Norbert Donner-Banzhoff

99mTc : technetium-99m 201TI : thallium 201 ABCB1 : ATP-binding cassette sub-family B member 1 ABI : ankle-brachial index ACC : American College of Cardiology ACCF : American College of Cardiology Foundation ACCOMPLISH : Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension ACE : angiotensin converting enzyme ACIP : Asymptomatic Cardiac Ischaemia Pilot ACS : acute coronary syndrome ADA : American Diabetes Association ADP : adenosine diphosphate AHA : American Heart Association ARB : angiotensin II receptor antagonist ART : Arterial Revascularization Trial ASCOT : Anglo-Scandinavian Cardiac Outcomes Trial ASSERT : Asymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial AV : atrioventricular BARI 2D : Bypass Angioplasty Revascularization Investigation 2 Diabetes BEAUTIFUL : Morbidity-Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction BIMA : bilateral internal mammary artery BMI : body mass index BMS : bare metal stent BNP : B-type natriuretic peptide BP : blood pressure b.p.m. : beats per minute CABG : coronary artery bypass graft CAD : coronary artery disease CAPRIE : Clopidogrel vs. Aspirin in Patients at Risk of Ischaemic Events CASS : Coronary Artery Surgery Study CCB : calcium channel blocker CCS : Canadian Cardiovascular Society CFR : coronary flow reserve CHARISMA : Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilization, Management and Avoidance CI : confidence interval CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease Epidemiology Collaboration CMR : cardiac magnetic resonance CORONARY : The CABG Off or On Pump Revascularization Study COURAGE : Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation COX-1 : cyclooxygenase-1 COX-2 : cyclooxygenase-2 CPG : Committee for Practice Guidelines CT : computed tomography CTA : computed tomography angiography CV : cardiovascular CVD : cardiovascular disease CXR : chest X-ray CYP2C19*2 : cytochrome P450 2C19 CYP3A : cytochrome P3A CYP3A4 : cytochrome P450 3A4 CYP450 : cytochrome P450 DANAMI : Danish trial in Acute Myocardial Infarction DAPT : dual antiplatelet therapy DBP : diastolic blood pressure DECOPI : Desobstruction Coronaire en Post-Infarctus DES : drug-eluting stents DHP : dihydropyridine DSE : dobutamine stress echocardiography EACTS : European Association for Cardiothoracic Surgery EECP : enhanced external counterpulsation EMA : European Medicines Agency EASD : European Association for the Study of Diabetes ECG : electrocardiogram Echo : echocardiogram ED : erectile dysfunction EF : ejection fraction ESC : European Society of Cardiology EXCEL : Evaluation of XIENCE PRIME or XIENCE V vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization FAME : Fractional Flow Reserve vs. Angiography for Multivessel Evaluation FDA : Food & Drug Administration (USA) FFR : fractional flow reserve FREEDOM : Design of the Future Revascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease GFR : glomerular filtration rate HbA1c : glycated haemoglobin HDL : high density lipoprotein HDL-C : high density lipoprotein cholesterol HR : hazard ratio HRT : hormone replacement therapy hs-CRP : high-sensitivity C-reactive protein HU : Hounsfield units ICA : invasive coronary angiography IMA : internal mammary artery IONA : Impact Of Nicorandil in Angina ISCHEMIA : International Study of Comparative Health Effectiveness with Medical and Invasive Approaches IVUS : intravascular ultrasound JSAP : Japanese Stable Angina Pectoris KATP : ATP-sensitive potassium channels LAD : left anterior descending LBBB : left bundle branch block LIMA : Left internal mammary artery LDL : low density lipoprotein LDL-C : low density lipoprotein cholesterol LM : left main LMS : left main stem LV : left ventricular LVEF : left ventricular ejection fraction LVH : left ventricular hypertrophy MACE : major adverse cardiac events MASS : Medical, Angioplasty, or Surgery Study MDRD : Modification of Diet in Renal Disease MERLIN : Metabolic Efficiency with Ranolazine for Less Ischaemia in Non-ST-Elevation Acute Coronary Syndromes MERLIN-TIMI 36 : Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes: Thrombolysis In Myocardial Infarction MET : metabolic equivalents MI : myocardial infarction MICRO-HOPE : Microalbuminuria, cardiovascular and renal sub-study of the Heart Outcomes Prevention Evaluation study MPI : myocardial perfusion imaging MRI : magnetic resonance imaging NO : nitric oxide NSAIDs : non-steroidal anti-inflammatory drugs NSTE-ACS : non-ST-elevation acute coronary syndrome NYHA : New York Heart Association OAT : Occluded Artery Trial OCT : optical coherence tomography OMT : optimal medical therapy PAR-1 : protease activated receptor type 1 PCI : percutaneous coronary intervention PDE5 : phosphodiesterase type 5 PES : paclitaxel-eluting stents PET : positron emission tomography PRECOMBAT : Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease PTP : pre-test probability PUFA : polyunsaturated fatty acid PVD : peripheral vascular disease QoL : quality of life RBBB : right bundle branch block REACH : Reduction of Atherothrombosis for Continued Health RITA-2 : Second Randomized Intervention Treatment of Angina ROOBY : Veterans Affairs Randomized On/Off Bypass SAPT : single antiplatelet therapy SBP : systolic blood pressure SCAD : stable coronary artery disease SCORE : Systematic Coronary Risk Evaluation SCS : spinal cord stimulation SES : sirolimus-eluting stents SIMA : single internal mammary artery SPECT : single photon emission computed tomography STICH : Surgical Treatment for Ischaemic Heart Failure SWISSI II : Swiss Interventional Study on Silent Ischaemia Type II SYNTAX : SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery TC : total cholesterol TENS : transcutaneous electrical neural stimulation TERISA : Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina TIME : Trial of Invasive vs. Medical therapy TIMI : Thrombolysis In Myocardial Infarction TMR : transmyocardial laser revascularization TOAT : The Open Artery Trial WOEST : What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing Guidelines summarize and evaluate all evidence available, at the time of the writing process, on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome, as well …

Shared decision making (SDM) is a process by which a healthcare choice is made by the patient, significant others, or both with one or more healthcare professionals. However, it has not yet been widely adopted in practice. This is the second update of this Cochrane review.To determine the effectiveness of interventions for increasing the use of SDM by healthcare professionals. We considered interventions targeting patients, interventions targeting healthcare professionals, and interventions targeting both.We searched CENTRAL, MEDLINE, Embase and five other databases on 15 June 2017. We also searched two clinical trials registries and proceedings of relevant conferences. We checked reference lists and contacted study authors to identify additional studies.Randomized and non-randomized trials, controlled before-after studies and interrupted time series studies evaluating interventions for increasing the use of SDM in which the primary outcomes were evaluated using observer-based or patient-reported measures.We used standard methodological procedures expected by Cochrane.We used GRADE to assess the certainty of the evidence.We included 87 studies (45,641 patients and 3113 healthcare professionals) conducted mainly in the USA, Germany, Canada and the Netherlands. Risk of bias was high or unclear for protection against contamination, low for differences in the baseline characteristics of patients, and unclear for other domains.Forty-four studies evaluated interventions targeting patients. They included decision aids, patient activation, question prompt lists and training for patients among others and were administered alone (single intervention) or in combination (multifaceted intervention). The certainty of the evidence was very low. It is uncertain if interventions targeting patients when compared with usual care increase SDM whether measured by observation (standardized mean difference (SMD) 0.54, 95% confidence interval (CI) -0.13 to 1.22; 4 studies; N = 424) or reported by patients (SMD 0.32, 95% CI 0.16 to 0.48; 9 studies; N = 1386; risk difference (RD) -0.09, 95% CI -0.19 to 0.01; 6 studies; N = 754), reduce decision regret (SMD -0.10, 95% CI -0.39 to 0.19; 1 study; N = 212), improve physical (SMD 0.00, 95% CI -0.36 to 0.36; 1 study; N = 116) or mental health-related quality of life (QOL) (SMD 0.10, 95% CI -0.26 to 0.46; 1 study; N = 116), affect consultation length (SMD 0.10, 95% CI -0.39 to 0.58; 2 studies; N = 224) or cost (SMD 0.82, 95% CI 0.42 to 1.22; 1 study; N = 105).It is uncertain if interventions targeting patients when compared with interventions of the same type increase SDM whether measured by observation (SMD 0.88, 95% CI 0.39 to 1.37; 3 studies; N = 271) or reported by patients (SMD 0.03, 95% CI -0.18 to 0.24; 11 studies; N = 1906); (RD 0.03, 95% CI -0.02 to 0.08; 10 studies; N = 2272); affect consultation length (SMD -0.65, 95% CI -1.29 to -0.00; 1 study; N = 39) or costs. No data were reported for decision regret, physical or mental health-related QOL.Fifteen studies evaluated interventions targeting healthcare professionals. They included educational meetings, educational material, educational outreach visits and reminders among others. The certainty of evidence is very low. It is uncertain if these interventions when compared with usual care increase SDM whether measured by observation (SMD 0.70, 95% CI 0.21 to 1.19; 6 studies; N = 479) or reported by patients (SMD 0.03, 95% CI -0.15 to 0.20; 5 studies; N = 5772); (RD 0.01, 95%C: -0.03 to 0.06; 2 studies; N = 6303); reduce decision regret (SMD 0.29, 95% CI 0.07 to 0.51; 1 study; N = 326), affect consultation length (SMD 0.51, 95% CI 0.21 to 0.81; 1 study, N = 175), cost (no data available) or physical health-related QOL (SMD 0.16, 95% CI -0.05 to 0.36; 1 study; N = 359). Mental health-related QOL may slightly improve (SMD 0.28, 95% CI 0.07 to 0.49; 1 study, N = 359; low-certainty evidence).It is uncertain if interventions targeting healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD -0.30, 95% CI -1.19 to 0.59; 1 study; N = 20) or reported by patients (SMD 0.24, 95% CI -0.10 to 0.58; 2 studies; N = 1459) as the certainty of the evidence is very low. There was insufficient information to determine the effect on decision regret, physical or mental health-related QOL, consultation length or costs.Twenty-eight studies targeted both patients and healthcare professionals. The interventions used a combination of patient-mediated and healthcare professional directed interventions. Based on low certainty evidence, it is uncertain whether these interventions, when compared with usual care, increase SDM whether measured by observation (SMD 1.10, 95% CI 0.42 to 1.79; 6 studies; N = 1270) or reported by patients (SMD 0.13, 95% CI -0.02 to 0.28; 7 studies; N = 1479); (RD -0.01, 95% CI -0.20 to 0.19; 2 studies; N = 266); improve physical (SMD 0.08, -0.37 to 0.54; 1 study; N = 75) or mental health-related QOL (SMD 0.01, -0.44 to 0.46; 1 study; N = 75), affect consultation length (SMD 3.72, 95% CI 3.44 to 4.01; 1 study; N = 36) or costs (no data available) and may make little or no difference to decision regret (SMD 0.13, 95% CI -0.08 to 0.33; 1 study; low-certainty evidence).It is uncertain whether interventions targeting both patients and healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD -0.29, 95% CI -1.17 to 0.60; 1 study; N = 20); (RD -0.04, 95% CI -0.13 to 0.04; 1 study; N = 134) or reported by patients (SMD 0.00, 95% CI -0.32 to 0.32; 1 study; N = 150 ) as the certainty of the evidence was very low. There was insuffient information to determine the effects on decision regret, physical or mental health-related quality of life, or consultation length or costs.It is uncertain whether any interventions for increasing the use of SDM by healthcare professionals are effective because the certainty of the evidence is low or very low.

Cost of illness study alongside a randomized controlled trial.To describe the costs of care for patients with low back pain (1) and to identify patient characteristics as predictors for high health care cost during a 1-year follow-up (2).Low back pain (LBP) is one of the leading causes of high health care costs in industrialized countries (Life time prevalence, 70%). A lot of research has been done to improve primary health care and patients' prognosis. However, the cost of health care does not necessarily follow changes in patient outcomes.General practitioners (n = 126) recruited 1378 patients consulting for LBP. Sociodemographic data, pain characteristics, and LBP-related cost data were collected by interview at baseline and after 6 and 12 months. Costs were evaluated from the societal perspective. Predictors of high cost during the subsequent year were studied using logistic regression analysis.Mean direct and indirect costs for LBP care are about twice as high for patients with chronic LBP compared to acutely ill patients. Indirect costs account for more than 52% to 54% of total costs. About 25% of direct costs refer to therapeutic procedures and hospital or rehabilitational care. Patients with high disability and limitations in daily living show a 2- to 5-fold change for subsequent high health care costs. Depression seems to be highly relevant for direct health care utilization.Interventions designed to reduce high health care costs for LBP should focus on patients with severe LBP and depressive comorbidity. Our results add to the economic understanding of LBP care and may give guidance for future actions on health care improvement and cost reduction.

Background Shared decision making (SDM) can reduce overuse of options not associated with benefits for all and respects patient rights, but has not yet been widely adopted in practice. Objectives To determine the effectiveness of interventions to improve healthcare professionals' adoption of SDM. Search methods For this update we searched for primary studies in The Cochrane Library, MEDLINE, EMBASE, CINAHL, the Cochrane Effective Practice and Organisation of Care (EPOC) Specialsied Register and PsycINFO for the period March 2009 to August 2012. We searched the Clinical Trials.gov registry and the proceedings of the International Shared Decision Making Conference. We scanned the bibliographies of relevant papers and studies. We contacted experts in the field to identify papers published after August 2012. Selection criteria Randomised and non‐randomised controlled trials, controlled before‐and‐after studies and interrupted time series studies evaluating interventions to improve healthcare professionals' adoption of SDM where the primary outcomes were evaluated using observer‐based outcome measures (OBOM) or patient‐reported outcome measures (PROM). Data collection and analysis The three overall categories of intervention were: interventions targeting patients, interventions targeting healthcare professionals, and interventions targeting both. Studies in each category were compared to studies in the same category, to studies in the other two categories, and to usual care, resulting in nine comparison groups. Statistical analysis considered categorical and continuous primary outcomes separately. We calculated the median of the standardized mean difference (SMD), or risk difference, and range of effect across studies and categories of intervention. We assessed risk of bias. Main results Thirty‐nine studies were included, 38 randomised and one non‐randomised controlled trial. Categorical measures did not show any effect for any of the interventions. In OBOM studies, interventions targeting both patients and healthcare professionals had a positive effect compared to usual care (SMD of 2.83) and compared to interventions targeting patients alone (SMD of 1.42). Studies comparing interventions targeting patients with other interventions targeting patients had a positive effect, as did studies comparing interventions targeting healthcare professionals with usual care (SDM of 1.13 and 1.08 respectively). In PROM studies, only three comparisons showed any effect, patient compared to usual care (SMD of 0.21), patient compared to another patient (SDM of 0.29) and healthcare professional compared to another healthcare professional (SDM of 0.20). For all comparisons, interpretation of the results needs to consider the small number of studies, the heterogeneity, and some methodological issues. Overall quality of the evidence for the outcomes, assessed with the GRADE tool, ranged from low to very low. Authors' conclusions It is uncertain whether interventions to improve adoption of SDM are effective given the low quality of the evidence. However, any intervention that actively targets patients, healthcare professionals, or both, is better than none. Also, interventions targeting patients and healthcare professionals together show more promise than those targeting only one or the other.

PURPOSEWe wanted to determine the effect of promoting the effective communication of absolute cardiovascular disease (CVD) risk and shared decision making through disseminating a simple decision aid for use in family practice consultations. METHODSThe study was based on a pragmatic, cluster randomized controlled trial (phase III) with continuing medical education (CME) groups of family physicians as the unit of randomization.In the intervention arm, 44 physicians (7 CME groups) consecutively recruited 550 patients in whom cholesterol levels were measured.Forty-seven physicians in the control arm (7 CME groups) similarly included 582 patients.Four hundred sixty patients (83.6%) of the intervention arm and 466 patients (80.1%) of the control arm were seen at follow-up.Physicians attended 2 interactive CME sessions and received a booklet, a paper-based risk calculator, and individual summary sheets for each patient.Control physicians attended 1 CME-session on an alternative topic.Main outcome measures were patient satisfaction and participation after the index consultation, change in CVD risk status, and decisional regret at 6 months' follow-up. RESULTSIntervention patients were signifi cantly more satisfi ed with process and result (Patient Participation Scale, difference 0.80, P <.001).Decisional regret was signifi cantly lower at follow-up (difference 3.39, P = .02).CVD risk decreased in both groups without a signifi cant difference between study arms.CONCLUSION A simple transactional decision aid based on calculating absolute individual CVD risk and promoting shared decision making in CVD prevention can be disseminated through CME groups and may lead to higher patient satisfaction and involvement and less decisional regret, without negatively affecting global CVD risk.

Background/objective: Chest pain is a common complaint and reason for consultation. We aimed to study the epidemiology of chest pain with respect to underlying aetiologies and to establish pre-work-up probabilities for the primary care setting. Methods: 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 on the aetiology of chest pain at the time of patient recruitment. Results: The prevalence of chest pain among all attending patients was 0.7%. The majority (55.9%) of patients were women. Mean age was 59 (35–93) years. Of these patients, 53.2% had chest pains at the time of consultation and 29.6% presented with acute (<48 hours’ duration) chest pain. Pain originating from the chest wall was diagnosed in 46.6% of all patients, stable ischaemic heart disease (IHD) in 11.1%, and psychogenic disorders in 9.5%; 3.6% had acute coronary syndrome (ACS).Conclusion: The study adds important information about the epidemiology of chest pain as a frequent reason for consulting primary care practitioners. We provide updated pre-work-up probabilities for IHD for each age and sex category.

A proper representation of the uncertainty involved in a prediction is an important prerequisite for the acceptance of machine learning and decision support technology in safety–critical application domains such as medical diagnosis. Despite the existence of various probabilistic approaches in these fields, there is arguably no method that is able to distinguish between two very different sources of uncertainty: aleatoric uncertainty, which is due to statistical variability and effects that are inherently random, and epistemic uncertainty which is caused by a lack of knowledge. In this paper, we propose a method for binary classification that does not only produce a prediction of the class of a query instance but also a quantification of the two aforementioned sources of uncertainty. Despite being grounded in probability and statistics, the method is formalized within the framework of fuzzy preference relations. The usefulness and reasonableness of our approach is confirmed on a suitable data set with information about patients suffering from chest pain.

Background.Diagnostic reasoning in primary care patients with abdominal pain is a complex challenge for GPs. To ensure evidence-based decision making for this symptom, GPs need setting-specific knowledge about the prevalence, potential risks for diseases and chance of recovery or risk of undesirable courses of disease.

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 <or= 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.

Although shared decision making (SDM) has become increasingly important in bioethical discussions and clinical practice, it is not clear in which treatment situations SDM is suitable. We address this question by investigating social norms on the appropriateness of SDM in different situations. We conducted qualitative expert interviews with patients, general practitioners, and health administration and research professionals. SDM was considered to be most important in severe illness and chronic condition. Furthermore, SDM was indicated to be required if there is more than one therapeutic option, especially if it is not clear which option is best. Interviewees classified end-of-life decisions and decisions about prevention as those that primarily should be made by informed patients. On the other hand a paternalistic decision was considered most appropriate in emergency situations and when the patient does not want to participate in decision making. This study demonstrates that multiple situational factors and their interactions must be considered regarding the scope of SDM in medical consultation. Research addressing this question will help physicians adjust their consultation style and allow implementations of SDM and decision aids to be tailored more appropriately to complex treatment situations.

The main focus of the paper is on the description of the development and current state of research and implementation of patient-centered care (PCC) and shared decision making (SDM) after fifteen years of substantial advances in health policy and health services research. What is the current state of SDM in health policy? The “Patients’ Rights Act” from 2013 standardizes all rights and responsibilities within the framework of medical treatment for German citizens and legal residents. This comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on a clinician-patient-partnership. What is the current state of SDM interventions and patient decision support tools? SDM training programs for healthcare professionals have been developed. Their implementation in medical schools has been successful. Several decision support tools – primarily with support from health insurance funds and other public agencies – are to be implemented in routine care, specifically for national cancer screening programs. What is the current state of research and routine implementation? The German government and other public institutions are constantly funding research programs in which patient-centered care and shared decision-making are important topics. The development and implementation of decision tools for patients and professionals as well as the implementation of CME trainings for healthcare professionals require future efforts. What does the future look like? With the support of health policy and scientific evidence, transfer of PCC and SDM to practice is regarded as meaningful. Research can help to assess barriers, facilitators, and needs, and subsequently to develop and evaluate corresponding strategies to successfully implement PCC and SDM in routine care, which remains challenging.

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

Regular physical activity has multiple health benefits, especially in older people. Therefore, the World Health Organization recommends at least 2.5 h of moderate physical activity per week. The aim of the POWER Study was to investigate whether volunteer-assisted walking improves the physical performance and health of older people.We approached people aged 65 years and older with restricted mobility due to physical limitations and asked them to participate in this multicentre randomised controlled trial. The recruitment took place in nursing homes and the community setting. Participants randomly assigned to the intervention group were accompanied by volunteer companions for a 30-50 min walk up to three times a week for 6 months. Participants in the control group received two lectures that included health-related topics. The primary endpoint was physical function as measured with the Short Physical Performance Battery (SPPB) at baseline and 6 and 12 months. The secondary and safety endpoints were quality of life (EQ-5D-5L), fear of falling (Falls Efficacy Scale), cognitive executive function (the Clock Drawing Test), falls, hospitalisations and death.The sample comprised 224 participants (79% female). We failed to show superiority of the intervention with regard to physical function (SPPB) or other health outcomes in the intention-to-treat analyses. However, additional exploratory analyses suggest benefits in those who undertook regular walks. The intervention appears to be safe regarding falls.Regular physical activity is essential to preserve function and to improve health and quality of life. Against the background of a smaller-than-planned sample size, resulting in low power, and the interference of the COVID-19 pandemic, we suggest that community based low-threshold interventions deserve further exploration.The trial was registered with the German Clinical Trials Register ( www.germanctr.de ), with number DRKS00015188 on 31/08/2018.

In Brief Study Design. Cluster randomized controlled trial. Objective. To improve quality of care for patients with low back pain (LBP) a multifaceted general practitioner education alone and in combination with motivational counseling by practice nurses has been implemented in German general practices. We studied effects on functional capacity (main outcome), days in pain, physical activity, quality of life, or days of sick leave (secondary outcomes) compared with no intervention. Summary of Background Data. International research has lead to the development of the German LBP guideline for general practitioners. However, there is still doubt about the most effective implementation strategy. Although effects on process of care have been observed frequently, changes in patient outcomes are rarely seen. Methods. We recruited 1378 patients with LBP in 118 general practices, which were randomized to 1 of 3 study arms: a multifaceted guideline implementation (GI), GI plus training of practice nurses in motivational counseling (MC), and the postal dissemination of the guideline (controls, C). Data were collected (questionnaires and patient interviews) at baseline and after 6 and 12 months. Multilevel mixed effects modeling was used to adjust for clustering of data and potential confounders. Results. After 6 months, functional capacity was higher in the intervention groups with a cluster adjusted mean difference of 3.650 between the MC group and controls (95% CI = 0.320–6.979, P = 0.032) and 2.652 between the GI group and controls (95% CI = −0.704 to 6.007, P = 0.120). Intervention effects were more pronounced regarding days in pain per year with an average reduction of 16 (GI) to 17 days (MC) after 6 months (12 and 9 days after 12 months) compared with controls. Conclusion. Active implementation of the German LBP guideline results in slightly better outcomes during 6 months follow-up than its postal dissemination. Results are more distinct when practice nurses are trained in motivational counseling. A RCT on 1387 patients with low back pain was performed to study the effectiveness of a guideline implementation strategy alone or in combination with motivational counseling by practice nurses. Both interventions lead to better functional capacity and less days in pain during 6 months follow-up compared with controls.

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.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.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.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.

The main focus of the present paper is to describe 1) the healthcare system specific influences on patient participation in medical decision making and 2) the current state of research and implementation of shared decision making (SDM) after ten years of substantial advances in health policy and research in this field. WHAT ABOUT POLICY REGARDING SDM? The "Medical Patients Rights Act" is to standardise all the rights and responsibilities within the scope of medical treatment. This also comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on the partnership of clinicians and patients. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? SDM training programmes for healthcare professionals have been developed and partly implemented. Several decision support interventions - primarily with support from health insurance funds - have been developed and evaluated. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? Against the background of the German health policy's endorsement of patient participation, the German government and other public institutions are currently funding different research programmes in which shared decision making is playing a substantial role. The development and implementation of decision support tools for patients and professionals as well as the implementation of trainings for healthcare professionals require stronger efforts. WHAT DOES THE FUTURE LOOK LIKE? With the support of health policy and with the utilisation of scientific evidence, the transfer of shared decision making into practice is considered to be meaningful in the German healthcare system. The translation into routine care will remain an important task for the future.

In Brief Study Design. Cost-effectiveness analysis alongside a cluster randomized controlled trial. Objective. To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. Summary of Background Data. Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. Methods. This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)-–both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain–related health care costs were valued for 2004 from the societal perspective. Results. For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. Conclusion. Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone. The study presents a secondary cost-effectiveness analysis of 2 guideline implementation strategies alongside a cluster randomized trial. Trends in favor of both interventions are visible, but effects attenuate when adjusting for health care utilization prior to the study period.

In industrialized countries, low back pain (LBP) is one of the leading causes for prolonged sick leave, early retirement, and high health care costs. Providing the same treatments to all patients is neither effective nor feasible, and may impede patients' recovery. Recent studies have outlined the need for subgroup-specific treatment allocation.This is a cross-sectional study that used baseline data from consecutively recruited patients participating in a guideline implementation trial regarding LBP in primary care. Classification variables were employment status, age, pain intensity, functional capacity (HFAQ), depression (CES-D), belief that activity causes pain (FABQ subscale), 2 scales of the SF-36 (general health, vitality), and days in pain per year. We performed k-means cluster analyses and split-half cross-validation. Subsequently, we investigated whether the resulting groups incurred different direct and indirect costs during a 6-month period before the index consultation.A 4-cluster solution showed good statistical quality criteria, even after split-half cross-validation. "Elderly patients adapted to pain" (cluster 1) and "younger patients with acute pain" (cluster 4) accounted for 55% of all patients. Cluster validation showed the lowest direct and indirect costs in these groups. About 72% of total costs per patient referred to clusters 2 and 3 ("patients with chronic severe pain with comorbid depression" and "younger patients with subacute pain and emotional distress").Our study adds substantially to the knowledge of LBP-related case-mix in primary care. Information on differential health care needs may be inferred from our study, enabling decision makers to allocate resources more appropriately and to reduce costs.

AimTo investigate the frequencies of different and relevant underlying etiologies of chest pain in general practice.MethodsWe systematically searched PubMed and EMBASE. Two reviewers independently rated the eligibility of publications and assessed the risk of bias of included studies. We extracted data to calculate the relative frequencies of different underlying conditions and investigated the variation across studies using forest plots, I2, tau2, and prediction intervals. With respect to unexplained heterogeneity, we provided qualitative syntheses instead of pooled estimates.ResultsWe identified 11 eligible studies comprising about 6500 patients. The overall risk of bias was rated as low in 6 studies comprising about 3900 patients. The relative frequencies of different conditions as the underlying etiologies of chest pain reported by these studies ranged from 24.5 to 49.8% (chest wall syndrome), 13.8 to 16.1% (cardiovascular diseases), 6.6 to 11.2% (stable coronary heart disease), 1.5 to 3.6% (acute coronary syndrome/myocardial infarction), 10.3 to 18.2% (respiratory diseases), 9.5 to 18.2% (psychogenic etiologies), 5.6 to 9.7% (gastrointestinal disorders), and 6.0 to 7.1% (esophageal disorders).ConclusionThis information may be of practical value for general practitioners as it provides the pre-test probabilities for a range of underlying diseases and may be suitable to guide the diagnostic process.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Epidemiologic surveys frequently show that women more often and are more affected by low back pain (LBP). The aim of this secondary analysis of a randomized controlled study was to explore whether presentation and course of LBP of women is different from men, and if sex affects the use of healthcare services for LBP.Data from 1342 [778 (58%) women] patients presenting with LBP in 116 general practices were collected. Patients completed standardized questionnaires before and after consultation and were contacted by phone 4 weeks, 6 months, and 12 months later for standardized interviews by study nurses. Functional capacity was assessed with Hannover Functional Ability Questionnaire (HFAQ). Logistic regression models-adjusting for sociodemographic and disease-related data-were conducted to investigate the effect of sex for the use of healthcare services.Women had on average a lower functional capacity at baseline and after 12 months. They were more likely to have recurrent or chronic LBP and to have a positive depression score. Being female was associated with a low functional capacity after 12 months (odds ratio: 1.7, 95% confidence interval: 1.2-2.3), but baseline functional capacity, chronicity, and depression were stronger predictors. In univariate analysis, women had a tendency of higher use of healthcare services. Those differences disappeared after adjustment.Our findings confirm that women are more severely affected by LBP and have a worse prognosis. Utilization of healthcare services cannot be fully explained by female sex, but rather by a higher impairment by back pain and pain in other parts of the body characteristic of the female population.

The Platelet Function Analyzer (PFA-100) is increasingly being used in the workup of patients with a bleeding diathesis. A profound knowledge of the possible diagnostic performance of this test is essential in order to make sound clinical decisions based on its results. It was the aim of this study to systematically review the published literature and provide valid estimates of the diagnostic performance of the PFA-100 for detecting disorders of primary haemostasis in newly presenting patients with a bleeding diathesis. A comprehensive literature search was performed for studies published between January 1994 and February 2006. Studies were eligible for the systematic review if they provided data supposed to be applicable to the determination of the diagnostic performance of the PFA-100. Furthermore, they were included in a meta-analysis if study reporting allowed calculation of sensitivity and specificity and if study quality ensured minimized biases of these estimates for the described clinical setting. Pooled weighted sensitivity, specificity and diagnostic odds ratio were calculated applying random effects modelling and constructing summary operator characteristic curves. This was done separately for the available test modifications using either collagen/epinephrine (PFA-EPI) or collagen/adenosine-diphosphate (PFA-ADP) for platelet activation. Thirty-six articles were included in the systematic review. Six studies met our eligibility criteria for a meta-analysis. The major reason for exclusion from the meta-analysis was a case-control design. A total of 1486 and 1259 patients were included in the meta-analysis of the diagnostic performance of the PFA-EPI and PFA-ADP, respectively. Pooled weighted sensitivity and specificity of the PFA-EPI/PFA-ADP in detecting a disorder of primary haemostasis were: 82.5/66.9% (95%-confidence interval (95%-CI): 76.0-88.9%/57.9-75.9%), and 88.7/85.5% (95%-CI: 84.3-93.1%/82.0-89.1%). 83/75% of patients with a positive PFA-EPI/PFA-ADP result do have a disorder of primary haemostasis whereas 88/79% with a negative PFA-EPI/PFA-ADP result do not. The PFA-EPI appeared to have a higher sensitivity and better predictive values than the PFA-ADP in detecting disorders of primary haemostasis, although a rigorous gold standard definition for a disorder of primary haemostasis, particularly for platelet disorders, was not applied in most studies. The majority of the studies lacked important requirements for quality and reporting, precluding a more precise and definitive characterization of the clinical utility of the PFA-100. This emphasizes the need for an evidence-based critical appraisal of diagnostic studies in haemostasis research in order to promote the conducting of studies that produce clinically relevant results.

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. 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 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. 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.

Abstract Guidelines portray low back pain (LBP) as a benign self‐limiting disease which should be managed mainly by primary care physicians. For the German health care system we analyze which factors are associated with receiving specialist care and how this affects treatment. This is a longitudinal prospective cohort study. General practitioners recruited consecutive adult patients presenting with LBP. Data on physical function, on depression, and on utilization of health services were collected at the first consultation and at follow‐up telephone interviews for a period of 12 months. Logistic regression models were calculated to investigate predictors for specialist consultations and use of specific health care services. Large proportions (57%) of the 1342 patients were seeking additional specialist care. Although patients receiving specialist care had more often chronic LBP and a positive depression score, the association was weak. A total of 623 (46%) patients received some form of imaging, 654 (49%) physiotherapy and 417 (31%) massage. Consulting a specialist remained the strongest predictor for imaging and therapeutic interventions while disease‐related and socio‐demographic factors were less important. Our results suggest that the high use of specialist care in Germany is due to the absence of a functioning primary care gate keeping system for patient selection. The high dependence of health care service utilization on providers rather than clinical factors indicates an unsystematic and probably inadequate management of LBP.

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.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.

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

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.

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.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.

Chest wall syndrome (CWS) is the most frequent aetiology of chest pain in a primary care setting.The aims of the study are to describe the epidemiology, clinical characteristics and prognosis of CWS and to provide a simple decision rule for diagnosis.We included 1212 consecutive patients with chest pain aged 35 years and older attending 74 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 the diagnosis of CWS.GPs diagnosed pain originating from the chest wall in 46.6% of all patients. In most patients, pain was localized retrosternal (52.0%) and/or on the left side (69.2%). In total, 28.0% of CWS patients showed persistent pain and most patients reported no temporal association of pain (72.3%). In total, 55.4% of patients still had chest pain after 6 months. A simple score containing four determinants (localized muscle tension, stinging pain, pain reproducible by palpation and absence of cough) shows an area under the receiver operating characteristic curve of 0.78 (95% confidence interval: 0.75-0.81).This study broadens the knowledge about pain characteristics and the diagnostic accuracy of selected signs and symptoms for CWS. A simple four-point score can help the GP in the diagnostic workup of chest pain patients.

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 1966 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.

Shared decision making (SDM) is often advocated as an ideal for making medical decisions. Until now, however, opinions regarding which treatment situations warrant SDM have not been systematically investigated. The purpose of this study was to examine social norms regarding medical decision making, using a factorial survey design.The factorial survey applied in this study consisted of 7 situational factors (e.g., the reason for consultation), each with 2 to 3 levels (e.g., prevention and severe disease). These factors were turned into various descriptions of treatment situations. A total of 101 physicians, 115 patients, and 113 members of self-help groups participated in the study. Each participant assessed 10 vignettes using a 5-point scale to indicate who they thought should make the decision in each specific situation.Most assessments across the 3 groups called for a shared decision (39%). Ordered logistic regression analysis demonstrated that, according to study participants, all 7 situational factors (reason for consultation, time frame of negative outcomes, time pressure, number of therapeutic options, side effects, scientific evidence of efficacy, and desire to participate) significantly affected how decisions regarding treatment should be made. The strongest factor was the patient's desire to participate in decision making (odds ratio = 1.84; P ≤ 0.001), followed by the reason for consultation (odds ratio = 0.69; P ≤ 0.001).This study reveals that there is a general desire for SDM in a variety of treatment situations. Furthermore, based on the responses of our participants, our findings also lay the framework in determining which treatment situations warrant SDM.

Background. While dichotomous tasks and related cognitive strategies have been extensively researched in cognitive psychology, little is known about how primary care practitioners (general practitioners [GPs]) approach ill-defined or polychotomous tasks and how valid or useful their strategies are. Objective. To investigate cognitive strategies used by GPs for making a diagnosis. Methods. In a cross-sectional study, we videotaped 282 consultations, irrespective of presenting complaint or final diagnosis. Reflective interviews were performed with GPs after each consultation. Recordings of consultations and GP interviews were transcribed verbatim and analyzed using a coding system that was based on published literature and systematically checked for reliability. Results. In total, 134 consultations included 163 diagnostic episodes. Inductive foraging (i.e., the initial, patient-guided search) could be identified in 91% of consultations. It contributed an average 31% of cues obtained by the GP in 1 consultation. Triggered routines and descriptive questions occurred in 38% and 84% of consultations, respectively. GPs resorted to hypothesis testing, the hallmark of the hypothetico-deductive method, in only 39% of consultations. Limitations. Video recordings and interviews presumably interfered with GPs’ behavior and accounts. GPs might have pursued more hypotheses and collected more information than usual. Conclusions. The testing of specific disease hypotheses seems to play a lesser role than previously thought. Our data from real consultations suggest that GPs organize their search for information in a skillfully adapted way. Inductive foraging, triggered routines, descriptive questions, and hypotheses testing are essential building blocks to make a diagnosis in the generalist setting.

<h2>Abstract</h2><h3>Objective</h3> Low disease prevalence poses challenges for diagnostic accuracy studies because of the large sample sizes that are required to obtain sufficient precision. The aim is to collate and discuss designs of diagnostic accuracy studies suited for use in low-prevalence situations. <h3>Study Design and Setting</h3> We conducted a literature search including backward citation tracking and expert consultation. Two reviewers independently selected studies on designs for estimating diagnostic accuracy in a low-prevalence situation. During a 1-day expert meeting, all designs were discussed and recommendations were formulated. <h3>Results</h3> We identified six designs for diagnostic accuracy studies that are suitable in low-prevalence situations because they reduced the total sample size or the number of patients undergoing the index test or reference standard depending on which poses the highest burden. We described the advantages and limitations of these designs and evaluated efficiencies in sample sizes, risk of bias, and alignment with the clinical pathway for applicability in routine care. <h3>Conclusion</h3> Choosing a study design for diagnostic accuracy studies in low-prevalence situations should depend on whether the aim is to limit the number of patients undergoing the index test or reference standard, and the risk of bias associated with a particular design type.

Abstract Background 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. Methods 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. Results 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%. Conclusions 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.

To assess the feasibility and outcome of measuring the theory of planned behaviour (TPB) in patients receiving routine counselling versus counselling with a decision aid (DA) during primary care consultation on cardiovascular risk prevention. A DA was developed, based on models of shared decision-making (SDM) and the TPB. We evaluated the impact of the intervention in a randomized controlled trial. Main outcomes were previously reported. To assess the intermediate social cognitive processes and our theoretical framework, we evaluated the impact of the intervention on a TPB scale. The TPB scale showed satisfactory measurement properties. Factor analysis (main component analysis, confirmatory model) could mostly replicate the assumptions of the model. 44% of variance of the behavioural intention to adhere to the decision after counselling was explained in linear regression models. Of the TPB components, only attitude towards the decision and moral norm were significantly more positive in the intervention. No difference was found with regard to intention to adhere to the decision. High risk resulted in higher values of the TPB components in both groups. Most DAs are developed and tested without explicitly referring to a theoretical model of psychosocial processes. The TPB may serve as a useful theoretical framework. Trials on DAs demonstrate positive effects on psychological outcomes of patients without leading to better objective health results. Our study might contribute to an explanation: DAs might not cause stronger adherence to decisions even though one's attitude towards the decision becomes more positive.

Arriving at an agreed-on and valid explanation for a clinical problem is important to patients as well as to clinicians. Current theories of how clinicians arrive at diagnoses, such as the threshold approach and the hypothetico-deductive model, do not accurately describe the diagnostic process in general practice. The problem space in general practice is so large and the prior probability of each disease being present is so small that it is not realistic to limit the diagnostic process to testing specific diagnoses on the clinician's list of possibilities. Here, new evidence is discussed about how patients and clinicians collaborate in specific ways, in particular, via a process that can be termed inductive foraging, which may lead to information that triggers a diagnostic routine. Navigating the diagnostic challenge and using patient-centered consulting are not separate tasks but rather synergistic.

Abstract Background Collaborative care approaches between general practitioners (GPs) and pharmacists have received international recognition for medication optimization and deprescribing efforts. Although specialist providers have been shown to influence deprescribing, their profession so far remains omitted from collaborative care approaches for medication optimization. Similarly, while explorative studies on role perception and collaboration between GPs and pharmacists grow, interaction with specialists for medication optimization is neglected. Our qualitative study therefore aims to explore GPs’, community pharmacists’ and specialist providers’ role perceptions of deprescribing, and to identify interpersonal as well as structural factors that may influence collaborative medication optimization approaches. Method Seven focus-group discussions with GPs, community pharmacists and community specialists were conducted in Hesse and Lower Saxony, Germany. The topic guide focused on views and experiences with deprescribing with special attention to inter-professional collaboration. We conducted conventional content analysis and conceptualized emerging themes using the Theoretical Domains Framework. Results Twenty-six GPs, four community pharmacists and three community specialists took part in the study. The main themes corresponded to the four domains ‘Social/professional role and identity’ (1), ‘Social influences’ (2), ‘Reinforcement’ (3) and ´Environmental context and resources’ (4) which were further described by beliefs statements, that is inductively developed key messages. For (1), GPs emerged as central medication managers while pharmacists and specialists were assigned confined or subordinated tasks in deprescribing. Social influences (2) encompassed patients’ trust in GPs as a support, while specialists and pharmacists were believed to threaten GPs’ role and deprescribing attempts. Reinforcements (3) negatively affected GPs’ and pharmacists’ effort in medication optimization by social reprimand and lacking reward. Environmental context (4) impeded deprescribing efforts by deficient reimbursement and resources as well as fragmentation of care, while informational and gate-keeping resources remained underutilized. Conclusion Understanding stakeholders’ role perceptions on collaborative deprescribing is a prerequisite for joint approaches to medication management. We found that clear definition and dissemination of roles and responsibilities are premise for avoiding intergroup conflicts. Role performance and collaboration must further be supported by structural factors like adequate reimbursement, resources and a transparent continuity of care.

Abstract Background For evidence-based decision making, primary care physicians need to have specific and reliable information on the pre-test probabilities of underlying diseases and a symptom’s course. We performed a systematic review of symptom-evaluating studies in primary care, following three research questions: (1) What is the prevalence of the symptom cough in children consulting primary care physicians? (2) What are the underlying aetiologies of cough and the respective frequencies? (3) What is the prognosis of children with cough? Methods Following a pre-defined algorithm and independent double reviewer ratings we searched MEDLINE and EMBASE. All quantitative original research articles in English, French or German were included if they focused on unselected study populations of children consulting a primary care physician for cough. We used the random effects model for meta-analysis in subgroups, if justifiable in terms of heterogeneity. Results We identified 14 eligible studies on prevalence, five on aetiology and one on prognosis. Prevalence estimates varied between 4.7 and 23.3% of all reasons for an encounter, or up to estimates of 60% when related to patients or consultations. Cough in children is more frequent than in adults, with lowest prevalences in adolescents and in summer. Acute cough is mostly caused by upper respiratory tract infections (62.4%) and bronchitis (33.3%); subacute or chronic cough by recurrent respiratory tract infection (27.7%), asthma (up to 50.4% in cough persisting more than 3 weeks), and pertussis (37.2%). Potentially serious diseases like croup, pneumonia or tuberculosis are scarce. In children with subacute and chronic cough the total duration of cough ranged from 24 to 192 days. About 62.3% of children suffering from prolonged cough are still coughing two months after the beginning of symptoms. Conclusion Cough is one of the most frequent reasons for an encounter in primary care. Our findings fit in with current guideline recommendations supporting a thoughtful wait-and-see approach in acute cough and a special awareness in chronic cough of the possibility of asthma and pertussis. Further evidence of aetiological pre-test probabilities is needed to assess the diagnostic gain based on patient history and clinical signs for differential diagnoses of cough in children.

To examine the psychometric properties of the German version of the 'observing patient involvement' scale (OPTION) by analysing video recordings of primary care consultations dealing with counselling in cardiovascular prevention.Cross-sectional assessment of physician-patient interaction by two rater pairs and two experts in shared decision making (SDM).Primary care.Fifteen general practitioners provided 40 videographed consultations.Video ratings using the OPTION instrument.Mean differences on item level between the four raters were quite large. Most items were skewed towards minimal levels of shared decision making. Measures of inter-rater association showed low to moderate associations on item level and high associations on total score level. Cronbach-α of the whole scale based on the data of all four raters is 0.90 and therefore on a high level. An oblique factor analysis revealed two factors, but both factors were highly correlated so we can confirm a one-dimensional structure of the instrument. ROC analyses between the rater total scores and dichotomized expert ratings (SDM yes/no) revealed a good discriminability of the OPTION total score. Physicians with more expertise in shared decision making received higher OPTION ratings.The German version of the OPTION scale is reliable at total score level. Some items need further revision in the direction of more concrete, observable behaviour. We were only able to perform a quasi-validation of the scale. Validity issues need further research efforts.

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.

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.

Background: Physicians attempting to make a diagnosis arrive at specific hypotheses early in their encounter with patients. Further data are collected in the light of these early hypotheses. While this hypothetico-deductive model has been accepted as both a description of physicians’ data gathering and a norm, little attention has been paid to the preceding stage of the consultation.Hypothesis: It is suggested that ‘inductive foraging’ is a relevant and appropriate mode of data acquisition for the first part of the patient encounter.Methods: Research evidence from cognitive psychology and medical reasoning research is discussed.Results: With inductive foraging, ‘pattern failure’ rather than ‘pattern recognition’ is the mode of discovery. Largely, guidance should be left to the patient to lead the clinician into areas where departures from normality are to be found. This is in contrast to active and focused ‘deductive inquiry,’ which should be used only after most aetiologies, but a few have eliminated.Implication: Especially when the prevalence of serious disease is low, and a wide range of diagnoses must be evaluated, such as in General Practice, inductive foraging is a rational and efficient diagnostic strategy. Previously, too little attention has been paid to the initial stage of the consultation. Premature closure at this point may result in diagnostic error.

The Marburg Heart Score (MHS) is a simple, valid, and robust clinical decision rule assisting GPs in ruling out coronary heart disease (CHD) in patients presenting with chest pain.To investigate whether using the rule adds to the GP's clinical judgement.A comparative diagnostic accuracy study was conducted using data from 832 consecutive patients with chest pain in general practice.Three diagnostic strategies were defined using the MHS: diagnosis based solely on the MHS; using the MHS as a triage test; and GP's clinical judgement aided by the MHS. Their accuracy was compared with the GPs' unaided clinical judgement.Sensitivity and specificity of the GPs' unaided clinical judgement was 82.9% (95% confidence interval [CI] = 72.4 to 89.9) and 61.0% (95% CI = 56.7 to 65.2), respectively. In comparison, the sensitivity of the MHS was higher (difference 8.5%, 95% CI = -2.4 to 19.6) and the specificity was similar (difference -0.4%, 95% CI = -5.3 to 4.5); the sensitivity of the triage was similar (difference -1.5%, 95% CI = -9.8 to 7.0) and the specificity was higher (difference 11.6%, 95% CI = 7.8 to 15.4); and both the sensitivity and specificity of the aided clinical judgement were higher (difference 8.0%, 95% CI = -6.9 to 23.0 and 5.8%, 95% CI = -1.6 to 13.2, respectively).Using the Marburg Heart Score for initial triage can improve the clinical diagnosis of CHD in general practice.

Fatigue is a main or secondary reason for 10-20% of all consultations with a primary care physician.This review is based on pertinent publications retrieved by a comprehensive, selective literature search on the epidemiology, etiology, and diagnostic evaluation of fatigue as a leading symptom of disease, as well as on the treatment of its common causes. Information was also included from the literature search we conducted for the German clinical practice guideline on fatigue that was issued by the German College of General Practitioners and Family Physicians (Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin, DEGAM).Fatigue can be due to any of a broad spectrum of diseases, including decompensation of already known conditions. Sleep disorders and sleep-related disorders of breathing, depression (18.5%), and excessive psychosocial stress are the most common causes of persistent fatigue. Previously undiagnosed cancer is a rare cause, accounting for only 0.6% of cases (95% confidence interval [0.3; 1.3]). Anemia and other organic causes are rare as well (4.3% [2.7; 6.7]). Investigations beyond the history, physical examination, and simple laboratory tests are needed only in the presence of additional symptoms or findings. If the diagnosis remains unclear, watchful waiting and regularly scheduled follow-up help prevent an excessive focus on somatic causes, leading to overdiagnosis. Irrespective of specific causes, psychoeducative and psychotherapeutic approaches should be discussed with the patient, as well as an individually adapted exercise program.The work-up of fatigue as a chief complaint should be guided by investigating common and/or potentially dangerous disorders. Since the latter are rare, an exclusively somatic focus should be avoided in order to prevent overdiagnosis.

Depression is common among older people. It is associated with increased mortality and use of health services. We could identify no prior systematic review of treatment for depression in either primary care attenders or population samples of older people.The aim of this study was to carry out a systematic review of trials of treatments for depression of patients over 60 years of age in primary care or population samples.We searched Medline, Embase, Cinahl, the Cochrane Library, Psyclit, BIDS--Social Science and BIDS--Science Citation Indices for trials of drug treatment, interpersonal psychotherapy, cognitive behavioural psychotherapy, counselling and social interventions for late life depression in English, French or German published between 1980 and June 1999.Of the studies identified, only two were of patients over 60 years of age and met all inclusion criteria for content and quality. Three further studies that were not restricted to but included patients over the age of 60 years also fulfilled our criteria. We found no studies of psychological therapies for depression in older people. With few exceptions, studies were limited to older people who reached a diagnostic threshold and excluded those with 'subcase level depression'.There is little evidence of effectiveness for a variety of treatment approaches for depression in older people in primary care, particularly in those with less severe depression. As older people take more medication, making contra-indications to the use of antidepressant drugs more likely, there is a pressing need for studies of the efficacy of non-pharmacological interventions in primary care settings.

Up to now it has not been systematically investigated in which kind of clinical situations a consultation style based on shared decision making (SDM) is preferred by patients and physicians. We suggest the factorial survey design to address this problem.This method, which so far has hardly been used in health service research, allows to vary relevant factors describing clinical situations as variables systematically in an experimental random design and to investigate their importance in large samples.To identify situational factors for the survey we first performed a literature search which was followed by a qualitative interview study with patients, physicians and health care experts. As a result, 7 factors (e.g. "Reason for consultation" and "Number of therapeutic options") with 2 to 3 levels (e.g. "One therapeutic option" and "More than one therapeutic option") will be included in the study. For the survey the factor levels will be randomly combined to short stories describing different treatment situations.A randomized sample of all possible short stories will be given to at least 300 subjects (100 GPs, 100 patients and 100 members of self-help groups) who will be asked to rate how the decision should be made. Main outcome measure is the preference for participation in the decision making process in the given clinical situation.Data analysis will estimate the effects of the factors on the rating and also examine differences between groups.The results will reveal the effects of situational variations on participation preferences. Thus, our findings will contribute to the understanding of normative values in the medical decision making process and will improve future implementation of SDM and decision aids.

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.ISRCTN: ISRCT71348772.

Acute chest pain of non-traumatic origin is a common reason for presentation to physician's offices and emergency rooms. Coronary heart disease is the cause in up to 25% of cases. Because acute chest pain, depending on its etiology, may be associated with a high risk of death, rapid, goal-oriented management is mandatory.This review is based on pertinent articles and guidelines retrieved by a selective search in PubMed.History-taking, physical examination, and a 12-lead electrocardiogram (ECG) are the first steps in the differential diagnostic process and generally allow the identification of features signifying a high risk of lifethreatening illness. If the ECG reveals ST-segment elevation, cardiac catheterization is indicated. The timedependent measurement of highly sensitive troponin values is a reliable test for the diagnosis or exclusion of acute myocardial infarction. A wide variety of other potential causes (e.g., vascular, musculoskeletal, gastroenterologic, or psychosomatic) must be identified from the history if they are to be treated appropriately. Elderly patients need special attention.Acute chest pain is a major diagnostic challenge for the physician. Common errors are traceable to non-recognition of important causes and to an inadequate diagnostic work-up. Future studies should be designed to help optimize the interdisciplinary management of patients with chest pain.

Objective To construct a clinical prediction rule for coronary artery disease (CAD) presenting with chest pain in primary care. Study Design and Setting Meta-Analysis using 3,099 patients from five studies. To identify candidate predictors, we used random forest trees, multiple imputation of missing values, and logistic regression within individual studies. To generate a prediction rule on the pooled data, we applied a regression model that took account of the differing standard data sets collected by the five studies. Results The most parsimonious rule included six equally weighted predictors: age ≥55 (males) or ≥65 (females) (+1); attending physician suspected a serious diagnosis (+1); history of CAD (+1); pain brought on by exertion (+1); pain feels like “pressure” (+1); pain reproducible by palpation (−1). CAD was considered absent if the prediction score is <2. The area under the ROC curve was 0.84. We applied this rule to a study setting with a CAD prevalence of 13.2% using a prediction score cutoff of <2 (i.e., −1, 0, or +1). When the score was <2, the probability of CAD was 2.1% (95% CI: 1.1–3.9%); when the score was ≥ 2, it was 43.0% (95% CI: 35.8–50.4%). Conclusions Clinical prediction rules are a key strategy for individualizing care. Large data sets based on electronic health records from diverse sites create opportunities for improving their internal and external validity. Our patient-level meta-analysis from five primary care sites should improve external validity. Our strategy for addressing site-to-site systematic variation in missing data should improve internal validity. Using principles derived from decision theory, we also discuss the problem of setting the cutoff prediction score for taking action.

To analyse the prevalence and incidence of pregabalin and gabapentin (P/G) prescriptions, typical therapeutic uses of P/G with special attention to pain-related diagnoses and discontinuation rates.Secondary data analysis.Primary and secondary care in Germany.Four million patients in the years 2009-2015 (anonymous health insurance data).None.P/G prescribing rates, P/G prescribing rates associated with pain therapy, analysis of pain-related diagnoses leading to new P/G prescriptions and the discontinuation rate of P/G.In 2015, 1.6% of insured persons received P/G prescriptions. Among the patients with pain first treated with P/G, as few as 25.7% were diagnosed with a typical neuropathic pain disorder. The remaining 74.3% had either not received a diagnosis of neuropathic pain or showed a neuropathic component that was pathophysiologically conceivable but did not support the prescription of P/G. High discontinuation rates were observed (85%). Among the patients who had discontinued the drug, 61.1% did not receive follow-up prescriptions within 2 years.The results show that P/G is widely prescribed in cases of chronic pain irrespective of neuropathic pain diagnoses. The high discontinuation rate indicates a lack of therapeutic benefits and/or the occurrence of adverse effects.

Diagnosen zu stellen ist eine zentrale ärztliche Aufgabe. Mit klinischen Leitlinien und Handlungsempfehlungen bietet medizinische Forschung dazu die Grundlage. Aber im Alltag kommen vielfältige, oft widersprüchliche Gesichtspunkte hinzu: kollegiale Normen, Erwartungen von Patient*innen, wirtschaftliche Anreize, erstaunliche Traditionen und eine ärztliche Erfahrung, die tiefe Weisheiten, aber auch Irreführungen und Trugschlüsse umfassen kann. Das Buch macht deutlich, dass neben medizinischen Erkenntnissen auch Ethnologie, Philosophie, Psychologie und Medizingeschichte helfen, diesen Alltag zu verstehen; ihre Befunde sind handlungsrelevant für Praxis und Krankenhaus. Für angehende, aber auch erfahrene Ärzt*innen liest sich das Buch daher spannend und erhellend. Worauf basieren die im klinischen Alltag erlernten Diagnosen? Wie und warum werden Entscheidungen getroffen? Zuviel oder zu wenig Patientenpartizipation? Welche Rolle sollen technische Untersuchungen spielen? Welche Konsequenzen haben ärztliche Diagnosen für Patient*innen, Versorgungsstrukturen und die oft langfristige Weiterbehandlung. Fallbeispiele, klinische Bezüge und zusammenfassende Darstellungen, erleichtern das Verständnis und ermutigen dazu, Widersprüche und Paradoxien zu erkennen und auszuhalten, um so zu einer souveränen Grundhaltung zu finden und auch bei nicht eindeutigen Fällen verantwortungsvolle Entscheidungen treffen zu können.

Abstract Background Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled “ P revention by lay-assisted O utdoor- W alking in the E lderly at R isk” POWER-study investigates whether volunteer-supported outdoor-walking improves physical function and quality of life in older people living independently or in nursing homes. This sub-study explores the experiences of older participants and volunteers in relation to their physical and psychosocial well-being as well as the challenges faced by both groups. A further aim was to explore volunteers’ experience with people living in nursing homes during the first pandemic lockdown (spring 2020). Methods The sub-study was designed as mixed-methods approach consisting of 11 individual semi-structured guide-based interviews (nursing home residents), two focus group interviews (volunteers), and a cross-sectional questionnaire survey (volunteers). The interviews were audiotaped, transcribed verbatim, and analyzed by content analysis as described by Kuckartz. Topics addressed in the interviews were triangulated by means of a questionnaire. The quantitative data were analyzed using descriptive statistics. Results Participants’ evaluation of the intervention was generally positive. Nursing home residents appreciated the social interaction associated with the assisted walking, which motivated them to take part regularly, provided a sense of safety, and caused pleasure on both sides. The impact on physical health status of the nursing home residents of this sub-study varied to a large degree as reported in interviews: in some cases, an improvement in physical performance, a decrease in physical complaints, and an improvement in gait or independence was reported. If not, reference was made to previous or sudden illnesses and the advanced age of the participants. Despite the COVID-19-lockdown and the associated restrictions, about 60% of contacts were still possible and participants planned to continue the assisted walks after the lockdown. Conclusion Volunteers have a positive effect on the quality of life, mobility, and general health of nursing home residents. Even more than the improvement of physical performance, social interaction was seen as helpful. Despite their advanced age, the nursing home residents were curious and open to new contacts. When removing the identified barriers, it might be possible to integrate this program into the long-term everyday life of nursing homes. Trial registration DRKS-ID: DRKS00015188, date of registration: 31.08.2018.

Abstract Background The rates of coronary angiograms (CA) and related procedures (percutaneous intervention [PCI]) are significantly higher in Germany than in other Organisation for Economic Co-ordination and Development (OECD) countries. The current guidelines recommend non-invasive diagnosis of coronary heart disease (CHD); CA should only have a limited role in choosing the appropriate revascularisation procedure. The aim of the present study was to explore whether improvements in guideline adherence can be achieved through the implementation of regional treatment pathways. We chose four regions of Germany with high utilisation of CAs for the study. Here we report the results of the concomitant qualitative study. Methods General practitioners and specialist physicians (cardiologists, hospital-based cardiologists, emergency physicians, radiologists and nuclear medicine specialists) caring for patients with suspected CHD were invited to develop regional treatment pathways. Four academic departments provided support for moderation, provision of materials, etc. The study team observed session discussions and took notes. After the development of the treatment pathways, 45 semi-structured interviews were conducted with the participating physicians. Interviews and field notes were transcribed verbatim and underwent qualitative content analysis. Results Pathway development received little support among the participants. Although consensus documents were produced, the results were unlikely to improve practice. The participants expressed very little commitment to change. Although this attempt clearly failed in all study regions, our experience provides relevant insights into the process of evidence appraisal and implementation. A lack of organisational skills, ignorance of current evidence and guidelines, and a lack of feedback regarding one’s own clinical behaviour proved to be insurmountable. CA was still seen as the diagnostic gold standard by most interviewees. Conclusions Oversupply and overutilisation can be assumed to be present in study regions but are not immediately perceived by clinicians. The problem is unlikely to be solved by regional collaborative initiatives; optimised resource planning within the health care system combined with appropriate economic incentives might best address these issues.

In patients with chest pain, GPs have to identify those with coronary heart disease (CHD) to arrange for further investigation and treatment. Previous studies have shown that only between 8% and 18% of patients have CHD. In primary care, the history is the most important diagnostic tool. However, there are only few studies exploring diagnostic criteria that GPs actually use in their daily practice.To identify GPs' diagnostic criteria for diagnosing CHD in patients with chest pain.In a semi-structured interview, 23 GPs were asked to describe their individual diagnostic criteria in two of their patients with chest pain they had prospectively identified. Interview data were taped, transcribed and analysed qualitatively.Histories of 39 patients were described, of which 17 patients were thought to have CHD and/or an indication for an emergency hospital admission. GPs mentioned the person-specific discrepancy, that is differences in behaviour or a different appearance of a patient in comparison to previous consultations, as an important diagnostic criterion. Known risk factors for CHD and past illness behaviour also influenced the GPs' diagnoses.Apart from classical textbook criteria, GPs make use of their prior knowledge of individual patients in a specific way. Discrepancies between previous and actual consultations alert the GPs for serious diseases. At the primary care level, medical practitioners use criteria that differ from secondary or tertiary care.

Background: Evidence on the effectiveness of educational interventions on prescribing behaviour modification in prevention of cardiovascular disease is still insufficient. We evaluated the effects of a brief educational intervention on prescription of hydroxymethylglutaryl-CoA reductase inhibitors (statins), inhibitors of platelet aggregation (IPA), and antihypertensive agents (AH). Design: Cluster randomised controlled trial with continuous medical education (CME) groups of general practitioners (GPs). Methods: Prescription of statins, IPA, and AH were verified prior to study start (BL), immediately after index consultation (IC), and at follow-up after 6 months (FU). Prescription in patients at high risk (&gt;15% risk of a cardiovascular event in 10 years, based on the Framingham equation) and no prescription in low-risk patients (≤ 15%) were considered appropriate. Results: An intervention effect on prescribing could only be found for IPA. Generally, changes in prescription over time were all directed towards higher prescription rates and persisted to FU, independent of risk status and group allocation. Conclusions: The active implementation of a brief evidence-based educational intervention on global risk in CVD did not lead directly to risk-adjusted changes in prescription. Investigations on an extended time scale would capture whether decision support of this kind would improve prescribing risk-adjusted sustainably.

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.

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.The study is registered with Deutsches Register Klinischer Studien (DRKS00004633).

Psychological constructs depend on cultural context. It is therefore important to show the equivalence of measurement instruments in cross-cultural research. There is evidence that in Russian-speaking immigrants, cultural and language issues are important in health care. We examined measurement equivalence of the Patient Health Questionnaire-9 (PHQ-9), the Patient Health Questionnaire-15 (PHQ-15), the Hamburg Self-Care Questionnaire (HamSCQ), and the questionnaire on communication preferences of patients with chronic illness (KOPRA) in native-born Germans, Russian-speaking immigrants living in Germany, and native-born Russians living in the former Soviet Union (FSU). All four questionnaires fulfilled requirements of measurement equivalence in confirmatory factor analyses and analyses of differential item functioning. The Russian translations can be used in Russian-speaking immigrants and native-born Russians. This offers further possibilities for cross-cultural research and for an improvement in health care research in Russian-speaking immigrants in Germany. The most pronounced differences occurred in the KOPRA, which point to differences in German and Russian health care systems.

In the last 15 years Evidence-based Medicine (EbM) has gained much publicity in the German-speaking countries, but it is currently difficult to conclude how much the contents of EbM with its five steps according to Sackett have spread. Data from the year 2006 show that less than half of all medical faculties in Germany have introduced EbM into undergraduate teaching and that there is a shortage in EbM teaching activities for graduates in the German-speaking countries as well. The goal of this survey is to display the undergraduate and graduate Evidence-based Practice teaching activities in the German-speaking countries.In a two-step survey, we first sent out a total of 551 letters to medical faculties, colleges, boards of physicians, the German Hospital Association, the associations of statutory health insurance physicians in Germany, the Medical Service of the German health insurances and asked the 30 participants of the 2011 EbM Academy as key informants in writing to give details about potential providers of EbM teaching activities. Via email we also consulted the members of the German-speaking colleges of general practitioners and family medicine and the German Network for EBM, course participants and contact persons of familiar teaching activities. In a second step a pre-tested detailed questionnaire with 36 items in the five categories framework and structure, participant characterisation, contents and didactics, evaluation and publication, and planning and publicity was sent to potential providers.Altogether 185 teaching activities were identified, 80 % of which were located in Germany, 13 % in Austria and 7 % in Switzerland. In 82.6 % of the cases it was either a seminar, a course or a workshop with a median of 20 participants and an average duration of 17.9hours. The teaching activities mainly addressed students (63.2 %), physicians (37.8 %), caregivers and members of other health care professions with little or no prior knowledge of EbM. The first three steps of EbM (formulating clinical questions, search for and appraisal of the literature) were taught in more than 75 % of the teaching activities, whereas steps four and five (integration of results, evaluation) were only taught in 53.9 % and 33.3 % of the cases, respectively.Compared to 2006, a remarkable increase in EbM teaching activities was observed in the German-speaking areas. These activities address different target audiences; the main content focus is on the first steps of EbM.

Diagnostic decision-making is usually disease-focussed and intended to examine the patient's medical condition accurately. But diagnostic interventions may serve further purposes that are not yet fully understood.To explore GPs' diagnostic behaviour not related to confirming or refuting a specific disease.We recorded 295 primary care consultations in 12 practices. One hundred thirty-four consultations comprised at least one diagnostic episode. GPs were asked to reflect on their own diagnostic thinking in interviews for every single case. Qualitative and quantitative analyses were applied with focus on the GPs' cognitive processes during diagnostic decision-making.Primary care physicians clearly stated that they requested some tests for other reasons than diagnosing disease. A feeling of uncertainty stimulated diagnostic procedures aiming to regulate the anticipation of regret. We identified patients' reassurance, patients' requests and strategic issues as further motives for diagnostic actions.Besides focussing on disease in the diagnostic process, emotional and strategic goals are hidden motives that play a critical role in clinical decision-making. They might even represent an initial factor in a cascade of interventions leading to overdiagnosis. How GPs might control these influences provides an important aspect for further research, practice and teaching.

The “Innovation Fund” provides incentives for the development and testing of healthcare innovations in the area of the statutory health insurance with the aim to improve the quality of care in Germany. Over a period of initially four years (2016-19), 300 million Euro will be allocated annually to projects on “innovative forms of healthcare provision” and “health services research”. Using a formalized procedure, the ten-member expert advisory board appointed by the German Federal Ministry of Health (BMG) assess all applications on the basis of various criteria for scientific quality, potential of innovation, relevance for health service delivery, and implementability. The present discussion paper sets out important considerations for submission and assessment and puts them up for discussion. (As supplied by the authors)

International concern about quality of medical care has led to intensive study of interventions to ensure care is consistent with best evidence. Simple, inexpensive, feasible and effective interventions remain limited.We examined the impact of one-sentence evidence summaries appended to consultants' letters to primary care practitioners on adherence of the practitioners to recommendations made by the consultants regarding medication for patients with chronic medical problems.Cluster-randomised trial.Secondary/primary care interface (urban district hospital/referral practices).178 practices received one or more discharge letters with evidence summaries. The 66 practices in the intervention group provided feedback on 172 letters, and the 56 practices in the control group provided feedback on 96 letters.Appending an evidence summary to discharge letters resulted in a decrease in non-adherence to discharge medication from 29.6% to 18.5% (difference adjusted for underlying medical condition 12.5%; p = 0.039). Among the five possible reasons for discontinuing discharge medication, the evidence summaries seemed to have the largest impact on budget-related reasons for discontinuation (2.6% in the intervention versus 10.7% in the control group (p = 0.052)). Most clinicians (72%) were enthusiastic about continuing receiving evidence summaries with discharge letters in routine care.The one-sentence evidence summary is a simple, inexpensive, well-accepted intervention that may improve primary care practitioners' adherence to evidence-based consultant recommendations.

From 1999 to 2001, the German Society of General Practice and Family Medicine (DEGAM) pioneered a faculty development programme to help general practitioners (GPs) interested in an academic career to develop their skills in teaching, primary care, quality assurance and research. The programme involves five weekend-training sessions over 18 months and applies a learner-centred approach. Participants choose the learning formats and switch between the roles of learners, teachers, chair persons and programme organizers. This article evaluates the acceptability and feasibility of the programme. Data were collected over a two-year period from the 16 participants who completed the first training programme. The evaluation involved a focus group, telephone interviews and email questionnaires. Participants appreciated the learner centred format of the programme and gained new teaching and research skills. They also learned to better assess and critically reflect on their professional work as GPs and reported improved academic ‘survival skills’ due to collaborative networks with colleagues. The faculty development programme proved advantageous for the personal and professional development of the participating GPs. It constitutes a promising tool for the further development of General Practice as an academic discipline that is still in the process of establishing itself at medical schools in Germany. The journey of a thousand miles begins with a first step: (Lao-Tse, 6th century B.C.)

Satisfaction with treatment is regarded as an important outcome measure, but its suitability has not been thoroughly investigated in the context of shared decision making (SDM). The authors evaluated whether both patients’ and physicians’ satisfaction ratings differ between an intervention group and a control group within a structured tool for cardiovascular prevention (ARRIBA-Herz). In a pragmatic, cluster-randomized, controlled trial, 44 family physicians in the intervention group consecutively recruited 550 patients whereas 47 physicians in the control group included 582 patients. Main findings were high satisfaction ratings independent of group allocation in patients and physicians. Significant differences had only negligible effect sizes. Compared to global satisfaction ratings, the effects of the shared decision-making process are better measured by a more concrete approach representing different steps of this process. Further research should refine behaviorally oriented questionnaires that measure SDM and a version for physicians should also be created.

In shared decision-making, patients are empowered to actively ask questions and participate in decisions about their healthcare based on their preferences and values. Decision aids should help patients make informed choices among diagnostic or treatment options by delivering evidence-based information on options and outcomes; however, they have rarely been field tested, especially in the primary care context. We therefore evaluated associations between the use of an interactive, transactional and evidence-based library of decision aids (arriba-lib) and communication and decision-making in patients and physicians in the primary care context.Our electronic library of decision aids ('arriba-lib') includes evidence-based modules for cardiovascular prevention, diabetes, coronary heart disease, atrial fibrillation and depression. Twenty-nine primary care physicians recruited 192 patients. We used questionnaires to ask patients and physicians about their experiences with and attitudes towards the programme. Patients were interviewed via telephone 2 months after the consultation. Data were analysed by general estimation equations, cross tab analyses and by using effect sizes.Only a minority (8.9%) of the consultations were felt to be too long because physicians said consultations were unacceptably extended by arriba-lib. We found a negative association between the detailedness of the discussion of the clinical problem's definition and the age of the patients. Physicians discuss therapeutic options in less detail with patients who have a formal education of less than 8 years. Patients who were counselled by a physician with no experience in using a decision aid more often reported that they do not remember being counselled with the help of a decision aid or do not wish to be counselled again with a decision aid.Arriba-lib has positive associations to the decision-making process in patients and physicians. It can also be used with older age groups and patients with less formal education. Physicians seem to adapt their counselling strategy to different patient groups. Prior experience with the use of decision aids has an influence on the acceptance of arriba-lib in patients but not on their decision-making or decision implementation.

<h3>Background</h3> 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. <h3>Methods</h3> 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. <h3>Results</h3> 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. <h3>Interpretation</h3> 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.

The concept of shared-decision-making is a well-established approach to increase the participation of patients in medical decisions. Using lifetime risk or time-to-event (TTE) formats has been increasingly suggested as they might have advantages, e.g. in younger patients, to better show consequences of unhealthy behaviour. In this study, the most-popular ten-year risk illustration in the decision-aid-software arribaTM (emoticons), is compared within a randomised trial to a new-developed TTE illustration, which is based on a Markov model. Thirty-two General Practitioners (GPs) took part in the study. A total of 304 patients were recruited and counseled by their GPs with arribaTM, and randomized to either the emoticons or the TTE illustration, followed by a patient questionnaire to figure out the degree of shared-decision-making (PEF-FB9, German questionnaire to measure the participation in the shared decision-making process, primary outcome), as well as the decisional conflict, perceived risk, accessibility and the degree of information, which are all secondary outcomes. Regarding our primary outcome PEF-FB9 the new TTE illustration is not inferior compared to the well-established emoticons taking the whole study population into account. Furthermore, the non-inferiority of the innovative TTE could be confirmed for all secondary outcome variables. The explorative analysis indicates even advantages in younger patients (below 46 years of age). The TTE format seems to be as useful as the well-established emoticons. For certain patient populations, especially younger patients, the TTE may be even superior to demonstrate a cardiovascular risk at early stages. Our results suggest that time-to-event illustrations should be considered for current decision support tools covering cardiovascular prevention. The study was registered at the German Clinical Trials Register and at the WHO International Clinical Trials Register Platform ( ICTRP, ID DRKS00004933 ); registered 2 February 2016 (retrospectively registered).

Aims The aim of this systematic review was to identify generic instruments for drug discontinuation in patients with polypharmacy in the primary care setting. Methods We systematically searched PubMed and EMBASE, 8 guideline databases (AWMF, NICE, NGC, SIGN, NHMRC, CPG, KCE), the Cochrane Library and grey literature (Google) in 2016 and 2017. Two independent researchers screened and analysed data. The drug discontinuation instruments of the included publications were described and classified. Results We identified 16 relevant publications. Here we found complex algorithms as well as instruments composed of distinct sequential steps. Two guidelines are constructed as electronic web‐applications. Instruments revealed diverging emphases on the stages of deprescribing, i.e. preparation, drug evaluation, decision‐making and implementation. Accordingly, 3 types of instruments emerged: general frameworks, detailed drug assessment tools and comprehensive discontinuation guidelines. Conclusion Diverse generic instruments exist for different areas of applications in regard to drug discontinuation. However, there is still a need for practical and user‐friendly tools that support physicians in communicational aspects, visualise trade‐offs and also enhance patient involvement.

Coronary angiographies (CAs) are among the most common diagnostic procedures carried out in German hospitals, and substantial regional differences in their frequency of use have been documented. Given the heterogeneity with regard to the expected benefits and the varying scope for discretion depending on the indication for the procedure, we hypothesized that the observed variation and the association of need and supply factors differs by indication for CA.We investigated the correlation between supply factors and the regional rates of CAs in Germany while controlling for need using spatial-autoregressive error models (SARE) and spatial cross-regressive models with autoregressive errors (SCRARE). The overall rates of CAs and the rates in specific patient subgroups, namely, patients with and without myocardial infarction (MI), were calculated based on a comprehensive set of nationwide routine data from three statutory health insurances at the district level.Although little variation was found in cases with MI, considerable variation was seen in the overall cases and cases without MI. The SARE models revealed a positive association between the number of hospitals with a cardiac catheterization laboratory per 10,000 population and the rates of overall cases and cases without MI, whereas no such relationship existed in cases with MI. Additionally, an association between regional deprivation and the rates of CAs was found in cases with MI, but no such association was seen in cases without MI.The results supported the hypothesis that the relative association of need and supply factors differed by the indication for CA. Although the regional differences in the frequency of use of CAs can only be explained in part by the factors examined in our study, it offers insight into patient access to and the provision of CA services and can provide a platform for further local research.

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.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.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.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.

Uncertainty is ever-present when doctors make decisions. For general practitioners (GPs) the task of diagnosing and prognosing is particularly difficult. They are faced with a broad range of unselected patients and their problems. For this particular task they have developed strategies that are adapted to the ecology of their practice. Some of these rules and heuristics are intended to reduce the likelihood of harm to the patient, e.g. missing a serious disease. Others help doctors and their patients to deal with uncertainty on a subjective level. Cognitive processes of practicing doctors are still far from being elucidated. However, reflecting on their work will help professionals improve their development and the quality of their work.

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.

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.

Coronary heart disease (CHD) is a common medical problem worldwide that demands shared care of general practitioners and cardiologists for concerned patients. In order to improve the cooperation between both medical specialists and to optimize evidence-based care, a treatment pathway for patients with CHD was developed and evaluated in a feasibility study according to the recommendation for the development and evaluation of complex interventions of the British Medical Research Council (MRC). In the context of this feasibility study the objective of the present research was to investigate the contributions of different disease related (e.g. prior myocardial infarction), pathway related (e.g. basic medication) and demographic variables on patients` perceived health related quality of life (HRQoL) as a relevant and widely used outcome measure in cardiac populations.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.

Background: Thyroid hormones are among the most prescribed drugs in Germany. Although iodine supply has been improving in the last decade, annual prescriptions for thyroid hormones are rising. The aim of this study was to provide prevalence of thyroid hormone prescribing and to explore reasons for thyroid hormone prescription in primary care settings. Study design: A cross-sectional study. Methods: Data collection took place in six general practitioner (GP) practices in Hesse, Germany. We used the records of six GP practices to estimate prevalence of thyroid hormone prescribing. All patients who received a prescription of the active ingredient levotyroxine during the preceding 3 months were mailed a study invitation. A proportion of the identified patients were interviewed. In addition, demographical data and all medical findings related to thyroid disease were recorded. Results: On average, 9.2% (SD 4.6) of all patients from participating practices were taking thyroid hormones. The majority were female (82.5%). In 47.7% of the study participants, the GP's diagnosis, according to their records, was nonexistent. In 13.6% of cases, the documentation of the diagnostic information was incomplete. While 25% of interviewed patients with high educational background initiated further diagnostic investigation, only 4.4% of the patients with lower education did so. Conclusion: In the majority of patients treated with thyroid hormones, doctors had not documented the precise indication for prescription. Keywords: thyroid hormones, represcription, primary health care

It has been debated for years whether long-term thyroid hormone intake causes fractures. Not only have previous studies suffered from design limitations, they also reached contradictory conclusions. We investigated thyroid hormones (thyroxine) as a possible risk factor for fractures in a cohort of 6.7 million persons based on administrative data. The database consists of anonymized settlement data of approximately 70 German statutory health insurances covering a time period of six years. All subjects aged 60 and above were included in the study; subjects with repeated thyroxine prescriptions were assigned to the exposure group; members without thyroxine prescriptions to the control group. Outcome was any incident fracture during a declared time period. In order to calculate fracture risk, we performed multivariate cox regression analyses to adjust for confounders. Of 798 770 subjects fulfilling the inclusion criteria, 11.7% took thyroxine regularly and belong to the exposure group. The final cox regression showed that subjects taking thyroxine have a 6.3% higher risk (HR 1.063; CI 1.046–1.080, p = < .0001) than members of the control group. The study supports the assumption that long term thyroxine intake leads to an increase in fracture risk among patients older than 60 years. The findings have implications for long term thyroxine treatment.

Abstract Background Experienced and anticipated regret influence physicians’ decision-making. In medicine, diagnostic decisions and diagnostic errors can have a severe impact on both patients and physicians. Little empirical research exists on regret experienced by physicians when they make diagnostic decisions in primary care that later prove inappropriate or incorrect. The aim of this study was to explore the experience of regret following diagnostic decisions in primary care. Methods In this qualitative study, we used an online questionnaire on a sample of German primary care physicians. We asked participants to report on cases in which the final diagnosis differed from their original opinion, and in which treatment was at the very least delayed, possibly resulting in harm to the patient. We asked about original and final diagnoses, illness trajectories, and the reactions of other physicians, patients and relatives. We used thematic analysis to assess the data, supported by MAXQDA 11 and Microsoft Excel 2016. Results 29 GPs described one case each (14 female/15 male patients, aged 1.5–80 years, response rate &lt; 1%). In 26 of 29 cases, the final diagnosis was more serious than the original diagnosis. In two cases, the diagnoses were equally serious, and in one case less serious. Clinical trajectories and the reactions of patients and relatives differed widely. Although only one third of cases involved preventable harm to patients, the vast majority (27 of 29) of physicians expressed deep feelings of regret. Conclusion Even if harm to patients is unavoidable, regret following diagnostic decisions can be devastating for clinicians, making them ‘second victims’. Procedures and tools are needed to analyse cases involving undesirable diagnostic events, so that ‘true’ diagnostic errors, in which harm could have been prevented, can be distinguished from others. Further studies should also explore how physicians can be supported in dealing with such events in order to prevent them from practicing defensive medicine.

Background. Among patients presenting with low back pain (LBP), GPs have to identify those with serious, treatable conditions. However, excluding these conditions in every patient with LPB is time consuming and of low yield. We have suggested that identifying those patients where these serious conditions need to be considered can be made more efficient through asking patient if they feel their LBP is new or unfamiliar in some way. Objective. To evaluate the diagnostic validity of a simple heuristic based on the patient's view of the familiarity of LBP. Methods. Cross-sectional diagnostic study with delayed-type reference standard, nested within a three-arm randomized trial of quality improvement for LBP. A total of 1378 patients presenting, with LBP, to one of 126 participating GPs were included. They were asked whether their LBP was familiar or not (index test). At 1 year, patients were interviewed with regard to relevant conditions that in hindsight might explain their LBP. Reviewers deciding on disease status (reference standard) were blinded to the results of the index test. Results. Totally 1190 patients answered the index test question and were available for interview at 1 year. Only four of these had a serious cause of their LBP. Two of these were identified by the familiarity heuristic, resulting in low sensitivity. Conclusion. The number of diseased patients was too small to obtain a reliable estimate of sensitivity. Low prevalence of serious disease in primary care poses difficulties for diagnostic research. In hindsight we would question whether an RCT-setting emphasizing non-specific LBP is suitable for this kind of research. At present, the familiarity heuristic cannot be recommended for patients presenting with LBP.

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.

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.

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.

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.

Deprescribing is an important task for general practitioners (GPs) in the face of risky polypharmacy. The electronic tool "MediQuit" was developed to guide GPs and patients through a deprescribing consultation that entails a drug-selection phase, shared decision making, and advice on safe implementation.A pilot study was conducted to determine the target group of patients that is selected for consultation and to assess the impact, patient involvement, and feasibility of the tool.This was an uncontrolled pilot study. GPs from two German regions were invited to use MediQuit in consultations with a view to deprescribing one drug, if appropriate. They selected patients on the basis of broad inclusion criteria. Collected data entailed participants' characteristics, patients' medication lists, deprescribed drugs, and feasibility assessments. Patients were contacted shortly after the consultation and again after 4 weeks.In total, 16 GPs agreed to participate, of whom ten actually performed deprescribing consultations. They selected 41 predominately older patients on excessive polypharmacy. Deprescribing was achieved in 70% of consultations in agreement with patients. Drugs deprescribed were symptom-lowering and preventive drugs (mainly anatomical therapeutic chemical classes A and C). GPs found MediQuit useful in initiating communication on this issue and enhancing deliberations for a deprescribing decision. The median consultation length was 15 min (interquartile range 10-20). At follow-up, GPs and patients infrequently disagreed on which drug(s) was discontinued, and GPs rated patient involvement higher than did patients themselves.MediQuit assists in identifying concrete deprescribing opportunities, patient involvement, and shared decision making. The three-step deprescribing procedure is well-accepted once initial organizational efforts are overcome. After revision, further studies are needed to enhance the quality of evidence on acceptance and effectiveness.

Abstract Background Cough is a relevant reason for encounter in primary care. For evidence-based decision making, general practitioners need setting-specific knowledge about prevalences, pre-test probabilities, and prognosis. Accordingly, we performed a systematic review of symptom-evaluating studies evaluating cough as reason for encounter in primary care. Methods We conducted a search in MEDLINE and EMBASE. Eligibility criteria and methodological quality were assessed independently by two reviewers. We extracted data on prevalence, aetiologies and prognosis, and estimated the variation across studies. If justifiable in terms of heterogeneity, we performed a meta-analysis. Results We identified 21 eligible studies on prevalence, 12 on aetiology, and four on prognosis. Prevalence/incidence estimates were 3.8–4.2%/12.5% (Western primary care) and 10.3–13.8%/6.3–6.5% in Africa, Asia and South America. In Western countries the underlying diagnoses for acute cough or cough of all durations were respiratory tract infections (73–91.9%), influenza (6–15.2%), asthma (3.2–15%), laryngitis/tracheitis (3.6–9%), pneumonia (4.0–4.2%), COPD (0.5–3.3%), heart failure (0.3%), and suspected malignancy (0.2–1.8%). Median time for recovery was 9 to 11 days. Complete recovery was reported by 40.2- 67% of patients after two weeks, and by 79% after four weeks. About 21.1–35% of patients re-consulted; 0–1.3% of acute cough patients were hospitalized, none died. Evidence is missing concerning subacute and chronic cough. Conclusion Prevalences and incidences of cough are high and show regional variation. Acute cough, mainly caused by respiratory tract infections, is usually self-limiting (supporting a “wait-and-see” strategy). We have no setting-specific evidence to support current guideline recommendations concerning subacute or chronic cough in Western primary care. Our study presents epidemiological data under non non-pandemic conditions. It will be interesting to compare these data to future research results of the post-pandemic era.

The concept of care pathways is widely used to provide efficient, timely, and evidence-based medical care. Recently, the investigation of actual empirical patient pathways has gained attention. We demonstrate the usability of State Sequence Analysis (SSA), a data mining approach based on sequence clustering techniques, on comprehensive insurance claims data from Germany to identify empirical ambulatory care sequences. We investigate patients with coronary artery disease before invasive coronary angiography (CA) and compare identified patterns with guideline recommendations. This patient group is of particular interest due to high and regionally varying CA rates.Events relevant for the care of coronary artery disease patients, namely physician consultations and medication prescriptions, are identified based on medical guidelines and combined to define states. State sequences are determined for 1.5 years before CA. Sequence similarity is defined for clustering, using optimal matching with theory-informed substitution costs. We visualize clusters, present descriptive statistics, and apply logistic regression to investigate the association of cluster membership with subsequent undesired care events.Five clusters are identified, the included patients differing with respect to morbidity, urbanity of residential area, and health care utilization. Clusters exhibit significant differences in the timing, structure, and extent of care before CA. When compared with guideline recommendations, 3 clusters show signs of care deficits.Our analyses demonstrate the potential of SSA for exploratory health care research. We show how SSA can be used on insurance claims data to identify, visualize, and investigate care patterns and their deviations from guideline recommendations.

Pharyngitis due to Group A beta-hemolytic streptococci (GAS) is seen as the main indication for antibiotics for sore throat. In primary care settings prescription rates are much higher than the prevalence of GAS. Recommendations in international guidelines differ considerably. A German guideline suggested to consider antibiotics for patients with Centor or McIsaac scores ≥ 3, first choice being penicillin V for 7 days, and recommended analgesics for all. We investigated, if the implementation of this guideline lowers the antibiotic prescription rate, and if a rapid antigen detection strep-test (RADT) in patients with scores ≥ 3 lowers the rate further.HALS was an open pragmatic parallel group three-arm cluster-randomized controlled trial. Primary care practices in Northern Germany were randomized into three groups: Guideline (GL-group), modified guideline with a RADT for scores ≥ 3 (GL-RADT-group) or usual care (UC-group). All practices were visited and instructed by the study team (outreach visits) and supplied with material according to their group. The practices were asked to recruit 11 consecutive patients ≥ 2 years with an acute sore throat and being at least moderately impaired. A study throat swab for GAS was taken in every patient. The antibiotic prescription rate at the first consultation was the primary outcome.From October 2010 to March 2012, 68 general practitioners in 61 practices recruited 520 patients, 516 could be analyzed for the primary endpoint. Antibiotic prescription rates did not differ between groups (p = 0.162) and were about three times higher than the GAS rate: GL-group 97/187 patients (52%; GAS = 16%), GL-RADT-group 74/172 (43%; GAS = 16%) and UC-group 68/157 (43%; GAS = 14%). In the GL-RADT-group 55% of patients had scores ≥ 3 compared to 35% in GL-group (p < 0.001). After adjustment, in the GL-RADT-group the OR was 0.23 for getting an antibiotic compared to the GL-group (p = 0.010), even though 35 of 90 patients with a negative Strep-test got an antibiotic in the GL-RADT-group. The prescription rates per practice covered the full range from 0 to 100% in all groups.The scores proposed in the implemented guideline seem inappropriate to lower antibiotic prescriptions for sore throat, but better adherence of practitioners to negative RADTs should lead to fewer prescriptions.DRKS00013018, retrospectively registered 28.11.2017.

Chest pain is a frequent consultation issue in primary care, with coronary artery disease (CAD) being a serious potential cause. Primary care physicians (PCPs) assess the probability for CAD and refer patients to secondary care if necessary. Our aim was to explore PCPs' referral decisions, and to investigate determinants which influenced those decisions.PCPs working in Hesse, Germany, were interviewed in a qualitative study. We used 'stimulated recall' with participants to discuss patients with suspected CAD. With a sample size of 26 cases from nine practices we reached inductive thematic saturation. Interviews were audio-recorded, transcribed verbatim and analyzed by inductive-deductive thematic content analysis. For the final interpretation of the material, we used the concept of decision thresholds proposed by Pauker and Kassirer.PCPs reflected on their decisions for or against a referral. Aside from patient characteristics determining disease probability, we identified general factors which can be understood as influencing the referral threshold. These factors relate to the practice environment, to PCPs themselves and to non-diagnostic patient characteristics. Proximity of specialist practice, relationship with specialist colleagues, and trust played a role. PCPs sometimes felt that invasive procedures were performed too easily. They tried to steer their patients through the system with the intent to avoid over-treatment. Most PCPs were unaware of guidelines but relied on informal local consensus, largely influenced by specialists. As a result, PCPs gatekeeping role was limited.We could identify a large number of factors that impact referral for suspected CAD. Several of these factors offer possibilities to improve care at the clinical and system level. The threshold model proposed by Pauker and Kassirer was a useful framework for this kind of data analysis.

Publications on the frequency of defined symptoms in the practice setting, underlying conditions and prognosis have been rare in the past. Also, studies addressing these questions have suffered from several methodological problems. We therefore developed criteria to help investigators improve the quality of study design, implementation and publication. Studies evaluating symptoms in practice can make an important contribution to a more rational approach to diagnostic decision making especially in primary care.

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.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.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.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.

Randomisation is regarded as an essential principle ensuring the internal validity of clinical trials. This is why randomised controlled trials (RCTs) lead every evidence hierarchy of therapeutic interventions. At the same time, there are controversies about the role of RCTs in health research. The article addresses the principle of randomisation and deals with some of the more prominent arguments against RCT.

Gastrointestinal (GI) disease is one of the leading aetiologies of chest pain in a primary care setting. The aims of the study are to describe clinical characteristics of GI disease causing chest pain and to provide criteria for clinical diagnosis.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 each patient and decided about the aetiology of chest pain. Multivariable regression analysis was performed to identify clinical predictors that help to rule in or out the diagnosis of GI disease and Gastroesophageal Reflux Disease (GERD).GI disease was diagnosed in 5.8% and GERD in 3.5% of all patients. Most patients localised the pain retrosternal (71.8% for GI disease and 83.3% for GERD). Pain worse with food intake and retrosternal pain radiation were associated positively with both GI disease and GERD; retrosternal pain localisation, vomiting, burning pain, epigastric pain and an average pain episode < 1 hour were associated positively only with GI disease. Negative associations were found for localized muscle tension (GI disease and GERD) and pain getting worse on exercise, breathing, movement and pain location on left side (only GI disease).This study broadens the knowledge about the diagnostic accuracy of selected signs and symptoms for GI disease and GERD and provides criteria for primary care practitioners in rational diagnosis.

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. Centre for Reviews and Dissemination (University of York): CRD42011001170

Background: Some three million Russian-speaking immigrants from the former Soviet Union live in Germany today.Many of them underwent a different kind of medical socialization than the indigenous population, but the experiences and expectations of this group of patients have hardly been studied to date.Methods: In a qualitative study, 24 chronically ill native Germans and 25 chronically ill Russian-speaking immigrants were recruited via notices, through their primary care physicians, and by word of mouth and underwent a semistructured interview in their mother tongue (German or Russian) about their experiences with their primary care physicians.The interviews were recorded using an audio device, translated into German if necessary, and transcribed, and their content was analyzed with the MAXQDA software package.Results: The immigrants were less satisfied with their primary care physicians than the native Germans.This manifested itself in a weaker patient-physician connection and frequent changes of physician due to dissatisfaction with treatment.Both groups considered themselves inadequately informed about matters of health, but they gave differing reasons for this.On the other hand, the participants in both groups had practically the same general expectations from their primary care physicians.However, detailed analysis revealed cultural differences.Conclusion: Physicians in Germany should be more aware of the culturally based expectations of immigrant patients in order to understand their needs better, improve the physician-patient relationship, and ensure equal opportunities in health care.For example, many immigrants would prefer their doctors to communicate with them in a manner that non-immigrants would consider paternalistic.►Cite this as:

Objective. Several reports have discussed a relationship between blood pressure (BP) and psychological well-being scales. Lower BP readings were associated with higher levels of psychological distress and fatigue. This study sought to replicate the association found by previous secondary analyses of epidemiological surveys. Design. Cross-sectional study. Setting. Academic Family Medicine Department in Toronto, Canada. Subjects. 214 practice attenders. Study measures. Extent of psychological abnormalities with the General Health Questionnaire (GHQ), self-reported fatigue, in-clinic and home BP measurements. Results. No significant relationship between blood pressure levels and GHQ-score or fatigue could be demonstrated. This applies to clinic and home measurements for systolic and diastolic pressure. Neither adjustment for age or sex nor for several confounders through multiple linear regression produced significant associations in the postulated direction. No nonlinear relationship could be shown either. The study had a power of 95% to detect a correlation of r = 0.22 (α = 0.05, one-sided). Conclusion. The study, specifically addressing the possible link between blood pressure and psychological dysfuntion/fatigue, could not confirm the previously reported association. Problems related to type-I error in epidemiological research are discussed.

To determine whether there is an association between the 'clinic-home blood pressure difference' (CHBPD) and psychological distress in a sample not selected without regard to blood pressure and hypertension status.A cross-sectional study.An academic family medicine department in Toronto, Canada.Consecutive attenders (n = 214) of the primary care facility. Subjects aged less than 16 years and those being administered psychotropic or blood pressure-lowering agents were excluded.The CHBPD was calculated from clinic blood pressure readings and self-measurements by subjects at home; psychological distress was measured by the 30-item version of the General Health Questionnaire (GHQ).No significant association between the CHBPD and psychological distress could be shown for systolic and diastolic blood pressures. The same applied to GHQ subdomains and the CHBPD modelled on several independent variables by multiple linear regression analyses.The results from this study, using a large sample drawn from a community, support the view that the CHBPD is not related to anxiety, depression and other forms of psychological distress, but rather is a reaction specific to the clinic setting itself.

Hintergrund: Die Effektivität einer komplexen Intervention ist abhängig vom Erfolg ihrer Implementierung. Wir wollten Hinderungs- und Motivationsgründe für die Umsetzung der Beratungsstrategie ARRIBA-Herz☺ in verschiedenen Stadien der Verhaltensänderung erfassen. Methoden: Bei ARRIBA-Herz☺ handelt es sich um eine Beratungsstrategie in der Herz-Kreislaufprävention auf der Grundlage von Framingham-Daten. Der Patient wird nach der Berechnung seines individuellen Globalrisikos für ein kardiovaskuläres Ereignis im Sinne einer Partizipativen Entscheidungsfindung (PEF) an der Therapieentscheidung beteiligt. Nach der Implementierung des Beratungskonzepts in hausärztlichen Praxen wurden strukturierte Leitfadeninterviews mit 90 Hausärzten durchgeführt, denen das Konzept vorgestellt worden war. Die Kategorisierung der Interviews erfolgte anhand der Stufen des Transtheoretischen Modells der Verhaltensänderung (TTM), das einzelne Stufen der Verhaltensänderung klar definiert. Ergebnisse: Motivation und individueller Bedarf bestimmten den Grad von Kompetenzerwerb und Umsetzung von Risikokalkulation und Partizipativer Entscheidungsfindung. Persönliche Grundhaltungen spielten eine wichtige Rolle. Praktikabilität, Effekte für Arzt und Patienten sowie ökonomische Erwägungen hatten in einzelnen TTM-Stadien unterschiedliche Relevanz. Diskussion und Schlussfolgerungen: Implementierungsmaßnahmen sollten spezifisch an Motivationsstadien und Bedürfnisse in der Zielgruppe angepasst sein und vorhandene Grundhaltungen berücksichtigen.

No change in strategy is needed despite the hype surrounding the recent JUPITER study This week, the New England Journal of Medicine published the randomised controlled trial JUPITER,1 which compared rosuvastatin (20 mg daily) with placebo in 18 000 patients with no apparent vascular disease, low density lipoprotein cholesterol (LDL-C) of less than 3.4 mmol/l (130 mg/dl), and high sensitivity C reactive protein concentrations of 2.0 mg/l or higher. The combined primary end point was myocardial infarction, stroke, arterial revascularisation, hospital admission for unstable angina, or death from cardiovascular causes. The trial was stopped after a median of two years after a highly significant improvement in the primary end point with rosuvastatin (hazard ratio 0.56; 95% confidence interval 0.46 to 0.69; P<0.00001). It is hardly surprising that the JUPITER study is seen by many as opening the door to new avenues to prevention. What do the results mean? Do we really have to change our ways of targeting our preventive efforts—for example, measure high sensitivity C reactive protein on a regular basis? …

Five years ago the “fire and forget approach” was proposed as a strategy for prescribing lipid lowering drugs.1 It involves prescribing a standard dose of statins to patients at high risk of cardiovascular disease without further testing or dose adjustment. This strategy was contrasted to the “treat to target strategy,” which aims to achieve target concentrations of low density lipoprotein by titrating drugs and other measures accordingly. Since then, several trials have shown that high dose statins in a supposed treat to target approach are more effective than the standard dose. Accordingly, the United Kingdom quality and outcomes framework and the Scottish Intercollegiate Guidelines Network guideline number 97 emphasise the importance of measuring cholesterol and having targets.2 So, is the treat to target strategy now the best option? None of the large statin trials used the treat to target strategy suggested by most lipid experts, and none was based on the targets suggested by current guidelines.3 They either used a fixed dose of statin throughout or made only minimal adjustments. Even the recent trials of high dose statins evaluated a fixed 80 mg dose of atorvastatin. So a mismatch exists between what was assessed in trials and what is recommended for everyday practice. The most cited US guideline4 requires practitioners to classify patients into three risk categories according to five factors. It recommends that practitioners should aim at different target concentrations of low density lipoprotein depending on the patient’s risk category. It is therefore not surprising that practitioners may choose to ignore these recommendations. Surveys universally show that low density lipoprotein goals are rarely met.5 Complex strategies are also prone to producing errors. For example, statins may be withheld in people at high risk who have normal lipid concentrations, or treatment may be stopped once targets have been reached. Moreover, practitioners might be tempted to prescribe drugs like ezetimibe, which modify cholesterol concentrations but according to a recent announcement by the manufacturer have failed to show an effect even on the surrogate of intima thickness, let alone clinical outcomes.6 What do recent trials tell us? Two types of trial can be used to evaluate treatments—explanatory trials and pragmatic trials. Explanatory trials try to control factors that might dilute the treatment effect by having narrow inclusion criteria, participants and study centres that are highly compliant, and outcomes that are close to the assumed mechanism of treatment. Because the results of such studies tell us little about how things work in real life, pragmatic trials are also needed before treatments can be recommended. Pragmatic trials should not be seen as poor quality, and the early statin trials were clearly pragmatic in nature. The more recent ones, however, have moved towards the explanatory type. For example, people randomised to the TNT (treating to new targets) trial had to have clinically evident coronary heart disease and low density lipoprotein concentrations within a range of 3.4 mmol/l to 6.5 mmol/l during statin wash-out, but below 3.4 mmol/l after wash-in, when taking 10 mg of atorvastatin each day. The results may therefore not be generaliseable beyond this specific group of people.7 While the results of such trials are hailed as proof that serum lipids are the most important causal factor for arteriosclerosis, other findings put this into perspective. All participants in the heart protection study had a simvastatin wash-in phase.8 Benefit in the main study was independent of the pretreatment concentration of low density lipoprotein and the low density lipoprotein response to statin. A recent systematic review on statin treatment in patients with diabetes reported similar findings; this led the authors to question the treat to target approach.9 Benefits associated with lipid concentrations should generally be interpreted with caution, because lower concentrations of low density lipoprotein may simply reflect better compliance with statins, other drugs, such as aspirin and antihypertensives, or lifestyle changes, and may not be the result of statin dose titration.10 According to the TNT trial, 50 people as specified above would have to be treated for five years to prevent one event. This benefit may not be reaped unless eligible people have been identified and had their blood lipids checked regularly. In other words, benefit can only come from rigorously implementing the treat to target approach. In everyday practice the benefit from the TNT trial would be diluted considerably. Alternatively, the fire and forget strategy is supported by many high quality clinical trials, such as the 4S trial.11 None of these trials made treat to target dose adjustments. Therefore, the treat to target strategy still has to be tested in a pragmatic trial. Whether funding for such a trial will ever be available remains to be seen. Another question is whether we should force single risk factors, such as high cholesterol, to very low values with very high doses of statins as the treat to target approach suggests. As doses of statins are increased the returns get smaller,12 whereas side effects continue to rise in a linear fashion.13 A more effective approach might be to modify several risk factors with a cocktail of various preventive drugs that do not need dose adjustments.14 Despite the results of recent high dose statin trials, it is unclear whether possible benefit really translates into clinical practice. All we can say is that everyone at high risk of cardiovascular complications should be offered a standard dose of statin. Anyone with manifest disease would be eligible, irrespective of their initial cholesterol concentration. Only once we have achieved this should we think of further refinements.