确立唇腭裂患者报告结局量表（CLEFT-Q）的内容效度：一种用于唇腭裂的新型患者报告结局工具
Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate.
作者信息
Tsangaris Elena, Wong Riff Karen W Y, Goodacre Tim, Forrest Christopher R, Dreise Marieke, Sykes Jonathan, de Chalain Tristan, Harman Karen, O'Mahony Aisling, Pusic Andrea L, Thabane Lehana, Thoma Achilleas, Klassen Anne F
机构信息
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Surgery, Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Department of Plastic Surgery, Spires Cleft Center, Oxford Radcliffe Children's Hospital, Oxford, United Kingdom; Department of Plastic Surgery, University of Groningen, Groningen, the Netherlands; Department of Otolaryngology/Facial Plastic Surgery, UC Davis Health System, Sacramento, Calif.; Auckland Plastic Surgical Centre, Auckland, New Zealand; Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; Department of Cleft Orthodontic/Prosthodontic, St. James Hospital, Dublin, Ireland; Department of Plastic and Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center, New York, N.Y.; Department of Surgery, Division of Plastic Surgery, McMaster University, Hamilton, Ontario, Canada; and Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
出版信息
Plast Reconstr Surg Glob Open. 2017 Apr 25;5(4):e1305. doi: 10.1097/GOX.0000000000001305. eCollection 2017 Apr.
BACKGROUND
The CLEFT-Q is a new patient-reported outcome instrument designed to measure outcomes that matter to patients. The aim of this qualitative study was to establish content validity of the CLEFT-Q in patients who differ by age and culture.
METHODS
Patients aged between 6 and 29 years were recruited from plastic surgery clinics in Canada, India, Ireland, the Philippines, the Netherlands and the United States. Healthcare providers and other experts participated in a focus group or provided individual feedback. Input was sought on all aspects of the CLEFT-Q (item wording, instructions, and response options), and to identify missing content. Patient interviews and expert feedback took place between September 2013 and September 2014.
RESULTS
Sixty-nine patients and 44 experts participated. The first draft of the CLEFT-Q consisted of 163 items measuring 12 constructs. The first round of feedback identified 92 items that required revision. In total, 3 rounds of interviews, and the involvement of an artist to create pictures for 17 items, were needed to establish content validity. At the conclusion of cognitive interviews, the CLEFT-Q consisted of 13 scales (total 171 items) that measure appearance, health-related quality of life, and facial function. The mean Flesch-Kincaid readability statistic for items was 1.4 (0 to 5.2).
CONCLUSION
Cognitive interviews and expert review allowed us to identify items that required re-wording, re-conceptualizing, or to be removed, as well as any missing items. This process was useful for refining the CLEFT-Q scales for further testing.
背景
CLEFT-Q是一种新的患者报告结局工具，旨在测量对患者重要的结局。这项定性研究的目的是确定CLEFT-Q在年龄和文化不同的患者中的内容效度。
方法
从加拿大、印度、爱尔兰、菲律宾、荷兰和美国的整形外科诊所招募了6至29岁的患者。医疗服务提供者和其他专家参加了焦点小组或提供了个人反馈。就CLEFT-Q的各个方面（项目措辞、说明和回答选项）征求意见，并确定缺失的内容。患者访谈和专家反馈于2013年9月至2014年9月期间进行。
结果
69名患者和44名专家参与。CLEFT-Q的初稿包括163个项目，测量12个结构。第一轮反馈确定了92个需要修订的项目。总共需要进行3轮访谈，并让一名艺术家为17个项目创作图片，以建立内容效度。在认知访谈结束时，CLEFT-Q由13个量表（共171个项目）组成，用于测量外貌、健康相关生活质量和面部功能。项目的平均弗莱什-金凯德可读性统计量为1.4（0至5.2）。
结论
认知访谈和专家评审使我们能够识别需要重新措辞、重新概念化或删除的项目，以及任何缺失的项目。这个过程有助于完善CLEFT-Q量表，以便进一步测试。
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