Supporting Shared Decision-making About Surveillance After Breast Cancer With Personalized Recurrence Risk Calculations: Development of a Patient Decision Aid Using the International Patient Decision AIDS Standards Development Process in Combination With a Mixed Methods Design.

BACKGROUND: Although the treatment for breast cancer is highly personalized, posttreatment surveillance remains one-size-fits-all: annual imaging and physical examination for at least five years after treatment. The INFLUENCE nomogram is a prognostic model for estimating the 5-year risk for locoregional recurrences and second primary tumors after breast cancer. The use of personalized outcome data (such as risks for recurrences) can enrich the process of shared decision-making (SDM) for personalized surveillance after breast cancer. OBJECTIVE: This study aimed to develop a patient decision aid (PtDA), integrating personalized risk calculations on risks for recurrences, to support SDM for personalized surveillance after curative treatment for invasive breast cancer. METHODS: For the development of the PtDA, the International Patient Decision Aids Standards development process was combined with a mixed methods design inspired by the development process of previously developed PtDAs. In the development, 8 steps were distinguished: establishing a multidisciplinary steering group; definition of the end users, scope, and purpose of the PtDA; assessment of the decisional needs of end users; defining requirements for the PtDA; determining the format and implementation strategy for the PtDA; prototyping; alpha testing; and beta testing. The composed steering group convened during regular working-group sessions throughout the development process. RESULTS: The "Breast Cancer Surveillance Decision Aid" consists of 3 components that support the SDM process: a handout sheet on which personalized risks for recurrences, calculated using the INFLUENCE-nomogram, can be visualized and which contains an explanation about the decision for surveillance and a login code for a web-based deliberation tool; a web-based deliberation tool, including a patient-reported outcome measure on fear of cancer recurrence; and a summary sheet summarizing patient preferences and considerations. The PtDA was assessed as usable and acceptable during alpha testing. Beta testing is currently ongoing. CONCLUSIONS: We developed an acceptable and usable PtDA that integrates personalized risk calculations for the risk for recurrences to support SDM for surveillance after breast cancer. The implementation and effects of the use of the "Breast Cancer Surveillance Decision Aid" are being investigated in a clinical trial.

Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series.

INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice. METHODS AND ANALYSIS: Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients' perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals' perspective on the implementation process. ETHICS AND DISSEMINATION: The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM. TRIAL REGISTRATION NUMBER: NL8374, NL8375 and NL8376.

Rising C-reactive protein and procalcitonin levels precede early complications after esophagectomy.

BACKGROUND: Elective esophagectomy with gastric tube reconstruction carries a high risk for complications. Early and accurate diagnosis could improve patient management. Increased C-reactive protein (CRP) levels may be associated with any, surgical or infectious, complication and procalcitonin (PCT) specifically with infectious complications. METHODS: We measured CRP and PCT on post-operative days 0, 1, 2, and 3 in 45 consecutive patients. Complications were recorded up to 10 days post-esophagectomy. RESULTS: Twenty-eight patients developed a post-operative complication (5 surgical, 14 infectious, 9 combined surgical/infectious, including anastomotic leakage), presenting on day 3 or later. Elevated days 2 and 3 and a rise in CRP preceded the diagnosis of general or combined surgical/infectious complications (minimum area under the receiver operating characteristics curve (AUROC) 0.75, P = 0.006). Elevated day 3 PCT preceded combined complications (AUROC 0.86, P < 0.001). High day 1 and 3 PCT levels preceded anastomotic leakage (minimum AUROC 0.76, P = 0.005), as did the day 3 CRP levels and their increases (minimum AUROC 0.78, P = 0.002). CONCLUSIONS: This small study suggests that high or increasing CRP levels may precede the clinical diagnosis of general or surgical/infectious complications after esophagectomy. Elevated PCT levels may more specifically and timely precede combined surgical/infectious complications mainly associated with anastomotic leakage.