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The availability and routine use of electronic health records (EHRs) have become commonplace in healthcare systems of many high-income countries. While there is an ever-growing body of literature pertaining to their use, evidence surrounding the importance of EHR interoperability and its impact on patient safety remains less clear. There is, therefore, a need and opportunity to evaluate the evidence available regarding this relationship so as to better inform health informatics development and policies in the years to come. This systematic review aims to evaluate the impact of EHR interoperability on patient safety in health systems of high-income countries.
A systematic literature review will be conducted via a computerised search through four databases: PubMed, Embase, Health Management Information Consortium and PsycInfo for relevant articles published between 2010 and 2020. Outcomes of interest will include impact on patient safety and the broader effects on health systems. Quality of the randomised quantitative studies will be assessed using Cochrane Risk of Bias Tool. Non-randomised papers will be evaluated with the Risk of Bias In Non-Randomised Studies—of Interventions tool. Drummond’s Checklist will be used for publications pertaining to economic evaluation. The National Institute for Health and Care Excellence quality appraisal checklist will be used to assess qualitative studies. A narrative synthesis will be conducted for included studies, and the body of evidence will be summarised in a summary of findings table.
This review will summarise published studies with non-identifiable data and, thus, does not require ethical approval. Findings will be disseminated through preprints, open access peer-reviewed publications, and conference presentations.
Keywords: health informatics, telemedicine, information technology, information management, health services administration & management, health policy
Inclusion of quantitative, qualitative and mixed-methods studies can provide a comprehensive overview of the multitude of ways in which interoperable electronic health records (EHRs) may affect patient safety and health systems.
Using robust methodology to examine the wealth of existing literature, the proposed systematic review attempts to answer a pragmatic question that is integral to future health informatics development and policies.
The heterogeneity of methods and outcomes assessed may potentially obscure the true effect interoperable EHRs may have had on patient safety.
Potential small sample size in subgroup analyses may negatively impact the statistical power in quantitative data synthesis.
Limiting the search strategy to English-only publications may not capture studies exploring EHR experiences in non-English-speaking countries.
Electronic health records (EHRs) have become an integral part of modern healthcare since their initial mainstream implementation in the mid-late 2000s through the passing of the Health Information Technology (HIT) for Economic and Clinical Health Act in the US and the National Health Service (NHS) National Programme for IT initiative (NPfIT) in England. 1–4 From the documentation and retrieval of patient records and the prescription of medications, to coordinating complex care plans between different healthcare providers and electronic billing, EHRs fulfil a multitude of roles for both clinicians and patients alike. 5–9
In order to achieve EHR’s full potential, it is critical to improve interoperability—that is, ‘the ability of health information systems to work together within and across organisation boundaries in order to advance effective delivery of healthcare for individuals and communities’. 10 The lack of universal interoperability is often cited as one of the many significant shortcomings of EHRs currently in use, resulting in duplication in healthcare costs, increased clinician workload fatigue and poses a potential risk to patient safety. 2 This is especially problematic for patient populations with chronic conditions, polypharmacy and multiple comorbidities who are reliant on effective patient information sharing via EHRs to facilitate their care. 11
Poor EHR interoperability is detrimental to patient safety and costly for health systems. Its consequences range from increased risks of medication errors, fragmentation of patient data, to iatrogenic harm resulting from redundant testing, and additional healthcare expenditure. 12–17 In the fragmented EHR landscape of the UK, measuring the effect of poor interoperability remains challenging. 18 Although there is a growing body of literature investigating areas such as the facilitators and barriers to EHR greater adoption, technical capabilities, and usability, 19 20 no systematic review has been conducted exploring specifically the problem of interoperability among the assortment of EHRs in use, how it affects patient safety, and ultimately the financial cost savings lost to health systems.
In a recent systematic review by Dobrow et al assessing the effects of EHR and HIT interoperability on health systems, 130 publications were included, with the majority being studies conducted in the US, used quantitative methods and focused primarily on acute healthcare settings. The authors noted that the use of interoperable EHRs had a positive impact on outcome measures such as quality of care and productivity. 19 However, in domains such as stakeholder engagement, performance and reliability, security and privacy, information quality and ease of use, the benefits of interoperable EHRs were less clear. 19 Among the 130 publications, 17 were reviews with the majority directed at exploring facilitators and barriers to EHR implementation and the general benefits and impact of EHR use. While this review did focus on studies pertaining to the topic of interoperable EHRs, this was done from a broad perspective and included studies exploring a wide range of outcomes related to the effects of EHR on healthcare rather than specifically on their implications to patient safety.
In another review by Hersh et al, the authors explored how health information exchange (HIE) affected health systems on a variety of domains, including costs, healthcare utilisation, health outcomes, healthcare worker attitudes and sustainability. Despite the widespread routinely use of HIE, the authors described a general lack of robust evidence on the quality, costs, efficiency, usage and sustainability. 21 However, there was some evidence demonstrating HIEs being associated with reduced utilisation and costs in emergency care settings despite methodological issues being present in many of the included publications. 21 Although this review was ambitious in the wide scope of interest regarding the effects of HIE use, patient safety was not a primary topic of focus. Another limitation of this study was that it only contained US-based publications, and, thus, findings lack generalisability internationally to other health systems in high-income countries (HIC) which are both organised and financed differently.
The overall aim of this literature review is to explore how EHR interoperability impacts patient safety, in the context of health systems in HICs. The results generated will aim to inform healthcare policymakers and help shape more effective EHR system implementation and modernisation efforts in the coming years.
A computerised search of the literature published in the last 10 years (2010–2020) will be performed on PubMed/Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Health Management Information Consortium and PsycInfo. This publication timeframe was chosen as it coincides with the mainstream implementation of EHRs in several HIC healthcare systems such as Kaiser Permanente in the US, and, thus, would select for the most up to date, relevant evidence concerning EHR interoperability and patient safety challenges faced by healthcare systems today to be included. 22 23 The list of search strings used will include both free text and controlled terms, whenever supported ( table 1 ) and will be iteratively refined in consultation with the Imperial College St. Mary’s campus medical librarian. For a sample of the search strategy, please see online supplemental file 1.
Concepts and database search terms