Improving Social Needs Intervention Research: Key Questions for Advancing the Field.

Spurred by accumulated evidence documenting how social determinants of health shape health outcomes as well as the push for better value, the healthcare sector is embracing interventions that address patients' health-related social needs. An increasing number of healthcare organizations and payers are experimenting with strategies to identify needs and connect patients to resources that address identified needs with the goal of improving health outcomes, reducing avoidable utilization of costly health services, and improving health equity. Although many studies link social factors to health, relatively little published research exists about how the healthcare sector can effectively intervene to help identify and address social needs. This paper summarizes emerging evidence and identifies key areas where more research is needed to advance implementation and policy development. Although some healthcare-based social needs interventions have been shown to improve health and reduce avoidable utilization, important gaps remain in terms of comparative effectiveness and cost effectiveness of social needs intervention approaches. Additionally, the field would benefit from an increased understanding of mechanisms of action to maximize practitioners' ability to tailor interventions. More research is also needed to guard against unintended consequences and ensure these interventions reduce health inequities. Finally, implementation science research should identify supports and incentives for adoption of effective interventions. Focusing both public and private research efforts on these evidence gaps can help advance identification of interventions that maximize both health equity and healthcare value. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.

How Much Does Medication Nonadherence Cost the Medicare Fee-for-Service Program?

BACKGROUND: Medication adherence is associated with lower health care utilization and savings in specific patient populations; however, few empirical estimates exist at the population level. OBJECTIVE: The main objective of this study was to apply a data-driven approach to obtain population-level estimates of the impact of medication nonadherence among Medicare beneficiaries with chronic conditions. RESEARCH DESIGN: Medicare fee-for-service (FFS) claims data were used to calculate the prevalence of medication nonadherence among individuals with diabetes, heart failure, hypertension, and hyperlipidemia. Per person estimates of avoidable health care utilization and spending associated with medication adherence, adjusted for healthy adherer effects, from prior literature were applied to the number of nonadherent Medicare beneficiaries. SUBJECTS: A 20% random sample of community-dwelling, continuously enrolled Medicare FFS beneficiaries aged 65 years or older with Part D (N=14,657,735) in 2013. MEASURES: Avoidable health care costs and hospital use from medication nonadherence. RESULTS: Medication nonadherence for diabetes, heart failure, hyperlipidemia, and hypertension resulted in billions of Medicare FFS expenditures, millions in hospital days, and thousands of emergency department visits that could have been avoided. If the 25% of beneficiaries with hypertension who were nonadherent became adherent, Medicare could save $13.7 billion annually, with over 100,000 emergency department visits and 7 million inpatient hospital days that could be averted. CONCLUSION: Medication nonadherence places a large resource burden on the Medicare FFS program. Study results provide actionable information for policymakers considering programs to manage chronic conditions. Caution should be used in summing estimates across disease groups, assuming all nonadherent beneficiaries could become adherent, and applying estimates beyond the Medicare FFS population.

Trends in the Relationship Between Obesity and Disability, 1988-2012.

Rising obesity rates, coupled with population aging, have elicited serious concern over the impact of obesity on disability in later life. Prior work showed a significant increase in the association between obesity and disability from 1988 to 2004, calling attention to disability as a cost of longer lifetime exposure to obesity. It is not known whether this trend has continued. We examined functional impairment and impairment in activities of daily living (ADL) (defined as severe or moderate to severe) for adults aged 60 years or older (n = 16,770) over 3 time periods in the National Health and Nutrition Examination Survey. The relative odds of impairment for obese individuals versus normal-weight individuals significantly increased from period 1 (1988-1994) to period 2 (1999-2004) for all outcomes. In period 3 (2005-2012), this association remained stable for functional and severe ADL impairment and decreased for moderate-to-severe ADL impairment. The fraction of population disability attributable to obesity followed a similar trend. The trend of an increasing association between obesity and disability has leveled off in more recent years, and is even improving for some measures. These findings suggest that public health and policy concerns that obesity would continue to become more disabling over time have not been borne out.

Population Health Measurement at Centers for Medicare & Medicaid Services: Bridging the Gap Between Public Health and Clinical Quality.

As Medicare and Medicaid increasingly shift to alternative payment models focused on population-based payments, there is an urgent need to develop measures of population health that can drive health improvement. In response, an assessment and design project established a framework for developing population health measures from a payer perspective, conducted environmental scans of existing measures and available data infrastructure, and conducted a gap analysis informing measure development and infrastructure needs. The work, summarized here, makes recommendations for creating a set of core measures, demonstrates some of the key challenges in applying a traditional quality measure development framework to population health, and complements recent efforts by the National Academy of Medicine and others with a focus on a payer perspective.

Comparison of Handgrip and Leg Extension Strength in Predicting Slow Gait Speed in Older Adults.

OBJECTIVES: To compare the relative predictive power of handgrip and leg extension strength in predicting slow walking. DESIGN: Report of correlative analysis from two epidemiological cohort studies. SETTING: Foundation of the National Institutes of Health Sarcopenia Project. PARTICIPANTS: Men and women aged 67 to 93 (N=6,766). MEASUREMENTS: Leg strength, handgrip strength, and gait speed were measured. Strength cutpoints associated with slow gait speed were developed using classification and regression tree analyses and compared using ordinary least squares regression models. RESULTS: The cutpoints of lower extremity strength associated with slow gait speed were 154.6 N-m in men and 89.9 N-m in women for isometric leg extension strength and 94.5 N-m in men and 62.3 N-m in women for isokinetic leg extension strength. Weakness defined according to handgrip strength (odds ratios (OR)=1.99 to 4.33, c-statistics=0.53 to 0.67) or leg strength (ORs=2.52 to 5.77; c-statistics=0.61 to 0.66) was strongly related to odds of slow gait speed. Lower extremity strength contributed 1% to 16% of the variance and handgrip strength contributed 3% to 17% of the variance in the prediction of gait speed depending on sex and mode of strength assessment. CONCLUSION: Muscle weakness of the leg extensors and forearm flexors is related to slow gait speed. Leg extension strength is only a slightly better predictor of slow gait speed. Thus, handgrip and leg extension strength appear to be suitable for screening for muscle weakness in older adults.

Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies.

BACKGROUND: Hip fracture is an important problem for older adults with significant functional consequences. After hip fracture, reduced muscle loading can result in muscle atrophy. METHODS: We compared thigh muscle characteristics in the fractured leg with those in the nonfractured leg in participants from the Baltimore Hip Studies 7th cohort using computed tomography (CT) scan imaging. RESULTS: At 2 months postfracture, a single 10-mm axial CT scan was obtained at the midthigh level in 47 participants (26 men and 21 women) with a mean age of 80.4 years (range 65-96), and thigh muscle cross-sectional area (CSA), CSA of intermuscular adipose tissue (IMAT), as well as mean radiological attenuation were measured. Total thigh muscle CSA was less on the side of the fracture by 9.2 cm(2) (95% CI: 5.9, 12.4 cm(2)), whereas the CSA of IMAT was greater by 2.8 cm(2) (95% CI: 1.9, 3.8 cm(2)) on the fractured side. Mean muscle attenuation was lower on the side of the fracture by 3.61 HU (95% CI: 2.99, 4.24 HU). CONCLUSIONS: The observed asymmetry is consistent with the effect of disuse and inflammation in the affected limb along with training effects in the unaffected limb due to the favoring of this leg with ambulation during the postfracture period.

Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies.

BACKGROUND: Hip fracture is an important problem for older adults with significant functional consequences. After hip fracture, reduced muscle loading can result in muscle atrophy. METHODS: We compared thigh muscle characteristics in the fractured leg to those in the nonfractured leg in participants from the Baltimore Hip Studies 7th cohort using computed tomography scan imaging. RESULTS: At 2 months postfracture, a single 10mm axial computed tomography scan was obtained at the midthigh level in 43 participants (23 men, 20 women) with a mean age of 79.9 years (range: 65-96 years), and thigh muscle cross-sectional area, cross-sectional area of intermuscular adipose tissue, and mean radiologic attenuation were measured. Total thigh muscle cross-sectional area was less on the side of the fracture by 9.46cm(2) (95% CI: 5.97cm(2), 12.95cm(2)) while the cross-sectional area of intermuscular adipose tissue was greater by 2.97cm(2) (95% CI: 1.94cm(2), 4.01cm(2)) on the fractured side. Mean muscle attenuation was lower on the side of the fracture by 3.66 Hounsfield Units (95% CI: 2.98 Hounsfield Units, 4.34 Hounsfield Units). CONCLUSIONS: The observed asymmetry is consistent with the effect of disuse and inflammation in the affected limb along with training effects in the unaffected limb due to the favoring of this leg with ambulation during the postfracture period.

The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates.

BACKGROUND: Low muscle mass and weakness are common and potentially disabling in older adults, but in order to become recognized as a clinical condition, criteria for diagnosis should be based on clinically relevant thresholds and independently validated. The Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project used an evidence-based approach to develop these criteria. Initial findings were presented at a conference in May 2012, which generated recommendations that guided additional analyses to determine final recommended criteria. Details of the Project and its findings are presented in four accompanying manuscripts. METHODS: The Foundation for the National Institutes of Health Sarcopenia Project used data from nine sources of community-dwelling older persons: Age, Gene/Environment Susceptibility-Reykjavik Study, Boston Puerto Rican Health Study, a series of six clinical trials, Framingham Heart Study, Health, Aging, and Body Composition, Invecchiare in Chianti, Osteoporotic Fractures in Men Study, Rancho Bernardo Study, and Study of Osteoporotic Fractures. Feedback from conference attendees was obtained via surveys and breakout groups. RESULTS: The pooled sample included 26,625 participants (57% women, mean age in men 75.2 [±6.1 SD] and in women 78.6 [±5.9] years). Conference attendees emphasized the importance of evaluating the influence of body mass on cutpoints. Based on the analyses presented in this series, the final recommended cutpoints for weakness are grip strength <26kg for men and <16kg for women, and for low lean mass, appendicular lean mass adjusted for body mass index <0.789 for men and <0.512 for women. CONCLUSIONS: These evidence-based cutpoints, based on a large and diverse population, may help identify participants for clinical trials and should be evaluated among populations with high rates of functional limitations.

Grip strength cutpoints for the identification of clinically relevant weakness.

BACKGROUND: Weakness is common and contributes to disability, but no consensus exists regarding a strength cutpoint to identify persons at high risk. This analysis, conducted as part of the Foundation for the National Institutes of Health Sarcopenia Project, sought to identify cutpoints that distinguish weakness associated with mobility impairment, defined as gait speed less than 0.8 m/s. METHODS: In pooled cross-sectional data (9,897 men and 10,950 women), Classification and Regression Tree analysis was used to derive cutpoints for grip strength associated with mobility impairment. RESULTS: In men, a grip strength of 26-32 kg was classified as "intermediate" and less than 26 kg as "weak"; 11% of men were intermediate and 5% were weak. Compared with men with normal strength, odds ratios for mobility impairment were 3.63 (95% CI: 3.01-4.38) and 7.62 (95% CI 6.13-9.49), respectively. In women, a grip strength of 16-20 kg was classified as "intermediate" and less than 16 kg as "weak"; 25% of women were intermediate and 18% were weak. Compared with women with normal strength, odds ratios for mobility impairment were 2.44 (95% CI 2.20-2.71) and 4.42 (95% CI 3.94-4.97), respectively. Weakness based on these cutpoints was associated with mobility impairment across subgroups based on age, body mass index, height, and disease status. Notably, in women, grip strength divided by body mass index provided better fit relative to grip strength alone, but fit was not sufficiently improved to merit different measures by gender and use of a more complex measure. CONCLUSIONS: Cutpoints for weakness derived from this large, diverse sample of older adults may be useful to identify populations who may benefit from interventions to improve muscle strength and function.

Cutpoints for low appendicular lean mass that identify older adults with clinically significant weakness.

BACKGROUND: Low lean mass is potentially clinically important in older persons, but criteria have not been empirically validated. As part of the FNIH (Foundation for the National Institutes of Health) Sarcopenia Project, this analysis sought to identify cutpoints in lean mass by dual-energy x-ray absorptiometry that discriminate the presence or absence of weakness (defined in a previous report in the series as grip strength <26kg in men and <16kg in women). METHODS: In pooled cross-sectional data stratified by sex (7,582 men and 3,688 women), classification and regression tree (CART) analysis was used to derive cutpoints for appendicular lean body mass (ALM) that best discriminated the presence or absence of weakness. Mixed-effects logistic regression was used to quantify the strength of the association between lean mass category and weakness. RESULTS: In primary analyses, CART models identified cutpoints for low lean mass (ALM <19.75kg in men and <15.02kg in women). Sensitivity analyses using ALM divided by body mass index (BMI: ALMBMI) identified a secondary definition (ALMBMI <0.789 in men and ALMBMI <0.512 in women). As expected, after accounting for study and age, low lean mass (compared with higher lean mass) was associated with weakness by both the primary (men, odds ratio [OR]: 6.9 [95% CI: 5.4, 8.9]; women, OR: 3.6 [95% CI: 2.9, 4.3]) and secondary definitions (men, OR: 4.3 [95% CI: 3.4, 5.5]; women, OR: 2.2 [95% CI: 1.8, 2.8]). CONCLUSIONS: ALM cutpoints derived from a large, diverse sample of older adults identified lean mass thresholds below which older adults had a higher likelihood of weakness.

Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project.

BACKGROUND: This analysis sought to determine the associations of the Foundation for the National Institutes of Health Sarcopenia Project criteria for weakness and low lean mass with likelihood for mobility impairment (gait speed ≤ 0.8 m/s) and mortality. Providing validity for these criteria is essential for research and clinical evaluation. METHODS: Among 4,411 men and 1,869 women pooled from 6 cohort studies, 3-year likelihood for incident mobility impairment and mortality over 10 years were determined for individuals with weakness, low lean mass, and for those having both. Weakness was defined as low grip strength (<26kg men and <16kg women) and low grip strength-to-body mass index (BMI; kg/m(2)) ratio (<1.00 men and <0.56 women). Low lean mass (dual-energy x-ray absorptiometry) was categorized as low appendicular lean mass (ALM; <19.75kg men and <15.02kg women) and low ALM-to-BMI ratio (<0.789 men and <0.512 women). RESULTS: Low grip strength (men: odds ratio [OR] = 2.31, 95% confidence interval [CI] = 1.34-3.99; women: OR = 1.99, 95% CI 1.23-3.21), low grip strength-to-BMI ratio (men: OR = 3.28, 95% CI 1.92-5.59; women: OR = 2.54, 95% CI 1.10-5.83) and low ALM-to-BMI ratio (men: OR = 1.58, 95% CI 1.12-2.25; women: OR = 1.81, 95% CI 1.14-2.87), but not low ALM, were associated with increased likelihood for incident mobility impairment. Weakness increased likelihood of mobility impairment regardless of low lean mass. Mortality risk patterns were inconsistent. CONCLUSIONS: These findings support our cut-points for low grip strength and low ALM-to-BMI ratio as candidate criteria for clinically relevant weakness and low lean mass. Further validation in other populations and for alternate relevant outcomes is needed.

An evidence-based comparison of operational criteria for the presence of sarcopenia.

BACKGROUND: Several consensus groups have previously published operational criteria for sarcopenia, incorporating lean mass with strength and/or physical performance. The purpose of this manuscript is to describe the prevalence, agreement, and discrepancies between the Foundation for the National Institutes of Health (FNIH) criteria with other operational definitions for sarcopenia. METHODS: The FNIH Sarcopenia Project used data from nine studies including: Age, Gene and Environment Susceptibility-Reykjavik Study; Boston Puerto Rican Health Study; a series of six clinical trials from the University of Connecticut; Framingham Heart Study; Health, Aging, and Body Composition Study; Invecchiare in Chianti; Osteoporotic Fractures in Men Study; Rancho Bernardo Study; and Study of Osteoporotic Fractures. Participants included in these analyses were aged 65 and older and had measures of body mass index, appendicular lean mass, grip strength, and gait speed. RESULTS: The prevalence of sarcopenia and agreement proportions was higher in women than men. The lowest prevalence was observed with the FNIH criteria (1.3% men and 2.3% women) compared with the International Working Group and the European Working Group for Sarcopenia in Older Persons (5.1% and 5.3% in men and 11.8% and 13.3% in women, respectively). The positive percent agreements between the FNIH criteria and other criteria were low, ranging from 7% to 32% in men and 5% to 19% in women. However, the negative percent agreement were high (all >95%). CONCLUSIONS: The FNIH criteria result in a more conservative operational definition of sarcopenia, and the prevalence was lower compared with other proposed criteria. Agreement for diagnosing sarcopenia was low, but agreement for ruling out sarcopenia was very high. Consensus on the operational criteria for the diagnosis of sarcopenia is much needed to characterize populations for study and to identify adults for treatment.

Body mass index is positively associated with bone mineral density in US older adults.

UNLABELLED: Literature has been conflicting as to whether obesity is protective against osteoporosis. Understanding the relationship is particularly important in light of the increasing prevalence of obesity among older adults. Study results confirm a protective association between obesity and osteoporosis in a recent, nationally representative sample of US older adults. PURPOSE: Currently, the majority of US older adults are either overweight or obese. Evidence regarding the relationship between body composition measures and bone mass is conflicting, possibly because different measures of obesity reflect multiple mechanisms. Additionally, there are important age, gender, and racial differences in a risk of osteoporosis and fat mass composition. The objective of this study was to examine the association between body mass index (BMI) and bone mineral density (BMD) in a recent, nationally representative sample of US older adults as well as to see if this relationship differs by age, sex, and race. METHODS: Data for this study were obtained from the National Health and Nutrition Examination Survey (2005-2008) for adults ages 50 and older (n = 3,296). Linear regression models were used to predict BMD of the femoral neck (measured by dual-energy X-ray absorptiometry (DXA)) as a function of BMI (measured height and weight) and a range of study covariates. RESULTS: Every unit increase in BMI was associated with an increase of 0.0082 g/cm(2) in BMD (p < 0.001). Interaction terms for BMI and age (p = 0.345), BMI and sex (p = 0.413), and BMI and race (p = 0.725) were not statistically significant. CONCLUSIONS: Study results confirm the positive association between BMI and BMD, and this relationship does not differ by age, sex, or race. A 10-unit increase in BMI (e.g., from normal BMI to obese) would result in moving an individual from an osteoporotic BMD level to a normal BMD level. Results demonstrate a protective, cross-sectional association between obesity and osteoporosis in a recent sample of US older adults.

Serum 25-hydroxyvitamin D, transitions between frailty states, and mortality in older adults: the Invecchiare in Chianti Study.

OBJECTIVES: To assess whether serum 25-hydroxyvitamin D (25(OH)D) concentrations relate to transitions between the states of robustness, prefrailty, and frailty and to mortality in older adults. DESIGN: The Invecchiare in Chianti (InCHIANTI) Study, a prospective cohort study. SETTING: Tuscany, Italy. PARTICIPANTS: Adults aged 65 and older (N = 1,155). MEASUREMENTS: Serum 25(OH)D concentrations measured at baseline; frailty state (robust, prefrail, frail) assessed at baseline and 3 and 6 years after enrollment; and vital status determined 3 and 6 years after enrollment. RESULTS: The median (interquartile range) 25(OH)D concentration was 16.0 ng/mL (10.4-25.6 ng/mL; multiply by 2.496 to convert to nmol/L). Prefrail participants with 25(OH)D levels less than 20 ng/mL were 8.9% (95% confidence interval (CI) = 2.5-15.2%) more likely to die, 3.0% (95% CI = -5.6-14.6%) more likely to become frail, and 7.7% (95% CI = -3.5-18.7%) less likely to become robust than prefrail participants with 25(OH)D levels of 20 ng/mL or more. In prefrail participants, each 5-ng/mL decrement of continuous 25(OH)D was associated with 1.46 times higher odds of dying (95% CI = 1.18-2.07) and 1.13 higher odds of incident frailty (95% CI = 0.90-1.39) than with recovery of robustness. Transitions from robustness or frailty were not associated with 25(OH)D levels. CONCLUSION: Results provide evidence that prefrailty is an "at risk" state from which older adults with high 25(OH)D levels are more likely to recover than to decline, but high 25(OH)D levels were not associated with recovery from frailty. Thus, 25(OH)D levels should be investigated as a potential therapy to treat prefrailty and prevent further decline.