Corinna Leonhardt

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].

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.

Are fear-avoidance beliefs in low back pain patients a risk factor for low physical activity or vice versa? A cross-lagged panel analysis.

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

Low back pain patient subgroups in primary care: pain characteristics, psychosocial determinants, and health care utilization.

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.

Determinants for receiving acupuncture for LBP and associated treatments: a prospective cohort study

BackgroundAcupuncture 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.MethodsThis 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.ResultsA 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.ConclusionReceiving 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.

Chronic low back pain patient groups in primary care – A cross sectional cluster analysis

BackgroundDue to the heterogeneous nature of chronic low back pain (CLBP), it is necessary to identify patient groups and evaluate treatments within these groups. We aimed to identify groups of patients with CLBP in the primary care setting.MethodsWe performed a k-means cluster analysis on a large data set (n = 634) of primary care patients with CLBP. Variables of sociodemographic data, pain characteristics, psychological status (i.e., depression, anxiety, somatization), and the patient resources of resilience and coping strategies were included.ResultsWe found three clusters that can be characterized as “pensioners with age-associated pain caused by degenerative diseases”, “middle-aged patients with high mental distress and poor coping resources”, and “middle-aged patients who are less pain-affected and better positioned with regard to their mental health”.ConclusionsOur results supported current knowledge concerning groups of CLBP patients in primary care. In particular, we identified a group that was most disabled and distressed, and which was mainly characterized by psychological variables. As shown in our study, pain-related coping strategies and resilience were low in these patients and might be addressed in differentiating treatment strategies. Future studies should focus on the identification of this group in order to achieve effective treatment allocation.Trial registrationGerman Clinical Trial Register DRKS00003123