Web-based Validation Pelvic Floor Questionnaires

Completed

• Conditions: Pelvic Floor Dysfunction
• Interventions: Other: paper form; Other: web/smartphone form

• Registration Number: NCT02724891
• Lead Sponsor: Columbia University

Brief Summary

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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-31
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1 paper form first	paper form	paper questionnaires first then web/smart phone questionnaires after a 2-week washout period
Arm 2 web/smartphone form first	paper form	web/smart phone questionnaires first then paper questionnaires after a 2-week washout period
Arm 1 paper form first	web/smartphone form	paper questionnaires first then web/smart phone questionnaires after a 2-week washout period
Arm 2 web/smartphone form first	web/smartphone form	web/smart phone questionnaires first then paper questionnaires after a 2-week washout period

Primary Outcome Measures

Name	Time	Method
Test-retest reliability of PFDI-20 in the electronic format	minimum 2 week interval until subject receives treatment for the condition or up to one year	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.
Test-retest reliability of PFIQ-7 in the electronic format	minimum 2 week interval until subject receives treatment for the condition or up to one year	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.
Test-retest reliability of PISQ-12 in the electronic format	minimum 2 week interval until subject receives treatment for the condition or up to one year	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.
Test-retest reliability of BSS in the electronic format	minimum 2 week interval until subject receives treatment for the condition or up to one year	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.

Trial Locations

Locations (5)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States