Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom.
PLoS Med. 2020 Sep 21;17(9):e1003344. doi: 10.1371/journal.pmed.1003344. eCollection 2020 Sep.
Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesize data from several studies, increasing sample size and, consequently, power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging because of poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies that has been developed using a widely accepted robust methodology. The objective of this project was to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline.
We established a preliminary checklist of reporting items to be considered for inclusion in the guideline. We invited representatives of key stakeholder groups to participate in a 2-round Delphi survey. A total of 52 individuals participated in both rounds of the survey, scoring items with regards to their importance for inclusion in the STROPS guideline. We then held a consensus meeting, at which 8 individuals considered the results of the Delphi survey and voted on whether each item ought to be included in the final guideline. The STROPS guideline consists of 54 items and is accompanied by an explanation and elaboration document. The guideline contains items that are particularly important in the field of pharmacogenetics, such as the drug regimen of interest and whether adherence to treatment was accounted for in the conducted analyses. The guideline also requires that outcomes be clearly defined and justified, because in pharmacogenetic studies, there may be a greater number of possible outcomes than in other types of study (for example, disease-gene association studies). A limitation of this project is that our consensus meeting involved a small number of individuals, the majority of whom are based in the United Kingdom.
Our aim is for the STROPS guideline to improve the transparency of reporting of pharmacogenetic studies and also to facilitate the conduct of high-quality systematic reviews and meta-analyses. We encourage authors to adhere to the STROPS guideline when publishing pharmacogenetic studies.
为了检测药物遗传学标志物与治疗反应之间存在统计学显著关联，通常需要大量样本。可以进行荟萃分析来综合来自多个研究的数据，从而增加样本量，并提高检测到显著遗传效应的能力。然而，由于研究报告中关键数据的报告质量较差，对药物遗传学研究数据进行稳健综合分析通常具有挑战性。目前，还没有使用广泛认可的稳健方法制定的药物遗传学研究报告指南。本项目旨在制定加强药物遗传学研究报告的质量（STROPS）指南。
我们建立了一份初步的报告项目清单，以供纳入指南考虑。我们邀请了主要利益相关者团体的代表参加两轮德尔菲调查。共有 52 人参加了两轮调查，对纳入 STROPS 指南的重要性进行了评分。然后，我们举行了一次共识会议，8 人考虑了德尔菲调查的结果，并投票决定每个项目是否应纳入最终指南。STROPS 指南共有 54 个项目，并附有一份解释和说明文件。该指南包含了在药物遗传学领域特别重要的项目，例如研究中关注的药物方案，以及在进行分析时是否考虑了对治疗的依从性。该指南还要求明确和合理地定义结局，因为在药物遗传学研究中，可能会有比其他类型研究更多的可能结局（例如，疾病-基因关联研究）。本项目的一个局限性是我们的共识会议涉及的人数较少，大多数人都在英国。
我们的目标是通过 STROPS 指南提高药物遗传学研究报告的透明度，并促进高质量系统评价和荟萃分析的进行。我们鼓励作者在发表药物遗传学研究时遵守 STROPS 指南。
