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Developing a Patient-Reported Outcome Measure for Cleft Lip and Palate (CLEFT-Q): Item Generation
Karen W.Y. Wong, MD MSc FRCSC1, Tim Goodacre, BSc MBBS FRCS2, Christopher R. Forrest, MD MSc FRCSC FACS1, Andrea Pusic, MD MHS FRCSC3, Arun Gosain, MD4, Jessica Johnson, MPH HBHSc5, Jessica Lawson, MSc6, Stefan Cano, PhD7, Anne Klassen, BA DPhil5.
1Hospital for Sick Children, Toronto, ON, Canada, 2Spires Cleft Centre, Oxford Radcliffe Hospitals, Oxford, United Kingdom, 3Memorial Sloan-Kettering Cancer Center, New York, NY, USA, 4Rainbow Babies and Children's Hospital, Cleveland, OH, USA, 5McMaster University, Hamilton, ON, Canada, 6City University London, London, United Kingdom, 7Peninsula College of Medicine and Dentistry, Plymouth, Devon, United Kingdom.

PURPOSE:
The goal of cleft surgery is to improve the physical, psychological, and social well-being of patients with cleft lip and/or palate (CLP), but there is no scientifically sound instrument available to measure these outcomes from the perspective of the patient. The purpose of this study was to complete the first stage of developing a patient-reported outcome (PRO) measure for children with CLP called the CLEFT-Q.
METHODS:
The first stage of developing a PRO measure involves item generation based on a conceptual framework for quality of life issues in patients with CLP. To develop this framework, we first conducted a systematic literature review to identify all health concepts important to patients with CLP. Our team then conducted in-depth qualitative interviews with 60 children with CLP, aged 6-22, in three different countries. Interviews were transcribed verbatim and line-by-line coding was used to establish categories and themes. Constant comparison was used to examine relationships within and across codes and categories. Interviewing continued until no new themes emerged. We then generated a bank of items from this combined data.
RESULTS:
Our systematic review synthesized evidence from 26 studies of children with CLP and identified a range of health concepts studied to date. These findings were used to develop a preliminary framework of PRO concepts for this population. Patient interviews revealed a number of different concepts not identified in the systematic review. Using both sources of information, we identified the following 8 themes important to patients with CLP: client/family-centered care, decision making, physical needs, psychological health needs, social function, information needs, surgical/treatment process, and treatment outcome. These themes were used to develop a conceptual framework to account for the main health concerns of patients with CLP. Items were then developed within this framework for possible use in a draft version of the CLEFT-Q.
CONCLUSIONS:
We used the conceptual framework presented to complete the first stage of development of the CLEFT-Q, the first PRO instrument being designed for children with CLP. From the qualitative interviews, several concepts have arisen that have not been previously studied in this population. We have generated items from our conceptual framework for a draft version of the CLEFT-Q that will next undergo field-testing, followed by psychometric evaluation. The ability to measure patient-reported outcomes in children with CLP should greatly enhance our understanding of how best to manage and prioritize treatment protocols for this complex population.


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