Shared decision-making in the Netherlands: Progress is made, but not for all. Time to become inclusive to patients.

Dutch initiatives targeting shared decision-making (SDM) are still growing, supported by the government, the Federation of Patients' Organisations, professional bodies and healthcare insurers. The large majority of patients prefers the SDM model. The Dutch are working hard to realise improvement in the application of SDM in daily clinical practice, resulting in glimpses of success with objectified improvement on observed behavior. Nevertheless, the culture shift is still ongoing. Large-scale uptake of SDM behavior is still a challenge. We haven't yet fully reached the patients' needs, given disappointing research data on patients' experiences and professional behavior. In all Dutch implementation projects, early adopters, believers or higher-educated persons have been overrepresented, while patients with limited health literacy have been underrepresented. This is a huge problem as 25% of the Dutch adult population have limited health literacy. To further enhance SDM there are issues to be addressed: We need to make physicians conscious about their limited application of SDM in daily practice, especially regarding preference and decision talk. We need to reward clinicians for the extra work that comes with SDM. We need to be inclusive to patients with limited health literacy, who are less often actually involved in decision-making and at the same time more likely to regret their chosen treatment compared to patients with higher health literacy.

Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial.

BACKGROUND: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming. OBJECTIVE: This study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice. METHODS: This multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement-5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. RESULTS: This trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program. CONCLUSIONS: This theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study. TRIAL REGISTRATION: Netherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35543.

Shared decision making in cancer treatment: A Dutch national survey on patients' preferences and perceptions.

OBJECTIVE: Shared decision making (SDM) for cancer treatment yields positive results. However, it appears that discussing essential topics for SDM is not fully integrated into treatment decision making yet. Therefore, we aim to explore to what extent discussion of therapy options, treatment consequences, and personal priorities is preferred and perceived by (former) cancer patients. METHODS: An online questionnaire was distributed by the Dutch Federation of Cancer Patient Organisations among (former) cancer patients in 2018. RESULTS: Among 3785 (former) cancer patients, 3254 patients (86%) had discussed treatments with their health care provider (HCP) and were included for analysis. Mean age was 62.1 ± 11.5; 55% were female. Discussing the option to choose no (further) treatment was rated by 2751 (84.5%) as very important (median score 9/10-IQR 8-10). Its occurrence was perceived by 28% (N = 899), and short- and long-term treatment consequences were discussed in 81% (N = 2626) and 53% (N = 1727), respectively. An unmet wish to discuss short- and long-term consequences was reported by 22% and 26%, respectively. Less than half of the (former) cancer patients perceived that personal priorities (44%) and future plans (34%) were discussed. CONCLUSION: In the perception of (former) cancer patients, several essential elements for effective SDM are insufficiently discussed during cancer treatment decision making.

Evaluation of a multilevel implementation program for timeout and shared decision making in breast cancer care: a mixed methods study among 11 hospital teams.

OBJECTIVE: Evaluation of a multilevel implementation program on shared decision making (SDM) for breast cancer clinicians. METHODS: The program was based on the 'Measurement Instrument for Determinants of Innovations-model' (MIDI). Key factors for effective implementation were included. Eleven breast cancer teams selected from two geographical areas participated; first six surgery teams and second five systemic therapy teams. A mixed method evaluation was carried out at the end of each period: Descriptive statistics were used for surveys and thematic content analysis for semi-structured interviews. RESULTS: Twenty-eight clinicians returned the questionnaire (42%). Clinicians (96%) endorse that SDM is relevant to breast cancer care. The program supported adoption of SDM in their practice. Limited financial means, time constraints and concurrent activities were frequently reported barriers. Interviews (n = 21) showed that using a 4-step SDM model - when reinforced by practical examples, handy cards, feedback and training - helped to internalize SDM theory. Clinicians experienced positive results for their patients and themselves. Task re-assignment and flexible outpatient planning reinforce sustainable change. Patient involvement was valued. CONCLUSION: Our program supported breast cancer clinicians to adopt SDM. PRACTICE IMPLICATIONS: To implement SDM, multilevel approaches are needed that reinforce intrinsic motivation by demonstrating benefits for patients and clinicians.

Effects and Working Mechanisms of a Multilevel Implementation Program for Applying Shared Decision-Making while Discussing Systemic Treatment in Breast Cancer.

Background: Enhancing the application of shared decision-making (SDM) is critical for integrating patient preferences in breast cancer treatment choices. We investigated the effect of an adapted multilevel SDM implementation program in breast cancer care. Methods: Breast cancer patients qualifying for (neo)adjuvant systemic treatment were included in a multicenter before−after study. Consultations were audio recorded between June 2018 and July 2019 and analyzed using the five-item Observing Patient Involvement in Decision-Making (OPTION-5) instrument to score SDM application by clinicians. The Shared Decision-Making Questionnaire (SDM-Q-9) was used to rate patients' perceived SDM level. Consultation duration, decision types, number of options discussed and consultations per patient were monitored. Regression analysis was used to investigate the correlated variables and program components. Results: Mean OPTION-5 scores increased from 33.9 (n = 63) before implementation to 54.3 (n = 49) after implementation (p < 0.001). The SDM-Q-9 scores did not change: 91.1 (n = 51) at baseline versus 88.9 (n = 23) after implementation (p = 0.81). Without increasing consultation time, clinicians discussed more options after implementation. The regression analysis showed that exposure to the implementation program, redistribution of tasks and discussing feedback from consultations was associated with a higher level of SDM. Conclusion: The multilevel program helped clinicians achieve clinically relevant improvement in SDM, especially when it is tailored to (individuals in) teams and includes (e-)training, discussing feedback on consultations and redistribution of tasks.

Accelerating implementation of shared decision-making in the Netherlands: An exploratory investigation.

OBJECTIVE: To prioritize strategies to implement shared decision-making (SDM) in daily practice, resulting in an agenda for a nationwide approach. METHODS: This was a qualitative, exploratory investigation involving: Interviews (N = 43) to elicit perceived barriers to and facilitators of change, focus group discussions (N = 51) to develop an implementation strategy, and re-affirmation through written feedback (n = 19). Professionals, patients, researchers and policymakers from different healthcare sectors participated. Determinants for change were addressed at four implementation levels: (1) the concept of SDM, (2) clinician and/or patient, (3) organizational context and (4) socio-political context. RESULTS: Following the identification of perceived barriers, four strategies were proposed to scale up SDM: 1) stimulating intrinsic motivation among clinicians via an integrated programmatic approach, 2) training and implementation in routine practice, 3) stimulating the empowerment of patients, 4) creating an enabling socio-political context. CONCLUSION: Clinicians mentioned that applying SDM makes their job more rewarding and indicated that implementation in daily practice needs ground-up redesign. The challenge is to effectively influence the behavior of clinicians and patients alike, and adapt clinical pathways to facilitate the exploration of patient values. PRACTICE IMPLICATIONS: Stakeholders should connect nationwide initiatives to pool information, and make the healthcare system supportive of implementing SDM.

Shared decision making, a buzz-word in the Netherlands, the pace quickens towards nationwide implementation .

Currently, shared decision making (SDM) is on the agenda among target patient representative groups, policy makers and professional bodies. Although the International Conference for Shared Decision Making (ISDM) 2011 generated a positive boost, hesitation was also felt among Dutch clinicians, who are challenged by many new tasks. No hesitation is seen among the majority of patients, opting mostly for the SDM model. We haven't reached these patients' needs fully yet, given disappointing research data on patients' experiences and professional behaviour. There is plenty of room for improvement in daily practice, for which many best practices are being designed and increasingly implemented, such as national campaigns to empower patients, central governance of patient decision aids that are developed along clinical practice guidelines, postgraduate training, collaborative learning and system changes, and merging goal setting and SDM in complex care. This is explicitly supported by the Dutch government, the Ministry of Health, patient groups, professional bodies and health insurers. The culture shift in the minds and hearts of patients and clinicians has started but is still ongoing. Enthusiasm for this way of working could be undermined if SDM is defined and implemented in a simplistic, dogmatic manner leading to irresponsible transferring of the professionals' uncertainty, responsibility, and decisional stress to patients.

Shared decision making in the Netherlands, is the time ripe for nationwide, structural implementation?

WHAT ABOUT POLICY REGARDING SDM? The Dutch health care system has been reformed in 2006 to make it more patient-oriented and demand-driven. We shortly describe four strategies of this health care reform. Although research projects are now fully spread over the country, a coordinated research agenda on SDM is lacking. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? The Dutch governmental healthcare internet portal for patients hosts 16 patient decision aids. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? There is quite a strong patient participation movement in the Netherlands, on macro and meso level. Limited effort, related to the local research projects has been put into training professionals in SDM skills. WHAT DOES THE FUTURE LOOK LIKE? We need concerted action on the level of educating health care professionals, empowering patients, making patient decision aids easily accessible, supporting the professionals in this new task, and measuring the process of SDM in performance indicators used in quality assurance. The Dutch Platform for SDM that will be launched in Maastricht in June 2011 is therefore a timely and relevant initiative.

How to integrate individual patient values and preferences in clinical practice guidelines? A research protocol.

BACKGROUND: Clinical practice guidelines are largely conceived as tools that will inform health professionals' decisions rather than foster patient involvement in decision making. The time now seems right to adapt clinical practice guidelines in such a way that both the professional's perspective as care provider and the patients' preferences and characteristics are being weighed equally in the decision-making process. We hypothesise that clinical practice guidelines can be adapted to facilitate the integration of individual patients' preferences in clinical decision making. This research protocol asks two questions: How should clinical practice guidelines be adapted to elicit patient preferences and to support shared decision making? What type of clinical decisions are perceived as most requiring consideration of individual patients' preferences rather than promoting a single best choice? METHODS: Stakeholders' opinions and ideas will be explored through an 18-month qualitative study. Data will be collected from in-depth individual interviews. A purposive sample of 20 to 25 key-informants will be selected among three groups of stakeholders: health professionals using guidelines (e.g., physicians, nurses); experts at the macro- and meso-level, including guideline and decision aids developers, policy makers, and researchers; and patient representatives. Ideas and recommendations expressed by stakeholders will be prioritized by nominal group technique in expert meetings. DISCUSSION: One-for-all guidelines do not account for differences in patients' characteristics and for their preferences for medical interventions and health outcomes, suggesting a need for flexible guidelines that facilitate patient involvement in clinical decision making. The question is how this can be achieved. This study is not about patient participation in guideline development, a closely related and important issue that does not however substitute for, or guarantee individual patient involvement in clinical decisions. The study results will provide the needed background for recommendations about potential effective and feasible strategies to ensure greater responsiveness of clinical practice guidelines to individual patient's preferences in clinical decision-making.

Effectiveness of self-management interventions on mortality, hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure: a systematic review.

OBJECTIVE: This review examined the effectiveness of self-management interventions compared to usual care on mortality, all-cause hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure. METHODS: A systematic review was performed. MEDLINE, EMBASE, CINAHL and the Cochrane Library were searched between 1996 and 2009. Randomized controlled trials were selected evaluating self-management interventions designed for patients with chronic heart failure. Outcomes of interest are mortality, all-cause hospital readmissions, chronic heart failure hospitalization rate and quality of life. RESULTS: Nineteen randomized controlled trials were identified. The effectiveness of heart failure management programs initiating self-management interventions in patients with chronic heart failure indicate a positive effect, although not always significant, on reduction of numbers of all-cause hospital readmitted patients and due to chronic heart failure, decrease in mortality and increasing quality of life. CONCLUSION: This systematic review found that current available published studies show methodological shortcomings impairing validation of the effectiveness of self-management interventions on mortality, all-cause hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure. PRACTICE IMPLICATIONS: Further research should determine independent effects of self-management interventions and different combinations of interventions on clinical and patient reported outcomes.

A generic tool for development of decision aids based on clinical practice guidelines.

OBJECTIVE: Patient involvement in medical decision making has been suggested to contribute to patients' satisfaction and better patient outcomes. Decision aids are particularly useful for preference-sensitive decisions. Ideally, these should be based on up-to-date evidence-based guidelines. The objective of this project was to develop a generic format for development and maintenance of decision aids based on evidence-based guidelines. METHODS: Decision aids, evidence-based guidelines and IPDAS standards were used for development of a generic format for decision aids. Patient focus groups were used to assess patients' information needs, expectations, personal values and preferences for presentation of information. RESULTS: We developed a generic format for decision aids and six specific decision aids derived from evidence-based guidelines. The decision aids were published on the Dutch national health care portal. Furthermore, we reached formal agreement on ownership and maintenance of the decision aids with all stakeholders. We achieved these results within 12 months. CONCLUSION: Our generic format facilitated the efficient production of specific decision aids based on evidence-based guidelines. PRACTICE IMPLICATIONS: If guidelines and decision aids are developed in parallel, high-quality patient information can be produced within a short time frame. The process of development should include adequate patient involvement and a strategy for maintenance.

Shared decision-making in the Netherlands--current state and future perspectives.

Dutch government policy is aimed at introducing regulated competition among health care providers and among health care insurers and at empowering patients for being involved in decision-making in health care. Along with this, many Dutch organisations have been created to foster patient orientation within health care and increase patients' power for medical decision-making. The challenge is to deliver reliable and well-balanced information for patients and the public, eg. in patient-tailored web-based formats. The approach of patient participation in medical decision-making has been formally defined in a specific law (WGBO), and the principle of recognising the patient's view is increasingly reflected in the national guidelines for health care professionals. The theme of patient participation in medical decision making is a fairly widespread research topic theme in the Netherlands, including mutual exchange among the researchers in a vivid network. The real bottleneck is perhaps the implementation of patient participation into professional practice. Some recommendations for facilitating a change are made.

Considered judgement in evidence-based guideline development.

BACKGROUND: Clinical practice guidelines should be based on the best available evidence. However, this evidence is often incomplete, controversial, or lacking. Other considerations beyond the evidence are therefore needed to be able to formulate specific and applicable recommendations for clinical practice. OBJECTIVE: The aim of this study is to obtain consensus among experts about a set of domains and items covering the most relevant 'other considerations' to formulate recommendations in evidence-based guideline development. METHODS: An initial list of 10 domains and 49 items for a systematic and considered judgement of scientific evidence was generated from the literature. A panel of Dutch experts in guideline development tested this list using a two-round Delphi consensus technique. Each expert was asked to independently score the relevance of the items on a 4-point Likert scale, ranging from 'very important' to 'not important'. The final list consisted of items that were included by at least 60% consensus. RESULTS: Twenty-eight experts participated in the first Delphi round and 21 of them in the second round. High scoring domains were 'clinical relevance', 'safety', and 'availability of resources'. There was consensus about the relevance of 37 items. The domain 'conflicts of interest by industry' was excluded because of lack of consensus. CONCLUSION: This is the first formal consensus approach towards structuring the considered judgement process in formulating recommendations in clinical guidelines. The final list of items can be used to facilitate the process of guideline development. The next step is to test the practical usefulness and applicability of this list in guideline development.