Exploring Associations of Somatic Symptom Disorder with Personality Dysfunction and Specific Maladaptive Traits.

INTRODUCTION: According to ICD-11, personality disorders (PDs) are defined by the severity of self and interpersonal dysfunction in terms of personality functioning (PF) and an optional assessment of specific maladaptive personality trait expressions. Also, somatoform disorders are replaced by somatic symptom disorder (SSD). This study examines associations using the novel diagnostic criteria of SSD in an unselected primary care sample, PF, and maladaptive traits in patients with and without SSD. METHODS: An anonymized cross-sectional study was conducted. A questionnaire including SSD-12 (Somatic Symptom Disorder B Criteria Scale-12) and PHQ-15 (Patient Health Questionnaire-15), LPFS-BF 2.0 (Level of Personality Functioning Scale - Brief Form) and PID-5BF+M (Modified Personality Inventory for DSM-5 - Brief Form Plus) was used. A bifactor (S-1) model was calculated with PF (reference for general factor) and personality traits (specific factors) to estimate associations between PF, specific maladaptive personality traits, and SSD. Differences in personality scales between SSD and non-SSD patients were calculated with the Mann-Whitney U test. RESULTS: A total of 624 patients in six general practices participated (mean age 47 years; 60.4% female). SSD-12 and PHQ-15, respectively, showed significant associations with PF (γ = 0.51; γ = 0.48; p < 0.001), negative affectivity (γ = 0.50; γ = 0.38, p < 0.001) and psychoticism (γ = 0.29; γ = 0.28; p < 0.010). Besides, SSD-12 was significantly associated with disinhibition (γ = -0.38; p < 0.010) and anankastia (γ = -0.16; p < 0.010). Patients with SSD showed significantly impaired PF and maladaptive traits in all scales (p < 0.001). CONCLUSION: Impaired PF explains moderate to large amounts of the SSD symptoms and maladaptive personality traits negative affectivity, psychoticism, disinhibition, and anankastia show specific associations beyond PF. An in-depth understanding of these relations might be helpful to improve doctor-patient communication and treatment in SSD.

Implementation of an internet-based asthma patient education program in primary care: results of a single-arm trial.

Asthma education programs (AEPs) for patients are known to be important to provide skills to effectively manage the disease. We developed an electronic AEP (eAEP) and assessed the extent to which patients with asthma in primary care are capable to use the eAEP and whether asthma knowledge improved after eAEP.A single-arm pilot study was performed between November 2019 and December 2020 in 12 general practices in Upper Bavaria, Germany. Asthma knowledge was assessed by the Asthma Knowledge Test (AKT) at baseline, 2 weeks after completion of the eAEP, as well as after 3 and 6 months. AKT sum scores at baseline and follow-up were compared with each other using the Wilcoxon test.In total, 72 patients with asthma were included, of whom all participated in the 2-week follow-up, while data on the 3- and 6-month follow-up was available in 62 and 51 patients, respectively. The eAEP was well accepted and positively evaluated by participants. The mean AKT score significantly (p < .001) increased from 22.8 ± 11.0 at baseline to 44.6 ± 8.3 two weeks after completion of the eAEP. After 3 months, the mean score was still 41.8 ± 7.6, and after 6 months it was 40.2 ± 9.3 (p < .001 each compared to baseline).The internet-based asthma education program was well accepted by primary care patients and resulted in a major increase of asthma knowledge. Thus, it has the potential to be an important adjunct in the treatment of patients with asthma in general practice.

[Effects of the Risk of Recourse Claims on the Work of General Practitioners and Orthopedists - A Nationwide Survey]. / Auswirkungen der Regressgefahr auf die Tätigkeit von Hausärzt*innen und Orthopäd*innen ­ Bundesweite Befragung.

OBJECTIVE: The aim of this study was to investigate the influence of the perceived risk of recourse claims and the extent of personal recourse experience among general practitioners (GPs) and orthopedists in private practice. METHODS: A four-page questionnaire on the effects and consequences of the threat of recourse or recourse actually experienced was sent to a nationwide random sample of 1000 GPs and 1000 orthopedists. RESULTS: The response rate was 41% for GPs and 39% for orthopedists; 47% of the participating GPs and 55% of the orthopedists stated that the risk of recourse was a heavy burden in everyday practice, 37/47% that it had a strong influence on their medical practice. 51/25% stated that they referred to a (different) specialist at least occasionally despite the indication of a prescription. 72% of GPs and 59% of orthopedists had recourse at least once, 36 and 19%, respectively more than 3 times. 18% of GPs and 26% of orthopedists had experienced recourse claims of more than € 5000. The emotional burden caused by the worst regress was perceived by 72 and 78%, respectively of those affected by recourse as severe or very severe. CONCLUSION: The risk of recourse can have a strong impact on the work of GPs and orthopedists in private practice. Recourse is often felt to be emotionally stressful and sometimes seen as inhibiting establishing a practice.

[General Practitioners' Experiences with COVID-19: a Survey After the First Wave of the Pandemic in March/April 2020]. / Erfahrungen von HausärztInnen mit COVID-19 und der Pandemie ­ ein Survey nach der ersten Pandemiewelle im März/April 2020.

BACKGROUND AND OBJECTIVES: The first wave of the COVID-19 pandemic (Mar-Apr 2020) posed significant challenges for primary care. The goal of this study was to analyse the burden of the crisis situation as experienced by the general practitioners (GPs) at its beginning and over the course of the pandemic and to identify factors predictive of the sense of being overburdened. METHODS: In this cross-sectional study, a total of 6300 randomly selected GPs in four federal states of Germany were contacted per post in order to survey changes in health care they provided and their psychological burden in the context of the pandemic between August and October 2020. RESULTS: The response rate was 23%; 46% of the participants were female. At the beginning of the pandemic, 40% of the participants experienced a high or a very high level of being overburdened; later on, it was only 10%. With increasing numbers of COVID patients, the sense of being overburdened increased, as also their perceived capability to care for COVID patients. Predictors of a sense of being overburdened were, among others, a high level of psychological stress, excessive organising efforts, poor capability to care for COVID patients, and scarce supply of protective equipment. CONCLUSION: Despite a sense of being overburdened initially, GPs felt increasingly capable of caring for COVID patients. To help GPs in future crisis situations like this pandemic, organization of care should be simplified to the extent possible so that they can focus on patient care.

Effectiveness of an online education program for asthma patients in general practice: study protocol for a cluster randomized controlled trial.

BACKGROUND: Asthma education programs (AEPs) have been shown to increase quality of life and reduce emergency treatments and hospital admissions. Despite the proven benefits, only a minority of asthma patients attend such programs. To increase the number of educated patients, an online education program (electronic AEP, eAEP) for asthma patients has been developed. The present study aims to investigate the effectiveness of the eAEP in terms of asthma knowledge, asthma control and emergency treatments in general practice settings. METHODS: This is a cluster randomized controlled trial including 100 patients with bronchial asthma from 20 general practices in Bavaria, Germany. General practices will be randomly assigned to either the intervention or control group. Patients in the intervention group will receive access to the eAEP and instructions to complete this program within two weeks. Patients in the control group will receive usual care including a referral to face-to-face AEP (fAEP) by a certified primary care physician or a pulmonologist according to guideline recommendations. Furthermore, patients of both the intervention and control groups will be invited to a follow-up consultation in their general practice after completion of the eAEP and fAEP (three weeks and twelve weeks after study inclusion, respectively) to discuss any open issues. Outcomes for both groups will be assessed at baseline (t0), after two weeks (t1), three months (t2) and six months (t3). The primary outcome is the comparison of asthma knowledge gain between intervention and control groups after completion of the eAEP (two weeks after study inclusion) and fAEP (twelve weeks after study inclusion), respectively. Secondary outcomes include asthma control, frequency of emergency treatments, patient autonomy as well as attitudes towards asthma medication. DISCUSSION: The results of the present trial will provide knowledge about the effectiveness of an online education program for asthma patients compared to usual care in primary care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00028805 . Registered 22 April 2022.

[Experiences with Regional Medical Coordinators in Ambulatory Care in the Early COVID-19 Phase 2020 in Bavaria: Survey of Regional Ambulatory Coordinators and General Practitioners]. / Erfahrungen mit Versorgungsärzt*innen in der frühen COVID-19-Phase 2020 in Bayern ­ Befragung von Versorgungs- und Hausärzt*innen.

BACKGROUND: During the state of emergency in Bavaria in the early Corona phase 2020, some physicians in ambulatory care were appointed as regional medical coordinators (RMCs). The aim of the present study was to evaluate this newly introduced but temporary position. METHODS: In November 2020, a paper-based questionnaire was sent out to all 85 RMCs who could be identified through an internet research and to all 197 teaching practices of the Institute of General Practice and Health Services Research at the Technical University of Munich. The data analysis was descriptive and anonymised. RESULTS: Overall, 75 (88%) RMCs and 156 (79%) general practitioners (GPs) were included. 97% of the RMCs and 67% of the GPs assessed the introduction of RMCs in ambulatory care as reasonable, but also as an intervention concerning the self-administration of physicians (RMCs: 59% and GPs: 42%). 37% of the GPs stated that RMCs should be avoided as far as possible in future pandemic situations. Overall, GPs with more intensive contact to an RMC showed higher levels of agreement. Both groups rated the collaboration and communication strategies of politics, authorities and the Bavarian Association of Statutory Health Insurance Physicians as difficult and often contradictory. However, most of the RMCs assessed the cooperation with politics and authorities at the local level as positive. The lack of medical protective equipment at the beginning of the pandemic was judged critically by both groups of the respondents. CONCLUSIONS: The establishment of RMCs in the early Corona phase 2020 in Bavaria was considered sensible by almost all RMCs and the majority of the surveyed GPs. For the future, it seems necessary to involve primary care physicians more intensively and permanently in decision-making processes and to strengthen existing structures.

COVID-19 vaccine hesitancy in people with migratory backgrounds: a cross-sectional study among Turkish- and German-speaking citizens in Munich.

BACKGROUND: This study aimed to investigate the knowledge, attitudes, behaviors, and COVID-19 vaccine hesitancy of people with migratory backgrounds among Turkish- and German-speaking patients in Munich. METHODS: Primary outcomes were the intention to get vaccinated for COVID-19 and COVID-19 knowledge levels (25 true/false items). Other variables included demographics, attitudes to COVID-19 and vaccination (7 items), and behaviors regarding COVID-19 (7 items). The attitude and behavior questions had 5-point Likert scales. Of the 10 Turkish-speaking family physicians in Munich, six agreed to administer Turkish or German questionnaires to consecutive patients in February 2021. Furthermore, participants with either citizenship, country of origin, native language, or place of birth being non-German were categorized as "Having a migratory background." Data from 420 respondents were analyzed. RESULTS: Women constituted 41.4% (n = 174), the mean age was 42.2 ± 15.5 years, 245 (58.3%) preferred the Turkish questionnaire, 348 (82.9%) had a migratory background, and 197 (47.9%) intended to be vaccinated. The mean knowledge, attitude, and behavioral scores were 21.5 ± 3.2 (max = 25), 3.7 ± 0.8 (max = 5), and 4.0 ± 0.5 (max = 5). While 42.3% (n = 145) of the participants with a migratory background considered getting vaccinated, this proportion was 76.5% (n = 52) for non-immigrant Germans (Chi-square = 26.818, p < 0.001). Non-migratory background (odds ratio (OR): 3.082), high attitude scores (OR: 2.877), male sex (OR: 2.185), years of schooling (OR: 1.064), and age (OR: 1.022) were positively associated with vaccination intention. CONCLUSIONS: We suggest initiating or supporting projects run by persons or groups with immigrant backgrounds to attempt to elaborate and change their vaccination attitudes.

Health literacy and eHealth among adult asthma patients - results of a cross sectional survey.

Background: To investigate HL (health literacy) and eHealth literacy (eHL) among two groups of asthma outpatients, those with prior asthma education and those without. In addition, we aimed to compare two shortened versions of a HL measure instrument.Methods: A cross-sectional survey was conducted with a sample of adult asthma patients (n = 129). Half of them had received asthma patient education prior to the study (n = 64). The study collected demographic data, questions on HL (HLS-EU-Q16) and eHL (eHEALS).Results: In the main analysis respondents' mean HL values were almost identical in both groups, 11.9 (SD = 3.1) among trained and 11.8 (SD = 3.5) among untrained patients, demonstrating a problematic level of HL, according to the instrument. In the subdivision of sum scores, the HL level of trained patients was categorized more often as problematic (43%) than among untrained patients (20%). Bland-Altman plots of the 6-item and 16-item versions of the HLS-EU suggest only limited agreement between the versions. In terms of eHL, trained patients showed a mean of 3.0 (SD = 1.1) and untrained patients a mean of 3.2 (SD = 1.0). Analysis of HL and eHL showed no difference between groups.Conclusions: No consistent differences between groups were found, suggesting that trained patients did not benefit from asthma education regarding HL and eHL. The 6-item and 16-item versions of the HLS-EU were not easily interchangeable, limiting its use in a busy outpatient practice.AbbreviationseHEALSElectronic Health Literacy ScaleeHLElectronic Health Literacy HLS-EUEuropean Health Literacy Survey.

Diagnostic accuracy of capnovolumetry for the identification of airway obstruction - results of a diagnostic study in ambulatory care.

BACKGROUND: One of the known weaknesses of spirometry is its dependence on patients' cooperation, which can only partially be alleviated by educational efforts. Therefore, procedures less dependent on cooperation might be of value in clinical practice. We investigated the diagnostic accuracy of ultrasound-based capnovolumetry for the identification of airway obstruction. METHODS: Consecutive patients from a pulmonary outpatient clinic were included in the diagnostic study. As reference standard, the presence of airway obstruction was evaluated via spirometry and bodyplethysmography. Capnovolumetry was performed as index test with an ultrasound spirometer providing a surrogate measure of exhaled carbon dioxide. Receiver operating characteristic (ROC) analysis was performed using the ratio of slopes of expiratory phases 3 and 2 (s3/s2) ≥ 0.10 as primary capnovolumetric parameter for the recognition of airway obstruction. Logistic regression was performed as secondary analysis to identify further useful capnovolumetric parameters. The diagnostic potential of capnovolumetry to identify more severe degrees of airway obstruction was evaluated additionally. RESULTS: Of 1400 patients recruited, 1287 patients were included into the analysis. Airway obstruction was present in 29% of patients. The area under the ROC-curve (AUC) of s3/s2 was 0.678 (95% CI 0.645, 0.710); sensitivity of s3/s2 ≥ 0.10 was 47.7 (95% CI 42.7, 52.8)%, specificity 79.0 (95% CI 76.3, 81.6)%. When combining this parameter with three other parameters derived from regression analysis (ratio area/volume phase 3, slope phase 3, volume phase 2), an AUC of 0.772 (95% CI 0.743, 0.801) was obtained. For severe airway obstruction (FEV1 ≤ 50% predicted) sensitivity of s3/s2 ≥ 0.10 was 75.9 (95% CI 67.1, 83.0)%, specificity 75.8 (95% CI 73.3, 78.1)%; for very severe airway obstruction (FEV1 ≤ 30% predicted) sensitivity was 86.7 (95% CI 70.3, 94.7)%, specificity 72.8 (95% CI 70.3, 75.2)%. Sensitivities increased and specificities decreased considerably when the combined capnovolumetric score was used as index test. CONCLUSIONS: Capnovolumetry by way of an ultrasound spirometer had a statistically significant albeit moderate potential for the recognition of airway obstruction in a heterogeneous population of patients typically found in clinical practice. Diagnostic accuracy of the capnovolumetric device increased with the severity of airway obstruction. TRIAL REGISTRATION: The study is registered under DRKS00013935 at German Clinical Trials Register (DRKS).

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review.

OBJECTIVE: To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures. DESIGN: Systematic review with meta-analysis. METHODS: Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected. Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation. RESULTS: Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham. Conditions included low back (N = 7 trials), arthritis (4), angina (4), abdominal pain (3), endometriosis (3), biliary colic (2), and migraine (2). Thirteen trials (52%) reported an adequate concealment of allocation. Fourteen studies (56%) reported on adverse events. Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%). In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = -0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = -0.11 to 0.19, P = 0.63, I2 = 36%). The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions. CONCLUSIONS: There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain. Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

Participation factors for asthma education programs - a cross sectional survey.

BACKGROUND: Although the impact of asthma education on important outcomes (e.g. emergency visits) has been well established, only an estimated quarter of asthma patients in Germany have received patient education yet. The aim of the study was to identify patient factors that could increase participation in asthma education programs. METHODS: This cross-sectional study investigated participation factors and differences between trained (n = 64) and untrained (n = 65) asthma patients from a large outpatient center in Germany. The survey included answers to asthma-related questions and open questions on patient education as well as such about knowledge of health literacy and eHealth. RESULTS: Mean age of participants was 55 ± 19 years and 61% were female. Trained patients were more likely to participate in disease management programs (odds ratio (OR) 6.85; 95%CI 2.17-21.59), were more frequently non-smokers (OR 0.07; 95%CI 0.01-0.85) and more often had an asthma action plan (OR 20.2; 1.55-263.41). Open questions' analysis of untrained asthma patients revealed that patients felt they were not adequately informed about asthma education (37%). About one-third of all patients (27%) showed openness to online asthma education. Analysis of HL and eHealth showed no difference between the groups. CONCLUSION: Untrained asthma patients should be informed even more intensively by their physicians about the importance and value of asthma education. Asthma education does not seem to benefit patients' health literacy. Online asthma education is of interest to approximately one-third of asthma patients. This should be motivation to develop and implement online asthma education concepts.

On the edges of medicine - a qualitative study on the function of complementary, alternative, and non-specific therapies in handling therapeutically indeterminate situations.

BACKGROUND: In routine practice, general practitioners (GPs) see many patients for whom treatment might not be necessary, or evidence-based treatments are not available, yet often a treatment is prescribed. We denote such situations as therapeutically indeterminate. We aimed to investigate 1) whether therapeutically indeterminate situations play a role in the accounts of GPs in their practical work; 2) the role of complementary and alternative medicine (CAM) modalities or non-specific therapies, and of other strategies used in handling therapeutically indeterminate situations; and 3) factors associated with preferences for specific strategies. METHODS: We performed semi-structured, individual face-to-face interviews with 20 purposively sampled, experienced GPs from Bavaria, Germany. A grounded theory approach was used for data analysis. RESULTS: Participants reported that therapeutically indeterminate situations recur often in their daily practice. Professionally legitimate strategies such as empathetic consultations without providing a treatment intervention did not seem to suffice for coping with all of these situations. CAM treatments were used frequently, but motives varied. While some participants were convinced that these treatments were active and effective, others were uncertain or had doubts and used them as a relational tool, as a non-specific treatment or as a beneficial placebo. Conventional drugs were also used in a non-specific manner or despite doubts regarding the risk-benefit ratio. The extent to which GPs felt responsible for offering solutions in therapeutically indeterminate situations seemed to influence their preference for specific strategies. CONCLUSION: Our results demonstrate the important role of CAM and the somewhat smaller role of non-specific therapies for German general practitioners in dealing with therapeutically indeterminate situations. The concept of therapeutically indeterminate situations may be helpful in better understanding why many general practitioners treat patients in situations where treatment does not appear to be clearly indicated.

Validity of the Somatic Symptom Disorder-B Criteria Scale (SSD-12) in primary care.

Aim: The Somatic Symptom Disorder-B Criteria Scale (SSD-12) assesses the psychological features of DSM-5 somatic symptom disorder. The purpose of the current study was to investigate the psychometric characteristics and validity of the 12-item instrument to demonstrate its suitability in primary care. Method: The study was designed as a cross-sectional survey set in five primary care practices from Munich, Germany (n = 501, 52.0% female, mean age 47 ± 16 years). Item and scale characteristics, as well as measures of reliability and validity, were determined. Results: The SSD-12 has good item characteristics and excellent reliability (Cronbach's α = 0.92). Confirmatory factor analyses provided evidence to support a general factor model of the SSD-12 in primary care (comparative fit index > 0.98, Tucker-Lewis index > 0.98, root mean square error of approximation = 0.090, 90% confidence interval: 0.078-0.102). SSD-12 total sum-score was significantly associated with somatic symptom burden (r = 0.48, P < 0.001), general anxiety (r = 0.54, P < 0.001) and depressive symptoms (r = 0.60, P < 0.001). At the group level, SSD-12 scores could differentiate between different patient groups (e.g. with and without chronic illness). Conclusions: The SSD-12 appears to be a reliable, valid and time-efficient self-report measure of the psychological characteristics related to the experience of somatic symptoms which is suitable for primary care. Future research should evaluate its responsiveness to treatment and feasibility as a screening tool in different clinical settings.

Do general practice patients with and without appointment differ? Cross-sectional study.

BACKGROUND: Even in practices with a comprehensive appointment system a minority of patients walks in without prior notice, sometimes causing problems for practice service quality. We aimed to explore differences between patients consulting primary care practices with and without appointment. METHODS: Consecutive patients visiting five primary care practices without an appointment and following patients with an appointment were asked to fill in a four-page questionnaire addressing socio-demographic characteristics, the reason for encounter, urgency of seeing a physician, depressive, somatic and anxiety symptoms, personality traits, and satisfaction with the practice. Physicians also documented the reason for encounter and assessed the urgency. Data were analyzed using univariate and multivariate methods. RESULTS: Two hundred fifty-one patients without and 250 patients with appointment participated. Patients without appointment were significantly younger (mean age 44 vs. 50 years) and reported less often chronic diseases (29% vs. 45%). Also, reasons for encounter differed (e.g., 27% vs. 16% with a respiratory problem). Patients' ratings of urgency did not differ between groups (p = 0.46), but physicians rated urgency higher among patients without appointment (p < 0.001). In logistic regression analyses younger age, male gender, absence of chronic disease, positive screening for at least one mental disorder, low values on the personality trait openness for experience, a high urgency rating by the physician, and a respiratory or musculoskeletal problem as reason for encounter were significantly associated with a higher likelihood of being a patient without appointment. CONCLUSIONS: In this study, younger age and a high urgency rating by physicians were the variables most consistently associated with the likelihood of being a patient without appointment. Overall, differences between patients seeking general practices with a comprehensive appointment system without prior notice and patients with appointments were relatively minor.

Accuracy of FENO for diagnosing asthma: a systematic review.

BACKGROUND: Measurement of FENO might substitute bronchial provocation for diagnosing asthma. We aimed to investigate the diagnostic accuracy of FENO measurement compared with established reference standard. METHODS: Systematic review and diagnostic meta-analysis. Data sources were Medline, Embase and Scopus up to 29 November 2015. Sensitivity and specificity were estimated using a bivariate model. Additionally, summary receiver-operating characteristic curves were estimated. RESULTS: 26 studies with 4518 participants (median 113) were included. Risk of bias was considered low for six of seven items in five studies and for five items in seven studies. The overall sensitivity in the meta-analysis was 0.65 (95% CI 0.58 to 0.72), the overall specificity 0.82 (0.76 to 0.86), the diagnostic OR 9.23 (6.55 to 13.01) and the area under the curve 0.80 (0.77 to 0.85). In meta-regression analyses, higher cut-off values were associated with increasing specificity (OR 1.46 per 10 ppb increase in cut-off) while there was no association with sensitivity. Sensitivities varied significantly within the different FENO devices, but not specificities. Neither prevalence, age, use of bronchoprovocation in >90% of participants or as exclusive reference standard test, nor risk of bias were significantly associated with diagnostic accuracy. CONCLUSIONS: There appears to be a fair accuracy of FENO for making the diagnosis of asthma. The overall specificity was higher than sensitivity, which indicates a higher diagnostic potential for ruling in than for ruling out the diagnosis of asthma.

WITHDRAWN: Propranolol for migraine prophylaxis.

BACKGROUND: Propranolol is one of the most commonly prescribed drugs for migraine prophylaxis. OBJECTIVES: We aimed to determine whether there is evidence that propranolol is more effective than placebo and as effective as other drugs for the interval (prophylactic) treatment of patients with migraine. SEARCH METHODS: Potentially eligible studies were identified by searching MEDLINE/PubMed (1966 to May 2003) and the Cochrane Central Register of Controlled Trials (Issue 2, 2003), and by screening bibliographies of reviews and identified articles. SELECTION CRITERIA: We included randomised and quasi-randomised clinical trials of at least 4 weeks duration comparing clinical effects of propranolol with placebo or another drug in adult migraine sufferers. DATA COLLECTION AND ANALYSIS: Two reviewers extracted information on patients, methods, interventions, outcomes measured, and results using a pre-tested form. Study quality was assessed using two checklists (Jadad scale and Delphi list). Due to the heterogeneity of outcome measures and insufficient reporting of the data, only selective quantitative meta-analyses were performed. As far as possible, effect size estimates were calculated for single trials. In addition, results were summarised descriptively and by a vote count among the reviewers. MAIN RESULTS: A total of 58 trials with 5072 participants met the inclusion criteria. The 58 selected trials included 26 comparisons with placebo and 47 comparisons with other drugs. The methodological quality of the majority of trials was unsatisfactory. The principal shortcomings were high dropout rates and insufficient reporting and handling of this problem in the analysis. Overall, the 26 placebo-controlled trials showed clear short-term effects of propranolol over placebo. Due to the lack of studies with long-term follow up, it is unclear whether these effects are stable after stopping propranolol. The 47 comparisons with calcium antagonists, other beta-blockers, and a variety of other drugs did not yield any clear-cut differences. Sample size was, however, insufficient in most trials to establish equivalence. AUTHORS' CONCLUSIONS: Although many trials have relevant methodological shortcomings, there is clear evidence that propranolol is more effective than placebo in the short-term interval treatment of migraine. Evidence on long-term effects is lacking. Propranolol seems to be as effective and safe as a variety of other drugs used for migraine prophylaxis.

Reasons for encounters and psychiatric comorbidity in an urban Bavarian primary care out-of-hour service - results of a cross sectional study.

BACKGROUND: International studies have shown a contribution of psychiatric comorbidity to high utilization rates in out-of-hour primary care (OOHC). Up to now, the impact of psychiatric comorbidity in German OOHC remains unclear. Therefore, we aimed to investigate reasons for encounter (RFE), possible psychiatric comorbidity, utilization rates, and a possible association between utilization rate and psychiatric comorbidity among patients of an urban OOHC unit. METHODS: In a cross-sectional, prospective, naturalistic study five hundred self-referred patients completed a self-designed questionnaire addressing RFE, past office visits and personal information. Additionally, we employed three validated questionnaires (PHQ-9, PHQ-15 and GAD-7) to screen for mental disorders. We collected information about past visits through computerized patients' charts. Diagnoses were classified according to the International Classification of Primary Care-2. RESULTS: The most frequent RFE were musculoskeletal complaints (36%), followed by respiratory diseases (13%), gastrointestinal problems (10%), skin conditions (8%) and urologic ailments (6%). Of the included patients 58% were working fulltime and 61% had greater than or equal to 10 years of education. The mean age was 37.3 in females and 40.5 years in males. Prevalence of psychiatric comorbidity was 27%. Only 3% visited the office more than twice over a 12 months period. We could not find an association between high utilization and psychiatric comorbidity. CONCLUSION: In this study, musculoskeletal complaints were the most frequent RFE. Patients were predominantly young, employed and educated. The prevalence of psychiatric comorbidity was similar to the prevalence in common general practitioner offices and showed no significant relation to frequent attendance. This information might help to prepare physicians better for patient care in OOHC.

How do medical students engaging in elective courses on acupuncture and homeopathy differ from unselected students? A survey.

BACKGROUND: We aimed to investigate whether students at German medical schools participating in elective courses on acupuncture and homeopathy differ from an unselected group of students regarding attitudes and personality traits. METHODS: Elective courses on acupuncture and homeopathy in the academic half-year 2013/14 all over Germany were identified and participants invited to fill in a questionnaire including nineteen questions on attitudes towards Complementary and Alternative Medicine (CAM), orientation towards science, care and status orientation, and a short validated instrument (Big-Five-Inventory-10) to measure personality traits (extraversion, neuroticism, openness, conscientiousness, and agreeableness). Participants of a mandatory family medicine course at one university served as unselected control group. RESULTS: Two hundred twenty and 113 students from elective courses on acupuncture and homeopathy, respectively, and 315 control students participated (response rate 93%). Students participating in elective courses had much more positive attitudes towards CAM, somewhat lower science and status orientation, and somewhat higher care orientation than control group students (all p-values for three-group comparisons < 0.001). There were no differences between the three groups regarding personality traits with the exception of lower values for agreeableness in controls (p = 0.009). CONCLUSIONS: The findings of this study show that attitudes of students participating in elective courses on acupuncture or homeopathy at German medical schools differ to a considerable degree from the attitudes of unselected students.

Efficacy of selective serotonin reuptake inhibitors and adverse events: meta-regression and mediation analysis of placebo-controlled trials.

BACKGROUND: It has been suggested that the efficacy of antidepressants has been overestimated in clinical trials owing to unblinding of drug treatments by adverse events. AIMS: To investigate the association between adverse events and the efficacy of selective serotonin reuptake inhibitors (SSRIs). METHOD: The literature was searched to identify randomised, double-blind, placebo-controlled trials of SSRIs in the treatment of major depression. Efficacy outcomes were response to treatment and change in depressive symptoms. Reporting of adverse events was used as an indicator of tolerability. Random effects meta-analyses were used to calculate pooled estimates. Meta-regression analyses were performed to investigate the association between adverse events and efficacy. Potential mediation was investigated with the Baron & Kenny approach. RESULTS: A total of 68 trials (n = 17 646) were included in the analyses. In meta-analysis SSRIs were superior to placebo in terms of efficacy (odds ratio, OR = 1.62, 95% CI 1.51-1.72). More patients allocated to SSRIs reported adverse events than did patients receiving placebo (OR = 1.73, 95% CI 1.58-1.89). Meta-regression analyses did not find an association between adverse events and efficacy (P = 0.439). There was no indication of adverse events mediating the effect of SSRI treatment. CONCLUSIONS: Our results do not support, but also do not unequivocally disprove, the hypothesis that adverse events lead to an overestimation of the effect of SSRIs over placebo.

Acupuncture for the prevention of tension-type headache.

BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.