Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study.

BACKGROUND: Axial spondyloarthritis (axSpA) is a disabling inflammatory joint disease with chronic low back pain (CLBP) as leading symptom. Recognizing axSpA in the large amount of CLBP patients is difficult for general practioners (GP). This evaluation aims to assess the effect of a referral strategy for axSpA in young primary care patients with CLBP by comparing the use of the strategy with usual care. The effect is measured at three different levels; by patient reported outcomes (the clinical effect), process and costs evaluation. METHODS/DESIGN: This study design is a cluster randomized controlled trial with GP as clusters. GPs throughout the Netherlands are invited to participate and randomized to either the intervention or the control group. Patients from participating GPs are invited to participate if they have ever been registered with low back pain, without radiation (ICPC L03) and aged 18-45 years. To be included in the study, patients need to have current low back pain and chronic low back pain (>12 weeks). In the intervention arm a referral strategy for axSpA will be applied in CLBP patients, in the control arm care as usual will be provided for CLBP patients. The referral strategy consists of four easy to use variables. All are questions about the back pain complaints of the patients. Data is prospectively collected in an online database at baseline (T0), 4 months (T1), 12 months (T2) and 24 months (T3). After time point T1 (4 months) patients from the control group will also receive the intervention i.e. the application of a referral strategy for axSpA. The effect of the referral strategy is measured at three different levels, by patient outcomes (e.g. pain scores, quality of life), process measures (e.g. number of axSpA diagnoses by rheumatologists) and by costs (work productivity and health care resources use). Our primary outcome is the Roland Morris Disability Questionnaire after 4 months, secondary outcomes are pain and quality of life. Costs will be assessed before and after the use of the referral strategy, to estimate if the use of the strategy will lead to a reduction in health care costs and improvement in work participation. DISCUSSION: It is anticipated that using the axSpA referral strategy for primary care CLBP patients will increase the quality of life of CLBP patients, will result in more (correct) diagnoses of axSpA by the rheumatologists, and will be cost-effective. Ultimately, the results of this study may contribute to the startup of a national implementation of the axSpA referral strategy to identify timely CLBP patients with axSpA. TRIAL REGISTRATION: NCT01944163 , date of registration; September 6, 2013 (Clinicaltrials.gov).

Tetanus- a case report highlighting the challenges in diagnosis and treatment.

Tetanus has become an increasingly rare infectious disease due to the development of successful vaccination programs in the mid-20th century. In resource-rich countries, mainly unvaccinated or partly vaccinated risk groups are affected, whereas tetanus still remains prevalent in resource-limited countries. The decreasing incidence in developed countries has hindered clinical trials evaluating the best treatment modalities for tetanus infections. Current guidelines are based on a small number of studies and case reports. So far, these studies have shown potential benefits of treating tetanus infections with benzodiazepines, magnesium sulfate and baclofen. Additionally, several treatments have been shown to be useful in stabilizing and supporting patients with tetanus. However, each treatment modality has limitations, from negative side effects to logistical challenges, especially in developing countries. Therefore, further knowledge is required to evaluate the best use of each treatment and to further optimize patient care. This knowledge can contribute to the reduction of the burden of disease in countries where tetanus remains prevalent and where resources are limited, though vaccination is the most effective method to achieve this. This case report describes the treatment of a Dutch patient with tetanus infection and illustrates the role of benzodiazepines as well as other key aspects of treating patients with tetanus.

Magnetic Resonance Imaging of the Sacroiliac Joints Indicating Sacroiliitis According to the Assessment of SpondyloArthritis international Society Definition in Healthy Individuals, Runners, and Women With Postpartum Back Pain.

OBJECTIVE: To compare magnetic resonance images (MRIs) of the sacroiliac (SI) joints of healthy subjects and individuals with known mechanical strain acting upon the SI joints to those of patients with axial spondyloarthritis (SpA) and patients with chronic back pain. METHODS: Three readers who had received standardized training and were blinded with regard to study group randomly scored MRIs of the SI joints of 172 subjects, including 47 healthy individuals without current or past back pain, 47 axial SpA patients from the Spondyloarthritis Caught Early (SPACE) cohort (with a previous MRI confirmed positive for sacroiliitis), 47 controls with chronic back pain (irrespective of MRI results) from the SPACE cohort, 7 women with postpartum back pain, and 24 frequent runners. MRIs were scored according to the Assessment of SpondyloArthritis international Society (ASAS) definition and Spondyloarthritis Research Consortium of Canada (SPARCC) index. RESULTS: Of the 47 healthy volunteers, 11 (23.4%) had an MRI positive for sacroiliitis, compared to 43 (91.5%) of 47 axial SpA patients and 3 (6.4%) of 47 patients with chronic back pain. Three (12.5%) of the 24 runners and 4 (57.1%) of the 7 women with postpartum back pain had a positive MRI. Using a SPARCC cutoff of ≥2 for positivity, 12 (25.5%) of 47 healthy volunteers, 46 (97.9%) of 47 positive axial SpA patients, 5 (10.6%) of 47 controls with chronic back pain, 4 (16.7%) of 24 runners, and 4 (57.1%) of 7 women with postpartum back pain had positive MRIs. Deep bone marrow edema (BME) lesions were not found in healthy volunteers, patients with chronic back pain, or runners, but were found in 42 (89.4%) of 47 positive axial SpA patients and in 1 (14.3%) of 7 women with postpartum back pain. CONCLUSION: A substantial proportion of healthy individuals without current or past back pain has an MRI positive for sacroiliitis according to the ASAS definition. Deep (extensive) BME lesions are almost exclusively found in axial SpA patients.

Work outcome in yet undiagnosed patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis; results of a cross-sectional study among patients with chronic low back pain.

BACKGROUND: To understand the impact of yet undiagnosed non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) on work outcomes in a cohort of patients with long-lasting chronic low back pain (CLBP). METHODS: Data were used from a primary care CLBP cohort that was established to understand the prevalence of nr-axSpA and AS. Clinical characteristics comprised measures of back pain (visual analogue scale), inflammation (C-reactive protein) and physical functioning (Roland Morris Disability Questionnaire (RMDQ)). Worker outcomes comprised a question on employment and the Work Productivity and Activity Impairment (WPAI) questionnaire, distinguishing absenteeism, presenteeism, and overall work impairment in those employed and activity impairment in all patients. For each disease subgroup, employment ratio compared to the general population was assessed by indirect standardization. Factors associated with work productivity were explored by zero inflated negative binomial (ZINB) regression models. RESULTS: Patients with CLBP (n = 579) were included (41% male, mean age 36 years), of whom 71 (12%) were identified as having nr-axSpA and 24 (4%) as having AS. The standardized employment ratios were 0.89 (95% CI 0.84-0.94), 0.97 (95% CI 0.85-1.09) and 0.81 (95% CI 0.56-1.06) for patients with CLBP, nr-axSpA and AS, respectively. Scores for the WPAI subdomains were not significantly different between patients with CLBP, nr-axSpA or AS. The ZINB models showed significant associations between visual analog scale (VAS) score for pain and RMDQ and work productivity. CONCLUSION: The impact of yet undiagnosed nr-axSpA and AS on patients' work outcomes was substantial but was not significantly different from those of patients with long-standing CLBP. Variables significantly associated with reduced work productivity were VAS for pain and RMDQ score.

External Validation of a Referral Rule for Axial Spondyloarthritis in Primary Care Patients with Chronic Low Back Pain.

OBJECTIVES: To validate and optimize a referral rule to identify primary care patients with chronic low back pain (CLBP) suspected for axial spondyloarthritis (axSpA). DESIGN: Cross-sectional study with data from 19 Dutch primary care practices for development and 38 for validation. PARTICIPANTS: Primary care patients aged 18-45 years with CLBP existing more than three months and onset of back pain started before the age of 45 years. MAIN OUTCOME: The number of axSpA patients according to the ASAS criteria. METHODS: The referral rule (CaFaSpA referral rule) was developed using 364 CLBP patients from 19 primary care practices and contains four easy to use variables; inflammatory back pain, good response to nonsteriodal anti-inflammatory drugs, family history of spondyloarthritis and a back pain duration longer than five years. This referral rule is positive when at least two variables are present. Validation of the CaFaSpA rule was accomplished in 579 primary care CLBP patients from 38 practices from other areas. Performance of the referral rule was assessed by c-statistic and calibration plot. To fit the final referral rule the development and validation datasets were pooled leading to a total study population of 943 primary care participants. RESULTS: The referral rule was validated in 579 patients (41% male, mean age 36 (sd7.0). The percentage of identified axSpA patients was 16% (n=95). External validation resulted in satisfactory calibration and reasonable discriminative ability (c-statistics 0.70 [95% CI, 0.64-0.75]). In the pooled dataset sensitivity and specificity of the referral rule were 75% and 58%. CONCLUSIONS: The CaFaSpA referral rule for axSpA consists of four easy to use predictors for primary care physicians and has a good predictive value in this validation study. The referral rule has the potential to be a screening tool for primary care by identifying CLBP patients suspected for axSpA.

Identifying axial spondyloarthritis in Dutch primary care patients, ages 20-45 years, with chronic low back pain.

OBJECTIVE: To identify axial spondyloarthritis (SpA) in Dutch primary care patients with chronic low back pain (CLBP), and to design a simple referral model for general practitioners (GPs) that would identify patients at risk for axial SpA. METHODS: Patients (ages 20-45 years) with CLBP were identified from GP records. Assessments included inflammatory back pain questionnaires, medical interviews, physical examinations, HLA-B27, C-reactive protein level, conventional radiography, and magnetic resonance imaging. The outcome measure was axial SpA defined by the Assessment of SpondyloArthritis international Society (ASAS) criteria. Multivariable regression analysis with bootstrapping was used to develop the referral model. RESULTS: A total of 364 patients (mean ± SD age 36.3 ± 6.8 years) was recruited with a median symptom duration of 9.0 years. Eighty-six patients (24%) fulfilled the ASAS criteria for axial SpA. Of all potential determinants, the ASAS inflammatory back pain questionnaire, good response to nonsteroidal antiinflammatory drugs, family history of SpA, and symptom duration were identified as most relevant for diagnosing axial SpA by multivariable regression analysis related to axial SpA. The shrunken regression coefficients were, respectively, 1.04, 0.83, 0.73, and 0.23. The combination of these 4 items proved a useful area under the receiver operating characteristic curve of 0.75 (SE 0.03). In a simplified score model, at the suggested cutoff value of 1.5, the sensitivity was 83% and specificity was 59%. CONCLUSION: This study shows that 1 of 4 primary care patients with CLBP was classified as having axial SpA. A preselection in primary care based on a combination of clinical items may be useful to facilitate the identification of patients at risk of axial SpA.