The French Organ Transplant Data System

Transcription

1 77 The French Organ Transplant Data System William Nigel Strang, Philippe Tuppin, Alain Atinault, Christian Jacquelinet Agence de la biomédecine 1 avenue Stade de France SAINT DENIS LA PLAINE CEDEX France Abstract The Agence de la Biomédecine is a state agency dealing with Public Health issues related, among others, to organ, tissue and cell transplantation in France. The Agence maintains a national information system used to coordinate and administer organ procurement and transplant activities and to perform the evaluation of organ transplantation activities. This paper describes the core uses and functional requirements of Cristal, the donor, recipient and allocation software of the information system and its evolution in the new system. Keywords: Organ transplantation, Organ allocation, Decisional Information System, Health Planning, Government Agencies, Computer Communication Networks, Software 1. Introduction Computer systems have been intimately associated with organ transplantation since its entry into mainstream medical practice in the 60 s [1] evolving from recipient follow up through to the essential functions of waiting list administration, the coordination of procurement and the allocation of organs to patients on the waiting list. These activities create favourable conditions for the pre and post transplant follow up of patients since the mandatory identification of all transplant patients generates a cohort that includes the complete treated population[2] [3]. The Agence de la Biomédecine is the state agency in charge of public health issues related to organ, tissue and cell transplantation and medically assisted procreation, embryology and human genetics in France. It is responsible for the registration of patients on and the management of the national organ transplant waiting list, the allocation of all organs retrieved in France or abroad the evaluation of these activities [4]. The Agence de la Biomédecine develops and maintains Cristal to record information concerning patients at registration, transplantation and pre and post transplantation followup as well as information concerning the coordination of donor procurement and organ allocation. This primary role, supporting the allocation of a scarce resource to patients, directly contributes to health care. Cristal is also the primary source of the accurate and controlled data used for the evaluation of organ retrieval and transplant activities that are published both in the annual report of the Agence de la Biomédecine and in the context of specific studies.

2 78 2. The transplantation process Coordination of transplant and procurement activities in France is organised into six areas known as inter-regions. Decentralised departments of the Agence de la Biomédecine, the Services de regulation et d Appui * (SRAs) are responsible for the control and coordination of organ procurement and allocation activities within each inter-region. [5] [6] Hospital procurement coordinators, or other sources, inform the SRAs of potential brain dead donors. As the pre-procurement clinical, administrative and ethical procedures progress the available information can be recorded in the potential donor s dossier within Cristal. The SRA proposes the potentially available organs to transplant teams according to procedures defined in French legislation and following a hierarchy of local (the same hospital or network), inter-regional, national and international levels. Flows between the inter-regions are coordinated by the Regulation Nationale based near Paris as are exchanges with non-french organisations Organs must first be proposed to recipients who benefit from a priority. In the absence of or after national or regional priorities, the order of the propositions (for organs other than the kidney) is based on a rota that permits local variation and practises. The propositions and the replies of the teams are recorded within Cristal. As soon as the organ of a donor is proposed to a team, the donor s dossier becomes available for consultation by the team via Cristal. Kidneys are currently proposed according to two procedures: a points score system similar to that proposed by Starzl [7], or according to the number of mismatches, the waiting time and the degree of immunisation. After the procurement and transplantation of the donor s organs the link between the donors organs and the recipients is recorded in Cristal. Donor records and data entry The donor record is created early on the process by the SRA after initial contact with the hospital procurement coordinator. Hospital procurement coordinators gather the medical records of the donor and complete a standardised nationwide donor dossier. This document, preceded by essential documents (blood group, serologies) is faxed to the SRA who enters the data in Cristal. Waiting list registration and the pre-transplant period. 130 organ transplant teams are active within the 30 teaching hospitals throughout France. To benefit an organ transplant in France patients must be registered on the national waiting list by identified members of transplant teams, or their proxies. Pre-transplant visit reports should be entered into Cristal every year for the kidney and every six months for the other organs. Pre-transplant events should recorded in Cristal The patient may die. The patient may decide to leave the waiting list. The improvement or degradation of the patients state may render transplantation inappropriate. The transplant team may declare a temporary contra-indication. The patient may be accorded a priority. * Literally the support and dispatch agencies If the information is not entered directly it is not available for consultation by the transplant teams, however, for operational reasons the system tolerates a deferred recording of the details of the donor dossier.

3 79 Transplantation When a donor becomes available Cristal helps select the most eligible transplant patients via the implementation of the legal criteria in a series of programs that also take into account the ongoing regional and national priorities. After transplantation the information that the patient has been transplanted with a specific organ of a specific donor is recorded in Cristal. A detailed report of concerning the perioperative and 1 month post operative period should be recorded in Cristal. The post transplant period There are currently about 6500 patients on the waiting list in Cristal. The number of post transplant patients in Cristal is about Post transplant follow up information should be entered into Cristal annually. The data entry confirms that the patient is living and indicates the occurrence of important episodes over the past year (complications, treatment changes). 3. Cristal: A centralised and integrated communications system Cristal is a centralised system. A single copy of the software runs on a powerful, secure, computer based near Paris. For the time being users run a terminal emulation session on their computer and communicate over a modem-to-modem direct dial link with the central computer. Cristal is integrated, that is to say Cristal is used to administer the national transplant waiting list, records patient details and pre and post transplantation follow up and is also used to record donor information, provides guidance concerning patient priority and emergency situations and records the proposition of organs to transplant teams (with their responses) as well as the final allocation of the organ. Cristal can be appropriately viewed as a communication support infrastructure between the transplant teams and the organ allocation teams in the SRAs[8]. Cristal Data Structures Figure 1 illustrates a simplified vision of the data structures of Cristal. Each patient is identified in the table Patients and has one or more transplant dossiers containing pre and post-transplant information and a series of visit reports. At transplantation the donors organs are linked to the various recipients in a transplants and organs table. The donor is recorded in the donor table and the donor s dossier is recorded as a set of data in an associated table. Patients Transplant dossier Transplants & Organs Donors Visits Dossier Data 1 to many 1 to 1 Many to many Cardinalities Data Figure 1 The core data structures of Cristal

4 80 Matching donors to recipients Cristal helps match recipients to donors characteristics according to the applicable legal dispositions. Given the age and blood group of the donor (and the HLA for kidney recipients) the donor matching program produces ordered lists of recipients and transplant centres that the regulators in the SRAs use to pilot the organisation of the procurement process. 4. Discussion and perspectives Throughout the paper the conditional tense has been used whenever the data entry activities of transplant teams, beyond those that are obligatory for organ allocation have been described. As early as 1967 Murray and Barnes[2] identified that information gathering for transplant patient follow up and the completion of questionnaires for the then Human Kidney Transplant Register was burdensome for the clinical staff, considered to be largely redundant and was carried out with variable assiduity. This state of affairs has worsened considerably over the last 40 years. Many reasons underlie this major obstacle to fully exploiting the potential of an exhaustive data set and we are addressing those that we can in the migration of Cristal. Meeting the challenges Functional migration The Agence is also in charge of the Renal Epidemiology and Information Network (REIN) used for the follow-up of all patients treated by dialysis in France, linking the cohorts of dialysed and transplanted patients to offer a complete evaluation of end-stage renal disease treatment. The information system of the Agence is becoming a decisional information system supporting evaluation studies and decision making for public health policies in the field of organ failure, replacement therapies and transplantation. Due to individual and societal concerns, its use for organ allocation also requires an accurate evaluation process. To make relevant public health decisions, it is important to correlate temporal and geographical data related to health needs and their determinants (patients data), to temporal and geographical data related to health supplies and their determinants (health care offer, organ retrieval). Providing statistics for deciders requires the integration of data coming from consolidated sources with Data-warehousing techniques. This extension of Cristal to support the national dialysis information system (Diadem) will complete the description of the treatment of end-stage renal failure in France. Attaining this objective leads to two key requirements: A reliable patient identification process Facilitating a complete and coherent patient follow up. Software migration Cristal is archaic it used obsolete technology at its launch in 1996 (Oracle Forms 3). Since 2001 the computer department has been modernising its technology and methods. In 2002 we installed secure internet platforms on which a series of applications related to Cristal were deployed in 2003 including a geographical referential and a meta-thesaurus 9,10, saw the first modules of Cristal for internet deployed namely the Cristal Quality tools, used for the traceable correction by the quality monitors and a simple interface onto the transplant team directory. In 2005 the first medical module, Cristal

5 81 Immunology, was deployed for the HLA laboratories. Cristal version 2 uses a service based architecture (Figure 2) Portal (Security, identification & authentication) Cristal Recipients Version 2 Diadem Identification unique Thesaurus Forms engine & sate event model Data dictionary Query Library Structures & Authorisations Quality & data correction Cristal V1/2 Extractions Info service Statistical Analysis Figure 2 The services that are used to construct Cristal Version 2 Improving patient identification Currently during patient identification Cristal checks for birth names and given names that are the same as, or that start with the entered name. This is insufficient and needs to be completed by phonetic searching, normalised string searching and other algorithms. These functions will be shared between Cristal and the software being developed for the end stage renal disease data system (Diadem). Improving patient follow up Five steps are being undertaken to improve patient follow up Human resources and financing Staff dedicated to gathering and entering the data are now associated with most transplant teams. The posts are directly financed by the administration and the financing mode has recently changed supporting and perpetuating these posts. The posts are directly attached to the regional health authority, but the national coordination centre of the Agence de la Biomédecine coordinates the work. Item review and the forms engine The items gathered in Cristal are under constant review whilst respecting the need for stability in the data analysed. The application used to the end stage renal disease data system includes a form engine that permits documented evolutions of the items gathered. This forms engine is destined for use by Cristal. Clinician appropriation and the forms engine Many transplants centres and groups of transplant centres set up their own data systems to observe their own cohorts of patients. Until the clinicians in the transplant centres perceive the national administrative system as a tool that they can use to meet their own then the data gathering for Cristal will continue to be a secondary activity. The forms engine aims to promote this appropriation of the system. It produces data collection forms using declarative descriptions of the data to be collected. The items, grouped in sections may be simple or complex. Items can be conditional on the basis of previous replies and may be repeatable. The values entered are verified by unitary controls and by more complex logic bringing implying multiple items and other data. It is also provides the possibility to gather

6 82 information at the local, network centres, regional and national levels. as well as ad hoc questionnaires for logic driven transversal studies or longitudinal studies. Data integration Much of the data typed into Cristal is already present in other computer systems, be they medical records, lab results, administrative information, clinical trial systems or other transplant recipient follow up systems. The long term intention of the Agence de la Biomédecine is to be able to integrate information from such disparate sources directly into Cristal. Towards a French consolidated end stage renal disease data system The most powerful incentive towards the use of Cristal comes from its integration with the National Dialysis data system based on the work of Landais et al12,13. The ability to apprehend the complete illness and treatment history will hopefully bring considerable added interest to the participating clinicians. 5. Conclusion The solution being developed for Cristal and Diadem is a specific instance of software of a generic type (patient identification linked to configurable follow up). The architecture retained during the migration of Cristal and its integration with Diadem, if proven to work by experience, provides a generic model and basis which could be used and extended to the patient registers in certain of the Agency s other domains of activity. 6. References [1] Murray JE, Barnes BA. Introductory remarks on kidney transplantation with observations on kidney transplant registry. Transplantation Jul;5(4):Suppl: [2] US Renal Data System: Excerpts from the USRDS 2004 Annual Data Report. Am J Kidney Dis 45:S1 S280 (suppl 1) [3] Cecka JM. The OPTN/UNOS Renal Transplant Registry Clin Transpl. 2003;:1-12 [4] Atinault A. Règles et organisation de la transplantation rénale du prélèvement. Encycl Méd Chir, Néphro-uro, a-10,2001, 12p [5] Desvaux C, Claquin J. Prélèvement d'organes et de tissus en France : modalités réglementaires. Objectifs soins, Avril 2003, n 115, pp [6] Desvaux C, Atinault A, Claquin J. Législation des prélèvements et greffes d organes. Objectif Soins Numéro 79, octobre 1999, pp (1ère partie) [7] Starzl A multifactorial system for equitable selection of cadaver kidney recipients. JAMA Jun 12;257(22): [8] Smith T. Computerized kidney registry links transplant centers.forum (Wash) Nov-Dec;1(2):36-7. [9] Jacquelinet C, Burgun A, Strang N, Denis D, Boutin B, Le Beux P. Design considerations for an ontology in the domain of organ failure and transplantation. Stud Health Technol Inform. 2002;90: [10] Jacquelinet C, Burgun A, Delamarre D, Strang N, Djabbour S, Boutin B, Le Beux P. Developing the ontological foundations of a terminological system for end-stage diseases, organ failure, dialysis and transplantation. Int J Med Inform Jul;70(2-3): [11] Jacquelinet C, Burgun A, Djabbour S, Delamarre D, Clerc P, Boutin B, Le Beux P. A contextual coding system for transplantation and end stage diseases.stud Health Technol Inform. 2003;95: [12] Landais P, Simonet A, Guillon D, Jacquelinet C, Ben Said M, Mugnier C, Simonet M.SIMS REIN: a multi-source information system for end-stage renal disease C R Biol Apr;325(4): [13] Ben Said M, Simonet A, Guillon D, Jacquelinet C, Gaspoz F, Dufour E, Mugnier C, Jais JP, Simonet M, Landais P. A dynamic Web application within an n-tier architecture: a Multi-Source Information System for end-stage renal disease. Stud Health Technol Inform. 2003;95: Address for correspondence Nigel Strang, Direction des systèmes d information, Agence de la biomédecine 1 avenue Stade de France SAINT DENIS LA PLAINE CEDEX France, Nigel.Strang@biomedecine.fr