Development and Content Validity of a Novel Patient-Reported Outcome Measure for Total Laryngectomy: The LARY-Q

Michael P Wu; Manraj N Kaur; Allen L Feng; Rakasa Pattanaik; Rachael Kammer; Bridget MacLeod; Anna Choi Farshi; Glenn Bunting; Mark A Varvares; Andrea L Pusic; Anne F Klassen; Daniel G Deschler

doi:10.1016/j.jvoice.2023.04.009

Development and Content Validity of a Novel Patient-Reported Outcome Measure for Total Laryngectomy: The LARY-Q

J Voice. 2023 May 6:S0892-1997(23)00132-7. doi: 10.1016/j.jvoice.2023.04.009. Online ahead of print.

Authors

Affiliations

¹ Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, MA. Electronic address: mpwu@partners.org.
² Department of Surgery (Plastic and Reconstructive Surgery), Brigham and Women's Hospital, Boston, MA.
³ Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, MA.
⁴ Boston University Sargent College of Health and Rehabilitation Sciences, Boston, MA.
⁵ Voice and Speech Laboratory, Massachusetts Eye and Ear, Boston, MA.
⁶ Department of Pediatrics, McMaster University, Hamilton, ON, Canada.

PMID: 37156685
DOI: 10.1016/j.jvoice.2023.04.009

Abstract

Objectives: To develop a patient-reported outcomes measure (PROM) for total laryngectomy.

Study design: Qualitative interviews with a purposive sample of patients with total laryngectomy, followed by cognitive debriefing interviews with patients and expert feedback.

Methods: Concept elicitation was performed using in-depth qualitative interviews with a purposive sample of patients who had undergone total laryngectomy. Patients were recruited from head and neck surgery and speech-language pathology clinics as well as via laryngectomy support groups. Interviews were conducted, recorded, transcribed, and coded, resulting in a conceptual framework and item pool. Using the item pool, preliminary scales were drafted. The scales were revised iteratively over 5 rounds using feedback from cognitive interviews with patients and multi-institutional and multi-disciplinary expert feedback.

Results: A total of 15 patients with total laryngectomy (mean age 68 years, range 57-79) were interviewed resulting in 1555 codes. The codes were used to form a conceptual framework grouped into top-level domains of stoma, function, health-related quality of life, devices, and experience of care. Items were used to form 15 preliminary scales that were revised over five rounds of cognitive debriefing interviews (n = 9 patients) and expert feedback (n = 17 experts). The field-test version of the LARY-Q has 18 scales and 277 items in total.

Conclusions: The LARY-Q is a novel PROM designed to assess outcomes associated with total laryngectomy. The next step involves a field test study with a heterogenous sample of patients to assess the psychometric properties of the LARY-Q and perform item reduction.

Keywords: Patient-reported outcomes; Quality of life; Total laryngectomy.