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

Area of Science:

• Plastic Surgery
• Patient-Reported Outcomes
• Health Outcomes Research

Background:

• Cleft lip and palate (CL/P) significantly impacts appearance and quality of life.
• Patient-reported outcome measures (PROMs) are crucial for evaluating surgical effectiveness.
• The CLEFT-Q is a PROM designed for individuals with CL/P.

Purpose of the Study:

• To evaluate the internal responsiveness of CLEFT-Q scales.
• To estimate minimally important differences (MIDs) for CLEFT-Q scales following cleft-related surgery.

Main Methods:

• A prospective cohort study involving 7 cleft centers across North America and the UK.
• Participants (ages 8-29) with CL/P completed CLEFT-Q scales before and 6 months after surgery (rhinoplasty, orthognathic, or cleft lip scar revision).
• Internal responsiveness was assessed using Cohen's d effect sizes (ESs), and MIDs were estimated using distribution-based methods.

Main Results:

• Significant changes in CLEFT-Q scales were observed across all three surgical groups.
• Effect sizes varied by scale and surgery type, with notable responsiveness in scales related to the operated area (e.g., nose post-rhinoplasty, jaws post-orthognathic surgery).
• Estimated MIDs provide a quantitative threshold for interpreting meaningful change in CLEFT-Q scores.

Conclusions:

• The CLEFT-Q scales demonstrate good internal responsiveness for key outcomes in patients undergoing cleft-specific surgeries.
• The estimated MIDs offer valuable benchmarks for interpreting the clinical significance of changes in CLEFT-Q scores.
• This study supports the utility of CLEFT-Q as a reliable PROM for evaluating treatment outcomes in CL/P patients.