| Methods |
All patients were stratified for treatment center. The first 45 patients among 126 patients were recruited in the control group to avoid contamination. Subsequent eligible patients were randomized in the 2 educated groups. Only the randomized groups are eligible for our review |
| Participants |
126 patients were enrolled in the study, but 105 attended for randomization. Patients (aged > 18 years) with an acute exacerbation of asthma who had not previously taken part in any asthma educational program. Patients older than 40 years of age in whom the best forced expiratory volume in 1 second (FEV1) was lower than 80% of predicted were excluded. All patients with concurrent medical illnesses that in the judgment of the investigators contraindicated study participation were also excluded |
| Interventions |
The patients in Group C (control) received the usual treatment given for an acute asthma exacerbation. In addition to standard treatment as for Group C treatment, patients in Group Limited Education (LE) were given a self action plan that was explained by the on call physician. The action plan used "traffic lights" (green, yellow, red) to describe specific states of asthma control based on Peak Expiratory Flow and symptoms and actions that the patient should take for each state (pages 1415 to 1416). Subjects were all instructed by a respiratory therapist or study nurse in the proper use of an inhaler. In addition to what patients in Group LE received, the patients in Group Structured Education participated in a structured asthma educational program based on the PRECEDE model of health education within 2 weeks after their randomization. Structured educational intervention group Group SE. In addition to what patients in Group LE received, the patients in Group SE participated in a structured asthma educational program based on the PRECEDE model of health education within 2 weeks after their randomization. Briefly, this model takes into consideration 3 different issues that are important when dealing with health‐related behaviors: predisposing factors (belief, attitude, knowledge); enabling factors (community resource, family support); and reinforcement. The teaching was provided individually or in small groups according to patient preference. The intervention focused mainly on self management. To increase patient self confidence in making his or her own treatment decisions, the interaction with the patient was based on the self efficacy theory of Bandura. Reinforcement was provided at the 6‐month follow‐up visit |
| Outcomes |
Compliance with inhaled corticosteroids was evaluated according to the patient's own estimation at 2 weeks and 12 months. Patient outcome measures included number of urgent visits for an acute exacerbation of asthma, lung function tests, knowledge, use of an action plan, compliance with inhaled corticosteroids, quality of life score |
| Notes |
The method of measuring adherence is very insensitive because it only indicates whether the person had a prescription for inhaled corticosteroids, not whether they used it |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No mention of process of randomization. (pg 1415) "All patients were stratified for treatment center. To avoid contamination of the control group, the first 45 patients were recruited in the control group. Subsequent eligible patients were randomized in the two educated groups. At this point in time, physicians unfamiliar with the prescription of self action plans were given information either by the study coordinator or the investigator". |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided on allocation concealment. (pg 1) "All patients were stratified for treatment center. To avoid contamination of the control group, the first 45 patients were recruited in the control group. Subsequent eligible patients were randomized in the two educated groups." |
| Selective reporting (reporting bias) |
Unclear risk |
Apparently, all declared outcomes were reported but protocol was not available. Hence, marked uncertain |
| Other bias |
Unclear risk |
No limitations noted in discussion and no clear biases |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No information provided |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) URGENCY VISITS ‐ No information provided |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Subjective outcome |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) URGENCY VISITS ‐ Patients kept track of this information. Any blinding could have been broken |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No information provided |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) URGENCY VISITS ‐ No information provided |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Compliance data collected from 48 only. No group‐wise distribution available: thus, unable to predict the effect |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) URGENCY VISITS ‐ No dropout information provided |
