Interface design principles for usable decision support: A ... - Core

Journal of Biomedical Informatics 45 (2012) 1202–1216

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Journal of Biomedical Informatics journal homepage: www.elsevier.com/locate/yjbin

Methodological Review

Interface design principles for usable decision support: A targeted review of best practices for clinical prescribing interventions Jan Horsky a,b,c,⇑, Gordon D. Schiff b,c, Douglas Johnston f, Lauren Mercincavage g, Douglas Bell d,e, Blackford Middleton a,b,c a

Clinical Informatics Research and Development, Partners HealthCare, Boston, United States Division of General Medicine and Primary Care, Brigham and Women’s Hospital, Boston, United States Harvard Medical School, Boston, United States d UCLA Department of Medicine, Los Angeles, United States e RAND Health, Santa Monica, CA, United States f RTI International, Waltham, MA, United States g Westat, Cambridge, MA, United States b c

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Article history: Received 26 February 2012 Accepted 6 September 2012 Available online 17 September 2012 Keywords: Clinical decision support systems (CDSSs) Electronic health records systems (EHRs) System design and development Software usability Human–computer interaction (HCI) Patient safety

a b s t r a c t Developing effective clinical decision support (CDS) systems for the highly complex and dynamic domain of clinical medicine is a serious challenge for designers. Poor usability is one of the core barriers to adoption and a deterrent to its routine use. We reviewed reports describing system implementation efforts and collected best available design conventions, procedures, practices and lessons learned in order to provide developers a short compendium of design goals and recommended principles. This targeted review is focused on CDS related to medication prescribing. Published reports suggest that important principles include consistency of design concepts across networked systems, use of appropriate visual representation of clinical data, use of controlled terminology, presenting advice at the time and place of decision making and matching the most appropriate CDS interventions to clinical goals. Specificity and contextual relevance can be increased by periodic review of trigger rules, analysis of performance logs and maintenance of accurate allergy, problem and medication lists in health records in order to help avoid excessive alerting. Developers need to adopt design practices that include user-centered, iterative design and common standards based on human–computer interaction (HCI) research methods rooted in ethnography and cognitive science. Suggestions outlined in this report may help clarify the goals of optimal CDS design but larger national initiatives are needed for systematic application of human factors in health information technology (HIT) development. Appropriate design strategies are essential for developing meaningful decision support systems that meet the grand challenges of high-quality healthcare. Ó 2012 Elsevier Inc. Open access under CC BY-NC-ND license.

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Retrieval and selection of articles considered in this review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2. Document organization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recommended attributes of clinical decision support in EHR systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Consistency of design concepts, visual formats, and terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2. Flexibility of interaction, workflow integration, and rapid alert-response action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3. Presentation of advice in a way that cultivates trust over time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4. Advice: assessment, suggestion and recommendation – not commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5. Maintenance and re-use of intermediate variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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⇑ Corresponding author at: Clinical Informatics Research and Development, Partners HealthCare, 93 Worcester St., Suite 201, Wellesley, MA 02481, United States. Fax: +1 781 416 8771. E-mail address: [email protected] (J. Horsky). 1532-0464 Ó 2012 Elsevier Inc. Open access under CC BY-NC-ND license. http://dx.doi.org/10.1016/j.jbi.2012.09.002

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3.6. Periodic review of system inferences and human actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.7. Clinical data standards, interoperability, integrity and robust architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8. Innovation and third-party developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Decision support for electronic ordering and medication prescribing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1. Consistency of terms and text formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2. Concise and unambiguous language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3. Appropriate representational formats of data and distinctive entry screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4. Organization of orders by problem and clinical goal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5. Clinical context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6. Interventions embedded in forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.7. Complex order forms and calculators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design specifics for alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1. Interruptive vs. non-intrusive alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2. Display and organization of reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3. Filtering of frequent interruptive alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4. Revision of alert trigger rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5. Prompts for patient record maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1. Introduction Health care professionals have been increasingly migrating from paper patient charts to electronic health records (EHRs) with clinical decision support (CDS) [1,2]. EHR systems have been shown to make medical care safer for patients and of higher quality, at least in some implementations, primarily through the use of CDS [3–8]. The expected benefits of health information technology (HIT) gave rise to national legislation intended to increase the use of EHRs by clinicians, namely the Health Information Technology for Economic and Clinical Health (HITECH) part of the American Recovery and Reinvestment Act of 2009 [9]. As a result, at least one form of CDS is required to be functional in EHRs by the end of 2012. The U.S. Department of Health and Human Services further provides financial stimuli for the ‘‘meaningful use’’ of certified technology to achieve health and efficiency goals in the first phase of the Medicare and Medicaid EHR Incentive Program [10]. Developing highly effective decision support, however, represents a serious challenge. Design of alerts, reminders, and other types of intervention requires detailed analysis of numerous factors that affect their accuracy, specificity, clarity, clinical relevance and, in turn, the ability of clinicians to take timely and appropriate actions in response. Teams of professionals engaged in developing EHR human interfaces often include informaticists, clinical experts and sometimes human–computer interaction (HCI) specialists, but the complexity of the task requires a diverse set of skills and training they may collectively lack. For example, user-centered design process includes assessments of human performance, ethnographic observations, analyses of interviews, think-aloud studies and cognitive tasks and the description of mental models in addition to medical and computer expertise. A compendium of best practices, methods and design recommendations may help in providing reliable and evidence-based guidance. To illustrate the design complexity, evidence shows that to maximize effectiveness, advisory information needs to be delivered to the appropriate clinician at the time he or she is making a decision, has to include content that is relevant in the context of the clinical task in a concise form that allows quick and unambiguous interpretation, and must provide response options whose effects are clearly understandable [11,12]. The visual salience of interventions must also be carefully calibrated according importance and work environment conditions [13]. Alerts should not

create unnecessary distractions but still be distinctly noticeable when warning about events that may negatively affect patient safety. However, current EHRs often fall short of delivering in full the benefit of readily available, compiled and tailored relevant medical knowledge regarding the patient at hand to the clinician, and fail to achieve high performance levels because their human interfaces are not optimally designed for efficient interaction, do not display medical data in appropriate context or in formats that lower cognitive effort required to interpret them correctly or because they are not integrated well into clinical environments and personal workflows [14]. Poor usability continues to be one of the leading obstacles to CDS adoption and a deterrent to routine use in clinical practice [15]. We reviewed published reports describing EHR and CDS system implementation efforts and collected the best available design conventions, procedures, practices and lessons learned in the process. This empirical and sometimes anecdotal evidence was evaluated, interpreted and synthesized with established HCI principles and complemented by recommended design practices from software usability literature. The focus of this review was CDS for medication prescribing and although it also discusses the design of interventions in systems related to this clinical task, the lists of recommendations are not exhaustive.

2. Background Decision support attempts to assist clinicians with diagnostic and care decisions by displaying relevant and often patient-specific information at various points in the course of care. The most recognizable type of intervention is an alert triggered when conditions encoded in clinical rules and algorithms are met; for example, if a medication for which a patient has a recorded allergy is prescribed. A reminder may include in the logic temporal considerations to prompt for due immunizations or periodic laboratory tests. Alerts and reminders (terms sometimes used interchangeably) are the most common forms of decision support although medical and procedural knowledge may also be provided to clinicians in the form of electronic guidelines, order sets, calculators, reports and dashboards, documentation templates and diagnostic or clinical workflow support tools. An example of selected common types of decision support interventions is in Table 1 [12,16,17].

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Table 1 Common types of decision support interventions. Intervention

Description

Alerts, reminders

Provide real-time notification of errors, potential hazards or omissions related to interactive events (e.g., the submission of a new order), in response to new data (e.g., laboratory results) or to the passage of time (e.g., reminders about due care)

Ordering support

Real-time critique of medication and procedure orders may suggest drug alternatives or appropriate dosing based on patient characteristics (kidney and liver function, gender, age, weight), alert to drug, allergy and food interactions, and to duplicate therapy or formulary adherence. Order sets for a specific purpose such as a hospital admission, problem-oriented ambulatory visit or a medical condition may aggregate orders for procedures, radiology, laboratories and medications. Complex ordering tools may include forms with built-in calculators and guided dosing (e.g., for total parenteral nutrition, weight-based heparin, etc.)

Guidelines

Clinicians may browse electronic documents or obtain patient-specific recommendations with infobuttons that use the patient record to perform context-based searches in one or more knowledge bases and summarize the retrieved information for automatic display. Automatic critique of medication orders can also be derived from institutional or national guidelines

Forms, templates

Guide documentation, care planning, the ordering of tests and procedures, etc. They can be embedded in screens with contextual patient information, activated on demand or bypassed when not needed

Clinical context

Clinical reasoning is less cognitively demanding when data are aggregated and presented in formats that visually emphasize relationships and dependencies, allowing fast perceptual judgments. Complete sets of relevant information on one screen also reduce the likelihood of omission errors. Medication order screens may include allergies, relevant lab results with trends, corollary orders, formulary status and costs. The context is embedded in layout and therefore is minimally intrusive

Clinical pathways

Adherence to best practices can be supported by allowing step-wise processing of complex protocols over time and multiple patient encounters such as pneumonia admissions or multiday and multi-cycle chemotherapy treatments. These interventions may be more or less intrusive depending on clinical task complexity

One way to classify CDS systems is according to the way clinicians interact with interventions [18,19]. Passive forms of advice are initiated on demand (or ‘‘pulled’’) by clinicians at the time of their choosing by clicking on links that lead to pages and static documents (e.g., electronic guidelines) or on algorithmic ‘‘infobuttons’’ that formulate queries with specific data from a patient record and retrieve contextual information from remote databases. Although minimally disruptive of workflow, clinicians have to recognize their need for advice. Active interventions such as alerts, on the other hand, are ‘‘pushed’’ by the system to the clinician automatically for real-time critiquing of clinically significant actions (e.g., ordering), warning about events and data that indicate a current or imminent negative change in the patient state (e.g., abnormal laboratory results), as reminders about due care (e.g., annual tests) or to increase regulatory compliance, quality assurance and administrative initiatives [20]. However, their most common function is to assist with medication prescribing by checking dose and frequency values and by monitoring interactions with other drugs, diseases and allergies [21]. Interruptions of ongoing activity and diversion of attention from clinical work may be appropriate for warnings about highseverity conditions but may quickly become an irritant, hazardous disruption when used inappropriately for frequent alerts about minimally important, contextually irrelevant or false-positive events [22–24]. Alert design that reflects and controls the level of intrusiveness can mitigate the negative effects of excessive alerting and work interruption by adjusting its saliency to risk severity. An indirect kind of decision support fosters optimal decisionmaking in a more subtle manner by focusing attention on specific information, encouraging systematic consideration of data and possibly influencing prioritization of actions [16]. A substantial amount of medical knowledge can be embedded in the design of information displays, entry modules, templates, order sets and in the visual representation of clinical data [25,26] that help clinicians better comprehend patient’s current physiological state [27]. For example, relevant test results, medications, allergies and problems may be displayed within medication order screens to clarify the clinical context and to add justification to suggested modifications. Templates and forms may automatically populate fields with data from the patient record or from clinical calculators and serve as checklists to minimize errors of omission. Order sets give implicit advice by showing a selection of the most appropriate

interventions for specific therapeutic, diagnostic or procedural tasks. Medical knowledge embedded in the design tends to recommend actions without overly prescriptive directives and allows clinicians to freely consider relevant information during medical reasoning. The quality of HIT design and human–computer interaction characteristics of its interfaces are among the most decisive factors determining the effect of CDS on care and patient safety by influencing the adoption rate and routine use by clinicians [28]. It is essential to engage clinicians in the design process from the earliest stages and frequently evaluate functional, interactive, cognitive and perceptual characteristics of the system so it can optimally support clinical work [29,30]. However, there is scant distilled, up-to-date CDS design guidance that can be referenced and readily used today by commercial and academic development institutions. Specific best practices and standards of design and usability testing of HIT products are not readily available [31] and many vendors therefore use their own, proprietary guidelines that vary widely in recommendations and the quality of research evidence.

2.1. Retrieval and selection of articles considered in this review Design lessons and best practices discussed in this report were derived from peer-reviewed and trade literature that had the implementation of CDS rather than its design as the primary topic because of the paucity of published reports directly describing system interface design. We conducted a targeted literature review to identify and evaluate statements about design by clinicians and implementers. Those judged to be consistent with widely accepted HCI and usability principles were then reformulated as recommended practices. The search scope was limited to the last 15 years to focus on issues relevant to contemporary technology. We searched PubMed and Web of Science databases for articles containing keywords and free-text terms that we categorized into four thematically related groups described below (Systems, Activity, Usability, Cognition). We then combined the sets of references resulting from searches in each category in the final search with the AND operator. Search terms were entered as keywords in all PubMed fields joined with the OR operator although a subset related to types of HIT in the Systems category was used to search Medical Subject Headings exclusively. In addition, we ran similar

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Table 2 Questions for vendors about general system attributes related to usability and safety. Attribute

Question to a vendor

Clinical setting

Intended for ambulatory, general inpatient, emergency or critical care? Are intervention types matched to each setting? Can modifications be made to accommodate local variations? Are physicians, nurses, administrative staff affected differently? How extensive is required training for each role? Are established professional role responsibilities redistributed? What may be the unintended consequences of a new process? Can saliency level be adjusted (tiered) according to severity? Does the system ‘‘degrade gracefully?’’ How is alert frequency and advice accuracy affected by gaps in patient records? Can system and user actions be accessed and analyzed? Are they appropriate for the intended clinical environment and tasks? Is the expected time lag acceptable in given clinical context? Can third-party additions be integrated and connected to services? Are nomenclatures, terminologies, controls and design concepts consistent?

Clinician roles Workflow changes Intrusiveness Missing, erroneous EHR data Activity logs Active, passive interventions Latency of advice Access to data services Consistency

searches in PsychInfo, Books @ Ovid and ACM Digital library databases and added the results into the final set of references. Systems – Medical Subject Headings: Medical Records Systems, Computerized; Decision Support Systems; Clinical Hospital Information Systems; Reminder Systems; Ambulatory Care Information Systems; Clinical Laboratory Information Systems; Clinical Pharmacy Information Systems; Decision Making, Computer-Assisted; Electronic Health Records; Electronic prescribing. Keywords: EHR; electronic health record; electronic patient record; electronic medical record; electronic prescribing; clinical computing; CPOE; computerized prescriber order entry; computerized prescriber order entry, physician order entry; provider order entry; electronic ordering; computerized ordering; CCDS; CDS; decision support; clinical decision support; computerized clinical decision support; alert system. Activity: design; development; implementation. Usability: usability; usability principles; HCI; human–computer interaction; CHI; computer–human interaction; information design; cognitive engineering; adaptive display; cognitive workload; cognitive effort; UI; user interface; human interface; user-centered; human-centered; cognitive analysis; cognitive task analysis. Cognition: Clinical decision-making; clinician decision making; medical decision making; medical reasoning; physician decision making; provider decision making; physician reasoning; provider reasoning. Results from all searches were aggregated into a final set of 1544 references. Three researchers (JH, DJ, LM) reviewed the abstracts of these articles for comments about design or implementation of CDS and 421 relevant articles were entered into a database. Two researchers (JH, DJ) further reviewed these to identify content that could be extracted as potential recommendations and selected 112 articles for analysis and inclusion in this report. As the primary focus of most reviewed articles was not a direct description of system design, our inclusion criteria were limited to the identification of concepts related to human interfaces, usability, safety and positive and negative findings from implementation efforts that referred to system design. Recommendations were discussed in conference calls and revised by manuscript reviews until consensus was reached. Several articles by authors identified by the search who published further work on relevant topics in 2011 were also reviewed and added.

2.2. Document organization The report is divided into three parts describing different aspects of CDS design and organized approximately from general to more specific. Section 3 contains advice related to interface

usability, visual attributes of data presentation, maintenance and interoperability of entire EHR systems with decision support. Section 4 is focused on the design of medication prescribing interventions and Section 5 provides design specifics for alerts and reminders. Recommendations derived from general usability concepts and heuristics may be applicable to more than one system and individual sections may therefore have some content overlap.

3. Recommended attributes of clinical decision support in EHR systems Clinical decision support is typically functionally embedded in electronic health records and medication prescribing modules. A conceptual division between CDS and the application that invokes it is not always clearly defined [32]. The whole system has generally consistent visual and functional characteristics such as screen layout conventions, buttons, dialog boxes, entry modules and other interface artifacts across all component modules. The discussion of optimal CDS design attributes in the following sections emphasizes decision support interventions but is applicable to clinical information systems in their entirety. The goal of having vendors and institutional developers adhere to common design approaches is to produce systems with analogous sets of basic characteristics that are derived from human– computer interaction research and are based on proven usability principles routinely followed in other domains [33]. Clinicians could then expect reasonable continuity in the visual presentation of identical or similar medical data and consistency of interactive behavior across the systems they may be using concurrently, even if developed by different vendors. Implementers and system architects could then rely in integration planning on the assumption that some modifications will be possible to make in order to conform the system to the constraints and demands of specific clinical environments. For example, systems may always allow administrators to control alert salience according to the message importance level and implementation environment or to adjust the rules for alert activation over time to achieve and maintain optimal level of performance. Usability measures such as effectiveness, efficiency and subjective satisfaction characteristics should be included as criteria in the procurement of EHR systems to help in the selection process [34]. Table 2 lists questions clinicians may pose to vendors when considering a purchase, with further details elaborated in the sections below. The largest effort to date at setting design standards, guidelines and providing toolkits for developers is the Common User Interface (CUI), a joint project of the National Health Service (NHS) in the

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Table 3 Summary of desirable system attributes. Attribute

Recommendation

References

Perceptual grouping and data relationships Consistent terminology Consistent wording Acceptable density of information on screen Workflow integration Cultivation of trust Advice rather than commands Alternatives rather than stops Intermediate states System logs Interoperability and data standards

Same visual attributes of related items. Distinct appearance of dissimilar objects

[62–64,66]

Tests, procedures, orders and sets, alerts, menus should use consistent language [To]..[do this] Desired outcome comes first, followed by action Segment long lists, tables to short groups, use blank space to aggregate, separate

[65,91,98] [65,67] [11,67,98]

Appropriate sequence of screens, context, type and timing of advice by clinical task Avoid black box advice, maintain high specificity, context, justification Highlight potential problems, safety hazards, suggest actions – not directives Suggest alternatives to audited actions, provide direct links to carry them out Maintain clinical state variables from aggregated data, use refine to decision logic Allow access to logs, analyze periodically to increase specificity, sensitivity of alert rules Normalize ‘‘source of truth’’ data to common representational formats, reconcile multiple medication, problem, allergy lists Facilitate manual corrections or additions of data in the EHR as part of response actions to alerts Missing, outdated, erroneous or contradictory data must not result in incorrect advice or lower safety Allow certified companies access to data services, interface development; separate code and content

[6,11,12,19,64,67,68,73] [11,69–73] [74–77,79] [6,11,78] [73,80] [19,49,81] [82–86]

Patient record maintenance Graceful degradation Third party access

United Kingdom and Microsoft [35]. It provides guidance on clinical documentation, the entry and display of medical concepts in forms and their matching to SNOMED CT terms, consistent navigation, icons and semiology, formatting and layout of medication items, safe identification of patients and on other interface design areas. Similar initiatives are under way in the United States at the National Institute for Standards and Technology (NIST) [36,37], Agency for Health care Research and Quality (AHRQ) [38–40], Health Information and Management Systems Society (HIMSS) [12,28,41,42] and elsewhere. The failure to address system deficiencies deriving from inadequate interface design leading to unintended consequences and errors that propagate through networked systems built according to different or discordant design principles represents a serious and unresolved set of problems [43]. These deficiencies may lead to the weakening of the safeguards that HIT provides against medical error and may even increase risk for patients under certain conditions [44]. An analysis of patient safety incidents reported over two years by clinicians in one hospital found that human factors accounted for half of the problems in which information technology was a significant factor [45]. Evidence from published reports on the incidence of HIT-related medical errors suggests that deficient interface design may cause or contribute to decreased cognitive performance of clinicians [46,47], complicate medication dosing (for example of potassium chloride) [48–50], engender unsafe workarounds [51,52], fail to reduce the number of adverse drug events in an EHR lacking appropriate dosing decision support [53–55], facilitate medication error risk [56], exacerbate poor responses to medication safety alerts (in a simulated study) [57] and increase duplicate medication order errors [58]. Evidence from over three decades of research and design of devices and software in safety–critical industries such as nuclear power, military and commercial aviation is extremely encouraging in showing that significant advances in safety can be achieved through human factors methods, cognitive engineering and strong usability practices in design. The United States government now requires human factors analysis, evaluation and testing for all procured systems and issues directives and guidelines for best practices applicable to defense (US Army Manpower and Personnel Integration Best Practices) [59], nuclear power (HFE Program Review Model by the Nuclear Regulatory Commission) [60], commercial aviation (Human Factors Design Standard by the Federal Aviation Commission) [61] and medical devices (Pre-Market Approval of Medical Devices Best Practices by the Food and Drug Administration). A summary of recommended design principles and desirable EHR system characteristics discussed in this section is in Table 3.

[6,17,19,74,84] [89] [90]

3.1. Consistency of design concepts, visual formats, and terminology An effective design convention to minimize errors of commission (e.g., the confusion of screen objects that look similar) and to increase the speed of target recognition in visual searches by allowing quick perceptual judgments is to make conceptually similar items share salient attributes and dissimilar items appear clearly distinct for easy differentiation [62]. For example, order entry screens and modules for all fluids should have the same background color and layout of fields that are distinctively different from orders for intravenous medication and medicated drips. Visual cues (e.g., font, color, placement) indicating abnormal test results need to be identical across all interconnected systems so that clinicians do not have to interpret their meaning but can use faster perceptual judgment. Similarly, the method of responding to interventions needs to be uniform with contextual information and navigational controls presented consistently in all connected systems [63]. Text entries in forms and tables should always be aligned into basic geometric forms that visually connect items belonging to the same group and form easy to follow hierarchies of related entries [64]. All terms, including the names of laboratory tests, procedures and order sets, need to be used consistently across menus, lookup tables and in advisory messages generated by decision support interventions to minimize errors of misidentification and delays in interpretation and visual lookups. A nomenclature of conceptual categories should also be consistent and unambiguous. For example, if alerts are classified into three severity tiers such as ‘‘critical,’’ ‘‘significant’’ and ‘‘caution,’’ the same terms need to be used in all alerts, messages and textual references. Similarly, consistent color coding, use of highlights and fonts and visual hierarchies needs to be maintained within all modules of a system and preferably across all interoperable systems [65,66]. Prompts and instructions should employ a consistent wording style. The infinitive construction, which starts with the expression ‘‘To [accomplish the stated goal], [do this]’’ is effective in preventing errors associated with acting in response to a prompt before reading the consequence of the action. For example, rather than stating ‘‘Press the Continue button to override,’’ the explanatory message should read ‘‘To override, press Continue’’ [65]. Consistent use of identical design concepts within and across systems is essential for shortening the time required to gain interaction proficiency, and for lowering cognitive effort and mental fatigue that contribute to eventual misses of significant warnings or to overlooking data indicating abnormal and critical patient states.

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3.2. Flexibility of interaction, workflow integration, and rapid alertresponse action A primary concern of many clinicians is the speed of completing tasks. Thus, they need to rapidly receive advice and take an appropriate action at a convenient point in the workflow without extraneous effort or delay [11]. While the acceptable screen transition time is well under a second, the overall perceived difficulty of interaction is directly related to the number of clicks required to respond, the complexity of menus to navigate when entering coded data and the time and cognitive effort required to find items on the screen (e.g., finding the most recent lab values in a long entry list). Interaction complexity can be alleviated by carefully managing the density of screen information, segmenting long tables and lists into sections separated by headers that can guide visual searches more directly to the target item (i.e., allowing to skip entire groups without reading each item) [67] and anticipating follow-up steps in common workflows by providing shortcuts or prioritizing the placement of screens and modules in expected sequences. For example, a reminder to administer a scheduled immunization should be followed, after acceptance, by an ordering screen that contains a review of other immunizations that may be due, allergies, medications or other contextual patient data, or a link to schedule an appointment if the vaccine is not given at the present time. Tight integration with clinical workflows [6] and presentation of relevant advice at the time and place of decision making are key to effective performance [19,68]. Clinicians are more likely to accept and routinely use an electronic system that meets their expectations of flexibility, individuality of advice, and reliability [69]. Optimal CDS performance is thus determined by appropriate matching of interventions to specific clinical goals, workflow contexts and clinical environments. Matching criteria and further details on aligning decision support with clinical goals can be found in the HIMSS CDS Implementation Guide [12]. The authors describe a six-stage model that consists of identifying stakeholders and determining CDS goals, cataloging existing HIT infrastructure, selecting interventions for workflow objectives, validating the proposed plan, testing interventions and finally evaluating the effects of interventions on care.

3.3. Presentation of advice in a way that cultivates trust over time Clinicians must be convinced that the advice is accurate and relevant and will contribute to improving prescribing safety, quality of documentation and efficiency [70]. Visual, cognitive and interaction characteristics of CDS interventions can determine whether clinicians will regard CDS as effective and useful clinical tools or rather as unwelcome and irrelevant intrusions [71]. For example, high specificity and relevance of alerts is crucial for developing confidence in the ability of the system to make accurate and comprehensive inferences about a patient’s medical state, take into account appropriate clinical context, present the advice at the appropriate level of urgency and suppress irrelevant messages [72]. Interventions should unobtrusively, but effectively, remind clinicians of things they have truly overlooked, support corrections, and present key data and knowledge in appropriate context so the right decisions are made in the first place [73]. Systems need to avoid the impression of a ‘‘black box’’ giving advice that cannot be subjectively evaluated. An explanation of medical logic, including formulas for calculating values, should be accessible on demand so that the justification for alerting is transparent and verifiable. A drug alert suggesting a dosing change, for example, may include a link to additional details on why the advisory was shown, further supporting evidence from academic

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literature and guidelines, and a contact to local authorities responsible for the explanation of CDS rationale [11]. Frequent selective overrides of specific alerts by many clinicians may be an indication of several kinds of design problems: poor design of response mechanism (e.g., inconvenient ways to accept it), possible flaws in medical logic or a sign of inaccuracies in the patient record. The assumption that the problem of frequent overrides lies with ‘‘noncompliant clinicians’’ should be resisted. A periodic review of underutilized or ignored advisory interventions may point to gaps in rules logic or to inadequately updated patient data that trigger irrelevant alerts. For example, there may be medications in the patient record that have been discontinued or those with their course already completed [74]. A clinician may be aware of that fact and therefore correctly consider the advice inappropriate. Such events work against cultivating trust in CDS. A broader strategy to avoid distrust in the relevance of decision support is to avoid recommendations that are controversial. Rather, advice should be given only for aspects of care in which there is little disagreement on appropriate management [75]. 3.4. Advice: assessment, suggestion and recommendation – not commands Health information technology, to a certain degree, codifies expert knowledge and problem solving that are the core competencies of healthcare professionals. Some clinicians may perceive computer-generated, overly prescriptive advice infringing on their sense of professional autonomy [76]. Systems should therefore formulate advisory messages in the manner of highlighting potential or actual problems that require attention and suggest therapeutic opportunities rather than imposing strict, inflexible and unsolicited dictates [77]. However, merely giving an assessment without recommending an action and providing a convenient way to either carry out or disregard it is generally not an effective way to change behavior [6,78]. For example, an intervention may recommend that a clinician prescribe an antidepressant and include a justification with supporting research evidence rather than simply suggest that the patient is depressed. Physicians may strongly resist a suggestion not to carry out an action when an acceptable alternative is not offered [11]. However, alerts are also often perceived only as cues for considering other options rather than as highly reliable information sources whose recommendations should always be followed [77]. Suggesting equally effective and appropriate alternative actions is complex and not always possible. In medication prescribing, for example, the recommended options need to include the alternative drug and its dose and frequency appropriate for the patient’s clinical context. As the actual indications may differ from those considered by the decision logic, contextual information from the record needs to be evident to support the relevance of the advice [79]. For example, the last measured serum creatinine levels, presence of other interacting drugs and the standard dose may be included on the alert as contextual information. 3.5. Maintenance and re-use of intermediate variables Electronic representations of a patient’s physiological and clinical state can be algorithmically derived from data stored in the record. These ‘‘intermediate states’’ (or state variables) are inferences from primary data that can be conceptualized in clinically relevant terms and further used in decision logic. Clinicians often find these state variables to be more intuitive and convenient for reasoning than single data points [80]. They may be monitored and automatically updated over time to reflect changes in laboratory results, medications, problems, procedures, passages of time and other

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data. For example, a clinical rule may trigger reminders for a Pap screening test for female patients, with varying frequency depending on age. An entry of a hysterectomy procedure, however, may create a ‘‘post-hysterectomy state’’ variable that suppresses further reminders. More complex patient states (e.g., ‘‘patient is on anticoagulation therapy’’) can be created with sophisticated data-driven derivations that trigger more extensive and more specific interventions [73]. 3.6. Periodic review of system inferences and human actions Managing the specificity, sensitivity and other performance characteristics of alerts is necessary to help prevent excessive alerting and is often possible by analyzing detailed logs generated by automatic system audits [49]. System logs should maintain records of automated inferences and recommendations and of response actions taken by clinicians (e.g., overrides) that are timestamped, identifiable and with sufficient detail to determine which data, actions and patient or system states triggered each intervention [19]. Automatic monitoring of overrides should notify administrators when a preset threshold for the number of alerts that are not accepted is reached in any given time period. Such performance data can also provide critical feedback to knowledge engineers developing the clinical logic for the CDS interventions [81]. System performance should be periodically reviewed by analyzing the logs. Descriptive statistics can show the proportion and distribution of alert overrides across clinical services, locations, individual clinicians and patients. Trends and systematic patterns in overriding certain alerts may serve as a proxy measure of their precision and practicality. For example, frequent and consistent overrides may point to outdated or incorrect criteria in decision logic, irrelevancy for particular clinical context (e.g., in case of medication refills or health maintenance reminders for hospitalized patients), erroneous data in the patient record (e.g., medication and allergy lists that are not well maintained) or to inconvenient design of alerts that are either too intrusive or are activated at a point in the clinical workflow when the suggested response cannot be made. Records showing minimal use of specific order sets may indicate their poor fit to the intended task, inconvenient access (e.g., placed in an unexpected menu group or hierarchy level) or that clinicians simply may not know about their existence. Overuse of entry fields such as free-text comments for data intended as coded entries may be a sign of workarounds employed to bypass difficult screen controls or poorly designed workflows. Patterns of use that significantly differ from expectations may be further investigated by help desk logs and complaints as well as by informal interviews or discussions with clinicians or by observing their work directly. Systems should allow easy access to logs and provide tools for their analysis or let analysts import log data in common formats into third-party software. 3.7. Clinical data standards, interoperability, integrity and robust architecture Decision support algorithms may need to evaluate data from several sources, such as the patient record, laboratory result repository, pharmacy and other ancillary or legacy systems. Syntactic and semantic interoperability assures that services can retrieve remote data and that their meaning is preserved for decision support rules to process them correctly. For example, amylase and lipase tests are method-dependent but may be stored under the same name on different systems; white blood count (WBC) designation can contain results on one system and an order (intent) on another. Further, when clinical data are aggregated from multiple sources they may need to be ‘‘normalized’’ into a common representational

format (common or converted units of measurement, reference range, etc.) and analogous data reconciled by identifying their ‘‘source of truth’’ [82]. Timely maintenance of patient allergy lists and trigger rules can reduce the number of ‘‘false-positive’’ alerts that have low clinical value over time. Institutions with several EHRs need to integrate multiple instances of allergy lists stored on different networked systems that may contain conflicting or unreconciled information [83]. Shared lists of allergies, medications and problems for each patient should serve as singular reliable sources on which the decision support rules operate across the network [84,85]. Pharmacy systems receiving electronic prescriptions should also have their own automatic drug–drug and drug–allergy checking in addition to decision support built into the ordering system [86]. The networked systems, however, should share the same clinical context so that pharmacists can better evaluate the appropriateness of each prescription. A summary screen containing key patient information, for example, may include flags for all alerts that physicians have overridden, including the rationale and relevant details (e.g., the patient is taking high-risk medications such as warfarin or monoamine oxidase inhibitors) to minimize the number of unnecessary callbacks from pharmacists to clinicians for clarification. The precision of clinical logic rules that activate decision support interventions depends on the quality of information stored in the electronic record. This data, however, may be missing, incorrect, imprecise, dated or otherwise unreliable. The inference engine (i.e., the set of rules and algorithms that generate advice) needs to function safely in such conditions and prevent the system from giving inappropriate advice. Designers need to consider how systems detect and respond to erroneous or contradictory data, the effects of missing or incorrect information on the appropriateness of the advice, and how to facilitate convenient manual corrections of patient data. For example, a drug dosing calculator that requires patient’s weight to compute dose adjustment may prompt for the weight to be entered if missing (e.g., once per session, to avoid over-alerting) or ask to acknowledge a possibly erroneous entry of ‘‘10 lb’’ [87,88]. However, the rules need to reflect specific conditions of use, such as patients in neonatal units where the weight of 10 lb would not be considered improbable. Frequently overridden allergy alerts may include a link to remove the allergy from a list in the patient’s record. Systems should follow a pattern of ‘‘graceful degradation’’ and continue to function at a reduced level of performance when components fail or data are not available [89]. Robustness of large networked systems may be reduced by unanticipated interaction of safety devices built into each sub-system that were designed to be effective in stand-alone installations but may introduce emergent vulnerability into complex networks without adequate testing. A significant near-miss incident, for example, was attributed to the interaction of major and minor faults which were individually insufficient to have produced an incident; a drug-dispensing unit at an emergency department became locked and unresponsive after a failure in a connected HIS generated a continuous stream of warning messages, causing, in turn, a significant delay in obtaining medications for a critically ill patient [44]. Optimal degree of fault tolerance and acceptance of idiosyncratic human interaction is also required to maintain safe operation over time. 3.8. Innovation and third-party developers Institutions and practices depend on the agility of vendors in making cyclical updates, developing new additions and providing customized components. These constraints make the adaptation process of CDS to different clinical environments difficult and protracted. A recent decision by a prominent HIT company to allow

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certified third-party developers to write native applications for their EHR application and thus eliminating the need for specialized interfaces to connect legacy systems may signal an important trend in opening previously proprietary, monolithic platforms to innovation and customization [90]. Offering software development kits and access to common services is essential for data integration and allowing their consistent visual representation across all networked systems. The emergence of service-oriented architecture and the separation of clinical content from the underlying software code will also allow more customization and sharing of CDS rules and clinical logic across different systems. 4. Decision support for electronic ordering and medication prescribing The most common form of CDS is medication prescribing support during electronic order entry, known widely as computerized physician order entry (CPOE). Clinicians may encounter an interruptive alert (a modal dialog box) that requires a response either by acknowledgment and justification of the order as written or by changing to the suggested course before interaction with the system can resume. A less intrusive approach is to embed decision support messages in the clinician’s visual field on the screen for non-urgent notifications so that explicit acknowledgment and work interruption is avoided. Appropriate forms of intervention can increase the speed, accuracy and safety of ordering by guiding clinicians through the interactive process toward selecting the correct medication or a test in the correct manner [20]. Order sets (groups of associated orders for a specific clinical purpose such as an admission) are also considered a form of decision support because they function both as checklists for the completeness of a clinical intervention and as reminders to follow up and monitor the effects of interventions (e.g., corollary orders for appropriate laboratory tests), as well as pre-structured guidelines for dosing regimens. Recommended design approaches for decision support used in clinical ordering are described in the following sections and summarized in Table 4. 4.1. Consistency of terms and text formats Accurate representation of rich clinical discourse in decision support requires well-defined and consistently applied terminology for observations, assessments and medical concepts. Terms

for adverse reactions, problems, procedures and other activities or items as well as conceptual categories describing groups of related data should be standardized across all networked systems and combined with spell-checking and automatic suggestions to make their entry and lookup faster [91]. Although standard terminology promotes semantic clarity, the speed of finding specific words or data on the screen by visual scanning is increased by their consistent appearance. Lists of available medication orders, for example, are often extensive and displayed in long, scrolling tables or drop-down menus that make the task of finding a specific order strenuous, cognitively demanding and error-prone. Their quick identification can be reinforced by visual cues in the text formats of drug names that belong to defined categories. For example, generic drug names can be printed in lowercase while brand name equivalents may have the first letter capitalized, giving each a distinctive visual form [20]. An entire group of names can then be skipped without reading during lookups. However, printing text in all caps in structured lists, tables or in continuous sentences and paragraphs should be avoided as all words become visually more similar and therefore harder to differentiate and read [92]. Items in lists, especially medications, need to be clearly distinguishable from each other to minimize the misreading of lookalike and sound-alike drug names. The Joint Commission has published a register of drugs with similar names that should not be adjacent in pick lists [93]. They also recommend not using certain abbreviations, such as IU (International Unit) and IV (intravenous) that can be confused with one another [94], either in longhand writing or in screen fonts that are small in size or uncommon. Another useful practice is writing a part of a drug’s name in upper case letters (‘‘Tall man’’ lettering) to make similar items more visually distinct [95,96]. For example, ‘‘prednisone’’ and ‘‘prednisolone’’ may be written as ‘‘predniSONE’’ and ‘‘prednisoLONE,’’ respectively. A list of drug name pairs with suggested Tall man letters is issued and maintained by the Institute for Safe Medication Practices (ISMP) [97]. Research evidence of their effectiveness, however, is scant. Legibility of numbers and visibility of decimal points are important for preventing errors of commission. For example, some screen fonts (especially serif) have similar appearance for the digits 1 and 7 that can easily be confused in time-constrained work conditions or on poorly adjusted monitors [65]. The use of sans serif font families (Arial, Helvetica and other) is recommended, with minimal size of 10 or 11 (although exceptions are possible with caution).

Table 4 Summary of design recommendations for medication ordering. Design recommendation

Example

References

Consistent terminology Format text to visually associate drug categories Emphasize differences in similar drug names Clearly legible font Unambiguous units Manageable pick lists Multiple entry options Concise language

Adverse reactions, problems, procedures, medical concepts, assessments, drug and drug class names Lowercase for generic drugs, capitalize first letter for brands. Avoid lists of drug names in all caps

[91] [20]

Avoid adjacent look-or-sound-alike names in lists and excessive abbreviation. Use Tall man lettering

[93–96]

Use sans serif fonts, size 10 or 11 if possible Use only standard abbreviations placed closely adjacent to values. Include rates for infusions Break long lists into sections separated by space or headers for fast lookup. Avoid excessive variation Limit time by start and stop times or duration Place important words first, details later in the sentence. Display ten words or less and provide a link to the full text Show trends in graphs rather than tables for contextual data, facilitate temporal associations Layout, color of IV fluid orders should be different from medicated drips; visually distinguish ‘‘last’’ and ‘‘dated’’ lab results Sets by a procedure, clinical task, problem should be customizable by institutions and clinicians Show relevant patient information on ordering screens; use contextual information to refine rules Content, layout, instructions can be automatically modified by patient-specific EHR data Periodically analyze overused, underused orders, consistent alert overrides, integrity of entered data

[65,67] [99] [65,67] [100] [73,102]

Representational formats Visually distinct screens for confusable items Custom order sets Clinical context Active order forms Log analysis

[14,25,26,49,103,104] [49] [105,106] [11,20,49,50,107–110] [105,106,111] [20]

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Some systems include dose variants of one medication in lookup lists as a shortcut to allow their ordering with a single click, without the need to further select a dose, frequency and form in a subsequent step. However, if the lists are not well maintained and allowed to grow without limits, this approach may inadvertently increase search time by making visual identification of the target dose more cognitively demanding and the overall ordering task longer. For example, there may be a dozen variations on Amoxicillin orders, such as ‘‘Amoxicillin/CLAV. SUSP 125 MG/ 31.25 MG (5 ML).’’ A heuristic recommendation for the display of search results as lists that have to be further visually scanned for a target item is to limit them to about 8 to 12 by the time five characters are typed into the search box [67,98]. Restricting drug name entries to only the most frequent dosing variations is essential for fast visual lookups. Units should always be unambiguous, even for automatically calculated measures, and adjacent to the respective numerical value rather than in a separate table column. For example, entries that contain multiple descriptive values, such as concentrated electrolytes orders (potassium chloride) always need to include the rate of infusion in close proximity to volume and concentration [99]. Complex ordering can be made cognitively easier by allowing the entry of information in convenient and usual formats that are automatically parsed into required coded segments. For example, intravenous drips, medications and time-limited orders for which duration needs to be specified should allow entering time in hours or days in addition to start and stop times to prevent errors in time calculation [100]. The respective date and time entries are then calculated automatically and entered in the appropriate fields. 4.2. Concise and unambiguous language Brief and clear recommendations are the most effective [11]. Language used in messages needs to be succinct and use instantly recognizable terms that can be accurately interpreted in a single reading [67,98]. For example, if the value of a weight-based heparin dose calculated specifically for a given patient is inserted in the middle of a boilerplate explanatory paragraph, clinicians may dismiss the entire dialog box without reading its content. They may thus miss a patient-specific recommendation that seems to look like a generic reminder at a first glance [101]. The most salient part of a message (e.g., dose, patient weight) should be shown before any other supporting information is given. Messages within alerts should be generally shorter than ten words and accompanied by an immediately actionable item while a guideline needs to fit on a single screen to be effective [73]. For example, a recommendation about aspirin use may be worded as ‘‘use aspirin in patients status-post myocardial infarction unless otherwise contraindicated’’ [11]. A link to further evidence may also be included as clinicians often contend that more information should be accessible [102]. 4.3. Appropriate representational formats of data and distinctive entry screens The representational format of clinical data (e.g., HbA1c values over several months as a table or a trend graph) is important for supporting quick perceptual judgments and accurate decisions [103]. Anticoagulation orders, for example, should display clotting times (INR) as trends, not as isolated numbers, with medication dosage displayed in a way that facilitates temporal associations and trends [14,104]. Screens, modules and dialogs for ordering easily confused interventions should be clearly visually distinguishable by layout, color or shape and have unambiguous labels. For example, continuous IV

fluid infusions limited by time and medicated IV drips limited by volume, especially those that include different concentrations, need to be clearly distinct so the ordering clinician is always aware of which type of medication delivery is being ordered. Similarly, when displaying time-sensitive inpatient laboratory results, visual indicators such as color, font or conspicuous spatial arrangement should indicate the difference between the most recent available results and those that may already be ‘‘dated’’ (e.g., the values may have already changed in response to drug therapy) [49]. 4.4. Organization of orders by problem and clinical goal Individual orders and order sets should be aggregated into groups and hierarchies according to criteria such as clinical departments, organ systems, clinical diagnosis, clinical goal, condition or a procedure [105]. They can also be nested in menus corresponding to clinical problems and common scenarios, such as the admission of a patient with upper gastrointestinal hemorrhage to the intensive care unit [106]. Individual orders within order sets can also have some fields pre-populated with common standard doses and frequencies or provide calculated weight-based doses. This organization reflects cognitive models corresponding to clinical states, tasks or problems. Instructions on modifying a set for patients with specific diagnoses or in a particular service should be accessible via a link. System designers should provide convenient tools for editing and structuring selection menus for orders and sets so that ordering modules can be customized to better support common clinical tasks without the need for programming or relying on vendor services. Organizations should create core sets of orders and maintain them via periodic reviews by a steering committee while smaller practices can develop over time a collection of most frequently used sets. Some practitioners advocate allowing individual clinicians to save and use their own modified versions of order sets. Such customization was initially considered valuable for promoting clinician buy-in but recently recognized as a potential source of uncontrolled modifications that can defeat the goal of care standardization and make systematic updates more challenging. 4.5. Clinical context Ordering screens should display appropriate contextual information from the electronic record such as laboratory values required for dosing adjustments so that clinicians do not have to navigate away from the ordering screen to see or recall from memory key data. For example, relevant laboratory results may be shown on aminoglycosides, warfarin and other medication orders dosed with respect to serum drug levels, physiological markers, when renal or liver function is affected and when specific values (e.g., BMI, or absolute neutrophil count) need to be considered [20]. Contextual information should account for the relationships and correlates between clinically dependent data. For example, an intervention may suggest lowering a drug dose when kidney function worsens and prompt for corollary lab or other orders [11], show allergies, renal function, microbiology results, sensitivities and the unit in which the patient is located when ordering antibiotics and suggest the best and least expensive brand or a generic and its dose [107]. Although identical or same-class medications usually should not be prescribed for a patient, rules that check for multiple orders must accommodate cases in which such orders are appropriate while still ensuring safety [108], such as when more than one analgesic is ordered on an as-needed basis or when a patient may require two different antibiotics or more than one type of anticoagulant. Complex rules may also be needed to inform clinicians ordering potassium chloride (drip or bolus) when the patient

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already has another active order for potassium and when there has not been a serum potassium value recorded in the past 12 hours, or the most recent value is greater than 4.0 [49,50]. Increasing the variety of information sources that are available to the decision rules engines to access and consider—medical and laboratory claims, test results, feedback from physicians, and self-reported data from patients who are enrolled in disease management or complete health risk assessments—is likely to greatly increase the specificity and credibility of clinical alerts in the future and increase the response of clinicians to potentially risky medication [109,110]. 4.6. Interventions embedded in forms Decision support can be structurally embedded into order forms that either adjust the content according to patient-specific criteria or prompt for actions and additional information entry. For example, forms may substitute or add gender-specific fields, display or prompt for renal function or pregnancy status, perform automatic clinical calculations, enforce policies via field restrictions and audit for permitted range of entry values or incompatible medication route selections. Clinicians can be guided through complex orders with dialogs and forms with selection lists and suggested values that will populate appropriate fields in the resulting order. Order dialog forms help create accurate orders and are complementary to decision support tools such as automated order checks that are activated only after an order is completed [106]. A key issue is avoiding errors where such automaticity leads to inattention and complacency (i.e., failure to review an automatically generated order).

5. Design specifics for alerts and reminders Alerts and reminders are triggered by clinical rule engines that monitor data stored in the EHR, user actions and the passage of time. Research evidence suggests that clinicians may be exposed to so many electronic messages that rather than providing assistance, alerts may paradoxically add to cognitive effort and gradually lead to their near automatic dismissal (override) without reading the message [74,102,112]. This learned behavior is largely the result of poor alert specificity and low perceived signal-tonoise ratio that limits the ability to differentiate true positive stimuli from false positives (noise) according to the Signal Detection Theory [113,114]. The behavioral change is sometimes referred to as ‘‘alert fatigue’’ and applies also to auditory signals coming from inpatient monitoring devices [115]. There are several design approaches to limit the number of alerts perceived as having low utility. Rules that trigger specific alerts can be filtered to suppress low-severity drug–drug interactions, or be prioritized and made more specific by combining patient and provider-specific data [116]. Alerts can also be tiered into two or three severity levels and presented in more and less intrusive forms according to importance [13]. Another way of reducing the total number of messages presented to a single physician is redirecting them instead to pharmacists, nurses or other staff when appropriate and desirable [20]. Alerts should be sensitive to clinical context by incorporating more patient-specific data into trigger rules, provide clear, unambiguous information display and carefully calibrate intrusiveness to be proportional to their level of importance. A summary of these design recommendations for alerts and reminders is in Table 5.

4.7. Complex order forms and calculators Some decision support interventions may require more attention and interaction as the complexity of orders increases. Contextual, stepwise instructions and prompts with questions requiring a response may be presented to clinicians to guide them through the ordering process of multiple and interdependent medications, procedures and associated tests. For example, a list of indications for blood test orders may be displayed, followed by a menu of relevant tests for each indication. The most complex forms of drug dosing decision support (e.g., dosing calculators) should integrate patient-specific laboratory results, active orders, weight, and allergies with complex guidelines or protocols and present calculated values with aggregated information derived from intermediate variables for decision making [105]. Wherever possible, the system should perform drug-dosing calculations on behalf of the clinician based upon accepted algorithms or nomograms to minimize computational errors and to speed up the calculation step [111]. The algorithm used by the system should be made accessible on demand by a link to promote trust in the reasoning process.

5.1. Interruptive vs. non-intrusive alerts Alerts (active CDS) are typically designed as modal dialog boxes (requiring an action to dismiss) and have one or more buttons and advisory content. They are inherently and purposely disruptive as their explicit acknowledgment by a mouse click or a keystroke is necessary to continue. The interruption of an ongoing activity is appropriate to get the attention of clinicians when warning about potentially adverse consequences, such as the probability of severe drug or allergy interaction with the medication that is being prescribed. However, this option should be reserved only for highseverity warnings and used judiciously [20]. One of the primary objectives of decision support is to unobtrusively but effectively remind clinicians of things they have truly overlooked and support corrections [105]. Two or three severity levels are generally sufficient to assign advisories into appropriate categories of visual saliency and intrusiveness and improve the overall rate of compliance [13]. They can be designated as ‘‘high,’’ ‘‘moderate’’ and ‘‘low’’ or simply as ‘‘critical’’ and significant’’ and appropriately color-coded.

Table 5 Summary of design recommendations for alerts and reminders. Design recommendation

Example

References

Tiered severity level Concise text, justification Clear response options Concurrent alert priority Unobtrusive reminders Meaningful color sets Text luminosity Filtering rules Curate, revise trigger rules Prompt for EHR edits

Synchronous, interruptive alerts should be reserved only for high severity warnings (of 2–3 levels) Content should be limited to 1–2 lines, with a justification separated by white space Buttons (order or cancel) with simple labels, action links to additional options (alternatives) Multiple alerts for a single order should be prioritized, deemphasizing low–severity alerts May be designed as flags in names lists; prioritized and color-coded messages in reserved screen areas 5–6 colors to maintain emphasis effect, matched across all systems. Use color shades for gradients Dark text on light background and high contrast ratio aid reading – match appropriate color pairs Increase specificity by evaluating more EHR data in trigger rules and suppress ‘‘false positives’’ Periodic reviews of frequently overridden alerts by a committee that includes pharmacists Include a link to edit allergy and medication lists in alerts that are frequently overridden

[13,20] [11,64,79] [64,98] [58,73,117] [17,73,79] [61,66,67,119] [67,121] [74,79,105,123,125] [104,126–129] [6,17,84]

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Interruptive dialogs should have simple and clearly defined response options, such as [Order] and [Cancel] buttons and a very concise justification. Multi-word button labels and verbose messages make the selection of the intended response by perceptual judgment difficult and generally do not add clarity [11,64,79,98]. The default action (i.e., completed by pressing the Return key) should be the desired action [7]. In some instances, when an alternative medication or test is offered, a link (or a button) may be added that closes the dialog and populates appropriate fields in an open order form with the suggested values. Reasons for override may also be prompted routinely so that knowledge engineers trying to determine why some alerts are consistently ignored can review override reasons, and analyze them in conjunction with activity logs [20]. Multiple simultaneous alerts related to the same order (e.g., drug–allergy and therapeutic duplication and a dose alert) may have a diminished effect if perceived as excessive and distractive. The usefulness of concurrent alerts needs to be evaluated; those that do not absolutely contribute to improving the prescribing process should be suppressed or deemphasized [117]. Those that remain need to be prioritized by severity so that, for example, a low-importance allergy interaction does not conceal a therapy duplication warning [58,73]. Advisory messages of lower importance should be displayed in a more subtle format to avoid excessive alerting. For example, interactions between systemic and topical drugs, alerts for drug allergy in case of medication intolerance, and alerts for events to which an active response is not urgent or possible should be displayed in non-intrusive, asynchronous presentation formats [79]. These can be text messages in sidebars that can be read without explicit acknowledgment or for the moment ignored [17]. Other examples of embedded CDS include guidelines for vaccine administration displayed alongside an order set menu for pneumonia and flu vaccines, listing the most recent results of serum electrolyte tests displayed with orders for intravenous fluid therapy medications, or dosing weight and pharmacy recommended dosing guidelines for weight-dependent medications [105]. 5.2. Display and organization of reminders Reminders to take certain actions at the present time or in the near future (e.g., schedule a mammogram) can take several forms. One approach is to simply add flags to patient names in lists. Short descriptive messages may also be placed in designated locations on the screen when an individual patient record is opened. Messages that prompt for routine actions (e.g., periodic lab tests for patients with chronic conditions) should be offloaded from physician workflows entirely and redirected to support staff. Reminders can be prioritized by sort order or by color-coding. For example, red with progressively more saturated shades may indicate importance or priority and a color set such as red–orange–yellow, employed consistently throughout the application, may indicate levels of importance. The use of color should be consistent and controlled to convey meaningful concepts such as importance level, hierarchy, category or to differentiate data with different attributes (e.g., real-time and historical [65,66,118]). The entire palette should be ideally matched across all networked applications and not exceed five or six in total as competing color combinations distract from the saliency (or pop-out effect) of screen items that are intended to draw attention [37,66,67]. Sufficient contrast (luminosity) needs to be maintained between the foreground (text) and background colors which can be often accomplished by using non-saturated hues for any larger areas of the screen [61,67,119]. Usual and widely accepted cultural and professional conventions should be followed in the selection of colors to emphasize specific meanings. For

example, red for high priority, danger, stop, error and abnormal conditions (e.g., laboratory values outside of the normal range), orange for medium priority, yellow for low priority or minimal caution, green for completed items or safe conditions, blue for informational messages, gray and half-tone saturation for unavailable selections or de-emphasized text and black on white background for primary, standard information. Recognizing that 7–11% of male health care practitioners have some degree of color vision deficiency, particularly in distinguishing reds and greens [120], designers should consider avoiding distinctions that use similar hues of red vs. green [121]. 5.3. Filtering of frequent interruptive alerts Filtering alerts by increasing the specificity of trigger rules may help to decrease the number of interruptive messages with little evidentiary basis or clinical relevance or those that are redundant [74,122]. To date, drug–drug interactions have represented a major challenge for informatics and pharmacology to both define evidence based standardized alerts and to deliver effectively significance-prioritized warnings. Drug interaction alerts should be primarily patient-specific by taking into account age, gender, body weight, allergies, mitigating circumstances, drug serum levels, renal function and comorbidity [123]. For example, standard alerts related to abnormal renal function should be suppressed for patients on dialysis although it is a nontrivial task to ensure that relevant EHR data are complete and updated. Time intervals between interacting drugs should also be considered as earlier drugs might have been completely metabolized. If a potential interaction did not result in problems for a specific patient in the past, physicians should be able to suppress the alert for subsequent dose adjustments to avoid redundant messages [79]. Systems should be able to, where appropriate, suppress alerts at the time of renewal of previously tolerated medication combinations for the same patient [17,74]. However, suppressing a drug– drug interaction alert after it has been overridden only once per patient was not favored by prescribers and even less by pharmacists according to one study [117]. There is an ongoing debate whether individual clinicians should be allowed to turn off specific alerts they consider uninformative or whether entire classes of alerts could be safely suppressed for particular specialists, who may not need the same level of support as generalists. Evidence shows that rather than knowledge deficit, the cause of most errors is forgetfulness, oversight, and the distracting influence of interruptions, all of which are as prevalent in the work of most specialists as they are for generalists and residents [105,124]. If specificity is high and alerts are only presented in potentially unsafe situations, specialists who already know them do not seem to object to receiving these alerts [125]. 5.4. Revision of alert trigger rules Maintaining high specificity of alerts is dependent on the quality of the knowledge base for triggering rules and the completeness and accuracy of electronic health records on which the rules operate. Error-producing conditions may exist in commercially available and institutionally developed databases and customization or periodic reviews are necessary [126]. A committee of physicians that includes domain experts and pharmacists for drug-related alerts should periodically revise rules with a focus on frequently overridden alerts and suggest safe and effective ways for either suppressing alerts of low value or changing their presentation format [127]. Such reviews may take into account the fact that patients with long-term use of certain medications have demonstrated their capacity to tolerate them and consider the suppression of alerts for refills [128].

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Combining pharmacology and laboratory data into decision rules provides a powerful tool to guide initial drug choice (i.e., drugs where there are laboratory-based indications and contraindications), drug dosing (renal or hepatic, blood level–guided adjustments), laboratory monitoring (laboratory signals of toxicity, baseline and ongoing monitoring), laboratory result interpretation (drug interfering with test) and for broader quality improvement (surveillance for unrecognized toxicity, monitoring clinician response delays) [104]. For example, when laboratory tests signal drug toxicity, alerts can be used to limit the extent of an adverse drug event and enhance the timeliness of interventions to minimize its harm [104,129]. 5.5. Prompts for patient record maintenance Clinicians keep patient records up to date by periodically reviewing problem lists, medication and allergy lists and other important clinical information. If a record does not accurately represent what the clinician knows to be true about the patient, many alerts would appear irrelevant and will be overridden [74]. Corrections can be facilitated by prompting clinicians to update when a specific alert is being consistently overridden. For example, when a physician overrides a drug–allergy alert and selects from the ‘‘reason for override’’ menu ‘‘Patient does not have this allergy/Tolerates’’ or ‘‘Patient taking already,’’ a link to edit the allergy list should be shown in the alert [17]. When reasons are not required to be entered, an algorithm may decide after repeated overrides to prompt the clinician and provide a link to open the record for editing. Conversely, entering a newly captured allergy should also be prompted if it can be inferred that an allergic reaction may have occurred, for example in certain instances when a new order for diphenhydramine has been written and a drug is discontinued [84]. Allergy documentation should capture UMLS-coded allergen and reaction, and discriminate between true allergies and sensitivities or intolerances. Automatic prompts and requests for entering additional data need to be used sparingly, however. Clinicians generally resent systems that require extensive data entry at times that conflict with workflows priorities [6], especially when the data entries may be perceived as redundant [19]. 6. Limitations This review and the resulting recommendations address mostly medication prescribing, the most common type of clinical work for which decision support is available. The design of alerts and reminders is discussed in detail along with recommendations for other interventions related to prescribing such as order sets, dose calculators and also pharmacy systems that may be linked to prescribing systems at clinical sites. Our description of preferred usability characteristics and interface design extends to EHRs because CDS for prescribing is often functionally embedded with in those systems and the visual and functional conventions used for both should be consistent. However, the list of design recommendations is not exhaustive and may not cover all aspects of electronic records. Likewise, other HIT technologies that use CDS such as diagnostic expert systems, radiology ordering, emergency and critical care applications and others were out of scope for this review. Available literature is most often focused on alerts; other types of decision support intervention may therefore be underrepresented in design recommendations. Clinicians also sometimes disagree on what is a preferred attribute of CDS. In such cases, we report the opinions and refrain from making a recommendation. The literature review process itself may have missed some

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studies or technical reports that are not indexed in the databases we searched. Our survey of information contained in conference proceedings and materials from workshops was limited to those referenced by healthcare sources online such as the sites maintained by AHRQ, ONC and NIST.

7. Conclusion Decision support systems are potentially powerful and effective information tools, particularly when providing well-founded, unambiguous and actionable advice tightly integrated into clinical workflows [130]. Their performance level and ensuing tangible benefit to clinicians, however, can be significantly reduced by poor or outmoded design, incorrect implementation and inadequate data maintenance. Rather than increasing the quality and safety of care, inadequately designed systems may become disruptive and give only marginally relevant guidance that is largely ignored or, at worst, irritates and impedes the flow of cognitive and clinical work [74]. Usability is currently one of the primary concerns of clinicians and a key factor in their decisions about adopting HIT for routine use. Designing information systems for a domain as complex as health care is challenging and few guidelines exist for developers to follow common, effective and safe practices. Several decades of development and use of IT in other safety–critical industries shows, however, that significant advance can be achieved by systematic focus on human factors and user-centered design. Published findings reviewed in this report suggest, for example, that consistent design concepts and appropriate forms of visual representation of clinical data, the use of controlled terminology and the delivery of advice at the time and place of decision making collectively lower the necessary cognitive effort for effective interaction and shorten the time needed to acquire use proficiency. Evidence-based matching of interventions to clinical goals and their tight integration with workflows increase the likelihood that the provided advice will be followed. High specificity and relevance of alerts and their parsimonious use have an outsize effect on the perception of CDS as a valuable and trustworthy reference source that clinicians may develop over time. Their prescribing behavior is also more likely to be altered by advice formulated as suggestions highlighting potential problems rather than as rigid commands. Excessive alerting – the most frequently expressed reason for dissatisfaction with current forms of decision support – can be mitigated by periodic review of trigger rules, analysis of performance logs and good maintenance of health records such as allergy, problem and medication lists on which decision engines partly rely. Further studies that directly describe and analyze the relationship between more or less optimal interface design characteristics and criteria such as the rate and severity of errors or the effect on prescribing behavior are needed to understand what forms of CDS are the most effective in specific environments and what processes can designers follow to appropriately match interventions to clinical tasks. Future trends will move toward collecting empirical data on human performance that could guide the development of adaptive systems that anticipate errors, respond to them, or substitute less serious errors that allow clinicians to intervene before adverse events occur [131]. The competitive advantage of highly usable and reliable HIT systems has long been recognized by many in the industry. However, several large vendors in a recent AHRQ survey acknowledged that practices such as formal usability testing, user-centered design process and routine involvement of cognitive and usability engineering experts are not common [31]. Institutional and private purchasers also place high value on usability characteristics but

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often are not sufficiently informed to recognize even substantial design flaws until they become apparent well into the implementation process [34]. Academic and commercial HIT developers need to adapt their current design practices to include formal user-centered, iterative design processes that share common standards and recommendations. Their innovation efforts should reflect HCI research methods rooted in ethnography and cognitive science that rely on models derived from evidence gathered in authentic clinical environments and from insights gained by observing clinicians doing their work rather than on purely laboratory-based design ideas divorced from daily practice. Suggestions outlined in this paper may help clarify the goals of optimal CDS design in particular but larger national initiatives like the nascent NIST guidelines for systematic application of human factors in system development process [36,37,132] are needed to advance the HIT design field in general. Employing appropriate design strategies and adhering closely to principles of optimal human–computer interaction is crucial for creating systems that are responsive to the dynamic character of clinical work. It is therefore essential to understand the cognitive mechanisms of errors in order to develop effective HIT interventions [133]. Advanced design, careful implementation and continuous monitoring of performance are key requirements for delivering meaningful decision support that meets the grand challenges of contemporary, high-quality healthcare [73].

Acknowledgments This work was funded by the U.S. Office of the National Coordinator (ONC) for Health Information Technology, through contract HHSP23320095649WC, task order HHSP23337009T. We also want to thank Dr. Jonathan Teich for his insightful comments on an earlier draft.

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