Differences between observers in interpreting double-blind placebo-controlled food challenges: A randomized trial

作者：Brand Paul L P^*; Landzaat Berghuizen Marlouk A

来源：Pediatric Allergy and Immunology, 2014, 25(8): 755-759.

DOI：10.1111/pai.12313

• food allergy
• double-blind placebo-controlled food challenge
• priming

BackgroundInterpretation of double-blind placebo-controlled food challenges (DBPCFC) can be difficult, particularly with ambiguous subjective symptoms. Early opening of the challenge key (which day is verum and which placebo) may influence the clinician%26apos;s interpretation of the DBPCFC result. %26lt;br%26gt;MethodsFifty-one clinicians reviewing results of 19 DBPCFCs with ambiguous clinical symptoms were randomized into a key first strategy (opening the DBPCFC key before reviewing the symptoms on both challenge days and deciding on the DBPCFC result) or a symptoms first strategy (reviewing symptoms and interpreting both test days as positive or negative before opening the key and deciding on the DBPCFC result). %26lt;br%26gt;ResultsThe proportion of DBPCFCs considered inconclusive was comparable between the two strategy groups (p=0.791). Participants in the symptoms first group were more likely to consider a DBPCFC as positive (in 14 tests, 73.7%) than subjects in the key first group (four tests, 21.1%). The number of positive tests was higher in the symptoms first group (median 50.0%, interquartile range [IQR] 23.1-76.9%) than in the key first groups (44.0%, IQR 12.0-68.0%, p=0.031). This was independent of the participant%26apos;s profession (pediatrician or other), age, gender, or years of experience (p%26gt;0.3). %26lt;br%26gt;ConclusionsClinicians differ in their interpretation of DBPCFC results when symptoms are ambiguous. Opening the key of a DBPCFC before reviewing and interpreting symptoms significantly reduces the likelihood of the challenge being interpreted as positive. Guidelines for performing DBPCFCs should standardize the moment of opening the challenge key.

• 出版日期2014-12