ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0853

A Combined Patient Registry and Biobank Laboratory Information System for Prospective Multisite Chronic Rheumatic Disease Research Using REDCap

Craig Willers1, Tom Lynch1, Vibhasha Chand2, Mohammad Islam3, Marissa Lassere4, Helen Keen5, Tony Kenna6, Susan Lester7, Ranjeny Thomas8, Premarani Sinnathurai9, Mihir Wechalekar10, Ashley Fletcher11, Daniel Lightowler12, Sheeraz Mohd13, Nishta Ramnoruth14, Carlee Ruediger15, Helen Weedon16 and Lyn March17, 1Institute of Bone and Joint Research, Kolling Institute, University of Sydney, St Leonards, Australia, 2Public Health and Preventive Medicine, Monash University, Melbourne, Australia, 3Information and Communications Technology, University of Sydney, Sydney, Australia, 4St George Hospital; School of Population Health, University of New South Wales, Carlton, Australia, 5University of Western Australia, Daglish, Australia, 6Queensland University of Technology, School of Biomedical Sciences, Brisbane, Australia, 7Rheumatology Department, The Basil Hetzel Institute, The Queen Elizabeth Hospital, Adelaide, Australia, 8University of Queensland, Diamantina Institute, Brisbane, Australia, 9Institute of Bone and Joint Research, Kolling Institute, University of Sydney; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, Australia, 10Flinders Medical Centre, Southern Adelaide Local Health Network, Bedford Park, Australia, 11Cabrini Health, Malvern, Australia, 12Medical School, University of Western Australia; Rheumatology Department, Fiona Stanley Hospital, Perth, Australia, 13Fiona Stanley Hospital, South Metropolitan Health Services, Perth, Australia, 14Diamantina Institute, University of Queensland, Brisbane, Australia, 15University of Adelaide; The Queen Elizabeth Hospital, Adelaide, Australia, 16Flinders University, Bedford Park, Australia, 17Institute of Bone and Joint Research, Kolling Institute, University of Sydney; Department of Rheumatology, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, Sydney, Australia

Meeting: ACR Convergence 2021

Keywords: , , , ,

Session Information

Date: Sunday, November 7, 2021

Title: Research Methodology Poster (0846–0854)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: As we enter the big data revolution, comprehensive informatics solutions are essential to realising precision medicine for rheumatic and other chronic disease patients, especially for curating high-quality, large-scale and longitudinal biospecimen and linked data collections. In establishing the Australian Arthritis and Autoimmune Biobank Collaborative (A3BC), we sought to develop a low-cost, nation-scale data management system capable of managing our multi-site longitudinal biobank-registry and its complex biobank and data requirements. This included broad life-course data from adults and children across clinical/phenotypic, biological, patient-reported and administrative health data domains, collected to enable holistic multidisciplinary research towards improved outcomes for people living with arthritis and autoimmune conditions (Figure 1).

Methods: We assessed several international commercial and non-profit software platforms using standardised system requirement criteria and follow-up interviews. Vendor compliance scoring was prioritised to meeting our project-critical requirements. Consumer / end-user co-design was integral to refining our system requirements for optimised adoption. Customisation of the selected software solution was performed to optimise field auto-population between participant timepoints and forms, using external modules that do not impact core code. Institutional and independent testing was used to ensure data security.

Results: We selected the widely used research web application, Research Electronic Data Capture (REDCap), which is “free” for non-profit REDCap Consortium members. REDCap is highly configurable and customisable to a variety of biobank and registry needs and can be developed/ maintained by end-users with modest IT skill, time and cost. We created a secure, comprehensive participant-centric biobank-registry database that includes best practice data security measures (incl login for multi-site access using academic and government user credentials), permission-to-contact and dynamic itemised e-consent (Figure 2A), a complete chain of custody from consent to biospecimen/data collection to publication, complex longitudinal patient-reported surveys, a fully integrated biobanking workflow (Figure 2B), disease-specific case report forms (Figure 2C), integration of record-level extracted/ linked participant data, significant form auto-population for streamlined data capture, and native dashboards for operational visualisations. The system (Figure 3) has the capacity to enrol participants with a range of diagnoses as well as healthy or at-risk controls (e.g. first degree relatives).

Conclusion: We utilised REDCap to develop an economical, easily-adaptable and sustainable model and recommend it for prospective chronic disease biobanks or biobank-registry projects supporting research into disease prediction, targeted treatments and prevention strategies.

Figure 1. The A3BC is a national arthritis and autoimmune disease biobank-registry network developing state-of-the-art data collection, data linkage and big data analytics (incl. machine-learning) capabilities for better enabling and translating research discovery. It integrates a broad range of ‘omic’ (genomic, microbiomic etc), patient-reported (demographics, treatment, quality of life, diet etc), medical and administrative health data from people adults and children across Australia. Collected data and biological samples are deidentified and made available for ethics-approved research into understanding the causes, improving treatments or preventions, and finding cures for arthritis and autoimmune conditions.

Figure 2. (A) In line with global trends in clinical research we created a Permission to Contact (PTC) and dynamic electronic consent (eConsent) strategy to maximise patient engagement in our biobank-registry. (B) We made extensive use of REDCap’s action tag, smart variable and external module functionalities for defining auto-population and branching logic rules to dramatically reduce user effort in recording pre-analytical variables, an important aspect of biobank quality management and tracking for downstream applications. (C) An interactive 66 swollen / 68 tender joint count data collection tool was designed and implemented in our electronic case report form (eCRF) using the REDCap Image Map external module. Joint map image use permission granted by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT).

Figure 3. To enable both participant- and sample-centric functionalities, the system was designed as five linked REDCap projects, each representing a relational data table. Several unique linkage keys are used across the A3BC database tables to ensure a complete chain of custody is maintained from the point of collection through to storage, transfer, return of results and publication. Of note, we customised a ‘Current Details’ form as our central source of truth for participant contact details, consent status and collected samples. This form uses an underlying external module for hierarchical field auto-population to pull changes in specified fields from different locations across the Main project into a single location.

Disclosures: C. Willers, None; T. Lynch, None; V. Chand, None; M. Islam, None; M. Lassere, Merck Sharp & Dohme (MSD), 12, This investigator-initiated clinical trial was supported by an unrestricted education grant from Merck Sharp & Dohme (MSD) in 2016-2018, Pfizer Australia, 12, Chair, Steering Committee of the Australian Rheumatology Association Database (ARAD). ARAD has been supported with unrestricted educational grants administered through the Australian Rheumatology Association, Eli Lilly Australia, 12, Chair, Steering Committee of the Australian Rheumatology Association Database (ARAD). ARAD has been supported with unrestricted educational grants administered through the Australian Rheumatology Association, Janssen-Cilag Pty Limited (Janssen) Australia, 12, Chair, Steering Committee of the Australian Rheumatology Association Database (ARAD). ARAD has been supported with unrestricted educational grants administered through the Australian Rheumatology Association; H. Keen, Roche, 6, Abbvie, 6, Roche, 12, education/travel; T. Kenna, None; S. Lester, None; R. Thomas, Merck, 5, CSL, 1, 5, BMS, 6, Janssen-Cilag, 2, 6; P. Sinnathurai, None; M. Wechalekar, Janssen Research and Development, Philadelphia, USA, 5; A. Fletcher, None; D. Lightowler, Janssen-Cilag, 5, Chiesi Farmaceutici, 5; S. Mohd, None; N. Ramnoruth, None; C. Ruediger, None; H. Weedon, None; L. March, Eli Lilly Australia, 6, 12, ARAD has been supported with unrestricted educational grants administered through the Australian Rheumatology Association, Janssen-Cilag Pty Limited (Janssen) Australia, 12, A3BC receives unrestricted grants from Janssen, Pfizer Australia, 6, 12, ARAD has been supported with unrestricted educational grants administered through the Australian Rheumatology Association, AbbVie Australia, 6, Sandoz Australia, 6, OMERACT (multiple), 12, I am Executive of OMERACT that receives grants from 30 companies.

To cite this abstract in AMA style:

Willers C, Lynch T, Chand V, Islam M, Lassere M, Keen H, Kenna T, Lester S, Thomas R, Sinnathurai P, Wechalekar M, Fletcher A, Lightowler D, Mohd S, Ramnoruth N, Ruediger C, Weedon H, March L. A Combined Patient Registry and Biobank Laboratory Information System for Prospective Multisite Chronic Rheumatic Disease Research Using REDCap [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/a-combined-patient-registry-and-biobank-laboratory-information-system-for-prospective-multisite-chronic-rheumatic-disease-research-using-redcap/. Accessed .

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