Amy E. Bonomi

The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.

PURPOSE We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scales ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patients perspective.

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.

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.

Assessment of chronic illness care (ACIC): a practical tool to measure quality improvement.

OBJECTIVE To describe initial testing of the Assessment of Chronic Illness Care (ACIC), a practical quality-improvement tool to help organizations evaluate the strengths and weaknesses of their delivery of care for chronic illness in six areas: community linkages, self-management support, decision support, delivery system design, information systems, and organization of care. DATA SOURCES (1) Pre-post, self-report ACIC data from organizational teams enrolled in 13-month quality-improvement collaboratives focused on care for chronic illness; (2) independent faculty ratings of team progress at the end of collaborative. STUDY DESIGN Teams completed the ACIC at the beginning and end of the collaborative using a consensus format that produced average ratings of their systems approach to delivering care for the targeted chronic condition. Average ACIC subscale scores (ranging from 0 to 11, with 11 representing optimal care) for teams across all four collaboratives were obtained to indicate how teams rated their care for chronic illness before beginning improvement work. Paired t-tests were used to evaluate the sensitivity. of the ACIC to detect system improvements for teams in two (of four) collaboratives focused on care for diabetes and congestive heart failure (CHF). Pearson correlations between the ACIC subscale scores and a faculty rating of team performance were also obtained. RESULTS Average baseline scores across all teams enrolled at the beginning of the collaboratives ranged from 4.36 (information systems) to 6.42 (organization of care), indicating basic to good care for chronic illness. All six ACIC subscale scores were responsive to system improvements diabetes and CHF teams made over the course of the collaboratives. The most substantial improvements were seen in decision support, delivery system design, and information systems. CHF teams had particularly high scores in self-management support at the completion of the collaborative. Pearson correlations between the ACIC subscales and the faculty rating ranged from .28 to .52. CONCLUSION These results and feedback from teams suggest that the ACIC is responsive to health care quality-improvement efforts and may be a useful tool to guide quality improvement in chronic illness care and to track progress over time.

Self-Management Aspects of the Improving Chronic Illness Care Breakthrough Series: Implementation With Diabetes and Heart Failure Teams

Self-management is an essential but frequently neglected component of chronic illness management that is challenging to implement. Available effectiveness data regarding self-management interventions tend to be from stand-alone programs rather than from efforts to integrate self-management into routine medical care. This article describes efforts to integrate self-management support into broader health care systems change to improve the quality of patient care in the Chronic Illness Care Breakthrough Series. We describe the general approach to system change (the Chronic Care Model) and the more specific self-management training model used. The process used in training organizations in self-management is discussed, and data are presented on teams from 21 health care systems participating in a 13-month-long Breakthrough Series to address diabetes and heart failure care. Available system-level data suggest that teams from a variety of health care organizations made improvements in support provided for self-management. Improvements were found for both diabetes and heart failure teams, suggesting that this improvement process may be broadly applicable. Lessons learned, keys to suc cess, and directions for future research and practice are discussed.

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 of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale

We developed a 12-item bone marrow transplant subscale (BMTS) for the general Functional Assessment of Cancer Therapy (FACT) measure. The subscale combined with the FACT, (FACT-BMT) is a 47-item, valid and reliable measure of five dimensions of quality of life in bone marrow transplant patients. The three-step validation process involved the generation and selection of BMT-specific items and the testing of the overall measure. Items were selected from a list produced by seven oncology experts and 15 patients and were designed to assess content not represented in the general FACT items. A total of 182 patients completed the FACT-BMT at baseline, prior to BMT. An analysis measuring sensitivity to change was performed with 74 patients after transplantation and 60 patients over the three time-points of baseline, hospital discharge and 100 days. The FACT-BMT and all subscales were correlated, sensitivity to change was measured, and the internal consistency for each scale was calculated. Coefficients of reliability and validity ranged from 0.86 to 0.89 for the entire FACT-BMT and 0.54 to 0.63 for the BMTS. The BMTS was able to discriminate patients on the basis of performance status rating and also demonstrated sensitivity to change over time. The FACT-BMT has good psychometric properties for use in assessing quality of life in bone marrow transplant patients. The addition of the bone marrow transplant subscale to the general FACT measure makes it an excellent choice for use in BMT clinical trials.

Medical and Psychosocial Diagnoses in Women With a History of Intimate Partner Violence

BACKGROUND We characterized the relative risk of a wide range of diagnoses in women with a history of intimate partner violence (IPV) compared with never-abused women. METHODS The sample comprised 3568 English-speaking women who were randomly sampled from a large US health plan and who agreed to participate in a telephone survey to assess past-year IPV history using questions from the Behavioral Risk Factor Surveillance System (physical, sexual, and psychological abuse) and the Womens Experience with Battering Scale. Medical and psychosocial diagnoses in the past year were determined using automated data from health plan records. We estimated the relative risk of receiving diagnoses for women with a past-year IPV history compared with women with no IPV history. RESULTS In age-adjusted models, compared with never-abused women, abused women had consistently significantly increased relative risks of these disorders: psychosocial/mental (substance use, 5.89; family and social problems, 4.96; depression, 3.26; anxiety/neuroses, 2.73; tobacco use, 2.31); musculoskeletal (degenerative joint disease, 1.71; low back pain, 1.61; trauma-related joint disorders, 1.59; cervical pain, 1.54; acute sprains and strains, 1.35); and female reproductive (menstrual disorders, 1.84; vaginitis/vulvitis/cervicitis, 1.56). Abused women had a more than 3-fold increased risk of being diagnosed with a sexually transmitted disease (3.15) and a 2-fold increased risk of lacerations (2.17) as well as increased risk of acute respiratory tract infection (1.33), gastroesophageal reflux disease (1.76), chest pain (1.53), abdominal pain (1.48), urinary tract infections (1.79), headaches (1.57), and contusions/abrasions (1.72). CONCLUSION Past-year IPV history was strongly associated with a variety of medical and psychosocial conditions observed in clinical settings.

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.

Health Care Utilization and Costs Associated with Physical and Nonphysical-Only Intimate Partner Violence

OBJECTIVE To estimate health care utilization and costs associated with the type of intimate partner violence (IPV) women experience by the timing of their abuse. METHODS A total of 3,333 women (ages 18-64) were randomly sampled from the membership files of a large health plan located in a metropolitan area and participated in a telephone survey to assess IPV history, including the type of IPV (physical IPV or nonphysical abuse only) and the timing of the abuse (ongoing; recent, not ongoing but occurring in the past 5 years; remote, ending at least 5 years prior). Automated annual health care utilization and costs were assembled over 7.4 years for women with physical IPV and nonphysical abuse only by the time period during which their abuse occurred (ongoing, recent, remote), and compared with those of never-abused women (reference group). RESULTS Mental health utilization was significantly higher for women with physical or nonphysical abuse only compared with never-abused women-with the highest use among women with ongoing abuse (relative risk for those with ongoing abuse: physical, 2.61; nonphysical, 2.18). Physically abused women also used more emergency department, hospital outpatient, primary care, pharmacy, and specialty services; for emergency department, pharmacy, and specialty care, utilization was the highest for women with ongoing abuse. Total annual health care costs were higher for physically abused women, with the highest costs for ongoing abuse (42 percent higher compared with nonabused women), followed by recent (24 percent higher) and remote abuse (19 percent higher). Women with recent nonphysical abuse only had annual costs that were 33 percent higher than nonabused women. CONCLUSION Physical and nonphysical abuse contributed to higher health care utilization, particularly mental health services utilization.