Getting our priorities straight: a novel framework for stakeholder-informed prioritization of cancer genomics research.

PURPOSE: Prioritization of translational research on genomic tests is critically important given the rapid pace of innovation in genomics. The goal of this study was to evaluate a stakeholder-informed priority-setting framework in cancer genomics. METHODS: An external stakeholder advisory group including patients/consumers, payers, clinicians, and test developers used a modified Delphi approach to prioritize six candidate cancer genomic technologies during a 1-day meeting. Nine qualitative priority-setting criteria were considered. We used a directed, qualitative content-analysis approach to investigate the themes of the meeting discussion. RESULTS: Stakeholders primarily discussed six of the original nine criteria: clinical benefits, population health impacts, economic impacts, analytical and clinical validity, clinical trial implementation and feasibility, and market factors. Several new priority-setting criteria were identified from the workshop transcript, including "patient-reported outcomes," "clinical trial ethics," and "trial recruitment." The new criteria were incorporated with prespecified criteria to develop a novel priority-setting framework. CONCLUSION: This study highlights key criteria that stakeholders can consider when prioritizing comparative effectiveness research for cancer genomic applications. Applying an explicit priority-setting framework to inform investment in comparative effectiveness research can help to ensure that critical factors are weighed when deciding between many potential research questions and trial designs.

How frequent is rotational mismatch within 0°±10° in kinematically aligned total knee arthroplasty?

Rotational mismatch of the tibial component on the femoral component within 0°±10° is associated with better function after mechanically aligned total knee arthroplasty (TKA). Kinematically aligned TKA has gained interest; however, the percentage of kinematically aligned TKA within 0°±10° is unknown. The authors prospectively followed all patients who underwent TKA for primary osteoarthritis between December 2011 and April 2012 (194 patients, 195 knees). Each underwent kinematically aligned TKA with manual instruments. Aligning the anteroposterior axis of the tibial component parallel to the line that bisects the oval boundary of the lateral tibial condyle set internal/external rotation. Removing bone from the posterior femoral condyles equal in thickness to the femoral component after correction for cartilage wear set internal/external rotation and anteroposterior translation of the femoral component. Rotational mismatch of the tibial component on the femoral component was determined from a computed tomography scan of the knee. Ninety-seven percent of kinematically aligned TKA with fixed-bearing components had a rotational mismatch within 0°±10° (overall range, -11° to 11°). This percentage was higher and the range narrower than the 85% of TKA within 0°±10° and the -14° to 16° range reported for mechanically aligned TKA. The use of manual instruments to kinematically aligned TKA reliably limited rotational mismatch to within 0°±10°, which has been associated with better function.

Value-of-information analysis within a stakeholder-driven research prioritization process in a US setting: an application in cancer genomics.

OBJECTIVE: The objective of this study was to evaluate the feasibility and outcomes of incorporating value-of-information (VOI) analysis into a stakeholder-driven research prioritization process in a US-based setting. METHODS: . Within a program to prioritize comparative effectiveness research areas in cancer genomics, over a period of 7 months, we developed decision-analytic models and calculated upper-bound VOI estimates for 3 previously selected genomic tests. Thirteen stakeholders representing patient advocates, payers, test developers, regulators, policy makers, and community-based oncologists ranked the tests before and after receiving VOI results. The stakeholders were surveyed about the usefulness and impact of the VOI findings. RESULTS: The estimated upper-bound VOI ranged from $33 million to $2.8 billion for the 3 research areas. Seven stakeholders indicated the results modified their rankings, 9 stated VOI data were useful, and all indicated they would support its use in future prioritization processes. Some stakeholders indicated expected value of sampled information might be the preferred choice when evaluating specific STUDY DESIGN: Limitations. Our study was limited by the size and the potential for selection bias in the composition of the external stakeholder group, lack of a randomized design to assess effect of VOI data on rankings, and the use of expected value of perfect information v. expected value of sample information methods. CONCLUSIONS: Value of information analyses may have a meaningful role in research topic prioritization for comparative effectiveness research in the United States, particularly when large differences in VOI across topic areas are identified. Additional research is needed to facilitate the use of more complex value of information analyses in this setting.