Kennedy 2002.

Study characteristics
Methods	Study design: prospective multicentre cluster‐RCT Study duration: patients were recruited between July 1999–August 2000, and followed for 12 months. The trial ended 12 months after the last patient entered the study Setting: outpatient departments of 19 hospitals
Participants	State of disease at beginning of study per IG/CG: N (%) active: CG: 85 (23.3%); IG: 69 (29.6%) N (%) relapse in past 18 months: CG: 196 (53.7%); IG: 137 (50.7%) N (%) in remission with no flare‐ups in past 18 months: CG: 58 (15.9%); IG: 47 (17.4%) Disease type per IG/CG: mix of UC and CD Disease type N (%): CG: UC: 226 (61.9%); CD: 139 (38.1%) IG: UC: 177 (65.6%); CD: 92 (34.1%) Inclusion criteria: established UC or CD, over the age of 16 years, able to write English Exclusion: NR Age at beginning of study per IG/CG: Mean age (SD) for CG: 46.3 (15.1); IG: 44.4 (14.9) Sex per IG/CG: N (%) males in CG: 157 (43%); IG: 112 (41.55) N (%) females in CG: 208 (57%); IG: 158 (58.5) Disease duration per IC/CG: Diagnosed in the past year: IG: 15/119 CG: 21/121 Diagnosed over 20 years ago: IG: 14/119 CG: 12/121 Number randomised per IG/CG: IG: 9 control sites and 119 participants; CG: 10 control sites and 121 participants Number reaching end of study per IG/CG: IG: 70 participants; CG: 94 participants
Interventions	IG: participants received guidebooks for both Crohn's and UC CG: standard care which was deemed appropriate by the hospital specialist
Outcomes	Duration of follow‐up: 12 months Primary outcomes as defined by study authors: quality of life, health service resource use, and patient satisfaction. Secondary outcomes as defined by study authors: enablement/confidence to cope with the condition.
Notes	Funding source: Health Technology Assessment Programme of the UK NHS & Career Scientist Award in Public Health funded by the NHS R&D programme Conflicts of interest: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Cluster randomisation mentioned but no description of the method and no information could be provided by the authors. Author was contacted, no response received.
Allocation concealment (selection bias)	Unclear risk	It is unclear if all clusters were randomised at the same time. We contacted the authors but received no response
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding within cluster sites receiving intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention of any outcome assessment blinding. Author was contacted, no response received.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Balanced attrition and reasons given
Selective reporting (reporting bias)	Unclear risk	No protocol/trial registration. Appropriate outcomes reported as per the method section
Other bias	Low risk	No baseline imbalances. Clustering taken into account for the analysis. No other concerns.