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

Objectives 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. Design 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). Setting Large urban teaching hospital. Participants Speech and language therapists, laryngectomees, non-dysphagic volunteers, post-radiotherapy dysphagic patients. Main outcome measure Preliminary validation of SOAL questionnaire. Results 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). Conclusions 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. [ABSTRACT FROM AUTHOR]