Applying GRADE for diagnosis 59 2 Describe the time interval and any interventions between index test(s) and reference standard No timeline was described in the manuscript; probably no concerns Was there an appropriate interval between index test(s) and reference standard? No timeline was described in the manuscript; probably no concerns Did all patients receive a reference standard? Yes/no/unclear Did patients receive the same reference standard? Yes/no/unclear Were all patients included in the analysis? Yes/no/unclear Could the patient flow have introduced bias? RISK: LOW/HIGH/UNCLEAR Since excluded patients were not mentioned King, 2008 [3] First author King Year of publication 2008 Journal Annals of Allergy, Asthma & Immunology Setting Secondary care, USA Study design Diagnostic accuracy study Study population 28 older (≥60; mean: 67.8y, 11 female), 20 younger (20-59; mean: 34.1, 14 female) patients with suspected perennial allergic rhinitis with or without allergic asthma. Perennial rhinitis was defined as symptoms during most of the year for at least 1 year. Patients were referred to hospital or allergy clinics. Index test Specific IgE to D.pteronyssinus in kUA/L. Positive test: sIgE ≥ 0.35 kUA/L Reference test Baseline peak nasal inspiratory flow (PNIF) and symptom scores. Nasal challenge with increasing concentrations D.pteronyssinus (0.1, 10, 100, 1000 AU/mL) at 30 min. intervals. PNIF and symptoms (runny nose, nasal congestion, sneezing, itchy nose, itchy/gritty eyes, runny/watery eyes, red/burning eyes, ear/palate itch) scores (scores 0-3, max. total 24). Positive test: doubling of symptom scores to a minimum postchallenge score of 10, PNIF decline ≥50%, failure to return within 20% of baseline PNIF after challenge. Performance of the index test True positives 11/43=26% False positives 5/43=12% False negatives 2/43=5% True negatives 25/43=58% Sensitivity 84.62% [11/13] (95%CI: 54.55-98.08) Specificity 83.33% [25/30] (95%CI: 65.28-94.36) Pre-test probability 13/43=30% Risk of bias (QUADAS-2) Domain 1: Patient selection A. Risk of bias Describe methods of patient selection Suspected clinical diagnosis of perennial allergic rhinitis, with or without asthma, age 20-59 or ≥60 yrs. Symptoms during most of the year ≥1 yr. Exclusion criteria: skin disease at place of skin tests, use of β-blockers, cigarette smoking, systemic diseases, pregnancy/lactation, nude sunbathing ≥30 days, immunotherapy in the last year, antihistamines/nasal
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