computer methods and programs in biomedicine ELSEVIER
Computer Methods and Programs in Biomedicine 45 11994) 159 164
TANIT AIM Project (A2036):Telematics for ANaesthesia and Intensive Therapy C l a i r e L. B o w e s *a, J o s H o l l a n d b "Kontron Instruments Ltd., Croxley Business Park, Blackmoor Lane, WatJord, Hert~s WDI 8XQ, L K I'Driiger Medical Eh'ctronics. IBC Weg 1, 5680 GA Best, The Netherhmd~
Abstract
On-going work relating to the development of advanced telematics systems for Critical Care environments is described. This work is in part sponsored by the Commission of European Communities under the AIM TANIT project. Two example departments have been selected for piloting in the project: Intensive Care and Anaesthesia. The objective of this paper is to outline the complex issues that need to be addressed when developing such systems. Key words: Intensive care; Anaesthesia; Advanced telematics systems: Piloting; Evaluation; Data transfer standards; Critical care medical record: Data protection, security and confidentiality; H u m a n computer interface: Clinical audit; Patient costing; Resource management; Transferability; Integration; Clinical decision support; Intelligent signal processing
1. Introduction Critical Care environments (e.g., Intensive Care Units, Anaesthesia Departments, Coronary Care Units, Neonatal Units, Burns Units) are specifically set up to enable significant resources, both in terms of equipment and personnel, to bear on critically ill patients who are almost certain to be suffering from a number of interacting problems. These environments can account for more than 30% of hospital expenditure, and it is important that these growing expenses are monitored and contained. There are many different types of paper record maintained within Critical Care environments to
* Corresponding author.
cover specific areas of care and treatment, and the patient is normally connected to numerous monitoring and therapeutic devices. Thus there can be difficulty in collating data from these diverse sources to enable the most effective clinical decisions to be made [1]. Moreover, the complexity of clinical practice in Critical Care is great, and is increasing. This, together with the growing demand for health care to be both socially and financially effective, has resulted in the need for new solutions. The development of Critical Care telematics systems that support both clinical and unit management activities is a tool for this. The T A N I T project (Telematics for ANaesthesia and Intensive Therapy) has been set-up to address these issues. It is within the Advanced lnformatics in Medicine (AIM) Programme of the
(1169-2607/94/$1)7.00 (7 1994 Elsevier Science Ireland Ltd. All rights reserved SSDI 0169-2607(94)01568-Z
160
C.L. Bowes, J. Holland/Comput. Methods Programs Biomed. 45 (1994) 159-164
Commission of European Communities (CEC). The TANIT project management is shared between Kontron Instruments Limited, UK (the Co-ordinator) and Drfiger Medical Electronics, NL (who have nominated the Project Manager). These two major European equipment manufacturers are joined by 17 other academic/industrial partners to form the consortium.
2. TANIT project goal The goal is to produce demonstrable references for Critical Care departmental systems that are
ii;
transferable in time and space throughout Europe and beyond. They must be open to the healthcare information space and adhere to appropriate data transfer and security standards. The core of TANIT is the development of two pilot systems: Intensive Care and Anaesthesia, i.e., two major components of Critical Care. These pilots are aiming to meet the needs of health care professionals (e.g., doctors, nurses), departmental managers, hospital managers and health care authorities. It is well recognised that such systems have to reflect the working practices of the units in which they are installed [2,3] and be integrated
ii%Healthcbre
............................
Fig. 1. Schematic representation of TANIT.
C.L. Bowes, J. Holland / Comput. Methods" Programs Biomed. 45 (1994) 159 164
within the hospital environment, and so they must be adaptable/configurable enough to suit local conditions. It should be noted that weakness in this area severely limited the market penetration of previous generation systems. 3. Overview of the TANIT project
TANIT is bringing together work carried out over the last twenty years by European companies and universities in the application of Information Technologies to various aspects of Critical Care environment information processing. Among others, it is building on the functional specification derived in the I N F O R M project (Information Management and Decision Support in High Dependency Environments) and on findings from the ICSIC project (Integrated Communication System for Intensive Care). These projects were both part of the AIM Exploratory Phase (A1029 and A1025 respectively). The two pilot systems that form the core of TANIT do not intend just to support logging/ trending of automatically acquired/manually entered data, data storage and report printing as the previous generation of systems did. They also aim to improve: • quality of care delivered to the patient; • patient outcome (and to monitor it); • cost-effectiveness in the application of resources.
This can be achieved by ensuring that the completed systems: • will provide a comprehensive support for the care of the patient; • are effectively integrated into the daily routine of health care professionals; • support communication activities among 'clinical team members' and between the team and the outside world; • enhance the exploitation of the clinical data enabling more effective decisions to be made; • provide high quality clinical audit and resource utilisation data.
161
The pilot developments are therefore supported by a number of activities whose role is to generate practical recommendations (sometimes in the form of prototypes) and guidelines for the design of the systems. The issues addressed by the fifteen TANIT workpackages can be categorised as follows: (1) data management; (2) communication of data/information/knowledge; (3) advanced exploitation of data; (4) quality assurance/evaluation of pilots. The data management issues (category 1) covered by the two pilot workpackages include automatic acquisition and manual entry of data, data processing, storage, retrieval and printing of reports. Further issues required to ensure that the local users (e.g., doctors, nurses) accept the computer systems as part of their daily routine are being addressed by the 'Human Computer Interaction' and 'Co-operative Work Support' workpackages. Even though 'patient care' is in itself 'local', the data/information/knowledge associated with it has to be shared and communicated within the Critical Care environment, and also with the surrounding health information space, in an effective and secure way (category 2). These complex issues are being addressed by six workpackages in TANIT. For example, appropriate European and international 'Data Standards' are being monitored. Another workpackage, 'Data Protection, Security and Confidentiality', is surveying the legal issues in different European countries that concern access to clinical data and to the computer system; state-of-the-art technical solutions are being proposed to support access control and file protection. The transferability of the 'Medical Record' between health care professionals, from one clinical period to another, and from one clinical environment to another is also being addressed. Another workpackage, 'Co-operative Work Support', is looking at the mediator role of the computer system in supporting synchronous and asynchronous communication among clinical team members, and yet another is studying the 'Integration' of remotely collected data into the
162
C.L. Bowes', J. Holland/Comput. Methods" Programs Biomed. 45 (1994) 159 164
computer system. Finally in category 2, the 'Transferability' workpackage is investigating the clinical/technical portability of the computer systems into different clinical environments, different hospitals and different countries. In category 3, methods to improve the information content of data generated by the bedside monitoring devices are being defined by the 'Signals' workpackage, and the 'Clinical Decision Support' workpackage is studying the process of complex decision making in selected areas. The 'Health Care Evaluation/Clinical Audit' and 'Resource Management/Patient Costing' workpackages are determining ways to exploit the data collected by the computer systems so that the quality of care, patient outcome and cost-effectiveness in the application of resources can be assessed. Finally, common methodologies for evaluation of the two pilot systems are being defined (category 4). The methodologies aim to be generic enough for them to be utilised within Critical Care environments not specifically addressed in TANIT. Evaluation issues are being systematically addressed throughout the development cycle of the pilots (i.e., from specification and design, to system development and installation on site). The challenging objectives of TANIT are hindered by the current lack of relevant European and international standards. The project is not only monitoring the progress of these standards, but members of the consortium are also actively involved their development. The TANIT consortium is well represented on each of the seven CEN/TC 251 Working Groups (WG), and also in the associated Project Teams. Members of TANIT are actively involved in the CEN/TC 251 WG 5 activity associated with the interconnection of medical devices in acute care areas. 4. Brief overview of TANIT pilot systems
4.1. Intensive Care Unit (ICU) pilot The ICU pilot (Kontron Instruments Ltd. has responsibility for this) consists of two separate but closely interrelated components: (i) clinical component which supports management and delivery of patient care;
(ii) management component which supports clinical audit data (the assessment of care delivered and its outcome), the determination of costs of patient care and the management of the ICU environment. Within TANIT, the top level design for the complete clinical component of the pilot has been realised, and an example part of it has been implemented and installed in a pilot site. A preliminary design and implementation of the management component are also being realised and installed in a pilot site. There are many novel features in the initial implementation of the ICU pilot, and these are undergoing formal evaluation in a UK pilot site. A considerable level of evaluation has already been undertaken at numerous hospital sites throughout Europe. This has been performed by showing designs to medical and nursing experts at pilot sites and asking them to complete associated questionnaires. A clinical panel of experts (doctors, nurses) has been actively involved in the pilot design. Much emphasis has been placed on the user interface of the pilot, and it has been designed in conjunction with experts in Human Computer Interaction. 4.2. Anaesthesia pilot The Anaesthesia pilot (Drfi, ger Medical Electronics has responsibility for this) consists of several components: (i) (ii) (iii) (iv) (v)
pre-operative data collection unit; induction room system; operating room system; recovery room system; integrated departmental system, including networking, with organisational and management functions.
Within TANIT, the stand-alone operating room system has been implemented with full functionality. The top level design for the 'total' Anaesthesia system has been realised. In addition, the basic recovery room system (with network) has been implemented.
C.L. Bowes, J. Itolland / Comput. MethmA Pro granr~- Bionted. 45 (Ig94) 159 164
Formal clinical evaluation of the operating room system has been undertaken at five European sites to date, and the evaluation of the recovery room system is underway. The human computer interface of the pilot (which is touch screen based) has been appraised separately by experts in this field.
Public domain TANIT Deliverables
5. Conclusions
D I0
Important issues that need to be addressed when developing information management systems for Critical Care have been described. The coverage of these issues has not been comprehensive in this paper, but rather the intention was to overview the breadth of the task. To summarise, the T A N I T pilots will provide:
D11
• comprehensive, integrated support for both clinical and departmental management functions; • integrated departmental systems that are the basis of state-of-the-art products for worldwide markets; • methods for measuring quality of care delivered and its effectiveness; • methods for measuring effectiveness of resource usage. The developed systems are open to the healthcare information space and adhere to appropriate data transfer and security standards. Importantly, the solutions are transferable to other acute healthcare environments. For future development and evaluation, the results of the current T A N I T project can be exploited in the following ways: • contribution to healthcare harmonisation in Europe, and to medical informatics standards development; • evaluation platform for novel telematics developments (emerging from T A N I T workpackages, other AIM project and other programmes): • testbed for European standardisation.
D1 D9
D14 D24 D26 D32 D34 D35 D36
163
Data transfer standards, first proposal (explorative introduction). Interim recommendations for data protection in Critical Care computer systems. Part 1: Regulatory framework of confidentiality for medical records. Overall methodologies for evaluation of prototype/pilot implementations. Interim report on, and recommendations for, transferable Critical Care Environmental medical record. User requirements of signal processing, and methodologies for signal validation. Data protection in Critical Care computer systems: final recommendations. Proposal for transferable Critical Care Environment medical record. Update on data transfer standards for Critical Care Environment computm systems. Synthesis and conclusions of the T A N I T project. Prototype hardware and software for data protection in Critical Care computer systems. Interim recommendations l\~r dala protection in Critical Care computer systems; Parts I & II.
Please contact the authors of this paper if information is required on the restricted T A N I T deliverables, components of these may be made available through negotiation. Acknowledgements The work described in this paper is being partially undertaken within in a research and development project named T A N I T (Telematics for ANaesthesia and Intensive Therapyl. The project, which commenced in January 1992, is under the Advanced lnformatics in Medicine (AIM) Programme of the Commission of the European Communities as project number A2{}36. The T A N I T consortium is as follows (main contacts are gi;en for each institution):
Partners P01 Konlron Instruments Ltd. Watlk)rd (Dr.Claire Bowes); P02 Dr/iger Medical Electronics. Best (lng.Nol Nuyten): P03
164
C.L. Bowes, J. Holland/Comput. Methods Programs Biomed. 45 (1994) 159-164
University College London (Dr.Mark Leaning); P04 University of Aberdeen (Dr.Jim Hunter, Dr.Robert Logic); P05 Lille Group (University Hospital); and INSERM (Prof.Regis Beuscart, Dr.Marie-Christine Chambrin); P06 Universit/it Stuttgart, IAT (Dr. Michael Burmester); P07 Universit/it Ulm, Clinic of Anaesthesiology (Dr. Wolfgang Friesdorf); P08 Istituto di Fisiologia Clinica, CNR, Pisa (Dr.Rita Balocchi); P09 Sogess s.r.l., Milano (Dr.Mauro Mereu); P10 Staff s.a., Brussels/Louvain-la-Neuve (Ir. Jos Holland);
Associated Contractors A01A Instit.Biomed.Equip.Eval. & Services, Sheffield (Dr. Adrian Wilson); A01B University of Leeds Industrial Services, Leeds (Dr. Mark Howes); A01C Mayday University Hospital, London (Dr. Paul Collinson); A01D Uppsala University (Prof. Torgny Groth); A10A State University, Gent (Dr. Georges DeMoor, Dr. Filip DeMeyer); A10B Dr. Louis Corbeel, Wavre; A10C Universit/it Bremen, KI Labor (Dr. Michael Hortmann, Prof. Manfred Wischnewsky); A10D Uni-
versidad Polit~cnica, TEB, Madrid (Dr. Enrique Gomez); AI0E Helmholtz Institute for Biomedical Engineering, Aachen (Dipl.-Ing. Bernhard Thull.);
References [1] P. McNair, J. Brender and S. Ladefoged, Impact on resource consumption from application of sequential test strategy. Lecture notes on medical informatics: Proc. 9th Medical Informatics Europe '90, Glasgow. Springer-Verlag, Heidelberg (1990) 381-387. [2] L.S. Avila and M.M. Shabot, Keys to the successful implementation of an ICU patient data management system. Int. J. Clin. Monit. Comput. 5 (1988) 15-25. [3] C. Ambroso, C. Bowes, M.-C. Chambrin, K. Gilhooly, C. Green, A. Kari, R. Logie, G. Marraro, M. Mereu, P. Rembold and M. Reynolds, INFORM: European Survey of Computers in Intensive Care Units. Int. J. Clin. Monit. Comput. 9 (1992) 53-61.