Search

Abstract Background Migraine is common and can be highly disabling. Adequate migraine self-management (SM) can mitigate the potentially adverse health effects of migraine. However, adequate SM can be challenging to implement in everyday life, for instance, at the workplace. We aimed to explore how migraine SM is carried out at work and which occupational factors may determine effective implementation according to employees with migraine. We also explored the potential impact of the COVID-19 pandemic and the associated re-arrangement of working conditions on migraine SM at work. Methods We conducted semi-structured qualitative interviews (08/2020–01/2021). Participants were eligible if they have worked for at least six months with a minimum of twenty hours per week and with a migraine diagnosis. The interviews were transcribed and content-analyzed using MAXQDA. Results Migraine SM was perceived to be influenced by social interactions at work (e.g., in terms of understanding vs. stigmatization), the level of job decision latitude (JDL, i.e., the extent to which one is able to influence work processes, e.g., when working from home), and workplace design (e.g., in terms of opportunities to withdraw from work). During the COVID-19 pandemic, especially increased JDL appeared to favorably influence migraine SM. Conclusions Migraine SM at work is fostered or complicated by various psychosocial working conditions. By considering these facilitators and barriers, more migraine-friendly workplaces can be created.

Introduction To examine the long-term health and economic impact of a lifestyle diabetes prevention program in people with high risk of developing type 2 diabetes in Germany.Research design and methods We assessed the lifetime cost-effectiveness of a 2-year pragmatic lifestyle program for preventing type 2 diabetes targeting German adults aged 35–54 and 55–74 years old with hemoglobin A1c (HbA1c) from 6.0% to 6.4%. We used the Centers for Disease Control and Prevention RTI Diabetes Cost-Effectiveness Model to run a simulation on the program effectiveness. We estimated incremental health benefits in quality-adjusted life years (QALYs) and costs using an established simulation model adapted to the German context, from a healthcare system and societal perspective. The cost-effectiveness of the program was measured by incremental cost-effectiveness ratios (ICERs) in cost per QALY. We projected the number of type 2 diabetes cases prevented by participation rate if the program was implemented nationwide.Results The lifestyle program would result to more QALYs and higher costs. The lifetime ICERs were 14 690€ (35–54 years old) and 14 372€ (55–74 years old) from a healthcare system perspective and cost saving (ICER=−3805€) and cost-effective (ICER=4579€), respectively, from a societal perspective. A total of 10 527 diabetes cases would be prevented over lifetime if the program was offered to all eligible people nationwide and 25% of those would participate in the program.Conclusions Implementing the lifestyle intervention for people with HbA1c from 6.0% to 6.4% could be a cost-effective at standard willingness to pay level strategy for type 2 diabetes prevention. The intervention in the younger cohort could be cost saving from a societal perspective. The successful implementation of a lifestyle-based diabetes prevention program could be an important component of a successful National Diabetes Strategy in Germany.

BackgroundDigital mental health interventions (DMHIs) are capable of closing gaps in the prevention and therapy of common mental disorders. Despite their proven effectiveness and approval for prescription, use rates remain low. The reasons include a lack of familiarity and knowledge as well as lasting concerns. Medical students were shown to have a comparatively higher risk for common mental disorders and are thus an important target group for raising awareness about DMHIs. At best, knowledge is already imparted during medical school using context-sensitive information strategies. Yet, little is known about medical students’ information preferences regarding DMHIs. ObjectiveThis study aims to explore information preferences for DMHIs for personal use among medical students in Germany. MethodsA discrete choice experiment was conducted, which was developed using an exploratory sequential mixed methods research approach. In total, 5 attributes (ie, source, delivery mode, timing, recommendation, and quality criteria), each with 3 to 4 levels, were identified using formative research. Data were analyzed using logistic regression models to estimate preference weights and the relative importance of attributes. To identify subgroups of students varying in information preferences, we additionally performed a latent class analysis. ResultsOf 309 participants, 231 (74.8%) with reliable data were included in the main analysis (women: 217/309, 70.2%; age: mean 24.1, SD 4.0 y). Overall, the conditional logit model revealed that medical students preferred to receive information about DMHIs from the student council and favored being informed via social media early (ie, during their preclinic phase or their freshman week). Recommendations from other students or health professionals were preferred over recommendations from other users or no recommendations at all. Information about the scientific evidence base was the preferred quality criterion. Overall, the timing of information was the most relevant attribute (32.6%). Latent class analysis revealed 2 distinct subgroups. Class 1 preferred to receive extensive information about DMHIs in a seminar, while class 2 wanted to be informed digitally (via email or social media) and as early as possible in their studies. ConclusionsMedical students reported specific needs and preferences regarding DMHI information provided in medical school. Overall, the timing of information (early in medical education) was considered more important than the information source or delivery mode, which should be prioritized by decision makers (eg, members of faculties of medicine, universities, and ministries of education). Study findings suggest general and subgroup-specific information strategies, which could be implemented in a stepped approach. Easily accessible digital information may promote students’ interest in DMHIs in the first step that might lead to further information-seeking behavior and the attendance of seminars about DMHIs in the second step.

Abstract Background The reduction of myocardial infarction (MI) and narrowing the gap between the populations with and without diabetes are important goals of diabetes care. We analyzed time trends for sex-specific incidence rates (IR) of first MI (both non-fatal MI and fatal MI) as well as separately for first non-fatal MI and fatal MI in the population with and without diabetes. Methods Using data from the KORA myocardial infarction registry (Augsburg, Germany), we estimated age-adjusted IR in people with and without diabetes, corresponding relative risks (RR), and time trends from 1985 to 2016 using Poisson regression. Results There were 19,683 people with first MI (34% fatal MI, 71% men, 30% with diabetes) between 1985 and 2016. In the entire study population, the IR of first MI decreased from 359 (95% CI: 345–374) to 236 (226–245) per 100,000 person years. In men with diabetes, IR decreased only in 2013–2016. This was due to first non-fatal MI, where IR in men with diabetes increased until 2009–2012, and slightly decreased in 2013–2016. Overall, fatal MI declined stronger than first non-fatal MI corresponding to IRs. The RR of first MI substantially increased among men from 1.40 (1.22–1.61) in 1985–1988 to 2.60 (2.26–2.99) in 1997–2000 and moderately decreased in 2013–2016: RR: 1.75 (1.47–2.09). Among women no consistent time trend for RR was observed. Time trends for RR were similar regarding first non-fatal MI and fatal MI. Conclusions Over the study period, we found a decreased incidence of first MI and fatal MI in the entire study population. The initial increase of first non-fatal MI in men with diabetes needs further research. The gap between populations with and without diabetes remained.

Abstract The aim of this study was to investigating the impact of major depression symptoms and diabetes-related distress on future health care costs and lost workdays in individuals with diabetes. We linked survey data from a random sample of a German statutory health insurance (SHI) with diabetes (n = 1488, 63.0% male, mean age 66.9 years) with their SHI data one year after the survey. Within the survey data we identified major depression symptoms (Patient Health Questionnaire-9) and diabetes-related distress (Problem Areas in Diabetes Scale). We retrieved health care costs and lost workdays from SHI data. To assess the impact of major depression symptoms and diabetes-related distress on health care costs and lost workdays, we adjusted regression models for age, sex, education, employment status, and diabetes duration, type, and severity. Major depression symptoms were associated with significantly higher costs (by a factor of 1.49; 95% CI: 1.18–1.88). Lost workdays were also more likely for respondents with depression symptoms (RR1.34; 0.97–1.86). Health care costs (by a factor of 0.81; 0.66–1.01) and the risk of lost workdays (RR 0.86; 0.62–1.18) may be lower among respondents with high diabetes-related distress. While major depression and diabetes-related distress have overlapping indicators, our results indicate different impacts on health care costs.

Objectives To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.Design Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.Setting Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.Participants A total of 74 individuals with cardiovascular diseases.Outcomes Risk and time preferences.Results The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.Conclusions The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

Objectives The German Incentives for Physical Activity in Cardiac Patients trial is a three-arm, randomised controlled trial for secondary prevention of coronary heart disease (CHD). Guidance for developing complex interventions recommends pre-trial health economic modelling. The aim of this study is to model the long-term cost-effectiveness of the incentive-based physical activity interventions in a population with CHD.Methods A decision-analytical Markov model was developed from a health services provider perspective, following a cohort aged 65 years with a previous myocardial infarction for 25 years. Monetary and social incentives were compared relative to no incentive. Intervention effects associated with physical activity were used to determine the costs, quality-adjusted life-years (QALYs) gained, incremental cost-effectiveness and cost–utility ratios. The probability of cost-effectiveness was calculated through sensitivity analyses.Results The incremental QALYs gained from the monetary and social incentives, relative to control, were respectively estimated at 0.01 (95% CI 0.00 to 0.01) and 0.04 (95% CI 0.02 to 0.05). Implementation of the monetary and social incentive interventions increased the costs by €874 (95% CI €744 to €1047) and €909 (95% CI €537 to €1625). Incremental cost–utility ratios were €25 912 (95% CI €15 056 to €50 210) and €118 958 (95% CI €82 930 to €196 121) per QALY gained for the social and monetary incentive intervention, respectively. With a willingness-to-pay threshold set at €43 000/QALY, equivalent to the per-capita gross domestic product in Germany, the probability that the social and monetary incentive intervention would be seen as cost-effective was 95% and 0%, respectively.Conclusions Exercise-based secondary prevention using inventive schemes may offer a cost-effective strategy to reduce the burden of CHD.

Abstract Gestational diabetes mellitus (GDM) is one of the most common medical complications in pregnancy. Information on key figures such as screening rates, prevalence of GDM or utilization of follow-up care and associated factors varies widely and is often lacking. The aim of our study is to provide information on screening rates for and prevalence of GDM as well as utilization of follow-up care in Germany. We used data (2010–2020) from a large, nationwide statutory health insurance containing information on inpatient and outpatient care, including diagnoses, medication and treatments. Descriptive analyses were performed to assess screening rates, prevalence of GDM and participation rates in follow-up care. A log-binomial regression model was calculated to analyze associated factors. Screening rates among pregnant women increased from 40.2% (2010) to 93.3% (2020) and prevalence from 9.4% (2010) to 15.1% (2020). The proportion of women attending follow-up care remained stable over time (around 42%). Age, educational level, insulin prescription, hypertension and obesity were positively associated with participation in follow-up care. Although over 90% of women in Germany are screened for GDM during pregnancy, follow-up care is used much less. Further research is needed to understand the trends in GDM healthcare (from screening to follow-up care) and the reasons for women's (non-)participation, as well as the attitudes and routines of the healthcare providers involved.

BackgroundPregnancies in women with pre-existing medical conditions are on the rise. These pregnancies are characterized by an increased rate of maternal and perinatal complications, which can result in higher health care expenditures and altered pregnancy experiences. The purpose of this study is to integrally analyze maternity care for women with pre-existing conditions in the framework of a risk-adapted, interdisciplinary care by recording three substantial parts of maternity care: (1) maternal and perinatal outcome; (2) hospital costs and reimbursements covering the period from preconception counseling or initial antenatal visit to discharge after birth; and (3) women’s experience of reproductive choice and becoming a mother in the presence of a pre-existing condition.MethodsIn this observational, prospective, longitudinal, and monocentric cohort study, we aim to include a total of 1,500 women over a recruitment period of 15 months. Women registering for care at the Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Germany, are allocated to three groups based on their health and risk status: women with pre-existing conditions, as well as healthy women with obstetric risk factor and healthy women with a low-risk pregnancy. Participants are observed from time of initial consultation until discharge after birth. Analysis focuses on (1) maternal and perinatal outcome, especially rate of severe maternal and neonatal morbidity; (2) costs and reimbursements; and (3) surveys to capture of women’s experience and health-related quality of life during the time of reproductive choice, pregnancy, and childbirth in the presence of pre-existing medical conditions.DiscussionWith its complex three-dimensional design, the ForMaT-Trial is aiming to provide a comprehensive analysis of pregnancy and childbirth in women with pre-existing conditions. The results may serve as a basis for counseling and care of these women. By analyzing costs of specialized care, data for discussing reimbursement are generated. Lastly, our results may increase awareness for the perception of reproductive choice, pregnancy and motherhood in this continuously rising population.Clinical trial registration: German Clinical Trials Register, DRKS00030061, October 28, 2022.

IntroductionEstimated 50,000 minor children in Germany experience a newly diagnosed cancer in one of their parents every year. Family resilience has proven to be an important concept against life crises. However, little research exists regarding family resilience in the context of parental cancer with minor children. Based on the “Family Resilience Framework,” the aim of the study is to investigate the processes of family resilience of affected families. In addition, we explore which combinations of promoting family resilience processes can be characterized.MethodsAs part of the mixed-method quasi-experimental interventional study “F-SCOUT,” a qualitative content analysis was used to analyze the documentation of the “Family-Scouts” (a fixed contact person who advises, accompanies, and supports the families). Documentation was performed by families’ study inclusion (T0), after 3 months (T1) and 9 months (T2) concerning current family situation, organization of everyday life, emotional coping, open communication within the family, and planned tasks.ResultsThe N = 73 families had between one and six children. In 58 (79%) families, the mother had cancer. In the course of the analysis, a category system with 10 main categories and 36 subcategories emerged. Family resilience processes were described to different extents. Combinations of categories promoting family resilience were characterized by the use of social resources, flexibility, economic resources, and open communication.DiscussionThe findings are consistent with existing assumptions about family resilience in terms of the importance of social resources, family cohesion, mutual support, flexibility, open communication, and psychological well-being. In contrast to the findings of previous research, spirituality, and collaborative problem-solving indicate less centrality here. In turn, the findings on economic resources and information-seeking provide a valuable addition to the family resilience literature in the context of parental cancer with minor children.Clinical trial registrationClinicalTrials.gov, identifier NCT04186923.

Objective: To analyze the proportion of diabetes among all hospitalized cases in Germany between 2015 and 2020. Methods: Using the nationwide Diagnosis-Related-Groups statistics, we identified among all inpatient cases aged ≥ 20 years all types of diabetes in the main or secondary diagnoses based on ICD-10 codes, as well all COVID-19 diagnoses for 2020. Results: From 2015 to 2019, the proportion of cases with diabetes among all hospitalizations increased from 18.3% (3.01 of 16.45 million) to 18.5% (3.07 of 16.64 million). Although the total number of hospitalizations decreased in 2020, the proportion of cases with diabetes increased to 18.8% (2.73 of 14.50 million). The proportion of COVID-19 diagnosis was higher in cases with diabetes than in those without in all sex and age subgroups. The relative risk (RR) for a COVID-19 diagnosis in cases with vs without diabetes was highest in age group 40–49 years (RR in females: 1.51; in males: 1.41). Conclusions: The prevalence of diabetes in the hospital is twice as high as the prevalence in the general population and has increased further with the COVID-19 pandemic, underscoring the increased morbidity in this high-risk patient group. This study provides essential information that should help to better estimate the need for diabetological expertise in inpatient care settings.

Key points Patients with diabetes often have comorbid depression. Those patients are struggling to meet their treatment goals. Thus, they have a higher risk of getting diabetes related complications as for example coronary heart diseases. A lot of different tools and instruments are available to diagnose depression, to screen for depression among patients with diabetes or to identify depression symptoms or depressive disorder in clinical or epidemiological studies, including interview, questionnaires or claims data. It would be helpful to know if the tools that are used identify the same people or, if this is not the case, whether people identified by different tools have different characteristics or health outcomes. We found that different methods do not identify the same people with depression. There was no clear pattern of differences between the identified groups, however, we found some initial indications that the method chosen is related to particular underlying characteristics in the population identified. Further research with larger data sets is necessary to see if there are differences among the persons that are identified by different tools to give recommendations which screening tool to use for what purpose.

Abstract Background The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. Methods Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. Results There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as “good”, while for a PCS score above 40 there is a reverse effect. Conclusions The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

Abstract To investigate (i) the importance and priorities of research objectives for people with type 1 (T1DM) and type 2 diabetes (T2DM); (ii) subgroups with specific research priorities; (iii) associated factors (e.g., sociodemographic characteristics) of the subgroups. The cross-sectional survey was conducted in 2018 using data from 869 respondents (29.0% response, 31.2% female, mean age 61.3 years, 62.7% T2DM) from a German statutory health insurance population. Diabetes-related research priorities were assessed with a questionnaire. Subgroups and associated factors were identified using latent class analysis. Three subgroups were found in T1DM: (1) high priority for the research topic ‘healing diabetes’ and moderate priority for the research topic ‘prevention of long-term complications’, (2) priorities for simplifying handling (high) and stress reduction (moderate), (3) priorities for healing diabetes (high) and simplifying handling (high). Three subgroups were found in T2DM: (1) priorities for simplifying handling (moderate), diabetes prevention (moderate) and prevention of long-term complications (moderate), (2) priorities for stress reduction (high) and diabetes prevention (moderate), (3) priorities for simplifying handling (high) and stress reduction (high). Classes differed in age and HbA1c. Knowledge about research priorities enables researchers to align their work with the needs of people with diabetes.

Abstract Background The Calcaneus is the largest bone of the foot and the most frequent tarsal bone to be fractured. Overall, it causes round about 10 cases per 100,000 residents per year mainly in men. Especially displaced intra-articular calcaneus fractures often have early and late complications and its associated disability. There are various strategies for the treatment of displaced intra-articular calcaneus fractures, but the gold standard is still subject of a long-standing controversy. Minimally invasive procedures became more common in an attempt to reduce the high rate of complications associated with open reduction and internal fixation. With the increase in minimally invasive techniques, screw fixation also gained in significance. The current literature does not sufficiently elucidate whether the screw fixation is superior to other treatment options especially in relation to adverse events, health-related quality of life and postoperative pain. This study aims to investigate benefits and harms of treating displaced intra-articular calcaneus fractures (types II, III and IV according to Sanders) with screw fixation in adults. Methods A systematic review will be conducted based on the principles described in the Cochrane Handbook. We will include adults with displaced intra-articular calcaneus fractures of Sanders type II, III and IV. The surgical method of screw fixation shall be compared to other surgical interventions to stabilise calcaneus fractures. Primary outcomes are serious adverse events, health-related quality of life and postoperative pain level. MEDLINE, CENTRAL, CINAHL, Web of Science and bibnet.org, ClinicalTrial.gov and the World Health Organization International Clinical Trials Registry Platform (ICTR) will be searched. Screening and data extraction will be performed by two authors independently. A third author will arbitrate disputes. Risk of Bias will be assessed with the Cochrane tool. Meta-analysis will be performed if participants, interventions, comparisons and outcomes are sufficiently similar to ensure a result that is clinically meaningful. Discussion Due to the increasing use of minimally invasive techniques and the increasing use of screw fixation instead of open reduction and plate fixation, it is important to analyse the benefits and harms of screw fixation for calcaneus fractures. Screw fixation could, in the future, help to operate in a less invasive and tissue preserving manner while still achieving an adequate functional result for the patient Systematic review registration CRD42021244695

Abstract Background According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. Methods This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. Discussion This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. Trial registration ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

Background Since 2020, physicians and psychotherapists in Germany can prescribe digital mental health services (dMHSs). However, even future healthcare professionals (HCPs), such as medical and psychology students, remain reluctant to use dMHSs, although they are a risk group for mental health issues themselves. Reasons include scepticism and lacking awareness of dMHSs, which can be addressed by acceptance-facilitating interventions (AFIs) such as information strategies. To date, though, little is known about their information needs. Methods Semi-structured interviews with n = 21 students were conducted between August and September 2021. Students of legal age studying psychology or medicine at a German university could participate. Interview recordings were transcribed verbatim and content-analyzed according to Mayring, using deductive and inductive coding. Results Most students reported having little experience with dMHSs. Digital health has barely been raised in their study, even though it was perceived as crucial for personal needs as well as in preparation for their work as HCPs. Students favoured receiving information on and recommendations for dMHSs from their university via, e.g. social media or seminars. Among others, information about data safety, scientific evidence base and application scope were preferred. Additionally, information on costs as well as user reviews seemed to be essential components of information strategies because students were concerned that high costs or low usability would hinder uptake. Conclusions The results give first insights on how future HCPs would like to be informed on dMHSs. Future research should focus on systematic variations of AFIs' components mimicking real-world decision scenarios to increase the adoption of dMHSs.

Abstract Background Diabetes mellitus is an established risk factor for acute myocardial infarction (AMI). Incidence of AMI in people with diabetes remains significantly higher than in those without diabetes. However, published data are conflicting, and previous reviews in this field have some limitations regarding the definitions of AMI and source population (general population or people with diabetes as a population at risk) and concerning the statistical presentation of results. Aims To analyse the incidence of AMI in people with diabetes compared to those without diabetes and to investigate time trends. Methods We will perform a systematic literature search in MEDLINE, Embase and LILACS designed by an experienced information scientist. Two review authors will independently screen the abstracts and full texts of all references on the basis of inclusion criteria regarding types of study, types of population and the main outcome. Data extraction and assessment of risk of bias will be undertaken by two review authors working independently. We will assess incidence rate or cumulative incidence and relative risk of AMI comparing populations with and without diabetes. Discussion This review will summarise the available data concerning the incidence of AMI in people with and without diabetes and will thus contribute to the assessment and interpretation of the wide variations of incidence, relative risks and time trends of AMI in these populations. Systematic review registration PROSPERO CRD42020145562

Abstract Background Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. Methods Family-SCOUT is a project supported by the German Innovation Fund ( https://innovationsfonds.g-ba.de/ ). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher’s exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. Discussion The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. Trial registration ClinicalTrials.gov , NCT04186923. Retrospectively registered on 4 December 2019.

BackgroundThe World Health Organization recommends 150 minutes of moderate to vigorous physical activity (PA), which translates to approximately 7000 to 10,000 steps per day for adults. In Germany, less than half of the population in this age range meets this recommendation, highlighting the need for population-based intervention approaches for promoting daily PA. ObjectiveThe complex community-based PA intervention “10,000 Steps Ghent,” which was originally developed in Belgium and was shown to be effective for PA promotion, has been adapted for implementation and evaluation in 2 German cities. The original Belgian study is currently being replicated, and we aim to examine the effectiveness of the adapted intervention among adults living in intervention city districts in Duesseldorf when compared with those living in control city districts in Wuppertal, over the course of 1 year. MethodsA controlled intervention trial examining the effects of an intervention addressing multiple levels (eg, individual level: website; organizational level: PA promotion in companies; community level: media campaigns and environmental changes) is being conducted. PA and various secondary outcomes will be assessed in 2 random samples of adults aged 25 to 75 years (n=399 in each city) at baseline and after 1 year. ResultsFunding for this study was obtained in March 2020. Recruitment for this study and baseline data collection were conducted from May 2021 to March 2022 (as of March 2022, 626 participants were enrolled in the study). The intervention will be implemented in Duesseldorf for 1 year from April 2022 onward, and follow-up assessments will be conducted, starting in May 2023 (until September 2023). Data analysis will be performed in fall 2023, and the results will be published in spring 2024. ConclusionsTo our knowledge, this is the first research project (currently underway in Germany) that is aimed at replicating the effects of a complex intervention for PA promotion that was previously shown to be effective in another European country. Trial RegistrationGerman Clinical Trials Register DRKS00024873; https://tinyurl.com/4c9e8azh International Registered Report Identifier (IRRID)DERR1-10.2196/39175

Gestational diabetes mellitus (GDM) is an important risk factor for pregnancy complications. Since 2012, the Federal Joint Committee’s maternity directive recommends a two-step screening for GDM with a pre-test and subsequent diagnostic test if the pre-test is positive. This study analyses the implementation and development over time of GDM screening participation and prevalence in Germany. The data basis is the external inpatient obstetrics quality assurance documentation, which covers all births in hospital. Women with diabetes before pregnancy were excluded. The study defined women as GDM cases if the condition was documented in maternity records or if the ICD-10 diagnosis O24.4 was coded for inpatients at discharge and figures were determined for the years 2013 to 2018. As the documentation of screening tests has only been included in the data set since 2016, screening participation for the years 2016 to 2018 were estimated and evaluated based on the pre-test and/or diagnostic tests documented in maternity records. In 2018, the majority of all women who gave birth in hospitals had had a pre-test conducted (65.0%) or a pre-test and diagnostic test (18.2%) in line with the two-step procedure. A further 6.7% received a diagnostic test alone. GDM screening participation increased over time from 83.4% in 2016 to 89.9% in 2018. The prevalence of a documented GDM increased from 4.6% to 6.8% between 2013 and 2018. In 2018, this equates to 51,318 women with GDM. Reliably assessing the extent and causes of this development will require continuous analyses of screening implementation, documentation and changes in maternal risk factors.

Abstract Background Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients’ reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. Methods In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. Discussion To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. Trial registration ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.

Abstract Introduction Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. Methods The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. Discussion We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management. Trial registration ClinicalTrials.gov NCT04233970 . Registered on 18 January 2020

Abstract Background There is considerable evidence that repetitive negative thoughts are often associated with adverse health outcomes. The study aims are (i) to identify the frequency and valence of thoughts about health in people with diabetes mellitus using questions based on the day reconstruction method (DRM) and (ii) to analyse associations between thoughts about health and health-related quality of life (HRQoL), diabetes-related distress and depressive symptoms. Methods Cross-sectional study of a random sample of a German statutory health insurance population with diabetes aged between 18 and 80 linking questionnaire and claims data. Associations between frequency and valence of thoughts about health on a previous day and HRQoL assessed by a 12-Item Short-Form Health Survey, diabetes-related distress assessed using the Problem Areas in Diabetes scale and depressive symptoms assessed by Patient Health Questionnaire-9 were analysed using linear and logistic regression analysis, adjusting for sociodemographic and clinical characteristics. Results Thoughts about health were analysed in 726 participants (86% type 2 diabetes, 62% male, mean age 67.6 ± 9.7 years). A total of 46% had not thought about their health the day before, 17.1% reported low frequency and negative thoughts, 21.4% low frequency and positive thoughts, 12.1% high frequency and negative thoughts and 3.4% high frequency and positive thoughts. The presence of thoughts about health irrespective of their frequency and valence is associated with a lower physical and mental component summary score of the 12-Item Short-Form Health Survey. Negative thoughts are associated with high diabetes-related distress. Frequent or negative thoughts are associated with depressive symptoms. Conclusions Thoughts about health are a part of everyday life for a substantial number of people with diabetes. Surprisingly, even positive thoughts are associated with poorer HRQoL in our study. Further research within the DRM paradigm is needed to understand how thoughts about health may affect people’s (assessment of) state of health. Thoughts about health should be considered in diabetes education and patient counselling with a view to preventing and treating emotional disorders. More attention should be paid to the outcomes of interventions that may themselves lead to an increase in the frequency of thoughts about health.

Abstract Background Current evidence suggests that the information needs of people with diabetes mellitus differ across patient groups. With a view to being able to provide individualized information, this study aims to identify (i) the diabetes-related information needs of people with diabetes mellitus; (ii) different subgroups of people with specific information needs; and (iii) associated characteristics of the identified subgroups, such as sociodemographic characteristics, diabetes-related comorbidities, and well-being. Methods This cross-sectional study was based on data from 837 respondents with diabetes mellitus who participated in the population-based KORA (Cooperative Health Research in the Augsburg Region) Health Survey 2016 in Southern Germany (KORA GEFU 4 study) (45.6% female, mean age 71.1 years, 92.8% Type 2 diabetes). Diabetes-related information needs were assessed with a questionnaire asking about patients’ information needs concerning 11 diabetes-related topics, e.g. ‘long-term complications’ and ‘treatment/therapy’. Subgroups of people with different information needs and associated characteristics were identified using latent class analysis. Results We identified the following four classes of people with different information needs: ‘high needs on all topics’, ‘low needs on all topics’, ‘moderate needs with a focus on complications and diabetes in everyday life’, and ‘advanced needs with a focus on social and legal aspects and diabetes research’. The classes differed significantly in age, years of education, type of diabetes, diabetes duration, diabetes-related comorbidities, smoking behaviour, diabetes education, current level of information, and time preference. Conclusions Knowledge about different patient subgroups can be useful for tailored information campaigns or physician-patient interactions. Further research is needed to analyse health care needs in these groups, changes in information needs over the course of the disease, and prospective health outcomes.

Since the WHO’s “Influenza Pandemic Preparedness Plan” in 1999, pandemic preparedness plans at the international and national level have been constantly adapted with the common goal to respond early to outbreaks, identify risks, and outline promising interventions for pandemic containment. Two years into the COVID-19 pandemic, public health experts have started to reflect on the extent to which previous preparations have been helpful as well as on the gaps in pandemic preparedness planning. In the present commentary, we advocate for the inclusion of social and ethical factors in future pandemic planning—factors that have been insufficiently considered so far, although social determinants of infection risk and infectious disease severity contribute to aggravated social inequalities in health.

Abstract Background Pulmonary rehabilitation offers potential benefits to people with asthma. It is however unknown if rehabilitation favourably affects patients’ health care needs. We therefore examined if rehabilitation reduced needs and, in addition, if it improved asthma control. Methods One hundred fifty patients with asthma were surveyed in three rehabilitation clinics at admission and at discharge. Additionally, we surveyed 78 participants with asthma twice 4 weeks apart. The latter sample (i.e. the control group) was recruited through other pathways than rehabilitation clinics. The Patient Needs in Asthma Treatment (NEAT) questionnaire and the Asthma Control Test (ACT) were completed at baseline and follow-up. Differences between baseline and follow-up and between rehabilitation and control group were examined by t-tests and chi-squared-tests. Univariate ANCOVAS were used to examine if NEAT and ACT follow-up scores differed significantly between groups. Within the rehabilitation group, linear regressions were used to examine if self-reported utilization of more interventions that addressed needs were associated with NEAT scores at follow-up. Results At baseline, there were no differences between the rehabilitation and the control group regarding needs and asthma control. At follow-up, the rehabilitation group showed reduced needs (t(149) = 10.33, p

Abstract Background Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. Methods This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12 months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. Discussion This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. Trial registration German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

Introduction Diabetic sensorimotor polyneuropathy (DSPN) affects approximately 30% of people with diabetes, while around half of cases are symptomatic. Currently, there are only few pathogenetically oriented pharmacotherapies for DSPN, one of which is benfotiamine, a prodrug of thiamine with a high bioavailability and favourable safety profile. While benfotiamine has shown positive effects in preclinical and short-term clinical studies, no long-term clinical trials are available to demonstrate disease-modifying effects on DSPN using a comprehensive set of disease-related endpoints.Methods and analysis The benfotiamine on morphometric, neurophysiological and clinical measures in patients with type 2 diabetes trial is a randomised double-blind, placebo-controlled parallel group monocentric phase II clinical trial to assess the effects of treatment with benfotiamine compared with placebo in participants with type 2 diabetes and mild to moderate symptomatic DSPN. Sixty participants will be 1:1 randomised to treatment with benfotiamine 300 mg or placebo two times a day over 12 months. The primary endpoint will be the change in corneal nerve fibre length assessed by corneal confocal microscopy (CCM) after 12 months of benfotiamine treatment compared with placebo. Secondary endpoints will include other CCM measures, skin biopsy and function indices, variables from somatic and autonomic nerve function tests, clinical examination and questionnaires, general health, health-related quality of life, cost, safety and blood tests.Ethics and dissemination The trial was approved by the competent authority and the local independent ethics committee. Trial results will be published in peer-reviewed journals, conference abstracts, and via online and print media.Trial registration number DRKS00014832.

In den Bürgerwissenschaften, auch bekannt unter dem englischen Begriff Citizen Science, existiert eine Vielzahl an Forschungsansätzen und Methoden. Während diese in vielen wissenschaftlichen Disziplinen gut etabliert sind, finden sich augenscheinlich relativ wenige davon in der medizinischen und Gesundheitsforschung. Allerdings zeigt ein Blick in die Praxis, dass bürgerwissenschaftliche Ansätze in der Medizin und Gesundheitsforschung durchaus praktiziert werden, jedoch häufig unter anderen Namen. Der Artikel bietet aus interdisziplinärer Perspektive einen (selektiven) Überblick über Begriffe, reflektiert diese und die dahinterstehenden Methoden und diskutiert sie vergleichend. Im Fokus steht dabei der Grad der Beteiligung der Bürger*innen bzw. Patient*innen an wissenschaftlicher Forschung.

Introduction Women with gestational diabetes mellitus (GDM) have a higher risk of developing type 2 diabetes mellitus compared with women who never had GDM. Consequently, the question of structured aftercare for GDM has emerged. In all probability, many women do not receive care according to the guidelines. In particular, the process and interaction between obstetrical, diabetic, gynaecological, paediatric and general practitioner care lacks clear definitions. Thus, our first goal is to analyse the current aftercare situation for women with GDM in Germany, for example, the participation rate in aftercare diabetes screening, as well as reasons and attitudes stated by healthcare providers to offer these services and by patients to participate (or not). Second, we want to develop an appropriate, effective and patient-centred care model.Methods and analysis This is a population-based mixed methods study using both quantitative and qualitative research approaches. In various working packages, we evaluate data of the GestDiab register, of the Association of Statutory Health Insurance Physicians of North Rhine and the participating insurance companies (AOK Rheinland/Hamburg, BARMER, DAK Gesundheit, IKK classic, pronova BKK). In addition, quantitative (postal surveys) and qualitative (interviews) surveys will be conducted with randomly selected healthcare providers (diabetologists, gynaecologists, paediatricians and midwives) and affected women, to be subsequently analysed. All results will then be jointly examined and evaluated.Ethics and dissemination The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (Ethics Committee No.: 2019-738). Participants of the postal surveys and interviews will be informed in detail about the study and the use of data as well as the underlying data protection regulations before voluntarily participating. The study results will be disseminated through peer-reviewed journals, conferences and public information.Trial registration number DRKS00020283.

Following publication of the original article [1], the authors opted to revise Table 1. Below is the updated version of the table.

In addition to the Robert Koch Institute’s health surveys, analyses of secondary data are essential to successfully developing a regular and comprehensive description of the progression of diabetes as part of the Robert Koch Institute’s diabetes surveillance. Mainly, this is due to the large sample size and the fact that secondary data are routinely collected, which allows for highly stratified analyses in short time intervals. The fragmented availability of data means that various sources of secondary data are required in order to provide data for the indicators in the four fields of action for diabetes surveillance. Thus, a milestone in the project was to check the suitability of different data sources for their usability and to carry out analyses. Against this backdrop, co-operation projects were specifically funded in the context of diabetes surveillance. This article presents the results that were achieved in co-operation projects between 2016 and 2018 that focused on a range of topics: from evaluating the usability of secondary data to statistically modelling the development of epidemiological indices. Moreover, based on the data of the around 70 million people covered by statutory health insurance, an initial estimate was calculated for the documented prevalence of type 2 diabetes for the years 2010 and 2011. To comparably integrate these prevalences over the years in diabetes surveillance, a reference definition was established with external expertise.

Abstract Background Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study. Methods/design This multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65 years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level. The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level. The implementation strategy comprises a facilitators’ workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents’ participation and activities after 12 months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents’ quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost–utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation. Discussion We expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals. Trial registration DRKS, DRKS00015185. Registered on 1 August 2018. Universal Trial Number U1111–1218-1555. Registered on 26 July 2018.

Introduction Multiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1–2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS.Methods and analysis A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses.Ethics and dissemination The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars.Trial registration number ClinicalTrials.gov Registry (NCT03968172); Pre-results.

Abstract Background Caesarean sections (CSs) are associated with increased risk for maternal morbidity and mortality. The recommendations of the recently published German national health goal ‘Health in Childbirth’ (Gesundheit rund um die Geburt) promote vaginal births (VBs). This randomised controlled trial (RCT) evaluates the effects of a complex intervention pertaining to the birth environment, based on the sociology of technical artefacts and symbolic interactionism. The intervention is intended to foster an upright position and mobility during labour, which lead to a higher probability of VB. Methods/design This study is an active controlled superiority trial with a two-arm parallel design. The complex intervention involves making changes to the birthing room to encourage an upright position and mobility of women in labour and to relax them, which may help them to cope with labour and may increase self-determination. This may result in more VBs. Included in the study are primiparae and multiparae with a singleton foetus in cephalic presentation at term planning a VB. According to the sample size calculation, 3800 women in 12 obstetrical units are to be included. Randomisation will be performed centrally and controlled by an independent coordination centre. Blinding of participants and staff is not possible. Key outcomes are VB, episiotomy, perineal tears, epidural analgesia, critical outcome of newborn at term and maternal self-determination during birth. Additionally, a health economic evaluation will be performed. Discussion This is the first adequately powered multicentre RCT examining the effect of a redesigned birthing room on the probability of a VB and patient-centred physical and emotional outcomes. An increase in the number of VBs by 5% from a baseline of 74% to 79% would result in 21,000 women per year experiencing a VB rather than a CS in Germany. Expected benefits are greater self-determination during labour, improved physical and emotional client-centred outcomes, fewer medical interventions and a reduction in health-care costs. Trial registration German Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00012854. Registered on 7 March 2018.

Abstract Background The 20–70% participation of diabetes patients in lifestyle interventions (LSI) worldwide seems to be rather sub-optimal, in spite of all intents of such interventions to delay further progress of the disease. Positive effects through LSI are expected in particular for patients who suffer less from diabetes-related limitations or other chronic diseases. Seeing that diabetes prevalence and with it mortality are increasing, LSI have become an inherent part of diabetes treatment standards. Various qualitative studies have been carried out to identify participation barriers for LSI. However, these have not resulted in more detailed knowledge about the relative importance of factors with an inhibiting impact on participation. Since it cannot be assumed that all of the influencing factors have equivalent values, it is necessary to investigate their individual importance with regard to a positive or negative decision about participating. There are no systematic reviews on patient preferences for LSI programs in diabetes prevention. As a result, the main objectives of this systematic review are to (i) identify existing patient preference elicitation studies related to LSI for diabetic patients, (ii) summarize the methods applied and findings, and (iii) appraise the reporting and methodological quality of such studies. Methods We will perform systematic literature searches to identify suitable studies from 14 electronic databases. Retrieved study records will be included based on predefined eligibility criteria as defined in this protocol. We will run abstract and full-text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives, since no pooling for quantified preferences is for methodological reasons implementable. We will pay special attention to aspects of methodological quality of preference elicitation by applying established evaluation criteria of the ISPOR and some own developed criteria for different elicitation techniques. All critical stages within the screening, data extraction, and synthesis processes will be conducted by two pairs of authors. This protocol adheres to PRISMA and PRISMA-P standards. Discussion The proposed systematic review will provide an overview of the methods used and current practice in the elicitation and quantification of patients’ preferences for diabetes prevention lifestyle interventions. Furthermore, the methodological quality of the identified studies will be appraised as well. Systematic review registration PROSPERO CRD42018086988

Mainly because of the large number of people affected and associated significant health policy implications, the Robert Koch Institute (RKI) is developing a public health surveillance system using diabetes as an example. In a first step to ensure long-term and comparable data collection and establish efficient surveillance structures, the RKI has defined a set of relevant indicators for diabetes surveillance. An extensive review of the available literature followed by a structured process of consensus provided the basis for a harmonised set of 30 core and 10 supplementary indicators. They correspond to the following four fields of activity: (1) reducing diabetes risk, (2) improving diabetes early detection and treatment, (3) reducing diabetes complications, (4) reducing the disease burden and overall costs of the disease. In future, in addition to the primary data provided by RKI health monitoring diabetes surveillance needs to also consider the results from secondary data sources. Currently, barriers to accessing this data remain, which will have to be overcome, and gaps in the data closed. The RKI intentends to continuously update this set of indicators and at some point apply it also to further chronic diseases with high public health relevance.

Abstract Background Patients with type 2 diabetes mellitus (T2DM) with poor glycaemic control can represent a challenge from the perspective of the general practitioner (GP). Apart from patient-sided factors, the understanding of GPs’ attitudes may provide ideas for improved management in these patients. The aim of this study is to reveal attitudes of GPs towards T2DM patients with poor metabolic control. Methods Qualitative research in German general practice; 20 GPs, randomly chosen from participants of a larger study; in-depth narrative interviews, audio-recorded and transcribed; inductive coding and categorisation in a multi-professional team; abstraction of major themes in terms of attitudinal responses. Results 1) Orientation on laboratory parameters: GPs see it as their medical responsibility to achieve targets, which instil a sense of security. 2) Resignation: GPs believe their efforts are in vain and see their role as being undermined. 3) Devaluation of the patient: GPs blame the “non-compliance” of the patients and experience care as a series of conflicts. 4) Fixed role structure: The expert GP on the one hand, the ignorant patient on the other. 5) Solidarity with the patient: GPs appreciate a doctor-patient relationship in terms of partnership. Conclusions The conflict GPs experience between their sense of duty and feelings of futility may lead to perceptions such as personal defeat and insecurity. GPs (and patients) may benefit from adjusting the patient-doctor relationship with regard to shared definitions of realistic and authentic goals.

Abstract Background The purpose of this study was to identify and analyse currently available knowledge on information needs of people with diabetes mellitus, also considering possible differences between subgroups and associated factors. Methods Twelve databases including MEDLINE, EMBASE and the Cochrane Library were searched up until June 2015. Publications that addressed self-reported information needs of people with diabetes mellitus were included. Each study was assessed by using critical appraisal tools, e.g. from the UK National Institute for Health and Care Excellence. Extraction and content analysis were performed systematically. Results In total, 1993 publications were identified and 26 were finally included. Nine main categories of information needs were identified, including ‘treatment-process’, ‘course of disease’, ‘abnormalities of glucose metabolism’ and ‘diabetes through the life cycle’. Differences between patient subgroups, such as type of diabetes or age, were sparsely analysed. Some studies analysed associations between information needs and factors such as participation preferences or information seeking. They found, for example, that information needs on social support or life tasks were associated with information seeking in Internet forums. Conclusion Information needs in people with diabetes mellitus, appear to be high, yet poorly investigated. Research is needed regarding differences between diverse diabetes populations, including gender aspects or changes in information needs during the disease course. Systematic review registration The review protocol has been registered at Prospero (CRD42015029610).

Abstract Background Type 2 diabetes mellitus (T2DM), a highly prevalent chronic disease, puts a large burden on individual health and health care systems. Computer simulation models, used to evaluate the clinical and economic effectiveness of various interventions to handle T2DM, have become a well-established tool in diabetes research. Despite the broad consensus about the general importance of validation, especially external validation, as a crucial instrument of assessing and controlling for the quality of these models, there are no systematic reviews comparing such validation of diabetes models. As a result, the main objectives of this systematic review are to identify and appraise the different approaches used for the external validation of existing models covering the development and progression of T2DM. Methods We will perform adapted searches by applying respective search strategies to identify suitable studies from 14 electronic databases. Retrieved study records will be included or excluded based on predefined eligibility criteria as defined in this protocol. Among others, a publication filter will exclude studies published before 1995. We will run abstract and full text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives. We will pay special attention to aspects of quality of these models in regard to the external validation based upon ISPOR and ADA recommendations as well as Mount Hood Challenge reports. All critical stages within the screening, data extraction and synthesis processes will be conducted by at least two authors. This protocol adheres to PRISMA and PRISMA-P standards. Discussion The proposed systematic review will provide a broad overview of the current practice in the external validation of models with respect to T2DM incidence and progression in humans built on simulation techniques. Systematic review registration PROSPERO CRD42017069983 .

Correction During the production process for this article [1] some errors were introduced into Table 2. The correct version of Table 2 can be found below; the original article [1] has also been updated with the correct version of Table 2. BMC apologises to the authors and to readers for this error.

Abstract Background The use of multiple licit and illicit substances plays an important role in many university students’ lives. Previous research on multiple substance use patterns of university students, however, often fails to examine use of different illicit substances and/or hookah. Our objective was to complement and advance the current knowledge about common consumption patterns regarding illicit substances and hookah use in this group. Methods Students from eight German universities completed an online survey as part of the INSIST study (‘INternet-based Social norms Intervention for the prevention of substance use among STudents’) regarding their consumption of alcohol, tobacco, hookah, cannabis and other illicit substances. Cluster analysis identified distinct consumption patterns of concurrent and non-concurrent substance use and multinomial logistic regressions described key sociodemographic factors associated with these clusters. Results Six homogeneous groups were identified: ‘Alcohol Abstainers’ (10.8%), ‘Drinkers Only’ (48.2%), ‘Drinkers and Cigarette Smokers’ (14.6%), ‘Cannabis and Licit Substance Users’ (11.2%), ‘Hookah Users with Co-Use’ (9.8%) and ‘Illicit Substance Users with Co-Use’ (5.4%). Illicit substance use clustered with the consumption of alcohol, tobacco and cannabis. Hookah use was regularly associated with alcohol consumption, less commonly associated with tobacco or cannabis use and very rarely associated with use of other illicit substances. Individuals consuming licit and illicit substances or hookah were mostly male and lived together with other students. Characteristics such as the number of years an individual had spent studying at a university, subject of study, immigrant background and religious affiliation were less commonly associated with cluster membership. Conclusions Although we found substance use patterns in our sample largely similar to previous reports, we identified an important subgroup of individuals using both illicit and licit substances. These individuals may benefit especially from targeted interventions that focus on modifying addictive behavior patterns. Trial registration DRKS00007635 . Registered 17 December 2014 (retrospectively registered).

Abstract Background Information-seeking behaviour is necessary to improve knowledge on diabetes therapy and complications. Combined with other self-management skills and autonomous handling of the disease, it is essential for achieving treatment targets. However, a systematic review addressing this topic is lacking. The aims of this systematic review were to identify and analyse existing knowledge of information-seeking behaviour: (1) types information-seeking behaviour, (2) information sources, (3) the content of searched information, and (4) associated variables that may affect information-seeking behaviour. Methods The systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) requirements. MEDLINE, CINAHL, EMBASE, ScienceDirect, PsycInfo, Cochrane Library, Web of Science, CCMed, ERIC, Journals@OVID, Deutsches Ärzteblatt and Karlsruher virtueller Katalog (KvK) databases were searched. Publications dealing with information-seeking behaviour of people with diabetes mellitus published up to June 2015 were included. A forward citation tracking was performed in September 2016 and June 2017. Additionally, an update of the two main databases (MEDLINE, CINAHL) was conducted, considering studies published up to July 2017. Studies published in languages other than English or German were excluded, as well as letters, short reports, editorials, comments and discussion papers. A study selection and the critical appraisal of the selected studies were performed independently by two reviewers. A third reviewer was consulted if any disagreement was found. Data extraction and content analysis were performed using selected dimensions of Wilson’s ‘model of information behaviour’. Results Twenty-six studies were included. Five ‘types of information-seeking behaviour’ were identified, e.g. passive and active search. The ‘Internet’ and ‘healthcare professionals’ were the most frequently reported sources. ‘Diet’, ‘complications’, ‘exercise’ and ‘medications and pharmacological interactions’ were the most frequently identified content of information. Seven main categories including associated variables were identified, e.g. ‘socioeconomic’, ‘duration of DM’, and ‘lifestyle’. Conclusion The systematic review provides a valuable overview of available knowledge on the information-seeking behaviour of people with diabetes mellitus, although there are only a few studies. There was a high heterogeneity regarding the research question, design, methods and participants. Although the Internet is often used to seek information, health professionals still play an important role in supporting their patients’ information-seeking behaviour. Specific needs of people with diabetes must be taken into consideration. Systematic review registration PROSPERO CRD42016037312

IntroductionProximal femoral fractures (PFF) are among the most frequent fractures in older people. However, the situation of people with a PFF after hospital discharge is poorly understood. Our aim is to (1) analyse healthcare provision, (2) examine clinical and patient-reported outcomes (PROs), (3) describe clinical and sociodemographic predictors of these and (4) develop an algorithm to identify subgroups with poor outcomes and a potential need for more intensive healthcare.Methods and analysisThis is a population-based prospective study based on individually linked survey and statutory health insurance (SHI) data. All people aged minimum 60 years who have been continuously insured with the AOK Rheinland/Hamburg and experience a PFF within 1 year will be consecutively included (SHI data analysis). Additionally, 700 people selected randomly from the study population will be consecutively invited to participate in the survey. Questionnaire data will be collected in the participants’ private surroundings at 3, 6 and 12 months after hospital discharge. If the insured person considers themselves to be only partially or not at all able to take part in the survey, a proxy person will be interviewed where possible. SHI variables include healthcare provision, healthcare costs and clinical outcomes. Questionnaire variables include information on PROs, lifestyle characteristics and socioeconomic status. We will use multiple regression models to estimate healthcare processes and outcomes including mortality and cost, investigate predictors, perform non-responder analysis and develop an algorithm to identify vulnerable subgroups.Ethics and disseminationThe study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (approval reference 6128R). All participants including proxies providing written and informed consent can withdraw from the study at any time. The study findings will be disseminated through scientific journals and public information.Trial registration numberDRKS00012554.

An amendment to this paper has been published and can be accessed via the original article.