1. Validation of self-administered single item screening questions (SISQs) for unhealthy alcohol and other drug use in primary care patients at two sites Jennifer McNeely, Charles M. Cleland, Shiela M. Strauss, Joseph J. Palamar, John Rotrosen, Marc N. Gourevitch, Richard Saitz

2. No relevant financial relationships to disclose

3. Objectives 1.Describe the need for a self-administered approach to substance use screening 2. Single Item Screening Questions (SISQs) for alcohol and drug use 3.Present results of a validation study in primary care 4.Discuss feasibility and application

4. Screening for substance use in primary care Medical providers fail to identify clinically relevant substance use Barriers to screening: o Time o Workflow o Knowledge/Training o Discomfort o Attitudes D’Amico, Medical Care 2005 Sterling, Addict Med Clin Pract 2012 Friedmann, J Gen Int Med 2000 Friedmann, Arch Int Med 2001 Anderson, Alcohol Alcoholism 2004 McCormick, J Gen Int Med 2006

5. Self-administered screening is a more feasible approach Education Monitoring Office-based counseling Treatment Screening Assessment Low RiskModerate Risk High Risk or Dependence + Screening: SISQ-alcohol and SISQ-drug

6. Single Item Screening Questions SISQ-alcohol How many times in the past year have you had X or more drinks in a day? (X=5 for men, and X=4 for women) SISQ-drug How many times in the past year have you used an illegal drug or used a prescription medication for non- medical reasons (for example, because of the experience or feeling it caused?

7. Prior validation of SISQs Adult primary care patients (N=286) Single site, urban safety net medical center Good sensitivity and specificity for detection of unhealthy use SISQ-alcohol: Sensitivity 82%, Specificity 79% SISQ-drug: Sensitivity 85%, Specificity 96% Smith et al., JGIM 2009 Smith et al., Arch Int Med 2010

8. Current Study Screening (computer)Validation Measures (interviewer) Referrals Incentive Timeline Follow Back SIP-A and SIP-D MINI-Plus REALM Demographics Saliva drug screen Second Consent SUBS SISQ-alcohol, SISQ-drug

9. Reference standard measures Timeline follow- back (30d) SIP-ASIP-DMINI-Plus screening MINI-Plus abuse or dep Intercept oral fluid test* Alcohol Unhealthy use +++ Disorder+ Drugs Unhealthy use ++++ Disorder+ * Collected at Site A only

10. Statistical Analysis 1.Comparison of SISQs to composite reference standards 2.Examined site differences 3.Calculate sensitivity, specificity, AUC: o Unhealthy use o Substance use disorder 4. Subgroup analyses

11. Study Sites and Recruitment Adult primary care clinics 2 urban safety net hospitals Patients presenting for medical visits Consecutive recruitment Eligibility Criteria: Age 21-65 Current clinic patient Fluent in English No disability preventing computer use

12. Participant Recruitment Screened: N = 2131 Eligible: N = 915 1216 were excluded Language: 679 Age: 306 Not a patient: 168 Other: 115 Completed interview: N = 459 Site A: 265* Site B: 194 453 declined No time: 363 Other: 90 1 lost data *230 (87%) Site A participants agreed to saliva test

13. Characteristics of the 459 participants Age (years)Mean = 46, SD = 12 Range = 21-65 Sex (%)Male Female Transgender 48.4 51.2 0.4 Race/Ethnicity (%)Black/African American Hispanic White/Caucasian Other 51.8 20.2 19.1 8.6 Country of Birth (%)United States Outside of United States 64.6 35.3

14. Education and Health Literacy Highest Level of Education Health Literacy Level

15. Prevalence of substance use Substance Past year use (MINI) N (%) Past month use (TLFB) N (%) Alcohol103 (22.3) a 89 (19.3) b Drugs114 (24.7) c 73 (15.8) c Specific drug categories Illicit drugs108 (23.4) Marijuana--58 (12.6) Cocaine--12 (2.6) Heroin--10 (2.2) Hallucinogens--1 Prescription drugs (non-medical use)21(4.6) Opioids--5 Benzodiazepines--3 Stimulants--2

16. Unhealthy use Substance+ on SISQ N (%) + on Reference N (%) Sensitivity % (95% CI) Specificity % (95% CI) AUC (95% CI) Alcohol 155 (34) 146 (32) 73.3 (65.3, 80.3) 84.7 (80.2, 88.5) 0.79 (0.75, 0.83) Drugs 107 (23) 122 (27)71.3 (62.4, 79.1) 94.3 (91.3, 96.6) 0.83 (0.79, 0.87) Oral fluid test results: 8 tested positive, all reported use on SISQ  No change to results

17. Substance use disorder Substance+ on SISQ N (%) + on Reference N (%) Sensitivity % (95% CI) Specificity % (95% CI) AUC (95% CI) Alcohol 155 (34) 60 (13) 86.7 (75.4, 94.1) 74.2 (69.6, 78.4) 0.80 (0.76, 0.85) Drugs 107 (23) 74 (16)85.1 (75.0, 92.3) 88.6 (85.0, 91.6) 0.87 (0.83, 0.91)

18. Subgroup Analysis Subgroups anticipated to have greater difficulty with self-administered screening: Male Age greater than 50 Hispanic/Latino Primary language other than English Born outside US Education or health literacy lower than high school level

19. Subgroup Analysis No differences for SISQ-alcohol Lower sensitivity of SISQ-drug among: Primary language other than English (p<0.01) Less than high school education (p<0.01) SensitivitySpecificity English 74.3 (65.1, 82.2)94.4 (90.7, 96.9) Non-English 46.2 (19.2, 74.9)94.3 (87.1, 98.1) SensitivitySpecificity High school 79.0 (66.8, 88.3)95.2 (91.0, 97.8) < High school 63.3 (49.9, 75.4)93.3 (88.0, 96.7)

21. Limitations Safety net primary care populations English speaking only Tested in research context, with assurance of confidentiality

22. Conclusions SISQs accurately identified unhealthy substance us in primary care patients Lower sensitivity and specificity than interviewer-administered versions Efficiency, fidelity, and patient comfort may be advantages to self-administered approach

23. Acknowledgements Funding: K23 Career Development Award NIDA K23 DA030395 NYU-HHC CTSI Pilot Grant NIH/NCATS UL1 TR000038 The MITRE Corporation (contract from ONC and SAMHSA) Staff and others: Seville Meli Jacqueline German Ritika Batajoo Catherine Federowicz Marshall Gillette Charlie Jose Emily Maple Keshia Toussaint Julianne Cameron Arianne Ramautar Derek Nelsen Linnea Russell Study participants