There are also a number of stand-alone systems, some of the diagnostic systems and some drug interaction systems, for example. This means that patient data have to be entered twice—once into the medical record system, and again, into the decision support system. For many physicians, this double data entry can limit the usefulness of such systems. A related question is who should enter the data in a stand-alone system or even in the integrated hospital systems. Physicians are usually the key decision makers, but they are not always the person who interacts with the hospital systems.
The case study mentioned earlier described a situation where the physician who received the alert ignored it. La Lande gained without collaboration between the information technology professionals and the clinicians. The problem is there are no standards that are universally agreed upon for clinical vocabulary and, since most of the decision support systems have a controlled vocabulary, errors can have a major impact see Chapter 4 for more discussion on vocabulary and other design issues.
While more research still needs to be done evaluating the impact of CDSS outside the development settings and the factors that promote or impede integration, it is likely that increased commercialization will continue. CDSS for non-clinican users such as patients are likely to grow as well see Chapter There is increasing interest in clinical computing and, as handheld and mobile computing become more widely adopted, better integration into the process of care may be easier54 In addition, the concerns over medical errors and patient safety are prompting a variety of initiatives that will lead to increased incorporation of CDSS.
Physicians are legally obligated to practice in accordance with the standard of care, which at this time does not mandate the use of CDSS.
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However, that may be changing. The issue of the use of information technology in general, and clinical decision support systems in particular, to improve patient safety, has received a great deal of attention recently.
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The Leapfrog Group3 has advocated physician order entry with an implicit coupling of CDSS to provide alerts to reduce medication errors as one of their main quality criteria. Even if the standard of care does not yet require the use of such systems, there are some legal and ethical issues that have not yet been well addressed see Chapter 6 for a fuller discussion of these issues. One interesting legal case that has been mentioned in relation to the use of technology in health care is the Hooper decision. This case involved two tugboats the T.
Hooper and its sister ship that were pulling barges in the s when radios receiving sets were available, but not widely used on tugboats. Because the boats did not have a radio, they missed storm warnings and their cargo 1. Overview of Clinical Decision Support Systems 13 sank. The barge owners sued the tugboat company, even though the tugboat captains were highly skilled and did the best they could under the circumstances to salvage their cargo.
They were found liable for not having the radio, even though it was still not routinely used in boats. Parts of the following excerpt from the Hooper decision have been cited in other discussions of CDSS It never may set its own tests, however persuasive be its usages. Courts must in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission. But here there was no custom at all as to receiving sets; some had them, some did not; the most that can be urged is that they had not yet become general.
Certainly in such a case we need not pause; when some have thought a device necessary, at least we may say that they were right, and the others too slack. They also include legal and ethical issues that are discussed in more detail in Chapter 6. Assuring That Users Understand the Limitations In , Brannigan and Dayhoff highlighted the often different philosophies of physicians and software developers.
Healthcare Information Management, ;16 4 — Physicians undergo rigorous training, have to pass multiple licensing examinations, and are held in high esteem by society for their knowledge and skills. There is usually a version 1. The vendors of these systems have an obligation to learn from the developers, and to inform the clinicians using the CDSS of its strengths and limitations.
What rules are actually included in the system and what is the evidence behind the rules?
How was the system tested before implementation? Sim et al. Does the clinical vocabulary in the system match that in the EMR? What are the normal values assumed by a system alerting to abnormal laboratory tests, and do they match those at the client site? The answers to the questions about what exactly the user is getting are not always easy to obtain.
A few years ago, the chapter authors conducted a survey of the nine vendors listed in the top companies of the annual vendor revenue survey of Healthcare Informatics. These companies also indicated that their EMR systems contained decision support functionality. If they answered yes, they were asked what the knowledge source was, if the knowledge base was updated, how often the knowledge base was updated, and if there was an additional charge for the updates.
None of the vendor Web sites contained answers to all of the questions on the survey. The knowledge source was given on one of the nine vendor Web sites, and two of the nine vendor Web sites indicated that they provided templates to develop the rules.
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All nine of the vendors needed to be contacted to obtain additional information. Obtaining this information turned out to be a more challenging task than expected. Three of the vendor representatives with whom we spoke were very helpful and open to answering the questions. The other six did not know the answers to some or all of the questions and said they would refer our questions to someone else who would call us back. Two of those contacts returned answers to most of our questions, leaving us with four companies for whom we could not obtain answers to most of our questions.
Two of the vendors who said they provided updates were not sure how often they occurred. The results also show that seven of the nine vendors provide templates to develop the rules. Three of these seven vendors did not have an answer to the question about the amount of effort that is involved for the customer in building these rules. Four of the seven vendors said it did not take much 16 E. La Lande effort to build the rules with the templates. In fact, one vendor pointed out that the time consuming part was researching, validating, and approving new rules.
Also, one vendor said they provide a community Web site for their customers to post and share rules.
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For some systems, an effort has been made to use standards that can be shared among different sites, for example, the Arden syntax for medical logic modules,65 but local clinicians must still review the logic in shared rules to assure that they are appropriate for the local situation. Using in-house clinicians to determine the rules in the CDSS can assure its applicability to the local environment, but that means extensive development and testing must be done locally to assure the CDSS operates appropriately.
Often a considerable amount of physician time is needed. Without adequate involvement by clinicians, there is a risk that the CDSS may include rules that are inappropriate for the local situation, or, if there are no built-in rules, that the CDSS may have only limited functionality.
On the other hand, local development of the logic behind the rules may also mean that caution should be exercised if the rules are used at different sites. The important thing is for the user to learn at the outset what roles the vendor and the client will have to play in the development and maintenance of the systems. Based on our experience, and despite the fact that many of the vendors did make an effort to provide the answers for us, there were still many important questions for which we could not easily obtain the information. Although these systems have decision support capabilities, the effort involved in customizing the CDSS for the local site may be considerable, and the result may be that CDSS capabilities are underutilized.
It is not known whether the users of some CDSS need special clinical expertise to be able to use it properly, in addition to the mechanics of training on the use of the CDSS. For instance, systems that base their 1. Overview of Clinical Decision Support Systems 17 recommendations on what the user enters directly or on what was entered into the medical record by clinicians have been shown to reach faulty conclusions or make inappropriate recommendations if the data on which the CDSS bases its recommendations are incomplete or inaccurate.
Diagnostic systems, for instance, may make an appropriate diagnostic suggestion that the user fails to recognize. As these systems mature and are more regularly integrated into the healthcare environment, another possible concern about user expertise arises. Will users lose their ability to determine when it is appropriate to override the CDSS?
The solution to the problem is not to remove the technology, but to remain alert to both the positive and negative potential impact on clinician decision making. Systems that are available for users if they need them, such as online guidelines or protocols, may not be used if the user has to choose to consult the system, and especially if the user has to enter additional data into the system.
Automated alerting or reminder systems that prompt the user can address the issue of the user not recognizing the need for the system, but another set of problems arises with the more automated systems. They must be calibrated to alert the user often enough to prevent serious errors, but not so frequently that they will be ignored eventually. Assuring the Knowledge Base Is Monitored and Maintained Once the CDSS is operational at the client site, a very important issue involves the responsibility for updating the knowledge base in a timely manner.
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New diseases are discovered, new medications come on the 18 E. La Lande market, and issues like the threat of bioterrorist actions prompt a need for new information to be added to the CDSS. Does the vendor have an obligation to provide regular knowledge updates?