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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.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.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.

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 the five Danish regions responsible for public health care set out to succeed and to develop a model that can ensure lasting SDM based on learnings from large-scale real-world implementation initiatives that go beyond the 'barriers' and 'facilitators' research approach. This paper aims to describe this process and the development of a generic model, SDM:HOSP for systematic implementation of SDM at somatic and mental health care hospitals.Methods: This project was carried out in the Region of Southern Denmark with five major hospital units, including mental health care service. Based on existing theory of SDM, SDM implementation, implementation science including the System of Profound Knowledge and The South Danish Improvement Model, 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 train leaders, teach clinicians to become SDM teachers, clinicians to perform SDM, support development of patient decision aids (PtDAs), and support systematic planning, execution and follow-up of the implementation. Field testing was done including continuous participant evaluations. After one year of implementation, an overall evaluation was done. 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 generic 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.

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.

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.

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

021 - A Prospective Cohort Study of Shared Decision Making in Lung Cancer Diagnostics: Impact of Using a Patient Decision AidStine R Søndergaard1, Poul Henning Madsen2, Ole Hilberg1,5, Karina M Jensen1, Karina Olling4, Karina D Steffensen3,4,5Background and aim Patients referred to fast-track evaluation with suspicion of lung malignancy are, based on CT scans, most often recommended further evaluation to establish diagnosis. However, in a significant number of the patients lung cancer is not very likely but at the same time cannot be ruled out based on the CT scan and referral note. In this group of patients it is not scientifically clear whether to recommend further diagnostic, invasive procedures with potential risks involved, arrange close follow- up with regular CT scans, or deselect further evaluation. Guidelines have encouraged the use of Shared Decision Making (SDM) to engage patients in the decision on the intensity of the diagnostic process, but the practice is not consistent among pulmonologists. With its systematic approach, SDM can help clinicians engage their patients to ensure that decision making is based on patient preferences as well as evidence based clinical information.The aim of this study was to investigate the impact on patient-reported outcomes of introducing SDM and an in-consultation 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) six months after the consultation.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, reported 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. This may encourage the increased uptake of SDM in the initial process of lung cancer diagnostics.

Highlights • Film significantly lowered the patient-reported symptoms of the skin two weeks following RT. • Almost all patients treated after mastectomy would prefer film on their entire chest wall. • A significantly lower severity of radiodermatitis with film vs standard care was present after mastectomy. • Almost all breast cancer patients would prefer film as a standard offer during radiotherapy., 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

IntroductionShared decision making (SDM) is a key element on the agenda of today’s health care system. Despite considerable interest from policy-makers, health care professionals and patients, SDM is not yet routine practice in clinical encounters. Health care professionals report barriers to SDM such as lack of skills and lack of decision support. Patient decision aids (PtDAs) have been shown to be an effective and reliable support in the dialogue between patient and health care professional. The aim of this study was to develop and test a patient decision aid template that could be adapted to different clinical encounters.Methods A systematic development process guided by the International Patient Decision Aid Standards (IPDAS) model was adopted and collaboration with a design school was established. Scope and purpose of prototypes were defined, steering groups were established and a PtDA template was designed. Alpha testing was conducted by structured interviews with patients and health care professionals. ResultsIn the alpha test, 39 patients and 24 health care professionals participated. Patients and health care professionals rated the PtDA highly for usability and acceptability and the PtDAs were found suitable for preparing patients to make preference-sensitive decisions.Qualitative findings were used to refine the PtDA.ConclusionUsing a systematic process and high user involvement we developed a PtDA template and two prototypes that meet the IPDAS criteria. Testing of the PtDA prototypes, showed that the template can be adapted to other clinical settings without affecting the quality of the PtDA. Next step is to field test these prototypes with larger groups of patients and professionals, and to test additional prototypes based on the PtDA template in different clinical settings. The PtDA template will be made available in a web-based “build-your-own-PtDA” software platform, making development of PtDAs more accessible for all health care professionals.

Background: Patient involvement, including shared decision-making (SDM), has become a key topic in the healthcare system. Only a few studies have been conducted in Denmark on how women with breast cancer experience being involved in the decision-making process during their treatment.Aim: The aim of the study was therefore to explore patients’ experiences in the decision-making process during their treatment course and whether or not it was clear to the individual patient that they had a choice.Methods: The study is based on a qualitative semi-structured interview of 7 patients with breast cancer conducted during February 2017 at a regional hospital for cancer treatment. The design is phenomenological-hermeneutic with inspiration from Ricoeur’s interpretation theory.Results: Through analysis and interpretation of the interviews, 2 themes were identified: (1) Real choice or course determined by the health professionals and (2) Treatment efficiency at the expense of time for consideration for options. The patients experienced that there was neither time for consideration in relation to their treatment, nor time to reflect on their situation. In the decision-making situations, most of the patients felt that they gave their consent only to a treatment course organized by the health professionals. They did not feel that they had a choice, but rather that participation was a prerequisite for getting well.Conclusions: The results of this study can contribute to the improvement of person-centered care and treatment by illustrating patient attitudes to the shared decision-making process and indicating where patient education would play a crucial role in increasing patient involvement in decisions about their care.

Shared decision making in care for the gynecologic cancer patient Steffensen KD, Fokdal LU, Oer Knudsen A, Vestergaard Madsen C, Jensen PT, Lundvall L, Olling K, Lemley B, Blou D, Büchmann H, Haee M Introduction: Treatment of recurrent ovarian cancer is complex and may involve surgery, chemotherapy or surveillance options that should be discussed with patients to reach a shared decision. This project aims to develop and test a patient decision aid (PDA) to facilitate shared decision making (SDM) in treatment planning of the ovarian cancer patient with relapse and furthermore, to evaluate SDM implementation methods Material & Methods: Development, testing, evaluation, and implementation of a PDA for women with relapsed ovarian cancer will be performed at three hospitals in Denmark. The test phase will include; 1) Alpha test: Patients and clinicians are interviewed based on a structured interview guide based on internationally validated questionnaires used to assess, to what extent the PDA prepare the patient to make a decision. 2) Betatest: Validated outcome measures, such a SDM-Q9, SDM-Q-DOC, OPTION and CollaboRATE will be used to assess patients and doctors experiences of SDM in consultations with patients experiencing a disease relapse at baseline before introduction of the PDA (Betatest 1) and after the use of the PDA (Betatest 2) Results: Based on an existing generic platform we have developed a PDA for platinum-sensitive as well as platinum-resistant relapse. The patient-clinician conversation in which the PDA is used consists of 5 steps: 1) The purpose of the PDA is presented 2) The patient is informed of the available treatment possibilities 3) The patients personal preferences is identified, what is important/concerns the patient 4) Patient's options and harms/benefits of each option are reviewed 5) A shared treatment decision is made with the patient Conclusions: The project results are intended to be disseminated on a national level through the Danish Gynecological Cancer Group for the benefit of other cancer patients. The generic PDA template can also be adjusted and used to develop new tools for other clinical decisions within Danishhealthcare

SHARED DECISION MAKING IN THE CARE FOR THE GYNECOLOGIC CANCER PATIENT Background and Aims:Despite surgery and adjuvant chemotherapy, a large number of patients with ovarian cancer experience relapse. Treatment of recurrent disease is complex and strategies that involve both surgery and chemotherapy or surveillance can be discussed. This project aims to contribute to and evaluate clinical implementation of shared decision making (SDM) in ovarian cancer patients. A patient decision aid (PDA) will be developed to facilitate SDM related to treatment planning of the ovarian cancer patient with relapseMethods:The project includes development, testing, evaluation, and implementation of a PDA for women with relapsed ovarian cancer at three hospitals in Denmark. This wide test environment will enable national dissemination and ensure a uniform treatment of future Danish ovarian cancer patients. The test phase will include;1) Alpha test: Patients and clinicians are interviewed based on a structured interview guide based on internationally validated questionnaires used to assess, to what extent the PDA prepare the patient to make a decision.2) Beta test: Validated outcome measures, such as SDM-Q9, SDM-Q-DOC, OPTION and CollaboRATE will be used to asses patients and doctors experiences of SDM in consultations with patients experiencing a disease relapse at baseline before introduction of the PDA (Beta test 1) and after the use of the PDA (Beta test 2)Results:Based on an existing generic platform we have developed a PDA for relapsed platinum-sensitive as well as platinum-resistant ovarian cancer. The patient-clinician conversation in which the PDA is used consists of 5 steps:Purpose of the PDA is presentedPatient is informed of the available treatment possibilitiesPatients personal preferences is identified, what is important/concerns the patientPatient's options and harms/benefits of each option are reviewedA shared treatment decision is made with the patientConclusions:The result of the project will be implemented broadly and systematically for the benefit of other cancer patients. The generic model can also be used to develop new tools for other clinical decisions within the health service