Thomas M. Gill

A standard procedure for creating a frailty index.

BackgroundFrailty can be measured in relation to the accumulation of deficits using a frailty index. A frailty index can be developed from most ageing databases. Our objective is to systematically describe a standard procedure for constructing a frailty index.MethodsThis is a secondary analysis of the Yale Precipitating Events Project cohort study, based in New Haven CT. Non-disabled people aged 70 years or older (n = 754) were enrolled and re-contacted every 18 months. The database includes variables on function, cognition, co-morbidity, health attitudes and practices and physical performance measures. Data came from the baseline cohort and those available at the first 18-month follow-up assessment.ResultsProcedures for selecting health variables as candidate deficits were applied to yield 40 deficits. Recoding procedures were applied for categorical, ordinal and interval variables such that they could be mapped to the interval 0–1, where 0 = absence of a deficit, and 1= full expression of the deficit. These individual deficit scores were combined in an index, where 0= no deficit present, and 1= all 40 deficits present. The values of the index were well fit by a gamma distribution. Between the baseline and follow-up cohorts, the age-related slope of deficit accumulation increased from 0.020 (95% confidence interval, 0.014–0.026) to 0.026 (0.020–0.032). The 99% limit to deficit accumulation was 0.6 in the baseline cohort and 0.7 in the follow-up cohort. Multivariate Cox analysis showed the frailty index, age and sex to be significant predictors of mortality.ConclusionA systematic process for creating a frailty index, which relates deficit accumulation to the individual risk of death, showed reproducible properties in the Yale Precipitating Events Project cohort study. This method of quantifying frailty can aid our understanding of frailty-related health characteristics in older adults.

Effect of Structured Physical Activity on Prevention of Major Mobility Disability in Older Adults: The LIFE Study Randomized Clinical Trial

IMPORTANCE In older adults reduced mobility is common and is an independent risk factor for morbidity, hospitalization, disability, and mortality. Limited evidence suggests that physical activity may help prevent mobility disability; however, there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability. OBJECTIVE To test the hypothesis that a long-term structured physical activity program is more effective than a health education program (also referred to as a successful aging program) in reducing the risk of major mobility disability. DESIGN, SETTING, AND PARTICIPANTS The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial that enrolled participants between February 2010 and December 2011, who participated for an average of 2.6 years. Follow-up ended in December 2013. Outcome assessors were blinded to the intervention assignment. Participants were recruited from urban, suburban, and rural communities at 8 centers throughout the United States. We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations, defined as a score on the Short Physical Performance Battery of 9 or below, but were able to walk 400 m. INTERVENTIONS Participants were randomized to a structured, moderate-intensity physical activity program (n = 818) conducted in a center (twice/wk) and at home (3-4 times/wk) that included aerobic, resistance, and flexibility training activities or to a health education program (n = 817) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises. MAIN OUTCOMES AND MEASURES The primary outcome was major mobility disability objectively defined by loss of ability to walk 400 m. RESULTS Incident major mobility disability occurred in 30.1% (246 participants) of the physical activity group and 35.5% (290 participants) of the health education group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.98], P = .03).Persistent mobility disability was experienced by 120 participants (14.7%) in the physical activity group and 162 participants (19.8%) in the health education group (HR, 0.72 [95% CI, 0.57-0.91]; P = .006). Serious adverse events were reported by 404 participants (49.4%) in the physical activity group and 373 participants (45.7%) in the health education group (risk ratio, 1.08 [95% CI, 0.98-1.20]). CONCLUSIONS AND RELEVANCE A structured, moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability. These findings suggest mobility benefit from such a program in vulnerable older adults. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01072500.

Trajectories of Disability in the Last Year of Life

BACKGROUND Despite the importance of functional status to older persons and their families, little is known about the course of disability at the end of life. METHODS We evaluated data on 383 decedents from a longitudinal study involving 754 community-dwelling older persons. None of the subjects had disability in essential activities of daily living at the beginning of the study, and the level of disability was ascertained during monthly interviews for more than 10 years. Information on the conditions leading to death was obtained from death certificates and comprehensive assessments that were completed at 18-month intervals after the baseline assessment. RESULTS In the last year of life, five distinct trajectories were identified, from no disability to the most severe disability: 65 subjects had no disability (17.0%), 76 had catastrophic disability (19.8%), 67 had accelerated disability (17.5%), 91 had progressive disability (23.8%), and 84 had persistently severe disability (21.9%). The most common condition leading to death was frailty (in 107 subjects [27.9%]), followed by organ failure (in 82 subjects [21.4%]), cancer (in 74 subjects [19.3%]), other causes (in 57 subjects [14.9%]), advanced dementia (in 53 subjects [13.8%]), and sudden death (in 10 subjects [2.6%]). When the distribution of the disability trajectories was evaluated according to the conditions leading to death, a predominant trajectory was observed only for subjects who died from advanced dementia (67.9% of these subjects had a trajectory of persistently severe disability) and sudden death (50.0% of these subjects had no disability). For the four other conditions leading to death, no more than 34% of the subjects had any of the disability trajectories. The distribution of disability trajectories was particularly heterogeneous among the subjects with organ failure (from 12.2 to 32.9% of the subjects followed a specific trajectory) and frailty (from 14.0 to 27.1% of the subjects followed a specific trajectory). CONCLUSIONS In most of the decedents, the course of disability in the last year of life did not follow a predictable pattern based on the condition leading to death.

Assessing risk for the onset of functional dependence among older adults: the role of physical performance.

BACKGROUND: Approximately 10% of nondisabled, community‐dwelling adults aged 75 years and older lose independence in basic activities of daily living (ADLs) each year. The purpose of this study was to evaluate whether simple tests of physical performance could identify older adults, independent in their basic ADLs, who were at increased risk for the onset of functional dependence.

Characteristics Associated with Fear of Falling and Activity Restriction in Community-Living Older Persons

To identify the characteristics associated with restricting activity because of fear of falling (activity restriction) and to determine which characteristics distinguish older persons who restrict activity from those who have fear of falling but do not restrict their activities (fear of falling alone).

Prognostic Significance of Potential Frailty Criteria

OBJECTIVES: To determine the independent prognostic effect of seven potential frailty criteria, including five from the Fried phenotype, on several adverse outcomes.

Effects of Testosterone Treatment in Older Men

BACKGROUND Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established. METHODS We assigned 790 men 65 years of age or older with a serum testosterone concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive either testosterone gel or placebo gel for 1 year. Each man participated in one or more of three trials--the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial. The primary outcome of each of the individual trials was also evaluated in all participants. RESULTS Testosterone treatment increased serum testosterone levels to the mid-normal range for men 19 to 40 years of age. The increase in testosterone levels was associated with significantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire (P<0.001), as well as significantly increased sexual desire and erectile function. The percentage of men who had an increase of at least 50 m in the 6-minute walking distance did not differ significantly between the two study groups in the Physical Function Trial but did differ significantly when men in all three trials were included (20.5% of men who received testosterone vs. 12.6% of men who received placebo, P=0.003). Testosterone had no significant benefit with respect to vitality, as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue scale, but men who received testosterone reported slightly better mood and lower severity of depressive symptoms than those who received placebo. The rates of adverse events were similar in the two groups. CONCLUSIONS In symptomatic men 65 years of age or older, raising testosterone concentrations for 1 year from moderately low to the mid-normal range for men 19 to 40 years of age had a moderate benefit with respect to sexual function and some benefit with respect to mood and depressive symptoms but no benefit with respect to vitality or walking distance. The number of participants was too few to draw conclusions about the risks of testosterone treatment. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00799617.).

Restricted activity among community-living older persons: incidence, precipitants, and health care utilization.

Restricted activity, defined as staying in bed for at least half a day or cutting down on ones usual activities because of an illness or injury (1), has high face validity as a measure of health and functional status, especially for older persons, who often value quality of life over longevity (2). The importance of restricted activity was recognized more than 20 years ago in the U.S. Surgeon Generals original Healthy People Report (3), which identified reduction of restricted activity as one of its two major goals for older persons. Subsequently, several clinical trials of preventive interventions have included restricted activity as a key outcome measure (4-7). Despite this attention, relatively little is known about the epidemiology of restricted activity among older persons. Previous studies, based largely on one-time assessments, have suggested that only a minority of community-living older persons experience restricted activity in the course of 1 year (8, 9). The factors precipitating restricted activity, moreover, have not been well defined. Finally, whether older persons seek medical attention in the setting of restricted activity has not been studied. Those who do not seek attention may consider restricted activity to be a normal part of aging and may miss a chance for successful evaluation and intervention. In this prospective cohort study, we sought to better elucidate the epidemiology of restricted activity in community-living older persons. Our goals were to more accurately estimate the rate of restricted activity, identify the health-related and non-health-related problems leading to restricted activity, and determine whether restricted activity is associated with increased health care utilization. Methods Study Sample The study sample comprised the 754 participants of the Precipitating Events Project, a longitudinal study of nondisabled, community-living persons 70 years of age or older. Participants in the Precipitating Events Project were identified from a computerized list of 3157 age-eligible members of a large health plan in New Haven, Connecticut. Members were eligible if they were communityliving, English-speaking, and nondisabled (that is, required no personal assistance) in four key activities of daily livingbathing, walking, dressing, and transferring from a chair. Plan members were excluded on the basis of three criteria: diagnosis of a terminal illness with a life expectancy less than 12 months, plans to move out of the New Haven area during the next 12 months, and significant cognitive impairment with no available proxy. Enrollment To minimize potential selection effects, a computerized randomization program was used to assign each age-eligible health plan member a unique number. Screening for eligibility and enrollment proceeded sequentially from March 1998 to October 1999. Potential participants were sent a letter that briefly described the study and explained that they would be contacted by phone. During the phone interview, eligibility was assessed, and a home visit was scheduled among consenting eligible persons. During the home visit, eligibility was verified, informed consent was obtained, and a comprehensive baseline assessment was completed. On the basis of gait speed, cognitive status, and age, participants were categorized into one of three risk groups for disability by using a model developed and validated in an earlier study (Table 1) (10). To ensure that enough participants were included in each risk group, participants were enrolled in a 4:2:1 ratio for low, intermediate, and high risk for disability, respectively. Table 1. Risk Model for Disability and Number of Participants Enrolled, according to Phase Assembly of the Precipitating Events Project cohort is shown in the Figure. We applied our stratified sampling strategy in three phases. In phase 1, all eligible and consenting persons were enrolled. In phase 2, persons were excluded from the study if they indicated during the screening telephone interview that they had walked 0.5 mile or for 30 minutes continuously without stopping within the past month. In phase 3, persons who were eligible based on the screening telephone interview were excluded from the study if they were found to have low risk for disability during the home visit. The enrollment procedures in phases 2 and 3 were otherwise identical to those in phase 1. Figure. Assembly of Precipitating Events Project cohort. The number of participants enrolled in each of the three phases is shown in Table 1. During phase 1, 77% of the participants had low risk for disability. Phase 2 was designed to decrease this percentage by excluding persons who were likely to have low risk for disability. The sensitivity and specificity of the screening question used during phase 2 were 66% and 76%, respectively, for low disability risk (based on gold standard data from the first 282 participants enrolled during phase 1). Other candidate screening questions, alone or in combination, had a lower sensitivity or specificity (or both). As shown in the Figure, only 4.6% (126 of 2735) of the health plan members who could be contacted declined to complete the screening telephone interview, and 75.2% (754 of 1002) of the eligible members agreed to participate in the study. Persons who declined to participate did not differ significantly from those who were enrolled in terms of age or sex. Baseline Data Collection Trained research nurses used standard instruments to perform baseline interviews and assessments. Clinical data included 13 self-reported, physician-diagnosed chronic conditions: hypertension; myocardial infarction; congestive heart failure; stroke; diabetes; arthritis; hip fracture; fracture of wrist, arm, or spine since 50 years of age; amputation of leg; chronic lung disease; cirrhosis or liver disease; cancer (other than minor skin cancers); and Parkinson disease. Cognitive status was assessed by using the Folstein Mini-Mental State Examination (11). Timed rapid gait was assessed by having the participants walk back and forth over a 10-foot course as quickly and safely as possible (10). Follow-up Data Collection The occurrence of restricted activity and health-related and non-health-related problems leading to restricted activity were ascertained during monthly telephone interviews by using a standardized, four-step protocol. First, participants were asked two questions related to restricted activity: Since we last talked on [date of last interview], have you stayed in bed for at least half a day due to an illness, injury, or other problem? and Since we last talked on [date of last interview], have you cut down on your usual activities due to an illness, injury, or other problem? Second, if participants had restricted activity (that is, answered yes to either question), they were asked sequentially whether they had had any of 24 prespecified problems since we last talked on [date of last interview]. To develop our list of potential problems, we identified common physical and mental health symptoms that community-living older persons had reported in previous studies (12-14), and we supplemented these symptoms with other events that we deemed important on the basis of our own clinical and research experience (15). Third, immediately after each yes response to a specific problem, participants were asked, Did this problem cause you to stay in bed for at least half a day or to cut down on your usual activities? (that is, did it lead to restricted activity). Finally, participants with restricted activity were asked to specify any other reasons why they stayed in bed for at least half a day or cut down on their usual activities. Participants without restricted activity were not asked about the specific problems. During pilot testing, we found that the test-retest reliability of this four-step protocol was high, with a value of 0.90 for the presence or absence of restricted activity and a value of 0.75 or greater for the presence or absence of 20 of the 24 problems leading to restricted activity (mean time between assessments, 4.1 days among 20 persons). The value was less than 0.6 for only 3 of the problems (swelling in feet or ankles, fear of falling, and frequent or painful urination). During the monthly telephone interviews, participants were also asked whether they had stayed at least overnight in a hospital and whether they had seen a physician in the office or emergency department since their last interview. The research protocol was approved by the Yale University School of Medicine Institutional Review Board. Statistical Analysis We calculated the rate of restricted activity for the overall cohort and for subgroups defined by sex and risk for disability by dividing the number of months in which participants reported staying in bed for at least half a day or cutting down on their usual activities by the total person-months of follow-up. These analyses were repeated for staying in bed for at least half a day and for cutting down on ones usual activities alone (that is, without staying in bed for at least half a day). We then calculated the overall and stratified rates for each of the prespecified problems leading to restricted activity by using person-months with restricted activity as the denominator. The mean number of problems per episode of restricted activity was also calculated. Finally, the rates of health care utilization, including physician office visits, emergency department visits, and hospital admissions, were calculated for months with and months without restricted activity. The events of interest in this study were potentially recurrent in nature; that is, participants may have experienced restricted activity or used health care services in more than one month. Because standard statistical approaches based on the binomial or Poisson distributions assume independence among events, we used alternative methods, designed specifically for recurrent events, t

Change in disability after hospitalization or restricted activity in older persons.

CONTEXT Disability among older persons is a complex and highly dynamic process, with high rates of recovery and frequent transitions between states of disability. The role of intervening illnesses and injuries (ie, events) on these transitions is uncertain. OBJECTIVES To evaluate the relationship between intervening events and transitions among states of no disability, mild disability, severe disability, and death and to determine the association of physical frailty with these transitions. DESIGN, SETTING, AND PARTICIPANTS Prospective cohort study conducted in greater New Haven, Connecticut, from March 1998 to December 2008 of 754 community-living persons aged 70 years or older who were nondisabled at baseline in 4 essential activities of daily living: bathing, dressing, walking, and transferring. Telephone interviews were completed monthly for more than 10 years to assess disability and ascertain exposure to intervening events, which included illnesses and injuries leading to either hospitalization or restricted activity. Physical frailty (defined as gait speed >10 seconds on the rapid gait test) was assessed every 18 months through 108 months. MAIN OUTCOME MEASURE Transitions between no disability, mild disability, and severe disability and 3 transitions from each of these states to death, evaluated each month. RESULTS Hospitalization was strongly associated with 8 of the 9 possible transitions, with increased multivariable hazard ratios (HRs) as high as 168 (95% confidence interval [CI], 118-239) for the transition from no disability to severe disability and decreased HRs as low as 0.41 (95% CI, 0.30-0.54) for the transition from mild disability to no disability. Restricted activity also increased the likelihood of transitioning from no disability to both mild and severe disability (HR, 2.59; 95% CI, 2.23-3.02; and HR, 8.03; 95% CI, 5.28-12.21), respectively, and from mild disability to severe disability (HR, 1.45; 95% CI, 1.14-1.84), but was not associated with recovery from mild or severe disability. For all 9 transitions, the presence of physical frailty accentuated the associations of the intervening events. For example, the absolute risk of transitioning from no disability to mild disability within 1 month after hospitalization for frail individuals was 34.9% (95% CI, 34.5%-35.3%) vs 4.9% (95% CI, 4.7%-5.1%) for nonfrail individuals. Among the possible reasons for hospitalization, fall-related injury conferred the highest likelihood of developing new or worsening disability. CONCLUSIONS Among older persons, particularly those who were physically frail, intervening illnesses and injuries greatly increased the likelihood of developing new or worsening disability. Only the most potent events, ie, those leading to hospitalization, reduced the likelihood of recovery from disability.

Resilience of community-dwelling older persons.

Objectives:  To assess resilience of community‐dwelling older persons using a new scale based on response to a stressful life event and to identify the demographic, clinical, functional, and psychosocial factors associated with high resilience.