Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach.

Recently, health insurance claims have regained the attention of the scientific community as a source of real-world evidence in health care research and quality improvement. To date, very few studies are available which investigate the validity of health insurance claims; these may be affected by bias from several sources, such as possible upcoding of co-morbidities and complications for reimbursement advantages. The IDOMENEO study investigates the inpatient treatment of peripheral arterial disease (PAD) comprehensively using various data sources with a consortium involving experts from health care research and data privacy, a large health insurance fund, biostatisticians, jurists, and computer scientists. Prospective registry data were collected from 30-40 vascular centres in Germany using the GermanVasc registry. In addition, health insurance claims data were prospectively collected from BARMER, the second largest health insurance fund in Germany. The consortium is currently developing a data privacy compliant method of health insurance claims data validation, the methodological foundations of which are described here.

Predictors of bleeding or anemia requiring transfusion in complex endovascular aortic repair and its impact on outcomes in health insurance claims.

OBJECTIVE: This study aimed to determine predictors and outcomes associated with bleeding or anemia requiring transfusion (BAT) after fenestrated or branched endovascular aneurysm repair (FB-EVAR). METHODS: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate BAT in elective FB-EVAR performed between 2008 and 2017. International Classification of Diseases and German Operations and Procedure Key codes were used. RESULTS: A total of 959 patients (24.8% with BAT) matching the inclusion criteria were identified during the study period. Compared with patients without BAT, patients with BAT were older (74.4 vs 73.0 years; P = .015) and suffered more frequently from congestive heart failure (18.5% vs 9.4%), cardiac arrhythmias (26.9% vs 14.7%), and hereditary or acquired coagulopathy (31.9% vs 6.2%; all P < .001). Coagulopathy (odds ratio [OR], 3.65; 95% confidence interval [CI], 2.29-5.84), female sex (OR, 2.67; 95% CI, 1.78-4.00), and multiple comorbidities (OR, 1.10; 95% CI, 1.07-1.14) were independent predictors of BAT (all P < .001). BAT was associated with higher in-hospital (11.3% vs 2.6%), 30-day (12.2% vs 3.1%), and 90-day (18.5% vs 4.4%) mortality (all P < .001). Furthermore, myocardial infarction (23.9% vs 2.8%) and paraplegia (9.7% vs 0.7%) were more frequent in the BAT group (all P < .001). In multivariable analyses, BAT was associated with worse short-term (OR, 3.19; 95% CI, 1.63-6.33; P = .001) and long-term survival (hazard ratio, 1.62; 95% CI, 1.24-2.11; P < .001). CONCLUSIONS: Patients with hereditary or acquired coagulopathy, patients with multiple comorbidities, and women are at higher risk for development of BAT after FB-EVAR. The occurrence of this event was strongly associated with higher major complication rates and worse short-term and long-term survival. This emphasizes a need to further illuminate the value of patient blood management in FB-EVAR.

Quality Indicators in Peripheral Arterial Occlusive Disease Treatment: A Systematic Review.

OBJECTIVES: This systematic review aimed to identify evidence based quality indicators for invasive revascularisation of symptomatic peripheral arterial occlusive disease (PAOD). METHODS: A systematic search of clinical practice guidelines, consensus statements, systematic reviews, and meta-analyses reporting quality indicators in patients undergoing invasive open and percutaneous revascularisations for symptomatic PAOD (PROSPERO registration number: CRD42019116317) was performed. Furthermore, a grey literature search was conducted involving databases of professional vascular medical organisations. The identified publications were screened independently by two reviewers for possible inclusion and full texts of potentially relevant records were independently evaluated for eligibility. Disagreement was resolved by discussion involving a third reviewer. RESULTS: From 685 articles initially identified, one systematic review and one consensus statement focusing on quality indicators were selected for inclusion in the review. From these sources, a total of three process quality indicators matched the search criteria: one on pharmacological intervention, another on smoking cessation, and a third on surveillance of lower extremity vein bypass grafts. The grey literature search revealed an additional 31 structure, process, and outcome quality indicators. CONCLUSIONS: This study revealed a lack of published evidence based quality indicators concerning invasive treatment for PAOD in the literature. An additional 31 indicators from the databases of professional societies and organisations have not been incorporated in prior guidelines. Interestingly, no indicator related to patient reported outcomes could be identified from either high quality sources or grey literature. Further research and harmonisation of different quality indicators is needed to enhance their evidence and subsequently improve patient centred decision making on invasive treatment.

Comparing physicians' and patients' reporting on adverse reactions in randomized trials on acupuncture-a secondary data analysis.

BACKGROUND: We aimed to compare patients' and physicians' safety reporting using data from large acupuncture trials (44,818 patients) and to determine associations between patient characteristics and reporting of adverse reactions. METHODS: Six pragmatic randomized trials with an additional non-randomized study arm that included those patients who refused randomization were evaluated. Patients received acupuncture treatment for osteoarthritis of the hip or knee, chronic neck pain, chronic low back pain, chronic headache, dysmenorrhea, or allergic rhinitis or asthma. Safety outcomes were evaluated by questionnaires from both the physicians and the patients. To determine level of agreement between physicians and patients on the prevalence of adverse reactions, Cohen's kappa was used. With multilevel models associations between patient characteristics and reporting of adverse reactions were assessed. RESULTS: Patients reported on average three times more adverse reactions than the study physicians: for bleeding/haematoma, 6.7% of patients (n = 2458) vs. 0.6% of physicians (n = 255) and for pain, 1.7% of patients (n = 636) vs. 0.5% of physicians (n = 207). We found only minor agreements between patients and physicians (maximum Cohen's kappa: 0.50, 95% confidence interval [0.49;0.51] for depressive mood). Being a female and participation in the randomization were associated with higher odds of reporting an adverse reaction. CONCLUSIONS: In our study, patients' and physicians' reports on adverse reactions of acupuncture differed substantially, possibly due to differences in patients' and physicians' questionnaires and definitions. For the assessment of safety, we strongly support the inclusion of patients' and physicians' reports while ensuring standardization of data collection and definitions.

Prevalence of impaired functional reading ability and its association with quality of life, daily activity, mobility and social participation among general older adults in Germany.

BACKGROUND: The prevalence of visual impairment and of impaired functional reading ability rapidly increase with age. However, functional reading ability is essential for an autonomous lifestyle. We analyzed the prevalence of impaired functional reading ability in the general elderly population and the association of impaired functional reading ability with quality of life, daily activities, mobility, and social participation. METHODS: Cross-sectional data from a population-based cohort were analyzed. Participants aged ≥65 years were tested for their functional reading ability using (1) Nieden charts (cognitive reading ability) and (2) a test in which a telephone number had to be found (reading comprehension). Prevalences of impaired functional reading ability were calculated. In multivariable regression models, the associations of cognitive reading ability (1) with quality of life, daily activities, mobility, and social participation were examined. RESULTS: 60 of 780 participants (7.69%) were able to read the third last text of the Nieden test (good cognitive reading ability), whereas 7 participants (0.9%) were unable to read any of the texts. 716 participants (91.8%) identified the phone book entry successfully (good reading comprehension). Multivariable regression models revealed no significant associations of the cognitive reading ability (1) with quality of life, daily activities, social participation, and mobility. CONCLUSION: Our results showed a high prevalence of impaired cognitive reading ability (1). Reading comprehension (2) was slightly affected. The loss of cognitive reading ability usually progresses over years; signs and symptoms might remain unrecognized when compensated by other functions.

Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries.

OBJECTIVE: To develop a minimum core data set for evaluation of acute limb ischaemia (ALI) revascularisation treatment and outcomes that would enable collaboration among international registries. METHODS: A modified Delphi approach was used to achieve consensus among international multidisciplinary vascular specialists and registry members of the International Consortium of Vascular Registries (ICVR). Variables identified in the literature or suggested by the expert panel, and variables, including definitions, currently used in 15 countries in the ICVR, were assessed to define both a minimum core and an optimum data set to register ALI treatment. Clinical relevance and practicability were both assessed, and consensus was defined as ≥ 80% agreement among participants. RESULTS: Of 40 invited experts, 37 completed a preliminary survey and 31 completed the two subsequent Delphi rounds via internet exchange and face to face discussions. In total, 117 different items were generated from the various registry data forms, an extensive review of the literature, and additional suggestions from the experts, for potential inclusion in the data set. Ultimately, 35 items were recommended for inclusion in the minimum core data set, including 23 core items important for all registries, and an additional 12 more specific items for registries capable of capturing more detail. These 35 items supplement previous data elements recommended for registering chronic peripheral arterial occlusive disease treatment. CONCLUSION: A modified Delphi study allowed 37 international vascular registry experts to achieve a consensus recommendation for a minimum core and an optimum data set for registries covering patients who undergo ALI revascularisation. Continued global harmonisation of registry infrastructure and definition of items allows international comparisons and global quality improvement. Furthermore, it can help to define and monitor standards of care and enable international research collaboration.

Population Based Analysis of Gender Disparities in 23,715 Percutaneous Endovascular Revascularisations in the Metropolitan Area of Hamburg.

BACKGROUND: The worldwide prevalence of peripheral artery disease (PAD) is increasing and endovascular revascularisation (ER) has become the primary invasive treatment option. This study aims to illuminate gender disparities in ER of PAD. METHODS: This is a retrospective, cross sectional study design. All inpatient invasive, percutaneous endovascular treatments of PAD conducted in the metropolitan area of Hamburg (Germany) were collected consecutively between 01/2004 and 12/2015. Relevant socio-demographic risk factors, technical assessments, procedural details, and in hospital outcomes were collected and subsequently analysed. RESULTS: A total of 23,715 ERs were identified (39.7% females). Female patients were older (74 vs. 70 years, p < .001) and more often suffered from rest pain (12.0% vs. 9.7%, p < .001) at the time of presentation. No differences were found for index lesion complexity (Trans-Atlantic Inter-Society Consensus classes) and the ankle brachial index was less often stated not to be valid in females (5.9% vs. 7.1%, p = .005 for intermittent claudication; 28.5% vs. 32.0%, p = .001 for chronic limb threatening ischaemia, CLTI). If the ER was performed for CLTI, crural vessels below the knee were less often revascularised in females (32.2% vs. 42.7%, p < .001). Peri-operative major bleeding complications including pseudoaneurysms occurred twice as often in females, and female gender was an independent predictor of bleeding complications in the adjusted analyses (OR 2.32, 95% CI 1.49-3.64, p < .001 for IC; OR 1.67, 95% CI 1.10-2.53, p = .017 for CLTI). Lastly, females were more often transferred to nursing homes when compared with males (0.3% vs. 0%, p = .001 for IC; 2.5% vs. 1.2%, p < .001 for CLTI). CONCLUSION: In this study considering percutaneous ER for PAD, female patients were older, had different clinical symptoms, suffered more often from complications, and were at risk of social isolation after discharge when compared with their male counterparts. These results emphasise the need for further studies to evaluate a gender based treatment algorithm in PAD.

Gender disparities in fenestrated and branched endovascular aortic repair.

OBJECTIVES: Gender disparities in risk factors and outcomes following aortic repair are important issues in healthcare. To date, no large-scale multicentre study addresses this topic in complex endovascular aortic repair. We aimed to determine the outcomes following fenestrated or branched endovascular aortic repair of aneurysms and dissections in female and male patients. METHODS: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate gender disparities in elective fenestrated or branched endovascular aortic repair of thoraco-abdominal or abdominal aortic aneurysms or dissections performed between 2008 and 2017. Elixhauser comorbidities and the linear van Walraven score were used to adjust for confounders in the multivariable analyses. RESULTS: There were 959 patients in the cohort, in whom 163 (17%) were female. The mean age was 73 ± 8 years with no differences between females and males. No gender disparities were observed regarding the van Walraven comorbidity score (6.9 vs 6.8, P = 0.83), but complications occurred more frequently in females. Acute renal failure (relative risk 1.71, 95% confidence interval 1.06-2.77), paraplegia (relative risk 2.71, 95% confidence interval 1.28-5.77) and bleeding or anaemia requiring transfusion (relative risk 1.76, 95% confidence interval 1.39-2.22) were more common in women. In multivariable models, female patients were at a higher risk of in-hospital death (odds ratio 3.206, P < 0.001). Consequently, female gender was associated with lower long-term survival (hazard ratio 1.506, P = 0.006). CONCLUSIONS: In complex endovascular aortic repair, females are more likely to experience complications and have worse in-hospital and, consequently, long-term survival when compared to males. Future studies should include anatomic parameters to determine the impact of anatomy on outcome disparities.

Impact of weekend treatment on short-term and long-term survival after urgent repair of ruptured aortic aneurysms in Germany.

OBJECTIVE: There is some evidence that weekend admission to the hospital is associated with worse outcomes compared with weekday admission. However, only a few studies have focused on weekend vs weekday surgery outcomes. This study aimed to determine whether there is a weekend effect on outcomes in the treatment of ruptured aortic aneurysms in Germany. METHODS: Health insurance claims of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate short-term and long-term mortality after weekend vs weekday treatment of ruptured aortic aneurysm. Patients undergoing endovascular repair (ER) or open surgical repair (OSR) between January 2008 and December 2016 were included in the study. Both propensity score matching and regression methods were used to adjust for confounding. RESULTS: There were 1477 patients in the cohort, of whom 517 (35.0%) underwent ER and 960 (65.0%) OSR. Overall, 995 (67.4%) patients underwent an operation on weekdays (Monday to Thursday), and 482 (32.6%) patients underwent an operation on a weekend (Friday to Sunday). In multivariable models, patients who underwent an operation on a weekend were at higher risk of in-hospital death after OSR (49.2% vs 38.0%; odds ratio [OR], 1.61; P = .001), and there was a trend toward higher in-hospital mortality after ER (29.5% vs 21.2%; OR, 1.55; P = .056). The ER of thoracic or thoracoabdominal aortic ruptures was associated with significantly higher in-hospital mortality compared with ER of abdominal aortic aneurysm (OR, 1.69; P = .026). CONCLUSIONS: Weekend repairs of ruptured aortic aneurysms are associated with worse in-hospital survival compared with weekday surgery. ER of thoracic or thoracoabdominal aortic ruptures is associated with worse in-hospital survival compared with ER of ruptured abdominal aortic ruptures. This might be an international phenomenon requiring joint learning and action in times of centralization of aortic procedures.

Multidisciplinary team decision is rare and decreasing in percutaneous vascular interventions despite positive impact on in-hospital outcomes.

Background: Worldwide prevalence of peripheral artery disease (PAD) is increasing and peripheral vascular intervention (PVI) has become the primary invasive treatment. There is evidence that multidisciplinary team decision-making (MTD) has an impact on in-hospital outcomes. This study aims to depict practice patterns and time changes regarding MTD of different medical specialties. Methods: This is a retrospective cross-sectional study design. 20,748 invasive, percutaneous PVI of PAD conducted in the metropolitan area of Hamburg (Germany) were consecutively collected between January 2004 and December 2014. Results: MTD prior to PVI was associated with lower odds of early unsuccessful termination of the procedures (Odds Ratio 0.662, p < 0.001). The proportion of MTD decreased over the study period (30.9 % until 2009 vs. 16.6 % from 2010, p < 0.001) while rates of critical limb-threatening ischemia (34.5 % vs. 42.1 %), patients´ age (70 vs. 72 years), PVI below-the-knee (BTK) (13.2 % vs. 22.4 %), and rates of severe TASC C/D lesions BTK (43.2 % vs. 54.2 %) increased (all p < 0.001). Utilization of MTD was different between medical specialties with lowest frequency in procedures performed by internists when compared to other medical specialties (7.1 % vs. 25.7 %, p < 0.001). Conclusions: MTD prior to PVI is associated with technical success of the procedure. Nonetheless, rates of MTD prior to PVI are decreasing during the study period. Future studies should address the impact of multidisciplinary vascular teams on long-term outcomes.

Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry.

BACKGROUND: Atherosclerotic disease of the lower extremity arteries (PAD) remains a significant burden on global healthcare systems with increasing prevalence. Various guidelines on the diagnosis and treatment of patients with PAD are available but they often lack a sufficient evidence base for high-grade recommendations since randomized and controlled trials (RCT) remain rare or are frequently subject to conflicts of interest. This registry trial aims to evaluate the outcomes of catheter-based endovascular revascularisations vs. open-surgical endarterectomy vs. bypass surgery for symptomatic PAD on medical and patient-reported outcomes. METHODS AND DESIGN: The study is a prospective non-randomized multicentre registry trial including invasive revascularisations performed in 10 000 patients treated for symptomatic PAD at 30 to 40 German vascular centres. All patients matching the inclusion criteria are consecutively included for a recruitment period of six months (between May and December 2018) or until 10 000 patients have been included in the study registry. There are three follow-up measures at three, six, and 12 months. Automated completeness and plausibility checks as well as independent site visit monitoring will be performed to assure high internal and external validity of the study data. Study endpoints include relevant major cardiovascular and limb events and patient-reported outcomes from two Delphi studies with experts in vascular medicine and registry-based research. DISCUSSION: It remains unclear if results from RCT can reflect daily treatment practice. Furthermore, great costs and complexity make it challenging to accomplish high quality randomized trials in PAD treatment. Prospective registry-based studies to collect real-world evidence can help to overcome these limitations.

Incidence, Predictors, and Outcomes of Colonic Ischaemia in Abdominal Aortic Aneurysm Repair.

OBJECTIVE/BACKGROUND: Colonic ischaemia (CI) is a severe complication following abdominal aortic aneurysm (AAA) repair, leading to high morbidity and mortality. The aim of the study was to determine the incidence, predictors, and outcomes of CI following AAA repair. METHODS: National claims from Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate CI after intact (iAAA) and ruptured (rAAA) AAA repairs. Patients undergoing endovascular (EVAR) or open surgical (OSR) repairs between January 2008 and December 2017 were included in the study. RESULTS: There were 9145 patients (8248 iAAA and 897 rAAA) undergoing EVAR or OSR procedures and the median follow up was 2.28 years. Most patients were male (79.2% iAAA, 79.3% rAAA); the median age was 73.0 years (iAAA group) and 76.0 years (rAAA group). Overall, CI occurred 97 (1.2%) times after iAAA and 95 (10.6%) after rAAA. In univariable analyses CI occurred less often after EVAR than after OSR (0.6% vs. 3.7%; p < .001). Acute post-operative renal and respiratory insufficiencies were also related to the occurrence of CI (p < .001). CI was associated with greater in hospital mortality (42.2% vs. 2.7% for iAAA, 64.2% vs. 36.3% for rAAA; p < .001) and lower long-term survival for iAAA (Kaplan-Meier analysis). In multivariable analyses, rAAA (odds ratio [OR] 5.59), and higher van Walraven comorbidity score (OR 1.09) were independently associated with greater risk of CI occurrence. EVAR use (OR 0.30) was protective. EVAR use remained protective in stratified analyses within iAAA (OR 0.32) and rAAA (OR 0.26). CONCLUSION: Post-operative CI after AAA repair is not common but is associated with worse in hospital outcomes and lower long-term survival. EVAR was protective after both rAAA and iAAA repairs. When discussing the treatment of AAA with patients the protective effect of EVAR should be considered. Future studies should validate predictive scores and advance preventive strategies.

Indicators of outcome quality in peripheral arterial disease revascularisations - a Delphi expert consensus.

INTRODUCTION: Peripheral arterial disease (PAD) affects a continuously increasing number of people worldwide leading to more invasive treatments. Indication to perform invasive revascularisations usually arises from consensus-based recommendations of practice guidelines and from few randomized controlled trials where outcome measures focus mainly on risk factors associated with mortality and morbidity. To date, no broad consensual agreement of experts on valid indicators of outcome quality exists for PAD. METHODS: A literature review was conducted to collect indicators of outcome quality from studies of PAD. The Delphi technique was used to achieve a consensual agreement on a set of core indicators. The expert panel of the two-round Delphi approach was formed by leading vascular specialists joining the IDOMENEO study, physician assistants, wound nurses, and patient representatives. Items were scored via a web-based anonymised electronic questionnaire using a five-point Likert-scale. RESULTS: Out of 40 invited experts 30 joined the panel and completed round one. Twenty-four experts completed the second and final round. Forty-three indicators of outcome quality were initially identified and validated by the panel. After two Delphi rounds, 12 indicators (27.9 %) achieved the limit of agreement for relevance and four (9.3 %) for practicability. Major adverse limb events (MALE), major amputation, and major re-intervention (or re-operation) were consented as both highly relevant and practicable. Additionally, major adverse cardiovascular events (MACE), myocardial infarction, stroke or transient ischaemic attack, all-cause death, all re-intervention (or re-operation), wound infection, vascular access-related major complication, walking distance, and Rutherford-classification were consented as highly relevant. Ankle-brachial-index was consented as highly practicable. CONCLUSIONS: This Delphi approach of vascular experts identified three indicators as highly relevant and clinically practicable to be recommended as indicators of outcome quality in invasive PAD treatment. Among others, these consented items may help in harmonising future studies and quality benchmarking increasing their comparability, validity, and efficiency.

Predictors of medication adherence among patients with severe psychiatric disorders: findings from the baseline assessment of a randomized controlled trial (Tecla).

BACKGROUND: Schizophrenia and bipolar disorder are characterized by a high disease burden. Antipsychotic medication is an essential part of the treatment. However, non-adherence is a major problem. Our aim was to examine potential determinants of non-adherence for patients with severe mental disorders. METHODS: Baseline data of the study "Post stationary telemedical care of patients with severe psychiatric disorders" (Tecla) were used. Medication adherence was assessed with the Medication Adherence Report Scale German version (MARS-D). A logistic regression was calculated with age, sex, education, employment status, level of global functioning, social support and intake of typical and atypical antipsychotics as predictors. RESULTS: N = 127 participants were included in the analysis (n = 73 men, mean age 42 years). The mean MARS-D Score was 23.4 (SD 2.5). The most common reason for non-adherence was forgetting to take the medicine. Significant positive determinants for adherence were older age (OR 1.02, 95% CI 1.011-1.024, p < 0.0001), being employed (OR 2.46, 95% CI 1.893-3.206, p < 0.0001), higher level of global functioning (overall measure of how patients are doing) (OR 1.02, 95% CI 1.012-1.028, p < 0.0001), having social support (OR 1.02, 95% CI 1.013-1.026, p < 0.0001), and intake of typical antipsychotics (OR 2.389, 95% CI 1.796-3.178, p < 0.0001). A negative determinant was (female) sex (OR 0.73, 95% CI 0.625-0.859, p = 0.0001). CONCLUSIONS: Especially employment, functioning and social support could be promising targets to facilitate adherence in patients with schizophrenia or bipolar disorder. TRIAL REGISTRATION: This study is retrospectively registered at the German Clinical Trials Register with the trial registration number DRKS00008548 at 21/05/2015.

MOVING: Motivation-Oriented interVention study for the elderly IN Greifswald: study protocol for a randomized controlled trial.

BACKGROUND: Cardiovascular diseases (CVD) are the leading cause of mortality. In 2014, they were responsible for 38.9% of all causes of death in Germany. One major risk factor for CVD is a lack of physical activity (PA). A health-promoting lifestyle including regular PA and minimizing sitting time (ST) in daily life is a central preventive measure. Previous studies have shown that PA decreases in older age; 2.4-29% of the people aged over 60 years achieve the World Health Organization recommendations. This age group spends on average 9.4 h per day in sedentary activities. To increase PA and decrease ST, a low-threshold intervention, consisting of individualized feedback letters based on objectively measured data of PA and ST, was developed. The research question is: Do individual feedback letters, based on accelerometer data, have a positive effect on PA and ST? METHODS/DESIGN: MOVING is a two-arm, randomized controlled trial. Inclusion criteria are age ≥ 65 years and the ability to be physically active. Exclusion criteria are the permanent use of a wheelchair and simultaneous participation in another study on PA. At baseline participants who give informed consent will receive general information and recommendations about the positive effects of regular PA and less ST. Participants of both groups will receive an accelerometer device, which records PA and ST over a period of seven consecutive days following by a randomization. Participants in the intervention group will receive automatically generated, individualized feedback letters by mail based on their PA and ST at baseline and at 3-month follow-up. Further follow-up examinations will be carried out at 6 and 12 months. The primary outcome is the increase of PA and the reduction of ST after 6 months in the intervention group compared to the control group. DISCUSSION: The goal of the study is to examine the effects of a simple feedback intervention on PA and ST in elderly people. We aim to achieve an effect of 20% increase in moderate-to-vigorous physical activity (MVPA). The intervention may have the potential to decrease crucial cardiovascular risk factors and, therefore, contribute to prevention of CVD. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00010410 . Registered on 17 May 2017.

Gender differences in abdominal aortic aneurysms in Germany using health insurance claims data.

BACKGROUND: Endovascular aortic repair (EVAR) has emerged as standard of care for abdominal aortic aneurysm (AAA). Real-world evidence is limited to compare this technology to open repair (OAR). Major gaps exist related to short-term and long-term outcomes, particularly in respect of gender differences. MATERIALS AND METHODS: Health insurance claims data from Germany's third largest insurance provider, DAK-Gesundheit, was used to investigate invasive in-hospital treatment of intact (iAAA) and ruptured AAA (rAAA). Patients operated between October 2008 and April 2015 were included in the study. RESULTS: A total of 5,509 patients (4,966 iAAA and 543 rAAA) underwent EVAR or OAR with a median follow-up of 2.44 years. Baseline demographics, comorbidities, and clinical characteristics of DAK-G patients were assessed. In total, 84.6 % of the iAAA and 79.9 % of the rAAA were male. Concerning iAAA repair, the median age (74 vs. 73 years, p < .001) compared to men was higher in females, but their EVAR-rate (66.8 % vs. 71.1 %, p = .018) was lower. Besides higher age of female patients (80 vs. 75 years, p < .001), no further statistically significant differences were seen following rAAA repair. In-hospital mortality was slightly lower in males compared to females following iAAA (2.3 % vs. 3.1 %, p = .159) and rAAA (37.3 % vs. 43.1 %, p = .273) repair. Concerning iAAA repair, a higher rate of female patients was transferred to another hospital (3.7 % vs. 2.0 %, p = 0.008) or discharged to rehabilitation (6.0 % vs. 2.7 %, p < .001) compared to male patients. CONCLUSIONS: In this large German claims data cohort, women are generally older and more often transferred to another hospital or discharged to rehab following iAAA repair. Nonetheless, no significantly increased risk of in-hospital or late death appeared for women in multivariate analyses. Further studies are necessary to evaluate the impact of recent gender-specific treatment strategies on overall outcome under real-world settings.

mosaicQA - A General Approach to Facilitate Basic Data Quality Assurance for Epidemiological Research.

BACKGROUND: Epidemiological studies are based on a considerable amount of personal, medical and socio-economic data. To answer research questions with reliable results, epidemiological research projects face the challenge of providing high quality data. Consequently, gathered data has to be reviewed continuously during the data collection period. OBJECTIVES: This article describes the development of the mosaicQA-library for non-statistical experts consisting of a set of reusable R functions to provide support for a basic data quality assurance for a wide range of application scenarios in epidemiological research. METHODS: To generate valid quality reports for various scenarios and data sets, a general and flexible development approach was needed. As a first step, a set of quality-related questions, targeting quality aspects on a more general level, was identified. The next step included the design of specific R-scripts to produce proper reports for metric and categorical data. For more flexibility, the third development step focussed on the generalization of the developed R-scripts, e.g. extracting characteristics and parameters. As a last step the generic characteristics of the developed R functionalities and generated reports have been evaluated using different metric and categorical datasets. RESULTS: The developed mosaicQA-library generates basic data quality reports for multivariate input data. If needed, more detailed results for single-variable data, including definition of units, variables, descriptions, code lists and categories of qualified missings, can easily be produced. CONCLUSIONS: The mosaicQA-library enables researchers to generate reports for various kinds of metric and categorical data without the need for computational or scripting knowledge. At the moment, the library focusses on the data structure quality and supports the assessment of several quality indicators, including frequency, distribution and plausibility of research variables as well as the occurrence of missing and extreme values. To simplify the installation process, mosaicQA has been released as an official R-package.

TranslatiOnal Registry for CardiomyopatHies (TORCH) - rationale and first results.

AIMS: Non-ischemic cardiomyopathies (CMPs) comprise heart muscle disorders of different causes with high variability in disease phenotypes and clinical progression. The lack of national structures for the efficient recruitment, clinical and molecular classification, and follow-up of patients with non-ischemic CMPs limit the thorough analysis of disease mechanisms and the evaluation of novel diagnostic and therapeutic strategies. This paper describes a national, prospective, multicenter registry for patients with non-ischemic CMPs. The main objective of this registry is to create a central hub for clinical outcome studies, a joint resource for diagnostic and therapeutic trials, a common biomaterial bank, and a resource for detailed molecular analyses utilizing patients' biomaterials. METHODS AND RESULTS: A comprehensive characterization of the register population and patients' subgroups is planned. First analyses will include descriptive methods evaluating the distribution of outcome variables and possible risk factors followed by test statistics in a cross-sectional design. The aim of the current study is to recruit 2300 patients all over Germany. Eligible participants are patients with primary non-ischemic cardiomyopathies, including hereditary and inflammatory dilated CMP (DCM), left-ventricular noncompaction CMP (LVNC), hypertrophic CMP (HCM), arrhythmogenic right-ventricular CMP (ARVC), myocarditis, and amyloidosis. Of already recruited patients 70% are male and 30% female. With 56% of patients included, DCM is most common. CONCLUSION/OUTCOME: The primary outcome is all-cause death. Key secondary endpoints are cardiovascular death, adequate ICD shock, survived sudden cardiac death, syncope, documented potentially life-threatening arrhythmia, cardiac transplantation, hospitalization due to worsening of heart failure (HF), and any non-elective cardiovascular hospitalization.

Data privacy management and data quality monitoring in the German Centre for Cardiovascular Research's multicentre TranslatiOnal Registry for CardiomyopatHies (DZHK-TORCH).

AIMS: The multicentric TranslatiOnal Registry for CardiomyopatHies (TORCH) of the German Centre for Cardiovascular Research aims to recruit 2300 patients with non-ischemic cardiomyopthies. METHODS AND RESULTS: The investigations were performed after standard operating procedures. The data are collected in standardized electronic case report forms provided by the data holding of the central data management of the German Centre for Cardiovascular Research using secuTrial (interActive Systems GmbH, Berlin, Germany). The personal-identifying data and informed consent are collected, stored, and quality-checked by the independent Trusted Third Party in Greifswald. The quality management of the medical data is performed by the data and quality centre Greifswald. In December 2014, the recruitment for TORCH has started. Currently, data and biomaterial from about 1397 patients and more than 74 500 biomaterial aliquots were collected. Regular study centre-specific quality reports address completeness and plausibility of data and provide detailed information about current missing or implausible data entries to improve the data quality by using a query management in addition. CONCLUSIONS: A regular quality control and reporting improve the data quality in TORCH and will support high-quality data analysis and the translation of research results into routine care.

Relationship between objectively measured intensity of physical activity and self-reported enjoyment of physical activity.

Physical activity is an important factor for the maintenance of health. Enjoyment of physical activity is essential to motivate persons to engage in sufficient physical activity. We examined whether self-reported enjoyment of PA is associated with objective measurement of the intensity of PA. A cardiovascular examination program was provided for individuals aged 40-75 years without a history of cardiovascular events in Greifswald, Germany between 2012 and 2013. Participants (n = 255) were asked to wear a three-axial accelerometer device (ActiGraph, GT3X +, Pensacola, Florida, USA) for 7 consecutive days. After wearing the device, the participants were asked to complete the 18-item self-administered physical activity enjoyment scale (PACES). Participants' (n = 200) daily minutes of moderate-to-vigorous physical activity (MVPA) and their enjoyment of PA were analysed in a linear regression approach. The mean age of the participants was 56.3 ± 9.7 years, 41.0% were male. The average MVPA duration was 44.4 ± 27.3 min per day. In the regression analysis, enjoyment of PA was positively associated with MVPA (ß = 0.18, 95% CI (0.05; 0.31), p = 0.009), participants with higher enjoyment of PA showed higher MVPA. We found a positive association between MVPA and enjoyment of PA, although for male participants only. Between bouted MVPA and enjoyment of PA there was no significant relationship.