Conference Papers Online Session 6: Working with Knowledge - Coming Back to and Using the Information held in Records Creating "Living Records": An Epidemiological Case Study Jenny Learmont Australian Red Cross Blood Service There is no need for me to explain to this audience the distinction between static records - like births deaths and marriages, for example - that are all separate demographic pieces of unlinked data, and living records such as those created in relation to property acquisition - say Torrens title - whereby all data pertaining to a particular property can be traced from the first owner to the latest purchaser. The records I created in the HIV Lookback department, as you will see, are obviously living and not static records.   How does Lookback work, what records were created, and how does Lookback fit into an epidemiology context? Lookback is a term now widely used in blood banking circles. It is the term given to describe the processes involved in tracing units that may have been infected with a virus transmissible through blood, which were transfused to recipients.  Lookback attempts to identify wherever possible all positive donors prior to 1985 and recipients who may have been inadvertently infected with HIV (and more latterly Hepatitis C) and who were unaware they were carrying the virus, and to keep a record of the outcome.   What records were created?  Traditionally, the records created in relation to Lookback procedures were limited to basic demographic details, and the outcome of the tracing. That is, whether or not the recipient was infected, and the date of transfusion infection.  When I commenced HIV Lookback at the Red Cross Blood Transfusion Centre in Sydney in 1985, the records were initially hand-kept, and were difficult to correlate. One of my first actions was to introduce a very basic computer based system. The system established two separate registries one for donors identified as positive to HIV and the other for reported or traced HIV positive recipients.   The registries were highly confidential and were protected by a secure password from the main blood bank computer system. Each case and each donor was given a discrete number. However the "stand alone" systems were linked by the numbered codes.  The aim of the registries I created was to add to the basic demographic data, additional information that not only updated the HIV status of recipients (including the progression from HIV to AIDS), but also recorded data on deaths from AIDS as they occurred. Formerly, Lookback records did not include this data - -and indeed, to the best of my knowledge, no other Lookback registry in the world contains this information. Furthermore, and perhaps most importantly, I entered the data on the registry in such a way that it recorded not only the current status of the recipients, but also provided their medical/HIV history from their first tracing. I have to add, however, that there was never any intention to link in a research sense the donor and recipient information held in these records. (Though I can now see that it would have made sense to follow all identified donors in the same way. The threat of possible legal action against donors would have made this task extremely difficult, however.)  Creating these records was not without its problems. There were even impediments for following the progression of HIV in blood transfusion recipients. In the blood bank setting it was not traditional blood bank practice to be involved in any way with the recipients of its products which had been delivered in good faith as a safe and often life saving product. There was fear in many quarters that this overstepping of traditional blood banking boundaries was dangerous within a medico-legal context.  Even to go as far as we did was, as I have said, contrary to blood banking policy, as it involved contacting the recipient’s physician to get updated information. However, my rationale for the capturing of context in situ was simply that I saw it as an essential part of my tracing and record-keeping role. In addition, I was lucky to have two factors working in my favour.  One was the director at this time, Dr Gordon Archer, who fully supported what I was doing. The second was that, as the Red Cross is the only supplier of blood in New South Wales, it was easy to establish the networking links with major hospitals and with the small group of immunologists or infectious disease physicians who were caring for the recipients which are so vital for tracing purposes. The physicians themselves, with consent from their patients, supplied all the information I asked for.  Epidemiology If we look at what we were doing in the context of Epidemiology, we can see that we were collecting more data than is normally sought. Ann Bowling in her recent book, Research Methods in Health, notes: "Traditionally, epidemiology has been concerned with the distribution of, specific causes of, and risk factors for, diseases in populations."  By the time I set up the registry, the causes and risk factors of HIV were well known, and I was not concerned with this aspect of epidemiological record keeping. However, we did identify where the infections caused by blood transfusion occurred—which, as it happens, was only in the Sydney metropolitan area. In addition, by identifying and recording the number of infected units donated in any one year compared with the number of units collected in any one year, we could estimate the yearly infectivity of the blood supply from 1980 to the introduction of screening in May 1985. We took one further epidemiological step in that we followed the progression of HIV in a blood transfusion population. We were thereby able to establish the median time to progression to AIDS in this particular group.  How was the early identification, in 1989, of the group now termed the Sydney Blood Bank Cohort (SBBC) possible, and how was the information interpreted?  Because of the records we had constructed, we were able to do more than is customary in Lookback tracing. The data I collected and the resulting correlation I was able to make led me to discover a group of HIV positive recipients and their single donor who have not progressed to AIDS. This is the most important result to come out of the Lookback registry. The recipients and donor who make up the SBBC are the only group so far identified in the world who share an attenuated form of HIV which has halted their progression to AIDS.  There were several factors that led to this discovery. There is no formula for all the pieces that eventually came together and led to the identification of the SBBC. However, there are certain components without which it would never have been possible. Firstly, and most importantly, were the records themselves. The fact that I consistently updated data on the recipients and recorded this data on my registry in a cumulative - or dynamic, rather than one-off or static - way, enabled me to see new and unlikely connections. This in turn led to new insights, new directions and new interpretations about HIV progression.  The origins of the SBBC really commenced in mid 1987. An elderly man tested for HIV only because he was aware that transfusion prior to 1985 carried a risk of infection. On discovering he was positive his family doctor referred him to Dr John Wells at Royal North Shore Hospital. Dr Wells reported the case to me, as was the normal practice, and Lookback procedures were put in place. All the donors who had donated any of the units in 1983 which had been transfused to the recipient in question, and had not donated since screening commenced in 1985, were sent letters from the Blood Bank requesting they contact us. One donor rang in immediately, informing my assistant he was HIV positive but had believed he only became infected in 1985. During the conversation he commented on how well he was. This conversation was reported to me - we did not record it. It was a ‘creative moment’ which should have been recorded but instead was, for reasons I cannot quite fathom, committed to my not always perfect memory.  Further tracing proceeded from this donor (and many others at this time) and two further cases were identified, both having been infected in 1984. The fact that they were both without any symptoms was not remarkable, as they had only been infected for three years.   Later in 1987 Dr Wells again contacted me with another case of a woman with HIV who had also only been tested because she was aware of transfusion as a risk - she was well with no symptoms. What was remarkable and coincidental, and a very important part of this unfolding story, was that although not living in the same area as Dr Well’s first patient she had visited the same general practitioner who had referred her on to Dr Wells.  With the same Lookback procedures in place we were able to identify that she had received a unit from the same donor as the elderly gentleman. A unit we were aware of, but due to inadequate record keeping in the early 80s before computerized records (late 1983), we had been unable to identify the hospital which had received this unit.  1989  In 1989, during my yearly contact with physicians, I had a conversation with Dr Wells about his two patients who I knew had received blood from the same donor. We discussed this and how interesting it was that they were both still very well and as far as I knew so was the donor - at least up till 1987 when we traced him.   The Hypothesis  I reflected on this, and although the conventional wisdom was that if you remained well it must be something, as yet not discovered, to do with the immune system, I thought why could it not be something to do with the virus. I decided to look at all donors who had given units that had infected three or more people. I could not have done without the record system I had created. Imperfect as it was, it still enabled me to extract the eight or more donors in question and provided the designated numbers allocated to each of their infected recipients. From there it was easy to extract a hard copy of these recipients and connect groups to donors. When I came to the above donor I could see immediately that there were three other recipients connected to this donor whose updated records indicated were all still extremely well.   The Interpretation  For me it was an "ah ah" moment. I believed the reason they were well must be due to the virus they had received. [I have often been asked about this moment of discovery and important as it was I have often tried to explain the importance of the "records" - so I was delighted to be asked to speak here to-day, for at scientific conferences this fact seems to be of little consequence.]  These were very early days and my belief that the reason they were well must be due to the virus was not a belief shared by many. (I also believed if we could find out what was different about the virus there could be the possibility of a vaccine.)  My ongoing contact with Dr Wells was another essential part of this story. He and I were fascinated with what my records had revealed and he suggested we contact Professor Cunningham at Westmead, as it was essential to be able to isolate the virus before we could go any further.   There is one more very important part of this story that relates to the donor that needs mentioning. I had never met the donor when we started trying to isolate the virus in 1989 and I was working on the belief that he was still well. (It was not normal practice to contact donors after they had been referred on for medical care). At the end of 1990, in the course of quite another matter, I had to contact this particular donor. He was extremely well and agreed to be part of the study we had undertaken and furthermore to give us access to all his medical records. Most fortuitously he had enrolled in 1985 in the Sydney Prospective Study and we have immune function results from then to this day - this is quite remarkable. As well, our records can now prove that he is one of only three donors who were donating in 1981 and were, even at this very early stage of the HIV epidemic in Sydney, by then positive to the AIDS virus.  From 1989 to 1992 there were many setbacks but eventually in late 1992 our description of the group was published in the Lancet.  In 1995 Dr Nick Deacon and colleagues from the Macfarlane Burnet Centre with the Blood Bank team released our findings in Science – we now had the scientific proof so essential to prove my original hypothesis that it was the virus which was responsible for the halting of progression to AIDS.   What are the limits to the capturing of context as was done with the HIV transfusion transmitted registry? There seems to be an inability by some to free themselves of their tunnel vision and see broader possibilities. I am aware, in my own rather limited world of blood banking, just how important it is with all blood borne viruses not only for Lookback procedures to be standard practice, but also for the essential follow-up of creating detailed records and their continual up-dating to be become standard practice. Only then will the records be available to look for trends and possibilities. And yet this is rarely, if ever done in a Blood Banking setting.  With another virus transmissible by blood transfusion, Hepatitis C, although there has been a commitment in dollar terms for Lookback for Hepatitis C in all states, none as yet has carried record-keeping procedures as far as they might. All is not quite lost, as in one state, Victoria, the Blood bank has attracted additional funding, and plans to do a prospective epidemiological study of all recipients identified with Hepatitis C.  There is no doubt that budgetary constraint and the distinctions made between operational and research money, play a large part in doing follow up of this kind. And in the research world where the research dollar is a constantly shrinking commodity it is extremely difficult to get additional funding. However the value of the records, not only in case I have been describing, which can be revisited and which have the potential to hold important data for research, need not be an extremely costly endeavor and is one which needs to be supported to become accepted as "best practice".  The Significance of Good Records It seems to me that the importance of the records themselves cannot be over emphasized. If I hadn’t had my data recorded in one central location the importance of these people would not be known, even today. Members of the SBBC are all under different physicians and without the blood bank’s ability to link them together there would be no reason for their physicians to think their Long-term survival was in any different to other Long-term survivors of whom there are around 2% in all infected populations.[1]  Lookback procedures played a very important part as well. The four in the group that we traced would most likely still not be identified as they are well and have no signs or symptoms of HIV.   Lastly, our work would not have been possible without the ongoing support and co-operation of the people in the SBBC with whom I have constant contact and who are all fully informed of all our results. Their physicians have also played an important role in keeping the records "living."  What emerges from this case study is that it is important in keeping records to ensure that the data collected is as comprehensive as possible and it must be longitudinal. Current data must be able to be related to previously collected data.  Data must also be collected and organized in such a way as to be able to provide answers to as wide a range of questions as well as specific questions. No one can know just what questions might be asked of the data and for me the original paradigm was to follow progression. As you know, luck, serendipity, play an enormously important part in scientific discovery. Such luck, however, depends upon data being available.  Finally, data is next to useless without sympathetic interpretation and informed human involvement and participation in its collection. I believe data that is accumulated without discussion, without any consultation of the needs of individuals working in the field of inquiry, will most likely be left to corrupt slowly away on hard disks, perhaps unused and unknown.  PS A history of my department is planned covering what I have just talked about and other work and projects which have flowed from the registries. I have been aware that to achieve this I would need an "angel" to help make sense of the rather idiosyncratic way in which I have done much of my filing. After this conference I now know that what I need is an archivist.       [1] Long-term Non-progression (LTNP)

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Date modified: 7 October 1999