From the Rehabilitation Teaching and Research Unit, Department of Medicine, University of Otago, Wellington, New Zealand (WMML); Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (JPE); Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, Illinois (AWH); Department of Biomedical, Surgical and Dental Sciences, University of Milan "La Statale," Italy (SN); and IRCCS Istituto Ortopedico Galeazzi, Milan, Italy (SN).
Am J Phys Med Rehabil. 2020 Mar;99(3):191-197. doi: 10.1097/PHM.0000000000001368.
We examined and appraised the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and its extension from the perspective of the reporting of comparison groups (ie, interventions or control conditions against which an experimental intervention is compared) in clinical trials on rehabilitation topics.
We downloaded the CONSORT 2010 Statement and all endorsed and unofficial extensions reported on the CONSORT and EQUATOR Web sites. We extracted all statements on the selection, design, delivery, or interpretation of data from comparison groups in clinical trials. We discussed preliminary findings during the Cochrane Rehabilitation Methodology Meeting in Kobe and then further by email before finalizing results.
We identified 23 standards reported across the CONSORT 2010 Statement and 10 extensions. Overall, these standards address many, but not all, issues related to reporting of comparison groups in rehabilitation trials.
We recommend that additional standards be created for the selection of types of comparisons, choices around reporting of "usual care," reporting of intended "mechanisms of control," and reporting a rationale for the hypothesized superiority of one intervention over another when superiority trial design are used. Rehabilitation research would benefit from development of a specific checklist and guidelines to help researchers make best use of existing extensions.
我们从康复主题临床试验中比较组（即与实验干预措施进行比较的干预措施或对照条件）报告的角度，检查和评价了 CONSORT 2010 声明及其扩展内容。
我们下载了 CONSORT 2010 声明以及 CONSORT 和 EQUATOR 网站上报告的所有认可和非官方扩展内容。我们从临床试验的比较组中提取了所有关于选择、设计、实施或解释数据的声明。我们在神户的 Cochrane 康复方法学会议上讨论了初步结果，然后通过电子邮件进一步讨论，最后确定了结果。
我们在 CONSORT 2010 声明和 10 个扩展中确定了 23 个标准。总的来说，这些标准涉及了康复试验中报告比较组的许多问题，但不是全部问题。
我们建议为选择比较类型、报告“常规护理”的选择、报告“控制机制”的意图以及在使用优越性试验设计时报告假设一种干预措施优于另一种干预措施的合理性制定额外的标准。康复研究将受益于制定特定的清单和指南，以帮助研究人员充分利用现有的扩展内容。
