PedsQL gastrointestinal symptoms scales and gastrointestinal worry scales in pediatric patients with inflammatory bowel disease in comparison with healthy controls

Inflammatory Bowel Diseases

Volumn 21, Issue 5, 2015, Pages 1115-1124

  Varni, James W ^a,b   Franciosi, James P ^c,l   Shulman, Robert J ^d   Saeed, Shehzad ^c   Nurko, Samuel ^e   Neigut, Deborah A ^f   Bendo, Cristiane B ^g   Patel, Ashish S ^h   Self, Mariella M ^d   Saps, Miguel ^i,j   Zacur, George M ^c,m   Denham, Jolanda ^j   Dark, Chelsea Vaughan ^b,n   Pohl, John F ^k  

^a TEXAS A M COLLEGE OF MEDICINE   (United States)

^b TEXAS A AND M UNIVERSITY   (United States)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e BOSTON CHILDREN S HOSPITAL   (United States)

^f CHILDREN S HOSPITAL COLORADO   (United States)

^g FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

^h UNIVERSITY OF TEXAS AT DALLAS   (United States)

ⁱ NORTHWESTERN UNIVERSITY   (United States)

^j OHIO STATE UNIVERSITY   (United States)

^k PRIMARY CHILDREN'S MEDICAL CENTER   (United States)

^l NEMOURS CHILDREN S HOSPITAL   (United States)

^m UNIVERSITY OF MICHIGAN   (United States)

ⁿ Children's Medical Center   (United States)

more..

Author keywords

Crohn's disease; inflammatory bowel disease; patient reported outcomes; PedsQL; ulcerative colitis

Indexed keywords

ADOLESCENT; ARTICLE; BLOATING; CONSTIPATION; CONTROLLED STUDY; CROHN DISEASE; DIARRHEA; DIGESTIVE SYSTEM DISEASE ASSESSMENT; DYSPHAGIA; FEASIBILITY STUDY; FEMALE; FOOD INTAKE; GASTROINTESTINAL REFLUX; GASTROINTESTINAL SYMPTOM; GASTROINTESTINAL WORRY SCALE; HEARTBURN; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA AND VOMITING; PATIENT WORRY; PEDIATRIC QUALITY OF LIFE INVENTORY GASTROINTESTINAL SYMPTOM SCALE; PRIORITY JOURNAL; QUALITY OF LIFE ASSESSMENT; RECTUM HEMORRHAGE; SELF REPORT; STOMACH DISCOMFORT; STOMACH PAIN; ULCERATIVE COLITIS; ANXIETY; CASE CONTROL STUDY; CHILD; COMPARATIVE STUDY; COMPLICATION; FOLLOW UP; GASTROINTESTINAL DISEASES; INFLAMMATORY BOWEL DISEASE; PARENT; PRESCHOOL CHILD; PROGNOSIS; PSYCHOLOGY; QUALITY OF LIFE; RISK FACTOR; SEVERITY OF ILLNESS INDEX;

ADOLESCENT; ANXIETY; CASE-CONTROL STUDIES; CHILD; CHILD, PRESCHOOL; FEMALE; FOLLOW-UP STUDIES; GASTROINTESTINAL DISEASES; HUMANS; INFLAMMATORY BOWEL DISEASES; MALE; PARENTS; PROGNOSIS; QUALITY OF LIFE; RISK FACTORS; SEVERITY OF ILLNESS INDEX;

EID: 84929083864     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/MIB.0000000000000351     Document Type: Article

References (58)

1. Kappelman MD, Moore KR, Allen JK, et al. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013;58:519-525.
2. Ruel J, Ruane D, Mehandru S, et al. IBD across the age spectrum-is it the same disease?. Nat Rev Gastroenterol Hepatol. 2014;11:88-98.
3. Malaty HM, Fan X, Opekun AR, et al. Rising incidence of inflammatory bowel disease among children: a 12-year study. J Pediatr Gastroenterol Nutr. 2010;50:27-31.
4. Kappelman MD, Rifas-Shiman SL, Kleinman K, et al. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007;5:1424-1429.
5. Gasparetto M, Guariso G. Highlights in IBD epidemiology and its natural history in the paediatric age. Gastroenterol Res Pract. 2013;2013:1-12.
6. Mamula P, Markowitz JE, Baldassano RN. Inflammatory bowel disease in early childhood and adolescence: special considerations. Gastroenterol Clin North Am. 2003;32:967-995.
7. Crandall WV, Margolis PA, Kappelman MD, et al. Improved outcomes in a quality improvement collaborative for pediatric inflammatory bowel disease. Pediatrics. 2012;129:e1030-e1041.
8. Samson CM, Morgan P, Williams E, et al. Improved outcomes with quality improvement interventions in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2012;55:679-688.
9. Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22: 1889-1905.
10. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309:814-822.
11. FDA. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville, MD: Food and Drug Administration, U.S. Department of Health and Human Services; 2009.
12. FDA. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT Workshop). College Park, MD: Center for Drug Evaluation and Research, Food and Drug Administration; 2012.
13. FDA. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II Workshop). College Park, MD: Center for Drug Evaluation and Research, Food and Drug Administration; 2013.
14. Williet N, Sandborn WJ, Peyrin-Biroulet L. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2014;12:1246-1256.
15. Kunz JH, Hommel KA, Greenley RN. Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 Generic Core Scales. Inflamm Bowel Dis. 2010;16: 939-946.
16. Perrin JM, Kuhlthau K, Chughtai A, et al. Measuring quality of life in pediatric patients with inflammatory bowel disease: psychometric and clinical characteristics. J Pediatr Gastroenterol Nutr. 2008;46:164-171.
17. Ryan JL, Mellon MW, Junger KW, et al. The clinical utility of healthrelated quality of life screening in a pediatric inflammatory bowel disease clinic. Inflamm Bowel Dis. 2013;19:2666-2672.
18. Marcus SB, Strople JA, Neighbors K, et al. Fatigue and health-related quality of life in pediatric inflammatory bowel disease. Clin Gastroenterol Hepatol. 2009;7:554-561.
19. Varni JW, Kay MT, Limbers CA, et al. PedsQL Gastrointestinal Symptoms Module item development: qualitative methods. J Pediatr Gastroenterol Nutr. 2012;54:664-671.
20. Varni JW, Bendo CB, Denham J, et al. PedsQL Gastrointestinal Symptoms Module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2014;59:347-355.
21. Griffiths AM, Nicholas D, Smith C, et al. Development of a quality-of-life index for pediatric inflammatory bowel disease: dealing with differences related to age and IBD type. J Pediatr Gastroenterol Nutr. 1999;28: S46-S52.
22. Otley A, Smith C, Nicholas D, et al. The IMPACT questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002;35:557-563.
23. Gallo J, Grant A, Otley AR, et al. Do parents and children agree?. Qualityof-life assessment of children with inflammatory bowel disease and their parents. J Pediatr Gastroenterol Nutr. 2014;58:481-485.
24. Wernera H, Landolt MA, Buehrb P, et al. Validation of the IMPACT-III quality of life questionnaire in Swiss children with inflammatory bowel disease. J Crohns Colitis. 2014;8:641-648.
25. Abdovic S, Pavic AM, Milosevic M, et al. The IMPACT-III (HR) questionnaire: a valid measure of health-related quality of life in Croatian children with inflammatory bowel disease. J Crohns Colitis. 2013;7: 908-915.
26. Varni JW, Bendo CB, Denham J, et al. PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Qual Life Res. 2015;24:363-378.
27. Schunemann HJ, Akl EA, Guyatt GH. Interpreting the results of patient reported outcome measures in clinical trials: the clinician's perspective. Health Qual Life Outcomes. 2006;4:62.
28. Varni JW, Limbers CA. The Pediatric Quality of Life Inventory: measuring pediatric health-related quality of life from the perspective of children and their parents. Pediatr Clin North Am. 2009;56:843-863.
29. Hattie J, Cooksey RW. Procedures for assessing the validities of tests using the 'known-groups' method. Appl Psychol Meas. 1984;8:295-305.
30. Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 Generic Core Scales in healthy and patient populations. Med Care. 2001;39:800-812.
31. Varni JW, Burwinkle TM, Seid M, et al. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003;3:329-341.
32. Varni JW, Burwinkle TM, Seid M. The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. Qual Life Res. 2006;15:203-215.
33. Alonso EM, Limbers CA, Neighbors K, et al. Cross-sectional analysis of health-related quality of life in pediatric liver transplant recipients. J Pediatr. 2010;156:270-276.
34. Pohl JF, Limbers CA, Kay MT, et al. Health-related quality of life in pediatric patients with long-standing pancreatitis. J Pediatr Gastroenterol Nutr. 2012;54:657-663.
35. Varni JW, Thompson KL, Hanson V. The Varni/Thompson Pediatric Pain Questionnaire: I. Chronic musculoskeletal pain in juvenile rheumatoid arthritis. Pain. 1987;28:27-38.
36. Fairclough DL. Design and Analysis of Quality of Life Studies in Clinical Trials: Interdisciplinary Statistics. New York, NY: Chapman & Hall/ CRC; 2002.
37. McHorney CA, Ware JE, Lu JFR, et al. 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32:40-66.
38. Roth PL. Missing data: a conceptual review for applied psychologists. Personnel Psychol. 1994;47:537-570.
39. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297-334.
40. Nunnally JC, Bernstein IR. Psychometric Theory. 3rd ed. New York, NY: McGraw-Hill; 1994.
41. McHorney CA, Ware JE, Rogers W, et al. The validity and relative precision of MOS short-And long-form health status scales and Dartmouth COOP charts: results from the Medical Outcomes Study. Med Care. 1992; 30:MS253-MS65.
42. Fayers PM, Machin D. Quality of Life: Assessment, Analysis, and Interpretation. New York, NY: Wiley; 2000.
43. McHorney CA, Ware JE, Raczek AE. The MOS 36-item short-form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31: 247-263.
44. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Erlbaum; 1988.
45. Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol. 1999;52: 861-873.
46. Wyrwich KW, Norquist JM, Lenderking WR, et al. Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res. 2013;22:475-483.
47. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56: 395-407.
48. Hilliard ME, Lawrence JM, Modi AC, et al. Identification of minimal clinically important difference scores of the Pediatric Quality of Life Inventory in children, adolescents, and young adults with type 1 and type 2 diabetes. Diabetes Care. 2013;36:1891-1897.
49. McGraw KO, Wong SP. Forming inferences about some intraclass correlation coefficients. Psychol Methods. 1996;1:30-46.
50. Bartko JJ. The intraclass correlation coefficient as a measure of reliability. Psychol Rep. 1966;19:3-11.
51. SPSS. SPSS 19.0 for Windows. Chicago, IL: SPSS, Inc.; 2010.
52. King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011;11:171-184.
53. Kim SC, Ferry GD. Inflammatory bowel diseases in pediatric and adolescent patients: clinical, therapeutic, and psychosocial considerations. Gastroenterology. 2004;126:1550-1560.
54. Baldassano RN, Piccoli DA. Inflammatory bowel disease in pediatric and adolescent patients. Gastroenterol Clin North Am. 1999;28:445-458.
55. Eiser C, Varni JW. Health related quality of life and symptom reporting: similarities and differences between children and their parents. Eur J Pediatr. 2013;172:1299-1304.
56. Hyams J, Markowitz J, Otley A, et al. Evaluation of the pediatric crohn disease activity index: a prospective multicenter experience. J Pediatr Gastroenterol Nutr. 2005;41:416-421.
57. Turner D, Otley AR, Macks D, et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007;133:423-432.
58. Varni JW, Bendo CB, Nurko S, et al. Health-related quality of life in pediatric patients with functional and organic gastrointestinal diseases. J Pediatr. 2015;166:85-90.