Evaluating the Impact of a Shared Decision-making Intervention for Patients with Renal Cell Carcinoma: The SDM-RCC Study Protocol.

The aim of the SDM-RCC study is to evaluate the impact of a comprehensive shared decision-making (SDM) intervention for patients with renal cell carcinoma (RCC) on the decision-making process and outcomes. The intervention includes online patient decision aids (PtDAs) and training of health care professionals (HCPs) in the use of PtDAs and SDM. The study is a multicenter, prospective pretest-posttest cohort in six Dutch hospitals, focusing on patients with localized or metastatic RCC. The primary outcome is the observed quality of the decision-making process, measured using OPTION-5 scores. Secondary outcomes include perceived quality of the decision-making process, decision quality, and implementation of the intervention (user statistics and interviews). Quantitative analysis will be performed on questionnaire data, while qualitative analysis will be performed on interviews using coding based on established frameworks. The study results could improve understanding of the decision-making process for RCC patients from patient, HCP, and observer perspectives. The SDM tool implemented is expected to support the decision-making process. PATIENT SUMMARY: We are conducting a trial on the effects of a tool to support shared decision-making by patients with kidney cancer who are facing treatment decisions. This paper outlines the protocol that will be used for the trial.

Real-world outcomes of first-line chemotherapy for unresectable stage III and IV bladder cancer.

PURPOSE: For many malignancies, considerable divergence between the efficacy found in clinical trials and effectiveness in routine practice have been reported (efficacy-effectiveness gap). The purpose of this study was to evaluate the efficacy-effectiveness gap in palliative first-line (1L) chemotherapy treatment (CTx) for urothelial carcinoma of the bladder. METHODS: From seven Dutch teaching hospitals, all patients diagnosed with unresectable stage III (cT2-4aN1-3M0) and IV (cT4b and/or cM1) disease, who received 1L-CTx (for both primary as recurrent disease after radical cystectomy) between 2008 and 2016, were captured. Results were compared with data from seven randomised trials that investigated 1L gemcitabine + cisplatin (GemCis) and/or gemcitabine + carboplatin (GemCarbo). RESULTS: Of the 835 included patients, 191 received 1L-CTx. Median overall survival (mOS) of GemCis patients (N = 88) was 10.4 months [95% CI 7.9-13.0], which was shorter compared to clinical trial findings (range mOS: 12.7-14.3 months) despite comparable clinical characteristics. The mOS of GemCarbo patients (N = 92) was 9.3 months [95% CI 7.5-11.1]. Patients who received GemCarbo had worse prognostic characteristics (higher age, impaired renal function and worse performance status (all P-values < 0.001)) compared to GemCis patients, but were equal in occurrence of dose reductions (24.4% vs. 29.5%, P-value = 0.453), early termination (55.7% vs. 54.1%, P-value = 0.839), clinical best response (P-value = 0.733), and toxicity (68.1% vs. 63.3%, P-value = 0.743). In multivariable regression, GemCis was not superior to GemCarbo (HR 0.90 [95% CI 0.55-1.47], P-value = 0.674). CONCLUSION: There seems to be an efficacy-effectiveness gap in 1L GemCis treatment, despite patients having similar baseline characteristics. Early termination of treatment occurred more often and dose reduction less often compared to clinical trials, hinting towards abandonment of treatment in case of adverse events. Patients treated with 1L GemCis did not have superior survival compared to GemCarbo patients, even though GemCarbo patients had worse baseline characteristics.

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.

Health Outcomes Management Evaluation-A National Analysis of Dutch Heart Care.

AIMS: A group of heart centres in the Netherlands have been at the forefront internationally to implement the principles of value-based healthcare. This study aims to give an up-to-date assessment of outcome-based quality improvement in 2020 at a national level in Dutch heart care. METHODS AND RESULTS: Physicians and healthcare professionals for each participating hospital filled out a questionnaire with 26 detailed questions on quality improvement and organization of care. In total, 20 hospitals participated; 11 heart centres with thoracic surgery and 9 without thoracic surgery. Results show that outcome reports are actively used within the heart centres to support quality improvement initiatives. In 50% of the centres, apart from physicians, also nurses and hospital management are involved. For 60% of the heart centres, outcome measurement is embedded in strategy and annual plans. The stage of development of supporting IT infrastructure (outcome measurement in the Electronic Health Record and dashboards) is very diverse. A wide range of different learning strategies supports outcome-based quality improvement. CONCLUSION: Health outcomes have become a relevant element in quality improvement and organization of Dutch heart centres. Earlier research shows that in 2012-2016 heart centres focused mainly on measuring outcomes. Now in 2020, heart centres are more able to actually use the acquired insights based on these measurements to initiate improvement projects. The diversity in how this is done indicates that this field is still strongly developing and shows potential for heart centres to share best practices in the implementation of value-based healthcare.

Development of the First Patient-centred Set of Outcomes for Muscle-invasive and Metastatic Bladder Cancer: A Multicentre Initiative.

BACKGROUND: To improve and compare outcomes in healthcare, it is necessary to standardise outcome measurements. There are no widely accepted standardised outcome measures reflecting quality of care for bladder cancer (BCa) patients. OBJECTIVE: The aim of this study was to create a standardised set of outcomes for patients with muscle-invasive or metastatic BCa, using the value-based healthcare principles. DESIGN SETTING AND PARTICIPANTS: A multidisciplinary working group of 25 healthcare professionals and patient representatives was assembled, to develop the set. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used an online RAND-modified Delphi process to prioritise, discuss, and reach consensus regarding the outcomes, case-mix variables, and treatment factors. RESULTS AND LIMITATIONS: Recognising the heterogeneity of patients with BCa, the working group defined the scope as patients with muscle-invasive and metastatic BCa. A total of 24 outcomes, including ten patient-reported outcomes, were included in the standard set of outcomes, covering survival, complication rates, recurrence of disease, readmissions after treatment, and quality of life (QoL). Fourteen case-mix variables were included. The EQ-5D and European Organisation for Research and Treatment of Cancer quality of life (EORTC-QLQ) questionnaires were recommended to measure QoL. CONCLUSIONS: We developed the first standardised set of patient-centred outcomes for muscle-invasive and metastatic BCa. The sue of this set enables institutions to monitor, compare, and improve the quality of BCa care, on an international level. PATIENT SUMMARY: Our group of healthcare professionals and patient representatives recommended a standardised set of patient-centred outcomes to be followed during the treatment of patients with muscle-invasive or metastatic bladder cancer, in order to monitor, compare, and improve the quality of care.

Increased long-term mortality after open colorectal cancer surgery: A multicentre population-based study.

AIM: Unlike meta-analyses of randomized controlled trials, population-based studies in colorectal cancer (CRC) patients have shown a significant association between open surgery and increased 30- and 90-day mortality compared with laparoscopic surgery. Long-term mortality, however, is scarcely reported. This retrospective population-based study aimed to compare long-term mortality after open and laparoscopic surgery for CRC. METHOD: The Dutch Colorectal Audit and the Dutch Cancer Centre registry were used to identify patients from three large nonacademic teaching hospitals who underwent curative resection for CRC between 2009 and 2018. Patients with relative contraindications for laparoscopic surgery (cT4 or pT4 tumours, distant metastasis requiring additional resection and emergency surgery) were excluded. Multivariable regression was used to assess the effect of laparoscopic surgery on long-term mortality with adjustment for gender, age, American Society of Anesthesiologists score, TNM stage, chemoradiation therapy and other confounders. RESULTS: We included 4531 patients, of whom 1298 (29%) underwent open surgery. The median follow-up was 43 months (interquartile range 23-71 months). Open surgery was associated with an increased risk of long-term mortality (adjusted hazard ratio 1.26, 95% confidence interval 1.10-1.45, p = 0.001). Mixed-effects Cox regression with year of surgery as a random effect also showed an increased risk after open surgery (adjusted hazard ratio 1.33, 95% confidence interval 1.11-1.52, p = 0.004). CONCLUSION: Open surgery seems to be associated with increased long-term mortality in the elective setting for CRC patients. A minimally invasive approach might improve long-term outcomes.

Treatment patterns and clinical outcomes of chemotherapy treatment in patients with muscle-invasive or metastatic bladder cancer in the Netherlands.

This retrospective study was performed to evaluate real-world oncological outcomes of patients treated with chemo-based therapy for muscle-invasive or metastatic bladder cancer (MIBC/mBC) and compare results to data from RCTs and other cohorts. Among 1578 patients diagnosed, 470 (30%) had MIBC/mBC. Median overall survival (mOS) for RC alone (47 months), first-line (13 months) and second-line (7 months) chemotherapy, and chemotherapy for recurrent disease (8 months) were similar to literature. Treatment with neoadjuvant and induction chemotherapy (NAIC) was only utilized in 9% of patients, and often in patients with poor disease status, resulting in a lower mOS compared to literature (35 and 20 months, respectively). Patients treated with chemotherapy had many adversities to treatment, with only 50%, 13%, 18% and 7% of patients in NAIC, first-line, salvage after RC, and second-line setting completing the full pre-planned chemotherapy treatment. Real-world data shows NAIC before RC is underutilized. Adversities during chemotherapy treatment are frequent, with many patients requiring dose reduction or early treatment termination, resulting in poor treatment response. Although treatment efficacy between RCTs and real-world patients is quite similar, there are large differences in baseline characteristics and treatment patterns. Possibly, results from retrospective studies on real-world data can deliver missing evidence on efficacy of chemotherapy treatment on older and 'unfit' patients.

Developing process measures in value-based healthcare: the case of aortic valve disease.

Background: As process measures can be means to change practices, this article presents process measures that impact on outcome measures for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) within value-based healthcare. Methods: Desk research and observations of patient trajectories were performed to map the processes involved in TAVR and SAVR. Semistructured interviews were conducted with healthcare professionals (n=8) and patients (n=2) to explore which processes were most important in relation to a standard set of outcome measures that was already monitored. Additionally, open interviews (n=2) were held to prioritise results. A focus group was performed for validation of the formulated process measures. Numerical data for these measures was not collected. Results: Process maps of the full cycle of care of TAVR and SAVR treatments in theory and in practice were developed. 28 processes were found important by interview participants due to their expected impact on patient-relevant outcomes. Seven processes were prioritised to be most important and were formulated into 12 process measures for both TAVR and SAVR: 'Number of times that deficient information provision to SAVR patients causes negative outcomes', 'Type of TAVR/SAVR prosthesis', 'Brand of TAVR prosthesis', 'Number of times the frailty score of a TAVR/SAVR patient >75 years is measured', 'Time between TAVR/SAVR surgery indication and surgery', 'Number of times that anticoagulants are stopped within 3 days before surgery', 'Time in hours between TAVR/SAVR surgery and permanent pacemaker implantation' and 'Percentage of standardised pain measurements'. Conclusion: This study proposes an addition of select process measures to standard sets of outcome measures to improve healthcare quality. It illustrates a clear method for identifying process measures with impact on health outcomes in the future.

Defining and Measuring a Standard Set of Patient-Relevant Outcomes in Coronary Artery Disease.

Systematic outcome measurement enables to continuously improve treatment results and stimulates dissemination of best practices. For patients with coronary artery disease, no examples yet exist of standard sets of patient-relevant outcome measures that have already been fully implemented at a large scale in clinical care. The aim of this paper is twofold: (1) to share the standard set of outcome measures as developed by Meetbaar Beter, and (2) to show how the standard set is presented and published to support improvement of cardiac care. A step-wise approach was followed by an expert panel to construct a standard set of outcome measures. This resulted in a comprehensive set of relevant outcome measures, comprising 4 generic and 11 treatment-specific outcomes. Both short-term and long-term outcomes measures up to 5 years of follow-up were included. Relevant initial conditions were selected to enable case-mix adjustment. The standard set has been implemented in 21 hospitals across the Netherlands. The results and experiences have been used to fine-tune the set in 4 reporting cycles in 2012 to 2016, using an annual maintenance cycle. Currently about 83,000 percutaneous coronary interventions and 30,000 coronary artery bypass graftings are included in the dataset, covering the majority of all percutaneous coronary interventions and coronary artery bypass graftings in the Netherlands. In conclusion, Meetbaar Beter has defined and implemented a comprehensive set of patient-relevant outcome measures for coronary artery disease, and the variation of the results among the centers indicates that there are sufficient opportunities to further improve cardiac care in the Netherlands.