[Summary text]
Skal allergen-specifik immunterapi bruges til behandling af allergisk rhinoconjunctivitis udløst af husstøvmider hos patienter, der ikke er symptomfrie på antihistamin og nasalsteriod?
Symptomscore (kritisk)
Medicinscorer (kritisk)
Anafylaksi (kritisk)
Livskvalitet (vigtig)
Fraværsdage frs arbejde/skole (vigtig)
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label: YES
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: All patients had to have skin test positivity and serum sIgEonly to D.pt and/or D.f.
Excluded criteria: Patients with polysensitization toother aeroallergens, systemic immunological disorders,severe asthma with forced expiratory volume in 1 s(FEV1) o70%, severe atopic dermatitis and previous useof allergen immunotherapy were excluded from the trial.
Intervention Characteristics
Intervention
Control
Continuous:
Dichotomous:
Sponsorship source: This work was supported by The Marmara UniversityScientific Research Committee (BAPKO no. TIP/SAGTUS-140607-0114, 2007).
Country: Turkey
Setting:
Comments:
Authors name: A. O. Eifan
Institution: Division of Pediatric Allergy and Immunology, Marmara University Medical Faculty, Istanbul, Turkey
Email: a.eifan@imperial.ac.uk
Address: Aarif O. Eifan, Marmara UniversityMedical Faculty, Pediatric Allergy andClinical Immunology, Istanbul, Turkey
Identification:
Participants:
Study design:
Baseline characteristics:
Kirsten Skamstrup Hansen medication score seems to be both use of beta-2 agonist = asthma medication and antihistamines
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Adverse outcomes:
From ARIA Guideline
not RCT, retrospective design
Wrong comparator
Wrong intervention
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Wrong intervention
Wrong intervention
liquid allergen stalloral
Wrong comparator
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Wrong study design
Wrong intervention
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Wrong study design
Wrong intervention
Wrong study design
Wrong patient population
Wrong study design
Wrong intervention
Wrong intervention
Wrong patient population
Wrong study design
Observationel study
Wrong intervention
Wrong patient population
Wrong intervention
no full text article
Wrong intervention
Wrong intervention
Wrong comparator
Wrong comparator
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "Using a computer-generated randomization method, patients were randomized"
computer-generated random numbers.
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Comment: Not described
nor access to the randomization code, which was kept locked and sealed by a doctor not involved with the study. The code was only opened after all the data had been collected and were ready for statistical analysis.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Comment: Open la and outcome self-reported
The trial was performed as a double-blind, randomized, placebo-controlled study,
Detection bias due to knowledge of the allocated interventions by outcome assessors
Comment: Probably not outcome is self-reported.
ALK). The doctors carrying out the SIT had no knowledge of, nor access to the randomization code, which was kept locked and sealed by a doctor not involved with the study.
Attrition bias due to amount, nature or handling of incomplete outcome data
Comment: 2/16, 2/16 dropout in both groups. Equal dropout
There were dropouts early in the study, and date were insufficient on the subjects for an intention-to treat analysis. No flow chart.
Reporting bias due to selective outcome reporting
Comment: Described outcome seems assessed but no trial protocol.
No study protocol
Bias due to problems not covered elsewhere in the table