Jaghult 2007.
Study characteristics | ||
Methods |
Study design: prospective RCT Study duration: NR Setting: IBD Clinic |
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Participants |
State of disease at beginning of study per IG/CG: all participants had inactive disease Disease type per IG/CG: CD: 26/16; UC: 26/16 Inclusion criteria: people with confirmed diagnosis of CD or UC of less than 2 years’ duration and in clinical remission, and who visited the IBD clinic between November 2002 and November 2004. Patient also had to have a good understanding of the Swedish language and be able to complete a questionnaire. Exclusion: people with any other chronic disease Age at beginning of study per IG/CG: mean (range) IG: 41.71 (17‐75); CG: 39.44 (18‐73) Sex per IG/CG: Number of male/female IG: 22/30; CG: 19/13 Disease duration per IC/CG: mean (range) years IG: 1.60 (1‐2); CG: 1.59 (1‐2) Number randomised per IG/CG: IG: 55; CG: 44 Number reaching end of study per IG/CG: IG: 52; CG: 32 |
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Interventions |
IG: participants attended a multi professional group‐based education programme with CD patients in separate groups from UC patients. CG: participants received regular information during visits to the IBD clinic. |
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Outcomes |
Duration of follow ‐up: 6 months Primary outcomes as defined by study authors: HRQoL measured using the Health Index (HI), IBDQ and the RFIPC Secondary outcomes as defined by study authors: coping capacity measured using the Sense of Coherence (SOC) questionnaire. |
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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 | Author response: computer‐generated randomisation |
Allocation concealment (selection bias) | High risk | Author response: "patients were randomized to an intervention or control group, using allocation concealment". However, after contact, the author stated that they were "the only one that had access to the allocation list, and it was locked in a cabinet." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not possible to blind the patients to the intervention (education) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Author response: Unblinded for outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Author response about reasons for drop‐outs: For the control group 6 patients dropped out and gave the reason that they wanted to be in the intervention group. In the intervention group there were 3 dropouts without giving an explanation. This resulted in 55 patients receiving the intervention and 38 receiving the control intervention. |
Selective reporting (reporting bias) | High risk | No protocol/trial registration. Only mean of results given with no standard deviation. After contact the author responded that they "did not perform this analysis". |
Other bias | Low risk | No baseline imbalances and no other concerns. |