Continuous Quality Control Monitoring Service
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CQCSM Continuous Quality Control and Monitoring Service

Calibrating to MedAvante Centralized Expert Trainers

Assessment reliability can be dramatically reduced by differing interpretations of scales and conventions as well as poor interviewing technique. This reduced reliability can have a profound effect on study power.

Maximizing inter-rater reliability and reducing rater variability can have a profound effect on both the power and sample size requirements for a study. For example, improving the intra-class correlation coefficient (ICC)* from 0.70 to 0.90 would increase the study power from 50% to 72%.

Traditional rater training is insufficient at best. True inter-rater reliability is rarely achieved in multi center trials. Critically, after rater training at the study outset sponsors have:

  • No visibility to the quality of patients enrolled
  • No visibility to quality of the assessments

Using MedAvante's central bank of expert trainers, sponsors can:

  1. Monitor locally administered screening and symptom-severity assessments
  2. Assess the subject based on the site interview
  3. Calibrate the site raters to the central MedAvante expert trainer cohort

How Medavante CQC Works:

  1. Site-based raters digitally record all their subject interviews through provided laptop.
  2. All the recorded interviews and source documents are uploaded to MedAvante via internet.
  3. Recorded Interviews & the source document both electronically tracked and automatically routed to a MedAvante trainer according to an algorithm agreed upon with the Sponsor.
  4. MedAvante expert trainer listens to the entire subject interview
    • Provides own score of interview scale: automated workflow program will not provide site's scores until MedAvante expert trainer enters their assessment scores.
    • Scores the site-based rater's clinical interviewing skills using the Rater Applied Performance Scale (RAPS).
  5. Provides Sponsor with the real-time Quality Scorecard & provides the site-based raters with calibrating feedback
    • MedAvante expert trainers are calibrated to provide consistent feedback to all site raters to minimize rater variability.

The remediation plan is comprised of a customized algorithm to determine the frequency and number of subject interview evaluations, level of concordance required with centralized expert trainers assessments and  comprehensive and consistent, personalized feedback to the site-based rater. This rigorous process, as defined in the MedAvante CQC Continuous Monitoring  methodology, returns substantial rewards. Other providers may provide a remote independent review but only MedAvante measures the site assessments against a single uniform world wide standard benchmark of clinical excellence.

  • To achieve this uniform benchmark, no other organization has MedAvante's on-going internal QC (20% of raters time) and rigorous quality control. If the trainers are not calibrated, they will distribute "noise" to the study.