Factors affecting general practitioners' decisions about plain radiography for back pain: implications for classification of guideline barriers – a qualitative study

BACKGROUND: General practitioners often diverge from clinical guidelines regarding spine radiography. This study aimed to identify and describe A) factors general practitioners consider may affect their decisions about ordering plain radiography for back pain and B) barriers to guideline adherence suggested by such factors. METHODS: Focus group interviews regarding factors affecting ordering decisions were carried out on a diverse sample of Norwegian general practitioners and were analysed qualitatively. Results of this study and two qualitative studies from the Netherlands and USA on use of spine radiography were interpreted for barriers to guideline adherence. These were compared with an existing barrier classification system described by Dr Cabana's group. RESULTS: The factors which Norwegian general practitioners considered might affect their decisions about ordering plain radiography for back pain concerned the following broader issues: clinical ordering criteria, patients' wishes for radiography and the general practitioner's response, uncertainty, professional dignity, access to radiology services, perception of whether the patient really was ill, sense of pressure from other health care providers/social security, and expectations about the consequences of ordering radiography. The three studies suggested several attitude-related and external barriers as classified in a previously reported system described by Dr Cabana in another study. Identified barriers not listed in this system were: lack of expectancy that guideline adherence will lead to desired health care process, emotional difficulty with adherence, improper access to actual/alternative health care services, and pressure from health care providers/organisations. CONCLUSIONS: Our findings may help implement spine radiography guidelines. They also indicate that Cabana et al.'s barrier classification system needs extending. A revised system is proposed

Disc and nerve root findings on lumbar MRI with straightened vs flexed hips and knees—pilot study

Objective: To compare disc and nerve root findings, image quality, and pain between supine lumbar MRI positions with straightened vs flexed hips and knees. Methods: In this prospective pilot study, 14 adults with sciatica or suspected lumbar radiculopathy underwent MRI supine with their hips and knees flexed and then straightened. For each position, two experienced radiologists assessed disc contour, location/size of disc herniation, nerve root affection, image quality, image evaluation difficulty, and sagittal angles between the vertebral bodies at each disc level L3-S1. Patients scored pain (0–10) after MRI in each position. We compared MRI assessments and mean pain scores (t-test, log-transformation) between the two positions. Results: We found no clear difference in disc bulges, disc herniation, nerve root affection, image quality, or image evaluation difficulty between MRI with straightened vs flexed knees/hips. Herniation size differed ≤ 0.6 mm between the two positions. Sagittal angles between neighboring vertebral bodies differed ≤3.8°. Mean pain score after MRI with straightened vs flexed knees/hips was 4.64 vs 3.29 (p = 0.005). Conclusion: In this pilot study, supine lumbar MRI with straightened vs flexed hips/knees showed similar disc and nerve root findings. The straightened position appeared more painful. Advances in knowledge: In previous studies, spondylolisthesis increased on supine MRI with straightened vs flexed lower limbs, but corresponding data on disc findings were lacking. In this pilot study, supine lumbar MRI with straightened rather than flexed hips and knees was more painful and did not improve the diagnosis of disc or nerve root findings.publishedVersio

Implementation of checklists in health care; learning from high-reliability organisations

<p>Abstract</p> <p>Background</p> <p>Checklists are common in some medical fields, including surgery, intensive care and emergency medicine. They can be an effective tool to improve care processes and reduce mortality and morbidity. Despite the seemingly rapid acceptance and dissemination of the checklist, there are few studies describing the actual process of developing and implementing such tools in health care. The aim of this study is to explore the experiences from checklist development and implementation in a group of non-medical, high reliability organisations (HROs).</p> <p>Method</p> <p>A qualitative study based on key informant interviews and field visits followed by a Delphi approach. Eight informants, each with 10-30 years of checklist experience, were recruited from six different HROs.</p> <p>Results</p> <p>The interviews generated 84 assertions and recommendations for checklist implementation. To achieve checklist acceptance and compliance, there must be a predefined need for which a checklist is considered a well suited solution. The end-users ("sharp-end") are the key stakeholders throughout the development and implementation process. Proximity and ownership must be assured through a thorough and wise process. All informants underlined the importance of short, self-developed, and operationally-suited checklists. Simulation is a valuable and widely used method for training, revision, and validation.</p> <p>Conclusion</p> <p>Checklists have been a cornerstone of safety management in HROs for nearly a century, and are becoming increasingly popular in medicine. Acceptance and compliance are crucial for checklist implementation in health care. Experiences from HROs may provide valuable input to checklist implementation in healthcare.</p

Five-year development of lumbar disc degeneration—a prospective study

Objective: To examine the impact of demographic, clinical, and genetic factors as well as herniated discs on 5-year development of disc degeneration in the lumbar spine, and to investigate associations between changes in lumbar degenerative findings and pain. Materials and methods: In 144 patients with lumbar radicular pain or low back pain, we scored disc degeneration, herniated discs, and high-intensity zones in the posterior annulus fibrosus on lumbar magnetic resonance imaging (MRI) at baseline and 5-year follow-up. Genotyping (TaqMan assay) was performed for genes encoding vitamin D receptor (VDR), collagen XIα (COL11A), matrix metalloproteinase 1/9 (MMP1/MMP9), and interleukin 1α/1RN (IL-1α/IL-1RN). Associations were analyzed using multivariate linear regression adjusted for age, sex, smoking, body mass index, and baseline scores for degenerated discs and herniated discs (when analyzing impact of baseline factors) or for pain (when analyzing associations with pain). Results: Progression of disc degeneration over 5 years was significantly (p < 0.001) related to higher age and less disc degeneration at baseline, but not to sex, smoking, body mass index, herniated discs, or variants in the studied genes. No associations were identified between changes in disc degeneration or high-intensity zones and pain at 5-year follow-up. However, increased number of herniated discs over 5 years was associated with pain at rest (p = 0.019). Conclusions: Age and disc degeneration at baseline, rather than genetic factors, influenced the 5-year development of disc degeneration in patients with lumbar radicular pain or low back pain. Development of herniated discs was related to pain at rest.Five-year development of lumbar disc degeneration—a prospective studypublishedVersio

Preoperative fatty infiltration of paraspinal muscles assessed by MRI is associated with less improvement of leg pain 2 years after surgery for lumbar spinal stenosis

Abstract Purpose Fatty infiltration (FI) of the paraspinal muscles may associate with pain and surgical complications in patients with lumbar spinal stenosis (LSS). We evaluated the prognostic influence of MRI-assessed paraspinal muscles’ FI on pain or disability 2 years after surgery for LSS. Methods A muscle fat index (MFI) was calculated (by dividing signal intensity of psoas to multifidus and erector spinae) on preoperative axial T2-weighted MRI of patients with LSS. Pain and disability 2 years after surgery were assessed using the Oswestry disability index, the Zurich claudication questionnaire and numeric rating scales for leg and back pain. Multivariate linear and logistic regression analyses (adjusted for preoperative outcome scores, age, body mass index, sex, smoking status, grade of spinal stenosis, disc degeneration and facet joint osteoarthritis) were used to assess the associations between MFI and patient-reported clinical outcomes. In the logistic regression models, odds ratios (OR) and 95% confidence intervals (CI) were calculated for associations between the MFI and ≥ 30% improvement of the outcomes (dichotomised into yes/no). Results A total of 243 patients were evaluated (mean age 66.6 ± 8.5 years), 49% females (119). Preoperative MFI and postoperative leg pain were significantly associated, both with leg pain as continuous (coefficient − 3.20, 95% CI − 5.61, − 0.80) and dichotomised (OR 1.51, 95% CI 1.17, 1.95) scores. Associations between the MFI and the other outcome measures were not statistically significant. Conclusion Preoperative FI of the paraspinal muscles on MRI showed statistically significant association with postoperative NRS leg pain but not with ODI or ZCQ.publishedVersio

Longitudinal Relationship Between Reduced Modic Change Edema and Disability and Pain in Patients With Chronic Low Back Pain

Study Design. Secondary analyses of a randomized trial [Antibiotics In Modic changes (MCs) study]. Objective. To assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP). Summary of Background Data. It is not clear whether or not reduced MC edema implies improved clinical outcomes. Patients and Methods. Linear regression was conducted separately in 2 subgroups with MC edema at baseline on short tau inversion recovery (STIR) or T1/T2-weighted magnetic resonance imaging, respectively. Independent variable: reduced edema (yes/no) at 1 year on STIR or T1/T2-series, respectively. Dependent variable: 1-year score on the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), or 0 to 10 numeric rating scale for LBP intensity, adjusted for the baseline score, age, smoking, body mass index, physical workload, and baseline edema on STIR (STIR analysis only). Post hoc, we, in addition, adjusted all analyses for baseline edema on STIR, treatment group (amoxicillin/placebo), and prior disc surgery—or for disc degeneration. Results. Among patients with MC edema on STIR at baseline (n = 162), reduced edema on STIR was not significantly related to the RMDQ (B: −1.0, 95% CI: −2.8, 0.8; P = 0.27), ODI (B:−1.4, 95% CI: −5.4, 2.6; P = 0.50), or LBP intensity scores (B: −0.05, 95% CI: −0.8, 0.7; P = 0.90) after 1 year. Among patients with MC edema on T1/T2-series at baseline (n = 116), reduced edema on T1/T2 (i.e., reduced volume of the type 1 part of MCs) was not significantly related to RMDQ (B: −1.7, 95% CI: −3.8, 0.3; P = 0.10) or ODI score (B: −2.3, 95% CI: −7.1, 2.5; P = 0.34) but was significantly related to LBP intensity at 1 year (B: −0.9, 95% CI: −1.8, −0.04; P = 0.04; correlation coefficient: 0.24). The post hoc analyses supported these results. Conclusion. Reduced MC edema over 1 year was not significantly associated with pain-related disability but was (on T1/T2-series) significantly but weakly related to reduced LBP intensity.publishedVersio

Apparent diffusion coefficient values in Modic changes – interobserver reproducibility and relation to Modic type

Background Modic Changes (MCs) in the vertebral bone marrow were related to back pain in some studies but have uncertain clinical relevance. Diffusion weighted MRI with apparent diffusion coefficient (ADC)-measurements can add information on bone marrow lesions. However, few have studied ADC measurements in MCs. Further studies require reproducible and valid measurements. We expect valid ADC values to be higher in MC type 1 (oedema type) vs type 3 (sclerotic type) vs type 2 (fatty type). Accordingly, the purpose of this study was to evaluate ADC values in MCs for interobserver reproducibility and relation to MC type. Methods We used ADC maps (b 50, 400, 800 s/mm2) from 1.5 T lumbar spine MRI of 90 chronic low back pain patients with MCs in the AIM (Antibiotics In Modic changes)-study. Two radiologists independently measured ADC in fixed-sized regions of interests. Variables were MC-ADC (ADC in MC), MC-ADC% (0% = vertebral body, 100% = cerebrospinal fluid) and MC-ADC-ratio (MC-ADC divided by vertebral body ADC). We calculated mean difference between observers ± limits of agreement (LoA) at separate endplates. The relation between ADC variables and MC type was assessed using linear mixed-effects models and by calculating the area under the receiver operating characteristic curve (AUC). Results The 90 patients (mean age 44 years; 54 women) had 224 MCs Th12-S1 comprising type 1 (n = 111), type 2 (n = 91) and type 3 MC groups (n = 22). All ADC variables had higher predicted mean for type 1 vs 3 vs 2 (p  50% of their mean value was less frequent for MC-ADC (9% of MCs) vs MC-ADC% and MC-ADC-ratio (17–20%). Conclusions The MC-ADC variable (highest mean ADC in the MC) had best interobserver reproducibility, discriminated between MC type groups, and may be used in further research. ADC values differed between MC types as expected from previously reported MC histology.publishedVersio

Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)

Objective To evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. Design A cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. Setting Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. Participants 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). Interventions Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. Main outcome measures Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER). Results Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. Conclusions Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.publishedVersio

Association of Modic change types and their short tau inversion recovery signals with clinical characteristics : a cross sectional study of chronic low back pain patients in the AIM-study

Background: Modic Changes (MCs, magnetic resonance imaging (MRI) signal changes in the vertebral bone marrow extending from the vertebral endplate) may represent a subgroup of nonspecific chronic low back pain that could benefit from a specific management. The primary aim was to compare clinical characteristics between patients with type 1 versus type 2 MCs. The secondary aim was to explore associations between clinical characteristics and MC related short tau inversion recovery (STIR) signals. Methods: This cross-sectional study used baseline data prospectively collected between 2015 and 2017 on the 180 patients included in the AIM-study (Antibiotics In Modic changes), a randomized controlled trial in a Norwegian hospital out-patient setting of patients with chronic low back pain, a lumbar disc herniation within the last 2 years, low back pain intensity score ≥ 5 (on a 0–10 scale) and current type 1 or type 2 MCs at the previously herniated lumbar disc level. We used prespecified clinical characteristics including self-report measures, physiologic measures and functional measures from clinical history and examination. The diagnostic accuracy of various clinical characteristics to discriminate between patients with type 1 MCs (with or without additional type 2 MCs) and patents with type 2 MCs only (not type 1) were assessed by calculating the area under the receiver-operating curve. We assessed the correlations of clinical characteristics with details of MC related STIR signal increase. Results: No clinical characteristic differed between patients with type 1 (n = 118) versus type 2 (but not type 1) (n = 62) MCs. The clinical characteristics showed no/minor differences or no/weak correlations with MC related STIR signal increase. Patients with a positive Springing test (at any lumbar level) had slightly less volume of STIR signal increase than those with a negative test (mean difference 1.3 on a 0–48 scale, 95% CI 0.3 to 2.3). Conclusion: Clinical characteristics were similar for patients with type 1 MCs and patients with type 2 MCs, and showed no clinically relevant correlations with MC related STIR signal increase.The trial was funded by governmental organisations; Helse Sør-Øst (grant no: 2015090) and Helse Vest (grant no: 911938 and 911891).publishedVersio

Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case–control biopsy study

Introduction Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs. Methods and analysis This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses. Ethics and dissemination The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.publishedVersio