Janson 2009.

Methods	Randomized controlled trial
Participants	The study location was San Francisco, California, USA 45 participants were randomized to the intervention group and 39 participants were randomized to the control group The inclusion criteria were non‐smokers (5 or fewer pack‐years of smoking history) who were aged 18 to 55 years with moderate‐to‐severe asthma (i.e. FEV1 < 80% of predicted value, daily symptoms, and 1 night‐time awakening per week), and had spirometric evidence of reversible airflow obstruction or bronchial reactivity to inhaled methacholine The exclusion criteria were: had received systemic steroids within 4 weeks of study enrollment, an upper respiratory tract infection within 6 weeks of enrollment, pregnancy, cardiac, gastrointestinal, or psychiatric disease, or other lung disease, previous participation in a formal asthma education program, mild or intermittent asthma, smoker, or non‐reversible airflow obstruction
Interventions	Intervention: SELF MANAGEMENT EDUCATIONAL INTERVENTION Participants in the individualized self management group received both the self monitoring of the control group plus an individualized self management component. Self management sessions were held by a certified asthma educator and respiratory therapist. The sessions consisted of asthma facts and medication actions and individualized components such as verbal and graphic interpretation of spirometric results, peak flow trends, metered dose inhaler technique error, and skin allergen results (with strategies to control specific personal environmental exposures). The peak flow monitor was modified for the intervention group to use a traffic light analogy and correlated to a simple written action plan Control: SELF MONITORING ALONE Control patients attended the same number of visits as intervention patients, but control visits were only for data collection. During each phase of the trial, all participants measured morning peak flow with an electronic peak flowmeter (Airwatch; iMetrikus, Carlsbad, Calif) and also recorded their daily values in a diary. All participants were told that higher peak flow numbers meant their airways were more open and lower numbers meant their airways were more closed. An electronic medication monitor, which concealed readings from the subject (Doser CT; MediTrack, Hudson, Mass), was placed on each ICS inhaler. Participants also monitored daily symptoms, night‐time awakenings, and tabulated ICS and inhaled b‐agonist (IBA) use in the diary. Data from the electronic monitors and diary pages were collected at each study visit
Outcomes	The measures of adherence were an electronic medication monitor on each ICS inhaler. Data from the electronic monitors were collected at each study visit. ICS adherence was calculated as the percentage of prescribed doses taken each week as measured by the electronic device validated for monitoring metered dose inhaler use. The numerator was capped at the prescribed doses per day to avoid overestimation of adherence to greater than 100% per day The patient outcomes were pulmonary function assessed by spirometry before bronchodilator use and after withholding short‐acting b‐agonists for 6 or more hours and long‐acting beta‐agonists for 24 or more hours. FEV1 per cent predicted was used as a proxy variable for overall lung function; induced sputum samples were collected at the end of the run‐in phase, the end of the intervention, and the end of the study to assess the degree of airway inflammation. Inflammation markers were eosinophils, neutrophils, eosinophil cationic protein (ECP), and tryptase; quality of life and perceived asthma control were assessed by using validated and self completed questionnaires; morning peak flow (measured by using the electronic peak flowmeter by participant), asthma symptoms (rated daily by participants on validated 10‐point numeric rating scales), symptom‐free days, night‐time awakenings, and inhaled beta‐agonist use were all recorded daily in participant diary and summed weekly for analysis
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(pg 841) Participants were randomized using a computer‐generated method
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not mentioned. At the end of the run‐in phase, participants (n584) were randomized using a computer‐generated method to individualized asthma self management education with self monitoring of symptoms, peak flow, and night‐time awakenings (intervention group) or self monitoring alone (control group)
Selective reporting (reporting bias)	High risk	Self report data on adherence were collected but not reported. (pg 842) Electronic and diary adherence and peak flow data were compared to look for concurrence, but only the electronic data for both were used in the analysis
Other bias	Unclear risk	The authors note the following: (pg 845) data dumping just before a research visit; loss of data with failed or lost inhalers ‐ self reporting for some outcomes (loss of diary, incomplete entries, errors in entries, not completed)
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) ELECTRONIC MEDICATION MONITOR ‐ (pg 841) Except for the study co‐ordinator, who had no role in data management or assessment, the investigators were blinded to group assignment
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SYMPTOM CONTROL ‐ Except for the study co‐ordinator, who had no role in data management or assessment, the investigators were blinded to group assignment
Blinding of participants (performance bias) Adherence measure	Low risk	(PRIMARY) ELECTRONIC MEDICATION MONITOR ‐ Author's comment: patients were aware of the monitor but could not see any data or counts. So even if they knew it was being monitored over the course of 6 months they had no feedback. Risk of bias is very low
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) SYMPTOM CONTROL ‐ Author's note: I believe there is a low risk of bias as all subjects in both groups followed the same protocol. Complete blinding was not possible due to the nature of the intervention. However, both groups were told the same information about the study verbally and in the consent form. All subjects were told we were studying 2 kinds of monitoring for asthma management. Subjects in the control group had no contact or knowledge of the intervention group
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) ELECTRONIC MEDICATION MONITOR ‐ (pg 841) Except for the study co‐ordinator, who had no role in data management or assessment, the investigators were blinded to group assignment
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) SYMPTOM CONTROL ‐ Except for the study co‐ordinator, who had no role in data management or assessment, the investigators were blinded to group assignment
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) ELECTRONIC MEDICATION MONITOR ‐ Author's note: 3 subjects from each group had some days of incomplete adherence data due to either lost or failed medication monitors. For these subjects we used all data available
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) SYMPTOM CONTROL ‐ Not enough information to judge. (pg 841) "We enrolled 95 subjects and randomized 84 subjects. Intention‐to‐treat analyses included all participants randomized, 78 with completed data and 6 with incomplete data."