Assessing the completeness of patient-reported outcomes reporting in congestive heart failure clinical trials.

Abstract

Objective: We aim to evaluate the quality of patient-reported outcomes included in randomized control trials for the treatment of congestive heart failure using the International Society for Quality of Life Research (ISOQOL) checklist, a validated tool for critically appraising the quality of patient-reported outcomes.

Design: We performed a cross-sectional analysis of 65 randomized control trials with patient-reported outcomes for drug intervention trials for treating congestive heart failure.

Setting: N/A.

Participants: N/A.

Main outcome measures: The primary outcome of this study was to evaluate the reporting completeness of patient-reported outcomes in congestive heart failure clinical trials with drug interventions according to the ISOQOL checklist.

Results: Our search returned 1114 studies, of which, 65 are included in the analysis. The average completion of the ISOQOL reporting standards was 44.51%. Higher completion of the ISOQOL patient-reported outcome standards was observed in the clinical trials with patient-reported outcomes as primary endpoints compared to the clinical trials with patient-reported outcomes as a secondary endpoint. The multivariable regression model showed that clinical trials with patient-reported outcomes as a primary endpoint had a 21.46% better completion percentage (t = 4.45, p ⩽ 0.001) when controlling for PRO recording duration and trial registration. Eight (8/65, 12.31%) of the clinical trials met the satisfaction criteria of completing two-thirds of the ISOQOL patient-reported outcomes reporting standards. All of these RCTs had a patient-reported outcome as a primary endpoint.

Conclusion: Our analysis of the reporting of patient-reported outcomes in congestive heart failure clinical trials with drug interventions suggests that the quality of reporting is suboptimal. This evidence of substandard reporting of patient-reported outcomes is disconcerting as it reduces the transparency of randomized control trials, which are considered the foundation of evidenced-based medicine. Inadequate reporting may result in clinicians implementing misrepresented or incomplete evidence into clinical practice. Validated reporting tools, such as the ISOQOL, can be used by trialists and clinicians alike to improve and critically appraise the reporting of patient-reported outcomes in randomized control trials.

Trial registration: N/A.