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Draft Research Plan

Draft Research Plan for Drug Use in Adolescents and Adults, Including Pregnant Women: Screening

This opportunity for public comment expired on August 31, 2016 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Draft: Proposed Analytic Framework

Go to Text Description below.

Text Description.

Figure 1 is the analytic framework that depicts the five Key Questions to be addressed in the systematic review. The figure illustrates how screening for drug use in adolescents and adults, including pregnant women, may result in improved behavioral outcomes, including drug abstinence, frequency and/or quantity of drug use, or other risky behaviors (Key Question 1a) and improved health, social, and legal outcomes (Key Question 1b). Within the screening piece of the framework, there is also a question related to the accuracy of drug use screening instruments (Key Question 2) and potential harms of screening (Key Question 3). Additionally, the figure illustrates how interventions to reduce drug use may have an impact on behavioral outcomes (Key Question 4a) and health outcomes (Key Question 4b) and whether these interventions result in any adverse events (Key Question 5).

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. a. Does primary care screening for drug use* in adolescents and adults, including pregnant women, reduce drug use or improve other risky behaviors?
    b. Does primary care screening for drug use* in adolescents and adults, including pregnant women, reduce morbidity or mortality or improve other health, social, or legal outcomes?
  2. What is the accuracy of drug use screening instruments?
  3. What are the harms of primary care screening for drug use in adolescents and adults, including pregnant women?
  4. a. Do interventions to reduce drug use, with or without referral, reduce drug use or improve other risky behaviors in screen-detected persons?
    b. Do interventions to reduce drug use, with or without referral, reduce morbidity or mortality or improve other health, social, or legal outcomes in screen-detected persons?
  5. What are the harms of interventions to reduce drug use in screen-detected persons?

* Includes illicit drug use and nonmedical pharmaceutical drug use.

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the association between reduced drug use and health outcomes?

Draft: Proposed Research Approach

The proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Aim Screening for and/or treatment of illicit drug use and/or nonmedical pharmaceutical drug use, with or without addressing other substances or behaviors Studies in which the only aim is targeting another behavior (e.g., alcohol misuse, tobacco use) (i.e., change in drug use is not a stated aim but is a reported outcome)
Condition Use of the following drugs, defined as any drug use that can result in poor health consequences, including meeting criteria for a drug use disorder:
  • Cannabinoids (marijuana, hashish, synthetic cannabinoids)
  • Club drugs (3,4-methylenedioxymethamphetamine [MDMA or ecstasy], flunitrazepam [Rohypnol], gamma-hydroxybutyrate [GHB])
  • Dissociative drugs (ketamine, phencyclidine [PCP] and analogs, Salvia divinorum [salvia], dextromethorphan [DXM])
  • Hallucinogens (lysergic acid diethylamide [LSD or acid], N,N-dimethyltryptamine [DMT], mescaline, psilocybin)
  • Inhalants (also known as volatile substances)
  • Opioids (heroin, opium, Mitragyna speciosa [kratom])
  • Stimulants (cocaine, amphetamine, Catha edulis [khat], methamphetamine)
  • Prescription opioids
  • Prescription sedatives (tranquilizers, depressants)
  • Prescription stimulants
  • Over-the-counter drugs (e.g., DXM)
  • Combination of any of the above
  • Medical use of drugs as prescribed
  • Nonpsychoactive drugs (e.g., anabolic steroids, laxatives, aspirin)
Population All KQs: Adolescents and adults age 12 years and older

KQs 1–3: Studies whose participants are not selected on the basis of drug use or a related behavior or condition

KQs 4, 5: Studies in which at least 50% of the enrolled sample is recruited via population-based screening

A priori subpopulations at greater risk for drug use or its consequences will be examined based on the following factors: age (particularly young adults ages 18 to 25 years and adolescents ages 12 to 17 years), sex, race/ethnicity, socioeconomic status, pregnancy status, concurrent substance use (tobacco or alcohol), severity of the disorder, and presence of comorbid mental health conditions
  • Treatment-seeking individuals
  • Studies limited to persons with concomitant mental health disorders (e.g., posttraumatic stress disorder, depression)
  • Studies limited to persons presenting in an emergency setting for drug-related issues (e.g., motor vehicle injury)
  • Studies limited to persons receiving chronic opioid therapy
  • Studies limited to other groups not generalizable to primary care (e.g., psychiatric inpatients, persons who are court-mandated to treatment)
Screening KQs 1, 3: Screening for drug use using a brief standardized instrument or set of questions that is conducted in person or via telephone, mail, or electronically

KQ 2: Accuracy of screening instruments, such as the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Cut down, Annoyed, Guilty, Eye-opener–Adapted to Include Drug Use (CAGE-AID); Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT); Drug Abuse Screening Test (DAST), including the DAST-10; 4P's (Past use, Pregnancy, use by Parents and Partners) Plus; and the National Institute on Drug Abuse Quick Screen
  • Studies without any screening instruments or questions
  • Laboratory tests
  • Newborn screening tests for drug exposure (e.g., testing of meconium, infant hair, or umbilical cord specimens)
Interventions
  • Counseling (with or without medication*) designed to reduce drug use, with or without referral
  • Counseling interventions can vary in their approach (e.g., 12-step, cognitive behavioral therapy, motivational enhancement therapy), specific strategies (e.g., action plans, diaries), delivery method (e.g., face-to-face, Web-based, individual, group-based), length of contact (e.g., brief, extended), and the number of contacts (e.g., single, multiple)
  • Interventions to prevent drug use initiation
  • Contingency management
  • Vocational rehabilitation
  • Community-based media or policy interventions
  • Naloxone
Comparisons KQs 1, 3: No screening or usual care

KQ 2: Reference standard (i.e., structured or semistructured clinical interview)

KQs 4, 5:
  • No intervention
  • Usual care
  • Waitlist
  • Attention control (e.g., intervention is similar in format and intensity but on a different content area)
  • Minimal intervention (e.g., no more than one single brief contact per year, brief written materials such as pamphlets)
Active intervention
Settings KQs 1–3: Population-based screening that takes place in a setting that is applicable to primary care, including: primary care clinics; prenatal clinics; obstetric/gynecology clinics; and research clinic/office, home, or other community settings, including electronic or computer-based screening

KQs 4, 5: Interventions in a screen-detected population that take place in a traditional primary care setting or one that is applicable to or referable from primary care, including: primary care clinics; prenatal clinics; obstetric/gynecology clinics; behavioral/mental health clinics; substance abuse treatment centers; and research clinic/office, home, or other community settings, including electronic or computer-based interventions
Screening that takes place in:
  • Behavioral/mental health clinic
  • Substance abuse treatment center
  • Emergency department/trauma center
  • Worksite
  • Inpatient/residential facility
  • Other institutions (e.g., correctional facility)
Outcomes KQs 1b, 4b:
  • All-cause mortality
  • Drug-related mortality (intentional and unintentional)
  • Drug-related morbidity (e.g., mental health symptoms/disorders, STI/HIV transmission, hepatitis B or C virus transmission, respiratory infection, cardiovascular complications, stroke, seizure, nonfatal overdose, injuries and accidents, cognitive impairment, visit to emergency department, inpatient stay)
  • Obstetrical/perinatal/neonatal outcomes (e.g., perinatal mortality, preterm labor/delivery, low birth weight, placental abruption, intrauterine growth restriction, toxemia, antepartum or postpartum hemorrhage, maternal hypertension, decreased neonate length/head circumference, neonate neurobehavioral effects, congenital anomalies, neonatal abstinence syndrome, neonatal intensive care unit admission, decreased length of neonate hospitalization)
  • Quality of life
  • Drug-related problems, such as legal problems, social and family relations, employment, and school performance
KQ 2: Sensitivity and specificity or data to calculate one or both

KQs 1a, 4a:
  • Drug use (required) (self-report and/or biologic measures):
    • Abstinence (use/no use)
    • Frequency and/or quantity of drug use
    • Severity of drug use disorder (reported as an index measured by a standardized questionnaire, such as the Short Inventory of Problems, Addiction Severity Index, or Severity of Dependence Scale)
  • Composite substance use
  • Other risky behaviors (e.g., alcohol, tobacco, or other drug use; risky sexual behaviors)
KQs 3, 5:
  • Serious harms at any time point after the screening or intervention began (e.g., death, seizure, cardiovascular event, other medical issue requiring urgent medical treatment, serious obstetrical/perinatal/neonatal complication attributable to included medications)
  • Demoralization due to failed quit attempt
  • Stigma, labeling, and/or discrimination
  • Insurability status
  • Job loss
  • Interference with the doctor-patient relationship
  • Attitudes, knowledge, and beliefs related to drug use
  • Intention to change behavior
  • Intervention participation/compliance
Outcome assessment timing At least 6 months after baseline measurement (except for studies in pregnant women, for which shorter lengths of followup will be included)  
Study design KQs 1, 3: Studies that compare individuals who receive screening with those receiving no screening or usual care, including randomized controlled trials, cluster randomized controlled trials, nonrandomized controlled trials, and prospective cohort studies

KQ 2: Studies of screening accuracy reporting sensitivity and specificity compared with a structured or semistructured clinical interview

KQs 4, 5:
  • Randomized, controlled trials
  • Large comparative cohort studies (for harms of included medications only)
KQs 1, 3: Retrospective cohort studies

KQs 4, 5: Prospective and retrospective cohort studies

All KQs: Case control studies, time series studies, before-after studies, cross-sectional studies, case studies, case series, editorials/commentaries
Country Studies conducted in countries categorized as "Very High" on the 2015 Human Development Index (as defined by the United Nations Development Programme) Studies conducted in countries that are not categorized as "Very High" on the 2015 Human Development Index
Publication date Studies whose primary results were published from 1992 to present Studies whose primary results were published prior to 1992
Language English Non-English
Quality Fair or good quality Poor quality (according to design-specific USPSTF criteria)

* Medications used to manage withdrawal symptoms, relieve cravings, or prevent relapse for the treatment of addiction to opioids include: methadone (Dolophine, Methadose), buprenorphine hydrochloride (Subutex), buprenorphine hydrochloride and naloxone hydrochloride (Suboxone), and naltrexone (Vivitrol). No other medications are approved by the U.S. Food and Drug Administration for the treatment of drug use.

Abbreviation: STI=sexually transmitted infection.

Current as of: August 2016

Internet Citation: Draft Research Plan: Drug Use in Adolescents and Adults, Including Pregnant Women: Screening. U.S. Preventive Services Task Force. August 2016.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/drug-use-in-adolescents-and-adults-including-pregnant-women-screening

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