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A WHO tool for risk-based decision making on blood safety interventions.
Janssen, Mart P; Nuebling, C Micha; Lery, François-Xavier; Maryuningsih, Yuyun S; Epstein, Jay S.
Afiliação
  • Janssen MP; Transfusion Technology Assessment Group, Donor Medicine Research Department, Sanquin Research, Amsterdam, The Netherlands.
  • Nuebling CM; Division of Major Policy Issues, Paul-Ehrlich-Institut, Langen, Germany.
  • Lery FX; Technical Standards and Specifications Unit, Health Products Policy and Standards Department, WHO Headquarters, Geneva, Switzerland.
  • Maryuningsih YS; Blood and Other Product of Human Origin, Health Products Policy and Standards Department, WHO Headquarters, Geneva, Switzerland.
  • Epstein JS; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Transfusion ; 61(2): 503-515, 2021 02.
Article em En | MEDLINE | ID: mdl-33368381
ABSTRACT

BACKGROUND:

Risk-based 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- and middle-income 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-Criteria Decision Assessment and a novel step-by-step qualitative assessment. STUDY DESIGN AND

METHODS:

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.

RESULTS:

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-by-step qualitative approach helps structuring the thought process and argumentation for a preferred intervention in a systematic manner.

CONCLUSION:

The relative strengths and weaknesses of the quantitative and step-by-step qualitative approach to risk-based 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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Gestão de Riscos / Sistemas de Apoio a Decisões Clínicas / Segurança do Sangue / Política de Saúde Tipo de estudo: Diagnostic_studies / Etiology_studies / Evaluation_studies / Prognostic_studies / Qualitative_research Limite: Humans Idioma: En Revista: Transfusion Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Holanda

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Gestão de Riscos / Sistemas de Apoio a Decisões Clínicas / Segurança do Sangue / Política de Saúde Tipo de estudo: Diagnostic_studies / Etiology_studies / Evaluation_studies / Prognostic_studies / Qualitative_research Limite: Humans Idioma: En Revista: Transfusion Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Holanda