Effects of a shared decision-making implementation programme on patient-centred communication in oncology-Secondary analysis of a randomised controlled trial.

BACKGROUND: There is a need for better implementation of patient-centred (PC) communication and shared decision-making (SDM) in routine cancer care. OBJECTIVE: The aim of this study was to assess whether a programme to implement SDM in oncology had effects on PC communication in clinical encounters. DESIGN: This study constitutes a secondary analysis of data derived from an implementation trial applying a stepped wedge design that, among other strategies, incorporated training and coaching to enhance the PC communication skills of physicians. SETTING AND PARTICIPANTS: We analysed audio recordings of clinical encounters collected in three departments of a comprehensive cancer centre in Germany before and after rolling out the implementation programme. MAIN VARIABLES STUDIED: We assessed the PC communication skills of physicians. MAIN OUTCOME MEASURES: Each recording was rated by two researchers using the German version of the Four Habits Coding Scheme (4HCS), an observer-based measure of PC communication. Interrater reliability of the outcome measure was acceptable but moderate. Demographic data of patients participating in audio recordings were analysed. METHODS: Data were analysed using descriptive statistics and linear mixed-effects models. RESULTS: In total, 146 encounters, 74 before and 72 after implementation, were evaluated. The mean age of patients was 57.1 years (SD = 13.8), 70.3% were female, the largest portion of patients had medium formal education (32.4%) and were (self-) employed (37.8%). No statistically significant effect of the implementation programme on the physicians' PC communication skills was found. DISCUSSION: The results indicate that the investigated programme to implement SDM in oncology, including training and coaching, had no effects on PC communication in clinical encounters. These results are in contrast to other studies that report the effects of specific training or coaching on PC communication. Reasons for the lack of effect include the short duration of our training compared to other studies, limited reliability and moderate interrater reliability of the 4HCS scale, limited reach of the intervention programme as well as the inclusion of physicians regardless of their exposure to the interventions. CONCLUSION: Further research is needed to develop implementation strategies that improve physicians' PC communication skills. PATIENT CONTRIBUTION: Data on patients and clinical encounters with patients and physicians were analysed. There was no other patient or public involvement.

Correction: Application of the skills network approach to measure physician competence in shared decision making based on self-assessment.

[This corrects the article DOI: 10.1371/journal.pone.0282283.].

Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is highly relevant in oncology but rarely implemented in routine care. In a stepped-wedge cluster randomized implementation trial, the outcome evaluation of a theoretically and empirically based multi-component SDM implementation program did not show a statistically significant effect on patient-reported SDM uptake. Within this SDM implementation trial, a thorough a priori planned process evaluation was conducted. Thus, the aim of this study was to investigate factors influencing SDM implementation in the context of a multi-component SDM implementation program. METHODS: We conducted qualitative process evaluation of a stepped-wedge SDM implementation trial. Qualitative data included interviews with nurses and physicians of participating departments, field notes by the study team, and meeting minutes. Data were analyzed via deductive and inductive qualitative content analysis on basis of the Consolidated Framework for Implementation Research (CFIR). RESULTS: Transcripts of 107 interviews with 126 nurses and physicians, 304 pages of field note documentation, and 125 pages of meeting minutes were analyzed. Major factors influencing SDM implementation were found for all domains of the CFIR: a) four regarding characteristics of the individuals involved (e.g., perceived personal relevance, individual motivation to change), b) eleven regarding the inner setting (e.g., leadership engagement, networks and communication, available resources, compatibility with clinical practice), c) two regarding the outer setting (e.g., culture of health care delivery), d) eight regarding characteristics of the intervention (e.g., relative advantage, adaptability), and e) three regarding the implementation process (e.g., integration into existing structures). Furthermore, we found strong interrelations between several of the influencing factors within and between domains. CONCLUSIONS: This comprehensive process evaluation complements the outcome evaluation of the SDM implementation trial and adds to its interpretation. The identified influencing factors can be used for planning, conducting, and evaluating SDM implementation in the future. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351, registered 8 January 2018, https://clinicaltrials.gov/ct2/show/NCT03393351.

Application of the skills network approach to measure physician competence in shared decision making based on self-assessment.

Several approaches to and definitions of 'shared decision making' (SDM) exist, which makes measurement challenging. Recently, a skills network approach was proposed, which conceptualizes SDM competence as an organized network of interacting SDM skills. With this approach, it was possible to accurately predict observer-rated SDM competence of physicians from the patients' assessments of the physician's SDM skills. The aim of this study was to assess whether using the skills network approach allows to predict observer-rated SDM competence of physicians from their self-reported SDM skills. We conducted a secondary data analysis of an observational study, in which outpatient care physicians rated their use of SDM skills with the physician version of the 9-item Shared Decision Making Questionnaire (SDM-Q-Doc) during consultations with chronically ill adult patients. Based on the estimated association of each skill with all other skills, an SDM skills network for each physician was constructed. Network parameters were used to predict observer-rated SDM competence, which was determined from audio-recorded consultations using three widely used measures (OPTION-12, OPTION-5, Four Habits Coding Scheme). In our study, 28 physicians rated consultations with 308 patients. The skill 'deliberating the decision' was central in the population skills network averaged across physicians. The correlation between parameters of the skills networks and observer-rated competence ranged from 0.65 to 0.82 across analyses. The use and connectedness of the skill 'eliciting treatment preference of the patient' showed the strongest unique association with observer-rated competence. Thus, we found evidence that processing SDM skill ratings from the physicians' perspective according to the skills network approach offers new theoretically and empirically grounded opportunities for the assessment of SDM competence. A feasible and robust measurement of SDM competence is essential for research on SDM and can be applied for evaluating SDM competence during medical education, for training evaluation, and for quality management purposes. [A plain language summary of the study is available at https://osf.io/3wy4v.].

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Development and content validity of the Experienced Patient-Centeredness Questionnaire (EPAT)-A best practice example for generating patient-reported measures from qualitative data.

INTRODUCTION: To effectively foster patient-centeredness (PC), it is crucial to measure its implementation. So far, there is no German measure to assess PC comprehensively. The aim of this study is to develop and select items for the Experienced Patient-Centeredness (EPAT) Questionnaire, a patient-reported experience measure (PREM). The EPAT intends to assess PC from the perspective of adult patients treated for different chronic diseases in inpatient and outpatient settings in Germany. Furthermore, we aim at providing a best-practice example for developing PREMs from qualitative data. METHODS: The development process comprised a three-phase mixed-method design: (1) preparation, (2) item generation and (3) item selection and testing of content validity. We generated items using qualitative content analysis based on information from focus groups, key informant interviews and literature search. We selected items using relevance rating and cognitive interviews. Participants were patients from four chronic disease groups (cancer, cardiovascular disease, mental disorder, musculoskeletal disorder) and healthcare experts (e.g., clinicians, researchers, patient representatives). RESULTS: We conducted six focus groups with a total of 40 patients, key informant interviews with 10 experts and identified 48 PREMs from international literature. After team discussion, we reached a preliminary pool of 152 items. We conducted a relevance rating with 32 experts and 34 cognitive interviews with 21 patients. We selected 125 items assessing 16 dimensions of PC and showed high relevance and comprehensibility. CONCLUSIONS: The EPAT questionnaire is currently undergoing psychometric testing. The transparent step-by-step report provides a best practice example that other researchers may consider for developing PREMs. Integrating literature and experts with a strong focus on patient feedback ensured good content validity. The EPAT questionnaire will be helpful in assessing PC in routine clinical practice in inpatient and outpatient settings for research and quality improvement. PATIENT OR PUBLIC CONTRIBUTION: Patients were not involved as active members of the research team. While developing the funding proposal, we informally reached out to several patient organizations who all gave us positive feedback on the study aims, thereby confirming their relevance. Those patient organizations endorsed the funding proposal with formal letters of support and supported recruitment by disseminating advertisements for study participation.

Assessment of person-centeredness in healthcare and social support services for women with unintended pregnancy (CarePreg): protocol for a mixed-method study.

INTRODUCTION: For women with unintended pregnancy, access to high-quality care has been found limited due to social stigma and legal restrictions, especially when seeking abortion. To foster person-centeredness (PC), recognising the experiences and needs of women is the first premise. This study aims to (1) identify relevant dimensions of PC (2) evaluate PC in healthcare and social support services, (3) develop recommendations for further actions in healthcare and social support services for women with unintended pregnancy. METHODS AND ANALYSIS: We will use a mixed-methods approach. Phase 1: expert workshops with 10-15 healthcare professionals and counsellors and semistructured interviews with 15-20 women with unintended pregnancy will be conducted to assess the relevance of PC dimensions. Phase 2: quantitative assessment of PC dimensions within healthcare and support services will be conducted. We aim to include 600 women with an unintended pregnancy (1) until 24 weeks of pregnancy or (2) who sought abortion within the past 8 weeks, over three measurement points within 12 months. To deepen the results, semistructured interviews will be conducted. Phase 3: a workshop with 10-15 experts and an online survey with 100-150 experts will be used to indicate recommendations. Participants will be gained through relevant care facilities. An ethical advisory board and an advisory board of affected women will be involved throughout the study. ETHICS AND DISSEMINATION: The study will be carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association and principles of good scientific practice. The study was approved by the Local Psychological Ethics Committee of the University Medical Center Hamburg-Eppendorf, Germany (LPEK-0260). Written informed consent will be sought prior to study participation. The study results will be disseminated in scientific journals, through collaboration partners and plain language press releases.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

Translation and psychometric evaluation of the German version of the IcanSDM measure - a cross-sectional study among healthcare professionals.

BACKGROUND: Shared decision-making (SDM) between patients and healthcare professionals (HCPs) is a key component of patient-centred care. To implement SDM in clinical practice and to evaluate its effects, it is helpful to know about HCPs' perception of SDM barriers. The measure IcanSDM was developed in Canada and assesses the perception of SDM barriers. To our knowledge, no equivalent measure exists in German. Therefore, the aim of this study was to translate and adapt the IcanSDM measure to be used by a German speaking population and evaluate its psychometric properties. METHODS: This is a cross-sectional psychometric study based on a secondary analysis of baseline data from a SDM implementation study. The original 8-item IcanSDM was translated into German using a team translation protocol. We assessed comprehensibility via cognitive interviews with n = 11 HCPs. Based on results of cognitive interviews, the translated IcanSDM version was revised. Two hundred forty-two HCPs filled out the measure. Psychometric analysis included acceptance (completion rate), item characteristics (response distribution, skewness, item difficulties, corrected item-total correlations, inter-item correlations), factorial structure (confirmatory factor analysis (CFA), model fit), and internal consistency (Cronbach's α). RESULTS: We translated and adapted the German IcanSDM successfully except for item 8, which had to be revised after the cognitive interviews. Completion rate was 98%. Skewness of the items ranged between -.797 and 1.25, item difficulties ranged between 21.63 and 70.85, corrected item-total-correlations ranged between .200 and .475, inter-item correlations ranged between .005 and .412. Different models based on CFA results did not provide a valid factorial structure. Cronbach's α ranged between .563 and .651 for different factor models. CONCLUSION: We provide the first German measure for assessing perception of SDM barriers by HCPs. The German IcanSDM is a brief measure with good acceptance. However, we found unsatisfying psychometric properties, which were comparable to results of the original scale. In a next step, the IcanSDM should be further developed and modified and predictive validity should be evaluated.

A skills network approach to physicians' competence in shared decision making.

BACKGROUND: Measurement of physicians' competence in shared decision making (SDM) remains challenging with frequent disagreement between assessment methods. OBJECTIVE: To conceptualize and measure physicians' SDM competence as an organized network of behavioural skills and to determine whether processing patient-reported data according to this model can be used to predict observer-rated competence. DESIGN: Secondary analysis of an observational study. SETTING AND PARTICIPANTS: Primary and specialty outpatient care physicians and consecutively recruited adult patients with a chronic condition who faced a treatment decision with multiple acceptable choices. MEASURES: Network parameters constructed from patients' assessment of physicians' SDM skills as measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and observer-rated SDM competence of physicians measured by three widely used observer-rated instruments. RESULTS: 29 physicians (12 female, 17 male; mean age 50.3 years) recruited 310 patients (59.4% female, 40.6% male; mean age 54.0 years) facing a decision mainly regarding type 2 diabetes (36.4%), chronic back pain (32.8%) or depressive disorder (26.8%). Although most investigated skills were interrelated, elicitation of the patient's treatment preferences showed the strongest associations with the other skills. Network parameters of this skill were also decisive in predicting observer-rated competence. Correlation between predicted competence scores and observer-rated measurements ranged from 0.710 to 0.785. CONCLUSIONS: Conceptualizing physicians' SDM competence as a network of interacting skills enables the measurement of observer-rated competence using patient-reported data. In addition to theoretical implications for defining and training medical competences, the findings open a new way to measure physicians' SDM competence under routine conditions.

Adaptation and qualitative evaluation of Ask 3 Questions - a simple and generic intervention to foster patient empowerment.

BACKGROUND: Patients are often not actively engaged in medical encounters. Short interventions like Ask 3 Questions (Ask3Q) can increase patient participation in decision-making. Up to now, Ask3Q was not available in German. OBJECTIVE: To translate Ask3Q and evaluate its acceptability and feasibility. METHODS: We translated and adapted several English versions of Ask3Q using a team translation protocol and cognitive interviews. Acceptability and feasibility of the final German Ask3Q version were assessed via focus groups and interviews with patients and healthcare professionals (HCPs). Data were analysed via qualitative content analysis. RESULTS: Translation and adaptation were successful. Participants of focus groups and interviews perceived Ask3Q as a tool to empower patients to ask more questions. Moreover, it was seen as a guideline for physicians not to forget conveying important information. Several characteristics of patients, HCPs, the clinical setting and the intervention were identified as facilitators and barriers for an effective implementation of Ask3Q. CONCLUSION: We provide the German version of Ask3Q. According to participants, implementation of Ask3Q in the German healthcare system is feasible. Future studies should evaluate if positive effects of Ask3Q can be replicated for patient participation and communication behaviour of HCPs in Germany.

Translation and psychometric evaluation of the German version of the Organisational Readiness for Implementing Change measure (ORIC): a cross-sectional study.

OBJECTIVES: To translate the Organisational Readiness for Implementing Change measure into German and assess its psychometric properties. DESIGN: Cross-sectional psychometric study based on secondary analysis of baseline data from a shared decision-making implementation study. SETTING: Three departments within one academic cancer centre in Hamburg, Germany. PARTICIPANTS: For comprehensibility assessment of the translated ORIC version, we conducted cognitive interviews with healthcare professionals (HCPs, n=11). Afterwards, HCPs (n=230) filled out the measure. PRIMARY AND SECONDARY OUTCOME MEASURES: The original English version of the ORIC was translated into German using a team translation protocol. Based on comprehensibility assessment via cognitive interviews with HCPs, the translated version was revised. We analysed acceptance (completion rate), factorial structure (exploratory factor analysis (EFA), confirmatory factor analysis (CFA), model fit), item characteristics (item difficulties, corrected item-total correlations, inter-item correlations) and internal consistency (Cronbach's α). RESULTS: Translation and cognitive testing of the German ORIC was successful except for item 10, which showed low comprehensibility as part of content validity in cognitive interviews. Completion rate was >97%. EFA and CFA provided a one-factorial structure. Item difficulties ranged between 55.98 and 65.32, corrected item-total-correlation ranged between 0.665 and 0.774, inter-item correlations ranged between 0.434 and 0.723 and Cronbach's α was 0.93. CONCLUSIONS: The German ORIC is a reliable measure with high completion rates and satisfying psychometric properties. A one-factorial structure of the German ORIC was confirmed. Item 10 showed limited comprehensibility and therefore reduces content validity of the measure. The German ORIC can be used to analyse organisational readiness for change as a precursor for implementation success of various interventions.

Cancer patients' preferred and perceived level of involvement in treatment decision-making: an epidemiological study.

Background: We aimed to analyze preferred and perceived levels of patients' involvement in treatment decision-making in a representative sample of cancer patients.Material and Methods: We conducted a multicenter, epidemiological cross-sectional study with a stratified random sample based on the incidence of cancer diagnoses in Germany. Data were collected between January 2008 and December 2010. Analyses were undertaken between 2017 and 2019. We included 5889 adult cancer patients across all cancer entities and disease stages from 30 acute care hospitals, outpatient facilities, and cancer rehabilitation clinics in five regions in Germany. We used the Control Preferences Scale to assess the preferred level of involvement and the nine-item Shared Decision-Making Questionnaire to assess the perceived level of involvement.Results: About 4020 patients (mean age of 58 years, 51% female) completed the survey. Response rate was 68.3%. About a third each preferred patient-led, shared, or physician-led decision-making. About 50.7% perceived high levels, about a quarter each reported moderate (26.0%) or low (24.3%) levels of shared decision-making. Sex, age, relationship status, education, health care setting, and tumor entity were linked to preferred and/or perceived decision-making. Of those patients who preferred active involvement, about 50% perceived high levels of shared decision-making.Conclusion: The majority of patients with cancer wanted to be involved in medical decisions. Many patients perceived a high level of shared decision-making. However, many patients' level of involvement did not fit their preference. This study provides a solid basis for efforts to improve shared decision-making in German cancer care.

Assessing the relevance and implementation of patient-centredness from the patients' perspective in Germany: results of a Delphi study.

OBJECTIVE: Patient-centredness (PC) has particularly grown in relevance in health services research as well as in politics and there has been much research on its conceptualisation. However, conceptual work neglected the patients' perspective. Thus, it remains unclear which dimensions of PC matter most to patients. This study aims to assess relevance and current degree of implementation of PC from the perspective of chronically ill patients in Germany. METHODS: We conducted a Delphi study. Patients were recruited throughout Germany using community-based strategies (eg, newspapers and support groups). In round 1, patients rated relevance and implementation of 15 dimensions of PC anonymously. In round 2, patients received results of round 1 and were asked to re-rate their own results. Participants had to have at least one of the following chronic diseases: cancer, cardiovascular disease, mental disorder or musculoskeletal disorder. Furthermore, patients had to be at least 18 years old and had to give informed consent prior to participation. RESULTS: 226 patients participated in round 1, and 214 patients in round 2. In both rounds, all 15 dimensions were rated highly relevant, but currently insufficiently implemented. Most relevant dimensions included 'patient safety', 'access to care' and 'patient information'. Due to small sizes of subsamples between chronic disease groups, differences could not be computed. For the other subgroups (eg, single disease vs multi-morbidity), there were no major differences. CONCLUSION: This is one of the first studies assessing PC from patients' perspective in Germany. We showed that patients consider every dimension of PC relevant, but currently not well implemented. Our results can be used to foster PC healthcare delivery and to develop patient-reported experience measures to assess PC of healthcare in Germany.

Adaptation and qualitative evaluation of encounter decision aids in breast cancer care.

PURPOSE: Shared decision-making is currently not widely implemented in breast cancer care. Encounter decision aids support shared decision-making by helping patients and physicians compare treatment options. So far, little was known about adaptation needs for translated encounter decision aids, and encounter decision aids for breast cancer treatments were not available in Germany. This study aimed to adapt and evaluate the implementation of two encounter decision aids on breast cancer treatments in routine care. METHODS: We conducted a multi-phase qualitative study: (1) translation of two breast cancer Option Grid™ decision aids; comparison to national clinical standards; cognitive interviews to test patients' understanding; (2) focus groups to assess acceptability; (3) testing in routine care using participant observation. Data were analysed using qualitative content analysis. RESULTS: Physicians and patients reacted positively to the idea of encounter decision aids, and reported being interested in using them; patients were most receptive. Several adaptation cycles were necessary. Uncertainty about feasibility of using encounter decision aids in clinical settings was the main physician-reported barrier. During real-world testing (N = 77 encounters), physicians used encounter decision aids in one-third of potentially relevant encounters. However, they did not use the encounter decision aids to stimulate dialogue, which is contrary to their original scope and purpose. CONCLUSIONS: The idea of using encounter decision aids was welcomed, but more by patients than by physicians. Adaptation was a complex process and required resources. Clinicians did not follow suggested strategies for using encounter decision aids. Our study indicates that production of encounter decision aids alone will not lead to successful implementation, and has to be accompanied by training of health care providers.

Assessment of patient centredness through patient-reported experience measures (ASPIRED): protocol of a mixed-methods study.

INTRODUCTION: The impact of patient centredness (PC) in healthcare has grown over the years. However, conceptualisations of PC are heterogeneous. Existing patient-reported measures of PC have shown inconsistencies and shortcomings. This impedes the comparison of results across studies. To foster PC, it is important to know which dimensions matter most to patients and to be able to measure its current extent from the patients' perspective. This study aims (1) to assess relevance of dimensions of PC from the patients' perspective, (2) to develop and psychometrically test a core set of patient-reported experience measures (PREMs) assessing PC and (3) to investigate the feasibility of implementation of this core set in routine healthcare. METHODS AND ANALYSIS: A mixed-methods approach will be used. In phase 1, 200 patients will assess the relevance of the dimensions of PC in a Delphi study using a plain language description. In phase 2, the core set of PREMs will be developed through literature reviews, focus groups, key informant interviews and content validity ratings. The core set will be tested psychometrically in a cross-sectional study with 2000 inpatient and outpatients with different chronic conditions (ie, cancer, cardiovascular diseases, mental disorders and musculoskeletal disorders). In phase 3, the feasibility of implementation of the core set will be assessed through semistructured interviews with healthcare practitioners after piloting in routine care. Furthermore, an expert workshop will be held on how to foster implementation. ETHICS AND DISSEMINATION: The study will be carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association and principles of good scientific practice. The study was approved by the Ethics Committee of the Medical Association Hamburg, Germany (study ID: PV5724). The study results will be disseminated in scientific journals and through collaboration partners and plain language press releases.

Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. METHODS: We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. DISCUSSION: This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.

Organizational- and system-level characteristics that influence implementation of shared decision-making and strategies to address them - a scoping review.

BACKGROUND: Shared decision-making (SDM) is poorly implemented in routine care, despite being promoted by health policies. No reviews have solely focused on an in-depth synthesis of the literature around organizational- and system-level characteristics (i.e., characteristics of healthcare organizations and of healthcare systems) that may affect SDM implementation. A synthesis would allow exploration of interventions to address these characteristics. The study aim was to compile a comprehensive overview of organizational- and system-level characteristics that are likely to influence the implementation of SDM, and to describe strategies to address those characteristics described in the literature. METHODS: We conducted a scoping review using the Arksey and O'Malley framework. The search strategy included an electronic search and a secondary search including gray literature. We included publications reporting on projects that promoted implementation of SDM or other decision support interventions in routine healthcare. We screened titles and abstracts, and assessed full texts for eligibility. We used qualitative thematic analysis to identify organizational- and system-level characteristics. RESULTS: After screening 7745 records and assessing 354 full texts for eligibility, 48 publications on 32 distinct implementation projects were included. Most projects (N = 22) were conducted in the USA. Several organizational-level characteristics were described as influencing the implementation of SDM, including organizational leadership, culture, resources, and priorities, as well as teams and workflows. Described system-level characteristics included policies, clinical guidelines, incentives, culture, education, and licensing. We identified potential strategies to influence the described characteristics, e.g., examples how to facilitate distribution of decision aids in a healthcare institution. CONCLUSIONS: Although infrequently studied, organizational- and system-level characteristics appear to play a role in the failure to implement SDM in routine care. A wide range of characteristics described as supporting and inhibiting implementation were identified. Future studies should assess the impact of these characteristics on SDM implementation more thoroughly, quantify likely interactions, and assess how characteristics might operate across types of systems and areas of healthcare. Organizations that wish to support the adoption of SDM should carefully consider the role of organizational- and system-level characteristics. Implementation and organizational theory could provide useful guidance for how to address facilitators and barriers to change.

Shared decision-making in physical therapy: A cross-sectional study on physiotherapists' knowledge, attitudes and self-reported use.

OBJECTIVE: This study aimed a) to investigate knowledge, attitudes, and self-reported use of shared decision-making (SDM) among physiotherapists in Germany, b) to explore their association with demographic characteristics, and c) to assess barriers to the implementation of SDM. METHODS: We assessed above mentioned domains using an online survey. Two-level logistic regression models were used to examine factors associated with knowledge, attitudes and self-reported use of SDM. RESULTS: 60.5% of a total sample of 357 participants reported to have had no knowledge on SDM before participating in the survey. Attitudes towards SDM were mostly positive, half of all participants expressed a preference for SDM. About two thirds of all participants reported to use a rather paternalistic approach in routine care. Knowledge, attitudes, and self-reported use of SDM were associated with several demographic characteristics. CONCLUSION: SDM was perceived as an appropriate concept in physiotherapy. However, missing knowledge and limited self-reported use of SDM in routine care on the one hand and positive attitudes towards SDM on the other hand indicate a need for action. PRACTICE IMPLICATIONS: In order to emphasize the use of SDM in physiotherapy efforts need to be undertaken in research, clinical practice and health policy.