Background and Objective
The core outcome set (COS) recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), developed to standardize outcome selection and prevent outcome reporting bias. Few studies have evaluated the COS uptake, which is vital for prompt improvement in transparency and standardization for outcome reporting, refinement of development strategies of the COS, and optimization of resource utilization. This study aimed to analyze potential factors influencing the uptake of IMMPACT-recommended COS in randomized controlled trials (RCTs) on chronic neck or shoulder pain.
Study Design and Setting
In this cross-sectional study, two investigators independently screened registry entries retrieved from the WHO International Clinical Trials Registry Platform. Data extraction and COS uptake assessment, with expert consultation, were performed in a masked and repeated manner.
Results
A total of 1057 RCT registrations were included between February 2, 2004 and February 8, 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%). Univariable and multivariable analyses did not reveal consistent, significant differences in various outcome domains in RCTs categorized according to the study period, blinding and prospective registration statuses, follow-up duration, and sample size. The most commonly reported IMMPACT-recommended outcome measures were the Visual Analogue Scale (n = 547, 58.4%) and Numerical Rating Scale (n = 287, 30.6%) in the pain domain.
Conclusion
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, which exhibited either a downward trend or an initial increase followed by a decrease, indicating the need for further improvement and promotion. Future studies should assess the applicability of IMMPACT-recommended COS for RCTs on chronic neck or shoulder pain and explore the development of a COS specific to this field.
Keywords: core outcome set; outcome measures; uptake; chronic neck or shoulder pain; randomized controlled trials; Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
Wenqiang Li, Guoliang Li, Jiaheng Shang, Siyan Zhan, Lin Zeng
Disease Category: Anaesthesia & pain control
Disease Name: Neck pain, Shoulder pain
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Epidemiologists
- Ethicists
- Methodologists
- Researchers
- Statisticians
- COS uptake study
- Other
- Survey
Two investigators independently screened registry entries retrieved from the WHO ICTRP. Data extraction and COS uptake assessment, with expert consultation, were performed in a masked and repeated manner. The Kruskal–Wallis H or the Mann–Whitney U test was used to compare the total number of reported core domains among the study groups. Fisher’s exact test was used to compare the percentage of RCTs reporting specific core domains and the percentage of RCTs in each category reporting core domain totals among the study groups. Binomial logistic regression model and Poisson regression model were used to evaluate potential factors impacting the uptake of the IMMPACT-recommended COS.