Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G)

Kamradt M, Bozorgmehr K, Krisam J, et al. Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G). Health and Quality of Life Outcomes. 2014;12(1): 185

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

Reflection of illness and strategies for handling advanced lung cancer - a qualitative analysis in patients and their relatives

Background: Lung cancer patients are often diagnosed in an advanced stage of disease. In a situation of palliative treatment, both patients and their relatives experience existential burden. Evidence suggests that multi-professional teams should deal with them as dyads. However, little is known about differences in their individual situation. The purpose of this study is to explore and compare reflections that arise out of the context of diagnosis and to compare how patients and their relatives try to handle advanced lung cancer. Methods: Data was collected by qualitative interviews. A total of 18 participants, 9 patients diagnosed with advanced lung cancer (ICD- 10 C-34, stage IV) starting or receiving palliative treatment and 9 relatives were interviewed. Data was interpreted using qualitative content analysis. Results: Reflection aspects were “thoughts about the cause”, “meaning of belief” and “experience of inequity”. Patients often experienced the diagnosis as inequity and were more receptive for believing in treatment success. The main strategies found were “repression”, “positive attitude”, “strong focus on the present” and “adjustment of life terms”. Patient and relative dyads used the same strategies, but with different emphasis. That life time is limited was more frequently realized by relatives than by patients. Conclusion: While strategies used by relatives are similar to those of patients’, they are less reflective and more pragmatic in terms of handling daily life and organizing care. The interviewed patients were mostly not able to takeover these tasks. To strong was their belief in treatment success, their repression of the future and the focus on the present. This implicates, that in terms of end-of-life care, relatives are important to reach patients who are often not receptive to this topic

Converting habits of antibiotic use for respiratory tract infections in German primary care – study protocol of the cluster-randomized controlled CHANGE-3 trial

Background: The overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance. Although it is well known that acute respiratory tract infections (ARTI) are mainly caused by viruses and are often self limiting, antibiotics are too frequently prescribed in primary care. CHANGE-3 examines whether a complex intervention focusing on improving communication and provision of prescribing feedback reduces antibiotic use in patients suffering from ARTI. Methods/design: The CHANGE-3 trial is a cluster-randomized controlled trial nested within a web-based public campaign conducted in two regions in Germany. A total of 114 medical practices will be included. Practices randomized to the intervention will receive a practice-specific antibiotic-prescription feedback and an educational outreach visit. During the visit the whole practice team will receive an introduction to e-learning modules addressing patient-centered communication on antibiotics. Furthermore, the practices will receive tablet PCs with information on antibiotics and the treatment of ARTI to be presented to patients. Practices randomized to the control will provide care as usual. The primary outcome measure is the antibiotic prescribing rate for patients with a history of ARTI. Data collected before the intervention, during the intervention and after the intervention will be compared. The use of narrow- vs. broad-spectrum antibiotics will be analyzed as a secondary outcome. A process evaluation is also part of the trial. Discussion: This study should contribute to the growing body of research on reducing antibiotic prescription. Trial registration: ISRCTN, ISRCTN15061174. Registered retrospectively on 13 July 2018

Exploring Physician Perspectives on Using Real-world Care Data for the Development of Artificial Intelligence–Based Technologies in Health Care: Qualitative Study

BackgroundDevelopment of artificial intelligence (AI)–based technologies in health care is proceeding rapidly. The sharing and release of real-world data are key practical issues surrounding the implementation of AI solutions into existing clinical practice. However, data derived from daily patient care are necessary for initial training, and continued data supply is needed for the ongoing training, validation, and improvement of AI-based solutions. Data may need to be shared across multiple institutions and settings for the widespread implementation and high-quality use of these solutions. To date, solutions have not been widely implemented in Germany to meet the challenge of providing a sufficient data volume for the development of AI-based technologies for research and third-party entities. The Protected Artificial Intelligence Innovation Environment for Patient-Oriented Digital Health Solutions (pAItient) project aims to meet this challenge by creating a large data pool that feeds on the donation of data derived from daily patient care. Prior to building this data pool, physician perspectives regarding data donation for AI-based solutions should be studied. ObjectiveThis study explores physician perspectives on providing and using real-world care data for the development of AI-based solutions in health care in Germany. MethodsAs a part of the requirements analysis preceding the pAItient project, this qualitative study explored physician perspectives and expectations regarding the use of data derived from daily patient care in AI-based solutions. Semistructured, guide-based, and problem-centered interviews were audiorecorded, deidentified, transcribed verbatim, and analyzed inductively in a thematically structured approach. ResultsInterviews (N=8) with a mean duration of 24 (SD 7.8) minutes were conducted with 6 general practitioners and 2 hospital-based physicians. The mean participant age was 54 (SD 14.1; range 30-74) years, with an average experience as a physician of 25 (SD 13.9; range 1-45) years. Self-rated affinity toward modern information technology varied from very high to low (5-point Likert scale: mean 3.75, SD 1.1). All participants reported they would support the development of AI-based solutions in research contexts by donating deidentified data derived from daily patient care if subsequent data use was made transparent to them and their patients and the benefits for patient care were clear. Contributing to care optimization and efficiency were cited as motivation for potential data donation. Concerns regarding workflow integration (time and effort), appropriate deidentification, and the involvement of third-party entities with economic interests were discussed. The donation of data in reference to psychosomatic treatment needs was viewed critically. ConclusionsThe interviewed physicians reported they would agree to use real-world care data to support the development of AI-based solutions with a clear benefit for daily patient care. Joint ventures with third-party entities were viewed critically and should focus on care optimization and patient benefits rather than financial interests

A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial

Abstract Background Lifestyle-related risk factors can increase complications during pregnancy and negatively impact the health of a mother and her child. Knowledge about these compliances among many pregnant women and women of childbearing age is lacking. In the study AOK-Family + , we propose the evaluation of a newly developed counselling intervention. The intervention aims to raise awareness and to provide relevant information about the impact of lifestyle-related risk factors during pregnancy. The aim of the proposed study is to evaluate the effect of this counselling intervention on women’s knowledge of lifestyle-related risk factors during pregnancy and the concomitant healthy behaviours. Methods A cluster-randomised trial with three arms in Baden-Wuerttemberg, Germany, is proposed. Pregnant women and women of childbearing age will be allocated to one of three groups: online intervention, on-site intervention, or a waiting-list control. Trained counsellors from AOK Baden-Wuerttemberg, a German statutory health insurer, will conduct the counselling sessions. Data collection is conducted throughout validated questionnaires administered at three intervals: before counselling (t0), directly after counselling (t1), and at a 6-week follow-up (t2). The primary outcomes will be health knowledge and healthy behaviours relating to LRFFs during pregnancy. A process evaluation will examine the processes, used resources, and future implementations through additional quantitative questions and qualitative interviews and focus groups. Discussion Based on this study, an implementation strategy for future conduction of lifestyle consultation during pregnancy could be developed with the aim of reducing pre- and post-mortem mobility and mortality. Trial registration The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12

Antibiotic prescribing for acute, non-complicated infections in primary care in Germany: baseline assessment in the cluster randomized trial ARena

Background: Antimicrobial resistance is fueled by inappropriate use of antibiotics. Global and national strategies support rational use of antibiotics to retain treatment options and reduce resistance. In Germany, the ARena project (Sustainable reduction of antibiotic-induced antimicrobial resistance) intended to promote rational use of antibiotics for acute non-complicated infections by addressing network-affiliated physicians, primary care teams and patients through multiple interacting interventions. The present study documented patterns of antibiotic prescribing for patients with acute non-complicated infections who consulted a physician in these networks at the start of the ARena project. It explored variation across subgroups of patients and draws comparisons to prescribing patterns of non-targeted physicians. Methods: This retrospective cross-sectional analysis used mixed logistic regression models to explore factors associated with the primary outcome, which was the percentage of patient cases with acute non-complicated respiratory tract infections consulting primary care practices who were treated with antibiotics. Secondary outcomes concerned the prescribing of different types of antibiotics. Descriptive methods were used to summarize the data referring to targeted physicians in primary care networks, non-targeted physicians (reference group), and patient subgroups. Results: Overall, antibiotic prescribing rates were 32.0% in primary care networks and 31.7% in the reference group. General practitioners prescribed antibiotics more frequently than other medical specialist groups (otolaryngologists vs. General practitioners OR = 0.465 CI = [0.302; 0.719], p < 0.001, pediatricians vs. General practitioners: OR = 0.369 CI = [0.135; 1.011], p = 0.053). Quinolone prescribing rates were 9.9% in primary care networks and 8.1% in reference group. Patients with comorbidities had a higher likelihood of receiving an antibiotic and quinolone prescription and were less likely to receive a guideline-recommended substance. Younger patients were less likely to receive antibiotics (OR = 0.771 CI = [0.636; 0.933], p = 0.008). Female gender was more likely to receive an antibiotic prescription (OR = 1.293 CI = [1.201, 1.392], p < 0.001). Conclusion: This study provided an overview of observed antibiotic prescribing for acute non-complicated respiratory tract infections in German primary care at the start of the ARena project. Findings indicate potential for improvement and will serve as comparator for the post-interventional outcome evaluation to facilitate describing of potential changes

Health-Related Quality of Life in Primary Care: Which Aspects Matter in Multimorbid Patients with Type 2 Diabetes Mellitus in a Community Setting?

<div><p>Background and Objective</p><p>Knowledge about predictors of health-related quality of life for multimorbid patients with type 2 diabetes mellitus in primary care could help to improve quality and patient-centeredness of care in this specific group of patients. Thus, the aim of this study was to investigate the impact of several patient characteristics on health-related quality of life of multimorbid patients with type 2 diabetes mellitus in a community setting.</p><p>Research Design and Methods</p><p>A cross-sectional study with 32 primary care practice teams in Mannheim, Germany, and randomly selected multimorbid patients with type 2 diabetes mellitus (N = 495) was conducted. In order to analyze associations of various patient characteristics with health-related quality of life (EQ-5D index) a multilevel analysis was applied.</p><p>Results</p><p>After excluding patients with missing data, the cohort consisted of 404 eligible patients. The final multilevel model highlighted six out of 14 explanatory patient variables which were significantly associated with health-related quality of life: female gender (r = -0.0494; p = .0261), school education of nine years or less (r = -0.0609; p = .0006), (physical) mobility restrictions (r = -0.1074; p = .0003), presence of chronic pain (r = -0.0916; p = .0004), diabetes-related distress (r = -0.0133; p < .0001), and BMI (r = -0.0047; p = .0045).</p><p>Conclusion</p><p>The findings of this study suggest that increased diabetes-related distress, chronic pain, restrictions in (physical) mobility, female gender, as well as lower education and, increased BMI have a noteworthy impact on health-related quality of life in multimorbid patients with type 2 diabetes mellitus seen in primary care practices in a community setting. The highlighted aspects should gain much more attention when treating multimorbid patients with type 2 diabetes mellitus.</p></div

Sample description (included patients) with observed means and standard deviation for continuous, and absolute and relative frequencies for categorical variables.

<p>Sample description (included patients) with observed means and standard deviation for continuous, and absolute and relative frequencies for categorical variables.</p