Web-based Validation Pelvic Floor Questionnaires
Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 1N4
- University Of Calgary
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72701
- University of Arkansas
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Irving Medical Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Hospital
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53726
- University of Wisconsin School of Medicine and Public Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Case-Crossover
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Arm 1 paper form first
paper questionnaires first then web/smart phone questionnaires after a 2-week washout period
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questionnaires in paper form
questionnaires in web/smartphone
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Arm 2 web/smartphone form first
web/smart phone questionnaires first then paper questionnaires after a 2-week washout period
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questionnaires in paper form
questionnaires in web/smartphone
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Test-retest reliability of PFDI-20 in the electronic format
Prazo: minimum 2 week interval until subject receives treatment for the condition or up to one year
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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.
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minimum 2 week interval until subject receives treatment for the condition or up to one year
|
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Test-retest reliability of PFIQ-7 in the electronic format
Prazo: minimum 2 week interval until subject receives treatment for the condition or up to one year
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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.
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minimum 2 week interval until subject receives treatment for the condition or up to one year
|
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Test-retest reliability of PISQ-12 in the electronic format
Prazo: minimum 2 week interval until subject receives treatment for the condition or up to one year
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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
Prazo: 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.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cara Grimes, MD, Columbia University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- AAAO8451
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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