[Learning from Errors: Qualitative Analysis of Expert Reports on Malpractice in Family Medicine]. / Aus Fehlern lernen ­ qualitative Analyse von Gutachten zu hausärztlichen Behandlungsfehlern.

BACKGROUND: Expert committees of the German medical associations provide a free and out-of-court evaluation of putative cases of medical malpractice. They prepare reports that contain valuable information on process steps that precede the actual treatment error. The aim of the present study was to identify and systematically categorize individual process steps in the expert reports and thus to lay the foundations for the understanding of malpractice evaluation processes. METHODS: In this study, ten randomly selected and anonymized expert reports of the Expert Committee for Questions of Medical Liability of the District Medical Association of South Württemberg with identified GP treatment errors were evaluated, using the method of qualitative content analysis. In an iterative process, central elements of expert reports were classified into a deductively and inductively built category system. RESULTS: Six main categories with associated subcategories were identified: 1) structural aspects of the report, 2) doctor-patient communication, 3) medical course, 4) patient's experience, 5) action by the GP team, and 6) coordinative role in the health care system. The category system showed sufficient reliability with repeated use. CONCLUSION: This study offers an opportunity to learn from errors. The proposed system allows to structure the complexity of expert reports on GP malpractice and may thus serve as a tool in various contexts. In particular, it facilitates the preparation and comparative analysis of reports in a structured way. It could also be used in health care research as well as in education and training.

Research tasks as part of the general practice clerkship in undergraduate medical education - a pilot project on feasibility and acceptance.

OBJECTIVE: To assess the integration of a research task performed by students during their two-week clerkship in general practice. METHODS: Students were assigned to interview five patients with coronary heart disease using a standardised questionnaire focusing on potential interaction of medications with statins. Acceptance and feasibility was assessed by means of a questionnaire survey of teaching physicians (n = 20) and students (n = 20). RESULTS: According to most teaching physicians and students the recruitment of patients during the two-week clerkship was possible, and the practice work flow was not disturbed by the project. Both groups considered the research task on the documentation of potential drug interactions with statins as suitable. According to the teaching physicians the project had a learning effect for the students. In contrast, the students graded their learning effect less highly between 'satisfactory' and 'sufficient'. The overall assessment of the project by the students was on average 'satisfactory' and differed from the assessment by the teaching physicians ('good'). CONCLUSIONS: Adequate informing of students and participating physicians about the nature of the project and presenting preliminary results of the data in a plenary session at the end of the clerkship are essential for the acceptance of such projects.

Students' performing of practical research tasks for their scientific qualification - an approach within the family practice internship in undergraduate education.

BACKGROUND: Future physicians should be educated in evidence-based medicine. So it is of growing importance for medical students to acquire both practical medical and basic research competencies. However, possibilities and concepts focusing on the acquisition of basic practical research competencies during undergraduate medical studies in Germany are rare. Therefore the aim of this article is to develop a didactic and methodological concept for research-based teaching and learning based on the initial results from the block placement in general practice. METHODS: Connecting medical didactic approaches with classic educational control measures (knowledge, acceptance and transfer evaluation, process evaluation, and outcome evaluation). RESULTS: We describe the steps for implementing a research task into the block placement in general practice. Also stressed is the need to develop didactic material and the introduction of structural changes. Furthermore, these steps are integrated with the individual educational control measures. A summary serves to illustrate the learning and teaching concept (Block Placement Plus). CONCLUSION: The conceptualisation of the Block Placement Plus leads to changes in the daily life routine of medical education during the undergraduate block placement in general practice. The concept can in principle be transferred to other courses. It may serve as an instrument for teachers within the framework of a longitudinal curriculum for the scientific qualification of medical students.

[The stable patient collective as a potential pitfall of prospective primary health-care studies. A qualitative inquiry among general practitioners]. / Der feste Patientenstamm als potentielle Fallgrube prospektiver Studien im primärärztlichen Sektor: Eine qualitative Erhebung unter Studienhausärzten.

BACKGROUND AND PURPOSE: Transparency and disclosure of problems in primary health-care studies can add enormous information to the planning and conduction of such studies. By means of the inquiry of study participants, important data on study problems can be found out. Therefore, the aim of this qualitative study was to identify the causes of unexpected results of an intervention study in general practitioners' (GPs) practices by means of an inquiry of the participating GPs. The very study was about diagnosing alcohol- related health disorders at two points of time 1 year apart each with 2,400 primary health-care patients. METHODS: 39 of the 43 participating GPs of the study mentioned were asked by telephone about the possible causes of the unexpected study results. Data analysis was conducted according to the Qualitative Content Analysis of Philipp Mayring. RESULTS: The GPs mentioned problems that are already described in the international literature: the high expenses for study documentation, tabooed health topics, and declining participation motivation at the end of the study. A further cause of the unexpected study results was picked up: the repeated patient recruitment of this intervention study. It was unclear for the GPs whether they could include the same patients at the first and second recruitment point of time. Moreover, one main reason for the unexpected study results seems to be the stable patient collective of GPs' practices; according to that, only few new patients could be included at the second time point of recruitment. CONCLUSION: In primary health-care research requiring several time points for patient recruitment, one has to consider potential tabooed health topics and the special situation in primary health-care practices. This situation is characterized by a stable amount of known patients, even over years. The here-discussed causes of recruitment problems might be essential to avoid selection bias in primary health-care studies.

[Factors associated with influenza vaccination information--a cross-sectional study in elderly primary care patients]. / Faktoren, die mit Angaben zum Impfschutz gegen Influenza assoziiert sind--eine Querschnittuntersuchung bei älteren hausärztlichen Patienten.

General practitioners (GPs) play an important role in influenza vaccination. However, reliable data on the influenza immunisation coverage rate in primary care patients are quite rare. Due to a lack of personal and time resources general practitioners cannot afford to collect such data by themselves. Hence fifth-year students have been involved in the scientific data collection during their practical placement in 118 GP practices. Using logistic regression analysis of a representative sample (n = 541) plausible factors associated with the influenza immunisation coverage rate have been identified. These factors were found to be both patient- and practice-specific. This practice-oriented study was conducted to improve the available data base on the influenza immunisation coverage rate among elderly patients in primary care settings.

Statin use and its association with musculoskeletal symptoms--a cross-sectional study in primary care settings.

INTRODUCTION: Musculoskeletal complaints are very common in primary care settings. Lipid-lowering drugs are one of several causes of musculoskeletal symptoms. However, data showing an association of lipid-lowering drug therapy and increased odds of musculoskeletal complaints in primary care patients are lacking. OBJECTIVE: To investigate the association between statin use and the reporting of muscular complaints by patients and simultaneously control for several known factors of musculoskeletal complaints. METHODS: In a cross-sectional study with 1031 consecutive patients (>50 years of age) in 26 offices of GPs, two investigators collected the data from the office files and by interviewing the patients. A logistic regression model was used to identify variables affecting the odds of muscular symptoms. RESULTS: The prevalence of lipid-lowering drug prescription was 23% (n = 239) and that of muscular complaints was 40% (n = 411). In all, 44% (n = 106) of the patients with lipid-lowering drug prescription had muscular complaints compared to 39% (n = 305) of the patients without lipid-lowering drug therapy. Statin prescription and 10 variables remained in the final model. Statin prescription is associated with a 1.5-fold odds of musculoskeletal complaints compared to non-prescription {odds ratio [OR] = 1.5 [95% confidence interval (CI), 1.1-2.0], P = 0.02}. CONCLUSION: Having a statin prescription appears to be an independent factor associated with musculoskeletal symptoms in primary care settings. Statin use may be more often associated with musculoskeletal complaints than previously assumed.

Detection and management of alcohol use disorders in German primary care influenced by non-clinical factors.

AIMS: The primary objective was to assess the proportion of detected and correctly referred patients in German primary care. The secondary objective was to identify patient and practitioner characteristics that predict detection and correct referral. METHODS: In this clustered cross-sectional survey in German primary care, 3003 patients were consecutively invited to participate, and were asked to fill in a standardized health questionnaire. They were then screened for problematic alcohol consumption using the Alcohol Use Disorders Identification Test. The physicians recorded their assessment of the presence of any alcohol use disorder and documented the treatment course of all identified patients for 3 months. RESULTS: Correctly identified problem drinkers were 38.6% in a per-protocol analysis and 33.6% using a worst-case scenario. Referral behaviour of physicians was in conformity with current practice guidelines in 64.6% of the documented cases and 27.0% in a worst-case scenario. Several patient (e.g. sex, age) and practitioner characteristics (e.g. age), which influence the diagnosis and referral of patients, could be identified. CONCLUSIONS: There is a clear need to increase the special diagnostic and therapeutic skills of general practitioners so that they may be able to indicate and perform secondary prevention. Further research should focus on the likely effects of the implementation of these diagnostic and management tools.

Impact of CYP2D6 genotype on adverse effects during treatment with metoprolol: a prospective clinical study.

OBJECTIVE: Our objective was to study the impact of the cytochrome P450 (CYP) 2D6 polymorphism on the tolerability of metoprolol in a real-life primary care setting. The adverse effects studied comprised effects related to the central nervous system, cardiovascular effects, and sexual dysfunction. METHODS: Patients in whom treatment with metoprolol was considered were enrolled into this prospective, 6-week multicenter study. The dosage of metoprolol was determined on an individual basis and could be freely adjusted on clinical grounds. The indication for treatment was hypertension in about 90% of cases. Systolic and diastolic blood pressure, resting heart rate, and plasma metoprolol and alpha-hydroxymetoprolol concentrations were measured. CYP2D6 genotyping covered alleles *3 to *10 and *41 and the duplications. Possible adverse effects of metoprolol were systematically assessed over a 6-week period by means of standardized rating scales and questionnaires. RESULTS: The final study population comprised 121 evaluable patients (all white patients); among them, there were 5 ultrarapid metabolizers (UMs) (4.1%), 91 extensive metabolizers (EMs) (75%), 21 intermediate metabolizers (IMs) (17%), and 4 poor metabolizers (PMs) (3.3%). Plasma metoprolol concentrations normalized for the daily dose and metoprolol/alpha-hydroxymetoprolol ratios at steady state were markedly influenced by CYP2D6 genotype and displayed a gene-dose effect. The median of the dose-normalized metoprolol concentration was 0.0088 ng/mL, 0.047 ng/mL, 0.34 ng/mL, and 1.34 ng/mL among UMs, EMs, IMs, and PMs, respectively (P<.0001). There was no significant association between CYP2D6 genotype-derived phenotype (EMs and UMs combined versus PMs and IMs combined) and adverse effects during treatment with metoprolol. There was a tendency toward a more frequent occurrence of cold extremities in the PM plus IM group as compared with the EM plus UM group (16.0% versus 4.2%, P=.056; relative risk, 3.8 [95% confidence interval, 1.03--14.3]). CONCLUSIONS: CYP2D6 genotype-derived phenotype was not significantly associated with a propensity for adverse effects to develop during treatment with metoprolol. However, the results concerning tolerability of metoprolol in PMs were inconclusive because of the small number of PMs enrolled.

[Rationale and methods of the UNAMET study (dose- and CYP2D6-genotype-dependent adverse drug reactions of metoprolol)--a contribution to quality improvement in pharmacotherapy]. / Rationale und Methodik der UNAMET-studie (Unerwünschte Arzneimittelwirkungen von Metoprolol in Abhängigkeit von Dosis und CYP2D6-Genotyp)--ein Beitrag zur Qualitäts- verbesserung in der Pharmakotherapie.

Metoprolol has not yet been systematically studied in terms of quality of life and incidence of adverse drug reactions (ADRs). Metoprolol is metabolized by polymorphic CYP2D6, therefore poor CYP2D6 metabolizers may be at higher risk of ADRs. Therefore, it is to be proven whether genotyping is useful to guide initial dose selection. In the ongoing UNAMET study, nonrandomized out-patients start treatment with metoprolol for various disorders. With the use of standard questionnaires, the patients are prospectively evaluated for common ADRs (headache, dizziness, tiredness, sleep disturbances, dyspnea, cold extremities, sexual dysfunction) and quality of life. The questionnaires are filled out before and until 6 weeks after initiating therapy; blood pressure and heart rate are also measured. The acquired data are then related to the patients' metoprolol dose and plasma concentrations, as well as to their metabolic ratio of metoprolol/alpha-OH-metoprolol and CYP2D6 genotype.

[Quality of antithrombotic therapy in patients with chronic atrial fibrillation: the AFib Trial]. / Qualität der antithrombotischen Therapie bei chronischem Vorhofflimmern: AFib-Studie.

BACKGROUND: Large randomised studies have definitely shown that oral anticoagulation effectively reduces thromboembolic complications, e.g. stroke, in patients with chronic non-valvular atrial fibrillation (AFib). However, less than 50% of the eligible AFib patients receive anticoagulation, although their risk of thromboembolic disease is increased 5-7 fold as compared to individuals who have a regular sinus rhythm. This is the reason why undertreatment needs to be evaluated and addressed. In Germany, data on the antithrombotic therapy of these patients are sparse, national guidelines are lacking. AIM OF THE STUDY: This prospective cohort study is the first one to evaluate the quality of antithrombotic prevention in two groups of AFib outpatients in two different, socio-demographically comparable regions of Germany (Südbaden and Südwürttemberg) over a period of several years. Quality of care is defined as the percentage of AFib patients in a certain region treated according to international guidelines. If the percentage in both cohorts does not exceed 80%, guidelines are to be developed and implemented in Südwürttemberg on consideration of the specific treatment conditions in this region; their applicability is to be evaluated later. METHODS: Office-based specialists of internal and general medicine are currently recruiting 200 AFib patients in each study region for documentation of their clinical data. Besides the quality of antithrombotic chemoprevention, relevant problems emerging in antithrombotic therapy in an ambulant setting will be identified. In the area of intervention (Südwürttemberg) experts and office-based physicians will exclusively develop evidence-based guidelines and disseminate them among doctors. Six months after the implementation of these guidelines in Südwürttemberg, their influence on prescribing patterns will be determined by comparing the proportion of anticoagulated AFib patients in Südwürttemberg to that of the control cohort (Südbaden). In addition, secondary outcomes of interest include deaths, days of hospitalisation, and incidence of stroke or bleeding episodes for different antithrombotic treatments.