Development, implementation and evaluation of patient decision aids supporting shared decision making in women with recurrent ovarian cancer.

Objective: Shared decision making (SDM) and use of patient decision aids (PtDAs) are key components in patient-centered care in relapsed ovarian cancer. This paper describes the development and implementation process of PtDAs into a clinical routine in three departments. Methods: Two PtDAs were developed in collaboration between patients and clinicians. Acceptability and usability of the PtDAs were tested on clinicians and patients using items from the internationally validated questionnaire "Preparation for Decision Making Scale". Results: Ten patients and 15 clinicians participated in the study. Most patients indicated that PtDAs would be helpful as preparation for the decision-making process with the clinicians. Ten (75%) of the clinicians responded that the PtDAs helped the patients to understand the benefits and disadvantages of each treatment option. Generally, the clinicians indicated that they would use SDM if they had a PtDA tailored to the clinical situation. Conclusions: Two PtDAs were systematically developed, tested, and implemented thereby supporting an SDM intervention. The PtDAs are still in use at the participating departments. Innovation: This study was successful in reusing a generic template for a patient decision aid (PtDA) developed at one institution and implemented in two other institutions. This was guided by a well-described systematic development process for PtDAs.

"SDM:HOSP"- a generic model for hospital-based implementation of shared decision making.

BACKGROUND: Shared decision making (SDM) is a core element in the meeting between patient and healthcare professionals, but has proved difficult to implement and sustain in routine clinical practice. One of five Danish regions set out to succeed and to develop a model that ensures lasting SDM based on learnings from large-scale real-world implementation initiatives that go beyond the 'barriers' and 'facilitators' research approach. This paper describes this process and development of a generic implementation model, SDM:HOSP. METHODS: This project was carried out in the Region of Southern Denmark with five major hospital units. Based on existing theory of SDM, SDM implementation, implementation science and improvement methodology, a process of four phases were described; development of conceptual elements, field-testing, evaluation, and development of the final implementation model. The conceptual elements developed aimed to prepare leaders, train SDM teachers, teach clinicians to perform SDM, support development of patient decision aids, and support systematic planning, execution and follow-up. Field testing was done including continuous participant evaluations and an overall evaluation after one year. RESULTS: Data from field testing and learnings from the implementation process, illustrated the need for a dynamic and easy adjustable model. The final SDM:HOSP model included four themes; i)Training of Leaders, ii) Training of Teachers and Clinicians, iii) Decision Helper, and iv) 'Process', each with details in three levels, 1) shared elements, 2) recommendations, and 3) local adaption. CONCLUSIONS: A feasible and acceptable model for implementation of SDM across hospitals and departments that accounts for different organizations and cultures was developed. The overall design can easily be adapted to other organizations and can be adjusted to fit the specific organization and culture. The results from the ongoing and overall evaluation suggest promising avenues for future work in further testing and research of the usability of the model.

Implementation of patient-centred care in Denmark: The way forward with shared decision-making.

LEGAL AND POLITICAL LANDSCAPE IN SHARED DECISION MAKING: Current Danish legislation empowers patients in securing their rights, but there are no present legislative developments in Denmark to support patient involvement. Policy initiatives within health care, however, show positive trends by, for example, including recommendations for shared decision making (SDM) in national clinical guidelines and the allocation of resources to fund projects in SDM. Within the last five years, three out of five regions have launched centers in patient involvement and SDM to focus on training, implementation of patient decision aids (PtDAs) and to foster the cultural change in SDM. A national dissemination of a template for easy building of PtDAs accessible via an online platform is one of the latest initiatives. THE WAY FORWARD: Although the political discourse on SDM is gathering speed, an unclear definition and purpose of SDM is a barrier to real-life implementation. Politicians, leaders and clinicians seem to be moving at different paces and in different directions and are lacking consensus on SDM as a paradigm requiring training, leadership and a patient-centered mindset. CONCLUSION: Many relevant initiatives are underway. However, SDM is also challenged by the lack of legislation and a central push for real SDM implementation in Denmark.

Shared decision making in recurrent ovarian cancer: Implementation of patient decision aids across three departments of oncology in Denmark.

Objective: Patients with relapsed ovarian cancer are offered multiple treatment options. To match treatment with the individual patient's life situation and preferences, healthcare professionals can apply shared decision making (SDM) including patient decision aids (PtDAs).This study aimed to evaluate the implementation of two different PtDAs in consultations with patients suffering from relapsed ovarian cancer. Methods: We analyzed the following data before and after implementation of the PtDAs: 1) observed SDM using the OPTION instrument, 2) physician treatment recommendations, and 3) patients' and physicians' evaluations of SDM in consultations using the CollaboRATE, SDM-Q-9, and SDM-Q-Doc. Results: Significant improvement in observed SDM was found after the implementation (p = 0.002). Improvement of SDM was detected in consultations conducted by physicians reporting more than two hours of SDM-training (p < 0.001), but not when physicians reported less than two hours of SDM-training.No before/after differences in treatment recommendations and in patients' and physicians' evaluations were found. Conclusion: Implementation of PtDAs improved the level of observed SDM. Training of physicians in SDM is necessary for improved SDM practice. Innovation: Discussing oncological treatment options with the use of PtDAs is not standard practice in Denmark. The present study is one of the first Danish studies focusing on how to implement SDM and PtDAs in oncological consultations.

Practitioners' views on shared decision-making implementation: A qualitative study.

INTRODUCTION: Shared decision-making (SDM) refers to the collaboration between patients and their healthcare providers to make clinical decisions based on evidence and patient preferences, often supported by patient decision aids (PDAs). This study explored practitioner experiences of SDM in a context where SDM has been successfully implemented. Specifically, we focused on practitioners' perceptions of SDM as a paradigm, factors influencing implementation success, and outcomes. METHODS: We used a qualitative approach to examine the experiences and perceptions of 10 Danish practitioners at a cancer hospital experienced in SDM implementation. A semi-structured interview format was used and interviews were audio-recorded and transcribed. Data was analyzed through thematic analysis. RESULTS: Prior to SDM implementation, participants had a range of attitudes from skeptical to receptive. Those with more direct long-term contact with patients (such as nurses) were more positive about the need for SDM. We identified four main factors that influenced SDM implementation success: raising awareness of SDM behaviors among clinicians through concrete measurements, supporting the formation of new habits through reinforcement mechanisms, increasing the flexibility of PDA delivery, and strong leadership. According to our participants, these factors were instrumental in overcoming initial skepticism and solidifying new SDM behaviors. Improvements to the clinical process were reported. Sustaining and transferring the knowledge gained to other contexts will require adapting measurement tools. CONCLUSIONS: Applying SDM in clinical practice represents a major shift in mindset for clinicians. Designing SDM initiatives with an understanding of the underlying behavioral mechanisms may increase the probability of successful and sustained implementation.

Providing Balanced Information about Options in Patient Decision Aids: An Update from the International Patient Decision Aid Standards.

BACKGROUND: The objective of this International Patient Decision Aids Standard (IPDAS) review is to update and synthesize theoretical and empirical evidence on how balanced information can be presented and measured in patient decision aids (PtDAs). METHODS: A multidisciplinary team conducted a scoping review using 2 search strategies in multiple electronic databases evaluating the ways investigators defined and measured the balance of information provided about options in PtDAs. The first strategy combined a search informed by the Cochrane Review of the Effectiveness of Decision Aids with a search on balanced information. The second strategy repeated the search published in the 2013 IPDAS update on balanced presentation. RESULTS: Of 2450 unique citations reviewed, the full text of 168 articles was screened for eligibility. Sixty-four articles were included in the review, of which 13 provided definitions of balanced presentation, 8 evaluated mechanisms that may introduce bias, and 42 quantitatively measured balanced with methods consistent with the IPDAS criteria in PtDAs. The revised definition of balanced information is, "Objective, complete, salient, transparent, evidence-informed, and unbiased presentation of text and visual information about the condition and all relevant options (with important elements including the features, benefits, harms and procedures of those options) in a way that does not favor one option over another and enables individuals to focus attention on important elements and process this information." CONCLUSIONS: Developers can increase the balance of information in PtDAs by informing their structure and design elements using the IPDAS checklist. We suggest that new PtDA components pertaining to balance be evaluated for cognitive bias with experimental methods as well by objectively evaluating patients' and content experts' beliefs from multiple perspectives.

The impact of shared decision making on time consumption and clinical decisions. A prospective cohort study.

OBJECTIVE: Concerns of increased time consumption and of the impact on clinical decisions may restrain doctors from shared decision making (SDM). This paper evaluates consultation length and decisions made when using an in-consult patient decision aid (PtDA). METHODS: This prospective cohort study compared an unexposed cohort with a cohort exposed to SDM and a PtDA in two preference-sensitive decision situations: invasive lung cancer diagnostics and adjuvant treatment for early breast cancer. Outcome measures were consultation length and decisions made. RESULTS: The study included 261 consultations, 115 were in the SDM-exposed cohort. Consultations were inconsiderably longer in the SDM cohort; 2 min, 11 s (p = 0.2217) for lung cancer diagnostics and 3 min, 57 s (p = 0.1128) for adjuvant breast cancer treatment. In lung cancer diagnostics, consultation length became more uniform and decisions tended to become conservative after introduction of SDM. For adjuvant breast cancer, slightly more patients in the SDM cohort chose to decline treatment. CONCLUSION: Shared decision making did not take significantly longer time and led to slightly more conservative decisions. PRACTICE IMPLICATIONS: SDM may be implemented without considerable impact on consultation length. The impact on clinical decisions depends mainly on the clinical situation.

The impact of a patient decision aid on shared decision-making behaviour in oncology care and pulmonary medicine-A field study based on real-life observations.

OBJECTIVE: A patient decision aid (PtDA) is often developed and evaluated to support shared decision making (SDM) and a patient-centred approach. In this study, a PtDA template was developed to support two different preference sensitive decisions: adjuvant therapy for breast cancer and diagnostic workup for lung cancer. The aim of the study was to explore whether a PtDA improved SDM and supported a patient-centred approach from an observational point of view. METHODS: Real-life observations were conducted using the validated observational instrument OPTION 12. Three nurses conducted observations of consultations in two different clinical settings. The study consisted of a baseline cohort (phase 1) and an intervention cohort (phase 2). In phase 1, standard consultations were observed. Subsequently, the PtDA was introduced, and in phase 2, consultations with the clinician using the PtDA were observed. RESULTS: Twenty-nine observations were conducted in phase 1 and 24 in phase 2. Using a PtDA increased the overall OPTION score significantly (P < .0001), both in decisions on adjuvant treatment for breast cancer and on diagnostic workup of lung cancer. Items in the OPTION instrument regarding systematic conversation to obtain SDM had a higher increase of scores compared to items regarding a patient-centred approach. CONCLUSION: Real-life observations and the use of a validated observational tool provided comprehensive knowledge as to how a PtDA affects SDM in consultations. Applying a PtDA resulted in a significant overall increase of SDM behaviour in decisions on adjuvant treatment after breast cancer surgery and diagnostic workup in case of a small suspicion of lung cancer. In conclusion, the PtDA supports SDM in consultations independently of type of decision and department.

A prospective cohort study of shared decision making in lung cancer diagnostics: Impact of using a patient decision aid.

OBJECTIVE: The objective of this study was to describe the impact on patient-reported outcomes of introducing Shared Decision Making (SDM) and a Patient Decision Aid (PtDA) in the initial process of lung cancer diagnostics. METHODS: We conducted a prospective cohort study, where a control cohort was consulted according to usual clinical practice. After introducing SDM through a PtDA and training of the staff, the SDM cohort was enrolled in the study. All patients completed four questionnaires: the Decisional Conflict Scale (DCS) before and after the consultation, the CollaboRATE scale after the consultation, and the Decision Regret Scale (DRS). RESULTS: Patients exposed to SDM and a PtDA had significantly improved DCS scores after the consultation compared to the control group (a difference of 10.26, p = 0.0128) and significantly lower DRS scores (a difference of 8.98, p = 0.0197). Of the 82 control patients and 52 SDM patients 29% and 54%, respectively, gave the maximum score on the CollaboRATE scale (Pearson's chi2 8.0946, p = 0.004). CONCLUSION: The use of SDM and a PtDA had significant positive impact on patient-reported outcomes. PRACTICE IMPLICATIONS: Our results may encourage the increased uptake of SDM in the initial process of lung cancer diagnostics.

Predicting acute odynophagia during lung cancer radiotherapy using observations derived from patient-centred nursing care.

During radiotherapy, lung cancer patients commonly experience pain while swallowing (odynophagia) of food and drink. Observations from patient-centred nursing practice have been used to generate predictive models for odynophagia needing prescription pain medication during external beam lung radiotherapy for non-small cell and small-cell lung cancer. Three multivariate logistic models were evaluated in repeat cross-validation: a manual-stepwise model and two supervised machine learning models. Overall predictive performance was good. Correct classification rates ranged from 0.82 to 0.84, and areas under the receiver operator curve ranged from 0.83 to 0.85. Model sensitivity (range: 0.92-0.97) was higher than model specificity (range: 0.58-0.63). Further validation of the models in clinical context is required. A predictive model for pain medication for odynophagia prior to commencement of radiotherapy would support Radiotherapy Technologists Nurses (RTNs) in directing nursing interventions towards patients at risk.

Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - A Danish intra-patient randomized multicentre study.

BACKGROUND AND PURPOSE: Radiodermatitis is a well-known toxicity of radiotherapy and barrier film has been shown to reduce the severity of radiodermatitis. We have validated prior findings in a Danish cohort, using a similar barrier film and patient reported outcomes. MATERIALS AND METHODS: 101 Danish breast cancer patients were included at three radiotherapy centres. Based on randomization either the lateral or medial part of their chest was covered by Mepitel film; making the patients their own control. The primary endpoint was patient reported symptoms and experience. A secondary endpoint was radiotherapy staff evaluation of dermatitis. RESULTS: Within the skin area covered by film, the patients reported a statistical significant lower level of pain (p < .001), itching (p = 0.005), burning sensation (p = 0.005) as well as edema (p = 0.017) and reduced sensitivity (p < .001). Most patients (76%) would have preferred film on the entire treatment area (p < 0.001) and Mepitel Film as a standard treatment option (84%) (p < 0.001). Patients treated after mastectomy had a significantly lower severity of radiation-induced dermatitis with film at the end of RT compared to standard care (p = 0.005). However, in the blinded staff evaluation, no significant differences were found at follow-up. CONCLUSIONS: Patients reported reduced symptoms from the skin with Mepitel Film and the majority would have preferred film as a standard offer to cover their entire treatment area. Especially women treated after mastectomy had a significantly lower level of radiodermatitis and preferred the film over standard care.