Validation of patient- and GP-reported core sets of quality indicators for older adults with multimorbidity in primary care: results of the cross-sectional observational MULTIqual validation study.

BACKGROUND: Older adults with multimorbidity represent a growing segment of the population. Metrics to assess quality, safety and effectiveness of care can support policy makers and healthcare providers in addressing patient needs. However, there is a lack of valid measures of quality of care for this population. In the MULTIqual project, 24 general practitioner (GP)-reported and 14 patient-reported quality indicators for the healthcare of older adults with multimorbidity were developed in Germany in a systematic approach. This study aimed to select, validate and pilot core sets of these indicators. METHODS: In a cross-sectional observational study, we collected data in general practices (n = 35) and patients aged 65 years and older with three or more chronic conditions (n = 346). One-dimensional core sets for both perspectives were selected by stepwise backward selection based on corrected item-total correlations. We established structural validity, discriminative capacity, feasibility and patient-professional agreement for the selected indicators. Multilevel multivariable linear regression models adjusted for random effects at practice level were calculated to examine construct validity. RESULTS: Twelve GP-reported and seven patient-reported indicators were selected, with item-total correlations ranging from 0.332 to 0.576. Fulfilment rates ranged from 24.6 to 89.0%. Between 0 and 12.7% of the values were missing. Seventeen indicators had agreement rates between patients and professionals of 24.1% to 75.9% and one had 90.7% positive and 5.1% negative agreement. Patients who were born abroad (- 1.04, 95% CI = - 2.00/ - 0.08, p = 0.033) and had higher health-related quality of life (- 1.37, 95% CI = - 2.39/ - 0.36, p = 0.008), fewer contacts with their GP (0.14, 95% CI = 0.04/0.23, p = 0.007) and lower willingness to use their GPs as coordinators of their care (0.13, 95% CI = 0.06/0.20, p < 0.001) were more likely to have lower GP-reported healthcare quality scores. Patients who had fewer GP contacts (0.12, 95% CI = 0.04/0.20, p = 0.002) and were less willing to use their GP to coordinate their care (0.16, 95% CI = 0.10/0.21, p < 0.001) were more likely to have lower patient-reported healthcare quality scores. CONCLUSIONS: The quality indicator core sets are the first brief measurement tools specifically designed to assess quality of care for patients with multimorbidity. The indicators can facilitate implementation of treatment standards and offer viable alternatives to the current practice of combining disease-related metrics with poor applicability to patients with multimorbidity.

Experiences of patients with multimorbidity with primary care and the association with patient activation: a cross-sectional study in Germany.

OBJECTIVES: This study aimed to explore the association between patient activation and patients' experience of care among an elderly multimorbid population in Germany. DESIGN: Cross-sectional study. SETTING: Primary care practices in two German settings. PARTICIPANTS: 346 patients with 3 or more chronic conditions aged 65 years and over from 36 primary care practices. OUTCOME MEASURES: Patient activation was measured with the patient activation measure (PAM). To assess patient experiences with primary care, a set of questions concerning domains of primary care were included. Multilevel regression analyses were performed to examine which domains of care were associated with patient activation. RESULTS: Out of 1243 invited patients, a total of 346 took part in the study (participation rate 27.8 %). Mean PAM score was 76.1. Across all patients, 3.8% achieved PAM level 1, 7.5% level 2, 27.2% level 3% and 60.7% level 4. PAM scores suggest a highly activated patient group. In the regression analysis, three out ten domains of patients' experiences showed an association with patient activation. The domains 'being involved in decision as much as desired' (B=-8.56, p=0.012) and 'receiving a self-management plan' (B=6.51, p=0.051) were associated with higher patient activation scores. Patients with an up-to-date medication plan had lower patient activation scores (B=-12.01, p=0.041). CONCLUSION: Specific domains of primary care were found to be associated with patient activation. To enhance patient activation, primary care physicians may increase involvement of patients in decisions. Future research should examine the causality of these associations. TRIAL REGISTRATION NUMBER: DRKS00015718.

Measuring the Quality of Care for Older Adults With Multimorbidity: Results of the MULTIqual Project.

BACKGROUND AND OBJECTIVES: Providing health care for older adults with multimorbidity is often complex, challenging, and prone to fragmentation. Although clinical decision making should take into account treatment interactions, individual burden, and resources, current approaches to assessing quality of care mostly rely on indicators for single conditions. The aim of this project was to develop a set of generic quality indicators for the management of patients aged 65 and older with multimorbidity that can be used in both health care research and clinical practice. RESEARCH DESIGN AND METHODS: Based on the findings of a systematic literature review and eight focus groups with patients with multimorbidity and their family members, we developed candidate indicators. Identified aspects of quality were mapped to core domains of health care to obtain a guiding framework for quality-of-care assessment. Using nominal group technique, indicators were rated by a multidisciplinary expert panel (n = 23) following standardized criteria. RESULTS: We derived 47 candidate quality indicators from the literature and 4 additional indicators from the results of the focus groups. The expert panel selected a set of 25 indicators, which can be assigned to the levels of patient factors, patient-provider communication, and context and organizational structures of the conceptual framework. DISCUSSION AND IMPLICATIONS: We developed a comprehensive indicator set for the management of multimorbidity that can help to highlight areas with potential for improving the quality of care and support application of multimorbidity guidelines. Furthermore, this study may serve as a blueprint for participatory designs in the development of quality indicators.

Self-management perspectives of elderly patients with multimorbidity and practitioners - status, challenges and further support needed?

BACKGROUND: Patients with multimorbidity (here defined as three or more chronic conditions) require constant treatment and care. Furthermore, they have to manage their health and diseases in daily life. Offering support to patients' medical self-management is an important task of primary care. The aim of this study was to explore, what further support is needed from the perspective of patients' and primary care practitioners. METHODS: A qualitative study using individual semi-structed interviews with 17 patients with multimorbidity and 7 practitioners (4 primary care physicians and 3 practice assistants) was conducted in Germany. Data were audio-recorded, pseudonymised and transcribed verbatim. Data analysis was performed using qualitative content analysis to structure data into themes and subthemes. All data were managed and organised in MAXQDA. RESULTS: The three broad themes: current status, challenges and further support emerged. Patients reported on unfulfilled needs regarding role or emotional management, like coping with loneliness, loss of independence and, changing habits. The importance of social contact was highlighted by patients and practitioners. Patients articulated further support from their primary care practitioners on coping with the disease. Practitioners' wished for further support in aspects of social participation, public transport, and community resources. CONCLUSION: Challenges regarding self-management of elderly patients with multimorbidity may be addressed by harnessing social support and community initiatives.

Quality of care for people with multimorbidity: a focus group study with patients and their relatives.

BACKGROUND: Prevalence of people with multimorbidity rises. Multimorbidity constitutes a challenge to the healthcare system, and treatment of patients with multimorbidity is prone to high-quality variations. Currently, no set of quality indicators (QIs) exists to assess quality of care, let alone incorporating the patient perspective. We therefore aim to identify aspects of quality of care relevant to the patients' perspective and match them to a literature-based set of QIs. METHODS: We conducted eight focus groups with patients with multimorbidity and three focus groups with patients' relatives using a semistructured guide. Data were analysed using Kuckartz's qualitative content analysis. We derived deductive categories from the literature, added inductive categories (new quality aspects) and translated them into QI. RESULTS: We created four new QIs based on the quality aspects relevant to patients/relatives. Two QIs (patient education/self-management, regular updates of medication plans) were consented by an expert panel, while two others were not (periodical check-ups, general practitioner-coordinated care). Half of the literature-based QIs, for example, assessment of biopsychosocial support needs, were supported by participants' accounts, while more technical domains regarding assessment and treatment regimens were not addressed in the focus groups. CONCLUSION: We show that focus groups with patients and relatives adding relevant aspects in QI development should be incorporated by default in QI development processes and constitute a reasonable addition to traditional QI development. Our QI set constitutes a framework for assessing the quality of care in the German healthcare system. It will facilitate implementation of treatment standards and increase the use of existing guidelines, hereby helping to reduce overuse, underuse and misuse of healthcare resources in the treatment of patients with multimorbidity. TRIAL REGISTRATION NUMBER: German clinical trials registry (DRKS00015718), Pre-Results.

Consensus views on competencies and teaching methods for an interprofessional curriculum on complementary and integrative medicine: A Delphi study.

OBJECTIVE: A collaborative team is necessary to help patients achieve their healthcare goals using complementary medicine. At present, healthcare professionals do not feel sufficiently qualified to provide this service. This study sought to identify competencies and teaching methods for interprofessional training on complementary and integrative medicine at medical schools. METHODS: Sixty-five German-speaking experts with various professional backgrounds were invited to take part in a three-round Delphi study. In the first round, predefined competencies were assessed on a seven-point Likert scale, and participants were invited to propose additional competencies that would be evaluated in the subsequent rounds. The competencies were ranked based on the participant assessments and were assigned to four relevance groups. In the second and third rounds, suitable teaching methods were identified using free-text fields and multiple-choice questions. In a final workshop, participants synthesized the outcomes of the previous sessions and derived key competencies that would be a benefit to undergraduate interprofessional training in complementary and integrative medicine at medical schools. RESULTS: The three rounds plus final worksop were attended by 50, 40, 36 and 11 experts. The competencies that these experts determined to be highly relevant to teaching complementary and integrative medicine emphasized, in particular, the respectful treatment of patients and the importance of taking a medical history. From these highly relevant competencies, three key targets were agreed upon in the final workshop: students are able to 1) classify and assess complementary medical terms and methods; 2) work collaboratively and integrate patients into the interprofessional team; 3) involve patients and their relatives respectfully and empathetically in all healthcare processes. To achieve these competency goals, the following teaching methods were highlighted: students discuss therapy options based on authentic patient cases with each other and practice empathic patient communication incorporating complementary medicine. Further, the theoretical background of complementary medicines could be provided as online-training, to use the class sessions for hands-on exercises and interprofessional exchange and discussion. CONCLUSION: Despite the heterogeneous panel of experts, a consensus was reached on the competency orientation and teaching approaches. The results can promote the implementation of interprofessional training for complementary medicine in undergraduate education.

Fostering Appropriate Antibiotic Use in a Complex Intervention: Mixed-Methods Process Evaluation Alongside the Cluster-Randomized Trial ARena.

The cluster randomized trial ARena (sustainable reduction of antibiotic-induced antimicrobial resistance, 2017-2020) promoted appropriate use of antibiotics for acute non-complicated infections in primary care networks (PCNs) in Germany. A process evaluation assessed determinants of practice and explored factors associated with antibiotic prescribing patterns. This work describes its findings on uptake and impacts of the complex intervention program and indicates potential implementation into routine care. In a nested mixed-methods approach, a three-wave study-specific survey for participating physicians and medical assistants assessed potential impacts and uptake of the complex intervention program. Stakeholders received a one-time online questionnaire to reflect on network-related aspects. Semi-structured, open-ended interviews, with a purposive sample of physicians, medical assistants and stakeholders, explored program component acceptance for daily practice and perceived sustainability of intervention component effects. Intervention components were perceived to be smoothly integrable into practice routines. The highest uptake was reported for educational components: feedback reports, background information, e-learning modules and disease-specific quality circles (QCs). Participation in PCNs was seen as the motivational factor for guideline-oriented patient care and adoption of new routines. Future approaches to fostering appropriate antibiotics use by targeting health literacy competencies and clinician's therapy decisions should combine evidence-based information sources, audit and feedback reports and QCs.

Findings from a three-round Delphi study: essential topics for interprofessional training on complementary and integrative medicine.

BACKGROUND: Integrating complementary medicine into medical care promotes patient-oriented care. A well-informed and collaborative professional healthcare team is essential for effective and patient-safe implementation of these methods. At present, the skills for patient counseling, therapy and care regarding complementary medicine vary among the professional groups involved. Professionals generally feel that they are not sufficiently qualified in this area. Curricular concepts for Complementary and Integrative Medicine (CIM) are virtually non-existent in undergraduate interprofessional training. The aim of this study is to initiate a consensus-building process between various experts (professionals, students, patient and faculty representatives) in order to identify which topics should be the focus of such a curriculum. METHODS: A three-round Delphi study was carried out from March 2018 to March 2019 to compile the experience and knowledge of experts in the field of integrative patient care and interprofessional education. Sixty-five experts from Germany and German-speaking Switzerland with various professional backgrounds and experiences were asked to name general content, therapy methods and treatment reasons which should be addressed in interprofessional seminars. In the subsequent rounds these were rated on a seven-point Likert scale. The ratings were assigned to relevance groups and discussed in a final workshop in July 2019. RESULTS: The response rates for the three rounds were 76% (n = 50), 80% (n = 40) 90% (n = 36); and 21% (n = 11) for the final workshop. The experts suggested that topics could be aligned along the most common treatment reasons such as insomnia, generalized pain, fatigue and back pain. However, it is important that students also receive an overview of the evidence base for different therapeutic concepts, especially in the field of classical natural medicine, acupuncture and mind-body medicine, and that they get an overview of the effects and interactions of frequently used procedures. CONCLUSION: Consensus was reached among the various experts on the most important topics for an interprofessional CIM curriculum. The systematic evaluation of the topics in this study can help to create a curriculum that achieves a high level of acceptance among teachers, lecturers and students, and thus facilitates implementation at universities and medical faculties.

Role competencies in interprofessional undergraduate education in complementary and integrative medicine: A Delphi study.

OBJECTIVES: Physicians and other health professionals like nurses, physiotherapists and midwives should be prepared to work in a patient-centred and team-based manner through appropriate interprofessional training. This includes consideration of patients' preferences for complementary treatment methods, as well as reflection of one's own professional role and that of the others. The CanMEDS Physician Competency Framework is an established instrument that describes the competencies of health professionals in seven roles. We investigated which role competencies should be addressed in an undergraduate interprofessional curriculum on Complementary and Integrative Medicine. DESIGN: In a Delphi study, an interprofessional expert group evaluated the relevance of the CanMEDS role competencies (n = 49) and the respective individual competencies (n = 30) on a seven-point Likert scale. For analysis, we assigned the competencies according to the ratings, to four groups of relevance (consensus: >80 %) and compared the proportions of individual competencies classified as relevant within the seven role competencies. RESULTS: The role Medical Expert was rated as highly relevant for all individual competencies. For the roles Professional, Collaborator, Communicator and Scholar, all or most individual competencies were rated at least as relevant. For the roles Leader or Health Advocate all individual competencies were rated as not relevant. CONCLUSIONS: In order to improve healthcare including complementary treatment options, it is initially of great importance to impart expert and communication skills in undergraduate interprofessional training in addition to improving teamwork. The acquisition of management and consulting skills could only be given priority in a later phase of training.

Applying Digital Information Delivery to Convert Habits of Antibiotic Use in Primary Care in Germany: Mixed-Methods Study.

BACKGROUND: Antimicrobial resistance is an important global health issue. In Germany, the national agenda supports various interventions to convert habits of antibiotic use. In the CHANGE-3 (Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care) study, digital tools were applied for information delivery: tablet computers in primary care practices, e-learning platforms for medical professionals, and a public website to promote awareness and health literacy among primary care physicians, their teams, and their patients. OBJECTIVE: This study is embedded in the process evaluation of the CHANGE-3 study. The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany. METHODS: This study used a convergent-parallel mixed-methods design. Audio-recorded semistructured telephone interviews were conducted with physicians, nonphysician health professionals, and patients in the CHANGE-3 program. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was performed based on the inductive category of information provision via digital information tools. Identified themes were related to the main postulates of Diffusion of Innovations theory (DIT) to provide an explanatory frame. In addition, data generated through a structured survey with physicians and nonphysician health professionals in the program were analyzed descriptively and integrated with the qualitative data to explore the complementarity of the findings. RESULTS: Findings regarding the acceptance and uptake of digital devices were related to three postulates of DIT: innovation characteristics, communication channels, and unanticipated consequences. Participants considered the provided digital educative solutions to be supportive for promoting health literacy regarding conversion of habits of antibiotic use. However, health care professionals found it challenging to integrate these solutions into existing routines in primary care and to align them with their professional values. Low technology affinity was a major barrier to the use of digital information in primary care. Patients welcomed the general idea of introducing health-related information in digital formats; however, they expressed concerns about device-related hygiene and the appropriateness of the digital tools for older patients. CONCLUSIONS: Patients and medical professionals in German primary care are reluctant to use digital devices for information and education. Using a Diffusion of Innovations approach can support assessment of existing barriers and provide information about setting-specific preconditions that are necessary for future tailoring of implementation strategies. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 15061174; http://www.isrctn.com/ISRCTN15061174.

Promoting rational antibiotic prescribing for non-complicated infections: understanding social influence in primary care networks in Germany.

BACKGROUND: Primary care networks in Germany are formalized regional collaborations of physicians and other healthcare providers. Common goals are optimized healthcare processes and services for patients, enhanced communication, agency for professional concerns and strengthened economic power. In the ARena study (Sustainable reduction of antibiotic-induced antimicrobial resistance), 14 primary care networks in two federal German states aimed to promote appropriate antibiotics use for acute non-complicated infections by fostering awareness and understanding. Factors related to the role of primary care networks were to be identified. METHODS: For this study, audio-recorded telephone interviews were conducted with physicians, non-physician health professionals and stakeholder representatives. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was based on the inductive categories 'social support', 'social learning', 'social normative pressures' and 'social contagion' to reflect social influence processes. Data generated through a survey with physicians and non-physician health professionals were analyzed descriptively to foster understanding of the networks' potential impact on antibiotic prescribing. RESULTS: Social influence processes proved to be relevant regarding knowledge transfer, manifestation of best-practice care and self-reflection. Peer communication was seen as a great asset, the main reason for membership and affirmative for own perspectives. All interviewed physicians (n = 27) considered their network to be a strong support factor for daily routines, introduction of new routines, and continuity of care. They utilized network-offered training programs focusing on best practice guideline-oriented use of antibiotics and considered their networks supportive in dealing with patient expectations. A shared attitude combined with ARena intervention components facilitated reflective management of antibiotic prescribing. Non-physician health professionals (n = 11) also valued network peer exchange. They assumed their employers joined networks to offer improved and continuous care. Stakeholders (n = 7) expected networks and their members to be drivers for care optimization. CONCLUSION: Primary care networks play a crucial role in providing a platform for professional peer exchange, social support and reassurance. With regards to their impact on antibiotic prescribing for acute non-complicated infections, networks seem to facilitate and amplify quality improvement programs by providing a platform for refreshing awareness, knowledge and self-reflection among care providers. They are well suited to promote a rational use of antibiotics. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046. Registered 24 August 2017.

The complex phenomenon of dysrational antibiotics prescribing decisions in German primary healthcare: a qualitative interview study using dual process theory.

Background: Antibiotic prescription rates in primary care in Germany are moderate, but still considered too high. The ARena study (Sustainable reduction of antibiotic-induced antimicrobial resistance) was initiated to foster awareness and understanding of the growing challenge and promotes rational antibiotics use for acute, non-complicated and self-limiting infections. Methods: The present study was performed as part of the process evaluation of the ARena study. Interviews were conducted with a purposive sample of physicians participating in the ARena study to identify factors relevant to primary care physicians' decision-making when prescribing antibiotics for acute non-complicated infections. Generated data were audio-recorded. Pseudonymized verbatim transcripts were coded using a pre-defined framework. The Dual Process Theory was applied to provide understanding of individual health professional factors that induce dysrational prescribing decisions. Results: Based on medical as well as non-medical considerations, physicians developed habits in decision making on antibiotics prescribing. They acknowledged inadequate antibiotics prescribing for acute, non-complicated infections in situations involving uncertainty regarding diagnosis, prognosis, continuity of care, patient expectations and when not knowing the patient. Educative efforts empowered physicians to override habitual prescribing. A theory-driven model provides transparency as to how dysrational prescribing decisions occur and suggests remedy by providing new experiences and new recognizable patterns through educative efforts. Conclusions: Educational interventions may only change prescribing behaviours if they result in active rational rather than routine-based decision-making on antibiotics prescribing. Trial registration: ISRCTN, ISRCTN58150046.

["Critical discussion should be encouraged!" - a qualitative analysis of medical students' evaluation of a complementary medicine course]. / "Kritische Diskussion sollte mehr gefördert werden!"­ Eine qualitative Auswertung der Lehrevaluation von Medizinstudierenden zur komplementärmedizinischen Lehre.

BACKGROUND: In 2002, the new version of the German Medical Licensure Act integrated Naturopathy and Complementary Medicine into the cross-sectoral unit 12 "Rehabilitation, Physical Medicine and Naturopathy" (QB12) of the medical undergraduate course. At the University of Heidelberg, Complementary Medicine (CAM) is an obligatory clinical subject of the medical undergraduate curriculum and is delivered in the form of lectures and small group work. As a central educational objective, medical students should be able to explain the principles of classical Naturopathy and the most commonly used CAM procedures. The aim was to explore the attitudes, learning needs and interests of medical students with regard to Naturopathy and CAM, and thus establish the teaching requirements. METHODS: The lectures and internships were evaluated using a faculty-based teaching evaluation form. The free-text of the evaluation forms between winter semester 2011/2012 and summer semester 2013 were assessed using Mayring qualitative content analysis. RESULTS: The free-texts were divided into three deductive main categories (Attitudes, Learning Needs and Interests) and further subcategories. A central topic was the polarization of views in medical students regarding CAM; it ranged from lively resistance to great enthusiasm. Strikingly, comments often showed that students had significant reservations with respect to CAM and would require further evidence from the teachers in order to embrace this concept. This was particularly prominent in the use of non-pharmaceutical methods. DISCUSSION: Our results show that evidence-based teaching, combined with practical experience, contributes positively to the critical appraisal of CAM amongst medical students. These findings can serve as the basis for planning, implementation and realization of CAM teaching within mainstream undergraduate medical education.

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

BACKGROUND: Despite 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. METHODS: A 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. DISCUSSION: The ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046 . Registered 24 August 2017.

Carcinogenic Etheno DNA Adducts in Alcoholic Liver Disease: Correlation with Cytochrome P-4502E1 and Fibrosis.

BACKGROUND: One mechanism by which alcoholic liver disease (ALD) progresses is oxidative stress and the generation of reactive oxygen species, among others due to the induction of cytochrome P-4502E1 (CYP2E1). Experimental data underline the key role of CYP2E1 because ALD could be partially prevented in rats by the administration of the specific CYP2E1 inhibitor chlormethiazole. As CYP2E1 is linked to the formation of carcinogenic etheno DNA adducts in ALD patients, a causal role of alcohol-induced CYP2E1 in hepatocarcinogenesis is implicated. The purpose of this study was to investigate CYP2E1 induction in ALD, and its correlation with oxidative DNA lesions and with hepatic histology. METHODS: Hepatic biopsies from 97 patients diagnosed with ALD were histologically scored for steatosis, inflammation, and fibrosis. CYP2E1 and the exocyclic etheno DNA adduct 1,N6 -etheno-2'deoxyadenosine (εdA) were determined immunohistochemically. In addition, in 42 patients, 8-hydroxydeoxyguanosine (8-OHdG) was also evaluated using immunohistochemistry. RESULTS: A significant positive correlation was found between CYP2E1 and εdA (p < 0.0001) as well as between CYP2E1 and 8-OHdG (p = 0.039). Both CYP2E1 (p = 0.0094) and ɛdA (p < 0.0001) also correlated significantly with the stage of hepatic fibrosis. Furthermore, a significant correlation between the fibrosis stage and the grade of lobular inflammation (p < 0.0001) was observed. However, the amount of alcohol consumed did not correlate with any of the parameters determined. CONCLUSIONS: These data suggest an important role of CYP2E1 in the generation of εdA, in the fibrotic progression of ALD, and thus in alcohol-mediated hepatocarcinogenesis. CYP2E1 may be a target in the treatment of ALD and a potential prognostic marker for disease progression.

Job Profile of Non-Medical Practitioners: A Cross- Sectional Study from the Health Service Perspective.

BACKGROUND: The demand for complementary and alternative medicine (CAM) is rising. The German 'Heilpraktiker' is a non-medical naturopathic practitioner (NMNP) providing CAM. Their numbers are rising constantly; however, little is known about their practices and reasons for consultation and on what kind of treatment they offer. METHODS: All 1,096 NMNPs in the German federal state of Schleswig-Holstein were invited to participate in a questionnaire study to gain first insights into their nearly unexplored group setting. RESULTS: A total of 262 NMNPs responded to the itemized questionnaire; 60 answered the questionnaire suggested for non-responders. Out of the 262 NMNPs, 211 (81%) were female. The average age was 53 years. Analyzing the most frequent reasons for consultation, 68.2% were found to be general and unspecified reasons, followed by psychological causes (64.1%) and musculoskeletal complaints (53.1%). About 68% of the participants treat conditions of pain. The most commonly used group of methods was found to comprise para-medicinal procedures. CONCLUSIONS: Our analysis gives first insights into the occupational profile of the German NMNPs, their scope of activities and treatment methods. It is a first step towards health service research that might provide a basis for further studies.

Addressing holistic healthcare needs of oncology patients: Implementation and evaluation of a complementary and alternative medicine (CAM) course within an elective module designed for healthcare professionals.

BACKGROUND: Patients, and especially oncology patients, increasingly demand information and application of complementary therapies to supplement their conventional medical treatment and follow-up care. Due to the widespread interest in holistic treatment opportunities in oncology populations, healthcare professionals need to be prepared in differentiating evidence-based methods of the complementary and alternative medicine (CAM) spectrum and how to consult with patients about it. OBJECTIVE: This paper reports on the implementation and evaluation of a newly designed module "Complementary and Alternative Medicine in oncological healthcare" in the bachelor degree program Interprofessional Health Care (B.Sc.). DESIGN: The study applied a developed evaluation questionnaire to capture students' perspectives on the CAM contents. This assessment instrument was administered pre and post the CAM teaching unit. SETTING: Interprofessional medical education, University Hospital Heidelberg, Germany. RESULTS: The integration of the CAM elective module was possible and was met by positive response. Students' interest was reflected in an increase of their self-reported knowledge gain and positive CAM attitude. Comparison of pre and post evaluation data demonstrate that, particularly, students' expectations on developing their own opinion about CAM, and getting an overview of the evidence-base of different CAM methods have been met. CONCLUSIONS: Evaluation results indicate that the module content was in line with the students' expectations and may have positively impacted on their general CAM attitude. The results support us in continuing to offer this CAM course within the elective module to prepare today's healthcare professionals for patient-oriented healthcare delivery.

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.

[Joint replacement quality index: the perspective of resident physicians]. / "Qualitätsindex Endoprothetik" aus Sicht von niedergelassenen Ärzten.

BACKGROUND AND AIM: Joint replacement is an established therapy for arthrosis. The quality index for joint replacement (knee and hip) should include screening for quality of patient-centred care in hospitals providing replacements, on the basis of administrative data. The quality index summarizes 16 inpatient and posthospital complications (indicators). The aim of the study was to evaluate this quality index from the medical practitioner's viewpoint. METHODS: Four semistructured focus groups with 11 family physicians and 8 orthopaedic/trauma surgeons were conducted. The discussions were recorded, transcribed and analysed qualitatively according to Mayring. RESULTS: Infections and the revision of a total joint arthroplasty have been weighted as the most important indicators from the existing quality indicators. Between the participants some differences regarding the relevance of the indicators thrombosis and pulmonary embolism occurred. These indicators were weighted as more important by family physicians than orthopedic/trauma surgeons. For eight of the indicators, imprecision in words/meaning was criticized. In an open-ended second section, 20 new indicators within the areas complications, management and overall sector communication were identified. CONCLUSION: Major amendments of the quality index for the joint replacement are necessary. The knowledge gained from this study may serve as a basis for this development.

Involving patients in detecting quality gaps in a fragmented healthcare system: development of a questionnaire for Patients' Experiences Across Health Care Sectors (PEACS).

OBJECTIVE: The purpose of this study was to develop and validate a generic questionnaire to evaluate experiences and reported outcomes in patients who receive treatment across a range of healthcare sectors. DESIGN: Mixed-methods design including focus groups, pretests and field test. SETTING: The patient questionnaire was developed in the context of a nationwide program in Germany aimed at quality improvements across the healthcare sectors. PARTICIPANTS: For the field test, 589 questionnaires were distributed to patients via 47 general practices. MAIN MEASUREMENTS: Descriptive item analyzes non-responder analysis and factor analysis (PCA). Retest coefficients (r) calculated by correlation of sum scores of PCA factors. Quality gaps were assessed by the proportion of responders choosing a response category defined as indicating shortcomings in quality of care. RESULTS: The conceptual phase showed good content validity. Four hundred and seventy-four patients who received a range of treatment across a range of sectors were included (response rate: 80.5%). Data analysis confirmed the construct, oriented to the patient care journey with a focus on transitions between healthcare sectors. Quality gaps were assessed for the topics 'Indication', including shared-decision-making (6 items, 24.5-62.9%) and 'Discharge and Transition' (10 items; 20.7-48.2%). Retest coefficients ranged from r = 0.671 until r = 0.855 and indicated good reliability. Low ratios of item-non-response (0.8-9.3%) confirmed a high acceptance by patients. CONCLUSIONS: The number of patients with complex healthcare needs is increasing. Initiatives to expand quality assurance across organizational borders and healthcare sectors are therefore urgently needed. A validated questionnaire (called PEACS 1.0) is available to measure patients' experiences across healthcare sectors with a focus on quality improvement.