[Analysis on status quo of outcomes and measurement instruments of randomized controlled trials of acupuncture for post-stroke dysphagia].

Abstract

Objective: To analyze the report status of outcomes and measurement instruments of randomized controlled trials (RCTs) of acupuncture for post-stroke dysphagia, so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia.

Methods: RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e. CNKI, SinoMed, Wanfang, PubMed, EMbase, Web of Science and clinical trial registries i.e. ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR), from January 1st, 2012 to October 30th, 2021. By literature screening and data extraction, outcomes and measurement instruments were summarized and analyzed.

Results: A total of 172 trials (including 165 RCTs and 7 ongoing trials registrations) were included, involving 91 outcomes. The outcomes could be classified into 7 domains according to functional attributes, namely clinical manifestation, physical and chemical examination, quality of life, TCM symptoms/syndromes, long-term prognosis, safety assessment and economic evaluation. It was found that there were various measurements instruments with large differences, inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes.

Conclusion: The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results. Thus, it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.