Draft Research Plan
Draft Research Plan for Cognitive Impairment in Older Adults: Screening
This opportunity for public comment expires on July 26, 2017 at 8:00 PM EST
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 Review will form the basis of the USPSTF Recommendation Statement on this topic.
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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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.
Draft: Proposed Analytic Framework
Abbreviation: MCI=mild cognitive impairment.
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 cognitive impairment in adults age 65 years or older may result in improved intermediate outcomes (decisionmaking) and health outcomes (patient, family/caregiver, and societal outcomes) (Key Question 1). There is also a question related to the accuracy of screening instruments used to detect cognitive impairment (Key Question 2) and potential harms of screening (Key Question 3). Additionally, the figure illustrates how interventions for early-stage dementia may have an effect on intermediate outcomes (decisionmaking) and health outcomes (patient, family/caregiver, and societal outcomes) (Key Question 4), and whether these interventions result in any harms (Key Question 5).
Draft: Proposed 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?
Draft: Proposed Contextual Questions
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Does diagnosis of cognitive impairment (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?
Draft: 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 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; reversible causes of cognitive impairment|
|Populations||KQs 1–3: Community-dwelling older adults (including those residing in independent living facilities) age ≥65 years, without a current diagnosis of mild cognitive impairment or dementia; informal caregivers taking some kind of responsibility for the care of the patient, such as a spouse, de facto partner, relative, or friend; can receive a caregiver’s pension||Studies comprised exclusively of persons living with HIV/AIDS, Down syndrome, posttraumatic brain injury, Parkinson's disease, or stroke and those living in special settings outside of the community (e.g., hospitals, nursing or care homes, rehabilitation centers, other long-term care facilities); professional caregivers who are formally or professionally trained and paid a salary|
|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, geropsychology, or neurology clinics
|Screening||Screening instruments that can be delivered in primary care in ≤10 minutes for clinician administration or ≤20 minutes for self-administration; 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:
Family/caregiver-related outcomes: (a priori defined as primary or secondary outcomes in the trial)
KQ 2: Sensitivity, specificity, likelihood ratios, positive predictive value, negative predictive value, 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)
KQ 5: Serious adverse events (e.g., death, serious adverse drug reactions), 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 Get 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
KQ2: Cost-related outcomes
KQs 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 that are 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 studies
KQs 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 reports
KQ 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)|
Internet Citation: Draft Research Plan: Cognitive Impairment in Older Adults: Screening. U.S. Preventive Services Task Force. June 2017.