Domitilla Masi

Background: The range of decisions and considerations that women with advanced breast cancer (ABC) face can be overwhelming and difficult to manage. Research shows that most patients prefer a shared decision-making (SDM) approach as it provides them with the opportunity to be actively involved in their treatment decisions. The current engagement of these patients in their clinical decisions is suboptimal. Moreover, implementing SDM into routine clinical care can be challenging as patients may not always feel adequately prepared or may not expect to be involved in the decision-making process. Objective: Avalere Health developed the Preparation for Shared Decision-Making (PFSDM) tool to help patients with ABC feel prepared to communicate with their clinicians and engage in decision making aligned with their preferences. The goal of this study was to validate the tool for its acceptability and usability among this patient population. Methods: We interviewed a diverse group of women with ABC (N=30). Interviews were audiorecorded, transcribed, and double coded by using NVivo. We assessed 8 themes to understand the acceptability and usability of the tool. Results: Interviewees expressed that the tool was acceptable for preparing patients for decision making and would be useful for helping patients know what to expect in their care journey. Interviewees also provided useful comments to improve the tool. Conclusions: This validation study confirms the acceptability and usability of the PFSDM tool for women with ABC. Future research should assess the feasibility of the tool’s implementation in the clinical workflow and its impact on patient outcomes.

BACKGROUND The range of decisions and considerations that women with advanced breast cancer (ABC) face can be overwhelming and difficult to manage. Research shows that most patients prefer a shared decision-making (SDM) approach as it provides them with the opportunity to be actively involved in their treatment decisions. The current engagement of these patients in their clinical decisions is suboptimal. Moreover, implementing SDM into routine clinical care can be challenging as patients may not always feel adequately prepared or may not expect to be involved in the decision-making process. OBJECTIVE Avalere Health developed the Preparation for Shared Decision-Making (PFSDM) tool to help patients with ABC feel prepared to communicate with their clinicians and engage in decision making aligned with their preferences. The goal of this study was to validate the tool for its acceptability and usability among this patient population. METHODS We interviewed a diverse group of women with ABC (N=30). Interviews were audiorecorded, transcribed, and double coded by using NVivo. We assessed 8 themes to understand the acceptability and usability of the tool. RESULTS Interviewees expressed that the tool was acceptable for preparing patients for decision making and would be useful for helping patients know what to expect in their care journey. Interviewees also provided useful comments to improve the tool. CONCLUSIONS This validation study confirms the acceptability and usability of the PFSDM tool for women with ABC. Future research should assess the feasibility of the tool’s implementation in the clinical workflow and its impact on patient outcomes.

Despite growing research demonstrating the potential for shared decision making (SDM) to improve health outcomes, patient preferences—including financial trade-offs—are still not routinely incorporated into health care decision making. As the US health care delivery system transitions to rewarding value-based care, the question of “value to whom?” assumes greater importance. To achieve the goals of value-based care, the patient voice must be incorporated into clinical decision making by embedding SDM as a routine part of clinical practice. Identified as a priority by the Centers for Medicare & Medicaid Services (CMS), SDM-related measures and initiatives have already been integrated into CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) demonstration projects (eg, the Oncology Care Model and Transforming Clinical Practice Initiative) and value-based payment programs (eg, the Merit-based Incentive Payment System, Medicare Shared Savings Program) to incentivize more proactive SDM engagement between patients and their providers. Furthermore, CMS has also integrated formal shared decision-making encounters into coverage and reimbursement policies (eg, for implantable cardioverter defibrillators), demonstrating a growing interest in SDM and its potential for eliciting and promoting the integration of patient preferences into the clinical decision-making process. In addition to increasing policy efforts to promote SDM, we need more research investments aimed at understanding how to optimize the science and practice of meaningful SDM. The current landscape and proposed road map for next steps in research, outlined in this review article, will help ensure the transition of pilots and research projects regarding the implementation of SDM into sustainable solutions.