Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome

Clinical and Translational Gastroenterology

Volumn 5, Issue , 2014, Pages

  Marquis, P ^a   Lasch, K E ^b   Delgado Herrera, L ^c   Kothari, S ^d   Lembo, A ^e   Lademacher, C ^f   Spears, G ^g   Nishida, A ^h   Tesler, Waldman L ^h   Piault, E ^h   Rosa, K ^h   Zeiher, B ^h  

^a Two Legs Consulting   (United States)

^b PHARMERIT INTERNATIONAL   (United States)

^c ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^f ASTELLAS PHARMA INC   (Japan)

^g ADELPHI REAL WORLD   (United Kingdom)

^h UNIVERSITY OF NORTH CAROLINA WILMINGTON   (United States)

Author keywords

Functional GI Disorders

Indexed keywords

ABDOMINAL CRAMP; ABDOMINAL PAIN; ABDOMINAL PRESSURE; ADULT; AGED; ARTICLE; BLOATING; BURNING SENSATION; CONCEPT FORMATION; CONCEPTUAL FRAMEWORK; CONTENT VALIDITY; DEFECATION URGENCY; DIARRHEA; DISEASE SEVERITY; FEMALE; HUMAN; IBS D DAILY SYMPTOM DIARY; IBS D SYMPTOM EVENT LOG; INTESTINE MOTILITY; INTESTINE SOUND; IRRITABLE COLON; MAJOR CLINICAL STUDY; MALE; MEASUREMENT ACCURACY; MUSCLE SPASM; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITATIVE RESEARCH; RECTAL SPASM; RELIABILITY; SATIETY; STOMACH EMPTYING; STOMACH PAIN; SYMPTOM ASSESSMENT; TRIANGULATION; 17 ITEM DIARRHEA PREDOMINANT IRRITABLE BOWEL SYNDROME DAILY SYMPTOM DIARY; APPROPRIATENESS; ASSESSMENT OF HUMANS; ASTELLAS STOOL FORM SCALE; CLINICAL EVALUATION; COMPREHENSIVENESS; CONTROLLED STUDY; DATA PROCESSING; DATA TRIANGULATION; DIARRHEA PREDOMINANT IRRITABLE BOWEL SYNDROME; DIGESTIVE TRACT PARAMETERS; FOUR ITEM DIARRHEA PREDOMINANT IRRITABLE BOWEL SYNDROME SYMPTOM EVENT LOG; GASTROINTESTINAL SYMPTOM; INCOMPLETE EVACUATION; INTERVIEW; ONE ON ONE COGNITIVE INTERVIEW; PARAMETERS; PATIENT REPORTED OUTCOME SYMPTOM MEASURE; QUALITATIVE ANALYSIS; READING; RECTAL BURNING; RECTUM DISEASE; STOOL CONSISTENCY; STUDY DESIGN; UNDERSTANDABILITY;

EID: 84903309923     PISSN: None     EISSN: 2155384X     Source Type: Journal    
DOI: 10.1038/ctg.2014.7     Document Type: Article

References (40)

1. Longstreth GF, Thompson WG, Chey WD et al. Functional bowel disorders. Gastroenterology 2006; 130: 1480-1491.
2. Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis and treatment: an update for health-care practitioners. J Gastroenterol Hepatol 2010; 25: 691-699.
3. Gilkin RJ Jr. The spectrum of irritable bowel syndrome: a clinical review. Clin Ther 2005; 27: 1696-1709. (Pubitemid 41815223)
4. US Department of Health and Human Services, Food and Drug Adminstration, Center for Drug Evaluation and ResearchGuidance for Industry: Irritable Bowel Syndrome-Clinical Evaluation of Products for Treatment, Silver Spring, MD, 2012.
5. Committee for Medicinal Products for Human Use. Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome (CPMP/EWP/785/97). European Medicines Agency, May 2012.
6. US Department of Health and Human ServicesGuidance for Industry: Irritable Bowel Syndrome-Clinical Evaluation of Products for Treatment. Draft Guidance: Silver Spring, MD, 2010.
7. Muller-Lissner S, Koch G, Talley NJ et al. Subject's Global Assessment of Relief: an appropriate method to assess the impact of treatment on irritable bowel syndrome-related symptoms in clinical trials. J Clin Epidemiol 2003; 56: 310-316. (Pubitemid 36593309)
8. Wiklund IK, Fullerton S, Hawkey CJ et al. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol 2003; 38: 947-954. (Pubitemid 37153623)
9. 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. (Pubitemid 27183522)
10. O'Donnell LJ, Virjee J, Heaton KW. Detection of pseudodiarrhoea by simple clinical assessment of intestinal transit rate. BMJ 1990; 300: 439-440. (Pubitemid 20069266)
11. Chassany O, Marquis P, Scherrer B et al. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut 1999; 44: 527-533. (Pubitemid 29169953)
12. Groll D, Vanner SJ, Depew WT et al. The IBS-36: a new quality of life measure for irritable bowel syndrome. Am J Gastroenterol 2002; 97: 962-971. (Pubitemid 34408255)
13. Patrick DL, Drossman DA, Frederick IO et al. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci 1998; 43: 400-411. (Pubitemid 28124621)
14. The EuroQol Group. EuroQol-5D: a new facility for the measurement of health-related quality of life. Health Pol 1990; 16: 199-208.
15. Bushnell DM, Martin ML, Ricci JF et al. Performance of the EQ-5D in patients with irritable bowel syndrome. Value Health 2006; 9: 90-97. (Pubitemid 44044741)
16. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983; 67: 361-370. (Pubitemid 13098606)
17. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993; 4: 353-365.
18. PRO Labels-Patient Reported Outcomes Labels. [electronic article]. Available at:http://www mapi-prolabels org/2010, accessed: November 2013.
19. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Nurs Ethics 2002; 9: 105-109.
20. United States Health Insurance Portability and Accountability Act of 1996. Public Law 104-191. US Statut Large 1996; 110: 1936-2103.
21. Lasch KE, Marquis P, Vigneux M et al. PRO development: rigorous qualitative research as the crucial foundation. Qual Life Res 2010; 19: 1087-1096.
22. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007; 19: 349-357. (Pubitemid 350186969)
23. Strauss A, Corbin J. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Sage: London, UK, 1998.
24. K. Charmaz. Good Days Bad Days: the Self in Chronic Illness and Time. Rutgers University Press: New Brunswick, NJ, 1991.
25. Charmaz K. Grounded theory. In Smith JA, Harre R, Van Langenhove L (eds). Rethinking Methods in Psychology. Sage: London, UK, 1995. pp. 27-49.
26. Glaser B, Strauss AL. The Constant Comparative Method of Qualitative Analysis. Discovery of Grounded Theory: Strategies for Qualitative Research. Aldine de Gruyter: New York, NY, 1967. pp. 101-116.
27. Muhr T. User's Manual for Atlas.ti 5.0 Berlin: Atlas.ti. [5.0]Berlin 2004.
28. US Department of Health and Human Services, Food and Drug Adminstration, Center for Drug Evaluation and ResearchGuidance for Industry: Irritable Bowel Syndrome-Clinical Evaluation of Products for Treatment, Silver Spring, MD, 2012.
29. Willis GB. Cognitive Interviewing in Practice: Think-Aloud, Verbal Probing, and Other Techniques. Cognitive Interviewing: A Tool for Improving Questionnaire Design. Sage Publishers: Thousand Oaks, CA, 2005. pp. 42-63.
30. Kerr C, Nixon A, Wild D. Assessing and demonstrating data saturation in qualitative inquiry supporting patient-reported outcomes research. Expert Rev Pharmacoecon Outcomes Res 2010; 10: 269-281.
31. US Department of Health and Human ServicesDraft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Food and Drug Administration: Silver Spring, MD, 2006.
32. Mertz HR, Beck CK, Dixon W et al. Validation of a new measure of diarrhea. Dig Dis Sci 1995; 40: 1873-1882.
33. Janesick VJ. The Dance of Qualitative Research: Metaphor, Methodology, and Meaning. Handbook of Qualitative Research. Sage Publications: London, UK, 1994 209-218.
34. Patton M. Qualitative Research & Evaluation Methods. Sage Publications: London, UK, 2002.
35. Drossman DA, Chang L, Bellamy N et al. Severity in irritable bowel syndrome: a Rome Foundation Working Team Report. Am J Gastroenterol 2011; 106: 1749-1759.
36. Drossman DA, Morris CB, Hu Y et al. A prospective assessment of bowel habit in irritable bowel syndrome in women: defining an alternator. Gastroenterology 2005; 128: 580-589. (Pubitemid 40585359)
37. Whelan K, Judd P, Taylor M. Defining and reporting diarrhoea during enteral tube feeding: do health professionals agree. J Hum Nutr Diet 2003; 16: 21-26. (Pubitemid 36367484)
38. Whelan K, Judd P, Taylor M. Assessment of fecal output in patients receiving enteral tube feeding: validation of a novel chart. Eur J Clin Nutr 2004; 58: 130-137.
39. Whelan K, Judd P, Preedy V et al. Covert assessment of concurrent and construct validity of a chart to characterize fecal output and diarrhea in patients receiving enteral nutrition. J Parent Enteral Nutr 2008; 32: 160-168. (Pubitemid 351464904)
40. Gwee KA, Bak YT, Ghoshal UC et al. Asian consensus on irritable bowel syndrome. J Gastroenterol Hepatol 2010; 25: 1189-1205.