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PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls

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Abstract

Objective

The primary objective was to compare the gastrointestinal (GI) symptoms and worry of pediatric patients with functional GI disorders (FGIDs) and organic GI diseases to healthy controls utilizing the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms and Worry Scales for patient self-reports ages 5–18 years and parent proxy-reports for ages 2–18 years. The secondary objective was to compare FGIDs and organic GI diseases to each other.

Methods

The PedsQL™ Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 587 pediatric patients with GI disorders and 685 parents of patients. Patients had physician-diagnosed GI disorders (chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn’s disease, ulcerative colitis, and gastroesophageal reflux disease). Ten 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, and Diarrhea were administered along with two Gastrointestinal Worry Scales. Five hundred and thirteen healthy children and 337 parents of healthy children completed the PedsQL™ Gastrointestinal Scales in an Internet panel survey.

Results

The PedsQL™ Gastrointestinal Symptoms and Worry Scales distinguished between pediatric patients with FGIDs and organic GI diseases in comparison with healthy controls, supporting known-groups validity. Patients with FGIDs reported more GI symptoms and worry than patients with organic GI diseases.

Conclusions

The PedsQL™ Gastrointestinal Symptoms and Worry Scales may be utilized as common metrics across pediatric patient groups with FGIDs and organic GI diseases and healthy samples to measure GI-specific symptoms in clinical research and practice.

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Abbreviations

PedsQL™:

Pediatric Quality of Life Inventory™

FDA:

Food and Drug Administration

HRQOL:

Health-related quality of life

GI:

Gastrointestinal

FGIDs:

Functional gastrointestinal disorders

PRO:

Patient-reported outcome

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Acknowledgments

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

Conflict of interest

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. Nurko is supported by NIH Grant K24DK082792A. Dr. Shulman is supported by NIH Grants R01 NR013497, R34 AT006986, and T32 DK007664. These grants are not related to the current study. The other authors report no competing interests related to this study.

Author information

Authors and Affiliations

  1. Department of Pediatrics, College of Medicine, Texas A&M University, College Station, TX, USA

    James W. Varni

  2. Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, 3137 TAMU, College Station, TX, 77843-3137, USA

    James W. Varni

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

    Cristiane B. Bendo

  4. Division of Pediatric Gastroenterology, Nationwide Children’s Hospital, Ohio State University School of Medicine, Columbus, OH, USA

    Jolanda Denham

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

    Robert J. Shulman

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

    Mariella M. Self

  7. Division of Gastroenterology, Hepatology and Nutrition, Children’s Hospital Colorado, Aurora, CO, USA

    Deborah A. Neigut & Alyson Yeckes

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

    Samuel Nurko

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

    Ashish S. Patel

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

    James P. Franciosi & Shehzad Saeed

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

    Miguel Saps

  12. Division of Pediatric Gastroenterology, Hepatology and Nutrition, Goryeb Children’s Hospital, Morristown Medical Center, Morristown, NJ, USA

    Annette Langseder

  13. 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. Cristiane B. Bendo
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  3. Jolanda Denham
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  4. Robert J. Shulman
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  8. Ashish S. Patel
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  9. James P. Franciosi
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  13. Shehzad Saeed
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  14. John F. Pohl
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Corresponding author

Correspondence to James W. Varni.

Additional information

For the Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Module Testing Study Consortium.

A list of the Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Module Testing Study Consortium sites is contained in the “Appendix”.

Drs. Franciosi and Denham are now at the Division of Gastroenterology, Hepatology and Nutrition, Nemours Children’s Hospital, Orlando, FL.

Appendix

Appendix

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 and Design, Colleges of Architecture and Medicine, Texas A&M University, College Station, TX (PI: James W. Varni, Ph.D.), and nine 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, Ph.D.); 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).

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Varni, J.W., Bendo, C.B., 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 24, 363–378 (2015). https://doi.org/10.1007/s11136-014-0781-x

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