Vaz 2019.
Study characteristics | ||
Methods |
Study design: prospective RCT Study duration: NR Setting: gastroenterology clinic |
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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 |
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Interventions |
IG: a 30‐minute educational session using the IBD Pocket Guide CG: participants received usual care |
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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 |
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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 |
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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. |