Applying GRADE for diagnosis 55 2 Appendix 2. Characteristics of included studies Diagnostic accuracy Garcia Robaina, 2003 [1] First author Garcia Robaina Year of publication 2003 Journal International Archives of Allergy and Immunology Setting Tertiary care, Spain Study design Diagnostic accuracy study Study population 42 patients with positive skin tests to house dust mites, 31 females, mean age 21.7 years (SD: 7.02; range 11-38). 2 patients with asthma alone, 12 with rhinoconjunctivitis alone and 28 with rhinoconjunctivitis and asthma. Previously treated with antihistamines, corticosteroids and/or β-agonists. Clinical symptoms of house dust mite allergy. Index test Specific IgE to D.pteronyssinus Reference test Conjunctival challenge: 1 drop of increasing concentrations (0,1 HEP D.pteronyssinus/ml – 100 HEP/ml or positive reaction) of extract applied to the conjunctival sac. Saline solution as control in other eye. Positive test when erythema and pruritus of conjunctiva. Evaluation 20 min, 3 and 6 hrs after test. Performance of the index test True positives 31/32=97% False positives 0/32=0% False negatives 0/32=0% True negatives 1/32=3% Sensitivity 100.00% [31/31] (95%CI: 88.78-100.00) Note: Sensitivity was calculated by reviewers. Specificity 100.00% [1/1] (95%CI: 2.50-100.00) Note: Specificity was calculated by reviewers. Pre-test probability 31/32=97% Risk of bias (QUADAS-2) Domain 1: Patient selection A. Risk of bias Describe methods of patient selection See above Was a consecutive or random sample of patients enrolled? Yes/no/unclear Was a case-control design avoided? Yes/no/unclear (only patients with asthma and/or rhinoconjunctivitis included Did the study avoid inappropriate exclusions? Yes/no/unclear Could the selection of patients have introduced bias? RISK: LOW/HIGH/UNCLEAR B. Concerns regarding applicability Describe included patients (prior testing, intended use of index test and setting) Only patients with confirmed rhinoconjunctivitis or asthma were included. The IgE-test in this systematic review is intended to be used in patients suspected of having allergic rhinitis Is there concern that the included patients do not match the review question? CONCERN: LOW/HIGH/UNCLEAR Domain 2: Index test A. Risk of bias Describe the index test and how it was conducted and interpreted See above
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