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Gastrointestinal symptoms predictors of health-related quality of life in pediatric patients with functional gastrointestinal disorders

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Abstract

Objectives

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).

Methods

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.

Results

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.

Conclusions

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.

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Abbreviations

IBS:

Irritable bowel disease

FAP:

Functional abdominal pain

FGID:

Functional gastrointestinal disorder

HRQOL:

Health-related quality of life

PedsQL™:

Pediatric Quality of Life Inventory™

PRO:

Patient-reported outcome

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Acknowledgments

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.

Funding

No funding was specifically designated for the PedsQL™ Gastrointestinal Symptoms Module field test study data collection effort or manuscript preparation.

Author information

Authors and Affiliations

  1. Professor Emeritus, Department of Pediatrics, College of Medicine, Texas A&M University, 3137 TAMU, College Station, TX, 77843-3137, USA

    James W. Varni

  2. Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station, TX, USA

    James W. Varni

  3. Department of Pediatrics, Baylor College of Medicine, Children’s Nutrition Research Center, Texas Children’s Hospital, Houston, TX, USA

    Robert J. Shulman

  4. Departments of Psychiatry and Pediatrics, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX, USA

    Mariella M. Self

  5. Center for Motility and Functional Gastrointestinal Disorders, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA

    Samuel Nurko

  6. Division of Gastroenterology, Hepatology and Nutrition, Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Miguel Saps

  7. Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

    Shehzad A. Saeed

  8. Division of Pediatric Gastroenterology, Children’s Medical Center of Dallas, University of Texas Southwestern Medical School, Dallas, TX, USA

    Ashish S. Patel

  9. Department of Psychology, Texas A&M University, College Station, TX, USA

    Chelsea Vaughan Dark

  10. Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil

    Cristiane B. Bendo

  11. Department of Pediatric Gastroenterology, Primary Children’s Hospital, University of Utah, Salt Lake City, UT, USA

    John F. Pohl

Authors
  1. James W. Varni
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  2. Robert J. Shulman
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  3. Mariella M. Self
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  4. Samuel Nurko
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  5. Miguel Saps
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  6. Shehzad A. Saeed
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  7. Ashish S. Patel
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  8. Chelsea Vaughan Dark
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  9. Cristiane B. Bendo
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  10. John F. Pohl
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Consortia

on behalf of the Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Module Testing Study Consortium

  • Jolanda Denham
  • , James P. Franciosi
  • , Deborah A. Neigut
  • , Samuel Nurko
  • , Ashish S. Patel
  • , John F. Pohl
  • , Shehzad Saeed
  • , Miguel Saps
  • , Mariella M. Self
  • , Robert J. Shulman
  • , James W. Varni
  • , Barbara Verga
  •  & George M. Zacur

Corresponding author

Correspondence to James W. Varni.

Ethics declarations

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

Informed consent was obtained from all individual participants included in the study.

Additional information

The Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Module Testing Study Consortium members are listed in the "Appendix".

Appendix: The Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Module Testing Study Consortium

Appendix: The Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Module Testing Study Consortium

The Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Module Testing Study Consortium sites include a Network and Statistical Center at the Center for Health Systems & Design, Colleges of Architecture and Medicine, Texas A&M University, College Station, TX (PI: James W. Varni, PhD), and 9 primary research data collection sites: Division of Pediatric Gastroenterology, Nationwide Children’s Hospital, Ohio State University School of Medicine, Columbus, OH (PI: Jolanda Denham, MD); Department of Pediatrics, Baylor College of Medicine, Children’s Nutrition Research Center, Texas Children’s Hospital, Houston, TX (PIs: Robert J. Shulman, MD and Mariella M. Self, PhD); Division of Gastroenterology, Hepatology and Nutrition, Children’s Hospital Colorado, Aurora, CO (PI: Deborah A. Neigut, MD); Center for Motility and Functional Gastrointestinal Disorders, Boston Children’s Hospital, Harvard Medical School, Boston, MA (PI: Samuel Nurko, MD); Division of Pediatric Gastroenterology, Children’s Medical Center of Dallas, University of Texas Southwestern Medical School, Dallas, TX (PI: Ashish S. Patel, MD); Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH (PIs: James P. Franciosi, MD, Shehzad Saeed, MD, and George M. Zacur, MD); Division of Gastroenterology, Hepatology and Nutrition, Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL (PI: Miguel Saps, MD); Division of Pediatric Gastroenterology, Hepatology and Nutrition, Goryeb Children’s Hospital, Morristown Medical Center, Morristown, NJ (PI: Barbara Verga, MD); Department of Pediatric Gastroenterology, Primary Children’s Hospital, University of Utah, Salt Lake City, UT (PI: John F. Pohl, MD).

See Appendix Tables 3, 4, and 5.

Table 3 Pearson’s product–moment intercorrelations among the PedsQL™ Gastrointestinal Symptoms Scales for pediatric patients with functional constipation
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Table 4 Pearson’s product–moment intercorrelations among the PedsQL™ Gastrointestinal Symptoms Scales for pediatric patients with functional abdominal pain
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Table 5 Pearson’s product–moment intercorrelations among the PedsQL™ Gastrointestinal Symptoms Scales for pediatric patients with irritable bowel syndrome
Full size table

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Varni, J.W., Shulman, R.J., Self, M.M. et al. Gastrointestinal symptoms predictors of health-related quality of life in pediatric patients with functional gastrointestinal disorders. Qual Life Res 26, 1015–1025 (2017). https://doi.org/10.1007/s11136-016-1430-3

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