Data from: Quality of descriptions of treatments: a review of published randomised controlled trials

OBJECTIVES: To be useable in clinical practice, treatments studied in trials must provide sufficient information to enable clinicians and researchers to replicate. We sought to assess the completeness of treatment descriptions in published randomised controlled trials using a checklist and to determine the extent to which peer reviewers and editors comment on the quality of reporting of treatments. DESIGN: Cross-sectional study. SETTING: Trials published in the BMJ, a general medical journal. PARTICIPANTS: 51 trials published in the BMJ were independently evaluated by two raters using the checklist. Reviewers' and editors' comments were also assessed for statements on treatment descriptions. PRIMARY AND SECONDARY OUTCOME MEASURES: Proportion of trials rated as replicable (primary outcome). RESULTS: For 57% (29/51) of the papers, published treatment descriptions were not considered sufficient to allow replication. Most poorly described aspects were the actual procedures involved including the sequencing of the technique (what happened and when) and the physical or informational materials used (e.g. training materials): 53% and 43% not clear, respectively. For a third of treatments, the dose/duration of individual sessions was not clear and for a quarter the schedule (interval, frequency, duration, or timing) was not clear. Although the majority of problems were not picked up by reviewers and editors, when they were detected only about two-thirds were fixed before publication. CONCLUSIONS: Journals wanting to publish research of use to practicing health care professionals need to pay more attention to descriptions of treatments. Our checklist, may be useful for reviewers, and editors and could help ensure important details of treatments are provided before papers are in the public domain.研究目标：为使治疗方案可应用于临床实践，临床试验中所研究的治疗方案需提供足够信息，以使临床医师与研究人员能够复现该治疗方案。本研究旨在通过核查清单评估已发表随机对照试验（randomised controlled trial, RCT）中治疗方案描述的完整性，并探究同行评审专家与编辑对治疗方案报告质量的评论情况。 研究设计：横断面研究（cross-sectional study） 研究场景：发表于综合医学期刊《英国医学期刊》（British Medical Journal, BMJ）的临床试验。 研究对象：由两名评估者使用核查清单独立评估《英国医学期刊》（BMJ）发表的51项临床试验；同时对评审专家与编辑的评论中涉及治疗方案描述的相关内容进行分析。 主要与次要结局指标：被评定为可复现的试验占比（主要结局指标）。 研究结果：57%（29/51）的已发表论文中，其治疗方案描述被认为不足以支持治疗方案的复现。描述最不充分的内容包括实际操作流程（如技术实施顺序，即具体操作内容与实施时机）以及所使用的实体或信息类材料（如培训资料），二者未明确说明的比例分别为53%与43%。三分之一的治疗方案未明确单次疗程的剂量/持续时长，四分之一的治疗方案未明确疗程安排（间隔、频率、持续时长或实施时机）。尽管多数问题未被评审专家与编辑发现，但在被检出的问题中，仅约三分之二在论文发表前得到了修正。 研究结论：旨在将研究成果发表以供执业医疗专业人员参考的期刊，需进一步加强对治疗方案描述的审核。本研究使用的核查清单可辅助评审专家与编辑开展工作，有助于在论文公开前确保治疗方案的关键细节得到完整呈现。