Vasbinder 2015 E‐MATIC.

Methods	Design: open‐label, parallel‐group randomised controlled trial Duration: 52 weeks Setting: 5 outpatient clinics. The Netherlands Trial registration: Netherlands Trial Register NTR2583
Participants	Population: 219 children with asthma randomised to receive SMS adherence reminders (n = 108) or no reminders (n = 111) Age: 4 to 11 years of age; mean (SD) age in the intervention group 7.8 (2.2) years and in the control group 7.7 (2.1) years Baseline asthma severity: intervention group: 39.8% had poorly controlled asthma (ACT); control group: 36.5% Inclusion criteria: 4 to 11 years of age at the start of the study; doctor‐diagnosed asthma for at least 6 months; ICS use for at least 3 months; use of a pMDI; use of fluticasone, fluticasone/salmeterol or beclomethasone; at least 1 parent/career with a mobile phone Exclusion criteria: refusal to participate in the study Percentage withdrawn: not reported Other allowed medication: not reported
Interventions	Intervention summary: All children received an RTMM‐device that registers time and date of administered ICS doses. Children in the intervention group received “time‐tailored” text messages that were sent only when a dose was at risk of omission Control summary: All children received an RTMM‐device that registers time and date of administered ICS doses. Those in the control group do not receive such text messages Complex intervention: no
Outcomes	Outcomes measured: adherence to ICS; asthma control (ACT); frequency of asthma exacerbations and use of healthcare services (pharmacy data checked for OCS use and health records); disease‐specific quality of life; school/work absence; paediatric AQLQ; acceptance of e‐monitoring; economic evaluation Adherence calculation: proportion of all prescribed dosages taken by the child within a 6‐hour time frame around planned time of inhalation (i.e. from 3 hours before until 3 hours after) calculated from RTMM data on ICS use, attached to the inhaler
Notes	Type of publication: multiple peer‐reviewed journal articles Funding: supported by a non‐conditional grant from The Netherlands Organisation for Health Research and Development (ZonMw, grand registration number 171101005). The study is also partially sponsored by the pharmaceutical company GlaxoSmithKline. The manufacturer of the RTMM devices, Evalan BV, partially sponsors the study by providing devices at cost price
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer‐generated block randomisation was used per hospital with block size of 16 patients"
Allocation concealment (selection bias)	Low risk	"At registration at the RTMM software interface, children were automatically assigned to the intervention or control group" ‐ suggests that allocation was concealed, as this was performed at an IT interface
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Although physicians, researchers and patients were initially blinded for randomisation, patients were generally unblinded shortly after the start of the study period, when they found out whether they received SMS reminders or not" Knowledge about group allocation may have affected performance, especially in subjective measures such as PAQLQ and cACT
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessors described. Primary outcome ‐ adherence ‐ measured objectively and not likely to be at risk of detection bias, but for other outcomes (such as PAQLQ and cACT), the unblinded participant/career is the outcome assessor; therefore, these outcomes are at risk of bias
Incomplete outcome data (attrition bias) All outcomes	High risk	"Reasons why patients left the study prematurely were not systematically registered", and the total number of people who did not complete the study and hence had to have their data imputed is not reported. The numbers in Figure 2 suggest very low retention of around 50% in each arm
Selective reporting (reporting bias)	Low risk	Prospectively published protocol and all outcomes clearly reported in main publication
Other bias	Low risk	None noted

ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AE: asthma education; AQLQ: Asthma Quality of Life Questionnaire; BDP: beclomethasone dipropionate; BMQ: Beliefs about Medication Questionnaire; BTS/SIGN: British Thoracic Society/Scottish Intercollegiate Guidelines Network; cACT: Childhood Asthma Control Test; CBQ‐20: Conflict Behaviour Questionnaire‐20; CI: confidence interval; COPD: chronic obstructive pulmonary disease; CSQ: Consumer Satisfaction Questionnaire; CVD: cardiovascular disease; DDD: Daily Defined Doses; DPI: dry powder inhaler; ED: emergency department; EMA: Ecological Momentary Assessment; EMD: electronic monitoring device; EPAC: episode of poor asthma control; FEV₁: forced expiratory volume in one second; FP: fluticasone propionate; FSI: Functional Severity Index; FVC: forced vital capacity; GINA: Global Initiative for Asthma; GP: general practitioner; GSK: GlaxoSmithKline; HADS: Hospital Anxiety and Depression Scale; HFA inhaler: hydrofluoroalkane inhaler; HMO: health maintenance organisation; HRQOL: health‐related quality of life; ICS: inhaled corticosteroids; IPQ: Illness Perceptions Questionnaire; IQR: interquartile ratio; IRF: inhaler reminders and feedback; IT: information technology; ITT: intention‐to‐treat; IVR: interactive voice response; KAAM: Knowledge of Asthma and Asthma Medicine Questionnaire; KP: Kaiser Permanente; KPCO: Kaiser Permanente Colorado; KPH: Kaiser Permanente Hawaii; KPNW: Kaiser Permanente Northwest; LABA: long‐acting beta₂‐agonists; MARS‐A: Medication Adherence Report Scale; MD: mean difference; MDI: metered dose inhaler; MI: motivational interviewing; NAEPP: National Asthma Education and Prevention Program; NHLBI: National Heart, Lung, and Blood Institute; NS: not statistically significant; OCS: oral corticosteroid; PAD: personalised adherence discussion; PAQLQ: Paediatric Asthma Quality of Life Questionnaire; PDC: proportion of days covered; PedsQL: Paediatric Quality of Life Inventory; PEF: peak expiratory flow; pMDI: pressurised metered dose inhaler; PS: problem solving; QOL: quality of life; RTMM: real‐time medication monitoring; SABA: short‐acting beta₂‐agonists; SD: standard deviation; SF‐36: Short Form‐36; SMAQ: Simplified Medication Adherence Questionnaire; SMS: short message service/text message; SR: speech recognition; UC: usual care; URTI: upper respiratory tract infection; VAS: visual analogue scale