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To examine variables associated with engagement in (1) integrative health and medicine (IHM) and (2) nonpharmacologic modalities rather than opioids among United States adults with chronic pain.Methods: Using the 2019 National Health Interview Survey, we examined sociodemographic, pain, and mental health predictors of (1) the sum of IHM modalities (ie, chiropractic care, yoga/Tai Chi, massage, or meditation/guided imagery) used to manage pain and (2) exclusive engagement in nonpharmacologic pain management modalities (ie, IHM, a chronic pain self-management program, support groups, or physical, rehabilitative, occupational, or talk therapy) or opioids in the past 3 months.Results: Metropolitan residency, higher family income, higher education levels, increased number of pain locations, and increased frequency of pain limiting life/work activities were associated with increased odds of IHM engagement. Older age, male sex, non-Hispanic Black/African American race/ethnicity, and daily opioid use were associated with decreased odds of IHM engagement. Older age, male sex, and increased depressive symptoms were associated with decreases in the count of IHM modalities used to manage pain. Metropolitan residency, higher family income, and higher education levels were associated with increased odds of exclusive nonpharmacologic modality engagement. Older age and increasing frequency of pain limiting life/work activities were associated with decreased odds of exclusive nonpharmacologic modality engagement.Conclusions: We identified several contrasts between factors prevalent among individuals with chronic pain and factors associated with engagement in nonpharmacologic and IHM modalities. These results support efforts to address barriers to accessing these modalities among subpopulations of adults with chronic pain (eg, older adults, individuals identifying as Black/African American, rural residents, and those with lower levels of education and income).Plain Language Summary: This study examined factors influencing the use of integrative health and non-drug treatments for chronic pain in the United States. Results revealed that metropolitan residence, higher income, and education were associated with increased use of these treatments, while older age, male sex, daily opioid use, and non-Hispanic Black/African American ethnicity were associated with decreased use. The findings emphasize the importance of addressing barriers to these forms of care, especially among older adults, Black/African American individuals, and those with higher depressive symptoms and lower education and income levels, who are more likely to have chronic pain. [ABSTRACT FROM AUTHOR]

We used a collective impact model to form a statewide diabetes quality improvement collaborative to improve diabetes outcomes and advance diabetes health equity. Between 2020 and 2022, in collaboration with the Ohio Department of Medicaid, Medicaid Managed Care Plans, and Ohio's seven medical schools, we recruited 20 primary care practices across the state. The percentage of patients with hemoglobin A1c greater than 9% improved from 25% to 20% over two years. Applying our model more broadly could accelerate improvement in diabetes outcomes. (Am J Public Health. 2023;113(12):1254–1257. https://doi.org/10.2105/AJPH.2023.307410) [ABSTRACT FROM AUTHOR]

Background: Smoking is associated with an increased risk of multiple sclerosis (MS) and disability worsening. The relationship between smoking, cognitive processing speed, and brain atrophy remains uncertain. Objective: To quantify the impact of smoking on processing speed and brain volume in MS and to explore the longitudinal relationship between smoking and changes in processing speed. Methods: A retrospective study of MS patients who completed the processing speed test (PST) between September 2015 and March 2020. Demographics, disease characteristics, smoking history, and quantitative magnetic resonance imaging (MRI) were collected. Cross-sectional associations between smoking, PST performance, whole-brain fraction (WBF), gray matter fraction (GMF), and thalamic fraction (TF) were assessed using multivariable linear regression. The longitudinal relationship between smoking and PST performance was assessed by linear mixed modeling. Results: The analysis included 5536 subjects of whom 1314 had quantitative MRI within 90 days of PST assessment. Current smokers had lower PST scores than never smokers at baseline, and this difference persisted over time. Smoking was associated with reduced GMF but not with WBF or TF. Conclusion: Smoking has an adverse relationship with cognition and GMF. Although causality is not demonstrated, these observations support the importance of smoking cessation counseling in MS management. [ABSTRACT FROM AUTHOR]

Objective: The aim was to compare the outcomes of subdural electrode (SDE) implantations versus stereotactic electroencephalography (SEEG), the 2 predominant methods of intracranial electroencephalography (iEEG) performed in difficult‐to‐localize drug‐resistant focal epilepsy. Methods: The Surgical Therapies Commission of the International League Against Epilepsy created an international registry of iEEG patients implanted between 2005 and 2019 with ≥1 year of follow‐up. We used propensity score matching to control exposure selection bias and generate comparable cohorts. Study endpoints were: (1) likelihood of resection after iEEG; (2) seizure freedom at last follow‐up; and (3) complications (composite of postoperative infection, symptomatic intracranial hemorrhage, or permanent neurological deficit). Results: Ten study sites from 7 countries and 3 continents contributed 2,012 patients, including 1,468 (73%) eligible for analysis (526 SDE and 942 SEEG), of whom 988 (67%) underwent subsequent resection. Propensity score matching improved covariate balance between exposure groups for all analyses. Propensity‐matched patients who underwent SDE had higher odds of subsequent resective surgery (odds ratio [OR] = 1.4, 95% confidence interval [CI] 1.05, 1.84) and higher odds of complications (OR = 2.24, 95% CI 1.34, 3.74; unadjusted: 9.6% after SDE vs 3.3% after SEEG). Odds of seizure freedom in propensity‐matched resected patients were 1.66 times higher (95% CI 1.21, 2.26) for SEEG compared with SDE (unadjusted: 55% seizure free after SEEG‐guided resections vs 41% after SDE). Interpretation: In comparison to SEEG, SDE evaluations are more likely to lead to brain surgery in patients with drug‐resistant epilepsy but have more surgical complications and lower probability of seizure freedom. This comparative‐effectiveness study provides the highest feasible evidence level to guide decisions on iEEG. ANN NEUROL 2021;90:927–939 [ABSTRACT FROM AUTHOR]

Background: Accountable care organizations (ACOs), patient-centered medical homes (PCMHs), and the meaningful use of electronic health records (EHRs) generated particular attention during the last decade. Translating these reforms into meaningful increases in population health depends on improving the quality and clinical integration of primary care providers (PCPs). However, if these innovations spread more quickly among PCPs in urban and wealthier areas, then they could potentially worsen existing geographic disparities in health outcomes. Objective: To determine the market penetration of Medicare Shared Savings Program (MSSP) ACOs, PCMHs, and the meaningful use of EHRs among PCPs across urban and rural counties in Ohio. Design: Retrospective, observational study of the percent of PCPs in a county who are affiliated with PCMH, ACO, and meaningful use (MU) of EHR. Participants: PCPs in all of Ohio's 88 counties from 2011 to 2015. Main Measures: Primary care market penetration of ACO, PCMH, and meaningful use of EHR Key Results: In 2015, the Ohio primary care market penetration of PCMH was 23.4%, ACO was 27.7%, MU stage 1 was 55.8%, and MU stage 2 was 26.6%. During the study period, PCMH and ACO market penetration increased faster in urban counties relative to rural counties, and market penetration of meaningful use of EHR increased faster in rural counties. Conclusions: Market penetration of PCMH and ACOs increased faster in urban markets compared to rural markets. However, the adoption of EHRs increased faster in rural markets. The results are a cause for optimism as well as a call to action: although recent efforts to increase PCMH and ACO adoption were less effective among the rural population in Ohio, federal programs to accelerate adoption of EHRs were overwhelmingly successful in rural areas. [ABSTRACT FROM AUTHOR]

Background: Accelerated translation of real-world interventions for hypertension management is critical to improving cardiovascular outcomes and reducing disparities. Objective: To determine whether a positive deviance approach would improve blood pressure (BP) control across diverse health systems. Design: Quality improvement study using 1-year cross sections of electronic health record data over 5 years (2013–2017). Participants: Adults ≥ 18 with hypertension with two visits in 2 years with at least one primary care visit in the last year (N = 114,950 at baseline) to a primary care practice in Better Health Partnership, a regional health improvement collaborative. Interventions: Identification of a "positive deviant" and dissemination of this system's best practices for control of hypertension (i.e., accurate/repeat BP measurement; timely follow-up; outreach; standard treatment algorithm; and communication curriculum) using 3 different intensities (low: Learning Collaborative events describing the best practices; moderate: Learning Collaborative events plus consultation when requested; and high: Learning Collaborative events plus practice coaching). Main Measures: We used a weighted linear model to estimate the pre- to post-intervention average change in BP control (< 140/90 mmHg) for 35 continuously participating clinics. Key Results: BP control post-intervention improved by 7.6% [95% confidence interval (CI) 6.0–9.1], from 67% in 2013 to 74% in 2017. Subgroups with the greatest absolute improvement in BP control included Medicaid (12.0%, CI 10.5–13.5), Hispanic (10.5%, 95% CI 8.4–12.5), and African American (9.0%, 95% CI 7.7–10.4). Implementation intensity was associated with improvement in BP control (high: 14.9%, 95% CI 0.2–19.5; moderate: 5.2%, 95% CI 0.8–9.5; low: 0.2%, 95% CI−3.9 to 4.3). Conclusions: Employing a positive deviance approach can accelerate translation of real-world best practices into care across diverse health systems in the context of a regional health improvement collaborative (RHIC). Using this approach within RHICs nationwide could translate to meaningful improvements in cardiovascular morbidity and mortality. [ABSTRACT FROM AUTHOR]

Introduction: This study examines the uptake of a clinician-focused teachable moment communication process (TMCP) and its impact on patient receipt of tobacco cessation support. The TMCP is a counseling method that uses patient concerns to help clinicians guide behavior change discussions about tobacco. We evaluate the added value of the TMCP training in a health system that implemented an Ask-Advise-Connect (AAC) systems-based approach. Methods: A stepped wedge cluster randomized trial included eight community health centers. Training involved a web module and onsite skill development with standardized patients and coaching. Main outcome measures included contact and enrollment in cessation services among patients referred for counseling, prescription of cessation medications and quit attempts. Results: Forty-four of 60 eligible clinicians received the TMCP training. Among TMCP-trained clinicians 68% used a TMCP approach (documented by flowsheet use) one or more times, with the median number of uses being 15 (IQR 2–33). Overall, the TMCP was used in 661 out of 8198 visits by smokers (8%). There was no improvement in any of the tobacco cessation assistance outcomes for the AAC + TMCP vs. the AAC only period. Visits where clinicians used the TMCP approach were associated with increased ordering of tobacco cessation medications, (OR = 2.6; 95% CI = 1.9, 3.5) and providing advice to quit OR 3.2 (95% CI 2.2, 4.7). Conclusions: Despite high fidelity to the training, uptake of the TMCP approach in routine practice was poor, making it difficult to evaluate the impact on patient outcomes. When the TMCP approach was used, ordering tobacco cessation medications increased. Implications: Tobacco cessation strategies in primary care have the potential to reach a large portion of the population and deliver advice tailored to the patient. The poor uptake of the approach despite high training fidelity suggests that additional implementation support strategies, are needed to increase sustainable adoption of the TMCP approach. Trial Registration: clinicaltrials.gov #NCT02764385, registration date 06/05/2016. [ABSTRACT FROM AUTHOR]

Significance: Guidelines urge primary care practices to routinely provide tobacco cessation care (i.e., assess tobacco use, provide brief cessation advice, and refer to cessation support). This study evaluates the impact of a systems-based strategy to provide tobacco cessation care in eight primary care clinics serving low-income patients. Methods: A non-randomized stepped wedge study design was used to implement an intervention consisting of (1) changes to the electronic health record (EHR) referral functionality and (2) expansion of staff roles to provide brief advice to quit; assess readiness to quit; offer a referral to tobacco cessation counseling; and sign the referral order. Outcomes assessed from the EHR include performance of tobacco cessation care tasks, referral contact, and enrollment rates for the quitline (QL) and in-house Freedom from Smoking (FFS) program. Generalized estimating equations (GEE) methods were used to compute odds ratios contrasting the pre-implementation vs. 1-, 3-, 6-, and 12-month post-implementation periods. Results: Of the 176,061 visits, 26.1% were by identified tobacco users. All indicators significantly increased at each time period evaluated post-implementation. In comparison with the pre-intervention period, assessing smoking status (26.6% vs. 55.7%; OR = 3.7, CI = 3.6–3.9), providing advice (44.8% vs. 88.7%; OR = 7.8, CI = 6.6–9.1), assessing readiness to quit (15.8% vs. 55.0%; OR = 6.2, CI = 5.4–7.0), and acceptance of a referral to tobacco cessation counseling (0.5% vs. 30.9%; OR = 81.0, CI = 11.4–575.8) remained significantly higher 12 months post-intervention. For the QL and FFS, respectively, there were 1223 and 532 referrals; 324 (31.1%) and 103 (24.7%) were contacted; 241 (74.4%) and 72 (69.6%) enrolled; and 195 (80.9%) and 14 (19.4%) received at least one counseling session. Conclusions: This system change intervention that includes an EHR-supported role expansion substantially increased the provision of tobacco cessation care and improvements were sustained beyond 1 year. This approach has the potential to greatly increase the number of individuals referred for tobacco cessation counseling. [ABSTRACT FROM AUTHOR]

Objectives: The high prevalence of tobacco use at primary care safety‐net clinics represents an opportunity to offer assistance with cessation. Documentation of smoking status, offering advice and medications, and referral to cessation services are important steps in supporting cessation attempts and are required elements by payors and accrediting agencies to demonstrate care quality. This study examines tobacco cessation support rates and patient characteristics using electronic medical record (EMR) data. Methods: This cross‐sectional study engaged eight community health centers affiliated with a county hospital system in NE Ohio where adult tobacco use rates exceed 30%. EMR data from June 2014 through May 2016 were analysed to assess rates of tobacco cessation counselling, order of cessation medications, or both. The association of tobacco cessation support with patient characteristics and quit attempts was assessed using multivariable logistic regression models. Results: Among 21 702 current tobacco users, 74% had no intervention documented; 15.4% had counselling documented, 6.4% were prescribed tobacco cessation medication, and 4.2% had both documented. Males, those aged 18 to 34, and African Americans were more likely to have no documented intervention. Of current tobacco users with at least two visits, 5.6% had a quit attempt. Medication alone was associated with a greater likelihood of a quit attempt (AOR: 1.72 [95% CI: 1.36‐2.17]) as well as counselling and medication combined (AOR: 1.95 [95% CI: 1.48‐2.56]). Conclusions: Tobacco cessation support was lacking for 74% of current smokers and was less likely in subgroups including males, younger adults, and African Americans. Ordering tobacco cessation medication combined with counselling nearly doubled the likelihood of a quit attempt. [ABSTRACT FROM AUTHOR]

The article highlights a report on the study of Implications of changing blood pressure targets in urban primary care. Topics discussed include information on diagnosis of patients with hypertension in a diverse regional health improvement collaborative (RHIC); diagnosis of patients without hypertension at one safety-net health system within the RHIC; and adoption of the American College of Cardiology and American Heart Association guidelines for prevention and detection of hypertension.

Objective To assess long-term direct medical costs, health care utilization, and mortality following resective surgery in persons with uncontrolled epilepsy. Methods Retrospective longitudinal cohort study of Medicaid beneficiaries with epilepsy from 2000 to 2008. The study population included 7,835 persons with uncontrolled focal epilepsy ages 18-64 years, with an average follow-up time of 5 years. Of these, 135 received surgery during the study period. To account for selection bias, we used risk-set optimal pairwise matching on a time-varying propensity score, and inverse probability of treatment weighting. Repeated measures generalized linear models were used to model utilization and cost outcomes. Cox proportional hazard was used to model survival. Results The mean direct medical cost difference between the surgical group and control group was $6,806 after risk-set matching. The incidence rate ratio of inpatient, emergency room, and outpatient utilization was lower among the surgical group in both unadjusted and adjusted analyses. There was no significant difference in mortality after adjustment. Among surgical cases, mean annual costs per subject were on average $6,484 lower, and all utilization measures were lower after surgery compared to before. Significance Subjects that underwent epilepsy surgery had lower direct medical care costs and health care utilization. These findings support that epilepsy surgery yields substantial health care cost savings. [ABSTRACT FROM AUTHOR]

Randomized trials provide strong evidence regarding efficacy of interventions but are limited in their capacity to address potential heterogeneity in effectiveness within broad clinical populations. For example, a treatment that on average is superior may be distinctly worse in certain patients. We propose a technique for using large electronic health registries to develop and validate decision models that measure—for distinct combinations of covariate values—the difference in predicted outcomes among 2 alternative treatments. We demonstrate the methodology in a prototype analysis of in-hospital mortality under alternative revascularization treatments. First, we developed prediction models for a binary outcome of interest for each treatment. Decision criteria were then defined based on the treatment-specific model predictions. Patients were then classified as receiving concordant or discordant care (in relation to the model recommendation), and the association between discordance and outcomes was evaluated. We then present alternative decision criteria and validation methodologies, as well as sensitivity analyses that investigate 1) the imbalance between treatments on observed covariates and 2) the aggregate impact of unobserved covariates. Our methodology supplements population-average clinical trial results by modeling heterogeneity in outcomes according to specific covariate values. It thus allows for assessment of current practice, from which cogent hypotheses for improved care can be derived. Newly emerging large population registries will allow for accurate predictions of outcome risk under competing treatments, as complex functions of predictor variables. Whether or not the models might be used to inform decision making depends on the extent to which important predictors are available. Further work is needed to understand the strengths and limitations of this approach, particularly in relation to those based on randomized trials. [ABSTRACT FROM AUTHOR]

Background: Severe asthma occurs more often in older adult patients. We hypothesized that the greater risk for severe asthma in older individuals is due to aging, and is independent of asthma duration. Methods: This is a cross-sectional study of prospectively collected data from adult participants (N=1130; 454 with severe asthma) enrolled from 2002 – 2011 in the Severe Asthma Research Program. Results: The association between age and the probability of severe asthma, which was performed by applying a Locally Weighted Scatterplot Smoother, revealed an inflection point at age 45 for risk of severe asthma. The probability of severe asthma increased with each year of life until 45 years and thereafter increased at a much slower rate. Asthma duration also increased the probability of severe asthma but had less effect than aging. After adjustment for most comorbidities of aging and for asthma duration using logistic regression, asthmatics older than 45 maintained the greater probability of severe asthma [OR: 2.73 (95 CI: 1.96; 3.81)]. After 45, the age-related risk of severe asthma continued to increase in men, but not in women. Conclusions: Overall, the impact of age and asthma duration on risk for asthma severity in men and women is greatest over times of 18-45 years of age; age has a greater effect than asthma duration on risk of severe asthma. [ABSTRACT FROM AUTHOR]

Objectives. To examine the association of orthostatic hypotension with incident heart failure (HF) in older adults. Methods. Of the 5,273 community-dwelling adults aged 65 years and older free of baseline prevalent HF in the Cardiovascular Health Study, 937 (18%) had orthostatic hypotension, defined as ≥20 mmHg drop in systolic or ≥10 mmHg drop in diastolic blood pressure from supine to standing position at 3 minutes. Of the 937, 184 (20%) had symptoms of dizziness upon standing and were considered to have symptomatic orthostatic hypotension. Propensity scores for orthostatic hypotension were estimated for each of the 5,273 participants and were used to assemble a cohort of 3,510 participants (883 participants with and 2,627 participants without orthostatic hypotension) who were balanced on 40 baseline characteristics. Cox regression models were used to estimate the association of orthostatic hypotension with centrally adjudicated incident HF and other outcomes during 13 years of follow-up. Results. Participants (n = 3,510) had a mean (±standard deviation) age of 74 (±6) years, 58% were women, and 15% nonwhite. Incident HF occurred in 25% and 21% of matched participants with and without orthostatic hypotension, respectively (hazard ratio, 1.24; 95% confidence interval, 1.06–1.45; p = .007). Among matched participants, hazard ratios for incident HF associated with symptomatic (n = 173) and asymptomatic (n = 710) orthostatic hypotension were 1.57 (95% confidence interval, 1.16–2.11; p = .003) and 1.17 (95% confidence interval, 0.99–1.39; p = .069), respectively. Conclusions. Community-dwelling older adults with orthostatic hypotension have higher independent risk of developing new-onset HF, which appeared to be more pronounced in those with symptomatic orthostatic hypotension. [ABSTRACT FROM PUBLISHER]

Objective To demonstrate the potential of de-identified clinical data from multiple healthcare systems using different electronic health records (EHR) to be efficiently used for very large retrospective cohort studies. Materials and methods Data of 959 030 patients, pooled from multiple different healthcare systems with distinct EHR, were obtained. Data were standardized and normalized using common ontologies, searchable through a HIPAA-compliant, patient de-identified web application (Explore; Explorys Inc). Patients were 26 years or older seen in multiple healthcare systems from 1999 to 2011 with data from EHR. Results Comparing obese, tall subjects with normal body mass index, short subjects, the venous thromboembolic events (VTE) OR was 1.83 (95% CI 1.76 to 1.91) for women and 1.21 (1.10 to 1.32) for men. Weight had more effect then height on VTE. Compared with Caucasian, Hispanic/Latino subjects had a much lower risk of VTE (female OR 0.47, 0.41 to 0.55; male OR 0.24, 0.20 to 0.28) and African-Americans a substantially higher risk (female OR 1.83, 1.76 to 1.91; male OR 1.58, 1.50 to 1.66). This 13-year retrospective study of almost one million patients was performed over approximately 125 h in 11 weeks, part time by the five authors. Discussion As research informatics tools develop and more clinical data become available in EHR, it is important to study and understand unique opportunities for clinical research informatics to transform the scale and resources needed to perform certain types of clinical research. Conclusions With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed with minimal resources. [ABSTRACT FROM AUTHOR]

Aims: To examine the clinical effectiveness of angiotensin receptor blockers (ARBs) in older patients with heart failure and preserved ejection fraction (HF-PEF).Methods and Results: Of the 10 570 hospitalized HF-PEF patients, aged ≥ 65 years, EF ≥ 40%, in OPTIMIZE-HF (2003-2004), linked to Medicare data (up to 31 December 2008), 3806 were not receiving angiotensin-converting enzyme inhibitors or prior ARB therapy. Of these, 303 (8%) patients received new discharge prescriptions for ARBs. Propensity scores for the receipt of ARBs, estimated for each of the 3806 patients, were used to assemble a cohort of 296 pairs of patients receiving and not receiving ARBs, who were balanced on 114 baseline characteristics. Patients had a mean age of 80 years, mean EF of 55%, 69% were women, and 12% were African American. During 6 years of follow-up, the primary composite endpoint of all-cause mortality or HF hospitalization occurred in 79% (235/296) and 81% (241/296) of patients receiving and not receiving ARBs, respectively [hazard ratio (HR) associated with ARB use 0.88, 95% confidence interval (CI) 0.74-1.06; P = 0.179]. ARB use had no association with individual endpoints of all-cause mortality (HR 0.93, 95% CI 0.76-1.14; P = 0.509), HF hospitalization (HR 0.90, 95% CI, 0.72-1.14; P = 0.389), or all-cause hospitalization (HR 0.91, 95% CI 0.77-1.08; P = 0.265). These associations remained unchanged when we compared any (prevalent and new prescriptions) ARB use vs. non-use in a separately assembled propensity-matched cohort of 1137 pairs of HF-PEF patients.Conclusions: In real-world older HF-PEF patients, ARB use was not associated with improved clinical outcomes. [ABSTRACT FROM AUTHOR]

Aims To examine the clinical effectiveness of angiotensin receptor blockers (ARBs) in older patients with heart failure and preserved ejection fraction (HF-PEF). Methods and results Of the 10 570 hospitalized HF-PEF patients, aged ≥65 years, EF ≥40%, in OPTIMIZE-HF (2003–2004), linked to Medicare data (up to 31 December 2008), 3806 were not receiving angiotensin-converting enzyme inhibitors or prior ARB therapy. Of these, 303 (8%) patients received new discharge prescriptions for ARBs. Propensity scores for the receipt of ARBs, estimated for each of the 3806 patients, were used to assemble a cohort of 296 pairs of patients receiving and not receiving ARBs, who were balanced on 114 baseline characteristics. Patients had a mean age of 80 years, mean EF of 55%, 69% were women, and 12% were African American. During 6 years of follow-up, the primary composite endpoint of all-cause mortality or HF hospitalization occurred in 79% (235/296) and 81% (241/296) of patients receiving and not receiving ARBs, respectively [hazard ratio (HR) associated with ARB use 0.88, 95% confidence interval (CI) 0.74–1.06; P = 0.179]. ARB use had no association with individual endpoints of all-cause mortality (HR 0.93, 95% CI 0.76–1.14; P = 0.509), HF hospitalization (HR 0.90, 95% CI, 0.72–1.14; P = 0.389), or all-cause hospitalization (HR 0.91, 95% CI 0.77–1.08; P = 0.265). These associations remained unchanged when we compared any (prevalent and new prescriptions) ARB use vs. non-use in a separately assembled propensity-matched cohort of 1137 pairs of HF-PEF patients. Conclusions In real-world older HF-PEF patients, ARB use was not associated with improved clinical outcomes. [ABSTRACT FROM AUTHOR]

Aims Instrumental activities of daily living (IADLs) are tasks that are necessary for independent community living. These tasks often require intact physical and cognitive function, the impairment of which may adversely affect health in older adults. In the current study, we examined the association between IADL impairment and incident heart failure (HF) in community-dwelling older adults. Methods and results Of the 5795 community-dwelling adults, aged ≥65 years, in the Cardiovascular Health Study, 5511 had data on baseline IADL and were free of prevalent HF. Of these, 1333 (24%) had baseline IADL impairment, defined as self-reported difficulty with one or more of the following tasks: using the telephone, preparing food, performing light and heavy housework, managing finances, and shopping. Propensity scores for IADL impairment, estimated for each of the 5511 participants, were used to assemble a cohort of 1038 pairs of participants with and without IADL impairment who were balanced on 42 baseline characteristics. Centrally adjudicated incident HF occurred in 26% and 21% of matched participants with and without IADL impairment, respectively, during >12 years of follow-up [matched hazard ratio (HR) 1.33; 95% confidence interval (CI) 1.11–1.59; P = 0.002]. Unadjusted and multivariable-adjusted HRs for incident HF before matching were 1.77 (95% CI 1.56–2.01; P < 0.001) and 1.33 (95% CI 1.15–1.54; P < 0.001), respectively. IADL impairment was also associated with all-cause mortality (matched HR 1.19; 95% CI 1.06–1.34; P = 0.004). Conclusion Among community-dwelling older adults free of baseline HF, IADL impairment is a strong and independent predictor of incident HF and mortality. [ABSTRACT FROM PUBLISHER]

Background. Little is known about the association of rheumatic heart disease (RHD) with incident heart failure (HF) among older adults. Design. Cardiovascular Health Study, a prospective cohort study. Methods. Of the 4,751 community-dwelling adults ≥ 65 years, free of prevalent HF at baseline, 140 had RHD, defined as self-reported physician-diagnosed RHD along with echocardiographic evidence of left-sided valvular disease. Propensity scores for RHD, estimated for each of the 4,751 participants, were used to assemble a cohort of 720, in which 124 and 596 participants with and without RHD, respectively, were balanced on 62 baseline characteristics. Results. Incident HF developed in 33% and 22% of matched participants with and without RHD, respectively, during 13 years of follow-up (hazard ratio when RHD was compared to no-RHD 1.60; 95% confidence interval 1.13-2.28; P == 0.008). Pre-match unadjusted, multivariable-adjusted, and propensity-adjusted hazard ratios (95% confidence intervals) for RHD-associated incident heart failure were 2.04 (1.54-2.71; P < 0.001), 1.32 (1.02-1.70; P == 0.034), and 1.55 (1.14-2.11; P == 0.005), respectively. RHD was not associated with all-cause mortality (HR 1.09; 95% CI 0.82-1.45; P == 0.568). Conclusion. RHD is an independent risk factor for incident HF among community-dwelling older adults free of HF, but has no association with mortality. [ABSTRACT FROM AUTHOR]

Objectives. Widowhood is associated with increased mortality. However, to what extent this association is independent of other risk factors remains unclear. In the current study, we used propensity score matching to design a study to examine the independent association of widowhood with outcomes in a balanced cohort of older adults in the United States. Methods. We used public-use copies of the Cardiovascular Health Study data obtained from the National Heart, Lung, and Blood Institute. Of the 5,795 community-dwelling older men and women aged 65 years and older in Cardiovascular Health Study, 3,820 were married and 1,436 were widows or widowers. Propensity scores for widowhood, estimated for each of the 5,256 participants, were used to assemble a cohort of 819 pairs of widowed and married participants who were balanced on 74 baseline characteristics. The 1,638 matched participants had a mean (± standard deviation) age of 75 (±6) years, 78% were women, and 16% African American. Results. All-cause mortality occurred in 46% (374/819) and 51% (415/819) of matched married and widowed participants, respectively, during more than 11 years of median follow-up (hazard ratio associated with widowhood, 1.18; 95% confidence interval, 1.03–1.36; p = .018). Hazard ratios (95% confidence intervals) for cardiovascular and noncardiovascular mortalities were 1.07 (0.87–1.32; p = .517) and 1.28 (1.06–1.55; p = .011), respectively. Widowhood had no independent association with all-cause or heart failure hospitalization or incident cardiovascular events. Conclusions. Among community-dwelling older adults, widowhood was associated with increased mortality, which was independent of confounding by baseline characteristics and largely driven by an increased noncardiovascular mortality. Widowhood had no independent association with hospitalizations or incident cardiovascular events. [ABSTRACT FROM PUBLISHER]

Aims To test the hypothesis that baseline hypoalbuminaemia is associated with incident heart failure (HF) in community-dwelling older adults. Methods and results Of the 5795 community-dwelling adults aged ≥65 years in the Cardiovascular Health Study, 5450 were free of centrally adjudicated prevalent HF at baseline, and also had data on baseline serum albumin. Of these, 599 (11%) had hypoalbuminaemia, defined as baseline serum albumin levels ≤3.5 mg/dL. Propensity scores for hypoalbuminaemia were calculated for each patient and used to assemble a matched cohort of 582 pairs of participants with and without hypoalbuminaemia, who were well balanced on 58 baseline characteristics. Using Cox regression models, we estimated the association of hypoalbuminaemia with centrally adjudicated incident HF during 9.6 years of median follow-up. Matched participants had a mean (±SD) age of 74 (±6) years, 62% were women, and 16% were African Americans. Incident HF occurred in 25 and 20% of matched participants with and without hypoalbuminaemia, respectively [hazard ratio when hypoalbuminaemia was compared with normoalbuminaemia, 1.40; 95% confidence interval, 1.05–1.85; P = 0.020]. Pre-match unadjusted, multivariable-adjusted, and propensity-adjusted hazard ratios (95% confidence intervals) for incident HF associated with hypoalbuminaemia were 1.33 (1.12–1.58; P = 0.001), 1.33 (1.11–1.60; P = 0.002), and 1.25 (1.04–1.50; P= 0.016), respectively. The combined endpoint of incident HF or all-cause mortality occurred in 59 and 50% of matched participants with and without hypoalbuminaemia, respectively (hazard ratio, 1.33; 95% confidence interval, 1.11–1.61; P= 0.002). Conclusions Among community-dwelling older adults without HF, baseline hypoalbuminaemia was associated with increased risk of incident HF during 10 years of follow-up. [ABSTRACT FROM AUTHOR]

Background: The relationship between stage of chronic kidney disease (CKD) and incident heart failure (HF) remains unclear.Methods: Of the 5,795 community-dwelling adults ≥65 years in the Cardiovascular Health Study, 5,450 were free of prevalent HF and had baseline estimated glomerular filtration rate (eGFR: ml/min/1.73 m(2)) data. Of these, 898 (16%) had CKD 3A (eGFR 45-59 ml/min/1.73 m(2)) and 242 (4%) had CKD stage ≥3B (eGFR <45 ml/min/1.73 m(2)). Data on baseline proteinuria were not available and 4,310 (79%) individuals with eGFR ≥60 ml/min/1.73 m(2) were considered to have no CKD. Propensity scores estimated separately for CKD 3A and ≥3B were used to assemble two cohorts of 1,714 (857 pairs with CKD 3A and no CKD) and 557 participants (148 CKD ≥3B and 409 no CKD), respectively, balanced on 50 baseline characteristics.Results: During 13 years of follow-up, centrally-adjudicated incident HF occurred in 19, 24 and 38% of pre-match participants without CKD (reference), with CKD 3A [unadjusted hazard ratio (HR) 1.40; 95% confidence interval (CI) 1.20-1.63; p < 0.001] and with CKD ≥3B (HR 3.37; 95% CI 2.71-4.18; p < 0.001), respectively. In contrast, among matched participants, incident HF occurred in 23 and 23% of those with CKD 3A and no CKD, respectively (HR 1.03; 95% CI 0.85-1.26; p = 0.746), and 36 and 28% of those with CKD ≥3B and no CKD, respectively (HR 1.44; 95% CI 1.04-2.00; p = 0.027).Conclusions: Among community-dwelling older adults, CKD is a marker of incident HF regardless of stage; however, CKD ≥3B, not CKD 3A, has a modest independent association with incident HF. [ABSTRACT FROM AUTHOR]

Aims To determine independent associations of diabetes mellitus with outcomes in a propensity-matched cohort of patients with acute myocardial infarction (AMI) and systolic heart failure (HF). Methods and results In the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) trial, hospitalized AMI patients complicated by left ventricular ejection fraction ≤40% and symptoms of HF receiving standard therapy were randomized 3–14 days post-AMI to receive eplerenone 25–50 mg/day (n = 3319) or placebo (n = 3313). Of the 6632 patients, 2142 (32%) had a history of diabetes, who were older and sicker. Using propensity scores for diabetes, we assembled a cohort of 1119 pairs of patients with and without diabetes who were balanced on 64 baseline characteristics. Incident fatal or nonfatal recurrent AMI occurred in 136 (12%) and 87 (8%) of matched patients with and without diabetes, respectively, during 2.5 years of follow-up [hazard ratio (HR) when diabetes was compared with no-diabetes, 1.61; 95% confidence interval (CI), 1.23–2.10; P = 0.001]. Diabetes was associated with nonfatal AMI (HR, 1.68; 95% CI, 1.23–2.31; P = 0.001) but not with fatal AMI (HR, 1.42; 95% CI, 0.88–2.28; P = 0.146). Hazard ratios (95% CIs) for the association of diabetes with all-cause mortality, cardiovascular mortality, all-cause hospitalization, and cardiovascular hospitalization were 1.12 (0.93–1.37; P = 0.224), 1.11 (0.90–1.37; P = 0.318), 1.13 (1.00–1.27; P = 0.054), and 1.20 (1.01–1.44; P = 0.042), respectively. Conclusion In post-AMI patients with systolic HF, diabetes mellitus is a significant independent risk factor for recurrent short-term nonfatal AMI, but had no association with fatal AMI. [ABSTRACT FROM PUBLISHER]

Aim To determine if the association between hyperuricaemia and poor outcomes in heart failure (HF) varies by chronic kidney disease (CKD). Methods and results Of the 2645 systolic HF patients in the Beta-Blocker Evaluation of Survival Trial with data on baseline serum uric acid, 1422 had hyperuricaemia (uric acid ≥6 mg/dL for women and ≥8 mg/dL for men). Propensity scores for hyperuricaemia, estimated for each patient, were used to assemble a matched cohort of 630 pairs of patients with and without hyperuricaemia who were balanced on 75 baseline characteristics. Associations of hyperuricaemia with outcomes during 25 months of median follow-up were examined in all patients and in those with and without CKD (estimated glomerular filtration rate of <60 mL/min/1.73 m2). Hyperuricaemia-associated hazard ratios (HRs) and 95% confidence intervals (CI) for all-cause mortality and HF hospitalization were 1.44 (1.12–1.85, P = 0.005) and 1.27 (1.02–1.58, P = 0.031), respectively. Hazard ratios (95% CIs) for all-cause mortality among those with and without CKD were 0.96 (0.70–1.31, P = 0.792) and 1.40 (1.08–1.82, P = 0.011), respectively (P for interaction, 0.071), and those for HF hospitalization among those with and without CKD were 0.99 (0.74–1.33, P = 0.942) and 1.49 (1.19–1.86, P = 0.001), respectively (P for interaction, 0.033). Conclusion Hyperuricaemia has a significant association with poor outcomes in HF patients without CKD but not in those with CKD, suggesting that hyperuricaemia may predict poor outcomes when it is primarily a marker of increased xanthine oxidase activity, but not when it is primarily due to impaired renal excretion of uric acid. [ABSTRACT FROM PUBLISHER]

Aims Obesity is paradoxically associated with survival benefit in patients with chronic heart failure (HF). However, obesity complicates the management of diabetes mellitus (DM), which is common in HF. Yet, little is known about the impact of obesity in HF patients with DM. Therefore, we examined the association between obesity and outcomes in propensity-matched cohorts of HF patient with and without DM. Methods and results Of the 7788 participants with chronic mild to moderate HF in the Digitalis Investigation Group trial, 7379 were non-cachectic [body mass index (BMI) ≥20 kg/m2] at baseline. Of these, 2153 (29%) had DM, of whom 798 (37%) were obese (BMI ≥30 kg/m2). Of the 5226 patients without DM, 1162 (22%) were obese. Propensity scores for obesity were used to separately assemble 636 pairs of obese and non-obese patients with DM and 770 pairs of obese and non-obese patients without DM, who were balanced on 32 baseline characteristics. Among matched patients with DM, all-cause mortality occurred in 38 and 39% of obese and non-obese patients, respectively [hazard ratio (HR) when obesity was compared with no obesity 0.99; 95% confidence interval (CI) 0.80–1.22; P = 0.915]. Among matched patients without DM, all-cause mortality occurred in 23 and 27% obese and non-obese patients, respectively (HR associated with obesity 0.77; 95% CI 0.61–0.97; P = 0.025). Conclusion In patients with chronic mild to moderate HF and DM, obesity confers no paradoxical survival benefit. Whether intentional weight loss may improve outcomes in these patients needs to be investigated in future prospective studies. [ABSTRACT FROM AUTHOR]

Aims: Atrial fibrillation (AF)-associated poor outcomes in heart failure (HF) are often attributed to older age, advanced disease, and comorbidity burden of HF patients with AF. Therefore, we examined the effect of AF on outcomes in a propensity-matched study in which patients with and without AF were well balanced on all measured baseline characteristics. [ABSTRACT FROM PUBLISHER]

Context: High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well. To prevent hyperphosphatemia, patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus. However, phosphorus-containing additives are increasingly being added to processed and fast foods. The effect of such additives on serum phosphorus levels is unclear.Objective: To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease.Design, Setting, and Participants: Cluster randomized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio. Two hundred seventy-nine patients with elevated baseline serum phosphorus levels (>5.5 mg/dL) were recruited between May and October 2007. Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were randomly assigned to an intervention or control group.Intervention: Intervention participants (n=145) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants. Control participants (n=134) continued to receive usual care.Main Outcome Measure: Change in serum phosphorus level after 3 months.Results: At baseline, there was no significant difference in serum phosphorus levels between the 2 groups. After 3 months, the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants (95% confidence interval, -1.0 to -0.1 mg/dL). Intervention participants also had statistically significant increases in reading ingredient lists (P<.001) and nutrition facts labels (P = .04) but no significant increase in food knowledge scores (P = .13).Conclusion: Educating end-stage renal disease patients to avoid phosphorus-containing food additives resulted in modest improvements in hyperphosphatemia.Trial Registration: clinicaltrials.gov Identifier: NCT00583570. [ABSTRACT FROM AUTHOR]

The article presents a randomized controlled trial which examined the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels in patients with end-stage renal disease. 279 patients with elevated baseline serum phosphorus levels at 14 long-term hemodialysis facilities were included in the trial. Participants in the intervention group received education on avoiding foods with phosphorus additives. The control participants received usual care. Researchers found modest improvements in hyperphosphatemia with education for patients with end-stage renal disease.

Background: Among advanced-stage cancer patients, age is an important determinant of decision making about medical care. We examined age-related differences in patient well-being, care perspectives, and preferences, and the relationship between these patient characteristics and subsequent care practices including care communication, pain management, and acute care utilization during the early treatment phase of late-stage cancer.Methods: Patient demographics, well-being, and care perspectives were assessed during patient and physician baseline interviews. Care practices were measured using outpatient and inpatient records for the 30-day period after baseline assessment. Multivariate regression models were used to examine the patterns of association of age and other patient characteristics with care practices.Results: A total of 174 middle-aged and 149 older patients with recently diagnosed late-stage cancer were included. Older patients had more comorbidities but lower levels of depression, anxiety, and symptom distress. Older patients preferred pain relief/comfort as a treatment goal, but received fewer prescriptions for opioids. Whereas provider-initiated communication with patients/families was positively associated with severity of illness, patient/family-initiated communication was associated with patient psychosocial attributes and care perspectives. Satisfaction with care was inversely associated with reports of pain. Symptom distress was positively associated with subsequent opioid prescriptions and hospitalizations.Conclusions: Our results help to explain the role of patients' psychosocial attributes, care perspectives, and preferences in subsequent care practices during the early treatment phase for late-stage cancer. Age-related differences in patient well-being and care perspectives suggest a role for age-sensitive interventions in the treatment of advanced cancer patients. [ABSTRACT FROM AUTHOR]

Background. Among advanced-stage cancer patients, age is an important determinant of decision making about medical care. We examined age-related differences in patient well-being, care perspectives, and preferences, and the relationship between these patient characteristics and subsequent care practices including care communication, pain management, and acute care utilization during the early treatment phase of late-stage cancer. Methods. Patient demographics, well-being, and care perspectives were assessed during patient and physician baseline interviews. Care practices were measured using outpatient and inpatient records for the 30-day period after baseline assessment. Multivariate regression models were used to examine the patterns of association of age and other patient characteristics with care practices. Results. A total of 174 middle-aged and 149 older patients with recently diagnosed late-stage cancer were included. Older patients had more comorbidities but lower levels of depression, anxiety, and symptom distress. Older patients preferred pain relief/comfort as a treatment goal, but received fewer prescriptions for opioids. Whereas provider-initiated communication with patients/families was positively associated with severity of illness, patient/family-initiated communication was associated with patient psychosocial attributes and care perspectives. Satisfaction with care was inversely associated with reports of pain. Symptom distress was positively associated with subsequent opioid prescriptions and hospitalizations. Conclusions. Our results help to explain the role of patients' psychosocial attributes, care perspectives, and preferences in subsequent care practices during the early treatment phase for late-stage cancer. Age-related differences in patient well- being and care perspectives suggest a role for age-sensitive interventions in the treatment of advanced cancer patients. [ABSTRACT FROM AUTHOR]

Background: Electronic medical records (EMRs) have the potential to facilitate the design of large cluster-randomized trials (CRTs).Objective: To describe the design of a CRT of clinical decision support to improve diabetes care and outcomes.Methods: In the Diabetes Improvement Group-Intervention Trial (DIG-IT), we identified and balanced preassignment characteristics of 12,675 diabetic patients cared for by 147 physicians in 24 practices of 2 systems using the same vendor's EMR. EMR-facilitated disease management was system A's experimental intervention; system B interventions involved patient empowerment, with or without disease management. For our sample, we: (1) identified characteristics associated with response to interventions or outcomes; (2) summarized feasible partitions of 10 system A practices (2 groups) and 14 system B practices (3 groups) using intra-cluster correlation coefficients (ICCs) and standardized differences; (3) selected (blinded) partitions to effectively balance the characteristics; and (4) randomly assigned groups of practices to interventions.Results: In System A, 4,306 patients, were assigned to 2 groups of practices; 8,369 patients in system B were assigned to 3 groups of practices. Nearly all baseline outcome variables and covariates were well-balanced, including several not included in the initial design. DIG-IT's balance was superior to alternative partitions based on volume, geography or demographics alone.Conclusions: EMRs facilitated rigorous CRT design by identifying large numbers of patients with diabetes and enabling fair comparisons through preassignment balancing of practice sites. Our methods can be replicated in other settings and for other conditions, enhancing the power of other translational investigations. [ABSTRACT FROM AUTHOR]

Background: Poor prognosis in heart failure (HF) patients with diabetes is often attributed to increased co-morbidity and advanced disease. Further, this effect may be worse in women.Objective: To determine whether the effect of diabetes on outcomes and the sex-related variation persisted in a propensity score-matched HF population, and whether the sex-related variation was a function of age.Methods: Of the 7788 HF patients in the Digitalis Investigation Group trial, 2218 had a history of diabetes. Propensity score for diabetes was calculated for each patient using a non-parsimonious logistic regression model incorporating all measured baseline covariates, and was used to match 2056 (93%) diabetic patients with 2056 non-diabetic patients.Results: All-cause mortality occurred in 135 (25%) and 216 (39%) women without and with diabetes (adjusted HR = 1.67; 95% CI = 1.34 to 2.08; p<0.001). Among men, 535 (36%) and 609 (41%) patients without and with diabetes died from all causes (adjusted HR = 1.21; 95% CI = 1.07 to 1.36; p = 0.002). Sex-diabetes interaction (overall adjusted p<0.001) was only significant in patients > or = 65 years (15% absolute risk increase in women; multivariable p for interaction = 0.005), but not in younger patients (2% increase in women; p for interaction = 0.173). Risk-adjusted HR (95% CI) for all-cause hospitalisation for women and men were 1.49 (1.28 to 1.72) and 1.21 (1.11 to 1.32), respectively, also with significant sex-diabetes interaction (p = 0.011).Conclusions: Diabetes-associated increases in morbidity and mortality in chronic HF were more pronounced in women, and theses sex-related differences in outcomes were primarily observed in elderly patients. [ABSTRACT FROM AUTHOR]

Background: Poor prognosis in heart failure (HF) patients with diabetes is often attributed to increased comorbidity and advanced disease. Further, this effect may be worse in women. Objective: To determine whether the effect of diabetes on outcomes and the sex-related variation persisted in a propensity score-matched HF population, and whether the sex-related variation was a function of age. Methods: Of the 7788 HF patients in the Digitalis Investigation Group trial, 2218 had a history of diabetes. Propensity score for diabetes was calculated for each patient using a non-parsimonious logistic regression model incorporating all measured baseline covariates, and was used to match 2056 (93%) diabetic patients with 2056 non-diabetic patients. Results: All-cause mortality occurred in 135 (25%) and 216 (39%) women without and with diabetes (adjusted HR = 1.67; 95% CI = 1.34 to 2.08; p < 0.001). Among men, 535 (36%) and 609 (41%) patients without and with diabetes died from all causes (adjusted HR = 1.21; 95% CI = 1.07 to 1.36; p = 0.002). Sex-diabetes interaction (overall adjusted p < 0.001) was only significant in patients ⩾65 years (15% absolute risk increase in women; multivariable p for interaction = 0.005), but not in younger patients (2% increase in women; p for interaction = 0.173). Risk-adjusted HR (95% CI) for all-cause hospitalisation for women and men were 1.49 (1.28 to 1.72) and 1.21 (1.11 to 1.32), respectively, also with significant sex-diabetes interaction (p = 0.011). Conclusions: Diabetes-associated increases in morbidity and mortality in chronic HF were more pronounced in women, and theses sex-related differences in outcomes were primarily observed in elderly patients. [ABSTRACT FROM AUTHOR]

OBJECTIVES: The endoscopic secretin test (ePFT) takes an hour to perform, limiting its practicality for routine use. We sought to determine which timed endoscopic collections best predict the peak bicarbonate concentration from full hour-long test. METHODS: A cross-sectional study was performed of all ePFTs performed at our institution from 2000 to 2004. We compared 7 theoretical shortened tests [4-single collections (15, 30, 45, or 60 minutes after secretin) and 3-dual collections (15/30, 30/45, 45/60 minutes after secretin)] to the full test and to each other using multivariate linear and Deming regression models. RESULTS: The bicarbonate results of 240 ePFTs were analyzed. The dual 30/45-minute collection was the optimal method based on the closest agreement with the full test (94%). Deming regression reveals the 30/45 estimate to be the best combination from an analytic perspective, owing to its lack of significant proportional bias and minimal constant bias (5.1 mEq/L) as compared to the reference test. Use of the 30/45 method with the adjusted cutpoint 75 mEq/L produces very good specificity (93%) for ruling in exocrine insufficiency. CONCLUSIONS: A dual timed aspiration at 30 and 45 minutes can be used to screen for pancreatic exocrine insufficiency in patients with abdominal pain, simplifying the use of the ePFT in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: There is a growing consensus that quality of care for frail elders should include family and be evaluated in terms of patient-centered, family-focused care (PCFFC). Family caregivers are in a unique and sometimes sole position to evaluate such care. In the context of caring for physically frail elders, this study examined the extent to which objective burden was associated with caregiver perceptions of PCFFC and the extent to which it mediated the influence of other variables on perceptions of PCFFC. Design and Methods: In a study of frail elderly veterans receiving care in U.S. Department of Veterans Affairs ambulatory primary care clinics, informal caregivers assessed quality of care with 13 questions. Factor analysis of these items revealed an eight-item scale that specifically assessed PCFFC (α = .90). Regression analysis identified variables associated with caregiver (N = 210) assessments of PCFFC and the potential mediating effect of objective burden. Results: Caregiver assessments of PCFFC were positively associated with care recipient instrumental activity of daily living limitations (p = .04) and perspectives on the quality of their own patient care (p < .001). Greater objective burden was negatively associated with caregiver assessments of PCFFC (p < .001)and mediated (i.e., reduced)the relationship between care recipient perceptions of the quality of their own patient care and caregiver assessments of PCFFC (ΔR² = .06). Implications: These findings support recommendations for conducting caregiver assessments as part of routine care and highlight the importance of measuring objective burden and expectations for PCFFC in assisting physically frail elders. Primary care providers will require additional training in order to effectively implement and translate such caregiver assessments into clinical practice improvement. [ABSTRACT FROM AUTHOR]