Draft Research Plan
Draft Research Plan for Unhealthy Alcohol Use in Adolescents and Adults, Including Pregnant Women: Screening and Behavioral Counseling Interventions
This opportunity for public comment expired on September 21, 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.
Draft: Proposed Analytic Framework
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 unhealthy alcohol use may result in improved behavioral outcomes, including alcohol abstinence, frequency and/or quantity of alcohol 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 unhealthy alcohol use screening instruments (Key Question 2) and potential harms of screening (Key Question 3). Additionally, the figure illustrates how interventions to reduce unhealthy alcohol 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
- a. Does primary care screening for unhealthy alcohol use in adolescents and adults, including pregnant women, reduce alcohol use or improve other risky behaviors?
b. Does primary care screening for unhealthy alcohol use in adolescents and adults, including pregnant women, reduce morbidity or mortality or improve other health, social, or legal outcomes?
- What is the accuracy of commonly used instruments to screen for unhealthy alcohol use?
- What are the harms of screening for unhealthy alcohol use in adolescents and adults, including pregnant women?
- a. Do interventions to reduce unhealthy alcohol use, with or without referral, reduce alcohol use or improve other risky behaviors in screen-detected persons?
b. Do interventions to reduce unhealthy alcohol use, with or without referral, reduce morbidity or mortality or improve other health, social, or legal outcomes in screen-detected persons?
- What are the harms of interventions to reduce unhealthy alcohol use in screen-detected persons?
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).
|Aim||Screening for and treatment of unhealthy alcohol use, with or without addressing other substances or behaviors||Studies in which the only aim is targeting another behavior (e.g., drug or tobacco use) (i.e., change in alcohol use is not a stated aim, even if it is a reported outcome)|
|Condition||Unhealthy alcohol use, including:
|Population||All KQs: Adolescents and adults (age ≥12 years)
KQs 1–3: Studies whose participants are not selected on the basis of alcohol 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 screeningA priori subpopulations at greater risk for unhealthy alcohol use or its consequences will be examined based on the following: age, sex, race/ethnicity, socioeconomic status, pregnancy status, concurrent unhealthy drug use, severity of disorder, and presence of comorbid mental health conditions
|Screening||KQs 1, 3: Screening for alcohol 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 will be limited to the following instruments, which are most widely used and feasible for application in primary care:
|Comparators||KQs 1, 3: No screening or usual care
KQ 2: Comparison with reference standard (i.e., structured or semistructured clinical interview)KQs 4, 5:
|Setting||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; research clinics/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; research clinics/office, home, or other community settings, including electronic or computer-based interventions
|Screening that takes place in:
|Outcomes||KQs 1a, 4a:
KQs 1b, 4b:
KQ 2: Sensitivity and specificity or data to calculate one or both
KQs 3, 5:
|Outcome assessment timing||At least 6 months after baseline measurement (except for studies in pregnant women, for which shorter followup times will be included)|
|Study design||KQ 1: Randomized, controlled trials; cluster randomized, controlled trials; nonrandomized, controlled trials
KQ 2: Studies of screening accuracy reporting sensitivity and specificity (or data to calculate one or both) compared with a structured or semistructured clinical interview
KQ 3: Randomized, controlled trials; cluster randomized, controlled trials; nonrandomized, controlled trials; prospective cohort studiesKQs 4, 5: Randomized, controlled trials; large comparative cohort studies (for harms of medications only)
|All KQs: Case control studies, time series studies, before-after studies, cross-sectional studies, case studies, case series, editorials/commentaries
KQs 1, 3: Retrospective cohort studies
KQs 4, 5: Prospective and retrospective cohort studies (except for harms of medications, for which large cohort studies will be included)
|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 1985 to present||Studies whose primary results were published prior to 1985|
|Publication language||English||Languages other than English|
|Quality||Fair or good quality||Poor quality (according to design-specific USPSTF criteria)|
* Medications used to prevent relapse of alcohol use disorder include: naltrexone, acamprosate, and disulfiram. No other medications are approved by the U.S. Food and Drug Administration for the treatment of alcohol use.
Internet Citation: Draft Research Plan: Unhealthy Alcohol Use in Adolescents and Adults, Including Pregnant Women: Screening and Behavioral Counseling Interventions. U.S. Preventive Services Task Force. August 2016.