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PubMed | Sloan Kettering Cancer Center, University of Toronto, Modus Outcomes, Oxford Radcliffe Childrens Hospital and McMaster University
Type: Journal Article | Journal: BMJ open | Year: 2017

Patient-reported outcome (PRO) instruments should be developed according to rigorous guidelines in order to provide clinically meaningful, scientifically sound measurement. Understanding the methodology behind instrument development informs the selection of the most appropriate tool. This mixed methods protocol describes the development of an internationally applicable PRO instrument, the CLEFT-Q, for evaluating outcomes of treatment for cleft lip and/or palate (CL/P).The study includes three main phases that occur iteratively and interactively. In phase I, we determine what concepts are important to patients regarding their outcome. A conceptual framework for the CLEFT-Q is formed through a systematic review and an extensive international qualitative study. The systematic review ascertains what concepts have previously been measured in patients with CL/P. The qualitative study employs interpretive description and involves in-depth interviews with patients in high-income and lower-middle income countries. Preliminary items are generated from the qualitative data. Preliminary scales are then created for each theme in the framework. Cognitive debriefing interviews and expert clinician input are used to refine the scales in an iterative process. In phase II, the preliminary scales are administered to a large international group of patients with CL/P. The modern psychometric method of Rasch Measurement Theory analysis is employed to define the measurement characteristics. The preliminary scales are shortened based on these results. In phase III, further tests assess reliability, validity and responsiveness of the instrument.The study is approved by Research Ethics Boards for each participating site. Findings from this study will be published in open access peer-reviewed journals and presented at national and international conferences. Integrated knowledge translation is employed to engage stakeholders from the outset of the study. Successful execution of the CLEFT-Q will result in an internationally applicable PRO instrument for children and young adults with CL/P.


Klassen A.F.,McMaster University | Tsangaris E.,McMaster University | Forrest C.R.,University of Toronto | Wong K.W.Y.,University of Toronto | And 7 more authors.
Journal of Plastic, Reconstructive and Aesthetic Surgery | Year: 2012

Objective: Cleft lip and/or palate (CLP) is the most common congenital craniofacial anomaly. As a first step toward developing a quality of life (QOL) questionnaire for CLP patients, our team conducted a systematic literature review to identify studies that measured child- or proxy-reported outcomes of CLP. Design: PUBMED, CINAHL, EMBASE and PsycINFO were searched from their inception to July 2010 to identify studies that measured health-related concepts in CLP patients. Abstract and title screening was performed by two screeners. Full texts of all potentially relevant papers were obtained and examined by two reviewers. We identified publications that measured health concepts and categorized them to form a preliminary conceptual framework of CLP QOL issues. Results: A total of 4594 publications were identified. Twenty-six studies met our inclusion criteria. Research involved CLP patients living in nine countries with sample sizes ranging from 23 to 661. Health concepts were measured using 29 different questionnaires. No patient-reported outcome (PRO) instrument measuring QOL concerns of CLP patients currently exists. CLP-specific health concepts measured to date were categorized into a preliminary conceptual QOL framework with the following categories: physical, psychological and social health. Conclusions: Our review has helped to identify areas of health that have been well researched using either a patient or proxy patient-reported outcome instrument (e.g., self-concept; behavior) and areas where more research is required. © 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

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