Deprescribing of antidepressants: development of indicators of high-risk and overprescribing using the RAND/UCLA Appropriateness Method.

BACKGROUND: Antidepressants are first-line medications for many psychiatric disorders. However, their widespread long-term use in some indications (e.g., mild depression and insomnia) is concerning. Particularly in older adults with comorbidities and polypharmacy, who are more susceptible to adverse drug reactions, the risks and benefits of treatment should be regularly reviewed. The aim of this consensus process was to identify explicit criteria of potentially inappropriate antidepressant use (indicators) in order to support primary care clinicians in identifying situations, where deprescribing of antidepressants should be considered. METHODS: We used the RAND/UCLA Appropriateness Method to identify the indicators of high-risk and overprescribing of antidepressants. We combined a structured literature review with a 3-round expert panel, with results discussed in moderated meetings in between rounds. Each of the 282 candidate indicators was scored on a 9-point Likert scale representing the necessity of a critical review of antidepressant continuation (1-3 = not necessary; 4-6 = uncertain; 7-9 = clearly necessary). Experts rated the indicators for the necessity of review, since decisions to deprescribe require considerations of patient risk/benefit balance and preferences. Indicators with a median necessity rating of ≥ 7 without disagreement after 3 rating rounds were accepted. RESULTS: The expert panel comprised 2 general practitioners, 2 clinical pharmacologists, 1 gerontopsychiatrist, 2 psychiatrists, and 3 internists/geriatricians (total N = 10). After 3 assessment rounds, there was consensus for 37 indicators of high-risk and 25 indicators of overprescribing, where critical reviews were felt to be necessary. High-risk prescribing indicators included settings posing risks of drug-drug, drug-disease, and drug-age interactions or the occurrence of adverse drug reactions. Indicators with the highest ratings included those suggesting the possibility of cardiovascular risks (QTc prolongation), delirium, gastrointestinal bleeding, and liver injury in specific patient subgroups with additional risk factors. Overprescribing indicators target patients with long treatment durations for depression, anxiety, and insomnia as well as high doses for pain and insomnia. CONCLUSIONS: Explicit indicators of antidepressant high-risk and overprescribing may be used directly by patients and health care providers, and integrated within clinical decision support tools, in order to improve the overall risk/benefit balance of this commonly prescribed class of prescription drugs.

Local, collaborative, stepped and personalised care management for older people with chronic diseases (LoChro): study protocol of a randomised comparative effectiveness trial.

BACKGROUND: Multimorbid older adults suffering from a long-term health condition like depression, diabetes mellitus type 2, dementia or frailty are at high risk of losing their autonomy. Disability and multimorbidity in the older population are associated with social inequality and lead to soaring costs. Our local, collaborative, stepped and personalised care management for older people with chronic diseases (LoChro-Care) aims at improving outcomes for older multimorbid patients with chronic conditions whose social and medical care must be improved. METHODS: The study will evaluate the effects of LoChro-Care on functional health, depressive symptoms and satisfaction with care, resource utilisation as well as health costs in older persons with long-term conditions. The trial will compare the effectiveness of LoChro-Care and usual care in a cross-sectoral setting from hospital to community care. We will recruit 606 older adults (65+) admitted to local hospital inpatient or outpatient departments who are at risk of loss of independence. Half of them will be randomised to receive the LoChro-Care intervention, comprising seven to 16 contacts with chronic care managers (CCM) within 12 months. The hypothesis that LoChro-Care will result in better patient-centred outcomes will be tested through mixed-method process and outcome evaluation and valid measures completed at baseline and at 12 and 18 months. Cost-effectiveness analyses from the healthcare perspective will include incremental cost-effectiveness ratios. DISCUSSION: The trial will provide evidence about the effectiveness of local, collaborative, stepped and personalised care management for multimorbid patients with more than one functional impairment or chronic condition. Positive results will be a first step towards the implementation of a systematic cross-sectoral chronic care management to facilitate the appropriate use of available medical and nursing services and to enhance self-management of older people. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904 ; Trial registration date: 02. February 2018.

Well informed physician-patient communication in consultations on back pain - study protocol of the cluster randomized GAP trial.

BACKGROUND: Back pain is one of the most frequent causes of health-related work absence. In Germany, more than 70% of adults suffer from at least one back pain episode per annum. It has strong impact on health care costs and patients' quality of life. Patients increasingly seek health information on the internet. However, judging its trustworthiness is difficult. In addition, physicians who are being confronted with this type of information often experience it to complicate the physician-patient interaction. The GAP trial aims to develop, implement and evaluate an evidence-based, easy-to-understand and trustworthy internet information portal on lower back pain to be used by general practitioners and patients during and after the consultation. Effectiveness of GAP portal use compared to routine consultation on improving communication and informedness of both physicians and patients will be assessed. In addition, effects on health care costs and patients' days of sick leave will be evaluated. METHODS: We will conduct a prospective multi-centre, cluster-randomized parallel group trial including 1500 patients and 150 recruiting general practitioners. The intervention group will have access to the GAP portal. The portal will contain brief guides for patients and physicians on how to improve the consultation as well as information on epidemiology, aetiology, symptoms, benefits and harms of treatment options for acute, sub-acute and chronic lower back pain. The GAP portal will be designed to be user-friendly and present information on back pain tailored for either patients or physicians in form of brief fact sheets, educative videos, info-graphics, animations and glossaries. Physicians and patients will assess their informedness and the physician-patient communication in consultations at baseline and at two time points after the consultations under investigation. Days of sick leave and health care costs related to back pain will be compared between control and intervention group using routine data of company health insurance funds. DISCUSSION: The GAP-trial intends to improve the communication between physicians and their patients and the informedness of both groups. If proven beneficial, the evidence-based and user-friendly portal will be made accessible for all patients and health professionals in back pain care. Inclusion of further indications might be implemented and evaluated in the long term. TRIAL REGISTRATION: German Clinical Trials Register DRKS00014279 (registered 27th of April 2018).

Correction: Siegel et al. PEN-13: A New Generic 13-Item Questionnaire for Measuring Patient Enablement (German Version). Int. J. Environ. Res. Public Health 2019, 16, 4867.

In the original publication [...].

Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial.

BACKGROUND: Hypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs. METHODS: The study was conducted as a cluster randomised controlled trial (cRCT) with GP practices in Southwest Germany. Each GP practice included patients with treated but uncontrolled hypertension and/or with relevant comorbidity. After baseline assessment (T0) GP practices were randomly allocated into an intervention and a control arm. GPs of the intervention group took part in the SDM training. GPs of the control group treated their patients as usual. The intervention was blinded to the patients. Primary endpoints on patient level were (1) change of patients' perceived participation (SDM-Q-9) and (2) change of systolic BP (24h-mean). Secondary endpoints were changes of (1) diastolic BP (24h-mean), (2) patients' knowledge about hypertension, (3) adherence (MARS-D), and (4) cardiovascular risk score (CVR). RESULTS: In total 1357 patients from 36 general practices were screened for blood pressure control by ambulatory blood pressure monitoring (ABPM). Thereof 1120 patients remained in the study because of uncontrolled (but treated) hypertension and/or a relevant comorbidity. At T0 the intervention group involved 17 GP practices with 552 patients and the control group 19 GP practices with 568 patients. The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints. CONCLUSION: The study hypothesis that the SDM training enhanced patients' perceived participation and lowered their BP could not be confirmed. Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00000125.

Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT.

BACKGROUND: Hypertension is one of the key factors causing cardiovascular diseases which make up the most frequent cause of death in industrialised nations. However about 60% of hypertensive patients in Germany treated with antihypertensives do not reach the recommended target blood pressure. The involvement of patients in medical decision making fulfils not only an ethical imperative but, furthermore, has the potential of higher treatment success. One concept to enhance the active role of patients is shared decision making. Until now there exists little information on the effects of shared decision making trainings for general practitioners on patient participation and on lowering blood pressure in hypertensive patients. METHODS/DESIGN: In a cluster-randomised controlled trial 1800 patients receiving antihypertensives will be screened with 24 h ambulatory blood pressure monitoring in their general practitioners' practices. Only patients who have not reached their blood pressure target (approximately 1200) will remain in the study (T1 - T3). General practitioners of the intervention group will take part in a shared decision making-training after baseline assessment (T0). General practitioners of the control group will treat their patients as usual. Primary endpoints are change of systolic blood pressure and change of patients' perceived participation. Secondary endpoints are changes of diastolic blood pressure, knowledge, medical adherence and cardiovascular risk. Data analysis will be performed with mixed effects models. DISCUSSION: The hypothesis underlying this study is that shared decision making, realised by a shared decision making training for general practitioners, activates patients, facilitates patients' empowerment and contributes to a better hypertension control. This study is the first one that tests this hypothesis with a (cluster-) randomised trial and a large sample size.

[Evidence-based treatment of depression: what does the new S3- and national healthcare guideline Unipolar Depression really recommend?]. / Evidenzbasierte Behandlung bei depressiven Erkrankungen--was empfiehlt die neue S3-/Nationale Versorgungsleitlinie "Unipolare Depression" wirklich?

The paper reflects central recommendations and methodological issues of the new German guidelines for the treatment of depression, as discussed in the article New German Guidelines for the Treatment of Depression - The Central Role of Psychotherapy (Schauenburg et al. 2009). Members of the steering group for these guidelines disagree with the authors' description in several points, especially with reference to the efficacy of pharmacotherapy with antidepressants and psychotherapy, as well as the relationship between both strategies of therapy and their combination in diverse phases of treatment (acute/maintenance). Furthermore, we try to clarify some misunderstandings in matters of the guideline's methodology which arose in the paper cited.

PEN-13: A New Generic 13-Item Questionnaire for Measuring Patient Enablement (German Version).

Background: The purpose of our study was to develop and psychometrically test a German-language survey instrument that measures patient enablement generically and in greater detail than previous instruments. Methods: A multidisciplinary team developed 13 items to capture individual aspects of patient enablement (PEN-13). A pre-test with 26 subjects was followed by a random sample survey of N = 1168 subjects. An exploratory factor analysis was conducted in a random split-half sample of the data to explore PEN-13's factor structure; a confirmatory factor analysis was conducted in the validation sample. The internal consistency of the factors was evaluated using Cronbach's alpha, PEN-13's construct validity was checked by means of additional hypothesis testing. Results: The two factors self-management and patient-practitioner interaction, detected in the exploratory analysis, were confirmed with a few modifications in the confirmatory factor analysis, with the comparative fit index (CFI) amounting to 0.903. The Cronbach's alpha values of those two factors amounted to α = 0.90 and α = 0.82, respectively. The correlations of the PEN-13 score with the 'general self-efficacy' and 'health literacy' (HLS-EU-Q16) scores further confirmed its construct validity; the respective correlation coefficients amounted to 0.57 and 0.60. Conclusion: The German version of the survey instrument Patient Enablement Scale-13 items (PEN-13) shows acceptable psychometric properties. Practical implications: PEN-13 seems particularly suitable for health services research purposes. We recommend checking the results in another sample as well as evaluating its responsiveness to enablement-enhancing interventions.

Cost-effectiveness analysis of collaborative treatment of late-life depression in primary care (GermanIMPACT).

BACKGROUND: Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective. METHODS: This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively. CONCLUSION: Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.

[Individual patient satisfaction in 'Gesundes Kinzigtal': Interim results of a trend study]. / Individueller Patientennutzen im "Gesunden Kinzigtal" ­ Zwischenergebnisse einer Trendstudie.

INTRODUCTION: The integrated health care pilot model "Gesundes Kinzigtal" (GK) is recognized as a reference model for integrated healthcare in Germany. The aim of GK is to improve the health of the insured persons and, at the same time, to decrease their healthcare costs compared to usual care. The evaluation of GK has so far shown that GK might reach this aim. However, there are still no evaluation studies on GK focusing on patient-reported outcomes. This gap needs to be closed by a trend study, which is the main topic of this paper: We present interim results of this study, focusing on patient satisfaction with GK, insured persons' self-reported change of health behavior, their knowledge on health maintenance, and health-related quality of life. METHOD: The baseline survey of the trend study was conducted in 2013: 3,034 members of GK were invited to complete a standardized questionnaire (by mail). In the first follow-up survey in 2015, 3,471 members were invited. Health-related quality of life was measured by EQ-5D and EQ-VAS; the other above-mentioned indicators were developed by our work group. Conducting variance analysis and logistic regression analysis using SPSS, it was analyzed to what extent the above-mentioned indicators changed between the first and the second survey. RESULTS: The response rate was 23.4 % and 24.9 %, respectively. Overall patient satisfaction with GK and the mean EQ-5D value remained stable; the remaining indicators improved more or less over the course of time. Among these, the proportion of participants who indicated that they "now lead an overall healthier life" than before their enrolment into GK significantly increased from 25.6 % to 30.7 % (p=0.020). DISCUSSION AND CONCLUSION: The significant increase in the proportion of respondents who "now lead an overall healthier life" might be attributed to the fact that patient activation and empowerment was (and is) a top priority of the GK management strategy. Caution is advised, though, with this interpretation because of the limitations inherent to trend studies without an appropriate control group.

Encouraging Self-Management in Cardiovascular Disease Prevention.

BACKGROUND: Cardiovascular diseases are among the most common causes of death in industrialized countries. The goal of the DECADE study ("decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases") is to improve patient activation and health-related behavior by means of structured cardiovascular risk counseling and DECADE brochures. In this pilot study, the applicability of DECADE and the potential effects of the intervention on patients with cardiovascular risk factors were investigated. METHODS: 87 patients were included in the two-arm, randomized, controlled pilot study. All of them participated in four structured counseling sessions. The A+D group received DECADE brochures (intervention group), while the A group did not (control group). The change in patient activation four months later (PAM13-D) was the primary endpoint. Secondary endpoints included, among others, changes in health status and health-related behavior, goal achievement, and patient satisfaction. These changes were studied in an intention-to-treat analysis. RESULTS: Endpoint data were available for 78 patients (38 in the A+D group and 40 in the A group) at four months. The use of DECADE brochures had a significant beneficial effect on PAM13-D scores (an increase of 3.30 points, p = 0.023), corresponding to a moderate effect size of 0.54. Positive trends were seen in most of the other endpoints. The improved patient activation was associated with an overall reduction of risk factors. CONCLUSION: This pilot study shows that DECADE can support patient activation. The effects can be expected to be stronger in a larger study and in comparison to usual care. If this can be confirmed, DECADE should be embedded in routine patient care.

Coordinated Treatment of Depression in Elderly People in Primary Care.

BACKGROUND: Depression in the elderly is mainly treated by primary care physicians; the treatment is often suboptimal because of the limited resources available in pri- mary care. New models of care in which treatment by a primary care physician is supplemented by the provision of brief, low-threshold interventions mediated by care managers are showing themselves to be a promising approach. METHODS: In this open, cluster-randomized, controlled study, we sought to determine the superiority of a model of this type over the usual form of treatment by a primary care physician. Patients in primary care aged 60 and above with moderate depres- sive manifestations (PHQ-9: 10-14 points) were included in the study. The primary endpoint was the percentage of patients in remission (score <5 on the Patient Health Questionnaire, PHQ-9) after the end of the intervention (12 months after baseline). The study was registered in the German Clinical Studies Registry (Deutsches Register für Klinische Studien) with the number DRKS00003589. RESULTS: 71 primary care physicians entered 248 patients in the study, of whom 109 were in the control group and 139 in the intervention group. In an intention-to-treat analysis, the remission rate at 12 months was 25.6% (95% confidence interval [18.3; 32.8]) in the intervention group and 10.9% [5.4; 16.5]) in the control group (p = 0.004). CONCLUSION: This study demonstrates the superiority of the new care model in the primary care setting in Germany, as has been found in other countries.

The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial.

OBJECTIVE: Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time. METHODS: Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Südbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self-report. Depression severity and remission outcomes were assessed with the Brief PHQ-D. RESULTS: Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups. CONCLUSION: A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes. PRACTICE IMPLICATIONS: The study results encourage the implementation of patient participation in primary care of depression.

Three years of experience with a workshop for medical specialty examiners in South Baden: A project report and initial evaluation results.

Introduction: An oral exam (30-60 minutes) is administered at the end of every post-graduate medical specialty program or is required to attain additional specialized qualifications. In both undergraduate and post-graduate medical education oral exams are not considered to be very objective or reliable. To improve the quality of exams in medical specialties, the Regional Medical Association for South Baden (Bezirksärztekammer Südbaden) decided in 2013 to offer a training program for head examiners and others responsible for administering exams in medical specialties. Project Description: Following a survey of examiners and examinees conducted from January through June, 2013, on the difficulty level of examination questions, satisfaction with the test, and the need for training in administering exams, the first workshop of its kind was designed. Since 2013, six workshops with a total of 93 participants have been held and evaluated. Results: The evaluations (response rate: 86%) showed a high level of acceptance for the concept behind the training. A large number of participants felt the need to define minimum standards for exams, to standardize the required level of difficulty and the assessment criteria in each subject, and to give examiners the appropriate tools needed to improve the validity and reliability of the exams. Conclusion: Offering a training program for those responsible for administering medical specialty exams appears to be both meaningful and necessary in order to meet the existing need for increased validity and reliability. In light of the initial experiences with this workshop and the differing percentages of failed exam attempts nationwide, the implementation of examiner training is to be recommended in other regions in Germany. In other European countries examiners conducting medical specialty exams undergo appropriate training before administering their first exam.

DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases-a protocol of a randomized controlled pilot trial.

BACKGROUND: A healthy lifestyle can reduce cardiovascular risk (CVR) and prevent premature death. Usually most patients at increased CVR have difficulties implementing the necessary health behavior changes, such as smoking cessation, increasing of physical activity, healthy diet, stress reduction, etc. In this pilot study, a new intervention (DECADE) that includes a cardiovascular risk calculation, evidence-based decision aids, action planning, and follow-up support for patients to reduce their 10-year risk of cardiovascular diseases will be tested in primary care. The objectives of this trial are to test (1) the feasibility of the study design in preparation for the main trail including (2) the usability and acceptance of DECADE, and (3) initial data to ascertain that changes can be observed in these patients. METHODS: This randomized controlled pilot trial will generate initial data on the potential effects of DECADE on patients' self-evaluated activity and behavior change as well as on clinical outcomes such as blood pressure, cholesterol, body mass index (BMI), HbA1C, and CVR score. In the qualitative part of the study, we will analyze data collected in semi-structured interviews with participating general practitioners (GP) and in patient questionnaires. DISCUSSION: The outcomes of this pilot study will indicate whether DECADE is a promising intervention in the domain of patient-centered prevention of cardiovascular diseases (CVD) and whether a larger multi-center randomized controlled trial is feasible. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00010584.

New paths in post-graduate medical training in general practice - 8 years of experience with the pilot project Verbundweiterbildungplus Baden-Württemberg.

Background: In face of the looming shortage of general practitioners, primary healthcare providers and post-graduate training in general practice are increasingly becoming part of the political agenda in Germany. In 2009 the program "Verbundweiterbildung plus Baden-Württemberg" (VWB plus BW) was developed by the Competence Center for General Practice in Baden-Wuerttemberg to ensure primary healthcare in the future by enhancing the attractiveness of general medicine. This paper describes the experiences that have been gathered in developing a post-graduate training-program for physicians undergoing specialist training in general practice. Project description: The Competence Center for General Practice in Baden-Wuerttemberg supports the organization of regional networks dedicated to post-graduate medical education. First core element of the VWB plus BW program is a special seminar series for physicians pursuing post-graduate training. This seminar program is aligned with the German competency-based curriculum in general medicine and is meant to promote medical expertise and other related competencies, such as business and medical practice management and communication skills. Mentoring and advising the physicians regarding professional and personal planning form the second core element. The third core element is seen in the train-the-trainer seminars that address the competencies of the trainers. In order to focus the program's content closely on the needs of the target groups, scientifically based evaluations and research are carried out. Results: Since starting in 2009, 685 physicians have entered the program and 141 have passed the examination to become medical specialists (as of December 2016). In total, 31 networks, 60 hospitals and 211 general practices have participated. The seminar sessions have been rated on average with 1.43 on a six-point Likert scale by the physician trainees (1=extremely satisfied, 6=extremely dissatisfied). Alongside the medical training, these physicians viewed the exchange of information and experiences with other physicians as very positive and important. In 185 seminars lasting 90 minutes each, the seminar program has presently covered 250 out of 320 units in the competency-based curriculum for general medicine. A total of 281 trainers have been trained in 13 train-the-trainer courses and have rated this course on average with 1.36 on a six-point Likert scale. Above all, the trainers emphasized the exchange of information and experiences with other trainers as very positive. In 2013 the DEGAM concept for its Verbundweiterbildungplus program was developed based on that of the VWB plus BW. Since 2008 over 40 articles on the topic of post-graduate medical education have been published. Conclusion: The steadily increasing number of participants over the years demonstrates that the VWB plus BW is relevant for recent medical graduates and contributes to the attractiveness of general practice. The consistently excellent evaluations of the training program and the train-the-trainer course affirm the focus on the needs of the target groups. The post-graduate VWB plus BW program advances structured, competency-based and quality-oriented specialist training and fosters professional sharing between physicians - something that could also be relevant for other fields. The increasing numbers of participating physicians and specialists in general practice in Baden-Württemberg lead to the conclusion that the VWB plus BW program positively influences the number of general practitioners.

Herbal medicinal products - Evidence and tradition from a historical perspective.

BACKGROUND: Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice. METHOD: This analysis is based on a selective literature search in PubMed and in databases of medical and pharmaceutical history, interviews with licensing experts, a consensus meeting attended by researchers with a background in general medicine, phytotherapy, medical and pharmaceutical history, biometry, ethnopharmacology, pharmacognosy and the pharmaceutical industry. RESULTS AND DISCUSSION: The 2004 EU Directive, which governs the registration of Traditional Herbal Medicinal Products and demands proof of tradition, is a regulatory construct and, above all, the outcome of a political process that has ended in a pragmatic compromise. The concept of tradition applied in the Directive does not sufficiently reflect the semantic breadth of the term. The only condition defined is that a specific commercial preparation needs to have been on the market for 30 years (15 of them inside the EU). Such an approach does not make full scientific use of the evidence available because the information excerpted from historical sources, if adequately processed, may yield valuable insights. This applies to indications, modes of application, efficacy and product safety (innocuousness). Such criteria should enter in full into the benefit-risk-analysis of applied preparations, in the registration process as well as in the therapeutic practice. CONCLUSION: When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and above the formally stipulated regulatory provisions (30 years, product reference). To this end, the scientific methods (from among the natural, life or cultural sciences), which are recognized as authoritative in each case, must be applied.

[The National Disease Management Guideline for Asthma--what's new from the point of view of general practice]. / Nationale VersorgungsLeitlinie Asthma--Was ist neu aus Sicht der Allgemeinmedizin.

The National Disease Management Guideline for Asthma was developed through a consensus process that involved different medical societies, thus constituting a novelty in the improvement of the care for asthma patients in Germany. The German Association of General Practitioners (DEGAM) also participated in the development of the asthma guideline. The implementability of this new guideline in general practice will be discussed on the basis of the chapters that are most important to primary care physicians. The guideline offers many relevant aspects for the management of asthma in general practice. In future editions, the levels of evidence underlying the statements about diagnosis and therapy should be more elaborate, thus providing more concise decision aids for physicians in daily practice. In particular, the implementation aids on the guideline's website could be used to translate the content of the guidelines into practice. Continuous quality improvement and the further development of the implementation process would be most important in overcoming the cross-sectoral barriers of the German healthcare system and thus optimizing the quality of care.