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Introduction The 2030 Sustainable Development Agenda emphasizes the importance of quality of care in the drive to achieve universal health coverage. Despite recent progress, challenges in service delivery, efficiency and resource utilization in the health sector remain. Objective The Ministry of Health Department of Standards and Regulations sought to operationalize the Kenya Quality Assurance Model for Health. To this end, the European Practice Assessment (EPA) was adapted to the area of Reproductive and Maternal and Neonatal Health. Methods The adaptation process made use of a ten step-modified RAND Corporation/University of California Los Angeles (UCLA) Appropriateness Method. The steps included a scoping workshop, definition of five critical domains of quality in the Kenyan context (‘People, Management, Clinical Care, Quality & Safety, Interface between inpatients and outpatients care'), a review of policy documents, management and clinical guidelines, grey and scientific literature to identify indicators in use in the Kenyan health system and an expert panel process to rate their feasibility and validity. Results The resulting 278 indicators, clustered across the five domains, were broken-down into 29 dimensions and assigned measure specifications. A set of data collection tools were developed to furnish the indicators and piloted at two health facilities. They were subsequently finalized for use in 30 health facilities in 3 counties. Conclusions The integrative and indicator-based aspects of the EPA process could be readily adapted to facilitate the operationalization of a practical quality assurance approach in Kenya.

Dominik Ose,1,2 Eva C Winkler,3 Sarah Berger,1 Ines Baudendistel,1 Martina Kamradt,1 Felicitas Eckrich,1 Joachim Szecsenyi1 1Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany; 2Department of Population Health, Health System Innovation and Research, University of Utah, Salt Lake City, UT, USA; 3Program for Ethics and Patient-oriented Care in Oncology, National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany Purpose: Given the inherent complexity of cancer care, in which personal, social, and clinical aspects accumulate and interact over time, self-management support need to become more comprehensive. This study has the following two aims: 1) to analyze and describe the complexity of individual patient situations and 2) to analyze and describe already established self-management strategies of patients to handle this complexity.Methods: A qualitative study was conducted. Ten focus groups were performed collecting perspectives of the following three user groups: patients with colorectal cancer (n=12) and representatives from support groups (n=2), physicians (n=17), and other health care professionals (HCPs; n=16). Data were analyzed using qualitative content analysis.Results: The results showed that cancer patients are struggling with the complexity of their individual situations characterized by the 1) “complexity of disease”, 2) “complexity of care”, and 3) “complexity of treatment-related data”. To deal with these multifaceted situations, patients have established several individual strategies. These strategies are “proactive demanding” (eg, to get support and guidance or a meaningful dialog with the doctor), “proactive behavior” (eg, preparation of visits), and “proactive data management” (eg, in terms of merging treatment-related data a

Anika Sparla,1 Sebastian Flach-Vorgang,1 Matthias Villalobos,2 Katja Krug,1 Martina Kamradt,1 Kadiatou Coulibaly,1 Joachim Szecsenyi,1 Michael Thomas,2 Sinikka Gusset-Bährer,2 Dominik Ose1,3 1Department of General Practice and Health Services Research, Heidelberg University Hospital, 2Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research, Heidelberg, Germany; 3University of Utah, Department of Population Health Sciences, Health System Innovation and Research, Salt Lake City, UT, USA Purpose: Lung cancer is a disease with a high percentage of patients diagnosed in an advanced stage. In a situation of palliative treatment, both patients and their relatives experience diverse types of distress and burden. Little research has been done to identify the individual difficulties and resources for patients with advanced lung cancer and their relatives. Especially, standardized questionnaire-based exploration may not assess the specific distressing issues that pertain to each individual on a personal level. The purpose of this qualitative study is to explore and compare individual difficulties and resources for lung cancer patients and their relatives within the palliative care context.Methods: Data were collected by qualitative interviews. A total of 18 participants, nine patients diagnosed with advanced lung cancer (International Classification of Diseases, tenth edition, diagnosis C-34, stage IV) starting or receiving palliative treatment and nine relatives, were interviewed. Data were interpreted through qualitative content analysis.Results: We identified four main categories of difficulties: communication and conflicts, home and everyday life, thinking about cancer, and treatment trajectory. In general, difficulties were related to interpersonal relationships as well as to impact of chemotherapy. Family, profession

Background: Patients with multiple chronic conditions are at high risk of potentially avoidable hospital admissions, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices. Objective: To determine whether protocol-based care management delivered by medical assistants improves patient care in patients at high risk of future hospitalization in primary care. Design: Two-year cluster randomized clinical trial. Setting: 115 primary care practices in Germany. Patients: 2,076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by insurance data analysis. Intervention: We compared protocol-based care management including structured assessment, action planning, and monitoring delivered by medical assistants with usual care. Measurements: All-cause hospitalizations at 12 months (primary outcome) and quality of life scores (Short Form 12 Health Questionnaire [SF-12] and the Euroqol instrument [EQ-5D]). Results: Included patients had, on average, four co-occurring chronic conditions. All-cause hospitalizations did not differ between the groups at 12 months (risk ratio [RR] 1.01, 95% confidence interval [CI] 0.87 to 1.18) and 24 months (RR 0.98, CI 0.85 to 1.12) of intervention. Quality of life (SF-12 physical +1.16, CI 0.24 to 2.08; SF-12 mental +1.68, CI 0.60 to 2.77) and general health scores (EQ-5D +0.03, CI 0.00 to 0.05) improved significantly at 24 months of intervention. Intervention costs summed up to 10 United States dollars per patient per month. Limitations: Limitations included a small number of primary care practices and a low intensity of intervention. Conclusion: This type of low intensive intervention did not reduce all-cause hospital adm

Background: Disease Management Programmes (DMPs) have been introduced in Germany ten years ago with the aim to improve effectiveness and equity of care, but little is known about the degree to which enrolment in the programme meets the principles of equity in health care. We aimed to analyse horizontal equity in DMP enrolment among patients with coronary heart disease (CHD). Methods: Cross-sectional analysis of horizontal inequities in physician-reported enrolment in the DMP for CHD in a large population-based cohort-study in Germany (2008-2010). We calculated horizontal inequity indices (HII) and their 95% confidence intervals [95% CI] for predicted need-standardised DMP enrolment across two measures of socio-economic status (SES) (educational attainment, regional deprivation) stratified by sex. Need-standardised DMP enrolment was predicted in multi-level logistic regression models. Results: Among N = 1,280 individuals aged 55-84 years and diagnosed with CHD, DMP enrolment rates were 22.2% (women) and 35.0% (men). Education-related inequities in need-standardised DMP enrolment favoured groups with lower education, but HII estimates were not significant. Deprivation-related inequities among women significantly favoured groups with higher SES (HII = 0.086 [0.007; 0.165]. No such deprivation-related inequities were seen among men (HII = 0.014 [-0.048; 0.077]). Deprivation-related inequities across the whole population favoured groups with higher SES (HII estimates not significant). Conclusion: Need-standardised DMP enrolment was fairly equitable across educational levels. Deprivation-related inequities in DMP enrolment favoured women living in less deprived areas relative to those living in areas with higher deprivation. Further research is needed to gain a better understanding of the mechanisms that contribute to deprivation-related horizontal inequities in DMP enrolment among women.

Background: Disease Management Programmes (DMPs) have been introduced in Germany ten years ago with the aim to improve effectiveness and equity of care, but little is known about the degree to which enrolment in the programme meets the principles of equity in health care. We aimed to analyse horizontal equity in DMP enrolment among patients with coronary heart disease (CHD). Methods: Cross-sectional analysis of horizontal inequities in physician-reported enrolment in the DMP for CHD in a large population-based cohort-study in Germany (2008-2010). We calculated horizontal inequity indices (HII) and their 95% confidence intervals [95% CI] for predicted need-standardised DMP enrolment across two measures of socio-economic status (SES) (educational attainment, regional deprivation) stratified by sex. Need-standardised DMP enrolment was predicted in multi-level logistic regression models. Results: Among N = 1,280 individuals aged 55-84 years and diagnosed with CHD, DMP enrolment rates were 22.2% (women) and 35.0% (men). Education-related inequities in need-standardised DMP enrolment favoured groups with lower education, but HII estimates were not significant. Deprivation-related inequities among women significantly favoured groups with higher SES (HII = 0.086 [0.007; 0.165]. No such deprivation-related inequities were seen among men (HII = 0.014 [-0.048; 0.077]). Deprivation-related inequities across the whole population favoured groups with higher SES (HII estimates not significant). Conclusion: Need-standardised DMP enrolment was fairly equitable across educational levels. Deprivation-related inequities in DMP enrolment favoured women living in less deprived areas relative to those living in areas with higher deprivation. Further research is needed to gain a better understanding of the mechanisms that contribute to deprivation-related horizontal inequities in DMP enrolment among women.

Background: Disease Management Programmes (DMPs) have been introduced in Germany ten years ago with the aim to improve effectiveness and equity of care, but little is known about the degree to which enrolment in the programme meets the principles of equity in health care. We aimed to analyse horizontal equity in DMP enrolment among patients with coronary heart disease (CHD). Methods: Cross-sectional analysis of horizontal inequities in physician-reported enrolment in the DMP for CHD in a large population-based cohort-study in Germany (2008-2010). We calculated horizontal inequity indices (HII) and their 95% confidence intervals [95% CI] for predicted need-standardised DMP enrolment across two measures of socio-economic status (SES) (educational attainment, regional deprivation) stratified by sex. Need-standardised DMP enrolment was predicted in multi-level logistic regression models. Results: Among N = 1,280 individuals aged 55-84 years and diagnosed with CHD, DMP enrolment rates were 22.2% (women) and 35.0% (men). Education-related inequities in need-standardised DMP enrolment favoured groups with lower education, but HII estimates were not significant. Deprivation-related inequities among women significantly favoured groups with higher SES (HII = 0.086 [0.007; 0.165]. No such deprivation-related inequities were seen among men (HII = 0.014 [-0.048; 0.077]). Deprivation-related inequities across the whole population favoured groups with higher SES (HII estimates not significant). Conclusion: Need-standardised DMP enrolment was fairly equitable across educational levels. Deprivation-related inequities in DMP enrolment favoured women living in less deprived areas relative to those living in areas with higher deprivation. Further research is needed to gain a better understanding of the mechanisms that contribute to deprivation-related horizontal inequities in DMP enrolment among women.

Gerda Längst,1 Hanna Marita Seidling,2,3 Marion Stützle,2,3 Dominik Ose,1 Ines Baudendistel,1 Joachim Szecsenyi,1 Michel Wensing,1,4 Cornelia Mahler1 1Department of General Practice and Health Services Research, University Hospital of Heidelberg, Heidelberg, Germany; 2Cooperation Unit Clinical Pharmacy, University of Heidelberg, Heidelberg, Germany; 3Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany; 4Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare, Nijmegen, the Netherlands Purpose: This qualitative study in patients with type 2 diabetes and health care professionals (HCPs) aimed to investigate which factors they perceive to enhance or impede medication information provision in primary care. Similarities and differences in perspectives were explored.Methods: Eight semistructured focus groups were conducted, four with type 2 diabetes patients (n=25) and four with both general practitioners (n=13) and health care assistants (n=10). Sessions were audio and video recorded, transcribed verbatim, and subjected to computer-aided qualitative content analysis.Results: Diabetes patients and HCPs broadly highlighted similar factors as enablers for satisfactory medication information delivery. Perceptions substantially differed regarding impeding factors. Both patients and HCPs perceived it to be essential to deliver tailored information, to have a trustful and continuous patient–provider relationship, to regularly reconcile medications, and to provide tools for medication management. However, substantial differences in perceptions related to impeding factors included the causes of inadequate information, the detail required for risk-related information, and barriers to medication reconciliation. Medication self-management was a prevalent topic among patients, whereas HCPs’ focus was on fulfilling therapy and medication management

Katja Goetz,1 Jessica Bungartz,2 Joachim Szecsenyi,1 Jost Steinhaeuser3 1Department of General Practice and Health Services Research, University of Heidelberg, Heidelberg, Germany; 2Praxis Medizin im Zentrum, München, Germany; 3Institute of Family Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany Background: Patients’ evaluation of medical care is an essential dimension of quality of care and an important aspect of the feedback cycle for health care providers. The aim of this study was to document how patients with a Turkish background evaluate primary care in Germany and determine which aspects of care are associated with language abilities.Methods: The study was based on an observational design. Patients with a Turkish background from German primary care practices completed the EUROPEP (European Project on Patient Evaluation of General Practice Care) questionnaire consisting of 23 items. Seventeen primary care practices were involved with either German (n=8) or Turkish (n=9) general practitioners (GPs).Results: A convenience sample of 472 patients with a Turkish background from 17 practices participated in the study (response rate 39.9%). Practices with a German GP had a lower response rate (19.6%) than those with a Turkish GP (57.5%). Items evaluated the highest were “keeping data confidential” (73.4%) and “quick services for urgent health problems” (69.9%). Subgroup analysis showed lower evaluation scores from patients with good or excellent German language abilities. Patients who consulted a Turkish GP had higher evaluation scores.Conclusion: The evaluation from patients with a Turkish background living in Germany with either Turkish or German GPs showed lower scores than patients in other studies in Europe using EUROPEP. However, our results had higher evaluation scores than those of Turkish patients evaluating GPs in Turkey. Therefore, different explanation models for

Background: Disease Management Programmes (DMPs) have been introduced in Germany ten years ago with the aim to improve effectiveness and equity of care, but little is known about the degree to which enrolment in the programme meets the principles of equity in health care. We aimed to analyse horizontal equity in DMP enrolment among patients with coronary heart disease (CHD). Methods: Cross-sectional analysis of horizontal inequities in physician-reported enrolment in the DMP for CHD in a large population-based cohort-study in Germany (2008-2010). We calculated horizontal inequity indices (HII) and their 95% confidence intervals [95% CI] for predicted need-standardised DMP enrolment across two measures of socio-economic status (SES) (educational attainment, regional deprivation) stratified by sex. Need-standardised DMP enrolment was predicted in multi-level logistic regression models. Results: Among N = 1,280 individuals aged 55-84 years and diagnosed with CHD, DMP enrolment rates were 22.2% (women) and 35.0% (men). Education-related inequities in need-standardised DMP enrolment favoured groups with lower education, but HII estimates were not significant. Deprivation-related inequities among women significantly favoured groups with higher SES (HII = 0.086 [0.007; 0.165]. No such deprivation-related inequities were seen among men (HII = 0.014 [-0.048; 0.077]). Deprivation-related inequities across the whole population favoured groups with higher SES (HII estimates not significant). Conclusion: Need-standardised DMP enrolment was fairly equitable across educational levels. Deprivation-related inequities in DMP enrolment favoured women living in less deprived areas relative to those living in areas with higher deprivation. Further research is needed to gain a better understanding of the mechanisms that contribute to deprivation-related horizontal inequities in DMP enrolment among women.

Objectives: To examine the effectiveness of the quality management programme—European Practice Assessment—in primary care in Switzerland. Design: Longitudinal study with three points of measurement. Setting: Primary care practices in Switzerland. Participants: In total, 45 of 91 primary care practices completed European Practice Assessment three times. Outcomes: The interval between each assessment was around 36 months. A variance analyses for repeated measurements were performed for all 129 quality indicators from the domains: ‘infrastructure’, ‘information’, ‘finance’, and ‘quality and safety’ to examine changes over time. Results: Significant improvements were found in three of four domains: ‘quality and safety’ (F=22.81, p<0.01), ‘information’ (F=27.901, p<0.01) and ‘finance’ (F=4.073, p<0.02). The 129 quality indicators showed a significant improvement within the three points of measurement (F=33.864, p<0.01). Conclusions: The European Practice Assessment for primary care practices thus provides a functioning quality management programme, focusing on the sustainable improvement of structural and organisational aspects to promote high quality of primary care. The implementation of a quality management system which also includes a continuous improvement process would give added value to provide good care.

Background: Disease Management Programmes (DMPs) have been introduced in Germany ten years ago with the aim to improve effectiveness and equity of care, but little is known about the degree to which enrolment in the programme meets the principles of equity in health care. We aimed to analyse horizontal equity in DMP enrolment among patients with coronary heart disease (CHD). Methods: Cross-sectional analysis of horizontal inequities in physician-reported enrolment in the DMP for CHD in a large population-based cohort-study in Germany (2008-2010). We calculated horizontal inequity indices (HII) and their 95% confidence intervals [95% CI] for predicted need-standardised DMP enrolment across two measures of socio-economic status (SES) (educational attainment, regional deprivation) stratified by sex. Need-standardised DMP enrolment was predicted in multi-level logistic regression models. Results: Among N = 1,280 individuals aged 55-84 years and diagnosed with CHD, DMP enrolment rates were 22.2% (women) and 35.0% (men). Education-related inequities in need-standardised DMP enrolment favoured groups with lower education, but HII estimates were not significant. Deprivation-related inequities among women significantly favoured groups with higher SES (HII = 0.086 [0.007; 0.165]. No such deprivation-related inequities were seen among men (HII = 0.014 [-0.048; 0.077]). Deprivation-related inequities across the whole population favoured groups with higher SES (HII estimates not significant). Conclusion: Need-standardised DMP enrolment was fairly equitable across educational levels. Deprivation-related inequities in DMP enrolment favoured women living in less deprived areas relative to those living in areas with higher deprivation. Further research is needed to gain a better understanding of the mechanisms that contribute to deprivation-related horizontal inequities in DMP enrolment among women.

PURPOSE: Hospitalizations for ambulatory care-sensitive conditions (ACSCs) are seen as potentially avoidable with optimal primary care. Little is known, however, about how primary care physicians rate these hospitalizations and whether and how they could be avoided. This study explores the complex causality of such hospitalizations from the perspective of primary care physicians. METHODS: We conducted semistructured interviews with 12 primary care physicians from 10 primary care clinics in Germany regarding 104 hospitalizations of 81 patients with ACSCs at high risk of rehospitalization. RESULTS: Participating physicians rated 43 (41%) of the 104 hospitalizations to be potentially avoidable. During the interviews the cause of hospitalization fell into 5 principal categories: system related (eg, unavailability of ambulatory services), physician related (eg, suboptimal monitoring), medical (eg, medication side effects), patient related (eg, delayed help-seeking), and social (eg, lack of social support). Subcategories frequently associated with physicians' rating of hospitalizations for ACSCs as potentially avoidable were after-hours absence of the treating physician, failure to use ambulatory services, suboptimal monitoring, patients' fearfulness, cultural background and insufficient language skills of patients, medication errors, medication nonadherence, and overprotective caregivers. Comorbidities and medical emergencies were frequent causes attributed to ACSC-based hospitalizations that were rated as being unavoidable. CONCLUSIONS: Primary care physicians rated a significant proportion of hospitalizations for ACSCs to be potentially avoidable. Strategies to avoid these hospitalizations may target after-hours care, optimal use of ambulatory services, intensified monitoring of high-risk patients, and initiatives to improve patients' willingness and ability to seek timely help, as well as patients' medication adherence.

PURPOSE: Hospitalizations for ambulatory care-sensitive conditions (ACSCs) are seen as potentially avoidable with optimal primary care. Little is known, however, about how primary care physicians rate these hospitalizations and whether and how they could be avoided. This study explores the complex causality of such hospitalizations from the perspective of primary care physicians. METHODS: We conducted semistructured interviews with 12 primary care physicians from 10 primary care clinics in Germany regarding 104 hospitalizations of 81 patients with ACSCs at high risk of rehospitalization. RESULTS: Participating physicians rated 43 (41%) of the 104 hospitalizations to be potentially avoidable. During the interviews the cause of hospitalization fell into 5 principal categories: system related (eg, unavailability of ambulatory services), physician related (eg, suboptimal monitoring), medical (eg, medication side effects), patient related (eg, delayed help-seeking), and social (eg, lack of social support). Subcategories frequently associated with physicians' rating of hospitalizations for ACSCs as potentially avoidable were after-hours absence of the treating physician, failure to use ambulatory services, suboptimal monitoring, patients' fearfulness, cultural background and insufficient language skills of patients, medication errors, medication nonadherence, and overprotective caregivers. Comorbidities and medical emergencies were frequent causes attributed to ACSC-based hospitalizations that were rated as being unavoidable. CONCLUSIONS: Primary care physicians rated a significant proportion of hospitalizations for ACSCs to be potentially avoidable. Strategies to avoid these hospitalizations may target after-hours care, optimal use of ambulatory services, intensified monitoring of high-risk patients, and initiatives to improve patients' willingness and ability to seek timely help, as well as patients' medication adherence.

Care management is seen as a promising approach to address the complex care needs of patients with multimorbidity. Predictive modeling based on insurance claims data is an emerging concept to identify patients likely to benefit from care management interventions. We aimed to identify and explore patterns of multimorbidity in primary care patients with high predicted risk of future hospitalizations in order to develop a primary care-based care management intervention. We conducted a retrospective cohort study to assess insurance claims data of 6026 patients from 10 primary care practices in Germany. We stratified the population by the predicted likelihood of hospitalization (LOH) using a diagnostic cost group-based case-finding software. Co-occurrence of chronic conditions in multimorbid patients with an upper-quartile LOH score was explored by extraction of mutually exclusive patterns. Predictive modeling identified multimorbid elderly patients with a high number of co-occurring chronic conditions (mean number 7.8 [SD 3.1]). Assessing co-occurrence of highly prevalent chronic conditions in 1407 multimorbid patients with upper-quartile LOH revealed 471 mutually exclusive patterns with low single frequencies. The observed prevalence significantly exceeded expected prevalence for patterns with causal comorbidity. Additionally, chronic pain (related to osteoarthritis) or depression could be identified as discordant co-occurring conditions in 80% (12/15) of the most common multimorbidity patterns. High-risk primary care patients suffer from heterogeneous individual patterns of co-occurring chronic conditions. Care management interventions will have to account for discordant co-occurring conditions such as osteoarthritis and depression.

Care management is seen as a promising approach to address the complex care needs of patients with multimorbidity. Predictive modeling based on insurance claims data is an emerging concept to identify patients likely to benefit from care management interventions. We aimed to identify and explore patterns of multimorbidity in primary care patients with high predicted risk of future hospitalizations in order to develop a primary care-based care management intervention. We conducted a retrospective cohort study to assess insurance claims data of 6026 patients from 10 primary care practices in Germany. We stratified the population by the predicted likelihood of hospitalization (LOH) using a diagnostic cost group-based case-finding software. Co-occurrence of chronic conditions in multimorbid patients with an upper-quartile LOH score was explored by extraction of mutually exclusive patterns. Predictive modeling identified multimorbid elderly patients with a high number of co-occurring chronic conditions (mean number 7.8 [SD 3.1]). Assessing co-occurrence of highly prevalent chronic conditions in 1407 multimorbid patients with upper-quartile LOH revealed 471 mutually exclusive patterns with low single frequencies. The observed prevalence significantly exceeded expected prevalence for patterns with causal comorbidity. Additionally, chronic pain (related to osteoarthritis) or depression could be identified as discordant co-occurring conditions in 80% (12/15) of the most common multimorbidity patterns. High-risk primary care patients suffer from heterogeneous individual patterns of co-occurring chronic conditions. Care management interventions will have to account for discordant co-occurring conditions such as osteoarthritis and depression.

Dominik Ose, Cornelia Mahler, Ines Vogel, Sabine Ludt, Joachim Szecsenyi, Tobias FreundUniversity Hospital of Heidelberg, Department of General Practice and Health Services Research, Heidelberg, GermanyBackground: Medication adherence can be essential for improving health outcomes. Patients with multiple chronic conditions, often receiving multiple medications, are at higher risk for medication nonadherence. Previous research has focused on concordance between patients and providers about which medication should be taken. However, the question of whether patients and providers are concordant in rating actual medication intake has not been answered as yet. This study aimed to explore the extent and predictors of patient – provider concordance in rating medication adherence in patients with multiple chronic conditions.Methods: Overall medication adherence was measured by self-report (Medication Adherence Report Scale, MARS-D) in a sample of 92 patients with multiple chronic conditions. Twelve treating primary care physicians were asked to rate medication adherence in these patients using a mirrored version of the MARS-D. Concordance between external rating and self-reported medication adherence was analyzed descriptively. Predictors of concordance in rating medication adherence were explored in a multilevel analysis.Results: Patients rate their medication adherence markedly higher than their general practitioner. Accordingly, the percentage of concordance ranges between 40% (forgot to take medication) and 61% (deliberately omitted a dose). In multilevel analysis, concordance in rating medication adherence was positively associated with being the single primary care provider (β 2.24, P < 0.0001) and frequent questioning about medication use (β 0.66, P = 0.0031). At the patient level, “not [being] married” (ß −0.81, P = 0.0064) and “number of prescribed medications” (&beta

Cornelia Mahler1, Katja Hermann1, Susanne Jank2, Walter Emil Haefeli2, Joachim Szecsenyi11Department of General Practice and Health Services Research, 2Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, GermanyBackground: Regular intake of medicines prevents hospitalization and improves treatment outcomes in patients with chronic diseases; however, requires good patient–physician communication. Yet, this communication is often insufficient and characterized by misunderstandings. This paper aimed to explore whether a training session on medication counseling for general practitioners (GPs) can improve patient satisfaction about information on medicines.Methods: Within a seamless care project (HeiCare®), a questionnaire to assess patient satisfaction with information on medicines and other questions related to medication issues was distributed among 370 patients. Results were returned to physicians in a feedback report, discussed in a training session, and a subsequent second questionnaire was sent to patients.Results: Patients showed a significant increase in satisfaction with overall information on medicines and with information on potential problems when experiencing medication counseling after their GP received a feedback report and/or training session.Conclusion: Individual feedback and training sessions can improve medication counseling and GPs’ awareness of patients’ attitudes toward medicines and thus increase patients’ satisfaction with medicines information received. Regular feedback to the GP on patients’ satisfaction with information and patients’ beliefs in medicines can be obtained by patient surveys or by addressing these issues in regular medication counseling encounters. Physicians need to be trained to listen to patients’ views and concerns on medication.Keywords: medication counseling, patient satisfaction, beliefs in

Objective: Social support is an important element of family medicine within a primary care setting, delivered by general practitioners and practice nurses in addition to usual clinical care. The aim of the study was to explore general practitioner's, practice nurse's and people with type 2 diabetes' views, experiences and perspectives of the importance of social support in caring for people with type 2 diabetes and their role in providing social support. Methods: Interviews with general practitioners (n=10) and focus groups with practice nurses (n=10) and people with diabetes (n=9). All data were audio-recorded, fully transcribed and thematically analysed using qualitative content analysis by Mayring.Results: All participants emphasized the importance of the concept of social support and its impacts on well-being of people with type 2 diabetes. Social support is perceived helpful for people with diabetes in order to improve diabetes control and give support for changes in lifestyle habits (physical activity and dietary changes). General practitioners identified a lack of information about facilities in the community like sports or self-help groups. Practice nurses emphasized that they need more training, such as in dietary counselling. Conclusions: Social support given by general practitioners and practice nurses plays a crucial role for people with type 2 diabetes and is an additional component of social care. However there is a need for an increased awareness by general practitioners and practice nurses about the influence social support could have on the individual's diabetes management.

BACKGROUND: Coronary heart disease (CHD) is one of the most common long-term complications in people with type 2 diabetes. We analyzed whether or not gender differences exist in diabetes and CHD medication among people with type 2 diabetes. METHODS: The study was based on data from the baseline examination of the DIANA study, a prospective cohort study of 1,146 patients with type 2 diabetes conducted in South-West Germany. Information on diabetes and CHD medication was obtained from the physician questionnaires. Bivariate and multivariate analyses using logistic regression were employed in order to assess associations between gender and prescribed drug classes. RESULTS: In total, 624 men and 522 women with type 2 diabetes with a mean age of 67.2 and 69.7 years, respectively, were included in this analysis. Compared to women, men had more angiopathic risk factors, including smoking, alcohol consumption and worse glycemic control, and had more often a diagnosed CHD. Bivariate analyses showed higher prescription of thiazolidinediones and oral combination drugs as well as of angiotensin-converting enzyme (ACE) inhibitors, calcium channel blockers and aspirin in men than in women. After full adjustment, differences between men and women remained significant only for ACE inhibitors (OR = 1.44; 95%-confidence interval (CI): 1.11 - 1.88) and calcium channel blockers (OR = 1.42, 95%-CI: 1.05 - 1.91). CONCLUSIONS: These findings contribute to current discussions on gender differences in diabetes care. Men with diabetes are significantly more likely to receive oral combination drugs, ACE inhibitors and calcium channel blockers in the presence of coronary heart disease, respectively. Our results suggest, that diabetic men might be more thoroughly treated compared to women. Further research is needed to focus on reasons for these differences mainly in treatment of cardiovascular diseases to improve quality of care.

BACKGROUND: The co-occurance of multiple medical conditions has a negative impact on health related quality of life (HRQoL) for patients with type 2 diabetes. These patients demand for intensified care programs. Participation in a disease management program (DMP) for type 2 diabetes has shown to counterbalance this effect. However, it remains unclear which dimensions of HRQoL are influenced by the DMP. The aim of this study was to explore the HRQoL dimensions of patients with type 2 diabetes in the German DMP and patients in routine care (RC). METHODS: This analysis is part of a comparative evaluation of the German DMP for patients with type 2 diabetes. A questionnaire, including the HRQoL measure EQ-5D, was mailed to a random sample of 3,546 patients with type 2 diabetes (59.3% female). The EQ-5D dimensions were analyzed by grouping patients according to their participation in the German DMP for diabetes into DMP and RC. RESULTS: Compared to patients in DMP, patients in RC reported more problems for the dimensions mobility (P < 0.05), self care (P < 0.05) and performing usual activities (P < 0.01). Depending on the number of other conditions, remarkable differences for reporting "no problems" exist for patients with six or more comorbid conditions regarding the dimensions mobility (RC = 8.7%, DMP = 32.3%), self care (RC = 43.5%, DMP = 64.5%), usual activities (RC = 13.0%, DMP = 33.9%) and anxiety or depression (RC = 37.0%, DMP = 48.4%). CONCLUSION: Patients participating in the German DMP for type 2 diabetes mellitus show significantly higher ratings of their HRQoL in the dimensions mobility, self care and performing usual activities compared to patients in RC. This difference can also be observed in patients with significant comorbidities. As these dimensions are known to be essential for diabetes care, the German DMP may contribute to improved care even for comorbid diabetes patients.

BACKGROUND: The co-occurance of multiple medical conditions has a negative impact on health related quality of life (HRQoL) for patients with type 2 diabetes. These patients demand for intensified care programs. Participation in a disease management program (DMP) for type 2 diabetes has shown to counterbalance this effect. However, it remains unclear which dimensions of HRQoL are influenced by the DMP. The aim of this study was to explore the HRQoL dimensions of patients with type 2 diabetes in the German DMP and patients in routine care (RC). METHODS: This analysis is part of a comparative evaluation of the German DMP for patients with type 2 diabetes. A questionnaire, including the HRQoL measure EQ-5D, was mailed to a random sample of 3,546 patients with type 2 diabetes (59.3% female). The EQ-5D dimensions were analyzed by grouping patients according to their participation in the German DMP for diabetes into DMP and RC. RESULTS: Compared to patients in DMP, patients in RC reported more problems for the dimensions mobility (P < 0.05), self care (P < 0.05) and performing usual activities (P < 0.01). Depending on the number of other conditions, remarkable differences for reporting "no problems" exist for patients with six or more comorbid conditions regarding the dimensions mobility (RC = 8.7%, DMP = 32.3%), self care (RC = 43.5%, DMP = 64.5%), usual activities (RC = 13.0%, DMP = 33.9%) and anxiety or depression (RC = 37.0%, DMP = 48.4%). CONCLUSION: Patients participating in the German DMP for type 2 diabetes mellitus show significantly higher ratings of their HRQoL in the dimensions mobility, self care and performing usual activities compared to patients in RC. This difference can also be observed in patients with significant comorbidities. As these dimensions are known to be essential for diabetes care, the German DMP may contribute to improved care even for comorbid diabetes patients.

Background: Care management programmes are an effective approach to care for high risk patients with complex care needs resulting from multiple co-occurring medical and non-medical conditions. These patients are likely to be hospitalized for a potentially "avoidable" cause. Nurse-led care management programmes for high risk elderly patients showed promising results. Care management programmes based on health care assistants (HCAs) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need. Methods: PraCMan is a cluster randomized controlled trial with primary care practices as unit of randomisation. The study evaluates a complex primary care practice-based care management of patients at high risk for future hospitalizations. Eligible patients either suffer from type 2 diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure or any combination. Patients with a high likelihood of hospitalization within the following 12 months (based on insurance data) will be included in the trial. During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and resources as well as regular structured monitoring of symptoms. Assessment and monitoring will be performed by trained HCAs from the participating practices. Additionally, patients will receive written information, symptom diaries, action plans and a medication plan to improve self-management capabilities. This intervention is addition to usual care. Patients from the control group receive usual care. Primary outcome is the number of all-cause hospitalizations at 12 months follow-up, assessed by insurance claims data. Secondary outcomes are health-related quality of life (SF12, EQ5D), quality of chronic illness care (PACIC), health care utilisation and costs, medication adherence (MARS), depression status and severity (PHQ-9), self

Objective: In primary care, clinically recommended drug medication is often modified after hospitalization. The aim of the study was to examine the frequency and factors associated with GPs changing the hospital drug treatment in a sample of patients discharged from the hospital. Methods: In a prospective study, the prehospital, hospital and posthospital diagnoses and drug treatment of 130 patients consecutively recruited from 15 general practices were recorded over a period of 12 months. The ICD-10 classification was used to compare the data from hospitals and general practices. GPs who changed the hospital drug treatment were interviewed in a semistructured way concerning their reasons for changing. Results: The most frequent diagnoses during and after hospitalization were listed in the ICD-10 chapters ‘Diseases of the cardiovascular system’ (34.3%) and ‘Endocrine, nutritional and metabolic diseases’ (18%). Accordingly, the most frequently prescribed drug medication was related to these chapters (47.5% and 15.9%, respectively). Hospitalization led to a significant increase in the number of drugs per patient [prehospital 5.4; hospital 6.6; posthospital 6.7; (p < 0.001)]. GPs changed the hospital drug recommendations of the discharge letters in 60.7% of the cases. They omitted drugs in 27.6%, replaced prehospital drug medication in 26.3%, changed to other manufacturers in 9.3%, added new drugs in 13.1% and changed the dosage in 4.2% of the cases. Changes in drug medication correlated significantly with the number of drugs and number of diagnoses (p < 0.001). The most frequently mentioned reason for drug changing by GPs was cost savings (30.3%). But more often they changed drug medication for patient-related reasons (42.4%): 'better individual drug effect' in 18.5%, 'no reasonable indication' in 17.1% and 'not related to adequate diagnosis' in 6.8% of the cases. Conclusion: After hospital discharge, GPs changed more than half of posthospital drug recommendations. Alt

OBJECTIVE: Models for the structured delivery of care rely on organizational attributes of practice teams. The Survey of Organizational Attributes for Primary Care (SOAPC) is known to be a valid instrument to measure this aspect in the primary care setting. The aim of this study was to determine the validity of a translated and culturally adapted German version of the SOAPC. METHODS: The SOAPC was translated and culturally adapted according to established standards. The external validity of the German SOAPC was assessed using the German version of the Warr-Cook-Wall scale. A total of 200 practices randomly selected from a conference database were asked to participate in the validation study. Practice, clinicians and staff characteristics were determined via short-form questionnaires. We used standardized statistical procedures to reveal the psychometric properties of the SOAPC. RESULTS: A total of 54 practice teams participated by returning 297 completed questionnaires (297/425, response rate 69.8%). All four domains of the SOAPC (communication, decision making, stress/chaos, history of change) could be approved by factor analysis. Internal consistency is underlined by a Cronbach's alpha of 0.70 or higher in all categories. We show strong correlation with the Warr-Cook-Wall scale in all corresponding categories indexing high external validity. CONCLUSIONS: The German SOAPC is a reliable and valid instrument for the assessment of organizational attributes of practice teams as the providers of quality of care. Moreover, the tool makes it possible to map the state of implementation of quality management and practice organization. The availability of the German SOAPC encourages further research on this topic in German-speaking countries.

BACKGROUND: Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs). METHODS: This patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models. RESULTS: Baseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]). CONCLUSIONS: In this sample, with little room for improvement regarding evidence-based ph

BACKGROUND: Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs). METHODS: This patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models. RESULTS: Baseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]). CONCLUSIONS: In this sample, with little room for improvement regarding evidence-based ph

OBJECTIVE: Models for the structured delivery of care rely on organizational attributes of practice teams. The Survey of Organizational Attributes for Primary Care (SOAPC) is known to be a valid instrument to measure this aspect in the primary care setting. The aim of this study was to determine the validity of a translated and culturally adapted German version of the SOAPC. METHODS: The SOAPC was translated and culturally adapted according to established standards. The external validity of the German SOAPC was assessed using the German version of the Warr-Cook-Wall scale. A total of 200 practices randomly selected from a conference database were asked to participate in the validation study. Practice, clinicians and staff characteristics were determined via short-form questionnaires. We used standardized statistical procedures to reveal the psychometric properties of the SOAPC. RESULTS: A total of 54 practice teams participated by returning 297 completed questionnaires (297/425, response rate 69.8%). All four domains of the SOAPC (communication, decision making, stress/chaos, history of change) could be approved by factor analysis. Internal consistency is underlined by a Cronbach's alpha of 0.70 or higher in all categories. We show strong correlation with the Warr-Cook-Wall scale in all corresponding categories indexing high external validity. CONCLUSIONS: The German SOAPC is a reliable and valid instrument for the assessment of organizational attributes of practice teams as the providers of quality of care. Moreover, the tool makes it possible to map the state of implementation of quality management and practice organization. The availability of the German SOAPC encourages further research on this topic in German-speaking countries.

Background: Complex care management is seen as an approach to face the challenges of an ageing society with increasing numbers of patients with complex care needs. The Medical Research Council in the United Kingdom has proposed a framework for the development and evaluation of complex interventions that will be used to develop and evaluate a primary care-based complex care management program for chronically ill patients at high risk for future hospitalization in Germany. Methods and design: We present a multi-method procedure to develop a complex care management program to implement interventions aimed at reducing potentially avoidable hospitalizations for primary care patients with type 2 diabetes mellitus, chronic obstructive pulmonary disease, or chronic heart failure and a high likelihood of hospitalization. The procedure will start with reflection about underlying precipitating factors of hospitalizations and how they may be targeted by the planned intervention (pre-clinical phase). An intervention model will then be developed (phase I) based on theory, literature, and exploratory studies (phase II). Exploratory studies are planned that entail the recruitment of 200 patients from 10 general practices. Eligible patients will be identified using two ways of 'case finding': software based predictive modelling and physicians' proposal of patients based on clinical experience. The resulting subpopulations will be compared regarding healthcare utilization, care needs and resources using insurance claims data, a patient survey, and chart review. Qualitative studies with healthcare professionals and patients will be undertaken to identify potential barriers and enablers for optimal performance of the complex care management program. Discussion: This multi-method procedure will support the development of a primary care-based care management program enabling the implementation of interventions that will potentially reduce avoidable hospitalizations.

BACKGROUND: Due to technological progress and improvements in medical care and health policy the average age of patients in primary care is continuously growing. In equal measure, an increasing proportion of mostly elderly primary care patients presents with multiple coexisting medical conditions. To properly assess the current situation of co- and multimorbidity, valid scientific data based on an appropriate data structure are indispensable. CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) is an ambitious project in Germany to establish a system for adequate record keeping and analysis in primary care based on episodes of care. An episode is defined as health problem from its first presentation by a patient to a doctor until the completion of the last encounter for it. The study aims to describe co- and multimorbidity as well as health care utilization based on episodes of care for the study population of the first participating general practices. METHODS: The analyses were based on a total of 39,699 patients in a yearly contact group (YCG) out of 17 general practices in Germany for which data entry based on episodes of care using the International Classification of Primary Care (ICPC) was performed between 1.1.2006 and 31.12.2006. In order to model the relationship between the explanatory variables (age, gender, number of chronic conditions) and the response variables of interest (number of different prescriptions, number of referrals, number of encounters) that were applied to measure health care utilization, we used multiple linear regression. RESULTS: In comparison to gender, patients' age had a manifestly stronger impact on the number of different prescriptions, the number of referrals and number of encounters. In comparison to age (beta = 0.043, p < 0.0001), multimorbidity measured by the number of patients' chronic conditions (beta = 0.51, p < 0.0001) had a manifestly stronger impact the number of encounters for the observation period. Moreo

OBJECTIVE: To assess the association of obesity with quality of life, health service utilization and physical activity in a large sample of primary care patients with osteoarthritis (OA). METHODS: Data were retrieved from the PraxArt project, representing a cohort of 1021 primary care patients with OA. In 978 patients, height and weight were measured and the Body Mass Index (BMI) was calculated. The AIMS2-SF was used to assess quality of life (QoL). Data about health service utilization (HSU) were retrieved by means of patients' medical files. Concomitant depression was assessed by means of the Patient Health Questionnaire (PHQ-9). Patients were grouped into normal weight, overweight and obese according to the definition of the WHO and compared by means of analysis of covariance (ANCOVA). RESULTS: Obese and overweight persons achieved significantly higher scores on the AIMS2-SF lower body scale, the symptom, the affect and the work scale, indicating an increased burden by OA. The PHQ-9 score increased significantly over the three weight-groups, indicating a positive association of BMI and depression. With increasing BMI, the number of comorbidities increased and physical activity decreased significantly. After controlling for covariates, contacts to orthopaedics and performed x-rays remained significantly higher in obese patients, but not contacts to general practitioners. CONCLUSION: The results display a strong association of QoL and BMI, resulting in increased use of the health care system. Thus, the study emphasizes the need for appropriate approaches in primary care to break the vicious circle of overweight, depression, decreasing physical inactivity and decreasing QoL.

Background: Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design: HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific selfmanagement, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guidelineoriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient

Background: Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design: HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific selfmanagement, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guidelineoriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient

Background: Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group). In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP) to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt). Methods/Design: The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2) against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits). According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients) will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years) will be analyzed. Discussion: This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states.

Background: Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group). In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP) to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt). Methods/Design: The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2) against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits). According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients) will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years) will be analyzed. Discussion: This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states.

Background: Osteoarthritis (OA) has a high prevalence in primary care. Conservative, guideline orientated approaches aiming at improving pain treatment and increasing physical activity, have been proven to be effective in several contexts outside the primary care setting, as for instance the Arthritis Self management Programs (ASMPs). But it remains unclear if these comprehensive evidence based approaches can improve patients' quality of life if they are provided in a primary care setting. Methods/Design: PraxArt is a cluster randomised controlled trial with GPs as the unit of randomisation. The aim of the study is to evaluate the impact of a comprehensive evidence based medical education of GPs on individual care and patients' quality of life. 75 GPs were randomised either to intervention group I or II or to a control group. Each GP will include 15 patients suffering from osteoarthritis according to the criteria of ACR. In intervention group I GPs will receive medical education and patient education leaflets including a physical exercise program. In intervention group II the same is provided, but in addition a practice nurse will be trained to monitor via monthly telephone calls adherence to GPs prescriptions and advices and ask about increasing pain and possible side effects of medication. In the control group no intervention will be applied at all. Main outcome measurement for patients' QoL is the GERMAN-AIMS2-SF questionnaire. In addition data about patients' satisfaction (using a modified EUROPEP-tool), medication, health care utilization, comorbidity, physical activity and depression (using PHQ-9) will be retrieved. Measurements (pre data collection) will take place in months I-III, starting in June 2005. Post data collection will be performed after 6 months. Discussion: Despite the high prevalence and increasing incidence, comprehensive and evidence based treatment approaches for OA in a primary care setting are neither established nor evaluated in Germany. I

Introduction The 2030 Sustainable Development Agenda emphasizes the importance of quality of care in the drive to achieve universal health coverage. Despite recent progress, challenges in service delivery, efficiency and resource utilization in the health sector remain. Objective The Ministry of Health Department of Standards and Regulations sought to operationalize the Kenya Quality Assurance Model for Health. To this end, the European Practice Assessment (EPA) was adapted to the area of Reproductive and Maternal and Neonatal Health. Methods The adaptation process made use of a ten step-modified RAND Corporation/University of California Los Angeles (UCLA) Appropriateness Method. The steps included a scoping workshop, definition of five critical domains of quality in the Kenyan context (‘People, Management, Clinical Care, Quality & Safety, Interface between inpatients and outpatients care'), a review of policy documents, management and clinical guidelines, grey and scientific literature to identify indicators in use in the Kenyan health system and an expert panel process to rate their feasibility and validity. Results The resulting 278 indicators, clustered across the five domains, were broken-down into 29 dimensions and assigned measure specifications. A set of data collection tools were developed to furnish the indicators and piloted at two health facilities. They were subsequently finalized for use in 30 health facilities in 3 counties. Conclusions The integrative and indicator-based aspects of the EPA process could be readily adapted to facilitate the operationalization of a practical quality assurance approach in Kenya.