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Detection of Rater Errors on Cognitive Instruments in a Clinical Trial Setting

  • Donald J. Connor
  • C. W. Jenkins
  • D. Carpenter
  • R. Crean
  • P. Perera
Original Research
  • 1 Downloads

Abstract

Objectives

This study examines errors committed by raters in a clinical trial of a memory enhancement compound.

Background

Findings of clinical trials are directly dependent on the quality of the data obtained but there is little literature on rates or nature of rater errors on cognitive instruments in a multi-site setting.

Design

Double-blind placebo-controlled study.

Setting

21 clinical sites in North America.

Participants

Two hundred seventy-five participants.

Measurements

MMSE, WMS-R Logical Memory I & II, WMS-R Verbal Paired Associates I, WASi Vocabulary, WASi Matrix Reasoning, GDS and MAC-Q.

Results

The WMS-R Logical Memory I & II and WASi Vocabulary tests were found to have the greatest number of scoring errors. Few substantive errors were detected on source document review of the MMSE, GDS, MAC-Q and WMS-R Verbal Paired Associates I. Some additional administration and scoring issues were identified during feedback sessions with the raters.

Conclusions

Cognitive measures used in clinical trials are prone to errors which can be detected with proper monitoring. Some instruments are particularly prone to inter-rater variably and should therefore be targets for focused training and ongoing monitoring. Areas in need of further investigation to help inform and optimize quality of clinical trial data are discussed.

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Copyright information

© Serdi and Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Donald J. Connor
    • 1
  • C. W. Jenkins
    • 2
  • D. Carpenter
    • 3
  • R. Crean
    • 3
  • P. Perera
    • 3
  1. 1.Consultants in Cognitive and Clinical TrialsSan DiegoUSA
  2. 2.Alzheimer’s Therapeutic Research Institute and Department of NeurologyKeck School of Medicine of University of Southern CaliforniaSan DiegoUSA
  3. 3.Dart NeuroscienceSan DiegoUSA

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