Berding 2017.
Study characteristics | ||
Methods |
Study design: prospective RCT Study duration: 2011‐2015 Setting: IBD referral centres |
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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 |
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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) |
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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 |
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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 |
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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. |