Magnetic resonance imaging (MRI) is frequently performed during follow-up in patients with known lumbar-disk herniation and persistent symptoms of sciatica. The association between findings on MRI ...and clinical outcome is controversial.
We studied 283 patients in a randomized trial comparing surgery and prolonged conservative care for sciatica and lumbar-disk herniation. Patients underwent MRI at baseline and after 1 year. We used a 4-point scale to assess disk herniation on MRI, ranging from 1 for "definitely present" to 4 for "definitely absent." A favorable clinical outcome was defined as complete or nearly complete disappearance of symptoms at 1 year. We compared proportions of patients with a favorable outcome among those with a definite absence of disk herniation and those with a definite, probable, or possible presence of disk herniation at 1 year. The area under the receiver-operating-characteristic (ROC) curve was used to assess the prognostic accuracy of the 4-point scores regarding a favorable or unfavorable outcome, with 1 indicating perfect discriminatory value and 0.5 or less indicating no discriminatory value.
At 1 year, 84% of the patients reported having a favorable outcome. Disk herniation was visible in 35% with a favorable outcome and in 33% with an unfavorable outcome (P=0.70). A favorable outcome was reported in 85% of patients with disk herniation and 83% without disk herniation (P=0.70). MRI assessment of disk herniation did not distinguish between patients with a favorable outcome and those with an unfavorable outcome (area under ROC curve, 0.48).
MRI performed at 1-year follow-up in patients who had been treated for sciatica and lumbar-disk herniation did not distinguish between those with a favorable outcome and those with an unfavorable outcome. (Funded by the Netherlands Organization for Health Research and Development and the Hoelen Foundation; Controlled Clinical Trials number, ISRCTN26872154.).
Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica due to lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the ...rate of recovery, although evidence is lacking of its efficacy.
To determine outcomes and time to recovery in patients treated with tubular diskectomy compared with conventional microdiskectomy.
The Sciatica Micro-Endoscopic Diskectomy randomized controlled trial was conducted among 328 patients aged 18 to 70 years who had persistent leg pain (>8 weeks) due to lumbar disk herniations at 7 general hospitals in The Netherlands from January 2005 to October 2006. Patients and observers were blinded during the follow-up, which ended 1 year after final enrollment.
Tubular diskectomy (n = 167) vs conventional microdiskectomy (n = 161).
The primary outcome was functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica (score range: 0-23, with higher scores indicating worse functional status) at 8 weeks and 1 year after randomization. Secondary outcomes were scores on the visual analog scale for leg pain and back pain (score range: 0-100 mm) and patient's self-report of recovery (measured on a Likert 7-point scale).
Based on intention-to-treat analysis, the mean RDQ score during the first year after surgery was 6.2 (95% confidence interval CI, 5.6 to 6.8) for tubular diskectomy and 5.4 (95% CI, 4.6 to 6.2) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, -0.2 to 1.7). At 8 weeks after surgery, the RDQ mean (SE) score was 5.8 (0.4) for tubular diskectomy and 4.9 (0.5) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, -0.4 to 2.1). At 1 year, the RDQ mean (SE) score was 4.7 (0.5) for tubular diskectomy and 3.4 (0.5) for conventional microdiskectomy (between-group mean difference, 1.3; 95% CI, 0.03 to 2.6) in favor of conventional microdiskectomy. On the visual analog scale, the 1-year between-group mean difference in improvement was 4.2 mm (95% CI, 0.9 to 7.5 mm) for leg pain and 3.5 mm (95% CI, 0.1 to 6.9 mm) for back pain in favor of conventional microdiskectomy. At 1 year, 107 of 156 patients (69%) assigned to tubular diskectomy reported a good recovery vs 120 of 151 patients (79%) assigned to conventional microdiskectomy (odds ratio, 0.59 95% CI, 0.35 to 0.99; P = .05).
Use of tubular diskectomy compared with conventional microdiskectomy did not result in a statistically significant improvement in the Roland-Morris Disability Questionnaire score. Tubular diskectomy resulted in less favorable results for patient self-reported leg pain, back pain, and recovery.
isrctn.org Identifier: ISRCTN51857546.
Purpose
Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with ...lumbar spinal stenosis treated with IPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression.
Methods
A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden–The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwent spinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time.
Results
At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group 69 % (95 % CI 57–78 %) did not show a significant difference compared with standard bony decompression 60 % (95 % CI 48–71 %)
p
value 0.2. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (
p
< 0.01). Furthermore, long-term VAS back pain was significantly higher 36 mm on a 100 mm scale (95 % CI 24–48) in the IPD group compared to the bony decompression group 28 mm (95 % CI 23–34)
p
value 0.04.
Conclusions
This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional ‘simple’ decompression, two years after surgery. Moreover, in the IPD treatment arm, the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm.
Objective To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs.Design Cost utility analysis alongside a ...randomised controlled trial.Setting Nine Dutch hospitals.Participants 283 patients with sciatica for 6-12 weeks, caused by lumbar disc herniation.Interventions Six months of prolonged conservative care compared with early surgery.Main outcome measures Quality adjusted life years (QALYs) at one year and societal costs, estimated from patient reported utilities (UK and US EuroQol, SF-6D, and visual analogue scale) and diaries on costs (healthcare, patient’s costs, and productivity).Results Compared with prolonged conservative care, early surgery provided faster recovery, with a gain in QALYs according to the UK EuroQol of 0.044 (95% confidence interval 0.005 to 0.083), the US EuroQol of 0.032 (0.005 to 0.059), the SF-6D of 0.024 (0.003 to 0.046), and the visual analogue scale of 0.032 (−0.003 to 0.066). From the healthcare perspective, early surgery resulted in higher costs (difference €1819 (£1449; $2832), 95% confidence interval €842 to €2790), with a cost utility ratio per QALY of €41 000 (€14 000 to €430 000). From the societal perspective, savings on productivity costs led to a negligible total difference in cost (€−12, €−4029 to €4006).Conclusions Faster recovery from sciatica makes early surgery likely to be cost effective compared with prolonged conservative care. The estimated difference in healthcare costs was acceptable and was compensated for by the difference in absenteeism from work. For a willingness to pay of €40 000 or more per QALY, early surgery need not be withheld for economic reasons.Trial registration Current Controlled Trials ISRCTN 26872154.
We studied baseline magnetic resonance images of 155 patients with intermittent neurogenic claudication and lumbar spinal stenosis (LSS). Magnetic resonance imaging (MRI) and patient data were ...gathered from participants of a randomized trial.
It is believed that the narrowness of the lumbar spinal canal correlates to the severity of complaints and that it may be a good predictor of clinical outcome if treated. However, this hypothesis has never been (prospectively) tested.
MRI is an important tool to confirm the diagnosis of LSS as a cause for intermittent neurogenic claudication.
Three raters were asked to evaluate the magnetic resonance images (Schizas scale). Symptom severities at baseline and 1-year follow-up were quantified. The radiological scores were correlated with clinical baseline and outcome scores to assess diagnostic and prognostic value of MRI findings at baseline.
There was good agreement on the clinically relevant level of LSS (kappa range 0.57-0.64). MRI assessment of grading of compression (kappa 0.33-0.46) did not correlate with baseline MRDQ nor with outcome based on postoperative change in MRDQ (P = 0.61). However, both absence of epidural fat and presence of tortuous caudal nerves on magnetic resonance images (kappa 0.53-0.72 and 0.67-0.70) in patients with LSS were relatively good predictors for satisfactory recovery after surgery (P = 0.03 and P < 0.01).
The grading of compression on the preoperative MRI is neither ambiguous nor correlating to severity of clinical condition. It does, furthermore, not have the ability to predict the outcome after 1 year if surgically treated.
2.
Abstract To improve identification of child maltreatment, a new policy (‘Hague protocol’) was implemented in hospitals in The Netherlands, stating that adults attending the hospital emergency ...department after intimate partner violence, substance abuse or a suicide attempt should be asked whether they care for children. If so, these children are referred to the Reporting Center for Child Abuse and Neglect (RCCAN), for assessment and referrals to support services. An adapted, hospital-based version of this protocol (‘Amsterdam protocol’) was implemented in another region. Children are identified in the same manner, but, instead of a RCCAN referral, they are referred to the pediatric outpatient department for an assessment, including a physical examination, and referrals to services. We compared results of both protocols to assess how differences between the protocols affect the outcomes on implementation, detection of child maltreatment and referrals to services. Furthermore, we assessed social validity and results of a screening physical examination. We included 212 families from the Amsterdam protocol (cohort study with reports by pediatric staff and parents) and 565 families from the Hague protocol (study of RCCAN records and telephone interviews with parents). We found that the RCCAN identified more maltreatment than pediatric staff (98% versus at least 51%), but referrals to services were similar (82% versus 80% of the total sample) and parents were positive about both interventions. Physical examination revealed signs of maltreatment in 5%. We conclude that, despite the differences, both procedures can serve as suitable methods to identify and refer children at risk for maltreatment.
B cell–activation factor (BAFF) is critical for B cell maturation. Inhibition of BAFF represents an appealing target for desensitization of sensitized end‐stage renal disease (ESRD) patients. We ...conducted a Phase 2a, single‐arm, open‐label exploratory study investigating the effect of tabalumab (BAFF inhibitor) in patients with ESRD and calculated panel reactive antibodies (cPRAs) >50%. The treatment period duration was 24 weeks. Eighteen patients received tabalumab, at doses of 240‐mg subcutaneous (SC) at Week 0 followed by 120‐mg SC monthly for 5 additional months. Patients were followed for an additional 52 weeks. Immunopharmacologic effects were characterized through analysis of blood for HLA antibodies, BAFF concentrations, immunoglobulins, T and B cell subsets, as well as pre‐ and posttreatment tonsil and bone marrow biopsies. Significant reductions in cPRAs were observed at Weeks 16 (p = 0.043) and 36 (p = 0.004); however, absolute reductions were small (<5%). Expected pharmacologic changes in B cell subsets and immunoglobulin reductions were observed. Two tabalumab‐related serious adverse events occurred (pneumonia, worsening of peripheral neuropathy), while the most common other adverse events were injection‐site pain and hypotension. Three patients received matched deceased donor transplants during follow‐up. Treatment with a BAFF inhibitor resulted in statistically significant, but not clinically meaningful reduction in the cPRA from baseline (NCT01200290, Clinicaltrials.gov).
Treatment with a B cell–activating factor inhibitor in highly sensitized end‐stage kidney disease patients awaiting kidney transplant produces pharmacodynamic effects but does not lead to clinically meaningful reduction in calculated panel reactive antibodies.
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