Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review

Khic-Houy Prang; Bill Karanatsios; Ebony Verbunt; Hui-Li Wong; Justin Yeung; Margaret Kelaher; Peter Gibbs

doi:10.1016/j.cct.2022.106843

Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review

Contemp Clin Trials. 2022 Aug:119:106843. doi: 10.1016/j.cct.2022.106843. Epub 2022 Jul 2.

Authors

Khic-Houy Prang¹, Bill Karanatsios², Ebony Verbunt³, Hui-Li Wong⁴, Justin Yeung⁵, Margaret Kelaher⁶, Peter Gibbs⁷

Affiliations

¹ Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia. Electronic address: khic-houy.prang@unimelb.edu.au.
² Department of Surgery, Western Precinct, The University of Melbourne, Parkville, VIC, Australia; Western Health Chronic Disease Alliance, Western Health, St Albans, VIC, Australia. Electronic address: bill.karanatsios@wh.org.au.
³ Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia. Electronic address: ebony.verbunt@unimelb.edu.au.
⁴ Personalised Oncology Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Parkville, VIC, Australia. Electronic address: huili.wong@mh.org.au.
⁵ Department of Surgery, Western Precinct, The University of Melbourne, Parkville, VIC, Australia; Western Health Chronic Disease Alliance, Western Health, St Albans, VIC, Australia. Electronic address: justin.yeung@unimelb.edu.au.
⁶ Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia. Electronic address: mkelaher@unimelb.edu.au.
⁷ Personalised Oncology Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia; Department of Medical Oncology, Western Health, Sunshine, VIC, Australia. Electronic address: peter.gibbs@mh.org.au.

PMID: 35792338
DOI: 10.1016/j.cct.2022.106843

Abstract

Background: Clinical registries have become an important platform for performance measurement, quality improvement, and clinical research including registry-based randomised controlled trials (RRCTs). However, the success of RRCTs is highly dependent on the quality of the registry. The aim of this study was to undertake a scoping review to identify the key characteristics that a registry must possess to be considered of high quality to successfully support the conduct of a RRCT.

Methods: A comprehensive search of four databases and grey literature was conducted. A narrative synthesis was conducted with a focus on summarising the characteristics that a high-quality registry must possess to support the conduct of RRCTs, and the mechanisms underpinning the collection of high-quality data.

Results: A total of 50 articles were included. Data accuracy, completeness, population capture, data standardisation, and timeliness were identified as essential data attributes of a high-quality clinical registry. The legal and ethical environment in which a registry operates, the available infrastructure support, and ongoing participation by healthcare providers were identified as impacting the collection of high-quality data.

Conclusions: This review summarises the considerable work undertaken to determine the criteria with which to judge the suitability of a clinical registry to support a RRCT. Moving forward, the certification of individual clinical registries may be one way of identifying registries that can support a RRCT. In the interim, we propose the Registry Attributes Framework which can be used to ascertain the suitability of a registry to support a RRCT. Ultimately, the ideal goal should be to define minimum acceptable standards for a registry's key performance indicators (as depicted in the Framework) that would determine its certification status. New registries planned to support a RRCT should be designed and constructed against agreed standards once these are established.

Keywords: Quality; Registry; Registry trial; Review.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Data Accuracy*
Databases, Factual
Humans
Quality Improvement*
Randomized Controlled Trials as Topic
Registries