Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis.

BACKGROUND: Medical, endoscopic, and open/laparoscopic surgical methods are used to treat gastroesophageal reflux disease (GERD). This study aimed to perform a systematic review of randomized controlled trials comparing medical and surgical treatments of GERD in adult patients. METHODS: For the study, MEDLINE and EMBASE (1980-2012) were searched. Two reviewers independently assessed methodologic aspects and extracted data from eligible studies, focusing on patient-relevant outcomes. The primary outcomes were health-related and GERD-specific quality-of-life aspects. Standardized mean differences (SMDs) between treatment groups were calculated and combined using random-effect meta-analysis. RESULTS: The study identified 11 publications reporting on 7 trials comparing surgical (open or laparoscopic) and medical treatment of GERD. Meta-analysis of both quality-of-life aspects showed a pooled-effect estimate in favor of fundoplication (SMD 0.18; 95 % confidence interval [CI] 0.01-0.35; SMD 0.33; 95 % CI 0.13-0.54). Heartburn and regurgitation were less frequent after surgical intervention. However, a considerable proportion of patients still needed antireflux medication after fundoplication. Nevertheless, the surgical patients were significantly more satisfied with their symptom control and showed higher satisfaction with the treatment received. CONCLUSIONS: This systematic review showed that surgical management of GERD is more effective than medical management with respect to patient-relevant outcomes in the short and medium term. However, long-term studies still are needed to determine whether antireflux surgery is an equivalent alternative to lifelong medical treatment.

Antibiotics for community-acquired pneumonia in adult outpatients.

BACKGROUND: Lower respiratory tract infection (LRTI) is the third leading cause of death worldwide and the first leading cause of death in low-income countries. Community-acquired pneumonia (CAP) is a common condition that causes a significant disease burden for the community, particularly in children younger than five years, the elderly and immunocompromised people. Antibiotics are the standard treatment for CAP. However, increasing antibiotic use is associated with the development of bacterial resistance and side effects for the patient. Several studies have been published regarding optimal antibiotic treatment for CAP but many of these data address treatments in hospitalised patients. This is an update of our 2009 Cochrane Review and addresses antibiotic therapies for CAP in outpatient settings. OBJECTIVES: To compare the efficacy and safety of different antibiotic treatments for CAP in participants older than 12 years treated in outpatient settings with respect to clinical, radiological and bacteriological outcomes. SEARCH METHODS: We searched CENTRAL (2014, Issue 1), MEDLINE (January 1966 to March week 3, 2014), EMBASE (January 1974 to March 2014), CINAHL (2009 to March 2014), Web of Science (2009 to March 2014) and LILACS (2009 to March 2014). SELECTION CRITERIA: We looked for randomised controlled trials (RCTs), fully published in peer-reviewed journals, of antibiotics versus placebo as well as antibiotics versus another antibiotic for the treatment of CAP in outpatient settings in participants older than 12 years of age. However, we did not find any studies of antibiotics versus placebo. Therefore, this review includes RCTs of one or more antibiotics, which report the diagnostic criteria and describe the clinical outcomes considered for inclusion in this review. DATA COLLECTION AND ANALYSIS: Two review authors (LMB, TJMV) independently assessed study reports in the first publication. In the 2009 update, LMB performed study selection, which was checked by TJMV and MMK. In this 2014 update, two review authors (SP, SM) independently performed and checked study selection. We contacted trial authors to resolve any ambiguities in the study reports. We compiled and analysed the data. We resolved differences between review authors by discussion and consensus. MAIN RESULTS: We included 11 RCTs in this review update (3352 participants older than 12 years with a diagnosis of CAP); 10 RCTs assessed nine antibiotic pairs (3321 participants) and one RCT assessed four antibiotics (31 participants) in people with CAP. The study quality was generally good, with some differences in the extent of the reporting. A variety of clinical, bacteriological and adverse events were reported. Overall, there was no significant difference in the efficacy of the various antibiotics. Studies evaluating clarithromycin and amoxicillin provided only descriptive data regarding the primary outcome. Though the majority of adverse events were similar between all antibiotics, nemonoxacin demonstrated higher gastrointestinal and nervous system adverse events when compared to levofloxacin, while cethromycin demonstrated significantly more nervous system side effects, especially dysgeusia, when compared to clarithromycin. Similarly, high-dose amoxicillin (1 g three times a day) was associated with higher incidence of gastritis and diarrhoea compared to clarithromycin, azithromycin and levofloxacin. AUTHORS' CONCLUSIONS: Available evidence from recent RCTs is insufficient to make new evidence-based recommendations for the choice of antibiotic to be used for the treatment of CAP in outpatient settings. Pooling of study data was limited by the very low number of studies assessing the same antibiotic pairs. Individual study results do not reveal significant differences in efficacy between various antibiotics and antibiotic groups. However, two studies did find significantly more adverse events with use of cethromycin as compared to clarithromycin and nemonoxacin when compared to levofloxacin. Multi-drug comparisons using similar administration schedules are needed to provide the evidence necessary for practice recommendations. Further studies focusing on diagnosis, management, cost-effectiveness and misuse of antibiotics in CAP and LRTI are warranted in high-, middle- and low-income countries.

Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices.

BACKGROUND: Uncomplicated urinary tract infections (UTI) are usually treated with antibiotics as recommended by primary care guidelines. Antibiotic treatment supports clinical cure in individual patients but also leads to emerging resistance rates in the population. We designed a comparative effectiveness study to investigate whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen, reserving antibiotic treatment to patients who return due to ongoing or recurrent symptoms. METHODS/DESIGN: This is a randomized-controlled, double-blind, double dummy multicentre trial assessing the comparative effectiveness of immediate vs. conditional antibiotic therapy in uncomplicated UTI. Women > 18 and < 65 years, presenting at general practices with at least one of the typical symptoms dysuria or frequency/urgency of micturition, will be screened and enrolled into the trial. During an 18- months recruitment period, a total of 494 patients will have to be recruited in 45 general practices in Lower Saxony. Participating patients receive either immediate antibiotic therapy with fosfomycin-trometamol 1x3g or initial symptomatic treatment with ibuprofen 3x400mg for 3 days. The ibuprofen group will be provided with antibiotic therapy only if needed, i.e. for persistent or worsening symptoms. For a combined primary endpoint, we choose the number of all antibiotic prescriptions regardless of the medical indication day 0-28 and the "disease burden", defined as a weighted sum of the daily total symptom scores from day 0 to day 7. The study is considered positive if superiority of conditional antibiotic treatment with respect to the first primary endpoint and non-inferiority of conditional antibiotic treatment with respect to the second primary endpoint is proven. DISCUSSION: This study aims at investigating whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen. The comparative effectiveness design was chosen to prove the effectiveness of two therapeutic strategies instead of the pure drug efficacy.

Recommendations for the Outpatient Drug Treatment of Patients With COVID-19.

BACKGROUND: One of the purposes of outpatient treatment for COVID-19 patients is to prevent severe disease courses and hospitalization. There is a need for evidence-based recommendations to be applied in primary care and specialized outpatient settings. METHODS: This guideline was developed on the basis of publications that were retrieved by a systematic search for randomized controlled trials in the Cochrane COVID-19 trial registry. The quality of evidence was assessed with GRADE, and structured consensus generation was carried out with MAGICapp. RESULTS: Unvaccinated COVID-19 outpatients with at least one risk factor for a severe disease course may be treated in the early phase of the disease with sotrovimab, remdesivir, or nirmatrelvir/ritonavir. Molnupiravir may also be used for such patients if no other clinically appropriate treatment options are available. Immunosuppressed persons with COVID-19 who are at high risk, and whose response to vaccination is expected to be reduced, ought to be treated with sotrovimab. It should be noted, however, that the clinical efficacy of sotrovimab against infections with the omicron subtype BA.2 is uncertain at the currently used dose, as the drug has displayed reduced activity against this subtype in vitro. COVID-19 patients at risk of a severe course may be offered budesonide inhalation, according to an off-label recommendation of the German College of General Practitioners and Family Physicians (other medical societies do not recommend either for or against this treatment). Thrombo - embolism prophylaxis with low-molecular-weight heparin may be given to elderly patients or those with a pre-existing illness. No recommendation is made concerning fluvoxamine or colchicine. Acetylsalicylic acid, azithromycin, ivermectin, systemic steroids, and vitamin D should not be used for the outpatient treatment of COVID-19. CONCLUSION: Drug treatment is now available for outpatients with COVID-19 in the early phase. Nearly all of the relevant trials have been conducted in unvaccinated subjects; this needs to be kept in mind in patient selection.

The association between a journal's source of revenue and the drug recommendations made in the articles it publishes.

BACKGROUND: There is evidence to suggest that pharmaceutical companies influence the publication and content of research papers. Most German physicians rely on journals for their continuing medical education. We studied the influence of pharmaceutical advertising on the drug recommendations made in articles published in 11 German journals that focus on continuing medical education. METHODS: We conducted a cross-sectional study of all of the issues of 11 journals published in 2007. Only journals frequently read by general practitioners were chosen. Issues were screened for pharmaceutical advertisements and recommendations made in the editorial content for a specified selection of drugs. Each journal was rated on a five-point scale according to the strength with which it either recommended or discouraged the use of these drugs. We looked for differences in these ratings between free journals (i.e., those financed entirely by pharmaceutical advertising), journals with mixed sources of revenue and journals financed solely by subscription fees. The journals were also screened for the simultaneous appearance of advertisements and recommendations for the same drug within a certain period, which was adjusted for both journal and class of drug. RESULTS: We identified 313 issues containing at least one advertisement for the selected drugs and 412 articles in which drug recommendations were made. Free journals were more likely to recommend the specified drugs than journals with sources of revenue that were mixed or based solely on subscriptions. The simultaneous appearance of advertisements and recommendations for the same drug in the same issue of a journal showed an inconsistent association. INTERPRETATION: Free journals almost exclusively recommended the use of the specified drugs, whereas journals financed entirely with subscription fees tended to recommend against the use of the same drugs. Doctors should be aware of this bias in their use of material published in medical journals that focus on continuing medical education.

Sensitivity to change of the Neck Pain and Disability Scale.

The Neck Pain and Disability Scale (NPAD) is a 20-item instrument to measure neck pain and related disability. The aim of this study was to assess sensitivity to change of the NPAD. A total of 411 participants from 15 general practices in the middle of Germany completed a multidimensional questionnaire including the German version of the NPAD and self-reported demographic and clinical information. Sensitivity to change was analysed by linear regression analysis of the NPAD at follow-up and educational level, age class, depression, anxiety, and deficits in social support, respectively, and by Pearson's correlation analyses between mean change in NPAD at follow-up and mean change in prognostic markers. Those having more than basic education (regression coefficient -7.2, p < 0.001) and/or being in a younger age class (-2.9, p = 0.020) consistently reported significantly lower average NPAD scores at follow-up compared to those with basic education and/or a older age class. In contrast, those who were classified to be depressed (regression coefficient 2.1, p < 0.001), anxious (1.9, p < 0.001), or having deficits in social support (5.5, p = 0.004) reported significantly higher NPAD scores. Change in depression, anxiety, and social support scale between baseline and follow-up was significantly correlated with change in the NPAD score. Hence, these data are in the direction anticipated across all baseline factors investigated. In conclusion, the NPAD seems to be a sensitive measure for use in clinical practice and future studies of neck pain and related disability.

Serum levels of interleukin-6 and interleukin-10 in relation to depression scores in patients with cardiovascular risk factors.

It is currently unknown whether elevated cytokine levels in depression are confined to any specific subgroup of depressive patients. In this study, medical out-patients presenting with cardiovascular risk factors (N = 356) were assessed for both cognitive-affective and physical symptoms of depression using the Hospital Anxiety and Depression Scale (HADS) and the Maastricht questionnaire (MQ), respectively. In study participants assigned to the highest (≥21) and lowest (≤5) quartile for the MQ score, serum levels of cytokines were measured. We found highly significant associations between cognitive-affective symptoms of depression and elevated serum levels of interleukin-6 (IL-6; ρ = .231; p = .002) and interleukin-10 (IL-10; ρ = .370; p < .001), respectively. In multiple regression models elevated IL-10 serum concentration was independently related to cognitive-affective symptoms of depression (ρ = .165; p = .002). When all cytokines were included in one model, elevated IL-10 serum concentrations remained a significant predictor for depressive mood (ρ = .157; p = .009). In patients with cardiovascular risk factors and extreme scores for vital exhaustion, elevated serum IL-6 and even more IL-10 concentrations are linked to the presence of depressive mood. Future studies will have to test whether the so far unreported association of IL-10 with depressive mood represents a causal pathway involved in the pathogenesis or in the prognostic effect of depressive mood in cardiac patients.

Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection?--results of a randomized controlled pilot trial.

BACKGROUND: Uncomplicated lower urinary tract infections (UTI) are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options.This pilot study was set out 1) to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2) to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. METHODS: We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 x 400 mg oral or ciprofloxacin 2 x 250 mg (+1 placebo) oral, both for three days.Intensity of main symptoms--dysuria, frequency, low abdominal pain--was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none) to 4 (very strong). The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms), symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. RESULTS: Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39). On Day 4, 21/36 (58.3%) of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5%) in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42) than ciprofloxacin patients (1,3; SD 1,9), difference -0,33 (95% CI (-1,13 to +0,47)), PP (per protocol) analysis. During Days 0 and 9, 12/36 (33%) of patients in the ibuprofen-group received secondary antibiotic treatment due to ongoing or worsening symptoms, compared to 6/33 (18%) in the ciprofloxacin-group (non significant). A total of 58 non-serious adverse events were reported, 32 in the ibuprofen group versus 26 in the ciprofloxacin group (non significant). CONCLUSIONS: Our results support the assumption of non-inferiority of ibuprofen compared to ciprofloxacin for treatment of symptomatic uncomplicated UTI, but need confirmation by further trials. TRIAL REGISTRATION NUMBER: ISRCTN00470468. See Commentary http://www.biomedcentral.com/1471-2296/11/42.

Elevated serum levels of interleukin-10 and tumor necrosis factor α [corrected] are both associated with vital exhaustion in patients with cardiovascular risk factors.

BACKGROUND: Vital exhaustion, a psychological state characterized by unusual fatigue, irritability, and feelings of demoralization, has been identified as a risk factor for cardiovascular diseases and linked to elevated levels of pro-inflammatory cytokines. OBJECTIVE: The purpose of this study was to investigate the relationship between vital exhaustion and cytokine levels in patients with cardiovascular risk factors. METHOD: The entire cohort consisted of 356 primary-care patients with cardiovascular risk factors who participated in a study of early recognition of heart failure. All participants completed the Maastricht questionnaire (MQ) for assessing vital exhaustion. Cytokine serum levels were measured in all those subjects (N=178) who were assigned to the highest and lowest quartiles of the MQ, respectively. RESULTS: We found that elevated serum concentrations of IL-6, TNFα, and IL-10, but not IL-1ß or natriuretic peptides were associated with high MQ scores indicative of vital exhaustion. Using logistic regression analyses controlling for clinical variables and Type D personality, both TNFα (multivariate odds ratio [OR] =1.86; 95%-confidence interval [CI] =1.30-2.68; p=0.001) and IL-10(OR=1.62; 95%-CI=1.15-2.28; p=0.006), but not other cytokines significantly predicted vital exhaustion independently of other clinical and laboratory parameters examined [corrected]. CONCLUSION: The subjective state of vital exhaustion is linked to a substantial alteration in the pattern of secreted cytokines. Data suggest that a disturbance in the levels of both pro-inflammatory and anti-inflammatory mediators, rather than isolated stimulation by pro-inflammatory cytokines, is associated with the mental and physical changes of vital exhaustion.

Appropriateness of treatment recommendations for PPI in hospital discharge letters.

PURPOSE: The reasons for the dramatic increase in proton pump inhibitors (PPI) prescriptions remain unclear and cannot be explained solely by increased morbidity, new indications or a decrease in alternative medication. Inappropriate use and discharge recommendations in hospitals are considered to be possible explanations. As the quality of PPI recommendations in hospital discharge letters in Germany has not been investigated to date, we have studied the appropriateness of these referrals. METHODS: Hospital discharge letters with recommendations for PPI medication from 35 primary care practices in the county of Mecklenburg-Western Pomerania (MV; North-east Germany) were collected and analysed, and the appropriateness of the PPI indication was rated. RESULTS: No information justifying the recommendation for continuous PPI medication could be identified in 54.5% of the discharge letters; in 12.7%, the indication was uncertain, and in 32.7%, we found an evidence-based indication for PPI medication. The most common indication for adequate PPI use was nonsteroidal anti-inflammatory drug-prophylaxis in high-risk patients. CONCLUSIONS: Inadequate recommendations for PPIs in discharge letters are frequent. This may lead to a continuation of this therapy in primary care, thereby unnecessarily increasing polypharmacy and the risk of adverse events as well as burdening the public health budget. Hospitals should therefore critically review recommendations for PPI medication and the dosage thereof in their discharge letters and clearly document the reason for PPI use and the need for continuous prescription in primary care.

Feasibility and acceptance of electronic quality of life assessment in general practice: an implementation study.

BACKGROUND: Patients' health related quality of life (HRQoL) has rarely been systematically monitored in general practice. Electronic tools and practice training might facilitate the routine application of HRQoL questionnaires. Thorough piloting of innovative procedures is strongly recommended before the conduction of large-scale studies. Therefore, we aimed to assess i) the feasibility and acceptance of HRQoL assessment using tablet computers in general practice, ii) the perceived practical utility of HRQoL results and iii) to identify possible barriers hindering wider application of this approach. METHODS: Two HRQoL questionnaires (St. George's Respiratory Questionnaire SGRQ and EORTC QLQ-C30) were electronically presented on portable tablet computers. Wireless network (WLAN) integration into practice computer systems of 14 German general practices with varying infrastructure allowed automatic data exchange and the generation of a printout or a PDF file. General practitioners (GPs) and practice assistants were trained in a 1-hour course, after which they could invite patients with chronic diseases to fill in the electronic questionnaire during their waiting time. We surveyed patients, practice assistants and GPs regarding their acceptance of this tool in semi-structured telephone interviews. The number of assessments, HRQoL results and interview responses were analysed using quantitative and qualitative methods. RESULTS: Over the course of 1 year, 523 patients filled in the electronic questionnaires (1-5 times; 664 total assessments). On average, results showed specific HRQoL impairments, e.g. with respect to fatigue, pain and sleep disturbances. The number of electronic assessments varied substantially between practices. A total of 280 patients, 27 practice assistants and 17 GPs participated in the telephone interviews. Almost all GPs (16/17 = 94%; 95% CI = 73-99%), most practice assistants (19/27 = 70%; 95% CI = 50-86%) and the majority of patients (240/280 = 86%; 95% CI = 82-91%) indicated that they would welcome the use of electronic HRQoL questionnaires in the future. GPs mentioned availability of local health services (e.g. supportive, physiotherapy) (mean: 9.4 +/- 1.0 SD; scale: 1 - 10), sufficient extra time (8.9 +/- 1.5) and easy interpretation of HRQoL results (8.6 +/- 1.6) as the most important prerequisites for their use. They believed HRQoL assessment facilitated both communication and follow up of patients' conditions. Practice assistants emphasised that this process demonstrated an extra commitment to patient centred care; patients viewed it as a tool, which contributed to the physicians' understanding of their personal condition and circumstances. CONCLUSION: This pilot study indicates that electronic HRQoL assessment is technically feasible in general practices. It can provide clinically significant information, which can either be used in the consultation for routine care, or for research purposes. While GPs, practice assistants and patients were generally positive about the electronic procedure, several barriers (e.g. practices' lack of time and routine in HRQoL assessment) need to be overcome to enable broader application of electronic questionnaires in every day medical practice.

Antibiotics for community acquired pneumonia in adult outpatients.

BACKGROUND: Community-acquired pneumonia (CAP), the sixth most common cause of death worldwide, is a common condition representing a significant disease burden for the community, particularly in the elderly. Antibiotics are helpful in treating CAP and are the standard treatment. CAP contributes significantly to antibiotic use, which is associated with the development of bacterial resistance and side-effects. Several studies have been published concerning treatment for CAP. Available data arises mainly hospitalized patients studies. This is an update of our 2004 Cochrane Review. OBJECTIVES: To summarize current evidence from randomized controlled trials (RCTs) concerning the efficacy of different antibiotic treatments for CAP in participants older than 12. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2009, issue 1) which contains the Cochrane Acute Respiratory Infections Group's Specialized Register; MEDLINE (January 1966 to February week 2, 2009), and EMBASE (January 1974 to February 2009). SELECTION CRITERIA: RCTs in which one or more antibiotics were tested for the treatment of CAP in ambulatory adolescents or adults. Studies testing one or more antibiotics and reporting the diagnostic criteria as well as the clinical outcomes achieved, were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors (LMB, TJMV) independently assessed study reports in the first publication. In this update, LMB performed study selection, which was checked by TJMV and MMK. Study authors were contacted to resolve any ambiguities in the study reports. Data were compiled and analyzed. Differences between review authors were resolved by discussion and consensus. MAIN RESULTS: Six RCTs assessing five antibiotic pairs (1857 participants aged 12 years and older diagnosed with CAP) were included. The study quality was generally good, with some differences in the extent of the reporting. A variety of clinical, radiological and bacteriological diagnostic criteria and outcomes were reported. Overall, there was no significant difference in the efficacy of the various antibiotics. AUTHORS' CONCLUSIONS: Currently available evidence from RCTs is insufficient to make evidence-based recommendations for the choice of antibiotic to be used for the treatment of CAP in ambulatory patients. Pooling of study data was limited by the very low number of studies assessing the same antibiotic pairs. Individual study results do not reveal significant differences in efficacy between various antibiotics and antibiotic groups. Multi-drug comparisons using similar administration schedules are needed to provide the evidence necessary for practice recommendations.

Depression and anxiety as major determinants of neck pain: a cross-sectional study in general practice.

BACKGROUND: Although psychosocial factors are known to be highly linked with neck pain, current therapies focus on somatically based interventions such as medicinal or manipulatory therapies. This study examines how socio-demographic, psychosocial and medical history and health-promoting lifestyle factors interact with neck pain in general practice patients. METHODS: This is a cross-sectional survey including 448 patients from a general practice setting in Germany. Participants completed a comprehensive questionnaire including the Neck Pain and Disability Scale German version (NPAD-d) and the Hospital Anxiety and Depression Scale. Crude and adjusted regression analyses were done to assess the relationship between neck pain and socio-demographic, psychosocial and medical history and health-promoting lifestyle factors. RESULTS: Both in crude and adjusted regression analyses, depression and anxiety were highly significantly linked with increasing levels of neck pain. Educational level, deficits in social support and physical exercise were associated with neck pain in bivariate analyses, but these associations did not persist with adjustment for depression and anxiety. When investigating levels of depression and anxiety by NPAD-d quartile subgroups, those who were identified to have depressive mood or to be anxious were very likely to be in the group with the highest levels of neck pain. CONCLUSION: The higher the neck pain level, the more attention should be paid to psychosocial distress as a related burden. Further research is needed to elucidate the causality and the direction of the association between psychosocial distress and neck pain and to determine the benefit of psychosocial interventions.

Student evaluation of a primary care clerkship: quality assurance and identification of potential for improvement.

BACKGROUND: In Germany, like many other countries, general practice clerkships have only recently become mandatory during medical education. The biggest challenges for the organisation of such clerkships are achieving a minimum level of standardisation, and developing and maintaining a system of quality assurance. The aim of this study is to assess the instructional quality in teaching practices using a benchmark system. METHODS: Before commencing, students anonymously assessed the importance of core aspects of the mandatory primary care clerkship. After the clerkship, they evaluated learning opportunities and teaching performance. Based on this data, a benchmark system was developed to identify areas of strength and weakness for all practices as well as individual teaching practices. RESULTS: A total of 695 students evaluated 97 general practices belonging to a teaching network. Prior to the clerkship, most students considered recognition of frequent diseases (85%) and communication skills (65%) the most important learning goals. After the clerkship, nearly 90% of students confirmed that the general practitioner (GP) was good or excellent at teaching these two goals but only two-thirds thought the GP's teaching performance good or excellent in preventive medicine and screening. In an exemplary analysis, we identified the 2 best and the 2 worst practices that consistently received scores far above or below average, respectively. CONCLUSION: We were able to identify areas of weakness in teaching and identified specific GPs who did not meet the students' needs and expectations. This evaluation seems to be a useful quality assurance tool to identify the potential for improvement and faculty development.

Family practitioners' diagnostic decision-making processes regarding patients with respiratory tract infections: an observational study.

BACKGROUND: The influence of patient characteristics on family practitioners' (FPs') diagnostic decision making has mainly been investigated using indirect methods such as vignettes or questionnaires. Direct observation-borrowed from social and cultural anthropology-may be an alternative method for describing FPs' real-life behavior and may help in gaining insight into how FPs diagnose respiratory tract infections, which are frequent in primary care. OBJECTIVE: To clarify FPs' diagnostic processes when treating patients suffering from symptoms of respiratory tract infection. METHODS: This direct observation study was performed in 30 family practices using a checklist for patient complaints, history taking, physical examination, and diagnoses. The influence of patients' symptoms and complaints on the FPs' physical examination and diagnosis was calculated by logistic regression analyses. Dummy variables based on combinations of symptoms and complaints were constructed and tested against saturated (full) and backward regression models. RESULTS: In total, 273 patients (median age 37 years, 51% women) were included. The median number of symptoms described was 4 per patient, and most information was provided at the patients' own initiative. Multiple logistic regression analysis showed a strong association between patients' complaints and the physical examination. Frequent diagnoses were upper respiratory tract infection (URTI)/common cold (43%), bronchitis (26%), sinusitis (12%), and tonsillitis (11%). There were no significant statistical differences between "simple heuristic'' models and saturated regression models in the diagnoses of bronchitis, sinusitis, and tonsillitis, indicating that simple heuristics are probably used by the FPs, whereas "URTI/common cold'' was better explained by the full model. CONCLUSION: FPs tended to make their diagnosis based on a few patient symptoms and a limited physical examination. Simple heuristic models were almost as powerful in explaining most diagnoses as saturated models. Direct observation allowed for the study of decision making under real conditions, yielding both quantitative data and "qualitative'' information about the FPs' performance. It is important for investigators to be aware of the specific disadvantages of the method (e.g., a possible observer effect).

Simply no time? Barriers to GPs' participation in primary health care research.

BACKGROUND: Non-participation of general practitioners (GPs) is a serious source of bias for practice-based studies. Objective. To elucidate doctors' motives for non-participation in, and subjective barriers to, general practice research. METHODS: German GPs that had opted out of a quality assessment project involving electronic patient records (EPRs) were mailed a questionnaire regarding their attitudes towards general practice research and their specific objections to the current project. A sub-sample of doctors was interviewed. Their statements were coded and classified with regard to the reasons given for non-participation and possible motivating factors. RESULTS: The survey response rate was 37% (96/263); 21 GPs completed an additional qualitative interview. Nearly all respondents (88/96) considered general practice research to be important, but 58% had not previously participated in research projects and 56% would not do so in the future. Nearly half (47/96) were opposed to having data extracted from their EPRs. The qualitative analysis revealed deep concerns related to the collection of EPRs (e.g. potential misuse of data, being subject to control or resulting computer problems). Some GPs expressed concerns about recruiting their own patients for the study. Some doctors complained of not being sufficiently recognized as a partner or not having a voice in the research process. CONCLUSION: Doctors' negative attitudes, concerns and ambivalent feelings should be addressed in recruitment strategies, especially when the analysis of EPRs or direct patient contact is required. Some doctors do not participate in research out of principle and will be very difficult to convince.

TTM-based motivational counselling does not increase physical activity of low back pain patients in a primary care setting--A cluster-randomized controlled trial.

OBJECTIVE: To investigate the effectiveness of a TTM-based motivational counselling approach by trained practice nurses to promote physical activity of low back pain patients in a German primary care setting. METHODS: Data were collected in a cluster-randomized controlled trial with three study arms via questionnaires and patient interviews at baseline and after 6 and 12 months. We analysed total physical activity and self-efficacy by using random effect models to allow for clustering. RESULTS: A total of 1378 low back pain patients, many with acute symptoms, were included in the study. Nearly 40% of all patients reported sufficient physical activity at baseline. While there were significant improvements in patients' physical activity behaviour in all study arms, there was no evidence for an intervention effect. CONCLUSION: The outcome may be explained by insufficient performance of the practice nurses, implementation barriers caused by the German health care system and the heterogenous sample. PRACTICE IMPLICATIONS: Given the objective to incorporate practice nurses into patient education, there is a need for a better basic training of the nurses and for a change towards an organizational structure that facilitates patient-nurse communication. Counselling for low back pain patients has to consider more specificated aims for different subgroups.

Psychometric properties of a German version of the neck pain and disability scale.

The aim of this study is to evaluate the validity and the psychometric properties of a German version of the 20-item neck pain and disability scale (NPAD) for use in primary care settings. Four hundred and forty-eight participants from 15 general practices in the area of Göttingen Germany completed a multidimensional questionnaire including a newly developed German version of the NPAD (NPAD-d) and self-reported demographic and clinical information. Reliability was tested using Cronbach's alpha. Item-to-total score correlations were analysed. Factor structure was explored by using unrestricted principal factor analysis. Construct validity of the NPAD-d was evaluated by simple correlation analyses (Pearson's rho) with social and clinical characteristics. The discriminative abilities of the NPAD-d were examined by comparing differences between subgroups stratified on non-NPAD-d pain related characteristics using t tests for mean scores. Cronbach's alpha of NPAD-d was 0.94. Item-to-total scale correlations ranged between 0.414 and 0.829. Exploratory principal factor analysis indicated that the NPAD-d covers one factor with an explained variance of 48%. Correlation analysis showed high correlations with criterion variables. The NAPD-d scores of subgroups of patients were significantly different showing good discriminative validity of the scale. The NPAD-d demonstrated good validity and reliability in this general practice setting. The NPAD-d may be useful in the clinical assessment process and the management of neck pain.

Natriuretic peptide vs. clinical information for diagnosis of left ventricular systolic dysfunction in primary care.

BACKGROUND: Screening of primary care patients at risk for left ventricular systolic dysfunction by a simple blood-test might reduce referral rates for echocardiography. Whether or not natriuretic peptide testing is a useful and cost-effective diagnostic instrument in primary care settings, however, is still a matter of debate. METHODS: N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, clinical information, and echocardiographic data of left ventricular systolic function were collected in 542 family practice patients with at least one cardiovascular risk factor. We determined the diagnostic power of the NT-proBNP assessment in ruling out left ventricular systolic dysfunction and compared it to a risk score derived from a logistic regression model of easily acquired clinical information. RESULTS: 23 of 542 patients showed left ventricular systolic dysfunction. Both NT-proBNP and the clinical risk score consisting of dyspnea at exertion and ankle swelling, coronary artery disease and diuretic treatment showed excellent diagnostic power for ruling out left ventricular systolic dysfunction. AUC of NT-proBNP was 0.83 (95% CI, 0.75 to 0.92) with a sensitivity of 0.91 (95% CI, 0.71 to 0.98) and a specificity of 0.46 (95% CI, 0.41 to 0.50). AUC of the clinical risk score was 0.85 (95% CI, 0.79 to 0.91) with a sensitivity of 0.91 (95% CI, 0.71 to 0.98) and a specificity of 0.64 (95% CI, 0.59 to 0.67). 148 misclassifications using NT-proBNP and 55 using the clinical risk score revealed a significant difference (McNemar test; p < 0.001) that was based on the higher specificity of the clinical risk score. CONCLUSION: The evaluation of clinical information is at least as effective as NT-proBNP testing in ruling out left ventricular systolic dysfunction in family practice patients at risk. If these results are confirmed in larger cohorts and in different samples, family physicians should be encouraged to rely on the diagnostic power of the clinical information from their patients.