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

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

[Examining in General Practice: Licensure Examinations in a General Practice Setting]. / Prüfen in der Allgemeinmedizin ­ Staatsexamina im ambulanten hausärztlichen Setting.

General practitioners play a major role in the health care of the population. Only a small proportion of patients receives care from specialised consultants, in a hospital or in a university hospital. Most of the patients consult a general practitioner. The strengthening of general practice that is called for in the Master Plan for Medical Studies 2020 in new state examination formats, for instance, means that this central position in patient care will be reflected in studies and examinations in the future. The general medical setting is subject to a specific background with unselected patients and a hermeneutic understanding of cases. The format of the new final examination promotes general medical and interdisciplinary competencies in medical interviewing, physical examination, dealing with diseases that can be treated on an outpatient basis, prevention, and the application of general medical guidelines of ethics and law. The standardised oral-practical examination has newly been designed by the Institute for Medical and Pharmaceutical Examination Questions (IMPP). It includes real patients in an outpatient setting. In eight steps, it integrates communicative and technical examination aspects. Two trained examiners will observe and assess the performance of graduates using standardised evaluation forms. The new examination format was developed in 2019 by the IMPP and faculty from various medical schools, was tested in five general medical teaching practices, revised, and then piloted in fourteen examinations. Standardised specifications for the examination process, spatial equipment, and examiner training were developed by IMPP. With approximately 10,000 examinees per year and two students per examination day, a total of 5,000 examination days will be required in general practices. The expertise of the German College of General Practicioners and Family Physicians (DEGAM), the Society of University Teachers of General Medicine (GHA), and the university locations, together with the great potential as the largest specialist group in Germany suggest that the goal of recruiting and motivation of practices appears achievable. With regard to funding, political decisions are necessary. In an increasingly complex care system, the redesign of the oral-practical examination in the outpatient setting contributes to strengthening interdisciplinary and multi-professional cooperation.

Prescription of Benzodiazepines and Related Drugs in Patients with Mild Cognitive Deficits and Alzheimer's Disease.

INTRODUCTION: Benzodiazepines and related drugs (BZDR) should be avoided in patients with cognitive impairment. We evaluated the relationship between a BZDR treatment and the health status of patients with Alzheimer's disease (AD). METHODS: Cross-sectional study in 395 AD patients using bivariate and multiple logistic analyses to assess correlations between the prescription of BZDR and patients' characteristics (cognitive and functional capacity, health-related quality of life (HrQoL), neuropsychiatric symptoms). RESULTS: BZDR were used in 12.4% (n=49) of all participants. In bivariate analyses, the prescription was associated with a lower HrQoL, a higher need of care, and the presence of anxiety. Multivariate models revealed a higher risk of BZDR treatment in patients with depression (OR 3.85, 95% CI: 1.45 - 10.27). Community-dwelling participants and those treated by neurologists/psychiatrists had a lower risk of receiving BZDR (OR 0.33, 95% CI: 0.12 - 0.89 and OR 0.16, 95% CI: 0.07 - 0.36). DISCUSSION: The inappropriate use of BZDR conflicts with national and international guidelines. We suggest evaluating indications and treatment duration and improving the knowledge of alternative therapies in healthcare institutions.

Antidepressant medication in a German cohort of patients with Alzheimer's disease
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OBJECTIVE: The use of antidepressant drugs in dementia patients is associated with the risk of adverse events, and the evidence for relevant effects is scarce. We aimed to determine the associations between the prescription of antidepressants and patients' sociodemographic (e.g., age, gender, living situation) and clinical characteristics (e.g., disease severity, neuropsychiatric symptoms). MATERIALS AND METHODS: We included 395 institutionalized and community-dwelling patients with Alzheimer's disease (AD) across all severity stages of dementia in a cross-sectional study design. The patients' clinical characteristics comprised of cognitive status, daily activities, depressive symptoms, further neuropsychiatric symptoms, and health-related quality of life (HrQoL). We conducted multiple logistic regression analyses for the association between the use of antidepressant drugs and the covariates. RESULTS: Approximately 31% of the participants were treated with antidepressant drugs, with a higher chance of being medicated for institutionalized patients (χ2-test: p = 0.010). In the bivariate analyses, the use of antidepressants was significantly associated with higher levels of care, lower cognitive and daily life capacity, higher extent of neuropsychiatric symptoms, and a lower proxy-reported HrQoL. Finally, multiple logistic regression models showed a significantly higher use of antidepressants in patients treated by psychiatrists and neurologists (OR 2.852, 95% CI: 1.223 - 6.652). CONCLUSION: The use of antidepressant drugs in the study population was high, and the suitability of the treatment with antidepressants remains unclear. Participants with diminished cognitive and functional capacity, higher extent of neuropsychiatric symptoms, and those treated by neuropsychiatric specialists were more likely to be treated with antidepressants. The pharmaceutical treatment of patients with these clinical characteristics should be particularly considered in the daily care for dementia patients. Further longitudinal studies should evaluate the appropriateness of indications for antidepressants and the causative direction of correlations with the patients' clinical characteristics.
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Antipsychotic treatment of community-dwelling and institutionalised patients with dementia in Germany.

OBJECTIVE: A restrictive use of antipsychotic drugs in patients with Alzheimer's disease (AD) is recommended due to an increased risk of cerebrovascular events and mortality. We hypothesise that the prescription of antipsychotics is associated with the patients' socio-demographic and clinical status (e.g., dementia severity). METHODS: The prescription of antipsychotics was cross-sectionally evaluated in 272 community-dwelling and 123 institutionalised patients with AD across all severity stages of dementia. The patients' clinical characteristics covered the cognitive status, neuropsychiatric symptoms, daily activities, and quality of life (HrQoL). To determine associations with the use of antipsychotics bivariate and logistic regression analyses were conducted. RESULTS: Totally, 25% of the patients were treated with antipsychotics. significantly less frequently than nursing home inhabitants (15.1% vs. 45.5%). Severely demented patients (MMSE 0-9) received antipsychotics most often (51.5%). Additionally, multiple regression analyses revealed a higher chance of prescription for participants with depressive symptoms (OR 2.3, 95% CI: 1.019-5.160) and those treated by neuropsychiatric specialists (OR 3.4, 95% CI: 1.408-8.328). CONCLUSIONS: Further longitudinal studies are required to assess the appropriateness of indications for antipsychotics and the reasons for a higher use in nursing home inhabitants and patients with severe dementia and depression.

Psychological risk and protective factors for disability in chronic low back pain - a longitudinal analysis in primary care.

BACKGROUND: Utilizing psychological resources when dealing with chronic low back pain might aid the prevention of disability. The observational study at hand examined the longitudinal impact of resilience and coping resources on disability in addition to established risk factors. METHODS: Four hundred eighty four patients with chronic low back pain (>3 months) were recruited in primary care practices and followed up for one year. Resilience, coping, depression, somatization, pain and demographic variables were measured at baseline. At follow-up (participation rate 89%), data on disability was collected. We first calculated bivariate correlations of all the predictors with each other and with follow-up disability. We then used a multiple regression to evaluate the impact of all the predictors on disability together. RESULTS: More than half of the followed up sample showed a high degree of disability at baseline (53.7%) and had suffered for more than 10 years from pain (50.4%). Besides gender all of the predictors were bivariately associated with follow-up disability. However in the main analysis (multiple regression), disability at follow up was only predicted by baseline disability, age and somatization. There was no relationship between resilience and disability, nor between coping resources and disability. CONCLUSIONS: Although it is known that there are cross-sectional relationships between resilience/coping resources and disability we were not able to replicate it in the multiple regression. This can have several reasons: a) the majority of patients in our sample were much more disabled and suffered for a longer time than in other studies. Therefore our results might be limited to this specific population and resilience and coping resources might still have a protective influence in acute or subacute populations. b) We used a rather broad operationalization of resilience. There is emerging evidence that focusing on more concrete sub facets like (pain) self-efficacy and acceptance might be more beneficial. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00003123 (June 28th 2011).

The differential diagnosis of tiredness: a systematic review.

BACKGROUND: Tiredness is one of the most frequent complaints in primary care. Although often self-limiting and frequently associated with psychosocial stress, patients but also their physicians are often uncertain regarding a serious cause and appropriate diagnostic work-up. We conducted a systematic review and meta-analysis of studies reporting on differential diagnosis of fatigue in primary care. METHODS: MEDLINE, EMBASE and conference abstracts were searched for primary care based studies of patients presenting with tiredness. Twenty-six studies were included. We report on anaemia, malignancy, serious organic disease, depression and the chronic fatigue syndrome (CFS) as causes of tiredness as presenting complaint. RESULTS: We found considerable heterogeneity of estimates which was reduced by limiting our analysis to high quality studies. Prevalences were as follows-anaemia: 2.8 % (CI (confidence interval) 1.6-4.8 %); malignancy: 0.6 % (CI 0.3-1.3 %); serious somatic disease: 4.3 % (CI 2.7-6.7 %); depression 18.5 % (CI 16.2-21.0 %). Pooling was not appropriate for CFS. In studies with control groups of patients without the symptom of tiredness, prevalence of somatic disease was identical to those complaining of tiredness. Depression, however, was more frequent among those with tiredness. CONCLUSIONS: Serious somatic disease is rare in patients complaining of tiredness. Since prevalence is similar in patients without tiredness, the association may not be causal. Extensive investigations are only warranted in case of specific findings from the history or clinical examination. Instead, attention should focus on depression and psychosocial problems.

Diagnosing skin disease in primary care: a qualitative study of GPs' approaches.

BACKGROUND: Skin diseases are a common reason for consulting a GP. This regular occurrence happens despite most GPs' lack of knowledge and training in skin disease. OBJECTIVES: We aimed to explore different diagnostic approaches of GPs in patients presenting with a dermatological problem. In addition, we aimed to identify strategies used by GPs to handle diagnostic uncertainty in these patients. METHODS: We conducted interviews (20-40 minutes) with 14 GPs using a semi-structured guideline. Recalling encounters with patients with skin disease, GPs described their individual diagnostic strategies. Interviews were taped and transcribed verbatim. Qualitative analysis was conducted by two independent raters using a deductive-inductive approach. RESULTS: We identified several aspects of a complex decision-making process in GPs' diagnostic management of patients with dermatological problems. In the general diagnostic workup, GPs used a broad spectrum of different strategies such as spot diagnosis, stepwise refinement, pattern recognition trigger or test of treatment. GPs reduced diagnostic uncertainty through the identification of red flags, the application of the test of time, therapeutic trials and asking for further advice, including patient referral. CONCLUSIONS: GPs encounter a broad range of dermatological problems in their daily work using a variety of strategies in the workup of these patients. However, in a significant number of patients, there remains diagnostic uncertainty that is mainly reduced by specialist referral. Regular training in the diagnosis and treatment of common dermatological diseases should be offered to all GPs.

Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis.

BACKGROUND: The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins. METHODS: We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians' prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75,000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients' overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes). RESULTS: There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect. CONCLUSION: Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician's prescribing behaviour is affected by an established health care system, which is not easy to change. TRIAL REGISTRATION: ISRCTN71348772.

Differences between patients with chronic widespread pain and local chronic low back pain in primary care--a comparative cross-sectional analysis.

BACKGROUND: Chronic pain is a common reason for consultation in general practice. Current research distinguishes between chronic localized pain (CLP) and chronic widespread pain (CWP). The aim of this study was to identify differences between CWP and chronic low back pain (CLBP), a common type of CLP, in primary care settings. METHODS: Fifty-eight German general practitioners (GPs) consecutively recruited all eligible patients who consulted for chronic low back pain during a 5-month period. All patients received a questionnaire on sociodemographic data, pain characteristics, comorbidities, psychosomatic symptoms, and previous therapies. RESULTS: GPs recruited 647 eligible patients where of a quarter (n = 163, 25.2%) met the CWP criteria according to the American College of Rheumatology. CWP patients had significantly more comorbidities and psychosomatic symptoms, showed longer pain duration, and suffered predominantly from permanent pain instead of distinguishable pain attacks. CWP patients were more often females, are less working and reported a current pension application or a state-approved grade of disability more frequently. We found no other differences in demographic parameters such as age, nationality, marital status, number of persons in household, education, health insurance status, or in health care utilization data. CONCLUSIONS: This project is the largest study performed to date which analyzes differences between CLBP and CWP in primary care settings. Our results showed that CWP is a frequent and particularly severe pain syndrome. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00003123.

Chronic low back pain patient groups in primary care--a cross sectional cluster analysis.

BACKGROUND: Due to the heterogeneous nature of chronic low back pain (CLBP), it is necessary to identify patient groups and evaluate treatments within these groups. We aimed to identify groups of patients with CLBP in the primary care setting. METHODS: We performed a k-means cluster analysis on a large data set (n = 634) of primary care patients with CLBP. Variables of sociodemographic data, pain characteristics, psychological status (i.e., depression, anxiety, somatization), and the patient resources of resilience and coping strategies were included. RESULTS: We found three clusters that can be characterized as "pensioners with age-associated pain caused by degenerative diseases", "middle-aged patients with high mental distress and poor coping resources", and "middle-aged patients who are less pain-affected and better positioned with regard to their mental health". CONCLUSIONS: Our results supported current knowledge concerning groups of CLBP patients in primary care. In particular, we identified a group that was most disabled and distressed, and which was mainly characterized by psychological variables. As shown in our study, pain-related coping strategies and resilience were low in these patients and might be addressed in differentiating treatment strategies. Future studies should focus on the identification of this group in order to achieve effective treatment allocation. TRIAL REGISTRATION: German Clinical Trial Register DRKS00003123.

Comparison of Web-based and paper-based administration of ADHD questionnaires for adults.

BACKGROUND: Satisfactory psychometric properties in offline questionnaires do not guarantee the same outcome in Web-based versions. Any construct that is measured online should be compared to a paper-based assessment so that the appropriateness of online questionnaire data can be tested. Little research has been done in this area regarding Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. OBJECTIVE: The objective was to simultaneously collect paper-based and Web-based ADHD questionnaire data in adults not diagnosed with ADHD in order to compare the two data sources regarding their equivalence in raw scores, in measures of reliability, and in factorial structures. METHODS: Data from the German versions of the Connors Adult ADHD Rating Scales (CAARS-S), the Wender Utah Rating Scale (WURS-k), and the ADHD Self Rating Scale (ADHS-SB) were collected via online and paper questionnaires in a cross-sectional study with convenience sampling. We performed confirmatory factor analyses to examine the postulated factor structures in both groups separately and multiple group confirmatory factor analyses to test whether the postulated factor structures of the questionnaires were equivalent across groups. With Cronbach alpha, we investigated the internal consistency of the postulated factors in the different questionnaires. Mann-Whitney U tests with the effect size "Probability of Superiority (PS)" were used to compare absolute values in the questionnaires between the two groups. RESULTS: In the paper-based sample, there were 311 subjects (73.3% female); in the online sample, we reached 255 subjects (69% female). The paper-based sample had a mean age of 39.2 years (SD 18.6); the Web-based sample had a mean age of 30.4 years (SD 10.5) and had a higher educational background. The original four factor structure of the CAARS-S could be replicated in both samples, but factor loadings were different. The Web-based sample had significantly higher total scores on three scales. The five-factor structure of the German short form of the WURS-k could be replicated only in the Web-based sample. The Web-based sample had substantially higher total scores, and nearly 40% of the Web-based sample scored above the clinically relevant cut-off value. The three-factor structure of the ADHS-SB could be replicated in both samples, but factor loadings were different. Women in the Web-based sample had substantially higher total scores, and 30% of the Web-based sample scored above the clinically relevant cut-off value. Internal consistencies in all questionnaires were acceptable to high in both groups. CONCLUSIONS: Data from the Web-based administration of ADHD questionnaires for adults should not be used for the extraction of population norms. Separate norms should be established for ADHD online questionnaires. General psychometric properties of ADHD questionnaires (factor structure, internal consistency) were largely unaffected by sampling bias. Extended validity studies of existing ADHD questionnaires should be performed by including subjects with a diagnosis of ADHD and by randomizing them to Web- or paper-based administration.

[Tiredness/Fatigue-S3 guideline update]. / Müdigkeit ­ Update der S3-Leitlinie.

Background: Fatigue is one of the most common reasons for seeking medical counseling in the family medicine (FM), often entailing diagnostic uncertainty. Patients use terms describing emotional, cognitive, physical, and behavioral aspects. A number of biological, mental, and social causes may underlie the symptom of fatigue, often in combination. This guideline describes the procedures to be applied for primary undetermined symptomatology. Methods: The experts involved conducted a systematic search using the terms for fatigue in the context of FM in PubMed, Cochrane Library and via manual search. Concerning related guidelines, the National Institute for Health and Care Excellence (NICE) guideline was used for myalgic encephalitis/chronic fatigue syndrome (ME/CFS). In a structured consensus process, broad approval of the core recommendations/background text of the revised guideline was attained. Most important messages: 1) Alongside gathering information concerning the symptom characteristics, the anamnesis aims to collect information about pre-existing health conditions, sleeping behavior, use of drugs and psychosocial factors. 2) Depression and anxiety as two common causes will be identified based on screening questions. The occurrence of post-exertional malaise (PEM) will be inquired. 3) The following basic diagnostics are recommended: physical examination, laboratory tests (blood glucose, full blood count, blood sedimentation/CRP, transaminases/γ-GT, TSH). 4) Further examinations should be conducted only in case of specific indications. 5) A biopsychosocial approach is to be adopted. 6) Behavioral therapy and symptom-oriented activating measures can improve fatigue in underlying diseases and undetermined fatigue. 7) In case of PEM, further ME/CFS criteria should be collected and patients have to be supervised accordingly.

Associations between demographic, disease related, and treatment pathway related variables and health related quality of life in primary care patients with coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is a common medical problem worldwide that demands shared care of general practitioners and cardiologists for concerned patients. In order to improve the cooperation between both medical specialists and to optimize evidence-based care, a treatment pathway for patients with CHD was developed and evaluated in a feasibility study according to the recommendation for the development and evaluation of complex interventions of the British Medical Research Council (MRC). In the context of this feasibility study the objective of the present research was to investigate the contributions of different disease related (e.g. prior myocardial infarction), pathway related (e.g. basic medication) and demographic variables on patients` perceived health related quality of life (HRQoL) as a relevant and widely used outcome measure in cardiac populations. METHODS: Data assessing demographic, disease and pathway related variables of CHD patients included in the study were collected in a quasi-experimental design with three study arms (pathway developers, users, control group) via case record forms and questionnaires at baseline and after 6 and 12 (intervention groups), and 9 months (control group), respectively after the initial implementation on GP level. Additionally, at the same measuring points the CHD patients participating in the study were interviewed by phone regarding their perceived HRQoL, measured with the EuroQol EQ-5D as an index-based health questionnaire. Due to the hierarchical structure of the data, we performed cross-sectional and longitudinal linear mixed models to investigate the impact of disease related, pathway related and demographic variables on patients` perceived HRQoL. RESULTS: Of 334 initially recruited patients with CHD, a total of 290 were included in our analysis. This was an average 13.2% dropout rate from baseline assessment to the 12-month follow-up. At all assessment points, patients` HRQoL was associated with a variety of sociodemographic variables (e.g. gender, employment, education) in each study group, but there was no association with pathway related variables. In both cross-sectional and longitudinal analyses highest HRQoL values in patients were reported in the physician group that had developed the pathway. In the longitudinal analyses there were no significant changes in the reported HRQoL values of the three groups over time. CONCLUSIONS: The found associations between sociodemographic variables and the perceived HRQoL of patients with CHD are in line with other research. As there are no associations of HRQoL with pathway related variables like the basic medication, possible weaknesses in the study design or the choice of outcome have to be considered before planning and conducting an evaluation study according to the MRC recommendations. Additionally, as patients in the developer group reported the highest HRQoL values over time, a higher commitment of the GPs in the developer group can be assumed and should be considered in further research.

Referral from primary to secondary care in Germany: developing a taxonomy based on cluster analysis.

AIMS: Referrals from primary to secondary care may differ regarding motivation and initiative. Previous research on the frequency and variation of referrals has mostly treated referrals as homogeneous. We intended to develop a taxonomy regarding referrals from primary to secondary care in Germany that could support decision making on a macro level. METHODS: We analyzed 3,988 referrals by 29 German general practitioners (GPs). GPs were asked to document all referrals during one week; in subsequent audits they stated the reasons and initiative for any referral. We postulated the following five referral types: clinical problem, shared care, administrative, patient initiated and shared cost. The data were analyzed with k-means cluster analysis. RESULTS: We identified three of our five postulated referral types with cluster analytic techniques: shared care, clinical problem, and patient initiated. This solution accounted for 11.7% of total variance. The majority of referrals in German primary care practices were initiated by the GP, or they were part of a shared decision with patients. CONCLUSIONS: We suggest a taxonomy of referrals that might offer insights regarding the allocation of resources within the German health system. Referrals might be reduced by improved training of primary care physicians and by giving them more competencies in routine care of chronic patients.

Study protocol: Transition from localized low back pain to chronic widespread pain in general practice: identification of risk factors, preventive factors and key elements for treatment--a cohort study.

BACKGROUND: Chronic localized pain syndromes, especially chronic low back pain (CLBP), are common reasons for consultation in general practice. In some cases chronic localized pain syndromes can appear in combination with chronic widespread pain (CWP). Numerous studies have shown a strong association between CWP and several physical and psychological factors. These studies are population-based cross-sectional and do not allow for assessing chronology. There are very few prospective studies that explore the predictors for the onset of CWP, where the main focus is identifying risk factors for the CWP incidence. Until now there have been no studies focusing on preventive factors keeping patients from developing CWP. Our aim is to perform a cross sectional study on the epidemiology of CLBP and CWP in general practice and to look for distinctive features regarding resources like resilience, self-efficacy and coping strategies. A subsequent cohort study is designed to identify the risk and protective factors of pain generalization (development of CWP) in primary care for CLBP patients. METHODS/DESIGN: Fifty-nine general practitioners recruit consecutively, during a 5 month period, all patients who are consulting their family doctor because of chronic low back pain (where the pain is lasted for 3 months). Patients are asked to fill out a questionnaire on pain anamnesis, pain-perception, co-morbidities, therapy course, medication, socio demographic data and psychosomatic symptoms. We assess resilience, coping resources, stress management and self-efficacy as potential protective factors for pain generalization. Furthermore, we raise risk factors for pain generalization like anxiety, depression, trauma and critical life events. During a twelve months follow up period a cohort of CLBP patients without CWP will be screened on a regular basis (3 monthly) for pain generalization (outcome: incident CWP). DISCUSSION: This cohort study will be the largest study which prospectively analyzes predictors for transition from CLBP to CWP in primary care setting. In contrast to the typically researched risk factors, which increase the probability of pain generalization, this study also focus intensively on protective factors, which decrease the probability of pain generalization. TRIAL REGISTRATION: German Clinical Trial Register DRKS00003123.

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.

Do guidelines on first impression make sense? Implementation of a chest pain guideline in primary care: a systematic evaluation of acceptance and feasibility.

BACKGROUND: Most guidelines concentrate on investigations, treatment, and monitoring instead of patient history and clinical examination. We developed a guideline that dealt with the different aetiologies of chest pain by emphasizing the patient's history and physical signs. The objective of this study was to evaluate the guideline's acceptance and feasibility in the context of a practice test. METHODS: The evaluation study was nested in a diagnostic cross-sectional study with 56 General Practitioners (GPs) and 862 consecutively recruited patients with chest pain. The evaluation of the guideline was conducted in a mixed method design on a sub-sample of 17 GPs and 282 patients. Physicians' evaluation of the guideline was assessed via standardized questionnaires and case record forms. Additionally, practice nursing staff and selected patients were asked for their evaluation of specific guideline modules. Quantitative data was analyzed descriptively for frequencies, means, and standard deviations. In addition, two focus groups with a total of 10 GPs were held to gain further insights in the guideline implementation process. The data analysis and interpretation followed the standards of the qualitative content analysis. RESULTS: The overall evaluation of the GPs participating in the evaluation study regarding the recommendations made in the chest pain guideline was positive. A total of 14 GPs were convinced that there was a need for this kind of guideline and perceived the guideline recommendations as useful. While the long version was partially criticized for a perceived lack of clarity, the short version of the chest pain guideline and the heart score were especially appreciated by the GPs. However, change of clinical behaviour as consequence of the guideline was inconsistent. While on a concrete patient related level, GPs indicated to have behaved as the guideline recommended, the feedback on a more general level was heterogeneous. Several suggestions to improve guideline implementation were made by participating physicians. Due to the small number of practice nursing staff evaluating the flowchart and patients remembering the patient leaflet, no valid results regarding the flowchart and patient leaflet modules could be reported. CONCLUSIONS: Overall, the participating GPs perceived the guideline recommendations as useful to increase awareness and to reflect on diagnostic issues. Although behaviour change in consequence of the guideline was not reported on a general level, guidelines on history taking and the clinical examination may serve an important conservative and practical function in a technology driven environment. Further research to increase the implementation success of the guideline should be undertaken.