How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project
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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.; Castrén, 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, 03.2021, p. 342-350.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project
AU - Mikkelsen, Christina
AU - Mori, Gaia
AU - van Walraven, Suzanna M.
AU - Castrén, 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
N1 - Publisher Copyright: © 2020 International Society of Blood Transfusion Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2021/3
Y1 - 2021/3
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 - donor safety
KW - donor selection
KW - donor vigilance
KW - donors
KW - haemovigilance
UR - http://www.scopus.com/inward/record.url?scp=85096849473&partnerID=8YFLogxK
U2 - 10.1111/vox.13028
DO - 10.1111/vox.13028
M3 - SCORING: Journal article
C2 - 33191514
AN - SCOPUS:85096849473
VL - 116
SP - 342
EP - 350
JO - VOX SANG
JF - VOX SANG
SN - 0042-9007
IS - 3
ER -
