The Maine Lumbar Spine Study, Part I. Background and concepts.

Abstract

This paper describes the background and factors that led to the development and implementation of the Maine Lumbar Spine Study, a prospective cohort study of patients undergoing surgical and nonsurgical treatment of herniated lumbar disc with sciatica and symptomatic spinal stenosis. To define the factors leading to the study and the methods of designing and implementing a community-based effectiveness study to evaluate the outcomes of herniated lumbar intervertebral disc and spinal stenosis. Variations in the utilization of surgery for these conditions and physicians' uncertainty regarding the best way to manage them resulted in support of a community-based study of the effectiveness of treatment alternatives. A prospective cohort design was used. Methods of patient enrollment, data collection, management, and analysis are described. An innovative method of ascertaining the representativeness of the enrolled versus nonenrolled patient population is presented. The importance of developing community-based networks of physicians is discussed. These networks play an important role in analyzing practice pattern variations and in stimulating and participating in effectiveness research. Because effectiveness studies must be conducted at the community level, mechanisms must be developed with which to support and implement these efforts.