OBJECTIVES: Health technology assessment bodies are increasingly reviewing the clinical and economic evidence on various surgical procedures. Such reviews typically use a hierarchy of evidence, with randomized controlled trials (RCTs) designated Level I evidence and case-control and case-series studies designated Levels III and IV. The objective of this study was to explore the evidence available to determine the value of a well-established surgical procedure.
METHODS: A structured search of PubMed was conducted on rotator cuff surgery using Medical Subject Heading search terms. Internet searches identified evidence-based guidelines for this condition.
RESULTS: Two RCTs evaluating the efficacy of arthroscopic repair of rotator cuff tears concluded that arthroscopic repair was superior to the alternatives studied. Ten systematic reviews examining studies of surgical technique modifications for rotator cuff surgery were identified. All 10 reviews reported that, despite limitations, there was enough evidence to identify surgical techniques that resulted in improved clinical outcomes. Most of the systematic reviews found Level III or Level IV evidence for recommending one type of surgery over another. In 2010, the American Academy of Orthopaedic Surgeons (AAOS) published evidence-based guidelines to improve treatment for 25 different rotator cuff problems; 74 studies were deemed of sufficient quality for use in the guidelines. However, more than half of the 25 recommendations (n=15) were characterized as inconclusive owing to the levels of evidence available for review.
CONCLUSIONS: The pharmaceutical framework for evidence hierarchy often may not be appropriate for surgical procedures and devices. There are challenges to running clinical trials in surgical setting, making them impractical and unaffordable. Especially with well-established procedures, evidence review will require a balanced approach using the best available evidence and clinical expertise.
