Waters 2005.

Study characteristics
Methods	Study design: prospective RCT Study duration: NR Setting: outpatient clinic
Participants	State of disease at beginning of study per IG/CG: mean (nature of figures provided in brackets unclear in source article) CDAI mean score: IG: 126.8 (93.3); CG: 188.3 (117.1) (low score = better result) Seo UC activity index  (mean score) IG:111.8 (±25.8), CG: 114.1 (±37.8) (low score = better result) Disease type per IG/CG: mixed: UC/CD IG: 14/31; CG: 18/26 Inclusion criteria: people 17 years of age and older with a diagnosis of IBD confirmed by radiographic/endoscopic examination and/or histology/surgical pathology, who lived within a 2‐hour drive of the University of Alberta Hospital (Edmonton, Alberta), were able to attend the education programme, and had fluency in written and spoken English. Exclusion: people with short gut syndrome, disease limited to ulcerative proctitis, a proctocolectomy for UC, an ostomy, on total parenteral nutrition, or who underwent surgery during the study that required an ostomy Age at beginning of study per IG/CG: mean (SD) IG: 40.3 (12.8); CG: 45.0 (13.5) Sex per IG/CG: male/female IG: 29/16 CG: 22/22 Disease duration per IC/CG: mean (SD) years IG: 10.5 (9.0); CG: 13.4 (9.84) Number randomised per IG/CG: IG: 45; CG: 44 Number reaching end of study per IG/CG: IG: 31; CG: 38
Interventions	IG: the education group, in addition to standard of care, attended a 12‐hour structured education programme provided in 3‐ hour blocks over four consecutive weeks. CG: received standard care consisting of physician visits at the discretion of the physicians and patients, with physician‐directed ad hoc teaching during visits and the presentation of printed educational literature. The control group was offered the full education programme after the study data collection was completed.
Outcomes	Duration of follow‐up: 8 weeks Primary outcomes as defined by study authors: knowledge, assessed using the Crohn’s and Colitis Knowledge Questionnaire (CCKNOW) and the Knowledge Questionnaire (KQ) and QOL measured using IBDQ and RFIPC Secondary outcomes as defined by study authors: medication adherence was assessed by three methods: survey at baseline; a set of questions on the Patient Satisfaction Questionnaire; and participant self‐report; healthcare use measured by number of physician visits and hospital admissions related to IBD and the associated complications; participant satisfaction with medical care and the education programme was assessed with questionnaires using a Likert scale with 1 being “strongly agree” and 4 being “strongly disagree”.
Notes	Funding source: NR Conflicts of interest: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation method not specified. Author was contacted, no response received.
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment. Author was contacted, no response received.
Blinding of participants and personnel (performance bias) All outcomes	High risk	It is not possible to blind the participants to the intervention.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention of blinding of outcome assessor. Author was contacted, no response received.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The IG lost 14/45 and the CG lost 6/44. Reasons for drop‐outs given and we don't think they have an impact on the outcomes.
Selective reporting (reporting bias)	Unclear risk	The authors do not provide clear raw data for multiple results (QOL, medication adherence, healthcare visits) in their results section. Author was contacted, no response received.
Other bias	Low risk	No baseline imbalance between IG and CG. No other concerns.