Deyo R A, Battie M, Beurskens A J, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G
Department of Medicine, University of Washington, Seattle, USA.
Spine (Phila Pa 1976). 1998 Sep 15;23(18):2003-13. doi: 10.1097/00007632-199809150-00018.
An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain.
To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including meta-analyses, cost-effectiveness analyses, and multicenter studies.
Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well-being, work disability, and satisfaction with care.
The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such, as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used.
First, a six-item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF-12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of "disability days," and an optional single item on overall satisfaction with medical care.
Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6-item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.
一个国际背痛研究小组审议了背痛患者临床结局研究中标准化测量的建议。
促进临床试验及其他类型结局研究（包括荟萃分析、成本效益分析和多中心研究）中结局测量的更多标准化。
结局测量的更好标准化将有助于研究间结果的比较以及相关结局的更完整报告。由于背痛很少致命或完全治愈，结局评估很复杂且涉及多个维度。这些维度包括症状、功能、总体健康状况、工作能力丧失以及对治疗的满意度。
该小组在推荐一套标准结局测量指标时考虑了几个因素。这些因素包括测量指标的可靠性、有效性、反应性和实用性。此外，还考虑了与广泛使用和推广的指标集（如美国矫形外科医师学会腰椎组指标集）的兼容性，以便在使用这些工具时尽量减少变更的必要性。
首先，提出了一个六项指标集，其足够简短，可用于常规护理环境以进行质量改进和研究目的。一个扩展的结局集，将为研究目的提供更精确的测量，包括症状严重程度和频率的测量指标、罗兰或奥斯维斯特里残疾量表、SF - 12或欧洲五维度健康量表对总体健康状况的测量、关于症状满意度的问题、三种类型的“残疾天数”以及一个关于对医疗护理总体满意度的可选单项指标。
结局的标准化测量将促进临床护理的科学进步。可以推荐一个简短的六项问卷和一个有所扩展、更精确的问卷集。尽管许多考虑因素支持这些建议，但大多数工具还需要更多关于反应性和分数最小重要变化的数据。
