Dataset Information

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

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.

SUBMITTER: Bujar M

PROVIDER: S-EPMC5385334 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

Bujar Magdalena M McAuslane Neil N Walker Stuart R SR Salek Sam S

Frontiers in pharmacology 20170410

<b>Introduction:</b> 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 t ...[more]

PMID: 28443022

Similar Datasets

Project description:Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality of their decision-making processes and is considered the most promising tool for such purpose. This study aimed to further establish the measurement properties of the QoDoS by evaluating its reliability (internal consistency and test-retest reliability) and relevance in the target population. Methods: The study participants consisted of 55 individuals recruited from pharmaceutical companies, regulatory and HTA agencies. It was designed as a longitudinal study with participants assessed on two different occasions, at baseline (test 1) and then 7 days later (test 2). Internal consistency reliability was assessed with Cronbach's alpha and the test-retest reliability was evaluated using the intraclass correlation coefficients (ICC) based on absolute agreement, 2 way mixed-effects model for the four QoDoS domains. The relevance of the QoDoS was evaluated by applying cognitive debriefing using five short feedback questions following test 1. Results: Test 1 was completed by 44 study participants (80% response rate) and test 2 was completed by 32 of the 44 individuals, resulting in a 73% response rate. Cronbach's alpha coefficient was greater than 0.7 across all the domains for test 1 and test 2, ranging from 0.71 to 0.79, indicating good consistency of responses. For the overall score across all 47 items, the Cronbach's alpha coefficient was 0.81 for test 1 and 0.86 for test 2, which is rated as very good. The four QoDoS domains showed moderate to strong reproducibility (ICC range: 0.63-0.86). The outcome of the cognitive debriefing from the 43 respondents (98% response rate) confirmed the relevance (95% agreement), language clarity (95%) and completeness of items (86%); the clarity of the scaling (91%) as well as spontaneity of responses (95%). Conclusion: These results provide strong support for the relevance and reliability of the QoDoS, which are key properties for future longitudinal and cross-sectional applications of the instrument when evaluating quality of decision making by those involved in the lifecycle of medicines.

Project description:BackgroundDespite a national focus on post-acute care brought about by recent payment reforms, relatively little is known about how hospitalized older adults and their caregivers decide whether to go to a skilled nursing facility (SNF) after hospitalization.ObjectiveWe sought to understand to what extent hospitalized older adults and their caregivers are empowered to make a high-quality decision about utilizing an SNF for post-acute care and what contextual or process elements led to satisfaction with the outcome of their decision once in SNF.DesignQualitative inquiry using the Ottawa Decision Support Framework (ODSF), a conceptual framework that describes key components of high-quality decision-making.ParticipantsThirty-two previously community-dwelling older adults (≥ 65 years old) and 22 caregivers interviewed at three different hospitals and three skilled nursing facilities.Main measuresWe used key components of the ODSF to identify elements of context and process that affected decision-making and to what extent the outcome was characteristic of a high-quality decision: informed, values based, and not associated with regret or blame.Key resultsThe most important contextual themes were the presence of active medical conditions in the hospital that made decision-making difficult, prior experiences with hospital readmission or SNF, relative level of caregiver support, and pressure to make a decision quickly for which participants felt unprepared. Patients described playing a passive role in the decision-making process and largely relying on recommendations from the medical team. Patients commonly expressed resignation and a perceived lack of choice or autonomy, leading to dissatisfaction with the outcome.ConclusionsUnderstanding and intervening to improve the quality of decision-making regarding post-acute care supports is essential for improving outcomes of hospitalized older adults. Our results suggest that simply providing information is not sufficient; rather, incorporating key contextual factors and improving the decision-making process for both patients and clinicians are also essential.

Dataset Information

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

Publications

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets