Pulmonary Vascular Research Institute GoDeep: A meta‐registry merging deep phenotyping datafrom international PH reference centers

Abstract

The Pulmonary Vascular Research Institute GoDeep meta-registry is a collaboration of pulmonary hypertension (PH) reference centers across the globe. Merging worldwide PH data in a central meta-registry to allow advanced analysis of the heterogeneity of PH and its groups/subgroups on a worldwide geographical, ethnical, and etiological landscape (ClinTrial. gov NCT05329714). Retrospective and prospective PH patient data (diagnosis based on catheterization; individuals with exclusion of PH are included as a comparator group) are mapped to a common clinical parameter set of more than 350 items, anonymized and electronically exported to a central server. Use and access is decided by the GoDeep steering board, where each center has one vote. As of April 2022, GoDeep comprised 15,742 individuals with 1.9 million data points from eight PH centers. Geographic distribution comprises 3990 enrollees (25%) from America and 11,752 (75%) from Europe. Eightynine perecent were diagnosed with PH and 11% were classified as not PH and provided a comparator group. The retrospective observation period is an average of 3.5 years (standard error of the mean 0.04), with 1159 PH patients followed for over 10 years. Pulmonary arterial hypertension represents the largest PH group (42.6%), followed by Group 2 (21.7%), Group 3 (17.3%), Group 4 (15.2%), and Group 5 (3.3%). The age distribution spans several decades, with patients 60 years or older comprising 60%. The majority of patients met an intermediate risk profile upon diagnosis. Data entry from a further six centers is ongoing, and negotiations with >10 centers worldwide have commenced. Using electronic interface-based automated retrospective and prospective data transfer, GoDeep aims to provide in-depth epidemiological and etiological understanding of PH and its various groups/subgroups on a global scale, offering insights for improved management.

Pulmonary Hypertension Association's 2022 International Conference Scientific Sessions Overview

“…The GoDeep project was founded in 2018 under the umbrella of the Pulmonary Vascular Research Institute (PVRI) by three founding members, Imperial College London (UK), Johns Hopkins Hospital (USA), and Justus‐Liebig University Gieẞen (Germany), to compile data on patients with PH worldwide as a central meta‐registry 51 . Data from local PH registries is processed via an automated process that results in parameter translation and harmonization, data deidentification, and encrypted transfer of deidentified data to the GoDeep meta‐registry.…”

Real‐world evidence to advance knowledge in pulmonary hypertension: Status, challenges, and opportunities. A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative's Real‐world Evidence Working Group

“…Although PVRI-GoDeep investigators faced multiple challenges (Table 4), the ongoing success of PVRI-GoDeep demonstrates how careful planning can effectively overcome many challenges, create a novel source of PH RWD, and lay the groundwork for generating high-quality RWE that directly informs improvements in the care of PH patients. 126…”

“…The architects of GoDeep developed a strategy a priori to address the global disparities in PH epidemiologic data, employed a standardized framework and strict diagnostic criteria, and leveraged multiple EHR data sets to create a large, robust source of PH RWD. Although PVRI‐GoDeep investigators faced multiple challenges (Table 4), the ongoing success of PVRI‐GoDeep demonstrates how careful planning can effectively overcome many challenges, create a novel source of PH RWD, and lay the groundwork for generating high‐quality RWE that directly informs improvements in the care of PH patients 126 …”