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

Although numerous patient-reported outcome measures have been developed and validated to quantify the impact of voice problems on different aspects of life, to our knowledge no screening instrument exists that specifically captures voice disorders in a retrospective fashion. The aim of the present study was to examine the psychometric properties and diagnostic validity of a retrospective voice screening method, Screen11, according to the COSMIN framework for health-related, patient-reported outcome measures. The items in Screen11 have been used to establish the prevalence of voice disorders in both general and occupation-specific populations in the Nordic countries. However, the instrument has not been validated.

The voice patient group (n = 54) in this study comprised of patients from the Turku University Central Hospital phoniatric outpatient clinic seeking help for their voice problems. For these voice patients, we recruited voice-healthy controls (n = 61) who matched in terms of gender, age, and occupation. The participants responded to the Screen11 questionnaire along with the VHI and the VAPP.

The results of the initial exploratory factor analysis showed that all the Screen11 items loaded on a common underlying latent factor. Furthermore, Screen11 had high internal consistency (α = .93) and correlated sufficiently with other voice questionnaires.

The results indicate that Screen11, which screens for possible voice disorders at an early stage, was successfully validated. With respect to its diagnostic validity, the Screen11 sum score is preferable. A threshold of ≥ 15 should be used for differentiating patients with possible voice disorders from those with healthy voices.