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Mechanisms for the testing effect on patient-reported outcomes.

Salene M W Jones1, Lisa J Shulman2, Julie E Richards2,3

  • 1Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 98109, USA.

Contemporary Clinical Trials Communications
|March 28, 2020
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The testing effect, where patient-reported outcomes improve without intervention, can skew clinical trial results. This study explored its mechanisms, finding that participation itself, emotional support, and behavioral changes were perceived benefits.

Keywords:
Measurement reactivityRetest effectTest-retest effect

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Area of Science:

  • Psychology
  • Clinical Research
  • Patient-Reported Outcomes

Background:

  • The testing effect, an improvement in patient-reported outcomes (PROs) with repeated testing without intervention, can confound clinical trial interpretation.
  • PROs are increasingly used as endpoints in clinical trials, making understanding the testing effect crucial.

Purpose of the Study:

  • To investigate the potential mechanisms underlying the testing effect.
  • To explore participants' perceptions of benefits from study participation, which may relate to the testing effect.

Main Methods:

  • Qualitative analysis of exit interview feedback from 89 control group participants of a parent study on depression self-management.
  • Interviews focused on perceived benefits of participating in the control group.

Main Results:

  • Participants reported perceived benefits including study participation being meaningful, emotional support, and appreciating outreach.
  • Novel mechanisms contributing to perceived benefits were identified.
  • A potential negative testing effect was also reported by participants.
  • Previously identified mechanisms, such as behavioral change, were also noted.

Conclusions:

  • Study participation offers perceived benefits beyond the intervention itself, potentially influencing PROs.
  • Understanding these non-intervention-related benefits is essential for accurately interpreting PRO data in clinical trials.
  • Further research is needed to fully elucidate the complex mechanisms of the testing effect.