Development and preliminary validation of a patient-reported outcome measure for swallowing after total laryngectomy...

To develop and validate a laryngectomee-specific questionnaire to investigate swallowing function. This paper describes the generation of questionnaire items, pretesting with laryngectomees and a preliminary validation.

This study employed 2 phases: questionnaire development and questionnaire validation. Items were developed from patient (n = 10) and clinician (n = 6) focus groups. Content checking, acceptability and face validity were determined through pretesting with 10 laryngectomees and via consensus feedback from 35 speech and language therapists. During preliminary validation, the 17-item final questionnaire was administered to 3 different groups. Discrimination amongst groups was established by comparing questionnaire responses of a laryngectomee group (n = 19) with known dysphagic (n = 19) and non-dysphagic groups (n = 20). Questionnaire responses from the reference dysphagic group were compared with an instrumental assessment of swallowing, the modified barium swallow (MBS).

Large urban teaching hospital.

Speech and language therapists, laryngectomees, non-dysphagic volunteers, post-radiotherapy dysphagic patients.

Preliminary validation of SOAL questionnaire.

Normal, laryngectomee and dysphagic groups had significantly different SOAL scores, as did laryngectomees with different degrees of swallowing impairment (Kruskall Wallis, P << 0.001). The subjective SOAL score had a strong positive correlation with the reference measure of ratings on the MBS (r = 0.5; P = 0.03).

The swallowing outcome after laryngectomy (SOAL) questionnaire is a simple, self-administered tool to assess swallowing function post-total laryngectomy. Further specific testing with a laryngectomy cohort is necessary for full validation. Its potential value lies in screening for dysphagia in clinics or during long-term follow-up of laryngectomees.