Interpretability of the PedsQL™ gastrointestinal symptoms scales and gastrointestinal worry scales in pediatric patients with functional and organic gastrointestinal diseases

Journal of Pediatric Psychology

Volumn 40, Issue 6, 2014, Pages 591-601

  Varni, James W ^a,b   Bendo, Cristiane B ^c   Shulman, Robert J ^d   Self, Mariella M ^d,e   Nurko, Samuel ^f   Franciosi, James P ^g   Saps, Miguel ^h   Saeed, Shehzad ^g   Zacur, George M ^g   Vaughan Dark, Chelsea ^b   Pohl, John F ⁱ  

^a Department of Pharmacology and the Comprehensive Cancer Center   (United States)

^b TEXAS A AND M UNIVERSITY   (United States)

^c FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

^d TEXAS CHILDREN S HOSPITAL   (United States)

^e Department of Psychiatry ^*  (United States)

^f BOSTON CHILDREN S HOSPITAL   (United States)

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

^h NORTHWESTERN UNIVERSITY   (United States)

ⁱ UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

gastrointestinal symptoms; minimal important difference; patient reported outcomes; PedsQL

Indexed keywords

ADOLESCENT; ANXIETY; ATTITUDE TO HEALTH; CHILD; COMPLICATION; FEMALE; GASTROINTESTINAL DISEASES; HUMAN; MALE; PARENT; PEDIATRICS; PRESCHOOL CHILD; PSYCHOLOGY; PSYCHOMETRY; QUALITY OF LIFE; QUESTIONNAIRE; REPRODUCIBILITY; STANDARDS;

ADOLESCENT; ANXIETY; ATTITUDE TO HEALTH; CHILD; CHILD, PRESCHOOL; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; MALE; PARENTS; PEDIATRICS; PSYCHOMETRICS; QUALITY OF LIFE; REPRODUCIBILITY OF RESULTS; SURVEYS AND QUESTIONNAIRES;

EID: 84937428734     PISSN: 01468693     EISSN: 1465735X     Source Type: Journal    
DOI: 10.1093/jpepsy/jsv005     Document Type: Article

References (56)

1. Alonso, E. M., Limbers, C. A., Neighbors, K., Martz, K., Bucuvalas, J. C., Webb, T., & Varni, J. W. (2010). Cross-sectional analysis of health-related quality of life in pediatric liver transplant recipients. Journal of Pediatrics, 156, 270-276
2. Bjorner, J. B., Rose, M., Gandek, B., Stone, A. A., Junghaenel, D. U., & Ware, J. E. (2014). Difference in method of administration did not significantly impact item response: An IRT-based analysis from the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. Quality of Life Research, 23, 217-227
3. Calvert, M., Blazeby, J., Altman, D. G., Revicki, D. A., Moher, D., & Brundage, M. D. (2013). Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension. JAMA, 309, 814-822
4. Carle, A. C., Blumberg, S. J., Moore, K. A., & Mbwana, K. (2011). Advanced psychometric methods for developing and evaluating cut-point-based indicators. Child Indicators Research, 4, 101-126
5. Chitkara, D. K., Rawat, D. J., & Talley, N. J. (2005). The epidemiology of childhood recurrent abdominal pain in Western countries: A systematic review. American Journal of Gastroenterology, 100, 1868-1875
6. Chung, H., Kim, J., Cook, K. F., Askew, R. L., Revicki, D. A., & Amtmann, D. (2014). Testing measurement invariance of the patient-reported outcomes measurement information system pain behaviors score between the US general population sample and a sample of individuals with chronic pain. Quality of Life Research, 23, 239-244
7. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Erlbaum
8. Cronbach, L. J. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16, 297-334
9. Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of Clinical Epidemiology, 56, 395-407
10. Desai, A. D., Zhou, C., Stanford, S., Haaland, W., Varni, J. W., & Mangione-Smith, R. M. (2014). Validity and responsiveness of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales in the pediatric inpatient setting. JAMA Pediatrics, 168, 1114-1121
11. Eiser, C., & Varni, J.W. (2013). Health related quality of life and symptom reporting: Similarities and differences between children and their parents. European Journal of Pediatrics, 172, 1299-1304
12. Fairclough, D.L. (2002). Design and analysis of quality of life studies in clinical trials: Interdisciplinary statistics. New York, NY: Chapman & Hall/.CRC
13. Fayers, P. M., & Hays, R. D. (2014). Don't middle your MIDs: Regression to the mean shrinks estimates of minimally important differences. Quality of Life Research, 23, 1-4
14. FDA. (2009). 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
15. FDA. (2012, September 19). Gastroenterology regulatory endpoints and the advancement of therapeutics (GREATWorkshop). College Park, MD: FDA
16. Hartman, E. E., Pawaskar, M., Williams, V., McLeod, L., Dubois, D., Benninga, M. A., & Joseph, A. (2014). Psychometric properties of the PedsQL Generic Core Scales for children with functional constipation in the Netherlands. Journal of Pediatric Gastroenterology & Nutrition, 59, 739-747
17. Hilliard, M. E., Lawrence, J. M., Modi, A. C., Anderson, A., Crume, T., Dolan, L. M., & Hood, K. K. (2013). 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, 36, 1891-1897
18. Hyams, J., Markowitz, J., Otley, A., Rosh, J., Mack, D., Bousvaros, A., & Griffiths, A. (2005). Evaluation of the pediatric Crohn disease activity index: A prospective multicenter experience. Journal of Pediatric Gastroenterology and Nutrition, 41, 416-421
19. Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status: Ascertaining the minimal clinically important difference. Controlled Clinical Trials, 10, 407-415
20. Kim, S. C., & Ferry, G. D. (2004). Inflammatory bowel diseases in pediatric and adolescent patients: Clinical, therapeutic, and psychosocial considerations. Gastroenterology, 126, 1550-1560
21. Kunz, J. H., Hommel, K. A., & Greenley, R. N. (2010). Health-related quality of life of youth with inflammatory bowel disease: A comparison with published data using the PedsQL 4.0 Generic Core Scales. Inflammatory Bowel Diseases, 16, 939-946
22. Liu, H., Cella, D., Gershon, R., Shen, J., Morales, L. S., Riley, W., & Hays, R. D. (2010). Representativeness of the patient-reported outcomes measurement information system Internet panel. Journal of Clinical Epidemiology, 63, 1169-1178
23. Marcus, S. B., Strople, J. A., Neighbors, K., Weissberg-Benchell, J., Nelson, S. P., Limbers, C. A., Alonso, E.M. (2009). Fatigue and health-related quality of life in pediatric inflammatory bowel disease. Clinical Gastroenterology and Hepatology, 7, 554-561
24. McHorney, C. A. (2002). The potential clinical value of quality of life information. Medical Care, 40(Suppl), III-56-III-62
25. McLeod, L. D., Coon, C. D., Martin, S. A., Fehnel, S. E., & Hays, R. D. (2011). Interpreting patient-reported outcome results: US FDA guidance and emerging methods. Expert Review of Pharmacoeconomics and Outcomes Research, 11, 163-169
26. Mohammad, S., Di Lorenzo, C., Youssef, N. N., Miranda, A., Nurko, S., Hyman, P., & Saps, M. (2014). Assessment of abdominal pain through global outcomes and recent FDA recommendations in children: Are we ready for change? Journal of Pediatric Gastroenterology and Nutrition, 58, 46-50
27. Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41, 582-592
28. Nunnally, J. C., & Bernstein, I. R. (1994). Psychometric theory (3rd ed.). New York, NY: McGraw-Hill
29. Pohl, J. F., Limbers, C. A., Kay, M. T., Harman, A., Rollins, M., & Varni, J. W. (2012). Health-related quality of life in pediatric patients with longstanding pancreatitis. Journal of Pediatric Gastroenterology and Nutrition, 54, 657-663
30. Rasquin, A., Di Lorenzo, C., Forbes, D., Guiraldes, E., Hyams, J. S., Staiano, A., & Walker, L. S. (2006). Childhood functional gastrointestinal disorders: Child/adolescent. Gastroenterology, 130, 1527-1537
31. Reeve, B. B., Wyrwich, K. W., Wu, A. W., Velikova, G., Terwee, C. B., Snyder, C. F., Butt, Z. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22, 1889-1905
32. Reynolds, C. R., & Kamphaus, R. W. (2004). Behavior assessment system for children (2nd ed.). Circle Pines, MN: American Guidance Service
33. Ryan, J. L., Mellon, M. W., Junger, K. W., Hente, E. A., Denson, L. A., Saeed, S., & Hommel, K. A. (2013). The clinical utility of health-related quality of life screening in a pediatric inflammatory bowel disease clinic. Inflammatory Bowel Diseases, 19, 2666-2672
34. Saps, M., Sesphadri, R., Sztainberg, M., Schaffer, G., Marshall, B. M., & Di Lorenzo, C. (2009). A prospective school-based study of abdominal pain and other common somatic complaints in children. Journal of Pediatrics, 154, 322-326
35. Schünemann, H. J., Akl, E. A., & Guyatt, G. H. (2006). Interpreting the results of patient reported outcome measures in clinical trials: The clinician's perspective. Health and Quality of Life Outcomes, 4, 62
36. Turner, D., Otley, A. R., Macks, D., Hyams, J., De Bruijne, J., Uusoue, K., Griffiths, A. M. (2007). Development, validation, and evaluation of a Pediatric Ulcerative Colitis Activity Index: A prospective multicenter study. Gastroenterology, 133, 423-432
37. van den Berg, M. M., Benninga, M. A., & Di Lorenzo, C. (2006). Epidemiology of childhood constipation: A systematic review. American Journal of Gastroenterology, 101, 2401-2409
38. Varni, J. W., Bendo, C. B., Denham, J., Shulman, R. J., Self, M. M., Neigut, D. A., Pohl, J. F. (2014). PedsQLTM Gastrointestinal Symptoms Module: Feasibility, reliability, and validity. Journal of Pediatric Gastroenterology and Nutrition, 59, 347-355
39. Varni, J. W., Bendo, C. B., Denham, J., Shulman, R. J., Self, M. M., Neigut, D. A., Pohl, J. F. (2015). PedsQLTM Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Quality of Life Research, 24, 363-378
40. Varni, J. W., Bendo, C. B., Nurko, S., Shulman, R. J., Self, M. M., Franciosi, J. P., Pohl, J. F. (2015). Health-related quality of life in pediatric patients with functional and organic gastrointestinal diseases. Journal of Pediatrics, 166, 85-90
41. Varni, J. W., Burwinkle, T. M., & Seid, M. (2006). The PedsQLTM 4.0 as a school population health measure: Feasibility, reliability, and validity. Quality of Life Research, 15, 203-215
42. Varni, J. W., Burwinkle, T. M., Seid, M., & Skarr, D. (2003). The PedsQLTM 4.0 as a pediatric population health measure: Feasibility, reliability, and validity. Ambulatory Pediatrics, 3, 329-341
43. Varni, J. W., Burwinkle, T. M., Sherman, S. A., Hanna, K., Berrin, S. J., Malcarne, V. L., & Chambers, H. G. (2005). Health-related quality of life of children and adolescents with cerebral palsy: Hearing the voices of the children. Developmental Medicine and Child Neurology, 47, 592-597
44. Varni, J. W., Kay, M. T., Limbers, C. A., Franciosi, J. P., & Pohl, J. F. (2012). PedsQLTM Gastrointestinal Symptoms Module item development: Qualitative methods. Journal of Pediatric Gastroenterology and Nutrition, 54, 664-671
45. Varni, J. W., Lane, M., Burwinkle, T., Fontaine, E., Youssef, N., Schwimmer, J., Easley, D. (2006). Health-related quality of life in pediatric patients with irritable bowel syndrome: A comparative analysis. Journal of Developmental and Behavioral Pediatrics, 27, 451-458
46. Varni, J. W., & Limbers, C. A. (2009). The Pediatric Quality of Life InventoryTM: Measuring pediatric health-related quality of life from the perspective of children and their parents. Pediatric Clinics of North America, 56, 843-863
47. Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007a). How young can children reliably and validly self-report their health-related quality of life?: An analysis of 8, 591 children across age subgroups with the PedsQLTM 4.0 Generic Core Scales. Health and Quality of Life Outcomes, 5(1), 1-13
48. Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007b). Literature review: Health-related quality of life measurement in pediatric oncology: Hearing the voices of the children. Journal of Pediatric Psychology, 32, 1151-1163
49. Varni, J. W., Limbers, C. A., Sorensen, L. G., Neighbors, K., Martz, K., Bucuvalas, J. C., & Alonso, E. M. (2011). PedsQLTM Cognitive Functioning Scale in pediatric liver transplant recipients: Feasibility, reliability and validity. Quality of Life Research, 20, 913-921
50. Varni, J. W., Seid, M., & Kurtin, P. S. (2001). PedsQLTM 4.0: Reliability and validity of the Pediatric Quality of Life InventoryTM Version 4.0 Generic Core Scales in healthy and patient populations. Medical Care, 39, 800-812
51. Varni, J. W., Thompson, K. L., & Hanson, V. (1987). The Varni/Thompson Pediatric Pain Questionnaire: I Chronic musculoskeletal pain in juvenile rheumatoid arthritis. Pain, 28, 27-38
52. Williet, N., Sandborn, W. J., & Peyrin-Biroulet, L. (2014). Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clinical Gastroenterology and Hepatology, 12, 1246-1256
53. Wyrwich, K. W., Norquist, J. M., Lenderking, W. R., & Acaster, S. (2013). Methods for interpreting change over time in patient-reported outcome measures. Quality of Life Research, 22, 475-483
54. Wyrwich, K. W., Tierney, W. M., & Wolinsky, F. D. (1999). Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. Journal of Clinical Epidemiology, 52, 861-873
55. Youssef, N. N., Langseder, A. L., Verga, B. J., Mones, R. L., & Rosh, J. R. (2005). Chronic childhood constipation is associated with impaired quality of life: A case-controlled study. Journal of Pediatric Gastroenterology and Nutrition, 41, 56-60
56. Youssef, N. N., Murphy, T. G., Langseder, A. L., & Rosh, J. R. (2006). Quality of life for children with functional abdominal pain: A comparison study of patients' and parents' perceptions. Pediatrics, 117, 54-59