Ebook: Health Telematics for Clinical Guidelines and Protocols

Guidelines and protocols for clinical practice (sometimes also termed practice policies) are receiving increasing attention from clinicians and health services as means for applying best current knowledge to maximise the quality and efficiency of delivered healthcare within the given economic constraints. This volume contains the proceedings of a Conference organized in April 1994 by the Health Telematics programme (1991-1994), the AIM programme, which forms part of the Third Framework Programme for Research and Technological Development of the Commission of the European Communities.

Earlier discussions among projects participating in this programme had confirmed the growing and widespread importance of this trend within medicine, and the widely recognised potential for healthcare telematics to facilitate the creation, use and constant improvement of clinical guidelines so as to deliver fullest benefits to patients. This observation was strongly reinforced by the results of the EPISTOL study, an accompanying action of the Health Telematics programme set up to clarify the potential impact of knowledge-based systems (KBS) for the health sector. As the chapter in this volume by Pedro Barahona reports, applications of KBS to the use of clinical guidelines were highlighted by this study as a feasible and worthwhile objective for research and development in health telematics during the next few years.

A significant number of projects within the current Health Telematics programme were found to have an active interest in this subject. Accordingly, a Conference was convened to explore the scope and needs for further work in this area. This was accomplished by means of talks by domain experts, presentations by members of all interested Health Telematics projects, and discussion of future needs and measures, including inputs to planning of the CEC 4th Framework Programme and its Health Telmatics workplan.

Twenty-two speakers contributed to the meeting, including representatives of 13 Health Telematics projects and invited experts from outside organizations (Peter C Gøtzsche, The Nordic Cochrane Centre, Denmark; Jean-Louis Renaud-Salis, French Federation of Cancer Centres; Dr Ian Purves, The Sowerby Unit for Primary Care Informatics, Newcastle). Three parallel working sessions addressed issues relating to Primary and Community Care, Secondary and Shared Care, and Guidelines and Knowledge Engineering/Methodology. Specific clinical areas of guideline use presented by speakers included: general medical practice (prevention; prescribing; chronic disease management), cancer, cardiology, neurology, gastro-enterology, rehabilitation, shared care and intensive care.

Some of the conclusions and practical recommendations which emerged from the Conference are reported in Colin Gordon's chapter below. We believe that these Proceedings form an important addition to the literature of health telematics, reflecting the range and depth of innovative talent mobilised in the current European Health Telematics programme. We hope they provide some pointers towards practical ways in which telematics can help meet the health objectives of European citizens, governments, and healthcare professionals.

Colin Gordon and Jens Pihlkjaer Christensen (Editors)

This chapter reviews the motives behind the promotion, development and application of practice guidelines, defined as ‘systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances’. It surveys the state of progress and future prospects for telematics applications in this area, and reports the action points recommended by the 1994 AIM Conference. There exists significant evidence that use of guidelines can improve healthcare process and outcome, and that computerised aids assist this effect. they may also enhance the potential uses of guidelines and protocols for audit, resource management and shared care. A standard generic model for computerised representation of guidelines as knowledge bases in a common format has been proposed and may be a key factor in future progress. The development of computerised patient records of adequate scope and quality is generally recognised as an essential condition for computer-aided guideline use. Support for development, dissemination and application of healthcare guidelines and use has emerged, notably through the AIM EPISTOL study, as a feasible and useful application area of medical knowledge-based systems. It is essential that telematics developments in this field are grounded in an understanding of the healthcare practices to which guidelines are being applied, and of the changes in practice which guideline use may entail.

The Cochrane Collaboration was set up in 1992 as a world-wide network for creating and disseminating systematic reviews of randomised controlled trials (RCTs) in healthcare. Systematic reviewing of RCTs is an essential stage, prior to the creation and dissemination of clinical guidelines, in the practice of evidence-based medicine. This paper is intended to provide the health telematics community with an introduction to the motives, aims and activities of the Cochrane Collaboration.

The DILEMMA Generic Protocol Model (DGPM) is a trans-national ontology of clinical protocols designed using a blend of logic engineering and business modelling techniques, and developed as part of the AIM programme's DILEMMA project. It allows the declarative representation of clinical activities and the knowledge associated with them. It is being used to represent protocols of all sorts - including standards and guidelines - for use in acute, primary, home and shared care. Central to the model are the states that protocol-derived actions can assume, and the statements that must be true before transitions between those states can be proposed. Proposed transitions may then be scrutinised by clinicians, patients and carers, and approved or rejected. This approach enables the model to handle anticipated exception situations, as well as more normal protocol selection and application. Links to multi-media material are being investigated, to enable users to examine the evidence upon which protocols are based, and to provide decision support where deterministic reasoning is not readily available. The model is being discussed with other AIM projects, with a view to developing a European consensus, and generating a version of the model for submission to CEN TC251 as a European pre-normative standard

Computer-based guidelines for preventative care is an example of the way in which protocols can be put to use in an effective and useful way. However, computerised medical protocols will only be used on a large scale if they are integrated with the computer-based medical record.

The AIM-project ISAAC is working on the development of integrated tools for use in Primary Health Care, and especially General Practice. One of the tools under development is prevention.

In this article, prevention is used as an example of the implementation of protocols. After a short definition of prevention, the implementation of preventative modules (or protocols) in the ISAAC GP information system is discussed.

There are several conditions or critical factors if the implementation of prevention (and protocols) in a GP information system and in a GP practice is to be successful. In the discussion, some of the opportunities that are emerging with the use of information systems and telematics in primary health care are also discussed, together with the potential of ISAAC and the crucial role that must be played by healthcare providers.

This chapter introduces the role of clinical guidelines in improving the quality of care in Primary Health Care. It goes on to describe the literature with respect to the development, dissemination and implementation of clinical guidelines while attempting to highlight factors liable to impede their use. It concludes with a discussion of the role of informatics in ensuring the difficulties described are avoided.

Prescribing drugs for the treatment of medical conditions is a very common activity for a doctor. Prescribing has enormous economic importance. Costs are rising quickly and there is an urgent need for doctors to have easy assess to advice about the cheapest, most effective therapy. On average 80% of GPs in the UK use a computer for their medical work and the figure is rising rapidly. Currently available systems provide only very simple checks and reminders. More sophisticated advice is provided by our prototype program. The program uses logic engineering to give advice, based on simple protocols for prescribing, tailored both to the condition being treated and the individual patient. The essential logical elements of the prescribing decision are discussed. These simple prescribing protocols may be the final common pathway for prescribing advice from many, more complex protocols for recommendations for drug treatment.

To promote quality assurance and expertise in primary health care in the Netherlands the Dutch College of General Practitioners develops protocols, called standards. These standards concern medical action-taking in case of regular complaints and diseases in common practice. To improve dissemination of the standards and to develop effective and useful methods for quality assurance on the basis of the standards a project, called the Guidelines Automation Project (Richtlijnen Automatiseringsproject) was started to develop a computer program that can support quality assurance of medical action-taking in general practice on the basis of the NHG-standards. The main feature of the program is educational assessment. Other features of the program are: guidance for case data collection, stating of differential diagnoses, and disease profiles. These features also use patient case data as a starting point. In conclusion it is argued that all efforts towards an ‘electronic’ use of protocols in the health care delivery system will fail, unless we arrive at a care record that both with respect to its structure and to its content, is being founded on sound formal principles. Several problems need to be solved first. The implementation, and exploitation of protocols, though relatively simple from a knowledge representation point of view, is not a straightforward task.

Guidelines in primary health care have been developed to reduce assumed and undesired variation in certain aspects of care delivery by professionals. If systematically applied guidelines no doubt effect the quality of care. It is argued however that taking an organizational point of view on quality management yields new requirements with respect to development and application of guidelines. It is considered to be essential for managerial control purposes that guidelines have simple and valid indicators to monitor the actual application and to measure the preferred outcome. It is essential that the choice of guidelines to be implemented in an organization is determined in the context of an explicit plan for quality management.

Asthma is a common chronic disease of the lungs caused by inflammation of the airways affecting 6-7% of the population. Asthma is becoming commoner and there is evidence of under-diagnosis and poor management. Guidelines have been developed aimed at improving quality of care and in reducing social costs of asthma. The paper discusses an approach to implementing guidelines through decision-support systems in primary care, based on methods developed in the AIM GAMES-II project. We also describe a prototype system that has been developed and a programme of clinical evaluation.

Clinical activity has always demanded close co-operation and co-ordination between clinicians and specialities. This applies especially in hospitals and in the future it will apply equally in primary and community care. Co-operation and co-ordination require two things: access to guidelines to control shared, distributed clinical activity, and common access to the patient record. Act management facilitates this by managing the process of care as it passes from one performer to another, enabling each to know at what point in the process (or cycle) they stand, what is expected of them, what is expected of others, and enabling them to access the information that they require. This paper describes act management with reference to guidelines and it is a contribution to the process, presently under way, that is intended to bring the leading examples of act management from the AIM NUCLEUS project and guideline support from the AIM DILEMMA project into close interworking in the same system.

This paper describes the current status of the utilisation of clinical practice guidelines (protocols) in the ESTEEM project as one form of the clinical quality assurance procedures considered in the project. The performance of electrodiagnostic studies, in terms of which types of conclusions need to be inferred during the examination plan, is briefly described. The main focus of the paper is a description of an European multicentre clinical audit in the field of Clinical Neurophysiology, using a common data-entry protocol for prospective EMG case collection and assessment with the ultimate objective of building up a multicentre reference database of EMG cases.

PROCAS (PRofiles Of CAre System) is one of the Arm projects whose objectives are to improve the quality and efficieny of medical treatment. These will be realised in establishing a methodology for defining and developing what are termed “Profiles of Care”. These are sets of options for clinicians which are meant to create acceptable ways of managing patients with similar conditions and which represent good clinical practice. Moreover, a prototype system will be realised by the application of informatics and telematics, to enhance the provision of efficient and effective care in both hospitals and outpatient departments.

Because of the retrospective nature of the ICD-9-CM system for the classification of cardiological patients, a draft for a Prospective Patient Data Model, which involves the assessment of somatic, psychosocial, environmental and demographic axes, is being presented. This multi-axial evaluation allows for the generation of the smallest unit of diagnostic-therapeutic procedures, based on the definition of the patient's health problem; that is: the patient-orientated diagnosis or the appropriate indication.

In the new market-oriented UK National Health Service, hospitals succeed or fail on the quality of service they provide to their customers. It is therefore important that institutions like the Royal Brompton Hospital can meet the information and communication needs of General Practitioners and hospitals who use their services so that co-ordination between healthcare professionals involved in the cooperative care of individual patients can be ensured. One method of improving the relationship between healthcare professionals is by the use of consensus-based clinical protocols which define ‘best practice’ co-operative care for a particular condition. The Royal Brompton Hospital has been a clinical partner in the AIM project DILEMMA which has been examining technology and methodologies for applying clinical protocols supported by telematics to general practice and shared care. A detailed requirements analysis has been carried out to look at the problems of shared care in cardiology and this has resulted in a demonstration system being developed to show how protocol-directed shared care and its supporting technology could be implemented to solve real clinical problems. Conclusions have been drawn that concern the use of protocols and information technology generally in routine clinical care.

The paper discusses the potential roles for protocols of care within critical care environments from the perspective of providing real-time support for their application. The discussion is based around a conceptual model of care in critical care environments. This model has been developed in the wider context of developing information technology systems to support clinical care in critical care environments. The conceptual model of care is a three layer model which demonstrates both the hierarchical and temporal aspects of the care delivered to patients. It is proposed that if the value of protocols of care is to be realised in critical care environments then they must be seamlessly integrated into the routine data management associated with the care of patients. In order to demonstrate this and to evaluate the utility of this concept in the clinical environment, the systems from the AIM TANIT (Telematics in Anaesthesia and Intensive Therapy) project have been used as prototype platforms. The application of the concepts developed are described in two critical care environments: the anaesthesia department and the intensive care unit. Problems in using protocols of care in intensive care units suggest that integrating these with a problem solving methodology to create an integrated care plan may be a more appropriate approach to patient management.

This presentation discusses the problem involved in providing quality care for patients with Upper GI Cancer throughout a healthcare delivery system. It is argued that appropriate telecommunications technology exists for widespread dissemination of “best clinical practice”, but that it cannot be used effectively at present because of some limiting factors. These include lack of precisely defined aims concerning use of technology, lack of interactive quality control, and insufficient involvement of end-users. Upper gastrointestinal cancer is selected as a model for discussion - since there is wide discrepancy between outcome of therapy in early and late cases, there is evidence that early diagnosis is possible - and there is substantial evidence that it does not take place widely in practice.

Prospects for the future (with special reference to the 4th Framework) are discussed. It is argued that considerable opportunities exist. Future work should build on existing experience in informatics (eg. the “Telegastro” program) and in clinical practice (e.g. the Leeds “outreach” programmes) for (a) widespread dissemination of effective “best” clinical practice; and (b) continuing medical education.

The EPISTOL action was included in the accompanying measures of AIM ′91 - ′94 as a strategic study, aimed at clarifying the impact in the near future of knowledge based systems and techniques for the health sector, and provide recommendations with respect to the research and development work required within this period. In all the EPISTOL events, namely the Munich and Brussels workshops, the topic of clinical guidelines and protocol and based care raised considerable interest. This paper summarises these discussions, focussing on the KBS support for clinical guidelines.

Rehabilitation involves long-term, interdisciplinary processes. A model was developed, for the structured description of typical healthcare activities. Telematic services based on this model can support accurate data acquisition and communication among healthcare teams. Presentation of data within their context and according to the specific user's view is envisaged, based on deviations from the typical behaviours. Benefits are also expected in better understanding of the care processes themselves, easier comparison of different approaches, and diffusion of consensus-based knowledge.

Many computerised drug prescription systems have been developed, but they are rarely used in clinical practice; among the reasons are their lack of integration with the functioning of medical institutions and the lack of consideration of general and local clinical practice rules. We present in this paper how OPADE, a computerised drug prescription system does answer this shortcoming by introducing prescription guidelines called Prescribing Principles. We argue that introduction of these Prescribing Principles will not only allow for integration of the computer in medical practice but will also introduce a positive feed back loop in the prescribing process.

The extent to which protocols and guidelines will be used depends critically on how well they are integrated with existing medical records and each other. Effective integration requires consistent information structures and content, but if the union between components becomes too intimate it may restrict interaction with other applications. Such isolation leads to operational inefficiencies and can be financially unattractive. Systematic representation methods for protocols address part of the problem but are hampered by the unsuitability of existing medical terminologies; the effort required for bespoke development is prohibitive. Unifying and generalising terminological functions in a single “Terminology Server” that can support both construction of systems and their operational use promises to reduce development effort whilst allowing individual designers considerable independence. However, significant theoretical and practical questions remain about how far the problems of communication can be mitigated by a generalised, use-independent terminological system.

One of the key issues in the development (and subsequent application) of medical knowledge - be it in terms of a KBS or otherwise - is the assessment of its quality. We present a framework for how to manage and make measurable the quality of the semantic as well as pragmatic aspects of the knowledge embedded in classification models during the development of such models.