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. 2023 May 4;2023(5):CD013854. doi: 10.1002/14651858.CD013854.pub2

Berding 2017.

Study characteristics
Methods Study design: prospective RCT
Study duration: 2011‐2015
Setting: IBD referral centres
Participants State of disease at beginning of study per IG/CG: inactive or low disease activity
Disease type per IG/CG: mean (SD) Crohn’s disease: IG 3.1 (1.9); CG 3.8 (2.4) 0.096
Ulcerative colitis: IG 2.9 (3.0) CG 4.1 (3.2)
Inclusion criteria: patients aged 18 or over with an established diagnosis of IBD
Exclusion: insufficient language skills, severe vision or hearing impairment, serious physical or psychological comorbidity. Attendance at an IBD education programme up to 6 months before the study.
Age at beginning of study per IG/CG: Mean (SD) IG: 39.6 (13.2); CG 40.1 (12.3)
Sex per IG/CG: IG: 33.7% of 86 = 29 men, 57 women CG: 28.4% of 95 = 27 men, 68 women
Disease duration per IC/CG: mean (SD) years IG: 10.9 (10.8); CG: 9.6 (8.9)
Number randomised per IG/CG: IG 105; CG 102
Number reaching end of study per IG/CG: IG 84; CG 95
Interventions IG: a 2‐part patient education seminar involving tasks and discussions covering medical information and coping and self‐management skills lasting for 11.5 hours over two days.
CG: treatment as usual (no education)
Outcomes Duration of follow ‐up: 3 months
Primary outcomes as defined by study authors: disease related worries and concerns measured using the Rating Form of the IBD Patient Concerns Questionnaire
Secondary outcomes as defined by study authors: fear of progression, coping with anxiety, health competencies, HRQoL, symptoms of depression and anxiety, disease‐related knowledge and coping strategies
Notes Funding source: German Federal Ministry of Education and Research, the German Pension Insurance, the National Association of Statutory Health Insurers and Association of Private Health Insurers. Funding number 01GX1001.
Conflicts of interest: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated numbers used.
Allocation concealment (selection bias) Unclear risk Author states "To ensure allocation concealment, central block randomization (ratio 1: 1) was used", but this explanation does not ensure allocation concealment. Authors were contacted, no response was received.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding not possible due to the nature of the intervention (patient education).
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention of blinding of outcome assessment. Authors were contacted, no response was received.
Incomplete outcome data (attrition bias)
All outcomes Low risk The intervention group lost 21/105 (attendance issues n =19, did not return questionnaires n = 2) and the wait list group lost 7/102 (did not return questionnaires n=7). In the end, there is no major imbalance, taking into account the nature of the comparison and the outcomes assessed.
Selective reporting (reporting bias) Unclear risk No protocol or trial registration. Outcomes presented in the methods section were clearly presented.
Other bias Low risk No baseline imbalances, however the baseline characteristics are only presented for the completers and not for all randomised patients who completed the baseline assessment. No other concerns.