The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation

The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The measurement system, under development since 1987, began with the creation of a generic CORE questionnaire called the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-G (now in Version 4) is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is appropriate for use with patients with any form of cancer, and extensions of it have been used and validated in other chronic illness condition (e.g., HIV/AIDS; multiple sclerosis; Parkinson's disease; rheumatoid arthritis), and in the general population. The FACIT Measurement System now includes over 400 questions, some of which have been translated into more than 45 languages. Assessment of any one patient is tailored so that the most-relevant questions are asked and administration time for any one assessment is usually less than 15 minutes. This is accomplished both by the use of specific subscales for relevant domains of HRQOL, or computerized adaptive testing (CAT) of selected symptoms and functional areas. FACIT questionnaires can be administered by self-report (paper or computer) or interview (face-to-face or telephone). Available scoring, normative data and information on meaningful change now allow one to interpret results in the context of a growing literature base

Hadrons Without Strings

Descriptions of hadrons and glueballs can be constructed using strings to preserve gauge invariance. We show how this string dependence may be removed to all orders in perturbation theory.Comment: 11 pages, 3 figures, LaTe

Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer

We wish to correct a mistake in the abstract and conclusion of our published paper [1]. In the abstract and conclusion, the MID for EQ-VAS score should be reported as 7 rather than 0.07. EQ-VAS scores range from 0 to 100, while EQ-5D index-based scores are anchored by 0 (dead) and 1 (perfect health). The specific wording in the conclusion of the abstract should read “Important differences in EQ-5D utility and VAS scores were similar for all cancers and lung cancer, with the lower end of the range of estimates closer to the MID, i. e. 0.08 for UK-index scores, 0.06 for US-index scores, and 7 for VAS scores. Author details

Development of a Conceptual Framework and Calibrated Item Banks to Measure Patient-Reported Dyspnea Severity and Related Functional Limitations

AbstractObjectivesChronic obstructive pulmonary disease is a major global health problem. Although several patient-reported outcome (PRO) measures of chronic obstructive pulmonary disease exist, none were developed using patient-driven concept development. We developed an item bank for dyspnea severity and related functional limitations on the basis of a PRO conceptual framework derived from patient input.MethodsWe identified a large pool of existing items based on a conceptual framework and literature review. Using patient and expert review panels and an item refinement/modification process, we developed an item bank aligned with the conceptual framework, which subsequently underwent psychometric testing via an online Internet panel of dyspnea patients (N = 608).ResultsExploratory factor analysis suggested a dominant first factor accounting for about 78% of the total variance. Confirmatory factor analysis supported a unidimensional model. Item response theory analysis demonstrated good model fit, and differential item functioning analyses indicated that the 33-item scale showed potential for measurement equivalence across sex. A 10-item short form produced comparable scores (r = 0.98) and a computerized adaptive-testing simulation indicated efficient measurement with fewer items (mean 4.65 items).ConclusionsAn efficient patient-reported measure of dyspnea severity and related functional limitations, based on a patient-driven PRO conceptual framework, is now available for further validation and use

Development and validation of the caregiver roles and responsibilities scale in cancer caregivers

Purpose The Caregiver Roles and Responsibilities Scale (CRRS) was developed to facilitate formal assessment of broad life impacts for informal (i.e. unpaid) caregivers to people with cancer. Here we report the development and initial validation. Methods The CRRS was developed from the thematic analysis of two interview studies with cancer patients (stage III-IV breast, gynaecological, lung or melanoma) and caregivers. In the evaluation studies, participants completed the CRRS alongside the Caregiver Quality of Life - Cancer, the main criterion measure for concurrent validity, and the WHOQOL-BREF for additional convergent validity data. Questionnaires were completed at baseline, 7-days and 2-months. Demographic data and patient characteristics were collected at baseline. Results Two-hundred and forty-five caregivers to people with stage I-IV breast, colorectal, gynaecological, head and neck, lung or renal cancer or melanoma completed the CRRS at least once. The final 41 core items selected comprised five subscales: Support and Impact, Lifestyle, Emotional Health and Wellbeing, Self-care and Financial Wellbeing as well as three standalone items. Missing data rate was low (0.6%); there were no ceiling or floor effects for total scores. Cronbach’s alpha was 0.92 for the CRRS-41; 0.75-0.87 for the subscales. CRRS showed good test-retest reliability (ICC=0.91), sensitivity to change and the predicted pattern of correlation with validation measures r=0.75-0.89. The standalone 7-item jobs and careers subscale requires further validation. Conclusions Initial evaluation shows the CRRS has good validity and reliability and is a promising tool for the assessment of the effects of cancer and cancer treatment on the lives and wellbeing of informal caregivers

Development and validation of the patient roles and responsibilities scale in cancer patients

Purpose The Patient Roles and Responsibilities Scale (PRRS) was developed to enable a broader evaluation of the impact of cancer and cancer treatment, measuring ‘real world’ roles and responsibilities such as caring for others and financial and employment responsibilities. Here we report the development and initial validation. Methods The 29-item PRRS was developed from the thematic analysis of two interview studies with cancer patients and caregivers. In the evaluation study, participants completed the PRRS alongside the Social Difficulties Inventory (SDI), the main criterion measure for concurrent validity, and the Functional Assessment of Cancer Therapy – General (FACT-G) and WHO Quality Of Life-BREF (WHOQOL-BREF) for additional convergent validity data. Questionnaires were completed at baseline, 7-days (PRRS only) and 2-months. Demographic data and patient characteristics were collected at baseline. Results One hundred and thirty-five patients with stage III/IV breast, lung or gynaecological cancer or melanoma completed the PRRS at least once. Five items performed poorly and were removed from the scale. The final 16 core items selected comprised 3 dimensions: Family Wellbeing, Responsibilities and Social Life, and Financial Wellbeing, identified in principal component analysis, accounting for 61.5% of total variance. Missing data (0.6%) and floor/ceiling effects were low (0%/1.5%). Cronbach’s alpha was 0.9 for the PRRS-16; 0.79-0.87 for the subscales. PRRS showed good test-retest reliability (ICC-0.86), sensitivity to change and the predicted pattern of correlation with validation measures r=ǀ0.65-0.77ǀ. The standalone 7-item jobs and careers subscale requires further validation. Conclusions Initial evaluation shows the PRRS is psychometrically robust with potential to inform the evaluation of new treatments in clinical trials and real world studies

Screening Properties of the Diagnostic Criteria for Cancer-Related Fatigue

Background: Within the theoretical framework of the ICD diagnostic criteria of cancer-related fatigue, we aim to investigate how those criteria can be used for screening purposes. Methods: Fatigue was assessed in a mixed sample of 1,225 cancer patients during their stay in a rehabilitation clinic using four different fatigue measures and the diagnostic criteria (Criterion A; DC-A). Psychometric evaluations (e.g., acceptance, reliability, validity, item analyses) were conducted for the sum score and for all items of the diagnostic criteria. Results: A total of 678 (57.1%) patients tested positive according to the DC-A. The sum score of the DC-A had good reliability (Cronbach’s alpha = 0.87) and validity, corresponded closely with other fatigue scales, and, with less than 1% missing values, showed a high degree of patients’ acceptance. The highest accuracy (approx. 0.80) and Youden indices (> 0.55) were found for the items “Difficulties completing daily tasks” (A9), “Struggle to overcome inactivity” (A7), “Decreased motivation or interests” (A4), and “Unrefreshing sleep” (A6). Conclusion: The DC-A proved to be a well-accepted, easy to use, and reliable tool for measuring the severity of fatigue. In this paper, we make suggestions for the use of single items of the DC-A as a short and economical screening tool

Using Multiple Anchor- and Distribution-Based Estimates to Evaluate Clinically Meaningful Change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) Instrument

Objective: The interpretation of health-related quality of life (HRQL) data from clinical trials can be enhanced by understanding the degree of change in HRQL scores that is considered meaningful. Our objectives were to combine distribution-based and two anchor-based approaches to identify minimally important differences (MIDs) for the 27-item Trial Outcome Index (TOI), the seven-item Social Well-Being (SWB) subscale, and the six-item Emotional Well-being (EWB) subscale from the Functional Assessment of Cancer Therapy-Biological Response Modifiers (FACT-BRM) instrument. Methods: Distribution-based MIDs were based on the standard error of measurement. Anchor-based approaches utilized patient-reported global rating of change (GRC) and change in physician-reported performance status rating (PSR). Correlations and weighted kappa statistics were used to assess association and agreement between the two anchors. FACT-BRM changes were evaluated for three time periods: baseline to month 1, month 2 to month 3, and month 5 to month 6. Results: Association between GRC and change in PSR was poor. Correlation between the anchors and HRQL change scores was largest at month 1 and decreased through month 6. Combining results from all approaches, the MIDs identified were 5–8 points for the TOI, 2 points for the SWB subscale, and 2–3 points for the EWB subscale. Conclusions: We combined patient-reported estimates, physician-reported estimates, and distribution-based estimates to derive MIDs for HRQL outcomes from the FACT-BRM. These results will enable interpretation of treatment group effects in a clinical trial setting, and they can be used to estimate sample size or power when designing future studies