title: Launching Effectiveness Research to Guide Practice in Neurosurgery: A National Institute Neurological Disorders and Stroke Workshop Report.
abstract: This workshop addressed challenges of clinical research in neurosurgery. Randomized controlled clinical trials (RCTs) have high internal validity, but often insufficiently generalize to real-world practice. Observational studies are inclusive but often lack sufficient rigor. The workshop considered possible solutions, such as (1) statistical methods for demonstrating causality using observational data; (2) characteristics required of a registry supporting effectiveness research; (3) trial designs combining advantages of observational studies and RCTs; and (4) equipoise, an identified challenge for RCTs. In the future, advances in information technology potentially could lead to creation of a massive database where clinical data from all neurosurgeons are integrated and analyzed, ending the separation of clinical research and practice and leading to a new "science of practice."
authors.affiliation: National Institute Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.
authors.forename: Patricia
authors.initials: P
authors.lastname: Walicke
authors.affiliation: Department of Neurosurgery, University of Colorado-Anschutz Medical Campus, Aurora, Co-lorado.
authors.forename: Aviva
authors.initials: A
authors.lastname: Abosch
authors.affiliation: Department of Neurosurgery and Neuroscience Institute, Carolinas Healthcare System, Charlotte, North Caro-lina.
authors.forename: Anthony
authors.initials: A
authors.lastname: Asher
authors.affiliation: Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Fred G
authors.initials: FG
authors.lastname: Barker
authors.affiliation: Alan L. and Jacqueline B. Stuart Spine Research Center, Depart-ment of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massa-chusetts; Tufts University School of Medi-cine, Boston, Massachusetts.
authors.forename: Zoher
authors.initials: Z
authors.lastname: Ghogawala
authors.affiliation: Depart-ment of Neurosurgery, Penn State University, Milton S. Hershey Medical Center, Hershey, Pennsylvania.
authors.forename: Robert
authors.initials: R
authors.lastname: Harbaugh
authors.affiliation: Epilepsy Center, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Lara
authors.initials: L
authors.lastname: Jehi
authors.affiliation: Department of Neurosurgery, University of Utah, Salt Lake City, Utah.
authors.forename: John
authors.initials: J
authors.lastname: Kestle
authors.affiliation: National Institute Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.
authors.forename: Walter
authors.initials: W
authors.lastname: Koroshetz
authors.affiliation: Biostatistics, University of Michi-gan, Ann Arbor, Michigan.
authors.forename: Roderick
authors.initials: R
authors.lastname: Little
authors.affiliation: Department of Statistics, Harvard University, Cam-bridge, Massachusetts.
authors.forename: Donald
authors.initials: D
authors.lastname: Rubin
authors.affiliation: Department of Neurosurgery, Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Alex
authors.initials: A
authors.lastname: Valadka
authors.affiliation: Depart-ment of Epidemiology, University of Pittsburg, Pittsburgh, Pennsylvania.
authors.forename: Stephen
authors.initials: S
authors.lastname: Wisniewski
authors.affiliation: Department of Neurosurgery, Brigham and Women's Hospital, Center for Neuro- Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
authors.forename: E Antonio
authors.initials: EA
authors.lastname: Chiocca
mesh_terms: D000047:Academies and Institutes; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic; D017408:Guidelines as Topic; D006801:Humans; D009493:Neurosurgery / Q000379:methods*; D019635:Neurosurgical Procedures / Q000379:methods*; D012107:Research Design
keywords: Clinical trials; Effectiveness research; Equipoise; Randomized controlled trial; Registry