1. Quality of Life in Childhood Inflammatory Bowel Disease. Adrian Thomas, Booth Hall Childrens Hospital Manchester, UK

2. When I’m in remission I feel great and I think there is light at the end of the tunnel but when I’m not in remission I feel bad. I go very weak, lethargic & sick. I have bad tummy pains & the runs. I feel that nobody cares how I feel, the only people who understand me are my family, they support me through my bad days and encourage me to get well. I wish I knew more people with this illness, I feel that I’m on my own. When I’m in remission I feel great and I think there is light at the end of the tunnel but when I’m not in remission I feel bad. I go very weak, lethargic & sick. I have bad tummy pains & the runs. I feel that nobody cares how I feel, the only people who understand me are my family, they support me through my bad days and encourage me to get well. I wish I knew more people with this illness, I feel that I’m on my own. Age 10 Age 10

3. Health “a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity” “a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity” World Health Organisation World Health Organisation

4. What is meant by quality of life? n Encompasses not only physical and mental health but also the impact of the environment n May be affected by personality, education, culture, financial factors, community & family life n No universally accepted definition of QOL but should take into account subjective as well as objective perception of circumstances of life

5. Health related quality of life “the functional effect of an illness and its treatment on a patient, as perceived by the patient” “the functional effect of an illness and its treatment on a patient, as perceived by the patient” Schipper H et al 1990 Schipper H et al 1990

6. Measures of health related quality of life Emphasise patients self-assessment which may differ substantially from that of healthcare professionals Give a broader picture of health than disease parameters alone and should encompass: n issues directly related to disease (eg. symptoms) and n issues which are independent of disease but may be affected by it (attitudes, emotional state, personality) Should help to assess healthcare outcomes more fully

7. Measures of health related quality of life Generic n can compare QOL in children with IBD to normal children and children with other conditions n may be too imprecise to reflect impaired function in IBD or to guage response to therapy Disease specific n more sensitive to specific problems of children with IBD

8. Domains Domains Physical function Emotional/psychological Social (family, friends, school) Cognitive function (school performance) Symptoms (pain, bowel function, energy) Treatment (response & side effects) Body image Overall health

9. Potential uses of HRQOL instruments To assess individual patients or groups To monitor treatment in clinical setting To detect psychological disturbances To measure outcome in clinical trials To estimate/compare burden of the disease To identify patients needs To decide priorities in resource allocation

10. HRQOL in children n Physical, intellectual & emotional function constantly changing with normal development n Changing perception of health n Children more concerned about symptoms n Parents more concerned about long term consequences and side effects of treatment

11. Impact of chronic disease in children n 10% of children have a chronic physical illness n Behavioural problems, social isolation & psychological disturbance common in adolescents n May be special educational needs n Effects on parents & siblings

12. Psychiatric aspects of childhood IBD n In meta-analysis of chronic diseases IBD had most profound effect on mental health n Steinhausen - 56% IBD children cf. 18% of controls had psychiatric disorder (emotional) n Engstrom - psychiatric disorder in 60% with IBD, 30% with tension headaches, 20% with diabetes & 15% of healthy controls n Others - depressive disorders, lower self esteem, behavioural problems, obsessive-compulsive disorders common

13. HRQOL in children with IBD Focus groups n Initial denial of effect of CD on QOL n All felt angry, frustrated, fed up &/or worried n Frustration and anger about: symptoms, lack of understanding, investigations, hospitalisation, side effects of treatment & body image

14. Quality of life in childhood Crohns disease Rabbett H et al, J Pediatr Gastroenterol Nutr 1996;23:528-33 n QOL assessed by questionnaire in 16 children n School absence problem in 12 & distraction in 6 n Problems with sports in 8, 3 missed > 1 year n Problems also with holidays & staying at friends

15. Quality of life in childhood Crohns disease Rabbett H et al, J Pediatr Gastroenterol Nutr 1996;23:528-33 n Children on steroids had more depressive symptoms with some even wishing they were dead n Children more concerned about symptoms n Parents more concerned about long term consequences and side effects of treatment

16. A review of measures of quality of life for children with chronic illness Eiser C, Morse R. Arch Dis Child 2001;84:205-11 Aim: to identify available measures of QoL in children Aim: to identify available measures of QoL in children 19 generic & 24 disease specific measures identified, almost half developed in USA & many had problems: 19 generic & 24 disease specific measures identified, almost half developed in USA & many had problems: - limited availability of disease specific measures - discrepancy between child & parent ratings - lack of measures for self completion by children - lack of precision regarding domains of QoL - cultural appropriateness of measures developed elsewhere for children in UK - limited availability of disease specific measures - discrepancy between child & parent ratings - lack of measures for self completion by children - lack of precision regarding domains of QoL - cultural appropriateness of measures developed elsewhere for children in UK

17. Development of a quality of life index for pediatric IBD: dealing with differences related to age & IBD type Griffiths AM et al. J Pediatr Gastroenterol Nutr 1999;28:S46-S52 n Interviews held with 82 Canadian children aged 8-17 years with IBD (61 CD, 21 UC) n Important issues incorporated into 96 item reduction questionnaire n 117 different children with IBD scored each item for importance & frequency on visual analogue scale n Items ranked according to sum of scores, 33 item IMPACT questionnaire developed from 50 top ranking items

18. Top ranking items on IMPACT Worried about possibility of a flare-up Worried/upset that IBD is lifelong Feeling that its unfair to have IBD Concerned about weight Concerned/upset about looks Worried about needing surgery Stomach pains Worried about future health problems Angry about having IBD

19. A cross-cultural comparison of quality of life in children with inflammatory bowel disease Richardson G et al. J Pediatr Gastroenterol Nutr 2001;32:573-8 Aim: To determine whether IMPACT is suitable to measure HRQOL in UK children with inflammatory bowel disease Methods: The 96 item reduction questionnaire was scored by 53 children with IBD in the same way as in Canada Results: Close correlation between ranks & only 2 items ranked highly in UK not included in IMPACT. 91/96 items scored more highly (worse QOL) in UK than Canada

20. Simplification of IMPACT Some questions/responses in IMPACT were felt to be too complicated or upsetting, they’ve been simplified and made more child-friendly, new version called IMPACT-II Some questions/responses in IMPACT were felt to be too complicated or upsetting, they’ve been simplified and made more child-friendly, new version called IMPACT-II

21. Original IMPACT Question 5: Your doctor and nurse have told you that medicines and other treatments are used to keep your bowel condition under control, but not actually cure it. Put a mark on the line to show how you feel about this __________________________ __________________________ A A B IBD is going to be with me all I know that my bowel condition my life; its horrible having can’t be cured now but I never something thats lifelong. I can’t worry about that. I’m hopeful stop thinking about that research will find a cure one day

22. IMPACT-II Question 5: How much does it bother you that you have an illness that does not just go away? Not at all __________________________ Very much Not at all __________________________ Very much

23. Simplification of IMPACT n 21 UK children (10-17 yrs) with IBD completed (random order) both versions of IMPACT n 16 preferred IMPACT-II, 2 preferred IMPACT & 3 had no preference, commonest reason was: “easier to understand” n Mean time to complete: IMPACT 13.6 min, IMPACT-II 9.7 min, p<0.05. Mean QoL scores: IMPACT 137, IMPACT-II 132 p=ns.

24. Likert or Visual Analogue Scale?

25. The Visual Analogue Scale (VAS) n Here is an example question from the adapted questionnaire using the VAS. Question 12: How often do you think it is unfair that you have inflammatory bowel disease? Never__________________________ Very often Never__________________________ Very often

26. The Likert Scale n Here is the same question again with the answers given with the different format. Question 12: How often do you think it is unfair you have inflammatory bowel disease? Never Rarely Sometimes Often Very often Never Rarely Sometimes Often Very often

27. Likert or Visual Analogue Scale? 1) To determine which response scale was preferred by children with IBD 2) To check that the two response scales collected similar results

28. Methods n 20 children with IBD between the ages of 8-16 were asked to fill in two versions of IMPACT n The VAS and Likert questionnaires were distributed in random order n The children were asked to comment on their preferred response scales and asked to give reasons for their decision n Four children took part in cognitive interviews requiring them to ‘think out aloud’ when completing one of the questionnaires

29. Results of the study. n 75% preferred the Likert scale (p<0.01) n Main reason given was that it was easier to understand n Children didn’t know where to place their ‘X’ on the VAS and felt it didn’t reflect their answer n VAS supporters though it was more accurate Graph showing preference of response scale

30. Results cont... n This suggests that 8-12 year olds prefer the Likert scale to a greater degree than the older age group n 87.5% (7 out of 8) of 8-12 year olds prefer Likert n 66.6% (8 out of 12) of 13-16 year olds prefer Likert

31. Graph Showing Mean Scores from the two Questionnaires n Second aim was to check scores between different response scales were comparable n After translating scores (scale ranged 0-100, 0 being best and 100 being the worst possible quality of life) there was no significant difference n Likert = Mean score 27.1 n VAS = Mean score 26.3

32. Conclusions n Childhood Crohn’s disease and its treatment have a great impact on QOL n Future studies of treatment should include consideration of effects on QOL n The simplified questionnaire (IMPACT-II) was preferred by children with IBD and gave similar results n The Likert scale (IMPACT-III) was preferred to the VAS and also appeared to give similar results n Further validation is required