Considerations for Patient Identification and Enrolment for Retrospective Studies for the Collection of Long Term Follow-up Data
Author(s)
Brett N1, Gianchetti L2, Schellack G3, Bassel M4
1PPD, part of Thermo Fisher Scientific, Saint Laurent, QC, Canada, 2PPD, part of Thermo Fisher Scientific, Philadelphia, PA, USA, 3PPD, part of Thermo Fisher Scientific, Johannesburg, South Africa, 4PPD, part of Thermo Fisher Scientific, Montreal, QC, Canada
Presentation Documents
OBJECTIVES: Retrospective chart review studies aiming to collect longer-term data following completion of parent studies (i.e., studies planned months/years after the parent study) are challenged by several factors, including patient identification and site recruitment. It is critical to study success to maximize patient retention and identify considerations for ethics and data archiving which may depend on the original study methodology.
Our aim was to describe challenges and solutions for executing long-term, retrospective follow-up studies, based on the author’s experience and lessons learned from conducting these types of studies.METHODS: Learnings from four follow-up studies (North America and Europe) were synthesized, taking into consideration the methodology of the prior studies.
RESULTS: Challenges to patient enrolment included: 1. Low interest or inability of site to participate (i.e., lack of resources); 2. Data not retained from parent studies to identify patients; 3. Inability to access patient charts; 4. Patients lost to follow-up (LTFU); 5. Inability to engage patients for consent or re-consent.
Potential solutions include: 1. Initiate follow-up studies soon after parent studies to avoid loss of investigator interest or patient data; leverage key opinion leaders to emphasize research importance to increase site interest; 2. Provide key patient characteristics as an anchor, and EMR search algorithms to aid patient identification; 3. Clearly establish record retention policies/requirements to avoid records being prematurely discarded; 4. Review death registries for survival outcomes; 5. Engage country-specific ethics and site outreach experts for patient inclusion strategies; work collaboratively with sites to confirm parent study consent covers future data collection.CONCLUSIONS: Obtaining data for retrospective follow-up chart reviews can be complex, tailored solutions are needed to maximize sample size. Early identification of challenges and solutions is essential for study success. Strategic decision-making and bespoke solutioning should be led by experts in scientific design and operational conduct of retrospective follow-up studies.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
SA77
Topic
Methodological & Statistical Research, Study Approaches
Topic Subcategory
Electronic Medical & Health Records, Missing Data
Disease
No Additional Disease & Conditions/Specialized Treatment Areas