Building a Robust Investigator-Initiated Platform The I-CARE Experience /
Investigator-initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I-CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 coun...
Elmentve itt :
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| Dokumentumtípus: | Cikk |
| Megjelent: |
2026
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| Sorozat: | CLINICAL PHARMACOLOGY & THERAPEUTICS
119 No. 6 |
| Tárgyszavak: | |
| doi: | 10.1002/cpt.70231 |
| mtmt: | 36967072 |
| Online Access: | http://publicatio.bibl.u-szeged.hu/39418 |
| Tartalmi kivonat: | Investigator-initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I-CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 countries for up to 6 years. We describe patients and investigators' involvement in I-CARE and identify predictors of early withdrawal due to patient non-engagement. Patients' characteristics according to the number of electronic Patient-reported outcomes (ePRO) completed during follow-up were assessed. Predictors of early withdrawal due to patient non-engagement were identified using logistic regression. The coding of outcomes reported by patients and corrections by investigators on patients' ePROs were assessed. Among 12,846 patients included by 502 investigators, 79.3% and 77.3% filled more than one ePRO and at least one ePRO within 6 months before the study end date, respectively. All ePROs were completed in 72.8% and 56.4% of patients during year 1 and 3, respectively. Male gender, younger age (< 20), being unemployed or a student, and no previous history of abdominal surgery were associated with early withdrawal. Investigators corrected 52.5% of cancer or dysplasia reported by patients compared to 10% of serious infections. Investigators added or removed a treatment sequence in 19.6% of the 6708 patients treated with biologics. These results highlight the implication of patients in research and the importance of data validation by investigators alongside the challenge and potential of collecting medical data from patients. These findings can inform similar future initiatives in other diseases. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258). |
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| Terjedelem/Fizikai jellemzők: | 10 1537-1546 |
| ISSN: | 0009-9236 |