Davis 2019.
| Study characteristics | ||
| Methods |
Design: open‐label randomised controlled trial Duration: endpoint at 52 weeks Setting: recruited from 4 paediatric clinics; trial carried out in the United States |
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| Participants |
Population: 359 participants were randomised to receive digital intervention (n = 164 number) or control group (n = 155) Age: range from 11 to 17. Mean age in digital intervention was 13.1; SD 1.9. Mean age in control group was 13.2; SD 1.9. Proportion of male participants: digital intervention was 59.1% male; control group was 58.7% male Proportion of white ethnic participants: digital intervention was 32.3% white; control group was 40% white Asthma severity: mixed (mild to severe) Inclusion criteria: 11 to 17 years, spoke and read English or Spanish, had persistent asthma, were present for an acute or follow‐up asthma visit or a well‐child visit, and had previously visited the clinic at least once for asthma |
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| Interventions |
Digital intervention: participants received a question prompt list and watched a short video about asthma self‐management before seeing the provider. 1‐page question prompt list is co‐intervention. There were 2 intervention sessions. No digital interactivity with patient. No adherence feedback. Control group: received usual care (medical visits) |
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| Outcomes | Primary: self‐reported medication adherence | |
| Notes |
Type of publication: peer‐reviewed Funding: Patient‐Centered Outcomes Research institute CDR‐1402‐09777, the National Center for Advancing Translational Sciences (NCATS), National INstitutes of Health through grant award number UL1TR002489 COI: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated "were randomised" but no information on how participants were randomised |
| Allocation concealment (selection bias) | Unclear risk | No information given on how groups were allocated and whether researchers knew of upcoming allocations (did not state if the researchers were blinded and if medical practitioners were informed) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unlikely that blinding was achieved as the adolescents in the intervention group received a short video and prompt list, and no mention of blinding procedures being in place |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcome and participants unblinded; adherence was measured using a VAS, potentially affected by knowledge of allocation group |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were no data stating the number of N completed in each group; no information on dropouts ‐ results only from GEE analyses |
| Selective reporting (reporting bias) | Low risk | Outcome measures appear to all be reported as per methods |