PMID- 20230550
OWN - NLM
STAT- MEDLINE
DCOM- 20100920
LR  - 20140730
IS  - 1524-4733 (Electronic)
IS  - 1098-3015 (Linking)
VI  - 13
IP  - 4
DP  - 2010 Jun-Jul
TI  - Quantifying women's stated benefit-risk trade-off preferences for IBS treatment 
      outcomes.
PG  - 418-23
LID - 10.1111/j.1524-4733.2010.00694.x [doi]
AB  - BACKGROUND: The Food and Drug Administration, currently, is exploring 
      quantitative benefit-risk methods to support regulatory decision-making. A 
      scientifically valid method for assessing patients' benefit-risk trade-off 
      preferences is needed to compare risks and benefits in a common metric. 
      OBJECTIVES: The study aims to quantify the maximum acceptable risk (MAR) of 
      treatment-related adverse events (AEs) that women with diarrhea-predominant 
      irritable bowel syndrome (IBS) are willing to accept in exchange for symptom 
      relief. RESEARCH DESIGN: A stated-choice survey was used to elicit trade-off 
      preferences among constructed treatment profiles, each defined by symptom 
      severity and treatment-related AEs. Symptom attributes included frequency of 
      abdominal pain and discomfort, frequency of diarrhea, and frequency of urgency. 
      AE attributes included frequency of mild-to-moderate constipation and the risk of 
      four possible serious AEs. SUBJECTS: A Web-enabled survey was administered to 589 
      female US residents at least 18 years of age with a self-reported diagnosis of 
      diarrhea-predominant IBS. MEASURES: Preference weights and MAR were estimated 
      using mixed-logit methods. RESULTS: SUBJECTS were willing to accept higher risks 
      of serious AEs in return for treatments offering better symptom control. For an 
      improvement from the lowest to the highest of four benefit levels, subjects were 
      willing to tolerate a 2.65% increase in impacted-bowel risk, but only a 1.34% 
      increase in perforated-bowel risk. CONCLUSIONS: Variation in MARs across AE types 
      is consistent with the relative seriousness of the AEs. Stated-preference methods 
      offer a scientifically valid approach to quantifying benefit-risk trade-off 
      preferences that can be used to inform regulatory decision-making.
FAU - Johnson, F Reed
AU  - Johnson FR
AD  - RTI International, Research Triangle Park, NC 27709-2194, USA. frjohnson@rti.org
FAU - Hauber, A Brett
AU  - Hauber AB
FAU - Ozdemir, Semra
AU  - Ozdemir S
FAU - Lynd, Larry
AU  - Lynd L
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100310
PL  - United States
TA  - Value Health
JT  - Value in health : the journal of the International Society for Pharmacoeconomics 
      and Outcomes Research
JID - 100883818
RN  - 0 (Carbolines)
RN  - 0 (Gastrointestinal Agents)
RN  - 13Z9HTH115 (alosetron)
SB  - IM
MH  - Adult
MH  - Carbolines/*adverse effects
MH  - Drug and Narcotic Control
MH  - Female
MH  - Gastrointestinal Agents/*adverse effects
MH  - Humans
MH  - Irritable Bowel Syndrome/*drug therapy
MH  - Logistic Models
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - *Patient Preference
MH  - Quality of Life
MH  - Risk Assessment/methods/*statistics & numerical data
MH  - Severity of Illness Index
MH  - United States
EDAT- 2010/03/17 06:00
MHDA- 2010/09/21 06:00
CRDT- 2010/03/17 06:00
PHST- 2010/03/17 06:00 [entrez]
PHST- 2010/03/17 06:00 [pubmed]
PHST- 2010/09/21 06:00 [medline]
AID - S1098-3015(10)60076-9 [pii]
AID - 10.1111/j.1524-4733.2010.00694.x [doi]
PST - ppublish
SO  - Value Health. 2010 Jun-Jul;13(4):418-23. doi: 10.1111/j.1524-4733.2010.00694.x. 
      Epub 2010 Mar 10.