Publikationen

Wilke T, Müller S, Bauersachs R, Breithardt G. The influence of disease-specific symptoms on the health-related quality of life in patients with atrial fibrillation. 2012;15(7):A379.

Abstract

OBJECTIVES

To assess the health-related quality of life (HrQoL) in patients with atrial fibrillation (AF) in Germany and to identify the influence of the associated AF-specific symptoms on HrQoL.

METHODS

HrQoL of AF patients recruited into a prospective cohort study was assessed by using the written version of the SF 36. General HrQoL as well as physical and mental component summary scores were calculated for each patient. Secondly, AF-related symptoms based on the EHRA AF symptoms classification (palpitations, fatigue, dizziness, dyspnea, chest pain, anxiety) were collected by asking each patient to fill out written questionnaires during visiting a GP. To identify the influence of these symptoms on HrQoL, a linear regression was conducted for each component summary score, while controlling for additional socio-demographic/AF-related clinical parameters.

RESULTS

A total of 526 AF-patients were recruited in 71 study centers (female patients: 45.1 %, average age: 73.2 years, average CHA2DS2-VASc score: 3.8). The average SF-36-physical summary score was 38.6 (SD: 10.4). The average SF-36 mental component score was 46.5 (SD: 11.8). Only 14.8 % of the patients reported none of the EHRA-symptoms. The most frequent symptom was fatigue (72.1 % of all patients). The results of the first multivariate regression (R2=0.349) showed that the most important factors explaining the SF-36-physical component score were fatigue, chest pain, dizziness and dyspnea. Only two of the control variables had a significant influence on physical HrQoL (age; number of medications taken). In the second estimate addressing mental HrQoL (R2=0.349), none of these factors was significant. The most important factors explaining mental HrQoL were palpitations, dizziness and anxiety.

CONCLUSIONS

Wilke T, Müller S. The quality of anticoagulation therapy in patients with atrial fibrillation. Value in Health. 2012;15(4):A128.

Abstract

OBJECTIVES

The aim of this research was to assess the quality of anticoagulation therapy of patients with atrial fibrillation (AF) in a real life setting and to identify the causal factors explaining anticoagulation quality deficits. Furthermore, clinical consequences of suboptimal anticoagulation therapy (strokes, TIA, bleedings, embolism, myocardial infarcts) are identified.

METHODS

The INR values as well as other clinical events concerning AF patients recruited into a prospective cohort study (observation period of 12 month) were documented at every visit to the treating doctor. Using the Rosendaal linear trend method, the time in therapeutic range (TTR) of 2.0-3.0 was estimated. Additionally, the squared INR deviation was investigated. To identify causes of INR-values below/above 2.0-3.0, a logistic regression on the basis of a TTR   60% as the dichotomous outcome was conducted.

RESULTS

For 525 patients from 71 study centers, at least two INR values were available over a median observational period of 228.9 days (SD: 106.1 days). The average TTR was 68.1 % (SD: 26.3 %). The average deviation of INR value from the mean of the INR target range (2.5) was 0.44 (SD: 1.29). The results of the multivariate regression (R2 0,179) show that the most important factors explaining a poor quality of anticoagulation therapy are bridging periods and patients self-reported need of help regarding medication therapy without getting that help. In the group of patients with a TTR 60 %, the occurrence rate of clinical outcomes was higher (p 0.031) than in the group of patients with a TTR 60 %.

CONCLUSIONS

Labile INR values lead to negative clinical outcomes. In order to improve the situation, the main identified causes of poor anticoagulation quality should be addressed.

Wilke T, Groth A, Müller S, Ahrendt P, Schwartz D, Linder R, Ahrens S, Verheyen F. Prevalence and Incidence of Type 2 Diabetes Mellitus: An Analysis Based on 5.4 Million Patients. Value in Health. 2012;15(4):A174-A175.

Abstract

OBJECTIVES

The aim of this research was to assess the quality of anticoagulation therapy of patients with atrial fibrillation (AF) in a real life setting and to identify the causal factors explaining anticoagulation quality deficits. Furthermore, clinical consequences of suboptimal anticoagulation therapy (strokes, TIA, bleedings, embolism, myocardial infarcts) are identified.

METHODS

The INR values as well as other clinical events concerning AF patients recruited into a prospective cohort study (observation period of 12 month) were documented at every visit to the treating doctor. Using the Rosendaal linear trend method, the time in therapeutic range (TTR) of 2.0-3.0 was estimated. Additionally, the squared INR deviation was investigated. To identify causes of INR-values below/above 2.0-3.0, a logistic regression on the basis of a TTR < 60% as the dichotomous outcome was conducted.

RESULTS

For 525 patients from 71 study centers, at least two INR values were available over a median observational period of 228.9 days (SD: 106.1 days). The average TTR was 68.1 % (SD: 26.3 %). The average deviation of INR value from the mean of the INR target range (2.5) was 0.44 (SD: 1.29). The results of the multivariate regression (R2=0,179) show that the most important factors explaining a poor quality of anticoagulation therapy are bridging periods and patients self-reported need of help regarding medication therapy without getting that help. In the group of patients with a TTR<60 %, the occurrence rate of clinical outcomes was higher (p=0.031) than in the group of patients with a TTR>60 %.

CONCLUSIONS

Wilke T, Groth A, Müller S, Pfannkuche M, Verheyen F, Linder R, Maywald U, Kohlmann T, Feng YS, Breithardt G, Bauersachs R. Oral anticoagulation use by patients with atrial fibrillation in Germany. Adherence to guidelines, causes of anticoagulation under-use and its clinical outcomes, based on claims-data of 183,448 patients. Thrombosis & Haemostasis. 2012;107(6):1009–1194.

Abstract

Wilke T, Müller S, Morisky D.E. Toward Identifying the Causes and Combinations of Causes Increasing the Risks of Nonadherence to Medical Regimens: Combined Results of Two German Self-Report Surveys. Value in Health. 2011;14(8):1092–1100.

Abstract

OBJECTIVES

This study aimed to identify the causes of the nonadherence (NA) of German patients to their prescribed medication. In the course of the investigation, the NA risk profiles resulting from the combination of the various causes were identified.

METHODS

Two cross-sectional surveys with a total of 1517 patients (comprising 1177 patients contacted by telephone and forming survey 1 and a different set of 340 patients interviewed in-depth and face-to-face forming survey 2) were conducted. Self-reported NA was measured by the generic Morisky Medication Adherence Scale (MMAS). Survey 1 used a four-item MMAS and Survey 2 an eight-item MMAS.

RESULTS

Approximately 35% to 40% of the patients can be described as nonadherent. In survey 1, a few causes explain the NA (chronic disease, younger age, and fewer medications required to be taken). The more detailed survey 2 shows that the existence of intentional NA has considerably more influence than any other causal factors. Positive medication beliefs, a positive mood, and a good patient-doctor relationship reduce the NA risk. Furthermore, patients who are easily able to recognize the correct medication, as evidenced by ability to correctly identify the packaging, have a reduced NA probability. Concerning additive risk, patients who are chronically ill but display no other causes of risk have an NA probability of 10.4%. By contrast, in patients displaying all the identified causes of risk, the rate increases to 93.9%.

CONCLUSIONS

About one-third of patients can be classified as nonadherent. Intentional/medication-based NA causal factors explain the NA considerably better than do socioeconomics. The existence of more than one cause of risk considerably increases the NA risk of a patient.

Müller S, Wilke T, Pfannkuche M, Meßer I, Kurth A, Merk H, Steinfeldt F, Ganzer D, Perka C. Patientenpfade in der Thromboseprophylaxe nach Hüft- und Kniegelenkersatz. Der Orthopäde. 2011;40(7):585-590.

Abstract

ZUSAMMENFASSUNG

Ein wesentliches Element der Patientenversorgung nach einem Hüft- und Kniegelenkersatz stellt die medikamentöse Thromboseprophylaxe dar. Vor dem Hintergrund sinkender stationärer Akutverweildauern ist die Frage der Bedeutung und Organisation der ambulanten Thromboseprophylaxe in Verantwortung der Patienten zu beantworten (Patientenpfadanalyse).

Zur Analyse von Patientenpfaden wurde eine telefonische Befragung von 668 in Akutkliniken gewonnenen Patienten durchschnittlich 38 Tage nach der Operation durchgeführt (Fokus auf niedermolekulare Heparine). Rund 90% der Patienten stehen der Notwendigkeit gegenüber, mindestens an einem Tag die Thromboseprophylaxe im ambulanten/häuslichen Umfeld durchzuführen. Allein für 47,2% der Patienten ist das Linking – verstanden als „Überbrückungstage“ zwischen Akut- und Rehabilitationsaufenthalt – relevant. Die offensichtlich bestehende quantitative Bedeutung der ambulanten Thromboseprophylaxe zeigt sich auch in der Dauer der ambulanten Prophylaxephasen, die für 45,7% der interviewten Patienten zumindest 5 Tage beträgt.

Die ambulante Thromboseprophylaxe stellt hohe Anforderungen an die Patienten, insbesondere wenn diese mit der aus Patientensicht komplexen Gabeform der Spritze einhergeht. An der Versorgung Beteiligte sollten nicht „selbstverständlich“ davon ausgehen, dass Patienten im ambulanten Bereich die notwendige Prophylaxe zuverlässig betreiben. Vielmehr besteht Evidenz dafür, dass Non-Adhärenz von Patienten eine reale Versorgungsherausforderung darstellt.

Wilke T, Müller S, Groth A, Maywald U, Verheyen F. Anforderungen an ein effektives Adherence-Persistence-Programm am Beispiel von oralen Antidiabetika bei Diabetes mellitus Typ 2-Patienten. Gesundheitsökonomie & Qualitätsmanagement. 2011;16(5): 274-291.

Abstract

AIM

The aim of this review is 1. to give an overview about the extent of medication-based nonadherence (NA)/nonpersistence (NP) related to oral antidiabetics (OAD) in Diabetes mellitus type II (DM 2) therapy and 2. to evaluate the effectiveness of adherence interventions (AI) aimed to reduce NA/NP in OAD therapy in relation to their methodological quality.

METHOD

A systematic review of DM 2 studies regarding the extent of NA/NP concerning OAD and of AI effectiveness studies was conducted (Medline/NML and Embase). Only interventions aiming to improve medication adherence/persistence were included. All AI were evaluated regarding their methodological quality and their effectiveness (2 outcomes: adherence/persistence and clinical outcomes).

RESULTS

All in all, 62 studies evaluating the NA/NP extent in OAD and 15 publications evaluating 19 different AI were included in this review. According to the study mean, NA affects 29.1 % to 39.2 % and NP affects 56.1 % of the DM 2 patients; naturally, extent of NA/NP depends both on its definition and used NA/NP measures. Four dimensions of the methodological quality of AI were identified: 1. measurement of adherence/persistence/clinical outcomes, 2. measurement of NA/NP causes, 3. use of effective/validated intervention measures, 4. effective program evaluation. The authors defined 5 detailed methodological requirements per dimension and, based on this, developed a corresponding scoring model (MIN Score 0, MAX score 20). All 19 AI programs were evaluated in the scoring model (average score 8.05): Score < 5: 3 AI – no AI (0 %) with adherence/persistence/blood glucose level improvement; Score 5 – 9: 8 AI – 6 AI (75 %) with improvement in adherence/persistence/blood glucose levels; Score > 9: 8 AI – all AI (100 %) improved adherence and/or blood glucose levels.

CONCLUSION

In future, AI will play a much more important part than nowadays in the German health care system. However, the existing evidence concerning their limited effectiveness shows that a lot of research is needed in order to understand factors explain a program’s effectiveness. The scoring model provides first implications for the methodical evaluation of AI.

Wilke T, Greinacher A. Hospital-specific calculation of heparin-induced thrombocytopenia costs: a review. J Lab Med 2011;35(1); S:35-43.

Abstract

Costs for heparin-induced thrombocytopenia (HIT) should be considered for any assessment of the cost-effectiveness of a certain strategy of thrombosis prophylaxis in a hospital. Five recent studies analyzed the cost of HIT as primary outcome. These studies reported widely differing estimates for the costs of a HIT case, which might be largely related to the different methodological approaches. The most plausible HIT cost estimates range between €9,000 and €15,000 per case for European hospitals and US$30,000–45,000 per case for hospitals in the United States. The approximate threefold cost difference between Europe and the US is to some extent caused by the very different costs for certain interventions and treatments, i.e., they are dependent on the economic environment of the hospitals analyzed. Based on the assumption that clinical management of acute HIT does not differ substantially between different medical systems, we recently developed the HIT cost calculator based on detailed analysis of additional resources required owing to the presence of HIT in 128 patients with clinical HIT. This tool offers interested hospitals a very transparent method to calculate their own HIT-related costs.

Kasch R, Merk S, Kayser R, Lahm A, Drescher W, Schulz A.P, Wilke T, Flessa S. Kostenvergleichskalkulation der Schlitten- vs. bikondylären Oberflächenversorgung am Kniegelenk. Z Orthop Unfall. 2011;149(6): 646-652.

Abstract

BACKGROUND

The G-DRG system reimburses sledge endoprosthetic implantations (UKA) at a much lower rate than surface replacements (TKA), at significantly different cost weights (CW). Therefore, when only G-DRG payments are considered, the complete endoprosthesis implantation produces higher gains. An orientation on these revenues alone, however, does not provide the basis for an economically sound decision-making process. The aim of this study is to present a comparison of the variable costs of the two procedures.

MATERIAL AND METHODS

The mean cost and performance data of 28 Endo-Model UKA implantations and of 85 NexGen CR TKA replacements were compared with each other in 2007.

RESULTS

From the perspective of the hospital, when the correct medical indication is present, UKA treatment is of greater economic advantage. In this way the total unit contribution margin can be improved, and although the relative weighting is comparatively low, the costs are significantly lower than in a comparative analysis of the TKA.

CONCLUSION

For the desired maximisation of the unit contribution margin, assuming that it is the proper medical indication, the recommendation for the hospital would be implantation of the UKA. Considered from the economic perspective of gains and costs, the assumption that a TKA would be advantageous could not be confirmed in the present study.

Wilke T, Müller S, Neumann K, Loder T. Does the package design matter? The influence of OTC package design on patients’ drug knowledge. Pharmaceutical Medicine. 2011;25(5):307-317.

Abstract

INTRODUCTION

The objective of this study was to discover whether over-the-counter (OTC) package designs differ in their ability to transfer drug-safety-related information to pharmacy customers. The research was intended to answer two questions: (i) how well and quickly do customers comprehend, and what are the main characteristics of customers who have difficulty understanding relevant medical information on a package; and (ii) do alternative package designs provide for significantly different levels of comprehension? 

METHODS

We performed cross-sectional face-to-face interviews with 452 pharmacy customers in 17 German pharmacies. In each of three sequential experiments (one OTC brand per experiment), each participant was shown two packages of the same brand and was asked three drug-related questions per package. The different abilities of the three package designs to transfer information correctly and rapidly were compared by descriptive statistics; the significance of differences was tested by Wilcoxon tests. 

RESULTS

Older people, those with physical problems, people not in a receptive mood, and those with a poor doctor-patient relationship or a lack of trust in medicines in general, answered the questions with a significantly higher number of errors and/or required significantly more time to do so, than the remainder of the sample. When compared with two other package designs, one of the tested designs with special design characteristics proved superior. 

CONCLUSIONS

The design of a medication package can measurably influence the quality and speed of information transfer to pharmacy customers. Because drug safety and adherence are associated with drug knowledge, the design of packaging should be given more attention.