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1.  Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study 
Identification of prognostic factors for persistent pain and disability are important for better understanding of the clinical course of chronic unilateral lumbar radiculopathy and to assist clinical decision-making. There is a lack of scientific evidence concerning prognostic factors. The aim of this study was to identify clinically relevant predictors for outcome at 52 weeks.
116 patients were included in a sham controlled clinical trial on epidural injection of glucocorticoids in patients with chronic unilateral lumbar radiculopathy. Success at follow-up was ≤17.5 for visual analogue scale (VAS) leg pain, ≤22.5 for VAS back pain and ≤20 for Oswestry Disability Index (ODI). Fifteen clinically relevant variables included demographic, psychosocial, clinical and radiological data and were analysed using a logistic multivariable regression analysis.
At follow-up, 75 (64.7%) patients had reached a successful outcome with an ODI score ≤20, 54 (46.6%) with a VAS leg pain score ≤17.5, and 47 (40.5%) with a VAS back pain score ≤22.5.
Lower age (OR 0.94 (CI 0.89–0.99) for each year decrease in age) and FABQ Work ≥34 (OR 0.16 (CI 0.04-0.61)) were independent variables predicting a successful outcome on the ODI.
Higher education (OR 5.77 (CI 1.46–22.87)) and working full-time (OR 2.70 (CI 1.02–7.18)) were statistically significant (P <0.05) independent predictors for successful outcome (VAS score ≤17.5) on the measure of leg pain. Lower age predicted success on ODI (OR 0.94 (95% CI 0.89 to 0.99) for each year) and less back pain (OR 0.94 (0.90 to 0.99)), while higher education (OR 5.77 (1.46 to 22.87)), working full-time (OR 2.70 (1.02 to 7.18)) and muscle weakness at baseline (OR 4.11 (1.24 to 13.61) predicted less leg pain, and reflex impairment at baseline predicted the contrary (OR 0.39 (0.15 to 0.97)).
Lower age, higher education, working full-time and low fear avoidance beliefs each predict a better outcome of chronic unilateral lumbar radiculopathy. Specifically, lower age and low fear avoidance predict a better functional outcome and less back pain, while higher education and working full-time predict less leg pain. These results should be validated in further studies before being used to inform patients.
Trial registration
Current Controlled Trials ISRCTN12574253. Registered 18 May 2005.
PMCID: PMC4326298  PMID: 25887469
Chronic unilateral lumbar radiculopathy; Lumbar nerve root impingement; Outcome prediction; Radiculopathy; Sciatica
2.  Lean thinking in hospitals: is there a cure for the absence of evidence? A systematic review of reviews 
BMJ Open  2014;4(1):e003873.
Lean interventions aim to improve quality of healthcare by reducing waste and facilitate flow in work processes. There is conflicting evidence on the outcomes of lean thinking, with quantitative and qualitative studies often contradicting each other. We suggest that reviewing the literature within the approach of a new contextual framework can deepen our understanding of lean as a quality-improvement method. This article theorises the concept of context by establishing a two-dimensional conceptual framework acknowledging lean as complex social interventions, deployed in different organisational dimensions and domains. The specific aim of the study was to identify factors facilitating intended outcomes from lean interventions, and to understand when and how different facilitators contribute.
A two-dimensional conceptual framework was developed by combining Shortell's Dimensions of capability with Walshes’ Domains of an intervention. We then conducted a systematic review of lean review articles concerning hospitals, published in the period 2000–2012. The identified lean facilitators were categorised according to the intervention domains and dimensions of capability provided by the framework.
We provide a framework emphasising context by relating facilitators to domains and dimensions of capability. 23 factors enabling a successful lean intervention in hospitals were identified in the systematic review, where management and a supportive culture, training, accurate data, physicians and team involvement were most frequent.
In the absence of evidence, the two-dimensional framework, incorporating the context, may prove useful for future research on variation in outcomes from lean interventions. Findings from the review suggest that characteristics and local application of lean, in addition to strategic and cultural capability, should be given further attention in healthcare quality improvement.
PMCID: PMC3902334  PMID: 24435890
3.  Modic type I changes and recovery of back pain after lumbar microdiscectomy 
European Spine Journal  2012;21(11):2252-2258.
To investigate whether the presence of Modic changes type I (MC I) found on preoperative MRI scans represent a risk factor for persistent back pain 12 months after surgery amongst patients operated for lumbar disc herniation.
Cohort study of 178 consecutive patients operated with lumbar microdiscectomy. Preoperative MRI scans were evaluated by two independent neuroradiologists. Primary outcome measure was the visual analogue scale (VAS) for back pain. Secondary outcome measures were; VAS for leg pain, physical function (Oswestry Disability Index), and health-related quality of life (EQ-5D), self-reported benefit of the operation and employment status. The presence of MC I was used as exposition variable and adjusted for other risk factors in multivariate analyses.
The Modic classification showed a high inter-observer reproducibility. Patients with MC I had less improvement of back pain 12 months after surgery, compared to those who had no or other types of MC, but this negative association no longer showed statistical significance when adjusted for smoking, which remained the only independent risk factor for persistent back pain.
Patients with preoperative MC I can expect less but still significant improvement of back pain 1 year after microdiscectomy, but not if they smoke cigarettes.
PMCID: PMC3481096  PMID: 22842978
Clinical outcome; Microdiscectomy; Low back pain; Modic changes; Smoking
4.  Accuracy of physical examination for chronic lumbar radiculopathy 
Clinical examination of patients with chronic lumbar radiculopathy aims to clarify whether there is nerve root impingement. The aims of this study were to investigate the association between findings at clinical examination and nerve root impingement, to evaluate the accuracy of clinical index tests in a specialised care setting, and to see whether imaging clarifies the cause of chronic radicular pain.
A total of 116 patients referred with symptoms of lumbar radiculopathy lasting more than 12 weeks and at least one positive index test were included. The tests were the straight leg raising test, and tests for motor muscle strength, dermatome sensory loss, and reflex impairment. Magnetic resonance imaging (n = 109) or computer tomography (n = 7) were imaging reference standards. Images were analysed at the level of single nerve root(s), and nerve root impingement was classified as present or absent. Sensitivities, specificities, and positive and negative likelihood ratios (LR) for detection of nerve root impingement were calculated for each individual index test. An overall clinical evaluation, concluding on the level and side of the radiculopathy, was performed.
The prevalence of disc herniation was 77.8%. The diagnostic accuracy of individual index tests was low with no tests reaching positive LR >4.0 or negative LR <0.4. The overall clinical evaluation was slightly more accurate, with a positive LR of 6.28 (95% CI 1.06–37.21) for L4, 1.74 (95% CI 1.04–2.93) for L5, and 1.29 (95% CI 0.97–1.72) for S1 nerve root impingement. An overall clinical evaluation, concluding on the level and side of the radiculopathy was also performed, and receiver operating characteristic (ROC) analysis with area under the curve (AUC) calculation for diagnostic accuracy of this evaluation was performed.
The accuracy of individual clinical index tests used to predict imaging findings of nerve root impingement in patients with chronic lumbar radiculopathy is low when applied in specialised care, but clinicians’ overall evaluation improves diagnostic accuracy slightly. The tests are not very helpful in clarifying the cause of radicular pain, and are therefore inaccurate for guidance in the diagnostic workup of the patients. The study population was highly selected and therefore the results from this study should not be generalised to unselected patient populations in primary care nor to even more selected surgical populations.
PMCID: PMC3716914  PMID: 23837886
Sensitivity; Accuracy; Likelihood ratio; Lumbar radiculopathy; Physical examination
5.  Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults: an evidence and consensus-based update 
BMC Medicine  2013;11:50.
The management of minimal, mild and moderate head injuries is still controversial. In 2000, the Scandinavian Neurotrauma Committee (SNC) presented evidence-based guidelines for initial management of these injuries. Since then, considerable new evidence has emerged.
General methodology according to the Appraisal of Guidelines for Research and Evaluation (AGREE) II framework and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Systematic evidence-based review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology, based upon relevant clinical questions with respect to patient-important outcomes, including Quality Assessment of Diagnostic Accuracy Studies (QUADAS) and Centre of Evidence Based Medicine (CEBM) quality ratings. Based upon the results, GRADE recommendations, guidelines and discharge instructions were drafted. A modified Delphi approach was used for consensus and relevant clinical stakeholders were consulted.
We present the updated SNC guidelines for initial management of minimal, mild and moderate head injury in adults including criteria for computed tomography (CT) scan selection, admission and discharge with suggestions for monitoring routines and discharge advice for patients. The guidelines are designed to primarily detect neurosurgical intervention with traumatic CT findings as a secondary goal. For elements lacking good evidence, such as in-hospital monitoring, routines were largely based on consensus. We suggest external validation of the guidelines before widespread clinical use is recommended.
PMCID: PMC3621842  PMID: 23432764
computed tomography; GRADE; guidelines; head/brain injury/trauma; management; prediction rule; routines; S100/S100B/S100BB
6.  An observational study of compliance with the Scandinavian guidelines for management of minimal, mild and moderate head injury 
The Scandinavian guidelines for management of minimal, mild and moderate head injuries were developed to provide safe and cost effective assessment of head injured patients. In a previous study conducted one year after publication and implementation of the guidelines (2003), we showed low compliance, involving over-triage with computed tomography (CT) and hospital admissions. The aim of the present study was to investigate guideline compliance after an educational intervention.
We evaluated guideline compliance in the management of head injured patients referred to the University Hospital of Stavanger, Norway. The findings from the previous study in 2003 were communicated to the hospitals physicians, and a feed-back loop training program for guideline implementation was conducted. All patients managed during the months January through June in the years 2005, 2007 and 2009 were then identified with an electronic search in the hospitals patient administrative database, and the patient files were reviewed. Patients were classified according to the Head Injury Severity Scale, and the management was classified as compliant or not with the guideline.
The 1 180 patients were 759 (64%) males and 421 (36%) females with a mean age of 31.5 (range 0-97) years. Over all, 738 (63%) patients were managed in accordance with the guidelines and 442 (37%) were not. Compliance was not significantly different between minimal (56%) and mild (59%) injuries, while most moderate (93%) injuries were managed in accordance with the guidelines (p < 0.05). Noncompliance was caused by overtriage in 362 cases (30%) and undertriage in 80 (7%). Guideline compliance was 54% in 2005, 71% in 2007, and 64% in 2009.
This study shows higher guideline compliance after an educational intervention involving feed-back on performance. A substantial number of patients are exposed to over-triage, involving unnecessary radiation from CT examinations, and unnecessary costs from hospital admissions.
PMCID: PMC3352311  PMID: 22510221
Head injury; Guidelines; Implementation; Compliance
7.  Alcohol consumption, blood alcohol concentration level and guideline compliance in hospital referred patients with minimal, mild and moderate head injuries 
In 2000 the Scandinavian Neurotrauma Committee published guidelines for safe and cost-effective management of minimal, mild and moderate head injured patients.
The aims of this study were to investigate to what extent the head injury population is under the influence of alcohol, and to evaluate whether the physicians' compliance to the guidelines is affected when patients are influenced by alcohol.
This study included adult patients (≥15 years) referred to a Norwegian University Hospital with minimal, mild and moderate head injuries classified according to the Head Injury Severity Scale (HISS). Information on alcohol consumption was recorded, and in most of these patients blood alcohol concentration (BAC) was measured. Compliance with the abovementioned guidelines was registered.
The study includes 860 patients. 35.8% of the patients had consumed alcohol, and 92.1% of these patients had a BAC ≥ 1.00‰. Young age, male gender, trauma occurring during the weekends, mild and moderate head injuries were independent factors significantly associated with being under the influence of alcohol. Guideline compliance was 60.5%, and over-triage was the main violation. The guideline compliance showed no significant correlation to alcohol consumption or to BAC-level.
This study confirms that alcohol consumption is common among patients with head injuries. The physicians' guideline compliance was not affected by the patients' alcohol consumption, and alcohol influence could therefore not explain the low guideline compliance.
PMCID: PMC3101126  PMID: 21496318
8.  Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? 
Acta Orthopaedica  2011;82(1):56-63.
Background and purpose
Loss to follow-up may bias the outcome assessments of clinical registries. In this study, we wanted to determine whether outcomes were different in responding and non-responding patients who were included in a clinical spine surgery registry, at two years of follow-up. In addition, we wanted to identify risk factors for failure to respond.
633 patients who were operated for degenerative disorders of the lumbar spine were followed for 2 years using a local clinical spine registry. Those who did not attend the clinic and those who did not answer a postal questionnaire—for whom 2 years of outcome data were missing—and who would be lost to follow-up according to the standard procedures of the registry protocols, were defined as non-respondents. They were traced and interviewed by telephone. Outcome measures were: improvement in health-related quality of life (EQ-5D), leg pain, and back pain; and also general state of health, employment status, and perceived benefits of the operation.
We found no statistically significant differences in outcome between respondents (78% of the patients) and non-respondents (22%). Receipt of postal questionnaires (not being summoned for a follow-up visit) was the strongest risk factor for failure to respond. Forgetfulness appeared to be an important cause. Older patients and those who had complications were more likely to respond.
A loss to follow-up of 22% would not bias conclusions about overall treatment effects and, importantly, there were no indications of worse outcomes in non-respondents.
PMCID: PMC3229998  PMID: 21189113
9.  Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain 
Annals of the Rheumatic Diseases  2010;69(9):1643-1648.
To compare the long-term effectiveness of surgical and non-surgical treatment in patients with chronic low back pain.
Two merged randomised clinical trials compared instrumented transpedicular fusion with cognitive intervention and exercises in 124 patients with disc degeneration and at least 1 year of symptoms after or without previous surgery for disc herniation. The main outcome measure was the Oswestry disability index.
At 4 years 14 (24%) patients randomly assigned to cognitive intervention and exercises had also undergone surgery. 15 (23%) patients assigned fusion had undergone re-surgery. The mean treatment effect for the primary outcome was 1.1; 95% CI −5.9 to 8.2, according to the intention-to-treat analysis and −1.6; 95% CI −8.9 to 5.6 in the as-treated analysis. There was no difference in return to work.
Long-term improvement was not better after instrumented transpedicular fusion compared with cognitive intervention and exercises.
PMCID: PMC2938881  PMID: 19635718
10.  No impact of early intervention on late outcome after minimal, mild and moderate head injury 
To evaluate the effect of an educational intervention on outcome after minimal, mild and moderate head injury.
Three hundred and twenty six patients underwent stratified randomization to an intervention group (n = 163) or a control group (n = 163). Every second patient was allocated to the intervention group. Participants in this group were offered a cognitive oriented consultation two weeks after the injury, while subjects allocated to the control group were not. Both groups were invited to follow up 3 and 12 months after injury.
A total of 50 (15%) patients completed the study (intervention group n = 22 (13%), control group n = 28 (17%), not significant). There were no statistically significant differences between the intervention group and the control group.
There was no effect on outcomes from an early educational intervention two weeks after head injury.
PMCID: PMC2844351  PMID: 20181239
11.  Incidence of hospital referred head injuries in Norway: A population based survey from the Stavanger region 
In three previous Norwegian studies conducted between 1974 and 1993, the annual incidence rates of hospital admitted head injuries were 236, 200 and 169 per 100,000 population. The aim of this study was to describe the incidence of head injury in the Stavanger region and to compare it with previous Norwegian studies.
All head injured patients referred to Stavanger University Hospital during a one-year period (2003) were registered in a partly prospective and partly retrospective study. The catchment area for the hospital is strictly defined to a local population of 283,317 inhabitants (2003).
The annual incidence rate was 207/100,000 population for hospital referred head injury and 157/100,000 population for hospital admitted head injury. High age- and sex specific incidence rates were observed among the oldest, and the highest rate (882/100,000) among men above 90 years. More than 50% of the injuries were caused by falls.
Comparison with previous Norwegian studies indicates decreasing annual incidence rates for hospital admitted head injury during the last 30 years.
PMCID: PMC2650679  PMID: 19232086
12.  The risk of “getting worse” after lumbar microdiscectomy 
European Spine Journal  2004;14(1):49-54.
A frequent concern among patients operated for lumbar disc herniation is the risk of “getting worse”. To give an evidence-based estimate of the risk for worsening has been difficult, since previous studies have been more focused on unfavourable outcome in general, rather than on deterioration in particular. In this prospective study of 180 patients, we report the frequency of and the risk factors for getting worse after first time lumbar microdiscectomy. Follow-up time was 12 months. Primary outcome measure was the Oswestry disability index, assessing functional status and health-related quality of life. Of the patients 4% got worse. Independent risk factors of deterioration were a long duration of sick leave and a better functional status and quality of life prior to operation. We conclude that the risk of deterioration is small, but larger if the patient has been unable to work despite relatively small health problems. This study also demonstrates that changes in instrument scores should be reported, so that an accurate failure rate can be assessed.
PMCID: PMC3476683  PMID: 15138862
Lumbar discectomy; Outcome; Failed back; Prognostic factors
13.  Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial 
Objective To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks).
Design Multicentre, blinded, randomised controlled trial.
Setting Outpatient multidisciplinary back clinics of five Norwegian hospitals.
Participants Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity.
Interventions Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval.
Main outcome measures Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain.
Results Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n=40), estimated change in the Oswestry disability index from the adjusted baseline value was −4.7 (95% confidence intervals −0.6 to −8.8) at 6 weeks, −11.4 (−6.3 to −14.5) at 12 weeks, and −14.3 (−10.0 to −18.7) at 52 weeks. For the epidural saline intervention group (n=39) compared with the sham group, differences in primary outcome were −0.5 (−6.3 to 5.4) at 6 weeks, 1.4 (−4.5 to 7.2) at 12 weeks, and −1.9 (−8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were −2.9 (−8.7 to 3.0), 4.0 (−1.9 to 9.9), and 1.9 (−4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend.
Conclusions Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy.
Trial registration Current Controlled Trials ISRCTN No 12574253.
PMCID: PMC3172149  PMID: 21914755

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