SPINE Volume 35, Number 9S, pp S22–S27 ©2010, Lippincott Williams & Wilkins Methods for the Systematic Reviews on Patient Safety During Spine Surgery Joseph R. Dettori, MPH, PhD,* Daniel C. Norvell, PhD,* Mark Dekutoski, MD,† Charles Fisher, MD, MPH,‡ and Jens R. Chapman, MD§ Study Design. Systematic review. Objective. To provide a detailed description of the methods undertaken in the systematic search and analyt- ical summary of patient safety issues in spinal surgery, and to describe the process used to come to a clinical recommendation regarding challenges in the manage- ment 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 inter- vention. We present methods used in conducting the sys- tematic, evidence-based reviews, and expert panel recom- mendations 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 pub- lished 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 consider- ing 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 formu- lated 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 es- tablish a baseline of the current evidence on patient safety issues in spine surgery. This article reports the methods used in the reviews. Key words: systematic review, adverse events, spine sur- gery, complications, methods. Spine 2010;35:S22–S27 Understanding the medical literature regarding the as- sessment of patient centered outcomes and safety is crit- ical to developing an informed patient centered decision with respect to medical intervention. As surgery implic- itly creates greater risk this obligation is heightened. A solid understanding of complication type, incidence, risk factors, and impact is integral to the physician’s role. Furthermore, methods to reduce the impact or avoid them altogether depend heavily on this understanding. We present methods used in conducting the system- atic, evidence-based reviews and expert panel recom- mendations of key challenges to the spine surgical prac- tice. We undertook this project so as to enhance the physician’s awareness of the patient safety literature sur- rounding these controversial areas. It is our desire that spine surgeons will use the information from these re- views together with an understanding of their own ca- pacities and experience to better inform patients with respect to potential treatment outcomes, safety, and life impact. Materials and Methods Literature Search and Article Selection We identified articles for inclusion in 2 steps, Figure 1. In the first step, we conducted a systematic search of the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials 1 electronic databases to identify studies reporting patient safety with respect to the clinical questions identified above. The search period differed depending on completion of each article, but gen- erally ended between December 2008 and June 2009. Searches were conducted using standard MeSH terms (controlled vocabu- lary) as well as specific free-text terms and combinations of terms related to the clinical conditions. We then hand searched the bib- liographies of key articles to ensure each topic was comprehen- sively examined. All possible relevant articles were screened using titles and abstracts by 2 individuals independently. Those articles that did not meet a set of a priori retrieval criteria for each topic area were excluded. Any disagreement between screeners was re- solved through discussion. In the second step, we retrieved and examined the full text articles of those remaining and applied the same inclusion criteria once more. Those articles selected form the evidence base for this report. Inclusion Criteria Whether an article was included for review depended on whether the study question was one of therapy (whether one From the *Spectrum Research, Inc., Tacoma, WA; †Department of Orthopedic Surgery, Mayo Clinic, Mayo College of Medicine, Roch- ester, MN; ‡Department of Orthoapedic Surgery, Joint Spine Program, University of British Columbia, Vancouver, BC; and §Department of Orthoapedic Surgery, Harborview Medical Center, Seattle, WA. The manuscript submitted does not contain information about medical device(s)/drug(s). Supported by AOSpine North America. Analytic support for this work was provided by Spectrum Research, Inc. with funding from AOSpine North America. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. J.D., manuscript preparation and manuscript revision; D.N., manuscript preparation and manuscript revision; M.D., manuscript preparation and manuscript revision; C.F., manuscript revision; J.C., manuscript revision. Address correspondence and reprints to Joseph R. Dettori, MPH, PhD, Spectrum Research, Inc., 705 S. 9th St., Suite 203, Tacoma, WA 98405; E-mail: joe@specri.com S22