John Albright, MD, Clinical Specialty Expert
Physical Therapy October 2001 vol. 81 no. 10 1641-1674
Abstract
Introduction. A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back pain. Methods. Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analysis was conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies. Developing Recommendations. An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required, but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established. Validating the Recommendations. A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%. Results. Four positive recommendations of clinical benefit were developed. Therapeutic exercises were found to be beneficial for chronic, subacute, and postsurgery low back pain. Continuation of normal activities was the only intervention with beneficial effects for acute low back pain. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 85%). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation), there was a lack of evidence regarding efficacy. Conclusions. This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing guidelines that incorporates clinicians’ feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions for patients with low back pain where evidence was insufficient to make recommendations.