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The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines.

ABSTRACT: 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.

SUBMITTER: Bujar M

PROVIDER: S-EPMC6351444 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines.

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

Frontiers in pharmacology 20190123

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

PMID: 30728777

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Project description: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.

Project description:Neural correlates of decision making under risk are being increasingly utilized as biomarkers of risk for substance abuse and other psychiatric disorders, treatment outcomes, and brain development. This research relies on the basic assumption that fMRI measures of decision making represent stable, trait-like individual differences. However, reliability needs to be established for each individual construct. Here we assessed long-term test-retest reliability (TRR) of regional brain activations related to decision making under risk using the Balloon Analogue Risk Taking task (BART) and identified regions with good TRRs and familial influences, an important prerequisite for the use of fMRI measures in genetic studies. A secondary goal was to examine the factors potentially affecting fMRI TRRs in one particular risk task, including the magnitude of neural activation, data analytical approaches, different methods of defining boundaries of a region, and participant motion. For the average BOLD response, reliabilities ranged across brain regions from poor to good (ICCs of 0 to 0.8, with a mean ICC of 0.17) and highest reliabilities were observed for parietal, occipital, and temporal regions. Among the regions that were of a priori theoretical importance due to their reported associations with decision making, the activation of left anterior insula and right caudate during the decision period showed the highest reliabilities (ICCs of 0.54 and 0.63, respectively). Among the regions with highest reliabilities, the right fusiform, right rostral anterior cingulate and left superior parietal regions also showed high familiality as indicated by intrapair monozygotic twin correlations (ranging from 0.66 to 0.69). Overall, regions identified by modeling the average BOLD response to a specific event type (rather than its modulation by a parametric regressor), regions including significantly activated vertices (compared to a whole parcel), and regions with greater magnitude of task-related activations showed greater reliabilities. Participant motion had a moderate negative effect on TRR. Regions activated during decision period rather than outcome period of risky decisions showed the greatest TRR and familiality. Regions with reliable activations can be utilized as neural markers of individual differences or endophenotypes in future clinical neuroscience and genetic studies of risk-taking.

Dataset Information

The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines.

Publications

The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines.

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