Charles 2007.

Methods	Randomized controlled trial
Participants	The study location was Wellington, New Zealand 55 participants were randomized to the intervention group and 55 participants were randomized to the control group The inclusion criteria were age 12 to 65 years with a diagnosis of asthma, required to take regular inhaled corticosteroid (ICS) at a fixed dose, no exacerbation in the previous month or run‐in period, not pregnant or lactating, and if of child‐bearing potential, using contraception The exclusion criteria were a diagnosis of chronic obstructive pulmonary disease, the use of a long‐acting beta‐agonist, or a history of other clinically significant disease
Interventions	Intervention: AUDIOVISUAL REMINDER The intervention was an audiovisual reminder function (AVRF) attached to the inhaler. When the alarm was switched on, it generated a single beep, which sounded once every 30 seconds for 60 minutes after the predesignated time, which was programmed into the device. The alarm stopped if the MDI was actuated or after 60 minutes if not taken. The device was programmed to emit the alarm at predetermined times twice a day. The AVRF also had a colored light, which was green before MDI use, changing to red once the MDI was taken. This function served to remind patients whether they had taken the MDI as scheduled. Follow‐up period was 12 weeks Control: SMARTINHALER Control participants received the same Smartinhaler as intervention participants, but it did not have the audiovisual reminder device
Outcomes	The measures of adherence were a covert electronic monitor inside the asthma inhaler used by participants during the study. Participants were not aware of the monitor, which recorded each time the inhaler was used. Adherence was calculated based on the percentage of prescribed doses that were taken. Participants were prescribed 2 separate doses each day, taken at least 6 hours apart. A correction was applied to dose dumping (when 10 or more doses were actuated within a 3‐hour period). The patient outcomes were Asthma Control Questionnaire (ACQ) scores and Peak Expiratory Flow (PEF). Measures were taken at clinic visits at weeks 0, 6, 12, 18, and 24. At the clinic visits, subjects completed the ACQ and had 3 measurements of PEF with the highest value recorded. Subjects were instructed not to take their short‐acting beta‐agonist for 6 hours before the clinic visits
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(pg 813) The randomization was by reference to a computer‐generated random code concealed from the researcher, who opened an envelope at the time of randomization. After a 2‐week run‐in period, subjects were randomized to receive 1 of the 2 fluticasone propionate (FP) treatment regimens for a 24‐week period
Allocation concealment (selection bias)	Unclear risk	Does not specify opaque envelopes; description not clear enough to permit judgment of low risk. The randomization was by reference to a computer‐generated random code concealed from the researcher who opened an envelope at the time of randomization. After a 2‐week run‐in period, subjects were randomized to receive 1 of the 2 FP treatment regimens for a 24‐week period
Selective reporting (reporting bias)	Unclear risk	None detected, protocol not available
Other bias	Unclear risk	None noted but insufficient information provided
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SMARTINHALER ‐ ELECTRONIC MONITORING ‐ Data are objective; no indication staff were involved in altering data
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) PEAK EXPIRATORY FLOW ‐ The article does not provide information on the staff who collected the data, but it is an objective measure
Blinding of participants (performance bias) Adherence measure	Low risk	(PRIMARY) SMARTINHALER ‐ ELECTRONIC MONITORING ‐ Patients were not aware that adherence was being measured or that the study was about adherence
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) PEAK EXPIRATORY FLOW ‐ The patients were not aware of the purpose of the study
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) SMARTINHALER ‐ ELECTRONIC MONITORING ‐ Data are objective; procedures outlined for applying correction factors (i.e. dose dumping)
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) PEAK EXPIRATORY FLOW ‐ Objective measure, unlikely to be biased
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) SMARTINHALER ‐ ELECTRONIC MONITORING ‐ Dropouts are relatively balanced across conditions, but there are a significant number of them. Insufficient information to made a judgment
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) PEAK EXPIRATORY FLOW ‐ Not enough information provided to judge