Considering Breast Reconstruction after Mastectomy: A Patient Decision Aid Video and Workbook.

Each year, over 120,000 women in the United States are diagnosed with breast cancer and undergo mastectomy.1 Many of these women are candidates for more than 1 type of breast reconstruction, and the “best” decision often depends on personal preferences regarding the timing of reconstruction, use of autologous tissue versus implants, potential out-of-pocket costs, and short- versus long-term outcomes.2 In previous studies, patients reported multiple challenges to engaging in these complex, personal decisions, including difficulty understanding the terminology, personalizing the information, and weighing risk/benefit trade-offs during the stressful time between diagnosis and mastectomy.3,4 Providers report the need for addressing misinformation, improving patients’ realistic expectations, and having tools that can be delivered alongside the consultation to reinforce comprehension without impacting the clinical care flow.4 Over 105 randomized trials show that patient decision aids improve patients’ knowledge, realistic expectations, clarity about what matters most to them, preparation for making well-informed decisions, and satisfaction with the decision.5 Patient decision aids are evidence-based tools that provide up-to-date, balanced information about the options and structured support to improve deliberation and communication.5,6 They may be provided before, during, or after a consultation as brochures, videos, or websites.5,7 The goal of patient decision aids is to improve decision quality—the degree to which decisions are well informed and congruent with patients’ highest rated decision-making values.5 They also seek to reduce patients’ decisional conflict, ie, anxiety due to feeling uninformed, unclear, unsupported, or unsure.8 Studies show that for every unit increase in decisional conflict, patients are 3 times more likely to fail a knowledge test, 59 times more likely to change their minds, 5 times more likely to express regret, and 19% more likely to blame doctors for bad outcomes.8 Recent legislation has begun to provide reimbursement for shared decision-making consultations; however, relatively few patient decision aids have been successfully implemented in clinical care. Therefore, the International Patient Decision Aid Standards collaboration and the National Quality Forum are establishing guidelines for the systematic development and certification of patient decision aids.9,10 These guidelines emphasize rigorous development of high-quality, unbiased tools that are meaningful and understandable by diverse patients, as well as ready for rapid, scalable, and sustainable dissemination.7,11,12 They also recommend publishing formative work so that providers, patients, and policymakers can assess the quality of the patient decision aid. The purpose of this paper is therefore 2-fold: (1) to illustrate a systematic, user-centered process that clinical researchers can use to develop patient decision aids that align with the international guidelines and (2) to provide the results of the development and pilot testing of a patient decision aid video and interactive workbook entitled, Considering Breast Reconstruction after Mastectomy: A Video and Workbook for Women with Breast Cancer©. We hypothesized that engaging patients, providers, and other stakeholders in the codevelopment of a tool to address their identified decision-making needs would result in a tool that was understandable and acceptable.