[Patient safety in the Innovation Fund - Characterization, results and evaluation of completed projects: Results of a scoping review]. / Patientensicherheit im Innovationsfonds ­ Charakterisierung, Resultate und Bewertung abgeschlossener Projekte: Ergebnisse eines Scoping Reviews.

The German Innovation Fund has funded various studies on patient safety. Their thematic spectrum, methodological quality, results and recommendations of the Innovation committee were to be systematically investigated in order to derive proposals for optimizing transfer success. As part of a scoping review, all Innovation Fund projects funded in the period 2016-02/2023 with a focus on patient safety were analyzed. Each included study document was critically reviewed by two independent persons. The 16 included projects addressed a wide range of populations, indications and interventions. The study quality was mostly good. The results ranged from feasible indicator sets and the prevention of adverse drug reactions to the optimization of error management. For seven projects, the Innovation Committee recommended forwarding the results to healthcare institutions with the request that they take note and/or examine the feasibility of implementation in standard care. Implementation, however, has not yet taken place. In order to facilitate implementation, the joint development of an implementation strategy by the recipients of the Innovation Committee's recommendations is necessary.

[Experts' perspectives on the need and potentials of (cross-indication) mobile rehabilitation in the care of younger people with complex health impairments: A qualitative study]. / Expert*innensichtweisen zum Bedarf und zu den Potenzialen (indikationsübergreifender) mobiler Rehabilitation in der Versorgung jüngerer Menschen mit komplexen gesundheitlichen Beeinträchtigungen: eine qualitative Studie.

INTRODUCTION: In the German rehabilitation system, gaps in care exist that particularly affect people with complex impairments under 60 years of age. Home-based rehabilitation, an outreach form of outpatient rehabilitation, could bridge this gap by providing access to rehabilitation for this group of patients. Corresponding facilities so far barely exist in Germany. In view of the likely complexity and the associated problems of this group of people, needs-based care may also require a cross-indication approach in order to adequately address rehabilitation needs across different organ systems. The aim of this study is to assess 1) the general need for home-based rehabilitation and associated potentials, 2) attitudes towards a cross-indication approach, and 3) indication and allocation criteria for this approach from an expert perspective. METHODS: Data was collected from 08/2022 to 10/2022 through semi-structured individual telephone interviews with experts in the field of rehabilitation. Data were analyzed using qualitative content analysis according to Kuckartz and Rädiker. RESULTS: A total of n = 22 experts were interviewed. The experts see a high need for home-based rehabilitation for people with complex health impairments under the age of 60 in order to counteract existing care gaps within current rehabilitative offers. The potentials offered by home-based rehabilitation include, amongst others, flexibility, participation orientation and involvement of the social environment (e.g., of relatives). A cross-indication approach is considered relevant by the majority of the experts, especially in order to meet more complex needs (e.g., in the case of multimorbidity) in a holistic and needs-based manner. CONCLUSION: The results demonstrate the relevance of this topic and the necessity of expanding (cross-indication) home-based rehabilitation in Germany. According to the experts, (cross-indication) home-based rehabilitation can help to ensure the participation of a group of patients with complex and severe impairments under the age of 60.

[DemStepCare: Risk-stratified support for primary care-based dementia care - evaluation from general practitioner's view]. / DemStepCare: Risikostratifizierte Unterstützung der ambulanten Demenzversorgung ­ Bewertung aus hausärztlicher Perspektive.

OBJECTIVE: The innovation fund project DemStepCare aimed to optimize multi-professional care through case management, risk stratification, and crisis outpatient clinic. Here, the evaluation results from the perspective of the general practitioners are presented. METHODS: A quantitative survey was carried out at three time points regarding acceptance, benefit assessment and sensitivity to dementia of the general practitioners. In addition, qualitative interviews were conducted. RESULTS: Satisfaction with the overall project was high. Added value and relief factors were perceived and more effective and stable dementia care was achieved through collaboration with case management. Physicians reported increased subjective competence in diagnostics and disease management. CONCLUSIONS: The results confirm the benefit and effectiveness of DemStepCare from general practitioner's perspective.

Trans-Inclusive Communication and Self-Perceived Barriers to It, as Reported by Doctors-A Mixed-Methods Survey in Germany.

The majority of transgender and gender-nonconforming people (TGNC) report negative experiences with doctors in the healthcare system. As there is little knowledge about the communication behaviour of doctors towards TGNC, this survey aimed to assess the self-reported trans-inclusive communication of doctors and their willingness to communicate trans-inclusively, as well as their self-perceived barriers to it. A mixed-methods survey was applied for this. Firstly, we measured self-reported trans-inclusive communication behaviour based on the CommTrans questionnaire. Based on this, the overall willingness, as well as self-perceived barriers (qualitative) to communication, were assessed. In total, N = 57 doctors took part in the survey. Most participants reported not introducing themselves using pronouns (79.4%). Of these, 61.4% said that they would not be able to do this in the future either. Perceived barriers were classified into the following eight categories: necessity, sample-dependency, habit, structural barriers in practice, uncertainties in dealing with the topic, limits of patient-centredness, gender as a binary concept, and transphobia. In summary, doctors in Germany show different degrees of trans-inclusive communication. It is likely that this has a negative effect on TGNC, their health and access to the healthcare system.

Correction: Identification of Anterior Large Vessel Occlusion Stroke During the Emergency Call: Protocol for a Controlled, Nonrandomized Trial.

[This corrects the article DOI: 10.2196/51683.].

The non-paretic-hand-to-opposite-ear test: A simple test to detect aphasia and neglect and an indicator of large anterior vessel occlusion in patients with suspected acute stroke.

INTRODUCTION: Aphasia and neglect in combination with hemiparesis are reliable indicators of large anterior vessel occlusion (LAVO). Prehospital identification of these symptoms is generally considered difficult by emergency medical service (EMS) personnel. Therefore, we evaluated the simple non-paretic-hand-to-opposite-ear (NPE) test to identify aphasia and neglect with a single test. As the NPE test includes a test for arm paresis, we also evaluated the diagnostic ability of the NPE test to detect LAVO in patients with suspected stroke. METHODS: In this prospective observational study, we performed the NPE test in 1042 patients with suspected acute stroke between May 2021 and May 2022. We analyzed the correlation between the NPE test and the aphasia/neglect items of the National Institutes of Health Stroke Scale. Additionally, the predictive values of the NPE test for LAVO detection were calculated. RESULTS: The NPE test showed a strong, significant correlation with both aphasia and neglect. A positive NPE test result predicted LAVO with a sensitivity of 0.70, a specificity of 0.88, and an accuracy of 0.85. Logistic regression analysis showed an odds ratio of 16.14 (95% confidence interval 10.82-24.44) for predicting LAVO. CONCLUSION: The NPE test is a simple test for the detection of both aphasia and neglect. With its predictive values for LAVO detection being comparable to the results of LAVO scores in the prehospital setting, this simple test might be a promising test for prehospital LAVO detection by EMS personnel. Further prospective prehospital validation is needed.

Impact of a complex health services intervention in long-term care nursing homes on 3-year overall survival: results from the CoCare study.

BACKGROUND: The Coordinated medical Care (CoCare) project aimed to improve the quality of medical care in nursing homes by optimizing collaboration between nurses and physicians. We analyze the impact of the CoCare intervention on overall survival. METHODS: The effect of time-varying treatment on 3-year overall survival was analyzed with treatment as time-varying covariate within the entire cohort. To reduce bias due to non-random assignment to treatment groups, regression adjustment was applied. Therefore, age, sex, and level of care were used as potential confounders. RESULTS: The study population consisted of 8,893 nursing home residents (NHRs), of which 1,330 participated in the CoCare intervention. The three-year overall survival was 49.8% in the entire cohort. NHRs receiving the intervention were associated with a higher survival probability compared to NHRs of the control group. In a univariable cox model with time-dependent treatment, the intervention was associated with a hazard ratio of 0.70 [95%CI 0.56-0.87, p = 0.002]. After adjustment for age, sex and level of care, the hazard ratio increased to 0.82 but was still significant [95%CI 0.71-0.96, p = 0.011]. CONCLUSION: The analysis shows that optimizing collaboration between nurses and physicians leads to better survival of NHRs in Germany. This adds to the already published favorable cost-benefit ratio of the CoCare intervention and shows that a routine implementation of optimized collaboration between nurses and physicians is highly recommended.

Health Communication Preferences of Transgender and Gender-Diverse Individuals - Development and First Psychometric Evaluation of the CommTrans Questionnaire.

Patient-doctor communication is an important component of patient-centered care and should be adapted to the target group. Adapting communication to transgender and gender-diverse individuals is particularly difficult, as little is known about the preferences of this group. Thus, the aim of the study was to develop a questionnaire to assess the communication preferences of the target group. Based on a qualitative study, an item pool was created, which was tested in a survey in September 2022. An item analysis was conducted and items with unacceptable characteristics were removed. The remaining item pool was examined with an explorative factor analysis. The sample consisted of N = 264 individuals. Of the initial k = 43 items, k = 9 items remained in the final factor analysis. The final two factor solution explained 60.7% of the variance. The factors describe the emotional resonance in communication (Cronbach's α = .74; e.g. "My medical doctors should be happy for me when my treatment progresses positively.") as well as gender-related communication (Cronbach's α = .85; e.g. "My medical doctors should introduce themselves with pronouns."). Overall, the questionnaire captures the communication preferences of transgender and gender-diverse individuals in medical conversations. It covers two important topics for the target group, but further validation is necessary.

[Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. / Verbessert der Innovationsfonds die Versorgung? Eine kritische Bestandsaufnahme zum Stand der Implementierung erfolgreicher Innovationsfondsprojekte in die Versorgungspraxis.

INTRODUCTION: Since 2015, the Federal Joint Committee (G-BA)'s Innovation Fund has been supporting projects in health services research and new health service models ("Neue Versorgungsformen", NVF). By the end of 2022, 211 projects in the NVF category had been funded. A key objective is the transfer of successful projects into standard care. This article analyzes previous projects regarding their incorporation into routine care based on transfer recommendations of the Innovation Fund Committee ("Innovationsausschuss" IA). METHOD: Descriptive analysis of all projects completed by August 1, 2023 with transfer recommendations in the "NVF" funding stream. Presentation by topic, project duration, time until IA transfer decision, categorization, and number of institutions and organizations (recipients) addressed per project, their feedback published on the G-BA website, response rates per recipient group, and a content classification and interpretation of exemplary feedback. Recommendations based on the results and their discussion in an expert workshop. RESULTS: Out of 57 NVF projects, 17 had a transfer recommendation. A total of 57 feedback responses were received from a total of 431 recipients addressed by the IA across these projects. Response rates varied significantly. One-third of inquiries to the G-BA and its member organizations received a response (31%), while only every fifth inquiry to federal states (18%) and professional societies (18%) got a response. Less than one in ten inquiries to the Federal Ministry of Health (8%), administrative bodies (6%), and the German Medical Association (0%) received a response. Project-specific feedback within a recipient group was often contradictory or limited to regional scope. DISCUSSION AND CONCLUSION: The transfer process reveals significant structural and procedural obstacles regarding the incorporation of projects evaluated as successful into routine health care. To ensure that funding from the innovation fund is most effectively used, there needs to be a realistic chance of successful transfer of positive project outcomes into routine care. The DNVF recommends stronger involvement of rule-competent institutions, mandatory publication of responses, structured moderation of the transfer process, expanding types of selective contracts, financing of implementation phases and of studies drawing on results across successful NVF projects.

Identification of Anterior Large Vessel Occlusion Stroke During the Emergency Call: Protocol for a Controlled, Nonrandomized Trial.

BACKGROUND: Endovascular thrombectomy (ET), combined with intravenous thrombolysis if possible, is an effective treatment option for patients with stroke who have confirmed anterior large vessel occlusion (aLVO). However, ET is mainly limited to comprehensive stroke centers (CSCs), resulting in a lack of ET capacity in remote, sparsely populated areas. Most stroke networks use the "Drip and Ship" or "Mothership" strategy, resulting in either delayed ET or intravenous thrombolysis, respectively. OBJECTIVE: This study protocol introduces the Leitstellen-Basierte Erkennung von Schlaganfall-Patienten für eine Thrombektomie und daraufhin abgestimmte Optimierung der Rettungskette (LESTOR) strategy, developed to optimize the preclinical part of the stroke chain of survival to improve the clinical outcome of patients with suspected aLVO stroke. This involves refining the dispatch strategy for identifying patients with acute aLVO stroke using a phone-based aLVO query. This includes dispatching emergency physicians and emergency medical services (EMS) to urban emergency sites, as well as dispatching helicopter EMS to remote areas. If a highly suspected aLVO is identified after a standardized aLVO score evaluation during a structured examination at the emergency scene, prompt transport to a CSC should be prioritized. METHODS: The LESTOR study is a controlled, nonrandomized study implementing the LESTOR strategy, with a stepped-wedge, cluster trial design in 6 districts in southwest Germany. In an interprofessional, iterative approach, an aLVO query or dispatch protocol intended for use by dispatchers, followed by a coordinated aLVO examination score for use by EMS, is being developed, evaluated, and pretested in a simulation study. After the training of all participating health care professionals with the corresponding final aLVO query, the LESTOR strategy is being implemented stepwise. Patients otherwise receive usual stroke care in both the control and intervention groups. The primary outcome is the modified Rankin Scale at 90 days in patients with stroke receiving endovascular treatment. We will use a generalized linear mixed model for data analysis. This study is accompanied by a cost-effectiveness analysis and a qualitative process evaluation. RESULTS: This paper describes and discusses the protocol for this controlled, nonrandomized LESTOR study. Enrollment was completed in June 2023. Data analysis is ongoing and the first results are expected to be submitted for publication in 2024. The project started in April 2020 and will end in February 2024. CONCLUSIONS: We expect that the intervention will improve the clinical outcome of patients with aLVO stroke, especially outside the catchment areas of CSCs. The results of the accompanying process evaluation and the cost-effectiveness analysis will provide further insights into the implementation process and allow for a better interpretation of the results. TRIAL REGISTRATION: German Clinical Trials Register DRKS00022152; https://drks.de/search/de/trial/DRKS00022152. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51683.

Health literacy of trans and gender diverse individuals -a cross sectional survey in Germany.

INTRODUCTION: To date, there has been little research on the general health literacy of trans and gender diverse individuals, even though previous research undermines the importance of good health literacy in this sample. The aim of the article is therefore to describe the general health literacy of trans and gender diverse individuals based on a German survey. METHODS: In September 2022, a survey study was conducted in which health literacy was recorded using HLS-EU-16. Data will be presented descriptively; gender differences will be explored using a Χ2- test and a univariate analysis of variance (ANOVA). RESULTS: Out of N = 223 participants, n = 129 individuals (57.8%) identified as non-binary; n = 49 (22.0%) identified themselves as male, while n = 45 (20.2%) identified as female. Mean age was 28.03 years. Overall, 26.4% of all the participants showed an inadequate health literacy, as proposed by the HLS-EU-16. In trend, health-related task related to media use were more often perceived as easy compared to the German general population. CONCLUSION: Individuals, who identify as trans and gender diverse may have a general health literacy below average compared to the German general population. However, tasks related to media use were perceived as easy, which might be a good starting point for health literacy related interventions. TRIAL REGISTRATION: DRKS00026249, Date of registration: 15/03/2022.

Noise exposure among staff in intensive care units and the effects of unit-based noise management: a monocentric prospective longitudinal study.

BACKGROUND: Intensive care units (ICUs) are often too noisy, exceeding 70-80 dBA, which can have negative effects on staff. The corresponding recommendation of the World Health Organization (average sound pressure level below 35 dBA) is often not achieved. To date there is a lack of intervention studies examining the extent to which unit-based noise management in ICUs contributes to a reduction in noise exposure for the staff. The study therefore aims to provide answers to 1) how unit-based noise management sustainably reduces the subjective noise exposure among staff, and 2) how this intervention affects other noise-related topics. METHODS: We performed a monocentric prospective longitudinal study with three measurement points in a German university hospital in three ICUs. We collected data from different healthcare professionals and other professional groups between October 2021 and August 2022 using an online questionnaire. Data were analyzed using descriptive and inference statistics. RESULTS: A total of n = 179 participants took part in the surveys. The majority of participants were nurses or pediatric nurses. Most participants worked more than 75% full-time equivalent. Staff on the three ICUs reported high levels of noise exposure. No significant changes in noise exposure over time were observed. Participants were already aware of the topic and believed that a behavior change could positively influence the noise environment. CONCLUSIONS: This study provides an initial insight into how a unit-based noise management could contribute to a reduction in the subjective noise exposure among staff in ICUs. The results of this study highlight the importance of this topic. Future studies should aim to research aspects of adherence and their facilitators or barriers, which promote the sustained implementation of noise-reducing measures by staff. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00025835; Date of registration: 12.08.2021.

The economic impact of a local, collaborative, stepped, and personalized care management for older people with chronic diseases: results from the randomized comparative effectiveness LoChro-trial.

BACKGROUND: Within the ageing population of Western societies, an increasing number of older people have multiple chronic conditions. Because multiple health problems require the involvement of several health professionals, multimorbid older people often face a fragmented health care system. To address these challenges, in a two-group parallel randomized controlled trial, a newly developed care management approach (LoChro-Care) was compared with usual care. METHODS: LoChro-Care consists of individualized care provided by chronic care managers with 7 to 16 contacts over 12 months. Patients aged 65 + with chronic conditions were recruited from inpatient and outpatient departments. Healthcare utilization costs are calculated by using an adapted version of the generic, self-reporting FIMA©-questionnaire with the application of standardized unit costs. Questionnaires were given at 3 time points (T0 baseline, T1 after 12 months, T2 after 18 months). The primary outcome was overall 3-month costs of healthcare utilization at T1 and T2. The data were analyzed using generalized linear models with log-link and gamma distribution and adjustment for age, sex, level of care as well as the 3-month costs of care at T0. RESULTS: Three hundred thirty patients were analyzed. The results showed no significant difference in the costs of healthcare utilization between participants who received LoChro-Care and those who received usual care, regardless of whether the costs were evaluated 12 (adjusted mean difference € 130.99, 95%CI €-1477.73 to €1739.71, p = 0.873) or 18 (adjusted mean difference €192.99, 95%CI €-1894.66 to €2280.65, p = 0.856) months after the start of the intervention. CONCLUSION: This study revealed no differences in costs between older people receiving LoChro-Care or usual care. Before implementing the intervention, further studies with larger sample sizes are needed to provide robust evidence on the cost effects of LoChro-Care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904, https://drks.de/search/de/trial/DRKS00013904 ; date of first registration 02/02/2018.

Challenges and opportunities of evaluating work based interprofessional learning: insights from a pediatric interprofessional training ward.

Introduction: Interprofessional collaboration among healthcare professionals is fostered through interprofessional education (IPE). Work-based IPE has demonstrated effectiveness within interprofessional training wards. We developed the Interprofessional Training Ward in Pediatrics (IPAPED) and employ a combination of established assessment tools and a newly created IPAPED questionnaire, directed at to assess both students' learning experiences and program structure. This paper presents the development and analysis of the psychometric properties of the IPAPED questionnaire. Methods: Nursing trainees and medical students participated in IPAPED. The IPAPED questionnaire was developed to complement established instruments, based on IPE frameworks. Interprofessional collaboration and communication were represented in subscales in part 1 of the questionnaire. Part 2 focused on the IPAPED program itself. Statistical analyses included calculation of internal consistency for part 1 and exploratory factor analyses for part 2. Results: All IPAPED participants between November 2017 and November 2022 completed the questionnaire (n = 105). 94 of 105 questionnaires were analyzed. Internal consistency for part 1 was low (Cronbach's α <0.58). Exploratory factor analyses revealed three distinct factors: teaching and learning material, interprofessional learning facilitation and professional guidance by nurses on the ward. Discussion: Our results illustrate the challenge of performing high quality, theory based evaluation in a work-based setting. However, exploratory factor analyses highlighted the opportunity of focusing on both learning facilitators and staff on the wards to ensure a maximum learning output for participants. Developing program-specific questionnaires to gain insight into local structures has the potential to improve work-based IPE formats.

Effects of a Web-Based Lifestyle Intervention on Physical Fitness and Health in Physically Inactive Adults: A Randomized Controlled Trial.

Web-based lifestyle interventions are a new area of health research. This randomized controlled trial evaluated the effectiveness of an interactive web-based health program on physical fitness and health. N = 189 healthy adults participated in a 12-week interactive (intervention) or non-interactive (control) web-based health program. The intervention provided a web-based lifestyle intervention to promote physical activity and fitness through individualized activities as part of a fully automated, multimodal health program. The control intervention included health information. Cardiorespiratory fitness measured as maximum oxygen uptake (VO2max) was the primary outcome, while musculoskeletal fitness, physical activity and dietary behavior, and physiological health outcomes were assessed as secondary outcomes (t0: 0 months, t1: 3 months, t2: 9 months, t3: 15 months). Statistical analysis was performed with robust linear mixed models. There were significant time effects in the primary outcome (VO2max) (t0-t1: p = 0.018) and individual secondary outcomes for the interactive web-based health program, but no significant interaction effects in any of the outcomes between the interactive and non-interactive web-based health program. This study did not demonstrate the effectiveness of an interactive compared with a non-interactive web-based health program in physically inactive adults. Future research should further develop the evidence on web-based lifestyle interventions.

The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial.

BACKGROUND: eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity. OBJECTIVE: We examined the effectiveness of Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC), an internet-based, tailored, and interactive SC intervention. Our hypotheses were as follows: hypothesis 1, in the intervention group (IG; access to TK-SCC), a clinically relevant number of participants will be abstinent at the 12-month follow-up (T3); hypothesis 2, the number of abstinent participants will be significantly greater in the IG than the control group (CG) at T3; and hypothesis 3, in the IG, more intense use of TK-SCC will be positively associated with abstinence. METHODS: Individuals who smoke were randomized into the IG (563/1115, 50.49%) or CG (552/1115, 49.51%), which received a noninteractive, nontailored, and information-only web-based intervention. Data were collected before the intervention, at the postintervention time point (T1), at the 4-month follow-up (T2), and at T3. We tested hypothesis 1 through equivalence tests between the IG's success rate and success rates of comparable effective interventions reported in 2 current meta-analyses. For hypothesis 2, we conducted binary logistic regressions. For hypothesis 3, we assigned the IG participants to 1 of 4 user types and used binary logistic regressions with user types as the independent variable and smoking abstinence as the dependent variable. RESULTS: In the IG, 11.5% (65/563) and 11.9% (67/563) of participants were smoke free at T1 and T3, respectively. These values were statistically equivalent to the effects in the 2 meta-analyses, which reported 9% (z score=0.64, P=.74) and 10.9% (z score=-0.71, P=.24) success rates, respectively. In the CG, 6.2% (34/552) of the participants were smoke free at T1, which increased up to 8.2% (45/552) at T3. The difference between the IG and CG was statistically significant only at T1 (odds ratio [OR] 2.0, 99% CI 1.1 to 3.6; P=.002), whereas the effect was nonsignificant following α error corrections at T3 (OR 1.6, 99% CI 0.9 to 2.7; P=.02). In the IG, constant users of the program became smoke free significantly more often than rare users of the program (T1: OR 15.0, 99% CI 6.1 to 36.9; P<.001; T3: OR 6.5, 99% CI 2.8 to 15.5; P<.001). CONCLUSIONS: TK-SCC is effective for SC. However, its superiority compared with a minimal SC intervention could not be confirmed in the long term. Insufficient implementation of the techniques used and cotreatment bias could explain this outcome. Higher use intensity of TK-SCC was positively related to abstinence. Therefore, additional efforts to motivate users to adhere to intervention use as intended could improve the intervention's effectiveness. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020249, Universal Trial Number U1111-1245-0273; https://drks.de/search/de/trial/DRKS00020249. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05470-8.

Evaluating case management for caregivers of children with spinal muscular atrophy type I and II-an exploratory, controlled, mixed-methods trial.

Introduction: Spinal muscular atrophy (SMA) is a rare neuromuscular disease requiring various clinical specialists and therapists to provide care. Due to the disease's dynamic nature and the long distances between specialized centers and local providers, integrating care between disciplines can be challenging. Care that is inadequately integrated can compromise the quality of care and become a burden for patients and families. This trial aimed to improve the care of patients through a case management (CM) intervention. Methods: We conducted an exploratory, controlled, two-arm trial with pre-, post-, and follow-up measures (process and outcome evaluation). Proof of efficacy based on statistical significance was not our primary study objective since we were investigating a rare disease. Primary outcomes were caregivers' HRQoL and caregiver-rated quality of care integration. Our secondary outcome was the children's HRQoL. Results: Questionnaires and semi-structured interviews yielded heterogeneous results depending on caregivers' level of experience and desire (or possibility) to delegate care tasks. Discussion: Despite differing perceptions, all participants supported the establishment of a care coordination model. We recommend CM immediately after diagnosis to provide the greatest benefit to families. We hope that our trial will support the further development of CM interventions that can be customized for specific diseases.

Rehabilitation facilities' research needs and knowledge transfer in Southwest Germany: Data of the REHA-KNOWS study.

The REHA-KNOWS study was conducted to identify research needs, to explore attitudes and barriers towards health services research as well as to investigate knowledge transfer strategies in rehabilitation facilities in Southwest Germany. We designed a short online survey with 18 questions. From March to May 2023, we surveyed representatives of rehabilitation facilities in two German Federal States (Baden-Wuerttemberg and Saarland) using an online questionnaire provided via UniparkⓇ. The dataset contains all responses from n=88 individuals. We applied a list-based sampling approach and contacted n=206 rehabilitation facilities in total. Data collection started on March 2nd and the last response was received on May 2nd. As this sampling strategy allows multiple answers per facility, we applied an anonymized coding system to identify the affiliation of each respondent. In total, the 88 responses come from 74 centers. The dataset includes information on characteristics of the facility where the respondents work, the perceived benefits and barriers regarding health services research in practice, the need for research on specific topics and the transfer strategies established within the facilities. Analyses of these topics were performed in a descriptive and exploratory manner. This data offers the potential to be linked with data resulting from future research in this field in other Federal States of Germany. Further subgroup analyses can be performed with this dataset for specific research questions.

[Research partners in health services research: need, acceptance and feasibility of preparatory trainings]. / Forschungspartner*innen in der Versorgungsforschung: Bedarf, Akzeptanz und Umsetzbarkeit von vorbereitenden Schulungen.

AIM: The aim of this online survey was to assess the need, acceptance and practical feasibility of a training program for research partners in health services research by patients and the public. METHOD: In January 2023, we sent the survey to patient associations and groups nationwide via Patient Advisory Board members of the German Network for Health Services Research (DNVF). The survey included both closed and open questions. The research team analysed the information provided by the participants (n=125) descriptively and used content analysis according to Kuckartz and Rädiker (2022). RESULTS: The majority (90.4%) of respondents considered patient and the public involvement in the planning and implementation of scientific studies to be very or extremely important. 41.5% (17.9%) of respondents indicated that more than 10% (more than 25%) of patients would be willing to participate in free training and be available as research partners. More than three-quarters (76.8%) of respondents agreed that training was very or extremely important. Participants preferred written information (57.3%), short online training (56.5%) and short digital information sessions (53.2%). Frequently cited barriers to delivering training include travel costs (60%), time (53.3%) and the need for extensive prior information (48.3%). Participants' suggestions for successful training implementation included comprehensibility of the training program and its organisation (location, duration and format). CONCLUSION: In addition to the high training needs of research partners, the results also reveal some obstacles. A compact, comprehensible and digital information event with written information material increases acceptance. Researchers should take these results into account when designing and implementing training programs.

A cross-sectoral approach to utilizing health claims data for quality assurance in medical rehabilitation: study protocol of a combined prospective longitudinal and retrospective cohort study.

BACKGROUND: Measuring the quality of provided healthcare presents many challenges, especially in the context of medical rehabilitation. Rehabilitation is based on a holistic biopsychosocial model of health that includes a person's long-term functioning; hence, outcome domains are very diverse. In Germany, rehabilitation outcomes are currently assessed via patient and physician surveys. Health insurance claims data has the potential to simplify current quality assurance procedures in Germany, since its comprehensive collection is federally mandated from every healthcare provider. By using a cross-sectoral approach, quality assessments in rehabilitation can be adjusted for the quality provided in previous sectors and individual patient risk factors. METHODS: SEQUAR combines two studies: In a prospective longitudinal study, 600 orthopedic rehabilitation patients and their physicians are surveyed at 4 and 2 time points, respectively, throughout rehabilitation and a follow-up period of 6 months. The questionnaires include validated instruments used in the current best-practice quality assurance procedures. In a retrospective cohort study, a nationwide claims database with more than 312,000 orthopedic rehabilitation patients will be used to perform exploratory analysis for the identification of quality indicators. The identified SEQUAR claims data quality indicators will be calculated for our prospective study participants and tested for their ability to approximate or replace the currently used, best-practice quality indicators based on primary data. DISCUSSION: The identified SEQUAR quality indicators will be used to draft a novel, state-of-the-art quality assurance procedure that reduces the administrative burden of current procedures. Further research into the applicability to other indications of rehabilitation is required. TRIAL REGISTRATION: WHO UTN: U1111-1276-7141; DRKS-ID: DRKS00028747 (Date of Registration in DRKS: 2022/08/10).