LAS VEGAS - rules for data sharing and publications

SECONDARY ANALYSES OF THE LAS VEGAS STUDY

The LAS VEGAS consortium, together with the Clinical Trial Network (CTN) of the European Society of Anaesthesiology (ESA), welcomes proposals for secondary analyses using the LAS VEGAS study data at international, national and regional levels.

Request for subset/local data should be done through an application form to the LAS VEGAS Steering Committee. The LAS VEGAS Steering Committee then approves the request or not. The study procedure should not go through the CTN of the ESA. The LAS VEGAS Steering Committee has the final word on this, and will keep the CTN of the ESA Secretariat staff informed on the agreed study procedure. The study procedure should not be in contradiction with the ESA CTN SOPs (see attached of the SOP-CTN-001 and p 4/7 ESA CTN Studies Data Property section and ESA CTN Authorship Rules).

Summary aggregate data from the LAS VEGAS study will be made available for secondary analyses, but publication of secondary analyses have to await publication of the primary paper written on the LAS VEGAS study.

The COMPLETE DATASET is initially only provided, on request, to members of the Steering Committee of the LAS VEGAS study. After a period of 36 months from the publication of the primary paper written on the LAS VEGAS study, the COMPLETE DATASET is also provided, on request, to researchers beyond the Steering Committee of the LAS VEGAS study. NATIONAL DATASETS are provided, on request, to the National Coordinators; LOCAL DATASETS are provided, on request, to the Local Investigators.

Secondary analyses of subsequent publications using the COMPLETE DATASET

Any request regarding the COMPLETE DATASET is to be sent to the Study Coordinator (Sabrine Hemmes) or the Principal Investigator (Marcus Schultz) of the LAS VEGAS study. Each secondary analysis using the COMPLETE DATASET needs formal approval by the CTN of the ESA; decisions by the CTN of the ESA are made after consulting the Steering Committee of the LAS VEGAS study. Approved proposals are placed on the website of the ESA.

Results of secondary analyses using the COMPLETE DATASET are submitted for publication under the combined responsibility of the Steering Committee–member who performed the secondary analysis, and the Writing Committee of the primary paper of LAS VEGAS. Secondary analyses can be subject of re–analysis by the Writing Committee of the primary paper on the LAS VEGAS study before submission for publication can take place.

The Steering Committee–member who performs a secondary analysis using the COMPLETE DATASET decides who serves as co–authors, but should invite at least the Writing Committee of the primary paper written on the LAS VEGAS study or should submit the manuscript for publication under ‘PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology’, with a list of collaborators.

Secondary analyses of subsequent publications using NATIONAL or LOCAL DATASETS

Any request regarding NATIONAL or LOCAL DATASETs is to be sent to a National Coordinator or a Local Investigator of the LAS VEGAS study. Each secondary analysis using a NATIONAL DATASET needs formal approval by the CTN of the ESA; decisions by the CTN of the ESA are made after consulting the Steering Committee of the LAS VEGAS study. Approved proposals are placed on the website of the ESA. Secondary analyses using a NATIONAL DATASET do not need formal approval by the CTN of the ESA.

Results of secondary analyses using a NATIONAL DATASET are submitted for publication under the combined responsibility of the National Coordinator, and the Writing Committee of the primary paper of the LAS VEGAS study. The National Coordinator who performs a secondary analysis using a NATIONAL DATASET decides who serves as co–authors, but should consider to invite the Writing Committee of the primary paper written on the LAS VEGAS study, but should always add ‘for the PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology’ to the list of authors, with a list of collaborators.

Results of secondary analyses using a LOCAL DATASET are submitted for publication under the combined responsibility of the Local Investigator and the National Coordinator. The Local Investigator who performs a secondary analysis using a LOCAL DATASET decides who serves as co–authors, and should consider to add ‘for the PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology’ to the list of authors, if possible with a list of collaborators.