Through the patients' eyes: psychometric evaluation of the 64-item version of the Experienced Patient-Centeredness Questionnaire (EPAT-64).

BACKGROUND: Patient-reported experience measures (PREMs) are valuable tools to evaluate patient-centredness (PC) from the patients' perspective. Despite their utility, a comprehensive PREM addressing PC has been lacking. To bridge this gap, we developed the preliminary version of the Experienced Patient-Centeredness Questionnaire (EPAT), a disease-generic tool based on the integrative model of PC comprising 16 dimensions. It demonstrated content validity. This study aimed to test its psychometric properties and to develop a final 64-item version (EPAT-64). METHODS: In this cross-sectional study, we included adult patients treated for cardiovascular diseases, cancer, musculoskeletal diseases and mental disorders in inpatient or outpatient settings in Germany. For each dimension of PC, we selected four items based on item characteristics such as item difficulty and corrected item-total correlation. We tested structural validity using confirmatory factor analysis, examined reliability by McDonald's Omega and tested construct validity by examining correlations with general health status and satisfaction with care. RESULTS: Analysis of data from 2.024 patients showed excellent acceptance and acceptable item-total correlations for all EPAT-64 items, with few items demonstrating ceiling effects. The confirmatory factor analysis indicated the best fit for a bifactor model, where each item loaded on both a general factor and a dimension-specific factor. Omega showed high reliability for the general factor, while varying for specific dimensions. Construct validity was confirmed by absence of strong correlations with general health status and a strong correlation of the general factor with satisfaction with care. CONCLUSIONS: EPAT-64 demonstrated commendable psychometric properties. This tool allows comprehensive assessment of PC, offering flexibility to users who can measure each dimension with a four-item module or choose modules based on their needs. EPAT-64 serves multiple purposes, including quality improvement and evaluation of interventions aiming to enhance PC. Its versatility empowers users in diverse healthcare settings.

Mapping the Sun's coronal magnetic field using the Zeeman effect.

Regular remote sensing of the magnetic field embedded within the million-degree solar corona is severely lacking. This reality impedes fundamental investigations of the nature of coronal heating, the generation of solar and stellar winds, and the impulsive release of energy into the solar system via flares and other eruptive phenomena. Resulting from advancements in large aperture solar coronagraphy, we report unprecedented maps of polarized spectra emitted at 1074 nm by Fe+12 atoms in the active corona. We detect clear signatures of the Zeeman effect that are produced by the coronal magnetic field along the optically thin path length of its formation. Our comparisons with global magnetohydrodynamic models highlight the valuable constraints that these measurements provide for coronal modeling efforts, which are anticipated to yield subsequent benefits for space weather research and forecasting.

Development and psychometric validation of a patient safety assessment tool in German Radiation Oncology: the PaSaGeRO Study protocol.

INTRODUCTION: Ensuring patient safety in radiation oncology is crucial for delivering high-quality healthcare. Patient safety indicators (PSIs) provide a mechanism for identifying, quantifying and evaluating risks and the effectiveness of safety measures. However, there is currently no specialised set of PSIs tailored for radiation oncology in Germany. This study seeks to: (1) create PSIs specifically designed for radiation oncology settings, (2) develop and psychometrically validate an instrument for assessing safety in German radiation oncology facilities and (3) evaluate the feasibility of implementing this instrument in routine clinical practice. The finalised questionnaire will serve as a self-assessment instrument for radiation oncology departments, aiding them in evaluating their efficacy in ensuring patient safety, prioritising safety interventions and tracking performance over time. METHODS AND ANALYSIS: We are undertaking a 3-year, mixed methods study to address our objectives. For the identification of PSIs, we will conduct a comprehensive review on the PubMed database, along with reviewing national and international guidelines and recommendations. To refine the initial set of indicators, we will consult with experts, including physicians, medical physicists, nurses, administrators and radiation therapists through focus groups. We will employ a Delphi study for the final consensus and selection of indicators. Additionally, the perspectives of patients will be incorporated by formation of a project patient's committee which meets throughout the project phases. We will reformulate the identified PSIs into questionnaire items. The questionnaire's clarity and comprehensibility will be validated through cognitive interviews, followed by psychometric testing in a pilot group of over 150 participants from German radiation oncology departments. The final version of the questionnaire will then be implemented in routine healthcare settings and we will interview individual users about their experiences with the questionnaire in semistructured interviews. We will convene a subsequent expert workshop to discuss the study results and explore avenues for the questionnaire's broader implementation. The finalised questionnaire will be made accessible via a web app. We hereby present the study potocol as a pre-results report. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Hamburg Ethics Committee (Approval Number: 2023-101018-BO-ff). This trial is registered by the ARO (Arbeitsgemeinschaft Radioonkologie /working group for radiation oncology of the German Cancer Society), protocol number 2023-03 and in the German register for clinical trials with the number DRKS00034690. Study results will be published in conference papers and talks as well as journal papers with focus on open access journals. The results will be also disseminated during the implementation workshop in phase III, which will involve a diverse group of stakeholders. TRIAL REGISTRATION NUMBER: DRKS00034690.

Attitudes and experiences of cancer patients toward the provision of audio recordings of their own medical encounter: a cross-sectional online survey.

Background: The provision of audio recordings of their own medical encounters to patients, termed consultation recordings, has demonstrated promising benefits, particularly in addressing information needs of cancer patients. While this intervention has been explored globally, there is limited research specific to Germany. This study investigates the attitudes and experiences of cancer patients in Germany toward consultation recordings. Methods: We conducted a nationwide cross-sectional quantitative online survey, informed by semi-structured interviews with cancer patients. The survey assessed participants' attitudes, experiences and desire for consultation recordings in the future. The data was analyzed using descriptive statistics and subgroup analyses. Results: A total of 287 adult cancer patients participated. An overwhelming majority (92%) expressed a (very) positive attitude. Overall, participants strongly endorsed the anticipated benefits of the intervention, such as improved recall and enhanced understanding. Some participants expressed concerns that physicians might feel pressured and could become more reserved in their interactions with the use of such recordings. While a small proportion (5%) had prior experience with audio recording medical encounters, the majority (92%) expressed interest in having consultation recordings in the future. Discussion: We observed positive attitudes of cancer patients in Germany toward consultation recordings, paralleling international research findings. Despite limited experiences, participants acknowledged the potential benefits of the intervention, particularly related to recalling and comprehending information from medical encounters. Our findings suggest that the potential of the intervention is currently underutilized in German cancer care. While acknowledging the possibility of a positive bias in our results, we conclude that this study represents an initial exploration of the intervention's potential within the German cancer care context, laying the groundwork for its further evaluation.

Patient engagement in hematopoietic stem cell transplantation and cell therapy: a survey by the EBMT patient engagement task force & transplantation complications working party.

The EBMT (European Blood and Marrow Transplantation Society) aims to connect patients, the scientific community, and other stakeholders to improve hematopoietic stem cell transplantation and cellular therapy outcomes. We performed a cross-sectional online survey to understand the perceptions regarding Patient Reported Outcomes (PROs) and Patient Active Involvement in Research (PAIR) in over 800 stakeholders (n = 813). Patients (n = 278) and health care professionals (HCPs) (n = 351) were compared. We observed high openness for EBMT PRO collection (n = 680, 84.5% across stakeholders' groups; patients n = 256, 93.1% versus HCPs n = 273, 78.4% [p < 0.001]) and PAIR (n = 702, 87.3% across stakeholder groups; patients n = 256, 92.4% versus HCPs n = 296, 85.8% [p = 0.009]), with a significantly higher proportion of patients expressing interest compared to HCPs. Priority domains for PROs data-collection identified were the assessment of symptom experience, psychosocial and cognitive functioning. The most important issues for patients specifically were the data-collection of PROs reflecting cognitive function, the option of reporting data at home, the importance of identifying actionable targets to improve their recovery, and receiving feedback on their input when participating in research projects. Our multistakeholder approach suggests an added value to embracing patient engagement in the development of meaningful research and service design within the transplantation and cellular therapy community.

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.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Psycho-oncologists' experiences with video consultations during the Covid-19 pandemic and implications for the future-a multi-methods study.

OBJECTIVE: During the Covid-19 pandemic, there has been a substantial uptake of telemental health interventions. Consequently, the objective of this study was to assess psycho-oncologists' attitudes toward and experiences with video consultations (VC) since the beginning of the Covid-19 pandemic. Additionally, we sought to investigate psycho-oncologists' perspectives on the benefits and drawbacks of VC and its' potential implementation beyond the pandemic. METHODS: We used a multi-methods study design. First, semi-structured interviews with psycho-oncologists (N = 6) were conducted to inform the development of a cross-sectional online survey, which represented the quantitative part of our study. We invited psycho-oncologists, working in different settings, from all over Germany to participate. RESULTS: Data of N = 217 participants (88% female, 49% over 10 years work experience) of the online survey was analyzed. Psycho-oncologists' acceptance toward VC was average to high. In their daily practice, they preferred in-person consultations. Improved access to care and enhanced flexibility were seen as main advantages. The most significant disadvantages included technical issues, privacy concerns at home, loss of non-verbal cues and absence of physical presence for emotional support. Nevertheless, on average, psycho-oncologists wanted to continue seeing approximately 25% of their patients via VC in the future. CONCLUSIONS: Given the average to high acceptance of VC among psycho-oncologists and their desire to continue using VC flexibly even after the pandemic, it may be beneficial to implement VC into future psycho-oncology services. Still, future research should focus on the patients' perspective and the effectiveness of VC in psycho-oncology services.

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.

Conceptualization of patient-centered care in Latin America: A scoping review.

INTRODUCTION: Patient-centered care (PCC) has been declared as a desirable goal for health care in Latin American countries, but a coherent definition of what exactly PCC entails for clinical practice is missing. This article's aim was to identify how PCC is conceptualized in Latin American countries. METHODS: Scientific databases (MEDLINE, EMBASE, PsycINFO, CINAHL, Scielo, Scopus, Web of Science) and webpages of the ministries of health were searched, and experts were contacted for suggestions of literature. References were included if they contained one of a range of a priori defined keywords related to PCC in the title, were published between 2006 and 2021, and were carried out in or concerned Latin America. Definitions of PCC were extracted from the included articles and analyzed using deductive and inductive coding. Deductive coding was based on the integrative model of patient-centeredness, which unites the definitions of PCC in the international literature (mainly North America and Europe) and proposes 16 dimensions describing PCC. RESULTS: Thirty-two articles were included in the analysis and about half of them were from Brazil. Numerous similarities were found between the integrative model of patient-centeredness and the definitions of PCC given in the selected literature. The dimensions of the integrative model of patient-centeredness that were least and most prominent in the literature were physical support and patient information, respectively. A differentiation between PCC and family-centered care (FCC) was observed. Definitions of PCC and FCC as well as their cited references were diverse. CONCLUSION: A considerable overlap between the conceptualization of PCC in Latin America and the integrative model of patient-centeredness has been identified. However, there are substantial differences between countries in Latin America regarding the emphasis of research on PCC versus FCC and diverse conceptualizations of PCC and FCC exist. PATIENT CONTRIBUTION: This scoping review takes the patient's perspective based on the integrative model of patient-centeredness. Due to the study being a review, no patients, neither caregivers, nor members of the public, were involved.

Shared-Decision-Making Experiences in Breast Cancer Care with and without Patient Participation in Multidisciplinary Tumor Conferences: A Mixed-Methods-Study.

Purpose: This study aimed (1) to analyze patients' perceived shared decision-making (SDM) experiences over 4 weeks between patients participating or not in multidisciplinary tumor conferences (MTCs) and (2) to analyze the association of patients' active participation in and organizational variables of MTCs with patients' perceived SDM experience directly after MTC. Patients and Methods: From the N=317 patients, this observational study included patient surveys, observations, and audio transcripts from MTCs with (N=82) and without (N=145) patient participation in six breast and gynecologic cancer centers. We performed t tests for within- and between-group comparisons and linear regression with "patients' perceived SDM experiences in MTC" as the dependent variable. Results: Patients' perceived SDM experiences increased at 4 weeks after MTC (p<0.001) with lower perceived SDM experiences for participating versus nonparticipating patients (p<0.001). Linear regression showed that the organizational variable "round table seating arrangement" was significantly associated with higher perceived SDM experiences compared with a theater or U-shape arrangement (beta=-0.38, p=0.043; beta=-0.69, p=0.010) directly after MTC. Conclusion: Results provide first insights into patients' perceived SDM experiences in MTCs. SDM in MTCs is associated with organizational variables of MTCs. A round table seating arrangement in MTCs with patient participation seems important for patients' perceived SDM experiences. The relatively low perceived SDM experiences of participating patients directly after MTC indicates room for improvement, eg concerning patient-centered communication.

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.].

How shared is decision-making in multidisciplinary tumour conferences with patient participation? An observational study.

BACKGROUND: In some breast and gynaecologic cancer centres in Germany, patients participate in their own case discussion in multidisciplinary tumour conferences (MTCs), where treatment recommendations are discussed and finalized. However, the extent to which patients in MTCs are involved in decision-making on treatment recommendations remains largely unexplored. Hence, this study investigates how recommendations are communicated to patients and the extent to which the interactions with patients in MTCs are in line with shared decision-making (SDM). METHODS: In this observational study, we audio-recorded MTCs with patient participation in three breast and gynaecologic cancer centres in Germany. We qualitatively analysed the data with regard to content and linguistic aspects. RESULTS: We analysed 82 case discussions. Recommendations made during MTCs were regarding (i) treatment options, (ii) treatment initiation, (iii) next (treatment) steps and (iv) whether a treatment method should be initiated at all. The decision about recommendations depended in part on patients' preferences or further course/further outcomes. Although the purpose of MTCs is to provide recommendations, some recommendations were framed as the final decision. The majority of the decision-making conversation could be characterized as option talk (78%), during which patients were mostly proposed only one (treatment) option. CONCLUSIONS: This study establishes limited SDM in MTCs with patient participation. By indicating choices and thereby creating awareness of choices among patients, MTCs with patient participation could be used to foster SDM implementation. PATIENT OR PUBLIC CONTRIBUTION: Two representatives of a large self-help organization for patients with breast cancer assisted the research project, particularly, in discussing the results.

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.

Preference for shared decision-making among Arabic-speaking people with chronic diseases: a cross-sectional study.

OBJECTIVES: To assess Arabic-speaking patients' preference for involvement in decision-making in the United Arab Emirates (UAE) and characterise people who preferred involvement in decision-making. DESIGN: Cross-sectional quantitative study. The conduct and reporting of this research complied with Strengthening the Reporting of Observational Studies in Epidemiology guidelines for cross-sectional studies. SETTING: Participants were recruited from outpatient clinics of 10 major hospitals in four cities in the UAE: Abu Dhabi, Dubai, Sharjah and Umm al Quwain. PARTICIPANTS: Adult patients with at least one chronic disease completed a cross-sectional survey consisting of 37 items in six sections measuring variables that may influence preferred involvement in decision-making. These included health literacy, health status, unanswered questions about care and satisfaction with treatment decisions. Bivariate and multivariate analyses were performed to determine the predictors of patients' preferred involvement in decision-making. RESULTS: A total of 516 participants completed the survey. One-in-four participants preferred shared decision-making. Preferred involvement in decision-making was more frequent among women, not married, unemployed, people who rarely/never had unanswered questions and participants with anxiety/depression symptoms. After adjustment, not being married (OR=1.634; 95% CI 1.049 to 2.544) remained as a predictor of preferred involvement in decision-making, while having unanswered questions (OR=0.612; 95% CI 0.393 to 0.954) and problems in self-care were predictors of a preference for paternalistic decision-making (OR=0.423; 95% CI 0.181 to 0.993). CONCLUSIONS: Contrary to the results from Western countries, this study showed that a majority of Arabic-speaking patients with chronic diseases preferred a paternalistic decision-making model. At the same time, some subgroups of Arabic-speaking people (eg, women, unemployed patients) had a higher preference for participation in decision-making. Physicians' support and changes in healthcare systems are required to foster Arabic-speaking patients' involvement in treatment decision-making process.

Shared decision-making in routine breast cancer care in Germany-A cross-sectional study.

OBJECTIVE: Many preference-sensitive decisions have to be made in breast cancer care and little is known about the decision-making processes between breast cancer patients and the different health care professionals engaged in their treatment. METHODS: All female breast cancer patients who underwent surgery in four German breast centers between 07/2016 and 12/2018 were invited to fill in a survey. The decision-making process was evaluated using the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and a German measure to assess satisfaction with care (ZAPA). The higher the total score (0-100), the higher the experienced degree of participation and satisfaction, respectively. Participants were asked to separately rate consultations with their inpatient hospital doctors, outpatient gynecologists, outpatient oncologists and primary care providers. An overall mean score for the degree of participation and the satisfaction with care was calculated for each patient across all consultations assessed. Differences between the 4 treating physician groups were analyzed as well. RESULTS: Of 1068 approached patients, 563 with a mean age of 62 and a standard deviation (SD) of 12.2 years filled in the survey (response rate: 53%). The overall SDM-Q-9 score was 73.8 (SD: 20.8). Older patients stated a higher level of participation than younger, different physician groups were rated quite similarly. Overall satisfaction with care was 87.4 (SD: 15.5). CONCLUSIONS: Overall, patients reported to have experienced a high level of shared decision-making (SDM) and were quite satisfied with their treatment. However, we do not know whether non-responders might have had different experiences.

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.