{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T08:48:26Z","timestamp":1775292506431,"version":"3.50.1"},"reference-count":20,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,12,25]],"date-time":"2020-12-25T00:00:00Z","timestamp":1608854400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Risk\u2010based decision making is increasingly recognized as key to support national blood policy makers and blood operators concerning the implementation of safety interventions, especially to address emerging infectious threats and new technology opportunities. There is an urgent need for practical decision support tools, especially for low\u2010 and middle\u2010income countries that may not have the financial or technical capability to develop risk models. WHO supported the development of such a tool for blood safety. The tool enables users to perform both a quantitative Multi\u2010Criteria Decision Assessment and a novel step\u2010by\u2010step qualitative assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>This paper summarizes the content, functionalities, and added value of the new WHO tool. A fictitious case study of a safety intervention to reduce the risk of HIV transmission by transfusion was used to demonstrate the use and usefulness of the tool.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Application of the tool highlighted strengths and weaknesses of both the quantitative and qualitative approaches. The quantitative approach facilitates assessment of the robustness of the decision but lacks nuances and interpretability especially when multiple constraints are taken into consideration. Conversely, while unable to provide an assessment of robustness, the step\u2010by\u2010step qualitative approach helps structuring the thought process and argumentation for a preferred intervention in a systematic manner.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The relative strengths and weaknesses of the quantitative and step\u2010by\u2010step qualitative approach to risk\u2010based decision making are complementary and mutually enhancing. A combination of the two approaches is therefore advisable to support the selection of appropriate blood safety interventions for a particular setting.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16231","type":"journal-article","created":{"date-parts":[[2020,12,25]],"date-time":"2020-12-25T10:37:25Z","timestamp":1608892645000},"page":"503-515","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A <scp>WHO<\/scp> tool for risk\u2010based decision making on blood safety interventions"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1682-7817","authenticated-orcid":false,"given":"Mart P.","family":"Janssen","sequence":"first","affiliation":[{"name":"Transfusion Technology Assessment Group Donor Medicine Research Department, Sanquin Research  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5892-4105","authenticated-orcid":false,"given":"C. Micha","family":"Nuebling","sequence":"additional","affiliation":[{"name":"Division of Major Policy Issues Paul\u2010Ehrlich\u2010Institut  Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6226-4787","authenticated-orcid":false,"given":"Fran\u00e7ois\u2010Xavier","family":"Lery","sequence":"additional","affiliation":[{"name":"Technical Standards and Specifications Unit, Health Products Policy and Standards Department WHO Headquarters  Geneva Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9715-5938","authenticated-orcid":false,"given":"Yuyun S.","family":"Maryuningsih","sequence":"additional","affiliation":[{"name":"Blood and Other Product of Human Origin, Health Products Policy and Standards Department WHO Headquarters  Geneva Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2293-9062","authenticated-orcid":false,"given":"Jay S.","family":"Epstein","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,12,25]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"National Academies of Sciences Engineering and Medicine. Using 21st Century Science to Improve Risk\u2010Related Evaluations. National Academies Press Washington DC 2017."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12708"},{"issue":"2","key":"e_1_2_8_4_1","first-page":"94","article-title":"Malaria blood safety policy in five non\u2010endemic countries: a retrospective comparison through the lens of the ABO risk\u2010based decision\u2010making framework","volume":"17","author":"O'Brien SF","year":"2019","journal-title":"Blood Transfus"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13080"},{"key":"e_1_2_8_6_1","unstructured":"Alliance of Blood Operators Risk\u2010Based Decision\u2010Making Framework for Blood Safety Website [Internet].https:\/\/riskframework.allianceofbloodoperators.org\/. Accessed October 12 2020."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2010.00725.x"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2015.12.003"},{"key":"e_1_2_8_9_1","unstructured":"AbadieE RojasGC DemolisP et al.Benefit\u2010risk methodology project: development and testing of tools and processes for balancing multiple benefits and risks as an aid to informed regulatory decisions about medicinal products [Internet]. London;2008. p.28. Report No.: EMEA\/108979\/2009.https:\/\/www.ema.europa.eu\/en\/documents\/report\/benefit-risk-methodology-project_en.pdf."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2017.06.024"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3636"},{"key":"e_1_2_8_12_1","volume-title":"Benefit\u2010risk appraisal of medicines: a systematic approach to decision\u2010making","author":"Mussen F","year":"2009"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.203"},{"key":"e_1_2_8_14_1","first-page":"1","article-title":"Advancing structured decision\u2010making in drug regulation at the FDA and EMA","author":"Angelis A","year":"2020","journal-title":"Br J Clin Pharmacol"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2019.06.014"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1447"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2015.12.016"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1017\/bca.2017.12"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/2168479014565469"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejor.2004.05.031"},{"key":"e_1_2_8_21_1","first-page":"297","volume-title":"Proceedings of the Federated Conference on Computer Science and Information Systems (FedCSIS)","author":"Maida M","year":"2011"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.16231","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/trf.16231","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.16231","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,2]],"date-time":"2023-09-02T15:59:32Z","timestamp":1693670372000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.16231"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,25]]},"references-count":20,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,2]]}},"alternative-id":["10.1111\/trf.16231"],"URL":"https:\/\/doi.org\/10.1111\/trf.16231","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,25]]},"assertion":[{"value":"2020-08-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-25","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}