Development and validation of a universal esophageal patient-reported outcome measure: The Cleveland Clinic Esophageal Questionnaire (CEQ).

Autor: Sudarshan M; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: sudarsm2@ccf.org., Tasnim S; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Ramji S; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Rappaport J; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Barron JO; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Bribriesco AC; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Schraufnagel DP; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Lapin B; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Center for Outcomes Research and Evaluation, Neurological Institute, Cleveland Clinic Foundation, Cleveland, Ohio., Li Y; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Center for Outcomes Research and Evaluation, Neurological Institute, Cleveland Clinic Foundation, Cleveland, Ohio., Raymond DP; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Blackstone EH; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Murthy SC; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio., Raja S; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
Jazyk: angličtina
Zdroj: The Journal of thoracic and cardiovascular surgery [J Thorac Cardiovasc Surg] 2024 Apr; Vol. 167 (4), pp. 1490-1497.e17. Date of Electronic Publication: 2023 Aug 23.
DOI: 10.1016/j.jtcvs.2023.08.032
Abstrakt: Objective: Currently, there is no validated patient-reported outcome measure (PROM) applicable to all esophageal diseases. Our objective was to create a psychometrically robust, validated universal esophageal PROM that can also objectively assess patients' quality of life (QoL).
Methods: The pilot PROM constructed based on expert opinions, literature review, and previous unpublished institutional research had 27 items covering 8 domains. It was completed by 30 patients in the outpatient clinic followed by a structured debriefing interview, which allowed for refining the PROM. The final PROM: Cleveland Clinic Esophageal Questionnaire (CEQ) included 34 items across 6 domains (Dysphagia, Eating, Pain, Reflux & Regurgitation, Dyspepsia, Dumping), each accompanied by a corresponding QoL component. Further psychometric assessment of the PROM was conducted by evaluating (1) acceptability, (2) construct validity, (3) reliability, and (4) responsiveness.
Results: Five hundred forty-six unique patients (median 63.7 years [54.3-71.7], 53% male [287], 86% White) completed CEQ at >90% completion within 5 minutes. Construct validity was demonstrated by differentiating scores across esophageal cancer (n = 146), achalasia (n = 170), hiatal hernia (n = 160), and other diagnoses (n = 70). Internal reliability (Cronbach alpha 0.83-0.89), and test-retest reliability (intraclass correlation coefficients 0.63-0.85) were strong. Responsiveness was demonstrated through CEQ domains improving for 53 patients who underwent surgery for achalasia or hiatal hernia (Cohen d 0.86-2.59).
Conclusions: We have constructed a psychometrically robust, universal esophageal PROM that allows concise, consistent, objective quantification of symptoms and their effect on the patient. The CEQ is valuable in prognostication and tracking of longitudinal outcomes in both benign and malignant esophageal diseases.
Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
(Copyright © 2023 The American Association for Thoracic Surgery. All rights reserved.)
Databáze: MEDLINE