Introduction The number of people with peripheral arterial disease (PAD) increased by almost 25% between 2000 and 2010. The economic burden on healthcare systems caused by PAD will continue to rise because of the aging population and a further increase in risk factors. The aim of the study was to examine the cost-effectiveness of the 12-month patient-centered ‘Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease’ (TeGeCoach) program in a randomized controlled trial. Methods This is a cost-effectiveness analysis based on a two-arm, parallel-group, open-label, pragmatic, randomized-controlled clinical trial conducted by three German statutory health insurance funds with follow-up assessments after 12 and 24 months. Claims data for the calculation of costs and questionnaire data for the quantification of quality-adjusted life years (QALYs) based on the EQ5D-5L were used. From a healthcare payer’s perspective, cost-effectiveness was examined over 24 months follow-up using intention-to-treat (ITT) and modified ITT (mITT) and per protocol (PP) approaches. Results Assuming intervention costs of €672, the point estimates for the ITT analysis over 24 months showed non-significantly higher costs in the IG of €2003 and non-significantly higher QALYs of 0.02 compared to the control group. At a willingness to pay (WTP) threshold of €50,000, the probability of the TeGeCoach being cost-effective was 30%. Under the same assumptions, the mITT and the PP approach resulted in probabilities for cost-effectiveness of 79% and, 95%, respectively. Conclusion As demonstrated by the PP- and mITT-analysis, the treatment of PAD by TeGeCoach might be cost-effective under favorable assumptions. However, applying the stricter criteria represented by the ITT scenario, TeGeCoach couldn’t demonstrate its cost-effectiveness. Therefore, before TeGeCoach should be used in healthcare practice, it is necessary to adapt the program implementation. The effectiveness of these adjustments should then be verified in further studies.

Background. The 9-item Shared Decision Making Questionnaire (SDM-Q-9) is widely used to measure shared decision-making (SDM) across clinical settings, but no study so far has synthesized its psychometric properties. Purpose. We systematically reviewed and synthesized psychometric evidence of the SDM-Q-9. Data Sources. MEDLINE, Web of Science, PsycInfo, and CINAHL. Study Selection. Original studies in English or German, providing any information on psychometric properties of the SDM-Q-9 considering all possible interpretations and constructs measured by the instrument. Data Extraction. Details on study design, sample characteristics, and any information on psychometric evidence were extracted. Data Synthesis. 83 studies were included, with 73 articles contributing evidence on validity, 46 on reliability, and 3 on fairness. We found a high amount of psychometric evidence on validity and reliability of the SDM-Q-9, interpreting the score as SDM perceived by the patient. Evidence is lacking for other interpretations and fairness. Notable is the weak association of the SDM-Q-9 with physician-rated SDM. Conclusions. The SDM-Q-9 is highly reliable and valid for the subjectively experienced level of SDM by the patient. Further research is needed on alternative interpretations, and on fairness of the measure.

Background:Demoralization negatively affects the quality of life, especially in people with mental disorders. Objective:This study aims to assess demoralization in a cohort of community-dwelling older adults, to identify groups of individuals who share similar characteristics in terms of mental health conditions and the severity of demoralization domains, and to investigate the different characteristics across these groups. Methods:Participants were enrolled in 3 centers as part of the cross-sectional MentDis_ICF65+ study and were assessed using the Demoralization Scale and the Composite International Diagnostic Interview at baseline. A cluster analysis was conducted using the partitioning around medoids algorithm with Gower's distance to classify individuals based on demoralization severity and the diagnosis of mental health disorders, allocating individuals to a distinct number of patterns by examining their similarities across these variables. Results:Among the final sample of 1369 participants, 3 clusters were identified: the "low psychopathology" cluster, with very few mental health diagnoses; the "affective" cluster, characterized by affective disorders (100% of participants); and the "anxiety" cluster, characterized by anxiety disorders (100% of participants). Men were prevalent in the "low psychopathology" cluster (n=635, 59.1%; P<.001), while women were more prevalent in the "affective" cluster (n=133, 72.3%; P<.001) and the "anxiety" cluster (n=79, 71.8%; P<.001). The "affective" cluster had the highest mean scores for disheartenment (17.1, SD 6.7; P<.001), dysphoria (12.1, SD 3.5; P<.001), and loss of meaning (11.8, SD 4.9; P<.001) but the lowest for sense of failure (17.4, SD 3.2; P<.001). Conclusions:The identification of different clusters of demoralization and mental health disorders in community-dwelling older adults, as well as sex-based differences, highlights the need for tailored mental health interventions in this vulnerable population.

Introduction Healthcare workers (HCWs) have been disproportionately affected by the COVID-19 pandemic, both as carers and as patients. Many individuals developed persistent symptoms following an acute SARS-CoV-2 infection, known as post-COVID-19 syndrome (PCS). Previous research indicates that a significant proportion of HCWs experience long-lasting and debilitating symptoms of PCS. The aim of this study is to investigate the longitudinal symptom burden as well as the care pathways and treatment experiences of PCS-affected HCWs insured by the German Social Accident Insurance Institution for Health and Welfare. Methods and analysis The study uses a mixed-methods approach. The longitudinal survey will extend a cohort study of n=2436 HCWs (started in 2023) affected by PCS, adding two measurement points, set in 2025 (T 3 ) and 2026 (T 4 ). Additionally, interviews on care pathways and treatment experiences will be conducted with a subsample of n=60 PCS-affected HCWs. Another subsample of n=30 HCWs will be asked to participate in ecological momentary assessments of symptom burden, emotional well-being and coping strategies. Analyses of routinely collected data by the insurance company will complement the study data. The study is supported by an advisory board comprising PCS-affected HCWs who assist with the content of both qualitative and quantitative surveys. Ethics and dissemination This study was approved by the Local Ethics Committee of the University Medical Center Hamburg-Eppendorf, Germany (LPEK-0909, 1 May 2025; amendment: LPEK-0954, 18 September 2025). The results of the study will be presented at conferences and published in peer-reviewed journals. Registration details https://drks.de/search/de/trial/DRKS00035957

OBJECTIVE:This study aimed to evaluate the effectiveness of a needs-based communication skills training designed to foster patient-centered communication among nursing professionals. METHODS:We conducted a randomized controlled trial with a waitlist-control group at three hospitals in Hamburg, Germany. Data were collected at three time points. Primary outcome was self-efficacy in communication with patients directly after training participation. Secondary outcomes included training evaluation (intervention group only), knowledge about patient-centered communication, attitudes towards communication, communication behavior and health- and work-related distress. Data analyses employed mixed-model analyses, Chi²-test, and descriptive statistics. RESULTS:157 nursing professionals participated in the study, with 136 (87%) being female. Regarding the primary outcome, self-efficacy in communication with patients, the intervention group showed statistically significant post-training improvements compared to waitlist-control (Estimated Marginal Mean Difference -10.00, p < .001, d=0.81). Statistically significant post-training improvements were also observed for the secondary outcomes, subjective communication knowledge (p.001) and attitudes toward communication (p < .039). Additionally, participants rated the training as highly positive. CONCLUSION:To our knowledge, this is the first study to develop and evaluate a needs-based patient-centered communication skills training for nursing professionals in Germany. We found that the intervention had statistically significant effects on the participants' self-efficacy, subjective knowledge, and attitudes towards communication, while effects on other secondary outcomes were limited. Further research is needed to assess impact on other outcomes, such as participants' communication behavior and health- and work-related distress. PRACTICE IMPLICATIONS:Participation in a needs-based communication skills training is a promising way to improve patient-centered care by enhancing nursing professionals' communication skills.

ABSTRACT Background Communication skills training can enhance nursing professionals' patient‐centered communication skills, fostering positive health outcomes for both patients and nursing professionals. Understanding experiences and preferences of the target group is crucial when developing a specific communication skills training. Thus, it is essential to involve not only nurses but also nurse managers in the training development, as they offer a comprehensive overview of communication challenges experienced by nursing staff. Aim This study aimed to explore nurse managers' perspectives on essential content for developing a patient‐centered communication skills training. Design Qualitative study using semi‐structured interviews. Method We conducted interviews with nurse managers working at an academic medical center in Germany. Transcripts of audio‐recorded interviews were analysed using Kuckatz's qualitative content analysis. Results N = 18 nurse managers from various medical disciplines such as gynaecology, psychiatry, paediatrics, and neurology participated in the study. Participants identified enhancing general communication skills and strategies such as showing empathy and applying tailored communication, addressing communication challenges with patients, fostering professional self‐awareness, communication with relatives, and navigating culturally sensitive communication as potential content of a future patient‐centered communication skills training. Conclusion Nurse managers identified several communication aspects which should be included in a communication skills training, with many findings resembling those from international studies on communication in nursing care. However, our results are not limited to specific medical disciplines such as intensive care or oncology. Overall, these findings demonstrate that nurse managers are aware of nurses' communication challenges and needs and are willing to support efforts to improve their communication skills. Reporting Method No Patient or Public Contribution.

COVID-19 can result in long-term impairments, including cognitive difficulties and restrictions in social participation, which may not be fully captured by EQ-5D-5L. This study examined whether adding cognition (CO) and social participation (SP) bolt-ons improves EQ-5D-5L’s measurement properties in German healthcare workers (HCW) with SARS-CoV-2 infection. N = 3335 HCW with self-reported occupational COVID-19 completed an online survey including EQ-5D-5L, two candidate bolt-ons (CO, SP), and validated self-report instruments (e.g., Post-COVID Syndrome PCS-Score, PHQ-4, PTSD screening, SSD-12, WAI, WHODAS). Psychometric analyses covered distributional characteristics (response pattern, missing values, ceiling), construct (convergent and divergent) validity, known-groups validity, and explanatory power. Both bolt-ons showed acceptable distributional properties; adding CO modestly reduced overall ceiling effect, while adding SP resulted in negligible change (‘11111’ = 18.8

Abstract Background As improvements in anti-cancer treatments have extended survival, patients with advanced cancer and their family caregivers face existential tension between engaging in life and coping with uncertainty about illness trajectory and the course of treatment. For a subgroup, this tension is associated with overwhelming fear and existential distress. Such adjustment difficulties may increase the risk of mental disorders, poor quality of life, and suicidality, and impair prognostic awareness and patient-clinician communication. Despite growing interest in open conversations about end-of-life issues, systematic evidence on effective psychotherapies to best support psychological adaptation in patients with high levels of existential distress is still scarce. We aim to evaluate the effectiveness of a short-term psychodynamic therapy (ORPHYS) to mitigate existential distress compared to usual psycho-oncological treatment (TAU). Methods We conduct a two-arm parallel randomized controlled trial with an active control group. ORPHYS is a manualized individual face-to-face psychotherapy focusing on emotional and relational conflicts specific to cancer patients’ illness situation. Treatment lasts between 5 and 11 months with 15 to 31 weekly sessions (50 min). TAU includes at least one individual session provided by physicians or psychologists with experience in psycho-oncological care. Patients will be assessed pre-intervention and 3, 6, 9, and 12 months after baseline. Target sample size is 160 randomized participants. We recruit patients with stage III/IV solid tumors or advanced hematological cancer and clinically significant existential distress from psycho-oncology clinics and referring oncologists at Hamburg, Düsseldorf, and Würzburg Comprehensive Cancer Centers, Germany. The primary outcome is demoralization (Demoralization Scale-II). Secondary outcomes include diagnoses of affective, anxiety and stress-related disorders, death anxiety, dignity-related distress, and quality of life. Outcome assessments are conducted via self-report questionnaires and diagnostic interviews. Linear mixed models examine outcome differences between trial arms. A confirmatory test of the group contrast at 6-month follow-up after baseline is conducted. Discussion Due to an aging population and prolonged survival, there is a growing demand to help patients deal with existential challenges undergoing palliative cancer care. The study will contribute to knowledge about how clinicians can best help patients with advanced cancer who substantially struggle with uncertainty at the end of life. Trial registration German Clinical Trials Registry, DRKS00038173. Registered October 20th, 2025, https://drks.de/search/en/trial/DRKS00038173 . ClinicalTrials.gov, NCT07312760. Registered December 30, 2025, https://clinicaltrials.gov/study/NCT07312760 .

Health services research faces the challenge of providing sound recommendations for action for the further development of health systems and care. The application of causal inference methods offers health services researchers an excellent opportunity to identify causal relationships under everyday conditions. The role of clinical trials with a classic randomised controlled trial (RCT) design is recognised as suitable for gaining insights that help establish causal inference, but other methodological approaches to generating evidence also play an important role in health services research.The discussion paper presents key concepts and assumptions of causal inference and highlights their relevance for health services research. The paper makes it clear that in order to fulfil the assumptions, it is necessary to integrate theory, contextual knowledge, understanding of mechanisms and formal concepts, such as directed acyclic graphs (DAGs), into a suitable empirical study design. To this end, RCTs, quasi-experimental methods, causal machine learning, target trial emulation, in silico trials and the mixed-methods approach of integrated inference are presented and discussed in terms of their applicability in health services research and their internal and external validity.All of the approaches presented here can contribute to the estimation of causal effects when used in a targeted manner and in accordance with the central assumptions. Their suitability depends largely on the research question, data quality, theoretical modelling and contextual knowledge. The combination of complementary designs and high quality data sources can increase the robustness of causal conclusions.Causal inference in health services research is not only a methodological procedure, but an integrative process that systematically combines theory, methodology and contextual knowledge. By consistently linking these aspects, health services research can generate differentiated and actionable insights that go beyond correlative analyses and enable an understanding of the mechanisms of causal processes. This can lead, for example, to evidence-supported recommendations that critically examine the often non-evidence-based status quo and reliably evaluate the benefits of new models.

Abstract Background Diversity is essential in higher education, particularly in health-related programs (e.g., medicine, psychology, and other health professions). Inclusive and non-discriminatory learning environments are crucial for promoting equity and preparing future health care professionals to care for diverse populations. However, empirical evidence on students’ perceptions of diversity in German universities remains limited. This study aimed to 1) assess students’ perceptions of the diversity climate in their health-related degree programs and university contexts and 2) examine differences in psychosocial and academic variables between students with and without experiences of discrimination. Methods A national cross-sectional online survey was conducted between January and April 2024 among students in health-related degree programs at German universities. Measures included sociodemographic and educational characteristics, students’ perceptions of diversity climate (across three dimensions: age, ethnicity, gender), experiences of discrimination, diversity- and equity-oriented beliefs, sense of belonging to the university, study engagement, general and academic self-efficacy, and general and study-related stress. Descriptive analyses were conducted as well as independent t-tests to examine differences between groups. Results A total of 987 students from 83 universities across all 16 federal states participated. Students’ perceptions of the diversity climate were moderately to highly positive across age (M = 3.91/5, SD = .59), ethnicity (M = 3.63/5, SD = .65), and gender (M = 3.83/5, SD = .59). While the majority reported no personal discrimination at their university, 28% experienced discrimination within the past two years, most commonly due to gender (42%), physical appearance (23%), mental health (20%), or racial reasons (13%). Additionally, 45% had witnessed discrimination. Students with personal experiences of discrimination reported significantly less positive perceptions of the diversity climate, lower academic self-efficacy, study engagement, and sense of belonging at the university, higher stress, and stronger diversity- and equity-oriented beliefs. Across the full sample, 61% indicated that teaching materials do not adequately represent diverse groups, and 50% perceived lecturers as insufficiently responsive to discrimination. Conclusion Despite generally positive attitudes toward diversity, the students' high rates of experiences of discrimination and their associations with psychosocial and academic variables highlight the need for systematic efforts to promote inclusive learning environments. Targeted interventions, such as diversity training for staff and students, improved representation in teaching materials and curricula, and stronger institutional policies, are essential to promote equity and well-being in health-related education. By using a nationwide scope, focusing on health-related degree programs, and conducting a multidimensional assessment of students’ perceptions of diversity climate, this study offers important evidence to inform such efforts and addresses a notable gap in the literature.

BACKGROUND:Hospital-wide mortality review processes are increasingly used to analyze inpatient deaths and identify opportunities to improve patient safety. This study evaluated the feasibility of developing and implementing such a mortality review in a German academic medical center. METHODS:We developed a mortality review checklist based on the Harvard Mortality Review and conducted a pilot test to assess its usability and integration into clinical systems (stage 1). Findings from the pilot phase informed revisions to the checklist and review processes. The adapted checklist was then implemented hospital-wide over 12 months (stage 2). Implementation was evaluated using a multifaceted approach that included clinical and administrative data and an assessment of key barriers and facilitators. RESULTS:During implementation, attending physicians (review 1a) and project clinical risk managers (review 1b) were invited to review 1303 inpatient deaths. Physicians completed 482 reviews (36.99%), rating 21 deaths (4.3%) as potentially preventable. Project clinical risk managers completed reviews for all cases and identified 33 deaths (2.5%) as potentially preventable. Nosocomial infections were the most frequent complication identified in both reviews (Review 1a: 35.02%; Review 1b: 32.92%; κ=0.260). Agreement between physician and risk manager assessments ranged from poor to substantial across checklist sections with particularly low agreement for preventability ratings. Twenty interviews with physicians and project staff identified key barriers to implementing the mortality review, including limited physician resources, redundant documentation, lack of automation, and liability concerns, while perceived usefulness and usability of the review were rated high. CONCLUSIONS:Implementation of a hospital-wide mortality review checklist and associated processes was feasible but constraint by organizational barriers. Although physicians and clinical risk managers identified potentially preventable deaths, inter-rater agreement was low. Sustainable integration into routine care will require substantial adaptations to clinical workflows and organizational structures. As part of a broader patient safety efforts, structured mortality review processes may support learning from inpatient deaths.

KEY POINTS:Kidney function (GFR) correlated with somatic symptom burden bivariately, but not in the multiple regression model. Female sex, coronary heart disease, self-reported general health, proneness to illness, and depressive symptoms correlated with symptom burden. Similar biopsychosocial correlates of symptom burden were observed in individuals with CKD, coronary heart disease, and controls. BACKGROUND:Persistent somatic symptoms in individuals with CKD occur across all stages and affect patients' quality of life, morbidity, and mortality. We aimed to unravel associations between biopsychosocial factors and symptom burden in individuals with CKD. METHODS:This cross-sectional study analyzed individuals with CKD (eGFR <60 ml/min per 1.73 m 2 ) from the first 10,000 participants of the population-based Hamburg City Health Study. Somatic symptom burden (Patient Health Questionnaire-15) was the primary outcome. Its association with potential biologic ( e.g ., eGFR), psychologic ( e.g ., depressive symptoms), and sociodemographic correlates was analyzed in a multivariate prediction model. Correlates were compared with healthy controls and individuals with coronary heart disease (CHD). RESULTS:Somatic symptom burden in patients with non-dialysis CKD ( n =582, mean age: 69.58 years; 44.7% women; mean baseline eGFR: 52 ml/min per 1.73 m 2 ) increased with lower eGFR ( r =-0.161, P < 0.001). However, in a stepwise multiple linear regression model, eGFR was not correlated with symptom burden. By contrast, female sex, CHD, self-reported general health, proneness to illness, and depressive symptoms were associated with somatic symptom burden. Correlates of somatic symptom burden were compared with those in patients with CHD ( n =618, mean age: 67.13 years; 24.1% women; mean baseline eGFR: 81 ml/min per 1.73 m 2 ) and matched healthy controls ( n =582, mean age: 69.58 years; 44.7% women; mean baseline eGFR: 81 ml/min per 1.73 m 2 ). Self-reported general health and depression were associated with somatic symptom burden in all groups, while there were specific correlates in the CHD ( e.g ., age) and the healthy control group ( e.g ., expectancy of deterioration of health status). CONCLUSIONS:Somatic symptom burden in CKD was only marginally related to the eGFR but rather to biopsychosocial factors. Therefore, taking a biopsychosocial perspective on persistent somatic symptom in CKD is important. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER:Biopsychosocial correlates of somatic symptom burden in patients with CKD from the Hamburg City Health Study, 10.17605/OSF.IO/58S2R.

Abstract: The 9-item Shared Decision Making Questionnaire (SDM-Q-9) is widely used to measure shared decision-making (SDM) across clinical settings, but no study so far has synthesized its psychometric properties. In the present study, we systematically reviewed and synthesized psychometric evidence on the SDM-Q-9. The MEDLINE, Web of Science, PsycInfo, and CINAHL databases were searched for original studies in English or German, providing any information on psychometric properties of the SDM-Q-9 considering all possible interpretations and constructs measured by the instrument. Details on study design, sample characteristics, and information on psychometric evidence were extracted. We included 101 studies, with 49 articles contributing evidence on reliability, 91 on validity (87 on interrelations with other variables and 68 on the internal structure), and three on fairness. We found a high amount of psychometric evidence on the validity and reliability of the SDM-Q-9 as a measure of SDM perceived by the patient. Evidence is lacking for other interpretations and fairness. Notable is the weak association of the SDM-Q-9 with physician-rated SDM. In summary, substantial evidence supports reliability and validity of the SDM-Q-9 for assessing the subjectively experienced level of SDM by the patient, but further research is needed on alternative interpretations and on fairness of the measure.

Background: Attitudes toward medical communication play a crucial role in shaping nursing professionals' communication behavior. To date, there is no German measure that assesses attitudes towards communication in nursing professionals.Objective: The aims were (a) to translate and adapt the Attitudes Towards Medical Communication Scale for nursing professionals, and (b) to perform a preliminary evaluation of its psychometric properties.Design: We conducted a mixed-methods study.Methods: First, the 12-item measure was translated and adapted following the TRAPD team translation protocol. Then, data for psychometric testing were collected via an online survey involving nursing professionals from Germany working in clinical settings. We assessed item characteristics (e.g. corrected item-total-correlations, inter-item correlations, item difficulty), construct validity through confirmatory factor analysis and testing correlation with self-efficacy regarding clinical communication (hypothesizing a moderate correlation between r = 0.3 and r = 0.5), and internal consistency using McDonald's Omega.Results: The translation and adaptation process resulted in the Attitudes Towards Medical Communication Scale - German version for nursing professionals. N = 173 nursing professionals participated in the online survey. Due to low variance and/or low factor loadings as well as uncertainties about the match between the items' content and the construct of attitudes toward medical communication, we removed three items. The 9-item version yielded inconsistent results for model fit of our data (CFI = 0.91, TLI = 0.87, RMSEA = 0.11; factor loadings <0.4). Subsequent analysis demonstrated a moderate correlation with self-efficacy regarding clinical communication (r = 0.38) and adequate internal consistency (ω = 0.76).Conclusion: To our knowledge, the Attitudes Towards Medical Communication Scale - German version for nursing professionals is the first German measure assessing attitudes toward medical communication. Given the inadequate results regarding item characteristics and psychometric properties, further research is needed. This should include further exploration of the corresponding construct for the target group, as well as refinement of existing items or the addition of new ones.

Abstract:The impact of climate change on human health, healthcare, and health systems constitute one of the most pressing challenges of our time. In response, this position paper outlines perspectives, strategic approaches, and potential solutions aimed at fostering a climate-resilient and low-carbon healthcare sector. It was developed in collaboration with representatives from scientific societies, working groups, professional associations, and institutions with a dedicated expertise on the topic and was the subject of extensive interdisciplinary dialogue. This position paper reflects the outcome of a broad consensus-building process involving stakeholders from diverse academic and professional backgrounds. While it does not claim to be exhaustive, it represents the current state of discussions. The paper addresses six central topics: (1) Transformative research, (2) Research funding and research networking, (3) Data access and linkage, (4) Education and information opportunities, (5) Prevention, mitigation, and adaptation, as well as (6) Sustainability and climate neutrality in the health and research sector. The position paper advocates for intensified collaboration, courage and willingness to make decisions on the part of the scientific community, policymakers, and civil society to develop a future-proof and resilient healthcare system capable of withstanding the multifaceted challenges posed by climate change. This position paper is intended as a foundation for ongoing discourse and the development of concrete policy and practice-oriented strategies to enhance climate resilience and sustainability in health systems over the long term.

Abstract Background and aims Despite numerous trials, the optimal design of stroke aftercare programs remains unclear. The StroCare trial evaluated a structured, transitional and follow-up care program to improve health-related quality of life (HRQoL) up to 2 years after stroke but found no overall intervention effect. This post-hoc analysis explored whether treatment effects differed across patient characteristics. Methods At 12 and 24 months we fitted timepoint-specific linear regression models for PROMIS-10 Global Physical Health T-scores including interaction terms between treatment group and covariates prespecified in the main analysis. Interactions were examined individually and jointly in the intention-to-treat population using multiple imputation with pooled estimates for missing data, analogous to the main analysis. Results Pre-existing care level was strongly associated with worse HRQoL at 12 (ß=-3.8; p<0.0001) and 24 months (ß=-3.8; p<0.0001). Single-interaction models indicated a stronger attenuation of this negative association in the intervention group at 12 months (group x care level ß=2.4; p=0.03) and a similarly directed but weaker trend at 24 months (ß=2.0; p=0.066). In the full interaction model, this interaction was weaker (12 months: ß=2.2; p=0.058; 24 months: ß=1.7; p=0.13). No other covariates showed relevant effect moderation. Conclusions Given the post-hoc design and small proportion of patients with higher care levels in the study population, these results should be interpreted as hypothesis-generating. However, they suggest that structured aftercare programs may confer greater benefit in more dependent stroke survivors, a subpopulation underrepresented in aftercare trials. We therefore deem the targeted evaluation of such programs in this subpopulation in future trials warranted. Conflict of interest Bourry, Rafael: Nothing to disclose; Petter, Jonas: Nothing to disclose; Schrage, Theresa: Nothing to disclose; Molder, Janina: Nothing to disclose; Boskamp, Stefan: Nothing to disclose; Härter, Martin: Sourced funding with the Innovation Fund of the German Federal Joint Committee; Rosenkranz, Michael: Nothing to disclose; Schmidt, Holger: Nothing to disclose; Beisel, Andreas: Nothing to Disclose; Dams, Judith: Nothing to Disclose; König, Hans-Helmut: Nothing to disclose; Kriston, Levente: Sourced funding with the Innovation Fund of the German Federal Joint Committee; Thomalla, Götz: Sourced funding with the Innovation Fund of the German Federal Joint Committee

Patient decision aids (PDAs) are evidence informed tools designed to support patients in the process of making decisions about their health. The International Patient Decision Aid Standards (IPDAS) Collaboration last updated the standards in 2013 and the evidence about patient decision aids has expanded substantially. In this article, we report on an update to IPDAS that used a modified Delphi process with two rounds of voting to reach consensus on evidence informed changes to the criteria. The 202 participants were from 26 countries, and included patients/consumers, policy makers, researchers, and clinician researchers. IPDAS 5.0 includes seven qualifying criteria (necessary to be a patient decision aid), 10 essential criteria (necessary to reduce biased decisions), and 54 enhancing criteria (additional criteria that might improve the quality of a patient decision aid). The updated standards reflect the IPDAS Collaboration's founding goal of providing high quality patient decision aids for patients that minimise potential biases in the decisions made about potential healthcare options.