Trial Outcomes & Findings for Consensus Method to Evaluate the Conformity of Prescription of a Chemotherapy (NCT NCT02882178)
NCT ID: NCT02882178
Last Updated: 2021-01-08
Results Overview
Items selected by the consensus process to assess the conformity of prescription of cabazitaxel based on the the 26 items included in the Summary of Product Characteristics (SPC). Two independent panels of experts in the field of uro-oncology, one French panel and a European panel from the Genito-Urinary group of the European Organization for Research and Treatment of Cancer (EORTC-GU), were solicited in order to define the importance of each criterion of the SPC and to allow a qualitative assessment of conformity using a formal consensus method. The purpose of consensus methods is to assess the extent of agreement and to resolve disagreement among a group of selected individuals by identifying and selecting, through iterative ratings with feedback, specific points on which there is disagreement or uncertainty. We relied on the Delphi method as it is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn.
COMPLETED
18 participants
Baseline
2021-01-08
Participant Flow
Participant milestones
| Measure |
Experts of the Consensus Process
Experts involved in the consensus process
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experts of the Consensus Process
n=18 Participants
Experts involved in the consensus process
|
|---|---|
|
Age, Customized
> 18 years
|
18 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=18 Participants
|
|
Region of Enrollment
France
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: BaselineItems selected by the consensus process to assess the conformity of prescription of cabazitaxel based on the the 26 items included in the Summary of Product Characteristics (SPC). Two independent panels of experts in the field of uro-oncology, one French panel and a European panel from the Genito-Urinary group of the European Organization for Research and Treatment of Cancer (EORTC-GU), were solicited in order to define the importance of each criterion of the SPC and to allow a qualitative assessment of conformity using a formal consensus method. The purpose of consensus methods is to assess the extent of agreement and to resolve disagreement among a group of selected individuals by identifying and selecting, through iterative ratings with feedback, specific points on which there is disagreement or uncertainty. We relied on the Delphi method as it is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn.
Outcome measures
| Measure |
Experts of the Consensus Process
n=18 Participants
Experts involved in the consensus process
|
|---|---|
|
Items to Define Conformity to Cabazitaxel Conditions of Use
|
11 items
|
Adverse Events
Experts of the Consensus Process
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place