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. 2023 May 4;2023(5):CD013854. doi: 10.1002/14651858.CD013854.pub2

Vaz 2019.

Study characteristics
Methods Study design: prospective RCT
Study duration: NR
Setting: gastroenterology clinic
Participants State of disease at beginning of study per IG/CG: all randomised participants had inactive disease at baseline.
Disease type per IG/CG: mixed
67% had CD and 33% had UC, numbers were not specified for IG and CG
Inclusion criteria: confirmed IBD diagnosis (i.e. CD, UC, or indeterminate colitis), prescribed at least 1 daily oral medication for the control of IBD (i.e. steroid, thiopurine, or aminosalicylate).
Exclusion: significant developmental disorders or serious mental illness, enrolment in another intervention targeting adherence at the time of the study
Age at beginning of study per IG/CG: mean age (SD) of randomised participants in the study was 14.9 years (1.9); mean ages were not specified for the IG and CG separately.
Sex per IG/CG: 44% of all randomised participants were girls, and 56% were boys. Specific numbers for IG and CG not provided.
Disease duration per IC/CG: NR
Number randomised per IG/CG: IG: 7, CG: 6
Number reaching end of study per IG/CG: IG: 5, CG: 4
Interventions IG: a 30‐minute educational session using the IBD Pocket Guide
CG: participants received usual care
Outcomes Duration of follow‐up: 4 weeks
Primary outcomes as defined by study authors: medication adherence measured via the MedMinder Pill Dispensing System.
Secondary outcomes as defined by study authors: IBD knowledge measured using the IBD Knowledge Inventory Device (IBD‐KID).
Transition readiness measured using the c(TRAQ) Version 5.0
Notes Funding source: this study was supported by a National Institutes of Health training grant awarded to the Cincinnati Children’s Hospital Medical Center Division of Pediatric Gastroenterology, Hepatology and Nutrition (T32 DK007727).
Conflicts of interest: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated block randomisation (information provided by the author)
Allocation concealment (selection bias) High risk Only the lead investigator had access to the allocation and followed the randomisation schedule after they finished the run‐in period and qualified for the study (information provided by the author)
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 High risk Assessors were not blinded (information provided by the author)
Incomplete outcome data (attrition bias)
All outcomes Low risk Equal attrition between groups and the authors confirmed that in all cases, the participants found the study too difficult to complete and withdrew
Selective reporting (reporting bias) Unclear risk No trial registration or protocol. Results for all outcomes mentioned in the method section were reported, but not all raw data is clearly reported per group. Authors could not provide it.
Other bias Unclear risk Baseline characteristics of IG vs CG not reported. Authors could not provide them. No other concerns.