Evaluating reporting of patient-reported outcomes in peptic ulcer disease: a meta-epidemiological study of randomized controlled trials

ABSTRACT

Objectives

Peptic ulcer disease (PUD) can significantly affect quality of life (QoL). These QoL outcomes are often patient-reported, and their inclusion in clinical trials supplements efficacy outcomes to provide the patients’ perspective. This assese existing literature for completeness of PRO reporting across randomized controlled trials (RCTs) evaluating PUD.

Methods

This meta-epidemiological, cross-sectional study that assessed completeness of reporting among RCTs addressing management of PUD. We conducted a comprehensive literature search] 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 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 = yielded a final sample of 35 RCTs. The average completeness of reporting was 32.9% 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, sample size, and studies with conflicts of interest.

Conclusion

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.

KEYWORDS:

• Patient reported outcomes
• meta research
• peptic ulcer disease
• gastroenterology
• Meta-Epidemiology
• CONSORT-PRO

Acknowledgments

We are grateful to April Schweikhard who assisted in the development of our search strategy and to the OSU medical library for their procurement of relevant literature.

Declaration of interest

M Hartwell reports receiving funding from the National Institute of Justice for work unrelated to the current subject. M Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences — all outside of the present work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2022.2122955

Additional information

Funding

Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant.