Gastrointestinal symptoms predictors of health-related quality of life in pediatric patients with functional gastrointestinal disorders
- 500 Downloads
To investigate the patient-reported multidimensional gastrointestinal symptoms predictors of generic health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs).
The Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Scales and PedsQL™ 4.0 Generic Core Scales were completed in a 9-site study by 259 pediatric patients with functional constipation, functional abdominal pain (FAP), or irritable bowel syndrome (IBS). Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were identified as clinically important symptom differentiators from healthy controls based on prior findings, and subsequently tested for bivariate and multivariate linear associations with overall HRQOL.
Gastrointestinal symptoms were differentially associated with decreased HRQOL in bivariate analyses for the three FGIDs. In predictive models utilizing hierarchical multiple regression analyses controlling for age, gender, and race/ethnicity, gastrointestinal symptoms differentially accounted for an additional 47, 40, and 60 % of the variance in patient-reported HRQOL for functional constipation, FAP, and IBS, respectively, reflecting large effect sizes. Significant individual gastrointestinal symptoms predictors were identified after controlling for the other gastrointestinal symptoms in the FGID-specific predictive models.
Gastrointestinal symptoms represent potentially modifiable predictors of generic HRQOL in pediatric patients with FGIDs. Identifying the condition-specific gastrointestinal symptoms that are the most important predictors from the patient perspective facilitates a patient-centered approach to targeted interventions designed to ameliorate impaired overall HRQOL.
KeywordsIrritable bowel syndrome Functional constipation Functional abdominal pain Gastrointestinal symptoms Patient-reported outcomes PedsQL
Irritable bowel disease
Functional abdominal pain
Functional gastrointestinal disorder
Health-related quality of life
Pediatric Quality of Life Inventory™
Dr. Varni holds the copyright and the trademark for the PedsQL™ and receives financial compensation from the Mapi Research Trust, which is a nonprofit research institute that charges distribution fees to for-profit companies that use the Pediatric Quality of Life Inventory™. Dr. Varni received investigator-initiated funding from Takeda Pharmaceuticals North America, Inc. (Deerfield, Illinois) for the previous item generation qualitative methods study. Dr. Pohl received investigator-initiated funding from Takeda Pharmaceuticals North America, Inc. (Deerfield, Illinois) for the previous item generation qualitative methods study. Drs. Varni and Pohl did not receive funding from Takeda Pharmaceuticals North America, Inc. for the current quantitative methods field test study. Dr. Pohl has received the following funding: INSPPIRE to Study Acute Recurrent and Chronic Pancreatitis is Children, Grant # 10987759, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Pohl is on the speaker’s bureau for Medical Education Resources, Inc. Dr. Shulman is supported by NIH grants R01 NR013497 and T32 DK007664 and receives research funding from Mead-Johnson and is a consultant for Nutrinia. Dr. Nurko is supported by NIH grant K24DK082792A. Dr Saeed is on the speaker’s bureau for Abbvie, Inc. These grants are not related to the current study. The other authors report no competing interests related to this study. Dr. Saps is now at the Division of Digestive Diseases, Hepatology, and Nutrition, Nationwide Children’s Hospital, Ohio State University, Columbus, OH. Dr. Saeed is now at the Division of Pediatric Gastroenterology, Dayton Children’s Hospital, Wright State University, Dayton, OH. Dr. Vaughan Dark is now at the Division of Pediatric Pulmonology, Children’s Medical Center, Dallas, TX.
No funding was specifically designated for the PedsQL™ Gastrointestinal Symptoms Module field test study data collection effort or manuscript preparation.
Compliance with ethical standards
Conflict of interest
Item development for the PedsQL™ Gastrointestinal Symptoms Module was previously supported by Takeda Pharmaceuticals North America, Inc. Data collection for the healthy controls sample was supported by intramural funding from the Texas A&M University Foundation.
Human and animal rights
The research protocol for the field test study was approved by the Institutional Review Board at each participating institution. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees.
Informed consent was obtained from all individual participants included in the study.
- 6.Mohammad, S., Di Lorenzo, C., Youssef, N. N., Miranda, A., Nurko, S., Hyman, P., et al. (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.CrossRefPubMedPubMedCentralGoogle Scholar
- 8.Czyzewski, D. I., Lane, M. M., Weidler, E. M., Williams, A. E., Swank, P. R., & Shulman, R. J. (2011). The interpretation of Rome III criteria and method of assessment affect the irritable bowel syndrome classification of children. Alimentary Pharmacology & Therapeutics, 33, 403–411.CrossRefGoogle Scholar
- 12.Hartman, E. E., Pawaskar, M., Williams, V., McLeod, L., Dubois, D., Benninga, M. A., et al. (2014). Psychometric properties of the PedsQL Generic Core Scales for children with functional constipation in the Netherlands. Journal of Pediatric Gastroenterology and Nutrition, 59, 739–747.CrossRefPubMedGoogle Scholar
- 13.Varni, J. W., Shulman, R. J., Self, M. M., Nurko, S., Saps, M., Saeed, S., et al. (2015). Symptom profiles in patients with irritable bowel syndrome or functional abdominal pain compared to healthy controls. Journal of Pediatric Gastroenterology and Nutrition, 61, 323–329.CrossRefPubMedGoogle Scholar
- 17.Varni, J. W., Bendo, C. B., Denham, J., Shulman, R. J., Self, M. M., Neigut, D. A., et al. (2015). PedsQL™ 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.CrossRefPubMedGoogle Scholar
- 18.Varni, J. W., Franciosi, J. P., Shulman, R. J., Saeed, S., Nurko, S., Neigut, D. A., et al. (2015). PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with inflammatory bowel disease in comparison to healthy controls. Inflammatory Bowel Diseases, 21, 1115–1124.CrossRefPubMedGoogle Scholar
- 19.Varni, J. W., Bendo, C. B., Shulman, R. J., Self, M. M., Nurko, S., Franciosi, J. P., et al. (2015). Interpretability of the PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases. Journal of Pediatric Psychology, 40, 591–601.CrossRefPubMedPubMedCentralGoogle Scholar
- 23.Fairclough, D. L. (2002). Design and analysis of quality of life studies in clinical trials: Interdisciplinary statistics. New York: Chapman & Hall/CRC.Google Scholar
- 25.Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007). 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 PedsQL™ 4.0 Generic Core Scales. Health and Quality of Life Outcomes, 5(1), 1–13.CrossRefPubMedPubMedCentralGoogle Scholar
- 27.Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Erlbaum.Google Scholar
- 28.Cohen, J., Cohen, P., West, S. G., & Aiken, L. S. (2003). Applied multiple regression/correlation analysis for the behavioral sciences (3rd ed.). Mahwah, NJ: Erlbaum.Google Scholar
- 29.Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007). Impaired health-related quality of life in children and adolescents with chronic conditions: A comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL™ 4.0 Generic Core Scales. Health and Quality of Life Outcomes, 5(43), 1–15.CrossRefPubMedPubMedCentralGoogle Scholar
- 31.Cushing, C. C., Martinez-Leo, B., Bischoff, A., Hall, J., Helmrath, M., Hsi Dickie, B., Levitt, M. A., Peña, A., Zeller, M. H., & Frischer, J. S. (in press). Health related quality of life and parental stress in children with fecal incontinence: A normative comparison. Journal of Pediatric Gastroenterology & Nutrition.Google Scholar
- 35.Carlson, M. J., Moore, C. E., Tsai, C. M., Shulman, R. J., & Chumpitazi, B. P. (2014). Child and parent perceived food-induced gastrointestinal symptoms and quality of life in children with functional gastrointestinal disorders. Journal of the Academy of Nutrition and Dietetics, 114, 403–413.CrossRefPubMedGoogle Scholar
- 36.Chumpitazi, B. P., Weidler, E. M., Lu, D. Y., Tsai, C. M., & Shulman, R. J. (in press). Self-perceived food intolerances are common and associated with clinical severity in childhood irritable bowel syndrome. Journal of the Academy of Nutrition and Dietetics.Google Scholar
- 37.Reed-Knight, B., Squires, M., Chitkara, D. K., & van Tilburg, M. A. (in press). Adolescents with irritable bowel syndrome report increased eating-associated symptoms, changes in dietary composition, and altered eating behaviors: A pilot comparison study to healthy adolescents. Neurogastroenterology & Motility.Google Scholar
- 40.Ragnarsson, G., & Bodemar, G. (1998). Pain is temporally related to eating but not to defaecation in the irritable bowel syndrome (IBS): Patients’ description of diarrhea, constipation and symptom variation during a prospective 6-week study. European Journal of Gastroenterology and Hepatology, 10, 415–421.CrossRefPubMedGoogle Scholar
- 43.McKenzie, Y. A., Bowyer, R. K., Leach, H., Gulia, P., Horobin, J., O’Sullivan, N. A., Pettitt, C., Reeves, L. B., Seamark, L., Williams, M., Thompson, J., & Lomer, M. C. E. (in press). British Dietetic Association systematic review and evidence based practice guidelines for the dietary management of irritable bowel syndrome in adults (2016 update). Journal of Human Nutrition and Dietetics.Google Scholar