兰州大学循证社会科学交叉创新实验室 Innovation Laboratory of Evidence-based Social Sciences,Lanzhou University

The reporting quality of N-of-1 trials and protocols still needs improvement

Li, Xiuxia;Yang, Kehu
2022-08-01
Objective To evaluate the reporting quality of single-patient (N-of-1) trials and protocols based on the CONSORT Extension for N-of-1 trials (CENT) statement and the standard protocol items: recommendations for interventional trials (SPIRIT) extension and elaboration for N-of-1 trials (SPENT) checklist to examine the factors that influenced reporting quality. Methods Four electronic databases were searched to identify N-of-1 trials and protocols from 2015 to 2020. Quality was assessed by two reviewers. We calculated the overall scores based on binary responses in which "Yes" was scored as 1 (if the item was fully reported), and "No" was scored as 0 (if the item was not clearly reported or not definitely stated). Results A total of 78 publications (55 N-of-1 trials and 23 protocols) were identified. The mean reporting score (SD) of the N-of-1 trials and protocols were 29.24 (0.89) and 29.61 (1.83), respectively. For the items related to outcomes, sample size, allocation concealment protocol, and informed consent materials, the reporting quality was low. Our results showed that the year of publication (t = -0.793, p = 0.872 for the trials and t = 1.352, p = 0.623 for the protocols) and the impact factor of the journal (t = 1.416, p = 0.619 for the trials and t = 0.359, p = 0.667 for the protocols) were not factors associated with better reporting quality. Conclusion With the publication of the CENT 2015 statement and the SPENT 2019 checklist, authors should adhere to the relevant reporting guidelines and improve the reporting quality of N-of-1 trials and protocols.
J Evid Based Med
卷号:15|期号:4|页码:365-372
ISSN:1756-5383|收录类别:SCIE
DOI
10.1111/jebm.12484
EISSN
1756-5391
出版日期
2022-08-01
资助信息
National Social Science Fund of China, Grant/Award Number: 19ZDA142
资助机构
国家社会科学基金委员会
相关链接
https://onlinelibrary.wiley.com/doi/10.1111/jebm.12484
语种
English
国家
中国
学科领域
其他
WOS学科分类
Medicine, General & Internal
被引频次(WOS)
0
研究类型
其他
关键词
Author Keywords:CENT statement CONSORT guidelines reporting quality single-patient (N-of-1) trials SPENT checklist SPIRIT guidelines Keywords Plus:RANDOMIZED CONTROLLED-TRIALS METHODOLOGICAL QUALITY REGISTRATION ASSOCIATION STATEMENT GUIDELINE REFLECT