Methods for the Systematic Reviews on Patient Safety During Spine Surgery

Study Design. Systematic review. Objective. To provide a detailed description of the methods undertaken in the systematic search and analytical summary of patient safety issues in spinal surgery, and to describe the process used to come to a clinical recommendation regarding challenges in the management of patients undergoing spine surgery. Summary of Background Data. A solid understanding of complication type, incidence, risk factors, and impact is implicit to the physician's role in developing an informed patient centered decision with respect to surgical intervention. We present methods used in conducting the systematic, evidence-based reviews, and expert panel recommendations of key challenges to the spine surgical practice. It is our desire that spine surgeons will use the information from these reviews together with an understanding of their own capacities and experience to better inform patients with respect to potential treatment outcomes, safety, and life impact. Methods. A systematic search and critical review of the English language literature was undertaken for articles published on the safety of various surgical spine conditions. Citations were screened for relevance using a priori criteria, and relevant studies were critically reviewed. The strength of evidence for the overall body of literature in each topic area was determined by 2 independent reviewers considering study quality, study quantity, and consistency of results. Disagreements were resolved by consensus. Findings from studies meeting inclusion criteria were summarized. From these summaries, clinical recommendations were formulated from consensus achieved among subject experts through the Delphi process. Results. We identified and screened 2020 citations in 13 topic areas relating to safety in spine surgery. Of these, 273 met our predetermined inclusion criteria and were used to attempt to answer specific clinical questions within each topic area. Conclusion. We undertook systematic reviews to establish a baseline of the current evidence on patient safety issues in spine surgery. This article reports the methods used in the reviews.