Thea Schwaneberg

Pitfalls in accelerometer-based measurement of physical activity: The presence of reactivity in an adult population

When a behavior is monitored, it is likely to change, even if no change may be intended. This phenomenon is known as measurement reactivity. We investigated systematic changes in accelerometer‐based measures over the days of monitoring as an indicator of measurement reactivity in an adult population. One hundred seventy‐one participants from the general population (65% women; mean age = 55 years, range: 42‐65 years) wore accelerometers for 7 consecutive days to measure sedentary behavior and physical activity (PA). Latent growth models were used (a) to investigate changes in accelerometer wear time over the measurement days and (b) to identify measurement reactivity indicated by systematic changes in sedentary time (ST), light physical activity (LPA), and moderate‐to‐vigorous physical activity (MVPA). Over the measurement days, participants reduced accelerometer wear time by trend (rate of change [b] = −4.7 min/d, P = .051, Cohens d = .38), increased ST (b = 2.4 min/d, P = .018, d = .39), and reduced LPA (b = −2.4 min/d, P = .015, d = .38). Participants did not significantly reduce MVPA (P = .537). Our data indicated that accelerometry might generate reactivity. Small effects on ST and LPA were found. Thus, the validity of accelerometer‐based data on ST and LPA may be compromised. Systematic changes observed in accelerometer wear time may further bias accelerometer‐based measures. MVPA seems to be less altered due to the presence of an accelerometer.

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 Germanys 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.

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.

The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial

Background 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. Methods 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. Results 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). Conclusion 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.

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.

Grundlagen der Statistik und Anwendung in der Gefäßchirurgie

ZusammenfassungIn der vaskulären Forschung kommen zahlreiche statistische Kennzahlen und Methoden zum Einsatz. Die Auswahl des richtigen statistischen Verfahrens hängt jeweils von dem Kontext der Studienpopulation, der Häufigkeit eines Ereignisses oder der zugrunde liegenden Verteilung ab. Da es bisher nur wenige randomisierte klinische Studien (RCTs) in der Gefäßmedizin gibt und weil insbesondere Projekte der Qualitätsentwicklung auf sogenannte Real-World-Daten angewiesen sind, werden zunehmend nichtrandomisierte Daten aus Registern oder Routinedaten der Kostenträger verwendet, sodass geeignete statistische Verfahren zur Beurteilung der Validität dieser Datenquellen erforderlich werden. Dazu gehören die Standardkennzahlen Mittelwert, Standardabweichung, Varianz und Konfidenzintervalle, aber auch Überlebenszeitanalysen, Propensity Score Matching und Cox-Regression sowie die Darstellung der Ergebnisse in Form von Kaplan-Meier-Kurven und Forest-Plots. Diese werden in diesem Artikel erklärt und anhand von ausgewählten Publikationen aus der vaskulären Versorgungsforschung dargestellt. Die gewissenhafte Auswahl des geeigneten statistischen Verfahrens in der jeweiligen Situation und das Verstehen der Methoden und Ergebnisse in wissenschaftlichen Publikationen sind von großer Wichtigkeit für die Ableitung valider Erkenntnisse.AbstractIn vascular research many statistical methods are used. The selection of the right statistical method depends on study design, frequencies on events, and the data’s underlying distributions. In vascular surgery research, random clinical trials (RCTs) are rare. Likewise, quality improvement depends on real-world data. Therefore, the amount of registered and administered data analyses will increase in the next years as well as the usage of statistical methods to examine the validity of data. Among others, the mean, standard deviation, variance and confidence intervals, as well as survival analyses, propensity score matching, and Cox regression, have widespread use for illustration, e. g. Kaplan–Meier curves and forest plots. In the following, the most important statistical methods will be explained by means of select publications from the vascular surgery literature. The conscientious selection of the right analysis methods in every different situation is most important for valid knowledge gains.

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 Germanys 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.

Erratum to: Complex endovascular treatment of intact aortic aneurysms. An analysis of health insurance claims data

Erratum to:Gefässchirurgie (2018)https://doi.org/10.1007/s00772-018-0387-7 The article was wrongly published under the article type “Review”. Please note that the article is an “Original Paper”.The publisher apologizes to the authors and …

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

The multicentric TranslatiOnal Registry for CardiomyopatHies (TORCH) of the German Centre for Cardiovascular Research aims to recruit 2300 patients with non‐ischemic cardiomyopthies.