Rydman 1999.
| Study characteristics | ||
| Methods |
Design: single‐blind parallel‐group randomised controlled trial Duration: 8 to 20 weeks Setting: 1 inner city asthma clinic, part of Cook County Hospital, Illinois Trial registration: not reported |
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| Participants |
Population: 68 people with asthma randomised to face‐to‐face verbal training + demonstration (n = 36) or written training (package insert) (n = 32) Age: mean (SD) age in the intervention group 49.5 (16.5) years, and in the control group 43.6 (13.5) years Baseline asthma severity: baseline FEV1 (SD) (L) in the intervention group 2.18 (0.95), and in the control group 2.05 (0.75) Inclusion criteria: diagnosed, stable asthmatic patients who had been in the Pulmonary/Asthma clinic for 6 months Exclusion criteria: missed more than 25% of appointments in the previous 6 months, had an ED visit in the month before entry or 2 or more visits in the prior 6 months, taking more than 10 mg of oral prednisolone daily or 30 mg every other day, unable to read or understand English Percentage withdrawn: 11% of participants withdrew from the intervention arm, and 13% from the control arm Other allowed medication: All participants had access to albuterol in an MDI and pirbuterol in BAI |
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| Interventions |
Intervention summary: Experimental group received verbal instructions and demonstration on breath actuated inhaler technique. Participants were asked to demonstrate their inhalation technique to the instructor, who counselled them until their technique was deemed proper. Also were given written instructions (package insert). Both experimental and control group participants demonstrated their MDI technique to the instructor upon enrolment (baseline MDI). The instructor then gave them a demonstration of MDI technique and counselled them on correct use of the MDI Control summary: Control group received written instruction only on breath actuated inhaler use. After receiving instructions, participants also demonstrated their technique to the instructor, who did not correct them or give feedback if incorrect. Both experimental and control group participants demonstrated their MDI technique to the instructor upon enrolment (baseline MDI). The instructor then gave them a demonstration of MDI technique and counselled them on correct use of the MDI |
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| Outcomes |
Outcomes measured: BAI and MDI competency Technique assessment method used: Scoring was based on competency features repeated in scientific literature. Participants had to complete all steps successfully for each of the respective inhalers to be given a score of 1. If any steps were missed, participants were given an overall score of zero for that inhaler technique |
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| Notes |
Type of publication: single peer‐reviewed journal article Funding: funded in part by a grant from 3M Pharmaceuticals, St. Paul, Minnesota, USA |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomized either to an experimental group or control group in order to evaluate two different teaching methods" ‐ no further details (although randomisation reported to be 'successful' owing to lack of baseline imbalance) |
| 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 | "Patients demonstrated their BAI and MDI techniques to an independent physician who was blinded as to their group assignment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 68 participants were randomised (36 and 32 in experimental and control groups) and 60 were included in the analyses (32 and 28). Hence, 4 participants dropped out of each group, which was 11.1% and 12.5% drop‐out in intervention and control groups. These people were not included in the analysis, but drop‐out was low and balanced |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified, although all outcomes listed in Methods reported |
| Other bias | Low risk | None noted |