Research Article|Articles in Press

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



      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.


      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.


      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.


      : 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.

      Key Words

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