TY - JOUR
T1 - Evaluating reporting of patient-reported outcomes in peptic ulcer disease
T2 - a meta-epidemiological study of randomized controlled trials
AU - Anderson, Reece M.
AU - Streck, Sam
AU - Hughes, Griffin
AU - Sutterfield, Bethany
AU - Kee, Micah
AU - Wise, Audrey
AU - Hillman, Cody
AU - Ottwell, Ryan
AU - Hartwell, Micah
AU - Vassar, Matt
N1 - Funding Information:
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.
Publisher Copyright:
© 2022 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022/9/12
Y1 - 2022/9/12
N2 - 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 assesses 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.
AB - 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 assesses 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.
KW - CONSORT-PRO
KW - Meta-Epidemiology
KW - Patient reported outcomes
KW - gastroenterology
KW - meta research
KW - peptic ulcer disease
UR - http://www.scopus.com/inward/record.url?scp=85138416337&partnerID=8YFLogxK
U2 - 10.1080/14737167.2022.2122955
DO - 10.1080/14737167.2022.2122955
M3 - Article
C2 - 36073013
AN - SCOPUS:85138416337
SN - 1473-7167
VL - 22
SP - 1253
EP - 1260
JO - Expert Review of Pharmacoeconomics and Outcomes Research
JF - Expert Review of Pharmacoeconomics and Outcomes Research
IS - 8
ER -