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. 2015 May 27;2015(5):CD007988. doi: 10.1002/14651858.CD007988.pub2

Wilson 2010.

Methods RCT, patient recruitment: general population (i.e. clients of health insurance)
Setting: Kaiser Permanente clinics, USA (n = 5)
Participants Control patients: n = 204, women: 57.4%, mean age: 45.1, smokers: 16.2%, moderate‐severe asthma (according to GINA), FEV1: ˜70%, ICS use: % not clear
Intervention (a) patients: n = 204, women: 55.9%, mean age: 46.9, smokers: 16.2%, moderate‐severe asthma (according to GINA), FEV1: ˜70%, ICS use: % not clear
Intervention (b) patients: n = 204, women: 56.4%, mean age: 45.7, smokers: 15.2%, moderate‐severe asthma (according to GINA), FEV1: ˜70%, ICS use: % not clear
Interventions Name and duration of programme: the Better Outcomes of Asthma Treatment (BOAT) study, involving asthma education and two in‐person and three brief phone encounters, with or without shared decision making (SDM), where non‐physician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences, during 9 months
Intervention (a) group components (CDM)
Organisational ‐ patients: structured follow‐up
Organisational ‐ healthcare professionals or system: teamwork and collaborative processes between providers (discussion of recommendations between care manager and physician); healthcare professional training; explicit use of guidelines; quality control (audio taping to ensure proper intervention delivery)
Patient education: distribution of material and one on one education on asthma, management of the disease, and instruction on inhaler technique
Self‐management support: action plan
Frequency: session 1 at baseline (50 to 60 min), session 2 at 1 month (20 to 30 min), phone call at 3, 6, 9 months
Healthcare professionals involved: GP, care manager (nurse, respiratory therapist, pharmacist, or physician assistant)
Intervention (b) group components (augmented CDM)
Organisational ‐ patients: intervention (a); shared decision making for treatment regimen
Organisational ‐ healthcare professionals or system: intervention (a)
Patient education: intervention (a)
Self‐management support: intervention (a)
Frequency: intervention (a)
Healthcare professionals involved: intervention (a)
Control group components
Usual care (which includes referral to asthma care management programmes)
Number of components and dominant component: 9, mixed (organisational ‐ patient, education and self‐management)
Outcomes Organisational level
Process: continuous medication acquisition index for ICS only, all asthma controller (ICS, leukotriene modifiers, cromolyn sodium, theophylline), LABAs, and SABAs; % patients dispensed a LABA
Healthcare utilisation: asthma‐related visits, costs
Patient level
Quality of life: mini‐AQLQ score
Asthma symptoms and activity level: ATAQ score
Pulmonary function: FEV1; FEV1/FEV6
Time of outcome measurement: at 24 months
Notes Mini‐AQLQ: Asthma Quality of Life Questionnaire; ATAQ: Asthma Therapy Assessment Questionnaire
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer‐based adaptive randomisation algorithm was used
Allocation concealment (selection bias) Low risk Allocation was concealed from staff randomising patients
Blinding (performance bias and detection bias) 
 All outcomes Low risk All study personnel, except for care managers, were blinded to patient's study assignment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk See figure 2: less than 20% loss to follow‐up, rate is similar across groups
Selective reporting (reporting bias) Unclear risk Trial registered on www.clinicaltrials.gov but pre‐determined outcomes not mentioned
Other bias Low risk No other bias detected
Outcomes at baseline similar? Low risk See figures 3, 4, 5
Characteristics at baseline similar? Low risk See table 1
Adequate protection against contamination? Low risk Care managers of intervention group (a) and intervention group (b) were trained separately and worked independently