Predicting outcomes in chronic kidney disease: needs and preferences of patients and nephrologists.

INTRODUCTION: Guidelines on chronic kidney disease (CKD) recommend that nephrologists use clinical prediction models (CPMs). However, the actual use of CPMs seems limited in clinical practice. We conducted a national survey study to evaluate: 1) to what extent CPMs are used in Dutch CKD practice, 2) patients' and nephrologists' needs and preferences regarding predictions in CKD, and 3) determinants that may affect the adoption of CPMs in clinical practice. METHODS: We conducted semi-structured interviews with CKD patients to inform the development of two online surveys; one for CKD patients and one for nephrologists. Survey participants were recruited through the Dutch Kidney Patient Association and the Dutch Federation of Nephrology. RESULTS: A total of 126 patients and 50 nephrologists responded to the surveys. Most patients (89%) reported they had discussed predictions with their nephrologists. They most frequently discussed predictions regarded CKD progression: when they were expected to need kidney replacement therapy (KRT) (n = 81), and how rapidly their kidney function was expected to decline (n = 68). Half of the nephrologists (52%) reported to use CPMs in clinical practice, in particular CPMs predicting the risk of cardiovascular disease. Almost all nephrologists (98%) reported discussing expected CKD trajectories with their patients; even those that did not use CPMs (42%). The majority of patients (61%) and nephrologists (84%) chose a CPM predicting when patients would need KRT in the future as the most important prediction. However, a small portion of patients indicated they did not want to be informed on predictions regarding CKD progression at all (10-15%). Nephrologists not using CPMs (42%) reported they did not know CPMs they could use or felt that they had insufficient knowledge regarding CPMs. According to the nephrologists, the most important determinants for the adoption of CPMs in clinical practice were: 1) understandability for patients, 2) integration as standard of care, 3) the clinical relevance. CONCLUSION: Even though the majority of patients in Dutch CKD practice reported discussing predictions with their nephrologists, CPMs are infrequently used for this purpose. Both patients and nephrologists considered a CPM predicting CKD progression most important to discuss. Increasing awareness about existing CPMs that predict CKD progression may result in increased adoption in clinical practice. When using CPMs regarding CKD progression, nephrologists should ask whether patients want to hear predictions beforehand, since individual patients' preferences vary.

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.

Shared decision-making in advanced kidney disease: a scoping review.

OBJECTIVES: To provide a comprehensive overview of interventions that support shared decision-making (SDM) for treatment modality decisions in advanced kidney disease (AKD). To provide summarised information on their content, use and reported results. To provide an overview of interventions currently under development or investigation. DESIGN: The JBI methodology for scoping reviews was followed. This review conforms to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. DATA SOURCES: MEDLINE, Embase, Web of Science, Cochrane Library, Emcare, PsycINFO, PROSPERO and Academic Search Premier for peer-reviewed literature. Other online databases (eg, clinicaltrials.gov, OpenGrey) for grey literature. ELIGIBILITY FOR INCLUSION: Records in English with a study population of patients >18 years of age with an estimated glomerular filtration rate <30 mL/min/1.73 m2. Records had to be on the subject of SDM, or explicitly mention that the intervention reported on could be used to support SDM for treatment modality decisions in AKD. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently screened and selected records for data extraction. Interventions were categorised as prognostic tools (PTs), educational programmes (EPs), patient decision aids (PtDAs) or multicomponent initiatives (MIs). Interventions were subsequently categorised based on the decisions they were developed to support. RESULTS: One hundred forty-five interventions were identified in a total of 158 included records: 52 PTs, 51 EPs, 29 PtDAs and 13 MIs. Sixteen (n=16, 11%) were novel interventions currently under investigation. Forty-six (n=46, 35.7%) were reported to have been implemented in clinical practice. Sixty-seven (n=67, 51.9%) were evaluated for their effects on outcomes in the intended users. CONCLUSION: There is no conclusive evidence on which intervention is the most efficacious in supporting SDM for treatment modality decisions in AKD. There is a lot of variation in selected outcomes, and the body of evidence is largely based on observational research. In addition, the effects of these interventions on SDM are under-reported.

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.

Development of an online patient decision aid for kidney failure treatment modality decisions.

BACKGROUND: Patient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients' risk perception, and help patients make decisions congruent with their expectations and values. Our aim was to develop an online PtDA to support kidney failure treatment modality decision-making, that: 1) provides patients with real-world outcome information, and 2) facilitates SDM in clinical practice. METHODS: The International Patient Decision Aids Standards (IPDAS) development process model was complemented with a user-centred and convergent mixed-methods approach. Rapid prototyping was used to develop the PtDA with a multidisciplinary steering group in an iterative process of co-creation. The results of an exploratory evidence review and a needs-assessment among patients, caregivers, and clinicians were used to develop the PtDA. Seven Dutch teaching hospitals and two national Dutch outcome registries provided real-world data on selected outcomes for all kidney failure treatment modalities. Alpha and beta testing were performed to assess the prototype and finalise development. An implementation strategy was developed to guide implementation of the PtDA in clinical practice. RESULTS: The 'Kidney Failure Decision Aid' consists of three components designed to help patients and clinicians engage in SDM: 1) a paper hand-out sheet, 2) an interactive website, and 3) a personal summary sheet. A 'patients-like-me' infographic was developed to visualise survival probabilities for each treatment modality on the website. Other treatment outcomes were incorporated as event rates (e.g. hospitalisation rates) or explained in text (e.g. the flexibility of each treatment modality). No major revisions were needed after alpha and beta testing. During beta testing, some patients ignored the survival probabilities because they considered these too confronting. Nonetheless, patients agreed that every patient has the right to choose whether they want to view this information. Patients and clinicians believed that the PtDA would help patients make informed decisions, and that it would support values- and preferences-based decision-making. Implementation of the PtDA has started in October 2020. CONCLUSIONS: The 'Kidney Failure Decision Aid' was designed to facilitate SDM in clinical practice and contains real-world outcome information on all kidney failure treatment modalities. It is currently being investigated for its effects on SDM in a clinical trial.

Shared decision-making in advanced kidney disease: a scoping review protocol.

INTRODUCTION: Patients with advanced kidney disease (AKD) have to make difficult treatment modality decisions as their disease progresses towards end-stage kidney disease. International guidelines in nephrology suggest shared decision-making (SDM) to help patients make timely treatment modality decisions that align with their values and preferences. However, systematic reviews or scoping reviews on these SDM interventions and on their reported use or outcomes are lacking. This limits the adoption of SDM in clinical practice and hampers further research and development on the subject. Our aim is to provide a comprehensive and up-to-date overview of these SDM interventions by means of a scoping review of the literature. Scoping reviews can provide a broad overview of a topic, identify gaps in the research knowledge base and report on the types of evidence that address and inform practices. This paper presents our study protocol. METHODS AND ANALYSIS: The proposed scoping review will be performed in accordance with the Joanna Briggs Institute's (JBI) methodology for scoping reviews. It will cover both qualitative and quantitative scientific literature, as well as the grey literature on SDM interventions for treatment modality decisions in AKD. Only literature written in English will be considered for inclusion. Two independent reviewers will participate in an iterative process of screening the literature, paper selection and data extraction. Disagreements between the reviewers will be resolved by discussion until consensus is reached or after consultation with the research team when needed. Results will be reported with descriptive statistics and diagrammatic or tabular displayed information, accompanied by narrative summaries as explained in the JBI guidelines. ETHICS AND DISSEMINATION: Ethical approval for the conduct of this study is not required. We will analyse previously collected data for the proposed scoping review. Our results will be published in a peer-reviewed journal and disseminated through conferences and/or seminars.

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.