Moreau 2021.

Study characteristics
Methods	Study design: prospective RCT Study duration: NR Setting: 19 French Tertiary Centres
Participants	State of disease at beginning of study per IG/CG: NR Disease type per IG/CG: mixed N (%) in IG: CD 95 (71.4%), UC 38 (28.6%) N (%) in CG: CD 97 (75.2%), UC 32 (24.8%) Inclusion criteria: adults aged between 18 and 70 years; diagnosed with IBD (CD or UC); with either a recent diagnosis (less than 6 months), or significant event in the disease course and/or change in treatment (recent hospitalisation, complication, surgery, or immunosuppressant or biologic considered). Exclusion: patients unable to communicate, understand, or participate in the educational programme, mainly for linguistic reasons. Age at beginning of study per IG/CG: median age (IQR): IG 29.9 (25.2–42.0); CG 32.5 (24.9–42.2) Sex per IG/CG: N (%) IG Male 54 (40.6%) Female 79 (59.4%); CG Male 51 (39.5%) Female 78 (60.5%) Disease duration per IC/CG: median (IQR) months IG: 49.5 (6.4‐111.9); CG: 40.6 (7.3‐ 122.8) Number randomised per IG/CG: IG: 133; CG: 130 Number reaching end of study per IG/CG: IG: 133; CG: 129
Interventions	IG: education programme delivered by a dedicated staff (mainly nurses) using an illustrated book, covering the different dimensions of life with IBD. CG: no education programme. After 6 months, there was a cross‐over procedure and patients from the control group followed the same programme as the educated group.
Outcomes	Duration of follow ‐up: 12 months Primary outcomes as defined by study authors: the psycho‐pedagogic impact of the education programme on IBD patients’ skills with regard to their disease. It was measured by the change in composite ECIPE score from baseline to 6 months. Secondary outcomes as defined by study authors: the changes of ECIPE scores between 6 and 12 months in both groups; the impact of the education programme on disease progression (rates of hospitalisation, complications, or surgery), adherence to treatment (assessed by the modified Morisky adherence scale), quality of life (assessed by the short quality of life score for IBD (SIBDQ)), work productivity (assessed by the work productivity and activity impairment questionnaire (WPAI)), and patients’ concerns (assessed by the RFIPC); the impact of the education programme on the health care professionals performing the sessions.
Notes	Funding: financially supported by grants from MSD France and Association François Aupetit. Conflict of interest: JM received honoraria from MSD, Janssen, Abbvie, Pfizer, Ferring, Takeda, and Vifor; NH received honoraria from Janssen, Tillots Pharma, and MSD; LM received honoraria from Bayer, Merck, Novartis, Takeda; CTP received lecture fees from Abbvie, Takeda, Maat Pharma, Janssen, and advisory board fees from MSD and Tillots; MN received honoraria from Abbvie, Adacyte, Amgen, Biogen, Ferring, Janssen, Mayoli‐Spindler, MSD, Pfizer, and Takeda; RA received advisory board fees from Takeda, Abbvie, Norgine, Tillots, MSD, Biogen, and Janssen; JCG received honoraria from Abbvie, Pfizer, Janssen, Takeda, and MSD; SO received honoraria from MSD, Abbvie, Janssen,Otsuka, Takeda, Gilead, and GSK; XH received honoraria from Abbvie, Amgen, Biogen, Celltrion, Ferring, HAC Pharma, Hospira, Janssen, MSD, Pfizer, and Takeda; AA received honoraria from Abbvie, Janssen, Takeda, Ferring, and MSD; PS received honoraria from Takeda, MSD, Biocodex, Ferring, Pfizer, and AbbVie, and grant support from Biocodex; XR received honoraria from MSD, Abbvie, Biogen, Pfizer, Janssen, Takeda, and Theradiag; SN received lecturer or advisory board fees from AbbVie, MSD, Vifor Pharma, Pfizer, Janssen, and Ferring; GS received lecture fees and travel grants from MSD, Ferring, Takeda, Pfizer, Janssen, Vifor, HAC Pharma, Abbvie, Tillots, and Norgine; BM has no conflict of interest to declare; CS received honoraria from Takeda, lecture fees from Abbvie, Fresenius Kabi, Pfizer, and Janssen and travel accommodation from MSD, Takeda, Abbvie, Pfizer, and Janssen; MS received honoraria from Abbvie, Takeda, and Mylan: BC received honoraria from Abbvie, Mayoly Spindler, Sanofi, and Kyowa Kyrin; MF received honoraria from Abbvie, Ferring, MSD, Janssen, Takeda, Tillots, Gilead, Celgene, Boehringer, Biogen, Pfizer; FC received honoraria from Amgen, BMS, Celltrion, Enterome, Ferring, Janssen, Medtronic, Pfizer, Pharmacosmos, and Roche, as well as lecture fees from Abbvie, Astra, BMS, Ferring, Janssen, MSD, Pfizer, Pileje, Takeda, and Tillotts; LPB received honoraria from AbbVie, Janssen, Genentech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Boerhinger Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, grants from Abbvie, MSD, Takeda, and has stock options in CTMA; SC has no conflict of interest to declare; MA received honoraria from Abbvie, MSD, Janssen, Takeda, Pfizer, Novartis, Ferring, Tillots, Celgene, and Genentech/Roche.
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 (education)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The ECIPE score was calculated by a physician independent of the education team and blinded to the allocation group of the patient
Incomplete outcome data (attrition bias) All outcomes	Low risk	There was only 1 dropout and reason for dropout mentioned. No baseline imbalance between IG and CG
Selective reporting (reporting bias)	High risk	Trial registration mentions 3 other outcomes (hospitalisation, flare‐ups and major complications), the results of which were not presented in the paper. Also only odd ratios of outcomes were presented. Author was contacted, no response received. Trial number NCT02550158
Other bias	Low risk	No baseline imbalance between IG and CG. No other concerns.