An open call for topic proposals was issued to ESOT Sections and Committees in January 2022. Overall, 25 topic proposals were received and sent out to all members of the GT who rated them individually at a first step according to following criteria: 1) rating the proposal from 1 to 10; 2) recommending the topic yes/no; 3) marking the proposed group members 1) good proposition, 2) good but unbalanced, i3) needs to be discussed.

In a joint meeting, the GT reviewed and prioritized all submitted proposals and selected nine that met the following criteria: 1) cutting edge topics for which a consensus would have an impact on healthcare; 2) lack of similar guidelines or recommendations for this topic or an urgent need for an update of a previous version; 3) identification of barriers or data gaps requiring consensus recommendations to progress the field; 4) feasibility in the context of TLJ 3.0 meeting including minimal availability of published evidence; 5) completion of previous activated ESOT consensus processes; 6) collaborative forum of European and international leaders to exchange experience and knowledge.

Figure 1 shows the nine topics selected by the GT and validated by the ESOT Executive Committee for the ESOT consensus conference during the TLJ 3.0 in Prague on November 13th–15th (10).

For each of the selected topics, a specific steering committee (SC) was composed. The SC consists of a chair and co-chair, expert-members in the topic field, the Centre for Evidence in Transplantation (CET) (11), a YPT-representative working with the SC to collect and analyze the available topic-relevant literature, and a GT member to liaise with ESOT.

The GT had the final responsibility to nominate the SC members for each topic, though it did invite the topic proposers to suggest expert members. Depending on the balance of the proposed group representatives (expertise, gender, nationality etc., see below), the GT did either accept or request a modification of the member composition.

Each SC is led by a chair and a co-chair to warrant independency between topic proposers and guideline developers and to avoid bias and imbalances (12); selection of chair and co-chair followed a collaborative decision making process (GT and topic proposers) after exclusion of conflict of interests. The SC comprises of 8–14 members with a range of backgrounds to warrant a multidisciplinary expert discussion. In one case (Biomarker prediction in solid organ transplantation) the wide range of subtopics required a larger SC of 23 experts. When selecting SC members, consideration was given to: 1) representation of different disciplines and expertise; 2) gender balance; 3) broad geographic representation; 4) involvement of all health care professionals, if indicated and possible; 5) involvement of patient and public representatives if indicated; 6) involvement of members of ESOT YPT (young professionals in transplantation); 7) involvement of methodologists when indicated.

Some of the consensus topics are developed jointly with other international organizations. In those cases, representatives suggested by the partner organization were included as members of the SC and involved throughout the entire process.

The composition of the nine SC, including roles, is illustrated in Table 1.

Steering committee members participate on a voluntary basis and are not paid for their contribution. Travel and accommodation costs for meetings are reimbursed according to the relevant ESOT travel and meetings policy.

A number of virtual meetings were held by the SC to define the scope and aims of their topics and to work on their particular consensus process. Further meetings are scheduled in the upcoming months. Key issues were identified and implemented in the process to be worked on. The agreed clinical questions were formulated according to the PICO methodology (PICO = Population, Intervention, Comparator and Outcome) (13). All PICO questions are listed in Supplementary Appendix S1. In some cases (i.e., VBHC endpoints in liver transplantation), the strict PICO format was methodologically not applicable (see below). PICO eliminations will be decided upon full agreement during the open discussion that will precede the conference or in the context of the meeting itself. All these changes will be accurately recorded and reported to assure full transparency of the process.

Following the definition of the PICOs, for each topic, literature searches were developed by expert staff from the CET who have expertise in conducting systematic reviews. The searches were conducted in the Transplant Library, Medline, and Embase with or without a date limit (dates differed for each of the groups) and the exact search date of each search was recorded (and will be reported in each consensus-dedicated publication). Bibliographic searches consisted of a combination of Medical Subject Headings and keywords. Search terms and strategies will be provided in the specific topic related publications. Searches, excluding grey literature (some SC included congress abstracts upon request) and following removal of duplicate references, resulted in unique references which were selected for title/abstract screening. If titles/abstracts appeared relevant to the PICO question, corresponding full texts were acquired and reviewed for possible inclusion and interactive reading, and to support the development of consensus statements. Due to the breadth of topics included, a full systematic review process for article review was not performed at this time. Rather, titles and abstracts were reviewed by CET members.

PRISMA flowcharts describing the number of studies identified by the literature search and number of studies selected for inclusion in the consensus statement will appear in the following topic-specific publications.

A short summary of the evidence addressing each key question by the included studies was prepared in an evidence table. The workgroup proposed a recommendation for each key question, based on the quality of evidence rated using the GRADE approach, with high quality rated as A, medium quality as B, and low quality as C; very low quality of evidence was not considered. In particular, in the evaluation of the quality of evidence according to GRADE the following features were considered: study design, risk of bias, inconsistency, indirectness, imprecision, number of patients, effect, importance (14). Strength of recommendation was rated as 1 (strong) or 2 (weak).

The ESOT GT decided to maximize community involvement and inclusion of different perspectives while maintaining a high level of quality by assigning a panel to assess the documents prior to finalization. To establish these panels, an open call to attract jury members was launched in July 2022 via the ESOT webpage (15). Jury applicants register for the conference and specify their wish to be part of the recommendation voting process and the specific topic of interest. Jury member applicants’ CVs are subsequently evaluated by the GT before acceptance to ensure they have the necessary experience allowing them to fairly assess the recommendations. Furthermore, due to the focus on patient-centered medicine, patients and patients’ representatives are eligible to apply as jury members. Trainees will have the opportunity to follow the work of all included TLJ 3.0 panels as observers according to their particular interests (15). When jury members are appointed by the GT, conflicts of interests must be disclosed.

Jury members will receive the selected evidence as well as a preliminary version of the recommendations before the conference. They will be asked to provide the SC with comments and suggestions for potential changes and refinements before the start of the in-person meeting in Prague. In this way, a constructive discussion can take place during the face-to-face meeting.

Working groups will include SC members and jury members. Working group processes will consist of the following: 1) SC leaders will introduce and present their topic to an extended panel composed of all working group members in addition to conference participants registered to participate in the in-person consensus discussion; 2) a single SC member, will provide an overview of the evidence for each key question and present the proposed recommendations; 3) feedback will be provided by working group members and conference participants with particular attention to the generation of clear and concise consensus statements taking into account the suggestions emerged by the discussion 4) the following day the consensus recommendations will undergo the jury vote. Consensus will be considered achieved will be considered as reached if an agreement rate of >80% is achieved; topic lectures and proposed consensus statements will be presented to the entire TLJ 3.0 audience in a dedicated session on the last day of the in-person meeting in Prague.

Consensus conference participants are selected and distributed amongst the working groups by the GT members. Complete information including the list of consensus conference working group domains, processes regarding consensus conference participant selection, development and refinement of consensus statements, and modified Delphi methodology including consensus polling will be also reported in Transplant International after the face-to-face meeting in Prague.

A validation committee, including experts in validation procedures, will be formed after the jury members have been finalized. Consensus and recommendations will be reviewed by experts in validation according to the AGREE II guidelines: Appraisal of guidelines for research and evaluation II (16, 17). The complete validation and appraisal process will be published in due course after the in-person meeting in Prague.