Document Detail

Design issues in chemosensory trials.
MedLine Citation:
PMID:  2403809     Owner:  NLM     Status:  MEDLINE    
Randomized clinical trials in taste and smell disorders have been infrequent, in part because of difficulties in both the design and the conduct of such trials. Hyposmia and hypogeusia, impairments of smell and taste, respectively, have a variety of causes, such as upper respiratory infection, head trauma, or laryngectomy. Once definitive diagnosis is established, eligibility and exclusion criteria may relate to etiology. Since the sense of smell is more acute at younger ages and since women can generally identify odors more accurately than men, either prestratification or poststratification should be considered. A control or comparison group is essential because, occasionally, chemosenses spontaneously return to normal. Patient recruitment may be difficult, depending to a large extent on self-referrals, with the exception of head injury cases. To enroll an adequate number of patients in a reasonable length of time usually requires participation of multiple clinical centers. Objective measurements of taste and smell must be reliably obtained before and after intervention. Design issues specific to chemosensory trials are discussed in the context of an example, a factorial design trial of surgery and steroids in patients with olfactory defects.
M A Foulkes
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Archives of otolaryngology--head & neck surgery     Volume:  116     ISSN:  0886-4470     ISO Abbreviation:  Arch. Otolaryngol. Head Neck Surg.     Publication Date:  1990 Jan 
Date Detail:
Created Date:  1990-02-09     Completed Date:  1990-02-09     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8603209     Medline TA:  Arch Otolaryngol Head Neck Surg     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  65-8     Citation Subset:  AIM; IM    
National Institute of Neurological Disorders and Stroke, Biometry and Field Studies Branch, Bethesda, MD 20892.
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MeSH Terms
Olfaction Disorders / etiology,  therapy*
Randomized Controlled Trials as Topic
Research Design*
Sensory Thresholds / physiology
Smell / physiology
Taste Disorders / etiology,  therapy*
Taste Threshold / physiology

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