How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

How donor selection criteria can be evaluated with limited scientific evidence : lessons learned from the TRANSPOSE project. / Mikkelsen, Christina; Mori, Gaia; van Walraven, Suzanna M.; Castren, Johanna; Zahra, Sharon; MacLennan, Sheila; Seidel, Kirsten; Fontana, Stefano; Veropalumbo, Eva; Cannata, Livia; Pupella, Simonetta; Kvist, Maria; Happel, Marjan; Korkalainen, Piia; Chandrasekar, Akila; Paulus, Ulrike; Bokhorst, Arlinke; Wulff, Birgit; Fernandez-Sojo, Jesus; Eguizabal, Cristina; Urbano, Fernando; Vesga, Miguel Angel; van Kraaij, Marian; Merz, Eva-Maria; van den Hurk, Katja; Hansen, Morten Bagge; Slot, Ed; Ullum, Henrik.

In: Vox Sanguinis, Vol. 116, No. 3, 2021, p. 342-350.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Mikkelsen, C, Mori, G, van Walraven, SM, Castren, J, Zahra, S, MacLennan, S, Seidel, K, Fontana, S, Veropalumbo, E, Cannata, L, Pupella, S, Kvist, M, Happel, M, Korkalainen, P, Chandrasekar, A, Paulus, U, Bokhorst, A, Wulff, B, Fernandez-Sojo, J, Eguizabal, C, Urbano, F, Vesga, MA, van Kraaij, M, Merz, E-M, van den Hurk, K, Hansen, MB, Slot, E & Ullum, H 2021, 'How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project', Vox Sanguinis, vol. 116, no. 3, pp. 342-350. https://doi.org/10.1111/vox.13028

APA

Mikkelsen, C., Mori, G., van Walraven, S. M., Castren, J., Zahra, S., MacLennan, S., Seidel, K., Fontana, S., Veropalumbo, E., Cannata, L., Pupella, S., Kvist, M., Happel, M., Korkalainen, P., Chandrasekar, A., Paulus, U., Bokhorst, A., Wulff, B., Fernandez-Sojo, J., ... Ullum, H. (2021). How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project. Vox Sanguinis, 116(3), 342-350. https://doi.org/10.1111/vox.13028

Vancouver

Mikkelsen C, Mori G, van Walraven SM, Castren J, Zahra S, MacLennan S et al. How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project. Vox Sanguinis. 2021;116(3):342-350. https://doi.org/10.1111/vox.13028

Author

Mikkelsen, Christina ; Mori, Gaia ; van Walraven, Suzanna M. ; Castren, Johanna ; Zahra, Sharon ; MacLennan, Sheila ; Seidel, Kirsten ; Fontana, Stefano ; Veropalumbo, Eva ; Cannata, Livia ; Pupella, Simonetta ; Kvist, Maria ; Happel, Marjan ; Korkalainen, Piia ; Chandrasekar, Akila ; Paulus, Ulrike ; Bokhorst, Arlinke ; Wulff, Birgit ; Fernandez-Sojo, Jesus ; Eguizabal, Cristina ; Urbano, Fernando ; Vesga, Miguel Angel ; van Kraaij, Marian ; Merz, Eva-Maria ; van den Hurk, Katja ; Hansen, Morten Bagge ; Slot, Ed ; Ullum, Henrik. / How donor selection criteria can be evaluated with limited scientific evidence : lessons learned from the TRANSPOSE project. In: Vox Sanguinis. 2021 ; Vol. 116, No. 3. pp. 342-350.

Bibtex

@article{8c16acd718554732839820bfa54b756c,
title = "How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project",
abstract = "Background and objective Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle.Materials and methods From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence.Results The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process.Conclusions While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.",
keywords = "blood safety, donor health, donors, haemovigilance, donor vigilance, donor safety, donor selection, BLOOD-DONORS, CONSENSUS STATEMENT, HEPATITIS-B, TRANSFUSION, VIRUS, RISK, PLASMAPHERESIS, AUTOANTIBODIES, TRANSMISSION, INDIVIDUALS",
author = "Christina Mikkelsen and Gaia Mori and {van Walraven}, {Suzanna M.} and Johanna Castren and Sharon Zahra and Sheila MacLennan and Kirsten Seidel and Stefano Fontana and Eva Veropalumbo and Livia Cannata and Simonetta Pupella and Maria Kvist and Marjan Happel and Piia Korkalainen and Akila Chandrasekar and Ulrike Paulus and Arlinke Bokhorst and Birgit Wulff and Jesus Fernandez-Sojo and Cristina Eguizabal and Fernando Urbano and Vesga, {Miguel Angel} and {van Kraaij}, Marian and Eva-Maria Merz and {van den Hurk}, Katja and Hansen, {Morten Bagge} and Ed Slot and Henrik Ullum",
year = "2021",
doi = "10.1111/vox.13028",
language = "English",
volume = "116",
pages = "342--350",
journal = "Vox Sanguinis",
issn = "0042-9007",
publisher = "Wiley-Blackwell",
number = "3",

}

RIS

TY - JOUR

T1 - How donor selection criteria can be evaluated with limited scientific evidence

T2 - lessons learned from the TRANSPOSE project

AU - Mikkelsen, Christina

AU - Mori, Gaia

AU - van Walraven, Suzanna M.

AU - Castren, Johanna

AU - Zahra, Sharon

AU - MacLennan, Sheila

AU - Seidel, Kirsten

AU - Fontana, Stefano

AU - Veropalumbo, Eva

AU - Cannata, Livia

AU - Pupella, Simonetta

AU - Kvist, Maria

AU - Happel, Marjan

AU - Korkalainen, Piia

AU - Chandrasekar, Akila

AU - Paulus, Ulrike

AU - Bokhorst, Arlinke

AU - Wulff, Birgit

AU - Fernandez-Sojo, Jesus

AU - Eguizabal, Cristina

AU - Urbano, Fernando

AU - Vesga, Miguel Angel

AU - van Kraaij, Marian

AU - Merz, Eva-Maria

AU - van den Hurk, Katja

AU - Hansen, Morten Bagge

AU - Slot, Ed

AU - Ullum, Henrik

PY - 2021

Y1 - 2021

N2 - Background and objective Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle.Materials and methods From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence.Results The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process.Conclusions While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

AB - Background and objective Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle.Materials and methods From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence.Results The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process.Conclusions While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

KW - blood safety

KW - donor health

KW - donors

KW - haemovigilance

KW - donor vigilance

KW - donor safety

KW - donor selection

KW - BLOOD-DONORS

KW - CONSENSUS STATEMENT

KW - HEPATITIS-B

KW - TRANSFUSION

KW - VIRUS

KW - RISK

KW - PLASMAPHERESIS

KW - AUTOANTIBODIES

KW - TRANSMISSION

KW - INDIVIDUALS

U2 - 10.1111/vox.13028

DO - 10.1111/vox.13028

M3 - Journal article

C2 - 33191514

VL - 116

SP - 342

EP - 350

JO - Vox Sanguinis

JF - Vox Sanguinis

SN - 0042-9007

IS - 3

ER -

ID: 252412083