Final Research Plan
Final Research Plan for Cognitive Impairment in Older Adults: Screening
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 June 29 to July 26, 2017.
Key Questions to Be Systematically Reviewed
- Does screening for cognitive impairment in community-dwelling older adults in primary care–relevant settings improve decisionmaking, patient, family/caregiver, or societal outcomes?
- What is the accuracy of screening instruments to detect cognitive impairment in community-dwelling older adults?
- What are the harms of screening for cognitive impairment in community-dwelling older adults?
- Do interventions for mild to moderate dementia or mild cognitive impairment in community-dwelling older adults improve decisionmaking, patient, family/caregiver, or societal outcomes?
- What are the harms of interventions for mild to moderate dementia or mild cognitive impairment in community-dwelling older adults?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Does diagnosis of cognitive impairment (either dementia or mild cognitive impairment) improve patient, family/caregiver, or clinician decisionmaking?
- What is the effectiveness of interventions to prevent mild cognitive impairment or dementia in adults without current cognitive impairment?
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).
|Condition||KQs 1–3: Any cognitive impairment (mild cognitive impairment* or dementia†)
KQs 4, 5: Mild cognitive impairment* or mild to moderate dementia†
|KQs 4, 5: Severe dementia|
|Populations||KQs 1–3: Community-dwelling older adults (including those residing in independent living facilities) age ≥65 years (or studies with a mean age ≥65 years) without a current diagnosis of mild cognitive impairment or dementia; informal caregivers taking some responsibility for the care of the patient, such as a spouse, partner, relative, or friend
KQs 4–5: Community-dwelling older adults (including those residing in independent living facilities) age ≥65 years (or studies with a mean age ≥65 years) with a current diagnosis of mild cognitive impairment or dementia; informal caregivers taking some responsibility for the care of the patient, such as a spouse, partner, relative, or friend
|Settings||Primary care outpatient settings (ambulatory care), home, residential care facilities, assisted living facilities, and adult foster care||All KQs: Hospitals, intermediate care facilities (e.g., nursing homes, rehabilitation facilities, subacute care facilities), emergency departments, or other settings not generalizable to primary care
KQs 1–3: Studies in which participants are recruited from memory, dementia, geropsychiatry, or neurology clinics
|Screening||Screening instruments that can be delivered in primary care in ≤10 minutes by the clinician or ≤20 minutes by the patient; informant instruments||Screening instruments that take >10 minutes for clinician administration or >20 minutes for self-administration; biomarkers (cerebrospinal fluid, blood plasma, urine) or imaging (computed tomography, magnetic resonance imaging, positron emission tomography)|
|Comparisons||KQs 1, 3: No screening, usual care
KQ 2: Reference standard (clinical assessment or neuropsychologic testing with explicit diagnostic criteria, with or without expert consensus/conference)
|KQs 4, 5: Active intervention|
|Outcomes||KQs 1, 4: Decisionmaking outcomes:
Family/caregiver-related outcomes: (a priori defined as primary or secondary outcomes in the trial)
Societal outcomes: Safety (e.g., automobile accidents)
KQ 2: Sensitivity, specificity, likelihood ratios, positive and negative predictive values, area under the curve
KQ 3: Paradoxical effects (unwanted or unexpected direction of effects of outcomes), psychological harms (depression, anxiety), and harms due to labeling (psychological harms, insurance status, loss of driving privileges)KQ 5: Serious adverse events (e.g., death, serious adverse drug reactions), adverse reactions from medications, unexpected medical attention (e.g., emergency department visits, hospitalizations), paradoxical effects (unwanted or unexpected direction of effects of outcomes), and psychological harms (depression, anxiety)
|KQs 1, 4:
Decisionmaking outcomes: Cost-related outcomes
Patient-related outcomes: Cost-related outcomes; patient satisfaction (other than health-related quality of life); biomarker protein levels, brain matter volume, and brain cell activity level; function markers (e.g., Timed Up and Go Test, 6-meter timed walk, Functional Reach Test)
Family/caregiver-related outcomes: Cost-related outcomes; family/caregiver satisfaction (other than caregiver burden and health-related quality of life)
Societal outcomes: Cost-related outcomes
KQ 2: Cost-related outcomesKQs 3, 5: Patient or family/caregiver dissatisfaction (other than psychological harms or patient adherence)
|Timing of outcome assessment||KQs 1, 4: ≥3 months after baseline
KQs 3, 5: No minimum followup
|KQs 1, 4: <3 months after baseline|
|Countries||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 not categorized as “Very High” on the 2014 Human Development Index|
|Study designs||KQs 1, 4: Randomized, controlled trials; nonrandomized, controlled trials
KQ 2: Diagnostic accuracy studiesKQs 3, 5: Randomized, controlled trials; nonrandomized, controlled trials; open-label extensions of KQ 4 trials; cohort or case-control studies
|KQs 1, 4: Observational studies
KQ 2: Case-control studies
KQ 3, 5: Case series, case reportsKQ 5: Cohort or case-control studies with <1,000 participants
|Publication language||English||Languages other than English|
|Study quality||Fair- or good-quality studies||Poor-quality studies (according to design-specific USPSTF criteria)|
* Mild cognitive impairment is distinguished from dementia by virtue of causing cognitive impairment that is not severe enough to interfere with independence in daily function, although the nomenclature, definitions, and criteria may vary within the included body of evidence.
Response to Public Comment
A draft Research Plan was posted on the USPSTF Web site for public comment from June 29 to July 26, 2017. In response to public comment, the USPSTF defined mild cognitive impairment and clarified the specific etiologies of dementia that will be included, and clarified that studies conducted exclusively among persons with potential reversible causes of dementia will be excluded. The USPSTF made no substantive changes that altered the scope of the review.
Internet Citation: Final Research Plan: Cognitive Impairment in Older Adults: Screening. U.S. Preventive Services Task Force. November 2017.