Schatz 2006.
| Methods | RCT, patient recruitment: patients or clients of primary care clinic or pharmacy Setting: Kaiser Permanente Medical Care programme, San Diego, USA |
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| Participants |
Control patients: n = 31, women: 54.8%, mean age: 45.4, smokers: 16.7%, moderate‐severe asthma (according to FEV1), FEV1: 69.2%, ICS use: % not reported Intervention patients: n = 31, women: 32.3%, mean age: 45, smokers: 22.6%, moderate‐severe asthma (according to FEV1), FEV1: 66.7%, ICS use: % not reported |
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| Interventions |
Name and duration of programme: A regular care manager follow‐up in addition to an initial intensive individualised educational visit and use of a potent controller medication, during 12 months Intervention group components Organisational ‐ patients: structured follow‐up; advice or assistance as needed; distribution of free inhalers; review of patient's healthcare utilisation Organisational ‐ healthcare professionals or system: teamwork and collaborative processes between providers (GP contacted if inadequate control) Patient education: distribution of material and one on one education on asthma, management of the disease and inhalation technique Self‐management support: action plan; peak flow meter given with instructions; symptom and peak flow diaries; review of inhalation technique Frequency: initial visit with follow‐up at 1, 6, and 12 months; phone calls 1/month Healthcare professionals involved: GP, care manager Control group components Usual care (which includes distribution of free inhalers, distribution of material on asthma and its management, action plan, peak flow meter given with instructions, and symptom and peak flow diaries) Number of components and dominant component: 11, mixed (organisational ‐ patients, education and self‐management) |
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| Outcomes |
Organisational level Process: prescription of oral steroids Healthcare utilisation: % patients with any asthma‐related hospitalisation or ED visit Patient level Quality of life: mini‐AQLQ score (primary) Asthma symptoms and activity level: number of symptom‐free days; number of ß2‐agonists canisters Self‐management: asthma knowledge score Time of outcome measurement: at 12 months |
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| Notes | Mini‐AQLQ: Asthma Quality of Life Questionnaire | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomisation using a computer‐generated list of random numbers" |
| Allocation concealment (selection bias) | Unclear risk | No description of concealment |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Electronic records used for some data; no description if blinding for questionnaire data |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "follow‐up data were available on less than half of the control group patients at 12 months"; 72 patients randomised ‐ 17 losses to follow‐up (1 in intervention, 16 in usual care) = 45 patients (72.5%) |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | High risk | Low enrolment rate (7%) and significant differences between enrolled and not enrolled for age, sex, inhaled steroids use, and oral steroids |
| Outcomes at baseline similar? | Low risk | No significant differences for all outcomes except one (inhaled steroids) |
| Characteristics at baseline similar? | Low risk | No significant differences |
| Adequate protection against contamination? | Low risk | No risk of contamination (care manager only for intervention patients) |