SIREN Coordinating Center Website - https://siren.network/
Ellen Underwood, MS will present: Dmitrienki A and D’Agostino RB. Multiplicity Considerations in Clinical Trials. NEJM 2018;378:2115-22.
Valerie Durkalski-Mauldin, PhD will present: Yadav K and Lewis RJ. Gatekeeping Strategies for Avoiding False-Positive Results in Clinical Trials with Many Comparisons. JAMA 2017;318(14):1385-86.
Additional Reading: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, CBER, & Center for Biologics Evaluation and Research. (DRAFT) Guidance for Industry. January 2017.
D. Mark Courtney, MD, MSc will present: Kearon C, de Wit K, Parpia S, Schulman S, Afilalo M, Hirsch A, et al. Diagnosis of Pulmonary Embolism with D-Dimer Adjusted to Clinical Probability. NEJM 2019;381:2125-34.
Jaideep Kapur, MB, BS, PhD will present: Kapur J, Elm J, Chamberlain JM, Barsan W, Cloyd J, Lowenstein D, et al. Randomized Trial of Three Aniconvulsant Medications for Status Epilepticus. NEJM 2019;381:2103-13.
Jon Rittenberger, MD will present: Lascarrou J-B, Le Gouge A, Colin G., Grillet G., Girardie P, et al. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. NEJM DOI:10.1056/NEJMoa1906661. Published online October 2, 2019.
Geoffrey Barnes, MD will present: Chew DP, Lambrakis K, Blyth A, Seshadri A, Edmonds MJR, Briffa T, et al. A Randomized Trial of a 1-Hour Troponin T Protocol in Suspected Acute Coronary Syndromes: The Rapid Assessment of Possible ACS In the Emergency Department with High Sensitivity Troponin T (RAPID-TnT) Study. JAMA. 2019;321(17):1677-85.
Dan Spaite, MD will present: Spaite D, Bobrow B, Keim S, Barnhart B, Chikani V, Gaither J, et al. Association of Statewide Implementation of the Prehospital Traumatic Brain Injury Treatment Guidelines with Patient Survival Following Traumatic Brain Injury – The Excellence in Prehospital Injury Care (EPIC) Study. JAMA Surg. doi:10.1001/jamasurg.2019.1152. Published online May 8, 2019.
Karen Hirsch, MD, and Melissa Ann Vogelsong, MD will present: Nordberg P, Silvio Taccone F, Truhlar A, Forsberg S, Hollenberg J, Johnsson M, et al. Effect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest – The PRINCESS Randomized Clinical Trial. JAMA. 2019;321(17):1677-85.
James Chamberlain, MD will present: Dalziel SR, Borland ML, Furyk J, Bonisch M, Neutze J, Donath S, et al. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicenter, randomized controlled trial. Published Online April 17, 2019 http://dx.doi.org/10.1016/S0140-6736(19)30722-6
Shlomo Shinnar, MD, PhD will present: Lyttle MD, Rainford NEA, Messahel S, Humphreys A, Hickey H, Woolfall K, et al. Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicenter, open-label, randomized trial. Published Online April 17, 2019 http://dx.doi.org/10.1016/S0140-6736(19)30724-X
Editorial: Silbergleit R and Elm J. Levetiracetam no better than phenytoin in children with convulsive status epilepticus. Published Online April 17, 2019 http://dx.doi.org/10.1016/S0140-6736(19)30896-7
Benjamin Abella, MD and David Gaieski, MD will present: Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, et al. Coronary Angiography after Cardiac Arrest without ST-Segment Elevation. NEJM, March 18, 2019; DOI: 10.1056/NEFMoa1816897.
Mackenzie Cervenka, MD will present: Cervenka MC, Hocker S, Koenig M, Bar B, Henry-Barron B, et al. Phase I/II Multicenter Ketogenic Diet Study for Adult Superrefractory Status Epilepticus. Neurology 2017;88:938-43.
Valerie Durkalski-Mauldin,PhD will present: Woodcock J and LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. NEJM 2017;377:62-70.
Jordan Elm, PhD will present: Hemming K, Haines TP, Chilton PJ, Girling AJ, and Lilford RJ. The Stepped Wedge Cluster Randomised Trial: Rationale, Design, Analysis, and Reporting. BMJ 2015;351:h391.
Kees Polderman, MD will present: Cooper J, Nichol AD, Bailey M, Bernard S, Cameron PA, Pili-Floury S, et al. Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients with Severe Traumatic Brain Injury. JAMA 2018;320(21):2211-20.
TBA will present: Moseby-Knappe M, Mattsson N, Nielsen N, Zetterberg H, Blennow K, Dankiewicz J, et al. Serum Neurofilament Light Chain for Prognosis of Outcome After Cardiac Arrest. JAMA 2018 Oct 29. doi: 10.1001/jamaneurol.2018.3223. [Epub ahead of print]
Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, et al. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults with Out-of-Hospital Cardiac Arrest – A Randomized Clinical Trial. JAMA 2018;320(8):769-78.
Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, et al. Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome – The AIRWAYS-2 Randomized Clinical Trial. JAMA 2018;320(8):779-91.
Bolland MJ, Avenell A, Gamble GD, and Grey A. Systemic Review and Statistical Analysis of the Integrity of 33 Randomized Controlled Trials. Neurology 2016;87:1-12.
Cutter GR. To Catch a Crook, You Might Try Statistics. Nature Reviews Neurology 2017;13:9-10.
Kupferschmidt K. Tide of Lies: The Researcher at the Center of an Epic Scientific Fraud Remains an Enigma to the Scientists Who Exposed Him. Science 2018;361(6403):636-41.
Kuppermann N, Ghetti S, Schunk JE, Stoner MJ, Rewers A, McManemy JK, et al. Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis. N Engl J Med 2018;378:2275-87.
Gainza-Lein M, Fernandez IS, Jackson M, Abend N, Arya R, Brenton N, et al. Association of Time to Treatment with Short-term Outcomes for Pediatric Patients with Refractory Convulsive Status Epilepticus. JAMA Neurol 2018;75(4):410-18.
Schwamm LH, Wu O, Song SS, Latour L, Ford AL, Hsia AW, et al. Intravenous Thrombolysis in Unwitnessed Stroke Onset: MR WITNESS Trial Results. Ann Neurol 2018;00:1-14.
Kate M, Wannamaker R, Kamble H, Riaz P, Gioia LC, Buck B, et al. Penumbral Imaging-Based Thrombolysis with Tenecteplase Is Feasible up to 24 Hours After Symptom Onset. J of Stroke 2018;20(1):122-130.
Konstantinides SV, Vicault E, Danays T, Becattini C, Bertoletti L, Beyer-Westendorf J, et al. Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism. JACC 2017:69(12);1536-44.
Meinzer C, Martin R and Suarez JI. Bayesian Dose Selection Design for a Binary Outcome Using Restricted Response-Adaptive Randomization. Trials 2017:18;420-30.
Nogueira RG, Jadhav AP, Haussen A Bonafe, Budzik RF, Bhuva P, et al. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. NEJM 2018;378(1);11-21.
Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, et al. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. NEJM 2018:378;708-718.
Dickert NW, Eyal N, Goldkind SF, Grady C, Joffe S, Lo B, et al. Reframing Consent for Clinical Research: A Function-Based Approach. The American Journal of Bioethics 2017; 12:3-11.
Lentz J, Kennett M, Perlmutter J, and Forrest A. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemporary Clinical Trials 2016;49:65-69.