Wong Riff Karen W Y, Tsangaris Elena, Goodacre Timothy E E, Forrest Christopher R, Lawson Jessica, Pusic Andrea L, Klassen Anne F
1 Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
2 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Cleft Palate Craniofac J. 2018 Mar;55(3):442-450. doi: 10.1177/1055665617732854. Epub 2017 Dec 14.
The goal of treatment for individuals with cleft lip and/or palate (CL/P) is to improve physical, psychological, and social health. Outcomes of treatment are rarely measured from the patient's perspective. The aim of the study was to develop a conceptual framework for a patient-reported outcome (PRO) instrument for individuals with clefts (CLEFT-Q) by developing an in-depth understanding of issues that individuals consider to be important.
The qualitative methodology of interpretive description was used. Setting, Participants, and Intervention: We performed 136 individual in-depth interviews with participants with clefts of any age, presenting for cleft care, across 6 countries. Parents were involved if the child was more comfortable. Interviews were audio-recorded, transcribed verbatim, and coded using constant comparison. The data were used to develop a refined conceptual framework.
Participants described concepts of interest in 3 top-level domains, each of which included subdomains: appearance (face, nose, nostrils, teeth, lips, jaw, cleft lip scar), health-related quality of life (psychological, social, school, speech-related distress), and facial function (speech, eating/drinking). Participants were able to describe changes over time with regard to the 3 domains.
A conceptual framework of concepts of interest to individuals with CL/P formed the basis of the scales in the CLEFT-Q. Each subdomain represents an independently functioning scale. Understanding what matters to patients is essential in guiding PRO measurement.
唇腭裂（CL/P）患者的治疗目标是改善其身体、心理和社会健康状况。治疗结果很少从患者的角度进行衡量。本研究的目的是通过深入了解患者认为重要的问题，为唇腭裂患者报告结局（PRO）工具（CLEFT-Q）建立一个概念框架。
采用解释性描述的定性方法。背景、参与者和干预措施：我们在6个国家对136名不同年龄段前来接受腭裂治疗的唇腭裂患者进行了个人深度访谈。如果孩子觉得更自在，家长会参与访谈。访谈进行了录音，逐字转录，并采用持续比较法进行编码。这些数据被用于建立一个完善的概念框架。
参与者描述了3个顶级领域中感兴趣的概念，每个领域都包括子领域：外貌（面部、鼻子、鼻孔、牙齿、嘴唇、下巴、唇裂疤痕）、健康相关生活质量（心理、社交、学校、言语相关困扰）和面部功能（言语、进食/饮水）。参与者能够描述这3个领域随时间的变化。
唇腭裂患者感兴趣的概念的概念框架构成了CLEFT-Q量表的基础。每个子领域代表一个独立运作的量表。了解对患者重要的事情对于指导PRO测量至关重要。
