Authorship and Publication policy for European Renal cancer Ablation Registry (EuRECA)
1. Introduction:
The European Renal Cryoablation Ablation Registry (EuRECA) is a joint endeavour between Urological Surgeons and Interventional Radiologists to record and reflect on the group practice of tumour ablation in the management of smaller renal tumours. It was initiated in 2011 and has been developed in the first instance with website and database designers from the Universityof Aarhus, Denmark with an educational grant from Galil Medical Systems (Arden Hills, Minnesota).
As such it is planned to set out as on-line registry of both image-guided/percutaneous and laparoscopic-guided Cryoablation. It is however the intention of the Steering Committee to include other ablative techniques in due course.
Reflecting the balance of practice in this field the Steering Committee has sought and received the support of European-level professional bodies from both interventional radiology and urological surgery, namely the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) and the European Association of Urology (EAU).
The aim is to create a prospective, on-line registry and data resource regarding renal tumour ablation and setting out to record patient and tumour demographics, procedural details, complications and outcome, including longer term follow-up. This document does not seek to detail the content or workings of the database but does aim to provide guidance as to data handling, the publication of material from the database and authorship in this respect.
2. Data Ownership:
2.1 The prospective data ownership and responsibility will lie with the steering committee of the EuRECA. There is a Memorandum of Understanding (attached) with Galil Medical Systems (in the first instance) clarifying that the data falls under the Governance of the Steering Committee. No commercial benefactor will have any influence over the data, its handling or right to publication.
2.2 Whilst the database is notionally supported by the EAU andCIRSE neither party has any overwhelming right to influence data handling, publication or authorship. This right is held solely by the Steering Committee.
2.3 In the event of any dispute about data ownership or handing there is a voting mechanism within the Steering Committee of EuRECA. The Steering Committee is composed of 5 persons – 2 urological representatives and 2 interventional radiologist with the Chairman (a Urological Surgeon at the time of writing) holding the casting vote.
2.4 All contributing centres retain the right to publish utilizing their own datasets, submitted or otherwise.
3. Publication:
3.1 Any member of the steering committee or interested clinician (from IR or urology) may submit a request to analyse the prospective, accrued data for a clinical question. In this respect the request must come from clinician and/or clinical groups who have contributed substantively to the EuRECA project, not least in terms of submitted complete datasets. The suitability of the clinical enquiry and the proposed authors will be sanctioned by the Steering Committee.
3.2 Requests to investigate the dataset must usually come from substantial institutions or clinical groups with a published track record in this clinical area acknowledged by the Steering Committee. If the proposal is deemed poorly organised, or of limited scientific worth, or has too much overlap with previous or ongoing analyses, the Steering Committee retains the right to refuse use of the registry data.
3.3 It is to be expected that plans for data utilisation or publication is reasonably balanced between the clinical groups of interventional radiology (IR) and urological surgery (US), reflecting appropriately the proportion of quality data input to the registry.
4. Authorship:
4.1 As above the Steering Committee will ensure that there is an equitable balance of IR and urologist-led publications and first/senior authors. This balance will be monitored by the committee and in the event of imbalance this will be highlighted to the relevant professional bodies to encourage further participation from the relevant clinical groups.
4.2 Approval of a project, publication and authorship should reflect relative contributions to the database and will be denied in the event of an approach from an individual or institution who has provided only limited or poor quality data input.
4.3 Lead authorship – as is usual practice this should normally be awarded to the investigator who has provided the most practical input into the project.
4.4 Senior (end-name) authorship is usually attributed to the senior clinician who oversaw the project. The senior author will not necessarily have to originate from the same institution as the lead author.
5. Co-authorship:
5.1 This should reflect verifiable substantive input into any individual project. The main author “string” will normally be limited to a maximum of ten authors (or according to relevant journal rules).
5.2 Members if the Steering Committee do not have an automatic right to co-authorship. Again co-authorship should reflect verifiable and substantive practical input in to a project.
5.3 The Steering Committee retains the overall right to question authorship and deny approval for this where substantive involvement cannot be verified.
6.Retrospective and Prospective Data:
6.1 The EuRECA Registry is a prospective on-line data Registry and data-handling will be governed by the above rules.
6.2 To initiate the Registry there is a plan to populate a retrospective database segment, as far as is practicable, by a limited number of expert centres. The utilisation of this data is governed by the same principles and guidance outlined above. Namely, lead and senior authorship should reflect the number and quality of data entry. In the event of disagreement about authorship any contributor retains the right to withdraw their data without prejudice.
7. List of Publications:
Renal Cryoablation: Multidisciplinary, collaborative and perspective approach.
Ismail M, Nielsen TK, Lagerveld B, Garnon J, Breen D, King A, van Strijen M, Keeley FX Jr. Cryobiology. 2018 Aug; 83:90-94.
https://pubmed.ncbi.nlm.nih.gov/29890126/?from_term=renal+cryoablation&from_pos=1
Safety of percutaneous renal cryoablation: an international multicentre experience from the EuRECA retrospective percutaneous database.
Garnon J, Van Strijen MJ, Nielsen TK, King AJ, Montauban Van Swijndregt AD, Cazzato RL, Auloge P, Rousseau C, Dalili D, Keeley FX Jr, Lagerveld BW, Breen DJ. Eur Radiol. 2019 Nov; 29(11):6293-6299.
https://pubmed.ncbi.nlm.nih.gov/30989346/?from_term=safety+of+percutaneous+renal+cryoablation&from_pos=3
Laparoscopic vs Percutaneous Cryotherapy for Renal Tumors: A Systematic Review and Meta-Analysis.
Aboumarzouk OM, Ismail M, Breen DJ, Van Strijen M, Garnon J, Lagerveld B, Nielsen TK, Keeley FX Jr. J Endourol. 2018 Mar; 32(3):177-183.
https://pubmed.ncbi.nlm.nih.gov/29212363/?from_single_result=Laparoscopic+vs+Percutaneous+Cryotherapy+for+Renal+Tumors%3A+A+Systematic+Review+and+Meta-Analysis.+Aboumarzouk+OM%2C+Ismail+M%2C+Breen+DJ%2C+Van+Strijen+M%2C+Garnon+J%2C+Lagerveld+B%2C+Nielsen+TK%2C+Keeley+FX+Jr.+J+Endourol.+2018+Mar%3B+32%283%29%3A177-183.
Repeated Cryoablation as Treatment Modality After Failure of Primary Renal Cryoablation: A European Registry for Renal Cryoablation Multinational Analysis.
Sundelin MO, Lagerveld B, Ismail M, Keeley FX , Jr, Nielsen TK. J Endourol. 2019 Nov; 33(11):909-913.
https://pubmed.ncbi.nlm.nih.gov/31507206/?from_term=repeated+cryoablation+as+treatment+modality&from_pos=1
Oncological outcomes and complication rates after laparoscopic-assisted cryoablation: a European Registry for Renal Cryoablation (EuRECA) multi-institutional study.
Nielsen TK, Lagerveld BW, Keeley F, Lughezzani G, Sriprasad S, Barber NJ, Hansen LU, Buffi NM, Guazzoni G, van der Zee JA, Ismail M, Farrag K, Emara AM, Lund L, Østraat Ø, Borre M. BJU Int. 2017 Mar; 119(3):390-395.
https://pubmed.ncbi.nlm.nih.gov/27488479/?from_single_result=oncological+outcomes+and+complication+rates+after+laparoscopic-assisted+cryoablation
Renal Function Loss After Cryoablation of Small Renal Masses in Solitary Kidneys: European Registry for Renal Cryoablation Multi-Institutional Study.
Sriprasad S, Aldiwani M, Pandian S, Nielsen TK, Ismail M, Barber NJ, Lughezzani G, Larcher A, Lagerveld BW, Keeley FX Jr. J Endourol. 2020 Feb; 34(2):233-239
https://pubmed.ncbi.nlm.nih.gov/31724433/?from_term=renal+function+loss+after+cryoablation&from_pos=1
8. Any further Issues:
If further unanticipated situations or questions should arise these must be openly discussed by a quorate Steering Committee and voted on necessary. Any such discussions will be minuted and recorded.
Dr. D J. Breen.
EuRECA Steering Committee
27th September 2013