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. 2019 Aug 30;9(8):e028803.
doi: 10.1136/bmjopen-2018-028803.

Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review

Ruijin Qiu #  1 , Jiayuan Hu #  1 , Ya Huang  1 , Songjie Han  1 , Changming Zhong  1 , Min Li  1 , Tianmai He  1 , Yiyi Lin  1 , Manke Guan  1 , Jing Chen  2 , Hongcai Shang  3   4
Affiliations

Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review

Ruijin Qiu et al. BMJ Open. .

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.

Keywords: clinical trials, non-valvular atrial fibrillation; outcomes; systematic review.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
The flowchart of the systematic review.
Figure 2
Figure 2
The type and distribution of clinical trials.
Figure 3
Figure 3
The quality of outcome reporting in different types of clinical trials.
Figure 4
Figure 4
The quality of outcome reporting in different countries.
Figure 5
Figure 5
The summary of outcome reporting times.
Figure 6
Figure 6
The number of outcomes in different outcome domains in antiarrhythmic treatment trials.
Figure 7
Figure 7
The number of outcomes in different outcome domains in anticoagulant treatment trials.
See this image and copyright information in PMC

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References

    1. Odutayo A, Wong CX, Hsiao AJ, et al. . Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ 2016;354 10.1136/bmj.i4482 - DOI - PubMed
    1. January CT, Wann LS, Alpert JS, et al. . 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American heart association Task force on practice guidelines and the heart rhythm Society. J Am Coll Cardiol 2014;64:e1–76. 10.1016/j.jacc.2014.03.022 - DOI - PubMed
    1. Kirchhof P, Benussi S, Kotecha D, et al. . 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Rev Esp Cardiol 2017;70 10.1016/j.rec.2016.11.033 - DOI - PubMed
    1. Heart Rhythm Society of the Chinese Society of Biomedical Engineering, Nao Xin Tong Zhi Committee of the Chinese Association of Integrative Medicine . Expert consensus on Wenxin granule for treatment of cardiac arrhythmias. Chin Med J 2017;130:203–10. 10.4103/0366-6999.198003 - DOI - PMC - PubMed
    1. COMET Initiative Available: http://www.comet-initiative.org/ [Accessed 1 Apr 2019].

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