title: IMPLICATION OF ALTERNATIVE MINIMAL CLINICALLY IMPORTANT DIFFERENCE THRESHOLD ESTIMATION METHODS ON TECHNOLOGY ASSESSMENT.
abstract: OBJECTIVE
  Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA).
  
  
  METHODS
  Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information. Treatment effects were then compared with anchor-based MCID thresholds derived by Barnes et al. and thresholds obtained from an Agency for Healthcare Research and Quality (AHRQ) panel.
  
  
  RESULTS
  The change in rTNSS score from baseline, represented as the average of the twice-daily recorded scores of the rTNSS, was -2.1 (p < .001) for azelastine hydrochloride 0.10%, 1.35 (p = .014) for ciclesonide, and -1.47 (p < .001) for fluticasone furoate. The change in the rTNSS score from baseline, represented by sum of the AM and PM score, was -2.7 for MP-AzeFlu (p < .001). The rTNSS change from baseline for each product was compared with anchor-based MCID threshold and the AHRQ panel estimates. Comparison of the observed treatment effect to the anchor-based and AHRQ panel MCID thresholds results in different conclusions, with clinically important differences being inferred when anchor-based estimates serve as the reference point.
  
  
  CONCLUSIONS
  The AHRQ panel MCID threshold for the rTNSS was twelve times larger than the anchor-based estimates resulting in conflicting recommendations on whether different SAR treatments provide clinically meaningful benefit.
authors.affiliation: Department of Pharmacotherapy,University of Utahdiana.brixner@utah.edu.
authors.forename: Diana
authors.initials: D
authors.lastname: Brixner
authors.affiliation: Allergy & Asthma Medical Group & Research Center.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.affiliation: Xcenda,LLC.
authors.forename: Kellie
authors.initials: K
authors.lastname: Morland
authors.affiliation: Xcenda,LLC.
authors.forename: Cathryn A
authors.initials: CA
authors.lastname: Carroll
authors.affiliation: MEDA Pharma GmbH.
authors.forename: Ullrich
authors.initials: U
authors.lastname: Munzel
authors.affiliation: Institute of Health and Wellness,University of Glasgow.
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Lipworth
mesh_terms: D000730:Androstadienes / Q000627:therapeutic use; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000071081:Minimal Clinically Important Difference; D010793:Phthalazines / Q000627:therapeutic use; D011282:Pregnenediones / Q000627:therapeutic use; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013673:Technology Assessment, Biomedical / Q000379:methods*
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D010793:Phthalazines; D011282:Pregnenediones; C523187:fluticasone furoate; C120481:ciclesonide; C020976:azelastine
keywords: Intranasal combination; Intranasal corticosteroid; Outcome assessment; Seasonal allergic rhinitis; Treatment outcome