June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Perimetry Certification Provided by a Reading Center Improves Quality of Data Collection in Clinical Trials
Author Affiliations & Notes
  • Edeleidys Sanchez Saucedo
    Department of Ophthalmology/Casey Reading Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon, United States
  • Maria Parker
    Department of Ophthalmology/Casey Reading Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon, United States
  • Audra Miller
    Department of Ophthalmology/Casey Reading Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon, United States
  • Shobana Aravind
    Department of Ophthalmology/Casey Reading Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon, United States
  • Hiroshi Ishikawa
    Department of Ophthalmology/Casey Reading Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon, United States
    Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, Oregon, United States
  • Footnotes
    Commercial Relationships   Edeleidys Sanchez Saucedo None; Maria Parker None; Audra Miller None; Shobana Aravind None; Hiroshi Ishikawa None
  • Footnotes
    Support  Unrestricted Grant from Research to Prevent Blindness, New York, New York and P30 EY010572 and Foundation Fighting Blindness (Columbia, MD): C-CL-0711-0534-OHSU01 (Unrestricted, CEI)
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 109. doi:
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    • Get Citation

      Edeleidys Sanchez Saucedo, Maria Parker, Audra Miller, Shobana Aravind, Hiroshi Ishikawa; Perimetry Certification Provided by a Reading Center Improves Quality of Data Collection in Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2023;64(8):109.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The effect of perimetry certification to technicians on data quality in ophthalmology clinical trials is unknown. This observational study was performed to test the hypothesis that perimetry certification for technicians improves the quality of data collection in ophthalmology clinical trials.

Methods : The study examined 4,176 of static and 997 of kinetic perimetry submissions from 29 retrospective, prospective and mixed multisite clinical trials about retinal diseases, processed at Casey Reading Center (CRC) over eleven years. Data were extracted from documents generated on the CRC portal software platform. A submission included one or more perimetry tests for the same pre-defined clinic visit. A deviation was considered when test procedures deviated from trial requirements. Data quality impact was deemed when a deviation caused absent or incorrect data that could have led to different results if performed following trial requirements. Deviations were assessed, categorized and compared between certified versus uncertified technicians for impact on data quality. All variables were analyzed using absolute numbers and percentages.

Results : Figure 1 shows that most submissions of certified technicians had no deviations in both perimetries and uncertified technicians deviated more than certified technicians in both of them, in prospective and mixed trials. Certified technicians (3.2%-static, 16.5%-kinetic) impacted data quality less than uncertified technicians (55.9%-static, 25.0%-kinetic) in both perimetries. Figure 2 displays that in retrospective trials, uncertified technicians hardly affected data quality in static (0.2%), but did it in more than half of kinetic submissions (51.1%).

Conclusions : Results confirm the hypothesis that technicians participating in ophthalmology clinical trials, who were certified by CRC in perimetry, generated higher quality data. These findings suggest that perimetry certification for technicians would improve quality of data collection in clinical trials.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

 

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