ArticleTherapeutic advances in cardiovascular disease
Assessing the completeness of patient-reported outcomes reporting in congestive heart failure clinical trials.
Article in Therapeutic advances in cardiovascular disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe 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.
designWe performed a cross-sectional analysis of 65 randomized control trials with patient-reported outcomes for drug intervention trials for treating congestive heart failure.
settingN/A.
participantsN/A.
main outcome measuresThe 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.
resultsOur 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 (
conclusionOur 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 registrationN/A.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.