Validation of Bladder Health Instrument for Evaluation in Women (VIEW)
26 mai 2022 mis à jour par: University of Minnesota
The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans.
The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission.
To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument.
To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public.
The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women.
This will be through a combination of general population recruitment for completing mailed surveys, clinical population recruitment for completing surveys and an in-person evaluation, and postpartum women.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
1222
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35223
- University of Alabama at Birmingham
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California
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San Diego, California, États-Unis, 92121
- University of California, San Diego
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Yale University
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Illinois
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Chicago, Illinois, États-Unis, 60153
- Loyola University Chicago
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Missouri
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Saint Louis, Missouri, États-Unis, 63100
- Washington University School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
The BHI is intended for use in the general US population and it is critical that the BHI validation include individuals who meet these criteria.
The goal is to include women over the age of 18 that meet the inclusion criteria.
It is our hope to get a broad spectrum of women with varying degrees of bladder health, age, race, and community.
La description
Inclusion Criteria:
- Community dwelling
- Age ≥18 years old
- Female sex assigned at birth
- Fluent in written and spoken English
- Able to read and provide informed consent
Exclusion Criteria:
- Institutional living arrangement, e.g., skilled nursing, long term care or rehabilitation center
- Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Bladder Health Instrument
Délai: Will be assessed throughout the duration of study, an average of one year.
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Multi-item measurement is used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS consortium.
It is anticipated that the self-administeredBHI instrument (PAPI or CASI) will consist of approximately 85 items: 53-67 are items all respondents will be asked to answer, and 48 are asked only of women who self-identify as experiencing a specific LUTS.
The items cover the range of bladder health dimensions specified by our model.
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Will be assessed throughout the duration of study, an average of one year.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.
- McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247-63. doi: 10.1097/00005650-199303000-00006.
- Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.
- Lukacz ES, Bavendam TG, Berry A, Fok CS, Gahagan S, Goode PS, Hardacker CT, Hebert-Beirne J, Lewis CE, Lewis J, Low LK, Lowder JL, Palmer MH, Smith AL, Brady SS. A Novel Research Definition of Bladder Health in Women and Girls: Implications for Research and Public Health Promotion. J Womens Health (Larchmt). 2018 Aug;27(8):974-981. doi: 10.1089/jwh.2017.6786. Epub 2018 May 24.
- Brady SS, Bavendam TG, Berry A, Fok CS, Gahagan S, Goode PS, Hardacker CT, Hebert-Beirne J, Lewis CE, Lewis JB, Kane Low L, Lowder JL, Palmer MH, Wyman JF, Lukacz ES; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. The Prevention of Lower Urinary Tract Symptoms (PLUS) in girls and women: Developing a conceptual framework for a prevention research agenda. Neurourol Urodyn. 2018 Nov;37(8):2951-2964. doi: 10.1002/nau.23787. Epub 2018 Aug 22.
- Bandilla W, Bosnjak M, Altdorfer P. Survey Administration Effects?: A Comparison of Web-Based and Traditional Written Self-Administered Surveys Using the ISSP Environment Module. Soc Sci Comput Rev. 2003;21(2):235-243. doi:10.1177/0894439303021002009.
- Dillman DA, Sangster RL, Tarnai J, Rockwood TH. Understanding differences in people's answers to telephone and mail surveys. New Dir Eval. 1996;1996(70):45-61. doi:10.1002/ev.1034.
- Vernon SW, Tiro JA, Vojvodic RW, Coan S, Diamond PM, Greisinger A, Fernandez ME. Reliability and validity of a questionnaire to measure colorectal cancer screening behaviors: does mode of survey administration matter? Cancer Epidemiol Biomarkers Prev. 2008 Apr;17(4):758-67. doi: 10.1158/1055-9965.EPI-07-2855. Epub 2008 Apr 1.
- Schwarz N, Strack F, Hippler H, Bishop G. The impact of administration mode on response effects in survey measurement. Jobe JB, Loftus EF, eds. Appl Cogn Psychol. 1991;5(3):193-212. doi:10.1002/acp.2350050304.
- Cronbach L. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297-334. doi:10.1007/BF02310555.
- Swartz RJ, de Moor C, Cook KF, Fouladi RT, Basen-Engquist K, Eng C, Carmack Taylor CL. Mode effects in the center for epidemiologic studies depression (CES-D) scale: personal digital assistant vs. paper and pencil administration. Qual Life Res. 2007 Jun;16(5):803-13. doi: 10.1007/s11136-006-9158-0. Epub 2007 Feb 13.
- Messick S. The interplay of evidence and consequences in the validation of performance assessments. ETS Res Rep Ser. 1992;1992(1):i-42. doi:10.1002/j.2333-8504.1992.tb01470.x.
- Kane MT. Validating the Interpretations and Uses of Test Scores. J Educ Meas. 2013;50(1):1-73. doi:10.1111/jedm.12000.
- Hawkins M, Elsworth GR, Osborne RH. Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity. Qual Life Res. 2018 Jul;27(7):1695-1710. doi: 10.1007/s11136-018-1815-6. Epub 2018 Feb 20.
- American Educational Research Association. Standards for Educational and Psychological Testing. (Association AP, Education NC on M in, (U.S.) JC on S for E and PT, eds.). Washington, DC: Washington, DC : American Educational Research Association; 2014.
- Streiner D. Health Measurement Scales : A Practical Guide to Their Development and Use. Fifth edit. (Norman GR, Cairney J, ebrary I, eds.). New York, New York: New York, New York : Oxford University Press; 2015.
- Messick S. VALIDITY. Educ Test Serv Res Rep Ser. 1987;1987(2):i-208. doi:10.1002/j.2330-8516.1987.tb00244.x.
- CAMPBELL DT, FISKE DW. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychol Bull. 1959 Mar;56(2):81-105. No abstract available.
- Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: Final Data for 2017. Natl Vital Stat Rep. 2018 Nov;67(8):1-50.
- Chin HB, Baird DD, McConnaughey DR, Weinberg CR, Wilcox AJ, Jukic AM. Long-term Recall of Pregnancy-related Events. Epidemiology. 2017 Jul;28(4):575-579. doi: 10.1097/EDE.0000000000000660.
- Naughton MJ, Donovan J, Badia X, Corcos J, Gotoh M, Kelleher C, Lukacs B, Shaw C. Symptom severity and QOL scales for urinary incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S114-23. doi: 10.1053/j.gastro.2003.10.059.
- Miller JM, Ashton-Miller JA, Delancey JO. Quantification of cough-related urine loss using the paper towel test. Obstet Gynecol. 1998 May;91(5 Pt 1):705-9. doi: 10.1016/s0029-7844(98)00045-3.
- Gorsuch RL. Common Factor Analysis versus Component Analysis: Some Well and Little Known Facts. Multivariate Behav Res. 1990 Jan 1;25(1):33-9. doi: 10.1207/s15327906mbr2501_3. No abstract available.
- Lukacz ES, Constantine ML, Kane Low L, Lowder JL, Markland AD, Mueller ER, Newman DK, Rickey LM, Rockwood T, Rudser K; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Rationale and design of the validation of bladder health instrument for evaluation in women (VIEW) protocol. BMC Womens Health. 2021 Jan 7;21(1):18. doi: 10.1186/s12905-020-01136-w.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 juillet 2019
Achèvement primaire (Réel)
25 mai 2022
Achèvement de l'étude (Réel)
25 mai 2022
Dates d'inscription aux études
Première soumission
5 juillet 2019
Première soumission répondant aux critères de contrôle qualité
10 juillet 2019
Première publication (Réel)
11 juillet 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 mai 2022
Dernière vérification
1 mai 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00032238
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .