Rorah Drayton, Pollard Jonathan, Walters Corbin, Roberts Will, Hartwell Micah, Hemmerich Christian, Vassar Matt
Kansas City University-Joplin, Joplin, MO, USA.
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447241303724. doi: 10.1177/17539447241303724.
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.
We performed a cross-sectional analysis of 65 randomized control trials with patient-reported outcomes for drug intervention trials for treating congestive heart failure.
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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.
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 ( = 4.45, ⩽ 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.
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.
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我们旨在使用国际生活质量研究协会（ISOQOL）清单评估充血性心力衰竭治疗随机对照试验中患者报告结局的质量，该清单是一种用于严格评估患者报告结局质量的经过验证的工具。
我们对65项充血性心力衰竭药物干预试验的随机对照试验进行了横断面分析，这些试验均有患者报告结局。
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本研究的主要结局是根据ISOQOL清单评估充血性心力衰竭药物干预临床试验中患者报告结局的报告完整性。
我们的检索返回了1114项研究，其中65项纳入分析。ISOQOL报告标准的平均完成率为44.51%。与将患者报告结局作为次要终点的临床试验相比，将患者报告结局作为主要终点的临床试验中，ISOQOL患者报告结局标准的完成率更高。多变量回归模型显示，在控制患者报告结局记录时长和试验注册情况后，将患者报告结局作为主要终点的临床试验完成率高出21.46%（β = 4.45，P⩽0.001）。8项（8/65，12.31%）临床试验达到了完成ISOQOL患者报告结局报告标准三分之二的满意度标准。所有这些随机对照试验均将患者报告结局作为主要终点。
我们对充血性心力衰竭药物干预临床试验中患者报告结局报告情况的分析表明，报告质量欠佳。患者报告结局报告不规范的证据令人不安，因为这降低了随机对照试验的透明度，而随机对照试验被视为循证医学的基础。报告不充分可能导致临床医生在临床实践中采用有误导性或不完整的证据。试验者和临床医生都可以使用经过验证的报告工具，如ISOQOL，来改进并严格评估随机对照试验中患者报告结局的报告情况。
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