Web-based Validation Pelvic Floor Questionnaires
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | February 2015 |
| End Date: | October 2018 |
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.
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.
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.
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.
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)
We found this trial at
5
sites
750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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