Depression in primary care and the role of evidence-based guidelines: cross-sectional data from primary care physicians in Germany.

BACKGROUND: Depression is the most common mental health burden worldwide. Primary care physicians (PCPs) play a key role in the care provision for people with depression. The first objective of the present study was to examine the health care situation of depression in primary care, focusing on the cooperation between PCPs and mental health specialists. Secondly, we aimed at examining the role of the German S3 Guideline for Unipolar Depression in the primary care provision. METHODS: Data of N = 75 PCPs were analysed from a cross-sectional online survey. Analysis of descriptive information on the current status of primary health care and depression was conducted. Further, to examine factors that are related to the usage of guidelines, multiple regression was performed. RESULTS: Only 22.1% of PCPs described the quality of cooperation with ambulatory mental health specialist as good. The most frequent problems in the cooperation were of structural nature (49.3%, long waiting list, few therapy units, as well as barriers in the communication and the information exchange). With regard to the role of the guideline, 65% of PCPs reported never or seldom using the guideline and 31.7% of PCPs perceived the guideline as not useful at all. In addition, perceived usefulness of the S3 guideline was positively associated with the usage of the guideline. Results of the logistic regression revealed a significant association between the usage of the German S3 Guideline for Unipolar Depression and rating of perceived usefulness of the guideline (OR: 4.771; 95% CI: 2.15-10.59; p < 0.001). CONCLUSION: This study highlights the central role of PCPs and demonstrates major barriers in the outpatient health care provision of depression. Present findings suggest a strong need for collaborative health care models to resolve obstacles resulting from fragmented mental health care systems. Finally, reported perceived barriers in the implementation of the German S3 Guideline for Unipolar Depression indicate the urge to involve PCPs in the development of evidence-based guidelines, in order to ensure a successful implementation and usage of guidelines in clinical practice.

Impact of Parallel Topical Treatment with Nadifloxacin and Adapalene on Acne Vulgaris Severity and Quality of Life: A Prospective, Uncontrolled, Multicentric, Noninterventional Study.

INTRODUCTION: Daily parallel application of adapalene and nadifloxacin has been determined to be effective and well tolerated in patients with acne vulgaris in randomized, controlled clinical studies. Here, the authors report the results from a large, prospective, uncontrolled, multicentric, noninterventional study under real-life conditions in Germany. The effect of treatment on acne severity, safety, and, for the first time, health-related quality of life (HRQoL) was investigated. METHODS: Of the 292 patients (safety collective: 231 adults, 61 adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 adolescents) were treated with adapalene 0.1% cream or gel and nadifloxacin 1% cream for the defined minimum of 28 days. Patients were evaluated for acne severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and safety. RESULTS: After the median treatment duration of 37 and 38 days (adults and adolescents, respectively), 93.4% and 85.0% of adults and adolescents, respectively, exhibited a sustained decrease in acne severity. The LRAG decreased by at least 3 scores in 29.1% and 24.6% of female and male adults, respectively. HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children's Dermatology Life Quality Index). Female adults were more impaired in terms of HRQoL compared to male adults. The 2 best overall efficacy ratings were provided by physicians in 79.3% and 69.5% and by patients in 68.5% and 58.3% of adult and adolescent cases, respectively. The treatment was well tolerated, as reflected in the low number of 9 mild adverse events (AEs), all of which resolved without treatment. However, 4 patients terminated the study prematurely due to AEs. CONCLUSION: In this study, the parallel use of adapalene and nadifloxacin for at least 5 weeks resulted in a rapid improvement in acne severity, an increase in HRQoL, and a good safety profile. Therefore, it represents a promising treatment option that offers the possibility of flexible therapy adjustment.

Pharmacokinetic Drug-Drug Interactions Between Trospium Chloride and Ranitidine Substrates of Organic Cation Transporters in Healthy Human Subjects.

Trospium chloride, a muscarinic receptor blocker, is poorly absorbed with different rates from areas in the jejunum and the cecum/ascending colon. To evaluate whether organic cation transporter (OCT) 1, OCT2 and multidrug and toxin extrusion (MATE) 1 and MATE2-K are involved in pharmacokinetics, competitions with ranitidine, a probe inhibitor of the cation transporters, were evaluated in transfected HEK293 cells. Furthermore, a drug interaction study with trospium chloride after intravenous (2 mg) and oral dosing (30 mg) plus ranitidine (300 mg) was performed in 12 healthy subjects and evaluated by noncompartmental analysis and population pharmacokinetic modeling. Ranitidine inhibited OCT1, OCT2, MATE1, and MATE2-K with half maximal inhibitory concentration values of 186 ± 25 µM, 482 ± 105 µM, 134 ± 37 µM, and 35 ± 11 µM, respectively. In contrast to our hypothesis, coadministration of ranitidine did not significantly decrease oral absorption of trospium. Instead, renal clearance was lowered by ∼15% (530 ± 99 vs 460 ± 120 mL/min; P < .05). It is possible that ranitidine was not available in competitive concentrations at the major colonic absorption site, as the inhibitor is absorbed in the small intestine and undergoes degradation by microbiota. The renal effects apparently result from inhibition of MATE1 and/or MATE2-K by ranitidine as predicted by in vitro to in vivo extrapolation. However, all pharmacokinetic changes were not of clinical relevance for the drug with highly variable pharmacokinetics. Intravenous trospium significantly lowered mean absorption time and relative bioavailability of ranitidine, which was most likely caused by muscarinic receptor blocking effects on intestinal motility and water turnover.

Expression of components of the urothelial cholinergic system in bladder and cultivated primary urothelial cells of the pig.

BACKGROUND: Porcine urinary bladders are widely used for uro-pharmacological examinations due to their resemblance to the human organ. However, characterisations of the porcine urothelium at the molecular level are scarce up to now. As it has become clear over the last years that this tissue plays an important role in the signaling-pathways of the bladder, we examined whether the transporter and receptor pattern (with focus on the transmitter acetylcholine) is comparable to the human urothelium. With regard to in vitro studies, we also investigated if there is a difference between the native tissue and cultivated primary urothelial cells in culture. METHODS: Urothelium from German Landrace and Göttingen Minipig bladders was collected. One part of the German Landrace tissue was used for cultivation, and different passages of the urothelial cells were collected. The actual mRNA expression of different transporters and receptors was examined via quantitative real-time PCR. These included the vesicular acetylcholine transporter (VAChT), the choline acetyl transferase (ChAT), organic cation transporters 1-3 (OCT1-3), organic anion transporting polypeptide 1A2 (OATP1A2), P-glycoprotein (ABCB1), the carnitine acetyl-transferase (CarAT), as well as the muscarinic receptors 1-5 (M1-5). RESULTS: There is a strong qualitative resemblance between the human and the porcine urothelium with regard to the investigated cholinergic receptors, enzymes and transporters. CarAT, OCT1-3, OATP1A2 and ABCB1 could be detected in the urothelium of both pig races. Moreover, all 5 M-receptors were prominent with an emphasis on M2 and M3. VAChT and ChAT could not be detected at all. Cultures of the derived urothelial cells showed decreased expression of all targets apart from ABCB1 and CarAT. CONCLUSIONS: Based on the expression pattern of receptors, transporters and enzymes of the cholinergic system, the porcine urinary bladder can be regarded as a good model for pharmacological studies. However, cultivation of primary urothelial cells resulted in a significant drop in mRNA expression of the targets. Therefore, it can be concluded that the intact porcine urothelium, or the whole pig bladder, may be appropriate models for studies with anticholinergic drugs, whereas cultivated urothelial cells have some limitation due to significant changes in the expression levels of relevant targets.

[Psychopharmaceutical Medication in Brandenburgian Nursing Homes - An Exploratory Study]. / Psychopharmakamedikation in brandenburgischen Pflegeheimen ­ eine explorative Studie.

OBJECTIVE: Psychopharmaceuticals are often prescribed in nursing homes for elderly. Together with the general polypharmacy, the risk for adverse drug reactions and interactions is increased. METHODS: Medication data of 398 nursing home residents were analyzed. Guided interviews and focus groups were carried out with nurses, prescribing physicians and relatives. RESULTS: About 70 % of the residents received psychotropic drugs often with sedative properties. High work load, sociodemographic development and shortage of psychiatrists and neurologists had an influence on the prescription rates. CONCLUSION: Nurses and physicians need to be aware of possible adverse drug effects and interactions of psychotropics. The overall amount of psychopharmaceuticals prescribed in nursing homes should be reduced.

Effects of the P-Glycoprotein Inhibitor Clarithromycin on the Pharmacokinetics of Intravenous and Oral Trospium Chloride: A 4-Way Crossover Drug-Drug Interaction Study in Healthy Subjects.

The quaternary ammonium compound trospium chloride is poorly absorbed from 2 "absorption windows" in the jejunum and cecum/ascending colon, respectively. To confirm whether intestinal P-glycoprotein (P-gp) is involved, a 4-period, crossover drug interaction study with trospium chloride after intravenous (2 mg) and oral administration (30 mg) without and after comedication of clarithromycin (500 mg), an inhibitor for P-gp, was initiated in 12 healthy subjects. Pharmacokinetics of trospium was evaluated using gas chromatography-mass spectrometry, noncompartmental evaluation, and pharmacokinetic modeling. Trospium chloride was poorly absorbed after oral administration (absolute bioavailability, ∼8%-10%). About 30% of the bioavailable dose fraction was absorbed from the "narrow window". Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01). Bioavailability was not increased as hypothesized. The geometric mean ratios (90% confidence interval) for area under the plasma concentration-time curve, maximum concentration, and renal clearance accounted for 0.75 (0.56-1.01), 0.64 (0.45-0.89), and 1.00 (0.90-1.13), respectively. The amount of trospium absorbed from the "narrow window" was reduced in all subjects but from the "wider window" in only 9 of them. Bioavailability was strongly predicted by the maximum absorption rate of trospium in the distal "window" (rs2  = 0.910, P < .0001). In conclusion, the P-gp inhibitor clarithromycin significantly increases distribution volumes but not oral absorption of trospium. The amount absorbed from the "narrow window" was lowered in all subjects. However, the extent of all influences seems not to be of clinical relevance.

Interplay of the Organic Cation Transporters OCT1 and OCT2 with the Apically Localized Export Protein MATE1 for the Polarized Transport of Trospium.

The anticholinergic drug trospium is secreted into urine and, to a smaller extent, into bile. Chemically, it is an organic cation, and it is a substrate of the uptake transporters OCT1 and OCT2 as well as for the export proteins MATE1 and MATE2-K as determined in uptake studies using HEK293 cells. So far, neither MATE-mediated export nor the interplay of OCT-mediated uptake and MATE-mediated export have been investigated. Therefore, we used polarized monolayers of single- and double-transfected MDCKII cells (MDCK-OCT1, MDCK-OCT2, MDCK-MATE1, MDCK-OCT1-MATE1, and MDCK-OCT2-MATE1) and the respective control cells (MDCK-Co) for transcellular transport assays. We demonstrate that the transcellular, basal-to-apical transport of trospium is significantly higher in all cell lines compared to control cells over nearly the complete concentration range tested. The transcellular transport mediated by double-transfected MDCK-OCT1-MATE1 and MDCK-OCT2-MATE1 exceeded that in the single-transfected cells (MDCK-OCT1-MATE1 vs MDCK-OCT1: 2.2-fold; MDCK-OCT1-MATE1 vs MDCK-MATE1: 1.7-fold; MDCK-OCT2-MATE1 vs MDCK-OCT2: 6.1-fold; MDCK-OCT2-MATE1 vs MDCK-MATE1: 1.8-fold at a trospium concentration of 1.0 µM; p < 0.001 each). Thus, we show that MATE1 does not only mediate the uptake of trospium into HEK293 cells but also the efflux of trospium out of polarized MDCKII-cells. Furthermore, our results indicate that OCT1 or OCT2 as uptake transporters and MATE1 as an export protein contribute to the transcellular transport of trospium at concentrations normally reached during trospium therapy. These data suggest that both, OCT-mediated uptake as well as MATE1-mediated efflux may contribute to trospium renal and biliary elimination.

Antibiotic prescribing behavior among general practitioners - a questionnaire-based study in Germany.

BACKGROUND: This study investigates the barriers and facilitators of the use of antibiotics in acute respiratory tract infections by general practitioners (GPs) in Germany. METHODS: A multidisciplinary team designed and pre-tested a written questionnaire addressing the topics awareness of antimicrobial resistance (7 items), use of antibiotics (9 items), guidelines/sources of information (9 items) and sociodemographic factors (7 items), using a five-point-Likert-scale ("never" to "very often"). The questionnaire was mailed by postally to 987 GPs with registered practices in eastern Germany in May 2015. RESULTS: 34% (340/987) of the GPs responded to this survey. Most of the participants assumed a multifactorial origin for the rise of multidrug resistant organisms. In addition, 70.2% (239/340) believed that their own prescribing behavior influenced the drug-resistance situation in their area. GPs with longer work experience (> 25 years) assumed less individual influence on drug resistance than their colleagues with less than 7 years experience as practicing physicians (Odds Ratio [OR] 0.32, 95% Confidence Interval [CI] 0.17-0.62; P < 0.001). 99.1% (337/340) of participants were familiar with the "delayed prescription" strategy to reduce antibiotic prescriptions. However, only 29.4% (74/340) answered that they apply it "often" or "very often". GPs working in rural areas were less likely than those working in urban areas to apply delayed prescription. CONCLUSION: The knowledge on factors causing antimicrobial resistance in bacteria is good among GPs in eastern Germany. However measures to improve rational prescription are not widely implemented yet. Further efforts have to be made in order to improve rational prescription of antibiotic among GPs. Nevertheless, there is a strong awareness of antimicrobial resistance among the participating GPs.

Trospium chloride is absorbed from two intestinal "absorption windows" with different permeability in healthy subjects.

Intestinal P-glycoprotein is regio-selectively expressed and is a high affinity, low capacity efflux carrier for the cationic, poorly permeable trospium. Organic cation transporter 1 (OCT1) provides lower affinity but higher capacity for trospium uptake. To evaluate regional intestinal permeability, absorption profiles after gastric infusion of trospium chloride (30mg/250ml=[I]2) for 6h and after swallowing 30mg immediate-release tablets in fasted and fed healthy subjects, were evaluated using an inverse Gaussian density function to model input rate and mean absorption time (MAT). Trospium chloride was slowly absorbed (MAT ∼10h) after gastric infusion involving two processes with different input rates, peaking at about 3h and 7h. Input rates and MAT were influenced by dosage form and meal. In conclusion, trospium is absorbed from two "windows" located in the jejunum and cecum/ascending colon, whose uptake capacity might result from local abundance and functional interplay of P-glycoprotein and OCT1.

Rupatadine in Established Treatment Schemes Improves Chronic Spontaneous Urticaria Symptoms and Patients' Quality of Life: a Prospective, Non-interventional Trial.

INTRODUCTION: Chronic spontaneous urticaria (CSU) is a common and hard to treat condition associated with a substantial negative impact on patients' quality of life (QoL). Clinical studies have shown that rupatadine is effective and safe in the treatment of CSU, but data from routine clinical care are scarce. Therefore, we assessed the effectiveness and tolerability of rupatadine in established dosages on CSU activity and patients' QoL in a routine daily practice setting. METHODS: This was an open, prospective, non-interventional study performed in 146 dermatological practices in Germany. CSU patients for whom treatment with rupatadine was indicated were eligible to participate. Key symptoms of urticaria activity and their impact on patients' QoL were assessed at the beginning and the end of treatment. Adverse events (AEs) and withdrawals, as well as the dosage regimens chosen, were documented. Patients and physicians were requested to rate effectiveness and tolerability of therapy at the final visit. All statistical analyses were descriptive. RESULTS: The majority of the 660 patients screened to be treated (median age 44 years, IQR = 31-59 years, n = 654) received rupatadine 10 mg tablets once (477 patients) or twice (105 patients) daily for a median time of 28 days. After treatment, 93.2% of the patients (606/650) reported a clear overall improvement of symptoms. Rupatadine significantly reduced the urticaria activity score (UAS7) as well as the frequency and severity of existing angioedema episodes. Similarly all domains of the urticaria-specific QoL questionnaire (CU-Q2oL) were markedly improved. The majority of physicians and patients rated rupatadine treatment as effective and well tolerated. There were 39 (5.9%) early treatment withdrawals, and 21 patients (3.2%) experienced AEs. CONCLUSION: Rupatadine when given according to the routine treating schemes improves symptoms and CU-Q2oL of CSU patients; the drug is also safe and well tolerated. FUNDING: Dr. R. Pfleger GmbH.

Refractory overactive bladder: a common problem?

INTRODUCTION AND HYPOTHESIS: Unsatisfactory treatment outcome sometimes is described as frequently occurring in patients treated with first-line therapy for overactive bladder (OAB). The present article reviews the different circumstances which may result in failure to respond to lifestyle interventions, behavioral therapy, and/or antimuscarinic treatment. METHODS: An extensive literature search was conducted to identify relevant articles on pathophysiological, clinical, and pharmacological aspects of refractory OAB. RESULTS: Missing definition, unrealistic individual expectation of treatment outcomes, lack of communication between physician and patient as well as pathophysiological and pharmacological processes were identified as relevant for failure to respond to first-line OAB treatment. Increase of patient's motivation to adhere to the prescribed treatment, critical examination of the patient in regard to the initial diagnosis, and individual adjustment of antimuscarinic therapy may be appropriate tools to improve treatment outcome in OAB patients. CONCLUSIONS: Overall, the incidence of refractory OAB seems to be overestimated. There are several approaches to improve therapy results.

Expression of drug transporters and drug metabolizing enzymes in the bladder urothelium in man and affinity of the bladder spasmolytic trospium chloride to transporters likely involved in its pharmacokinetics.

The cationic, water-soluble quaternary trospium chloride (TC) is incompletely absorbed from the gut and undergoes wide distribution but does not pass the blood-brain barrier. It is secreted by the kidneys, liver, and intestine. To evaluate potential transport mechanisms for TC, we measured affinity of the drug to the human uptake and efflux transporters known to be of pharmacokinetic relevance. Affinity of TC to the uptake transporters OATP1A2, -1B1, -1B3, -2B1, OCT1, -2, -3, OCTN2, NTCP, and ASBT and the efflux carriers P-gp, MRP2 and MRP3 transfected in HEK293 and MDCK2 cells was measured. To identify relevant pharmacokinetic mechanisms in the bladder urothelium, mRNA expression of multidrug transporters, drug metabolizing enzymes, and nuclear receptors, and the uptake of TC into primary human bladder urothelium (HBU) cells were measured. TC was shown to be a substrate of OATP1A2 (Km = 6.9 ± 1.3 µmol/L; Vmax = 41.6 ± 1.8 pmol/mg·min), OCT1 (Km = 106 ± 16 µmol/L; Vmax = 269 ± 18 pmol/mg·min), and P-gp (Km = 34.9 ± 7.5 µmol/L; Vmax = 105 ± 9.1 pmol/mg·min, lipovesicle assay). The genetic OATP1A2 variants *2 and *3 were loss-of-function transporters for TC. The mRNA expression analysis identified the following transporter proteins in the human urothelium: ABCB1 (P-gp), ABCC1-5 (MRP1-5), ABCG2 (BCRP), SLCO2B1 (OATP2B1), SLCO4A1 (OATP4A1), SLC22A1 (OCT1), SLC22A3 (OCT3), SLC22A4 (OCTN1), SLC22A5 (OCTN2), and SLC47A1 (MATE1). Immuno-reactive P-gp and OATP1A2 were localized to the apical cell layers. Drug metabolizing enzymes CYP3A5, -2B6, -2B7 -2E1, SULT1A1-4, UGT1A1-10, and UGT2B15, and nuclear receptors NR1H3 and NR1H4 were also expressed on mRNA level. TC was taken up into HBU cells (Km = 18.5 ± 4.8 µmol/L; Vmax = 106 ± 11.3 pmol/mg·min) by mechanisms that could be synergistically inhibited by naringin (IC50 = 10.8 (8.4; 13.8) µmol/L) and verapamil (IC50 = 4.6 (2.8; 7.5) µmol/L), inhibitors of OATP1A2 and OCT1, respectively. Affinity of TC to OCT1 and P-glycoprotein may be the reason for incomplete oral absorption, wide distribution into liver and kidneys, and substantial intestinal and renal secretions. Absence of brain distribution may result from affinity to P-gp and a low affinity to OATP1A2. The human urothelium expresses many drug transporters and drug metabolizing enzymes that may interact with TC and other drugs eliminated into the urine.

Family practice web sites: new perspectives for patient care and health information?

BACKGROUND AND OBJECTIVES: To cater to the needs of informed and proactive patients in family medicine, health care providers could offer access to care and health information via practice Web sites. To determine the content and quality of family medicine Web sites, we performed a cross-sectional study on a large sample of family practices' Web sites in Berlin, Germany. METHODS: After screening of all family medicine practices in Berlin for the provision of their own practice Web site, we determined the content and quality using a predefined checklist based on a review of literature. RESULTS: Among 1,453 family practices in Berlin, only 211 (15%) had an accessible Web site. Online tools for appointment scheduling (17/211, 8%) or prescription ordering (8/211, 4%) were rarely provided. Approximately half of all Web sites (102/211) provided health information on a wide range of topics, with complementary medicine dominating. Transparency about the source and currentness of information and barrier-free design were identified as main areas in which there was a need for quality improvement. CONCLUSIONS: Family physicians should be trained in quality requirements for Web sites and in how to use online solutions for practice reorganization.

Counseling overweight in primary care: an analysis of patient-physician encounters.

OBJECTIVE: The aim of this study was to assess general practitioners' (GPs') and patients' practices and attitudes regarding overweight encountered during preventive counseling talks. METHODS: Twelve GPs audiotaped their preventive counseling talks with overweight patients, including the assessment of individual risk profiles and further medical recommendations. Fifty-two dialogues were transcribed and submitted to qualitative content analysis. RESULTS: Dietary advice and increased physical activity are mostly discussed during talks. Recommendations appear to be more individual if patients are given the chance to reflect on causes of their overweight during counseling talks. CONCLUSIONS: A dialogue approach affects the strength and quality of weight loss counseling in primary care. However, physicians and overweight patients rarely agreed on weight loss goals during the physician-patient talks. PRACTICAL IMPLICATIONS: Patient centeredness, particularly the integration of patients' perceptions towards weight management, might be an important step towards improving weight counseling in primary care.

[Overweight patients in primary care: how family physicians utilize medical check-up examinations for risk counselling. Content analysis of check-up counselling talks between physicians and patients]. / Ubergewichtige Patienten in der Hausarzt- praxis: Wie wird die Gesundheitsuntersuchung zur Risikoberatung genutzt? Eine qualitative Analyse von Arzt-Patient-Gesprächen.

BACKGROUND: The number of overweight patients in Germany has been continuously increasing during the past years. The so-called "check-up 35" consultation presents primary care providers with an opportunity for preventive counselling talks with the respective individuals. In this qualitative study we analysed family physician encounters. We were particularly interested in the way in which the subject matter was addressed and the risk counselling performed by the physicians when confronted with overweight patients. METHODS: Twelve physicians audio-taped their final check-up dialogue with 52 overweight or obese patients (BMI > or = 25 kg/m2). The interviews were transcribed, and a content analysis was conducted using the established method developed by Mayring. RESULTS: Physicians used direct or more often indirect strategies to address overweight in counselling talks that were most often initiated by their patients. They largely addressed this topic while communicating laboratory results. Some obese patients did not receive any advice on health risks. In the encounters analysed the physicians did not employ standardized risk counselling tools. CONCLUSIONS: The reasons for addressing overweight indirectly and the lack of standardized risk counselling with obese patients are carefully discussed.

[The public's perception of doctors is changing]. / Wandel des Arztbildes in der Offentlichkeit.

The public's perception of doctors is the subject of continuous change. The physician's image loses its uniformity to the extent that increasing knowledge and technical ability generate a multitude of different specialisations. A high complexity arises from the accompanying necessary regulations with the professional image considerably varying across perspectives. Due to this complexity the independence of the self-employed physician becomes increasingly obscure. At the same time, though, the image of the doctor as "an appropriate attendant" has not lost any of its radiance.

A situational judgement test of professional behaviour: development and validation.

AIMS: To describe the development of a single best answer multiple choice situational judgement test (SJT) to assess medical students' ability to judge professional behaviour; to present results of an expert validation of the SJT; to describe experiences with two different validation formats. METHODS: Based on educational objectives and work situations concerning professional behaviour, a SJT with 17 vignettes and 35 questions was developed. Best answers were developed according to available evidence. Forty-four experts validated the answers using either a rank order or a rating scale. RESULTS: For sixteen questions in the rating group, thirteen questions in the ranking group and twelve questions in both groups more than two thirds of the experts agreed on a best answer. In the ranking group some experts found it difficult to commit themselves to a single best answer as instructed. In the rating group some experts did not mark any of the proposed answer options as adequate. DISCUSSION: The definition of the construct of and experts for professional behaviour remain a challenge. Both validation scales have advantages and disadvantages. The two thirds criterion is somewhat arbitrary and lower or higher agreement may be acceptable or necessary depending on the purpose of the assessment.

Effects of mindfulness-based stress reduction on quality of life in nursing home residents: a feasibility study.

BACKGROUND: With demographic change, the number of elderly people is increasing. The aging process and associated stress diminishes their quality of life. Mindfulness-based stress reduction (MBSR) has been claimed to reduce stress and alleviate suffering. It might be a useful approach to improve the condition in the elderly. PATIENTS AND METHODS: To examine feasibility and potential effects of MBSR on nursing home residents in Germany, a non-randomized feasibility study was conducted including 22 participants; 15 of them participated in an 8-week MBSR course, 7 served as untreated comparison group. Health-related quality of life (SF-12), depressive symptoms (GDS-12R), cognitive impairment (MMST), activities of daily living (Barthel Index), satisfaction with life, physical pain and major complaints were assessed pre- and post-intervention. RESULTS: 9 out of 15 course participants completed the course (60%). They showed a significant increase in the SF-12 physical health score (p = 0.017). Depressive symptoms (GDS-12R) significantly declined within the meditation group (p = 0.04) and as compared to the untreated group (p = 0.011). In the comparison group, a significant decrease in major complaints (p = 0.011) and an increase in the SF-12 mental health score were found. The meditation group yielded positive changes in the SF-12 mental health score, in satisfaction with life and in pain intensity. CONCLUSIONS: In view of the setting, the completion rate of 60% appears to be acceptable. Significant results suggest that MBSR may help improve health-related quality of life and reduce symptoms of depression. Yet, as participants did not meet the requirement to practice independently, feasibility of conducting MBSR with elderly who live in a nursing home has to be questioned.

Prevention of infectious tick-borne diseases in humans: Comparative studies of the repellency of different dodecanoic acid-formulations against Ixodes ricinus ticks (Acari: Ixodidae).

BACKGROUND: Ticks of the species Ixodes ricinus are the main vectors of Lyme Borreliosis and Tick-borne Encephalitis - two rapidly emerging diseases in Europe. Repellents provide a practical means of protection against tick bites and can therefore minimize the transmission of tick-borne diseases. We developed and tested seven different dodecanoic acid (DDA)-formulations for their efficacy in repelling host-seeking nymphs of I. ricinus by laboratory screening. The ultimately selected formulation was then used for comparative investigations of commercially available tick repellents in humans. METHODS: Laboratory screening tests were performed using the Moving-object (MO) bioassay. All test formulations contained 10% of the naturally occurring active substance DDA and differed only in terms of the quantitative and qualitative composition of inactive ingredients and fragrances. The test procedure used in the human bioassays is a modification of an assay described by the U.S. Environmental Protection Agency and recommended for regulatory affairs. Repellency was computed using the equation: R = 100 - NR/N x 100, where NR is the number of non-repelled ticks, and N is the respective number of control ticks. All investigations were conducted in a controlled laboratory environment offering standardized test conditions. RESULTS: All test formulations strongly repelled nymphs of I. ricinus (100-81% protection) as shown by the MO-bioassay. The majority of ticks dropped off the treated surface of the heated rotating drum that served as the attractant (1 mg/cm2 repellent applied). The 10% DDA-based formulation, that produced the best results in laboratory screening, was as effective as the coconut oil-based reference product. The mean protection time of both preparations was generally similar and averaged 8 hours.Repellency investigations in humans showed that the most effective 10% DDA-based formulation (~1.67 mg/cm2 applied) strongly avoided the attachment of I. ricinus nymphs and adults for at least 6 hours. The test repellent always provided protection (83-63%) against I. ricinus nymphs equivalent to the natural coconut oil based reference product and a better protection (88-75%) against adult ticks than the synthetic Icaridin-containing reference repellent. CONCLUSION: We found that the 10% DDA-based formulation (ContraZeck(R)) is an easily applied and very effective natural repellent against I. ricinus ticks. By reducing the human-vector contact the product minimises the risk of transmission of tick-borne diseases in humans.