1 Computers, decision making and clinical effectiveness Paper prepared for the Institute for Public Policy Research John Fox1 Imperial Cancer Research Fund Lincoln’s Inn Fields London WC2A 3PX The problem Until recently, most citizens in countries like the UK felt sure that if they had medical problems they would be dealt with promptly, and as effectively as the medical art would allow. Furthermore, most of us look forward to continuing improvements in this art, as scientific understanding of diseases and their management increases. Although standards in most developed countries remain high, public confidence is apparently falling. The public frequently hears of service failures and high profile legal actions. We are all becoming increasingly aware that standards of care are not consistent across society. The increasing medical needs of an ageing population; rising costs of more and more sophisticated treatments and procedures, and a demand to provide an ever wider range of services with a limited budget, are all creating challenges to traditional ways of organising and delivering care. Furthermore, the unprecedented growth in our understanding of diseases and their management is not matched by equivalent abilities to apply that knowledge in practice. The problem is that it is now impossible for even the most dedicated medical professionals to stay up-to-date and know everything he or she may need to know about new drugs, new procedures and even new diseases. It has long been impossible for individual doctors and nurses to know everything there is to know about general medicine; it is now often impossible for them to keep abreast of developments in their individual specialties. Case: the treatment of cancer Studies of cancer treatment have shown that although there seems to be an international consensus on “best practice” for many patients who contract the disease, the expectation of a positive outcome can vary considerably between treatment centres. In particular, specialist centres have been shown to produce significantly better outcomes than general units for many cancers (Selby, 1995). This is suggestive. Specialist centres have much more experience than general units of course, and will often have more resources, better equipment and so on. But this is not the whole story. Another difficulty is the slow process by which new scientific knowledge is disseminated throughout the clinical community, and there are our individual limitations. Human beings are not all equally able to absorb new knowledge or equally open to evidence that their established practices are not the best. Consequently it is difficult to avoid a “lottery”: some patients get state-of-the-art care while others get something less. Variations in quality of care have been recognised particularly in the cancer field because society concentrates considerable resources on studying the causes, prevention, diagnosis and treatment of this disease. However, the 1 This paper was prepared at the invitation of the IPPR, but the views contained in it are those of the author and should not be attributed to the Institute. 2 same organisational and human factors are operational in all fields of medicine and there is growing evidence of similar variations in outcome in other specialties. Case: general medicine in the community As a contrast to specialist care, consider the GP who is responsible for providing front-line care for a couple of thousand people. The GP requires a basic knowledge of a vast number of diseases and drugs. The GP is the gatekeeper to hundreds of services for conditions that require specialist expertise, and therefore needs to have enough knowledge of what these services offer to be able to decide when they should be called upon and how to access them. This adds up to a prodigious personal and educational challenge: we expect the doctor to possess, and keep up-todate, tens of thousands of pieces of information. This is an impossible demand. The reality faced by all doctors is that they have too much to do, too much to know, and too little time. The solution to this problem cannot be to blame the individuals or the organisations that provide our medical services, punishing them through professional sanctions (or even the courts). What is needed are better ways of ensuring that, so far as is possible, information and knowledge are disseminated more effectively and brought to bear in a timely way. Some possible remedies The traditional solutions to such problems are to extend professional training and in-service “refresher” courses for healthcare professionals. But these are palliatives at best; training is expensive, and medical knowledge is increasing at a rate many times faster than formal training courses can accommodate. An alternative is to encourage more specialisation, but the effect of this can only be that individual clinicians know more and more about less and less. Most doctors have horror stories about patients who suffered unnecessarily because their conditions required skills that crossed specialty boundaries. More ambitious solutions are sometimes suggested, such as attempting to reduce the incidence of disease through improved public health policy or education. However, such changes are painfully slow. The processes that create the demand for more and better healthcare, such as the increasing age of the population, occur far faster than changes in policy or dissemination of public health knowledge. The political response to these circumstances can be to demand greater “efficiency” of healthcare professionals to insist upon improved performance or better management. But improving the performance of skilled people is not generally achieved by merely exhorting them to work harder, faster or more cheaply. Healthcare professionals probably make decisions, plan their time and remember what they need to remember about as well as they can. If they are to perform significantly better then they are likely to require help in some form. For these and other reasons the delivery of medical services is increasingly perceived as in crisis. Many people now believe that the only practical hope of overcoming, or even containing, the threat to public health is to introduce various forms of new technology. Among the most promising are “decision support” technologies that can assist clinicians in their decision making and in the organisation and management of their work. What is decision support? A typical decision support system is designed to assist the clinical professional in making decisions about the care of a patient in such a way that the outcome of care is likely to be improved. An obvious form of support system 3 that is widely adopted is the paper guideline, such as a pamphlet that provides an aide memoire to clinical staff in managing a particular category of patients. In the present context, however, the term decision support system (DSS) is used to refer to computer systems that offer information to the clinician in a more flexible form than can traditional paper media. Most of the early research on computer-based decision support systems was aimed at providing assistance for decisions about a patient’s diagnosis or the selection of treatment. However, the term is now more widely used to include any kind of decision - including the choice of drug to prescribe, what format and dose to use, which tests and investigations to order, what procedures to carry out, or whether to refer a patient to a specialist service. The idea that computers can help in the management of disease is well established. It goes back to a seminal paper by Ledley and Lusted (1959) who suggested that systematic, logical methods could play a role in medical decision making. The practical potential of mathematical techniques in medical decisions, such as the diagnosis of acute abdominal pain, was first convincingly demonstrated by Dr. Tim de Dombal at St. James’ Infirmary in Leeds, as early as 1972. For many years however it was widely felt that computers would never find a significant role in the process of medical decision making, and that if they did it could only be to the detriment of the patient. This view was the norm when doctors’ "clinical judgement" was seen as a human talent that was far beyond the capabilities of computers; when the abilities and practices of every doctor were popularly assumed to be comparable to those of the best in the profession; and before efficiency and the rational use of resources had acquired the importance they have today. In this paper I provide a brief overview of some of the kinds of computer system which are being developed to help improve patient care and some evidence of their efficacy and value, as well as sounding one or two cautions on their adoption. In this short piece we cannot acknowledge all the work that is being carried out in the field. For those who are interested in learning more about DSS technology and its relation to other aspects of medical information technology, I would recommend Coiera (1997) for a readable and informative review. One point that that should be emphasised at the outset is that DSSs primarily “add value” to existing organisations and activities, rather than being a competitor to them. In particular I shall argue that there is an important synergy between the goals of DSS designers and those of the movement for evidence-based medicine. Both communities are concerned with helping medical services manage the growing challenges to their effectiveness from the avalanche of new knowledge and budget restrictions outlined above. 4 Examples of medical decision support systems The UK is in the vanguard of countries that are introducing clinical decision support systems2. For example, the NHS has been evaluating a decision support system called Prodigy which is designed to help the general practitioner in routine drug prescribing. When the GP has arrived at a diagnosis for a patient Prodigy can be called up to recommend possible medications. Although Prodigy has attracted some controversy initial evaluations are promising and its use is likely to be encouraged. Another system which is also aimed at GP prescribing is CAPSULE, developed at the Imperial Cancer Research Fund. The intended use of this system is illustrated by the following scenario: A middle-aged man visits his GP with long-standing mild osteoarthritis, for which he has been previously prescribed naproxen, but his symptoms are no longer fully controlled. After reviewing the history, current medications etc. a British GP would normally consider the various medications he commonly uses, make a decision whether or not to change the dose or drug, and write out a prescription order for the pharmacist. If CAPSULE is used, however, the doctor presses a button requesting suggestions. The system examines the patient record, consults its comprehensive knowledge base of drugs and their uses, and displays a short-list of potentially suitable medications. The GP can ask for an explanation of the pros and cons of any of the drugs on this list, an example of which is shown in the inset at bottom right, as shown in figure 1. Figure 1: the CAPSULE system being used to suggest medication for osteoarthritis Here the user has asked to see the arguments for and against naproxen, which the patient is currently taking but is not at the top of the list of recommendations. CAPSULE reports that the drug is a generic treatment of choice in 2 The UK medical IT community has been very innovative and the research base is very strong by international standards. This offers great potential opportunities for UK industry. 5 the British National Formulary, and that it has been effective in the past as well as suiting the patient because of lack of side-effects. However, the patient has a history of asthma, and naproxen is contraindicated in this situation. Rather than simply increase the dose of naproxen, therefore, the GP accepts CAPSULE’s suggestion that paracetamol be substituted. In a systematic study with 42 GP volunteers, Walton et al (1997) found that CAPSULE could help GPs make decisions more quickly and improve their decisions quite dramatically - significantly increasing the quality of prescribing without increasing cost. A particularly compelling piece of evidence that computer-assisted prescribing can produce major benefits in terms of quality and cost of care was recently reported in a US outcome study of the use of antibiotics and other anti-infective agents for critically ill patients in hospital (Evans et al, 1998). Decision support led to highly significant reductions in allergies to drug use and other adverse events, excess drug dosages and antibiotic susceptibility mismatches. Highly significant reductions in drug costs, length of hospital stay, and total hospital costs were also recorded. Figure 2 shows an example of a more complex decision support system, for advising on the management of acute asthma. This is designed to help in the management of an acute attack during the first hour or two after the patient arrives at an accident and emergency department. A scenario for use of such a system is as follows. A young man arrives at the hospital in the early hours of the morning suffering from a serious asthma attack. Unfortunately no senior staff are immediately available, so the doctor on call asks the department computer to locate a guideline for acute asthma management. It proposes one published by the British Thoracic Society. This has been converted from the original text form in a way that permits the computer to “enact” the guideline, and assist the staff through the first hour or two of the patient’s care. Figure 2 shows a display of the guideline at a point early on in this process. The first panel shows the guideline rendered as a set of tasks in a structured “task network” or workflow diagram. (Access to the original guideline as a multimedia document and other published reference information is also available.) The second panel shows the point at which the doctor has finished the first task, “initial assessment”, having provided various prompts, reminders and data entry forms. The computer has suggested that the young man should provisionally be classified as suffering from a moderate attack according to British Thoracic Society criteria, and the user has accepted this suggestion. The recommended procedure for managing a moderate asthmatic will now be initiated (the rounded box at the top centre of panel 1). This procedure consists of reassessing the patient after 30 minutes, possibly with further medication, and again after 60 minutes. The system prompts for relevant information when it is needed. As the tasks are executed, the graphical interface shows which tasks are scheduled, overdue, complete, and so on. The system also monitors the electronic patient record (not seen here) for any information which might subsequently indicate a misclassification or other hazard and, if so, draw it to the clinician’s attention. 6 Figure 2: Computerised care guideline for the management of acute asthma in a hospital accident and emergency unit. The first panel shows an overview of the network of tasks recommended in the guideline. The second panel shows the system during the enactment of the first task of the guideline: assessment of the severity of the patient’s asthma attack. 7 Primary Technologies for Decision Support Two main traditions have influenced theories of decision making and the design of decision support systems to date:3 statistical decision theory and knowledge-based or “expert” systems. Statistical decision theory and decision analysis Decision analysis is strictly a family of techniques, though in practice statistical decision theory is the standard paradigm of this tradition. On this viewpoint a decision process is viewed as one of calculating the relative merit of different decision options, such as alternative diagnoses or treatments. For example, the likelihood of a diagnosis is determined by calculating its probability, usually based on population statistics. Decision theory can also be used to help make decisions about clinical actions. The expected value of a candidate treatment, for instance, can be computed by combining quantitative utility measures (such as the desirability of the possible therapy outcomes) with probabilities (of each of the possible consequences of the treatment). On this mathematical approach the best treatment is the one which has the highest expected value. Decision analysis is well established and well understood. If the assumptions of the theory are satisfied and the input numbers (probabilities and utilities) are well estimated the method will reliably identify the best (or “optimal”) decision. A clear and comprehensive presentation of the use of statistical decision theory in decision making is Dennis Lindley’s classic text, Making Decisions (1985). However, the statistical view is rather restrictive, and computer systems based on it can be difficult to set up. First of all, the theory requires that the designer knows, or can estimate reasonably accurately, all probability and utility parameters. This is frequently difficult in clinical practice. In addition, notwithstanding the undoubted power and generality of the mathematical approach, it really only addresses a small part of the clinical decision problem. The set of decision options and relevant information sources is frequently unknown when the need for a clinical decision is first recognised, and may only emerge progressively as a care process unfolds. However, the theory provides no guidance on such matters, as Lindley himself acknowledges: “The first task in any decision problem is to draw up a list of the possible actions that are available. Considerable attention should be paid to the compilation of this list [but] … we can provide no scientific advice as to how this should be done” Finally, experience shows that statistically based decision support systems are often unattractive to clinicians because, rightly or wrongly, they do not naturally think about their patients and their work in quantitative terms. In my judgement, a fair conclusion is that mathematical decision theory is an important intellectual foundation for work on clinical decision support, and will keep a significant place in the development of future decision support systems. However, many additional techniques will be needed to achieve the practicality, flexibility and compatibility with human understanding that are needed. The knowledge based systems approach Knowledge based systems, often called “expert systems”, were introduced as an alternative to classical mathematical methods for helping with decision making and other types of activity. 3 There are other approaches, such as work in operations research and multi-attribute decision theory, but they do not introduce major new issues which are important for the present discussion. 8 “An expert system is a computer program that (a) reasons with domain-specific knowledge that is symbolic as well as [quantitative]; (b) uses domain-specific methods that are heuristic (plausible) as well as algorithmic (certain); (c) performs as well as specialists in its problem area; (d) makes understandable both what it knows and the reasons for its answers; and (e) retains flexibility” (Buchanan and Smith, 1988). Expert systems introduced many new ideas, notably qualitative techniques for capturing the knowledge of human experts and emulating their problem solving and reasoning skills. This kind of symbolic representation is to be contrasted with the numerical representations of mathematical decision theory. For example, in many expert systems the diagnostic skills of a doctor are represented by means of if…then… rules, a simple but very powerful knowledge representation technique. Rules can be used to capture a surprising range of clinical thinking. They have been used to model reasoning about the physical structure of organs, and the function (both normal and abnormal) of physiological systems. They can emulate intuitive patterns of thinking about time and causality, incorporating uncertainty in a number of different ways. An advantage of knowledge based approaches over mathematical methods seems to be that they are more easily understood by clinicians. Furthermore, rules and other knowledge-based techniques can model more kinds of expertise than just the assessment of alternative hypotheses or actions. The more sophisticated methods can also include rules for scheduling and planning as well as decision making. They can capture relevance (when and how to use particular forms of knowledge), and they can express subtle concepts such as the clinical intention behind a decision or action. The designs of early knowledge-based systems were criticised for being ad hoc - lacking a rigorous theory to justify them. This is a matter of serious concern if such systems are to be used where lives are at stake. Clearly, we need to be confident that such systems are as safe as possible. However, the situation has improved rapidly in recent years and knowledge-based decision support systems now have a substantial body of mathematical theory underpinning them, providing confidence that they will be both safe and sound (Fox and Das, 1998). On the face of it, qualitative methods should also be inferior to statistical ones because they are less quantitatively precise, so one might expect them to make mistakes when fine judgement is needed. It turns out, however, that lack of precision often has no serious consequences in practice (e.g. Fox et al, 1980; O’Neil and Glowinski, 1990; Chard, 1991). Nevertheless, we must assume that there will be circumstances where precision is necessary, and it is now possible to combine knowledge based techniques with methods from mathematical decision theory where this is appropriate. The focus of research nowadays is not so much on competing theories, but on when each kind of technology may be used most profitably: exploring different types of application and establishing those areas in which they are likely to have most clinical value. Current forms of decision support Coiera (1997) lists about 20 clinical decision support systems that are reported to be in routine use. These cover a variety of functions in acute care, laboratory systems, educational applications and quality assurance and administration. Another way of organising decision support systems is in terms of the types of assistance that they offer. In this section I present a very short overview of the main types of function which are to be found in current DSSs, starting with decision support based on paper guidelines to provide a context for comparison. 9 Published guidelines and research results There are many different types of paper guideline. They include: comprehensive reviews and recommendations published by authoritative bodies (e.g. the British Thoracic Society’s guideline for the management of asthma); advisory pamphlets (e.g. the material distributed by pharmaceutical companies alongside their products); brief, problem-oriented management summaries (e.g. the flow diagrams and bullet point summaries often published in medical periodicals); descriptions of research studies, possibly including summary tables and graphs. Clinics and units often post published guidelines as reminders to clinical staff, and clinical audit groups write local guidelines which are often bound together into reference manuals. Increasingly, people are experimenting with similar material on computer, such as “multimedia documents”. When printed and multimedia guidelines are kept short they are often perceived as useful (though brevity may imply a compromise with quality). Lengthy documents, on the other hand, even when prepared to a high standard by authoritative individuals or bodies, are often perceived as worthy but impractical. Busy clinicians may not have time to read (even if they feel guilty for not doing so) and even when they do they may find it hard to absorb the detail or to translate the general principles of best practice offered into specific advice for particular patients. This material is an important first step towards systematising best practice but it is not the solution to the problems described above. To deliver effective decision support the information needs to be provided in a form that is relevant to the specific patient and at the point of care. Ordinary documents, whether on paper or on computer, are not a good way of achieving this. Clinical data analysis and interpretation One of the simplest and least controversial forms of decision support is the provision of facilities to carry out routine calculations, such as percentage peak flow or body mass index. A computer or calculator can be quicker and more reliable than a tired head. Functions for detecting subtle patterns in clinical parameters, such as blood sugar levels or blood pressures, and keying the results to recommended interventions, are also practical in many settings. Systems which calculate treatment parameters, such as optimal drug dosages, can be more controversial, though there is considerable research data to suggest that dosage calculations have considerable benefits in clinical practice (Walton, 1998). Electronic reminders Doctors are people, and people forget things. Even under favourable conditions (and many doctors feel that they rarely work under favourable conditions), slips occur, histories and other routines are not properly completed, potentially important measurements are omitted or significant clinical features are missed. Techniques to help remedy such common errors have been the subject of considerable research and the evidence that they can have value is now strong. Computer prompts (e.g. to ensure that planned clinical actions are carried out on time), reminders (e.g. for ensuring that full histories are taken) and alerts (e.g. for detecting adverse events) can lead to better compliance with best practice, and improved outcomes (Johnstone et al 1994). The introduction of computerised prompts and reminders may produce organisational challenges but requires little technical innovation. The first successful attempt at this was the HELP system developed at the Hospital of Latter Day Saints in Salt Lake City well over twenty years ago. The main technical difficulty is that a comprehensive system implies the availability of some form of electronic patient record. Nowadays, commercial 10 hospital information systems (mostly US products) and GP information systems (a UK strength) have built-in support for providing prompts and reminders associated with some form of clinical data record. Making decisions In many respects the most controversial applications of decision technology lie in supporting the decision process itself. The decision support functions summarised so far are not directly concerned with decision making, but with the collection and processing of the information which will be needed for decisions about diagnosis, therapy and so on, rather than making suggestions about a patient’s management, as illustrated in the examples above. However, there are good reasons to believe that it is in this area that DSS technologies will sometimes have their greatest benefits. One reason for controversy is that the original focus of DSS research was diagnosis, deciding what is wrong with the patient. With hindsight this was probably not the most promising place to start. Many clinicians say “our problem is not diagnosis, it is management of the patient’s condition” and this observation appears to strongly influence doctors’ behaviour. For example, doctors’ use of the Medline reference database was reviewed by Dr. Jeremy Wyatt; he found that the great majority of clinicians’ queries were management-oriented rather than diagnosis-oriented (pers. comm.). Diagnosis is, of course, important but, as figure 3 illustrates, it is only one of many different types of decision that clinicians take, and most of these are concerned with what to do rather than what is wrong with somebody. Although there are reasons to believe that clinicians can be over-confident in their diagnostic ability there is certainly one practical fact that supports their assessment of where the main decision-making problems lie: the presentation of diseases is relatively constant over time but best practice in the management of disease is continually changing. It is hardly surprising, therefore, if clinicians find it difficult to stay up to date. This seems to be reflected in results of studies on the impact of clinical DSSs. Systems aimed at supporting diagnosis decisions sometimes produce only modest successes (Johnstone et al, 1994). On the other hand several studies have indicated great value in disease management decisions. We gave examples earlier in the area of prescribing decisions. Similar results are becoming available for test selection. For example, Johan van der Lei and colleagues at Erasmus University in Rotterdam have developed a system called Bloedlink, for assisting GPs in making decisions about blood tests. In a one year study involving 60 GPs in Delft Bloedlink produced significant improvements in compliance with guidelines (report in preparation). For other common decisions, such as referral decisions and risk assessment, there is little data as yet, though many doctors see these as areas where they do not achieve the standards they would like. The need to improve resource management in clinical practice is also generally accepted. However, clinicians are naturally concerned that reducing costs should not take precedence over improving quality of care (the PRODIGY prescribing system has attracted some suspicion, probably unfairly, for precisely this reason). Walton’s study of prescribing showed a highly significant increase in prescribing quality together with a 50% reduction in the number of times the GPs missed a cheaper, but equally effective, substitute. In van der Lei’s study of test ordering he showed a 20% overall reduction in test ordering much of which was due to reduced ordering of inappropriate or outdated tests. There is apparently no conflict between better resource use and improved quality of care. 11 History taking Physical examination Tests and investigations Defining the clinical problem “clinical picture” Diagnosis Risk assessment Test selection Therapy selection Referral Planning & plan revisions Figure 3: some of the principle tasks carried out in clinical medicine, including just a few of the different types of decision that doctors have to take (bottom). If we are to provide medical professionals with practical tools, these must reflect the variety of medical procedures. Workflow One cannot discuss the effectiveness of clinical decision making without talking about the implementation of clinical decisions. The basic decision is some sort of choice, of a medication, say, or whether or not to refer a patient for further investigation. Other management decisions, however, particularly where difficult clinical problems are involved, require care plans that include a number of procedures that must be carried out over time, and may require coordination of different specialists and services. Even a simple procedure such as a GP’s request for blood tests (recall the Bloedlink example described earlier) may involve several tasks. First there is the initial diagnosis, then the selection of tests, and the preparation of a request to the testing laboratory (by letter or email). Once the report comes back to the GP the patient needs to be recalled and a decision taken about any management that is needed. The organisation of such tasks and associated “workflow” is not difficult, but in practice it is notorious for failures of communication, lost information, and patients “falling down the gap” between services. The growing emphasis on multidisciplinary shared care may be expected to exacerbate these problems. The functions that are required to implement workflow support include scheduling and time management facilities, process planning and resource control, communication and coordination. A wide range of computer techniques is available for assisting with these functions. Integrated methods The various forms of decision support described above are usually considered in isolation but they can also be used in combination. 12 In the long-term management of chronic conditions, such as diabetes, hypertension or asthma, there is a need for many different tasks to be carried out in a coordinated way. These include regular reassessment of the patient’s condition, detailed patient examination, analysis of trends and reassessments of treatment, as well as administrative tasks. Since these patients may require care over many years we also need to provide support for major reviews, as new medications become available or recommended practices change. We are also likely to see increasing use of complex therapy protocols, which are already widely used in cancer care. A cancer protocol will normally specify careful eligibility assessments, detailed data collection and coordination of surgical, radiotherapy and chemotherapy services. Chemotherapy typically requires several cycles of treatment, with precise combinations of cytotoxic drugs, constant monitoring for adverse events, and long-term follow-up of the patient. The asthma management application illustrated earlier was only concerned with an hour or two of care but it illustrates some of the basic concepts of integrated decision support. It shows how a guideline, protocol, or other description of recommended care can be formalised in terms of precisely described actions, decisions and other clinical tasks (Fox et al, 1997). This ability to proformalise medical procedures permits us to describe a recommended process of care in a form that can be enacted by a computer. The computer can subsequently act on behalf of service providers and professional organisations wishing to encourage compliance with guidelines, and shoulder much of the administrative burden for the clinicians4. Proformalisation also offers a new form of medical publishing by disseminating descriptions of recommended practice electronically, in a form that can be used directly to bring prompts, reminders and other forms of assistance to the point of care. Medical expertise, medical publishing and evidence-based medicine Medical expertise is traditionally acquired by a combination of apprenticeship and private study of published material. Unfortunately we now have to recognise that these traditional methods are insufficient to give the clinician all the knowledge that is needed and keep him or her up-to-date. Some areas of medical IT can be seen as offering new forms of apprenticeship, such as virtual reality training, telemedicine and teleconsulting. Decision support can be viewed as a new form of medical publishing, which permits us to “publish expertise” as well as reference information. Decision support technology may therefore offer an important mechanism by which the goal of disseminating Evidence-Based Medical Practice can be achieved. Countless specialist organisations are publishing state of the art guidelines for the management of specific conditions (such as the British Thoracic Society’s asthma guidelines, and the American College of Psychiatrists’ guideline on the management of acute depression). Others are carrying out systematic reviews of research across disciplines, and then distilling and publishing the results as scientifically validated clinical guidelines for improving the consistency and quality of care (notably the international Cochrane Collaboration). This effort is widely seen as a way of bringing a more objective and scientific approach to developing clinical practice. But it has a significant point of weakness; its results are generally published in the traditional way, on paper. As we have discussed, busy doctors and other healthcare professionals have little time to read and absorb, and hence properly apply, the contents of even modest-sized documents. Decision support offers a bridge between the authors of evidence-based guidelines and the clinicians whose behaviour they wish to influence. Figure 4 illustrates this relationship. The technique of “proformalisation” - a contraction of proxy (“authorised to act for another”) and formalise (“give definite form to”) - was developed by the Imperial Cancer Research Fund. 4 13 As we discussed earlier, the development of decision support systems can be based on local practices or individual clinical preferences. However, one could also start at the point where clinical research usually ends, with the publication of a systematic review of trials of therapies and other procedures (point 1 in figure 4). At this point the DSS designer can start to translate the validated evidence-based guidelines into a form that can be enacted on a computer (point 2 in figure 4). Figure 4: Synergy between decision support technology and evidence-based medicine The next step is to test the logic of the computerised guideline against realistic data, though at this stage this would not normally be in a clinical setting. The process progressively refines the medical content until agreed quality criteria are met. Point 4 is the first phase of clinical testing, in which a new guideline is evaluated in controlled conditions using standard randomised trials techniques. If the outcome data from the trial warrant it then the system could be published for use in routine clinical settings (point 5). Use of the Internet as a publishing medium is attractive because of the simplicity of the process and speed of dissemination. Finally, this approach offers a further bonus for clinical practice and research. If we are using electronic decision support systems then it is possible to store clinical information about patients automatically, including the decisions that were taken and the reasons for those decisions, and which actions were carried out and when. Such a database is a rich source of information for clinical audit and local policy assessment. If outcome data are also 14 recorded these can be automatically fed back to the research group that developed the guideline, in order for them to carry out statistical and other analyses of outcome and inform discussions of clinical effectiveness. Some possible negative consequences of decision support The central theme of this report is the potential of decision support technology to improve consistency and quality of care. But, whatever the improvements in clinical outcome or resource use, any new technology also has a potential for negative side effects. It is likely that many professionals will be concerned about becoming deskilled, for example. There are real questions about whether the technology could come between the clinician and patient, or otherwise undermine the human side of care. There are also problems of security, and the ethico-legal issues which arise as the boundary between technical and human responsibility becomes blurred. The time may be propitious to address these worries. Medical information technology, the requirements of clinicians, the introduction of the NHS network and the efficacy of decision support systems in clinical practice, are being widely debated. Changes to the NHS, and the role of IT in achieving these changes, are central to these debates. The proposed National Institute for Clinical Effectiveness (NICE), described in the recent White Paper on the NHS, could play an important role in monitoring and assessing the impact of decision technologies on clinical practice. Requirements for the successful introduction of clinical decision support systems Even if the evidence for the value of decision support systems is widely accepted, there are significant obstacles to be overcome before they can be put into general use. Content provision. The major requirement for developing any decision support system is, arguably, the medical knowledge base. The database of drugs for a prescribing aid must include comprehensive information about their uses, indications, contraindications, side-effects etc. In areas like pharmacology there are substantial sources of authoritative information about drug use, but in other areas the background knowledge may not be available in a directly usable form. The preparation of this knowledge base may be time-consuming since it may require extensive review of evidence and discussion, and even some clinical controversy. However, given the right organisation, the marginal cost of preparing a knowledge base in a form that is suitable for computerisation may not be high. After all, the basic work described needs to be done as part of any effort to improve clinical efficacy, whether the intended use involves computers or not. The movement for evidence-based medicine is already a major source of high quality guidelines. Another possible role for the NICE could be to oversee the translation of such content into a form that is suitable for use at the point of care. Electronic medical records. If decision support systems are to offer assistance that is appropriate for the individual patient, the means must exist for acquiring and storing all the personal information that is relevant to the decision. Some applications will only require basic data entry facilities. These are already available in commercial clinical information systems. It is generally recognised, however, that in the longer term DSSs will require electronic record systems that can store comprehensive and highly organised clinical data, reliably recording this information over days, weeks, or even lifetimes. The ability to record high quality structured data is needed for many reasons, not just decision support. Wellstructured records, using consistent medical terminology, easily accessible whenever and wherever they are 15 needed, are the foundations of care. They facilitate good decision making, improved communication between individuals and services, clinical (and financial) audit, and objective research on clinical effectiveness and outcome. Political and economic forces as well as clinical needs are creating pressures to meet these requirements, and efforts to deliver advanced record systems are a major focus of academic research and commercial developments. Fragmentation of research and development There are two more practical problems that need to be addressed if DSS technology is to be disseminated and used widely within a large health system such as the NHS. They are not primarily technical but organisational. First, there is a particular need for agreed standards on data and knowledge representation. Decision support technology has the potential to be used throughout medicine, but the scale of the problem should not be underestimated. An indication of this is given by the widely used Oxford Handbook of Clinical Medicine. This volume provides reference information for basic and routine medicine only, and its 800 pages cover about 400 common complaints and conditions, across 16 major disciplines, including 24 classes of emergency, and miscellaneous other topics. This is the core knowledge base of the general physician, yet every topic in the handbook points to a further and often large body of specialist information. If we develop DSSs for only a few of the areas it covers there is obvious scope here for a Tower of Babel of magnificent proportions. Another consequence of fragmentation is the common one of incompatible products. If there is no coordination of developments then there will be incompatibilities between one hospital’s electronic record system and another (already a problem) and between one supplier’s electronic system and another’s decision support products. A further problem will be that clinical guidelines that are developed by one content provider may only “run” on certain companies’ DSSs. Consequently, any general practitioner or medical director who wants to make a library of guidelines available will have to purchase a number of products in order to use them. Not only will the cost implications be unacceptable but the healthcare professionals who are asked to adopt them will naturally be unwilling to spend their time learning to use many different products, with different functions and operational procedures. A great deal of work is currently in progress that demonstrates the need for coordination of developments, including collaboration on standard knowledge components and decision support functions, such as drug knowledge bases and generic guideline formats which can be used and reused in a variety of specific applications. Current efforts to standardise clinical terminology and coding systems, such as the Read Codes are also important here. Good results will only be achieved through leadership and full consultation with clinicians, researchers and industry. At the time of writing, when the new NHS IT strategy has not been finalised, it is not clear what will be the appropriate mechanism for consultation. The NHS Executive itself may take the lead, through a revamped Information Management Group, for example, or delegate responsibility to the NICE. Whatever the mechanism the importance of consultation, particularly with the clinical end-users cannot be underestimated. A recent editorial on clinical decision support systems in the New England Journal of Medicine (Garibaldi, 1998) argues that lack of consultation and consequent lack of understanding of how healthcare professionals actually work, is the main reason for failure in introducing decision support technology into the clinical setting. Conclusions The inexorable growth in medical knowledge is placing an impossible burden on healthcare professionals. It is unreasonable to expect them to read, assimilate and correctly apply all the published information that is potentially relevant to their work. 16 Computer-based decision support systems offer a new form of publishing, permitting the electronic dissemination and “enactment” of validated clinical guidelines to provide assistance in a patient’s management. Such systems can provide timely prompts and reminders for busy clinicians, simplify data recording and analysis, and assist in improved management decisions and workflow. There is good evidence that these methods can help to meet growing demands for greater consistency and quality of care, while simultaneously reducing costs. Decision support technologies are not in competition with other approaches to improving clinical effectiveness, such as improved patient data recording, clinical audit or evidence-based medicine. 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