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

Burke, 2008, The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval, Clin Pharmacol Ther, 84, 281, 10.1038/clpt.2008.128 Camilleri, 2007, Primary end points for irritable bowel syndrome trials: a review of performance of endpoints, Clin Gastroenterol Hepatol, 5, 534, 10.1016/j.cgh.2007.03.004 Bijkerk, 2003, Outcome measures in irritable bowel syndrome: comparison of psychometric and methodological characteristics, Am J Gastroenterol, 98, 122, 10.1111/j.1572-0241.2003.07158.x Mangel, 1998, Adequate relief as an endpoint in clinical trials in irritable bowel syndrome, J Int Med Res, 26, 76, 10.1177/030006059802600203 El-Serag, 2002, Health-related quality of life among persons with irritable bowel syndrome: a systematic review, Aliment Pharmacol Ther, 16, 1171, 10.1046/j.1365-2036.2002.01290.x Whitehead, 2006, 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, 101, 1057, 10.1111/j.1572-0241.2006.00535.x Leventer, 2008, Clinical trial: dextofisopam in the treatment of patients with diarrhoea-predominant or alternating irritable bowel syndrome, Aliment Pharmacol Ther, 27, 197, 10.1111/j.1365-2036.2007.03566.x Lackner, 2008, Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility, Clin Gastroenterol Hepatol, 6, 899, 10.1016/j.cgh.2008.03.004 Ameen, 2007, 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, 132, A140 Francis, 1997, The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress, Aliment Pharmacol Ther, 11, 395, 10.1046/j.1365-2036.1997.142318000.x Irvine, 2006, Design of treatment trials for functional gastrointestinal disorders, Gastroenterology, 130, 1538, 10.1053/j.gastro.2005.11.058 Lembo, 2005, Irritable bowel syndrome: toward an understanding of severity, Clin Gastroenterol Hepatol, 3, 717, 10.1016/S1542-3565(05)00157-6 Spiegel, 2008, Predictors of patient-assessed illness severity in irritable bowel syndrome, Am J Gastroenterol, 103, 2536, 10.1111/j.1572-0241.2008.01997.x Drossman, 2007, Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment, Am J Gastroenterol, 102, 1442, 10.1111/j.1572-0241.2007.01283.x Norman, 2003, Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation, Med Care, 41, 582, 10.1097/01.MLR.0000062554.74615.4C Cohen, 1969 Cohen, 1988 Labus, 2007, The central role of gastrointestinal-specific anxiety in irritable bowel syndrome: further validation of the visceral sensitivity index, Psychosom Med, 69, 89, 10.1097/PSY.0b013e31802e2f24 Fehnel, 2006, Assessing global change and symptom severity in subjects with IBS: qualitative item testing, Am J Gastroenterol, 101, S483, 10.14309/00000434-200609001-01248 Gordon, 2003, Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy, Dig Dis Sci, 48, 1317, 10.1023/A:1024159226274