Are patient-reported outcomes evaluated in randomized controlled trials and meta-analyses regarding reconstruction methods after distal gastrectomy?
Background: Reconstruction method following gastrectomy affects the quality of life, which is often measured by patient-reported outcomes (PROs). Incorporating PROs within clinical trials provides a patient’s perspective for shared decision-making among patients and healthcare providers. However, it remains unclear how much attention is paid to PROs when conducting randomized controlled trials (RCTs) and meta-analyses (MAs) regarding reconstructions after distal gastrectomy.
Objectives: To evaluate how many RCTs and MAs incorporate PROs, and how the PRO is reported in RCTs.
Methods: This study is a cross-sectional analysis. We comprehensively searched MEDLINE and the Cochrane Library for topics that included gastrectomy and reconstruction. We included patients who underwent distal gastrectomy for gastric cancer. We included RCTs and MAs comparing postoperative outcomes among reconstruction types. We described the number of RCTs which measured PROs and MAs which incorporated PROs into the outcomes, and then assessed the completion of the CONSORT-PRO checklist adaptation for all RCTs reporting PROs.
Results: We identified 18 articles on 13 studies, and 10 articles of systematic reviews with MA. Of the 13 RCTs, 7 studies (53.8%) measured PROs, including quality-of-life and study-specific questionnaires. However, no article completes the CONSORT-PRO checklist adaption. The remaining six studies assessed surgical outcomes (e.g. reconstruction time, postoperative complications) and endoscopic findings of gastritis (e.g. RGB score) without PROs. In terms of systematic reviews with MA, only one study (10%), a Cochrane Review, set PROs as the outcome. Four studies of the remaining 9 included non-randomized studies.
Conclusions: Our study found a disparity between the use of PROs in RCTs and these of MAs. No RCTs using PROs adhered to the CONSORT-PRO adaptation. Our findings suggest that RCTs assessing postoperative quality of life among reconstruction types need to improve PRO reporting, and future MAs should incorporate PROs.
Patient, public and/or healthcare consumer involvement: As reconstruction methods affect postoperative quality of life, Shared decision-making in surgery is necessary among patients and medical personnel. There was no direct patient or healthcare consumer in this project, but the increasing number of accurate reporting PROs in RCTs and MAs will become direct benefits to these groups.