Do Methodological Flaws Invalidate a Randomized Trial of Lifestyle Modification Programs in Obese Patients?
Authors: James P. Mancuso
Journal: Annals of Internal Medicine (2009)

Letters7 July 2009Do Methodological Flaws Invalidate a Randomized Trial of Lifestyle Modification Programs in Obese Patients?James P. Mancuso, PhD, Robert A. Gerber, PharmD, MA, MBA, and Andres G. Digenio, MD, PhDJames P. Mancuso, PhDFrom Pfizer, New London, CT 06320; and Pfizer, Inc., South Lyme, CT 06376.Search for more papers by this author, Robert A. Gerber, PharmD, MA, MBAFrom Pfizer, New London, CT 06320; and Pfizer, Inc., South Lyme, CT 06376.Search for more papers by this author, and Andres G. Digenio, MD, PhDFrom Pfizer, New London, CT 06320; and Pfizer, Inc., South Lyme, CT 06376.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-151-1-200907070-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Dr. Berger raises 2 criticisms of our study. First, he claims that permuted block randomization with a fixed block size of 5 was inappropriate because it could lead to prediction of future allocations. Although such prediction is a valid theoretical concern, it implies an unlikely situation in which study personnel manipulate the randomization scheme at every step. Block size was neither included in the protocol nor made known to study personnel during the conduct of our study. Allocations were implemented with a voice response system that was transparent to study personnel. Thus, prediction of allocations was mitigated, and ...References1. Rosenberger WF, Sverdlov O. Handling covariates in the design of clinical trials. Stat Sci. 2008;23:404-19. CrossrefGoogle Scholar2. Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006;295:761-75. [PMID: 16478899] CrossrefMedlineGoogle Scholar3. Gadbury GL, Coffey CS, Allison DB. Modern statistical methods for handling missing repeated measurements in obesity trial data: beyond LOCF. Obes Rev. 2003;4:175-84. [PMID: 12916818] CrossrefMedlineGoogle Scholar4. Mallinckrodt CH, Lane PW, Schnell D, Peng Y, Mancuso JP. Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials. Drug Inf J. 2008;42:303-19. CrossrefGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Pfizer, New London, CT 06320; and Pfizer, Inc., South Lyme, CT 06376.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoComparison of Methods for Delivering a Lifestyle Modification Program for Obese Patients Andres G. Digenio , James P. Mancuso , Robert A. Gerber , and Roman V. Dvorak Do Methodological Flaws Invalidate a Randomized Trial of Lifestyle Modification Programs in Obese Patients? Vance W. Berger Metrics 7 July 2009Volume 151, Issue 1Page: 70-71KeywordsBody weightConflicts of interestForecastingLongitudinal studiesOverweightWeight loss ePublished: 7 July 2009 Issue Published: 7 July 2009 Copyright & PermissionsCopyright © 2009 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...