Evaluating Reporting of Patient-Reported Outcomes in Peptic Ulcer Disease: A Meta-Epidemiological Study of Randomized Controlled Trials

Introduction: Peptic ulcer disease (PUD) can have a significantly detrimental effect on quality of life (QoL). Patient-reported outcomes (PROs) are valuable tools for clinical decision-making. This study aimed to assess existing literature for completeness of PRO reporting across randomized controlled trials(RCTs) evaluating PUD.

Methods: This was a meta-epidemiological, cross-sectional study which assessed completeness of reporting among RCTs addressing management of PUD. We conducted a literature search using MEDLINE, Embase, and the Cochrane Register of Controlled Trials (CENTRAL) to identify RCTs with a PRO as a primary or secondary outcome. These RCTs were assessed for completion of reporting according to the PRO adaptation of Consolidated Standards of Reporting Trials (CONSORT) checklist. RCTs were also assessed for Risk of Bias (RoB) using the Cochrane RoB 2.0 tool.

Results: Masked, duplicate screening of 829 results from our search string yielded a study sample of 35 RCTs. The average completeness of reporting was 32.90% according to the CONSORT-PRO adaptation. Twenty-one (of 35; 60%) of the RCTs were assessed as having ‘high risk’ of bias and nine (of 35; 25.71%) were assessed as having ‘some concerns’ for risk of bias. Bivariate regression found completeness of reporting to be positively associated with increased PRO follow-up duration, larger sample size, and studies which report conflicts of interest.

Discussion: RCTs examining the treatment and prevention of PUD with PROs as an outcome measure have deficient reporting and ‘high risk’ of bias according to the CONSORT-PRO and Cochrane RoB guidelines.