A Prospective Study to Examine Responsiveness and Minimally Important Differences (MIDs) for the CLEFT-Q Scales Following Three Cleft-Specific Operations.

A Miroshnychenko,Mc Swan,C Rae,K Wong Riff,J Goldstein,A Klassen,Cr Forrest,A Thoma,K Harman,R Slator,T Goodacre

doi:10.1177/10556656211064479

Abstract

The aim of this study was to examine internal responsiveness and estimate minimally important differences (MIDs) for CLEFT-Q scales. In this prospective cohort study, participants completed the CLEFT-Q appearance and health-related quality of life (HRQL) scales before and six months after cleft-related surgery. Seven cleft centres in Canada, USA and UK participated. Patients were ages 8–29 years with CL/P. Patients underwent rhinoplasty, orthognathic or cleft lip scar revision surgery. Internal responsiveness was examined using Cohen's d effect sizes (ESs) based on the following interpretation: 0.20–0.49 small, 0.50–0.79 moderate and ≥ 0.80 large. MIDs were estimated using two distribution-based approaches. Participants had a rhinoplasty (n = 31), orthognathic (n = 21) or cleft lip scar revision (n = 18) surgery. Most participants were males (56%) and aged 8–11 years (41%). Following rhinoplasty, ESs were larger for the nose (0.92, p = 0.001) and nostrils (0.94, p < 0.001) scales than for the face scale (0.51, p = 0.003). MIDs ranged between 6.2–10.4. For orthognathic surgery, larger ES was observed for the jaws scale (1.80, p < 0.001) compared with the teeth (1.16, p < 0.001), face (1.15, p = 0.001) and lips (0.94, p < 0.001) scales. MIDs ranged between 5.9–14.4. In the cleft lip scar revision sample, the largest ES was observed for the nose scale (0.76, p = 0.03), followed by lips (0.58, p = 0.009) and cleft lip scar (0.50, p = 0.043) scales. MIDs ranged between 6.4–12.3. CLEFT-Q detected change in key outcomes for three cleft-specific surgeries, providing evidence of its responsiveness. Estimated MIDs will aid in interpreting this PROM.

Highlights

The CLEFT-Q is a patient reported outcome measure (PROM) for children and young adults with a cleft lip and/ or palate (CL/P)
The non-respondents to the postoperative follow up assessment were similar to respondents in terms of mean age (χ2 = 4.86, p = 0.18), type of operation (χ2 = 4.89, p = 0.18) and gender (χ2 = 4.22, p = 0.06), but were more likely to live in the UK rather than Canada or the USA (χ2 = 6.45, p = 0.04)
The average time between the pre- and postoperative assessments ranged between five months for rhinoplasty to seven months for cleft lip scar revision

Summary

Introduction

The CLEFT-Q is a patient reported outcome measure (PROM) for children and young adults with a cleft lip and/ or palate (CL/P). PROMs are tools designed to collect reports that come directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation by a physician or anyone else (Valderas et al, 2008). These tools must be carefully designed and tested to ensure their validity and reliability. Collaboration with international teams ensured that the rigorous development and validation processes of the CLEFT-Q scales accounted for multicultural perspectives on cleft-related care. Scales were field-tested internationally with 2434 patients to examine reliability and validity, and to develop a

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