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2.  Quality of care in patients with atrial fibrillation in primary care: a cross-sectional study comparing clinical and claims data 
GMS German Medical Science  2016;14:Doc13.
Objectives: Atrial fibrillation (AF) is a common cardiac arrhythmia with increased risk of thromboembolic stroke. Oral anticoagulation (OAC) reduces stroke risk by up to 68%. The aim of our study was to evaluate quality of care in patients with AF in a primary health care setting with a focus on physician guideline adherence for OAC prescription and heart rate- and rhythm management. In a second step we aimed to compare OAC rates based on primary care data with rates based on claims data.
Methods: We included all GP practices in the region Vorpommern-Greifswald, Germany, which were willing to participate (N=29/182, response rate 16%). Claims data was derived from the regional association of statutory health insurance physicians. Patients with a documented AF diagnosis (ICD-10-GM-Code ICD I48.-) from 07/2011–06/2012 were identified using electronic medical records (EMR) and claims data. Stroke and bleeding risk were calculated using the CHA2DS2-VASc and HAS-BLED scores. We calculated crude treatment rates for OAC, rate and rhythm control medications and adjusted OAC treatment rates based on practice and claims data. Adjusted rates were calculated including the CHA2DS2-VASc and HAS-BLED scores and individual factors affecting guideline based treatment.
Results: We identified 927 patients based on EMR and 1,247 patients based on claims data. The crude total OAC treatment rate was 69% based on EMR and 61% based on claims data. The adjusted OAC treatment rates were 90% for patients based on EMR and 63% based on claims data. 82% of the AF patients received a treatment for rate control and 12% a treatment for rhythm control. The most common reasons for non-prescription of OAC were an increased risk of falling, dementia and increased bleeding risk.
Conclusion: Our results suggest that a high rate of AF patients receive a drug therapy according to guidelines. There is a large difference between crude and adjusted OAC treatment rates. This is due to individual contraindications and comorbidities which cannot be documented using ICD coding. Therefore, quality indicators based on crude EMR data or claims data would lead to a systematic underestimation of the quality of care. A possible overtreatment of low-risk patients cannot be ruled out.
doi:10.3205/000240
PMCID: PMC5124766  PMID: 27980520
oral anticoagulation; atrial fibrillation; primary health care; quality of health care; vitamin K antagonists & inhibitors
3.  Systematic Review of Clinical Trials Assessing the Effectiveness of Ivy Leaf (Hedera Helix) for Acute Upper Respiratory Tract Infections 
Introduction. Among nonantibiotic cough remedies, herbal preparations containing extracts from leaves of ivy (Hedera helix) enjoy great popularity. Objective. A systematic review to assess the effectiveness and tolerability of ivy for acute upper respiratory tract infections (URTIs). Methods. We searched for randomized controlled trials (RCTs), nonrandomized controlled clinical trials and observational studies evaluating the efficacy of ivy preparations for acute URTIs. Study quality was assessed by the Jadad score or the EPHPP tool. Results. 10 eligible studies were identified reporting on 17463 subjects. Studies were heterogeneous in design and conduct; 2 were RCTs. Three studies evaluated a combination of ivy and thyme, 7 studies investigated monopreparations of ivy. Only one RCT (n = 360) investigating an ivy/thyme combination used a placebo control and showed statistically significant superiority in reducing the frequency and duration of cough. All other studies lack a placebo control and show serious methodological flaws. They all conclude that ivy extracts are effective for reducing symptoms of URTI. Conclusion. Although all studies report that ivy extracts are effective to reduce symptoms of URTI, there is no convincing evidence due to serious methodological flaws and lack of placebo controls. The combination of ivy and thyme might be more effective but needs confirmation.
doi:10.1155/2011/382789
PMCID: PMC2957147  PMID: 20976077
4.  Undergraduate medical education in Germany 
The purpose of this article is to give international readers an overview of the organisation, structure and curriculum, together with important advances and problems, of undergraduate medical education in Germany. Interest in medical education in Germany has been relatively low but has gained momentum with the new "Regulation of the Licensing of Doctors" which came into effect in 2003. Medical education had required substantial reform, particularly with respect to improving the links between theoretical and clinical teaching and the extension of interdisciplinary and topic-related instruction. It takes six years and three months to complete the curriculum and training is divided into three sections: basic science (2 years), clinical science (3 years) and final clinical year. While the reorganisation of graduate medical education required by the new "Regulation of the Licensing of Doctors" has stimulated multiple excellent teaching projects, there is evidence that some of the stipulated changes have not been implemented. Indeed, whether the medical schools have complied with this regulation and its overall success remains to be assessed systematically. Mandatory external accreditation and periodic reaccreditation of medical faculties need to be established in Germany.
doi:10.3205/000061
PMCID: PMC2716556  PMID: 19675742
undergraduate medical education; Germany; reform
5.  Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial 
BMC Family Practice  2016;17:80.
Background
The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care.
Results
This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively.
Conclusions
Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary.
Trial registration
The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov (Registration Number: NCT01065142) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé; Registration Number: 2009-A01142-55).
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-016-0473-4) contains supplementary material, which is available to authorized users.
doi:10.1186/s12875-016-0473-4
PMCID: PMC4949928  PMID: 27436289
Heart failure; Primary care; Quality of life; Patient education; Cluster randomised controlled trial
6.  Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial 
BMC Family Practice  2014;15:208.
Background
Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care.
Methods
A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient’s cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient’s education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients’ education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs.
Discussion
This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients’ education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training.
Trial registration
ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [NCT01065142, 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-014-0208-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s12875-014-0208-3
PMCID: PMC4305249  PMID: 25539989
Heart failure; Quality of life; Patient education; Primary care; Cluster-randomised controlled trial
7.  German medical students´ exposure and attitudes toward pharmaceutical promotion: A cross-sectional survey 
Objective: Early contact of medical students with pharmaceutical promotion has been shown in many international studies. We assessed the frequency and places of contact of German medical students to pharmaceutical promotion and examined their attitudes toward pharmaceutical promotional activities.
Methods: This cross-sectional survey was based on a self-developed questionnaire. It was distributed to all clinical students at the University of Goettingen Medical School in 2010. A 4-point rating scale was used to assess the attitudes toward different statements regarding pharmaceutical promotion.
Results: The overall response rate was 55% (702/1287). The proportion of students with direct contact to pharmaceutical sales representatives increased from 21% in the first clinical year up to 77% in the final year. 60% were contacted during their elective clerkship. 80% had accepted promotional gifts. 86% stated their prescribing behavior to be unsusceptible to the influence of accepting promotional gifts. However, 35% of the unsusceptible students assumed doctors to be susceptible. Almost all (90%) reported that dealing with pharmaceutical promotion was never addressed during lectures and 65% did not feel well prepared for interactions with the pharmaceutical industry. 19% agreed to prohibit contacts between medical students and the pharmaceutical industry.
Conclusions: German medical students get in contact with pharmaceutical promotion early and frequently. There is limited awareness for associated conflicts of interests. Medical schools need to regulate contacts and incorporate the topic in their curriculum to prepare students for interactions with the pharmaceutical industry.
doi:10.3205/zma000924
PMCID: PMC4152996  PMID: 25228934
Pharmaceutical promotion; medical students; medical education; Germany; cross sectional survey
8.  Safety relevant knowledge of orally anticoagulated patients without self-monitoring: a baseline survey in primary care 
BMC Family Practice  2014;15:104.
Background
Effective and safe management of oral anticoagulant treatment (OAT) requires a high level of patient knowledge and adherence. The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge.
Methods
This is a baseline survey of a cluster-randomized controlled trial in 22 general practices with an educational intervention for patients or their caregivers. We assessed knowledge about general information on OAT and key facts regarding nutrition, drug-interactions and other safety precautions of 345 patients at baseline.
Results
Participants rated their knowledge about OAT as excellent to good (56%), moderate (36%) or poor (8%). However, there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps. Half of the participants (49%) were unaware of dietary recommendations. The majority (80%) did not know which non-prescription analgesic is the safest and 73% indicated they would not inform pharmacists about OAT. Many participants (35-75%) would not recognize important emergency situations. After adjustment in a multivariate analysis, older age and less than 10 years education remained significantly associated with lower overall score, but not with self-rated knowledge.
Conclusions
Patients have relevant knowledge gaps, potentially affecting safe and effective OAT. There is a need to assess patient knowledge and for structured education programs.
Trial registration
Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586.
Universal Trial Number (UTN U1111-1118-3464).
doi:10.1186/1471-2296-15-104
PMCID: PMC4045910  PMID: 24885192
9.  Efficacy of Ambroxol lozenges for pharyngitis: a meta-analysis 
BMC Family Practice  2014;15:45.
Background
Ambroxol has a local anaesthetic action and is marketed for pain relief for sore throat. The objective is to examine the efficacy and safety of ambroxol for the relief of pain associated with acute uncomplicated sore throat.
Methods
A systematic review of the literature and meta-analysis. Selection criteria consisted of randomized controlled trials which compared ambroxol to placebo or any other treatment for sore throat. Two reviewers independently assessed for relevance, inclusion, and risk of bias. Weighted mean differences (WMDs) were calculated and are reported with corresponding 95% confidence intervals (CIs).
Results and conclusion
From 14 potentially relevant citations, five trials reported in three publications met the inclusion criteria, three of them were published twice. Ambroxol lozenges were compared in different dosages (5–30 mg) with mint flavoured lozenges and once with benzocaine. Main outcome was a ratio of pain reduction measured repeatedly over 3 h compared to baseline on 6-item verbal rating scale. A total of 1.772 adult patients participated in the trials. Pain intensity decreased in both study arms. A meta-analysis of the 5 controlled trials resulted in a difference in pain reduction compared to placebo of -0.11 (95% CI [-0.15, -0.07]; p < 0.0001) favouring ambroxol 20 mg. Quality of reporting of the studies was low. Ambroxol is slightly more effective in relieving pain in acute sore throat than mint flavoured lozenges over a period of 3 h. However, the additional benefits of ambroxol beyond three hours, remain unclear given that more than 50% of patients using mint flavoured lozenges for pain relief reported good or very good efficacy after 1 day compared to 69% with ambroxol. Ambroxol is a safe option for individual patients with mainly local symptoms asking for treatment.
doi:10.1186/1471-2296-15-45
PMCID: PMC3975147  PMID: 24621446
Pharyngitis; Sore throat; Mint flavoured lozenges; Ambroxol; Primary care; Pain relief; Meta-analysis
10.  Competence-based curriculum development for general practice in Germany: a stepwise peer-based approach instead of reinventing the wheel 
BMC Research Notes  2013;6:314.
Background
Improving postgraduate medical training is one important step to attract more medical students into general practice. Keeping pace with international developments moving to competence-based curricula for general practice training, the aim of this project was to develop and implement such a curriculum in Germany.
Methods
A five-step, peer-based method was used for the curriculum development process including panel testing and a “test version” of the curriculum for the pilot implementation phase. The CanMEDS framework served as a basis for a new German competence-based curriculum in general practice training. Four curricula from European countries and Canada were reviewed and, following required cultural adaptions, key strengths from these were integrated. For the CanMEDS “medical expertise” element of the curriculum, the WONCA ICPC-2 classification of patient’s “reason for encounters” was also integrated.
Results
Altogether, 37 participants were involved in the development process representing 12 different federal states in Germany, and including an expert advisor from Denmark. An official “test version” of the curriculum consisting of three parts: medical expertise, additional competencies and medical procedures was established. A system of self-assessment for trainees was integrated into the curriculum using a traffic light scale. Since March 2012, the curriculum has been made freely available online as a “test version”. In 2014, an evaluation is planned using feedback from users of the test model as a further stage of the implementation process.
Conclusions
The first German competence-based curriculum for general practice training has been developed using a pragmatic peer controlled approach and implementation is being trialed with a “test version” of the curriculum. This model project and its peer-based methodology may support competence-based curriculum development for other medical specialties both inside and outside Germany.
doi:10.1186/1756-0500-6-314
PMCID: PMC3751065  PMID: 23937795
Curriculum development; General practice; Physician shortage; CanMEDS
11.  General practice-based clinical trials in Germany - a problem analysis 
Trials  2012;13:205.
Background
In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy.
Methods
Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented.
Results
In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs) work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP) training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1) problem analysis, and definition of (2) structural prerequisites and (3) procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs), templates, checklists and other supporting materials for researchers.
Conclusion
All in all, our problem analyses revealed that a substantial number of barriers contribute to the low implementation of clinical research in German general practice. Some issues are deeply rooted in Germany’s market-based healthcare and academic systems and traditions. However, new developments may facilitate change: recent developments in the German research landscape are encouraging.
doi:10.1186/1745-6215-13-205
PMCID: PMC3543296  PMID: 23136890
Clinical trials; General practice; Barriers; Comparative effectiveness research; Research support
12.  Frequency and perceived severity of negative experiences during medical education in Germany – Results of an online-survery of medical students 
Aims: Negative experiences during the course of medical education have been reported in many countries, but little is known about the perceived severity of these experiences. We studied for the first time how often students at a medical university in Germany have had negative experiences, and how severe they perceive these to be.
Method: We asked medical students in an online survey whether they felt adequately appreciated, had experienced peer rivalry, verbal abuse by their mentors, physical abuse or mistreatment, sexual harassment, racial or ethnic discrimination, or any other kind of mistreatment.
Results: Of 391 students, 56% stated that they felt insufficiently appreciated, 51% had experienced rivalry, and 34% had suffered verbal abuse. Fifty-nine percent of the students felt highly aggrieved because of verbal abuse, while 46% were aggrieved by the ongoing rivalry and 32% by the lack of appreciation. Significantly fewer students felt upset because they were passed over or ignored (21%). Generally, female students felt more often aggrieved by these negative experiences than their male colleagues.
Conclusion: Of the possible negative experiences, the less prominent ones such as lack of appreciation or verbal abuse are not only frequent, they are also perceived as very upsetting. Medical teachers should reflect this more in their day-to-day dealings with students and aim to improve on their contact with the students accordingly.
doi:10.3205/zma000825
PMCID: PMC3420117  PMID: 22916081
medical education; medical schools; interpersonal relations; attitudes; stress; prejudice; sexual harassment; prevalence
13.  Practice nursed-based, individual and video-assisted patient education in oral anticoagulation - Protocol of a cluster-randomized controlled trial 
BMC Family Practice  2011;12:17.
Background
Managing oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only.
Methods and design
This trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range.
Discussion
This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we expect to discover differences in secondary outcomes, such as the time spent in the therapeutic range.
Trial registration
Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586
Universal Trial Number (UTN U1111-1118-3464)
doi:10.1186/1471-2296-12-17
PMCID: PMC3089775  PMID: 21477372
14.  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.
doi:10.1007/s00228-010-0871-9
PMCID: PMC2982961  PMID: 20694459
Proton pump inhibitors; Germany
15.  The experience and management of neck pain in general practice: the patients’ perspective 
European Spine Journal  2010;19(6):963-971.
The objective of this study is to investigate the perspective and expectation of patients presenting with neck pain in general practice. The study design is a qualitative analysis of patient interviews and was conducted in a primary care setting in Germany. Twenty patients aged 20–78, according to theoretical sampling were included in the study. Patients tried to cope autonomously with the situation and consulted GPs only if their self-help had failed. When patients asked for external help, they usually focused on somatic treatment options such as massage, physiotherapy or injections. Most patients reported to have experiences with somatic therapies; however, they felt that some or all of these treatments were inefficient or led only to short-time improvements. Patients often avoided psychosocial themes when talking to doctors for fear of being branded as ‘neurotic’. Although neck pain is difficult to manage and a burden for patients, they have obviously found a way of both living with their pain and a pragmatic approach of talking about their symptoms with their doctor. According to the patients’ statements, the interaction between doctor and patient seems to be rather distant, ensuring that both sides avoid any issues that might touch upon psychological aspects of neck pain.
doi:10.1007/s00586-010-1297-x
PMCID: PMC2899974  PMID: 20151163
General practice; Neck pain; Physician–patient relationship; Qualitative design
16.  Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial 
Background
Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.
Methods/Design
This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave.
Discussion
This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice.
Trial registration
ISRCTN 68205910
doi:10.1186/1471-2474-11-5
PMCID: PMC2820020  PMID: 20051119
17.  Are fear-avoidance beliefs in low back pain patients a risk factor for low physical activity or vice versa? A cross-lagged panel analysis 
Objective: The assumption that low back pain (LBP) patients suffer from “disuse” as a consequence of high fear-avoidance beliefs is currently under debate. A secondary analysis served to investigate whether fear-avoidance beliefs are associated cross-sectionally and longitudinally with the physical activity level (PAL) in LBP patients.
Methods: A total of 787 individuals (57% acute and 43% chronic LBP) were followed up over a period of one year with measurements of fear-avoidance beliefs and physical activity level. Fear-avoidance beliefs concerning physical activity were measured by the physical-activity subscale of the FABQ (Fear-Avoidance Beliefs Questionnaire), the physical activity level was assessed in weighted metabolic equivalents (MET) hours/week with a German self-report questionnaire. Data were investigated by structural equation modelling in a cross-lagged panel design for the whole sample and separately for acute and chronic LBP.
Results: The acute and chronic sub sample increased their total physical activity level significantly after one year. The structural equation modelling results did not support the disuse-aspect inherent in the fear-avoidance belief model. Cross-lagged path coefficients were low (.04 and .05 respectively) and, therefore, did not allow to predict final physical activity by initial fear-avoidance beliefs or vice versa.
Discussion: Consequently, due to missing links between fear-avoidance beliefs and physical activity in a longitudinal design, the assumptions of the fear-avoidance belief model have to be questioned. These findings are in line with other investigations published recently. Most probably, “fear-avoidance belief” represents a cognitive scheme that does not limit activity per se, but only is directed to the avoidance of specific movements.
doi:10.3205/psm000057
PMCID: PMC2736477  PMID: 19742047
fear-avoidance belief; physical activity; low back pain; structural equation modelling
18.  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.
doi:10.1186/1472-6920-9-17
PMCID: PMC2675518  PMID: 19368712
19.  Acceptance and perceived barriers of implementing a guideline for managing low back in general practice 
Background
Implementation of guidelines in clinical practice is difficult. In 2003, the German College of General Practitioners and Family Physicians (DEGAM) released an evidence-based guideline for the management of low back pain (LBP) in primary care. The objective of this study is to explore the acceptance of guideline content and perceived barriers to implementation.
Methods
Seventy-two general practitioners (GPs) participating in quality circles within the framework of an educational intervention study for guideline implementation evaluated the LBP-guideline and its practicability with a standardised questionnaire. In addition, statements of group discussions were recorded using the metaplan technique and were incorporated in the discussion.
Results
Most GPs agree with the guideline content but believe that guideline stipulations are not congruent with patient wishes. Non-adherence to the guideline and contradictory information for patients by other professionals (e.g., GPs, orthopaedic surgeons, physiotherapists) are important barriers to guideline adherence. Almost half of the GPs have no access to recommended multimodal pain programs for patients with chronic LBP.
Conclusion
Promoting adherence to the LBP guideline requires more than enhancing knowledge about evidence-based management of LBP. Public education and an interdisciplinary consensus are important requirements for successful guideline implementation into daily practice. Guideline recommendations need to be adapted to the infrastructure of the health care system.
Trial registration
BMBF Grant Nr. 01EM0113. FORIS (database for research projects in social science) Reg #: 20040116 [25].
doi:10.1186/1748-5908-3-7
PMCID: PMC2275295  PMID: 18257923
20.  Use of complementary alternative medicine for low back pain consulting in general practice: a cohort study 
Background
Although back pain is considered one of the most frequent reasons why patients seek complementary and alternative medical (CAM) therapies little is known on the extent patients are actually using CAM for back pain.
Methods
This is a post hoc analysis of a longitudinal prospective cohort study embedded in a RCT. General practitioners (GPs) recruited consecutively adult patients presenting with LBP. Data on physical function, on subjective mood, and on utilization of health services was collected at the first consultation and at follow-up telephone interviews for a period of twelve months
Results
A total of 691 (51%) respectively 928 (69%) out of 1,342 patients received one form of CAM depending on the definition. Local heat, massage, and spinal manipulation were the forms of CAM most commonly offered. Using CAM was associated with specialist care, chronic LBP and treatment in a rehabilitation facility. Receiving spinal manipulation, acupuncture or TENS was associated with consulting a GP providing these services. Apart from chronicity disease related factors like functional capacity or pain only showed weak or no association with receiving CAM.
Conclusion
The frequent use of CAM for LBP demonstrates that CAM is popular in patients and doctors alike. The observed association with a treatment in a rehabilitation facility or with specialist consultations rather reflects professional preferences of the physicians than a clear medical indication. The observed dependence on providers and provider related services, as well as a significant proportion receiving CAM that did not meet the so far established selection criteria suggests some arbitrary use of CAM.
doi:10.1186/1472-6882-7-42
PMCID: PMC2222227  PMID: 18088435
21.  Determinants for receiving acupuncture for LBP and associated treatments: a prospective cohort study 
Background
Acupuncture is a frequently used but controversial adjunct to the treatment of chronic low back pain (LBP). Acupuncture is now considered to be effective for chronic LBP and health care systems are pressured to make a decision whether or not acupuncture should be covered. It has been suggested that providing such services might reduce the use of other health care services. Therefore, we explored factors associated with acupuncture treatment for LBP and the relation of acupuncture with other health care services.
Methods
This is a post hoc analysis of a longitudinal prospective cohort study. General practitioners (GPs) recruited consecutive adult patients with LBP. Data on physical function, subjective mood and utilization of health care services was collected at the first consultation and at follow-up telephone interviews for a period of twelve months.
Results
A total of 179 (13 %) out of 1,345 patients received acupuncture treatment. The majority of those (59 %) had chronic LBP. Women and elderly patients were more likely to be given acupuncture. Additional determinants of acupuncture therapy were low functional capacity and chronicity of pain. Chronic (vs. acute) back pain OR 1.6 (CL 1.4–2.9) was the only significant disease-related factor associated with the treatment. The strongest predictors for receiving acupuncture were consultation with a GP who offers acupuncture OR 3.5 (CL 2.9–4.1) and consultation with a specialist OR 2.1 (CL 1.9–2.3). After adjustment for patient characteristics, acupuncture remained associated with higher consultation rates and an increased use of other health care services like physiotherapy.
Conclusion
Receiving acupuncture for LBP depends mostly on the availability of the treatment. It is associated with increased use of other health services even after adjustment for patient characteristics. In our study, we found that receiving acupuncture does not offset the use of other health care resources. A significant proportion of patients who received did not meet the so far only known selection criterion (chonicity). Acupuncture therapy might be a reflection of helplessness in both patients and health care providers.
doi:10.1186/1472-6963-6-149
PMCID: PMC1657011  PMID: 17112374

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