Browsing by Author "Becker, Annette"

Background: Implementation of guidelines in clinical practice is difficult. In 2003, the German College of General Practitioners and Family Physicians (DEGAM) released an evidence-based guideline for the management of low back pain (LBP) in primary care. The objective of this study is to explore the acceptance of guideline content and perceived barriers to implementation. Methods: Seventy-two general practitioners (GPs) participating in quality circles within the framework of an educational intervention study for guideline implementation evaluated the LBP-guideline and its practicability with a standardised questionnaire. In addition, statements of group discussions were recorded using the metaplan technique and were incorporated in the discussion. Results: Most GPs agree with the guideline content but believe that guideline stipulations are not congruent with patient wishes. Non-adherence to the guideline and contradictory information for patients by other professionals (e. g., GPs, orthopaedic surgeons, physiotherapists) are important barriers to guideline adherence. Almost half of the GPs have no access to recommended multimodal pain programs for patients with chronic LBP. Conclusion: Promoting adherence to the LBP guideline requires more than enhancing knowledge about evidence-based management of LBP. Public education and an interdisciplinary consensus are important requirements for successful guideline implementation into daily practice. Guideline recommendations need to be adapted to the infrastructure of the health care system. Trial registration: BMBF Grant Nr. 01EM0113. FORIS (database for research projects in social science) Reg #: 20040116 [25].

Objective: The assumption that low back pain (LBP) patients suffer from "disuse" as a consequence of high fear-avoidance beliefs is currently under debate. A secondary analysis served to investigate whether fear-avoidance beliefs are associated cross-sectionally and longitudinally with the physical activity level (PAL) in LBP patients. Methods: A total of 787 individuals (57% acute and 43% chronic LBP) were followed up over a period of one year with measurements of fear-avoidance beliefs and physical activity level. Fear-avoidance beliefs concerning physical activity were measured by the physical-activity subscale of the FABQ (Fear-Avoidance Beliefs Questionnaire), the physical activity level was assessed in weighted metabolic equivalents (MET) hours/week with a German self-report questionnaire. Data were investigated by structural equation modelling in a cross-lagged panel design for the whole sample and separately for acute and chronic LBP.Results: The acute and chronic sub sample increased their total physical activity level significantly after one year. The structural equation modelling results did not support the disuse-aspect inherent in the fear-avoidance belief model. Cross-lagged path coefficients were low (.04 and .05 respectively) and, therefore, did not allow to predict final physical activity by initial fear-avoidance beliefs or vice versa. Discussion: Consequently, due to missing links between fear-avoidance beliefs and physical activity in a longitudinal design, the assumptions of the fear-avoidance belief model have to be questioned. These findings are in line with other investigations published recently. Most probably, "fear-avoidance belief" represents a cognitive scheme that does not limit activity per se, but only is directed to the avoidance of specific movements.

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 (>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.

The goal of this Study was to evaluate the impact of depression and fear-avoidance beliefs on the willingness to commence and continue physical activity in patients with low back pain. Data from a controlled, randomized intervention study of 1,378 German patients in primary care settings (58% female, mean age 49 years) suffering predominantly from acute back pain were subjected to a secondary analysis. Results showed that patients with high scores on both depression and fear-avoidance beliefs reported the lowest physical activity (kcal/week). The most important predictors for physical activity after 6 and 12 months were baseline activity and expected self-efficacy. Important predictors for relapse into inactivity were low self-efficacy and low perceived benefits of physical activity. Neither depression nor fear-avoidance beliefs were significant predictors of physical activity or relapse after 6 or 12 months. It is concluded that relatively stable constructs such as depression or fear-avoidance beliefs do not seem to be suitable for explaining either actual or intended physical activity in low back pain patients. Future research should focus more strongly on the impact of cognitive and affective aspects of situational decision-making processes on physical activity in everyday situations.

Background: Acupuncture is a frequently used but controversial adjunct to the treatment of chronic low back pain (LBP). Acupuncture is now considered to be effective for chronic LBP and health care systems are pressured to make a decision whether or not acupuncture should be covered. It has been suggested that providing such services might reduce the use of other health care services. Therefore, we explored factors associated with acupuncture treatment for LBP and the relation of acupuncture with other health care services. Methods: This is a post hoc analysis of a longitudinal prospective cohort study. General practitioners (GPs) recruited consecutive adult patients with LBP. Data on physical function, subjective mood and utilization of health care services was collected at the first consultation and at follow-up telephone interviews for a period of twelve months. Results: A total of 179 (13%) out of 1,345 patients received acupuncture treatment. The majority of those (59%) had chronic LBP. Women and elderly patients were more likely to be given acupuncture. Additional determinants of acupuncture therapy were low functional capacity and chronicity of pain. Chronic ( vs. acute) back pain OR 1.6 ( CL 1.4-2.9) was the only significant disease-related factor associated with the treatment. The strongest predictors for receiving acupuncture were consultation with a GP who offers acupuncture OR 3.5 ( CL 2.9 - 4.1) and consultation with a specialist OR 2.1 ( CL 1.9 - 2.3). After adjustment for patient characteristics, acupuncture remained associated with higher consultation rates and an increased use of other health care services like physiotherapy. Conclusion: Receiving acupuncture for LBP depends mostly on the availability of the treatment. It is associated with increased use of other health services even after adjustment for patient characteristics. In our study, we found that receiving acupuncture does not offset the use of other health care resources. A significant proportion of patients who received did not meet the so far only known selection criterion (chonicity). Acupuncture therapy might be a reflection of helplessness in both patients and health care providers.

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 to 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 one of three 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 six 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 – 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 to controls. Two guideline implementation strategies / RCT 3 Conclusion: Active implementation of the German LBP guideline results in better outcomes during six months follow-up than its postal dissemination. Training of practice nurses in motivational counseling had no additional benefit.

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.

Background: In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy. Methods: Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented. Results: In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs) work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP) training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1) problem analysis, and definition of (2) structural prerequisites and (3) procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs), templates, checklists and other supporting materials for researchers. Conclusion: All in all, our problem analyses revealed that a substantial number of barriers contribute to the low implementation of clinical research in German general practice. Some issues are deeply rooted in Germany's market-based healthcare and academic systems and traditions. However, new developments may facilitate change: recent developments in the German research landscape are encouraging.

Background. Persistent pain is highly prevalent in older adults and can lead to functional limitations in activities of daily living, and to psychosocial distress. There is a lack of established active therapy programs, especially for older adults with chronic pain. Objectives. To develop a graded activity program and to evaluate its feasibility within a pilot study. Design. Phase I/phase II trial of a complex intervention. A mixed methods design was chosen to evaluate the feasibility, acceptability, and preliminary evidence of effectiveness. Subjects and Setting. Several experts participated in the program development. Sixteen community-dwelling older adults (73.9 +/- 5.9 years on average) with chronic low back pain and three primary care physical therapists attempted the program. Methods. Guided semi-structured interviews were conducted with all patients and therapists and used a content-analytic approach. Measurements of self-rated functional status (HFAQ), average pain (NRS), falls self-efficacy (FES-I), and catastrophizing and avoidance beliefs (CAS-D 651) were applied at baseline and after the intervention. Results. The interviews revealed high acceptance, satisfaction, and practicality. Besides improvements in function and pain, patients mentioned more positive attitudes towards pain, activity, and self-confidence. There was a clinically relevant increase in physical function by 20.3%, a decrease in pain intensity, and a reduction in catastrophizing and avoidance behavior. Conclusion. This graded activity program demonstrated feasibility and high acceptance in aged individuals and therapists. Future studies with larger samples must confirm effectiveness. The principles also appear applicable to other chronic pain conditions. The program could easily be implemented in routine primary care.

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.

Study Design. Cost of illness study alongside a randomized controlled trial. Objective. 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). Summary of Background Data. 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. Methods. 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. Results. 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. Conclusion. 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.

Objectives: 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. Methods: 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. Results: 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"). Discussion: 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.

Objective: 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. Methods: 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. Results: 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. Discussion: 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.

Sporisorium reilianum is a biotrophic maize (Zea mays) pathogen of increasing economic importance. Symptoms become obvious at flowering time, when the fungus causes spore formation and phyllody in the inflorescences. To understand how S. reilianum changes the inflorescence and floral developmental program of its host plant, we investigated the induced morphological and transcriptional alterations. S. reilianum infection promoted the outgrowth of subapical ears, suggesting that fungal presence suppressed apical dominance. Female inflorescences showed two distinct morphologies, here termed "leafy ear" and "eary ear." In leafy ears, all floral organs were replaced by vegetative organs. In eary ears, modified carpels enclosed a new female inflorescence harboring additional female inflorescences at every spikelet position. Similar changes in meristem fate and organ identity were observed in the tassel of infected plants, which formed male inflorescences at spikelet positions. Thus, S. reilianum triggered a loss of organ and meristem identity and a loss of meristem determinacy in male and female inflorescences and flowers. Microarray analysis showed that these developmental changes were accompanied by transcriptional regulation of genes proposed to regulate floral organ and meristem identity as well as meristem determinacy in maize. S. reilianum colonization also led to a 30% increase in the total auxin content of the inflorescence as well as a dramatic accumulation of reactive oxygen species. We propose a model describing the architectural changes of infected inflorescence as a consequence of transcriptional, hormonal, and redox modulation, which will be the basis for further molecular investigation of the underlying mechanism of S. reilianum-induced alteration of floral development.

Background: There is evidence to suggest that pharmaceutical companies influence the publication and content of research papers. Most German physicians rely on journals for their continuing medical education. We studied the influence of pharmaceutical advertising on the drug recommendations made in articles published in 11 German journals that focus on continuing medical education. Methods: We conducted a cross-sectional study of all of the issues of 11 journals published in 2007. Only journals frequently read by general practitioners were chosen. Issues were screened for pharmaceutical advertisements and recommendations made in the editorial content for a specified selection of drugs. Each journal was rated on a five-point scale according to the strength with which it either recommended or discouraged the use of these drugs. We looked for differences in these ratings between free journals (i.e., those financed entirely by pharmaceutical advertising), journals with mixed sources of revenue and journals financed solely by subscription fees. The journals were also screened for the simultaneous appearance of advertisements and recommendations for the same drug within a certain period, which was adjusted for both journal and class of drug. Results: We identified 313 issues containing at least one advertisement for the selected drugs and 412 articles in which drug recommendations were made. Free journals were more likely to recommend the specified drugs than journals with sources of revenue that were mixed or based solely on subscriptions. The simultaneous appearance of advertisements and recommendations for the same drug in the same issue of a journal showed an inconsistent association. Interpretation: Free journals almost exclusively recommended the use of the specified drugs, whereas journals financed entirely with subscription fees tended to recommend against the use of the same drugs. Doctors should be aware of this bias in their use of material published in medical journals that focus on continuing medical education.

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. (C) 2007 European Federation of Chapters of the International Association for the Study of Pain. Published by Elsevier Ltd. All rights reserved.