ObjectiveTo evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. MethodsLiterature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. ResultsA total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. ConclusionCOS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.
In the clinical evidence-based decision-making process, factors including benefits and harms, evidence certainty, cost and feasibility of interventions should be considered based on the best evidence. The development of decision threshold of effect size (DTES) for patient health outcomes can help stakeholders understand the benefits and harms of interventions, assess evidence certainty, and interpret research results. Based on international experience, the MERGE Working Group through group discussions, semi-structured interviews, expert consensus, and pilot application developed a set of 8-step guidelines for the development of DTES for health outcomes. These steps included necessity assessment, formation of working groups, selection of patient important outcomes, creation of scenarios based on the best evidence, design of expert consultation questionnaires, analysis of expert consultation results, face-to-face expert consensus, dissemination of the application and reevaluation. The DTES guideline development is intended to provide methodological guidance for stakeholders to develop DTES for health outcome indicators in different domains.