Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.

PURPOSE: This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS: Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION: The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.

Validation of the United States' version of the World Health Organization Quality of Life (WHOQOL) instrument.

In 1991, the World Health Organization initiated a project to simultaneously develop a quality of life (QOL) instrument in 15 countries: The World Health Organization Quality of Life (WHOQOL) instrument. This was intended as a generic QOL tool for use with patients across varying disease types, severities of illness, and cultural subgroups. The objective of the current study was to evaluate the WHOQOL-100 in the U.S., one of the original 15 participating countries. The WHOQOL is a 100-item self-report instrument consisting of 24 subscales within six domains: Physical, Psychological, Independence, Social, Environment, and Spiritual. Four additional items pertain to overall QOL/health. We tested the WHOQOL-100 (U.S. version) in a sample of 443 adults (n = 251 chronically ill, n = 128 healthy, and n = 64 childbearing) in the U.S. to test its reliability (internal consistency, test-retest), construct validity (convergent, discriminant), responsiveness, and factor structure. The WHOQOL-100 (U.S. version) has acceptable internal consistency (alpha range: 0.82-0.95 across domains) and reproducibility (ICC range: 0.83-0.96 at 2-week retest interval). It is responsive to change in clinical conditions, as evidenced by predicted score change (effect size) in women after childbirth. Construct validity was demonstrated by (1) its correlation with the Short Form-36 and Subjective Quality of Life Profile, and (2) its ability to discriminate between the diverse samples in this study. The conceptual structure was confirmed exactly with the exception of four facets that did not correlate most highly with the domains to which they were originally assigned, but these differences were minor. The WHOQOL measurement system is suitable for evaluating the QOL of adults in the U.S. The psychometric properties will be continually evaluated as more data become available in the U.S.

Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument.

The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.

Measuring quality of life: 1995 update.

Often, new treatments for cancer are evaluated solely on the basis of increased survival, depriving us of valuable information about other benefits and drawbacks of these treatments. It is important to raise the question of the quality of life as a companion to the question of quantity of life. The trade-off is not always between toxicity vs survival time; sometimes a treatment, however toxic, affords benefit not by virtue of increasing survival, but by palliation of tumor-induced pain or obstruction. Included in this paper is a table that reviews many available quality of life measures that have been designed for, or frequently used with, people with cancer. Proper selection of measures and supplementary questions is an important first step toward a successful evaluation of quality of life. Samples of many of these scales are included in the appendix.

Psychometric properties of the VSQLQ in black patients with mild hypertension. Vital Signs Quality of Life Questionnaire.

The Vital Signs Quality of Life Questionnaire (VSQLQ) is a condition- and culture-specific measure designed to assess health-related quality of life (HRQL) in black patients with hypertension. This study examined the instrument's reliability and validity when administered via personal interview to patients with mild systemic hypertension. Data were gathered from 304 black patients during the screening visit of a multicenter trial evaluating the efficacy of candesartan cilexetil (ATACAND). In addition to internal consistency and reproducibility, validity was assessed by correlating the VSQLQ with the Short Form-36 (SF-36). Sensitivity to sociodemographic effects and responsiveness to change was also examined. Cronbach's alpha levels were high (0.90, 0.92, 0.92 for frequency, intensity and combined scores, respectively) and the instrument was stable in patients reporting no health change over 8 weeks (ICC = 0.79, 0.79, and 0.80). Correlations between the VSQLQ and the SF-36 were moderate to high (0.32 to - 0.69) and statistically significant (p < 0.001). VSQLQ scores varied by gender, education, and income (p < 0.05). Patients who reported improvement in their general health status also reported significant improvements on the VSQLQ (n = 90; p < 0.05). Results support the reliability and validity of VSQLQ administered via personal interview to black patients with mild systemic hypertension.

Ascertainment of intimate partner violence using two abuse measurement frameworks.

OBJECTIVE: To estimate prevalence of intimate partner violence (IPV) according to two abuse ascertainment tools, and agreement between the tools. METHODS: 2504 women randomly selected from a health maintenance organization were asked about IPV exposure in their most recent intimate relationship using five questions on physical and sexual abuse, and fear due to partner's threats and controlling behavior from the Behavioral Risk Factor Surveillance Survey (BRFSS) and 10 questions from the Women's Experience with Battering (WEB) scale. IPV prevalence was estimated according to the BRFSS and WEB, and the proportion of women who were WEB+/BRFSS+, WEB-/BRFSS-, WEB-/BRFSS+, and WEB+/BRFSS-. RESULTS: In their most recent relationship, 14.7% of women reported abuse of any type on the BRFSS versus 7.0% on the WEB scale. In direct comparisons of the WEB and BRFSS questions, a higher percentage of abused women reported any IPV on the five BRFSS questions (88.4%) compared to the 10 WEB questions (42.0%). However, both the BRFSS and WEB identified some women as abused that would have been missed by the other instrument. CONCLUSIONS: Intimate partner violence prevalence depends on how women are asked about abuse. Resources permitting, more than one abuse ascertainment strategy (for example, both the BRFSS and WEB questions) should be tried in order to broadly identify as many women as possible who interpret themselves as abused.

Quality-of-life assessment in acute, chronic, and cancer pain: a pharmacist's guide.

OBJECTIVE: To describe instrumentation, or measures, available for use in assessing the impact of pain on the quality of life (QOL) of patients, and methods to evaluate the appropriateness of these QOL measures. DATA SOURCES: MEDLINE, PSYCHLit, and CANCERLit were searched from 1980 through 1997 to identify QOL instruments that included a pain subscale or pain-related items. DATA SYNTHESIS: Given the high prevalence of chronic diseases or conditions that include pain as a primary or secondary symptom, pharmacists should understand how pain affects the QOL of patients. Over the past two decades, emphasis has increased on developing instruments that assess health-related QOL concerns, including pain. Scores of measures--including utility measures--are available to measure general QOL in patients with conditions involving pain. Condition-specific instruments have also been developed to measure the impact of specific conditions, such as arthritis, on QOL. Guidelines are presented for evaluating QOL instrumentation, and existing measures used to evaluate the QOL of patients with acute and chronic pain are described. Pharmacists can use these guidelines to evaluate the usefulness of existing instruments for assessing the QOL of patients with pain. CONCLUSION: Using QOL measures in everyday practice may assist pharmacists in gaining insight into the effects of pain on their patients' QOL. This information may be useful in developing treatment programs that minimize pain and its associated side effects while maximizing patients' well-being.

Cancer pain management: barriers, trends, and the role of pharmacists.

OBJECTIVES: To describe barriers to optimal cancer pain management, activities that have been implemented in recent years to partially overcome these barriers, and the importance of the pharmacist's role in the cancer pain management process. SUMMARY: Cancer pain management remains a formidable challenge. Barriers in the United States include inadequate provider training; patients' reluctance to report pain; and deficiencies within the health care infrastructure, such as restrictive regulation of controlled substances and inadequate insurance coverage. Despite these barriers, recent efforts have raised awareness of the gap between suboptimal and optimal cancer pain management. These include: the development of guidelines (and the conduct of scientific studies) to educate providers about pain management or gaps in the cancer pain management process; regulation that has lessened provider restrictions in prescribing analgesics; the emergence of patient and provider advocacy groups; and the development of pain assessment instruments. Because of their clinical and pharmacologic expertise, pharmacists are crucial to the shaping and success of cancer pain management strategies in the United States today. CONCLUSION: Despite its high prevalence and the increasing awareness of the effects of pain on quality of life, cancer pain management remains secondary to treatment of the disease itself. Refining the cancer pain management process in the United States will depend on continued education and emphasis on pain assessment and a proactive approach to pain management, provider groups' effective collaboration with each other and with patients, and overcoming legal, regulatory, and cost barriers.

Spanish language translation and initial validation of the functional assessment of cancer therapy quality-of-life instrument.

OBJECTIVES: There is a need in the United States for culture-equivalent assessment of health-related quality of life, particularly among people who speak different languages and among those with low literacy skills. This report summarizes the adaptation of the Functional Assessment of Cancer Therapy (FACT) Scales for use with Spanish-speaking cancer patients, including those with low literacy. METHODS: The Spanish language version of the general Functional Assessment of Cancer Therapy scale plus five disease-specific subscales (breast, lung, colorectal, head and neck, HIV infection) were translated, reviewed, and revised, then evaluated in interviews with Spanish-speaking patients from the mainland United States and Puerto Rico. An iterative forward-backward-forward sequence of item translation, expert bilingual/bicultural advisor review, pretesting interviews with 92 patients, and further expert advisory input were used to establish semantic, content, and partial technical equivalence. RESULTS: The Functional Assessment of Cancer Therapy-General and five disease-specific subscales were translated successfully into wording that was easily understood and answered, leading to psychometric and scoring data similar to that of the English version. All but one of the 28 Functional Assessment of Cancer Therapy-General items and all of the disease-specific items were seen as culturally relevant. The result is a document that underwent iterative forward-backward translation and evaluation and was pretested successfully with native Spanish-speaking oncology patients living in the Central United States and Puerto Rico. CONCLUSIONS: The Functional Assessment of Cancer Therapy-General and five disease-specific subscales have been translated successfully into Spanish using a thorough translation and initial validation methodology. The methods and data provide a model for preparing a health status questionnaire for cross-cultural validation. The questionnaire is available for use in clinical trials and clinical practice.

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system.

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

Quality improvement in chronic illness care: a collaborative approach.

BACKGROUND: Despite rapid advances in the clinical and psycho-educational management of diabetes, the quality of care received by the average patient with diabetes remains lackluster. The "collaborative" approach--the Breakthrough Series (BTS; Institute for Healthcare Improvement [IHI]; Boston)--coupled with a Chronic Care Model was used in an effort to improve clinical care of diabetes in 26 health care organizations. METHODS: Descriptive and pre-post data are presented from 23 health care organizations participating in the 13-month (August 1998-September 1999) BTS to improve diabetes care. The BTS combined the system changes suggested by the chronic care model, rapid cycle improvement, and evidence-based clinical content to assist teams with change efforts. The characteristics of organizations participating in the diabetes BTS, the collaborative process and content, and results of system-level changes are described. RESULTS: Twenty-three of 26 teams completed participation. Both chart review and self-report data on care processes and clinical outcomes suggested improvement based on changes teams made in the collaborative. Many of the organizations evidencing the largest improvements were community health centers, which had the fewest resources and the most challenged populations. DISCUSSION: The initial Chronic Illness BTS was sufficiently encouraging that replication and evaluation of the BTS collaborative model is being conducted in more than 50 health care systems for diabetes, congestive heart failure, depression, and asthma. This model represents a feasible method of improving the quality of care across different health care organizations and across multiple chronic illnesses.