Background Systematic approaches to stakeholder-informed research prioritization are a central focus of comparative effectiveness research. Genomic testing in cancer is an ideal area to refine such approaches given rapid innovation and potentially significant impacts on patient outcomes. Objective To develop and pilot-test a stakeholder-informed approach to prioritizing genomic tests for future study in collaboration with the cancer clinical trials consortium SWOG. Methods We conducted a landscape-analysis to identify genomic tests in oncology using a systematic search of published and unpublished studies, and expert consultation. Clinically valid tests suitable for evaluation in a comparative study were presented to an external stakeholder group. Domains to guide the prioritization process were identified with stakeholder input, and stakeholders ranked tests using multiple voting rounds. Results A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy-makers, and community-based oncologists. We identified nine domains for research prioritization with stakeholder feedback: population impact; current standard of care, strength of association; potential clinical benefits, potential clinical harms, economic impacts, evidence of need, trial feasibility, and market factors. The landscape-analysis identified 635 studies; of 9 tests deemed to have sufficient clinical validity, 6 were presented to stakeholders. Two tests in lung cancer (ERCC1 and EGFR) and one test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. Conclusions Use of a diverse stakeholder group to inform research prioritization is feasible in a pragmatic and timely manner. Additional research is needed to optimize search strategies, stakeholder group composition and integration with existing prioritization mechanisms.
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.
It has been recently shown that chestwall recurrence of breast cancer and many other superficial diseases can be successfully treated with the combination of radiation, chemotherapy and hyperthermia. Conformal microwave antenna array for hyperthermia treatment of large area superficial diseases can significantly increase patient comfort while at the same time facilitate treatment of larger and more irregularly shaped disease. A large number of small efficient antennas is preferable for improved control of heating, as the disease can be more accurately contoured and the lower power requirement correlates with system reliability, linearity and reduced cost. Thus, starting from the initially proposed square slot antennas, we investigated new designs for multi-fed slot antennas of several shapes that maximize slot perimeter while reducing radiating area, thus increasing antenna efficiency. Simulations were performed with commercial electromagnetic simulation software packages (Ansoft HFSS) to demonstrate that the antenna size reduction method is effective for several dual concentric conductor (DCC) aperture shapes and operating frequencies. The theoretical simulations allowed the development of a set of design rules for multi-fed DCC slot antennas that facilitate conformal heat treatments of irregular size and shape disease with large multi-element arrays. Independently on the shape, it is shown that the perimeter of 10cm at 915 MHz delivers optimal radiation pattern and efficiency. While the maximum radiation is obtained for a circular pattern the rectangular shape is the one that feels more efficiently the array space.
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