Norbert Donner-Banzhoff

Absolute Cardiovascular Disease Risk and Shared Decision Making in Primary Care: A Randomized Controlled Trial

PURPOSE We 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. METHODS The 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. RESULTS Intervention patients were significantly more satisfied with process and result (Patient Participation Scale, difference 0.80, P<.001). Decisional regret was significantly lower at follow-up (difference 3.39, P = .02). CVD risk decreased in both groups without a significant 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.

Ruling out coronary artery disease in primary care: development and validation of a simple prediction rule

Background: 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. Methods: 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). Results: The prediction rule contained five determinants (age/sex, known vascular disease, patient assumes pain is of cardiac origin, pain is worse during exercise, and pain is not reproducible by palpation), with the score ranging from 0 to 5 points. The area under the curve (receiver operating characteristic curve) was 0.87 (95% confidence interval [CI] 0.83–0.91) for the derivation cohort and 0.90 (95% CI 0.87–0.93) for the validation cohort. The best overall discrimination was with a cut-off value of 3 (positive result 3–5 points; negative result ≤ 2 points), which had a sensitivity of 87.1% (95% CI 79.9%–94.2%) and a specificity of 80.8% (77.6%–83.9%). Interpretation: 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.

Effects of Two Guideline Implementation Strategies on Patient Outcomes in Primary Care : A Cluster Randomized Controlled Trial

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.

Acceptance and perceived barriers of implementing a guideline for managing low back in general practice

BackgroundImplementation 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.MethodsSeventy-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.ResultsMost 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.ConclusionPromoting adherence to the LBP guideline requires more than enhancing knowledge about evidence-based management of LBP. Public education and an interdisciplinary consensus are important requirements for successful guideline implementation into daily practice. Guideline recommendations need to be adapted to the infrastructure of the health care system.Trial registrationBMBF Grant Nr. 01EM0113. FORIS (database for research projects in social science) Reg #: 20040116 [25].

Chest pain in primary care: Epidemiology and pre-work-up probabilities

Abstract 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.

Shared decision making in medicine: The influence of situational treatment factors

OBJECTIVE 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. METHODS We conducted qualitative expert interviews with patients, general practitioners, and health administration and research professionals. RESULTS 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. CONCLUSION This study demonstrates that multiple situational factors and their interactions must be considered regarding the scope of SDM in medical consultation. PRACTICE IMPLICATIONS 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.

Sex Differences in Presentation, Course, and Management of Low Back Pain in Primary Care

ObjectiveEpidemiologic 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. MethodsData 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. ResultsWomen 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. DiscussionOur 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 impact of specialist care for low back pain on health service utilization in primary care patients: A prospective cohort study

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.

Use of complementary alternative medicine for low back pain consulting in general practice: a cohort study

BackgroundAlthough 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.MethodsThis 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 monthsResultsA 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.ConclusionThe 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.

Implementation of a guideline for low back pain management in primary care: a cost-effectiveness analysis.

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.