PMID- 21348950
OWN - NLM
STAT- MEDLINE
DCOM- 20110606
LR  - 20220409
IS  - 1752-8062 (Electronic)
IS  - 1752-8054 (Print)
IS  - 1752-8054 (Linking)
VI  - 4
IP  - 1
DP  - 2011 Feb
TI  - Random treatment assignment using mathematical equipoise for comparative 
      effectiveness trials.
PG  - 10-6
LID - 10.1111/j.1752-8062.2010.00253.x [doi]
AB  - In controlled clinical trials, random assignment of treatment is appropriate only 
      when there is equipoise, that is, no clear preference among treatment options. 
      However, even when equipoise appears absent because prior trials show, on 
      average, one treatment yields superior outcomes, random assignment still may be 
      appropriate for some patients and circumstances. In such cases, enrollment into 
      trials may be assisted by real-time patient-specific predictions of treatment 
      outcomes, to determine whether there is equipoise to justify randomization. The 
      percutaneous coronary intervention thrombolytic predictive instrument (PCI-TPI) 
      computes probabilities of 30-day mortality for patients having ST elevation 
      myocardial infarction (STEMI), if treated with thrombolytic therapy (TT), and if 
      treated with PCI. We estimated uncertainty around differences in their respective 
      predicted benefits using the estimated uncertainty of the model coefficients. 
      Using the 2,781-patient PCI-TPI development dataset, we evaluated the 
      distribution of predicted benefits for each patient. For three typical clinical 
      situations, randomization was potentially warranted for 70%, 93%, and 80% of 
      patients. Predictive models may allow real-time patient-specific determination of 
      whether there is equipoise that justifies trial enrollment for a given patient. 
      This approach may have utility for comparative effectiveness trials and for 
      application of trial results to clinical practice.
CI  - (c) 2011 Wiley Periodicals, Inc.
FAU - Selker, Harry P
AU  - Selker HP
AD  - Institute for Clinical Research and Health Policy Studies, Tufts Medical Center 
      and Tufts University School of Medicine, Tufts Clinical and Translational Science 
      Institute, Tufts University, Boston, Massachusetts, USA. 
      hselker@tuftsmedicalcenter.org
FAU - Ruthazer, Robin
AU  - Ruthazer R
FAU - Terrin, Norma
AU  - Terrin N
FAU - Griffith, John L
AU  - Griffith JL
FAU - Concannon, Thomas
AU  - Concannon T
FAU - Kent, David M
AU  - Kent DM
LA  - eng
GR  - KL2 RR025751/RR/NCRR NIH HHS/United States
GR  - KL 2RR025751-01A1/RR/NCRR NIH HHS/United States
GR  - R01 HS010280/HS/AHRQ HHS/United States
GR  - R01 HS 10280/HS/AHRQ HHS/United States
GR  - U01 HL077821/HL/NHLBI NIH HHS/United States
GR  - UL1 RR025752/RR/NCRR NIH HHS/United States
GR  - UL1 RR025752-01/RR/NCRR NIH HHS/United States
GR  - U01 HL077821-01/HL/NHLBI NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Transl Sci
JT  - Clinical and translational science
JID - 101474067
SB  - IM
MH  - Angioplasty, Balloon, Coronary
MH  - Comparative Effectiveness Research/*methods
MH  - Humans
MH  - Myocardial Infarction/mortality/therapy
MH  - Random Allocation
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Survival Analysis
MH  - *Therapeutic Equipoise
PMC - PMC3076795
MID - NIHMS261373
EDAT- 2011/02/26 06:00
MHDA- 2011/06/07 06:00
PMCR- 2011/02/01
CRDT- 2011/02/26 06:00
PHST- 2011/02/26 06:00 [entrez]
PHST- 2011/02/26 06:00 [pubmed]
PHST- 2011/06/07 06:00 [medline]
PHST- 2011/02/01 00:00 [pmc-release]
AID - CTS253 [pii]
AID - 10.1111/j.1752-8062.2010.00253.x [doi]
PST - ppublish
SO  - Clin Transl Sci. 2011 Feb;4(1):10-6. doi: 10.1111/j.1752-8062.2010.00253.x.