Development and validation of French version of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument.

OBJECTIVES The UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument (UCLA-SCTCGIT) 2.0 was developed to assess systemic sclerosis (SSc) associated gastrointestinal tract (GIT) symptoms severity and its impact on patients' well-being. Our objective was to translate the UCLA-GIT 2.0 from English to French and to evaluate the reliability and validity of the French version. METHODS UCLA-GIT 2.0 was adapted into French using a formal forward-backward translation method and administered to 76 French speaking patients with SSc. The patients also completed the SF-36. We evaluated the internal consistency reliability and construct validity by exploring associations between the UCLA SCTC GIT 2.0 and SF-36 scales. Patients were also classified into two groups based on unintended weight loss within the past 6 months (≥5% vs. <5% of total body weight). RESULTS Participants were mostly white (90%), female (81%) and had limited SSc (50%). Mean score of the UCLA-GIT 2.0 scales were: 0.35 for faecal soilage, 0.44 for diarrhoea, 0.45 for emotional well-being, 0.48 for both constipation and social functioning, 0.52 for reflux, and 0.95 for distension/bloating. The instrument had acceptable reliability (defined as Cronbach alpha≥0.69) except for the diarrhoea scale (alpha=0.56). The majority of hypothesized correlations were of moderate magnitude (coefficient≥0.30) and were in the appropriate direction. Patients with ≥5% unintended weight loss had worse UCLA-GIT scores in all scales (p<0.05 for distention/bloating scale). CONCLUSIONS The French version of the UCLA-GIT 2.0 has acceptable psychometric properties and can be used in French speaking SSc patients.