Web-based Validation Pelvic Floor Questionnaires

Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction

Patient-reported outcomes are commonly used in healthcare. Examples include validated symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and Reconstructive Surgery there are many questionnaires and diaries that have been validated for a paper-based administration. As technology is incorporated into delivery of medical care and research, investigators need to consider how to collect data electronically while ensuring that this new format is equivalent to the paper questionnaires they rely on. In this study, the investigators aim to validate a series of validated questionnaires and symptom diaries administered via the web and smartphone for a more streamlined care for the patients.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Dysfunction
• Intervention / Treatment: Other: paper form; Other: web/smartphone form

Detailed Description

Health questionnaires and health diaries are two forms of patient-reported outcomes (PRO) commonly used in healthcare. Health questionnaires are often used as intake logs, discerning and recording the symptoms and severity of a problem at the time of presentation. Health diaries, in contrast, are ongoing logs which allow for mindful attention to symptoms and monitoring of response to therapy. Unfortunately, both types of PRO forms are often under-utilized or uninterpretable because they are collected on paper. Within urogynecology, PRO scales such as the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Bristol Stool Chart, Bladder Diaries and others are used ubiquitously. Their impact, however, is diminished by poor compliance and recall bias. The move towards electronic PRO measures would be endorsed by patients (who can track and interact with their data), physicians (who can track progress and study group outcomes) and by regulators (who want to ensure accurate and reproducible data collection). Electronic PRO tools, particularly on the patient's own device, would allow for increased rate of reporting through mobile availability, time stamping of data to prevent recall bias and reduction in data entry mistakes and costs.

Study Procedures After informed consent is obtained, demographic data will be collected. Subjects will be administered the questionnaires either in paper or web-based or smartphone form based on a random number block scheme. At least two weeks later but prior to treatment they will complete the other form of the questionnaire. This can occur at their next office visit or can be completed at home. Subjects will be emailed and/or called by research staff to remind them to complete the second set of questionnaires.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72701
      • University of Arkansas
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53726
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This is a prospective validation study. Subjects will be recruited at their visit to the Female Pelvic Medicine and Reconstructive Surgery offices and clinics at Columbia and Cornell. Demographic information will be collected at the initial visit/enrollment including age, race, parity, and presenting complaint.

Questionnaires will be administered based on a randomization scheme. These include:

• Pelvic Floor Disorders Inventory short form (PFDI-20)
• Pelvic Floor Impact Questionnaire (PFIQ-7)
• Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
• Bristol Stool Scale (BSS)

Questionnaires will be administered via paper-based form, web-based, or smartphone app based on randomization scheme.

Description

Inclusion Criteria:

• Women at least 18 years of age presenting with pelvic floor dysfunction

Exclusion Criteria:

• Unable to repeat questionnaires or return to the office in 2 weeks
• No access to computer/web or smartphone
• Pregnancy (as gestational age will advance during 2 week time interval and symptoms may change)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1 paper form first; paper questionnaires first then web/smart phone questionnaires after a 2-week washout period	Other: paper form; questionnaires in paper form; Other: web/smartphone form; questionnaires in web/smartphone
Arm 2 web/smartphone form first; web/smart phone questionnaires first then paper questionnaires after a 2-week washout period	Other: paper form; questionnaires in paper form; Other: web/smartphone form; questionnaires in web/smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test-retest reliability of PFDI-20 in the electronic format	Subjects will complete the paper and either web-based or smartphone versions of the PFDI-20 with at least a 2 week interval between administration of the 2 versions.	minimum 2 week interval until subject receives treatment for the condition or up to one year
Test-retest reliability of PFIQ-7 in the electronic format	Subjects will complete the paper and either web-based or smartphone versions of the PFIQ-7 with at least a 2 week interval between administration of the 2 versions.	minimum 2 week interval until subject receives treatment for the condition or up to one year
Test-retest reliability of PISQ-12 in the electronic format	Subjects will complete the paper and either web-based or smartphone versions of the PISQ-12 with at least a 2 week interval between administration of the 2 versions.	minimum 2 week interval until subject receives treatment for the condition or up to one year
Test-retest reliability of BSS in the electronic format	Subjects will complete the paper and either web-based or smartphone versions of the BSS with at least a 2 week interval between administration of the 2 versions.	minimum 2 week interval until subject receives treatment for the condition or up to one year

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: University of Wisconsin, Madison; University of Calgary; University of Arkansas; The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Cara Grimes, MD, Columbia University

Publications and helpful links

General Publications

• Grimes CL, Antosh DD, Oliphant S, Yurteri-Kaplan L, Kim-Fine S, Melamud G, Heisler C, Chung DE; Collaborative Research in Pelvic Surgery Consortium (CoRPS). Correlation of Electronic (Web-Based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2020 Jun;26(6):396-400. doi: 10.1097/SPV.0000000000000713.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pelvic Floor Dysfunction
• Other Study ID Numbers: AAAO8451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No