PMID- 19706292
OWN - NLM
STAT- MEDLINE
DCOM- 20091224
LR  - 20220321
IS  - 1528-0012 (Electronic)
IS  - 0016-5085 (Print)
IS  - 0016-5085 (Linking)
VI  - 137
IP  - 6
DP  - 2009 Dec
TI  - Psychometric evaluation of patient-reported outcomes in irritable bowel syndrome 
      randomized controlled trials: a Rome Foundation report.
PG  - 1944-53.e1-3
LID - 10.1053/j.gastro.2009.08.047 [doi]
AB  - BACKGROUND & AIMS: There is debate about how best to measure patient-reported 
      outcomes (PROs) in irritable bowel syndrome (IBS). We pooled data to measure the 
      psychometric properties of IBS end points, including binary responses (eg, 
      "adequate relief") and 50% improvement in symptom severity. METHODS: We pooled 
      data from 12 IBS drug trials involving 10,066 participants. We tested the 
      properties of binary response and 50% improvement end points, including the 
      impact of baseline severity on performance, and measured construct validity using 
      clinical anchors. RESULTS: There were 9044 evaluable subjects (age, 44 years; 85% 
      female; 58% IBS constipation-prominent [IBS-C]; 31% IBS diarrhea-prominent 
      [IBS-D]). Using the binary end point, the proportion responding in the mild, 
      moderate, and severe groups was 42%, 40%, and 38%, respectively (P = .0008). 
      There was no effect of baseline severity on binary response (odds ratio [OR], 
      0.99; 95% confidence interval [CI], 0.99-1.0; P = .07). The proportions reaching 
      50% improvement in pain were 45%, 41%, and 41%, respectively; there was a small, 
      yet significant, impact of baseline severity (OR, 1.04; 95% CI, 1.03-1.05; P < 
      .0001) that did not meet clinical relevance criteria. Both end points revealed 
      strong construct validity and detected "minimally clinically important 
      differences" in symptoms. Both provided better discriminant spread in IBS-D than 
      IBS-C. CONCLUSIONS: Both the traditional binary and 50% improvement end points 
      are equivalent in their psychometric properties. Neither is impacted by baseline 
      severity, and both demonstrate excellent construct validity. They are optimized 
      for the IBS-D population but also appear valid in IBS-C.
FAU - Spiegel, Brennan
AU  - Spiegel B
AD  - Department of Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, 
      California, USA. bspiegel@mednet.ulca.edu
FAU - Camilleri, Michael
AU  - Camilleri M
FAU - Bolus, Roger
AU  - Bolus R
FAU - Andresen, Viola
AU  - Andresen V
FAU - Chey, William D
AU  - Chey WD
FAU - Fehnel, Sheri
AU  - Fehnel S
FAU - Mangel, Allen
AU  - Mangel A
FAU - Talley, Nicholas J
AU  - Talley NJ
FAU - Whitehead, William E
AU  - Whitehead WE
LA  - eng
GR  - 1 R24 AT002681/AT/NCCIH NIH HHS/United States
GR  - R24 AT002681/AT/NCCIH NIH HHS/United States
GR  - R24 AT002681-05/AT/NCCIH NIH HHS/United States
GR  - P30 DK041301/DK/NIDDK NIH HHS/United States
GR  - 2P30 DK 041301-17/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20090823
PL  - United States
TA  - Gastroenterology
JT  - Gastroenterology
JID - 0374630
SB  - IM
MH  - Abdominal Pain/etiology/*prevention & control/psychology
MH  - Adult
MH  - Female
MH  - Humans
MH  - Irritable Bowel Syndrome/complications/diagnosis/psychology/*therapy
MH  - Logistic Models
MH  - Male
MH  - Odds Ratio
MH  - *Pain Measurement
MH  - *Patient Satisfaction
MH  - Predictive Value of Tests
MH  - *Psychometrics
MH  - Randomized Controlled Trials as Topic
MH  - Reproducibility of Results
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC2793276
MID - NIHMS141061
EDAT- 2009/08/27 09:00
MHDA- 2009/12/25 06:00
PMCR- 2010/12/01
CRDT- 2009/08/27 09:00
PHST- 2009/04/29 00:00 [received]
PHST- 2009/07/28 00:00 [revised]
PHST- 2009/08/12 00:00 [accepted]
PHST- 2009/08/27 09:00 [entrez]
PHST- 2009/08/27 09:00 [pubmed]
PHST- 2009/12/25 06:00 [medline]
PHST- 2010/12/01 00:00 [pmc-release]
AID - S0016-5085(09)01481-4 [pii]
AID - 10.1053/j.gastro.2009.08.047 [doi]
PST - ppublish
SO  - Gastroenterology. 2009 Dec;137(6):1944-53.e1-3. doi: 
      10.1053/j.gastro.2009.08.047. Epub 2009 Aug 23.