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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.

Analytic Framework

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 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

  1. 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?
  2. What is the accuracy of commonly used instruments to screen for unhealthy alcohol use?
  3. What are the harms of screening for unhealthy alcohol use in adolescents and adults, including pregnant women?
  4. 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?
  5. What are the harms of interventions to reduce unhealthy alcohol use in screen-detected persons?

Contextual Questions

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

  1. What is the association between reduced alcohol use and health outcomes?
  2. What is the evidence to support current recommendations for alcohol use?

Research Approach

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).

Category Included Excluded
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:
  • Risky or hazardous use: consumption of alcohol above recommended daily, weekly, or per occasion amounts; consumption levels that increase the risk for health consequences
  • Harmful use: a pattern of drinking that is already causing damage to health; damage may be either physical (e.g., liver damage from chronic drinking) or mental (e.g., depressive episodes secondary to drinking)
  • A diagnosis of an alcohol use disorder (e.g., according to Diagnostic and Statistical Manual of Mental Disorders [DSM] or International Classification of Diseases [ICD] diagnostic systems.
 
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:
  • Treatment-seeking individuals (including those responding to recruitment advertising)
  • Persons with concomitant psychotic disorders (e.g., schizophrenia)
  • Persons presenting in an emergency setting for alcohol-related issues (e.g., motor vehicle injury)
  • Other groups not generalizable to primary care (e.g., psychiatric inpatients, persons who are court-mandated to treatment, persons who are incarcerated )
  • KQs 4, 5: Persons with dependent alcohol abuse (or studies in which >50% of the enrolled sample is persons with dependent alcohol use)
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:
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA) single- (for adults) or two-item (for adolescents) screening test, or comparable, including the Brief Screener for Tobacco, Alcohol, and other Drugs (BSTAD) (for adolescents)
  • Alcohol Use Disorders Identification Test (AUDIT), its abbreviated version (AUDIT-C), and variants of these
  • Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) (for accuracy of detecting alcohol use only)
  • Comorbidity Alcohol Risk Evaluation Tool (CARET) (for older adults)
  • TWEAK and T-ACE (for pregnant women)
  • Studies without any screening instruments or question(s)
  • Laboratory tests
Interventions
  • Counseling  designed to reduce unhealthy alcohol use, with or without referral
  • Counseling interventions can vary in their approach (e.g., 12-step program, 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)
  • Financial incentive
  • Vocational rehabilitation
  • Community-based media or policy interventions
  • Interventions to prevent initiation of use among nonusers
  • Pharmacotherapy
  • Contingency management
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:
  • 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  (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:
  • 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:
  • Alcohol use (required), self-report and/or biologic measures, including:
    • Frequency and/or quantity of alcohol use
    • Abstinence (use/no use)
    • Severity of alcohol use disorder (reported as an index measured by a standardized questionnaire, such as the Short Inventory of Problems, Addiction Severity Index, or the Severity of Dependence Scale)
    • Meeting criteria for alcohol use disorder
  • Other risky behaviors (e.g., other drug use, risky sexual behaviors)
KQs 1b, 4b:
  • All-cause mortality
  • Alcohol-related mortality (intentional and unintentional)
  • Alcohol-related morbidity (e.g., mental health symptoms/disorders; alcohol-related liver problems, including fatty liver disease, alcoholic hepatitis, and alcoholic cirrhosis; cancer; cardiovascular disease, such as cardiomyopathy; neuropathy; cognitive impairment; gastritis; gastric ulcers; pancreatitis; anemia; injuries, assaults, and accidents; visits to emergency department and inpatient stays)
  • 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, fetal alcohol spectrum disorders)
  • Quality of life
  • Alcohol-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, or 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 alcohol use
  • Intention to change behavior
  • Intervention participation/compliance
  • Alcohol use initiation
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)

 *According to the American Society of Addiction Medicine.

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.

Current as of: October 2016

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.
https://www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan/unhealthy-alcohol-use-in-adolescents-and-adults-including-pregnant-women-screening-and-behavioral-counseling-interventions

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