Richardson, Jonathan L. http://orcid.org/0000-0003-3494-9559
Moore, Alan http://orcid.org/0000-0002-6049-2540
Bromley, Rebecca L. http://orcid.org/0000-0003-4008-0917
Stellfeld, Michael
Geissbühler, Yvonne http://orcid.org/0000-0001-8528-6818
Bluett-Duncan, Matthew http://orcid.org/0000-0002-7539-6746
Winterfeld, Ursula http://orcid.org/0000-0002-9926-7164
Favre, Guillaume http://orcid.org/0000-0001-6181-3126
Alexe, Amalia http://orcid.org/0000-0003-3016-8579
Oliver, Alison M. http://orcid.org/0000-0002-4564-9984
van Rijt-Weetink, Yrea R. J. http://orcid.org/0000-0002-5997-3718
Hodson, Kenneth K. http://orcid.org/0000-0003-3091-6952
Rezaallah, Bita http://orcid.org/0000-0001-6351-8235
van Puijenbroek, Eugene P. http://orcid.org/0000-0002-2236-1398
Lewis, David J. http://orcid.org/0000-0001-9576-3489
Yates, Laura M. http://orcid.org/0000-0002-7963-625X
Funding for this research was provided by:
Innovative Medicines Initiative (821520)
Article History
Accepted: 6 March 2023
First Online: 28 March 2023
Declarations
:
: The ConcePTION project is jointly funded by the Innovative Medicines Initiative (call 13, topic 9, grant agreement number 821520) and through benefit in kind contributions from European Federation of Pharmaceutical Industries (EFPIA) companies. The contribution of EFPIA partners to this manuscript has involved the provision of personnel time and expertise only. No academic/clinical partners have received financial incentives from EFPIA partners during the performance of this task. All of the recommendations provided required consensual agreement.
: JLR, EvP, YRJvRW, MBD, AMO, UW, GF, and KKH declare no conflicts of interest, no other financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years, and no previous or ongoing relationships or activities that could appear to have influenced the submitted work. RLB’s institution has received a consultancy fee from UCB pharma for her work on a Women’s Health Advisory Board. AM was a Novartis associate whist working on this manuscript and other aspects of the ConcePTION project, and holds shares in Novartis Pharma AG. AA and BR are Novartis associates and hold shares in Novartis Pharma and Incyte. YG is an employee of Novartis Pharma AG. MS is an employee of Novo Nordisk A/S. LMY provided consultancy for Sanofi Genzyme South Africa on two occasions in 2021 relating to genetic testing in Gaucher’s disease (April 2021) and a conference lecture on genetic testing in cardiac clinics (September 2021). DJL is a full-time employee of Novartis Pharma GmbH and owns shares in Alcon, Novartis, and GlaxoSmithKline, and stock options in Novartis. DJL is Honorary Senior Lecturer (Clinical), School of Life and Medical Sciences, University of Hertfordshire.
: Not applicable.
: Not applicable.
: Not applicable.
: The CDE recommendations are provided in 14 tables of related data elements. The first peer reviewed version of these tables is provided in the supplementary appendix. Live versions of the recommendations are also published in full on the ENTIS website (ExternalRef removed). These recommendations will be updated when required to ensure the data elements and their definitions remain aligned with current PregPV research practices and needs. Copies of the latest CDE recommendations are available from the authors on written request, or via contact through the ENTIS website (ExternalRef removed).
: Not applicable.
: LMY, DJL, JLR, AM, and RLB identified the need for these recommendations, designed the format of the framework, and led the preliminary development of the recommendations. JLR, AM, RLB, MS, YG, MBD, UW, and LMY undertook the scoping review and identified the CDEs to be included in the framework and developed the initial definitions and data recommendations for these elements. All authors provided multiple rounds of feedback in the development of the framework. JLR and AM developed the first draft of the manuscript. All authors provided multiple rounds of feedback to finalise the manuscript. All of the authors have contributed equally to the preparation of this manuscript. All authors read and approved the final version.