head and Neck Quality of Life Questionnaire (Terrell et al. 1997) – this instrument measures eating, communication, pain and emotion. HIV-QL31 (Leplege et al., 1997) – a 31 item instrument that measures the impact of treatment and disease on quality of life in HIV infected persons. Hospice Quality of Life Index--Revised (McMillian 1996) – a 28 item scale specifically developed to measure quality of life in hospice. Domains measured include physical, psychological, spiritual, social and financial well being. LEIPAD (De Leo et al. for the World Health Organization, 1998) this is a 49 item self-administered questionnaire which includes core items that assess physical function, self-care, depression and anxiety, cognitive functioning, social functioning, sexual functioning, and life satisfaction. In addition this instrument includes a perceived personality disorder scale, anger scale, social desirability scale, self-esteem scale, and trust in God scale. McGill Quality of Life Questionnaire (Cohen 1995) – a 20 item scale specifically developed to measure quality of life at the end of life. A revised version of this instrument (Cohen et al. 1997) has been developed. The revised version differs from the original in that one question ('I feel close to people...') has been replaced by the question 'I feel supported...not at all/completely'. (See "Review of Potential Instruments" below for a more detailed description of this instrument.) Medical Outcomes Study, Short Form Health Survey (Ware1990) – this 36 item scale is based on the health status measurement of Rand’s Health Insurance Experiment. The following domains are measures: physical functioning, role limitations, bodily pain, social functioning, mental health, vitality, and general health perceptions, a short version the SF-12 survey has been used for persons with head and neck cancer (Terrell et al. 1997). In addition, the MOS SF 36 has been employed in persons with symptomatic HIV disease (Wachtel 1992). Missoula-VITAS Quality of Life Index (Byock and Merrimen, 1995) - there are two versions of this quality of life index which assess symptoms, function, interpersonal domains, well being, and transcendence. (See "Review of Potential Instruments" below for a more detailed description of this instrument.) National Hospice Study Quality of Life Scale (Greer 1984) Nottingham Health Profile (Hunt 1981) – a two section, 46 item scale that measures physical, social, and emotional health problems and their impact on functioning. Painter (unpublished) - a single item asking about the number of “good days” in the last week of life. Parkinson's Disease Quality of Life (PDQL) questionnaire (De Boer et al. 1996) - is a self administered 37 item multi-dimensional quality of life instrument which measures parkinsonian and systemic symptoms and social and emotional functioning. This instrument has been used to measure the impact of Parkinson's Disease on quality of life (Hobson et al. 1999). Perceived Quality of Life Scale (Patrick 1992) - a 20 item questionnaire with questions about health status and satisfaction with functioning. Prostate Cancer Index (Litwin et al 1998) - a multidimensional index that examines generic quality of life based on the work of Ware and colleagues, with new scales of sexuality and urinary symptoms for patients with prostate cancer. PROSQOLI Prostate Cancer Specific Quality of Life Instrument (Tannock et al. 1989) – this instrument measures pain, fatigue, appetite, constipation, physical activity, mood, family/marriage relationships, overall well-being, passing urine and present pain intensity. The PROSQOLI has been employed in a trial comparing it to the EORTC QLQ-C30 and a Trial Specific Module (Stockler et al. 1998). Quality of Life Index (Pedilla 1983) - a short, 14 item scale that measures general physical condition, important human activities, and general quality of life. Quality of Life for Respiratory Illness Questionnaire (Maille 1997) - a 55 item disease- specific scale for patients with mild to moderate chronic non-specific lung disease. Quality of Well-Being scale (Kaplan 1994) - this scale is unique in that it can summarize a patient’s quality of life into one number. The scale assesses mobility, physical activity, social activity, and 27 symptoms. Recently developed was an updated 71-item "mailed version" (Andresen et al. 1998) which was adjusted to overcome the difficulty in administering the earlier version. QOL-ACD Questionnaire for Cancer Patients Treated with Anticancer Drugs (Kurihara et al. 1999) – a 22 item scale that measures daily activity, physical condition, psychological condition, and social attitude, it also includes a Face Scale. QOL-RTI/HN Quality of Life-Radiation Therapy Instrument/Head and Neck Module (Trotti et al 1998, Johnson et al 1996) - is a 39-item instrument which includes 25 general quality of life questions and 14 head and neck specific items. SELF Scale (Linn 1984) - 54 item scale originally developed to measure quality of life among persons age 60 and older. SEIQoL-DW (O'Boyle at al. 1995) - this instrument has two components, first it asks the patient to choose and describe five domains they believe are the most important to their quality of life at that moment. They are then asked to rate how good or bad life is in each of those domains. 100mm Vertical bars are used to rate the domains where 0mm = "worst possible," and 100mm = "best possible". SEIQoL-DW, which has been employed in a study to measure quality of life in cancer patients (Campbell 1999), uses visual analogue scales in place of the 30 hypothetical profiles used in the original longer SEIQoL (O’Boyle et al. 1993) which, has been used in a study that tested the instrument's feasiblity on oncology patients (Broadhead et al. 1998). Sickness Impact Profile (Bergner 1976) – a 136 item instrument which measures how an illness impacts on a persons behavior. A well established instrument that many have utilized as a reference standard in measuring quality of life. SOLQ Seattle Obstructive Lung Disease Questionnaire (Tu et al. 1997) - is a 29 item instrument which measures physical function, emotional function, coping skills, and treatment satisfaction. Southwest Oncology Group Quality of Life Questionnaire (Moinpour 1990) - a scale developed for cancer patients incorporating questions from various function, symptoms, and global quality of life measures. Spitzer QL-Index (Spitzer 1981) – this is one of the earliest QOL instruments that measures activity level, social support, and mental well being. The scale is intended to be completed by a health care professional and consists of only five items. SA-SIP30 Stroke-Adapted 30-Item version of the Sickness Impact Profile to Assess Quality of Life (van Straten et al. 1997) – this questionnaire contains the domains body care and movement, social interaction, mobility, communication, emotional behavior, household management, alertness behavior, and ambulation. TIQ Therapy Impact Questionnaire (Tamburini et al. 1992) – is a 36 item questionnaire that assesses disease and therapy impact relating to physical symptoms, functional status, concomitant emotional and cognitive factors and social interaction. Well-Being Scale (Giasson, 1994) – this is a self-administered visual analogue scale that measures pain, nausea, depression, anxiety, shortness of breath, activity, appetite, relaxation, and inner peace. Review of potential instruments Missoula-VITAS Quality of Life Index, MVQOLI (Byock I.R. & Merriman M.P., 1998)
MVQOLI was designed to measure quality of life of patients with advanced incurable illnesses due to any underlying disease. As such, the target population for this instrument is those people who are aware both of their terminal status and that the goal of care is palliative. The instrument’s scoring system weights each quality of life dimension according to patient-reported importance, and the subjective language intends to measure a patient’s experience as it evolves over the progression of illness. MVQOLI is a patient-reported instrument with a total of 27 items--25 statements tapping five dimensions plus a global quality of life item and an item asking if the respondent completed the questionnaire without assistance. Each item consists either of a single statement with agree/disagree response anchors or of two statements that themselves act as positive and negative response anchors. For each item, a respondent chooses one of five circles between the two anchors, indicating the extent of agreement with the closest anchor; numbers do not mark the response choices. Five dimensions (symptom, function, interpersonal, well-being, and transcendent) were identified by literature review and informal interviews with hospice professionals, patients, and family members. Each dimension contains five statements (two aiming to assess a respondent’s current status regarding the dimension, two measuring satisfaction with the dimension, and one tapping the relative importance of the dimension to the respondent). The assessment and satisfaction items determine whether the dimension score is positive (adding to quality of life) or negative (detracting from quality of life), and the importance item determines the magnitude of the dimension score. ii. Reliability Internal consistency of the overall MVQOLI instrument was tested and shown to be good (Cronbach’s alpha = 0.77). Test-retest reliability was not evaluated. iii. Validity Content/face validity was assessed by hospice professional’s review of the instrument, with a 77% success rate in correctly assigning items to their intended dimensions. Concurrent validity was tested against the MQOLS-CA2 (Multidimensional QOL Scale-Cancer 2), with a Pearson’s correlation coefficient of 0.43. Construct validity
was examined with both convergent and divergent constructs. For convergence,
the MVQOLI dimensions score was compared with the overall quality of
life item, producing a Pearson’s correlation coefficient of 0.43.
For divergence, the MVQOLI score was compared with the KPS (an observer-rated
functional measure), producing a Pearson’s correlation coefficient
of 0.18. MVQOLI has been used with hospice patients primarily with cancer but also with end-stage lung disease and end-stage heart disease. The instrument was designed to serve as a clinical assessment tool to assist in designing care plans and interventions for terminally ill patients. The weighted dimension scores are amenable to graphic representations that can be useful for guiding patient-physician communication and care planning. In addition, the total score is translated into a positive number between 0 and 30; this positive score facilitates an analysis of aggregate group data. v. Burden The instrument was completed by 87% of patients who agreed to participate in the study. Those who completed the instrument were of various education levels and religious backgrounds, and they had known of their terminal status for varying lengths of time. No information is available about the time necessary for completion. vi. Alternative Forms The instrument was
designed as a patient-reported measure. No information is available
on whether completing the questionnaire with assistance impacts its
reliability or validity. MVQOLI has been tested mostly with Caucasian patients. vii. Conceptual Rational for Recommendation MVQOLI was developed specifically to assess the multidimensional quality of life of patients who know that they are dying and that the goal of treatment is palliative. Its weighting system facilitates patient and clinician identification of dimensions of quality of life that need intervention, making it a useful assessment tool for clinical settings. In addition, MVQOLI appears to be a valid measure that is acceptable to dying patients. ix. Future Research Development and testing of shorter versions appropriate for therapeutic trials is ongoing. Future research suggestions include testing whether completing MVQOLI impacts subsequent quality of life (i.e., test-retest reliability), extending its use to non-hospice and non-Caucasian patients with a variety of terminal diagnoses, and moving the global quality of life item to the front of the questionnaire.
McGill Quality of Life Questionnaire (Revised), MQOL (Cohen SR,, Mount BM, Bruera E, et al. 1997) i. Conceptual and Measurement Model MQOL was designed to measure quality of life of people at all stages of a life-threatening illness, from diagnosis to cure or death. The goal of creating the instrument was to overcome some of the shortcomings of traditional measures used to assess patients with life-threatening illnesses. That this, MQOL assesses general domains applicable to all patients, incorporates the existential domain, balances physical and non-physical aspects of quality of life, and includes both positive and negative influences on quality of life. MQOL is a patient-reported instrument that employs 16 items plus a single-item global scale, each with a 2-day time frame. Five domains (physical well-being, physical symptoms, psychological, existential, and support) were identified through principal component analysis, and each of the domains is scored as a separate sub-scale. An overall index score can be calculated from the means of the five sub-scales. The single-item global quality of life scale is included as a validity variable but also can be used in conjunction with the overall MQOL and sub-scale scores. The instrument was designed to be general in nature in order to maintain brevity and to assure applicability to all patients. For example, instead of asking about a long list of symptoms, respondents are asked to list the three symptoms that are the most problematic and then to rate those three symptoms for severity. Each question uses a 0-10 scale with anchors at each end.
ii. Reliability Internal consistency of the MQOL 16-item instrument (does not include the single-item rating) and the sub-scales was examined and found to be good. (The results below were reported in Cohen et al. 1997.)
*The physical well-being item did not load clearly with physical symptoms. As a result, it was considered a single-item and has since been re-written to ensure that it reflects physical well-being rather than general well-being. **The physical symptoms sub-scale consists of three identical items asking respondents to identify their three most troublesome symptoms and then rate the degree to which each has been a problem. Since the most troublesome physical symptoms may be unrelated, the lower internal consistency of this item is not surprising.
Test-retest reliability was tested among oncology patients , and the intraclass correlation coefficients (ICC) were found to be in the medium range (Cohen & Mount 2000).
Responsiveness to change over time was tested among oncology patients by asking patients to rank their days as good, average, or bad (Cohen & Mount 2000). These data were analyzed with three statistical methods.
iii. Validity Construct validity was demonstrated through analysis of patterns of correlations with items from the Spitzer Quality of Life Index and the MQOL’s single-item overall quality of life rating (measured both before and after the completion of the full questionnaires). Both the sub-scale scores and the total score were examined. The strongest evidence of validity comes from comparison with the single-item quality of life measure. Correlation with the single-item quality of life (measured after completing the full questionnaires) was highest with the MQOL total (0.66), followed by physical well-being (0.59), existential well-being scale (0.53), psychological symptoms (0.44), support (0.41), and physical symptoms (0.21). The highest correlations of an MQOL score with a SA-QLI domain are below. The SA-QLI includes a total score and five (5) subcategories (health, outlook, support, activity, and daily living).
Although the MQOL authors initially considered the single item as a validity measure, one of the reviewers [A.S.] suggests that the tests were at the same time validating the single item measure as an overall indicator. These correlations suggest that the single item reflects something different than simply physical and emotional well-being, which is supportive of the single item as tapping a broader concept.
iv. Interpretability MQOL has been used with patients with advanced cancer, patients with cancer at any stage, HIV-positive outpatients, palliative care inpatients, and hospice patients. Both the sub-scale scores and the overall score can range from 0 to 10, facilitating the identification of specific domains that need attention relative to overall quality of life. MQOL has been shown to be useful to providers in a clinical setting and was preferred by nurses over the Hospice Quality of Life Index-Revised instrument (Eischens MJ, Elliott BA, Elliott TE, 1998). The responsiveness to change tests show that the MQOL total score and its subscales (except for support) are able to detect change between good, average, and bad days. As a result, this instrument can be used to measure the impact of interventions in on self-rated type of day (e.g., good, average, or bad) among groups of patients. The instrument is not intended, though, to explain the reasons for high or low scores in the domains. Understanding the reasons behind quality of life scores for specific individuals requires a more in-depth discussion with the patients. In addition, the authors suggest measuring change in a group of patients since the test-retest reliability is not strong enough to be able to measure change in a single patient with confidence. Given this, the authors suggest that MQOL be used as an aid for physicians treating a single patient but not as a replacement for more in-depth conversations.
v. Burden The instrument takes between 10 and 30 minutes to be completed. During one study, two patients reported that completing the MQOL was upsetting, but 60% of the respondents preferred the MQOL to another instrument, primarily due to its comprehensiveness (Pratheepawanit N, Salek MS, Finlay IG, 1999).
vi. Alternative Forms The instrument was designed as a patient self-report measure that can be either self-completed or read aloud to the patient by a staff member. Testing of the instrument has shown that the mode of administration was not significantly correlated with MQOL scores. The mode of administration was correlated, though, with respondent’s age (older patients being more likely to have the questionnaire read aloud to them) and the SA-QLI daily living item (patients with worse daily living scores being more likely to have the questionnaire read aloud to them). vii. Cultural and Language Adaptations The instrument is being developed simultaneously in English and French.
viii. Conceptual Rationale for Recommendation MQOL offers a balanced assessment of both physical and non-physical domains as well as both positive and negative factors associated with quality of life. Although physical symptoms and pain management are crucial for excellent end-of-life care, studies show that non-physical domains (e.g., existential well-being) also are important to the overall quality of life of dying patients. In addition, MQOL appears to be a valid measure that is acceptable to patients, even those in the final few weeks of life (Tierney RM, Horton SM, Hannan TJ, et al. 1998), and the instrument has been shown to be useful for quality improvement efforts in a clinical setting.
ix. Future Research Future studies will contain experimental questions to try to improve the ability of MQOL score to predict the single-item quality of life score. This section was prepared originally by Anita Stewart, Ph.D., and was updated by Lisa C. Welch, M.A. To request a copy of this instrument, contact Dr. Cohen at robin.cohen@muhc.mcgill.ca
The EORTC (European Organization for Research and Treatment of Cancer) Study Group on Quality of Life has developed a family of questionnaires to measure health-related quality-of-life of cancer patients participating in clinical trials. The EORTC approach includes a core instrument (QLQ-C30) that is supplemented by several disease-specific modules. The core instrument addresses issues relevant to all cancer patients (see below for a more detailed review of the core instrument), and the modules address issues specific to each type of cancer or tumor location. To date, eleven disease-specific modules have been developed:
In general, the structure of module questions follows that of the core instrument, i.e. the use of four-point Likert scales or seven-point linear analogue scales. Development teams for these modules include members of several cultures in hopes of ensuring that items are cross-culturally relevant and understandable. Completely validated modules include the LC13, BR23, and H&N35; the other modules are at various stages in the validation and translation processes. Several additional modules are under development, including The Palliative Care Module (Phase II development as of May 15, 2000). All translations begin from an English version of the tool. The translation procedure includes two forward translations into the desired language and two backward translations to check for accuracy. EORTC also publishes several manuals, including one that details the scoring procedures and one that specifies module development guidelines. For more information about or permission to use the EORTC family of instruments, see the EORTC website (www.eortc.be/). EORTC Core Questionnaire, QLQ-C30 (Aaronson, Ahmedzai, Bergman et al. 1993; Osoba, Zee, Pater et al. 1994) i. Conceptual and Measurement Model (Does the scale represent a single domain or do model scales measure distinct domains? Is the variability of the scale reported? If so, please document it. What is the intended level of measurement, i.e. ordinal, interval, ratio or category?) The EORTC core questionnaire was developed to measure aspects of quality of life pertinent to patients with a broad range of cancers who are participating in clinical trials. Since 1986, international field tests have produced several generations of the core questionnaire. The current version of the core instrument (QLQ-C30, version 3) is a 30-item questionnaire consisting of the following:
The core questionnaire generally employs four-point Likert scale response categories (from 1=not at all to 4=very much). The global items, which use seven-point linear analogue scales ranging from 1=very poor to 7=excellent, are an exception to this general rule. The time frame for 25 of the 30 questions is one week; the remaining five questions do not specify a time frame. Iterative testing of reliability and validity have been conducted with large groups of patients with a wide variety of cancers, including breast, gynecological (cervical, endometrial, and ovarian), and lung cancers. Note: Unless otherwise indicated, the reliability and validity information reported below refers to version 2 of the questionnaire. ii. Reliability (Did they address internal consistency? Did they address reproducibility?) Internal consistency of the scales in version 2 was tested and found to be good (Cronbach’s alpha >.70), with the exception of the role function and cognitive function scales (Aaronson, Ahmedzai, Bergman et al. 1993; Osoba, Zee, Pater et al. 1994). Psychometric tests of modifications to version 2 of the questionnaire reveal improved internal consistency of the role functioning scale, with a Cronbach’s alpha ranging from 0.78 to 0.88 (Osoba D, Aaronson N, Zee B et al. 1997). Test-retest reliability information was not found. iii. Validity (How did they address content reliability? Any information on construct related validity? Any information on criterion validity?) Content/face validity was tested and shown to be acceptable. Inter-scale correlations were statistically significant but of only moderate size, indicating that scales assess distinct components of the concept of quality of life (Aaronson, Ahmedzei, Bergman et al. 1993). As expected, the strongest correlations were found between the physical function, role function and fatigue scales. Agreement between patients and researchers interpretations of questions also has been shown to be high (Groenvold, Klee, Sprangers, & Aaronson 1997). Construct validity has been demonstrated by the ability to discriminate between clinically relevant groups and by convergent validity with other scales.
iv. Responsiveness (Any information? Has the scale ever been used as an outcome measure? If so, what populations?) Comparisons between questionnaires completed at pre-treatment and on-treatment reveal an ability of the QLQ-C30 to detect change over time. For example, once patients were categorized according to evidence of performance status improvement after treatment, Aaronson, Ahmedzai, Bergman et al. (1993) found responsiveness in five sub-scales (physical function, role function, fatigue, nausea and vomiting, global quality of life). v. Interpretability (What populations has it been applied to? Is the score translated into a clinically relevant event? Does the score predict outcome events?) Raw scores for each sub-scale are calculated by averaging the sum of scores for each item in that sub-scale. Scores are standardized to range from 0 to 100, with higher scores representing higher levels of functioning or more symptoms. Scores are not weighted for relative importance. Overall quality of life scores correspond to the two global items, not to a sum of the sub-scale scores. A comparison between a subjective significance questionnaire and the QLQ-C30 demonstrated concordance, showing that changes in QLQ-C30 scores are meaningful in terms of small, moderate, or large changes in quality of life (Osoba, Rodrigues, Myles et al. 1998). In addition, EORTC publishes a Reference Values Manual to facilitate use of the QLQ-C30 and interpretation of scores. vi. Burden (Any information on cost or time to administer? Does the instrument impact on the respondent? How long does a survey take to complete? Response rates? Any problems with the missing data?) Most patients appreciated the opportunity to report their experiences, and few required assistance to complete the questionnaire. The average time for completion was between 11 and 12 minutes. (Aaronson, Ahmedzei, Bergman et al. 1993) vii. Alternative forms (What are the modes of administration? Alternatives? If an alternative exists, provide what is known for each of the above categories.) The QLQ-C30 questionnaire is patient self-reported. At times, the questionnaire also has been administered as part of an interview due to low patient performance status or preference. The interview administration showed no difference in item responses (Aaronson, Ahmedzei, Bergman et al. 1993). In addition, a computerized program with a touch-sensitive video monitor response system has been found to be highly acceptable to patients, with a mean completion time of 6.8 minutes and no unanswered items (Buxton, White, Osoba 1998). viii. Cultural and Language Adaptations (any information?) The core instrument has been translated into and validated in 38 languages. In addition, psychometric validation studies have been carried out among culturally diverse groups with satisfactory results (see Aaronson, Ahmedzai, Bergman et al. 1993; Osoba, Aaronson, Zee et al. 1997). ix. Conceptual rationale for recommendation QLQ-C30 is a relatively brief and well-tolerated instrument appropriate for use in clinical trials. The diverse membership of the EORTC Quality-of-Life Study Group has fostered cross-cultural collaboration throughout the instrument’s development, which makes the instrument useful for international as well as nationally-based trials. As a core instrument, the QLQ-C30 provides a base of comparable data across tumor sites, languages, and cultures. x. Future Research Ongoing research focuses on the translation and validation of modules to supplement the QLQ-C30. In addition, research concerning the responsiveness of the QLQ-C30 (as measured by comparison with subjective significance questionnaires) is continuing.
FACT/FACIT family of instruments The FACIT family of instruments assesses the health-related quality of life of people living with chronic illnesses. The measurement system began as a cancer-specific tool (Functional Assessment of Cancer Therapy, FACT) but has expanded to include other chronic illnesses as well (Functional Assessment of Chronic Illness Therapy, FACIT). In addition to the Functional Assessment of Cancer Therapy core questionnaire (see below for more detail) and supplemental sub-scales, the FACIT measurement system also includes the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI - Peterman AH, et al. 1997), the Functional Assessment of Multiple Sclerosis (FAMS) and an instrument for use with patients with Parkinson’s disease. The Functional Assessment of Cancer Therapy consists of a core instrument (FACT-G) that can be supplemented by various sub-scales. The core instrument addresses domains applicable to patients living with a wide variety cancers and other chronic illnesses, while the "additional concerns" sub-scales measure issues particular to a specific disease, treatment, or symptom. Sub-scales are added to the core instrument to create the following measures (also see www.glamm.com/ql/symp_inst.htm): Disease-specific concerns
Treatment-specific concerns
Symptom-specific concerns
Other available sub-scales include non-life threatening conditions (FANLTC), spiritual well-being (FACT-Sp), and palliative care. The FACIT Multilingual Translation Project aims to ensure that each questionnaire is relevant across cultures and languages without compromising reliability and validity (see Lent et al. 1999). The core questionnaire has been translated into over 30 languages, and some sub-scales (e.g., FACT-An, FACT-B, FACT-L) have been translated into several languages as well. Information on scoring and initial validation studies are available in the F.A.C.T. Manual. For more information or permission to use for all languages, contact the original version author, David F. Cella (d-cella@nwu.edu). FACIT Core Questionnaire, FACT-G (Cella et al. 1993, Lent et al. 1999) i. Conceptual and Measurement Model (Does the scale represent a single domain or do model scales measure distinct domains? Is the variability of the scale reported? If so, please document it. What is the intended level of measurement, i.e. ordinal, interval, ratio or category?) From its beginnings in 1987, FACT was intended to measure health-related quality of life for cancer patients participating in clinical trials. Quality of life was conceived as multidimensional and subjective. In order to include patient perceptions and values, input from cancer patients was combined with views of researchers and oncology specialists in order to shape the content and format of the original questionnaire. In addition, simplicity of the instrument was important in order for it to be feasible for use in clinical trials. The core/sub-scale model was based on the belief that a general set of questions would be relevant to all cancer patients and could be supplemented by other questionnaires more specific to a tumor site or symptom. FACT-G (version 4) is a 27-item questionnaire that measures four domains of quality of life (physical well-being, functional well-being, social/family well-being, emotional well-being). Version 4 includes as optional those items in version 3 that were intended to weigh the importance of each domain at the end of a sub-scale (including the supplemental "additional concerns" sub-scales). FACT-G employs a five-point Likert scale (0=not at all, 4=very much) for all questions. The optional weighting items use an 11-point scale [0=not al all, 10=very much so]. Note: Unless otherwise noted, psychometric results are based on testing of the 28-item second version of the core instrument (Cella DF et al. 1993). Versions 3 and 4 were modified mostly based on cross-cultural and cross-linguistic research, which did not compromise the instrument’s reliability and validity (Winstead-Fry P & Schultz A 1997; Lent et al. 1999). In addition, the psychometric results for version 2 were replicated in a rural sample (Winstead-Fry & Schultz 1997). ii. Reliability (Did they address internal consistency? Did they address reproducibility?) Internal consistency was tested and shown to be good.
*The "relationship with doctor" sub-scale was removed from version 4; a Treatment Satisfaction scale is being developed to explore this domain more thoroughly. Test-retest reliability of version 2 was examined with 60 patients and shown to be good (correlation coefficients ranging from .82 to .92). iii. Validity (How did they address content reliability? Any information on construct related validity? Any information on criterion validity?) Content/face validity was built-in to the development of the instrument by relying on both patients and oncology specialists to shape the content and form of the questionnaire. The FACIT Multilingual Translation Project’s iterative forward-backward-forward technique further ensures content validity for both non-English translations and the original English version. Construct validity of the 28-item version 2 instrument was examined with both convergent (FLIC, B-POMS, TMA, ECOG-PSR) and divergent (M-CSDS) constructs, revealing satisfactory Pearson correlation coefficients in the expected directions.
In addition, the total score was able to differentiate patients according to stage of disease, ECOG PSR, and location of administration (e.g., inpatient, outpatient). iv. Responsiveness (Any information? Has the scale ever been used as an outcome measure? If so, what populations?) Given that FACT-G is intended to be used in clinical trials, responsiveness is a key criterion. When using the indicator of performance status rating (PSR), FACT-G was shown to be responsive to change over time--particularly the physical and functional sub-scales, as expected. Psychometric tests on FACT-P (Esper et al. 1997) and FACT-B (Brady et al. 1997) also have demonstrated responsiveness. v. Interpretability (What populations has it been applied to? Is the score translated into a clinically relevant event? Does the score predict outcome events?) FACT-G has been combined with "additional concerns" sub-scales for use with patients with a wide variety of cancers. In addition, FACT-G has been incorporated in FACIT instruments focusing on other chronic illnesses (including HIV, multiple sclerosis, and Parkinson’s disease). Sub-scales are scored by adding or subtracting (depending on the wording of the question) scores for each item; the total score is a sum of each sub-scale score. For both sub-scales and the total score, higher scores reveal a more positive quality of life. vi. Burden (Any information on cost or time to administer? Does the instrument impact on the respondent? How long does a survey take to complete? Response rates? Any problems with the missing data?) Patients were able to complete version 2 of the questionnaire within 5 minutes and typically did not require assistance (Cella D et al. 1993). Given the scoring system of the FACT-G, non-response to individual items presents a problem. Research shows that substituting the mean of the completed items in a sub-scale (when more than half of the sub-scale is completed) is a reasonable approach for dealing with missing data (Fairclough DL & Cella DF 1996). vii. Alternative forms (What are the modes of administration? Alternatives? If an alternative exists, provide what is known for each of the above categories.) FACT-G is a patient-reported instrument. viii. Cultural and Language Adaptations (any information?) Version 4 incorporates changes based on the FACIT Multilingual Translation Project, which aims to ensure that each questionnaire is relevant across cultures and languages (Lent et al. 1999). FACT-G has been translated from English into over 30 languages, including Afrikaans, Bulgarian, Chinese (Taiwan/HongKong), Chinese (Mainland), Czech, Danish, Dutch German, Greek, French, Hebrew, Hungarian, Italian, Japanese, Norwegian, Polish, Portuguese, Russian, Tswana, Pedi, Zulu, Spanish, Swedish, and Thai. ix. Conceptual rationale for recommendation Since FACT-G was developed specifically for use in clinical trials, it is a brief instrument that appears acceptable to chronically ill patients. The optional weighting items at the end of each sub-scale provide a good opportunity for clinicians to judge the importance of each domain to a particular patient. As a general instrument, FACT-G produces a base of comparable information across diseases, treatments, and symptoms. In addition, the FACIT Multilingual Translation Project facilitates cross-cultural comparisons. x. Future Research Ongoing research is focusing on full validation of the non-English measures (Lent et al. 1999), which will allow for comparisons across cultures.
References 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 Nat Cancer Inst 1993;85:365-376. Andresen EM, Rothenberg BM, Kaplan RM. Performance of a self-administered mailed version of the Quality of Well-Being (QWB-SA) questionnaire among older adults. Med Care 1998;36:1349-1360. Axelsson B, Sjoden PO. Assessment of quality of life in palliative care. Acta Oncologica 1999;38:229-237. Bergman B, Aaronson NK, Ahmedzai S, et al. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer 1994;30A:635-642. Bergner M, Bobbitt RA, Pollard WE. Sickness Impact Profile: validation of a health status measure. Med Care 1976;14:57-61. Bjordal K, Hammerlid E, Ahlner Elmqvist M, et al. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol 1999;17:1008-1019 Blazeby JM, Alderson D, Winstone K, et al. Development of an EORTC questionnaire module to be used in quality of life assessment for patients with oesophageal cancer. Eu J Cancer 1996;32A:1912-1917. Broadhead JK, Robinson JW, Atkinson MJ. A new quality-of-life measure for oncology: the SEIQoL. J Psychosoc Oncol 1998;16:21-35. Buxton J, White M, Osoba D. Patients’ experiences using a computerized program with a touch-sensitive video monitor for the assessment of health-related quality of life. Qual Life Res 1998;7:513-19. Byock, IR. Missoula-VITAS Quality of Life Index: Version-25S. Missoula, MT: VITAS Healthcare Corporation, 1995. Byock, IR, Merriman MP. Measuring quality of life for patients with terminal illness: the Missoula-VITAS Quality of Life Index. Palliat Med 1998;12:231-244. Campbell S, Whyte F. Quality of life of cancer patients participating in phase I clinical trials using SEIQoL-DW. J Adv Nurs 1999;30:335-343. Cella DF, Tolsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993;11:570-579. Cella DF, Bonomi AE, Lloyd SR, et al. Reliability and validity of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life instrument. Lung Cancer 1995;12:199-220. Cella DF, McCain NL, Peterman AH, et al. Development and validation of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Qual Life Res 1996;5:450-63. Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol 1997;34:13-19. Cohen SR, Mount BM, Strobel MG, et al. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med 1995;9:207-219. Cohen SR, Mount BM, Bruera E, et al. Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med 1997;11:3-20. Cohen SR, Hassan SA, Lapoint BJ, Mount BM. Quality of life in HIV disease as measured by the McGill Quality of Life Questionnaire. AIDS 1996;10:1421-7. Cohen R.S. & Mount B.M. Living with Cancer: "Good" Days and "Bad" Days—What Produces Them? Cancer. 2000, October 15; 89, 8: 1854-1865. De Boer AGEM, Wijker W, Speelman JD, et al. Quality of life in patients with Parkinson's disease: development of a questionnaire. J Neurol Neurosurg Psychiatry 1996;61: 70-74. De Leo D, Diekstra FW, Lonnqvist J, et al. LEIPAD, an internationally applicable instrument to assess quality of life in the elderly. Behav Med 1998;24:17-27. Eischens MJ, Elliott, BA, Elliott, TE. Two hospice quality of life surveys: a comparison. American J Hosp PalliatCare 1998; 143-148. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208. Fairclough DL & Cella DF. Functional Assessment of Cancer Therapy (FACT-G): non-response to individual questions. Qual Life Res 1996;5:321-329. Ferrell BR, Hassey-Dow K, Grant M. Measurement of the QOL in cancer survivors. Qual Life Res 1995;4:523-31. Ferrans CE, Powers MJ. Quality of Life Index: development and psychometric properties. Adv Nurs Sci 1985;8:15-24. Finkelstein DM, Cassileth BR, Bonomi PD, et al. A pilot study of the Functional Living Index-Cancer (FLIC) scale for the assessment of quality of life for metastatic lung cancer patients. Am J Clin Oncol 1988;11:630-633. Giasson M, Bouchard L. Effect of therapeutic touch on the well-being of persons with terminal cancer. J Hol Nurs 1998;16:383-398. Gower NH, Rudd RM, Ruiz de Elvira MC, et al. Assessment of ‘quality of life’ using a daily diary card in a randomised trial of chemotherapy in small-cell lung cancer. Ann Oncol 1995;6:575-80. Greer DS, Mor V, Sherwood S, et al. National Hospice Study Final Report. Brown University: Providence, RI, 1984. Groenvold M, Klee MC, Sprangers MAG, & Aaronson NK. Validation of the EORTC QLQ-C30 Quality of Life Questionnaire Through Combined Qualitative and Quantiative Assessment of Patient-Observer Agreement. J Clin Epidemio 1997;50:441-450. Guyatt GH, Berman LB, Townsend M, et al. A measure of quality of life for clinical trials in chronic lung disease. Thorax 1987;42:773-778. Hobson P, Holden A, Meara J. Measuring the impact of Parkinson's Disease with the Parkinson's Disease Quality of Life questionnaire. Age Ageing 1999;28:341-346. Holmes WC, Shea JA. Two approaches to measuring quality of life in the HIV-AIDS population: HAT-QoL and MOS-HIV. Qual Life Res 1999;8:515-527. Howat SJ, Cull A, Greimel E, et al. The construction of an Ovarian Cancer Module. Edinburgh, Internal Report of the EORTC Study Group on Quality of Life, 1997. Hunt S, McKenna SP, McEwen J, et al. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med 1981;15 A:221-229. Johnson DJ, Casey L, Noriega B. A pilot study of patient quality of life during radiation therapy treatment. Qual Life Res 1994;3:267-272. Juarez G, Ferrell B, Borneman T. Cultural considerations in education for cancer pain managment. J Cancer Educ 1999;14:168-173. Kurihara M, Shimizu H, Tsuboi K, et al. Development of quality of life questionnaire in Japan: quality of life assessment of cancer patients receiving chemotherapy. Psycho-Oncol 1999;8:355-363. Leplege A, Rude N, Ecosse E, et al. Measuring quality of life from the point of view of HIV-positive subjects: the HIV-QL31. Qual Life Res 1997;6:585-594. Linn MW, Linn BS. Self-evaluation of life function (SELF) scale: a short, comprehensive self-report of health for elderly adults. J Gerontol 1984;39:603-612. List MA, D'Antonio LL, Cella DF, et al. The Performance Status Scale for head and neck cancer patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer 1996;77:2294-2301. Litwin MS, Hays RD, Fink A, et al. The UCLA Prostate Cancer Index. Development, reliability, and validity of a health-related quality of life measure. Med Care 1998;7:1002-1012. Maille AR, Koning CJ, Zwiderman AH, et al. The development of the ‘Quality-of-life for Respiratory Illness Questionnaire (QOL-RIQ)’: a disease-specific quality of life questionnaire for patients with mild to moderate chronic non-specific lung disease. Respir Med 1997;91:297-309. McLachlan SA, Devins GM, & Goodwin PJ. Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (LQ-C30) as a Measure of Psychosocial Function in Breast Cancer Patients. Eur J Can 1998;434:510-517. McMillan SC. Quality of life in hospice patients. ONF 1996;22:1401-9. McQuellon RP, Russell GB, Cella DF, et al. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplantation 1997;19:357-368. Moinpour CM, Hutchinson F, Hayden K, et al. Quality of life assessment in Southwest Oncology Group trials. Oncology-Huntington 1990;4:79-93. Nelson EC, Wasson JH, Johnson DJ, et al. Dartmouth COOP functional health assessment charts: brief measures for clinical practice. In: Spilker, B, ed. Quality of Life and Pharmacoeconomics in Clinical Trials. 2nd edition. Philadelphia: Lippincott-Raven Publishers, 1996. O'Boyle CA, McGee HM, Hickey A. The Schedule for the Evaluation of Individual Quality of Life: administration Manual. Dublin: Royal College of Surgeons in Ireland, Department of Psychology, 1993. O'Boyle CA, Browne J, Hickey A, et al. Schedule for the Evaluation of Individual Quality of Life (SEIQoL-DW): a direct weighting procedure for quality of life domains (SEIQoL-DW). Administration Manual. Dublin: Royal College of Surgeons in Ireland, Department of Psychology, 1995. Osoba D, Aaronson NK, Muller K, et al. The development and psychometric validation of a brain cancer quality-of-life questionnaire for use in combination with general cancer-specific questionnaires. Qual Life Res 1996;5:139-150. Osoba D, Aaronson N, Zee B, et al. Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer. The Study on Quality of Life of the EORTC and the Symptom Control and Quality of Life Committees of the NCI of Canada Clinical Trials Group. Qual Life Res 1997; 6:103-108. Osoba D, Rodrigues G, Myles, J et al. Interpreting the Significance of Changes in Health-Related Quality-of-Life Scores. J Clin Oncol 1998;16:139-144. 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, ovarian and lung cancer. Qual Life Res 1994;3:353-364. Padilla GV, Presant C, Grant M et al. Quality of Life Index for patients with cancer. Research in Nursing and Health 1983;6:117-126. Patrick D. Perceived quality of life scale. Revised March 1992. Peterman AH, Cella D, Mo F, McCain N. Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument.Qual Life Res 1997;6:572-584. Pratheepawanit N, Salek MS, Finlay IG. The applicability of quality-of-life assessment in palliative care: comparing two quality of life measures. Palliat Med 1999;13:325-334. Rabins PV, Kasper JD, Kleinman L, et al. Concepts and methods in the development of the ADRQL: an instrument for assessing health-related quality of life in persons with Alzheimer's Disease. J Mental Health Aging 1999;5:33-48. Schag CA, Ganz PA, Heinrich RL. Cancer Rehabilitation Evaluation System-Short Form (CARES- SF): a cancer specific rehabilitation and quality of life instrument. Cancer 1991;6:1406-1413. Spitzer WO, Dobson AJ, Hall J, et al. Measuring quality of life of cancer patients: a concise QL- Index for use by physicians. J Chron Dis 1981;34:585-597. Sprangers MA, Groenvold M, Arraras JI, et al. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996;14:2756-2768. Stead ML, Brown JM, Velikova G, et al. Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Br J Haematol 1999;104:605-611. Stewart AL, Hays RD, Ware JE. The MOS short-form general health survey: reliability and validity in a patient population. Med Care 1988;26:724-735. Stockler MR, Osoba D, Goodwin P, et al. Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a Trial Specific Module.J Clin Epidemiol 1998;51:137-145. Tamburini M. Quality of life assessment in advanced cancer research: the Therapy Impact Questionnaire. New Trends Experiment Clin Psychiatry 1997;8:64-67. Tannock I, Gospodarowicz M, Meakin W, et al. Treatment of metastatic prostate cancer with low dose prednisone: evaluation of pain and quality of life as pragmatic indices of response. J Clin Oncol 1989;7:590-597. Terrell JE, Nanavati KA, Esclamado RM, et al. Head and neck cancer-specific quality of life. Arch Otolaryngol Head Neck Surg 1997;123:1125-1132. Tierney RM, Horton, SM, Hannan, TJ, Tierney WM. Relationships between symptom relief, quality of life, and satisfaction with hospice care. Palliat Med. 1998;12:333-344. Trotti A, Johnson DJ, Gwede C et al. Development of a head and neck companion module for the Quality of Life-Radiation Therapy Instrument (QOL-RTI). Int J Rad Oncol Biol Phys 1998;42:257-261. Tu SP, McDonell MB, Spertus JA, et al. A new self-administered questionnaire to monitor health-related quality of life in patients with COPD. Chest 1997;112:614-622. van Straten A, de Haan RJ, Limburg M, et al. A Stroke-Adapted 30-Item Version of the Sickness Impact Profile to Assess Quality of Life (SA-SIP30). Stroke 1997;28:2155-2161. Velikova G, Wright EP, Smith AB, et al. Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires. J Clin Oncol 1999;17:998-1007. Wachtel T, Piette J, Mor V, et al. Quality of life in persons with human immunodificiency virus infection: measurement by the medical outcomes study instrument. Ann Intern Med 1992;116:129- 137. Weitzner MA, Meyers CA, Gelke CK, et al. The Functional Assessment of Cancer Therapy (FACT) Scale. Development of a brain subscale and revalidation of the general version (FACT-G) in patients with primary brain tumors. Cancer 1995;75:1151-1161. Winstead-Fry P & Schultz A. Psychometric Analysis of the Functional Assessment of Cancer Therapy-General (FACT-G) Sclae in a Rural Sample. Cancer 1997;79:2446-2452. Updated by Lisa C. Welch 8/30/00 |
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This web site is published by the Center for Gerontology and Health Care Research, Brown Medical School. For further information, e-mail Dr. Joan Teno or contact her at Brown Medical School, Box G-HLL, Providence, RI, 02912, USA. For questions or comments regarding this website, please e-mail the webmaster. Last edited February 17, 2004. |
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