Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study

Objective To analyse the uptake rate of Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-recommended core outcome set (COS) in randomised controlled trials (RCTs) on chronic neck or shoulder pain and its potential influencing factors.Design A cross-sectional study...

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Main Authors: Guoliang Li, Lin Zeng, Siyan Zhan, Wenqiang Li, Jiaheng Shang
Format: Article
Language:English
Published: BMJ Publishing Group 2025-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/6/e094482.full
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author Guoliang Li
Lin Zeng
Siyan Zhan
Wenqiang Li
Jiaheng Shang
author_facet Guoliang Li
Lin Zeng
Siyan Zhan
Wenqiang Li
Jiaheng Shang
author_sort Guoliang Li
collection DOAJ
description Objective To analyse the uptake rate of Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-recommended core outcome set (COS) in randomised controlled trials (RCTs) on chronic neck or shoulder pain and its potential influencing factors.Design A cross-sectional study.Setting WHO International Clinical Trials Registry Platform, involving 15 registries.Participants RCT registrations on chronic neck or shoulder pain.Primary outcome measures The uptake rate of IMMPACT-recommended COS in RCTs focusing on chronic neck or shoulder pain.Results A total of 1057 RCT registrations were included between 2 February 2004 and 8 February 2023. The most used domains were pain (n=1003, 94.9%) and physical functioning (n=971, 91.9%), while the remaining four core domains and supplementary domains received less attention (<10%), exhibiting either a downward trend or an initial increase followed by a decrease. Univariable and multivariable analyses did not indicate consistent, significant differences in various outcome domains in RCTs categorised according to the study period, blinding and prospective registration statuses, follow-up duration and sample size.Conclusions Although the pain and physical functioning domains were widely reported by RCTs on chronic neck or shoulder pain since the publication of IMMPACT-recommended COS, the uptake rate was low for other domains and outcome measures. The study period, blinding status, prospective registration, follow-up duration and sample size may influence COS uptake across domains.Trial registration number http://www.comet-initiative.org/Studies/Details/3213.
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spelling doaj-art-7278e00749474ca680a9cdfdcdd51cf72025-08-20T03:26:57ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-094482Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional studyGuoliang Li0Lin Zeng1Siyan Zhan2Wenqiang Li3Jiaheng Shang4Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaObjective To analyse the uptake rate of Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-recommended core outcome set (COS) in randomised controlled trials (RCTs) on chronic neck or shoulder pain and its potential influencing factors.Design A cross-sectional study.Setting WHO International Clinical Trials Registry Platform, involving 15 registries.Participants RCT registrations on chronic neck or shoulder pain.Primary outcome measures The uptake rate of IMMPACT-recommended COS in RCTs focusing on chronic neck or shoulder pain.Results A total of 1057 RCT registrations were included between 2 February 2004 and 8 February 2023. The most used domains were pain (n=1003, 94.9%) and physical functioning (n=971, 91.9%), while the remaining four core domains and supplementary domains received less attention (<10%), exhibiting either a downward trend or an initial increase followed by a decrease. Univariable and multivariable analyses did not indicate consistent, significant differences in various outcome domains in RCTs categorised according to the study period, blinding and prospective registration statuses, follow-up duration and sample size.Conclusions Although the pain and physical functioning domains were widely reported by RCTs on chronic neck or shoulder pain since the publication of IMMPACT-recommended COS, the uptake rate was low for other domains and outcome measures. The study period, blinding status, prospective registration, follow-up duration and sample size may influence COS uptake across domains.Trial registration number http://www.comet-initiative.org/Studies/Details/3213.https://bmjopen.bmj.com/content/15/6/e094482.full
spellingShingle Guoliang Li
Lin Zeng
Siyan Zhan
Wenqiang Li
Jiaheng Shang
Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study
BMJ Open
title Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study
title_full Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study
title_fullStr Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study
title_full_unstemmed Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study
title_short Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study
title_sort uptake of the immpact recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain a cross sectional study
url https://bmjopen.bmj.com/content/15/6/e094482.full
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