Using patient safety-event report data to assess health-IT safety: benefits and challenges
Authors: Jessica L Howe, A Zachary Hettinger, Raj M Ratwani
Journal: The Lancet Digital Health (2019)

With the pervasive use of health information technology (IT), there has been increasing attention on the effects of this technology on patient safety, as shown by headlines in mainstream media.1Schulte F Fry E Death by a thousand clicks: where electronic health records went wrong.http://fortune.com/longform/medical-records/Date: 2019Date accessed: May 5, 2019Google Scholar One method for identifying health IT safety implications is through the analysis of patient safety-event report data. Patient safety-event reports, which are clinician-generated descriptions of safety issues that span near misses (eg, almost administering the wrong medication to a patient) to harm that affects the patient (eg, wrong-sided surgery) and even death, can provide insights into what the risks are and can inform prioritisation and mitigation efforts. Previous studies have used these data to understand the general effects of health IT on safety and have focused on specific topics, such as usability, downtime, and interoperability.2Magrabi F Ong MS Runciman W Coiera E An analysis of computer-related patient safety incidents to inform the development of a classification.J Am Med Inform Assoc. 2010; 17: 663-670Crossref PubMed Scopus (111) Google Scholar, 3Howe J Adams KT Hettinger AZ Ratwani RM Electronic health record usability issues and potential contribution to patient harm.J Am Med Assoc. 2018; 319: 1276-1278Crossref PubMed Scopus (128) Google Scholar, 4Ratwani RM Savage E Will A et al.Identifying electronic health record usability and safety challenges in pediatric settings.Heal Aff. 2018; 37: 1752-1759Crossref Scopus (58) Google Scholar, 5Larsen E Fong A Wernz C Ratwani RM Implications of electronic health record downtime: an analysis of patient safety event reports.J Am Med Informatics Assoc. 2018; 25: 187-191Crossref PubMed Scopus (26) Google Scholar, 6Adams KT Howe JL Fong A et al.An analysis of patient safety incident reports associated with electronic health record interoperability.Appl Clin Inform. 2017; 8: 593-602Crossref PubMed Scopus (18) Google Scholar, 7Magrabi F Ong M-S Runciman W Coiera E Using FDA reports to inform a classification for health information technology safety problems.J Am Med Informatics Assoc. 2012; 19: 45-53Crossref PubMed Scopus (147) Google Scholar In The Lancet Digital Health, Guy Martin and colleagues8Martin G Ghafur S Cingolani I et al.The impact and preventability of 2,627 patient safety incidents related to health information technology failures: a retrospective analysis of a decade of incident reporting in England and Wales.Lancet Digital Health. 2019; 1: e127-e135Summary Full Text Full Text PDF Scopus (14) Google Scholar describe one of the largest analyses of health IT safety failures using a database of more than 13 million patient safety-event reports, and provided further evidence for the association between health IT and patient harm. 2627 events were identified as being related to health IT. The majority of these events caused no harm to patients, however, four deaths were reported. Approximately 75% of these health IT-related events were deemed to be preventable. The findings highlight the need to develop better measures of health-IT safety and to address safety issues through a systems-based approach. This study is unique given the size of the safety-event database that was analysed. Like most methods and data sources that are used to understand patient safety, studies that use patient safety-event report data have benefits, but also challenges that are important to recognise to fully understand the study implications. We discuss these benefits and challenges in the context of understanding health IT safety with a focus on the study by Martin and colleagues.8Martin G Ghafur S Cingolani I et al.The impact and preventability of 2,627 patient safety incidents related to health information technology failures: a retrospective analysis of a decade of incident reporting in England and Wales.Lancet Digital Health. 2019; 1: e127-e135Summary Full Text Full Text PDF Scopus (14) Google Scholar It is important to recognise that identifying health IT-related safety issues, particularly those related to the electronic health record (EHR), can be difficult, given that this technology is now a natural part of the care process and many clinicians might not attribute a safety concern to the EHR or other types of health IT. Further, certain legal barriers, such as contract language between the EHR vendor and health-care provider organisations, might prevent full transparency of safety issues by limiting the sharing of these issues, including screenshots of the health IT product.9Ratwani RM Hodgkins M Bates DW Improving electronic health record usability and safety requires transparency.J Am Med Assoc. 2018; 320: 2533-2534Crossref Scopus (21) Google Scholar Using patient safety-event report data to better understand the effects of health IT on patient safety affords several benefits. With a large dataset, such as that used by Martin and colleagues,8Martin G Ghafur S Cingolani I et al.The impact and preventability of 2,627 patient safety incidents related to health information technology failures: a retrospective analysis of a decade of incident reporting in England and Wales.Lancet Digital Health. 2019; 1: e127-e135Summary Full Text Full Text PDF Scopus (14) Google Scholar there is an opportunity to identify different ways health IT can impact safety, from medications to system downtime. Event reports also generally contain an associated level of patient harm, which provides the opportunity to associate the type of health-IT safety issue with severity of harm. The safety event reports in the study by Martin and colleagues8Martin G Ghafur S Cingolani I et al.The impact and preventability of 2,627 patient safety incidents related to health information technology failures: a retrospective analysis of a decade of incident reporting in England and Wales.Lancet Digital Health. 2019; 1: e127-e135Summary Full Text Full Text PDF Scopus (14) Google Scholar are also sourced from several different health-care provider sites, which increases the robustness and generalisability of the dataset because it likely includes different health-IT vendor products, implementations, and clinical workflows. The analyses of these data can provide new insights into how health IT affects safety and can be used to identify general trends and patterns for further analysis. There are also significant challenges with analysing patient safety-event data, particularly with large datasets in which manual review of each report is not feasible. Identifying health IT-related safety events from a database that includes more than 13 million reports requires the use of different search techniques and computational algorithms to identify relevant reports. This search process is likely to be imperfect, resulting in reports that are not actually related to health IT (ie, false positives) and reports that are missed because the fact that they are health IT related might not be indicated (ie, false negatives). Martin and colleagues8Martin G Ghafur S Cingolani I et al.The impact and preventability of 2,627 patient safety incidents related to health information technology failures: a retrospective analysis of a decade of incident reporting in England and Wales.Lancet Digital Health. 2019; 1: e127-e135Summary Full Text Full Text PDF Scopus (14) Google Scholar manually reviewed each report that was identified through their algorithmic search process; however, they provide no data on how many health IT reports were missed by the algorithmic approach. Without an estimate of search process accuracy, knowing how many reports were excluded but should have been included is difficult. Other challenges include harm events typically being under-reported, difficulties understanding all contributing factors to the event given the limited context in the reports, and the inability to establish a rate of occurrence, given that reporting is generally voluntary.10Pronovost P Morlock LL Sexton B Improving the value of patient safety reporting systems.in: Henriksen K Battles JB Keyes MA Grady ML Advances in patient safety: new directions and alternative approaches. vol 1. Agency for Healthcare Research and Quality, Rockville2008Google Scholar Thus, safety-event report data cannot be used to report the prevalence of health-IT safety incidents across populations. The study by Martin and colleagues8Martin G Ghafur S Cingolani I et al.The impact and preventability of 2,627 patient safety incidents related to health information technology failures: a retrospective analysis of a decade of incident reporting in England and Wales.Lancet Digital Health. 2019; 1: e127-e135Summary Full Text Full Text PDF Scopus (14) Google Scholar and other studies that analyse safety-event data to identify health IT safety issues provide new knowledge and insight into the types of health-IT hazards that exist and the effects of these hazards on patients. Understanding challenges with this approach provides the necessary context for applying this knowledge to improve safety. Ultimately, assessing the prevalence of health-IT safety issues and developing sustainable solutions will require a multipronged approach with safety-event report analysis as one key aspect. AZH and RMR report grants from the Agency for Healthcare Research and Quality, the Food and Drug Administration, PEW Charitable Trust, the Office of the National Coordinator, and the American Medical Association, outside the submitted work. All other authors declare no competing interests. The effects and preventability of 2627 patient safety incidents related to health information technology failures: a retrospective analysis of 10 years of incident reporting in England and WalesHealth IT is fundamental to the delivery of high-quality care, yet there is a poor understanding of the effects of IT failures on patient safety and whether they can be prevented. Failures are complex and involve interlinked aspects of technology, people, and the environment. Health IT failures are undoubtedly a potential source of substantial harm, but they are likely to be under-reported. Worryingly, three-quarters of IT failures are potentially preventable. There is a need to see health IT as a fundamental tenet of patient safety, develop better methods for capturing the effects of IT failures on patients, and adopt simple measures to reduce their probability and mitigate their risk. Full-Text PDF Open Access