PMID- 27084419 OWN - NLM STAT- MEDLINE DCOM- 20171026 LR - 20220321 IS - 2213-2201 (Electronic) VI - 4 IP - 4 DP - 2016 Jul-Aug TI - Minimal Clinically Important Difference (MCID) in Allergic Rhinitis: Agency for Healthcare Research and Quality or Anchor-Based Thresholds? PG - 682-688.e6 LID - S2213-2198(16)00056-8 [pii] LID - 10.1016/j.jaip.2016.02.006 [doi] AB - BACKGROUND: In 2013, the Agency for Healthcare Research and Quality (AHRQ) recommended that allergic rhinitis (AR) studies calculate a minimal clinically important difference (MCID) based on an estimated threshold equal to 30% of the maximum total nasal symptom score. Applying this threshold, their data showed no differences between well-established treatments, and a subsequent analysis using prescribing information found no differences between active treatments and placebo controls. OBJECTIVE: The objective of this study was to demonstrate the application of an evidence-based model to determine MCIDs for AR studies, with an absolute value for an anchor-based threshold and validated methods for calculating distribution-based thresholds. METHODS: Using the same studies as the AHRQ report, anchor- and distribution-based MCID thresholds were determined for 3 clinical comparisons identified by the AHRQ: (1) oral antihistamine+intranasal corticosteroid (INCS) versus INCS, (2) montelukast versus INCS, and (3) intranasal antihistamine+INCS in a single device versus the monotherapies. The outcomes were compared with those reported using the AHRQ threshold. RESULTS: No treatment comparison met the AHRQ-defined MCID threshold; all treatments were determined to be equivalent for all 3 queries. In contrast, the evidence-based model revealed some differences between treatments: INCS > montelukast; intranasal antihistamine+INCS > either monotherapy. No clinically relevant benefit was observed for adding an oral antihistamine to INCS, but some studies were not optimal choices for quantitative determination of MCIDs. Updating the literature search revealed no additional studies that met the AHRQ inclusion criteria. CONCLUSIONS: The evidence-based threshold for MCID determination for AR studies should supersede the threshold recommended in the AHRQ report. CI - Copyright (c) 2016 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Meltzer, Eli O AU - Meltzer EO AD - Division of Immunology and Allergy, Department of Pediatrics, University of California San Diego School of Medicine, San Diego, Calif; Allergy and Asthma Medical Group and Research Center, San Diego, Calif. Electronic address: eliomeltzer@gmail.com. FAU - Wallace, Dana AU - Wallace D AD - Florida Center for Allergy and Asthma Control, Nova Southeastern University College of Health Professions, Fort Lauderdale, Fla. FAU - Dykewicz, Mark AU - Dykewicz M AD - Section of Allergy and Immunology, Department of Internal Medicine, Saint Louis University School of Medicine, St. Louis, Mo. FAU - Shneyer, Lucy AU - Shneyer L AD - Shneyer Statistics LLC, Denville, NJ. LA - eng PT - Journal Article DEP - 20160412 PL - United States TA - J Allergy Clin Immunol Pract JT - The journal of allergy and clinical immunology. In practice JID - 101597220 RN - 0 (Acetates) RN - 0 (Adrenal Cortex Hormones) RN - 0 (Cyclopropanes) RN - 0 (Histamine Antagonists) RN - 0 (Quinolines) RN - 0 (Sulfides) RN - MHM278SD3E (montelukast) SB - IM CIN - J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):689-90. PMID: 27393780 MH - Acetates/therapeutic use MH - Adrenal Cortex Hormones/therapeutic use MH - Cyclopropanes MH - Evidence-Based Medicine MH - Government Agencies MH - Histamine Antagonists/therapeutic use MH - Humans MH - *Minimal Clinically Important Difference MH - Quinolines/therapeutic use MH - Rhinitis, Allergic/*drug therapy MH - Sulfides MH - United States OTO - NOTNLM OT - Allergic rhinitis OT - Intranasal antihistamine OT - Intranasal corticosteroid OT - Leukotriene receptor antagonist OT - Minimal clinically important difference (MCID) OT - Oral antihistamine OT - Seasonal allergic rhinitis (SAR) OT - Total nasal symptom score (TNSS) EDAT- 2016/04/17 06:00 MHDA- 2017/10/27 06:00 CRDT- 2016/04/17 06:00 PHST- 2015/10/19 00:00 [received] PHST- 2016/01/19 00:00 [revised] PHST- 2016/02/17 00:00 [accepted] PHST- 2016/04/17 06:00 [entrez] PHST- 2016/04/17 06:00 [pubmed] PHST- 2017/10/27 06:00 [medline] AID - S2213-2198(16)00056-8 [pii] AID - 10.1016/j.jaip.2016.02.006 [doi] PST - ppublish SO - J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):682-688.e6. doi: 10.1016/j.jaip.2016.02.006. Epub 2016 Apr 12.