Final Research Plan

Unhealthy Drug Use: Screening

October 20, 2016

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.

The final Research Plan is 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.

The draft Research Plan was available for comment from August 4 to August 31, 2016, at 8:00 p.m., ET.

Text Description is below the image.

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, reduced frequency and/or quantity of drug use, or reduction in 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).

  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 counseling interventions to reduce drug use, with or without referral, reduce drug use or improve other risky behaviors in screen-detected persons?
    b. Do counseling 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.

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?

The 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 illicit drug use and/or nonmedical pharmaceutical drug use and interventions for nondependent drug use, with or without addressing other substances or behaviors Studies in which the only aim is targeting another behavior (e.g., unhealthy alcohol use, 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-methylenedioxy- methamphetamine [MDMA or ecstasy], flunitrazepam [Rohypnol], gamma-hydroxybutyrate [GHB], synthetic cathinones [bath salts])
  • 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)
  • Illicit opioids (heroin, opium, Mitragyna speciosa [kratom], illicitly manufactured fentanyl [IMF])
  • Stimulants (cocaine, amphetamine, Catha edulis [khat], methamphetamine)
  • Prescription opioid pain relievers
  • Prescription sedatives (barbiturates, benzodiazepines, sleep medications)
  • 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

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
Studies limited to:
  • Treatment-seeking individuals (including those responding to recruitment advertising)
  • Persons with psychotic disorders (e.g., schizophrenia)
  • Persons presenting in an emergency setting for drug-related issues (e.g., motor vehicle injury)
  • Persons receiving chronic opioid therapy
  • Other groups not generalizable to primary care (e.g., psychiatric inpatients, persons who are court-mandated to receive treatment, persons who are incarcerated)
  • KQs 4, 5: Persons with dependent drug use (or studies in which >50% of the enrolled sample is persons with dependent drug use)
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; Global Appraisal of Individual Needs–Short Screener (GAIN-SS); 4P’s Plus (Past use, Pregnancy, use by Parents and Partners); National Institute on Drug Abuse Quick Screen; and single screening questions
  • 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)
  • Counseling 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, electronic, 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
  • Interventions to prevent initiation of use among nonusers
  • Pharmacotherapy
Comparisons KQs 1, 3:
  • No screening
  • 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; obstetrics/gynecology clinics; specialty medical treatment settings (e.g., diabetes management); school health 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; obstetrics/gynecology clinics; behavioral/mental health clinics; substance abuse treatment centers; school health clinics; and research clinic/office, home, or other community settings, including electronic or computer-based interventions. Screening to identify eligible participants must take place in a broad-based, general setting comparable to primary care with a defined population (e.g., primary care clinic, WIC program, orientation for incoming college freshman).
Screening that takes place in:
  • Behavioral/mental health clinic
  • Substance abuse treatment center
  • Emergency department/ trauma center
  • Worksites, including occupational screening
  • Inpatient/residential facility
  • Other institutions (e.g., correctional facility)
Outcomes 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 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, hospital inpatient stay)
  • Obstetrical/perinatal/neonatal outcomes (e.g., perinatal mortality, preterm labor/delivery, low birth weight, placental abruption, intrauterine growth restriction, preeclampsia, antepartum or postpartum hemorrhage, gestational 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/educational outcomes

KQ 2: Sensitivity and specificity or data to calculate one or both

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
  • Privacy issues (e.g., 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 and nonrandomized controlled trials

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

KQ 4, 5: Randomized, controlled trials and nonrandomized controlled trials
Prospective and retrospective cohort studies, case control studies, time series studies, before-after studies with no comparison group, cross-sectional studies, case studies, case series, editorials/commentaries
Country Studies conducted in countries categorized as "Very High" on the 2014 Human Development Index (as defined by the United Nations Development Programme) Studies conducted in countries that are not categorized as "Very High" on the 2014 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)

Abbreviation: STI = sexually transmitted infection; WIC = Special Supplemental Nutrition Program for Women, Infants, and Children.

A draft research plan was posted on the USPSTF Web site for public comment from August 4 to August 31, 2016. In response, the USPSTF revised the exclusion of studies limited to persons with concomitant mental health disorders to indicate that only studies limited to persons with psychotic disorders (e.g., schizophrenia) will be excluded. Studies limited to persons with other mental health conditions, such as depression, anxiety, and posttraumatic stress disorder will be included. Other minor modifications and clarifications were made as appropriate, including clarifying that the focus of KQ 4 is counseling interventions, which is consistent with the scope of the USPSTF, and updating some of the conditions (e.g., bath salts) and settings (e.g., school health clinics) that will be included in the review. A number of comments related to the conduct of the review (e.g., stratifying results by important subpopulations, such as by age group) or important discussion points that are not reflected in the research plan but will be addressed in the full evidence review. Public comments on the draft research plan for "Primary Care Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults, Including Pregnant Women" were also reviewed given the similar scope of the two proposed evidence reviews. Based on those comments, the USPSTF modified the exclusion criteria to clarify that interventions that target persons with dependent drug use are out of scope for this review; therefore, pharmacotherapy interventions (including medication-assisted therapy) will be excluded from the review.