Importance of Adjudication Committees in Retrospective Chart Review Studies for Outcomes Event Data Collection
Author(s)
Marielle Bassel, BA1, Paul Daniel Bibat, BSN, RN2, Kelly Donham, PhD2.
1PPD™ Observational Studies, Thermo Fisher Scientific, Montreal, QC, Canada, 2PPD™ Clinical Research Services, Thermo Fisher Scientific, Waltham, MA, USA.
1PPD™ Observational Studies, Thermo Fisher Scientific, Montreal, QC, Canada, 2PPD™ Clinical Research Services, Thermo Fisher Scientific, Waltham, MA, USA.
OBJECTIVES: Retrospective chart reviews analyze existing patient data to gain insights into health outcomes; however, a key limitation is incomplete or missing data. Safety event and outcomes data are essential for understanding the safety profile and effectiveness of medical interventions, supporting regulatory submissions and practice guidelines. Standardized assessments ensure consistency and reliability, enabling meaningful comparisons within and across global studies. This abstract demonstrates how an Adjudication Committee enhances outcome data accuracy using evidence from a chart review study.
METHODS: An Adjudication Committee of expert healthcare practitioners (HCPs) was established to independently review and determine hemostatic effectiveness for bleeding events, ensuring a bias-free assessment separate from sites. A Charter guided the review of data extracted from patient medical charts, following standard protocol definitions of hemostatic effectiveness to support the primary endpoint, classified via a binary assessment of ‘effective’ or ‘not effective’.
RESULTS: A total of 328 bleeding events were adjudicated by 3 HCPs. Of these, 85% were adjudicated with a definite hemostatic effectiveness rating of ‘effective’ or ‘not effective’; this high rate is attributable to the standardized definition utilized as well as committee guidance on data collection. A sub-cohort with a higher proportion of missing data showed an increased rate of definitive, standardized outcomes from 40% to 63%, significantly reducing the number of events where hemostatic effectiveness could not previously be determined and increasing the number of analyzable events for the primary outcome. The committee’s expert guidance and a collaborative approach to developing the Charter were streamlined, contributing to the reduction of undetermined events.
CONCLUSIONS: Adjudication committees allow for structured, unbiased expert reviews, enhancing the reliability of retrospective outcomes data. When dealing with complex or incomplete real-world data, their involvement can ensure data integrity and accuracy essential for regulatory or other decision-making processes, ultimately improving patient safety and informing healthcare guidance.
METHODS: An Adjudication Committee of expert healthcare practitioners (HCPs) was established to independently review and determine hemostatic effectiveness for bleeding events, ensuring a bias-free assessment separate from sites. A Charter guided the review of data extracted from patient medical charts, following standard protocol definitions of hemostatic effectiveness to support the primary endpoint, classified via a binary assessment of ‘effective’ or ‘not effective’.
RESULTS: A total of 328 bleeding events were adjudicated by 3 HCPs. Of these, 85% were adjudicated with a definite hemostatic effectiveness rating of ‘effective’ or ‘not effective’; this high rate is attributable to the standardized definition utilized as well as committee guidance on data collection. A sub-cohort with a higher proportion of missing data showed an increased rate of definitive, standardized outcomes from 40% to 63%, significantly reducing the number of events where hemostatic effectiveness could not previously be determined and increasing the number of analyzable events for the primary outcome. The committee’s expert guidance and a collaborative approach to developing the Charter were streamlined, contributing to the reduction of undetermined events.
CONCLUSIONS: Adjudication committees allow for structured, unbiased expert reviews, enhancing the reliability of retrospective outcomes data. When dealing with complex or incomplete real-world data, their involvement can ensure data integrity and accuracy essential for regulatory or other decision-making processes, ultimately improving patient safety and informing healthcare guidance.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO143
Topic
Clinical Outcomes, Methodological & Statistical Research
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)