An analysis of Patient Reported Outcomes among Congestive Heart Failure Clinical Trials

Background: More than 6.2 million Americans have congestive heart failure (CHF) and expected to increase to 8 million by 2030. Owing to the high prevalence of CHF, research efforts are essential for investigating therapies that decrease morbidity and mortality and improve patient-reported outcomes (PROs) among individuals with CHF. Randomized control trials (RCTs) are commonly used to investigate therapeutic efficacy, but can also be used to examine PROs. The CONSORT Statement created evidenced-based recommendations to be used by authors as a tool to ensure complete and appropriate reporting of trials. One extension of the CONSORT statement is the International Society for Quality of Life Research (ISOQOL), which is used to improve the reporting of PROs in RCTs. In this study, we focus on examining the reporting quality of RCTS that evaluate PROs for individuals with CHF using the ISOQOL screening guideline.

Methods: We searched PubMed for pharmacological intervention RCTs reporting PROs for the treatment of CHF. We included cluster designs, crossover designs and parallel arm studies designs with PROs and excluded all non-randomized study designs, as well as RCTs with a sample size less than 50. Using a pilot tested Google Form, two investigators independently and blindly applied the 28-item ISOQOL checklist to each RCT to evaluate for the completeness of PRO reporting.

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 PRO standards was observed in the RCTs with PROs as primary endpoints compared to the RCTs with PROs as a secondary endpoint. The multivariable regression model showed that RCTs with PROs 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 RCTs met the satisfaction criteria of completing ⅔ of the ISOQOL PRO reporting standards. All of these RCTs had a PRO as a primary endpoint.

Conclusion: Our analysis of the reporting of PROs in CHF RCTs with drug interventions suggests that the quality of reporting is suboptimal. This evidence of substandard reporting of PROs is disconcerting as it reduces the transparency of RCTs, 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 PROs in RCTs.