Methods |
Design: three group parallel trial
Purpose: examine whether patients with allergic rhinitis would have lower or higher symptom scores depending upon the presence of asthma |
Participants |
Patients: out‐patients with allergic, ragweed rhinitis
Baseline comparability: NS |
Interventions |
Placebo: injections without ragweed (caramelised glucose)
Untreated: no injections
Experimental: injections with polymerised ragweed (Co‐intervention: histamine, dosage part of composite outcome score) |
Outcomes |
Rhinitis symptom‐medication scores (sneeze, nasal congestion, histamine medication) |
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 |
Unclear risk |
NS |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
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 = 31 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |