Katharina Glassen

Evaluating the Quality of Colorectal Cancer Care across the Interface of Healthcare Sectors

Background Colorectal cancer (CRC) has a high prevalence in western countries. Diagnosis and treatment of CRC is complex and requires multidisciplinary collaboration across the interface of health care sectors. In Germany, a new nationwide established program aims to provide quality information of healthcare delivery across different sectors. Within this context, this study describes the development of a set of quality indicators charting the whole pathway of CRC-care including data specifications that are necessary to operationalize these indicators before practice testing. Methods Indicators were developed following a systematic 10 step modified ‘RAND/UCLA Appropriateness Method’ which involved a multidisciplinary panel of thirteen participants. For each indicator in the final set, data specifications relating to sources of quality information, data collection procedures, analysis and feedback were described. Results The final indicator set included 52 indicators covering diagnostic procedures (11 indicators), therapeutic management (28 indicators) and follow-up (6 indicators). In addition, 7 indicators represented patient perspectives. Primary surgical tumor resection and pre-operative radiation (rectum carcinoma only) were perceived as most useful tracer procedures initiating quality data collection. To assess the quality of CRC care across sectors, various data sources were identified: medical records, administrative inpatient and outpatient data, sickness-funds billing code systems and patient survey. Conclusion In Germany, a set of 52 quality indicators, covering necessary aspects across the interfaces and pathways relevant to CRC-care has been developed. Combining different sectors and sources of health care in quality assessment is an innovative and challenging approach but reflects better the reality of the patient pathway and experience of CRC-care.

Applicability of the assessment of chronic illness care (ACIC) instrument in Germany resulting in a new questionnaire: questionnaire of chronic illness care in primary care

BackgroundThe Chronic Care Model (CCM) is an evidence based, population based approach to improve care for people with chronic conditions. The Assessment of Chronic Illness Care (ACIC) instrument is widely used to measure to what extent within a healthcare system the CCM is implemented. The aim of this study was to translate and culturally adapt the ACIC Instrument for the German healthcare system.MethodsFor translating the ACIC instrument, principles of Good Practice for the Translation and Cultural Adaptation Process by the ISPOR Task Force were followed. Focus groups were additionally conducted with general practitioners to adapt the items culturally.ResultsThe ACIC instrument can not be used in the German healthcare system easily due to a multifaceted understanding of words, different levels of knowledge of the CCM and fundamental differences between health systems.ConclusionsAs following the CCM leads to benefits for patients with chronic illnesses, measuring to which extent it is implemented is of major interest. A new questionnaire using the CCM as its theoretical basis, sensitive to the healthcare systems of the host country has to be created. Knowledge transfer between countries by using an instrument from a different healthcare system can lead to a completely new questionnaire.

The generation of carcinogenic etheno-DNA adducts in the liver of patients with nonalcoholic fatty liver disease

BACKGROUND Nonalcoholic fatty liver disease (NAFLD), in particular its more aggressive form nonalcoholic steatohepatitis (NASH) is increasingly observed as a cause of end stage liver disease and hepatocellular carcinoma (HCC). Reactive oxygen species (ROS) are an important factor in the pathogenesis of HCC. ROS can react with polyunsaturated fatty acids derived from membrane phospholipids resulting in the production of reactive aldehydes as lipid oxidation (LPO) byproducts, such as 4-hydroxynonenal (4 HNE). 4 HNE can react with DNA to form mutagenic exocyclic etheno-DNA adducts. ROS is induced by inflammatory processes, but also by induction of cytochrome P450 2E1 (CYP2E1), as seen with chronic alcohol consumption. METHODS Immunohistochemical detection of CYP2E1, 4 HNE and hepatic exocyclic etheno-DNA adducts was performed on liver sections from 39 patients with NFLD. Spearman rank correlation was calculated to examine possible correlations. RESULTS Exocyclic etheno-DNA adducts were detected and correlated significantly with 4 HNE, but not with CYP2E1. CONCLUSIONS This is the first description of highly carcinogenic exocyclic etheno-DNA adducts in NAFLD patients. We could show that exocyclic etheno-DNA adducts significantly correlated with lipid peroxidation product 4 HNE, but not with CYP2E1, implying that in NAFLD ROS generation with consecutive DNA damage is rather inflammation driven through various cytokines than by induction of CYP2E1.

Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial

BackgroundDespite many initiatives to enhance the rational use of antibiotics, there remains substantial room for improvement. The overall aim of this study is to optimise the appropriate use of antibiotics in German ambulatory care in patients with acute non-complicated infections (respiratory tract infections, such as bronchitis, sinusitis, tonsillitis and otitis media), community-acquired pneumonia and non-complicated cystitis, in order to counter the advancing antimicrobial resistance development.MethodsA three-armed cluster randomised trial will be conducted in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) and an added cohort that reflects standard care. The trial is accompanied by a process evaluation.Each arm will receive a different set of implementation strategies. Arm A receives a standard set, comprising of e-learning on communication with patients and quality circles with data-based feedback for physicians, information campaigns for the public, patient information material and performance-based additional reimbursement. Arm B receives this standard set plus e-learning on communication with patients and quality circles with data-based feedback tailored for non-physician health professionals of the practice team and information material for tablet computers (culture sensitive). Arm C receives the standard set as well as a computerised decision support system and quality circles in local multidisciplinary groups.The study aims to recruit 193 practices which will provide data on 23,934 patients each year (47,867 patients in total).The outcome evaluation is based on claims data and refers to established indicators of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Primary and secondary outcomes relate to prescribing of antibiotics, which will be analysed in multivariate regression models. The process evaluation is based on interviews with surveys among physicians, non-physician health professionals of the practice team and stakeholders. A patient survey is conducted in one of the study arms. Interview data will be qualitatively analysed using thematic framework analysis. Survey data of physicians, non-physician health professionals of the practice team and patients will use descriptive and exploratory statistics for analysis.DiscussionThe ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice.Trial registrationISRCTN, ISRCTN58150046. Registered 24 August 2017.

Society Bulletins • Gesellschaftsmitteilungen

Für die SMGP ist diese Schnittstelle Neuland. Mit der laufenden Gesetzesänderung des Heilmittelgesetzes HMG 2, die Chancen aber auch Risiken für die Weiterentwicklung der Phytotherapie mit sich bringt, gewinnt das Thema aktuell an Bedeutung. Eine sinnvolle Abgrenzung von pflanzlichen Arzneimitteln gegenüber Nahrungsergänzungsmitteln sowie Medizinprodukten mit pflanzlichen Stoffen ist zwingend nötig. Bei den exklusiven Mittagshäppchen und Kaffeepausen im Kongresszentrum Trafo in Baden konnte das Thema weiter vertieft und «verdaut» werden.

Induction of Hepatic Cytochrome P450 2e1 in Alcoholic and Non-Alcoholic Fatty Liver as a Driving Force for Hepatic Fibrosis and Carcinogenesis

Introduction: As the childhood obesity epidemic grows, an increasing number of children are diagnosed with non-alcoholic fatty liver disease (NAFLD) and type 2 non-alcoholic steatohepatitis (NASH). One common finding in NASH patients is increased levels of free fatty acids (FFA). Peroxidation of FFA by reactive oxygen species (ROS) has been shown to cause damage to cellular membranes and organelles such as mitochondria. Studies in humans and animals have demonstrated that oxidative stress, which produces ROS, is a critical player in the pathogenesis of NASH. PON1 is an enzyme exclusively synthesized in the liver and functions as an antioxidant preventing the oxidation of High Density Lipoproteins (HDL). Studies in adults have shown comparable activity of PON1 in both liver and serum, thus making it a potential biomarker for evaluating liver disease. Adult human and animal studies have demonstrated decreased or depleted PON1 activity with diseased liver architecture and changes in plasma lipoprotein subclass distribution. This can lead to increased production of oxidative stress and subsequent atherosclerotic risk. Currently the relationships between PON1 and pediatric (type 2) NASH, is unknown. This study focuses on the gene expression of PON1 in type 2 NASH. Methods and Results: NASH was diagnosed according to Kleiners criteria. Data mining on NASH microarray database [1] showed a difference in the relative expression of PON1 among insulin resistant (1.77x) and non insulin resistant (2.24x) pediatric NASH patients compared to normal controls (NC). Additional quantitative analysis of the PON1 expression in liver tissue of NASH (n=18) and NC (n= 4) with GAPDH as the housekeeping gene was performed with real time PCR. PON1 mRNA expression level was found to be 8.18 times that of the NC (p< 0.005). Conclusion: The increase in the expression of PON1 in pediatric NASH livers suggests a shift in the balance between antioxidants and oxidative stress. This finding is in contrast to adult NASH studies where a decreased level of PON1 activity in serum was reported with NASH type I. Our findings suggest that the hepatic damage involved in type 2 NASH is not as extensive compared to the hepatic damage noted in type 1 NASH. In addition this data suggests that serum levels of PON1 are likely inadequate surrogate for liver biopsy when assessing pediatric liver disease, additional studies are necessary.