Version: May 28th, 2024

Statutes for the International Pancreatic Pain Consortium

May 20, 2024

1. A Steering Committee (SC) for the consortium will be appointed with representatives from selected countries in the “Pancreatic Pain Consortium” (Pain Consortium). The SC representatives will be balanced with respect to the scientific activity of the centers. The members of the SC will be elected on a yearly basis and revised yearly in a physical meeting (APA/DDW etc.) or a videoconference with participants from all active sites. The SC will organize with a chairman (director), an administrative lead director and members from selected countries.
2. The rules of the Pancreatic P-QST Consortium (now Pancreatic Pain Consortium) have been published for public access (doi: 10.1097/MPA.0000000000001912) and are still valid. They will be maintained by the administrative lead and revised by group decisions in the SC on a yearly basis based on the progress of the consortium.
3. The SC members and participants from all active sites will meet at videoconferences on a monthly basis and in person when possible at suitable scientific meetings (members not physically present will be invited to join online remotely). Face-to-face meetings endeavor at least once yearly.
4. Each site that wishes to participate (estimated to include > 50 patients) selects a “Responsible person” together with a “Backup” person (see the list on last page). The backup shall preferably be a person that is permanently employed at the institution and can be contacted by the SC. Any new sites joining the collaboration shall first inquire with the SC and if accepted, shall send information of the responsible person and back-up to the administrative lead.
5. Each site is individually responsible for its own data management and storage on the REDCap platform provided by the SC. The SC will appoint a person responsible for the coordination of data merging for analysis. All sites are obliged to store data in the same format for ease of merging.
6. Any potential group from the consortium can present a study protocol at the monthly video meetings. The SC will ensure that this is valid and has no overlap with current work. Proposals will be kept by the administrative lead for reference and sent out together with minutes from the video meetings. The studies and their progress will be discussed monthly to ensure progress.
7. Cross-sectional data and authorship: For publication, any site that has enrolled  > 50 patients will include up to two co-authors for the publication. More authors can be added if they participate in the writing process (to be decided by the SC and revised on a yearly basis). The entry only counts if all databoxes are filled in (complete data). The SC members are normally included as co-authors in all publications but can withdraw if appropriate. If a site does not include more than 10 new patients in one year, it is excluded, and the authors from that center will not be co-authors on forthcoming publications on the baseline data. Data are still available for research for the remaining group members. Sites can reactivate after a period of inactivity by enrolling new participants and contributing followup data.
8. Protocolled follow-up data and authorship: Follow-up visits shall be done according to prespecified protocols, and only sites that actively register complete (according to the definition above) follow-up visits will be included in publications that use such information Following the same rules as for the cross-sectional data, the number of authors will depend on the number of valid cases filled in when data extraction for a given study is done. The follow-up visits are only considered valid if they are recorded regularly and consistent with study protocols. Centers that become inactive (i.e., have not included follow-up data for more than one year or do not respond to emails)  are excluded, and the authors will not be included in subsequent studies. Data entries from the site can still be used for manuscripts by the other consortium members.
9. General rules for publications and authors: Members of the consortium are expected to participate in the writing process of a certain manuscript (active writer). However, all members of the consortium will be listed on the author list if they have contributed with the inclusion of patients according to the above criteria. The contribution of “authors that volunteer to participate in the writing” (different from so-called passive authors that only fill in data) shall be substantial and fulfil the Vancouver rules. The order of the authors will be decided by the site that made the proposal. Members of the consortium who have previously delivered data but have become inactive (moved to another hospital etc.) will only be included in the author list in manuscripts that are proposed during their active period.  All author lists will end with the acronym “On behalf of the Pancreatic Pain Consortium”. The group behind a given manuscript shall ask each site about authorship and feedback/edits once, and if not answered, a reminder shall be sent to the responsible person and the backup person. If this email is not answered within 2 weeks, the authors from the site will be excluded from the manuscript, but data entries from the site can still be used. For conference abstracts, the person presenting the work will typically be the first author.
10. General rules for writing manuscripts: When a topic is identified for a manuscript, the lead and last authors are identified. If they accept to write the manuscript, they are committed to drafting it within three months after receiving all data, eventually from a third party (e.g., engineers or statistical support). A near-final version is sent to all co-authors, who have no more than three weeks to respond. Exceptions can be granted at the discretion of the lead author. After the lead author has received all comments, a new version of the manuscript shall be circulated within one month. This will normally be the final version, and all co-authors have two weeks to respond with any comments. After the lead author has received all comments, the manuscript shall be submitted within one month. Any variation from this timeline needs to be addressed by the lead author making request to the Steering Committee. If the lead author is unable to complete the manuscript and a revised timeline is unable to be agreed upon, the senior author of the manuscript can reassign authorship duties as needed.
11. Specific data: Some projects may enroll specific patients (currently SF-COMPAT translations, SCHOKE and PDAC studies) or include very technical data (such as before and after a given treatment and EEG/ECG analysis). In such cases, the rules for the number of authors can be adapted to the specific project after discussion in the SC.
12. Centers will be required to utilize specific equipment at the direction of the SC, to ensure homogeneous data quality between the centers. Training requirements for P-QST, EEG/ECG and other tests will be determined by the SC. At a minimum, each new tester will need to be educated via video training and an in-person instruction session. Data obtained on 10-15 controls will need to be vetted by the SC for consistency with expected values prior to inclusion as a center.
13. Data validation will be performed by a designated team decided upon by the SC.

Steering Committee May 2024

Steering Committee:

Director: Asbjørn M Drewes

Administrative lead: Anna E Phillips

Steering Committee Members: Dhiraj Yadav, Vikesh Singh, Søren S Olesen, Mahya Faghih, Rupjyoti Talukdar & Louise Kuhlmann (REDCap responsible)

Responsible persons at the active sites  

1. Aalborg: Søren Schou Olesen, back-up Louise Kuhlman Frandsen
2. Pittsburgh: Anna E. Phillips, back-up Dhiraj Yadav
3. Baltimore: Mahya Faghih, back-up Vikesh Singh
4. Indiana/Indianapolis: Jeffrey Easler, back-up Suzette Schmidt
5. Dallas: Paul Tarnasky, back-up Elaina Vivian
6. Cincinnati Children’s: Juan Gurria, back-up Maisam Abu el Haija
7. Hyderabad: Misbah Unnisa, back-up Rupjyoti Talukdar
8. All-India Institute: Ankit Agarwal and Soumya Jagannath, backup Pramod Garg
9. Halle: Marko Damm, back-up Jonas Rosendahl
10. Budapest: Zoltan Hajnády, backup Peter Hegyi
11. Heidelberg: Ana Dugic, backup Patrick Michl