科学文章的读者是否应该获得临床试验中患者招募的知情同意书和相关信息?牙科案例研究。

IF 2.8 1区 哲学 Q1 MEDICAL ETHICS
Clovis Mariano Faggion
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引用次数: 1

摘要

研究中的伦理方面应该透明地报告。本研究旨在调查科学文献中是否充分报道了临床研究中与患者招募相关的知情同意书和信息。2016年11月至2021年11月期间发表的关于根覆盖程序的随机临床试验(RCT)选自PubMed数据库。项目/问题用于指导提取与患者招募相关的数据,重点是用于向患者澄清研究的知情同意书的详细报告。数据取自已发表的文章和在公共登记处发表的各自研究方案。还提取了与潜在选择性结果报告(SOR)相关的信息。总共对187份文件进行了初步筛选,纳入了74份随机对照试验报告。文章中没有发表知情同意书。只有一项研究方案提供了知情同意书的链接。发现研究方案和已发表文章中的报告存在偏差,表明存在SOR。在根覆盖程序的随机对照试验中,知情同意书和与患者招募相关的信息被严重低估。目前的调查结果可能会引发关于公开这一信息的必要性的进一步讨论和辩论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Should informed consent and information related to patient recruitment in clinical trials be available to the reader of scientific articles? A case study in dentistry.

Ethical aspects in research should be transparently reported. This study aimed to investigate whether informed consent and information related to patient recruitment in clinical studies are well reported in the scientific literature. Randomized clinical trials (RCTs) on root coverage procedures published between November 2016 and November 2021 were selected from the PubMed database. Items/questions were used to guide the extraction of data related to patient recruitment, with a focus on the detailed report of informed consent used to clarify the research to the patient. Data were extracted from the published article and the respective research protocol published in a public registry. Information related to potential selective outcome reporting (SOR) was also extracted. In total, 187 documents were initially screened and 74 reports of RCTs were included. No informed consent was published in the article. Only one research protocol provided a link to the informed consent. Deviations from reporting in the research protocol and published article were found, suggesting SOR. Informed consent and information related to patient recruitment in RCTs on root covering procedures are severely underreported. The present findings may stimulate further discussion and debate on the need for making this information publicly available.

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来源期刊
CiteScore
4.90
自引率
14.70%
发文量
49
审稿时长
>12 weeks
期刊介绍: Accountability in Research: Policies and Quality Assurance is devoted to the examination and critical analysis of systems for maximizing integrity in the conduct of research. It provides an interdisciplinary, international forum for the development of ethics, procedures, standards policies, and concepts to encourage the ethical conduct of research and to enhance the validity of research results. The journal welcomes views on advancing the integrity of research in the fields of general and multidisciplinary sciences, medicine, law, economics, statistics, management studies, public policy, politics, sociology, history, psychology, philosophy, ethics, and information science. All submitted manuscripts are subject to initial appraisal by the Editor, and if found suitable for further consideration, to peer review by independent, anonymous expert referees.
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