title: Outcome assessment in cellulitis clinical trials: is telephone follow up sufficient?
abstract: The US Food and Drug Administration has scrutinized clinical trial methodology in cellulitis, partly because the definition and timing of cure are debatable. We analysed the validity of telephone self-report as a proxy for in-person follow up in a cellulitis treatment trial comparing cephalexin alone with cephalexin-plus-trimethoprim/sulfamethoxazole. Our results demonstrate poor agreement between these two methods of outcome determination and have implications for future cellulitis clinical trial design and clinical management.
authors.affiliation: Department of Dermatology, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: vnambudiri@partners.org.
authors.forename: V E
authors.initials: VE
authors.lastname: Nambudiri
authors.affiliation: Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: R C
authors.initials: RC
authors.lastname: Dwyer
authors.affiliation: Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: C A
authors.initials: CA
authors.lastname: Camargo
authors.affiliation: Department of Dermatology, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: T S
authors.initials: TS
authors.lastname: Kupper
authors.affiliation: Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Pallin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002481:Cellulitis / Q000188:drug therapy*; D002506:Cephalexin / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage*; D014481:United States; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D002506:Cephalexin
keywords: Cellulitis; clinical trials; follow up; telephone; trial design