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

Borgaonkar 2002.

Study characteristics
Methods Study design: prospective RCT
Study duration: NR
Setting: ambulatory gastroenterology clinic
Participants State of disease at beginning of study per IG/CG:
IG active/inactive disease: 40% of 34 = 13.6 probably rounded to 14/20
CG active/inactive disease: 48% of 25 = 12/13
Disease type per IG/CG: mix IG: CD/UC 18/16 and CG CD/UC: 18/7
Inclusion criteria: patients were eligible to participate if their diagnosis had been confirmed by endoscopy, radiography, and/or histologic examination.
Exclusion: subjects were excluded if they were not fluent in English or had a significant comorbid illness that could potentially impair HRQoL (for example, rheumatoid arthritis)
Age at beginning of study per IG/CG: mean (SD) IG: 41.5 (11.9); CG: 43 (124.2)
Sex per IG/CG: N (%) IG: Female 21 (61.8%), Male: 13 (38.2%); CG: Female 12 (48%), Male 13 (52%)
Disease duration per IC/CG: mean (SD) months IG: 96.4 (85.21); CG: 9.6 (8.9)
Number randomised per IG/CG: IG: 34; CG: 25
Number reaching end of study per IG/CG: IG 30; CG 23
Interventions IG: information booklets available from the Crohn’s and Colitis Foundation of Canada administered to the IG.
CG: "usual care".
Outcomes Duration of follow ‐up: the mean time between enrolment and follow‐up was 27.0 ± 15.6 days for the education group and 22.6 ± 9.3 days for the control group
Primary outcomes as defined by study authors: HRQoL measured using the Inflammatory Bowel Disease Questionnaire (IBDQ), and the Quality Index in Crohn’s and Colitis (QuICC)
Secondary outcomes as defined by study authors: NR
Notes Funding source: NR
Conflicts of interest: NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Unclear risk No mention. Authors were contacted, no response was received.
Blinding of participants and personnel (performance bias)
All outcomes High risk It is not possible to blind participants to the intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention. Authors were contacted, no response was received.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Balanced attrition between groups but no details given about the dropouts. Authors were contacted, no response was received.
Selective reporting (reporting bias) Unclear risk No protocol or trial registration. Outcomes mentioned in the methods section were appropriate and reported in the results
Other bias Low risk There are no sizeable imbalances between groups. No other concerns.