Institute of General Medicine, Family Medicine and Preventive Medicine, Paracelsus Medical University, Strubergasse 21, Salzburg 5020, Austria.
Institute of Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Age Ageing. 2014 Nov;43(6):872-6. doi: 10.1093/ageing/afu086. Epub 2014 Jun 30.
to assess the proportion of registered randomised controlled trials in five core clinical geriatric journals and to analyse whether registered study outcomes correspond with published outcomes.
survey of original papers published 2008 to 2012.
two independent reviewers retrieved the sample through search in the web-based archives of Age and Ageing, the Journal of the American Geriatric Society, the American Journal of Geriatric Psychiatry, the Journal of the American Medical Directors Association and International Psychogeriatrics. Data extraction was performed by two independent reviewers using a pre-tested 13-item checklist. Registration status was checked and information provided in registers compared with information presented in the original publication. A third reviewer was consulted if no consensus could be reached.
the sample comprised 220 original publications on randomised controlled trials. A total of 140 (63.6%) were registered. Registration was in accordance with the ICMJE requirements in 54 out of 140 registered trials (38.6%). Less than one-third of registered papers (n = 40) reported on all study outcomes listed in the study register. In 74 out of the 80 non-registered trials, the missing registration was not declared in the publication. There was no consistent upward trend towards higher registration compliance throughout journals and years.
our survey shows that prospective trial registration and compliance between outcomes declared in the registry and reported in the publication is poor. Concerted action of authors, editors and peer-reviewers is overdue aimed to irreversibly implement the imperative of registration of randomised controlled trials and complete outcome reporting.
评估 5 本核心老年医学临床期刊中注册的随机对照试验的比例,并分析注册的研究结果是否与已发表的结果相符。
对 2008 年至 2012 年发表的原始论文进行调查。
两名独立的审查员通过在 Age and Ageing、美国老年学会杂志、美国老年精神病学杂志、美国医疗保健管理人员协会杂志和国际老年精神病学杂志的网络档案中进行搜索来检索样本。两名独立的审查员使用预先测试的 13 项清单进行数据提取。检查注册状态,并将注册处提供的信息与原始出版物中的信息进行比较。如果无法达成共识,则咨询第三位审查员。
样本包括 220 篇关于随机对照试验的原始出版物。共有 140 篇(63.6%)进行了注册。在 140 个已注册的试验中,有 54 个(38.6%)符合 ICMJE 的要求。在注册的 40 篇论文中,只有不到三分之一(n=40)报告了研究注册中列出的所有研究结果。在 80 个未注册的试验中,有 74 个(92.5%)未在出版物中声明缺失注册。整个期刊和年份的注册合规性并没有呈现出一致的上升趋势。
我们的调查显示,前瞻性试验注册和注册处报告的研究结果与出版物报告的结果之间的一致性很差。作者、编辑和同行评审员应采取一致行动,以不可逆转的方式实施随机对照试验的注册和完整结果报告的强制性要求。