Screen11: validating a screening instrument for voice disorders in accordance with the COSMIN framework.

Area of Science:

• Otolaryngology
• Speech-Language Pathology
• Psychometrics

Background:

• Patient-reported outcome measures are crucial for assessing voice problem impact.
• A validated retrospective screening instrument for voice disorders was previously lacking.
• The Screen11 items have been used in prevalence studies but lacked formal validation.

Purpose of the Study:

• To examine the psychometric properties and diagnostic validity of the Screen11 retrospective voice screening method.
• To assess Screen11 according to the COSMIN framework for health-related, patient-reported outcome measures.
• To establish Screen11 as a reliable tool for identifying potential voice disorders.

Main Methods:

• A voice patient group (n=54) and voice-healthy controls (n=61) participated.
• Participants completed the Screen11 questionnaire, Voice Handicap Index (VHI), and Voice Activity and Participation Profile (VAPP).
• Exploratory factor analysis was used to assess the underlying structure of Screen11.

Main Results:

• Exploratory factor analysis confirmed all Screen11 items loaded on a single latent factor.
• Screen11 demonstrated high internal consistency (Cronbach's alpha = .93).
• Screen11 scores correlated sufficiently with other established voice questionnaires.

Conclusions:

• Screen11 was successfully validated as a tool for early screening of voice disorders.
• The Screen11 sum score is recommended for diagnostic validity.
• A threshold score of ≥ 15 is suggested for differentiating patients with possible voice disorders from healthy individuals.