Skip to main content

Advertisement

SpringerLink
Log in

Item bank development, calibration and validation for patient-reported outcomes in female urinary incontinence

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Purpose

Current patient-reported outcomes for female urinary incontinence (UI) are limited by their inability to be tailored. Our objective is to describe the development and field testing of seven item banks designed to measure domains identified as important UI in females (UIf). We also describe the calibration and validation properties of the UIf-item banks, which allow for more efficient computerized adaptive testing (CAT) in the future.

Methods

The UIf-measures included 168 items covering seven domains: Stress UI (SUI), overactive bladder (OAB), urinary frequency, physical, social and emotional health impact and adaptation. Items underwent rigorous qualitative development and psychometric testing across two sites. Items were calibrated using item response theory and evaluated for internal consistency, construct validity and responsiveness.

Results

A total of 750 women (249 SUI, 249 OAB and 252 mixed UI) participated. Mean age was 55 ± 14 years, and 23 % were Hispanic and 80 % white. In addition to face and content validity, the measures demonstrated good internal consistency (coefficient alpha 0.92–0.98) and unidimensionality. There was evidence for construct validity with moderate-to-strong correlations with the UDI (r’s ≥ 0.6) and IIQ (r’s = ≥0.6) scales. The measures were responsive to change for SUI treatment (paired t test p < .001, ES range 1.3–2.9; SRM range 1.3–2.5) and OAB treatment (paired t test p < .05 for all domains except social health impact and adaptation, ES range 0.3–1.5, SRM range 0.4–1.0). The measures were responsive based on concurrent changes with the UDI and IIQ (p < 0.05). CAT versions were developed and pilot-tested.

Conclusions

The UIf-item banks demonstrate good psychometric characteristics and are a sufficiently valid set of customizable tools for measuring UI symptoms and life impact.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Nygaard, I., Barber, M. D., Burgio, K. L., et al. (2008). Prevalence of symptomatic pelvic floor disorders in US women. JAMA, 300, 1311–1316.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Dooley, Y., Kenton, K., Cao, G., et al. (2008). Urinary incontinence prevalence: Results from the national health and nutrition examination survey. Journal of Urology, 179, 656–661.

    Article  PubMed  Google Scholar 

  3. Abrams, P., Andersson, K. E., Birder, L., et al. (2010). Fourth international consultation on incontinence recommendations of the international scientific committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourology and Urodynamics, 29, 213–240.

    Article  CAS  PubMed  Google Scholar 

  4. Staskin, D., Tubaro, A., Norton, P. A., & Ashton-Miller, J. A. (2011). Mechanisms of continence and surgical cure in female and male SUI: Surgical research initiatives. Neurourology and Urodynamics, 30, 704–707.

    Article  PubMed  Google Scholar 

  5. de Ayala, R. J. (2009). The theory and practice of item response theory. New York: The Guilford Press.

    Google Scholar 

  6. Cotterill, N., Goldman, H., Kelleher, C., Kopp, Z., Tubaro, A., & Brubaker, L. (2011). What are the best outcome measures when assessing treatments for LUTD? Achieving the most out of outcome evaluation: ICI-RS. Neurourology and Urodynamics, 31, 400–403.

    Article  Google Scholar 

  7. Barber, M. D., Kuchibhatla, M. N., Pieper, C. F., & Bump, R. C. (2001). Psychometric evaluation of two comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. American Journal of Obstetrics and Gynecology, 185, 1388–1395.

    Article  CAS  PubMed  Google Scholar 

  8. Shumaker, S. A., Wyman, J. F., Uebersax, J. S., McClish, D., & Fantl, J. A. (1994). Health-related quality of life measures for women with urinary incontinence: The incontinence impact questionnaire and the urogenital distress inventory. Quality of Life Research, 3, 291–306.

    Article  CAS  PubMed  Google Scholar 

  9. Rogers, R. G., Kammerer-Doak, D., Villarreal, A., Coates, K., & Qualls, C. (2001). A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. American Journal of Obstetrics and Gynecology, 184, 552–558.

    Article  CAS  PubMed  Google Scholar 

  10. Cella, D., Riley, W., Stone, A., et al. (2010). The patient reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology, 63, 1179–1194.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Bjorner, J. B., Chang, C. H., Thissen, D., & Reeve, B. B. (2007). Developing tailored instruments: Item banking and computerized adaptive assessment. Quality of Life Research, 16(Suppl 1), 95–108.

    Article  PubMed  Google Scholar 

  12. Fries, J. F., Krishnan, E., Rose, M., Lingala, B., & Bruce, B. (2011). Improved responsiveness and reduced sample size requirements of PROMIS physical function scales with item response theory. Arthritis Research and Therapy, 13, R147.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Sung, V. W., Marques, F., Rogers, R. R., Williams, D. A., Myers, D. L., & Clark, M. A. (2011). Content validation of the patient-reported outcomes measurement information system (PROMIS) framework in women with urinary incontinence. Neurourology and Urodynamics, 30, 503–509.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Jabine, T., Straf, J. T., & Tourangeau, R. (1984). Cognitive aspects of survey design: Building a bridge between disciplines. Washington DC: National Academy Press.

    Google Scholar 

  15. Edelen, M. O., & Reeve, B. B. (2007). Applying item response theory (IRT) modeling to questionnaire development, evaluation, and refinement. Quality of Life Research, 16(Suppl 1), 5–18.

    Article  PubMed  Google Scholar 

  16. Sandvik, H., Espuna, M., & Hunskaar, S. (2006). Validity of the incontinence severity index: Comparison with pad-weighing tests. International Urogynecology Journal, 17, 520–524.

    Article  Google Scholar 

  17. Yalcin, I., & Bump, R. C. (2003). Validation of two global impression questionnaires for incontinence. American Journal of Obstetrics and Gynecology, 189, 98–101.

    Article  PubMed  Google Scholar 

  18. Hayton, J. C., Allen, D. G., & Scarpello, V. (2001). Factor retention decision in exploratory factor analysis: A tutorial on parallel analysis. Organizational Research Methods, 7, 191–205.

    Article  Google Scholar 

  19. Horn, J. L. (1965). A rationale and test for the number of factors in factor analysis. Psychometrika, 30, 179–185.

    Article  CAS  PubMed  Google Scholar 

  20. O’Connor, B. P. (2000). SPSS and SAS programs for determining the number of components using parallel analysis and Velicer’s MAP test. Behavior Research Methods, Instruments, and Computers, 32, 396–402.

    Article  PubMed  Google Scholar 

  21. Holzinger, K. J., & Swineford, F. (1937). The bi-factor method. Psychometrika, 2, 41–54.

    Article  Google Scholar 

  22. Jennrich, R. I., & Bentler, P. M. (2011). Exploratory bi-factor analysis. Psychometrika, 76, 537–549.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Jennrich, R. I., & Bentler, P. M. (2012). Exploratory bi-factor analysis: The oblique case. Psychometrika, 77, 442–454.

    Article  Google Scholar 

  24. Reise, S. P., Scheines, R., Widaman, K. F., & Haviland, M. G. (2013). Multidimensionality and structural coefficient bias in structural equation modeling a bifactor perspective. Educational and Psychological Measurement, 73, 5–26.

    Article  Google Scholar 

  25. Cohen, J. (1988). Statistical power analysis for the behavioural sciences (2nd ed.). New York: Academic Press.

    Google Scholar 

  26. Guyatt, G., Walter, S., & Norman, G. (1987). Measuring change over time: Assessing the usefulness of evaluative instruments. Journal of Chronic Diseases, 40, 171–178.

    Article  CAS  PubMed  Google Scholar 

  27. Subak, L. L., Adamson, G. D., & Boltz, N. L. (1992). Therapeutic donor insemination: A prospective randomized trial of fresh versus frozen sperm. American Journal of Obstetrics and Gynecology, 166, 1597–1604. (discussion 604-6).

    Article  CAS  PubMed  Google Scholar 

  28. Cai, L., Thissen, D., & du Toit, S. (2011). IRTPRO 2.0 for Windows. Scientific Software International, Chicago.

  29. Muthen, L.K., & Muthen, B.O. Mplus user’s guide. Seventh Edition. Los Angeles: Muthen & Muthen Copyright. 1998–2012.

  30. Computing RCTRFfS. R: (2014) A language and environment for statistical computing, Vienna. http://www.R-project.org.

  31. Choi, S. W., Gibbons, L. E., & Crane, P. K. (2011). Lordif: An R package for detecting differential item functioning using Iterative hybrid ordinal logistic regression/item response theory and monte carlo simulations. Journal of Statistical Software, 39, 1–30.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Hays, R. D., Morales, L. S., & Reise, S. P. (2000). Item response theory and health outcomes measurement in the 21st century. Medical Care, 38, 28–42.

    Article  Google Scholar 

  33. Thissen, D., & Wainer, H. (2001). Test Scoring. Mahwah: Erlbaum Associates.

    Google Scholar 

Download references

Acknowledgments

The authors wish to acknowledge Drs. Seung Choi, Matthew D. Barber, Linda Brubaker and David Williams for their contributions to this project.

Funding

Dr. Sung and this work are supported by Grant K23HD060665 and R21HD069962 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development or the National Institutes of Health. This research was also supported in part through the computational resources and staff contributions provided for the Social Sciences Computing Cluster (SSCC) at Northwestern University. Recurring funding for the SSCC is provided by Office of the President, Weinberg College of Arts and Sciences, Kellogg School of Management, the School of Continuing Studies and Northwestern University Information Technology.

Author information

Authors and Affiliations

  1. The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Women and Infants’ Hospital/Warren, Alpert Medical School of Brown University, 695 Eddy Street, Lower Level, Providence, RI, 02903, USA

    Vivian W. Sung

  2. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    James W. Griffith

  3. The Division of Urogynecology, Department of Obstetrics and Gynecology and Surgery, University of New Mexico, Albuquerque, NM, USA

    Rebecca G. Rogers

  4. The Division of Research, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA

    Christina A. Raker

  5. Department of Epidemiology and Obstetrics and Gynecology, Alpert Medical School and School of Public Health of Brown University, Providence, RI, USA

    Melissa A. Clark

Authors
  1. Vivian W. Sung
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. James W. Griffith
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Rebecca G. Rogers
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Christina A. Raker
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Melissa A. Clark
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vivian W. Sung.

Ethics declarations

Conflict of interest

Dr. Vivian Sung declares that she has no conflicts of interest. Dr. James Griffith declares that he has no conflicts of interest. Dr. Rebecca Rogers declares that she has no conflicts of interest. Her disclosures include: Health publishing: McGraw Hill—Royalties from textbook. Dr. Christina Raker declares that she has no conflicts of interest. Dr. Melissa Clark declares that she has no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

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

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 38 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sung, V.W., Griffith, J.W., Rogers, R.G. et al. Item bank development, calibration and validation for patient-reported outcomes in female urinary incontinence. Qual Life Res 25, 1645–1654 (2016). https://doi.org/10.1007/s11136-015-1222-1

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-015-1222-1

Keywords

Search

Navigation