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. 2022 Jun 13;2022(6):CD013030. doi: 10.1002/14651858.CD013030.pub2

Bender 2015.

Study characteristics
Methods Design: parallel, individually randomised controlled trial
Duration: endpoint at 104 weeks
Setting: recruited from Kaiser Permanente Colorado ‐ 18 primary care and 2 special care and 2 hospitals; trial carried out in the United States
Participants Population: 1187 children were randomised to receive speech recognition reminders for overdue medication (n = 590) or usual care (n = 597)
Age: range from 3 to 12 years. Mean age in reminders group was 8.2 years; SD: 0.13. Mean age in usual care group was 8.1 years; SD: 0.13.
Proportion of male participants: reminders group was 67.3% male; usual care group was 67.1% male
Proportion of white ethnic participants: reminders group was 43.3% white; usual care group was 44.1% white
Inclusion criteria: persistent asthma; 1 or more ICS script in last 6 months; enrolled in Kaiser Permanente Colorado for 1 year prior
Exclusion criteria: life‐threatening co‐morbidity; sibling enrolled in study; parent decline; ICS prescribed to betaken intermittently or as required; medication not bought at KPCO pharmacy
Percentage withdrawn:
Withdrawal from reminders group was 23.39%; withdrawal from usual care group was 25.13%
Allowed medication: none recorded
Disallowed medication: none recorded
Interventions Reminders group: speech recognition reminders for overdue medication group with 1 to 3 calls depending on whether patient has overdue medication or historically has. Two‐way interaction with patient. No adherence feedback. No co‐interventions used (one digital component involved only). Not a theory‐based intervention. No in‐person component.
Usual care group: usual care
Outcomes Primary:
Adherence (ICS proportion of days covered over 24 months)
Secondary:
Beta‐agonist use, oral steroid use, asthma‐related primary health care visits, ED visits, hospitalisations, after‐hours visits on weekends or weekdays, asthma related visits, parent satisfaction questionnaire
Notes Type of publication: peer‐reviewed
Funding: not stated
COI: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk States that it was randomised but no information about process
Allocation concealment (selection bias) Unclear risk Unclear what method of concealment was used
Blinding of participants and personnel (performance bias)
All outcomes Low risk No blinding described but unlikely to have influenced outcome
Blinding of outcome assessment (detection bias)
All outcomes Low risk No blinding described but unlikely to impact the outcome
Incomplete outcome data (attrition bias)
All outcomes Low risk Intention‐to‐treat analysis performed
Selective reporting (reporting bias) Low risk Study protocol available; results specified as per methods