Validation of endoscopic endonasal skull base surgery questionnaire

Abstract

Background: Nowadays most of pathologies of skull base are treated by endoscopic endonasal approach. This technique have comparable outcomes with the microscopic approach, less complications than external approach, and a hospital stay reduction. Quality of life assessment in patients with skull base tumors is important because of the complexity of surgery and associated significant morbidity. Multiple instruments have to be used to assess the quality of life of these patients because of a lack of a single ideal metric to measure symptom and endoscopic morbidity. Objectives: The aim of this study is to create and validate a new questionnaire of quality of life to assess the quality of life of patients operated by endoscopic endonasal approach for the extirpation of skull base tumors, and to use it as a tool to assess the stability of quality of life of these patients. Methods: The study will be a creation and validation of a quality of life questionnaire performed at Clínica Teknon and Hospital de la Santa Creu i Sant Pau. Relevant questions will be generated from a review of literature and interviews with health professionals, surgeons, patients and caregivers. The pool of questions will be reduced using a likert-type response scale to patients that have already been operated, and using standard psychometric criteria. Using a factor analysis the domains will be identified. Using a non-probabilistic consecutive sampling, 35 patients will be recruited in order to assess reliability and validity of the questionnaire. The internal consistency will be assessed using Cronbach α value and reliability using test-retest reliability. The validity of the construct will be assessed by testing if the clinical variable of the patient influences his quality of life domain score as hypothesized. Once created and validated, the questionnaire will be used prospectively to evaluate the stability of quality of life during 24 months to each of 35 patients that will be recruited from another non-probabilistic consecutive sampling. Final Goals: This unique and site-specific instrument would assess the quality of life of this patients more quickly and efficiently, would help to investigate possible predictors of functional outcome after surgery, and may help to guide the selection of optimal therapy, type of surgical approach, and reconstruction method and to implement measures that improve perioperative care of patient that dsire a fast functional and emotional recovery