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Background: Physical inactivity is associated with health risks, contributing to various diseases and all-cause mortality. Despite recommendations for regular physical activity (PA), many adults remain inactive, influenced by socioeconomic and environmental factors. Digital interventions, particularly web-based PA programs, offer promising possibilities to promote PA across populations. These programs vary in their effectiveness, reflecting differences in design, user engagement, and behavior change techniques employed. Objective: This study evaluates the effectiveness of the 12-week multimodal web-based TKFitnessCoach. The PA online program is part of the TK-HealthCoach. This study investigates the program's impact on self-reported PA levels, goal attainment, healthrelated quality of life, body weight, and eating behavior, comparing an interactive personalized web-based intervention and non-interactive web-based health information. Methods: In a randomized controlled trial (RCT), participants were allocated to either the intervention group (IG), receiving access to the interactive TK-FitnessCoach, or the control group (CG) that was provided a static website with evidence-based information on PA. The study targeted a German-speaking adult population interested in improving health behavior. Data was assessed at T0 (beginning of the study), T1 (postintervention), T2, 6 months, and T3, 12 months follow-ups, focusing on self-reported PA at T3 and on various secondary outcomes. Results: We achieved equally distributed sociodemographics in both the IG and the CG with a mean age of 42.8 (IG), resp. 43.1 years (CG), and female participants of 76.1 % (IG), resp. 74.7 % (CG). PA at baseline was 277.9 min/week in the IG and 273.3 min/week in the CG. Both, the IG (n = 1153 in the Intention-to-treat (ITT) dataset) and CG (n = 1177 in the ITT dataset) exhibited significant increases in PA over time (IG(T3-T0) = 72.92 min/week; CG(T3-T0) = 74.12 min/week).However, the study did not find significant differences in the effectiveness of the interactive TK-FitnessCoach compared to the non-interactive control in terms of improving PA and related health outcomes. The intensity of using the TK-FitnessCoach was not associated with PA. Conclusions: Both programs were effective in promoting PA among adults, with no significant differences observed between the two RCT groups. This highlights the potential of digital interventions in addressing physical inactivity, suggesting that the effectiveness of such programs may not solely depend on their interactivity but also on the quality and relevance of the information provided. Further research is needed to explore optimization strategies for such interventions, especially for persons with low PA, including user engagement, behavior change techniques, and the integration of objective PA tracking methods. Trial registration: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249.

Abstract 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.

Abstract 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 Χ 2 - 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.

Abstract 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.

Abstract 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.

Abstract 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.

Abstract 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).

Abstract Objective This study aimed to explore psychosocial consequences of (false) positive liver screening results and to identify influencing factors for perceived strain within a multistage screening programme for liver cirrhosis and fibrosis in Germany. Methods Between June 2018 and May 2019, all positively screened patients were asked to participate in the study (n = 158). N = 11 telephone interviews and n = 4 follow‐up interviews were conducted. Semi‐structured telephone interviews were carried out. The analysis followed a structuring content analysis approach. Thereby, categories were first defined deductively. Second, the categories were revised inductively based on the data. Results The main themes found regarding the consequences of the screening were categorised in emotional reactions and behavioural reactions. Few respondents described negative emotional consequences related to screening. Those seem to be mostly driven by suboptimal patient–provider communication and might be worsened when transparent information transfer fails to happen. As a result, patients sought information and support in their social environment. All patients reported positive attitudes towards liver screening. Conclusion To reduce the potential occurrence of psychosocial consequences during the screening process, medical screening should be performed in the context of transparent information. Regular health communication on the side of health professionals and increasing patients' health literacy might contribute to avoiding negative emotions in line with screening. Patient or Public Contribution This study recognises the wide‐ranging patients' perspectives regarding the consequences of liver screening which should be taken into consideration when implementing a new screening programme to ensure a patient‐centred approach.

Abstract Background Children with medical complexity (CMC) require long-term care accompanied by different health- and social care professionals. Depending on the severity of the chronic condition, caregivers spend a lot of time coordinating appointments, communicating between providers, clarifying social legal issues, and more. Effective care coordination is seen as key to addressing the fragmented care that CMC and their families often face. Spinal muscular atrophy (SMA) is a rare genetic, neuromuscular disease which care involves drug therapy and supportive treatment. We examined the care coordination experiences through a qualitative interview analysis of n = 21 interviews with caregivers of children with SMA I or SMA II. Results The code system consists of 7 codes and 12 sub-codes. “Disease and coordination management of the caregivers” describes the management of coordination-related illness demands. “General conditions of care” include enduring organizational aspects of the care network. “Expertise and skills” refers to both parent and professional expertise. “Coordination structure” describes the assessment of existing coordination mechanisms as well as the need for new ones. “Information exchange” defines the information exchange between professionals and parents as well as the exchange of parents among themselves and the perceived exchange between professionals. “Role distribution in care coordination” summarizes parents' “distribution” of coordinative roles among care network actors (including their own). “Quality of relationship” describes the perceived quality of the relationship between professionals and family. Conclusion Care coordination is influenced peripherally (e.g., by general conditions of care) and directly (e.g., by coordination mechanisms, interaction in the care network). Access to care coordination appears to be dependent on family circumstances, geographic location, and institutional affiliation. Previous coordination mechanisms were often unstructured and informal. Care coordination is frequently in the hands of caregivers mainly as the care network’s interface. Coordination is necessary and must be addressed on an individual basis of existing resources and family barriers. Existing coordination mechanisms in the context of other chronic conditions could also work for SMA. Regular assessments, centralized shared care pathways, and staff training and empowerment of families for self-management should be central components of all coordination models. Trial registration: German Clinical Trials Register (DRKS): DRKS00018778; Trial registration date 05. December 2019—Retrospectively registered; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00018778 .

BackgroundEndovascular 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. ObjectiveThis 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. MethodsThe 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. ResultsThis 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. ConclusionsWe 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 RegistrationGerman Clinical Trials Register DRKS00022152; https://drks.de/search/de/trial/DRKS00022152 International Registered Report Identifier (IRRID)DERR1-10.2196/51683

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.

IntroductionInterprofessional 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.MethodsNursing 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.ResultsAll 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

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.

BackgroundeHealth 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. ObjectiveWe 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. MethodsIndividuals 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. ResultsIn 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

IntroductionSpinal 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.MethodsWe 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.ResultsQuestionnaires and semi-structured interviews yielded heterogeneous results depending on caregivers' level of experience and desire (or possibility) to delegate care tasks.DiscussionDespite 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.

Abstract Background In the aging population of Western societies, an increasing number of older adults have multiple chronic diseases. As multifaceted health problems imply the involvement of several healthcare professionals, multimorbid older people frequently face a fragmentation of health care. Addressing these challenges, we developed a local, collaborative, stepped, and personalized care management approach (LoChro-Care) and evaluated its effectiveness. Methods A two-group, parallel randomized controlled trial was conducted comparing LoChro-Care recipients (IG) to participants with usual care (CG). Patients aged 65 + with chronic conditions were recruited at inpatient and outpatient departments of the Medical Center, University of Freiburg. Participants were allocated using block randomization (nIG = 261, nCG = 263). LoChro-Care comprised individualized care provided by chronic care managers with 7 to 13 contacts over 12 months. Questionnaires were given at 3 time points (T0: baseline, T1: after 12 months, T2: after 18 months). The primary outcome was the physical, psychological, and social health status represented by a composite score of functional health and depressive symptoms. Secondary outcomes were the participants’ evaluation of their health care situation, health-related quality of life (HRQL), and life-satisfaction (LS). The data were analyzed using linear mixed modelling. Results We analyzed N = 491 participants (nIG = 244, nCG = 247), aged M = 76.78 years (SD = 6.35). For the composite endpoint, neither a significant difference between IG and CG (p = .88) nor a group-time interaction (p = .52; p = .88) could be observed. Participants in both groups showed a significant decline on the primary outcome between T0 and T2 (p

Aim: This study explores nurses' experiences of caring for (potentially) brain-dead patients. Design: A qualitative interpretative phenomenological design was chosen to describe the phenomenon in all its complexity and dimensions. Methods: In 2016, twelve episodic interviews were conducted with intensive care nurses from six wards. The interviews related to their experiences of caring for (potentially) brain-dead patients and were analyzed according to Benner's Interpretative Phenomenology. Results: Three key phenomena were generated: 1) The brain is dead; the body is alive; 2) Coping within high performance medicine and 3) Power(-lessness). The participants' experience was that caring for a (potentially) brain-dead patient and explaining brain death to the patient's relatives is very demanding. In the intensive care unit, nurses are required to diligently provide exemplary methodical and routine care, most of the time without an outlet to relieve their own work-related burdens. In some situations, the interviewees felt powerless. Conclusion: The data collected have provided a deeper insight into the situation intensive care nurses face when caring for (potentially) brain-dead patients. Nevertheless, the authors recommend further research on all phenomena, and also the design of appropriate training and support for nurses.

BackgroundThe high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. ObjectiveThe purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. MethodsThe randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes. ResultsThe intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups. ConclusionsThe interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. Trial RegistrationGerman Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249 International Registered Report Identifier (IRRID)RR2-10.3390/ijerph19031393

Abstract Background Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries”. Methods RECUR builds on the technical infrastructure of Germany’s Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. Discussion The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry’s technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. Trial registration This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11th 2022.

Abstract Background Older patients at risk of functional decline are frequently affected by polypharmacy. This is associated with a further loss of independence. However, a relationship between functional disability and medications, such as ‘Potentially Inappropriate Medications’ (PIMs) and ‘Potential Prescribing Omissions’ (PPOs), as itemised for (de) prescribing in practice-orientated medication lists, has yet to be established. Methods As part of a randomised comparative effectiveness trial, LoChro, we conducted a cross-sectional analysis of the association between PIMs and PPOs measured using the ‘Screening Tool of Older Persons’ Prescription Criteria / Screening Tool To Alert to Right Treatment’ (STOPP/START) Version 2, with functional disability assessed using the ‘World Health Organization Disability Assessment Schedule 2.0’ (WHODAS). Individuals aged 65 and older at risk of loss of independence were recruited from the inpatient and outpatient departments of the local university hospital. Multiple linear regression analysis was used to model the potential prediction of functional disability using the numbers of PIMs and PPOs, adjusted for confounders including multimorbidity. Results Out of 461 patients, both the number of PIMs and the number of PPOs were significantly associated with an increase in WHODAS-score (Regression coefficients B 2.7 [95% confidence interval: 1.5-3.8] and 1.5 [95% confidence interval: 0.2-2.7], respectively). In WHODAS-score prediction modelling the contribution of the number of PIMs exceeded the one of multimorbidity (standardised coefficients beta: PIM 0.20; multimorbidity 0.13; PPO 0.10), whereas no significant association between the WHODAS-score and the number of medications was seen. 73.5 % (339) of the participants presented with at least one PIM, and 95.2% (439) with at least one PPO. The most common PIMs were proton pump inhibitors and analgesic medication, with frequent PPOs being pneumococcal and influenza vaccinations, as well as osteoporosis prophylaxis. Conclusions The results indicate a relationship between inappropriate prescribing, both PIMs and PPOs, and functional disability, in older patients at risk of further decline. Long-term analysis may help clarify whether these patients benefit from interventions to reduce PIMs and PPOs.

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.

Abstract Background The regional integrated health care model “Healthy Kinzigtal” started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. Methods This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. Results A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. Conclusions We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.

BackgroundTrans and gender-diverse individuals experience adverse health outcomes that might be due, in addition to other factors, to stigma and discrimination in the health care sector. At the same time, the concept of person-centred care acknowledges the role of patient-physician communication in health care outcomes. This study aims to explore patient-physician communication preferences in trans and gender-diverse individuals.MethodA qualitative interview study was conducted, including N = 10 participants between February and March 2022. Participants were interviewed using a semi-structured interview guideline, based on previous knowledge in person-centred care and sample specific communication. Participants were asked about their experiences and wishes in patient-physician centeredness. Analyses were conducting using a qualitative content analysis strategy.ResultsMean age was 29.3 years; n = 6 participants identified themselves within the binary gender concept, while n = 4 identified themselves with a non-binary gender. Communication preferences for patient-physician communication were categorised into four themes: general communication aspects (e.g. active listening); the role of gender during appointments (e.g. appropriate/inappropriate addressing); gender-neutral language (e.g. experiences use of gender neutral language by physicians); own communication style (e.g. early outing and justification). Furthermore, possible contextual factors of patient-physician communication where found (e.g. trusting relationship).ConclusionAdding knowledge to communication preferences of trans and gender-diverse individuals, this study was able to identify preferences that are specific to the sample as well as preferences that differ from the cis-gendered population. However, it remains unclear how the patient-physician communication preferences affects health care utilization and outcomes.Trial registrationGerman Clinical Trial Register (DRKS00026249).

Abstract Background Sarcoidosis is granulomatous disease of unknown origin affecting organ function and quality of life. The King’s Sarcoidosis Questionnaire (KSQ) serves as a tool to assess quality of life in sarcoidosis patients with general health and organ specific domains. A German translation has been validated in a German cohort. In this study we assessed, whether clinical parameters influence KSQ scores. Methods Clinical data (e.g. lung function, organ impairment, serological parameters) for the German validation cohort were extracted from clinical charts and investigated by correlation and linear regression analyses. Results KSQ subdomain scores were generally lower in patients with respective organ manifestation or on current therapy. LUNG subdomain was significantly predicted by lung functional parameters, however for general health status, only FeV1 exerted significant influence. GHS was not influenced by serological parameters, but was significantly negatively correlated with body mass index (BMI). KSQ provides additional information beyond lung function, clinical or serological parameters in sarcoidosis patients. Notably, high BMI is significantly negatively associated with patients’ well-being as measured by KSQ-GHS. Conclusion This observation may direct further studies investigating the effect of obesity on sarcoidosis-related quality of life and strategies to intervene with steroid-sparing therapies and measures of life style modifications. Trial registration This study was registered in the German Clinical Trials Register (reference number DRKS00010072). Registered January 2016.

BackgroundAn ever-increasing number of patients seek health information via the internet. However, there is an overabundance of differing, often low-quality information available, while a lack of health literacy makes it difficult for patients to understand and assess the quality and trustworthiness of the information at hand. The web portal tala-med was thus conceived as an evidence-based, up-to-date, and trustworthy information resource for lower back pain (LBP), which could be used by primary care physicians (PCPs) and patients during and following consultations for LBP. The current evidence demonstrates that patients with LBP could benefit from web portals. However, the use of such portals by patients remains low, thus limiting their effectiveness. Therefore, it is important to explore the factors that promote or hinder the use of web portals and investigate how patients perceive their usability and utility. ObjectiveIn this study, we investigated the acceptance, usability, and utility of the web portal tala-med from the patient perspective. MethodsThis qualitative study was based on telephone interviews with patients who had access to the web portal tala-med from their PCP. We used a semistructured interview guide that consisted of questions about the consultation in which patients were introduced to tala-med, in addition to questions regarding patient perceptions, experiences, and utilization of tala-med. The interviews were recorded, transcribed, and analyzed through framework analysis. ResultsA total of 32 half-hour interviews were conducted with 16 female and 16 male patients with LBP. We identified 5 themes of interest: the use of tala-med by PCPs during the consultation, the use of tala-med by patients, its usability, added values derived from its use, and the resultant effects of using tala-med. PCPs used tala-med as an additional information resource for their patients and recommended the exercises. The patients appreciated these exercises and were willing to use tala-med at home. We also identified factors that promoted or hindered the use of tala-med by patients. Most patients rated tala-med positively and considered it a clear, comprehensible, trustworthy, and practical resource. In particular, the trustworthiness of tala-med was seen as an advantage over other information resources. The possibilities offered by tala-med to recap and reflect on the contents of consultations in a time-flexible and independent manner was perceived as an added value to the PCP consultation. ConclusionsTala-med was well accepted by patients and appeared to be well suited to being used as an add-on to PCP consultations. Patient perception also supports its usability and utility. Tala-med may therefore enrich consultations and assist patients who would otherwise be unable to find good-quality web-based health information on LBP. In addition, our findings support the future development of digital health platforms and their successful use as a supplement to PCP consultations. International Registered Report Identifier (IRRID)RR2-10.1186/s12875-019-0925-8

BackgroundIntegrated care models aim to strengthen the collaboration between healthcare sectors to ensure a higher quality of care for children with chronic conditions. Assessing pediatric healthcare integration through families' experiences, therefore, is essential. Our study aimed to psychometrically test the PICS-D, the first German-language integrated care questionnaire, which is based on the Pediatric Integrated Care Survey (PICS) developed in the USA.MethodsWe examined construct validity using exploratory and confirmatory factor analyses (structural validity). Cronbach's α and McDonald's ωt coefficients explored reliability. Cognitive interviews assessed wording comprehension and item appropriateness.ResultsPICS-D was completed by 204 caregivers of children with chronic conditions (women = 84%; mean age = 41.4 years). Factor analyses identified 3 factors: “Team quality & communication”, “Family impact”, and “Access to care”. The 3-factorial structure showed a satisfying fit to confirmatory classical-test-theory-based models. Due to the insufficient reliability of the third factor, we recommend using only factors 1 and 2 for scoring the PICS-D.ConclusionThe PICS-D is a 13-item questionnaire to assess family-reported experiences in pediatric care integration, which has good psychometric properties. It may be useful in guiding quality improvement efforts or measuring the impact of a care plan or care model.Trial registration: German Clinical Trials Register (DRKS): DRKS00018778; Trial registration date 05. December 2019—Retrospectively registered; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00018778.

Abstract Aims To assess inter‐professional collaboration between nurses and physicians in long‐term care facilities and to determine if there are differences between subgroups of nurses. Design A cross‐sectional questionnaire survey was carried out between January 2018 and January 2020. Methods 408 health professionals (345 nurses, 63 physicians) from 37 nursing homes in Baden‐Wuerttemberg (Germany) participated in the survey. For data collection, the “Team‐Scale” and “Work Situation Questionnaire for nurses/physicians” instruments were used. Furthermore, five self‐generated items were employed assessing how ward rounds and documentation are implemented. For the evaluation, descriptive analyses, one‐way variance analyses (ANOVAs) and a multilevel analysis were performed. Results Inter‐professional teamwork was rated positively overall. However, the nursing staff usually gave more critical assessments than the physicians (for example, regarding mutual appreciation). Critical assessments could be used to initiate constructive change processes.

Abstract Background With rising numbers of elderly people living in nursing homes in Germany, the need for on-site primary care is increasing. A lack of primary care in nursing homes can lead to unnecessary hospitalization, higher mortality, and morbidity in the elderly. The project CoCare (“coordinated medical care”) has therefore implemented a complex health intervention in nursing homes, using inter alia, regular medical rounds, a shared patient medical record and medication checks, with the aim of improving the coordination of medical care. This study reports upon the results of a qualitative study assessing the perceived barriers and facilitators of the implementation of CoCare by stakeholders. Methods Focus group interviews were held between October 2018 and November 2019 with nurses, general practitioners and GP’s assistants working or consulting in a participating nursing home. A semi-structured modular guideline was used to ask participants for their opinion on different aspects of CoCare and which barriers and facilitators they perceived. Focus groups were analyzed using qualitative content analysis. Results In total, N = 11 focus group interviews with N = 74 participants were conducted. We found six themes describing barriers and facilitators in respect of the implementation of CoCare: understaffing, bureaucracy, complexity, structural barriers, financial compensation, communication and collaboration. Furthermore, participants described the incorporation of the intervention into standard care. Conclusion Barriers perceived by stakeholders are well known in the literature (e.g. understaffing and complexity). However, CoCare provides a good structure to overcome barriers and some barriers will dissolve after implementation into routine care (e.g. bureaucracy). In contrast, especially communication and collaboration were perceived as facilitators in CoCare, with the project being received as a team building intervention itself. Trial registration WHO UTN: U1111–1196-6611; DRKS-ID: DRKS00012703 (Date of Registration in DRKS: 2017 Aug 23).

Objective To explore patients’ with asplenia and general practitioners’ (GPs) (1) perceptions of a novel, Health Action Process Approach (HAPA)-based, educational intervention which targets to increase adherence to post-splenectomy sepsis (PSS) prevention measures and (2) their experience in implementing prevention measures following this intervention.Design A process evaluation conducted on average 3.5 (for patients) and 3.8 (for GPs) months after the intervention between January 2020 and April 2021 individually by means of semi-structured guideline-based telephone interviews. Data was analysed using qualitative content analysis.Participants Volunteer subsample of N=25 patients with asplenia and N=8 GPs who received the intervention. Inclusion criteria were met by prior participation in the intervention (German-speaking, of full age and insured by the cooperating health insurance). Patient selection was done by purposeful selection aiming at maximum variability in terms of adherence to preventative measures prior to intervention participation. Participating GPs are a non-purposeful selected convenience sample. For reasons of data protection, no personal data was collected.Results The intervention was positively evaluated and its personal relevancy for patients and for the GPs’ professional work became apparent. The intervention promoted risk awareness, intention to action, action planning and subsequently, improved adherence to preventative measures. Helpful factors for implementation among the patients were social support by relatives and GPs. Barriers to adherence identified in both groups can be divided into patient-attributed (eg, comorbidities), doctor-related (eg, lack of knowledge or support) as well as contextual factors (eg, vaccine supply constraints).Conclusions Our findings indicate a patient and GP perceived benefit of the intervention, but still identify prevailing barriers to implementation. In a further step, a quantitative evaluation of the intervention will be conducted and recommendations for integrating the intervention in usual care will be made.Trial registration number DRKS00015238.

Abstract Background A healthy lifestyle can help prevent diseases that impair quality of life and lead to premature death. The Techniker health insurance fund offers a comprehensive online health program to support users in achieving their health goals of Increasing Fitness, Losing and Maintaining Weight, or Smoking Cessation. Methods The aim of this study is to test the long-term effectiveness of the web-based TK-HealthCoach with regard to the primary outcomes of increased physical activity, sustainable weight reduction, and smoking abstinence. We are conducting three interconnected, randomized controlled trials (RCT), one for each health goal, within which participants are allocated to an intervention group (interactive online health program) or a control group (non-interactive online health program). The effects of the intervention groups compared to the control groups will be analyzed by multi-level models for change. Participants’ data are captured via online questionnaires before the program starts (baseline t0), again when it ends (t1), and later at two follow-up surveys (t2 and t3); the latter 12 months after t1. We are documenting socio-demographic, health-related, and psychological variables as well as usage behavior data of the programs. According to our sample size calculation, we have to enroll 1114 participants in each Losing and Maintaining Weight and Increasing Fitness RCT and 339 participants in the Smoking Cessation RCT. Additionally, 15–20 participants in the interactive smoking-cessation program will be invited to qualitative telephone interviews with the aim to obtain detailed information concerning utilization, compliance, and satisfaction. The online RCTs’ inclusion criteria are: adults of each gender regardless of whether they are insured with Techniker health insurance fund. Persons with impairments or pre-existing conditions require a medical assessment as to whether the program is suitable for them. Specific exclusion criteria apply to each program/RCT. Discussion We assume that study participants will improve their health behavior by using the offered online health programs and that each health goal’s intervention group will reveal advantages regarding the outcome variables compared to the control groups. Study enrollment started on January 1, 2020. Trial registration German Clinical Trials Register, Universal Trial Number (UTN): U1111-1245-0273 . Registered on 11 December 2019

BackgroundThis study aimed to translate the negative and positive items of the Psychological Consequences Questionnaire (PCQ) into German, to adapt this version to the context of screening for cirrhosis and fibrosis of the liver, and to test its psychometric properties.Materials and methodsThe three subscales (physical, emotional, and social) were translated into German using a forward-backward translation method. Furthermore, we adapted the wording to the context of liver diseases. In sum, the PCQ comprises twelve negative items and ten positive items. We tested the acceptability, distribution properties, internal consistency, scale structure, and the convergent validity using an analysis sample of 443 patients who were screened for cirrhosis or fibrosis of the liver.ResultsWe found low non-response and non-unique answer rates on the PCQ items in general. However, positive items had higher non-response rates. All items showed strong floor effects. McDonald’s Omega was high for both the negative (ω = 0.95) and the positive PCQ scale (ω = 0.90), as well as for the total PCQ scale (ω = 0.86). Confirmatory factor analysis could reproduce the three dimensions that the PCQ intends to measure. However, it suggests not summing up a total PCQ score and instead treat the subscales separately considering a higher order overall construct. Convergent validity with the short form of the Spielberger State-Trait Anxiety Inventory (STAI-Y-6) was acceptable.ConclusionOverall, our study results report a successful adaptation of the German PCQ with good performance in terms of acceptability, internal consistency, scale structure, and convergent validity. Floor-effects limit the content validity of the PCQ, which needs to be addressed in future research. However, the German version of the PCQ is a useful measurement for both negative and positive screening consequences - even in a non-cancer setting.

This randomized, controlled clinical trial examined the impact of a web-based weight loss intervention on diet quality. Furthermore, it was investigated whether corresponding changes in diet quality were associated with changes in measures of cardiovascular risk profile. Individuals with a body mass index (BMI) of 27.5 to 34.9 kg/m2 and an age of 18 to 65 y were assigned to either an interactive and fully automated web-based weight loss program focusing on dietary energy density (intervention) or a non-interactive web-based weight loss program (control). Examinations were performed at baseline (t0), after the 12-week web-based intervention (t1), and after an additional 6 (t2) and 12 months (t3). Based on a dietary record, the Healthy Eating Index-NVS (HEI-NVS) was calculated and analyzed using a robust linear mixed model. In addition, bootstrapped correlations were performed independently of study group to examine associations between change in HEI-NVS and change in dietary, anthropometric, and cardiometabolic variables. A total of n = 153 participants with a mean BMI of 30.71 kg/m2 (SD 2.13) and an average age of 48.92 y (SD 11.17) were included in the study. HEI-NVS improved significantly in the intervention group from baseline (t0) to t2 (p = 0.003) and to t3 (p = 0.037), whereby the course was significantly different up to t2 (p = 0.013) and not significantly different up to t3 (p = 0.054) compared to the control group. Independent of study group, there was a significant negative association between change in HEI-NVS and dietary energy density. A higher total score in HEI-NVS did not correlate with improvements in cardiovascular risk profile. The interactive and fully automated web-based weight loss program improved diet quality. Independent of study group, changes in HEI-NVS correlated with changes in energy density, but there was no association between improvements in HEI-NVS and improvements in cardiovascular risk profile.

Background: Spinal muscular atrophy (SMA) is a rare neuromuscular disease characterized by degeneration of the anterior horn cells in the spinal cord, resulting in muscle atrophy, and proximal muscle weakness. SMA presents with a wide range of symptoms requiring multiple clinical specialists and therapists. Integrating care between disciplines can be challenging due to the dynamic course of the disease, and great distances between specialist centers and local providers. Insufficient care integration can lead to suboptimal quality of care and more difficulties for patients and families. This study aims to improve care integration through a Case Management intervention, and taking a mixed-methods approach, to evaluate its impact.Methods: An exploratory, controlled, two-armed study with baseline, post- and follow-up measurement and process evaluation is conducted to evaluate our intervention compared to usual care. Through a multi-perspective state analysis, we investigate the experiences of caregivers and healthcare providers concerning the actual healthcare quality of patients with SMA I and II. Semi-structured interviews and care diaries are used. We apply that data to conceive a tailored Case Management intervention supplemented by a digital platform. The intervention's effect is examined in comparison to a control group taking a mixed-methods approach. As primary endpoints, we investigate the caregivers' health-related quality of life and the quality of care integration. Secondary endpoints are the use of healthcare services (patients and caregivers) and costs. We assess the process quality from the perspectives of caregivers and healthcare providers through semi-structured interviews.Discussion: This is an exploratory, controlled study to assess the impact of a tailored Case Management intervention to improve the care of patients with SMA I and II. After the evaluation, results on feasibility, expected effect sizes, and process quality will be available. On this basis, future randomized controlled trials can be planned. If demonstrated beneficial, the experience gained within this study may also be valuable for care strategies in other regions and other (non-pediatric) patient groups with rare diseases and/or chronic, complex conditions.Clinical Trial registration:https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018778, identifier: DRKS00018778.

Background The ratings of physician-patient communication are an important indicator of the quality of health care delivery and provide guidance for many important decisions in the health care setting and in health research. But there is no gold standard to assess physician-patient communication. Thus, depending on the specific measurement condition, multiple sources of variance may contribute to the total score variance of ratings of physician-patient communication. This may systematically impair the validity of conclusions drawn from rating data. Objective To examine the extent to which different measurement conditions and rater perspectives, respectively contribute to the variance of physician-patient communication ratings. Methods Variance components of ratings of physician-patient communication gained from 32 general practitioners and 252 patients from 25 family practices in Germany were analyzed using generalizability theory. The communication dimensions “shared decision making”, “effective and open communication” and “satisfaction” were considered. Results Physician-patient communication ratings most substantially reflect unique rater-perspective and communication dimension combinations (32.7% interaction effect). The ratings also represented unique physician and rater-perspective combinations (16.3% interaction effect). However, physicians’ communication behavior and the observed communication dimensions revealed only a low extent of score variance (1% physician effect; 3.7% communication dimension effect). Approximately half of the variance remained unexplained (46.2% three-way interaction, confounded with error). Conclusion The ratings of physician-patient communication minimally reflect physician communication skills in general. Instead, these ratings exhibit primarily differences among physicians and patients in their tendency to perceive shared decision making and effective and open communication and to be satisfied with communication, regardless of the communication behavior of physicians. Rater training and assessing low inferential ratings of physician-patient communication dimensions should be considered when subjective aspects of rater perspectives are not of interest.

BACKGROUND Surgical registries are becoming increasingly popular. In addition, Swiss legislation requires data on therapeutic outcome quality. The Swiss Association of Surgeons (Schweizerische Gesellschaft Chirurgie, SGC-SCC) has already agreed on a first minimum data set. However, in the long run the scope and content of the registry should be evidence-based and not only accepted by professional stakeholders. The MIDAS study aims at providing such evidence for the example population of patients undergoing emergency or elective hip surgery. Five relevant aspects are considered: (1) choice of instruments for assessing health related quality of life (HRQoL); (2) optimal time-point for assessment; (3) use of proxy assessments; (4) choice of pre-surgery risk factors; and (5) assessment of peri- and postoperative variables. METHODS MIDAS is a longitudinal observational multicentre study. All patients suffering from a femoral neck fracture or from arthritis of the hip joint with an indication for prosthetic joint replacement surgery will be offered participation. The study is based on a combination of routine data from clinical standard practice with specifically documented data to be reported by the treating clinician and data to be collected in cooperation with the patient – in particular patient-reported outcome measures (PROMs). The latter include the Health Utility Index Mark 3 (HUI3) and Euro-Qol-5D (EQ-5D) as generic instruments, Hip Disability and Osteoarthritis Outcome Score (HOOS) as a disease specific instrument for the assessment of HRQoL, and two performance-based functional tests. Data will be collected at baseline, during hospitalisation/at discharge and at three routine follow-up visits. All patients will be asked to name a person for assessing proxy-perceived HRQoL. DISCUSSION To the best of our knowledge, this is the first study explicitly addressing questions about the design of a national surgical registry in an empirical manner. The study aims at providing a scientific base for decisions regarding scope and content of a potential national Swiss surgical registry. We designed a pragmatic study to envision data collection in a national registry with the option of specifying isolated research questions of interest. One focus of the study is the use of PROMs, and we hope that our study and their results will inspire also other surgical registries to take this important step forward. Trial registration Registered at the “Deutsches Register Klinischer Studien (DRKS)”, the German Clinical Trials Registry, since this registry meets the scope and methodology of the proposed study. Registration no.: DRKS00012991