Article type
Abstract
Background: The extent of availability of the core outcome set (COS) for the top 25 diseases with the highest burden in China is unknown. In addition, the uptake of COSs in clinical trials for these diseases is unknown, along with the knowledge, perceptions, and views of the clinical trialist community in China on the use of COSs in relation to choosing outcomes for their research.
Methods: A mixed methods approach was used for this research. The COMET database was searched to identify completed and ongoing COSs since 2012 (the first publication about a COS in China). The Chinese Clinical Trial Registry was searched for clinical trials meeting the scope of published eligible COSs for research. The overlap of outcomes between the clinical trials and relevant COSs was assessed. Online questionnaires were sent to trialists, with an additional invitation to participate in semistructured interviews, to elicit information on facilitators and barriers to COS use.
Results: All but two (road injuries and hypertensive heart disease) of the highest-burden diseases in China have a published or ongoing COS available. Four COSs (lung cancer, ischemic stroke, type 2 diabetes mellitus, and knee osteoarthritis) and 398 clinical trials were included in the analysis of outcome matches. The median percentage of outcomes within a COS that matched to outcomes in clinical trials is 8%, 11%, 23%, and 40%, respectively. Only two trials reported all outcomes in the relevant COS. Responses to questionnaires were received from 71 (18%) trialists. The main facilitator to using a COS is knowledge of the utility of COSs, and the main barriers are a lack of validated tools to measure the outcomes and a perceived increased burden for clinicians and patients. Trialists believed that the scope of COSs are not relevant to their research objectives, which is a critical barrier for them to use full COSs.
Conclusions: COS uptake was low in clinical trials in China. COS developers should collaborate with trialists in China to improve COS development and use in the future.
Methods: A mixed methods approach was used for this research. The COMET database was searched to identify completed and ongoing COSs since 2012 (the first publication about a COS in China). The Chinese Clinical Trial Registry was searched for clinical trials meeting the scope of published eligible COSs for research. The overlap of outcomes between the clinical trials and relevant COSs was assessed. Online questionnaires were sent to trialists, with an additional invitation to participate in semistructured interviews, to elicit information on facilitators and barriers to COS use.
Results: All but two (road injuries and hypertensive heart disease) of the highest-burden diseases in China have a published or ongoing COS available. Four COSs (lung cancer, ischemic stroke, type 2 diabetes mellitus, and knee osteoarthritis) and 398 clinical trials were included in the analysis of outcome matches. The median percentage of outcomes within a COS that matched to outcomes in clinical trials is 8%, 11%, 23%, and 40%, respectively. Only two trials reported all outcomes in the relevant COS. Responses to questionnaires were received from 71 (18%) trialists. The main facilitator to using a COS is knowledge of the utility of COSs, and the main barriers are a lack of validated tools to measure the outcomes and a perceived increased burden for clinicians and patients. Trialists believed that the scope of COSs are not relevant to their research objectives, which is a critical barrier for them to use full COSs.
Conclusions: COS uptake was low in clinical trials in China. COS developers should collaborate with trialists in China to improve COS development and use in the future.