Quality of Life Research

, Volume 20, Issue 1, pp 45–55 | Cite as

The PedsQL™ Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants

  • James W. VarniEmail author
  • Christine A. Limbers
  • Katie Neighbors
  • Kris Schulz
  • Judith E. C. Lieu
  • Robert W. Heffer
  • Krista Tuzinkiewicz
  • Rita Mangione-Smith
  • Jerry J. Zimmerman
  • Estella M. Alonso



The PedsQL™ (Pediatric Quality of Life Inventory™) is a modular instrument designed to measure health-related quality of life (HRQOL) and disease-specific symptoms in children and adolescents ages 2–18. The new PedsQL™ Infant Scales were designed as a generic HRQOL instrument specifically for healthy and ill infants ages 1–24 months. The objective of this study was to report on the initial feasibility, internal consistency reliability, and validity of the PedsQL™ Infant Scales in healthy, acutely ill, and chronically ill infants.


The 36-item (ages 1–12 months) and 45-item (ages 13–24 months) PedsQL™ Infant Scales (Physical Functioning, Physical Symptoms, Emotional Functioning, Social Functioning, Cognitive Functioning) were completed by 683 parents of healthy, acutely ill, and chronically ill infants.


The PedsQL™ Infant Scales evidenced minimal missing responses, achieved excellent internal consistency reliability for the Total Scale Scores (α = 0.92), distinguished between healthy infants and acutely and chronically ill infants, and demonstrated a confirmatory factor structure largely consistent with the a priori conceptual model.


The results demonstrate the initial measurement properties of the PedsQL™ Infant Scales in healthy and ill infants. The findings suggest that the PedsQL™ Infant Scales may be utilized in the evaluation of generic HRQOL in infants ages 1–24 months.


PedsQL™ Infants Health-related quality of life Patient-reported outcomes 



Pediatric Quality of Life Inventory™


Food and Drug Administration


Health-related quality of life



This research was funded in part by intramural grants from the Texas A&M University Research Foundation and the Scott and White Memorial Hospital Research Foundation.

Competing Interests

Dr. Varni holds the copyright and the trademark for the PedsQL™ and receives financial compensation from the Mapi Research Trust, which is a non-profit research institute that charges distribution fees to for-profit companies that use the Pediatric Quality of Life Inventory™.


  1. 1.
    Varni, J. W., Burwinkle, T. M., & Lane, M. M. (2005). Health-related quality of life measurement in pediatric clinical practice: An appraisal and precept for future research and application. Health and Quality of Life Outcomes, 3(34), 1–9.Google Scholar
  2. 2.
    Matza, L. S., Swensen, A. R., Flood, E. M., Secnik, K., & Leidy, N. K. (2004). Assessment of health-related quality of life in children: A review of conceptual, methodological, and regulatory issues. Value in Health, 7, 79–92.CrossRefPubMedGoogle Scholar
  3. 3.
    Palermo, T. M., Long, A. C., Lewandowski, A. S., Drotar, D., Quittner, A. L., & Walker, L. S. (2008). Evidence-based assessment of health-related quality of life and functional impairment in pediatric psychology. Journal of Pediatric Psychology, 33, 896–983.CrossRefGoogle Scholar
  4. 4.
    World Health Organization. (1948). Constitution of the World Health Organization: Basic document. Geneva, Switzerland: World Health Organization.Google Scholar
  5. 5.
    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.Google Scholar
  6. 6.
    Patrick, D. L., & Deyo, R. A. (1989). Generic and disease-specific measures in assessing health status and quality of life. Medical Care, 27, S217–S233.CrossRefPubMedGoogle Scholar
  7. 7.
    Varni, J. W., Seid, M., & Rode, C. A. (1999). The PedsQL™: Measurement model for the Pediatric Quality of Life Inventory™. Medical Care, 37, 126–139.CrossRefPubMedGoogle Scholar
  8. 8.
    Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007). Parent proxy-report of their children’s health-related quality of life: An analysis of 13,878 parents’ reliability and validity across age subgroups using the PedsQL™ 4.0 Generic Core Scales. Health and Quality of Life Outcomes, 5(2), 1–10.CrossRefPubMedGoogle Scholar
  9. 9.
    Campo, J. V., Comer, D. M., Jansen-McWilliams, L., Gardner, W., & Kelleher, K. J. (2002). Recurrent pain, emotional distress, and health service use in childhood. Journal of Pediatrics, 141, 76–83.CrossRefPubMedGoogle Scholar
  10. 10.
    Janicke, D. M., Finney, J. W., & Riley, A. W. (2001). Children’s health care use: A prospective investigation of factors related to care-seeking. Medical Care, 39, 990–1001.CrossRefPubMedGoogle Scholar
  11. 11.
    Upton, P., Lawford, J., & Eiser, C. (2008). Parent-child agreement across child health-related quality of life instruments: A review of the literature. Quality of Life Research, 17, 895–913.CrossRefPubMedGoogle Scholar
  12. 12.
    Varni, J. W., & Limbers, C. A. (2009). The Pediatric Quality of Life Inventory™: Measuring pediatric health-related quality of life from the perspective of children and their parents. Pediatric Clinics of North America, 56, 843–863.CrossRefPubMedGoogle Scholar
  13. 13.
    Fekkes, M., Theunissen, N. C. M., Brugman, E., Veen, S., Verrips, E. G. H., Koopman, H. M., et al. (2000). Development and psychometric evaluation of the TAPQOL: A health-related quality of life instrument for 1–5-year-old children. Quality of Life Research, 9, 961–972.CrossRefPubMedGoogle Scholar
  14. 14.
    Bunge, E. M., Essink-Bot, M. L., Kobussen, M. P., van Suijlekom-Smit, L. W., Moll, H. A., & Ratt, H. (2005). Reliability and validity of health status measurement by the TAPQOL. Archives of Disease in Childhood, 90, 351–358.CrossRefPubMedGoogle Scholar
  15. 15.
    Klassen, A. F., Landgraf, J. M., Lee, S. K., Barer, M., Raina, P., Chan, H. W. P., et al. (2003). Health related quality of life in 3 and 4 year old children and their parents: Preliminary findings about a new questionnaire. Health and Quality of Life Outcomes, 1, 81.CrossRefPubMedGoogle Scholar
  16. 16.
    Raat, H., Landgraf, J. M., Oostenbrink, R., Moll, H. A., & Essink-Bot, M. L. (2007). Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample. Quality of Life Research, 16, 445–460.CrossRefPubMedGoogle Scholar
  17. 17.
    Aday, L. A. (1996). Designing and conducting health surveys: A comprehensive guide (2nd ed.). San Francisco: Jossey-Bass.Google Scholar
  18. 18.
    Fowler, F. J. (1995). Improving survey questions: Design and evaluation. Thousand Oaks, CA: Sage.Google Scholar
  19. 19.
    Schwarz, N., & Sudman, N. (Eds.). (1996). Answering questions: Methodology for determining cognitive and communicative processes in survey research. San Francisco: Jossey-Bass.Google Scholar
  20. 20.
    Fairclough, D. L. (2002). Design and analysis of quality of life studies in clinical trials: Interdisciplinary statistics. New York: Chapman & Hall/CRC.Google Scholar
  21. 21.
    Varni, J. W., Seid, M., & Kurtin, P. S. (2001). PedsQL™ 4.0: Reliability and validity of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales in healthy and patient populations. Medical Care, 39, 800–812.CrossRefPubMedGoogle Scholar
  22. 22.
    McHorney, C. A., Ware, J. E., Lu, J. F. R., & Sherbourne, C. D. (1994). The MOS 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Medical Care, 32, 40–66.CrossRefPubMedGoogle Scholar
  23. 23.
    Fairclough, D. L., & Cella, D. F. (1996). Functional assessment of cancer therapy (FACT-G): Non-response to individual questions. Quality of Life Research, 5, 321–329.CrossRefPubMedGoogle Scholar
  24. 24.
    Cronbach, L. J. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16, 297–334.CrossRefGoogle Scholar
  25. 25.
    Nunnally, J. C., & Bernstein, I. R. (1994). Psychometric theory (3rd ed.). New York: McGraw-Hill.Google Scholar
  26. 26.
    Pedhazur, E. J., & Schmelkin, L. P. (1991). Measurement, design, and analysis: An integrated approach. Hillsdale, NJ: Erlbaum.Google Scholar
  27. 27.
    McHorney, C. A., & Tarlow, A. R. (1995). Individual-patient monitoring in clinical practice: Are available health status surveys adequate? Quality of Life Research, 4, 293–307.CrossRefPubMedGoogle Scholar
  28. 28.
    Fayers, P. M., & Machin, D. (2000). Quality of life: Assessment, analysis, and interpretation. New York: Wiley.Google Scholar
  29. 29.
    Varni, J. W., Burwinkle, T. M., Katz, E. R., Meeske, K., & Dickinson, P. (2002). The PedsQL™ in pediatric cancer: Reliability and validity of the Pediatric Quality of Life Inventory™ Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer, 94, 2090–2106.CrossRefPubMedGoogle Scholar
  30. 30.
    Varni, J. W., Burwinkle, T. M., Rapoff, M. A., Kamps, J. L., & Olson, N. (2004). The PedsQL™ in pediatric asthma: Reliability and validity of the Pediatric Quality of Life Inventory™ Generic Core Scales and Asthma Module. Journal of Behavioral Medicine, 27, 297–318.CrossRefPubMedGoogle Scholar
  31. 31.
    Varni, J. W., Seid, M., Knight, T. S., Burwinkle, T. M., Brown, J., & Szer, I. S. (2002). The PedsQL™ in pediatric rheumatology: Reliability, validity, and responsiveness of the Pediatric Quality of Life Inventory™ Generic Core Scales and Rheumatology Module. Arthritis and Rheumatism, 46, 714–725.CrossRefPubMedGoogle Scholar
  32. 32.
    Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Erlbaum.Google Scholar
  33. 33.
    SPSS. (2008). SPSS 16.0 for Windows. Chicago: SPSS, Inc.Google Scholar
  34. 34.
    Hurley, A. E., Scandura, T. A., Schriesheim, C. A., Brannick, M. T., Seers, A., Vandenberg, R. J., et al. (1997). Exploratory and confirmatory factor analysis: Guidelines, issues, and alternatives. Journal of Organizational Behavior, 18, 667–683.CrossRefGoogle Scholar
  35. 35.
    Mulaik, S., James, L., Van Alstine, J., Bennett, N., Lind, S., & Stilwell, C. (1989). Evaluation of goodness-of-fit indices for structural equation models. Psychological Bulletin, 105, 430–445.CrossRefGoogle Scholar
  36. 36.
    Bentler, P. (1990). Comparative fit indexes in structural models. Psychological Bulletin, 107, 238–246.CrossRefPubMedGoogle Scholar
  37. 37.
    Steiger, J. H. (1990). Structural model evaluation and modification: An interval estimation approach. Multivariate Behavioral Research, 25, 173–180.CrossRefGoogle Scholar
  38. 38.
    Tucker, L. R., & Lewis, C. (1973). A reliability coefficient for maximum likelihood factor analysis. Psychometrika, 38, 1–10.CrossRefGoogle Scholar
  39. 39.
    Hu, L., & Bentler, P. M. (1999). Cutoff criteria for fit indices in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling, 6, 1–55.CrossRefGoogle Scholar
  40. 40.
    Browne, M. W., & Cudeck, R. (1992). Alternative ways of assessing model fit. Sociological Methods and Research, 21, 230–258.CrossRefGoogle Scholar
  41. 41.
    Hu. L., & Bentler, P. M. (1995). Evaluating model fit. In Hoyle, R. H. (Ed.) Structural equation modeling: Concepts, issues and applications (pp. 76–99). Thousand Oaks: Sage.Google Scholar
  42. 42.
    Joreskog, K. G., & Sorbom, D. (2003). LISREL 8.5. Lincolnwood, IL: Scientific Software International, Inc.Google Scholar
  43. 43.
    Varni, J. W., Limbers, C. A., & Newman, D. A. (2009). Using factor analysis to confirm the validity of children’s self-reported health-related quality of life across different modes of administration. Clinical Trials, 6, 185–195.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2010

Authors and Affiliations

  • James W. Varni
    • 1
    • 2
    Email author
  • Christine A. Limbers
    • 3
  • Katie Neighbors
    • 4
  • Kris Schulz
    • 5
  • Judith E. C. Lieu
    • 6
  • Robert W. Heffer
    • 7
  • Krista Tuzinkiewicz
    • 4
  • Rita Mangione-Smith
    • 8
  • Jerry J. Zimmerman
    • 8
  • Estella M. Alonso
    • 4
  1. 1.Department of Pediatrics, College of MedicineTexas A&M UniversityCollege StationUSA
  2. 2.Department of Landscape Architecture and Urban Planning, College of ArchitectureTexas A&M UniversityCollege StationUSA
  3. 3.Department of PsychologyBaylor UniversityWacoUSA
  4. 4.Department of Pediatrics, Children’s Memorial HospitalNorthwestern UniversityChicagoUSA
  5. 5.American Academy of Otolaryngology-Head and Neck Surgery FoundationAlexandriaUSA
  6. 6.Department of Otolaryngology-Head and Neck SurgeryWashington UniversitySt LouisUSA
  7. 7.Department of PsychologyTexas A&M UniversityCollege StationUSA
  8. 8.Department of Pediatrics, Seattle Children’s HospitalUniversity of WashingtonSeattleUSA

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