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Final Research Plan

Screening for Depression in Adults

July 03, 2014

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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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 Report will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from March 27 until April 23, 2014 at 5:00 p.m., ET.

General Adult Population, Including Older Adults

This figure is the analytic framework that depicts the two Key Questions (KQs) to be addressed by the systematic review. The figure illustrates how depression screening programs in the general adult population (including older adults) may improve health outcomes (KQ 1) but may also have possible harms (KQ 2).

 

Pregnant and Postpartum Women

This figure is the analytic framework that depicts the five Key Questions (KQs) to be addressed by the systematic review. The figure illustrates how depression screening programs in pregnant and postpartum women may improve health outcomes (KQ 1) and result in the identification of patients with depression (KQ 2) who may receive interventions. Interventions may result in changes in health outcomes (KQ 4). The analytic framework also depicts the possible adverse events occurring after screening (KQ 3) or treatment (KQ 5).

General Adult Population, Including Older Adults

  1. Do primary care depression screening programs in the general adult population, including older adults, result in improved health outcomes (decreased depressive symptomatology; decreased suicide deaths, attempts, or ideation; improved functioning; improved quality of life; or improved health status)?
    1. Does sending depression screening test results to providers (with or without additional care management supports) result in improved health outcomes?
    2. Does the effect of screening vary by population characteristics*?
  2. What are the harms associated with primary care depression screening programs in the general adult population, including older adults?
    1. Do the harms vary by population characteristics*?

Pregnant and Postpartum Women

  1. Do primary care depression screening programs in pregnant and postpartum women result in improved health outcomes (decreased depressive symptomatology; decreased suicide deaths, attempts, or ideation; improved functioning; improved quality of life; or improved health status)?
    1. Does sending depression screening test results to providers (with or without additional care management supports) result in improved health outcomes?
    2. Does the effect of screening vary by population characteristics*?
  2. What is the test performance of the most commonly used depression screening instruments in pregnant and postpartum women in primary care?
    1. Do the test performance characteristics of the screening instruments vary by population characteristics*?
  3. What are the harms associated with primary care depression screening programs in pregnant and postpartum women?
    1. Do the harms vary by population characteristics*?
  4. Does treatment (psychotherapy, antidepressants, or collaborative care) result in improved health outcomes (decreased depressive symptomatology; decreased suicide deaths, attempts, or ideation; improved functioning; improved quality of life; or improved health status) in pregnant and postpartum women who screen positive for depression in primary care?
    1. Do the effects of the interventions vary by population characteristics*?
  5. What are the harms of treatment in pregnant and postpartum who screen positive for depression in primary care?
    1. Do the harms vary by population characteristics*?
    2. What is the prevalence of other selected serious harms of treatment with antidepressants in the general (i.e., not limited to primary care) population of pregnant and postpartum women?

* Population characteristics include sex, age, race/ethnicity, comorbid conditions, and new-onset depression versus recurrent depression.

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

  1. How effective are usual care methods in identifying patients with depression (i.e., do they avoid underdiagnosis and overdiagnosis)?
  2. What is the acceptability of primary care depression screening to providers and patients?
  3. How is treatment managed in patients who screen positive for depression (e.g., how likely is it that treatment will be initiated or recommended by the provider and accepted by the patient, and how likely is the patient to receive a full therapeutic dose of treatment)? What is the acceptability of depression treatment to patients and providers?
  4. Is treatment (psychotherapy or pharmacologic) effective for relatively mild depression?
  5. Is treatment (psychotherapy or pharmacologic) effective for adults and older adults whose depression is identified through screening in primary care?
  6. What is the accuracy of the Patient Health Questionnaire and the Geriatric Depression Scale, two of the most commonly used depression screening instruments, in identifying patients with depression?

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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
General Adult Population, Including Older Adults
Condition definition Focus on major depressive disorder, persistent depressive disorder/dysthymia, and depression not otherwise specified, or “depression” with no further diagnostic specificity Trials restricted only to persons with bipolar disorder, schizoaffective disorder, seasonal affective disorder, cyclothymia, substance-induced mood disorder, minor depression, or adjustment disorder with depressed mood
Aim Studies targeting depression screening Studies restricted to screening or treatment of suicidality, bipolar disorder, or treatment-resistant depression
Population Adults, including older adults, age 18 years and older
  • Nonhuman populations
  • Children and adolescents (age <18 years), except when related to harms of antidepressants in pregnant women
  • Persons in institutions (e.g., psychiatric inpatients or prison inmates)
  • Persons in long-term care (e.g., nursing homes)
  • Trials limited to persons with comorbid conditions
  • Trials within closed preexisting social networks (e.g., church, worksite programs)
Intervention Brief standardized instrument designed to identify persons with depression (no more than 15 minutes if completed prior to visit, no more than 5 minutes if completed during visit); self-report, clinician-administered, or electronically delivered Trials primarily using treatment modalities other than psychotherapy or FDA-approved antidepressants (e.g., exercise, electroshock treatment, St. John's wort, social marketing, policy, system-level interventions, or adjunctive agents to enhance the effects of antidepressants)
Comparator Usual care, no screening, and screening with no feedback of results to providers  
Outcomes Benefits of screening (KQ 1):

Primary health outcomes

  • Depression symptoms
  • Depression remission

Other health outcomes

  • Depression response
  • Suicide deaths, attempts, or ideation
  • All-cause mortality
  • Quality of life
  • Functioning (including days of missed work)
  • Change in health status (e.g., improvement in comorbid conditions or reduction in physical complaints)
  • Emergency department visits or inpatient stays

Harms of screening (KQ 3):

  • Treatment avoidance
  • Deterioration in patient-provider relationship
  • Other harms reported by screening trials
  • Labeling or stigma
  • Inappropriate/unnecessary treatment

 
Timing of outcome assessment ≥6 weeks after baseline  
Setting
  • Primary care settings (e.g., internal medicine, family medicine, obstetrics/gynecology, family planning, military health clinics, university-based health clinics)
  • Virtual (e.g., online screening tools), if patients are identified through screening in primary care or other population-based screening
  • Psychotherapy: Mental health clinic setting acceptable only if patients are identified through screening in primary care or other population-based screening
  • Community/university research laboratories or other nonmedical centers
  • Mental health clinics (unless recruitment is through primary care screening)
  • Correctional facilities
  • School classrooms
  • Worksites
  • Inpatient/residential facilities
  • Emergency departments
Study design RCTs, CCTs All other study designs
Country Countries categorized as “Very High” on the Human Development Index (as defined by the World Health Organization) Countries not categorized as “Very High” on the Human Development Index
Language English Languages other than English
Study quality Fair or good Poor, according to design-specific USPSTF criteria
Pregnant and Postpartum Women
Condition definition Focus on major depressive disorder, persistent depressive disorder/dysthymia, and depression not otherwise specified, or “depression” with no further diagnostic specificity Trials restricted only to persons with bipolar disorder, schizoaffective disorder, seasonal affective disorder, cyclothymia, substance-induced mood disorder, minor depression, or adjustment disorder with depressed mood
Aim Screening (KQs 1, 3) and treatment (KQs 4, 5): Studies targeting depression screening and treatment

Diagnostic accuracy of screening (KQ 2): Studies addressing accuracy of depression screening instruments

Harms of antidepressants (KQ 5): Studies addressing harms of antidepressants		 Studies restricted to screening or treatment of suicidality, bipolar disorder, or treatment-resistant depression
Population Screening (KQs 1, 3): Pregnant and postpartum women age 18 years and older

Treatment (KQs 4, 5): Pregnant and postpartum women who screen positive for depression in a primary care setting or are identified through other population-based screening
  • Nonhuman populations
  • Children and adolescents (age <18 years), except when related to harms of antidepressants in pregnant women
  • Persons in institutions (e.g., psychiatric inpatients or prison inmates)
  • Persons in long-term care (e.g., nursing homes)
  • Trials limited to persons with comorbid conditions
  • Trials within closed preexisting social networks (e.g., church, worksite programs)
Intervention Screening (KQs 1, 3): Brief standardized instrument designed to identify persons with depression (no more than 15 minutes if completed prior to visit, no more than 5 minutes if completed during visit); self-report, clinician-administered, or electronically delivered

Instrument accuracy (KQ 2):): Limited to the most widely used screening tools in this population—the Patient Health Questionnaire (PHQ), in any form, including the related Primary Care Evaluation of Mental Disorders Patient Questionnaire (PRIME-MD, depression section), and the Edinburgh Postpartum Depression Scale (EPDS)

Treatment (KQs 4, 5): Primary care–relevant interventions, including psychotherapy, FDA-approved antidepressants (except tricyclic antidepressants and monoamine oxidase inhibitors), and collaborative care

 Treatment modalities other than psychotherapy or FDA-approved antidepressants (e.g., exercise, electroshock treatment, St. John's wort, social marketing, policy, system-level interventions, or adjunctive agents to enhance the effects of antidepressants); tricyclic antidepressants and monoamine oxidase inhibitors
Comparator Screening (KQs 1, 3): Usual care, no screening, and screening with no feedback of results to providers

Treatment (KQs 4, 5):

Psychotherapy

  • No intervention
  • Usual care
  • Waitlist
  • Attention control
  • Minimal intervention (e.g., usual care limited to no more than 15 minutes of information)

Antidepressants

  • No intervention
  • Placebo
  • Waitlist

Collaborative care

  • Usual care
 Treatment (KQs 4, 5 ): Active intervention (i.e., comparative effectiveness)
Outcomes Benefits of screening (KQ 1) and treatment (KQ 4):

Primary health outcomes

  • Depression symptoms
  • Depression remission

Other health outcomes

  • Depression response
  • Suicide deaths, attempts, or ideation
  • All-cause mortality
  • Quality of life
  • Functioning (including days of missed work)
  • Change in health status (e.g., improvement in comorbid conditions or reduction in physical complaints)
  • Child/infant outcomes (continuation of breastfeeding, achievement of recognized developmental milestones, reduced abuse or neglect)
  • Emergency department visits or inpatient stays

Diagnostic accuracy of screening (KQ 2):

  • Sensitivity
  • Specificity
  • Positive predictive value
  • Negative predictive value
  • Equivalent data to make such calculations (i.e., 2 x 2 table)

Harms of screening (KQ 3):

  • Treatment avoidance
  • Deterioration in patient-provider relationship
  • Others harms reported by screening trials
  • Labeling or stigma
  • Inappropriate/unnecessary treatment

Harms of antidepressant treatment (KQ 5):

  • Suicidality
  • Serotonin syndrome
  • Cardiac effects
  • Seizures (bupropion only)
  • Fetal/infant harms (neonatal death, major malformations, small for gestational age/low birth weight, preeclampsia)
  
Timing of outcome assessment Screening (KQs 1, 3): ≥6 weeks after baseline

Diagnostic accuracy of screening (KQ 2): Maximum of 2 weeks between screening and reference standard

Treatment (KQs 4, 5):

  • ≥6 weeks after baseline for treatment and harms of psychotherapy or collaborative care
  • No minimum followup for harms of antidepressants
  
Setting
  • Primary care settings (e.g., internal medicine, family medicine, obstetrics/gynecology, pediatrics [for postpartum screening], family planning, military health clinics, university-based health clinics)
  • Virtual (e.g., online screening tools), if patients are identified through screening in primary care or other population-based screening
  • Psychotherapy: Mental health clinic setting acceptable only if patients are identified through screening in primary care or other population-based screening

Harms of antidepressant treatment (KQ 5): Any outpatient clinical setting
  • Community/university research laboratories or other nonmedical centers
  • Mental health clinics (unless recruitment is through primary care screening)
  • Correctional facilities
  • School classrooms
  • Worksites
  • Inpatient/residential facilities
  • Emergency departments
Study design Benefits of screening (KQ 1), harms of screening (KQ 3), and benefits of treatment (KQ 4): RCTs, CCTs

Diagnostic accuracy (KQ 2): Comparison with gold standard (structured or semistructured diagnostic interview or a nonbrief [>5 minutes] unstructured interview with mental health clinician) within 2 weeks of screening in populations that include a full spectrum of patient severity for the given setting (i.e., studies cannot limit patient pool to only nondepressed and known/highly likely depressed patients)

Harms of antidepressant treatment (KQ 5): Systematic reviews; large comparative cohort or case-control observational studies published after identified systematic reviews that include observational studies

“Large” is operationalized as:

  • n ≥10,000 with at least 6 months of followup for suicide attempts and deaths
  • n ≥1,000 with at least 3 months of followup for other outcomes
 All other study designs
Country Countries categorized as “Very High” on the Human Development Index (as defined by the World Health Organization) Countries not categorized as “Very High” on the Human Development Index
Language English Languages other than English
Study quality Fair or good Poor, according to design-specific USPSTF criteria

Abbreviations: FDA = Food and Drug Administration; RCT = randomized, controlled trial; CCT = controlled clinical trial.

The draft Research Plan for this topic was posted for public comment from March 27 to April 23, 2014. Several comments requested that the USPSTF examine the effects of a positive screen on subsequent treatment processes, such as treatment initiation, referral for treatment, referral acceptance, and compliance. To address these factors more fully, the USPSTF broadened one contextual question. The USPSTF also expanded the inclusion criteria for studies to include several outcomes (e.g., emergency department visits, inpatient stays, and several child-related outcomes for pregnant and postpartum women) in response to comments.