| Methods |
The parents of the 60 children were randomized consecutively in groups of 4 to either the intervention or the control group by the nurses. This resulted in 32 children in the intervention group and 28 children in the control group. The 3 doctors that were involved in the group sessions also performed the follow‐up visits. Blinding could not be completed since the intervention was led by their physicians |
| Participants |
Patients were 60 children aged between 3 months to 6 years and had been given a diagnosis of asthma in the region, 1 to 2 months earlier. Asthma was defined by 3 or more episodes of wheezing before 2 years of age, or the first wheezing episode after the age of 2, or the first episode of wheezing in a child with other atopic diseases. The patients also had fulfilled the following criteria implying high risk for permanent asthma: wheezing without symptoms of upper respiratory tract infection (URTI) and/or proven allergy and/or atopic heredity |
| Interventions |
The intervention consisted of meetings in a group setting with the parents. The sessions took place in the afternoon and lasted about 1.5 hours. Shortly after the children were diagnosed as an asthmatic, 3 meetings (one every week for 3 weeks) took place and a follow‐up meeting took place 6 months later. 3 pediatricians, 3 nurses and 2 psychologists were involved in these sessions: one nurse was present on all occasions, and the doctors and psychologists on 3 each. The goal of all the meetings was to reach the parents' "main worry" and, apart from teaching about asthma, the following key question was asked: "What is asthma to you?" The use of dialogue and peer education, whereby the group was encouraged to share personal experiences was emphasized. The control group, as well as the intervention group, received basic education about asthma and its treatment, including how to use the Nebunette, and information on environmental control at the first visit to the clinic. They received a written treatment plan where the principle was high dose (0.2 mg x 4 of budesonide for 3 days) initially and then, in association with URTI, stepping down the therapy to the lowest possible dose according to the status of the child. The treatment was stopped if the child had no asthma for 6 months |
| Outcomes |
Compliance was measured in the following ways: 1) parents and doctors estimated adherence on a visual analog scale (VAS) at inclusion, at 6 months, and after 18 months; 2) adherence was measured between the 12‐ and 18‐month follow‐up visits using a diary in which the parents recorded the consumption of medicines, asthma symptoms, and other illnesses; 3) all the Metered Dose Inhalers (MDIs) with budesonide used during this period were weighed and the real consumption was estimated; and 4) the adherence according to parents was calculated as the number of doses given according to the diaries/the number of doses prescribed * 100. The verified adherence was defined as the real number of doses/the number of doses prescribed * 100. The verified adherence was considered acceptable if the index was 50 to 150 and poor if the index was <50
The following clinical outcomes were assessed: 1) parents estimated their children's asthma problems during the last 6 months, after 6 months and after 18 months on another VAS; 2) 3 doctors classified the children according to GINA guidelines including medication in 4 groups: mild, moderate, rather severe, and severe at inclusion, after 6 months and after 18 months; 3) during the first 6 and last 6 months of the 18‐month‐long study, the parents noted how many days the child was hospitalized and how many times they had to seek emergency help due to asthma; and 4) frequency of exacerbations, defined by the need for parents to stay at home to take care of their child due to asthma symptoms |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
(pg 603) "The parents of the 60 children were randomized consecutively in groups of four to either the intervention or the control group." No mention of random sequence generation process |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information provided; no mention of allocation concealment (pg 603) "The parents of the 60 children were randomized consecutively in groups of four to either the intervention or the control group." |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information provided. No protocol was found |
| Other bias |
Unclear risk |
No other obvious risks of bias and no limitation section of the paper to consult |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ (pg 603) The nurses carried out the randomization and the 3 doctors that were involved in the group sessions also performed the follow‐up visits. Therefore, a complete blinding procedure could not be established |
| Blinding of outcome assessment (detection bias)
Patient outcome |
High risk |
(PRIMARY) HOSPITALIZATIONS ‐ (pg 603) The nurses carried out the randomization and the 3 doctors that were involved in the group sessions also performed the follow‐up visits. Therefore, a complete blinding procedure could not be established |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ (pg 603) The nurses carried out the randomization and the 3 doctors that were involved in the group sessions also performed the follow‐up visits. Therefore, a complete blinding procedure could not be established |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) HOSPITALIZATIONS ‐ (pg 603) The nurses carried out the randomization and the 3 doctors that were involved in the group sessions also performed the follow‐up visits. Therefore, a complete blinding procedure could not be established |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ (pg 603) The nurses carried out the randomization and the 3 doctors that were involved in the group sessions also performed the follow‐up visits. Therefore, a complete blinding procedure could not be established |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) HOSPITALIZATIONS ‐ (pg 603) The nurses carried out the randomization and the 3 doctors that were involved in the group sessions also performed the follow‐up visits. Therefore, a complete blinding procedure could not be established |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ Reasons for missing data. (pg 605) "All families included were evaluated after 6 mo. After 18 mo, 29 of 32 in the intervention group and 24 of 28 in the control group were followed up. The dropouts in the control group consisted of a family who moved away after 6 mo. One girl was diagnosed as suffering from cystic fibrosis and left the study after 1 y. Another two families dropped out between the 12‐ and 18‐mo follow‐ups. In the intervention group, the parents of one girl did not visit any group session, another girl was diagnosed as ciliary dysfunction and yet another girl did not return for the 18‐mo control. The follow‐up rate was thus 86% in the control group, 91% in the intervention group and 88% for the total cohort after 18 mo. After 12 mo, 55 children remained in the study, but three of them used other nebulizers or types of steroids than those recommended. Thus, 52 children entered the 6‐mo adherence study. Four children did not need any inhaled steroids during the last 6 mo of the study, and the diaries for two patients were missing. The follow‐up rate for adherence data is thus 85%." Missing data have been accounted for |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) HOSPITALIZATIONS ‐ Groups slightly unbalanced for incomplete data ‐ not sure how this impacts the outcomes |
