Background 
There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.


Methods and Findings 
We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.


Conclusions 
There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.



Please see later in the article for the Editors' Summary

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The impact of eHealth on the quality and safety of health care: a systematic overview.

of “Roadmap for Provision of Safer Healthcare Information Systems: Preventing eIatrogenesis” Joan S. Ash, Ph.D., M.L.S., M.B.A.; Charles M. Kilo, M.D., M.P.H.; Michael Shapiro, M.A., M.S.; Joseph Wasserman, B.A.; Carmit McMullen, Ph.D.; William Hersh, M.D. BACKGROUND AND METHODS e-Iatrogenesis, defined as “patient harm caused at least in part by the application of health information technology” (Weiner et al., 2007), is of increasing concern as more and more hospitals are implementing health information systems (HIS). This report assesses how HIS can be designed, developed, implemented, monitored, and maintained to maximize safety. We specifically focus on hospital electronic health records (EHRs), clinical decision support (CDS), and computerized provider order entry (CPOE) systems. This white paper is intended to provide background for an Institute of Medicine (IOM) report on how the use of health information technology affects the safety of patient care by answering the following IOM-posed questions: • What are the risks of health care information systems that arise from workflow and related issues? • How have organizations acted to implement health care information systems safely? • What are the impacts of customization on safety? • What is the industry approach to managing change and customization? A recent literature review by Harrington et al. (2011) has summarized the EHR safety literature, so we first reviewed all papers cited in their report. Of their 43 references, we identified 37 that were relevant to the scope of this article. We analyzed the bibliographies of these selected papers and performed a reverse bibliography search on the articles deemed most relevant and published since 2000. In total, we identified over 100 sources relevant to the scope of this report. We then targeted topics for which published evidence was lacking and conducted several interviews with experts to help fill the knowledge gaps. 1 Full commissioned paper can be found in this project’s Public Access File. C-2 HEALTH IT AND PATIENT SAFETY PREPUBLICATION COPY: UNCORRECTED PROOFS RESULTS What Are the Risks of Health Information Systems That Arise from Workflow and Related Issues? We found seven publications (Chuo and Hicks, 2008; Joint Commission on Accreditation of Healthcare Organizations, 2008; Magrabi et al., 2010; Myers et al., 2011; Santell et al., 2009; Walsh et al., 2006; Zhan et al., 2006) presenting results of assessments of e-iatrogenic risk. All are studies of large databases of reported errors and they consistently indicate low levels of HISrelated risk, under 1 percent of all errors. All point to the need for human diligence when using HIS. Specifically, they indicate that HIS-related errors are due to inadequate staffing levels, lack of user experience, mislabeled bar-codes on medications, human distraction, inaccurate data entry, system downtime, and missing data. How Have Organizations Acted to Implement Health Information Systems Safely? Prior to implementation, health care organizations can mitigate risk. There is a large literature base devoted to the risks inherent in commercial EHR systems, and also warnings about their impact on workflow. Many publications offer guidance to hospitals about assessing workflow, selecting systems for purchase, conducting simulation tests, training, and other mechanisms for ensuring safe HIS implementation. Numerous publications exist to guide the implementation process itself, but there are also several pointing to the risks of rapid implementation without appropriate preparation. Finally, after implementation, continuous monitoring and improvement can mitigate safety risks. What Are the Impacts of Customization on Safety? The literature indicates that customization of the EHR to fit local situations seems to be necessary for many reasons, but there is scant research on how much customization or what form of customization is needed to optimize EHR use and what the risks are from either too much or too little customization. The content of CDS likewise needs adaptation, especially to avoid alert fatigue. Any customization must be done with care so that system upgrades can be accommodated. What Is the Industry Approach to Managing Change and Customization? The current industry approach is fragmented; a report sponsored by the Agency for Healthcare Research and Quality describes a wide variety of vendor practices related to usability of systems (McDonnell et al., 2010). Because purchasers must usually customize systems to fit local workflows and regulations, HIS safety depends on a combination of industry and local diligence.

Health IT and Patient Safety: Building Safer Systems for Better Care

The Health Information Technology for Economic and Clinical Health (HITECH) Act subsidizes implementation by hospitals of electronic health records with computerized provider order entry (CPOE), which may reduce patient injuries caused by medication errors (preventable adverse drug events, pADEs). Effects on pADEs have not been rigorously quantified, and effects on medication errors have been variable. The objectives of this analysis were to assess the effectiveness of CPOE at reducing pADEs in hospital-related settings, and examine reasons for heterogeneous effects on medication errors. Articles were identified using MEDLINE, Cochrane Library, Econlit, web-based databases, and bibliographies of previous systematic reviews (September 2013). Eligible studies compared CPOE with paper-order entry in acute care hospitals, and examined diverse pADEs or medication errors. Studies on children or with limited event-detection methods were excluded. Two investigators extracted data on events and factors potentially associated with effectiveness. We used random effects models to pool data. Sixteen studies addressing medication errors met pooling criteria; six also addressed pADEs. Thirteen studies used pre-post designs. Compared with paper-order entry, CPOE was associated with half as many pADEs (pooled risk ratio (RR) = 0.47, 95% CI 0.31 to 0.71) and medication errors (RR = 0.46, 95% CI 0.35 to 0.60). Regarding reasons for heterogeneous effects on medication errors, five intervention factors and two contextual factors were sufficiently reported to support subgroup analyses or meta-regression. Differences between commercial versus homegrown systems, presence and sophistication of clinical decision support, hospital-wide versus limited implementation, and US versus non-US studies were not significant, nor was timing of publication. Higher baseline rates of medication errors predicted greater reductions (P < 0.001). Other context and implementation variables were seldom reported. In hospital-related settings, implementing CPOE is associated with a greater than 50% decline in pADEs, although the studies used weak designs. Decreases in medication errors are similar and robust to variations in important aspects of intervention design and context. This suggests that CPOE implementation, as subsidized under the HITECH Act, may benefit public health. More detailed reporting of the context and process of implementation could shed light on factors associated with greater effectiveness.

https://link.springer.com/content/pdf/10.1186%2F2046-4053-3-56.pdf

The effectiveness of computerized order entry at reducing preventable adverse drug events and medication errors in hospital settings: a systematic review and meta-analysis

Computerized clinical decision support for prescribing: provision does not guarantee uptake.

Background
Many systematic reviews exist on interventions to improve safe and effective medicines use by consumers, but research is distributed across diseases, populations and settings. The scope and focus of such reviews also vary widely, creating challenges for decision-makers seeking to inform decisions by using the evidence on consumers’ medicines use.

This is an update of a 2011 overview of systematic reviews, which synthesises the evidence, irrespective of disease, medicine type, population or setting, on the effectiveness of interventions to improve consumers' medicines use.

Objectives
To assess the effects of interventions which target healthcare consumers to promote safe and effective medicines use, by synthesising review-level evidence.

Methods
Search methods: We included systematic reviews published on the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. We identified relevant reviews by handsearching databases from their start dates to March 2012.

Selection criteria: We screened and ranked reviews based on relevance to consumers’ medicines use, using criteria developed for this overview.

Data collection and analysis: We used standardised forms to extract data, and assessed reviews for methodological quality using the AMSTAR tool. We used standardised language to summarise results within and across reviews; and gave bottom-line statements about intervention effectiveness. Two review authors screened and selected reviews, and extracted and analysed data. We used a taxonomy of interventions to categorise reviews and guide syntheses.

Main results
We included 75 systematic reviews of varied methodological quality. Reviews assessed interventions with diverse aims including support for behaviour change, risk minimisation and skills acquisition. No reviews aimed to promote systems-level consumer participation in medicines-related activities. Medicines adherence was the most frequently-reported outcome, but others such as knowledge, clinical and service-use outcomes were also reported. Adverse events were less commonly identified, while those associated with the interventions themselves, or costs, were rarely reported.

Looking across reviews, for most outcomes, medicines self-monitoring and self-management programmes appear generally effective to improve medicines use, adherence, adverse events and clinical outcomes; and to reduce mortality in people self-managing antithrombotic therapy. However, some participants were unable to complete these interventions, suggesting they may not be suitable for everyone.

Other promising interventions to improve adherence and other key medicines-use outcomes, which require further investigation to be more certain of their effects, include:

· simplified dosing regimens: with positive effects on adherence;

· interventions involving pharmacists in medicines management, such as medicines reviews (with positive effects on adherence and use, medicines problems and clinical outcomes) and pharmaceutical care services (consultation between pharmacist and patient to resolve medicines problems, develop a care plan and provide follow-up; with positive effects on adherence and knowledge).

Several other strategies showed some positive effects, particularly relating to adherence, and other outcomes, but their effects were less consistent overall and so need further study. These included:

· delayed antibiotic prescriptions: effective to decrease antibiotic use but with mixed effects on clinical outcomes, adverse effects and satisfaction;

· practical strategies like reminders, cues and/or organisers, reminder packaging and material incentives: with positive, although somewhat mixed effects on adherence;

· education delivered with self-management skills training, counselling, support, training or enhanced follow-up; information and counselling delivered together; or education/information as part of pharmacist-delivered packages of care: with positive effects on adherence, medicines use, clinical outcomes and knowledge, but with mixed effects in some studies;

· financial incentives: with positive, but mixed, effects on adherence.

Several strategies also showed promise in promoting immunisation uptake, but require further study to be more certain of their effects. These included organisational interventions; reminders and recall; financial incentives; home visits; free vaccination; lay health worker interventions; and facilitators working with physicians to promote immunisation uptake. Education and/or information strategies also showed some positive but even less consistent effects on immunisation uptake, and need further assessment of effectiveness and investigation of heterogeneity.

There are many different potential pathways through which consumers' use of medicines could be targeted to improve outcomes, and simple interventions may be as effective as complex strategies. However, no single intervention assessed was effective to improve all medicines-use outcomes across all diseases, medicines, populations or settings.

Even where interventions showed promise, the assembled evidence often only provided part of the picture: for example, simplified dosing regimens seem effective for improving adherence, but there is not yet sufficient information to identify an optimal regimen.

In some instances interventions appear ineffective: for example, the evidence suggests that directly observed therapy may be generally ineffective for improving treatment completion, adherence or clinical outcomes.

In other cases, interventions may have variable effects across outcomes. As an example, strategies providing information or education as single interventions appear ineffective to improve medicines adherence or clinical outcomes, but may be effective to improve knowledge; an important outcome for promoting consumers' informed medicines choices.

Despite a doubling in the number of reviews included in this updated overview, uncertainty still exists about the effectiveness of many interventions, and the evidence on what works remains sparse for several populations, including children and young people, carers, and people with multimorbidity.

Authors' conclusions
This overview presents evidence from 75 reviews that have synthesised trials and other studies evaluating the effects of interventions to improve consumers' medicines use.

Systematically assembling the evidence across reviews allows identification of effective or promising interventions to improve consumers’ medicines use, as well as those for which the evidence indicates ineffectiveness or uncertainty.

Decision makers faced with implementing interventions to improve consumers' medicines use can use this overview to inform decisions about which interventions may be most promising to improve particular outcomes. The intervention taxonomy may also assist people to consider the strategies available in relation to specific purposes, for example, gaining skills or being involved in decision making. Researchers and funders can use this overview to identify where more research is needed and assess its priority. The limitations of the available literature due to the lack of evidence for important outcomes and important populations, such as people with multimorbidity, should also be considered in practice and policy decisions.

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Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews.

Computerised clinical decision support systems (CDSSs) are used widely to improve quality of care and patient outcomes. This systematic review evaluated the impact of CDSSs in targeting specific aspects of prescribing, namely initiating, monitoring and stopping therapy. We also examined the influence of clinical setting (institutional vs ambulatory care), system- or user-initiation of CDSS, multi-faceted vs stand alone CDSS interventions and clinical target on practice changes in line with the intent of the CDSS. We searched Medline, Embase and PsychINFO for publications from 1990-2007 detailing CDSS prescribing interventions. Pairs of independent reviewers extracted the key features and prescribing outcomes of methodologically adequate studies (experiments and strong quasi-experiments). 56 studies met our inclusion criteria, 38 addressing initiating, 23 monitoring and three stopping therapy. At the time of initiating therapy, CDSSs appear to be somewhat more effective after, rather than before, drug selection has occurred (7/12 versus 12/26 studies reporting statistically significant improvements in favour of CDSSs on = 50% of prescribing outcomes reported). CDSSs also appeared to be effective for monitoring therapy, particularly using laboratory test reminders (4/7 studies reporting significant improvements in favour of CDSSs on the majority of prescribing outcomes). None of the studies addressing stopping therapy demonstrated impacts in favour of CDSSs over comparators. The most consistently effective approaches used system-initiated advice to fine-tune existing therapy by making recommendations to improve patient safety, adjust the dose, duration or form of prescribed drugs or increase the laboratory testing rates for patients on long-term therapy. CDSSs appeared to perform better in institutional compared to ambulatory settings and when decision support was initiated automatically by the system as opposed to user initiation. CDSSs implemented with other strategies such as education were no more successful in improving prescribing than stand alone interventions. Cardiovascular disease was the most studied clinical target but few studies demonstrated significant improvements on the majority of prescribing outcomes. Our understanding of CDSS impacts on specific aspects of the prescribing process remains relatively limited. Future implementation should build on effective approaches including the use of system-initiated advice to address safety issues and improve the monitoring of therapy.

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James Reeve

Papers

Do computerised clinical decision support systems for prescribing change practice? A systematic review of the literature (1990-2007).