Note: This draft Recommendation Statement is not the final recommendation of the U.S. Preventive Services Task Force. This draft is distributed solely for the purpose of pre-release review. It has not been disseminated otherwise by the USPSTF. It does not represent and should not be interpreted to represent a USPSTF determination or policy.
This draft Recommendation Statement is based on an evidence review that was published on October 22, 2013 (available at http://www.uspreventiveservicestaskforce.org/uspstf14/dementia/dementart.htm).
The USPSTF makes recommendations about the effectiveness of specific preventive care services for patients without related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
This draft Recommendation Statement is available for comment from November 5 until December 2, 2013 at 5:00 PM ET. You may wish to read the entire Recommendation Statement before you comment. A fact sheet that explains the draft recommendations in plain language is available here.
Screening for Cognitive Impairment in Older Adults: U.S. Preventive Services Task Force Recommendation Statement
Summary of Recommendation and Evidence
The U.S. Preventive Services Task Force (USPSTF) concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for cognitive impairment.
This is an I statement.
See the Clinical Considerations section for suggestions for practice regarding the I statement.
Dementia affects approximately 2.4 to 5.5 million Americans. Its prevalence increases with age, to 5% in persons ages 71–79 years, 24% in persons ages 80–89 years, and 37% in those older than age 90 years.
The USPSTF found adequate evidence that some screening tools have sufficiently high sensitivity and specificity to be clinically useful in identifying dementia.
Benefits of Detection and Early Intervention
The USPSTF found inadequate direct evidence on the benefits of screening for cognitive impairment. There is evidence that several drug therapies and nonpharmacologic interventions have a small effect on cognitive function measures in the short-term for patients with mild to moderate dementia, but the magnitude of the clinically relevant benefit is uncertain. The USPSTF found adequate evidence that interventions targeted to caregivers have a small effect on measures of caregiver burden and depression, but the magnitude of the clinically relevant benefit is uncertain. The USPSTF found no published evidence on the impact of screening on decisionmaking or planning by patients, clinicians, or caregivers.
Harms of Detection and Early Intervention and/or Treatment
The USPSTF found inadequate evidence on the harms of screening for cognitive impairment and the harms of nonpharmacologic interventions. The USPSTF found adequate evidence that acetylcholinesterase inhibitors (AChEIs) are associated with adverse events, some of which are serious, including central nervous system disturbances and arrhythmia. Gastrointestinal symptoms are also common.
The USPSTF concludes that the evidence for screening for cognitive impairment is lacking and that the balance of benefits and harms cannot be determined.
Patient Population Under Consideration
This recommendation applies to adults older than age 65 years.
Suggestions for Practice Regarding the I Statement
Potential Preventable Burden
The prevalence of dementia in the United States is 5% in persons ages 71–79 years, rising to 24% in those ages 80–89 years and 37% in those older than age 90 years (1, 2). It is difficult to estimate the prevalence of older adults with mild cognitive impairment (MCI) because of differences in the definition of MCI and methods used in studies; estimates range widely, from 3% to 42% in adults age 65 years and older. About 40% to 50% of older adults report subjective memory complaints. Although the evidence for routine screening is insufficient, there may be important reasons to identify early cognitive impairment. Early recognition of cognitive impairment, in addition to its potential to help patients make diagnostic and treatment decisions, allows clinicians to anticipate problems patients may have in understanding and adhering to recommended therapy. This information may also be useful to patients and their caregivers and family members in anticipating and planning for future problems that may develop as a result of progression of cognitive impairment. Therefore, while the overall evidence on routine screening is insufficient, clinicians should remain alert to early signs or symptoms of cognitive impairment and evaluate as appropriate.
Information about the harms of screening, including labeling and the effect of false-positive results, is limited. AChEIs are associated with adverse events, some of which are serious, including central nervous system disturbances and bradycardia. Gastrointestinal symptoms are also common. Information about the harms of nonpharmacologic interventions is limited, but these harms are assumed to be few. Exercise interventions are not associated with serious adverse effects.
The cost of screening varies depending on the screening instrument. Some instruments take little time and are free to the public. The most widely studied instrument, the Mini-Mental State Examination (MMSE), takes approximately 10 minutes to administer and is not free. The estimated total health, long-term, and hospice care costs for dementia in the United States were $183 billion in 2011. Medicare and Medicaid pay approximately 40% to 70% of these costs, representing $130 billion. These costs do not include the estimated $202 billion in uncompensated care that informal caregivers provide annually (3).
Currently, diagnosis of dementia is initiated mostly on the basis of a clinician's suspicion of patient symptoms or caregiver concerns. As many as 29% to 76% of patients with dementia or probable dementia have not been diagnosed by a primary care physician (4-6). In 2011, Medicare added detection of cognitive impairment to the new Annual Wellness Visit benefit.
Assessment of Risk
Increasing age is the strongest known risk factor for cognitive decline. The ε4 allele of the lipoprotein E gene is a risk factor for Alzheimer's disease in nonHispanic whites. Other risk factors for cognitive decline or dementia with less evidence include cardiovascular risk factors (such as diabetes, tobacco use, hypercholesterolemia, hypertension, metabolic syndrome), depression, physical frailty, low educational level, low social support, and having never been married.
Several dietary and lifestyle factors have been associated with a decreased risk for dementia; these factors have weaker supporting evidence than those previously mentioned. Adequate folic acid intake, low saturated fat intake, longer-chain omega-3 fatty acids, high fruit and vegetable intake, Mediterranean diet, moderate alcohol intake, educational attainment, cognitive engagement, and participation in physical activity are all associated with a decreased risk for dementia.
Brief screening tests for cognitive impairment in the clinical setting generally include asking patients to perform a series of tasks that assess one or more cognitive domains (memory, attention, language, and visuospatial or executive functioning). Blood tests and radiology examinations are not currently used as screening tests. Although optimal sensitivity and specificity of the MMSE likely vary depending on the patient's age and education level, a large body of literature suggests a general cut-point of 23/24 or 24/25 is appropriate for most primary care populations.
Other instruments with more limited evidence include the Clock Draw Test, Mini-Cog, Memory Impairment Screen, Abbreviated Mental Test, Short Portable Mental Status Questionnaire, Free and Cued Selective Reminding Test, 7-Minute Screen, Telephone Interview for Cognitive Status, and Informant Questionnaire on Cognitive Decline in the Elderly. Each of these tests has reasonable test performance in some studies, but estimates of sensitivity and specificity vary, and the optimal diagnostic threshold/cut-point for many of these instruments is unclear.
Treatment and Interventions
Treatment for cognitive impairment focuses on a number of signs and symptoms, including quality of life, cognition, mood, and behavioral impairments.
There are multiple pharmacologic and nonpharmacologic interventions aimed at preventing, slowing, or reversing cognitive decline in older adults or improving caregiver burden and depression. U.S. Food and Drug Administration (FDA)-approved pharmacologic treatments include AChEIs and memantine. Nonpharmacologic interventions include cognitive training, lifestyle behavioral interventions, exercise, educational interventions, and multidisciplinary care interventions. A number of interventions focus on the caregiver and aim to improve caregiver morbidity and delay institutionalization of persons with dementia.
Research Needs and Gaps
More research on screening for and treatment of MCI is needed. Evidence on the impact of early detection of mild to moderate dementia on decisionmaking and planning is a critical gap in the evidence. Given the lack of evidence that treatment affects long-term cognitive outcomes for mild to moderate dementia, the impact on decisionmaking and planning could be the most compelling reason for screening. However, no studies provided information on this impact. Research on new interventions that clearly have an impact on the long-term clinical course of mild to moderate dementia is also critically needed.
Burden of Disease
Dementia is an acquired condition that is characterized by a decline in at least two cognitive domains (loss of memory, attention, language, and visuospatial or executive functioning) that is severe enough to affect social or occupational functioning (7). Patients with dementia may also exhibit behavioral and psychological symptoms. The major dementia syndromes in older adults include Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease with dementia, and dementia of mixed etiology (8). MCI is distinguished from dementia in that cognitive impairment is not severe enough to interfere with instrumental activities of daily life.
Dementia affects approximately 2.4 to 5.5 million Americans, but its prevalence is difficult to determine because of differences in definitions and populations used in studies (8-10). Age is the most important risk factor. Data from large population-based surveys indicate that the prevalence of dementia in the United States is 5% in persons ages 71 to 79 years, 24% in those ages 80 to 89 years, and 37% in those older than age 90 years (8). Prevalence varies by race; prevalence in adults age 71 years and older in one large study was 21.3% for blacks and 11.2% for whites (11). The prevalence of Alzheimer's disease in Hispanics is approximately 1.5 times that observed in the white population (11-13). Dementia also affects more women than men. In persons age 71 years and older, approximately 16% of women have dementia compared with 11% of men; these differences are primarily explained by women's longer life expectancy rather than any sex-based risk factors (14). Alzheimer's disease accounts for between 60% and 80% of all dementia, frontotemporal dementia accounts for 12% to 25%, 10% to 20% is considered vascular dementia, 5% to 10% is considered dementia with Lewy bodies, and between 10% and 30% is considered dementia with mixed etiology (8, 10, 15). Estimating the prevalence of MCI is difficult, and estimates range widely, from 3% to 42% in adults age 65 years and older, depending on the population and diagnostic criteria used (16, 17).
Scope of Review
In 2003, the USPSTF concluded that the evidence was insufficient to recommend for or against routine screening for dementia in older adults. To update its recommendation, the USPSTF commissioned a systematic review of the evidence on screening for cognitive impairment, including both dementia and MCI. The evidence review gathered evidence on 1) the benefits, harms, and diagnostic accuracy of brief screening instruments to detect cognitive impairment in older adults, and 2) the benefits and harms of commonly used treatment and management options for older adults with MCI or early dementia and their caregivers. Important potential benefits included decisionmaking, cognitive function, physical function, quality of life, safety, and caregiver burden. The review focused on screening adults in primary care and the management of screen-detected patients with cognitive impairment, excluding delirium. The review on treatment and management focused on studies of adults with mild to moderate dementia, as these are the patients most likely to be identified through screening.
Accuracy of Screening Tests
The review identified 55 studies on brief instruments that screen for cognitive impairment. Forty-six of the studies provided evidence on the accuracy of screening for dementia and 27 studies provided evidence on the accuracy of screening for MCI. These studies were conducted in primary care–relevant populations and most were brief (≤10 minutes) and administered in a clinical setting. Studies on self-administered instruments were also reviewed.
Screening instruments that were evaluated in more than two studies include the MMSE, Clock Drawing Test, verbal/category fluency tests, Informant Questionnaire on Cognitive Decline in the Elderly, Memory Impairment Screen, Mini-Cog, Abbreviated Mental Test, and the Short Portable Mental Status Questionnaire. The MMSE was the most evaluated instrument, with 25 published studies. The MMSE is a 30-point instrument with 11 items. It has been studied in a variety of populations; the mean age of participants ranged from 69 to 95 years, the mean prevalence of dementia ranged from 1.2% to 38%, and education level also varied widely but was not always reported. For the most commonly reported cut-points (23/24 or 24/25), the pooled sensitivity from 14 studies (n=10,185) was 88.3% (95% CI, 81.3% to 92.9%) and specificity was 86.2% (95% CI, 81.8% to 89.7%) (1, 2). The other instruments were studied in far fewer studies (four to seven studies each), had limited reproducibility in primary care–relevant populations, and had unknown optimal cut-points for each instrument. The sensitivity and specificity ranged widely in these studies.
Effectiveness of Early Detection and/or Treatment
No trials examined the direct effect of screening for cognitive impairment on important patient outcomes, including decisionmaking outcomes. The review identified more than 130 studies on a number of different interventions aimed at managing or treating mild to moderate dementia, including pharmacological and nonpharmacological interventions. Pharmacologic interventions included FDA-approved medications used to treat patients with Alzheimer's disease for the purpose of preventing/delaying cognitive decline (AChEIs and memantine), medications aimed at cardiovascular risk reduction for vascular dementia, nonsteroidal anti-inflammatory drugs, gonadal steroids, and dietary supplements. The review also considered evidence on nonpharmacologic interventions, including interventions aimed primarily at the caregiver or patient-caregiver dyad and interventions aimed primarily at the patient (such as cognitive training, rehabilitation, and/or stimulation, with or without motor skills training interventions; exercise interventions; multidisciplinary care interventions involving assessment and care coordination; and education-only interventions).
Fifty-four trials provided evidence on AChEIs for the treatment of mild to moderate Alzheimer's disease (donepezil, galantamine, rivastigmine, and tacrine), including four trials of persons with MCI. Ten additional trials reported on memantine in persons with moderate dementia. Many studies reported differences in scores on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The ADAS-cog is a validated instrument that assesses memory, attention, orientation, language, and praxis. Scores range from 0 to 70, with higher scores signifying greater cognitive impairment; a change of 4 points or more is commonly accepted to be clinically significant for patients with mild to moderate dementia. AChEIs and memantine improved global cognitive function by approximately 1- to 3-points difference on the ADAS-cog. A meta-analysis of seven rivastigmine trials reported a 3-point difference on the ADAS-cog (−3.06 [95% CI, −4.48 to −1.65]; I2=92.6%). Only four trials were conducted in persons with MCI and reported global cognitive function (18-21). These trials, for donepezil and galantamine, generally showed a small but unclear clinical impact on global cognitive function. Only half of the trials reported global physical function; findings were inconsistent and sparsely reported. Few studies reported outcomes beyond 6 months. Longer-term studies were generally consistent with studies of shorter duration and demonstrated statistically significant small improvements of unknown clinical importance.
The review considered 26 studies that evaluated other medications or supplements, including low-dose aspirin, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs, gonadal steroids, and dietary supplements, and did not find any evidence that these medications or supplements provided a benefit in global cognitive or physical function in persons with mild to moderate dementia or MCI (1).
The review identified 59 studies that evaluated the effect of nonpharmacological interventions aimed at the caregiver or both the patient and caregiver. Most of these trials evaluated interventions that included an educational component designed to increase caregiver skills. Although the approaches to education in the interventions varied, there was a generally consistent finding of small benefit on caregiver burden and depression outcomes in persons caring for patients with moderate dementia. The clinical meaning of the changes in caregiver burden and depression is unknown, but on average is likely small at best. Ten studies on exercise interventions were reviewed; the clinical impact of these results on important outcomes is uncertain because of the limited number of trials and the variability in studied populations, exercise interventions, and reported outcomes.
Fifteen cognitive intervention trials provided somewhat inconsistent evidence that cognitive stimulation plus or minus cognitive training appears to improve global cognitive function measures in the short-term for persons with MCI or dementia. However, it is difficult to determine the magnitude and certainty of the clinical benefit because of the limited number of trials, clinical and statistical heterogeneity combined, and imprecision of results.
Potential Harms of Screening and/or Treatment
No studies reported on the direct or indirect harms from false-positive or false-negative results, psychological harms, unnecessary diagnostic testing, or labeling. One study provided some information on the potential harms of screening for cognitive impairment in primary care. In this study of 3,573 older adults, about half of patients who had a positive screening test for cognitive impairment (207/434) declined a formal diagnostic workup for dementia. Only 233 out of 3,573 participants initially refused to be screened (22, 23).
Adverse effects from AChEIs are common. Withdrawal or discontinuation rates in studies of AChEIs were 14% for donepezil and rivastigmine and 17% for galantamine. Serious adverse events from these medications appear to occur with similar frequency across the different AChEIs. Bradycardia and adverse events related to bradycardia (such as falls, syncope) may result from taking AChEIs. Tacrine, which had very high discontinuation rates in trials, has an uncommon but serious adverse effect of liver toxicity. Tacrine is no longer used in the United States because of this reason. In trials, memantine did not differ from placebo in the percentage of withdrawals from medication due to adverse effects or serious adverse effects. Evidence on the harms of nonpharmacologic interventions in patients with dementia and/or their caregivers is limited.
Estimate of Magnitude of Net Benefit
The USPSTF found no evidence on the direct benefits and harms of screening for cognitive impairment, and therefore considered the indirect evidence on screening accuracy, early treatment, and harms. There is adequate evidence that some screening tools can accurately identify dementia. Treatment of mild to moderate dementia with several drug therapies and nonpharmacologic interventions results in small improvements in measures of cognitive function and caregiver outcomes, but the clinical significance of these improvements is uncertain. The USPSTF found no published evidence on the impact of screening on decisionmaking or planning by patients, clinicians, or caregivers. There is inadequate evidence on the harms of screening and nonpharmacologic interventions. The USPSTF found adequate evidence that AChEIs are associated with adverse events, some of which are serious. Overall, the USPSTF was unable to estimate the balance of benefits and harms of screening for cognitive impairment.
How Does Evidence Fit With Biological Understanding?
Dementia is the manifestation of various pathophysiologic changes in the brain; therefore, developing early interventions that would result in an important clinical impact on all types of dementia is difficult. The exact etiologic mechanism for many types of dementia is not known. Most dementia in the United States is a result of Alzheimer's disease, which is the target of most FDA-approved drugs for dementia. Given that current therapies for dementia do not appear to affect the long-term progression of mild to moderate cognitive impairment, many hope for effective interventions that can help patients and caregivers prepare for dealing with the symptoms of dementia.
Update of Previous USPSTF Recommendation
This recommendation updates the 2003 USPSTF recommendation on screening for dementia. This updated recommendation differs from the 2003 recommendation in that it considers the evidence on screening for and treatment of MCI in addition to dementia and how screening affects decisionmaking and planning. The current review found much more information on screening accuracy than the 2003 review, and the USPSTF was able to conclude that there is now adequate information on the accuracy of some screening tools. Similar to the 2003 review and recommendation, the USPSTF found that pharmacologic treatments result in small benefits of unknown clinical significance and concluded again that the overall evidence is insufficient to make a recommendation.
Recommendations of Others
There are no formal guidelines on screening for dementia or cognitive impairment from professional organizations. In 2011, Medicare began covering the detection of cognitive impairment as a part of the new Annual Wellness Visit benefit. In 2013, the Alzheimer's Association published guidance on the detection of cognitive impairment during the Annual Wellness Visit and recommended an algorithm starting with a health risk assessment, patient observation, and unstructured questioning. The use of a brief structured assessment (such as the General Practitioner Assessment of Cognition, Mini-Cog, Memory Impairment Screen, AD8, or short version of the Informant Questionnaire on Cognitive Decline in the Elderly) is recommended if signs or symptoms of cognitive impairment are present or if an informant is not available to confirm the absence of signs or symptoms (24).
Table 1: What the Grades Mean and Suggestions for Practice
Table 2: Levels of Certainty Regarding Net Benefit
|Level of Certainty*||Description|
|High||The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.|
|Moderate||The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by factors such as:
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
|Low||The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
More information may allow an estimation of effects on health outcomes.
*The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.
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18. Doody RS, Ferris SH, Salloway S, Sun Y, Goldman R, Watkins WE, et al. Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial. Neurology. 2009;72(18):1555-61.
19. Koontz J, Baskys A. Effects of galantamine on working memory and global functioning in patients with mild cognitive impairment: a double-blind placebo-controlled study. Am J Alzheimers Dis Other Demen. 2005;20(5):295-302.
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AHRQ Publication No. 14-05198-EF-2
Current as of November 2013
U.S. Preventive Services Task Force. Screening for Cognitive Impairment in Older Adults: Draft Recommendation Statement. AHRQ Publication No. 14-05198-EF-2. http://www.uspreventiveservicestaskforce.org/draftrec.htm