WORKING
P A P E R
Quality Indicators for
Preventive Care of the
Vulnerable Elder
DAVID C. RHEW
PAUL G. SHEKELLE
WR-178
August 2004
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QUALITY INDICATORS FOR PREVENTIVE CARE
OF THE VULNERABLE ELDER
David C. Rhew, MD
Paul G. Shekelle, MD, PhD
From the Greater Los Angeles VA Health Care System, Los Angeles, CA (D.C.R, P.G.S.); Zynx
Health Incorporated, a subsidiary of Cedars-Sinai Health System, Beverly Hills, CA (D.C.R);
RAND Health Sciences Program, Santa Monica, California (P.G.S.)
This study was supported by a contract from Pfizer Inc to RAND.
Corresponding author is Dr. Rhew at Greater Los Angeles VA Healthcare System,
West Los Angeles VAMC, Division of Infectious Diseases
11301 Wilshire Blvd, #111F
Los Angeles, CA 90073
(310) 268-3015
Word Count: 4,194
FAX: (310) 268-4928
e-mail: rhew@zynx.com
INTRODUCTION
It has been estimated that by the year 2030, there will be 70 million persons aged 65 or
older living in the US, and that elders will represent 20% of the US population.(1) As the
population continues to grow, conditions that commonly afflict elders will impact a larger
number of people.
Cancer is the leading cause of death among women age 60 to 79, and it is the second
leading cause of death among men age 60 and older and among women age 80 and older.(2)
Breast cancer is the second most common cause of death due to cancer for women age 60 to 79
and the third most common in women age 80 and older.(2) Incidence and survival rates from the
Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute
and breast cancer mortality data from the National Center for Health Statistics (NCHS)
demonstrate that the age group continuing to experience an increase in breast cancer-specific
mortality and for whom breast cancer-specific mortality rates are the highest are the 80 and 85+
years old age groups, respectively.(3) Colon cancer is the second most common cause of death
due to cancer in women age 80 and older and the third most common cause in women age 60 to
79. It is also the third most common cause of death due to cancer in men age 60 and older.(2)
Health-related issues such as excessive alcohol consumption, tobacco use, and lack of
exercise are also common problems in the elderly. They are associated with significant
morbidity and mortality and are potentially preventable. Four to 10% of elderly patients who
present to their primary care physician are alcoholics(4-6), and one study in 1989 from the
Health Care Financing Administration identified 87,147 hospitalizations related to alcohol
consumption in elderly Medicare beneficiaries.(7) The hospitalization rate for alcohol-related
2
diagnoses in that year was similar to that for patients with myocardial infarction.(7) Data from
the Third National Health and Nutrition Examination Survey (NHANES III) indicate that 10 to
20% of adults aged 65 to 84 years of age smoke(8), and more than 70% of all deaths attributable
to smoking occur in adults aged 65 or older.(9) NHANES III data also indicate that 17 to 48% of
persons aged 65 to 84 years of age live a sedentary lifestyle (ie, do not participate in leisure-time
physical activity).(8) Lack of exercise is associated with increased risk of developing cancer,
cardiovascular disease, and death.(10)
Early detection and prevention of medical illness may reduce morbidity and mortality in
the elderly population,(11) especially among those at greatest risk for developing and dying from
disease. Thus, implementation of preventive care measures represents a potential opportunity to
improve longevity and quality of life for vulnerable elders. In addition, screening for vulnerable
elders focuses on identifying sources of potential and current dysfunction in order to initiate
actions to improve function or delay or decrease disabilities. This paper evaluates the evidence
concerning cancer screening and other preventive health measures for vulnerable elders,
including comprehensive geriatric assessment, screening for problem drinking, and counseling
about smoking cessation and exercise.
METHODS
The methods for developing these quality indicators, including literature review and
expert panel consideration, are detailed in a preceding paper.(12) For preventive services, the
structured literature review identified 7,885 titles, from which abstracts and articles were
3
identified that were relevant to this report. Based on the literature and the authors’ expertise, 15
potential quality indicators were proposed.
RESULTS
Of the 15 potential quality indicators, 8 were judged valid by the expert panel process
(see ACOVE Quality Indicators) and 7 were not accepted. The literature summaries that support
each of the indicators judged to be valid by the expert panel process are described below.
Quality Indicator #1
Geriatric evaluation
ALL vulnerable elders newly admitted to a physician practice should receive within six months
the elements of a comprehensive geriatric assessment, BECAUSE such an assessment,
combined with treatment of the identified conditions, improves outcomes.
Supporting evidence: Comprehensive geriatric assessment (CGA) is defined as a
multidimensional evaluation, in which problems are uncovered, described and explained, if
possible, and in which the resources and strengths of the patient are catalogued, need for services
identified, and a coordinated care plan developed to focus interventions on the patient’s
problems.(13) It is particularly valuable when targeted to vulnerable or frail older people who
have multiple health problems and are at high risk for functional decline or death.
The medical elements of a CGA include special attention to cognition, physical function,
affect, visual impairment, hearing impairment, malnutrition, incontinence and disorders of
4
balance and mobility. In addition, the practitioner or interdisciplinary team evaluates the
psychological, social, economic and environmental status of the individual. Function is assessed
at three levels, basic ADLs, IADLs (intermediate or “instrumental”) and advanced ADLs, by
asking the patient or caregiver about the patient’s ability to perform the various activities.
Questions should be appropriate to the condition of the patient. For example, if the patient is
unable to walk, many of the IADLs and all of the advanced ADLs would become irrelevant and
the focus would be on the basic ADLs. Several validated screening instruments may be used.
The patient’s preferences for care are documented and advance directives discussed.
Although a CGA may be carried out by an individual practitioner, it typically involves
multiple health professionals working together. Participants regularly include a nurse or nurse
practitioner, a social worker and a physician. Often a psychologist, pharmacist, occupational
therapist, physical therapist or dietician contributes to the process.
A 1993 meta-analysis identified 28 controlled clinical trials of Comprehensive Geriatric
Assessment (CGA) programs, which are defined as programs that provide a comprehensive
assessment of medications, functional status, cognition, affect, gait/balance, nutrition, social
support system, and special senses, with referral for appropriate services and verification of
treatment and follow-up services as needed.(14) Programs were classified as hospital-based
geriatric evaluation and management units (GEM), inpatient geriatric consultation services
(IGCS), home assessment services (HAS), hospital home assessment services (HHAS), or
outpatient assessment services (OAS). Nearly 10,000 patients were studied among the 28 trials.
Summary odds ratios for mortality were statistically significant for the following types of
programs:
GEM at six-month follow-up (OR = 0.65, 95% C.I. = 0.46 to 0.91)
5
IGCS at six-month follow-up (OR = 0.77, 95% C.I. = 0.62 to 0.96)
HAS at 36-month follow-up (OR = 0.86, 95% C.I. = 0.75 to 0.99)
Other time points and categories of programs had summary odds ratios for mortality
favoring the intervention that did not reach conventional levels of statistical significance.(5)
Similar effects, not all reaching statistical significance, were reported for the outcomes of living
at home and for physical or cognitive function at six, 12, or 36 months. A meta-regression
analysis indicated that direct medical control over implementation of the recommendations was
associated with improvements in mortality and living situation.
Since the publication of this meta-analysis at least 23 reports of clinical trials of CGA
have been published.(15-37) Nine deserve comment here. Six randomized studies extended the
findings of beneficial effects for hospital-based CGA to the outpatient setting. In all six reports,
the patients studied were frail or vulnerable elders. The interventions included an in-home
assessment by physician assistants, nurses,(15) or gerontologic nurses,(16) an outpatient GEM
clinic,(17,18) a senior center-based, chronic illness self-management and disability prevention
program,(19) and CGA delivered at a community-based clinic.(20) The follow-up time in the
studies ranged from eight months to three years, with most studies reporting one-year outcomes.
All studies reported better outcomes among patients randomized to receive CGA. Not all
improvements in outcomes reached statistical significance. Typical results included the
following:
Improvements in the number of persons living outside of nursing homes (4% versus
10%, in one study)(16)
Improvements in physical functioning (about five points difference between groups
on the Medical Outcomes Study Short Form 36 PF-10 scale in one study)(20)
6
Improvements in affect and mood (eight-point difference between groups on the
Center for Epidemiologic Studies Depression test score)(17)
Another study found that the beneficial effects of a hospital-based CGA extended to three
years after the intervention, with the proportion of persons independent in two or more activities
of daily living greater among persons who received CGA (44%) than among controls (33%, p =
0.056).(21) There was also a statistically significant survival advantage relative to controls at
two years of follow-up for persons who received CGA.(21)
Two studies that reported no or limited benefit of CGA are worth noting here. The first
study reported no effect on health or one-year survival of a in-hospital CGA consultation with
limited follow-up.(22) This CGA program was targeted at persons with functional impairments,
geriatric syndromes, certain medical conditions, and at those age 80 or older. The second study
reported no effect on survival, hospital readmission, or nursing home placement at 60-day
follow-up from a CGA begun in hospital and completed at home.(23)
Many of the studies described above evaluated a hospital-based CGA program and most
of the others investigated multidisciplinary outpatient CGA evaluations. The expert panel
believed that requiring a multidisciplinary CGA was beyond the scope of available resources in
many areas of the country. However, they maintained that the elements of the CGA evaluation
were critical for the initial evaluation of any vulnerable elder in order to improve and preserve
health and function. Recognizing that the CGA can be a time expensive procedure, the panel
suggested that the elements of the CGA might be spread out over several clinic visits, allowing a
6-month period for their completion. From a practical perspective, many elements of a CGA can
be accomplished in the course of a usual adult initial examination. If functional level is high (for
example the patient is the president of the bridge club or plays tennis biweekly, indicating intact
7
social and physical function, respectively), then no additional testing and only minimal
documentation would be needed. On the other hand, for subclinical abnormalities or to evaluate
the extent of dysfunction, more complete evaluation of each of the components of the CGA
would be needed.
Quality Indicator #2
Follow-up of geriatric evaluation
IF the elements of a comprehensive geriatric assessment (CGA) are performed, THEN followup should assure the implementation of recommendations, BECAUSE this is likely to increase
the effectiveness of Comprehensive Geriatric Assessment in improving outcomes.
Supporting evidence: Several lines of indirect evidence support a relationship between
CGA efficacy and follow-up to assure implementation of the recommendations. First, programs
that engage in follow-up to assure implementation of the recommendations have a theoretical
advantage over programs that perform no such follow-up. Second, covariate analysis in the
meta-analysis reported above demonstrated that medical control over implementation of the
assessment recommendations was associated with improved effectiveness of CGA.(14) Medical
control over implementation assures that the recommendations are indeed implemented (another
alternative would be close follow-up between the CGA team and the primary care provider).
Finally, lack of assurance of CGA recommendation implementation has been postulated to
explain its lack of effectiveness in several trials that demonstrated minimal or no effect.(24-26)
From a practical perspective, the expert panel reasoned that primary care providers should
be capable of identifying and cataloging deficits in the elements of the CGA exam. While not
8
expected to be capable of treating each of the detected abnormalities, this provider would be
responsible for issuing appropriate referrals and ensuring follow-up in a continuity relationship so
that the patient’s function is preserved.
Quality Indicator #3
Problem drinking- screening
ALL vulnerable elders should be screened to detect problem drinking and hazardous drinking with
a history of alcohol use using standardized screening questionnaires (e.g., CAGE, AUDIT) at least
once, BECAUSE problem drinking is common in the elderly population, is responsible for a high
frequency of alcohol-related hospitalizations in the United States, and can be identified by
screening tests. Furthermore, brief physician advice can decrease alcohol use in older patients.
Supporting evidence: We identified 7 prospective studies that used either a “goldstandard” reference standard or a controlled study design to screen for problem drinking in
elders.(4,38-43) Five studies demonstrated that the AUDIT, CAGE, MAST, MAST-G, or
UMAST questionnaires may be helpful in discriminating problem drinkers in the elderly
population.(4,38-41) However, two studies(42,43) (plus an additional cross-sectional study(5)),
showed that the CAGE, and MAST questionnaires had poor sensitivity for detecting problem
drinking. A meta-analysis of studies evaluating alcohol screening tools for women demonstrated
that the CAGE questionnaire was insensitive for detecting heavy drinking among Caucasian
females, while the TWEAK and AUDIT questionnaires were adequate for African American or
Caucasian women.(44) In addition, a review article of alcohol screening tools used in the elderly
population concluded that the CAGE and MAST are the two most commonly used screening
9
tools and that the focus of screening tools should be expanded to include even lower levels of
alcohol consumption.(45) An expert-opinion based recommendation by the U.S. Preventive
Services Task Force stated that the AUDIT and CAGE questionnaires were appropriate screening
tools for problem drinking.(46) Since the development of this indicator, a systematic review has
demonstrated that the AUDIT and CAGE are the most effective screening tools. AUDIT is most
effective in screening primary care patients for at-risk, hazardous, or harmful drinking, while
CAGE is most effective in screening for alcohol abuse and dependency.(47) Also, a randomized
controlled trial (Project GOAL- Guiding Older Adult Lifestyles) has demonstrated that brief
physician advice consisting of two 10- to 15-minute counseling sessions can decrease alcohol use
in patients aged 65 and older.(48) The beneficial effects of the intervention were maintained for
the duration of the 12-month follow-up period.
Quality Indicator #4
Tobacco screening
ALL vulnerable elders should receive screening for tobacco use and nicotine dependence,
BECAUSE implementing screening systems to identify smokers increases the rate of clinician
intervention.
Supporting evidence: One meta-analysis performed by the Agency for Healthcare
Research and Quality (AHRQ) (previously known as the Agency for Healthcare Policy and
Research (AHCPR)) reviewed the efficacy of screening for tobacco use. This study was
originally published as part of an evidence-based clinical practice guideline in 1996(49), and was
then updated in 2000(50) at which time no additional studies pertaining to screening for tobacco
10
use were identified and included. In this meta-analysis, pooled data from nine randomized
controlled trials (RCTs) demonstrated that implementation of screening procedures to identify
smokers increased the rate of clinician intervention (odds ratio [OR] = 3.1, 95% C.I. = 2.2 to
4.2). Data from three RCTs indicated that implementation of screening to identify smokers
increased the rate of smoking cessation among those identified, but not significantly (OR = 2.0,
95% C.I. = 0.8 to 4.8). Furthermore, a recently published evidence-based consensus statement
recommends that healthcare systems and clinicians should implement screening methods to
identify, document, and treat all tobacco users at every visit.(51)
Quality Indicator #5
Tobacco counseling and therapy
IF a vulnerable elder uses tobacco regularly, THEN he or she should be offered counseling
and/or pharmacologic therapy to stop tobacco use at least once, BECAUSE data from metaanalyses of randomized controlled trials, cost-analyses, and expert recommendations indicate
that smoking cessation interventions are effective, may result in cost savings, and should be
implemented for all smokers. Furthermore, observational data suggest that smoking cessation
improves survival even among persons who stop smoking after age 70.
Supporting evidence: Meta-analyses and systematic reviews have reviewed the
effectiveness of various methods for smoking cessation.(49,50,52,53) One meta-analysis,
performed in 1996 and updated without need for changes in 2000, by the AHRQ(49,50)
demonstrated the following:
11
•
Clinician advice to stop smoking increased the rate of smoking cessation (OR = 1.3, 95%
C.I. = 1.1 to 1.6) (based on 7 RCTs).
•
Self-help (OR = 1.2, 95% C.I. = 1.0 to 1.6), individual counseling (OR = 2.2, 95% C.I. =
1.9 to 2.4), and group counseling (OR = 2.2, 95% C.I. = 1.6 to 3.0) were effective
smoking cessation interventions (based on 25 RCTs).
•
Three- to ten-minute counseling sessions increased the rate of smoking cessation (OR =
1.4, 95% C.I. = 1.2 to 1.7), and counseling more than ten minutes was more effective than
counseling ten minutes or less (OR = 2.4, 95% C.I. = 2.1 to 2.7), while counseling three
minutes or less was least effective (OR = 1.2, 95% C.I. = 1.0 to 1.5) (based on 56 RCTs).
•
Interventions of two to less than four weeks’ duration were associated with an odds ratio
for smoking cessation of 1.6 (95% C.I. = 1.3 to 2.0); interventions from four to eight
weeks’ duration were associated with an odds ratio of smoking cessation of 1.6 (95% C.I.
= 1.2 to 2.1); and interventions of more than eight weeks’ duration were associated with
an odds ratio of smoking cessation of 2.7 (95% C.I. = 2.2 to 3.2) (based on 55 RCTs).
•
A total of two to three person-to-person contacts was associated with an odds ratio of
smoking cessation of 2.0 (95% C.I. = 1.6 to 2.4), four to seven interventions were
associated with an odds ratio of smoking cessation of 2.5 (95% C.I. = 2.2 to 2.9), and
more than seven interventions were associated with an odds ratio of smoking cessation of
1.7 (95% C.I. = 1.2 to 2.5) (based on 55 RCTs).
Another meta-analysis published in 1988 evaluated 108 smoking cessation interventions in 39
controlled trials and demonstrated that counseling, providing literature, and providing nicotine
replacement resulted in a 6% higher rate of smoking cessation relative to controls.(53) A recently
12
published (2000) systematic review of 31 randomized trials demonstrated that brief physician
advice for smoking cessation was effective for at least 6 months (absolute risk reduction 2.5%;
odds ratio 1.69, 95% CI, 1.45 to 1.98).(52)
Economic analyses demonstrated that implementing the 1996 AHRQ smoking cessation
guidelines(54) and offering brief advice to stop smoking during routine office visits(55) were
cost-effective measures. Evidence-based recommendations have stated that smoking cessation
counseling should be provided to all smokers,(51,56,57) and the Department of Health and
Human Services report of the Surgeon General concluded that, based on evidence from several
prospective cohort and case-control studies, smoking cessation could significantly reduce
morbidity and mortality, even among persons who stopped smoking after age 70.(58)
Quality Indicator # 6
Physical activity- assessment and counseling
ALL vulnerable elders should receive an assessment of their activity level and be provided with
counseling to promote regular physical activity at least once, BECAUSE evidence exists that
physical activity and fitness reduce overall morbidity and mortality.
Supporting evidence: A meta-analysis,(59) three prospective observational studies,(6062) two retrospective studies,(63,64) and a review of the literature(65) demonstrated that
physical activity decreases the risk of death among persons of all ages. Furthermore, several
other studies showed that physical activity improves mental health, decreases bone loss, reduces
the incidence for coronary heart disease, lowers blood pressure, reduces weight, and decreases
the incidence of diabetes mellitus among elderly individuals.(66-73) Finally, an evidence-based
13
recommendation by the U.S. Preventive Services Task Force (USPSTF)(74) and a position
statement by the American College of Sports Medicine (ASCM)(75) were identified that
supported the policy of promoting exercise in elderly persons.
Quality Indicator # 7
Colorectal cancer screening
ALL vulnerable elders should be offered screening for colorectal cancer at least once with fecal
occult blood testing (FOBT) or should have had sigmoidoscopy in the last 5 years or
colonoscopy in the last 10 years, BECAUSE screening with these methods has been shown to
decrease mortality.
Supporting evidence: Randomized controlled trials of patients up to age 80 years have
found that using multiphase screening for colorectal cancer with the FOBT as the first stage of
screening resulted in a small but significant benefit for preventing cancer deaths.(76-79) A costeffectiveness analysis demonstrated that annual FOBT was the most cost-effective strategy for
screening for colorectal cancer in elderly patients.(80) A case-control study demonstrated that
patients who received sigmoidoscopy as a screening procedure experienced a survival
benefit.(81) However, the effectiveness of screening flexible sigmoidoscopy has not yet been
evaluated with randomized controlled trials. Two major organizations (the Canadian Task Force
on the Periodic Health Examination [CTFPHE](82) and the U.S. Preventive Services Task Force
[USPSTF])(83) performed evidence-based reviews of the literature (in 1994 and 1996,
respectively) and came to different conclusions on this issue. The CTFPHE concluded that
evidence was insufficient to include or exclude either multiphase screening with FOBT or
14
sigmoidoscopy from the Periodic Health Examination, while the USPSTF supported the use of
either FOBT or sigmoidoscopy as a colon cancer screening tool for persons older than age 50.
The age at which screening should be discontinued had not been established. Since the
development of these indicators, new data support the belief that colonoscopy is significantly
better than is sigmoidoscopy at detecting asymptomatic colon cancer.(84,85) However,
colonoscopy is substantially more expensive and has greater morbidity associated with the
procedure. Since the development of these indicators, Sonnenberg and colleagues have
published a cost-analysis study using a hypothetical population and a computer model that
demonstrated that screening for colorectal cancer with colonoscopy every 10 years starting at
age 50 is a more cost-effective strategy than annual fecal occult blood testing or sigmoidoscopy
every 10 years.(86) Nevertheless, it still remains to be determined which screening strategy is
most cost-effective for persons age 65 and older. Future studies are necessary before
colonoscopy can be considered the standard for colorectal screening in vulnerable elders.
Quality Indicator #8
Breast cancer screening
IF a vulnerable elderly woman is less than age 70, THEN she should be offered mammographic
screening for breast cancer every 2 years, BECAUSE use of mammography decreases breast
cancer mortality.
Supporting evidence: Three meta-analyses reported a statistically significant reduction
in risk of death from breast cancer among women up to age 70 to 74 who received screening
mammography (relative risk [RR] = 0.70, 0.71, 0.74).(87-89) However, two randomized
15
controlled trials of screening mammography(90,91) reported statistically significant reductions
in the risk of death due to breast cancer in women under age 70, but not in women age 70 or
older, while two case-control studies provided inconclusive evidence as to whether
mammography reduced breast cancer mortality among women age 65 and older.(92,93) An
economic analysis indicated that offering screening to women over the age of 70 decreased its
cost-effectiveness.(94) Finally, a retrospective analysis demonstrated that women age 65 to 74
benefited from screening mammography,(95) and an evidence-based review of the literature by
the U.S. Preventive Services Task Force (USPSTF) recommended the use of screening
mammography for women age 50 to 69.(96) Since the development of these indicators, Gotsche
and Olsen identified in a meta-analysis that only two of eight RCTs (i.e., Malmo(91) and
Canada(97)) were adequately randomized and pooled results from these two trials showed that
screening with mammography had no effect on breast cancer mortality or total mortality.(98)
However, one of the two studies(91) found that screening mammography reduced the risk of
death due to breast cancer in women under age 70. Additionally, a recently published
retrospective cohort study using population data from the SEER program demonstrated that
women aged 67 and older who did not receive mammography were more likely to be diagnosed
with breast cancer stage II or greater and also more likely to die from breast cancer than women
of the same age range who were regular users of mammography.(99)
DISCUSSION
Screening and prevention in vulnerable elders includes more than the traditional
measures thought of for the general population, such as cigarette smoking and cancer screening.
Screening and prevention in vulnerable elders includes an evaluation for the presence of geriatric
16
syndromes such as urinary incontinence, diminished hearing and vision, and early cognitive
impairment. These conditions are currently under-identified, and some treatments may reverse
or at least ameliorate the progression of decline.Some screening and prevention measures, such
as stopping cigarette use, stopping alcohol abuse, and increasing physical activity, render
immediate benefits and age or other medical conditions in general should not preclude
advocating their use. The decision to perform cancer screening, however, hinges on the life
expectancy for the individual patient and the time needed for screening to achieve benefits.
At least 5 years is needed in order for a group of average patients to accrue benefit from
cancer screening. The average life expectancy for a 75 year old person is about 10 years.(100)
Clearly, there is variability in life expectancy and patients with existing medical problems that
significantly reduce their life expectancy are not good candidates for cancer screening. Some
explicit definitions of such conditions are presented in the overview paper.(101) Providers will
need to consider life expectancy, competing morbidities, and patient preferences, when
considering recommending cancer screening for vulnerable elders.
Additional measures related to screening not presented here appear either in the relevant
condition-specific ACOVE papers (pneumonia, hearing, osteoporosis, etc.) or were considered
here and not accepted, such as the use of PSA screening for prostate cancer, because of
insufficient evidence and opinion supporting their use with improvements in patient outcomes.
In summary, we identified eight indicators addressing the following topics:
comprehensive geriatric assessment (2), problem drinking (1), tobacco use (2), physical activity
(1), and screening for colorectal cancer (1) and breast cancer (1). These indicators can potentially
17
serve as a basis to compare the care provided by different health care delivery systems and for
comparing the change in care over time.
18
ACKNOWLEDGEMENTS
The authors thank Scott E. Sherman, M.D. for his review of an earlier version of the monograph
containing the full set of proposed quality indicators and Patricia Smith for technical assistance.
19
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