A transdiagnostic group exercise intervention for mental health outpatients in Germany (ImPuls): results of a pragmatic, multisite, block-randomised, phase 3 controlled trial.

BACKGROUND: Globally, mental health conditions pose a substantial burden of disease. Despite the availability of evidence-based pharmacological and psychological treatments, the symptoms of a substantial subgroup of patients do not respond to these interventions, and only a minority of patients have access to them. This study aimed to assess the efficacy of ImPuls, a 6-month transdiagnostic group exercise intervention, plus treatment-as-usual, compared with treatment-as-usual alone in outpatients with various mental disorders. METHODS: In this pragmatic, two-arm, multisite, randomised controlled trial in Germany, ten outpatient rehabilitative and medical care facilities were involved as study sites. Participants were outpatients diagnosed according to ICD-10 with one or more of the following disorders based on structured clinical interviews: moderate or severe depression, primary insomnia, post-traumatic stress disorder (PTSD), panic disorder, or agoraphobia. Participants were required to be aged between 18 years and 65 years, insured by the health insurers Allgemeine Ortskrankenkasse Baden-Württemberg or Techniker Krankenkasse, fluent in German, and without medical contraindications for exercise. Blocks of six participants were randomly allocated to ImPuls plus treatment-as-usual or treatment-as-usual alone (allocation ratio: 1:1), stratified by study site. The randomisation sequence was generated by an external data manager. The team responsible for data collection and management was masked to the randomisation sequence. The ImPuls intervention comprised evidence-based outdoor exercises lasting 30 min, and aimed at achieving at least moderate intensity. It also incorporated behavioural change techniques targeting motivational and volitional determinants of exercise behaviour. Treatment-as-usual was representative of typical outpatient health care in Germany, allowing patients access to any standard treatments. The primary outcome was global symptom severity at 6 months after randomisation, measured using self-report on the Brief Symptom Inventory (BSI-18) and analysed in the intention-to-treat sample. No individuals with lived experience of mental illness were involved in conducting the study or writing the final publication. Safety was assessed in all participants. The trial was registered with the German Clinical Trials Register (DRKS00024152) with a completion date of June 30, 2024. FINDINGS: 600 patients provided informed consent, were recruited to the study, and underwent a diagnostic interview between Jan 1, 2021, and May 31, 2022. Following this, 199 were excluded on the basis of inclusion and exclusion criteria and one withdrew consent during the baseline assessment. Of the 400 eligible participants, 284 (71%) self-identified as female, 106 (27%) self-identified as male, and nine (2%) self-identified as other. The mean age was 42·20 years (SD 13·23; range 19-65). Ethnicity data were not assessed. 287 (72%) participants met the criteria for moderate or severe depression, 81 (20%) for primary insomnia, 37 (9%) for agoraphobia, 46 (12%) for panic disorder, and 72 (18%) for PTSD. 199 participants were allocated to the intervention group of ImPuls plus treatment-as-usual and 201 to the control group of treatment-as-usual alone. 38 (19%) participants did not receive the minimum ImPuls intervention dose. ImPuls plus treatment-as-usual demonstrated superior efficacy to treatment-as-usual alone in reducing global symptom severity, with an adjusted difference on BSI-18 of 4·11 (95% CI 1·74-6·48; d=0·35 [95% CI 0·14-0·56]; p=0·0007) at 6 months. There were no significant differences in the total number of adverse events or serious adverse events between the two groups. There was one serious adverse event (male, torn ligament) related to the intervention. INTERPRETATION: ImPuls is an efficacious transdiagnostic adjunctive treatment in outpatient mental health care. Our findings suggest that exercise therapy should be implemented in outpatient mental health care as an adjunctive transdiagnostic treatment for mental disorders such as depression, insomnia, panic disorder, agoraphobia, and PTSD. Transdiagnostic group exercise interventions might ameliorate the existing disparity in care provision between the many individuals in need of evidence-based treatment and the few who are receiving it. FUNDING: The German Innovation Fund of the Federal Joint Committee of Germany.

Incidence trend of type 2 diabetes from 2012 to 2021 in Germany: an analysis of health claims data of 11 million statutorily insured people.

AIMS/HYPOTHESIS: The aim of the study is to describe the time trend of type 2 diabetes incidence in the largest state of Germany, Bavaria, from 2012 to 2021, and to compare the incidence rates during the pandemic period (2020-2021) to the pre-pandemic period (2012-2019). METHODS: This secondary data analysis uses health claims data provided by the Bavarian Association of Statutory Health Insurance Physicians (KVB), covering approximately 11 million insurees, accounting for 85% of the total population of Bavaria, Germany. Newly diagnosed type 2 diabetes cases in adults (≥20 years) coded as E11 (Diabetes mellitus, Type 2) or E14 (Unspecified diabetes mellitus) under ICD-10, German modification (ICD-10-GM) for the study period 2012 to 2021 were included. Annual and quarterly age-standardised incidence rates (ASIR) stratified by sex, age and region were calculated using the European standard population. Sex-specific crude incidence rates (CIR) were calculated using 10-year age groups. Regression analyses adjusted for time trends, seasonal effects, and pandemic effects were used to analyse the incidence trend and to assess the effect of the pandemic. RESULTS: Overall, 745,861 new cases of type 2 diabetes were diagnosed between 2012 and 2021: 50.4% (376,193 cases) in women. The male/female ratio remained stable over the observation period, while the median age at diagnosis decreased from 61 to 58 years in men and from 66 years to 61 years in women. ASIR were consistently higher for men compared with women, with the yearly difference remaining stable over time (2012: 18%; 2021: 20%). An overall decreasing trend in ASIR was observed during the study period, with a strong decrease from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021 for both sexes. For men, ASIR decreased from 1514 per 100,000 person-years in 2012 to 995 per 100,000 person-years in 2021 (4.6% average annual reduction), and for women from 1238 per 100,000 person-years in 2012 to 796 per 100,000 person-years in 2021 (4.8% average annual reduction). This downward trend was also observed for age groups above 50 years. Regression analyses showed no significant change in incidence rates during the pandemic period (2020 and 2021) compared with the pre-pandemic period. CONCLUSIONS/INTERPRETATION: For the first time, a 10-year incidence trend of type 2 diabetes is reported for Germany, showing a strong decline from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021. The incidence trend of type 2 diabetes appears not to have been affected by the first 2 years of the COVID-19 pandemic. Despite an overall increasing prevalence, the incidence is decreasing, potentially resulting from robust screening by family physicians, reducing the median age at diagnosis by 3 to 5 years. However, further investigation is needed to fully identify the reasons for the declining incidence trend. Continued incidence monitoring is necessary to identify the long-term trend and the potential effect of the pandemic on diagnoses of type 2 diabetes.

The role of mesolevel characteristics of the health care system and socioeconomic factors on health care use - results of a scoping review.

BACKGROUND: Besides macrolevel characteristics of a health care system, mesolevel access characteristics can exert influence on socioeconomic inequalities in healthcare use. These reflect access to healthcare, which is shaped on a smaller scale than the national level, by the institutions and establishments of a health system that individuals interact with on a regular basis. This scoping review maps the existing evidence about the influence of mesolevel access characteristics and socioeconomic position on healthcare use. Furthermore, it summarizes the evidence on the interaction between mesolevel access characteristics and socioeconomic inequalities in healthcare use. METHODS: We used the databases MEDLINE (PubMed), Web of Science, Scopus, and PsycINFO and followed the 'Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols extension for scoping reviews (PRISMA-ScR)' recommendations. The included quantitative studies used a measure of socioeconomic position, a mesolevel access characteristic, and a measure of individual healthcare utilisation. Studies published between 2000 and 2020 in high income countries were considered. RESULTS: Of the 9501 potentially eligible manuscripts, 158 studies were included after a two-stage screening process. The included studies contained a wide spectrum of outcomes and were thus summarised to the overarching categories: use of preventive services, use of curative services, and potentially avoidable service use. Exemplary outcomes were screening uptake, physician visits and avoidable hospitalisations. Access variables included healthcare system characteristics such as physician density or distance to physician. The effects of socioeconomic position on healthcare use as well as of mesolevel access characteristics were investigated by most studies. The results show that socioeconomic and access factors play a crucial role in healthcare use. However, the interaction between socioeconomic position and mesolevel access characteristics is addressed in only few studies. CONCLUSIONS: Socioeconomic position and mesolevel access characteristics are important when examining variation in healthcare use. Additionally, studies provide initial evidence that moderation effects exist between the two factors, although research on this topic is sparse. Further research is needed to investigate whether adapting access characteristics at the mesolevel can reduce socioeconomic inequity in health care use.

A longitudinal analysis of health inequalities from adolescence to young adulthood and their underlying causes.

Research suggests that children of low-educated parents face greater health burdens during the passage from adolescence to young adulthood, as they are more likely to become low-educated themselves, establish behavioural and psychosocial disadvantages, or being exposed to unhealthy working conditions. However, studies examining the development and drivers of health inequalities during this particular life stage are limited in number and have produced varied results. This study investigates trajectories of self-rated health and overweight from 14 to 25 years of age, stratified by parental education, and explores the role of potential mediators (educational achievement, health behaviours, psychosocial factors, working conditions). We rely on prospective cohort data from the National Educational Panel Study (NEPS), a representative sample of 14,981 German ninth graders interviewed yearly from 2011 to 2021 (n = 90,096 person-years). First, we estimated random-effects growth curves for self-rated health and overweight over participants' age and calculated the average marginal effect of high versus low parental education. Second, a series of simulation-based mediation analyses were performed to test how much of health inequalities were explained by children's educational attainment (years of school education, years in university), health behaviours (smoking, alcohol, physical inactivity), psychosocial factors (number of grade repetitions, years in unemployment, chronic stress, self-esteem) and working conditions (physical and psychosocial job demands). We accounted for potential confounding by controlling for age, sex, migration background, residential area, household composition, and interview mode. Results show that higher parental education was related to higher self-rated health and lower probabilities of being overweight. Interaction between parental education and age indicated that, after some equalisation in late adolescence, health inequalities increased in young adulthood. Furthermore, educational attainment, health behaviours, psychosocial factors, and early-career working conditions played a significant role in mediating health inequalities. Of the variables examined, the level of school education and years spent in university were particular strong mediating factors. School education accounted for around one-third of the inequalities in self-rated health and one-fifth of the differences in overweight among individuals. Results support the idea that the transition to adulthood is a sensitive period in life and that early socio-economic adversity increases the likelihood to accumulate health disadvantages in multiple dimensions. In Germany, a country with comparatively low educational mobility, intergenerational continuities in class location seem to play a key role in the explanation of health inequalities in youth.

The role of sociodemographic, psychosocial, and behavioral factors in the use of preventive healthcare services in children and adolescents: results of the KiGGS Wave 2 study.

BACKGROUND: In Germany, various preventive services are offered to children and adolescents. These include regular standardized examinations (so called U/J examinations) and several vaccinations. Although strongly recommended, most of them are not mandatory. Our aim is to identify factors associated with the use of U/J examinations and vaccination against diphtheria, hepatitis B, Hib, pertussis, polio, and tetanus. While previous research has focused on sociodemographic factors, we also include socioeconomic, behavioral, and psychosocial factors. METHODS: We analyzed cross-sectional data from 15,023 participants (aged 0-17 years) of the nationwide representative KiGGS Wave 2 Survey. Participation in U/J examinations was assessed using a questionnaire, filled out by participants and/or their parents. Information on vaccination status was drawn from the participants' vaccination booklets. To identify relevant determinants for the use of preventive examinations and vaccinations, unadjusted and adjusted logistic regression models were employed with up to 16 different independent variables. RESULTS: Various independent variables showed an association with the use of preventive services. Higher socioeconomic status, absence of migration background, and lower household size were associated with significantly higher utilization of U examinations. Parents' marital status, area of residence, behavioral and psychosocial factors yielded insignificant results for most U/J examinations. Higher vaccination rates were found for children with no migration background, with residence in eastern Germany, lower household size, and with married parents. CONCLUSION: This study attempted to depict the influence of sociodemographic, psychosocial, and behavioral factors on the use of several preventive services. Our results indicate that predominantly sociodemographic variables influence the use of preventive services. Further efforts should be made to investigate the interplay of different determinants of healthcare use in children and adolescents.

Patient-reported effects of hospital-wide implementation of shared decision-making at a university medical centre in Germany: a pre-post trial.

OBJECTIVES: To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM). DESIGN: Pre-post study. SETTING: University Hospital Schleswig-Holstein (UKSH), Kiel Campus. PARTICIPANTS: Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH. INTERVENTIONS: The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate. MAIN OUTCOME MEASURES: In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICSPDM). Pre-post comparisons were done using t-tests. RESULTS: The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICSPDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges' g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects. CONCLUSIONS: The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care.

Analytical methods for identifying sequences of utilization in health data: a scoping review.

BACKGROUND: Healthcare, as with other sectors, has undergone progressive digitalization, generating an ever-increasing wealth of data that enables research and the analysis of patient movement. This can help to evaluate treatment processes and outcomes, and in turn improve the quality of care. This scoping review provides an overview of the algorithms and methods that have been used to identify care pathways from healthcare utilization data. METHOD: This review was conducted according to the methodology of the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews (PRISMA-ScR) Checklist. The PubMed, Web of Science, Scopus, and EconLit databases were searched and studies published in English between 2000 and 2021 considered. The search strategy used keywords divided into three categories: the method of data analysis, the requirement profile for the data, and the intended presentation of results. Criteria for inclusion were that health data were analyzed, the methodology used was described and that the chronology of care events was considered. In a two-stage review process, records were reviewed by two researchers independently for inclusion. Results were synthesized narratively. RESULTS: The literature search yielded 2,865 entries; 51 studies met the inclusion criteria. Health data from different countries ([Formula: see text]) and of different types of disease ([Formula: see text]) were analyzed with respect to different care events. Applied methods can be divided into those identifying subsequences of care and those describing full care trajectories. Variants of pattern mining or Markov models were mostly used to extract subsequences, with clustering often applied to find care trajectories. Statistical algorithms such as rule mining, probability-based machine learning algorithms or a combination of methods were also applied. Clustering methods were sometimes used for data preparation or result compression. Further characteristics of the included studies are presented. CONCLUSION: Various data mining methods are already being applied to gain insight from health data. The great heterogeneity of the methods used shows the need for a scoping review. We performed a narrative review and found that clustering methods currently dominate the literature for identifying complete care trajectories, while variants of pattern mining dominate for identifying subsequences of limited length.

Organization and quality of care in patient-sharing networks.

Healthcare systems seek to provide continuous and coordinated care of high quality. However, patient pathways in the ambulatory sector may differ and result in various provider units. Our aim was to analyze whether health outcomes and the quality of care differ between different types of patient-sharing physician networks. We analyzed administrative data on patients with diagnosed heart failure in Germany. We investigated distinct networks of ambulatory physicians by using a modular-based optimization algorithm and characterized each network as having either a key physician at its center or some other kind of configuration. We subsequently conducted multilevel regression analyses to estimate the impact a network's configuration has on hospitalization rates and guideline-based process indicators. We identified 1,847 networks, of which 27% had a key physician at their center. Compared to physician networks with other configurations, networks that had a key physician at their center were associated in our regression analysis with (a) somewhat lower hospitalization rates, and (b) heart failure treatment that was more frequently in concordance with the German national treatment guideline. Organizing healthcare for people with chronic disease into units that have a key physician at their center and include the relevant specialists may foster treatment that is effective and of higher quality.

Do physician networks with standardized audit and feedback deliver better quality care for older patients compared to regular care?: a quasi-experimental study using claims data from Bavaria, Germany.

BACKGROUND: Physician networks (PNs) are a recent development in Germany, designed to improve the coordination and quality of healthcare. We compared the performance of PNs that use a standardized system of audit and feedback to that of regular care. METHODS: We analysed a large sample of claims data from Bavaria, Germany, using nearest-neighbour propensity score matching. Patients who had ambulatory care-sensitive conditions (ACSCs) and were enrolled in PNs were matched with control patients receiving regular care. We examined potentially avoidable hospitalizations related to the 13 most common ACSCs (primary endpoints), as well as processes-of-care indicators for disease prevention, pharmacotherapy and coordination of care. RESULTS: There were no significant differences in rates of potentially avoidable hospitalizations between the two groups. However, the networks showed higher vaccination rates, increased participation in disease management programmes, and more frequent use of referrals when consulting specialist physicians. On average, network patients visited a greater number of specialists and had lower continuity of care compared to patients receiving regular care. Polypharmacy and PRISCUS-list prescriptions were more prevalent in the networks. CONCLUSIONS: PNs using audit and feedback do not appear to perform better than regular care in preventing hospitalizations due to ACSCs. However, they do perform better in disease prevention measures while showing inconclusive results for care coordination and pharmacotherapy. Further research is needed to understand effective collaboration among providers and its impact on the quality of care within PNs.

Socio-economic inequalities in body mass index among preschool children: do sports programs in early childhood education and care centers make a difference?

Background: Overweight in childhood is considered to be one of the most serious public health challenges. Many studies have investigated individual-level determinants of children's body mass index (BMI), yet studies exploring determinants at the meso-level are sparse. The aim of our study was to examine how a sports focus at early childhood education and care (ECEC) centers moderates the effect of parental socio-economic position (SEP) on children's BMI. Methods: We used data from the German National Educational Panel Study and included 1,891 children (955 boys and 936 girls) from 224 ECEC centers in our analysis. Linear multilevel regressions were used to estimate the main effects of family SEP and the ECEC center sports focus, as well as their interaction, on children's BMI. All analyses were stratified by sex and adjusted for age, migration background, number of siblings, and employment status of parents. Results: Our analysis confirmed the wellknown health inequalities in childhood overweight with a social gradient toward a higher BMI for children from lower SEP families. An interactive effect between family SEP and ECEC center sports focus was found. Boys with low family SEP not attending a sports-focused ECEC center had the highest BMI among all boys. In contrast, boys with low family SEP attending a sports-focused ECEC center had the lowest BMI. For girls, no association regarding ECEC center focus or interactive effects emerged. Girls with a high SEP had the lowest BMI, independent of the ECEC center focus. Conclusion: We provided evidence for the gender-specific relevance of sports-focused ECEC centers for the prevention of overweight. Especially boys from low SEP families benefited from a sports focus, whereas for girls the family's SEP was more relevant. As a consequence, gender differences in determinants for BMI at different levels and their interaction should be considered in further research and preventive measures. Our research indicates that ECEC centers may decrease health inequalities by providing opportunities for physical activity.

Experiences with and perception of patient-reported outcome measurement in patients undergoing knee and hip replacement in Germany.

BACKGROUND: Patient-reported outcome measures - PROMs - have been developed to provide an assessment of patients' physical function, symptoms, and health-related quality of life. With patient-centered care becoming increasingly important, several national strategies have been initiated for PROM measurement. However, Germany is only at the beginning of this process. The objective of this study is to assess patients' experience with and perception of completing PROMs in patients undergoing knee and hip replacement in Germany. METHODS: This study used survey data from patients undergoing hip or knee replacement surgery in a hospital in Germany. Before surgery, patients completed a PROMs survey. After at least 6 months, patients were re-contacted to fill in a questionnaire about their experiences with and perception of the PROMs data collection. RESULTS: Most patients either agreed or totally agreed that the time to fill in the questionnaire was appropriate (89%), that the purpose of the PROMs collection was clear (85%), that the questionnaire's content applied to their appointment (73%), and that this systematic assessment was beneficial (81%). The corresponding proportions were 54% for feeling productive while waiting and 50% for feeling that the information in the questionnaire affected the patient-doctor interaction positively. Only few significant associations were found between patient characteristics and the favorability of patients' ratings. There were no significant differences between hip and knee replacement surgery patients regarding the favorability rating on any survey question. CONCLUSIONS: The results of this study suggest that PROMs collection in the context of hip and knee replacement surgery is practicable and partly also perceived beneficial by patients. Orthopedic procedures could serve as a starting point for broader use and routine PROMs collection in Germany.

Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders-the ImPuls study.

BACKGROUND: Evidence suggests that patients suffering from different mental disorders benefit from exercise programs combined with behavior change techniques. Based on this evidence, we have developed an exercise program (ImPuls) specifically designed to provide an additional treatment option in the outpatient mental health care system. The implementation of such complex programs into the outpatient context requires research that goes beyond the evaluation of effectiveness, and includes process evaluation. So far, process evaluation related to exercise interventions has rarely been conducted. As part of a current pragmatic randomized controlled trial evaluating ImPuls treatment effects, we are therefore carrying out comprehensive process evaluation according to the Medical Research Council (MRC) framework. The central aim of our process evaluation is to support the findings of the ongoing randomized controlled trial. METHODS: The process evaluation follows a mixed-methods approach. We collect quantitative data via online-questionnaires from patients, exercise therapists, referring healthcare professionals and managers of outpatient rehabilitative and medical care facilities before, during, and after the intervention. In addition, documentation data as well as data from the ImPuls smartphone application are collected. Quantitative data is complemented by qualitative interviews with exercise therapists as well as a focus-group interview with managers. Treatment fidelity will be assessed through the rating of video-recorded sessions. Quantitative data analysis includes descriptive as well as mediation and moderation analyses. Qualitative data will be analyzed via qualitative content analysis. DISCUSSION: The results of our process evaluation will complement the evaluation of effectiveness and cost-effectiveness and will, for example, provide important information about mechanisms of impact, structural prerequisites, or provider qualification that may support the decision-making process of health policy stakeholders. It might contribute to paving the way for exercise programs like ImPuls to be made successively available for patients with heterogeneous mental disorders in the German outpatient mental health care system. TRIAL REGISTRATION: The parent clinical study was registered in the German Clinical Trials Register (ID: DRKS00024152, registered 05/02/2021, https://drks.de/search/en/trial/DRKS00024152 ).

Assessing needs-based supply of physicians: a criteria-led methodological review of international studies in high-resource settings.

BACKGROUND: Many health systems embrace the normative principle that the supply of health services ought to be based on the need for healthcare. However, a theoretically grounded framework to operationalize needs-based supply of healthcare remains elusive. The aim of this paper is to critically assess current methodologies that quantify needs-based supply of physicians and identify potential gaps in approaches for physician planning. To this end, we propose a set of criteria for consideration when estimating needs-based supply. METHODS: We conducted searches in three electronic bibliographic databases until March 2020 supplemented by targeted manual searches on national and international websites to identify studies in high-resource settings that quantify needs-based supply of physicians. Studies that exclusively focused on forecasting methods of physician supply, on inpatient care or on healthcare professionals other than physicians were excluded. Additionally, records that were not available in English or German were excluded to avoid translation errors. The results were synthesized using a framework of study characteristics in addition to the proposed criteria for estimating needs-based physician supply. RESULTS: 18 quantitative studies estimating population need for physicians were assessed against our criteria. No study met all criteria. Only six studies sought to examine the conceptual dependency between need, utilization and supply. Apart from extrapolations, simulation models were applied most frequently to estimate needs-based supply. 12 studies referred to the translation of need for services with respect to a physician's productivity, while the rest adapted existing population-provider-ratios. Prospective models for estimating future care needs were largely based on demographic predictions rather than estimated trends in morbidity and new forms of care delivery. CONCLUSIONS: The methodological review shows distinct heterogeneity in the conceptual frameworks, validity of data basis and modeling approaches of current studies in high-resource settings on needs-based supply of physicians. To support future estimates of needs-based supply, this review provides a workable framework for policymakers in charge of health workforce capacity planning.

Regional variations in multimorbidity burden among office-based physicians in Germany.

BACKGROUND: Multimorbidity is associated with higher utilization of healthcare services. However, many countries do not consider multimorbidity when estimating physician supply. The main aim of this study was to assess how regional multimorbidity levels can be integrated when estimating the need for office-based physician supply. METHODS: Claims data were used to measure and compare the proportions of multimorbid patients of GPs, ophthalmologists, orthopaedic specialists and neurologists, and examine spatial variations through Bernoulli cluster analysis of regional multimorbidity levels. To explore the interrelationship between current capacities and spatial occurrence of high-rate clusters, clusters were compared with the current supply of physicians. RESULTS: About 17 239 488 individuals out of approximately 67 million records were classified as multimorbid. Multimorbidity levels varied greatly between physician disciplines (31.5-60.1%). Bernoulli cluster analysis demonstrated that many high-rate areas were found for all specialized physicians, but clusters varied partially by size and location. The comparison with current physician supply at cluster level showed that more than a third of clusters with a significantly higher share of morbid patients seeing a GP are met, on an average, by GP supply below targeted values. In turn, clusters with significantly higher multimorbidity levels of specialized physicians were met, on an average, by supply that exceeded targeted values. CONCLUSION: Our study offers an approach to how to include discipline-specific multimorbidity at area level when estimating physician supply and discusses its relevance. The outcomes of our article can be used by policymakers to advance current planning strategies and to improve the quality of office-based care.

Diffusion of a new drug among ambulatory physicians-The impact of patient pathways.

When drugs enter the market, physicians' prescribing behavior plays a crucial role in the diffusion process. Although regulations to foster economically efficient prescribing exist, physicians have some degree of freedom in choosing medication and are subject to various influencing factors. The aim of the present analysis is to investigate how interaction among patients and physicians affects the diffusion. We look at two different ways that patient pathways might influence physicians and examine these effects for Sacubitril/Valsartan (S/V), a new drug for patients with heart failure. Using administrative data from Germany, we identify physicians who prescribed S/V in the first 2 years of its availability. We apply survival models to estimate the impact of the patient-physician interaction on the physicians' adoption time. To this end, we determine whether individual physicians treated patients that had been prescribed S/V, and how many other physicians already prescribing S/V were connected in patient-sharing networks. Our main findings are that patients with a previous prescription seem to induce adoption by demanding repeat prescriptions. Moreover, patients establish connections between physicians that may lead to prescriptions for new patients. Our results therefore suggest that patient pathways play a significant role in the diffusion of a new drug.

Comprehensive Implementation of Shared Decision Making in a Neuromedical Center Using the SHARE TO CARE Program.

Purpose: SHARE TO CARE (S2C) is a comprehensive, multi-module implementation program for shared decision making (SDM). It is currently applied at the University Hospital Schleswig-Holstein in Kiel, Germany, and among general practitioners at the Federal State of Bremen. This study examines the results of the full implementation of S2C in terms of effectiveness within the Kiel Neuromedical Center comprising the departments of neurology and neurosurgery. Method and Design: The S2C program consists of four combined intervention modules: 1) multimodal training of physicians; 2) a patient activation campaign including the ASK-3 method; 3) digital evidence-based patient decision aids; and 4) SDM support by nurses, e.g., as decision coaches. The SDM level before and immediately after implementation was retrospectively assessed in consecutively selected patients on the subscale "Patient Decision Making" of the Perceived Involvement in Care Scale (PICSPDM). Mean scores were compared with t-tests. Results: Eighty-nine percent of all physicians (N = 56) completed the SDM training. We developed a total of 12 evidence-based digital decision aids in the center, educated two decision coaches to support patients' decision processes by using decision aids. Physicians adjusted patients' pathways to incorporate the use of decision aids. Patients (n = 261) reported a significant increase in participation (p<0.001; Hedges' g = 0.49) in medical decision making. Conclusion: The S2C program has been successfully implemented within the entire Neuromedical Center. Patients reported a medium to small increase of perceived involvement in decision making demonstrating the effectiveness of the implementation. For future research, it might be interesting to investigate the sustainability of the effects of S2C. In addition, it seems useful to complement the patient-based evaluation with observer-based data.

Special orthopaedic geriatrics (SOG) - a new multiprofessional care model for elderly patients in elective orthopaedic surgery: a study protocol for a prospective randomized controlled trial of a multimodal intervention in frail patients with hip and knee replacement.

BACKGROUND: Due to demographic change, the number of older people in Germany and worldwide will continue to rise in the coming decades. As a result, the number of elderly and frail patients undergoing total hip and knee arthroplasty is projected to increase significantly in the coming years. In order to reduce risk of complications and improve postoperative outcome, it can be beneficial to optimally prepare geriatric patients before orthopaedic surgery and to provide perioperative care by a multiprofessional orthogeriatric team. The aim of this comprehensive interventional study is to assess wether multimorbid patients can benefit from the new care model of special orthopaedic geriatrics (SOG) in elective total hip and knee arthroplasty. METHODS: The SOG study is a registered, monocentric, prospective, randomized controlled trial (RCT) funded by the German Federal Joint Committee (GBA). This parallel group RCT with a total of 310 patients is intended to investigate the specially developed multimodal care model for orthogeriatric patients with total hip and knee arthroplasty (intervention group), which already begins preoperatively, in comparison to the usual orthopaedic care without orthogeriatric co-management (control group). Patients ≥70 years of age with multimorbidity or generally patients ≥80 years of age due to increased vulnerability with indication for elective primary total hip and knee arthroplasty can be included in the study. Exclusion criteria are age < 70 years, previous bony surgery or tumor in the area of the joint to be treated, infection and increased need for care (care level ≥ 4). The primary outcome is mobility measured by the Short Physical Performance Battery (SPPB). Secondary outcomes are morbidity, mortality, postoperative complications, delirium, cognition, mood, frailty, (instrumental) activities of daily living, malnutrition, pain, polypharmacy, and patient reported outcome measures. Tertiary outcomes are length of hospital stay, readmission rate, reoperation rate, transfusion rate, and time to rehabilitation. The study data will be collected preoperative, postoperative day 1 to 7, 4 to 6 weeks and 3 months after surgery. DISCUSSION: Studies have shown that orthogeriatric co-management models in the treatment of hip fractures lead to significantly reduced morbidity and mortality rates. However, there are hardly any data available on the elective orthopaedic care of geriatric patients, especially in total hip and knee arthroplasty. In contrast to the care of trauma patients, optimal preoperative intervention is usually possible. TRIAL REGISTRATION: German Clinical Trials Register DRKS00024102. Registered on 19 January 2021.

Sustainability of large-scale implementation of shared decision making with the SHARE TO CARE program.

Introduction: SHARE TO CARE (S2C) is a comprehensive implementation program for shared decision making (SDM). It is run at the University Hospital Schleswig-Holstein (UKSH) in Kiel, Germany, and consists of four combined intervention modules addressing healthcare professionals and patients: (1) multimodal training of physicians (2) patient activation campaign including the ASK3 method, (3) online evidence-based patient decision aids (4) SDM support by nurses. This study examines the sustainability of the hospital wide SDM implementation by means of the Neuromedical Center comprising the Departments of Neurology and Neurosurgery. Methods: Between 2018 and 2020, the S2C program was applied initially within the Neuromedical Center: We implemented the patient activation campaign, trained 89% of physicians (N = 56), developed 12 patient decision aids and educated two decision coaches. Physicians adjusted the patients' pathways to facilitate the use of decision aids. To maintain the initial implementation, the departments took care that new staff members received training and decision aids were updated. The patient activation campaign was continued. To determine the sustainability of the initial intervention, the SDM level after a maintenance phase of 6-18 months was compared to the baseline level before implementation. Therefore, in- and outpatients received a questionnaire via mail after discharge. The primary endpoint was the "Patient Decision Making" subscale of the Perceived Involvement in Care Scale (PICSPDM). Secondary endpoints were an additional scale measuring SDM (CollaboRATE), and the PrepDM scale, which determines patients' perceived health literacy while preparing for decision making. Mean scale scores were compared using t-tests. Results: Patients reported a significantly increased SDM level (PICSPDM p = 0.02; Hedges' g = 0.33; CollaboRATE p = 0.05; Hedges' g = 0.26) and improved preparation for decision making (PrepDM p = 0.001; Hedges' g = 0.34) 6-18 months after initial implementation of S2C. Discussion: The S2C program demonstrated its sustainability within the Neuromedical Center at UKSH Kiel in terms of increased SDM and health literacy. Maintaining the SDM implementation required a fraction of the initial intensity. The departments took on the responsibility for maintenance. Meanwhile, an additional health insurance-based reimbursement for S2C secures the continued application of the program. Conclusion: SHARE TO CARE promises to be suitable for long-lasting implementation of SDM in hospitals.

Assessing patients' acceptable and realised distances to determine accessibility standards for the size of catchment areas in outpatient care.

Healthcare planning aims to ensure availability of care in a needs-based, evenly distributed and locally available manner. However, many planning mechanisms lack accessibility standards. To determine standards, catchment areas must be derived from health-related travel assessments and a population's distance acceptance for different medical specialisation levels. We estimated distance acceptance using representative cross-sectional survey data (n = 1.598). Moreover, we used utilization data covering 88% of the German population (2014/15) to calculate realised travel distances for six medical specialties (n = 676.255.605 cases). We specified a gravity-based distance decay function and estimated regression-based distance thresholds from both samples. Realised distances were mostly below 30 min (90% of cases) indicating appropriate mean accessibility. The 5% observed distance threshold was between 23.7 min for GPs and 47.6 min for dermatologists. Depending on medical speciality, distance acceptance was mainly determined by distance, age, activity level and town size for GP visits and by health and income for specialist care. 5% acceptance thresholds varied between 27.9 min to GPs for elderly patients and 51.6 min to orthopaedists for younger patients. Acceptable distances for 90% of the population were 6 (8) minutes to GPs (specialists). The variation of thresholds, which depended on socio-demographic and health variables and the population share that is fully accepting, illustrates that healthcare planners should move beyond averages to realise equal access for equal need.

Health economic evaluation of the 'Flying Intervention Team' as a novel stroke care concept for rural areas: study protocol of the TEMPiS-GÖA study.

INTRODUCTION: Providing comprehensive stroke care poses major organisational and financial challenges to the German healthcare system. The quasi-randomised TEMPiS-Flying Intervention Team (TEMPiS-FIT) study aims to close the gap in the treatment of patients who had ischaemic stroke in rural areas of Southeast Bavaria by flying a team of interventionalists via helicopter directly to patients in the regional TEMPiS hospitals instead of transporting the patients to the next comprehensive stroke centre. The objective of the present paper is to describe the methods for the economic evaluation (TEMPiS-Gesundheitsökonomische Analyse (TEMPiS-GÖA)) alongside the TEMPiS-FIT study to determine whether the new form of care is cost-effective compared with standard care. METHODS AND ANALYSIS: The within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will be performed from a statutory health insurance perspective as well as from a societal perspective over the time horizon of 12 months after the patients' hospital discharge. Direct costs from outpatient and inpatient care are collected from routine data of the participating health insurance funds, while medical and non-medical costs from a patient's perspective are retrieved from primary data collected during the TEMPiS-FIT study and follow-up questionnaires. Results will be presented as incremental cost-effectiveness ratio and incremental cost-utility ratio quantifying the incremental costs and health benefits compared with standard care practice. The outcome of the CEA will be measured in costs per minute reduction in mean process time to thrombectomy. The outcome of the CUA will be presented as costs per quality-adjusted life year gained. ETHICS AND DISSEMINATION: Ethical approval for the TEMPiS-FIT study was granted by the Bavarian State Medical Association Ethics Committee (# 17056). Results will be disseminated via reports, presentations of the results in publications and at conferences and on the TEMPiS website. TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00023885. Registered on 2 July 2021 - retrospectively registered.