• 1
    Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology 2006; 130: 148091.
  • 2
    Chang L, Drossman DA. Rome Foundation Endpoints and Outcomes Conference 2009: optimizing Clinical Trials in FGID. Am J Gastroenterol 2010; 105: 72230.
  • 3
    Burke LB, Kennedy DL, Miskala PH, Papadopoulos EJ, Trentacosti AM. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther 2008; 84: 2813.
  • 4
    Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring, MD: Services USDoHaH, 2009.
  • 5
    Camilleri M, Mangel AW, Fehnel SE, Drossman DA, Mayer EA, Talley NJ. Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints. Clin Gastroenterol Hepatol 2007; 5: 53440.
  • 6
    Trentacosti AHR, Burke L, Griebel D, Kennedy D. Evolution of clinical trials for Irritable Bowel Syndrome: issues in endpoints and study design. Am J Gastroenterol 2010; 105: 7315.
  • 7
    Reeve BB, Hays RD, Bjorner JB, et al. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care 2007; 45: S2231.
  • 8
    Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care 2007; 45: S311.
  • 9
    ACG. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol 2009; 104: S135.
  • 10
    Grover M, Herfarth H, Drossman DA. The functional-organic dichotomy: postinfectious irritable bowel syndrome and inflammatory bowel disease-irritable bowel syndrome. Clin Gastroenterol Hepatol 2009; 7: 4853.
  • 11
    Long MD, Drossman DA. Inflammatory bowel disease, irritable bowel syndrome, or what?: a challenge to the functional-organic dichotomy. Am J Gastroenterol 2010; 105: 17968.
  • 12
    Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci 1998; 43: 40011.
  • 13
    Labus JS, Bolus R, Chang L, et al. The Visceral Sensitivity Index: development and validation of a gastrointestinal symptom-specific anxiety scale. Aliment Pharmacol Ther 2004; 20: 8997.
  • 14
    Dean BB, Aguilar D, Barghout V, et al. Impairment in work productivity and health-related quality of life in patients with IBS. Am J Manag Care 2005; 11: S1726.
  • 15
    Bijkerk CJ, De Wit NJ, Muris JW, Jones RH, Knottnerus JA, Hoes AW. Outcome measures in irritable bowel syndrome: comparison of psychometric and methodological characteristics. Am J Gastroenterol 2003; 98: 1227.
    Direct Link:
  • 16
    Terwee CB, Jansma EP, Riphagen de Vet HC II. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res 2009; 18: 111523.
  • 17
    DeWalt DA, Rothrock N, Yount S, Stone AA. Evaluation of item candidates: the PROMIS qualitative item review. Med Care 2007; 45: S1221.
  • 18
    Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol 2009; 104(Suppl. 1): S135.
  • 19
    Ericsson A, Simon H. Protocol Analysis: Verbal Reports as Data. 2nd ed. Cambridge, MA: MIT Press, 1993.
  • 20
    Willis G. Cognitive Interviewing and Questionnaire Design: A Training Manual. Washington, DC: National Center for Health Statistics, 1994.
  • 21
    Spiegel BM, Bolus R, Han S, et al. Development and validation of a disease-targeted quality of life instrument in chronic hepatitis B: the hepatitis B quality of life instrument, version 1.0. Hepatology 2007; 46: 11321.
  • 22
    Spiegel B, Bolus R, Harris LA, et al. Measuring IBS patient reported outcomes with an abdominal pain numeric rating scale: results from the proof cohort. Aliment Pharmacol Ther 2009; 30: 115970.
  • 23
    Spiegel B, Harris L, Lucak S, et al. Developing valid and reliable health utilities in irritable bowel syndrome: results from the IBS PROOF Cohort. Am J Gastroenterol 2009; 104: 198491.
  • 24
    Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988; 33: 12934.
  • 25
    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: 395402.
  • 26
    Drossman DA, Li Z, Toner BB, et al. Functional bowel disorders. A multicenter comparison of health status and development of illness severity index. Dig Dis Sci 1995; 40: 98695.
  • 27
    Goka AKSJ. Development and validation of an IBS symptom questionnaire and the relevance of the Rome Criteria to selection of patients for IBS clinical trials. Proceedings of the MWT symposium “Definition of a Responder in Clinical Trials for Functional Bowel Disorders.” Vienna, 1998.
  • 28
    Longstreth GF, Bolus R, Naliboff B, et al. Impact of irritable bowel syndrome on patients’ lives: development and psychometric documentation of a disease-specific measure for use in clinical trials. Eur J Gastroenterol Hepatol 2005; 17: 41120.
  • 29
    Talley NJ, Boyce PM, Owen BK, Newman P, Paterson KJ. Initial validation of a bowel symptom questionnaire and measurement of chronic gastrointestinal symptoms in Australians. Aust N Z J Med 1995; 25: 3028.
  • 30
    Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997; 32: 9204.
  • 31
    Leibbrand R, Cuntz U, Hiller W. Assessment of functional gastrointestinal disorders using the gastro-questionnaire. Int J Behav Med 2002; 9: 15572.
  • 32
    Chassany O, Marquis P, Scherrer B, et al. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut 1999; 44: 52733.
  • 33
    Roalfe AK, Roberts LM, Wilson S. Evaluation of the Birmingham IBS symptom questionnaire. BMC Gastroenterol 2008; 8: 30.
  • 34
    Adeyemo MA, Spiegel BM, Chang L. Meta-analysis: do irritable bowel syndrome symptoms vary between men and women? Aliment Pharmacol Ther 2010; 32: 73855.
  • 35
    Spiegel BM, Bolus R, Harris L, et al. Characterizing abdominal pain in IBS: guidance for study inclusion criteria, outcome measurement and clinical practice. Aliment Pharmacol Ther 2010 [Epub ahead of print].
  • 36
    Turk DCDR, Allen RR, Bellamy N, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 2003; 106: 33745.
  • 37
    Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain 1975; 1: 27799.
  • 38
    Spiegel B, Camilleri M, Bolus R, et al. Psychometric evaluation of patient reported outcomes in irritable bowel syndrome randomized controlled trials: a Rome Foundation report. Gastroenterology 2009; 137: 194453, e1–3.
  • 39
    Weinland S, Morris CB, Hu YJ, et al. Pain and bloating symptoms decrease after bowel movements in IBS: a reaffirmation of ROME criteria. Gastroenterology 2009; 136: M1229.
  • 40
    Weinland S, Morris CB, Hu YJ, et al. Episodes of irritable bowel syndrome – a quantitative examination of IBS-D, C & M symptoms using ecological momentary assessment. Gastroenterology 2009; 136: M1222.
  • 41
    Stone AA, Broderick JE, Shiffman SS, Schwartz JE. Understanding recall of weekly pain from a momentary assessment perspective: absolute agreement, between- and within-person consistency, and judged change in weekly pain. Pain 2004; 107: 619.
  • 42
    Stone AA, Schwartz JE, Broderick JE, Shiffman SS. Variability of momentary pain predicts recall of weekly pain: a consequence of the peak (or salience) memory heuristic. Pers Soc Psychol Bull 2005; 31: 13406.
  • 43
    Slappendel R, Simpson K, Dubois D, Keininger DL. Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain 2006; 10: 20917.
  • 44
    Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol 1999; 34: 8707.
  • 45
    Rentz AM, Yu R, Muller-Lissner S, Leyendecker P. Validation of the bowel function index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ 2009; 12: 37183.
  • 46
    Toner BB, Stuckless N, Ali A, Downie F, Emmott S, Akman D. The development of a cognitive scale for functional bowel disorders. Psychosom Med 1998; 60: 4927.