Manouchehri Elham, Alirezaei Somayeh, Roudsari Robab Latifnejad
Student in Reproductive Health, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Student in Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Iran J Nurs Midwifery Res. 2020 Nov 7;25(6):445-454. doi: 10.4103/ijnmr.IJNMR_223_19. eCollection 2020 Nov-Dec.
Randomized Controlled Trials (RCTs) are reliable methods for the evaluation of treatment effectiveness, which should be rigorous and must report with clarity. This study aimed to assess the compliance of published RCTs about the effect of physical activity on primary dysmenorrhea with the CONSORT 2017 statement.
In this study, the review of literature was carried out based on Consolidated Standards Of Reporting Trials (CONSORT). All the clinical trials focused on the effect of the physical activity on primary dysmenorrhea indexed in Web of Science, Pubmed, Scopus, Google Scholar, Science Direct, Embase, Magiran and Scientific Information Database (SID) were searched using keywords of dysmenorrhea, randomized clinical trial, physical activity and exercise from 2000 to 2019. Out of 1423 articles, 30 RCTs were critically appraised using CONSORT 2017 checklist. The reporting quality score of articles was identified between zero and 43.
The compliance rate with the CONSORT checklist was 55.58%. The mean (SD) score of the reporting quality was 23.37 (-5.15) with a minimum of 16 and a maximum of 37. The maximum weakness was in reporting the sample size and full trial protocol 23.33% and 6.67% respectively. Regarding new items of the consort 2017, if the blinding was not possible, the description of any attempts to limit bias was not described in 70% of articles.
Reporting sample size, trial protocol, method of blinding, and control of bias are issues that require more attention in reporting of RCT studies. We recommend that the authors use the CONSORT 2017 statement for conducting and reporting the clinical trials.
随机对照试验（RCT）是评估治疗效果的可靠方法，应严谨且报告清晰。本研究旨在评估已发表的关于体育活动对原发性痛经影响的随机对照试验与CONSORT 2017声明的合规情况。
本研究基于报告试验的统一标准（CONSORT）进行文献综述。使用痛经、随机临床试验、体育活动和运动等关键词，检索2000年至2019年在科学网、PubMed、Scopus、谷歌学术、科学Direct、Embase、Magiran和科学信息数据库（SID）中索引的所有关注体育活动对原发性痛经影响的临床试验。在1423篇文章中，使用CONSORT 2017清单对30项随机对照试验进行了严格评估。文章的报告质量得分在0至43分之间。
CONSORT清单的合规率为55.58%。报告质量的平均（标准差）得分为23.37（-5.15），最低为16分，最高为37分。最大的薄弱环节分别在于样本量报告和完整试验方案，分别为23.33%和6.67%。关于CONSORT 2017的新条目，如果无法进行盲法，70%的文章未描述任何限制偏倚的尝试。
样本量报告、试验方案、盲法方法和偏倚控制是随机对照试验研究报告中需要更多关注的问题。我们建议作者使用CONSORT 2017声明来开展和报告临床试验。
