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.

Recruitment status

COMPLETED

Target enrollment

18 participants

Primary outcome timeframe

Baseline

Results posted on

2021-01-08

Participant Flow

Participant milestones

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

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: Baseline

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.

Outcome measures

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Simone Mathoulin-Pélissier

Institut Bergonié

Phone: 0556333333

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place