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Abstract
Objectives To examine variation in outcomes, outcome measurement instruments (OMIs) and measurement times in clinical trials of non-valvular atrial fibrillation (NVAF) and to identify outcomes for prioritisation in developing a core outcome set (COS) in this field.
Design This study was a systematic review.
Data sources Clinical trials published between January 2015 and March 2019 were obtained from PubMed, the Cochrane Library, Web of Science, Wanfang Database, the China National Knowledge Infrastructure and SinoMed.
Eligibility criteria Randomised controlled trials (RCTs) and observational studies were considered. Interventions included traditional Chinese medicine and Western medicine. The required treatment duration or follow-up time was ≥4 weeks. The required sample size was ≥30 and≥50 in each group in RCTs and observational studies, respectively. We excluded trials that aimed to investigate the outcome of complications of NVAF, to assess the mechanisms or pharmacokinetics, or for which full text could not be acquired.
Data extraction and synthesis The general information and outcomes, OMIs and measurement times were extracted. The methodological and outcome reporting quality were assessed. The results were analysed by descriptive analysis.
Results A total of 218 articles were included from 25 255 articles. For clinical trials of antiarrhythmic therapy, 69 outcomes from 16 outcome domains were reported, and 28 (31.82%, 28/88) outcomes were reported only once; the most frequently reported outcome was ultrasonic cardiogram. Thirty-one outcomes (44.93%, 31/69) were provided definitions or OMIs; the outcome measurement times ranged from 1 to 20 with a median of 3. For clinical trials of anticoagulation therapy, 82 outcomes from 18 outcome domains were reported; 38 (29.23%, 38/130) outcomes were reported only once. The most frequently reported outcome was ischaemic stroke. Forty (48.78%, 40/82) outcomes were provided OMIs or definitions; and the outcome measurement times ranged from 1 to 27 with a median of 8.
Conclusion Outcome reporting in NVAF is inconsistent. Thus, developing a COS that can be used in clinical trials is necessary.
- outcomes
- clinical trials, non-valvular atrial fibrillation
- systematic review
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Footnotes
RQ and JH contributed equally.
Contributors RQ, JC and HS contributed to the study design. RQ extracted data from articles and drafted the manuscript. SH, YH, TH, CZ and JH contributed to the data extracting and assessment. ML, JH, JC, YL, MG and HS revised the manuscript. All authors read and approved the final manuscript.
Funding This work was supported by the National Natural Science Foundation of China [81430098].
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Ethical approval has been granted by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (DZMEC-KY-2017–81).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement The data are from published papers and do not include identifiable patient data.