Stratus OCT quality control in two multi-centre multiple sclerosis clinical trials

John L Keltner, Kimberly E. Cello, Laura J. Balcer, Peter A. Calabresi, Clyde E. Markowitz, John S Werner

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

The University of California (UC) Davis Reading Center evaluated 19,961 scans from 981 subjects in two multiple sclerosis therapeutic trials with the aim of determining the influence of optical coherence tomography quality control procedures on error rates. There was no optical coherence tomography technician certification in Trial 1, and technicians had very limited monitoring and feedback during the trial in view of the fact that data were received retrospectively. However, technicians were certified in Trial 2 and submitted data in accordance with the protocol. Trial 2 scans had higher signal strengths, fewer errors, and more useable data than the scans in Trial 1. Thus, certified technicians and prompt transmission of data for ongoing quality control monitoring provided higher quality data in multiple sclerosis trials.

Original languageEnglish (US)
Pages (from-to)57-64
Number of pages8
JournalNeuro-Ophthalmology
Volume35
Issue number2
DOIs
StatePublished - Apr 2011

Fingerprint

Optical Coherence Tomography
Quality Control
Multiple Sclerosis
Clinical Trials
Certification
Reading
Data Accuracy
Therapeutics

Keywords

  • Multiple sclerosis
  • neuro-ophthalmology
  • OCT
  • quality control
  • reading centre

ASJC Scopus subject areas

  • Ophthalmology
  • Clinical Neurology

Cite this

Stratus OCT quality control in two multi-centre multiple sclerosis clinical trials. / Keltner, John L; Cello, Kimberly E.; Balcer, Laura J.; Calabresi, Peter A.; Markowitz, Clyde E.; Werner, John S.

In: Neuro-Ophthalmology, Vol. 35, No. 2, 04.2011, p. 57-64.

Research output: Contribution to journalArticle

Keltner, John L ; Cello, Kimberly E. ; Balcer, Laura J. ; Calabresi, Peter A. ; Markowitz, Clyde E. ; Werner, John S. / Stratus OCT quality control in two multi-centre multiple sclerosis clinical trials. In: Neuro-Ophthalmology. 2011 ; Vol. 35, No. 2. pp. 57-64.
@article{e43fe6ac522a4e4a8da4f93b858d531c,
title = "Stratus OCT quality control in two multi-centre multiple sclerosis clinical trials",
abstract = "The University of California (UC) Davis Reading Center evaluated 19,961 scans from 981 subjects in two multiple sclerosis therapeutic trials with the aim of determining the influence of optical coherence tomography quality control procedures on error rates. There was no optical coherence tomography technician certification in Trial 1, and technicians had very limited monitoring and feedback during the trial in view of the fact that data were received retrospectively. However, technicians were certified in Trial 2 and submitted data in accordance with the protocol. Trial 2 scans had higher signal strengths, fewer errors, and more useable data than the scans in Trial 1. Thus, certified technicians and prompt transmission of data for ongoing quality control monitoring provided higher quality data in multiple sclerosis trials.",
keywords = "Multiple sclerosis, neuro-ophthalmology, OCT, quality control, reading centre",
author = "Keltner, {John L} and Cello, {Kimberly E.} and Balcer, {Laura J.} and Calabresi, {Peter A.} and Markowitz, {Clyde E.} and Werner, {John S}",
year = "2011",
month = "4",
doi = "10.3109/01658107.2011.557760",
language = "English (US)",
volume = "35",
pages = "57--64",
journal = "Neuro-Ophthalmology",
issn = "0165-8107",
publisher = "Informa Healthcare",
number = "2",

}

TY - JOUR

T1 - Stratus OCT quality control in two multi-centre multiple sclerosis clinical trials

AU - Keltner, John L

AU - Cello, Kimberly E.

AU - Balcer, Laura J.

AU - Calabresi, Peter A.

AU - Markowitz, Clyde E.

AU - Werner, John S

PY - 2011/4

Y1 - 2011/4

N2 - The University of California (UC) Davis Reading Center evaluated 19,961 scans from 981 subjects in two multiple sclerosis therapeutic trials with the aim of determining the influence of optical coherence tomography quality control procedures on error rates. There was no optical coherence tomography technician certification in Trial 1, and technicians had very limited monitoring and feedback during the trial in view of the fact that data were received retrospectively. However, technicians were certified in Trial 2 and submitted data in accordance with the protocol. Trial 2 scans had higher signal strengths, fewer errors, and more useable data than the scans in Trial 1. Thus, certified technicians and prompt transmission of data for ongoing quality control monitoring provided higher quality data in multiple sclerosis trials.

AB - The University of California (UC) Davis Reading Center evaluated 19,961 scans from 981 subjects in two multiple sclerosis therapeutic trials with the aim of determining the influence of optical coherence tomography quality control procedures on error rates. There was no optical coherence tomography technician certification in Trial 1, and technicians had very limited monitoring and feedback during the trial in view of the fact that data were received retrospectively. However, technicians were certified in Trial 2 and submitted data in accordance with the protocol. Trial 2 scans had higher signal strengths, fewer errors, and more useable data than the scans in Trial 1. Thus, certified technicians and prompt transmission of data for ongoing quality control monitoring provided higher quality data in multiple sclerosis trials.

KW - Multiple sclerosis

KW - neuro-ophthalmology

KW - OCT

KW - quality control

KW - reading centre

UR - http://www.scopus.com/inward/record.url?scp=79952952396&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79952952396&partnerID=8YFLogxK

U2 - 10.3109/01658107.2011.557760

DO - 10.3109/01658107.2011.557760

M3 - Article

VL - 35

SP - 57

EP - 64

JO - Neuro-Ophthalmology

JF - Neuro-Ophthalmology

SN - 0165-8107

IS - 2

ER -