Bynum 2001.
Study characteristics | ||
Methods |
Design: parallel‐group randomised controlled trial; blinding not stated Duration: 4 weeks Setting: recruited from rural junior high and high schools in southeastern Arkansas. Intervention delivered in health clinics in USA Trial registration: |
|
Participants |
Population: 49 adolescents with asthma randomised to tele‐pharmacy counselling (n = 24) or written instructions only (n = 25) (control) Age: across both groups: 12 to 14 years = 43%, 15 to 17 years = 50%, 18 to 19 years = 7% Baseline asthma severity: not reported Inclusion criteria: diagnosis of asthma, previous MDI use, male or female adolescents in grades 7 to 12, access to a local health clinic with interactive compressed video equipment Exclusion criteria: not reported Percentage withdrawn: 38% of participants withdrew from the intervention group, and 12% from the control group Other allowed medication: not reported |
|
Interventions |
Intervention summary: Participants in the tele‐pharmacy counselling group demonstrated MDI technique at baseline (pretest) during the first session. A pharmacist scored each performance using the MDI Technique Checklist. Participants received counselling that included verbal instructions and demonstrations by the pharmacist of any needed corrections to their MDI technique. Reassessment for MDI technique immediately followed counselling (post test). MDI technique was assessed a third time 2 to 4 weeks later (follow‐up). After the final assessment session, additional counselling by the pharmacist was provided for participants who needed corrections to their MDI technique or for those who had specific questions about asthma Control summary: The control group also demonstrated pretest, post‐test and follow‐up MDI technique. After completing the pretest assessment, this group received the "Patient’s Instructions for Use of the Metered‐Dose Inhaler" with written instructions for use of the MDI on a package insert provided with their placebo inhaler. These written instructions were reproduced from a patient inhaler package insert that included diagrams demonstrating proper MDI technique and instructions printed in small type. Counselling on correct MDI technique was not provided by the pharmacist during this assessment period. After reviewing the inhaler package insert, participants were immediately reassessed for MDI technique by the pharmacist. After completion of the final assessment, verbal instructions and demonstrations by the pharmacist were given to correct improper MDI technique. Participants in the control group were asked if they had any questions about asthma at this final session and were instructed accordingly |
|
Outcomes |
Outcomes measured: MDI inhaler technique, patient satisfaction with intervention measured using a "Telepharmacy Metered‐Dose Inhaler Technique Evaluation instrument" (not previously validated) Technique assessment method used: MDI Technique Checklist (validated) evaluated 8 skills for proper MDI technique, including preparation of inhaler equipment, position of the mouth on the inhaler mouthpiece and breathing techniques. Maximum score = 8 |
|
Notes |
Type of publication: single peer‐reviewed journal article Funding: funded by a grant from the Office for the Advancement of Telehealth in the Department of Health Resources and Services Administration |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | '"The participants in the study were assigned to either a tele‐pharmacy counselling group or a control group using a random number chart" |
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 | High risk | No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique may be at risk of detection bias |
Incomplete outcome data (attrition bias) All outcomes | High risk | Unbalanced drop‐out (38% in the intervention group and 12% in the control group) may have introduced bias. In addition, no flow diagram was presented, and reasons for drop‐out were not given, apart from 8 participants who were excluded as they had never used an MDI ("Three students did not attend any visit, 8 students had never used an MDI in the past (and, therefore, did not meet the inclusion criteria), and 2 students did not attend the follow‐up visit for comparison") |
Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper |
Other bias | Low risk | None noted |