November 30, 2018: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome? (Gregory E. Simon, MD, MPH, Susan M. Shortreed, PhD)

Speakers

Gregory E. Simon, MD, MPH
Senior Investigator, Kaiser Permanente Washington Health Research Institute

Susan M. Shortreed, PhD
Associate Investigator
Biostatistics Unit, Kaiser Permanente Washington Health Research Institute

Topic

Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome?

Keywords

Phenotype; Suicide prevention; Pragmatic trial; Ecode reporting

Key Points

  • The Suicide Prevention Outreach Trial (SPOT) design was used to conduct a pragmatic trial of two outreach programs to prevent suicide attempts and was used as example for validating computable phenotypes.
  • In the transition to ICD-10, there were changes in coding of injuries and poisonings, from “undetermined” to “self-inflicted” categories of events, leading to potential for miscoding and possible false positives or false negatives.

Discussion Themes

Assumptions about the applicability of data based on present interpretations are often applied to the future. However, data are always shifting and this fluidity should be taken into account when designing a trial.

Randomization can get rid of data biases but not data “noise.”

Providing complete transparency in reporting is the most important characteristic of valuable pragmatic clinical trial data in ascertaining the outcome.

Tags

@Collaboratory1, @GregSimonKPWHRI, @sshortreed, #pctGR, #phenotype, #suicideprevention, #pragmatictrial