Topic Abstract

Background: In 2008, the Agency for Healthcare Research and Quality (AHRQ) engaged the Oregon Evidence-based Practice Center (EPC) to conduct a systematic review on the effectiveness of medications to reduce the risk of primary breast cancer in women.¹ The aims of the review were to evaluate the comparative effectiveness of tamoxifen citrate, raloxifene, and tibolone to reduce the risk of primary breast cancer; to assess the nature and magnitude of harms; and to examine how benefits and harms vary by age, breast cancer risk status, and other factors. A number of research gaps and limitations were identified based on the comparative effectiveness review including determining the optimal candidates for risk-reduction medications; evaluating optimal doses, duration of treatment, timing of medication use, and adherence to treatment; and long-term tracking of outcomes, including unanticipated outcomes and follow-up of women enrolled in existing trials. The research gaps identified in this comparative effectiveness review (CER) present a logical starting place for the development and prioritization of research questions for future studies in this area.

Objective: The objective of this pilot project is to systematically develop and prioritize a list of research questions to address the research gaps related to the comparative effectiveness of medications to reduce the risk of primary breast cancer and to test the feasibility of the proposed process. Our aim is to provide sufficient detail—including populations, interventions, comparators, and outcomes—for researchers and funders to use to develop research proposals and solicitations, respectively. Secondarily, the methods of this pilot project are designed with feasibility for future, routine use as an important consideration. If successful, our general approach could feasibly be adopted to identify and prioritize future research needs as a matter of course in all systematic reviews.

Approach: In order to identify and prioritize research needs in this area, we will recruit up to 18 stakeholders from a variety of disciplines, representing multiple research interests in this area (e.g., methodological research, health outcomes research, patient advocacy, and health policy and practice decision-makers). Upon stakeholder recruitment, we will host a web-based presentation where the author of the original CER will present background on the review and the future research needs that were identified as well as to answer any questions that stakeholder might have on the topic. Shortly thereafter, each stakeholder will be asked to identify and detail any research gaps they feel exist on the subject. Open-ended responses will be thematically coded and summarized. Next, stakeholders will be asked to rate the priority for each identified research question according to criteria such as appropriateness, importance, desirability, potential impact, and feasibility/capacity. The priority given to each research question collectively as well as the level of consensus will be presented. Results will be analyzed for the stakeholder group as a whole as well as by appropriate subgroups (e.g., researchers versus funders).

¹ Nelson HD, Fu R, Humphrey L, Smith ME, Griffin JC, and Nygren P. Comparative Effectiveness of Medications To Reduce Risk of Primary Breast Cancer in Women. Comparative Effectiveness Review No. 17. 2009. Rockville, MD, Agency for Healthcare Research and Quality. (Prepared by Oregon Evidence-based Practice Center under Contract No. 290-2007-10057-1.).