| Methods |
The method of random allocation was not described |
| Participants |
Patients were 16 years of age or older, with moderate to severe asthma and the need to take daily anti‐inflammatory agent. The diagnosis of asthma was confirmed by either a documented reversibility greater than 15% in FEV1 or a PC20 methacholine less than or equal to 8 mg/ml when determined by the method described by Cockcroft and coworkers |
| Interventions |
The intervention is an asthma education program with an action plan based on peak‐flow monitoring (Group P) or an action plan based on asthma symptoms (Group S). The Control group (Group C) received instructions from their pulmonologists regarding medication use and influence of allergenic and non‐allergenic triggers. They were taught how to use their inhaler properly by the educator. A verbal action plan could be given by the physician. Groups P and S received the same education as the controls plus individual counseling with the specialized educator during a 1‐hour session. All participants received a book entitled "Understand and Control Your Asthma" at no extra charge. Group P received a self management plan based on peak expiratory flow (PEF). They were asked to continue measuring PEF twice a day and to keep a diary of the results. Each time, subjects only recorded the best of 3 measurements. Every attempt was made to ensure that patients knew how to interpret the measurement and how to respond to a change in PEF. At each follow‐up visit, the patient's diary card was reviewed, and if the action plan had not been implemented when required, further explanations were given regarding when treatment should be modified. Group S received a self management plan based on asthma symptom monitoring. These patients were asked to keep a daily diary of asthma symptom scores, using a scale of 0 (no symptoms) to 3 (night‐time asthma symptoms, severe daily symptoms preventing usual activities), and adjust their medications according to the severity of respiratory symptoms using the guidelines of the action plan |
| Outcomes |
Adherence was assessed at each follow‐up by weighing the used medication canisters. Patients were unaware of this. Treatment outcome was assessed, in terms of asthma morbidity, by a count of the days missed from work or school, the number of hospitalizations or visits to the emergency room for asthma, and the number of oral corticosteroids courses used since their last visit. These were self reported in a diary and recorded at each of the 1, 3, 6, 9, and 12‐month visits after randomization. Data regarding the number of visits to the emergency room, number of hospitalizations, and absenteeism at work or school during the 12 months prior to enrollment in the study were also collected for all patients by administering a questionnaire and reviewing the medical charts. Knowledge of asthma was also measured pre‐run‐in, at randomization, and at the final visit using a questionnaire |
| Notes |
To reduce financial barriers to treatment adherence, the investigators supplied asthma medication at no charge throughout the trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No details given. (pg 2) Visit R (randomization). Randomization into one of the 3 groups was done in each center, taking into account the name of the participating physician |
| Allocation concealment (selection bias) |
Unclear risk |
No information given. No details given. (pg 2) Visit R (randomization). Randomization into one of the 3 groups was done in each center, taking into account the name of the participating physician |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not found |
| Other bias |
High risk |
In the discussion section, the authors note that the fact that the patients were provided with free medication and sustained care may have contributed to the success of the study. All patients also received some sort of asthma education that may have influenced the results. Also, the inhaled corticosteroid therapy was adjusted prior to randomization and this may have had an effect on the success of the intervention. (pg 4) "The results of this study surprised us, as we had expected to find a greater decrease in asthma morbidity among patients who took part in the structured educational program. It can probably be explained by the fact that the control group may have been influenced by facilitating and reinforcing factors such as free medication and sustained care, including several follow‐up visits with the educator, as described in the PRECEDE model contrary to what happened in one of our previous studies. In the present study, however, control patients were instructed on how to use their inhalers properly, and physicians could give information regarding allergenic and nonallergenic triggers if judged important. To differentiate the benefits of optimal asthma treatment from those of asthma education, inhaled corticosteroid therapy was adjusted prior to randomization using peak‐flow monitoring. We agree that all patients received some degree of education during the run‐in period, as optimization of therapy itself requires interaction with the patient to document symptoms and adjust or change medication if necessary, an inherently educational process. Although the control group received more than the usual care treatment, there were marked differences between control and educated patients, as none of the patients from Group C received the book Understand and Control Asthma, none were given a written action plan, and none took part in a structured educational program. Finally, none of these patients had a peak‐flow meter at home after completion of the run‐in period. Apart from physician's recommendations, no reinforcement was given by the specialized educator with regard to compliance in patients in Group C. Enrolled in this study were patients with moderate to severe asthma (daily respiratory symptoms) who required chronic use of inhaled corticosteroids to maintain good control of their illness. We did not select a very high‐risk group of patients: these subjects did not have socioeconomic problems, nor had they had several visits to the emergency room or hospitalizations related to asthma in the year prior to enrollment. Previous studies have already shown that asthma morbidity can be decreased by education in these specific subgroups of patients. The results of our study do not rule out the possibility that education could decrease asthma morbidity under other circumstances. Indeed, this study was conducted in a tertiary care setting by asthma specialists, and had we conducted this study in patients with less optimal care or in high‐risk populations, we might have obtained different results. Furthermore, referring the patient to a specialized asthma educator may help physicians to complete the educational interventions, sometimes difficult to provide in a busy clinic. In order to assess compliance with treatment, we supplied the medication at no charge throughout the study. As inhaled corticosteroids are expensive, some patients, particularly those receiving high dosages, cannot afford this treatment. Had the asthmatic subjects paid for their own medication, it is possible that compliance with treatment would have been lower among control patients than among patients from the two educated groups, and this might have biased the outcome of the control group." |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) WEIGHT OF USED CANISTERS ‐ Blinding information not provided |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) DAYS LOST FROM WORK OR SCHOOL ‐ Insufficient information about blinding provided |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) WEIGHT OF USED CANISTERS ‐ Although it states that canisters were weighed without patients knowing, the patient was still asked to bring in the canister. Any blinding could have been broken due to the nature of the intervention |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) DAYS LOST FROM WORK OR SCHOOL ‐ subjective measure; blinding could have been broken due to the nature of the intervention |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) WEIGHT OF USED CANISTERS ‐ Blinding information not provided |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) DAYS LOST FROM WORK OR SCHOOL ‐ Insufficient information about blinding provided |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) WEIGHT OF USED CANISTERS ‐ Dropouts/missing information accounted for. Missing outcomes not enough to have an impact on the effect size |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) DAYS LOST FROM WORK OR SCHOOL ‐ incomplete data are accounted for |
