PMID- 29691998
OWN - NLM
STAT- MEDLINE
DCOM- 20191014
LR  - 20191210
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Linking)
VI  - 71
IP  - 2
DP  - 2019 Feb
TI  - A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in 
      Rheumatology 3x3 Methodology Applied to Two Active Comparator Trials.
PG  - 319-322
LID - 10.1002/acr.23590 [doi]
AB  - OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) 3x3 method analyzes the 
      occurrence of benefit and harm simultaneously at the individual patient level. We 
      applied this method to 2 recent rheumatoid arthritis (RA) trial data sets. 
      METHODS: The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) and the 
      Rheumatoid Arthritis Comparison of Active Therapies (RACAT) randomized trial 
      outcomes for safety were defined according to OMERACT as having no adverse events 
      (AEs), non-serious AEs, and serious AEs. Treatment efficacy was defined as good, 
      moderate, or no response. A good treatment response without any AEs was labeled 
      an unqualified success, and no treatment response but at least 1 AE was 
      considered an unmitigated failure. The association between benefit and harm was 
      assessed by chi-square or exact tests, as appropriate. RESULTS: In TEAR, 612 of 
      755 patients had response data at 48 weeks: 14% of patients experienced 
      unqualified success and 9% had unmitigated failure, with no difference between 
      the treatment arms. Treatment response and AE rates were not correlated. In 
      RACAT, 309 of 353 patients had response data at 48 weeks: 6% of patients 
      experienced unqualified success and 11% had unmitigated failure, with no 
      differences between the treatment arms. Response and AE rates were negatively 
      correlated. The frequency of AEs and serious AEs increased as response decreased 
      (P = 0.008). CONCLUSION: We found some evidence that clinical response may be 
      reduced by the co-occurrence of AEs.
CI  - (c) 2018 American College of Rheumatology.
FAU - Boers, Maarten
AU  - Boers M
AUID- ORCID: 0000-0002-6969-283X
AD  - VU University Medical Center, Amsterdam, The Netherlands.
FAU - Singh, Jasvinder A
AU  - Singh JA
AUID- ORCID: 0000-0003-3485-0006
AD  - University of Alabama at Birmingham and Birmingham VA Medical Center, Birmingham, 
      and Mayo Clinic College of Medicine, Rochester, Minnesota.
FAU - Cofield, Stacey S
AU  - Cofield SS
AD  - University of Alabama at Birmingham.
FAU - Bridges, S Louis Jr
AU  - Bridges SL Jr
AUID- ORCID: 0000-0003-3785-1389
AD  - University of Alabama at Birmingham.
FAU - Moreland, Larry W
AU  - Moreland LW
AD  - University of Pittsburgh, Pittsburgh, Pennsylvania.
FAU - O'Dell, James R
AU  - O'Dell JR
AD  - University of Nebraska Medical Center, Omaha.
FAU - Wu, Hongsheng
AU  - Wu H
AD  - Boston VA Medical Center, Boston, Massachusetts.
FAU - Leatherman, Sarah
AU  - Leatherman S
AD  - Boston VA Medical Center, Boston, Massachusetts.
FAU - Curtis, Jeffrey R
AU  - Curtis JR
AUID- ORCID: 0000-0002-8907-8976
AD  - University of Alabama at Birmingham.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190110
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Antirheumatic Agents/*administration & dosage
MH  - Arthritis, Rheumatoid/*diagnosis/*drug therapy/epidemiology
MH  - Drug Therapy, Combination
MH  - *Harm Reduction
MH  - Humans
MH  - Outcome Assessment, Health Care/*methods
MH  - Rheumatology/*methods
MH  - Treatment Outcome
EDAT- 2018/04/25 06:00
MHDA- 2019/10/15 06:00
CRDT- 2018/04/26 06:00
PHST- 2018/01/12 00:00 [received]
PHST- 2018/04/17 00:00 [accepted]
PHST- 2018/04/25 06:00 [pubmed]
PHST- 2019/10/15 06:00 [medline]
PHST- 2018/04/26 06:00 [entrez]
AID - 10.1002/acr.23590 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2019 Feb;71(2):319-322. doi: 10.1002/acr.23590. 
      Epub 2019 Jan 10.