Wilson 2010.
Methods | RCT, patient recruitment: general population (i.e. clients of health insurance) Setting: Kaiser Permanente clinics, USA (n = 5) |
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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 |
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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) |
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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 |
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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 |