PMID- 27919315
OWN - NLM
STAT- MEDLINE
DCOM- 20170710
LR  - 20170713
IS  - 1471-6348 (Electronic)
IS  - 0266-4623 (Linking)
VI  - 32
IP  - 6
DP  - 2016 Jan
TI  - IMPLICATION OF ALTERNATIVE MINIMAL CLINICALLY IMPORTANT DIFFERENCE THRESHOLD 
      ESTIMATION METHODS ON TECHNOLOGY ASSESSMENT.
PG  - 371-375
LID - 10.1017/S0266462316000593 [doi]
AB  - OBJECTIVES: 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. CONCLUSION: 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.
FAU - Brixner, Diana
AU  - Brixner D
AD  - Department of Pharmacotherapy,University of Utahdiana.brixner@utah.edu.
FAU - Meltzer, Eli O
AU  - Meltzer EO
AD  - Allergy & Asthma Medical Group & Research Center.
FAU - Morland, Kellie
AU  - Morland K
AD  - Xcenda,LLC.
FAU - Carroll, Cathryn A
AU  - Carroll CA
AD  - Xcenda,LLC.
FAU - Munzel, Ullrich
AU  - Munzel U
AD  - MEDA Pharma GmbH.
FAU - Lipworth, Brian J
AU  - Lipworth BJ
AD  - Institute of Health and Wellness,University of Glasgow.
LA  - eng
PT  - Journal Article
DEP - 20161206
PL  - England
TA  - Int J Technol Assess Health Care
JT  - International journal of technology assessment in health care
JID - 8508113
RN  - 0 (Androstadienes)
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Phthalazines)
RN  - 0 (Pregnenediones)
RN  - JS86977WNV (fluticasone furoate)
RN  - S59502J185 (ciclesonide)
RN  - ZQI909440X (azelastine)
SB  - IM
MH  - Androstadienes/therapeutic use
MH  - Anti-Allergic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - *Minimal Clinically Important Difference
MH  - Phthalazines/therapeutic use
MH  - Pregnenediones/therapeutic use
MH  - Rhinitis, Allergic, Seasonal/*drug therapy
MH  - Technology Assessment, Biomedical/*methods
OTO - NOTNLM
OT  - Intranasal combination
OT  - Intranasal corticosteroid
OT  - Outcome assessment
OT  - Seasonal allergic rhinitis
OT  - Treatment outcome
EDAT- 2016/12/07 06:00
MHDA- 2017/07/14 06:00
CRDT- 2016/12/07 06:00
PHST- 2016/12/07 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
PHST- 2016/12/07 06:00 [entrez]
AID - S0266462316000593 [pii]
AID - 10.1017/S0266462316000593 [doi]
PST - ppublish
SO  - Int J Technol Assess Health Care. 2016 Jan;32(6):371-375. doi: 
      10.1017/S0266462316000593. Epub 2016 Dec 6.