Voluntary Professor of Surgery, University of Miami School of Medicine, 9100 S. Dadeland Blvd. Suite 502, Miami, FL 33156-7815, USA.
J Plast Reconstr Aesthet Surg. 2013 Jan;66(1):3-8. doi: 10.1016/j.bjps.2012.07.005. Epub 2012 Sep 15.
The Declaration of Helsinki (DOH) mandates that clinical trials must follow specific ethical standards including independent ethical review and registration in a public database to protect the rights and safety of human subjects and promote public trust. The purpose of this study was to perform a systematic review to identify whether independent ethical review and trial registration had been documented in all prospective clinical studies published in the journals Plastic and Reconstructive Surgery, Annals of Plastic Surgery and the Journal of Plastic Reconstructive and Aesthetic Surgery from 7/2007 to 7/2011 and if there was any difference in documentation between journals and between types of studies.
The PubMed database was selected to search through the medical literature with specific inclusion criteria to disqualify irrelevant articles from the study. Appropriate articles were extracted, and all investigators assessed their quality and validity to maximize reproducibility. Each investigator systematically reviewed every article to determine whether independent ethical review and trial registration had been reported. Each investigator staged every study using the 2011 Oxford Centre for Evidence Based Medicine criteria. The data were then synthesized and analyzed for documentation of independent ethical review and trial registration.
Of the 235 studies retrieved, 155 met our inclusion criteria as prospective studies, 102 reported independent ethical review. Eight studies reported trial registration in a public database, two additional studies were registered at clinicaltrials.gov, but the publications did not document their registration. Seven of the reported studies did not comply with the DOH as they had been registered retroactively; thus only one study out of 155 (<1%) documented compliance with the DOH. Using Fisher's exact test, the only statistically significant difference between the groups was better documentation in PRS level 2 studies than in PRS level 3 studies (p = 0.007).
Plastic surgery clinical trials' documentation of compliance with international ethical guidelines must improve.
《赫尔辛基宣言》（DOH）要求临床试验必须遵循特定的伦理标准，包括独立的伦理审查和在公共数据库中注册，以保护人类受试者的权利和安全，并增强公众信任。本研究的目的是进行系统评价，以确定在 2007 年 7 月至 2011 年 7 月期间发表在《整形与重建外科杂志》、《整形外科学年鉴》和《整形重建与美容外科学杂志》上的所有前瞻性临床研究中是否记录了独立的伦理审查和试验注册，以及期刊之间和研究类型之间的记录是否存在差异。
选择 PubMed 数据库检索医学文献，设定具体的纳入标准以排除与研究无关的文章。提取合适的文章，所有调查员评估其质量和有效性，以最大程度地提高可重复性。每位调查员系统地审查每篇文章，以确定是否报告了独立的伦理审查和试验注册。每位调查员使用 2011 年牛津循证医学中心标准对每项研究进行分期。然后对数据进行综合分析，以确定独立伦理审查和试验注册的记录情况。
在检索到的 235 项研究中，有 155 项符合我们作为前瞻性研究的纳入标准，其中 102 项报告了独立的伦理审查。有 8 项研究在公共数据库中报告了试验注册，另外 2 项研究在 clinicaltrials.gov 上注册，但出版物没有记录他们的注册情况。在报告的 7 项研究中，有 7 项不符合 DOH，因为它们是事后注册的；因此，在 155 项研究中只有 1 项（<1%）记录了符合 DOH。使用 Fisher 精确检验，两组之间唯一具有统计学意义的差异是 PRS 水平 2 研究的记录比 PRS 水平 3 研究更好（p=0.007）。
整形外科学临床试验记录遵守国际伦理准则的情况必须改善。
