OUTCOME MEASURES FOR LOW-BACK-PAIN RESEARCH - A PROPOSAL FOR STANDARDIZED USE

Study Design. An international group of back pain researchers consider ed recommendations for standardized measures in clinical outcomes rese arch in patients with back pain. Objectives. To promote more standardi zation of outcome measurement in clinical trials and other types of ou tcomes research, including meta-analyses, cost-effectiveness analyses, and multicenter studies. Summary of Background Data. Better standardi zation of outcome measurement would facilitate comparison of results a mong studies, and more complete reporting of relevant outcomes. Becaus e back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, fun ction, general well-being, work disability, and satisfaction with care . Methods. The panel considered several-factors in recommending a stan dard battery of outcome measures. These included reliability, validity , responsiveness, and practicality of the measures. In addition, compa tibility with widely used and promoted batteries such as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to mini mize the need for changes when these instruments are used. Results; Fi rst, a six-item set was: proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and fo r research purposes. An expanded outcome set, which would provide more precise measusement for research purposes, includes measures of sever ity and frequency of symptoms, either the. Roland Or the Oswestry Disa bility Scale, either the SF-12 or the EuroOol measure of general healt h status, a question about satisfaction With symptoms, three types of ''disability days,'' and an optimal single item on overall satisfactio n with medical care. Conclusion, Standardized measurement of outcomes would facilitate scientific advances in clinical care. A Short, 6-item questionnaire and a somewhat expanded more precise battery of questio nnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally importa nt change in scores are needed for most of the instruments.