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Background: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes. Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation. Discussion: Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.

Objective: There is considerable practice variation and clinical uncertainty about the choice of prophylaxis for preventing venous thromboembolism in patients with traumatic brain injury. We performed a systematic review to assess both the effectiveness and safety of pharmacologic and mechanical prophylaxis, and the optimal time to initiate pharmacologic prophylaxis in hospitalized patients with traumatic brain injury. Data sources and study selection: MEDLINE®, EMBASE®, SCOPUS, CINAHL, International Pharmaceutical Abstracts, clinicaltrial.gov, and the Cochrane Library were searched in July 2012 to identify randomized controlled trials and observational studies reporting on the effectiveness or safety of venous thromboembolism prevention in traumatic brain injury patients. Data extraction: Paired reviewers extracted detailed information from included articles on standardized forms and assessed the risk of bias in each article. Data synthesis: Twelve studies (2 randomized controlled trials and 10 cohort studies) evaluated the effectiveness and safety of venous thromboembolism prophylaxis in patients with traumatic brain injury. Five of the included studies assessed the optimal timing of initiation of pharmacological prophylaxis. Low grade evidence supports the effectiveness of enoxaparin over control in reducing deep vein thrombosis. Low grade evidence also supports the safety of unfractionated heparin over control in reducing mortality in patients with traumatic brain injury. Evidence was insufficient for remaining comparisons and outcomes including the optimal timing of initiation of pharmacoprophylaxis. Conclusion: There is some evidence that pharmacoprophylaxis improves deep vein thromboses and mortality outcomes in patients hospitalized with traumatic brain injury. Additional studies are required to strengthen this evidence base.