- Email: [email protected]
Indian Transplant Registry—www.transplantindia.com
Indian Transplant Registry—www.transplantindia.com S. Shroff ABSTRACT The Indian Transplant Registry has been made possible due to the efforts of the Indian Society of Organ Transplantation (ISOT) over the past 5 years. The ISOT is about 20 years old and has more than 450 members related to multiorgan transplants with elected officers. It is in its first phase of development and is now available on the Web at www.transplantindia.com. The objective of developing this registry is to be able to view, collate, and audit the national data for all transplants in the country. In the first phase, “fast track” data are being captured with essential details of the program along with the yearly number of transplantations performed, the sex ratio, and type of transplantation. Over 10 major institutions have submitted their data to the registry. In the second phase, over 20 fields would be captured; all member institutions would be encouraged to enter data prospectively. In the third phase, audit of the data would be possible. The members of the ISOT have been supportive and enthusiastic about the registry as reflected in their data submission to date.
I
NDIA IS A sovereign democratic republic with a union of states. It is a developing country with a per capita income of $460/year. Only 2.2% of the population earns more than $1000/year and 29% fall below the poverty line, earning less than $100/year. India’s democracy is governed by the parliament and by a legislative assembly in each state with both bodies elected by the people every 5 years. Health is under the purview of the state. Any act relevant to health made in the central parliament needs to be ratified by the state assembly with or without any necessary changes to make it a law. Transplantation in India was started in the early 1970s; its activity is restricted mainly to teaching and well-equipped private institutions. With the introduction of cyclosporine in the 1980s the better graft outcomes led transplantation to be accepted as the best treatment modality for end-stage renal disease. The well-qualified clinicians in India, especially in cities like Vellore, Mumbai, and Chennai, made it possible to master the field of kidney transplantation in a short time. Living donation had been the only source of organs for transplantation before 1994 since there was no acceptance of the concept of brain death. In 1994, the Transplantation of Human Organs Act was passed in the Indian parliament. The aim of the legislation was to promote cadaveric organ transplantation by accepting brain death, curbing commerce in transplantation. It is currently estimated that annually doctors in the country perform approximately 3000 kidney and about 100 liver and cardiac transplantations. However, no accurate data are available.
© 2007 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 39, 711–713 (2007)
INDIAN SOCIETY OF ORGAN TRANSPLANTATION
The Indian Society of Organ Transplantation (ISOT), the apex transplant society in India, is promoted by transplant clinicians in all specialties from across the country. It conducts deliberations related to multiorgan transplants at its annual meetings. At present it has members representing specialties such as nephrology, transplant surgery, hepatology, cardiology, urology, vascular surgery, general surgery, cardiothoracic surgery, and basic sciences as related to immunology. It has more than 450 members; its officers are elected at its national meetings. The 20-year-old ISOT was started by stalwarts in the field of transplantation in India. ESTABLISHING THE INDIAN TRANSPLANT REGISTRY
In the past 5 years the ISOT has repeatedly deliberated regarding the need to establish a national transplant registry. Over the past 2 to 3 years the transplant registry has been taking shape with the consensus and cooperation of its members. During the 15th annual meeting of the ISOT, this initiative was given to the author with an ad hoc grant of From the Department of Urology and Renal Transplantation, Sri Ramachandra Medical College and Research Institute, Chennai, India. Address reprint requests to Dr Sunil Shroff, Head, Department of Urology and Renal Transplantation, Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600 116, India. E-mail: [email protected] 0041-1345/07/$–see front matter doi:10.1016/j.transproceed.2007.01.051 711
712
25,000 Rs. Since then, further sums have been granted for the registry on an ad hoc basis. On grant of the fund a domain name—www.transplantindia. com—was registered for 3 years and we hired a part-time programmer. A flow chart for navigation of the registry was developed by the author over the first few months. Within 3 months we developed a prototype registry with dummy data. It was shown to the members at a national conference held in Jaipur last year; at that time the registry was formally inaugurated by Dr R.S.V. Yadav, president of the body. Currently the registry has a part-time computer programmer who also is working as Web master for the registry operating from Chennai. OBJECTIVES OF THE NATIONAL TRANSPLANT REGISTRY
The purpose of the National Transplant Registry is to collect transplant-related data from various hospitals in the country. The collected data should at any time be able to derive the following information: (1) the total number of transplantations performed for any organ in the country; (2) the total number of transplantations performed in a year; (3) essential demographic data of Indian patients undergoing transplantations; (4) the immunosuppressive regimens used by various centers; (5) short- and long-term results of the allografts; (6) complications during management in the short-term and the long term; (7) graft and patient survivals after transplantations; (8) the HLA profiles of Indian patients; (9) the number of living and cadaveric donor transplants; (10) the relationship in cases of related transplants; and (11) the profiles of donors. The collected data are being stored on a secure server accessible by any registered full member of the ISOT. The information submitted by any institution is treated as confidential. A member institution on keying in the password has access to their data with the facility to edit, update, and upload their own data. They are allowed to view the national or regional data, but do not have access to another institution’s data. Development of the registry is taking place in phases. In the first phase, we are capturing “fast track” retrospective limited data related to kidney and liver transplantations. In the second phase, we plan to capture data on heart and other organ transplantations along with almost 20 additional kidney and liver fields for each patient. The follow-up data on each patient would require a unique file allotment for the patient; the program is likely to be much more complex. In the third phase, data queries will become operational and an audit can be performed on the provided information. RESULTS OF THE FIRST PHASE OF DATA CAPTURE Awareness of the Registry
Awareness of the registry has been created by including it in the agenda of the general body meetings of the ISOT and making presentations at the last 2 annual conferences. The
SHROFF
general consensus so far has been very positive from all of the members. The secretary of the Society, Dr Ajit Huligol, has sent letters to the members to cooperate by submitting their transplant data. Kidney Transplantations
Over 10 hospitals have submitted their retrospective data to the registry in the last 6 months. The first phase—fast track data— comprises retrospective data of the number of transplantations performed with only limited fields. Liver Transplantations
Three of the 4 institutions that are regularly performing liver transplantations have submitted their data. Since this program is young, it would be easier to keep the data accurate and complete. Cardiac Transplantations
Cardiac transplant data are currently not available, but efforts are being undertaken to obtain them. DISCUSSION
The Web-based, secure password-driven transplant registry has many advantages. It makes registry usage friendly, instantly available with the onus of keying in accurate data falling on the institution with minimal errors. The registry once fully operational would help to perform an ongoing audit on regional or national transplant data. An evidence-based audit can help with recommendations from members on standardized protocols. Members would be able to use the data in their own research publications without having to resort to guesswork. The registry would provide a reference document to the country’s health administrators and planners to earmark the required budget for this program. At present from the available fast track data, it is possible to know the yearly number of transplantations performed in the previous years, the type of transplants (living or cadaveric), and the sex ratio of the transplants. The Internet penetration in India over the past 3 years has been considerable with good connectivity available in most major cities and towns. Most major hospitals have access to computers and some have access to the Internet. The cost of connectivity has come down in the last 2 years, showing further downward trends. Being online 24/7 is no longer a distant dream in India. To make this endeavor successful, the current registry has a design-friendly program that follows a simple navigation system. Keeping security issues in mind, the program has a time-out option, which means an idle screen logs out after a certain period of time. If incorrect logins or passwords are keyed in more than 3 times, the system locks not allowing the user to proceed. A hospital performing transplantations in India can register on the Web site with their essential information, and request a login name and password. An e-mail will then be sent to the secretary of the Society. The instruction can be issued as a password within 24 to 48 hours.
INDIAN TRANSPLANT REGISTRY
The scope of the current registry is to first collate the national data of all transplant programs and then encourage members to start using it to prospectively enter their data. As the program is database-driven, more fields can be added in the future. It is also planned to create a similar desktop version ensuring that the data can be uploaded into a central server whenever the user logs onto the Internet. This synchronization ensures that the user does not have to make any effort to load their data into the central server. The added advantage is that the institution gets a free desktop program to keep their transplant information updated and to derive their own data therefrom. The registry can only be useful if members of the Society take interest in the endeavor. Initially incentives and regional grants can be made available to some institutions to help them identify a part-time co-coordinator to update the data. Institutions that do not have access to a computer and the Internet can be given special grants. Regional sessions or seminars for training co-coordinators would help to ensure that the program is used effectively. Institutions that keep their information updated can be rewarded to encourage other institutions to do so.
713
Sponsorship for the development of the registry has to constantly be encouraged by ISOT members. So far the financial investment in the development of the registry has been granting funds on an ad hoc basis. The registry now requires a full-time Web master who can play the dual role of managing the registry and training member institutions. This means an ongoing monthly financial commitment by the ISOT. It also requires financial support to keep it on a secure server, support yearly hosting and maintenance charges, as well as domain name re-registration charges. Currently there are no registries on a national level in the medical field in India except for a few state registries for cancer records in Kerala and some national drug trial data in the format of registries that are run by a few drug companies. In the field of transplantation, no national registries are available in the developing world; this is perhaps the first such effort. Even in Asia only a few countries like Singapore, Malaysia, Japan, Hong Kong, and Taiwan have transplant and donor registries. If successful in its goal, this registry should set an example to other medical societies to have registries for various conditions in India.
I
NDIA IS A sovereign democratic republic with a union of states. It is a developing country with a per capita income of $460/year. Only 2.2% of the population earns more than $1000/year and 29% fall below the poverty line, earning less than $100/year. India’s democracy is governed by the parliament and by a legislative assembly in each state with both bodies elected by the people every 5 years. Health is under the purview of the state. Any act relevant to health made in the central parliament needs to be ratified by the state assembly with or without any necessary changes to make it a law. Transplantation in India was started in the early 1970s; its activity is restricted mainly to teaching and well-equipped private institutions. With the introduction of cyclosporine in the 1980s the better graft outcomes led transplantation to be accepted as the best treatment modality for end-stage renal disease. The well-qualified clinicians in India, especially in cities like Vellore, Mumbai, and Chennai, made it possible to master the field of kidney transplantation in a short time. Living donation had been the only source of organs for transplantation before 1994 since there was no acceptance of the concept of brain death. In 1994, the Transplantation of Human Organs Act was passed in the Indian parliament. The aim of the legislation was to promote cadaveric organ transplantation by accepting brain death, curbing commerce in transplantation. It is currently estimated that annually doctors in the country perform approximately 3000 kidney and about 100 liver and cardiac transplantations. However, no accurate data are available.
© 2007 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 39, 711–713 (2007)
INDIAN SOCIETY OF ORGAN TRANSPLANTATION
The Indian Society of Organ Transplantation (ISOT), the apex transplant society in India, is promoted by transplant clinicians in all specialties from across the country. It conducts deliberations related to multiorgan transplants at its annual meetings. At present it has members representing specialties such as nephrology, transplant surgery, hepatology, cardiology, urology, vascular surgery, general surgery, cardiothoracic surgery, and basic sciences as related to immunology. It has more than 450 members; its officers are elected at its national meetings. The 20-year-old ISOT was started by stalwarts in the field of transplantation in India. ESTABLISHING THE INDIAN TRANSPLANT REGISTRY
In the past 5 years the ISOT has repeatedly deliberated regarding the need to establish a national transplant registry. Over the past 2 to 3 years the transplant registry has been taking shape with the consensus and cooperation of its members. During the 15th annual meeting of the ISOT, this initiative was given to the author with an ad hoc grant of From the Department of Urology and Renal Transplantation, Sri Ramachandra Medical College and Research Institute, Chennai, India. Address reprint requests to Dr Sunil Shroff, Head, Department of Urology and Renal Transplantation, Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600 116, India. E-mail: [email protected] 0041-1345/07/$–see front matter doi:10.1016/j.transproceed.2007.01.051 711
712
25,000 Rs. Since then, further sums have been granted for the registry on an ad hoc basis. On grant of the fund a domain name—www.transplantindia. com—was registered for 3 years and we hired a part-time programmer. A flow chart for navigation of the registry was developed by the author over the first few months. Within 3 months we developed a prototype registry with dummy data. It was shown to the members at a national conference held in Jaipur last year; at that time the registry was formally inaugurated by Dr R.S.V. Yadav, president of the body. Currently the registry has a part-time computer programmer who also is working as Web master for the registry operating from Chennai. OBJECTIVES OF THE NATIONAL TRANSPLANT REGISTRY
The purpose of the National Transplant Registry is to collect transplant-related data from various hospitals in the country. The collected data should at any time be able to derive the following information: (1) the total number of transplantations performed for any organ in the country; (2) the total number of transplantations performed in a year; (3) essential demographic data of Indian patients undergoing transplantations; (4) the immunosuppressive regimens used by various centers; (5) short- and long-term results of the allografts; (6) complications during management in the short-term and the long term; (7) graft and patient survivals after transplantations; (8) the HLA profiles of Indian patients; (9) the number of living and cadaveric donor transplants; (10) the relationship in cases of related transplants; and (11) the profiles of donors. The collected data are being stored on a secure server accessible by any registered full member of the ISOT. The information submitted by any institution is treated as confidential. A member institution on keying in the password has access to their data with the facility to edit, update, and upload their own data. They are allowed to view the national or regional data, but do not have access to another institution’s data. Development of the registry is taking place in phases. In the first phase, we are capturing “fast track” retrospective limited data related to kidney and liver transplantations. In the second phase, we plan to capture data on heart and other organ transplantations along with almost 20 additional kidney and liver fields for each patient. The follow-up data on each patient would require a unique file allotment for the patient; the program is likely to be much more complex. In the third phase, data queries will become operational and an audit can be performed on the provided information. RESULTS OF THE FIRST PHASE OF DATA CAPTURE Awareness of the Registry
Awareness of the registry has been created by including it in the agenda of the general body meetings of the ISOT and making presentations at the last 2 annual conferences. The
SHROFF
general consensus so far has been very positive from all of the members. The secretary of the Society, Dr Ajit Huligol, has sent letters to the members to cooperate by submitting their transplant data. Kidney Transplantations
Over 10 hospitals have submitted their retrospective data to the registry in the last 6 months. The first phase—fast track data— comprises retrospective data of the number of transplantations performed with only limited fields. Liver Transplantations
Three of the 4 institutions that are regularly performing liver transplantations have submitted their data. Since this program is young, it would be easier to keep the data accurate and complete. Cardiac Transplantations
Cardiac transplant data are currently not available, but efforts are being undertaken to obtain them. DISCUSSION
The Web-based, secure password-driven transplant registry has many advantages. It makes registry usage friendly, instantly available with the onus of keying in accurate data falling on the institution with minimal errors. The registry once fully operational would help to perform an ongoing audit on regional or national transplant data. An evidence-based audit can help with recommendations from members on standardized protocols. Members would be able to use the data in their own research publications without having to resort to guesswork. The registry would provide a reference document to the country’s health administrators and planners to earmark the required budget for this program. At present from the available fast track data, it is possible to know the yearly number of transplantations performed in the previous years, the type of transplants (living or cadaveric), and the sex ratio of the transplants. The Internet penetration in India over the past 3 years has been considerable with good connectivity available in most major cities and towns. Most major hospitals have access to computers and some have access to the Internet. The cost of connectivity has come down in the last 2 years, showing further downward trends. Being online 24/7 is no longer a distant dream in India. To make this endeavor successful, the current registry has a design-friendly program that follows a simple navigation system. Keeping security issues in mind, the program has a time-out option, which means an idle screen logs out after a certain period of time. If incorrect logins or passwords are keyed in more than 3 times, the system locks not allowing the user to proceed. A hospital performing transplantations in India can register on the Web site with their essential information, and request a login name and password. An e-mail will then be sent to the secretary of the Society. The instruction can be issued as a password within 24 to 48 hours.
INDIAN TRANSPLANT REGISTRY
The scope of the current registry is to first collate the national data of all transplant programs and then encourage members to start using it to prospectively enter their data. As the program is database-driven, more fields can be added in the future. It is also planned to create a similar desktop version ensuring that the data can be uploaded into a central server whenever the user logs onto the Internet. This synchronization ensures that the user does not have to make any effort to load their data into the central server. The added advantage is that the institution gets a free desktop program to keep their transplant information updated and to derive their own data therefrom. The registry can only be useful if members of the Society take interest in the endeavor. Initially incentives and regional grants can be made available to some institutions to help them identify a part-time co-coordinator to update the data. Institutions that do not have access to a computer and the Internet can be given special grants. Regional sessions or seminars for training co-coordinators would help to ensure that the program is used effectively. Institutions that keep their information updated can be rewarded to encourage other institutions to do so.
713
Sponsorship for the development of the registry has to constantly be encouraged by ISOT members. So far the financial investment in the development of the registry has been granting funds on an ad hoc basis. The registry now requires a full-time Web master who can play the dual role of managing the registry and training member institutions. This means an ongoing monthly financial commitment by the ISOT. It also requires financial support to keep it on a secure server, support yearly hosting and maintenance charges, as well as domain name re-registration charges. Currently there are no registries on a national level in the medical field in India except for a few state registries for cancer records in Kerala and some national drug trial data in the format of registries that are run by a few drug companies. In the field of transplantation, no national registries are available in the developing world; this is perhaps the first such effort. Even in Asia only a few countries like Singapore, Malaysia, Japan, Hong Kong, and Taiwan have transplant and donor registries. If successful in its goal, this registry should set an example to other medical societies to have registries for various conditions in India.