Turgeon 1996.
Study characteristics | ||
Methods |
Design: single‐blind parallel‐group randomised controlled trial Duration: 26 weeks Setting: 1 asthma clinic in a paediatric hospital, Canada Trial registration: not reported |
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Participants |
Population: 96 children and adolescents with asthma randomised to nurse training: interactive with feedback (n = 47) or nurse training: pictorial only (n = 49) Age: median (range) age in the intervention group was 4.5 (0.75 to 15) years, and in the control group 5.75 (0.75 to 15) years Baseline asthma severity: in the intervention group: 57% mild; 32% moderate; 11% severe asthma; in the control group: 55% mild; 35% moderate; 10% severe asthma Inclusion criteria: children between 1 and 18 years of age starting aerosol therapy for the first time Exclusion criteria: younger than 1 year or older than 18 years, previous teaching session of technique of aerosol administration, language other than French or English, if another member of the family suffered from asthma and was using inhalers Percentage withdrawn: 43% of participants withdrew from both intervention and control arms Other allowed medication: not reported |
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Interventions |
Intervention summary: Experimental participants received an interactive teaching session from the asthma clinic nurse that lasted about 15 minutes. Instruction was given with picture diagrams provided with inhalation devices by pharmaceutical companies. This was followed by interactive teaching consisting of immediate correction of faulty technique displayed by the child and/or parent. All participants received 2 teaching sessions at initial and 1‐month visits. Devices were MDIs with an Aerochamber, Nebuhaler or Venthaler and DPIs with Diskhaler or Turbuhaler Control summary: Control participants received instruction only by picture diagrams (didactic teaching) given by another nurse, who had no contact with the experimental group. All participants received 2 teaching sessions at initial and 1‐month visits |
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Outcomes |
Outcomes measured: technical ability in inhalation and Likert scales for parental perceptions of treatment at 1, 3 and 6 months (end of study); morbidity assessed at baseline and at 6 months; morbidity evaluated by a questionnaire derived from Beck et al, including number of asthma attacks, number of hospitalisations and duration of stay, number of ED visits, numbers of missed school days and disability days (unable to perform usual activities) Technique assessment method used: assessed by research assistant through direct observation of the child and/or parent administering a placebo aerosol. Score was calculated by using a checklist of essential steps of the technique ‐ 1 point for each correct step. Number of steps differed between devices, so scores were converted into percentages |
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Notes |
Type of publication: single peer‐reviewed journal article Funding: supported by the 'Fondation de l'Hopital Sainte‐Justine' through special funding from the Fonds de la Recherche en Sante de Quebec (FRSQ) and the Interservice Club Council (Telethon of Stars) granted to the Group in Evaluative, Clinical and Epidemiologic Research at the Ste‐Justine Hospital Research Center |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomised into experimental and control groups using a computer generated list of random numbers" |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No description of procedures intended to blind participants or personnel to group assignment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants were evaluated by a research assistant who was blind to the teaching assignment group at baseline and follow‐up visits, and inhalation technique assessed by this person was the main outcome reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | More than 40% dropped out from both arms; although they are reported to not differ significantly from those who completed in terms of baseline demographics, reason for drop ‐out is not given and no flow diagram is presented. No ITT analysis/adjustment for attrition is described |
Selective reporting (reporting bias) | High risk | No prospective trial registration identified. 'Morbidity indices' were collected during follow ‐up (e.g. number of attacks, hospitalisation and days of school missed) but were not fully reported, so could not be included in the meta‐analysis |
Other bias | Low risk | None noted |