Outcome assessment in cellulitis clinical trials: is telephone follow up sufficient?

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 alon...

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Bibliographic Details
Published in:Clinical microbiology and infection 2015-07, Vol.21 (7), p.676.e5-676.e7
Main Authors: Nambudiri, V.E., Dwyer, R.C., Camargo, C.A., Kupper, T.S., Pallin, D.J.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Anti-Bacterial Agents - administration & dosage
Cellulitis
Cellulitis - drug therapy
Cephalexin - administration & dosage
Child
Child, Preschool
clinical trials
Clinical Trials as Topic
follow up
Humans
Interviews as Topic
Middle Aged
telephone
Treatment Outcome
trial design
Trimethoprim, Sulfamethoxazole Drug Combination - administration & dosage
United States
Young Adult
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Summary: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.
ISSN:1198-743X
1469-0691
DOI:10.1016/j.cmi.2015.03.008