Using predictive analytics to improve pragmatic trial design.

Clinical Trials : Journal of the Society for Clinical Trials
Susan M Shortreed, Gregory E Simon

Abstract

Clinical trials embedded in health systems can randomize large populations using automated data sources to determine trial eligibility and assess outcomes. The suicide prevention outreach trial used real-world data for trial design and randomized 18,868 individuals in four health systems using patient-reported thoughts of death or self-harm (Patient Health Questionnaire item 9). This took 3.5 years. We consider if using predictive analytics, that is, suicide risk estimates based on prediction models, could improve trial "efficiency." We used data on mental health outpatient visits between 1 January 2009 and 30 September 2017 in seven health systems (HealthPartners; Henry Ford Health System; and Colorado, Hawaii, Northwest, Southern California, and Washington Kaiser Permanente regions). We used a suicide risk prediction model developed in these same systems. We compared five trial designs with different eligibility criteria: a response of a 2 or 3 on Patient Health Questionnaire item 9, a response of a 3, suicide risk score above 90th, 95th, or 99th percentile. We compared the sample that met each criterion, 90-day suicide attempt rate following first eligible visit, and necessary sample sizes to detect a 15%, 25%, and 35% relat...Continue Reading

References

Sep 15, 2001·Journal of General Internal Medicine·K KroenkeJ B Williams
Apr 8, 2009·Journal of Clinical Epidemiology·Kevin E ThorpeKalipso Chalkidou
Feb 9, 2012·BMJ : British Medical Journal·Tjeerd-Pieter van StaaLiam Smeeth
Jul 4, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Kalipso ChalkidouMerrick Zwarenstein
Sep 17, 2013·Psychiatric Services : a Journal of the American Psychiatric Association·Gregory E SimonEvette J Ludman
Jul 6, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Robert M Califf
Nov 18, 2016·Epidemiology and Psychiatric Sciences·J K CannerE B Schneider
Jul 5, 2017·International Journal of Methods in Psychiatric Research·Ronald C KesslerRobert M Bossarte
May 25, 2018·The American Journal of Psychiatry·Gregory E SimonSusan M Shortreed
Mar 15, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Susan M ShortreedGregory E Simon
Mar 17, 2019·American Journal of Epidemiology·Susan M ShortreedJennifer C Nelson

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