Physical activity (PA) can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs) on adherence was examined.A randomized study with four groups was conducted in the context of a health examination program among participants aged 40-75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance). The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme "day and night" or "day only" and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days). A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence.Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males). The mean wearing time was 84.04 hours (SD 20.75). Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005). SPCs had no additional effect on adherence (IRR 0.80; P=0.168).To assess PA, the wearing scheme day and night provides the best possible adherence in this group of participants. Further studies are necessary to examine adherence and the effects of additional SPCs in other samples or settings.
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.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.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.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.
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. 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. 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. 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.
Abstract. 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.
ObjectiveThis study aimed to determine predictors and outcomes associated with bleeding or anemia requiring transfusion (BAT) after fenestrated or branched endovascular aneurysm repair (FB-EVAR).MethodsHealth 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.ResultsA 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).ConclusionsPatients 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.
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.
