Newsletter 1:2001

March 1, 2001

The CTS website is a big success and we are delighted that it has evolved into such a widely used reference source. During the last 3-month period, 9086 users have accessed nearly 50.000 pages on our website (not counting search-robot visits). There is hardly a transplant conference or teaching session at which data from the CTS website are not presented.

As of March 1, 2001, all graphics shown on the CTS website have been updated. We have been able to include all data received in our office by February 20. An extra update will be run in two months so that late incoming mail as well as early updates resulting from the current mailing cycle will be available for your center-specific analysis runs.

Understandably, the center-specific analysis function is especially popular. I received some disappointed calls, however, from users who did not obtain the results they had expected. Invariably, the problems were related to the analysis of factors based on the yearly "Kidney Function and Immunosuppression" questionnaires (such as blood pressure, serum creatinine, or immunosuppressive maintenance regimens), and in every instance we found that this was related to incomplete reporting of the underlying data. I would therefore like to stress the importance of returning the colored CTS questionnaires. Although we have only just begun to analyze the data, this has become the most interesting part of the CTS study. As more of the longterm analysis results are presented on the website, centers not returning the completed colored questionnaires will increasingly feel that they are missing out on something important. We will be sending out summary printouts in order to give those centers who have not regularly reported the yearly data in the past an opportunity for entering any missing information.

Several study participants contacted me to indicate that, although they were generally pleased with the analysis of their own center´s data, they would like to analyze their transplants in greater detail (e.g. using different cut-offs than those preselected on the website, or by choosing additional variables). Another recurring theme is that centers would like to include variables in the analysis, which they themselves study as part of a research project, that are not captured in the CTS data collection. In addition, numerous centers have inquired over the years whether they could use the CTS database for local maintenance of their own transplant records, because well functioning transplant database systems seem to be a rarity. Based on these reasons, we decided some time ago to embark on a rather ambitious computer project, the fruits of which we hope to make available for use to CTS participants later this year. As always, these functions will be provided free of charge and their use is entirely voluntary.

1. We will make available a database for transplant data that can be installed on an individual PC at your center, by anyone with good computer skills. The database will be a mirror image of the central CTS database. It will allow for registration of new transplants as well as for entering follow up information in a user-friendly fashion. Moreover, it will provide space for entering data on variables that are not part of the CTS, in other words, the program will support special studies. We will use the familiar Windows format so that the program functions do not require special training. With the initial program package you will receive a download of your own center´s CTS data file. You may then choose to enter all subsequent data at your terminal and thereby maintain a database that is always up-to-date, or you may choose to continue sending forms to CTS for central data processing. In the latter case there will be a time delay with the database being updated on an interval basis. Data can be easily exported for local analysis using standard software (e.g. Excel), thus remote updating carries a substantial advantage. The program will support data transmission to CTS in an encrypted fashion. An important advantage of this system is that users maintain complete control through the retention of data records in their own computers. As a standard service function, at your request, we will forward all or part of your data to national or international registries.
2. The second part of the computer project concerns center-specific analysis via the internet. In addition to providing the familiar analysis according to preselected conditions, we will allow you to use all analysis functions without restrictions. You will be able to freely choose cut-offs for age, ischemia time, PRA, HLA match grades, systolic or diastolic blood pressure, etc., and you will be able to combine any variables of interest for analysis of your center´s data, including research variables that you have added to the database. We envision that this analysis function will be of interest mainly to larger centers with a sufficient number of transplants for meaningful in-depth analysis. There is an important precondition however: Because the use of the detailed analysis function is rather complicated, the potential of errors, and even worse, the possibility of erroneous reporting is considerable. We feel that access to this analysis feature will have to be restricted to individuals who have been properly instructed. To that end, we will evaluate whether distributing a detailed manual will suffice or whether holding short training courses will be necessary.

As you probably can guess, the development of this work is at a fairly advanced stage. Because we do not have the resources for assisting you on location, it is important to develop a robust, well functioning product before release of the software, and extensive testing is therefore on our agenda. We anticipate that the two new features will be ready for release later this year and we will keep you posted.

We have always considered it an important registry function to monitor the CTS data for interesting new trends, and we have repeatedly reported on preliminary findings. In this newsletter, we would like to call your attention to a trend that has concerned us for some time. As most of you know, we have made a special effort during the last few months to ascertain the correctness of data entries for patients receiving generic cyclosporine. It appears now that the patients for whom treatment with generic cyclosporine was definitely confirmed show a significantly lower graft success rate than patients receiving the cyclosporine-neoral formulation (Figure 1, p<0.01). These data refer to kidney recipients only; the numbers of recipients of other organs were too small for analysis. Of course, the result must be considered preliminary, but it appears rather striking. We did attempt to stratify for geographic region in order to reduce the likelihood of bias. Although the result was not conclusive, an unfavorable trend for generic cyclosporine was evident in all regions analyzed. Increased attention and caution with the use of generic cyclosporine would therefore seem appropriate.

My yearly appeal to all CTS participants for honest and accurate reporting shall not be forgotten. This appeal is directed primarily to new staff members who may not be familiar with the CTS rules. Perhaps the most important point is that the CTS is not a competition for the highest success rate. The study purpose is strictly scientific. Nothing is to be gained from withholding information on failures since the results of individual centers are not released. On the contrary, reporting of incorrect information would seriously jeopardize the work of all other CTS participants. Hopefully, the results obtained from our collaborative effort will contribute to improving the results of future transplants. Please report your data as accurately and complete as possible.

Thank you for your most valuable support.

Sincerely yours,

Gerhard Opelz