| Methods |
Design: five period cross‐over trial
Purpose: examine the effect of trachea‐noise biofeedback in asthma |
| Participants |
Patients: 'asthmatics were recruited with informed consent'
Baseline comparability: not relevant |
| Interventions |
Placebo: inhaled saline
Type of untreated: no inhalation or biofeedback
Type of experimental:
‐salbutamol inhalation
‐biofeedback wrong information
‐biofeedback correct information
(Co‐intervention: no asthma medication) |
| Outcomes |
Forced expiratory volume after 1 second (FEV1) |
| Notes |
Relevant outcome data not accessible |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'...the active and placebo bronchodilator inhaler given double blind..' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Relevant outcome data not accessible |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 16 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
