Faculty: Peter Warnke; Ben Roitberg

Residents: Ricky Wong; Javed Khader-Eliyas; Ashley Ralston; Melissa Stamates; Mahua Dey

Articles:

1) LeWitt P, Rezai AR, Leehey, MA, Ojemann SG, Flaherty AW, Eskandar EN, Kostyk SK, Thomas K, Sarkar, A, Siddiqui MS, Tatter SB, Schwalb JM, Poston KL, Henderson JM, Kurlan RM, Richard IH, Van Meter L, Sapan CV, During M, Kaplitt MG, Feigin A. AAV2-GAD gene therapy for advanced Parkinson’s disease: a double-blind, sham-surgery controlled, randomized trial Lancet Neurology 2011; 10:309-19

Stamates: LeWitt et al. completed the first multi-center, double-blind randomized trial in gene therapy insertion for advanced Parkinson’s disease to demonstrate any therapeutic effect. Gene transfer of glutamic acid decarboxylase and subsequent GABA production in the subthalamic nucleus (STN) was proposed by the authors as superior treatment to DBS and subthalamotomy when medication fails to control PD symptoms. The authors performed a gene therapy trial under rigorous experimental standards, whereas most such studies are open-label. The relative standardization of stereotactic frame placement and microelectrode recording allowed each center to uniformly infuse the treatment vector (Adeno-Associated Virus – AAV) into each subject’s bilateral subthalamic nuclei. Controls only received partial thickness burr holes and the injection was simulated but did not take place.

Continue reading ‘Sterotactic and Functional Neurosurgery’ »

University of Chicago Neurosurgery Journal Club, June 2011

Edited by: B Roitberg, MD

Faculty: F. Brown, B. Roitberg.

Residents: J. Hsieh, I. Takagi, N. Monim-Mansour, A. Bhansali, J. Khader-Elyias.

1) Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50.

Hsieh:
This Spine Patient Outcomes Research Trial (SPORT) evaluates surgery vs. non-surgical treatment for lumbar disc herniation. It is a landmark study, and is perhaps the single most publicized trial evaluating surgical management of back pain in scientific literature today. And as such, the study’s primary conclusion, that there is no difference in outcomes between surgery and non-surgery for lumbar disc herniation, can easily be misinterpreted and misquoted and warrants critical evaluation.

SPORT is a randomized clinical trial encompassing 13 multidisciplinary spine clinics. The lumbar disc herniation study enrolled a total of 501 surgical candidates with lumbar disk herniation and persistent signs
and symptoms of radiculopathy for at least 6 weeks. Patients were randomized to open discectomy or non-operative treatment. The primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity, satisfaction with symptoms, self-reported improvement, and employment status. Groups were compared using an intent-to-treat analysis. After analysis, the study concluded: “Between-group differences in
improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.” However, the devil is in the details.

The crux of the argument around SPORT lies in the intent-to-treat analysis and patient crossover. Say you are doing a study and you have randomized patients into two equal groups: A and B. Now by design, Group A is randomized to be your “Surgery” group and Group B is randomized to be your “Non Surgery” group. No matter what treatment the patient ultimately gets, you will analyze them as to their initial randomization. By doing this analysis, you preserve your randomization and can gauge the outcomes after prescribing treatment (i.e. your intent to treat) regardless of the treatment the patient ultimately receives. This is what researchers mean by “intent-to-treat” analysis.

Continue reading ‘SPORT and Related Studies of Spine Surgery Outcomes’ »

University of Chicago Journal Club, March 2011

Editor, B Roitberg, MD

Faculty:
Warnke P
Hekmat-Panah J
Roitberg B

Residents:
Khader-Eliyas J
Bhansali A
Dey M
Hsieh J

Article 1:

Williams A, Gill S, Varma T, Jenkinson C, Quinn N, Mitchell R, Scott R, Ives N, Rick C, Daniels J, Patel S, Wheatley K; PD SURG Collaborative Group. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson’s disease (PD SURG trial): a randomised, open-label trial. Lancet Neurol. 2010 Jun;9(6):581-91.

Khader-Eliyas:

The PD SURG trial we are discussing today is an open label randomized ‘intent to treat’ trial comparing medical treatment alone with combined medical and surgical treatment. The trial was conducted across 13 neurosurgical centers in the UK from 2000 to 2006. The investigators intended to prove the usefulness of deep brain stimulation in treating Parkinson’s patients by showing a 10-point difference between both groups on PDQ 39 (Parkinson’s disease Questionnaire). Secondary endpoints included changes in UPDRS (Unified Parkinsons Disease Rating Scale) and DRS II (Dementia Rating Scale II) at the end of 1 year following treatment. This article presents the follow up data at 1 year.

Continue reading ‘Deep Brain Stimulation for Parkinsons’s Disease’ »

The University of Chicago Journal Club, October 2010

Editor, B Roitberg, MD

Articles discussed:

1. “ISAT 2002”: Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74.
2. “ISAT 2005”: Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet 2005 Sep 3-9;366(9488):809-17.
3. “ISAT 2009”: Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J; ISAT Collaborators. Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009 May;8(5):427-33.
4. Lanterna LA, Tredici G, Dimitrov BD, Biroli F.Treatment of unruptured cerebral aneurysms by embolization with Guglielmi detachable coils: case-fatality, morbidity, and effectiveness in preventing bleeding – a systemic review of the literature. Neurosurgery. 2004 Oct;55(4):767-75; discussion 775-8.
5. P. Mitchell, R. Kerr, Mendelow, Molyneux. Could late rebleeding overturn the superiority of cranial aneurysm coil embolization over clip ligation seen in the ISAT? J Neurosurg. 2008 Mar;108(3):437-42.
6. Bakker NA, Metzemaekers JD, Groen RJ, Mooij JJ, Van Dijk JM. International Subarachnoid Aneurysm Trial 2009: Endovascular Coiling of Ruptured Intracranial Aneurysms Has No Significant Advantage Over Neurosurgical Clipping. Neurosurgery. 2010 May;66(5):961-2.

Continue reading ‘Coiling Aneurysms’ »

The University of Chicago Journal Club, August 2010

Editor, B Roitberg, MD

Introduction

This is the first publication of the “University of Chicago Journal Club” series. The format is new, and some explanation is in order.

- “Journal club” is a popular educational tool, familiar to many readers in some form. Residents, students and faculty meet to discuss one or more articles, trying to put the paper in perspective of previously published literature, practice, and personal experience. This is also an opportunity to critique study design, understand strengths and limitations of the various articles. Many formats can be used for a journal club, but most often a student or resident would review an article and discuss it, followed by comments and questions by faculty and other residents or students. For me, a journal club always felt like a much better way to learn that by just reading a few articles on my own. Even just listening to a journal club was illuminating. The goal of the new “journal club” series at SNI is to share our journal club at the University of Chicago Neurosurgery with the readers. The format is a work in progress, and we welcome comments and feedback.

Continue reading ‘Early decompressive surgery in malignant infarction of the middle cerebral artery’ »