Guideline defines seven core outcomes for traditional Chinese medicine trials in atrial fibrillation

ObjectivesThe inconsistent reporting of clinical trial results in patients with atrial fibrillation (AF) hinders the comparison of findings. Developing a core outcome set (COS) in studies evaluating traditional Chinese medicine (TCM) for AF and recommending measurement instruments and time points may help standardize the selection, reporting, and measurement of outcomes in clinical trials.MethodsLiterature and registered trials were retrieved to systematically collect outcomes. Physician questionnaire surveys and semi-structured patient interviews were conducted to collect outcomes of clinical interest. These outcomes were standardized and compiled into a preliminary outcome pool. Consensus criteria were established in advance. Through two rounds of Delphi surveys and consensus meetings, perspectives from multiple stakeholder groups were gathered to establish a COS for TCM for AF (COS-TCM-AF).ResultsA total of 87 individuals participated in the Delphi survey, with 70 completing both rounds. During the consensus meeting, 19 stakeholders determined that seven core outcomes should be involved in the COS-TCM-AF, including AF episode frequency, AF episode duration, AF burden, TCM symptom-palpitation, thromboembolic (TE) event rate, AF recurrence rate, and incidence of acute heart failure (HF)/acute exacerbation of chronic HF. Among these, AF episode frequency and AF episode duration applied only to patients with paroxysmal AF.ConclusionThis COS comprehensively addresses multiple aspects including AF episodes, patient symptoms, complication risks and long-term prognosis. It also recommends measurement instruments and time points. Its implementation will contribute to facilitating the comparison of similar studies and provide a reference for selecting and measuring outcomes.