Methods for specifying the target difference in a randomised controlled trial : the Difference ELicitation in TriAls (DELTA) systematic review

Peer reviewedPublisher PD

Minimum Information about a Biosynthetic Gene cluster

A wide variety of enzymatic pathways that produce specialized metabolites in bacteria, fungi and plants are known to be encoded in biosynthetic gene clusters. Information about these clusters, pathways and metabolites is currently dispersed throughout the literature, making it difficult to exploit. To facilitate consistent and systematic deposition and retrieval of data on biosynthetic gene clusters, we propose the Minimum Information about a Biosynthetic Gene cluster (MIBiG) data standard.Chemistry and Chemical Biolog

Posterior epidural migration of herniated lumbar disc fragment: a literature review.

Elsharkawy AE, Hagemann A, Klassen PD. Posterior epidural migration of herniated lumbar disc fragment: a literature review. Neurosurgical review. 2019;42(4):811-823

Posterior epidural migration of extruded lumbar disc fragment mimicking epidural mass: A case report

Introduction: Posterior epidural migration of the lumbar disc fragment is a very rare pathological entity. The pathomechanisms remain unclear. Case presentation: The authors present the case of a 78-year-old Germans male with refractory low back pain. Contrast-MRI showed an epidural mass at the level L1–2 with rim contrast enhancement. The preoperative diagnosis based on the clinical and history of the patient was most probably sequestrated disc fragment migrated posteriorly; differential diagnosis included all other causes of posteriorly located epidural mass.A left interlaminar approach L1–2 was performed. A sticky, capsulated, semi-hard and mobile mass was removed from the posterior epidural spaces. Intraoperative a lateral till the ventral disc fragments were found. An annular tear was found and discectomy was performed. Pathological examination showed a disc tissue with degenerative changes. The patient was pain-free until the last follow-up at 5months. Conclusions: Correlation between relevant clinical information and radiological finding may help to detect the posterior migrated disc fragment

An intradural lumbar disc fragment with free migration: A case of a missed intradural disc herniation

Introduction: Intradural lumbar disc herniation (ILDH) is a very rare pathological entity. The pathomechanisms and the natural course remain unclear. Case presentation: The authors present the case of a 58-year-old Germans male with repetitive microdiscectomies (MD) and intraoperative missed diagnosis of ILDH. The patient underwent standard MD due to lumbar disc herniation (LDH) at the level L4/5. Incidental durotomy (ID) was sealed with a ventromedial patch. Postoperative course was uneventful. 14 months later the patient presented with a L4 radiculopathy, having his second MD at the level L3/4. At this point the radiological images showed already a free floating intradural fragment at the level S1, clinically not significant. As in the previous surgery, the postoperative course was uneventful. After 18 months, he presented again complaining of low back pain and electric-like attacks of pain along the right L5 root for the prior five months. Contrast-MRI revealed that the known intradural disc-mass migrated from S1 to the level L4/5. A left L4 hemilaminectomy was performed. The durotomy identified a hard, white, shiny mass. The patient was pain-free until the last follow-up at 13 months. Conclusions: Intraoperative manipulation of disc fragments in the presence of an ID potentially leads to iatrogenic ILDH

Effectiveness of an annular closure device to prevent recurrent lumbar disc herniation a secondary analysis with 5 years of follow-up

IMPORTANCE: Patients with large annular defects following lumbar microdiscectomy for disc herniation are at increased risk for symptomatic recurrence and reoperation. OBJECTIVE: To determine whether a bone-anchored annular closure device in addition to lumbar microdiscectomy resulted in lower reherniation and reoperation rates vs lumbar microdiscectomy alone. DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a multicenter randomized clinical trial reports 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites. Patients in this study had a large annular defect (6-10 mm width) following lumbar microdiscectomy for treatment of lumbar disc herniation. Statistical analysis was performed from November to December 2020. INTERVENTIONS: Lumbar microdiscectomy with additional bone-anchored annular closure device (device group) or lumbar microdiscectomy only (control group). MAIN OUTCOMES AND MEASURES: The incidence of symptomatic reherniation, reoperation, and adverse events as well as changes in leg pain, Oswestry Disability Index, and health-related quality of life when comparing the device and control groups over 5 years of follow-up. RESULTS: Among 554 randomized participants (mean [SD] age: 43 [11] years; 327 [59%] were men), 550 were included in the modified intent-to-treat efficacy population (device group: n = 272; 270 [99%] were White); control group: n = 278; 273 [98%] were White) and 550 were included in the as-treated safety population (device group: n = 267; control group: n = 283). The risk of symptomatic reherniation (18.8% [SE, 2.5%] vs 31.6% [SE, 2.9%]; P < .001) and reoperation (16.0% [SE, 2.3%] vs 22.6% [SE, 2.6%]; P = .03) was lower in the device group. There were 53 reoperations in 40 patients in the device group and 82 reoperations in 58 patients in the control group. Scores for leg pain severity, Oswestry Disability Index, and health-related quality of life significantly improved over 5 years of follow-up with no clinically relevant differences between groups. The frequency of serious adverse events was comparable between the treatment groups. Serious adverse events associated with the device or procedure were less frequent in the device group (12.0% vs 20.5%; difference, −8.5%; 95% CI, −14.6% to −2.3%; P = .008). CONCLUSIONS AND RELEVANCE: In patients who are at high risk of recurrent herniation following lumbar microdiscectomy owing to a large defect in the annulus fibrosus, this study’s findings suggest that annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation over 5 years of follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0128343

Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis with 5 Years of Follow-up

Importance: Patients with large annular defects following lumbar microdiscectomy for disc herniation are at increased risk for symptomatic recurrence and reoperation. Objective: To determine whether a bone-anchored annular closure device in addition to lumbar microdiscectomy resulted in lower reherniation and reoperation rates vs lumbar microdiscectomy alone. Design, Setting, and Participants: This secondary analysis of a multicenter randomized clinical trial reports 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites. Patients in this study had a large annular defect (6-10 mm width) following lumbar microdiscectomy for treatment of lumbar disc herniation. Statistical analysis was performed from November to December 2020. Interventions: Lumbar microdiscectomy with additional bone-anchored annular closure device (device group) or lumbar microdiscectomy only (control group). Main Outcomes and Measures: The incidence of symptomatic reherniation, reoperation, and adverse events as well as changes in leg pain, Oswestry Disability Index, and health-related quality of life when comparing the device and control groups over 5 years of follow-up. Results: Among 554 randomized participants (mean [SD] age: 43 [11] years; 327 [59%] were men), 550 were included in the modified intent-to-treat efficacy population (device group: n = 272; 270 [99%] were White); control group: n = 278; 273 [98%] were White) and 550 were included in the as-treated safety population (device group: n = 267; control group: n = 283). The risk of symptomatic reherniation (18.8% [SE, 2.5%] vs 31.6% [SE, 2.9%]; P <.001) and reoperation (16.0% [SE, 2.3%] vs 22.6% [SE, 2.6%]; P =.03) was lower in the device group. There were 53 reoperations in 40 patients in the device group and 82 reoperations in 58 patients in the control group. Scores for leg pain severity, Oswestry Disability Index, and health-related quality of life significantly improved over 5 years of follow-up with no clinically relevant differences between groups. The frequency of serious adverse events was comparable between the treatment groups. Serious adverse events associated with the device or procedure were less frequent in the device group (12.0% vs 20.5%; difference, -8.5%; 95% CI, -14.6% to -2.3%; P =.008). Conclusions and Relevance: In patients who are at high risk of recurrent herniation following lumbar microdiscectomy owing to a large defect in the annulus fibrosus, this study's findings suggest that annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation over 5 years of follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT01283438

Proceedings of the Fourth Annual Deep Brain Stimulation Think Tank: A Review of Emerging Issues and Technologies

This paper provides an overview of current progress in the technological advances and the use of deep brain stimulation (DBS) to treat neurological and neuropsychiatric disorders, as presented by participants of the Fourth Annual DBS Think Tank, which was convened in March 2016 in conjunction with the Center for Movement Disorders and Neurorestoration at the University of Florida, Gainesveille FL, USA. The Think Tank discussions first focused on policy and advocacy in DBS research and clinical practice, formation of registries, and issues involving the use of DBS in the treatment of Tourette Syndrome. Next, advances in the use of neuroimaging and electrochemical markers to enhance DBS specificity were addressed. Updates on ongoing use and developments of DBS for the treatment of Parkinson's disease, essential tremor, Alzheimer's disease, depression, post-traumatic stress disorder, obesity, addiction were presented, and progress toward innovation(s) in closed-loop applications were discussed. Each section of these proceedings provides updates and highlights of new information as presented at this year's international Think Tank, with a view toward current and near future advancement of the field