https://orcid.org/0000-0001-7732-0211
Abstract
Introduction
Electronic medical records (EMRs) maintained in primary care in the UK and collected and stored in EMR databases offer a world-leading resource for observational clinical research. We aimed to profile one such database: the Optimum Patient Care Research Database (OPCRD).
Methods and Participants
The OPCRD, incepted in 2010, is a growing primary care EMR database collecting data from 992 general practices within the UK. It covers over 16.6 million patients across all four countries within the UK, and is broadly representative of the UK population in terms of age, sex, ethnicity and socio-economic status. Patients have a mean duration of 11.7 years’ follow-up (SD 17.50), with a majority having key summary data from birth to last data entry. Data for the OPCRD are collected incrementally monthly and extracted from all of the major clinical software systems used within the UK and across all four coding systems (Read version 2, Read CTV3, SNOMED DM+D and SNOMED CT codes). Via quality-improvement programmes provided to GP surgeries, the OPCRD also includes patient-reported outcomes from a range of disease-specific validated questionnaires, with over 66,000 patient responses on asthma, COPD, and COVID-19. Further, bespoke data collection is possible by working with GPs to collect new research via patient-reported questionnaires.
Findings to Date
The OPCRD has contributed to over 96 peer-reviewed research publications since its inception encompassing a broad range of medical conditions, including COVID-19.
Conclusion
The OPCRD represents a unique resource with great potential to support epidemiological research, from retrospective observational studies through to embedded cluster-randomised trials. Advantages of the OPCRD over other EMR databases are its large size, UK-wide geographical coverage, the availability of up-to-date patient data from all major GP software systems, and the unique collection of patient-reported information on respiratory health.
Data-Resource Access
OPCRD is governed by the Anonymized Data Ethics and Protocol Transparency (ADEPT) Committee, an independent, non-statutory expert advisory committee, commissioned by the Respiratory Effectiveness Group (REG, https://www.regresearchnetwork.org/)) to govern the standard of research conducted on real-world research databases. Access to the OPCRD is subject to proposals being reviewed and approved by ADEPT (https://www.regresearchnetwork.org/adept-committee/). Protocols are reviewed on the basis of scientific quality, public benefit, ethical considerations, and any risks posed to data subjects. The ADEPT committee may recommend that study-specific research ethics committee (REC) approval be sought if complex ethical issues arise for a particular study. REC approval will be required for any study that includes direct patient involvement. All proposed research must have intent to publish and must have a scientific, medical, or public health basis. Once ADEPT has approved the study, researchers will be required to sign a data-sharing agreement prior to being given access to anonymized datasets from OPCRD. Studies requiring use of OPCRD data will also be required to be registered on recognized study databases, such as the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP; https://www.encepp.eu) and ClinicalTrials.gov. The de-identified data required for research are fully anonymized before being provided to the researcher. Additional security and data-protection protocols are put in place to anonymize the data when a client receives unlimited access to their own client database derived from OPCRD. This includes applying additional redaction algorithms on free-text dosing instructions and removing any potential location indicators like practice identifiers and postcodes.
Data Sharing
See Data Resource Access section of manuscript.
Ethics Approval
The OPCRD received ethics approval from the NHS Health Research Authority HRA Research Ethics Committee (NHS HRA REC ref: 20/EM/0148) to receive and provide anonymized data for research purposes. This study was approved by ADEPT (ADEPT0121) on 15 February 2021.
Acknowledgments
This study is based wholly on data from the Optimum Patient Care Research Database (opcrd.co.uk) obtained under license from Optimum Patient Care Limited, and its execution was approved by recognized experts affiliated to the Respiratory Effectiveness Group. However, the interpretations and conclusions contained in this report are those of the authors alone.
Author Contributions
All authors made a significant contribution to the work reported, whether in the conception, study design, execution, acquisition of data, analysis and interpretation, or all these areas, took part in drafting, revising, or critically reviewing the article, gave final approval to the version to be published, have agreed on the journal to which the article has been submitted, and agree to be accountable for all aspects of the work.
Disclosure
A. Lynam, C. Curtis, J. Dennis and A. McGovern are employees of Momentum Data who were unpaid consultants to OPCRD in connection with the development of this manuscript. A. McGovern reports grants from Pfizer, Eli Lilly, AstraZeneca; personal fees from Boehringer Ingelheim, outside the submitted work. E.J Roberts, V. Carter, C. Price, C. Worthington are employees of Optimum Patient Care, UK. H. Heatley and B. Stanley are employees of Observational and Pragmatic Research Institute, Singapore. D. Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Merck, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. The authors report no other conflicts of interest in this work.