Pressure to provide milk among mothers of very low birth weight infants: an explorative study.

BACKGROUND: Pump-dependent mothers of very low birth weight (VLBW, < 1500g) infants experience specific challenges achieving sufficient milk supply in the neonatal intensive care unit (NICU) and are therefore less frequently able to achieve (exclusive) breast milk feeding. Stress due to the limitations on participating in the infant's care may contribute to this problem. Some explorative studies suggest that pressure to provide milk may be an additional stressor in mothers. However, the type of pressure to provide milk perceived by mothers of VLBW infants has rarely been examined. METHODS: A retrospective and anonymous questionnaire was conducted with mothers of VLBW infants aged 6 to 24 months at the time of data collection. Quantitative data and written comments were used to examine the mothers' perceptions. Descriptive and bivariate tests (Spearman´s rho, Pearson's chi2) were performed to show correlations between pressure to provide breast milk, parental stress (PSS:NICU: role alteration subscale), milk volume, and maternal factors. Pressure to provide milk was measured through two self-developed single items to differentiate between internal and external pressures. RESULTS: Data of n = 533 mothers of VLBW infants was analysed. More than 70% of the mothers agreed that they pressured themselves to provide milk for their infant. In contrast, 34% of the mothers agreed that they felt pressure from outside to provide milk. Higher milk volume 14 days post-partum was significantly correlated with higher internal (Spearman´s rho = 0.2017, p = 0.000) and higher external pressure to provide milk (Spearman´s rho = 0.2991; p = 0.000). Higher PSS:NICU parental role alteration scores were significantly correlated with more internal (Spearman´s rho = -0.2865, p = 0.000) and more external pressure to provide milk (Spearman´s rho = -0.1478; p = 0.002). Milk volume 14 days post-partum and the PSS:NICU were not significantly correlated (Spearman´s rho = -0.0190; p = 0.701). Qualitative analyses highlighted these results and enhanced the bidirectional relationships between maternal pressure to provide milk and milk volume. CONCLUSIONS: Especially internal pressure to provide milk is perceived by many mothers, being mutually dependent on milk supply and parental stress. Pressure to provide milk may be an important factor to decrease maternal stress in the NICU and, therefore, lead to more positive pumping and breastfeeding experiences. More research and validated instruments are needed to adequately measure pressure to provide milk with its different psychological, social, and environmental dimensions.

Safety and survival of docetaxel and cabazitaxel in metastatic castration-resistant prostate cancer.

OBJECTIVES: To investigate real-world haematological toxicity, overall survival (OS) and the treatment characteristics of docetaxel and cabazitaxel chemotherapy in metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This retrospective claims data study followed patients with mCRPC receiving cabazitaxel or docetaxel from their first chemotherapy infusion. Haematological toxicities were measured using treatment codes and inpatient diagnoses. OS was estimated using the Kaplan-Meier method. A multivariable Cox regression analysis was used to identify OS predictors. RESULTS: Data from 539 patients administered docetaxel and 240 administered cabazitaxel were analysed. Regarding adverse events, within 8 months of treatment initiation, some kind of treatment for haematological toxicity was documented in 31% of patients given docetaxel and in 61% of patients given cabazitaxel. In the same period, hospitalization associated with haematological toxicity was documented in 11% of the patients in the docetaxel cohort and in 15% of the patients in the cabazitaxel cohort. In the docetaxel cohort, 9.9% of patients required reverse isolation and 13% were diagnosed with sepsis during hospitalization. In the cabazitaxel cohort, the cumulative incidence was 7.9% and 15%, respectively. The median OS was reached at 21.9 months in the docetaxel cohort and, because of a later line of therapy, at 11.3 months in the cabazitaxel cohort. A multivariate Cox regression revealed that indicators of locally advanced and metastatic disease, severe comorbidities, and prior hormonal/cytotoxic therapies were independent predictors of early death. CONCLUSION: Cabazitaxel patients face an increased risk of haematological toxicities during treatment. Together with their short survival time, this calls for a strict indication when using cabazitaxel in patients with mCRPC.

Regional variation in coronary angiography rates: the association with supply factors and the role of indication: a spatial analysis.

BACKGROUND: Coronary angiographies (CAs) are among the most common diagnostic procedures carried out in German hospitals, and substantial regional differences in their frequency of use have been documented. Given the heterogeneity with regard to the expected benefits and the varying scope for discretion depending on the indication for the procedure, we hypothesized that the observed variation and the association of need and supply factors differs by indication for CA. METHODS: We investigated the correlation between supply factors and the regional rates of CAs in Germany while controlling for need using spatial-autoregressive error models (SARE) and spatial cross-regressive models with autoregressive errors (SCRARE). The overall rates of CAs and the rates in specific patient subgroups, namely, patients with and without myocardial infarction (MI), were calculated based on a comprehensive set of nationwide routine data from three statutory health insurances at the district level. RESULTS: Although little variation was found in cases with MI, considerable variation was seen in the overall cases and cases without MI. The SARE models revealed a positive association between the number of hospitals with a cardiac catheterization laboratory per 10,000 population and the rates of overall cases and cases without MI, whereas no such relationship existed in cases with MI. Additionally, an association between regional deprivation and the rates of CAs was found in cases with MI, but no such association was seen in cases without MI. CONCLUSIONS: The results supported the hypothesis that the relative association of need and supply factors differed by the indication for CA. Although the regional differences in the frequency of use of CAs can only be explained in part by the factors examined in our study, it offers insight into patient access to and the provision of CA services and can provide a platform for further local research.

Parental preference for webcams in neonatal intensive care units: an indicator of lacking trust?

BACKGROUND: Some neonatal intensive care units offer parents webcam systems for times when they cannot be in the ward. Leaving an infant in the ward can be challenging for parents, and trust in the neonatal healthcare professionals mitigates parents' worries of not knowing how their infant is doing while they are away. If parents lack trust in the neonatal healthcare professionals, they may attempt to compensate by using webcams. In this work, we examine whether an association exists between the parental preference to use a webcam and low trust in physicians and nursing staff. METHODS: In a nationwide, retrospective cross-sectional study, parents of infants with a birth weight below 1500 g were surveyed six to 18 months after their infant's birth. Parents who were not offered a webcam system in the ward were asked whether they would have opted for it. Trust was measured by the Trust in Physician and Trust in Nursing Staff scales. RESULTS: Of the parents who were not offered a webcam, 69% would have chosen to use a webcam if they had been granted the opportunity. The decision for or against a webcam was not significantly associated with either trust in physicians (OR = 0.654, 95% CI = 0.456, 0.937, p = .124) or trust in nursing staff (OR = 1.064, 95% CI = 0.783, 1.446, p = .932). CONCLUSIONS: While the majority of parents surveyed would opt for webcam usage, this preference should not be interpreted as an indicator of lacking trust in neonatal healthcare professionals.

Trust in medical professionals and its influence on the stress experience of parents of premature infants.

AIM: To examine parents' perceptions of stress and their trust in physicians and nursing staff and to investigate whether trust influences the parental perceptions of potential stressors resulting from their infant's hospitalisation in a neonatal intensive care unit. METHODS: Parents of very and extremely low birth weight infants were surveyed in a nationwide retrospective cross-sectional study 6-18 months after their child's birth. Parental stress was measured utilising the PSS:NICU_German/2-scales, and trust was measured by the scales Trust in Physicians and Trust in Nursing Staff. In addition to descriptive analyses, multiple linear regression models were conducted. RESULTS: The change in parents' anticipated roles was assessed as more stressful than their infant's appearance and behaviour. Trust in nursing staff significantly influenced the parental stress level. Although the level of trust in physicians was rated higher than trust in nursing staff, trust in physicians did not yield a significant effect on the parental stress experience. CONCLUSION: Efforts to foster parental trust in nursing staff may reduce the parental stress level and hence enable parents to better cope with the situation. The parental resources unleashed in this way can be employed to enhance parenting.

Health Care Analysis on Myocardial Revascularization in Patients with Chronic Coronary Artery Disease: The Multicenter REVASK Study: Design and Protocol.

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are available for revascularization of coronary artery disease (CAD) with the aims to reduce cardiovascular morbidity and mortality and to improve disease-related quality of life in particular. The German National Care Guideline (NVL-cKHK) on chronic CAD recommends the establishment of so-called heart teams for decision making in myocardial revascularization to improve the quality of care. Preferred recommendations for PCI or CABG are given for different patient subgroups depending on patient characteristics, concomitant diseases, and coronary morphology. The myocardial revascularization study (REVASK) is a noninterventional cohort study on care of patients undergoing PCI or CABG based on retrospective statutory health insurance (SHI) routine data, registry data from the German Cardiac Society (DGK) resp., the German Society for Thoracic and Cardiovascular Surgery (DGTHG), combined with prospective primary data collection from health care providers and patients. The primary goal is to investigate whether and to which extent heart teams, consisting of cardiologists and cardiac surgeons, increase guideline adherence in decision making for myocardial revascularization. Ultimately the study project aims to improve patient care in terms of decision making for appropriate myocardial revascularization. Through the consistent implementation of the German National Care Guideline on chronic Coronary Artery Disease (NVL-cKHK) and the European Guidelines on myocardial revascularization, the reduction of morbidity, mortality and the reduced need for subsequent revascularization procedures are also desirable from a health economics perspective.

The effects of webcams on German neonatal intensive care units - study protocol of a randomised crossover trial (Neo-CamCare).

BACKGROUND: The separation of parents and their prematurely born children during care in a neonatal intensive care unit (NICU) can have far-reaching consequences for the well-being of the parents and also of the children. The aim of this study is to evaluate the use of webcams on NICUs and to conduct a systematic assessment of their possible effects on parents and clinical staff. In addition, it aims at determining the need for webcams  in German NICUs and to identify possible barriers and moderators. The development and evaluation of practical guidance for the use of webcams will enable the comprehensive education of clinical staff and parents and, as a result, is intended to mitigate any potential undesirable consequences. METHODS: The study will be based on a mixed methods approach including all groups concerned in the care. Qualitative data will be collected in interviews and focus groups and evaluated using content analysis. The collection of quantitative data will be based on written questionnaires and will aim to assess the status quo as regards the use of webcams on German NICUs and the effects on parents, physicians, and nursing staff. These effects will be assessed in a randomised cross-over design. Four NICUs will be involved in the study and, in total, the parents of 730 premature babies will be invited to take part in the study. The effects on the nursing staff, such as additional workload and interruptions in workflows, will be evaluated on the basis of observation data. DISCUSSION: This study will be the largest multicentre study known to us that systematically evaluates the use of webcams in neonatal intensive care units. The effects of the  implementation of webcams on both parents and care providers will be considered. The results provide evidence to decide whether to promote the use of webcams on NICUs or not and what to consider when implementing them. TRIAL REGISTRATION: The trial has been registered at the German Clinical Trial Register (DRKS). Number of registration: DRKS00017755 , date of registration: 25.09.2019.

Use of over-the-scope clips in the colon in clinical practice: results from a German administrative database.

BACKGROUND : The efficacy and safety of over-the-scope (OTS) clips in the colon is limited. This study aimed to evaluate OTS clip use in the colon in routine colonoscopy. METHODS: Using administrative data from a large health insurance company, patients with OTS clip placement during colonoscopy were identified and analyzed by specific administrative codes. Indication for OTS clipping was analyzed, and follow-up was evaluated for surgical and repeat endoscopic interventions. RESULTS: In 505 patients, indications for OTS clips were iatrogenic perforations (n = 80; Group A), polypectomy (n = 315; Group B), colonic bleeding (n = 51; Group C), and various underlying diseases (n = 59; Group D). In 11 Group A patients (13.8 %), surgical interventions occurred, mostly within 24 hours after clipping (n = 9), predominantly overstitching (n = 8). OTS clipping during polypectomy (Group B) was for complications (e. g. bleeding in 27 %) or was applied prophylactically. Only five patients required early surgery, three of whom had colorectal cancer. In four Group C patients (7.8 %), surgical resections were performed (persistent bleeding n = 1, colorectal cancer n = 2), while six patients underwent early repeat colonoscopy for recurrent bleeding. During further follow-up (days 11-30), 17 patients underwent resection for colonic neoplasms (n = 12) or persistent bleeding (n = 4), but only one case could be directly traced back to local OTS clip complication. CONCLUSION: Colonic OTS clipping appears safe and effective in selected indications and complications in clinical routine but must be anatomically and technically feasible, avoiding overuse.

[Good Practice Data Linkage]. / Gute Praxis Datenlinkage (GPD).

Individual data linkage of different data sources for research purposes is being increasingly used in Germany in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to define such methodological standards for research projects. Another aim is to provide readers with a checklist for critical appraisal of research proposals and articles. Since 2016, an expert panel of members of different German scientific societies have worked together and developed 7 guidelines with a total of 27 practical recommendations. These recommendations include (1) research aims, questions, data sources and resources, (2) infrastructure and data flow, (3) data privacy, (4) ethics, (5) key variables and type of linkage, (6) data validation/quality assurance and (7) long-term use for future research questions. The authors provide a rationale for each recommendation. Future revisions will include any new developments in science and data privacy.

[Percutaneous coronary interventions : Use between 2004 and 2012 in Germany]. / Perkutane koronare Interventionen : Einsatz zwischen 2004 und 2012 in Deutschland.

BACKGROUND AND OBJECTIVE: Percutaneous coronary interventions (PCIs) are increasingly being performed in the treatment of coronary artery disease. The aim of this study is to describe the frequency of PCIs by age, sex, type, and setting of the intervention in Germany. METHODS: Based on routine data of more than eight million insurants from three statutory health insurance funds, quarterly sex- and age-specific intervention rates were calculated between 2004 and 2012. Moreover, inpatient PCIs were subdivided into PCIs with conventional bare metal stents (BMS) and PCIs with drug-eluting stents (DES). Rates were age- and sex-standardized according to the age and sex distribution of the particular years in Germany. RESULTS: Standardized rates increased from 277.3 to 382.2 per 100,000 person-years between 2004 and 2012. The intervention rate was three times higher in men than in women. The relative increase in the overall rate and in the rate of PCI with DES during the study period were 38 and 548 % respectively, whereas the rate of PCI with BMS declined by 48 %. Of all PCIs, 7-11 % were outpatient PCIs during the study period. CONCLUSIONS: PCIs are increasingly being performed in Germany, particularly PCI with DES. The frequency of PCI with BMS implantation is decreasing. Sex-specific differences in the frequency of PCI go beyond differences that would have been expected because of a differing morbidity profile. Our analyses indicate that comparatively few outpatient PCIs are performed.

Health literacy in patients with pulmonary embolism: development and validation of the HeLP (Health Literacy in Pulmonary Embolism)-Questionnaire.

Background: Pulmonary embolism (PE) is a common cardiovascular disease and health literacy is necessary to deal with its consequences after the acute event. The aim of this study was to develop and validate a new questionnaire to measure PE-specific health literacy. Methods: A mixed-methods design with qualitative and quantitative elements was used in the development process. A literature review about health literacy concepts and instruments and interviews with patients with PE and clinicians were conducted. Quantitative analyses included factor analyses, item response theory with a graded partial credit model, and reliability analyses in different test and validation samples. Furthermore, convergent and known-groups validity and responsiveness were assessed. Results: The qualitative results supported a concept of PE-related health literacy with four main topics: dealing with PE-related health information, disease management, health-related selfcare, and social support. An initial item pool of 91 items was developed. Further interviews and an online survey with patients with PE (n = 1,013) were used to reduce the number of items and to confirm structural validity. Confirmatory factor analyses in the final evaluation study with patients with PE (n = 238) indicated a good model fit of the four-factor structure. The Health Literacy in Pulmonary Embolism (HeLP)-Questionnaire showed good reliability (Cronbach's alpha: 0.82 to 0.90). All four subscales were responsive toward receiving a brochure with PE-related health information. Conclusion: The newly developed German HeLP Questionnaire comprises 23 items in four domains and showed good psychometric properties. Further evaluation of the questionnaire in different samples of patients with PE is needed.

The Abdominal Pain Unit (APU). Study protocol of a standardized and structured care pathway for patients with atraumatic abdominal pain in the emergency department: A stepped wedged cluster randomized controlled trial.

This study aims to improve emergency department (ED) care for patients suffering from atraumatic abdominal pain. An application-supported pathway for the ED will be implemented, which supports quick, evidence-based, and standardized diagnosis and treatment steps for patients with atraumatic abdominal pain at the ED. A mixed-methods multicentre cluster randomized controlled stepped wedge trial design will be applied. A total of 10 hospitals with EDs (expected n = 2.000 atraumatic abdominal pain patients) will consecutively (every 4 months) be randomized to apply the intervention. Inclusion criteria for patients are a minimum age of 18 years, suffering from atraumatic abdominal pain and being insured with a German statutory health insurance. Primary outcomes: acute pain score at time of discharge from ED, duration of treatment at the ED, patient-reported satisfaction. Secondary endpoints include patient safety and quality of care parameters, process evaluation parameters, and costs and cost-effectiveness parameters. Quantitative data will be gathered from patient-surveys, clinical records, and routine data from hospital information systems as well as from a participating German statutory health insurance. Descriptive and analytic statistical analysis will be performed to provide summaries and associations for primary patient-reported outcomes, process measures, quality measures, and costs. Qualitative data collection consists of participatory patient observations and semi-structured expert interviews, which will be inductively analysed. Findings will be disseminated in publications in peer-reviewed journals, on conferences, as well as via a project website. To ensure data protection, appropriate technical and organisational measures will be taken. Trial registration: DRKS00021052.

Treatment-Related Healthcare Costs of Metastatic Castration-Resistant Prostate Cancer in Germany: A Claims Data Study.

PURPOSE: Treatments for patients with metastatic castration-resistant prostate cancer (mCRPC) have expanded rapidly. They include the chemotherapies docetaxel and cabazitaxel, hormonal drugs abiraterone and enzalutamide, and best supportive care (BSC). Cabazitaxel has proven to be the last life-prolonging option, associated with a significant risk of serious adverse events. Given the lack of real-world evidence, we aimed to compare healthcare resource utilization (HRU) and costs in patients with mCRPC treated with cabazitaxel, docetaxel, abiraterone, enzalutamide, and BSC. METHODS: We used 2014-2017 claims data from a large German statutory health insurance fund, the Techniker Krankenkasse, to identify patients with mCRPC. Patient allocation to individual therapy regimens was based on clinical knowledge and included therapy cycles, duration of therapy, and continuous treatment. The study period lasted from the first claim until death, the end of data availability, a drug switch, or discontinuation of therapy, whichever came first. Multivariate regression models were used to compare monthly all-cause and mCRPC-related HRU and costs across cohorts by adjusting for baseline covariates (including age and comorbidities). RESULTS: The 3944 identified patients with mCRPC initiated treatment with cabazitaxel (n = 240), docetaxel (n = 539), abiraterone (n = 486), enzalutamide (n = 351), or BSC (n = 2328). In most domains, HRU was highest in the cabazitaxel cohort and lowest in the BSC group. Accordingly, the highest all-cause and mCRPC-related costs per month, respectively, were observed in patients receiving cabazitaxel (€7631/€6343), followed by abiraterone (€5226/€4579), enzalutamide (€5079/€4416), docetaxel (€2392/€1580), and BSC (€959/€438). Cost variations were mostly attributable to drugs, inpatient treatment, and sick leave payments. CONCLUSION: mCRPC treatment imposes a high economic burden on statutory health insurance. Cabazitaxel is associated with substantially higher expenses, resulting from higher drug costs and a greater need for inpatient treatment. As mCRPC continues to be incurable, decision makers and clinician leaders should carefully evaluate public access to innovative agents and optimal treatment strategies.

Follow-up of 3 Million Persons Undergoing Colonoscopy in Germany: Utilization of Repeat Colonoscopies and Polypectomies Within 10 Years.

INTRODUCTION: Given the sparsity of longitudinal studies on colonoscopy use, we quantified utilization of repeat colonoscopy within 10 years and the proportion of persons with polypectomies at first repeat colonoscopy using a large German claims database. METHODS: Based on the German Pharmacoepidemiological Research Database, we identified persons who underwent colonoscopy between 2006 and 2015 (index colonoscopy) and assessed colonoscopies and polypectomies during follow-up. We defined 3 subcohorts based on available procedure/diagnosis codes at index colonoscopy: persons with snare polypectomy, which is reimbursable for lesions ≥5 mm in size (cohort 1), with a forceps polypectomy (cohort 2), and without such procedures/diagnoses (cohort 3). We stratified all analyses by diagnostic vs screening index colonoscopy. RESULTS: Overall, we included 3,076,657 persons (cohort 1-3: 15%, 13%, 72%). Among persons with screening index colonoscopy (30%), the proportions with a repeat colonoscopy within 10 years in cohorts 1, 2, and 3 were 78%, 66%, and 43%, respectively, and a snare polypectomy at first repeat colonoscopy was performed in 27%, 17%, and 12%, respectively. In cohort 1, 32% of persons with a (first) repeat colonoscopy after 9 years had a snare polypectomy (after 3 years: 25%). Among persons with diagnostic index colonoscopies, 80%, 78%, and 65% had a repeat colonoscopy, and 27%, 17%, and 10% had a snare polypectomy at first repeat colonoscopy, respectively. DISCUSSION: Our study suggests substantial underuse of repeat colonoscopy among persons with previous snare polypectomy and overuse among lower risk groups. One-quarter of persons with a snare polypectomy at baseline had another snare polypectomy at first repeat colonoscopy.

Use of guideline-recommended drug therapy in patients undergoing percutaneous coronary intervention for stable coronary heart disease in Germany: a multilevel analysis of nationwide routine data.

OBJECTIVES: To determine the prescription of guideline recommended drug therapy in patients with stable coronary heart disease (sCHD) prior to percutaneous coronary intervention (PCI) in Germany and to examine the role of patient characteristics and features of regional healthcare supply in a multilevel model. DESIGN: Secondary data analysis of factors associated with the prescription of guideline recommended drug therapy using a multilevel model to analyse regional-level effects, over and above the effects of patient-level demographic and health status. SETTING: Office-based prescriptions in the year prior to the invasive procedure. PARTICIPANTS: A linked nationwide dataset from Germany's three largest statutory health insurance funds of all patients receiving PCI in the year 2016. MAIN OUTCOME MEASURES: Patients' odds of receiving optimal medical therapy and symptom-oriented therapy within 1 year prior to PCI. RESULTS: 68.6% of patients received at least one lipid-lowering drug and one symptom-oriented therapy prior to PCI. 43.6% received at least two agents to control their symptoms. Patients who received treatment in accordance with the recommendations had a greater number of diagnosed risk factors, a more severe history of cardiac disease and used a higher volume of ambulatory office-based physician services. The prescriptions prevalence for the symptom-oriented therapies differed significantly between eastern and western Germany, with a higher prevalence in the eastern districts. CONCLUSIONS: Guidelines can only provide decision-making corridors, and the applicability of recommendations must always be assessed on a case by case basis. Nevertheless, our analysis indicates that the prevalence of prescriptions in routine practice is subject to substantial variation and that conservative therapy options are not fully exhausted prior to PCI. This suggests that there might be room for improvement in the care of patients with sCHD.

Evaluation of outcome relevance of quality indicators in the emergency department (ENQuIRE): study protocol for a prospective multicentre cohort study.

INTRODUCTION: Quality of emergency department (ED) care affects patient outcomes substantially. Quality indicators (QIs) for ED care are a major challenge due to the heterogeneity of patient populations, health care structures and processes in Germany. Although a number of quality measures are already in use, there is a paucity of data on the importance of these QIs on medium-term and long-term outcomes. The evaluation of outcome relevance of quality indicators in the emergency department study (ENQuIRE) aims to identify and investigate the relevance of QIs in the ED on patient outcomes in a 12-month follow-up. METHODS AND ANALYSIS: The study is a prospective non-interventional multicentre cohort study conducted in 15 EDs throughout Germany. Included are all patients in 2019, who were ≥18 years of age, insured at the Techniker Krankenkasse (statutory health insurance (SHI)) and gave their written informed consent to the study.The primary objective of the study is to assess the effect of selected quality measures on patient outcome. The data collected for this purpose comprise medical records from the ED treatment, discharge (claims) data from hospitalised patients, a patient questionnaire to be answered 6-8 weeks after emergency admission, and outcome measures in a 12-month follow-up obtained as claims data from the SHI.Descriptive and analytical statistics will be applied to provide summaries about the characteristics of QIs and associations between quality measures and patient outcomes. ETHICS AND DISSEMINATION: Approval of the leading ethics committee at the Medical Faculty of the University of Magdeburg (reference number 163/18 from 19 November 2018) has been obtained and adapted by responsible local ethics committees.The findings of this work will be disseminated by publication of peer-reviewed manuscripts and presentations as conference contributions (abstracts, poster or oral presentations).Moreover, results will be discussed with clinical experts and medical associations before being proposed for implementation into the quality management of EDs. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00015203); Pre-results.

Good Practice Data Linkage (GPD): A Translation of the German Version.

The data linkage of different data sources for research purposes is being increasingly used in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to provide methodological guidelines and recommendations for research projects that have been consented to across different German research societies. Another aim is to endow readers with a checklist for the critical appraisal of research proposals and articles. This Good Practice Data Linkage (GPD) was already published in German in 2019, but the aspects mentioned can easily be transferred to an international context, especially for other European Union (EU) member states. Therefore, it is now also published in English. Since 2016, an expert panel of members of different German scientific societies have worked together and developed seven guidelines with a total of 27 practical recommendations. These recommendations include (1) the research objectives, research questions, data sources, and resources; (2) the data infrastructure and data flow; (3) data protection; (4) ethics; (5) the key variables and linkage methods; (6) data validation/quality assurance; and (7) the long-term use of data for questions still to be determined. The authors provide a rationale for each recommendation. Future revisions will include new developments in science and updates of data privacy regulations.