Borgaonkar 2002.
Study characteristics | ||
Methods |
Study design: prospective RCT Study duration: NR Setting: ambulatory gastroenterology clinic |
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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 |
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Interventions |
IG: information booklets available from the Crohn’s and Colitis Foundation of Canada administered to the IG. CG: "usual care". |
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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 |
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Notes |
Funding source: NR Conflicts of interest: NR |
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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. |