Department of Physiotherapy, Monash University, Melbourne, Australia.
BMC Med Res Methodol. 2010 Jul 3;10:62. doi: 10.1186/1471-2288-10-62.
There is considerable clinician and researcher interest in whether the outcomes for patients with low back pain, and the efficiency of the health systems that treat them, can be improved by 'subgrouping research'. Subgrouping research seeks to identify subgroups of people who have clinically important distinctions in their treatment needs or prognoses. Due to a proliferation of research methods and variability in how subgrouping results are interpreted, it is timely to open discussion regarding a conceptual framework for the research designs and statistical methods available for subgrouping studies (a method framework). The aims of this debate article are: (1) to present a method framework to inform the design and evaluation of subgrouping research in low back pain, (2) to describe method options when investigating prognostic effects or subgroup treatment effects, and (3) to discuss the strengths and limitations of research methods suitable for the hypothesis-setting phase of subgroup studies.
The proposed method framework proposes six phases for studies of subgroups: studies of assessment methods, hypothesis-setting studies, hypothesis-testing studies, narrow validation studies, broad validation studies, and impact analysis studies. This framework extends and relabels a classification system previously proposed by McGinn et al (2000) as suitable for studies of clinical prediction rules. This extended classification, and its descriptive terms, explicitly anchor research findings to the type of evidence each provides. The inclusive nature of the framework invites appropriate consideration of the results of diverse research designs. Method pathways are described for studies designed to test and quantify prognostic effects or subgroup treatment effects, and examples are discussed. The proposed method framework is presented as a roadmap for conversation amongst researchers and clinicians who plan, stage and perform subgrouping research.
This article proposes a research method framework for studies of subgroups in low back pain. Research designs and statistical methods appropriate for sequential phases in this research are discussed, with an emphasis on those suitable for hypothesis-setting studies of subgroups of people seeking care.
临床医生和研究人员都非常关注能否通过“亚组研究”来改善腰痛患者的治疗效果和治疗这些患者的医疗体系的效率。亚组研究旨在确定在治疗需求或预后方面存在临床重要差异的人群亚组。由于研究方法的激增以及对亚组结果的解释存在差异，现在及时展开关于亚组研究的研究设计和统计方法的概念框架（方法框架）的讨论是适时的。本文的目的是：（1）提出一个方法框架，为腰痛的亚组研究的设计和评估提供信息；（2）描述在研究预后效果或亚组治疗效果时的方法选择；（3）讨论适合亚组研究假设阶段的研究方法的优缺点。
提出的方法框架为亚组研究提出了六个阶段：评估方法研究、假设设定研究、假设检验研究、狭义验证研究、广义验证研究和影响分析研究。该框架扩展并重新标记了 McGinn 等人（2000 年）提出的适合临床预测规则研究的分类系统。这种扩展的分类及其描述性术语明确将研究结果与每种证据提供的类型联系起来。该框架的包容性邀请了对各种研究设计的结果进行适当考虑。描述了旨在测试和量化预后效果或亚组治疗效果的研究的方法途径，并讨论了示例。提出的方法框架是为计划、规划和执行亚组研究的研究人员和临床医生提供的对话路线图。
本文提出了一种用于腰痛亚组研究的研究方法框架。讨论了适用于该研究各个阶段的研究设计和统计方法，重点介绍了适合寻求治疗的人群亚组的假设设定研究的方法。
