Accuracy and Sterilizability of In-House Printed Patient-Specific Aortic Model for Surgeon-Modified Stent Grafts-A Workflow Description for Emergency Aortic Endovascular Procedures.

Introduction: The use of 3D-printed aortic models for the creation of surgeon-modified endoprostheses represents a promising avenue in aortic surgery. By focusing on the potential impact of sterilization on model integrity and geometry, this report sheds light on the suitability of these models for creating customized endoprostheses. The study presented here aimed to investigate the safety and viability of 3D-printed aortic models in the context of sterilization processes and subsequent remodeling. Methods: The study involved the fabrication of 3D-printed aortic models using patient-specific imaging data and established additive manufacturing techniques. Five identical aortic models of the same patient were printed. Two models were subjected to sterilization and two to disinfection using commonly employed methods, and one model remained untreated. The models were checked by in-house quality control for deformation (heat map analyses) after the sterilization and disinfection processes. Three models (sterilized, disinfected, and untreated) were sent for ex-house (Lufthansa Technik, AG, Materials Technologies and Central Laboratory Services, Hamburg, Germany) evaluation and subsequent quantification of possible structural changes using advanced imaging and measurement technologies (macroscopic and SEM/EDX examinations). After sterilization and disinfection, each aortic model underwent sterility checks. Results: Based on macroscopic and SEM/EDX examinations, distinct evidence of material alterations attributed to a treatment process, such as a cleaning procedure, was not identified on the three implants. Comparative material analyses conducted via the EDX technique yield consistent results for all three implants. Disinfected and sterilized models tested negative for common pathogens. Conclusions: The evaluation of 3D-printed aortic models' safety after sterilization as well as their suitability for surgeon-modified endoprostheses is a critical step toward their clinical integration. By comprehensively assessing changes in model integrity and geometry after sterilization, this research has contributed to the broader understanding of the use of 3D-printed models for tailor-made endovascular solutions. As medical technologies continue to evolve, research endeavors such as this one can serve as a foundation for harnessing the full potential of 3D printing to advance patient-centered care in aortic surgery.

Radiation Exposure and Contrast Agent Use during Endovascular Aortic Repair Using Mobile Versus Fixed Angiography Systems.

BACKGROUND: For (thoracic) endovascular aortic repair ((T)EVAR) procedures, both mobile (standard operating room (SOR)) and fixed C-arm (hybrid operating room (HOR)) systems are available. This study evaluated differences in key procedural parameters, and procedural success for (T)EVAR in the SOR versus the HOR. METHODS: All patients who underwent standard elective (T)EVAR at the Clinic for Vascular and Endovascular Surgery at the University Hospital Duesseldorf, Germany, between 1 January 2012 and 1 January 2019 were included. Data were retrieved from archived medical records. Endpoints were analyzed for SOR versus HOR during (T)EVAR. RESULTS: A total of 93 patients, including 50 EVAR (SOR (n = 20); HOR (n = 30)) and 43 TEVAR (SOR (n = 22); HOR (n= 21)) were included. The dose area product (DAP) for EVAR and TEVAR was lower in the SOR than in the HOR (EVAR, SOR: 1635 ± 1088 cGy·cm2; EVAR, HOR: 7819 ± 8928 cGy·cm2; TEVAR, SOR: 8963 ± 34,458 cGy·cm2; TEVAR, HOR: 14,591 ± 11,584 cGy·cm2 (p < 0.05)). Procedural fluoroscopy time was shorter in the SOR than in the HOR for EVAR and TEVAR (EVAR, SOR: 7 ± 4 min; EVAR, HOR: 18.8 ± 11.3 min; TEVAR, SOR: 6.6 ± 9.6 min; TEVAR, HOR: 13.9 ± 11.8 min (p < 0.05)). Higher volumes of contrast agent were applied during EVAR and TEVAR in the SOR than in the HOR (EVAR, SOR: 57.5 ± 20 mL; EVAR: HOR: 33.3 ± 5 mL (p < 0.05); TEVAR; SOR: 71.5 ± 53.4 mL, TEVAR, HOR: 48.2 ± 27.5 mL (p ≥ 0.05). CONCLUSION: The use of a fixed C-arm angiography system in the HOR results in higher radiation exposure and longer fluoroscopy times but lower contrast agent volumes when compared with mobile C-arm systems in the SOR. Because stochastic radiation sequelae are more likely to be tolerated in an older patient population and, in addition, there is a higher incidence of CKD in this patient population, allocation of patients to the HOR for standard (T)EVAR seems particularly advisable based on our results.

Being an Infant in a Pandemic: Influences of the COVID-19 Pandemic on Infants, Toddlers and Their Mothers in a Clinical Population.

The COVID-19 pandemic and the ongoing lockdowns might have had a strong impact on mental health of mothers and their infants/toddlers. For example, families had to deal with health issues and social isolation, which might have affected mental health and parent-child interactions. The aim of this study is to evaluate differences in (1) infantile regulatory disorders, (2) maternal mental health, (3) the impact of maternal mental health on infantile regulatory disorders, and (4) alterations in the mother-child interaction for participants recruited before versus after the onset of the first German lockdown. For this reason, mother-child dyads have been divided into two groups and were compared by analyzing clinical interviews on psychopathology of mother and child (M.I.N.I. & DC:05) and mother-child-interactions (Emotional Availability Scales). Results showed that (1) differences in infantile sleeping disorders emerged (phi = 0.243; p = 0.016) compared to the pre-lockdown group, while (2) the occurrence of maternal panic and anxiety increased in the post-lockdown group (phi = 0.229; p = 0.022). Moreover, there was (3) an association for maternal panic and child's sleep disorder, and (4) specific associations with maternal non-hostility in the mother-child-interaction. In conclusion, the present study highlights the differences of maternal mental health occurrences and infants' regulatory problems, as well as the possible effects of the COVID-19 pandemic for infants. In the pre-lockdown group, maternal non-hostility might have acted as a promotive factor against regulatory disorders, while this mechanism was mitigated in the post-lockdown group.

Endovascular coil-embolization of an unruptured, true UAA during early pregnancy- a case report.

BACKGROUND: True uterine artery aneurysms, especially during pregnancy, are a rare entity and not well understood. Clinical symptoms are unspecific pelvic pain and pressure. Diagnosis can be confirmed by transvaginal color-coded-sonography and/or magnetic resonance imaging. Because of potential risk of rupture, immediate interdisciplinary discussion and treatment planning in the best interests of both mother and child is crucial. CASE PRESENTATION: We present a 31-year-old pregnant woman with increasing pelvic pain and pressure. Diagnosis of an unruptured uterine artery aneurysm was confirmed by color-coded-sonography and magnetic resonance angiography. After interdisciplinary consultation, successful endovascular super-selective coil-embolization was performed by using X-ray fluoroscopy. Thus, fetal radiation dose during treatment with 4.33 mGy (VirtualDoseTM) was as low as possible with no immediate harm to the fetus. CONCLUSIONS: Unruptured true uterine artery aneurysms can be successfully treated by endovascular super-selective coil-embolization during early pregnancy with no immediate harm to the fetus.

Feasibility of a patient-oriented navigation programme for patients with lung cancer or stroke in Germany: Protocol of the CoreNAVI study.

BACKGROUND: Patient navigation programmes were introduced in the United States and recently gained interest in Germany, where the health care system is fragmented. Navigation programmes aim to decrease barriers to care for patients with age-associated diseases and complex care paths. Here we describe a feasibility study to evaluate a patient-oriented navigation model that was developed in a first project phase by integrating data about barriers to care, vulnerable patient populations and existing support services. METHODS: We designed a mixed-methods feasibility study that consists of two two-arm randomized controlled trials aligned with observational cohorts. The intervention group of the RCTs gets support by personal navigators for 12 months. The control group receives a brochure with regional support offers for patients and caregivers. The feasibility of the patient-oriented navigation model for two prototypic age-associated diseases, lung cancer and stroke, is evaluated with regard to its acceptance, demand, practicality and efficacy. This investigation includes process evaluation measures with detailed documentation of the screening and recruitment process, questionnaires about satisfaction with navigation, observant participation and qualitative interviews. Estimates of efficacy for patient-reported outcomes are obtained at three follow-up time points including satisfaction with care and health-related quality of life. Furthermore, we analyze health insurance data from patients of the RCT insured at a large German health insurance (AOK Nordost) to investigate heath care utilization, costs and cost effectiveness. TRIAL REGISTRATION: The study is registered at the German Clinical Trial Register (DRKS-ID: DRKS00025476).

[Utilization of routine data from different statutory health insurance funds: a practical report of experience from the TIM-HF2 study about data acquisition, validation, and processing]. / Nutzung von Routinedaten unterschiedlicher gesetzlicher Krankenkassen: Ein Erfahrungsbericht aus der TIM-HF2-Studie zur Datenerschließung, -validierung und -aufbereitung.

BACKGROUND: The randomized controlled clinical trial "TIM-HF2" investigated the benefit of telemonitoring in chronic heart failure. The health economic evaluation of this intervention was based on routine data from statutory health insurance (SHI) funds. Since participants were recruited independently of their SHI affiliation, there was a large number of potential data-providing SHI funds. This resulted in both organizational and methodological challenges, from participation of the data providers to data preparation. METHOD: The procedures are described from study planning and data acquisition to data review and processing in the TIM-HF2 trial. Based on the identification of potential problems for data completeness and data quality, possible solutions have been derived. RESULTS: In total, participants were insured with 49 different SHI funds, which provided routine data for a total of 1450 participants. About half of all initial data deliveries were correct. The most common problems in data preparation occurred in the machine readability of the data. Success factors for a high level of data completeness were close communication with the SHI funds and a high level of time and personnel commitment to intensive data checking and preparation. DISCUSSION: Based on the experience of the TIM-HF2 trial, a high heterogeneity has been detected in data management and transmission of routine data. Universally applicable data descriptions are desired to improve data access, quality, and usability for research purposes.

The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design.

BACKGROUND: Advanced ovarian cancer is managed by extensive surgery, which could be associated with high morbidity. A personalized pre-habilitation strategy combined with an 'enhanced recovery after surgery' (ERAS) pathway may decrease post-operative morbidity. PRIMARY OBJECTIVE: To analyze the effects of a combined multi-modal pre-habilitation and ERAS strategy on severe post-operative morbidity for patients with ovarian cancer (primary diagnosis or first recurrence) undergoing cytoreductive surgery. STUDY HYPOTHESIS: A personalized multi-modal pre-habilitation algorithm entailing a physical fitness intervention, nutritional and psycho-oncological support, completed by an ERAS pathway, reduces post-operative morbidity. TRIAL DESIGN: This is a prospective, controlled, non-randomized, open, interventional two-center clinical study. Endpoints will be compared with a three-fold control: (a) historic control group (data from institutional ovarian cancer databases); (b) prospective control group (assessed before implementing the intervention); and (c) matched health insurance controls. INCLUSION CRITERIA: Patients with ovarian, fallopian, or primary peritoneal cancer undergoing primary surgical treatment (primary ovarian cancer or first recurrence) can be included. The intervention group receives an additional multi-level study treatment: (1) standardized frailty assessment followed by (2) a personalized tri-modal pre-habilitation program and (3) peri-operative care according to an ERAS pathway. EXCLUSION CRITERIA: Inoperable disease or neoadjuvant chemotherapy, simultaneous diagnosis of simultaneous primary tumors, in case of interference with the overall prognosis (except for breast cancer); dementia or other conditions that impair compliance or prognosis. PRIMARY ENDPOINT: Reduction of severe post-operative complications (according to Clavien- Dindo Classification (CDC) III-V) within 30 days after surgery. SAMPLE SIZE: Intervention group (n=414, of which approximately 20% insure with the participating health insurance); historic control group (n=198); prospective control group (n=50), health insurance controls (for those intervention patients who are members of the participating health insurance). ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The intervention phase started in December 2021 and will continue until June 2023. As of March 2023, 280 patients have been enrolled in the intervention group. The expected completion of the entire study is September 2024. TRIAL REGISTRATION: NCT05256576.

Recording early deaths following emergency department visits in inpatient data: An observational study using data of 16 German hospitals.

OBJECTIVE: In German hospital emergency departments (EDs), no definite reimbursement rules exist for patients who die within 24 hours after arrival. Our study aimed to assess whether these cases were recorded and billed as inpatient stays. Furthermore, characteristics of patients who die within 24 hours following arrival at the ED were investigated for all ED visits, as well as for the subgroup of ED visits with an ED diagnosis or inpatient principal diagnosis of acute myocardial infarction. METHODS: This study was part of the INDEED project, which aimed to explore utilization and trans-sectoral patterns of care for patients treated in EDs in Germany. The study population includes ED visits of adult patients in 2016 in 16 German hospitals participating in the project. In the data set of combined ED, inpatient, and outpatient treatment information early deaths were classified as patients who died in the ED or in the hospital within 24 hours after arrival. Characteristics of visits followed by early death were analyzed descriptively. Mode of billing as inpatient or outpatient was validated by identifying corresponding billing information using linked inpatient and outpatient data. RESULTS: In 2016, 454,747 ED visits of adult patients occurred in the participating hospitals and 42.8% resulted in inpatient admission. Among these inpatients 8,317 (4.3%) died during the overall hospital stay, and 1,302 (0.7%) died within 24 hours following arrival. The proportion of early deaths among all deaths in patients with a diagnosis of acute myocardial infarction was higher (27%) compared to the overall patient population (16%). Although all cases of early death were classified as inpatients the corresponding inpatient data was missing in 1.9% of all early deaths and in 3.4% of early deaths with a diagnosis of acute myocardial infarction. Outpatient billing information suggesting that these cases were billed as outpatients, was found in 0.3% of all early deaths and in 0.8 to 1.7% of early deaths with a diagnosis of acute myocardial infarction, respectively. CONCLUSION: In-hospital mortality might be biased by incomplete recording of early deaths in inpatient data. However, the proportion of patients with early death who were billed as outpatients was marginal in the investigated study population of 16 hospitals. Although the study results are limited by restricted generalizability and subpar data quality, this finding indicates that early deaths might be almost completely recorded in German inpatient data. Nevertheless, data quality should be enhanced by establishing general billing rules for cases with a short treatment duration due to early death.

Primary and secondary data in emergency medicine health services research - a comparative analysis in a regional research network on multimorbid patients.

BACKGROUND: This analysis addresses the characteristics of two emergency department (ED) patient populations defined by three model diseases (hip fractures, respiratory, and cardiac symptoms) making use of survey (primary) and routine (secondary) data from hospital information systems (HIS). Our aims were to identify potential systematic inconsistencies between both data samples and implications of their use for future ED-based health services research. METHODS: The research network EMANET prospectively collected primary data (n=1442) from 2017-2019 and routine data from 2016 (n=9329) of eight EDs in a major German city. Patient populations were characterized using socio-structural (age, gender) and health- and care-related variables (triage, transport to ED, case and discharge type, multi-morbidity). Statistical comparisons between descriptive results of primary and secondary data samples for each variable were conducted using binomial test, chi-square goodness-of-fit test, or one-sample t-test according to scale level. RESULTS: Differences in distributions of patient characteristics were found in nearly all variables in all three disease populations, especially with regard to transport to ED, discharge type and prevalence of multi-morbidity. Recruitment conditions (e.g., patient non-response), project-specific inclusion criteria (e.g., age and case type restrictions) as well as documentation routines and practices of data production (e.g., coding of diagnoses) affected the composition of primary patient samples. Time restrictions of recruitment procedures did not generate meaningful differences regarding the distribution of characteristics in primary and secondary data samples. CONCLUSIONS: Primary and secondary data types maintain their advantages and shortcomings in the context of emergency medicine health services research. However, differences in the distribution of selected variables are rather small. The identification and classification of these effects for data interpretation as well as the establishment of monitoring systems in the data collection process are pivotal. TRIAL REGISTRATION: DRKS00011930 (EMACROSS), DRKS00014273 (EMAAGE), NCT03188861 (EMASPOT).

Cost-effectiveness of home non-invasive ventilation in patients with persistent hypercapnia after an acute exacerbation of COPD in the UK.

Home non-invasive mechanical ventilation (HMV) with home oxygen therapy (HOT) in patients with persistent hypercapnia following an acute exacerbation of chronic obstructive pulmonary disease delays hospital readmission. The economic impact of this treatment is unknown. We evaluated the cost-effectiveness of HMV in the UK healthcare system using data from a previously published efficacy trial. Quality-adjusted life-years (QALYs) were computed from EQ-5D-5L. Accounting for all direct patient costs HOT-HMV was £512 (95%CI £36 to £990) more expensive per patient per year than HOT-alone. This small increase in cost was accompanied by increased quality of life leading to an incremental cost-effectiveness ratio of £10 259 per QALY. HOT-HMV was cost-effective in this clinical population. Trial registration number: NCT00990132.

Impact of public health interventions to curb SARS-CoV-2 spread assessed by an evidence-educated Delphi panel and tailored SEIR model.

Aim: To use a Delphi-panel-based assessment of the effectiveness of different non-pharmaceutical interventions (NPI) in order to retrospectively approximate and to prospectively predict the SARS-CoV-2 pandemic progression via a SEIR model (susceptible, exposed, infectious, removed). Methods: We applied an evidence-educated Delphi-panel approach to elicit the impact of NPIs on the SARS-CoV-2 transmission rate R0 in Germany. Effectiveness was defined as the product of efficacy and compliance. A discrete, deterministic SEIR model with time step of 1 day, a latency period of 1.8 days, duration of infectiousness of 5 days, and a share of the total population of 15% assumed to be protected by immunity was developed in order to estimate the impact of selected NPI measures on the course of the pandemic. The model was populated with the Delphi-panel results and varied in sensitivity analyses. Results: Efficacy and compliance estimates for the three most effective NPIs were as follows: test and isolate 49% (efficacy)/78% (compliance), keeping distance 42%/74%, personal protection masks (cloth masks or other face masks) 33%/79%. Applying all NPI effectiveness estimates to the SEIR model resulted in a valid replication of reported occurrence of the German SARS-CoV-2 pandemic. A combination of four NPIs at consented compliance rates might curb the CoViD-19 pandemic. Conclusion: Employing an evidence-educated Delphi-panel approach can support SARS-CoV-2 modelling. Future curbing scenarios require a combination of NPIs. A Delphi-panel-based NPI assessment and modelling might support public health policy decision making by informing sequence and number of needed public health measures. Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-021-01566-2.

Advice for lay callers with low-risk poison exposures by a regional poison control center: the impact on health care expenditures.

BACKGROUND: Since establishing the first poison control centers (PCCs), there is a still ongoing debate regarding their relevance and financing. The present study aims to analyze whether a regional PCC can reduce the economic burden associated with utilization of health care structures due to low-risk poison exposures on the German health care system. METHODS: A decision-tree based cost-benefit analysis comparing a situation utilizing PCC consultation versus a hypothetical situation without PCC consultation for low-risk poison exposures from the German health care system's perspective was conducted. The model inputs were obtained by a representative telephone survey of lay callers supplemented by empirical PCC and literature data. A probabilistic and deterministic sensitivity analysis with varying input variables was performed to prove the robustness of the findings. RESULTS: In the underlying telephone survey, data of 378 lay callers could be considered and included in the decision tree model. As a result, the mean costs for handling one low-risk poison exposure case were €41.99 utilizing PCC consultation compared to €145.92 without PCC consultation, indicating a cost-benefit ratio of 3.48 for the existence of the PCC. The sensitivity analysis proved that the outcome of the decision analysis does not change significantly with varying inputs. CONCLUSION: The existence of PCCs relieve the burden on other health care providers and reduce health care costs to a relevant extent. Therefore, PCCs should be considered as an important supporting structure of the German health care system.

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.

Acupuncture and osteopathic medicine for atopic dermatitis: a three-armed, randomized controlled explorative clinical trial.

BACKGROUND: Patients with atopic dermatitis (AD) frequently use acupuncture (ACU) and osteopathic medicine (OM), although their therapeutic benefits are unclear. AIM: To investigate the effectiveness of ACU and OM in patients with AD. METHODS: In a three-armed, single-centre, randomized controlled open explorative clinical trial, adult patients with AD received ACU, OM or no study intervention (control group; CG) plus routine care. Outcomes included disease severity (SCORing Atopic Dermatitis; SCORAD), itching intensity (visual analogue scale; VAS), frequency of topical corticosteroid (TCS) use over 7 days and cost-effectiveness. Endpoints were analysed by analysis of covariance adjusted for the respective baseline value and TCS use. RESULTS: Overall, 121 patients (92 women, 29 men) with a mean ± SD age of 31.4 ± 10.5 years were randomized. After 12 weeks, the adjusted means (95% CI) for ACU, OM and control were, respectively, 22.3 (18.3-26.3), 26.4 (22.6-30.2) and 23.7 (19.9-27.5) for SCORAD (P = 0.32); 27.9 (19.5-36.4), 35.0 (26.9-43.0) and 42.3 (34.7-50.0) for VAS itching (P < 0.05); and 2.3 (0.8-3.9), 1.9 (0.4-3.5) and 4.3 (2.6-6.0), for TCS use (P = 0.10). ACU and OM were not cost-effective compared with the CG. CONCLUSION: Although no differences in disease severity were found, our findings indicate that ACU might reduce itching in patients with AD. Furthermore, ACU and OM showed a trend towards reducing TCS use.

Healthcare Utilization and Costs in Sepsis Survivors in Germany-Secondary Analysis of a Prospective Cohort Study.

Background: Survivors of sepsis often face long-term sequelae after intensive care treatment. Compared to the period of hospitalization, little is known about the ambulatory healthcare utilization in sepsis patients. The study evaluated healthcare utilization and associated costs of sepsis care including allied health professions after initial hospitalization. Methods: Secondary analysis was performed on data in 210 sepsis patients prospectively enrolled from nine intensive care study centers across Germany. Data was collected via structured surveys among their Primary care (Family-) physicians (PCPs) within the first month after discharge from ICU (baseline) and again at 6, 12 and 24 months after discharge, each relating to the period following the last survey. Costs were assessed by standardized cost unit rates from a health care system's perspective. Changes in healthcare utilization and costs over time were calculated using the Wilcoxon rank-sum test. Results: Of the 210 patients enrolled, 146 (69.5%) patients completed the 24 months follow-up. In total, 109 patients were hospitalized within the first 6 months post-intensive care. Mean total direct costs per patient at 0-6 months were €17,531 (median: €6047), at 7-12 months €9029 (median: €3312), and at 13-24 months €18,703 (median: €12,828). The largest contributor to the total direct costs within the first 6 months was re-hospitalizations (€13,787 (median: €2965). After this first half year, we observed a significant decline in inpatient care costs for re-hospitalizations (p ≤ 0.001). PCPs were visited by more than 95% of patients over 24 months. Conclusions: Sepsis survivors have high health care utilization. Hospital readmissions are frequent and costly. Highest costs and hospitalizations were observed in more than half of patients within the first six months post-intensive care. Among all outpatient care providers, PCPs were consulted most frequently. Clinical impact: Sepsis survivors have a high healthcare utilization and related costs which persist after discharge from hospital. Within outpatient care, possible needs of sepsis survivors as physiotherapy or psychotherapy seem not to be met appropriately. Development of sepsis aftercare programs for early detection and treatment of complications should be prioritized.

[The way to routine data from 16 emergency departments for cross-sectoral health services research : Experiences, challenges and solution approaches from the extraction of pseudonymous data for the INDEED project]. / Der Weg zu Routinedaten aus 16 Notaufnahmen für die sektorenübergreifende Versorgungsforschung : Erfahrungen, Herausforderungen und Lösungsansätze aus der Extraktion pseudonymer Daten für das Projekt INDEED.

BACKGROUND: In Germany there is currently no health reporting on cross-sectoral care patterns in the context of an emergency department care treatment. The INDEED project (Utilization and trans-sectoral patterns of care for patients admitted to emergency departments in Germany) collects routine data from 16 emergency departments, which are later merged with outpatient billing data from 2014 to 2017 on an individual level. AIM: The methodological challenges in planning of the internal merging of routine clinical and administrative data from emergency departments in Germany up to the final data extraction are presented together with possible solution approaches. METHODS: Data were selected in an iterative process according to the research questions, medical relevance, and assumed data availability. After a preparatory phase to clarify formalities (including data protection, ethics), review test data and correct if necessary, the encrypted and pseudonymous data extraction was performed. RESULTS: Data from the 16 cooperating emergency departments came mostly from the emergency department and hospital information systems. There was considerable heterogeneity in the data. Not all variables were available in every emergency department because, for example, they were not standardized and digitally available or the extraction effort was judged to be too high. CONCLUSION: Relevant data from emergency departments are stored in different structures and in several IT systems. Thus, the creation of a harmonized data set requires considerable resources on the part of the hospital as well as the data processing unit. This needs to be generously calculated for future projects.

Strategies to Enhance Retention in a Cohort Study Among Adults of Turkish Descent Living in Berlin.

Retention is important for statistical power and external validity in long-term cohort studies. The aims of our study were to evaluate different retention strategies within a cohort study of adults of Turkish descent in Berlin, Germany, and to compare participants and non-participants. In 2011-2012, a population-based study was conducted among adults of Turkish descent to primarily examine recruitment strategies. 6 years later, the participants were re-contacted and invited to complete a self-report questionnaire regarding their health status, health care utilization, and satisfaction with medical services. The retention strategy comprised letters in both German and Turkish, phone calls, and home visits (by bilingual staff). We calculated the response rate and retention rate, using definitions of the American Association for Public Opinion Research, as well as the relative retention rate for each level of contact. Associations of baseline recruitment strategy, sociodemographic, migration-related and health-related factors with retention were investigated by logistic regression analysis. Of 557 persons contacted, 249 (44.7%) completed the questionnaire. This was 50.1% of those whose contact information was available. The relative retention rate was lowest for phone calls (8.9%) and highest for home visits (18.4%). Participants were more often non-smokers and German citizens than non-participants. For all remaining factors, no association with retention was found. In this study, among adults of Turkish descent, the retention rate increased considerably with every additional level of contact. Implementation of comprehensive retention strategies provided by culturally matched study personnel may lead to higher validity and statistical power in studies on migrant health issues.

Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial.

BACKGROUND: Noninvasive remote patient management (RPM) in patients with heart failure (HF) has been shown to reduce the days lost due to unplanned cardiovascular hospital admissions and all-cause mortality in the Telemedical Interventional Management in Heart Failure II trial (TIM-HF2). The health economic implications of these findings are the focus of the present analyses from the payer perspective. METHODS AND RESULTS: A total of 1538 participants of the TIM-HF2 randomized controlled trial were assigned to the RPM and Usual Care group. Health claims data were available for 1450 patients (n = 715 RPM group, n = 735 Usual Care group), which represents 94.3% of the original TIM-HF2 patient population, were linked to primary data from the study documentation and evaluated in terms of the health care cost, total cost (accounting for intervention costs), costs per day alive and out of hospital (DAOH), and cost per quality-adjusted life year (QALY). The average health care costs per patient year amounted to € 14,412 (95% CI 13,284-15,539) in the RPM group and € 17,537 (95% CI 16,179-18,894) in the UC group. RPM led to cost savings of € 3125 per patient year (p = 0.001). After including the intervention costs, a cost saving of € 1758 per patient year remained (p = 0.048). CONCLUSION: The additional noninvasive telemedical interventional management in patients with HF was cost-effective compared to standard care alone, since such intervention was associated with overall cost savings and superior clinical effectiveness.

Acupressure in patients with seasonal allergic rhinitis: a randomized controlled exploratory trial.

BACKGROUND: Acupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients. METHODS: We conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks. RESULTS: Forty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: - 0.9 points (95% CI - 1.6 to - 0.2; p = 0.011) and VAS overall SAR symptoms: - 21.6 mm (95% CI - 36.3 to - 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI - 3.8 to - 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe. CONCLUSION: Results of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310.

Cost-effectiveness of patient navigation programs for stroke patients-A systematic review.

OBJECTIVE: Stroke remains a leading cause of premature death, impairment and reduced quality of life. Its aftercare is performed by numerous different health care service providers, resulting in a high need for coordination. Personally delivered patient navigation (PN) is a promising approach for managing pathways through health care systems and for improving patient outcomes. Although PN in stroke care is evolving, no summarized information on its cost-effectiveness in stroke survivors is available. Hence, the aim of this systematic review is to analyze the level of evidence on the cost-effectiveness of PN for stroke survivors. METHODS: A systematic literature search without time limitations was carried out in PubMed, EMBASE, CENTRAL, CINAHL as well as PsycINFO and supplemented by a manual search. Randomized controlled trials published prior to April 2020 in English or German were considered eligible if any results regarding the cost-effectiveness of PN for stroke survivors were reported. The review was conducted according to PRISMA guidelines. Quality of included studies was assessed with the RoB2 tool. Main study characteristics and cost-effectiveness results were summarized and discussed. RESULTS: The search identified 1442 records, and two studies met the inclusion criteria. Quality of included studies was rated moderate and high. Programs, settings and cost-effectiveness results were heterogeneous, with one study showing a 90% probability of being cost-effective at a willingness to pay of $25600 per QALY (health/social care perspective) and the other showing similar QALYs and higher costs. CONCLUSIONS: Since only two studies were eligible, this review reveals a large gap in knowledge regarding the cost-effectiveness of PN for stroke survivors. Furthermore, no conclusive statement about the cost-effectiveness can be made. Future attempts to evaluate PN for stroke survivors are necessary and should also involve cost-effectiveness issues.