Qureshi Riaz, Gough Alexander, Loudon Kirsty
Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, USA.
Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Trials. 2022 Apr 27;23(1):359. doi: 10.1186/s13063-022-06316-7.
Crystal clear RCT protocols are of paramount importance. The reader needs to easily understand the trial methodology and know what is pre-planned. They need to know there are procedures in place if there are, for instance, protocol breaches and protocol amendments are required, there is loss to follow-up and missing data, and how solicited and spontaneous reported adverse events are dealt with. This plan is important for the trial and for the results that will be published when the data is analysed. After all, individuals have consented to participate in these trials, and their time and their well-being matter. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) provides guidance to structure RCT protocols and ensures all essential information is included. But sadly, not all trialists follow the guidance, and sometimes, the information is misunderstood. Using experience peer-reviewing for Trials over the last 2 years, we have prepared information to assist authors, peer reviewers, editors, and other current and future SPIRIT protocol editors to use the SPIRIT guidance and understand its importance.
清晰明确的随机对照试验方案至关重要。读者需要轻松理解试验方法，并知晓预先规划的内容。他们需要知道，如果出现例如违反方案、需要修正方案、失访和数据缺失等情况，以及如何处理主动报告和自发报告的不良事件，都有相应的程序。该方案对于试验以及分析数据时即将发表的结果都很重要。毕竟，个体已同意参与这些试验，他们的时间和健康至关重要。《标准方案项目：干预性试验建议》（SPIRIT）为构建随机对照试验方案提供指导，并确保纳入所有必要信息。但遗憾的是，并非所有试验者都遵循该指导，有时信息也会被误解。基于过去两年对试验进行同行评审的经验，我们编写了相关资料，以帮助作者、同行评审人员、编辑以及其他当前和未来的SPIRIT方案编辑人员使用SPIRIT指导并理解其重要性。
