Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions

被引:13
作者
Li, Guowei [1 ,2 ,3 ]
Bhatt, Meha [1 ]
Wang, Mei [1 ,3 ]
Mbuagbaw, Lawrence [1 ,3 ]
Samaan, Zainab [4 ]
Thabane, Lehana [1 ,2 ,3 ]
机构
[1] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON L8S 4L8, Canada
[2] McMaster Univ, Ctr Evaluat Med, Programs Assessment Technol, Hlth Res Inst, Hamilton, ON L8N 1Y3, Canada
[3] St Josephs Healthcare Hamilton, Res Inst, Biostat Unit, Hamilton, ON L8N 4A6, Canada
[4] McMaster Univ, Dept Psychiat & Behav Neurosci, Hamilton, ON L8S 4L8, Canada
基金
加拿大健康研究院;
关键词
randomized controlled trial; reporting quality; transparency; guideline adherence; inconsistent reporting; PUBLISHED PRIMARY OUTCOMES; CONFERENCE ABSTRACTS; CLINICAL-TRIALS; CONSORT CHECKLIST; SUBGROUP ANALYSES; MEDICAL JOURNALS; REDUCING WASTE; QUALITY; IMPACT; PROTOCOLS;
D O I
10.1073/pnas.1708286114
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
070301 [无机化学]; 070403 [天体物理学]; 070507 [自然资源与国土空间规划学]; 090105 [作物生产系统与生态工程];
摘要
Evidence from a well-designed randomized controlled trial (RCT) is generally considered to be the gold standard that can inform clinical practice and guide decision-making. However, several deficiencies in the reporting of RCTs have frequently been identified, including incomplete, selective, and biased or inconsistent reporting. Such suboptimal reporting may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct. In this article, we present an overview of the reporting of RCTs in the biomedical literature with a focus on the three most common reporting problems: (i) lack of adherence to reporting guidelines, (ii) inconsistencies between trial protocols or registrations and full reports, and (iii) inconsistencies between abstracts and their corresponding full reports. Unsatisfactory levels of adherence to guidelines and frequent inconsistencies between protocols or registrations and full reports, and between abstracts and full reports, were consistently found in various biomedical research fields. A variety of factors were found to be associated with these reporting challenges. Improved reporting can build public trust and credibility of science, save resources, and enhance the ethical integrity of research. Therefore, joint efforts from the various sectors of the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers) are needed to reduce and reverse the current suboptimal state of RCT reporting in the literature.
引用
收藏
页码:2595 / 2599
页数:5
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