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1.  Development and validation of a generic questionnaire for the implementation of complex medical interventions 
GMS German Medical Science  2014;12:Doc08.
Introduction: The implementation of complex medical interventions in daily practice is often fraught with difficulties. According to the iterative phase model proposed by the British Medical Research Council (MRC), the development, implementation and evaluation of complex interventions should be theory-driven. A conceptual model that seems to be a promising framework is the Theory of planned behaviour (TPB). In our study we aimed to develop and validate a generic and multifaceted questionnaire based on the TPB to detect physicians’ willingness to implement complex medical interventions and the factors influencing this willingness.
Methods: The questionnaire was developed according to the literature and was informed by previous qualitative research of our department. It was validated on the example of an electronic library of decision aids, arriba-lib. The sample consisted of 181 General Practitioners (GPs) who received a training regarding arriba-lib and subsequently filled in the questionnaire, assessing the TPB variables attitude, subjective norm, perceived behaviour control and intention. Follow-up assessments were conducted after two (assessing retest reliability) and eight weeks (assessing target behaviour). We performed a confirmatory factor analysis investigating the factorial structure of our questionnaire according to the TPB. Beside the calculation of the questionnaire’s psychometric properties we conducted a structural equation model and an ordinal regression to predict actual behaviour regarding the installation and application of arriba-lib.
Results: The postulated three factorial model (attitude, subjective norm, perceived behaviour control) of our questionnaire based on the TPB was rejected. A two factorial model with a combined factor subjective norm/perceived behaviour control was accepted. The explained variance in the ordinal regression was low (Nagelkerke’s R2=.12). Neither attitude nor intention were able to predict the use or non-use of arriba-lib (attitude: p=.68, intention: p=.44). For the combined factor subjective norm/perceived behaviour control a significant, but small effect (p=.03) was shown.
Conclusions: The TPB is not an adequate theoretical framework to guide the development of a generic questionnaire in the context of the implementation of complex interventions. To enable the successful implementation of complex medical interventions evaluators have to go through the whole development and evaluation process according to the MRC-model, without short cuts. Further, it has to be discussed if a generic instrument can be valid and useful. Regarding the TPB a publication bias regarding the theory’s applicability might have to be considered.
PMCID: PMC3972438  PMID: 24696674
implementation; questionnaires; primary health care; theory of planned behaviour
2.  Chest pain in primary care: is the localization of pain diagnostically helpful in the critical evaluation of patients? - A cross sectional study 
BMC Family Practice  2013;14:154.
Chest pain is a common complaint and reason for consultation in primary care. Traditional textbooks still assign pain localization a certain discriminative role in the differential diagnosis of chest pain. The aim of our study was to synthesize pain drawings from a large sample of chest pain patients and to examine whether pain localizations differ for different underlying etiologies.
We conducted a cross-sectional study including 1212 consecutive patients with chest pain recruited in 74 primary care offices in Germany. Primary care providers (PCPs) marked pain localization and radiation of each patient on a pictogram. After 6 months, an independent interdisciplinary reference panel reviewed clinical data of every patient, deciding on the etiology of chest pain at the time of patient recruitment. PCP drawings were entered in a specially designed computer program to produce merged pain charts for different etiologies. Dissimilarities between individual pain localizations and differences on the level of diagnostic groups were analyzed using the Hausdorff distance and the C-index.
Pain location in patients with coronary heart disease (CHD) did not differ from the combined group of all other patients, including patients with chest wall syndrome (CWS), gastro-esophageal reflux disease (GERD) or psychogenic chest pain. There was also no difference in chest pain location between male and female CHD patients.
Pain localization is not helpful in discriminating CHD from other common chest pain etiologies.
PMCID: PMC3853238  PMID: 24138299
Chest pain; Pain localization; Coronary heart disease
3.  Authors’ response 
PMCID: PMC3426575
4.  Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis 
BMC Public Health  2013;13:623.
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.
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 > 75000). 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).
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.
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
PMCID: PMC3716622  PMID: 23819600
Evaluation studies; Intention to treat analysis; Cardiovascular diseases; Drug prescriptions; Hydroxymethylglutaryl-CoA Reductase Inhibitors
5.  Ruling out coronary heart disease in primary care: external validation of a clinical prediction rule 
The British Journal of General Practice  2012;62(599):e415-e421.
The Marburg Heart Score (MHS) aims to assist GPs in safely ruling out coronary heart disease (CHD) in patients presenting with chest pain, and to guide management decisions.
To investigate the diagnostic accuracy of the MHS in an independent sample and to evaluate the generalisability to new patients.
Design and setting
Cross-sectional diagnostic study with delayed-type reference standard in general practice in Hesse, Germany.
Fifty-six German GPs recruited 844 males and females aged ≥35 years, presenting between July 2009 and February 2010 with chest pain. Baseline data included the items of the MHS. Data on the subsequent course of chest pain, investigations, hospitalisations, and medication were collected over 6 months and were reviewed by an independent expert panel. CHD was the reference condition. Measures of diagnostic accuracy included the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, likelihood ratios, and predictive values.
The AUC was 0.84 (95% confidence interval [CI] = 0.80 to 0.88). For a cut-off value of 3, the MHS showed a sensitivity of 89.1% (95% CI = 81.1% to 94.0%), a specificity of 63.5% (95% CI = 60.0% to 66.9%), a positive predictive value of 23.3% (95% CI = 19.2% to 28.0%), and a negative predictive value of 97.9% (95% CI = 96.2% to 98.9%).
Considering the diagnostic accuracy of the MHS, its generalisability, and ease of application, its use in clinical practice is recommended.
PMCID: PMC3361121  PMID: 22687234
chest pain; medical history taking; myocardial ischaemia; sensitivity and specificity
6.  In-vivo-validation of a cardiovascular risk prediction tool: the arriba-pro study 
BMC Family Practice  2013;14:13.
Calculation of individual risk is the cornerstone of effective cardiovascular prevention. arriba is a software to estimate the individual risk to suffer a cardiovascular event in 10 years. Prognosis and the absolute effects of pharmacological and lifestyle interventions help the patient make a well-informed decision. The risk calculation algorithm currently used in arriba is based on the Framingham risk algorithm calibrated to the German setting. The objective of this study is to evaluate and adapt the algorithm for the target population in primary care in Germany.
arriba-pro will be conducted within the primary care scheme provided by a large health care insurer in Baden-Württemberg, Germany. Patients who are counseled with arriba by their general practitioners (GPs) will be included in the arriba-pro cohort. Exposure data from the consultation with arriba such as demographic data and risk factors will be recorded automatically by the practice software and transferred to the study centre. Information on relevant prescription drugs (effect modifiers) and cardiovascular events (outcomes) will be derived from administrative sources.
The study is unique in simulating a therapy naïve cohort, matching exactly research and application setting, using a robust administrative data base, and, finally, including patients with known cardiovascular disease who have been excluded from previous studies.
Trial registration
The study is registered with Deutsches Register Klinischer Studien (DRKS00004633).
PMCID: PMC3583804  PMID: 23339773
7.  Does the patient with chest pain have a coronary heart disease? Diagnostic value of single symptoms and signs – a meta-analysis 
Croatian Medical Journal  2012;53(5):432-441.
To determine the diagnostic value of single symptoms and signs for coronary heart disease (CHD) in patients with chest pain.
Searches of two electronic databases (EMBASE 1980 to March 2008, PubMed 1970 to May 2009) and hand searching in seven journals were conducted. Eligible studies recruited patients presenting with acute or chronic chest pain. The target disease was CHD, with no restrictions regarding case definitions, eg, stable CHD, acute coronary syndrome (ACS), acute myocardial infarction (MI), or major cardiac event (MCE). Diagnostic tests of interest were items of medical history and physical examination. Bivariate random effects model was used to derive summary estimates of positive (pLR) and negative likelihood ratios (nLR).
We included 172 studies providing data on the diagnostic value of 42 symptoms and signs. With respect to case definition of CHD, diagnostically most useful tests were history of CHD (pLR = 3.59), known MI (pLR = 3.21), typical angina (pLR = 2.35), history of diabetes mellitus (pLR = 2.16), exertional pain (pLR = 2.13), history of angina pectoris (nLR = 0.42), and male sex (nLR = 0.49) for diagnosing stable CHD; pain radiation to right arm/shoulder (pLR = 4.43) and palpitation (pLR = 0.47) for diagnosing MI; visceral pain (pLR = 2.05) for diagnosing ACS; and typical angina (pLR = 2.60) and pain reproducible by palpation (pLR = 0.13) for predicting MCE.
We comprehensively reported the accuracy of a broad spectrum of single symptoms and signs for diagnosing myocardial ischemia. Our results suggested that the accuracy of several symptoms and signs varied in the published studies according to the case definition of CHD.
PMCID: PMC3490454  PMID: 23100205
8.  Coronary heart disease in primary care: accuracy of medical history and physical findings in patients with chest pain – a study protocol for a systematic review with individual patient data 
BMC Family Practice  2012;13:81.
Chest pain is a common complaint in primary care, with coronary heart disease (CHD) being the most concerning of many potential causes. Systematic reviews on the sensitivity and specificity of symptoms and signs summarize the evidence about which of them are most useful in making a diagnosis. Previous meta-analyses are dominated by studies of patients referred to specialists. Moreover, as the analysis is typically based on study-level data, the statistical analyses in these reviews are limited while meta-analyses based on individual patient data can provide additional information. Our patient-level meta-analysis has three unique aims. First, we strive to determine the diagnostic accuracy of symptoms and signs for myocardial ischemia in primary care. Second, we investigate associations between study- or patient-level characteristics and measures of diagnostic accuracy. Third, we aim to validate existing clinical prediction rules for diagnosing myocardial ischemia in primary care. This article describes the methods of our study and six prospective studies of primary care patients with chest pain. Later articles will describe the main results.
We will conduct a systematic review and IPD meta-analysis of studies evaluating the diagnostic accuracy of symptoms and signs for diagnosing coronary heart disease in primary care. We will perform bivariate analyses to determine the sensitivity, specificity and likelihood ratios of individual symptoms and signs and multivariate analyses to explore the diagnostic value of an optimal combination of all symptoms and signs based on all data of all studies. We will validate existing clinical prediction rules from each of the included studies by calculating measures of diagnostic accuracy separately by study.
Our study will face several methodological challenges. First, the number of studies will be limited. Second, the investigators of original studies defined some outcomes and predictors differently. Third, the studies did not collect the same standard clinical data set. Fourth, missing data, varying from partly missing to fully missing, will have to be dealt with.
Despite these limitations, we aim to summarize the available evidence regarding the diagnostic accuracy of symptoms and signs for diagnosing CHD in patients presenting with chest pain in primary care.
Review registration
Centre for Reviews and Dissemination (University of York): CRD42011001170
PMCID: PMC3545850  PMID: 22877212
MeSH; Chest pain; Myocardial ischemia; Medical history taking; Sensitivity and specificity; Primary health care
9.  Development and validation of a clinical prediction rule for chest wall syndrome in primary care 
BMC Family Practice  2012;13:74.
Chest wall syndrome (CWS), the main cause of chest pain in primary care practice, is most often an exclusion diagnosis. We developed and evaluated a clinical prediction rule for CWS.
Data from a multicenter clinical cohort of consecutive primary care patients with chest pain were used (59 general practitioners, 672 patients). A final diagnosis was determined after 12 months of follow-up. We used the literature and bivariate analyses to identify candidate predictors, and multivariate logistic regression was used to develop a clinical prediction rule for CWS. We used data from a German cohort (n = 1212) for external validation.
From bivariate analyses, we identified six variables characterizing CWS: thoracic pain (neither retrosternal nor oppressive), stabbing, well localized pain, no history of coronary heart disease, absence of general practitioner’s concern, and pain reproducible by palpation. This last variable accounted for 2 points in the clinical prediction rule, the others for 1 point each; the total score ranged from 0 to 7 points. The area under the receiver operating characteristic (ROC) curve was 0.80 (95% confidence interval 0.76-0.83) in the derivation cohort (specificity: 89%; sensitivity: 45%; cut-off set at 6 points). Among all patients presenting CWS (n = 284), 71% (n = 201) had a pain reproducible by palpation and 45% (n = 127) were correctly diagnosed. For a subset (n = 43) of these correctly classified CWS patients, 65 additional investigations (30 electrocardiograms, 16 thoracic radiographies, 10 laboratory tests, eight specialist referrals, one thoracic computed tomography) had been performed to achieve diagnosis. False positives (n = 41) included three patients with stable angina (1.8% of all positives). External validation revealed the ROC curve to be 0.76 (95% confidence interval 0.73-0.79) with a sensitivity of 22% and a specificity of 93%.
This CWS score offers a useful complement to the usual CWS exclusion diagnosing process. Indeed, for the 127 patients presenting CWS and correctly classified by our clinical prediction rule, 65 additional tests and exams could have been avoided. However, the reproduction of chest pain by palpation, the most important characteristic to diagnose CWS, is not pathognomonic.
PMCID: PMC3444903  PMID: 22866824
Chest pain; Primary care; Thoracic wall; Musculoskeletal system; Decision support techniques; Diagnosis
10.  Associations between demographic, disease related, and treatment pathway related variables and health related quality of life in primary care patients with coronary heart disease 
Coronory 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.
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.
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.
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.
PMCID: PMC3464887  PMID: 22776102
Coronary artery disease; Quality of life; Multilevel analyses; Critical pathways
11.  arriba-lib: evaluation of an electronic library of decision aids in primary care physicians 
The successful implementation of decision aids in clinical practice initially depends on how clinicians perceive them. Relatively little is known about the acceptance of decision aids by physicians and factors influencing the implementation of decision aids from their point of view. Our electronic library of decision aids (arriba-lib) is to be used within the encounter and has a modular structure containing evidence-based decision aids for the following topics: cardiovascular prevention, atrial fibrillation, coronary heart disease, oral antidiabetics, conventional and intensified insulin therapy, and unipolar depression. The aim of our study was to evaluate the acceptance of arriba-lib in primary care physicians.
We conducted an evaluation study in which 29 primary care physicians included 192 patients. The physician questionnaire contained information on which module was used, how extensive steps of the shared decision making process were discussed, who made the decision, and a subjective appraisal of consultation length. We used generalised estimation equations to measure associations within patient variables and traditional crosstab analyses.
Only a minority of consultations (8.9%) was considered to be unacceptably extended. In 90.6% of consultations, physicians said that a decision could be made. A shared decision was perceived by physicians in 57.1% of consultations. Physicians said that a decision was more likely to be made when therapeutic options were discussed “detailed”. Prior experience with decision aids was not a critical variable for implementation within our sample of primary care physicians.
Our study showed that it might be feasible to apply our electronic library of decision aids (arriba-lib) in the primary care context. Evidence-based decision aids offer support for physicians in the management of medical information. Future studies should monitor the long-term adoption of arriba-lib in primary care physicians.
PMCID: PMC3461416  PMID: 22672414
12.  Qualitative evaluation of a local coronary heart disease treatment pathway: practical implications and theoretical framework 
BMC Family Practice  2012;13:36.
Coronary heart disease (CHD) is a common medical problem in general practice. Due to its chronic character, shared care of the patient between general practitioner (GP) and cardiologist (C) is required. In order to improve the cooperation between both medical specialists for patients with CHD, a local treatment pathway was developed. The objective of this study was first to evaluate GPs’ opinions regarding the pathway and its practical implications, and secondly to suggest a theoretical framework of the findings by feeding the identified key factors influencing the pathway implementation into a multi-dimensional model.
The evaluation of the pathway was conducted in a qualitative design on a sample of 12 pathway developers (8 GPs and 4 cardiologists) and 4 pathway users (GPs). Face-to face interviews, which were aligned with previously conducted studies of the department and assumptions of the theory of planned behaviour (TPB), were performed following a semi-structured interview guideline. These were audio-taped, transcribed verbatim, coded, and analyzed according to the standards of qualitative content analysis.
We identified 10 frequently mentioned key factors having an impact on the implementation success of the CHD treatment pathway. We thereby differentiated between pathway related (pathway content, effort, individual flexibility, ownership), behaviour related (previous behaviour, support), interaction related (patient, shared care/colleagues), and system related factors (context, health care system). The overall evaluation of the CHD pathway was positive, but did not automatically lead to a change of clinical behaviour as some GPs felt to have already acted as the pathway recommends.
By providing an account of our experience creating and implementing an intersectoral care pathway for CHD, this study contributes to our knowledge of factors that may influence physicians’ decisions regarding the use of a local treatment pathway. An improved adaptation of the pathway in daily practice might be best achieved by a combined implementation strategy addressing internal and external factors. A simple, direct adaptation regards the design of the pathway material (e.g. layout, PC version), or the embedding of the pathway in another programme, like a Disease Management Programme (DMP). In addition to these practical implications, we propose a theoretical framework to understand the key factors’ influence on the pathway implementation, with the identified factors along the microlevel (pathway related factors), the mesolevel (interaction related factors), and system- related factors along the macrolevel.
PMCID: PMC3489869  PMID: 22584032
Primary health care; Coronary artery disease; Clinical pathways; Qualitative research
13.  Multivariate modeling to identify patterns in clinical data: the example of chest pain 
In chest pain, physicians are confronted with numerous interrelationships between symptoms and with evidence for or against classifying a patient into different diagnostic categories. The aim of our study was to find natural groups of patients on the basis of risk factors, history and clinical examination data which should then be validated with patients' final diagnoses.
We conducted a cross-sectional diagnostic study in 74 primary care practices to establish the validity of symptoms and findings for the diagnosis of coronary heart disease. A total of 1199 patients above age 35 presenting with chest pain were included in the study. General practitioners took a standardized history and performed a physical examination. They also recorded their preliminary diagnoses, investigations and management related to the patient's chest pain. We used multiple correspondence analysis (MCA) to examine associations on variable level, and multidimensional scaling (MDS), k-means and fuzzy cluster analyses to search for subgroups on patient level. We further used heatmaps to graphically illustrate the results.
A multiple correspondence analysis supported our data collection strategy on variable level. Six factors emerged from this analysis: „chest wall syndrome“, „vital threat“, „stomach and bowel pain“, „angina pectoris“, „chest infection syndrome“, and „ self-limiting chest pain“. MDS, k-means and fuzzy cluster analysis on patient level were not able to find distinct groups. The resulting cluster solutions were not interpretable and had insufficient statistical quality criteria.
Chest pain is a heterogeneous clinical category with no coherent associations between signs and symptoms on patient level.
PMCID: PMC3228697  PMID: 22108386
14.  Do guidelines on first impression make sense? Implementation of a chest pain guideline in primary care: a systematic evaluation of acceptance and feasibility 
BMC Family Practice  2011;12:128.
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.
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.
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.
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.
PMCID: PMC3267789  PMID: 22103603
15.  Acceptance of shared decision making with reference to an electronic library of decision aids (arriba-lib) and its association to decision making in patients: an evaluation study 
Decision aids based on the philosophy of shared decision making are designed to help patients make informed choices among diagnostic or treatment options by delivering evidence-based information on options and outcomes. A patient decision aid can be regarded as a complex intervention because it consists of several presumably relevant components. Decision aids have rarely been field tested to assess patients' and physicians' attitudes towards them. It is also unclear what effect decision aids have on the adherence to chosen options.
The electronic library of decision aids (arriba-lib) to be used within the clinical encounter has a modular structure and contains evidence-based decision aids for the following topics: cardiovascular prevention, atrial fibrillation, coronary heart disease, oral antidiabetics, conventional and intensified insulin therapy, and unipolar depression. We conducted an evaluation study in which 29 primary care physicians included 192 patients. After the consultation, patients filled in questionnaires and were interviewed via telephone two months later. We used generalised estimation equations to measure associations within patient variables and traditional crosstab analyses.
Patients were highly satisfied with arriba-lib and the process of shared decision making. Two-thirds of patients reached in the telephone interview wanted to be counselled again with arriba-lib. There was a high congruence between preferred and perceived decision making. Of those patients reached in the telephone interview, 80.7% said that they implemented the decision, independent of gender and education. Elderly patients were more likely to say that they implemented the decision.
Shared decision making with our multi-modular electronic library of decision aids (arriba-lib) was accepted by a high number of patients. It has positive associations to general aspects of decision making in patients. It can be used for patient groups with a wide range of individual characteristics.
PMCID: PMC3143082  PMID: 21736724
16.  Gender bias revisited: new insights on the differential management of chest pain 
BMC Family Practice  2011;12:45.
Chest pain is a common complaint and reason for consultation in primary care. Few data exist from a primary care setting whether male patients are treated differently than female patients. We examined whether there are gender differences in general physicians' (GPs) initial assessment and subsequent management of patients with chest pain, and how these differences can be explained
We conducted a prospective study with 1212 consecutive chest pain patients. The study was conducted in 74 primary care offices in Germany from October 2005 to July 2006. After a follow up period of 6 months, an independent interdisciplinary reference panel reviewed clinical data of every patient and decided about the etiology of chest pain at the time of patient recruitment (delayed type-reference standard). We adjusted gender differences of six process indicators for different models.
GPs tended to assume that CHD is the cause of chest pain more often in male patients and referred more men for an exercise test (women 4.1%, men 7.3%, p = 0.02) and to the hospital (women 2.9%, men 6.6%, p < 0.01). These differences remained when adjusting for age and cardiac risk factors but ceased to exist after adjusting for the typicality of chest pain.
While observed gender differences can not be explained by differences in age, CHD prevalence, and underlying risk factors, the less typical symptom presentation in women might be an underlying factor. However this does not seem to result in suboptimal management in women but rather in overuse of services for men. We consider our conclusions rather hypothesis generating and larger studies will be necessary to prove our proposed model.
PMCID: PMC3125218  PMID: 21645336
17.  Accuracy of symptoms and signs for coronary heart disease assessed in primary care 
The British Journal of General Practice  2010;60(575):e246-e257.
Diagnosing the aetiology of chest pain is challenging. There is still a lack of data on the diagnostic accuracy of signs and symptoms for acute coronary events in low-prevalence settings.
To evaluate the diagnostic accuracy of symptoms and signs in patients presenting to general practice with chest pain.
Design of study
Cross-sectional diagnostic study with delayed-type reference standard.
Seventy-four general practices in Germany.
The study included 1249 consecutive patients presenting with chest pain. Data were reviewed by an independent reference panel, with coronary heart disease (CHD) and an indication for urgent hospital admission as reference conditions. Main outcome measures were sensitivity, specificity, likelihood ratio, predictive value, and odds ratio (OR) for non-trauma patients with a reference diagnosis.
Several signs and symptoms showed strong associations with CHD, including known vascular disease (OR = 5.13; 95% confidence interval [CI] = 2.83 to 9.30), pain worse on exercise (OR = 4.27; 95% CI = 2.31 to 7.88), patient assumes cardiac origin of pain (OR = 3.20; 95% CI = 1.53 to 6.60), cough present (OR = 0.08; 95% CI = 0.01 to 0.77), and pain reproducible on palpation (OR = 0.27; 95% CI = 0.13 to 0.56). For urgent hospital admission, effective criteria included pain radiating to the left arm (OR = 8.81; 95% CI = 2.58 to 30.05), known clinical vascular disease (OR = 7.50; 95% CI = 2.88 to 19.55), home visit requested (OR = 7.31; 95% CI = 2.27 to 23.57), and known heart failure (OR = 3.53; 95% CI = 1.14 to 10.96).
Although individual criteria were only moderately effective, in combination they can help to decide about further management of patients with chest pain in primary care.
PMCID: PMC2880766  PMID: 20529488
chest pain; medical history taking; myocardial ischaemia; primary health care; sensitivity and specificity
18.  Pitfalls in the statistical examination and interpretation of the correspondence between physician and patient satisfaction ratings and their relevance for shared decision making research 
The correspondence of satisfaction ratings between physicians and patients can be assessed on different dimensions. One may examine whether they differ between the two groups or focus on measures of association or agreement. The aim of our study was to evaluate methodological difficulties in calculating the correspondence between patient and physician satisfaction ratings and to show the relevance for shared decision making research.
We utilised a structured tool for cardiovascular prevention (arriba™) in a pragmatic cluster-randomised controlled trial. Correspondence between patient and physician satisfaction ratings after individual primary care consultations was assessed using the Patient Participation Scale (PPS). We used the Wilcoxon signed-rank test, the marginal homogeneity test, Kendall's tau-b, weighted kappa, percentage of agreement, and the Bland-Altman method to measure differences, associations, and agreement between physicians and patients.
Statistical measures signal large differences between patient and physician satisfaction ratings with more favourable ratings provided by patients and a low correspondence regardless of group allocation. Closer examination of the raw data revealed a high ceiling effect of satisfaction ratings and only slight disagreement regarding the distributions of differences between physicians' and patients' ratings.
Traditional statistical measures of association and agreement are not able to capture a clinically relevant appreciation of the physician-patient relationship by both parties in skewed satisfaction ratings. Only the Bland-Altman method for assessing agreement augmented by bar charts of differences was able to indicate this.
Trial registration
PMCID: PMC3120809  PMID: 21592337
19.  The association between a journal’s source of revenue and the drug recommendations made in the articles it publishes 
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.
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.
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.
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.
PMCID: PMC3060182  PMID: 21398223
20.  Strategies for prescribing statins 
BMJ : British Medical Journal  2008;336(7639):288-289.
Evidence supports prescribing a standard dose without further testing or dose adjustment
PMCID: PMC2234555  PMID: 18258935
21.  Effective continuing professional development for translating shared decision making in primary care: A study protocol 
Shared decision making (SDM) is a process by which a healthcare choice is made jointly by the healthcare professional and the patient. SDM is the essential element of patient-centered care, a core concept of primary care. However, SDM is seldom translated into primary practice. Continuing professional development (CPD) is the principal means by which healthcare professionals continue to gain, improve, and broaden the knowledge and skills required for patient-centered care. Our international collaboration seeks to improve the knowledge base of CPD that targets translating SDM into the clinical practice of primary care in diverse healthcare systems.
Funded by the Canadian Institutes of Health Research (CIHR), our project is to form an international, interdisciplinary research team composed of health services researchers, physicians, nurses, psychologists, dietitians, CPD decision makers and others who will study how CPD causes SDM to be practiced in primary care. We will perform an environmental scan to create an inventory of CPD programs and related activities for translating SDM into clinical practice. These programs will be critically assessed and compared according to their strengths and limitations. We will use the empirical data that results from the environmental scan and the critical appraisal to identify knowledge gaps and generate a research agenda during a two-day workshop to be held in Quebec City. We will ask CPD stakeholders to validate these knowledge gaps and the research agenda.
This project will analyse existing CPD programs and related activities for translating SDM into the practice of primary care. Because this international collaboration will develop and identify various factors influencing SDM, the project could shed new light on how SDM is implemented in primary care.
PMCID: PMC2988066  PMID: 20977774
22.  Ruling out coronary artery disease in primary care: development and validation of a simple prediction rule 
Chest pain can be caused by various conditions, with life-threatening cardiac disease being of greatest concern. Prediction scores to rule out coronary artery disease have been developed for use in emergency settings. We developed and validated a simple prediction rule for use in primary care.
We conducted a cross-sectional diagnostic study in 74 primary care practices in Germany. Primary care physicians recruited all consecutive patients who presented with chest pain (n = 1249) and recorded symptoms and findings for each patient (derivation cohort). An independent expert panel reviewed follow-up data obtained at six weeks and six months on symptoms, investigations, hospital admissions and medications to determine the presence or absence of coronary artery disease. Adjusted odds ratios of relevant variables were used to develop a prediction rule. We calculated measures of diagnostic accuracy for different cut-off values for the prediction scores using data derived from another prospective primary care study (validation cohort).
The prediction rule contained five determinants (age/sex, known vascular disease, patient assumes pain is of cardiac origin, pain is worse during exercise, and pain is not reproducible by palpation), with the score ranging from 0 to 5 points. The area under the curve (receiver operating characteristic curve) was 0.87 (95% confidence interval [CI] 0.83–0.91) for the derivation cohort and 0.90 (95% CI 0.87–0.93) for the validation cohort. The best overall discrimination was with a cut-off value of 3 (positive result 3–5 points; negative result ≤ 2 points), which had a sensitivity of 87.1% (95% CI 79.9%–94.2%) and a specificity of 80.8% (77.6%–83.9%).
The prediction rule for coronary artery disease in primary care proved to be robust in the validation cohort. It can help to rule out coronary artery disease in patients presenting with chest pain in primary care.
PMCID: PMC2934794  PMID: 20603345
23.  Accuracy of General Practitioners’ Assessment of Chest Pain Patients for Coronary Heart Disease in Primary Care: Cross-sectional Study with Follow-up 
Croatian Medical Journal  2010;51(3):243-249.
To estimate how accurately general practitioners’ (GP) assessed the probability of coronary heart disease in patients presenting with chest pain and analyze the patient management decisions taken as a result.
During 2005 and 2006, the cross-sectional diagnostic study with a delayed-type reference standard included 74 GPs in the German state of Hesse, who enrolled 1249 consecutive patients presenting with chest pain. GPs recorded symptoms and findings for each patient on a report form. Patients and GPs were contacted 6 weeks and 6 months after the patients’ visit to the GP. Data on chest complaints, investigations, hospitalization, and medication were reviewed by an independent panel, with coronary heart disease being the reference condition. Diagnostic properties (sensitivity, specificity, and predictive values) of the GPs’ diagnoses were calculated.
GPs diagnosed coronary heart disease with the sensitivity of 69% (95% confidence interval [CI], 62-75) and specificity of 89% (95% CI, 87-91), and acute coronary syndrome with the sensitivity of 50% (95% CI, 36-64) and specificity of 98% (95% CI, 97-99). They assumed coronary heart disease in 245 patients, 41 (17%) of whom were referred to the hospital, 77 (31%) to a cardiologist, and 162 (66%) to electrocardiogram testing.
GPs’ evaluation of chest pain patients, based on symptoms and signs alone, was not sufficiently accurate for diagnosing or excluding coronary heart disease or acute coronary syndrome.
PMCID: PMC2897083  PMID: 20564768
24.  Ruling out coronary heart disease in primary care patients with chest pain: a clinical prediction score 
BMC Medicine  2010;8:9.
Chest pain raises concern for the possibility of coronary heart disease. Scoring methods have been developed to identify coronary heart disease in emergency settings, but not in primary care.
Data were collected from a multicenter Swiss clinical cohort study including 672 consecutive patients with chest pain, who had visited one of 59 family practitioners' offices. Using delayed diagnosis we derived a prediction rule to rule out coronary heart disease by means of a logistic regression model. Known cardiovascular risk factors, pain characteristics, and physical signs associated with coronary heart disease were explored to develop a clinical score. Patients diagnosed with angina or acute myocardial infarction within the year following their initial visit comprised the coronary heart disease group.
The coronary heart disease score was derived from eight variables: age, gender, duration of chest pain from 1 to 60 minutes, substernal chest pain location, pain increasing with exertion, absence of tenderness point at palpation, cardiovascular risks factors, and personal history of cardiovascular disease. Area under the receiver operating characteristics curve was of 0.95 with a 95% confidence interval of 0.92; 0.97. From this score, 413 patients were considered as low risk for values of percentile 5 of the coronary heart disease patients. Internal validity was confirmed by bootstrapping. External validation using data from a German cohort (Marburg, n = 774) revealed a receiver operating characteristics curve of 0.75 (95% confidence interval, 0.72; 0.81) with a sensitivity of 85.6% and a specificity of 47.2%.
This score, based only on history and physical examination, is a complementary tool for ruling out coronary heart disease in primary care patients complaining of chest pain.
PMCID: PMC2832616  PMID: 20092615
25.  Gender differences in presentation and diagnosis of chest pain in primary care 
BMC Family Practice  2009;10:79.
Chest pain is a common complaint and reason for consultation in primary care. Research related to gender differences in regard to Coronary Heart Disease (CHD) has been mainly conducted in hospital but not in primary care settings. We aimed to analyse gender differences in aetiology and clinical characteristics of chest pain and to provide gender related symptoms and signs associated with CHD.
We included 1212 consecutive patients with chest pain aged 35 years and older attending 74 general practitioners (GPs). GPs recorded symptoms and findings of each patient and provided follow up information. An independent interdisciplinary reference panel reviewed clinical data of every patient and decided about the aetiology of chest pain at the time of patient recruitment. Multivariable regression analysis was performed to identify clinical predictors that help to rule in or out CHD in women and men.
Women showed more psychogenic disorders (women 11,2%, men 7.3%, p = 0.02), men suffered more from CHD (women 13.0%, men 17.2%, p = 0.04), trauma (women 1.8%, men 5.1%, p < 0.001) and pneumonia/pleurisy (women 1.3%, men 3.0%, p = 0.04) Men showed significantly more often chest pain localised on the right side of the chest (women 9.1%, men 25.0%, p = 0.01). For both genders known clinical vascular disease, pain worse with exercise and age were associated positively with CHD. In women pain duration above one hour was associated positively with CHD, while shorter pain durations showed an association with CHD in men. In women negative associations were found for stinging pain and in men for pain depending on inspiration and localised muscle tension.
We found gender differences in regard to aetiology, selected clinical characteristics and association of symptoms and signs with CHD in patients presenting with chest pain in a primary care setting. Further research is necessary to elucidate whether these differences would support recommendations for different diagnostic approaches for CHD according to a patient's gender.
PMCID: PMC2801475  PMID: 20003406

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