After some of your suggestions, we have updated authorship policies in PROMISE:
Authors in the main paper: centers providing 40 patients without missing data and at least 20% moderate-to-severe: 1 author, centers providing 80 patients without missing data and at least 20% moderate-to-severe: 2 authors. The other authors will be listed as collaborators (2 per center, the PROMISE study group). The final journal may restrict the number of authors, in that case authors will be chosen according to the number of patients included, up to the maximum number of authors allowed by the journal
Authors in collateral studies: you can always use data from your own centers for your studies not involving the PROMISE scale, and you will decide the authors. Collaborators contributing with 40 patients or more will have the possibility of collateral studies with the centers from a particular region/country, you will have 4 authors from your centers, 2 authors from the other center of that region/country and 1 from the designers of PROMISE. Authors contributing with 60 patients or more will have the possibility of collateral studies with the whole database. Authorship: the collaborating center will have 6 co-authors for their collateral study (including first and last author), 1 from the designers of PROMISE and up to 6 authors from top-collaborating centers. A scientific committee will review the proposal, and if OK we will share the database with the center. Timing is important: centers who claim first to perform a specific study after reaching the above mentioned threshold, will be on charge of that study. We will allow 1 collateral study per center. There will be a 6-month deadline for the draft of the paper after receiving the database.
Three hospitals from Spain have started to recruit patients in PROMISE, the validation of a patient reported outcome scale in acute pancreatitis, and several centers in other countries are almost ready to start. The PROMISE scale has been translated to many languages: Bulgarian, Chinese, English, Greek, Hungarian, Italian, Polish, Portuguese, Romanian, Russian, Turkish, Ukrainian and Urdu! 106 researchers from 88 centers, 31 countries involving 22 languages have joined this project.
PROMISE is a simple 7-question scale that has been derived from the opinion of patients who suffered an episode of acute pancreatitis. It is being validated in 4 types of variables: EORTC-30 QoL scale, severity according to the revised Atlanta classification, mortality and several markers of morbidity (hospital stay, time to oral re-feeding, need for ICU/invasive treatment, etc). The final aim is to have a tool to make clinical trials testing new treatments for this frequent disease.
We are utterly excited with this challenging collaborative effort!
Our colleagues from all around the world are helping us to translate the PROMISE scale, a patient-reported outcome scale in acute pancreatitis, to the languages of the participating centers. We have a definitive or provisional version of the PROMISE scale in Spanish, English, Italian, Ukranian, Turkish, Russian, Romanian, Greek, Bulgarian and Hungarian. Urdu and Korean are on the way! We use the technique of “back translation” to ensure that the new versions are accurate.
Up to now, 74 centers from 29 countries involving 20 different languages have joined PROMISE, the validation of a patient reported outcome scale in acute pancreatitis. We are very proud of the success of this investigator-initiated study with no support from the pharmaceutical industry. We have entered our first 4 patients in Alicante, Spain (coordinating center). The PROMISE scale can be done in 2 minutes, and the EORTC-30 QoL scale in 4 minutes, so the study is simple and feasible. We have used our calendar app in our cell phones to set alarms for calling our patients in the scheduled time points for the PROMISE scale and EORTC-30 QoL scale, making it easy. We have designed a tutorial involving all the practical aspects of the study (how to get a REDCap AEG account, how to enter data, tips and tricks, FAQ…)
All this work is centered on the patient views; we defend that medical care should be centered on the patient. We hope we will be able to validate this scale, which is aimed to test new treatments for acute pancreatitis.