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comparison, and outcome) that directed the literature search. The AAOS Medical Librarian created and executed the search (see Appendix III for search strategy). LITERATURE SEARCHES We begin the systematic review with a comprehensive search of the literature. Articles we consider were published prior to the start date of the search in a minimum of three electronic databases; PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. The medical librarian conducts the search using key terms determined from the guideline development group’s PICO questions. A CQV methodologist will review/include only primary literature but will supplement the electronic search with a manual search of the bibliographies of secondary literature sources, such as systematic reviews, as available. The methodologist will then evaluate all recalled articles for possible inclusion based on the study selection criteria and will summarize the evidence for the guideline work group who assist with reconciling possible errors and omissions. A study attrition diagram is provided in the appendix of each document that details the numbers of identified abstracts, recalled and selected studies, and excluded studies that were evaluated in the CPG. The search strategies used to identify the abstracts is also included in the appendix of each CPG document. DEFINING THE STRENGTH OF RECOMMENDATION Judging the quality of evidence is only a steppingstone towards arriving at the strength of a CPG recommendation. The strength of recommendation also takes into account the quality, quantity, and the trade-off between the benefits and harms of a treatment, the magnitude of a treatment’s effect, and whether data exists on critical outcomes. Strength of recommendation expresses the degree of confidence one can have in a recommendation. As such, the strength expresses how possible it is that a recommendation will be overturned by future evidence. It is very difficult for future evidence to overturn a recommendation that is based on many high quality randomized controlled trials that show a large effect. It is much more likely that future evidence will overturn recommendations derived from a few small retrospective comparative studies. Consequently, recommendations based on the former kind of evidence are given a “strong” strength of recommendation and recommendations based on the latter kind of evidence are given a “limited” strength. 18 View background material via the OAK3 CPG eAppendix 1 View data summaries via the OAK3 CPG eAppendix 2 To develop the strength of a recommendation, AAOS staff first assigned a preliminary strength for each recommendation that took only the final quality and the quantity of evidence (see Table 1). The recommendations can be further downgraded or upgraded based on the GRADE and Evidence-toDecision Framework criteria described above. VOTING ON THE RECOMMENDATIONS The recommendations and their strength were voted on by the guideline development group members during the final meeting. If disagreement between the guideline development group occurred, there was further discussion to see whether the disagreement(s) could be resolved. Recommendations were approved and adopted in instances where a simple majority (60%) of the guideline development group voted to approve; however, the guideline development group had consensus (100% approval) when voting on every recommendation for this guideline. Any recommendation strength upgrade or downgrade based on the Evidence-to-Decision Framework requires a super majority (75%) approval of the work group. 19 INTERPRETING THE STRENGTH OF EVIDENCE Table I. LEVEL OF EVIDENCE DESCRIPTIONS Strength Overall Strength of Evidence Description of Evidence Quality Strength Visual Strong Strong or Moderate Evidence from two or more “High” quality studies with consistent findings for recommending for or against the intervention. Or Rec is upgrade from Moderate using the EtD framework Moderate Strong, Moderate or Limited Evidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. Or Rec is upgraded or downgraded from Limited or Strong using the EtD framework. Limited Limited or Moderate Evidence from one or more “Low” quality studies with consistent findings or evidence from a single “Moderate” quality study recommending for or against the intervention. Or Rec is downgraded from Moderate using the EtD Framework. Consensus* No Evidence There is no supporting evidence, or higher quality evidence was downgraded due to major concerns addressed in the EtD framework. In the absence of reliable evidence, the guideline work group is making a recommendation based on their clinical opinion. Table II. INTERPRETING THE STRENGTH OF A RECOMMENDATION Strength of Recommendation Patient Counseling (Time) Decision Aids Impact of Future Research Strong Least Least Important, unless the evidence supports no difference between two alternative interventions Not likely to change Moderate Less Less Important Less likely to change Limited More Important Change possible/anticipated Consensus Most Most Important Impact unknown
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