Stephen Lloyd

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 Functional Assessment of Multiple Sclerosis quality of life instrument

Based on scientific literature and interviews with clinicians and patients, we developed a quality of life instrument for use with people with MS called the Functional Assessment of Multiple Sclerosis (FAMS).The initial item pool consisted of 88 questions: 28 from the general version of the Functional Assessment of Cancer Therapy quality of life instrument, plus 60 generated by patients, providers, and literature review. The validation samples comprised a mail survey cohort (N = 377) and a clinical cohort (N = 56). Both cohorts provided evidence for internal consistency of the derived subscales, test-retest reliability, content validity, concurrent validity, and construct validity. Principal components and Rasch measurement model analyses were applied sequentially to survey sample data, reducing test length to 44 questions, divided into six subscales: mobility, symptoms, emotional well-being (depression), general contentment, thinking/fatigue, and family/social well-being. Fifteen initially rejected questions were added back as miscellaneous (unscored) questions for their potential clinical and empirical value. The mobility subscale was strongly predictive of the Kurtzke Extended Disability Status Scale and the Scripps Neurologic Rating Scales. The other five subscales were not, indicating they measure aspects of patient quality of life not captured by the neurologic exam. The final 59-item English language instrument (FAMS version 2) is available for inclusion in clinical trials and clinical practice. NEUROLOGY 1996;47: 129-139

Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire

Purpose: The original Functional Assessment of Anorexia/Cachexia Therapy (FAACT) was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. Our primary purpose was to reduce the number of anorexia/cachexia subscale items in a manner that either retains or improves reliability, validity and precision. Methods: The FAACT was administered using an interactive computer program that allowed immediate entry of the data. A total of 213 patients were recruited. Results: A combined empirical and conceptual approach led to the reduction of the anorexia/cachexia subscale (A/CS) from 18 to 12 items. A 26-item trial outcome index (TOI) combining physical well-being (PWB), functional well-being (FWB), and the A/CS-12 was highly reliable and sensitive to change in performance status rating (PSR). We found that PWB, FWB, and A/CS-12 subscales performed differently. Specifically, PWB and FWB scores decreased in patients whose (PSR) worsened. However, although A/CS-12 scores were responsive to change in PSR over time, average A/CS-12 scores of all patients, even those whose PSR worsened, improved over the course of treatment. Conclusions: Elimination of six items from the anorexia/cachexia subscale of the FAACT was accomplished without loss of internal consistency or sensitivity to change in performance status. The A/CS-12 subscale provides unique, important information not captured by a generic chronic illness questionnaire.

Broken Dreams: A Study of the Effects of Divorce and Depression on Dream Content

To investigate the dream characteristics associated with a major life change, 29 women (ages 30-55) undergoing divorce were studied six nights in a sleep laboratory. The group was stratified on a self-report depression scale (the Beck Depression Inventory) into a depressed (N = 19, mean = 23.2) and nondepressed (N = 10, mean = 8.2) group and compared to a nondepressed married group who had never considered divorce. The dreams of those divorcing without major mood upset were longer and dealt with a wider time frame than those of the other two groups. They also dealt with marital status issues which were absent in the dreams of the depressed group. On follow-up those who had been depressed showed positive dream changes in mood, dreamlike quality, and identification of dream self with the marital role. The study suggests that some dream characteristics respond adaptively during life changes but that this is delayed when subjects are depressed. This raises the possibility of a corrective intervention for such persons.

Toward a treatment logic for sleep apnea: The place of the tongue retaining device

Abstract Twenty-four males suffering from sleep apnea syndrome were given a trial on a mechanical appliance, the Tongue Retaining Device (TRD), as a first treatment. Other treatments, behavioral or surgical, were added as needed over a period of a year, after which 2 nights of evaluation (with and without TRD) were used to test the efficacy of the TRD vs other treatments. Post-treatment the severity, as measured by the Apnea + Hypopnea Index (A + HI) on the night with the TRD, was significantly lower than either the pre-treatment or the post-treatment non-TRD night index. A disciminant function analysis including the initial difference in apnea severity associated with different sleep positions, initial weight and per cent obesity successfully predicted the treatment outcome in 20 patients (83%). It appears that the TRD can be used alone or in conjunction with other treatments to improve nocturnal respiration of patients with a wide range of apnea severity, provided that the level of this disorder is more severe when the patient sleeps in the supine position and his body weight is not greater than 50% above the ideal.

Establishing equivalence between scaled measures of quality of life

In this paper, methodologies which have been used in the pharmaceutical industry to demonstrate the equivalence of drug preparations, are applied to the measurement of quality of life (QOL). This approach is feasible when the generated data are measured on the same scale. Data from the quality of life instruments are transformed into interval scales by means of an appropriate scaling procedure. It is demonstrated that equivalence of QOL instruments is linked by a linear relationship between the QOL instruments Functional Assessment of Cancer Therapy (FACT) and the Functional Living Index-Cancer (FLIC). The linear relationship is derived using orthogonal least squares regression which takes into account that both measures are subject to error.

Data collection strategies for patient-reported information.

The U.S. health care transition demands increased accountability for medical care. This has contributed to increased interest in documenting medical outcomes, including improvements in health-related quality of life and treatment satisfaction. These data can only be obtained by asking patients directly about their current health state, perception of well-being, and satisfaction with care. Systematic collection of patient-reported data is often poorly done because its demands are underestimated and inadequately supported. Rigorous quality assurance is critical in any clinical trial or treatment delivery evaluation program.