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Draft Research Plan

Primary Care Screening for Depression in Adults


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

This draft Research Plan is available for comment from March 27 until April 23, 2014 at 5:00 p.m., ET. You may wish to read the entire Research Plan before you comment.


I. Proposed Analytic Framework

General Adult Population, Including Older Adults

Select Text Description below for details.

[D] Select for Text Description.

Pregnant and Postpartum Women

Select Text Description below for details.

[D] Select for Text Description.

II. Proposed Key Questions to Be Systematically Reviewed

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 depression screening programs in pregnant and postpartum women in primary 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)?
    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 depression screening programs in pregnant and postpartum women in primary care?
    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 primary care patients who screen positive for depression?
    1. Do the effects of the interventions vary by population characteristics*?
  5. What are the harms of treatment in pregnant and postpartum primary care patients who screen positive for depression?
    1. Do the harms of depression treatment vary by population characteristics*?
    2. What is the prevalence of other selected serious harms of antidepressants in the general (not limited to primary care–screened) population or pregnant and postpartum women?

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

III. Proposed Contextual Questions

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 screening for depression in primary care to providers and patients?
  3. In patients who screen positive for depression, how likely is it that treatment will be recommended by the provider and accepted by the patient? 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 adult and older adult primary care patients whose depression is identified through screening?
  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 who are depressed?

IV. 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 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 with a primary focus on 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 targeting 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
  • Institutionalized individuals (e.g., psychiatric inpatients or prison inmates)
  • Individuals in long-term care (e.g., nursing homes)
  • 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, 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
  • Change in health status (e.g., improvement in comorbid conditions or reduction in physical complaints)
  • Child/infant outcomes in postpartum women

Harms of screening (KQ 3):

  • Treatment avoidance
  • Deterioration in patient-provider relationship
  • Others 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 RCT, CCT 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 with a primary focus on 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 targeting screening or treatment of suicidality, bipolar disorder, or resistant depression
Population Screening (KQs 1, 3): Adult pregnant and postpartum women, age 18 years and older

Treatment (KQs 4, 5): Pregnant and postpartum women screening positive for depression in a primary care setting or identified through other population-based screening

  • Nonhuman populations
  • Children and adolescents (age <18 years), except when related to harms of antidepressants in pregnant women
  • Institutionalized individuals (e.g., psychiatric inpatients or prison inmates)
  • Individuals in long-term care (e.g., nursing homes)
  • 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): Limit to 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, 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)
Comparator Screening (KQs 1, 3): Usual care, no screening, 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
  • Change in health status (e.g., improvement in comorbid conditions or reduction in physical complaints)
  • Child/infant outcomes in postpartum women

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 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/birthweight
 
Timing of outcome assessment Screening (KQs 1, 3): 6 weeks after baseline

Diagnostic accuracy of screening (KQ 2): Maximum 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 antidepressants (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): RCT, CCT

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 full spectrum of patient severity for the given setting (i.e., 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

AHRQ Publication No. 14-05208-EF-5
Current as of March 2014


Internet Citation:

U.S. Preventive Services Task Force. Primary Care Screening for Depression in Adults: Draft Research Plan. AHRQ Publication No. 14-05208-EF-5. http://www.uspreventiveservicestaskforce.org/draftresplan3.htm



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