A retrospective analysis: The development of patient reported outcome measures for the assessment of Crohn's disease activity

Alimentary Pharmacology and Therapeutics

Volumn 41, Issue 1, 2015, Pages 77-86

  Khanna, R ^a,b   Zou, G ^a,b   D'Haens, G ^b,c   Feagan, B G ^a,b   Sandborn, W J ^b,d   Vandervoort, M K ^b   Rolleri, R L ^e   Bortey, E ^e   Paterson, C ^e   Forbes, W P ^e   Levesque, B G ^b,d  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b ROBARTS RESEARCH INSTITUTE   (Canada)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e Salix a Division of Valeant Pharmaceuticals North America LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABDOMINAL PAIN; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; COMPARATIVE STUDY; CORRELATIONAL STUDY; CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; DEFECATION HABIT; FEMALE; FOLLOW UP; HUMAN; INFLAMMATORY BOWEL DISEASE QUESTIONNAIRE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECEIVER OPERATING CHARACTERISTIC; REMISSION; RETROSPECTIVE STUDY; TREATMENT RESPONSE; WELLBEING; ADOLESCENT; CLINICAL TRIAL; CONTROLLED STUDY; DELAYED RELEASE FORMULATION; DOUBLE BLIND PROCEDURE; HEALTH STATUS INDICATOR; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PAIN; PATHOPHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; REPRODUCIBILITY; UNITED STATES; YOUNG ADULT;

DELAYED RELEASE FORMULATION; GASTROINTESTINAL AGENT; RIFAMYCIN; RIFAXIMIN;

ADOLESCENT; ADULT; AGED; CROHN DISEASE; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL AGENTS; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; PAIN; PATIENT OUTCOME ASSESSMENT; REGRESSION ANALYSIS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; RETROSPECTIVE STUDIES; RIFAMYCINS; ROC CURVE; UNITED STATES; YOUNG ADULT;

EID: 84915735329     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13001     Document Type: Article

References (19)

1. Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology 1979; 77: 843-6.
2. Best WR, Becktel JM, Singleton JW, et al. Development of a Crohn's Disease Activity Index. National Cooperative Crohn' s Disease Study. Gastroenterology 1976; 70: 439-44.
3. Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet 1980; 1: 514.
4. Sandler RS, Jordan MC, Kupper LL. Development of a Crohn's index for survey research. J Clin Epidemiol 1988; 41: 451-8.
5. Thia K, Faubion WA Jr, Loftus EV Jr, et al. Short CDAI: development and validation of a shortened and simplified Crohn 's disease activity index. Inflamm Bowel Dis 2011; 17: 105-11.
6. US Food and Drug Administration (FDA). In: Department of Health and Human Services (US) FDA, Center for Drug Evaluation and Research (CDER), ed. Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims. Rockville, MD. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf, 2009.
7. Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument. Value Health 2011; 14: 967-77.
8. Prantera C, Lochs H, Grimaldi M, et al. Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease. Gastroenterology 2012; 142(): e4.
9. Feagan BG, Rochon J, Fedorak RN, et al. Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators. N Engl J Med 1995; 332: 292-7.
10. Guyatt GH, Townsend M, Berman LB, et al. A comparison of Likert and visual analogue scales for measuring change in function. J Chronic Dis 1987; 40: 1129-33.
11. Donner A, Zou GY. Closed-form confidence intervals for functions of the normal mean and standard deviation. Stat Methods Med Res 2012; 21: 347-59.
12. Husted JA, Cook RJ, Farewell VT, et al. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol 2000; 53: 459-68.
13. Lahiff C, Safaie P, Awais A, et al. The Crohn's disease activity index (CDAI) is similarly elevated in patients with Crohn's disease and in patients with irritable bowel syndrome. Aliment Pharmacol Ther 2013; 37: 786-94.
14. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med 2005; 353: 1912-25.
15. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med 2007; 357: 228-38.
16. Korzenik JR, Dieckgraefe BK, Valentine JF, et al. Sargramostim for active Crohn's disease. N Engl J Med 2005; 352: 2193-201.
17. Jones J, Loftus EV Jr, Panaccione R, et al. Relationships between disease activity and serum and fecal biomarkers in patients with Crohn's disease. Clin Gastroenterol Hepatol 2008; 6: 1218-24.
18. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362: 1383-95.
19. Peyrin-Biroulet L, Reinisch W, Colombel JF, et al. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial. Gut 2014; 63: 88-95.