National Institute for Health and Welfare, Helsinki, Finland; Orton Orthopaedic Hospital, Scientific Unit, Helsinki, Finland.
Department of Rehabilitation, Foligno Hospital, Foligno, Perugia, Italy.
J Rehabil Med. 2022 Oct 10;54:jrm00319. doi: 10.2340/jrm.v54.2511.
The European Academy of Rehabilitation Medicine (EARM) held a debate in Hannover, Germany, on 1st of September 2016 on the pros and cons of randomized controlled trials (RCTs) and observational effectiveness studies (benchmarking controlled trials; BCTs). The debate involved a chairperson, a person presenting the substance of the debate, an opponent, and a rapporteur. The academicians participated in the discussion. Eight propositions and proposed statements formed the substance of the debate. There was agreement that a study question should be the starting point of an effectiveness study, and not the study method, i.e. RCT or BCT. The term "benchmarking" was questioned: does it mean market-oriented medicine? It was clarified that benchmarking refers to the methodological features of this study design: there must always be a comparison between peers. It was agreed that BCTs might be better than RCTs for use in rehabilitation studies, in which one often needs multi-centred studies, such as in the assessment of the effectiveness of pathways when there is complexity of processes, health systems, organizational issues, structures and facilities; or where interactions between therapists, doctors and patients differ between centres; and when assessing the implementation of rehabilitation. In addition, BCTs may deal with ethical issues, e.g. the acceptability of interventions, more easily than RCTs. Recommendations regarding the different approaches (RCTs or BCTs) should be provided by the scientific rehabilitation societies. Concern over the validity of BCTs was considered justified, as the validity criteria of BCTs cover all those related to RCTs and include the risk of selection bias between treatment arms. Appropriate description of the essentials of the study object, including adequate description of how the interventions were actualized in comparison to the study plan, are essential features for a valid and generalizable study for both RCTs and BCTs. BCTs are necessary to widen the evidence-base of effectiveness in rehabilitation. It was suggested that the rehabilitation field should support the concept of BCTs. It was proposed that education regarding BCTs is indicated, and stakeholders need to be convinced that BCTs are a valid alternative to RCTs. EARM and other physical and rehabilitation medicine (PRM) bodies could advance the use of BCTs for clinical and health policy decision-making.
2016 年 9 月 1 日，欧洲康复医学学会（EARM）在德国汉诺威就随机对照试验（RCT）和观察性有效性研究（基准对照试验；BCT）的优缺点进行了辩论。辩论由一名主席、一名辩论发言人、一名反对者和一名报告员组成。学者们参与了讨论。八项命题和拟议声明构成了辩论的实质内容。与会者一致认为，研究问题应该是有效性研究的起点，而不是研究方法，即 RCT 或 BCT。“基准”一词受到质疑：它是否意味着以市场为导向的医学？辩论澄清说，基准是指这种研究设计的方法学特征：必须始终在同行之间进行比较。与会者一致认为，对于康复研究，BCT 可能优于 RCT，因为康复研究通常需要多中心研究，例如在评估路径的有效性时，存在流程、卫生系统、组织问题、结构和设施的复杂性；或者当治疗师、医生和患者之间的相互作用在中心之间不同时；以及在评估康复实施情况时。此外，BCT 可能比 RCT 更容易处理伦理问题，例如干预措施的可接受性。不同方法（RCT 或 BCT）的建议应由科学康复协会提供。对 BCT 有效性的担忧被认为是合理的，因为 BCT 的有效性标准涵盖了所有与 RCT 相关的标准，并包括治疗组之间选择偏倚的风险。对于 RCT 和 BCT 而言，对于研究对象的重要内容进行适当的描述，包括对干预措施与研究计划相比如何实现的充分描述，是进行有效和可推广研究的重要特征。BCT 对于扩大康复有效性的证据基础是必要的。有人建议，康复领域应该支持 BCT 的概念。有人建议，应该对 BCT 进行教育，让利益相关者相信 BCT 是 RCT 的有效替代方案。EARM 和其他物理和康复医学（PRM）机构可以推进 BCT 在临床和卫生政策决策中的使用。
