Abstract
PurposeThe CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice.Materials and MethodsThe case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.ResultsFrom 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2).ConclusionIt is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed.
Highlights
The updated Consolidated Standards of Reporting Trials (CONSORT) extension for patient reported outcomes (PROs) aims to facilitate the use of PRO data in health policy and practice through the transparent reporting of PROs in randomized controlled trials (RCTs)[1]
Reporting PRO rationale linked to clinical hypotheses, and clear reporting of PRO results interpreted appropriately in the context of the clinical outcomes are critical to ensure that oncologists gather a “take-home” message to communicate to patients which encompasses clinical and PROs
Patient reported outcome reporting standards were at lowest levels in primary clinical papers
Summary
The updated Consolidated Standards of Reporting Trials (CONSORT) extension for patient reported outcomes (PROs) aims to facilitate the use of PRO data in health policy and practice through the transparent reporting of PROs in randomized controlled trials (RCTs)[1]. The statement endorses reporting the rationale/hypotheses for PRO assessment and it highlights the need for integrated reporting of the PROs with the clinical findings of the paper (extensions and elaborations 2a, 2b and P20/21 and 22) These latter recommendations are essential for critical interpretation of the trial, so called exegesis or a “take-home message”, for clinicians to understand and use results in clinical practice. The level of detail required for reporting the PRO data is unclear and this may have a detrimental impact on the overall clinically relevant trial conclusions
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