Inclusion of Patient-Reported Outcome Measures In Registered Clinical Trials: Evidence From Clinicaltrials.Gov (2007-2013)

Abstract

A209OBJECTIVES: Decisions on palliative chemotherapy (CT) for advanced gastric cancer require trade-offs between potential benefits and risks for patients. Healthcare providers and payers agreed that patient preferences should be considered. We conducted a CBC study in patients with mGC or mGEJ-Ca from Germany to evaluate their preferences when trading-off between treatment tolerability, quality of life and survival benefit. METHODS: German oncologists were contacted to identify patients with mGC or mGEJ-Ca who had completed ≥ 2 cycles of palliative CT (ongoing or completed). The primary objective was the quantitative evaluation of patient preferences for palliative CT in this population by CBC analysis. The CBC matrix, developed based on 6 in-depth qualitative interviews, spanned the 3 attributes ability to self-care as a key component for quality of life, treatment toxicity and survival benefit (3-4 factor levels each, 15 iterations). A minimum of 50 participants was needed. Eligible consenting patients completed the 45min standardized CBC-survey, choosing systematically among profiles. CBC models were estimated by mixed-logit regression (MLR) and hierarchical Bayes analysis (HB). Estimates of importance for each attribute and factor-level were calculated. RESULTS: Overall, 55 patients participated in the survey (78% male, median age 63yrs, 82% currently receiving CT). Patients considered low treatment toxicity as most important (45% relative importance, MLR analysis), followed by ability to self-care (32%) and an additional survival benefit of up to 3 months (3 months 23%, 2 months 18%, 1 month 11%). The MLR analysis showed high validity (certainty 37.9%, chi square p< 0.01, root likelihood 0.505). The HB analysis yielded similar results. CONCLUSIONS: Patient preferences related to palliative CT of gastric cancer can appropriately be assessed by CBC analysis. Though patients' varied experiences with chemotherapy may have impacted specific responses, across the population of patients with mGC or mGEJ-Ca improved treatment tolerability and quality of life were ranked highest.

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