What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials?

Abstract

Background: Although the number of clinical trials assessing health related quality of life (HRQoL) in chronic heart failure (CHF) has increased exponentially over the last decade, little is known about the quality of reporting. The purpose of this review was to assess the methodological and reporting rigor of HRQoL in RCTs of pharmacological therapy in CHF. Methods: The electronic data bases, Medline and EMBASE were searched from 1990 to 2009 using the key search terms ‘heart failure’ combined with ‘quality of life’, ‘pharmacological therapy’ and ‘randomized controlled trials’. A total of 136 articles were identified and evaluated according to the “Minimum Standard Checklist (MSC) for Evaluating HRQoL Outcomes”. Results: According to the MSC criteria, 26 (19.1%) studies were considered ‘very limited’, 91 (66.9%) were ‘limited’ and only 19 (14.0%) studies were considered to be of a ‘probably robust’ in terms of methodological and reporting rigor. In fact, the quality of HRQoL reporting has not improved over time. Conclusion: HRQoL is a critical consideration in CHF management, yet reporting is highly variable. There is a need to develop a standardized method for measuring and reporting HRQoL measures in clinical trials to aid in the interpretation and application of findings.