Empirical criteria for the selection of quality-of-life instruments for the evaluation of peripheral blood progenitor cell transplantation.

We propose a method for selecting quality-of-life instruments for use in phase III trials using the convergent validity of patient responses collected in phase I and II clinical trials. Two generic and two disease-specific instruments were administered to patients with breast cancer undergoing peripheral blood progenitor cell mobilization and transplantation. They included the visual analog scale from the EuroQoL EQ5D instrument, the SF-36, the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, and the Functional Assessment of Cancer Therapy instrument. No single instrument was found to have superior convergent validity in all domains, but the EORTC-QLQ-C30 seemed to perform better than the SF-36.

Construction of scales for the Center for Marital and Sexual Health (CMASH) Sexual Functioning Questionnaire.

The objective of this study was to identify a set of scales for summarizing the results of the Center for Marital and Sexual Health Sexual Functioning Questionnaire (CMASH SFQ). Scales for this instrument were constructed using patients' responses to the CMASH SFQ in a recent clinical trial of prostaglandin E1 (PGE1, alprostadil), an injectable vasodilator used to treat erectile dysfunction. A set of items was identified as a scale if they met predetermined standards of internal consistency, discriminant validity, and convergent validity. The reproducibility of the scales was then evaluated, and the extent to which the scales reliably measured change in treatment-related quality of life was assessed. Reliable and responsive scales for four domains related to sexual functioning were identified. Items in these scales were generally internally consistent; items in the scales and the scores for the scales generally satisfied criteria of discriminant validity; and the scales generally satisfied the standard for convergent validity. Evaluating patients' responses to the CMASH SFQ with scores for four reliable and responsive scales allows easier summarization of patients' sexual functioning and increases the statistical power of evaluations of the effects of interventions designed to improve sexual functioning.

Quality of life effects of alprostadil therapy for erectile dysfunction.

PURPOSE: We evaluated the quality of life effects of self-administered intracavernosal injection of alprostadil sterile powder for erectile dysfunction when used by patients for up to 18 months. MATERIALS AND METHODS: Clinical and self-reported measurements were used to assess physiological and psychological status at baseline, and at 3, 6, 12 and 18 months for 579 patients who entered the self-injection phase of an open label, flexible dose clinical trial. Quality of life was measured using the Center for Marital and Sexual Health Sexual Functioning Questionnaire, which focuses on the psychosocial and physical dimensions of erectile dysfunction; the Brief Symptom Inventory, which measures mental health, and the Duke Health Profile, which measures general quality of life. The primary evaluations were quality of life changes from baseline to post-initiation periods and reasons for treatment discontinuation. RESULTS: The Center for Marital and Sexual Health Sexual Functioning Questionnaire displayed improvements at all post-initiation periods in 10 questions (p < 0.001, Student's paired t-tests) grouped into scales representing frequency of sexual activity, erection, orgasm and satisfaction domains. On the Brief Symptom Inventory interpersonal sensitivity, anxiety and depression as well as global scores improved (p < 0.001). Overall mental health as measured by the Duke Health Profile also improved (p < 0.01) between baseline and 6 months. The reasons most frequently cited for treatment discontinuation were nonfirm erections and injection site pain. CONCLUSIONS: Clinical improvements in erectile function due to alprostadil therapy were associated with improvements in sexual activity, sexual satisfaction and overall mental health.