Translation, cross-cultural adaptation, and validation of the UCLA Scleroderma Clinical Trial Consortium...

To translate and adapt the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument 2.0 (UCLA SCTC GIT 2.0) into Dutch and validate it among Dutch systemic sclerosis (SSc) patients.

First, the UCLA SCTC GIT 2.0 questionnaire was translated and adapted according to international guidelines. The resulting Dutch GIT 2.0 was, in combination with the SSc Health Assessment Questionnaire (SHAQ) and Short Form-36 (SF-36) administered to SSc patients participating in a standardised medical assessment. Moreover, all previous clinical examinations and confirmed medical diagnoses related to GIT were extracted from the medical records. Internal consistency was determined by calculating Cronbach's alpha. To determine the reliability, the questionnaire was re-administered with an interval of two weeks to a subgroup of patients and the intraclass-correlation coefficient (ICC) was computed. Spearman correlation coefficients between GIT scores, SF-36 and SHAQ were computed. GIT scores were compared among patients with and without previous gastrointestinal examinations and/or diagnoses.

Eighty-nine patients with a mean age of 53.6 (SD 12) years, and predominantly female (76%) were included. The median total GIT score was 0.17 (Cronbach's alpha 0.921). The test-retest reliability of the total GIT score was good (n=27; ICC 0.749). Overall, the GIT total scores correlated significantly with the SHAQ visual analogue scale intestinal complaints and the SF-36. Significant differences between GIT total and subscale scores of patients with and without previous gastrointestinal examinations and diagnoses were present.

The Dutch GIT 2.0 questionnaire showed good internal consistency, construct validity and test-retest reliability.