Final Research Plan
Final Research Plan for Unhealthy Alcohol Use in Adolescents and Adults, Including Pregnant Women: Screening and Behavioral Counseling Interventions
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 25 to September 21, 2016, at 8:00 p.m., ET.
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 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).
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 counseling interventions to reduce unhealthy alcohol use, with or without referral, reduce alcohol use or improve other risky behaviors in screen-detected persons?
b. Do counseling 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?
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).
|Aim||Screening for unhealthy alcohol use and interventions for nondependent 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 screening
A 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
|Studies limited to:
|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:
|Active intervention (e.g., comparators with a reasonable expectation of affecting change in alcohol consumption)|
|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; specialty medical treatment settings (e.g., diabetes management, dialysis 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; school health clinics; behavioral/mental health clinics; substance abuse treatment centers; research clinics/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, orientation for incoming college freshmen)
|Screening that takes place in:
|Outcomes||KQs 1a, 4a:
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||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
KQs 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, and 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 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)|
Abbreviation: WIC = Special Supplemental Nutrition Program for Women, Infants, and Children.
Response to Public Comment
A draft research plan was posted on the USPSTF Web site for public comment from August 25 to September 21, 2016. In response to public comments, the USPSTF narrowed the scope of the review to target nondependent unhealthy alcohol use. While screening studies may screen for all levels of unhealthy alcohol use, interventions targeted at persons with dependent alcohol use will not be included (or studies in which >50% of participants meet criteria for alcohol dependence). Based on this change, the USPSTF also modified the inclusion criteria to exclude instrument accuracy studies of the CAGE questionnaire (since it is not used for identifying at-risk, subdiagnostic alcohol use) and pharmacotherapy intervention studies (since these are typically reserved for persons with alcohol dependence). In addition, the USPSTF revised the inclusion criteria to include studies limited to persons with concomitant nonpsychotic mental health disorders such as depression and anxiety disorders. The USPSTF made other minor modifications and clarifications as appropriate, such as expanding some outcomes ("school/educational outcomes" rather than "school performance"), including the ICD code system as a way to identify persons with the condition, and noting that interventions to prevent initiation of alcohol use in adolescents are excluded. Suggestions for implementation of the review (e.g., stratifying analyses based on alcohol use severity, noting the need for specificity when describing reference standards used in instrument accuracy studies) were noted but did not change the scope of the review and therefore are not shown in this document.
Internet Citation: Final Research Plan: Unhealthy Alcohol Use in Adolescents and Adults, Including Pregnant Women: Screening and Behavioral Counseling Interventions. U.S. Preventive Services Task Force. August 2017.