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Design issues in chemosensory trials.

M A Foulkes1

  • 1National Institute of Neurological Disorders and Stroke, Biometry and Field Studies Branch, Bethesda, MD 20892.

Archives of Otolaryngology--Head & Neck Surgery
|January 1, 1990
PubMed
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Designing clinical trials for smell and taste disorders presents unique challenges. Careful planning, including patient stratification and objective measurements, is crucial for successful outcomes in chemosensory research.

Area of Science:

  • Sensory science
  • Clinical trial design
  • Otolaryngology

Background:

  • Randomized clinical trials for taste and smell disorders are infrequent due to design and conduct challenges.
  • Hyposmia (impaired smell) and hypogeusia (impaired taste) stem from various causes, including infections, trauma, and surgery.
  • Spontaneous recovery of chemosenses necessitates control groups in study designs.

Purpose of the Study:

  • To discuss the specific design and conduct challenges in randomized clinical trials for taste and smell disorders.
  • To highlight considerations for patient eligibility, stratification, recruitment, and measurement in chemosensory research.
  • To illustrate these issues using a factorial trial example for olfactory defects.

Main Methods:

  • Review of challenges in designing and conducting randomized clinical trials for chemosensory impairments.

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  • Discussion of factors influencing trial design, such as patient demographics (age, sex) and etiology of the disorder.
  • Consideration of recruitment strategies, the need for multi-center participation, and objective pre- and post-intervention measurements.

    • Main Results:

    • Specific design issues for chemosensory trials include the need for age and sex stratification.
    • Patient recruitment can be difficult, often relying on self-referrals, necessitating multi-center collaborations.
    • Objective, reliable measurements of taste and smell before and after intervention are essential.

    Conclusions:

    • Successful clinical trials for smell and taste disorders require meticulous attention to design elements, including patient selection and objective outcome measures.
    • Addressing challenges in patient recruitment and ensuring adequate statistical power through multi-center studies are vital.
    • The discussed design principles are applicable to various chemosensory interventions, such as surgery and pharmacological treatments for olfactory deficits.