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* = Presenting author

P633 Quality of life in paediatric inflammatory bowel disease patients in a self-administered telemedicine randomised clinical study

K. Carlsen*1, 2, C. Jakobsen2, L. F. Hansen2, A. Paerregaard2, T. Kallemose3, L. B. Riis4, P.S. Munkholm5, V. Wewer2

1Hvidovre Hospital, Paediatric, Hvidovre, Denmark, 2Hvidovre Hospital, Department of Paediatrics, Hvidovre, Denmark, 3Hvidovre Hospital, Clinical Research Centre and Department of Orthopaedic, Hvidovre, Denmark, 4Herlev Hospital, Department of Pathology, Herlev, Denmark, 5North Zealand Hospital, Department of Gastroenterology, Frederikssund, Denmark

Background

Health-related quality of life (HRQoL) has become an import patient-reported outcome. IMPACT III is an International validated measure of HRQoL in paediatric inflammatory bowel disease (PIBD). So far no validated Danish PIBD HRQoL has been available. The aim of the study was evaluate the HRQoL by implementing the IMPACT III questionnaire in a self-administrated telemedicine randomised clinical trial.

Methods

In collaboration with the PIBD working group on quality of life (QoL) (Canada, the United Kingdom, and the Netherlands), IMPACT III was translated to Danish using a Cross-Cultural Adaptation of Self-Report Measure method. The questionnaire was implemented in the telemedicine application www.young.constant-care.com. Participants in the telemedicine study were randomised to either a web or control group for a 2-year period and were asked to answer the IMPACT III questionnaire every third month. Besides 1 annual pre-planned visit, the web group only attended outpatient visits scheduled on the basis of monthly web-reported symptom score. In contrast, the control group continued their standard quarterly outpatient visits. The repeated measures of HRQoL were statistically analysed by a mixed-effect model (MEM), ensuring correction of alterations during the observation period.

Results

In total, 53 patients (32 ulcerative colitis [UC]; 21 Crohn’s disease [CD]) were included (27 web; 26 control); median duration of participations in the web group was 86 weeks (IQR 36), and in the control, 92 weeks (IQR 20). Control patients had 172 outpatient visits in total, compared with 74 visits in the web group. Further, 292 IMPACT III questionnaires were answered; web 146 (UC 102, CD 44), control 146 (UC 72, CD 74). Mean score at baseline showed no statistic significant difference; web 149 (SEM 2.8 CI 95% 144; 1 55), control 145 (SEM 1.9 CI 95% 141; 149). MEM adjusted for gender and age at inclusion, found no difference in total HRQoL score comparing web versus control group. Looking at sub-scores regarding 6 domains (bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image, and treatment), only emotional functioning scored significantly lower HRQoL in the web group (p = 0.01, estimate -0.005 CI 95% -0.009; -0.001).

Conclusion

The telemedicine intervention with less needed outpatient visits was equal to standard care regarding patient-reported HRQoL outcome. IMPACT III is now available in Danish, ensuring the possibility of patient-reported outcome in future clinical trials.