학술논문

Validation of bladder health scales and function indices for women's research
Document Type
Report
Source
American Journal of Obstetrics and Gynecology. May, 2023, Vol. 228 Issue 5, 566.e1
Subject
Women -- Health aspects
Health
Language
English
ISSN
0002-9378
Abstract
Key words adaptive behavior; construct validity; instrument; lower urinary tract symptoms; multitrait-multimethod Background Existing bladder-specific measures lack the ability to assess the full range of bladder health, from poor to optimal health. Objective This study aimed to report evidence of validity of the self-administered, multidimensional bladder health scales and function indices for research in adult women. Study Design A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms in 7 clinical research centers. Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed-effects intraclass correlation coefficient models. Chi-square, Fisher exact, or t-tests were used for mode comparisons. Convergent validity was evaluated using Pearson correlations with the external construct measures, and known-group validity was established with comparison of women known and unknown to be symptomatic of urinary conditions. Results The sample included 1072 participants. Factor analysis identified 10 scales, with Cronbach's alpha ranging from 0.74 to 0.94. Intraclass correlation coefficients of scales ranged from 0.55 to 0.94. Convergent validity of the 10 scales and 6 indices ranged from 0.52 to 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration. Conclusion The paper and electronic forms of the bladder health scales and function indices are reliable and valid measures of bladder health for use in women's health research. Author Affiliation: (a) Division of Biostatistics, University of Minnesota, Minneapolis, MN (b) Patient Centered Research, Evidera, Bethesda, MD (c) Department of Health Policy, University of Minnesota, Minneapolis, MN (d) Departments of Urology and Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT (e) National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (f) School of Nursing, University of Michigan, Ann Arbor, MI (g) Department of Obstetrics and Gynecology, Washington University School of Medicine, Washington University in St. Louis, St. Louis, MO (h) Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL (i) School of Public Health, The University of Alabama at Birmingham, Birmingham, AL (j) Departments of Urology and Obstetrics and Gynecology, Loyola University Medical Center, Loyola University Chicago, Chicago, IL (k) Division of Urology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA (l) Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA (m) Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Diego, La Jolla, CA * Corresponding author: Melissa L. Constantine, PhD. for all queries related to methodology, psychometrics, data analysis and interpretation as well as BHS/BFI use and scoring. Article History: Received 18 July 2022; Revised 15 December 2022; Accepted 21 December 2022 (footnote) The authors report no conflict of interest. (footnote) This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health (NIH) by cooperative agreements (U24 DK106786, U01 DK106853, U01 DK106858, U01 DK106898, U01 DK106893, U01 DK106827, U01 DK106908, U01 DK106892). Additional funding was received from the National Institute on Aging, NIH Office of Research on Women's Health. (footnote) Clinical trials: (footnote) Date of registration: July 11, 2019 (footnote) Date of initial participant enrollment: July 31, 2019 (footnote) Clinical trial identification number: NCT04016298 (footnote) URL of the registration site: https://clinicaltrials.gov/ct2/show/NCT04016298?term=NCT04016298&draw=2&rank=1(https://clinicaltrials.gov/ct2/show/NCT04016298?term=NCT04016298&draw=2&rank=1) (footnote) Data sharing information NA (footnote) Cite this article as: Constantine ML, Rockwood T, Rickey L, et al. Validation of bladder health scales and function indices for women's research. Am J Obstet Gynecol 2023;228:566.e1-14. Byline: Melissa L. Constantine, PhD [cons0026@umn.edu] (a,b,*), Todd H. Rockwood, PhD (c), Leslie M. Rickey, MD (d), Tamara Bavendam, MD (e), Lisa Kane Low, PhD (f), Jerry L. Lowder, MD (g), Alayne D. Markland, DO (h), Gerald McGwin, PhD (i), Elizabeth R. Mueller, MD (j), Diane K. Newman, DNP (k), Sara Putnam, MS (a), Kyle Rudser, PhD (a), Ariana L. Smith, MD (k), Ann E. Stapleton, MD (l), Janis M. Miller, PhD (f), Emily S. Lukacz, MD [elukacz@ucsd.edu] (m,**), Linda Brubaker, MD, Elizabeth R. Mueller, MD, MSME; Marian Acevedo-Alvarez, MD, Colleen M. Fitzgerald, MD, MS, Cecilia T. Hardacker, MSN, RN, CNL, Jeni Hebert-Beirne, PhD, MPH, Missy Lavender, MBA, James W. Griffith, PhD, Kimberly Sue Kenton, MD, Melissa Simon, MD, MPH, Julia Geynisman-Tan, MD, Alayne D. Markland, DO, MSc, Tamera Coyne-Beasley, MD, MPH, FAAP, FSAHM, Kathryn L. Burgio, PhD, Cora E. Lewis, MD, MSPH, Gerald McGwin Jr., MS, PhD, Camille P. Vaughan, MD, MS, Beverly Rosa Williams, PhD, Emily S. Lukacz, MD, Sheila Gahagan, MD, MPH, D. Yvette LaCoursiere, MD, MPH, Jesse Nodora, DrPH, Janis M. Miller, PhD, APRN, FAAN, Lisa Kane Low, PhD, CNM, FACNM, FAAN, Bernard L. Harlow, PhD, Kyle D. Rudser, PhD, Sonya S. Brady, PhD, Haitao Chu, MD, PhD, Melissa L. Constantine, PhD, Cynthia S. Fok, MD, MPH, Peter Scal, PhD, Todd Rockwood, PhD, Diane K. Newman, DNP FAAN, Ariana L. Smith, MD, Amanda Berry, MSN, CRNP, Andrea Bilger, MPH, Heather Klusaritz, PhD, MSW, Terri Lipman, PhD, Ann E. Stapleton, MD, Jean F. Wyman, PhD, Siobhan Sutcliffe, PhD, ScM, MHS, Aimee S. James, PhD, MPH, Jerry L. Lowder, MD, MSc, Melanie R. Meister, MD, MSCI, Leslie M. Rickey, MD, MPH, Marie A. Brault, PhD, Deepa R. Camenga, MD, MHS, Shayna D. Cunningham, PhD, Julia Barthold, MD