Goals & Accomplishments
- LDLTregistry.org: The International Living Donor Liver Transplant (LDLT) Registry was developed to formally assess the outcomes after living liver donation as well as identify modifiable factors of outcomes.
- The goal of LDLTregistry.org is to improve the practice of LDLT by sharing of research and innovation.
- LDLTregistry.org is a powerful tool to observe: The course of disease, understand variations in treatment and outcomes, examine factors that influence prognosis, describe care patterns, assess effectiveness, monitor safety and harm, measure quality of care, and assess costs.
- LDLT outcome data are available from most developed countries, however, outcomes in developing countries remain unknown. There is a need to collect data from all parts of the world, to provide a single unified reference registry and allow meaningful comparisons as well as standardization of the procedure across the globe.
- Outcomes: Morbidity and mortality for both the donor and recipient until hospital discharge and up to 90 days postoperatively.
- LDLTregistry.org is open for participation to any surgeon, anesthesiologist, hepatologist, critical care physician and their team (maximum 3 members per team) performing LDLT worldwide.
- Auditors (data monitors) will be assigned to monitor the adherence to the registry protocol as well as auditing the quality of data collection of the different participating centers.
- All members will have unlimited access to their own submitted data as well as access to the whole dataset for publication upon a formal request from the LDLTregistry.org Committees.
- There will be group authorship for all LDLTregistry.org members in all publications derived from this project.
Terminology, Definitions & Responsibilities
- Chief and Co-Chief Investigators: Responsible for developing and overseeing all research activities to maximize efficient use of resources including people, time, and money. They may allocate members of the Scientific, Management and Administration Committee to participate in the different aspects of this project.
- Scientific Committee: This Committee is comprised of, among others, a diverse group of leaders in the field of LDLT. They will oversee the scientific part of the projects and give strategic direction, supporting the members of the Management and Administration Committee. They will decide about data sharing requests and will consider all such requests based on the quality and validity of the proposed project.
- Scientific Advisory Board: This Committee is comprised of world renown leaders and scientists with experience in public health and policy making. They will advise the Chief Investigators and Scientific Committee with strategic influence.
- Management Committee: This is a highly selected group of young, enthusiastic, and motivated clinicians and scientists involved in LDLT. They will lead and manage the work of the Administration Committee.
- Administration Committee: This is an additional group of hard working and efficient individuals that are assigned to either support some of the Management Committee members including safeguarding and applying regulations, arranging regular committee meetings, taking minutes, recording decisions and tasks clearly, as well as providing online support to the remaining committee members.
- Writing Committee: This is a group or LDLTregistry.org members allocated by and including the Chief Investigators and Founders who will draft the main manuscripts coauthored by all LDLTregistry.org members in the form of group authorship.
- LDLTregistry.org Member: Any surgeon, anesthesiologist, hepatologist, critical care physician or other member of any grade involved in LDLT is eligible and welcome to contribute with cases in the registry. Each member may form a team of 3 people in total.
- Auditors: Data monitors will be Identified by members at their local institution to monitor the adherence to the registry protocol as well as auditing the quality of data collection of the participating centers. Auditors should be non-surgeon physicians not directly involved in LDLT. Auditors will by formally acknowledged with PubMed cited group authorship in all publications.
- Country Leaders: They will recruit and co-ordinate collaborators in their own country or region. Country leaders may provide additional scientific and administrative support to the local collaborators. Country leaders will also obtain PubMed citable group authorship and accreditation for leadership. Everyone may request to become a country leader when registering their participation with LDLTregistry.org. The Committees of LDLTregistry.org will decide upon their nomination.
- Patient Representatives: A group of living liver donors or recipients that will ensure that the scientific questions of LDLTregistry.org are of importance to the patients and the general public.
- Founders | Research and Development Team: This team is fundamentally responsible for development of LDLTregistry.org as well as its research activities.
- Center eligibility: Any center worldwide involved in LDLT is eligible to participate in this Registry. There are no minimum number of cases to be submitted or selection criteria for centers.
- Patient eligibility: Both donors and recipients will be included in the registry, including adult and pediatric, as well as two stage LDLT, (e.g. Auxilary, RAPID, APOLT, ASPIRE, RAVAS) will be included. Domino and dual grafts will be excluded.
- Each center may form a team of 3 LDLTregistry.org members in total.
- Participants may include surgeons, anesthesiologists, hepatologists, critical care physicians and other members involved in LDLT.
- Auditors (data monitors) will be assigned to monitor the adherence to the registry protocol as well as auditing the quality of data collection of the participating centers. Auditors are not allowed to be directly involved in LDLT. Auditors will form the 4th member of the local team.
- LDLTregistry.org will act as the custodian of the data. All participants will be able to access their own submitted data without the need for permission from the LDLTregistry.org Committees.
- The Chief Investigators, Scientific and Management Committees together will decide about data sharing requests and will consider all such requests based on the quality and validity of the proposed project.
- There will be no surgeon, or center related data reporting, all data will be fully anonymized.
Data protection & security
- All data collected, processed and stored for the purpose of the project will remain confidential and comply with Good Clinical Practice for research (GCP) guidelines and the principles of the Data Protection Act 1998 (UK).
- Data submitted are anonymized prior to submission to the LDLTregistry.org data entry system.
- Access to the data entry system is protected by username and password during the registration process for individual local investigators.
- All electronic data transfer between participating centers and the coordinating centers will be encrypted using SSL/TLS protocol (HTTPS).
- The LDLTregistry.org platform is protected by additional web security software that monitors, identified and fixes threats, prevents attacks, accelerates website performance and meets international compliance standards.
- All LDLTregistry.org members, with submitted verified cases to the registry, will be PubMed cited as group authors in the main publications.
- The main manuscripts derived from LDLTregistry.org will be reported without named authorship, instead the term “LDLTregistry.org Collaborative” will be used. There will be no hierarchical authorship (no first author, no last author to reflect the collaborative effort, in keeping with other global studies.
- All LDLTregistry.org Members and Collaborators will be PubMed cited in the main publication as well as in any future studies. This includes all Committee Members and participants including Country Leaders and Patient Representatives.
- Spin-off studies may include formal authorship but must include the “LDLTregistry.org Collaborative” citing all participants.
- All articles will be published in peer reviewed journals.
- Open access will be encouraged.
- All members have the right to terminate their scientific collaboration with LDLTregistry.org after providing the reason and feedback to the Chief Investigators and Founders of LDLTregistry.org
Non-Performance & Conflict Resolution
- In the event of inadequate performance, the LDLTregistry.org member involved will be notified by email of our concerns. Following this a 30-day review will take place after which the member can be removed from the study and the authorship unless sufficient action has been taken to remedy the situation.
- Should conflict or issues surrounding adequate performance occur then the decision of the Founding Members will be final. No right of appeal or compensation will be offered.
- Should conflict occur between the Founding Members, then a democratic vote will take place as to the best course of action by the remaining members.
- LDLTregistry.org may be supported by Charities, Foundations, Societies, Sponsors, Grants and Crowed Funding.
- None of the funders will have direct or indirect influence on the main registry design, analyses or interpretation of the results.
Research ethics approval
- The LDLTregistry.org members (Local Principal Investigators) in the respective institutions must clarify the need for ethics and other regulatory approvals and ensure these are in place prior to data collection. It is the responsibility of the Local Principal Investigators, not LDLTregistry.org to ensure all regulatory approvals are in place.
- Since this study is effectively a large-scale international clinical audit of anonymized data already recorded in the course of routine patients care, we expect that in most countries no individual patient consent will be required. For countries where individual consent is required, we will provide an informed consent form in English that may be adjusted to local requirements.
- The Management and Administration Committee Members will support all participants with their respective institutional review boards/ethics committee applications.
- LDLTregistry.org has been recognized as an international audit in the UK and does not require any formal ethics approval.