Abstract
Introduction: 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.
Highlights
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 is consistent with previous research which has identified that the majority of pharmaceutical companies and regulatory authorities do not have formal assessments in place to periodically measure the quality of their decision making (Bujar et al, 2016a) and this could be partially explained by the fact that very few appropriate techniques exist to enable this to be done
This review identified a general paucity of research in the area of decision making in medicines’ development and review, but in the area of HTA
Summary
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. The general principles and steps for making a quality decision have been characterized by a number of academic and consultancy groups (Matheson and Matheson, 1998; Hammond et al, 1999; Blenko et al, 2010; SDG, 2011) and include identifying the problem and objectives; having creative implementable options; obtaining meaningful, reliable information upon which to base a decision; identifying clear consequences and trade-offs for each supportive element; considering uncertainty and eliminating biases; using logically correct reasoning; and making a commitment to action These principles have been applied across a number of disciplines such as economics, environmental protection, clinical practice, nuclear safety, and government affairs, to facilitate quality decision making (Ratliff et al, 1999; Dowding and Thompson, 2003; Morton et al, 2009; Thaler and Sustein, 2009; Wagner, 2013)
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