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dc.contributor.authorBujar, M
dc.contributor.authorMcAuslane, N
dc.contributor.authorWalker, S
dc.contributor.authorSalek, Mir-Saeed Shayegan
dc.date.accessioned2019-08-20T12:33:36Z
dc.date.available2019-08-20T12:33:36Z
dc.date.issued2017-04-10
dc.identifier.citationBujar , M , McAuslane , N , Walker , S & Salek , M-S S 2017 , ' Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment : A Systematic Review of the Literature. ' , Frontiers in Pharmacology , vol. 10 , no. 8 , 189 . https://doi.org/10.3389/fphar.2017.00189
dc.identifier.issn1663-9812
dc.identifier.otherPURE: 15694075
dc.identifier.otherPURE UUID: 3824c18f-5314-4f93-adfe-9878b26769fc
dc.identifier.otherScopus: 85018751834
dc.identifier.urihttp://hdl.handle.net/2299/21607
dc.description.abstractIntroduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.en
dc.language.isoeng
dc.relation.ispartofFrontiers in Pharmacology
dc.rightsOpen
dc.titleEvaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment : A Systematic Review of the Literature.en
dc.contributor.institutionDepartment of Pharmacy, Pharmacology and Postgraduate Medicine
dc.contributor.institutionPublic Health and Patient Safety Unit
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.contributor.institutionSchool of Life and Medical Sciences
dc.description.statusPeer reviewed
dc.relation.schoolSchool of Life and Medical Sciences
dc.description.versiontypeFinal Published version
dcterms.dateAccepted2017-04-10
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.3389/fphar.2017.00189
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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