Patient Generated Data

ACCESS PATIENT GENERATED health DATA

In addition to medical record data, Target RWE aggregates consented Patient Generated Health Data (PGHD) from both adult and pediatric participants by leveraging robust patient reported outcome (PRO) measures, surveys, and questionnaires. Target RWE’s PGHD are reported and recorded by patients (or by a proxy) and include information related to health, treatment histories, symptoms, lifestyle choices, among other datapoints. PGHD allow for the tracking of patients' well-being, and decision-making as they manage their disease. More importantly, Target RWE’s PGHD any potential gaps that may exist within the medical clinical records, providing a more comprehensive and robust patient journey.

PROs, surveys and/or questionnaires are completed at consent, including either quarterly, bi-annually, or yearly, depending on the disease state. An overview of the types of PROs collected to date are listed below; these measures are collected at the site visit and/or electronically. Additional PROs may be added throughout the course of the study and partners can provide feedback as to the addition of new PROs, surveys and/or questionnaires which will be approved for inclusion in the study by a therapeutically-aligned steering committee composed of key opinion leaders.

TARGET NASH Registry

 

TARGET-NASH’s PGHD include data derived from a robust set of measures and questionnaires (e.g., PROMIS, BEV Q15, etc.)  which are collected from both adult and pediatric participants at consent and on an approximately yearly basis, thereafter, repeated in years 2, 3, 4 & 5. Pediatric PROs (2-17 years) may be completed by a parent proxy.

TARGET DERM Registry

 

TARGET-DERM’s PGHD includes data derived from 25+ patient reported measures (e.g., PROMIS, POEM, NRS, UKWPC, DLQI, etc.) which are collected from both adult and pediatric participants at consent and on a quarterly basis thereafter, repeated in years 2, 3, 4 & 5. Pediatric PROs (ranging from 0-16 years) may be completed by a parent proxy. The dataset also includes a patient questionnaire on disease history, comorbidities, and lifestyle as well as information generated from a validated investigator global assessment (vIGA) to help supplement potential gaps.

Target IBD Registry

 

TARGET-IBD’s PGHD includes data derived from a robust set of measures (e.g., PRO-2, MIBDI, EuroEQ-5D, PUCAI, etc.) which are collected from both adult and pediatric participants with either Ulcerative Colitis (UC), Crohn’s Disease (CD) or Inflammatory Bowel Disease Unclassified (IBDU). PROs are completed at consent and on a quarterly basis thereafter, repeated in years 2, 3, 4 & 5. Pediatric PROs (2-17 years) may be completed by a parent proxy.

For more information on PROs, surveys and/or questionnaires related to our TARGET-HCC, TARGET-HBV, TARGET-PBC and TARGET-ASTHMA registries, please contact us.