Gastroenterology
Volume 137, Issue 6 , Pages 1944-1953.e3 , December 2009

Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report

  • Brennan Spiegel

      Affiliations

    • Department of Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, California
    • Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California
    • UCLA/VA Center for Outcomes Research and Education (CORE), Los Angeles, California
    • Corresponding Author InformationReprint requests Address requests for reprints to: Brennan M.R. Spiegel, MD, MSHS, 11301 Wilshire Boulevard, Building 115, Room 215, Los Angeles, California 90073. fax: (310) 268-4510
    • ,
  • Michael Camilleri

      Affiliations

    • Mayo Clinic, Rochester, Minnesota
    • ,
  • Roger Bolus

      Affiliations

    • Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California
    • UCLA/VA Center for Outcomes Research and Education (CORE), Los Angeles, California
    • ,
  • Viola Andresen

      Affiliations

    • Hamburg, Germany
    • ,
  • William D. Chey

      Affiliations

    • University of Michigan, Ann Arbor, Michigan
    • ,
  • Sheri Fehnel

      Affiliations

    • RTI Health Solutions, Research Triangle Park, North Carolina
    • ,
  • Allen Mangel

      Affiliations

    • RTI Health Solutions, Research Triangle Park, North Carolina
    • ,
  • Nicholas J. Talley

      Affiliations

    • Mayo Clinic, Jacksonville, Florida
    • ,
  • William E. Whitehead

      Affiliations

    • University of North Carolina, Chapel Hill, North Carolina

Received 29 April 2009 ,Accepted 12 August 2009.

References 

  1. Burke LB, Kennedy DL, Miskala PH, et al. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther. 2008;84:281–283
  2. Camilleri M, Mangel AW, Fehnel SE, et al. Primary end points for irritable bowel syndrome trials: a review of performance of endpoints. Clin Gastroenterol Hepatol. 2007;5:534–540
  3. Bijkerk CJ, de Wit NJ, Muris JW, et al. Outcome measures in irritable bowel syndrome: comparison of psychometric and methodological characteristics. Am J Gastroenterol. 2003;98:122–127
  4. Mangel AW, Hahn BA, Heath AT, et al. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res. 1998;26:76–81
  5. El-Serag HB, Olden K, Bjorkman D. Health-related quality of life among persons with irritable bowel syndrome: a systematic review. Aliment Pharmacol Ther. 2002;16:1171–1185
  6. Whitehead WE, Palsson OS, Levy RL, et al. Reports of “satisfactory relief” by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement. Am J Gastroenterol. 2006;101:1057–1065
  7. Leventer SM, Raudibaugh K, Frissora CL, et al. Clinical trial: dextofisopam in the treatment of patients with diarrhoea-predominant or alternating irritable bowel syndrome. Aliment Pharmacol Ther. 2008;27:197–206
  8. Lackner JM, Jaccard J, Krasner SS, et al. Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroenterol Hepatol. 2008;6:899–906
  9. Ameen VZ, Health AT, McSorley D, et al. Global measure of adequate relief predicts clinically important difference in pain and is independent of baseline pain severity in irritable bowel syndrome (abstract 941). Gastroenterology. 2007;132:A140
  10. Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395–402
  11. Irvine EJ, Whitehead WE, Chey WD, et al. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology. 2006;130:1538–1551
  12. Lembo A, Ameen VZ, Drossman DA. Irritable bowel syndrome: toward an understanding of severity. Clin Gastroenterol Hepatol. 2005;3:717–725
  13. Spiegel B, Strickland A, Naliboff BD, et al. Predictors of patient-assessed illness severity in irritable bowel syndrome. Am J Gastroenterol. 2008;103:2536–2543
  14. Drossman D, Morris CB, Hu Y, et al. Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment. Am J Gastroenterol. 2007;102:1442–1453
  15. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582–592
  16. Cohen J. Statistical power analysis for the behavioral sciences. London: Academic Press; 1969;
  17. Cohen J. Statistical power analysis for the behavioral sciences. Lawrence Erlbaum Associates, Inc; 1988;
  18. Labus JS, Mayer EA, Chang L, et al. The central role of gastrointestinal-specific anxiety in irritable bowel syndrome: further validation of the visceral sensitivity index. Psychosom Med. 2007;69:89–98
  19. Fehnel SJJ, Kurtz C, Mangel A. Assessing global change and symptom severity in subjects with IBS: qualitative item testing. Am J Gastroenterol. 2006;101:S483
  20. Gordon S, Ameen V, Bagby B, et al. Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy. Dig Dis Sci. 2003;48:1317–1323

 Conflicts of interest The authors disclose the following: Dr Spiegel has served as a consultant for AstraZeneca, McNeail Consumer, Novartis, Prometheus, Takeda Pharmaceuticals, and TAP Pharmaceuticals and has received grant support from Amgen, AstraZeneca, Bristol Myers Squibb, Novartis, Salix, and Takeda. Dr Camilleri has served as a consult for GlaxoSmithKline and has received research support from Ironwood Pharmaceuticals and Novartis. Drs Fehnel and Mangel are employees of RTI Health Solutions. Dr Chey is a consultant for Novartis, GlaxoSmithKline, Solvay, and Ironwood and is on the speaker's bureau of Novartis. Dr Talley is a consultant for Astellas Pharma Inc US, AstraZeneca, Centocor, Eisai, Elsevier, Ferring Pharmaceuticals, Focus, Gilead, In2MedEd, Ironwood Pharmaceuticals, McNeil Consumer, Medscape, Meritage Pharma, Metabolic Pharma, Microbia Inc, Novartis, Optum HC, Salix, SK Life Sciences, Steigerwald, The Journal of Medicine, Therevance, and Wyeth and received grant support from GlaxoSmithKline, Dynogen, and Tioga. The remaining authors disclose no conflicts.

 Funding Supported by the Rome Foundation and by a Veteran's Affairs Health Services Research and Development (HSR&D) Career Development Transition Award (RCD 03-179-2; to B.S.), the CURE Digestive Disease Research Center (NIH 2P30 DK 041301-17; to B.S.), and NIH Center Grant 1 R24 AT002681-NCCAM (to B.S.).

PII: S0016-5085(09)01481-4

doi: 10.1053/j.gastro.2009.08.047

Gastroenterology
Volume 137, Issue 6 , Pages 1944-1953.e3 , December 2009

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