Utilization of electronic patient-reported outcome measures in cystic fibrosis research: Application to the GALAXY study
| Autor: | A. Jay Freeman, Phuong T. Vu, Sonya L. Heltshe, Sarah Jane Schwarzenberg, Umer Khan, Melita Romasco, Baha Moshiree, Steven D. Freedman, Christopher H. Goss, Meghana Sathe |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Pulmonary and Respiratory Medicine Patient-Reported Outcomes Measurement Information System Gi symptoms Pediatrics medicine.medical_specialty Biomedical Research Adolescent Cystic Fibrosis Cystic fibrosis Article Food and drug administration Young Adult Quality of life Humans Medicine Patient Reported Outcome Measures Prospective Studies Child business.industry Outcome measures Electronic patient-reported outcome medicine.disease Mobile Applications Clinical research Child Preschool Pediatrics Perinatology and Child Health Female business |
| Zdroj: | J Cyst Fibros |
| ISSN: | 1569-1993 |
| DOI: | 10.1016/j.jcf.2021.07.002 |
| Popis: | BACKGROUND: The Food and Drug Administration considers patient-reported outcome measures (PROMs) an essential part of clinical research studies for approval of new drugs and new indications for existing drugs. GALAXY evaluated the feasibility of electronic PROMs (ePROMS) to conduct a comprehensive evaluation of gastrointestinal (GI) symptoms in persons with cystic fibrosis (pwCF). METHODS: Three validated GI ePROMs (PAC-SYM, PAGI-SYM and PAC-QOL) were combined with a Stool-Specific questionnaire to make up the GALAXY ePROMs and administered prospectively across 26 CF centers in the United States. The ePROMs were completed at enrollment visit and then electronically at weeks 1, 2 and 4. PwCF at least 2 years and older were eligible for the study. Reminders were only provided by the mobile application during the study window. RESULTS: There were 402 participants enrolled in GALAXY. Of those, 169 (42%) were under 18 years old and 193 (48%) were female. The proportion of all follow-up weeks with at least 1 ePROM fully completed was 80%, slightly higher in those ≥18 years of age (82.5%) compared to those |
| Databáze: | OpenAIRE |
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