Research has demonstrated that the use of potentially inappropriate medication (PIM) is highly prevalent among older individuals and may lead to increased healthcare costs, adverse drug reactions, hospitalizations, and mortality.

AimsTo understand differences in patient reported outcomes (PRO) between patients initiating mirabegron or an antimuscarinic using a validated PRO instrument, OAB-Satisfaction (OAB-S). MethodsThis prospective observational study used real-time prescription claims from Humana to identify Medicare patients initiating mirabegron or an antimuscarinic to participate in a series of three phone surveys over ninety days. ResultsA total of 1897 mirabegron and 2444 randomly selected antimuscarinic initiators were identified; 174 mirabegron and 193 antimuscarinic initiators completed all three surveys. Among responders, mirabegron initiators were slightly older (76 vs 75 years, P=0.032), included more males (32% vs 23%, P=0.044), more likely to have prior OAB treatment (21% vs 13%, P=0.048), and had greater medication burden (number of unique medications: 10.0 vs 8.7, P=0.014). There were no between-group differences at any time or on any OAB-S scale. There were significant within-group differences at follow-up compared to baseline for OAB-S scales: impact on daily living, with improvement over the 90-day survey period for both mirabegron (P=0.008) and antimuscarinic (P<0.001); interruption of day-to-day life, with improvement for both mirabegron (P<0.001) and antimuscarinic (P<0.001); and improvement in OAB control for mirabegron (P<0.001) and antimuscarinic (P<0.001). ConclusionsMirabegron initiators tended to be older, had a greater number of unique medications and previously tried prescriptions to treat OAB; nonetheless, mirabegron, and antimuscarinic initiators reported similar trends in improvement in PROs over the first 90 days of treatment. Significant improvement in daily impact of OAB was observed after treatment initiation; however, no significant differences between groups were observed.

ObjectivesTo examine potentially inappropriate medication (PIM) use in older adults initiating an antimuscarinic medication for the treatment of overactive bladder (OAB).DesignRetrospective database analysis.SettingMedical and pharmacy claims data.ParticipantsMedicare Advantage Prescription Drug Plan members aged 65 and older newly initiated on an antimuscarinic OAB treatment were identified and assigned to PIM and non-PIM comparison groups based on 2012 American Geriatrics Society Beers Criteria and/or the presence of an anticholinergic medication interaction at the time of initiation of treatment (N = 66,275).MeasurementsHealthcare costs and OAB medication use.ResultsOf members initiated on an antimuscarinic OAB medication, 31.1% had a drug-drug or drug-disease or syndrome interaction. Dementia was the most common disease or syndrome interaction (11.3%), followed by constipation (8.6%) and delirium (2.9%). Paroxetine (2.6%), amitriptyline (2.2%), cyclobenzaprine (1.7%), and meclizine (1.6%) were the most common interacting medications. Subjects in the PIM group had greater healthcare costs over 12 months of follow-up ($12,001) than those in the non-PIM group ($9,373) after controlling for baseline characteristics (P < .001). There was no difference between the PIM and the non-PIM groups in odds of discontinuing OAB treatment at 12 months after controlling for baseline characteristics (odds ratio = 0.98, 95% confidence interval = 0.89-1.07, P = .63).ConclusionPotentially inappropriate medication use was highly prevalent and was associated with greater total healthcare costs. Providers should carefully consider medical history and concurrent medication use when initiating antimuscarinic medication for the treatment of OAB. Development of interventions to reduce potentially inappropriate use of antimuscarinics in individuals with OAB is warranted.

Background The Global initiative for chronic Obstructive Lung Disease guidelines recommend assessment of COPD severity, which includes symptomatology using the modified Medical Research Council (mMRC) or COPD assessment test (CAT) score in addition to the degree of airflow obstruction and exacerbation history. While there is great interest in incorporating symptomatology, little is known about how patient reported symptoms are associated with future exacerbations and exacerbation-related costs. Methods The mMRC and CAT were mailed to a randomly selected sample of 4,000 Medicare members aged >40 years, diagnosed with COPD (≥2 encounters with International Classification of Dis eases-9th Edition Clinical Modification: 491.xx, 492.xx, 496.xx, ≥30 days apart). The exacerbations and exacerbation-related costs were collected from claims data during 365-day post-survey after exclusion of members lost to follow-up or with cancer, organ transplant, or pregnancy. A logistic regression model estimated the predictive value of exacerbation history and symptomatology on exacerbations during follow-up, and a generalized linear model with log link and gamma distribution estimated the predictive value of exacerbation history and symptomatology on exacerbation-related costs. Results Among a total of 1,159 members who returned the survey, a 66% (765) completion rate was observed. Mean (standard deviation) age among survey completers was 72.0 (8.3), 53.7% female and 91.2% white. Odds ratios for having post-index exacerbations were 3.06, 4.55, and 16.28 times for members with 1, 2, and ≥3 pre-index exacerbations, respectively, relative to members with 0 pre-index exacerbations (P<0.001 for all). The odds ratio for high vs low symptoms using CAT was 2.51 (P<0.001). Similarly, exacerbation-related costs were 73% higher with each incremental pre-index exacerbation, and over four fold higher for high-vs low-symptom patients using CAT (each P<0.001). The symptoms using mMRC were not statistically significant in either model (P>0.10). Conclusion The patient-reported symptoms contribute important information related to future COPD exacerbations and exacerbation-related costs beyond that explained by exacerbation history.

BACKGROUND:Clinical inertia, which has been defined as the recognition of a problem with a patient's management but failing to act, is a concern in type 2 diabetes (T2D) because it places the patient at risk of diabetes-related complications. Despite managed care organizations making significant investment in this area, little is known about the impact of educational programs aimed at aligning patients and their physicians with diabetes guidelines and thus overcoming clinical inertia.OBJECTIVE:To assess the impact of an educational intervention specifically designed to align patients and their physicians with 2012 American Diabetes Association (ADA) guidelines on glycated hemoglobin (A1c) testing frequency and insulin initiation.METHODS:The "Act on Threes" educational intervention was a 12-month, randomized controlled prospective study that included Medicare Advantage patients aged 18-85 years with T2D, who received ≥ 3 oral antidiabetes drugs (OADs) and/or had A1c not at goal and/or had no recent A1c evaluation over 12 months, as identified through the analysis of administrative claims data (May 1, 2011-April 30, 2013) from the Humana database. Identified patients were randomized 3:1 to receive the Act on Threes educational intervention in conjunction with standard care (intervention group) or standard care alone (control group). For the educational intervention, patients and physicians were simultaneously mailed general and targeted information aimed at aligning them to 3 vital aspects of A1c control: timely measurement of A1c every 3 months; timely treatment intensification to meet A1c goals with treatment intensification every 3 months if A1c is not at goal; and insulin initiation when appropriate, including patients receiving ≥ 3 OADs with A1c not at goal. Control patients were only enrolled if the treating physician was not involved in the care of any patients in the intervention group. The primary outcome measures were A1c testing frequency based on the ADA standard for compliance of ≥ 2 tests per year and insulin initiation in the 12-month postintervention period. A1c levels were evaluated for the subgroup of patients with available A1c measurements in the pre- and postintervention periods. Descriptive statistics were used to analyze differences between the intervention and control groups. Multiple logistic regression analysis was used to identify determinants of insulin initiation in the full study cohort.RESULTS:6,243 patients (mean age 70 years; 43.5% female) were identified: 4,555 were randomized to the intervention group and 1,688 to the control group. The percentage of patients with ≥ 2 A1c tests per year was not significantly different postintervention for patients in the intervention and control groups (47.7% vs. 46.8%, respectively; P = 0.995). Intriguingly, the frequency of A1c testing increased significantly from pre- to postintervention in the intervention and control groups. Change in A1c level from pre- to postintervention was also similar for the 2 groups (P = 0.240). A similar percentage of patients in the intervention and control groups initiated insulin during the postintervention period (6.3% vs. 7.6%, respectively; P = 0.059).CONCLUSIONS:This randomized controlled study demonstrated that, compared with standard care, the Act on Threes educational intervention combined with standard care did not result in any significant differences in the frequency of A1c testing or in the initiation of insulin in patients with T2D. These findings are in contrast to uncontrolled comparative studies showing significant improvements in outcomes postintervention and reinforce the importance of study design in evaluating the effectiveness of educational programs.DISCLOSURES:This study was funded by Sanofi U.S. Reynolds, Davis, Kamble, and Uribe are employees of Comprehensive Health Insights, which was contracted by Sanofi U.S. to conduct, publish, and present this study. Bieszk and Wei are employees of Sanofi U.S. Reynolds and Uribe provided expertise and key clinical insights for the study design and methodology, provided interpretations of the data, contributed to the discussion, and reviewed the manuscript. Bieszk and Wei codeveloped the study design, researched data, contributed to discussion, and reviewed the manuscript. Davis and Kamble collected the data, provided study design, clinical insights, statistical and analytic reflections of the data, drafted the study reports, and reviewed the manuscript. All authors had full access to all the data in the study. Reynolds is the guarantor of this work and, as such, takes responsibility for the integrity of the data and the accuracy of the data analysis.ACKNOWLEDGMENTS:Writing/editorial support in the preparation of this manuscript, which was funded by Sanofi U.S., was provided by Rosalie Gadiot, PhD, of Excerpta Medica, who wrote the initial draft of the manuscript.

ObjectivesTo compare medical condition burden, healthcare resource use, and healthcare costs of household members (HHMs) of individuals diagnosed with Alzheimer's disease (AD) with those of HHMs of matched individuals without AD.DesignRetrospective cohort study based on administrative claims data collected between January 1, 2007, and December 31, 2011.SettingMedicare Advantage Prescription Drug (MAPD) plan.ParticipantsMAPD plan members with a diagnosis of AD (International Classification of Disease Ninth Revision, Clinical Modification, code 331.0) were selected and linked to a HHM to form patient-HHM dyads. AD dyads were matched to non-AD dyads.MeasurementsHealth-related endpoints, including medical condition burden, healthcare resource use, and direct healthcare costs, were measured during 36months of continuous health plan enrollment.ResultsIndividuals with AD (n=1,861) were linked to HHMs (n=1,861), and these AD dyads were matched to 1,861 non-AD patient-HHM dyads. AD HHMs had greater medical condition burden scores than non-AD HHMs, with mood disorders, anxiety disorders, insomnia, substance abuse or dependence, cardiovascular disease, and rheumatoid arthritis being more prevalent in AD HHMs. Emergency department and outpatient service use were more common in AD HHMs than in non-AD HHMs, and AD HHMs had greater healthcare costs.ConclusionHHMs of individuals diagnosed with AD demonstrated greater medical condition burden, healthcare resource use, and direct healthcare costs than non-AD HHMs. These findings demonstrate the significant clinical and financial impact of AD on HHMs of individuals with AD.

BACKGROUND:Varenicline, a nicotinic acetylcholine receptor partial agonist, is a pharmacotherapy indicated for smoking cessation treatment. To date, no research has examined the relationship between out-of-pocket (OOP) expense and varenicline adherence among Medicare beneficiaries.OBJECTIVES:To (a) characterize medication utilization patterns of varenicline among Medicare members newly initiated on varenicline and (b) examine the relationship between member OOP expense and varenicline medication adherence.METHODS:In this retrospective cohort study, pharmacy claims data were used to identify Medicare Advantage Prescription Drug Plan (MAPD) members newly initiated on varenicline. Demographic and clinical characteristics, varenicline medication utilization patterns, and pharmacy costs (total and varenicline-specific) were determined for members included in the study. Varenicline adherence was measured by calculating the proportion of days covered (PDC) over a period of 84 days (12 weeks) after initiation. Multiple regression analysis was used to examine the relationship between varenicline OOP cost and varenicline medication utilization, while controlling for sociodemographic characteristics, clinical factors, and nonvarenicline pharmacy costs.RESULTS:A total of 15,452 MAPD members were included in the analysis. Mean (SD) subject age was 62.6 (10.0) years; 21.1% (n = 3,256) were dual eligible; and 33.0% (n = 5,106) received a low-income subsidy. Mean (SD) initial varenicline treatment episode duration was 50.8 (37.8) days, with a mean (SD) varenicline days' supply of 47.8 (32.6) obtained by members during the initial treatment episode. Mean (SD) PDC was 0.51 (0.24), and 14.9% (n = 2,302) of members were classified as adherent to treatment (PDC  ≥  0.80). Greater varenicline OOP expense was significantly associated with lower PDC (regression coefficient = -0.058, P  less than  0.001) and significantly associated with lower odds of receiving a refill for varenicline (odds ratio 0.594, 95% CI: 0.540-0.655, P  less than  0.001).CONCLUSIONS:Among Medicare beneficiaries newly initiated on varenicline, medication adherence was suboptimal, and greater OOP cost was associated with lower adherence and lower odds of refilling varenicline.

OBJECTIVE To determine whether an intensive lifestyle intervention (ILI) designed to sustain weight loss and improve physical fitness in overweight or obese persons with type 2 diabetes was associated with bone loss after 4 years of follow-up. RESEARCH DESIGN AND METHODS This randomized controlled trial of intensive weight loss compared an ILI with a diabetes support and education (DSE) group among 1,309 overweight or obese subjects. Bone mineral density was assessed at baseline and after 1 year and 4 years of intervention. RESULTS ILI was effective in producing significant weight loss (5.3% vs. 1.8% in ILI and DSE, respectively; P < 0.01) and increased fitness (6.4% vs. −0.8%) at year 4. In men, ILI participants had a greater rate of bone loss during the first year (−1.66% vs. −0.09% per year in ILI and DSE, respectively). Differences between groups were diminished by one-half after 4 years (−0.88% vs. −0.05% per year in ILI and DSE, respectively) but remained significant (P < 0.01). The difference in rate of hip bone loss between groups over 4 years was related to increased weight loss in ILI. Among women, the rate of bone loss did not differ between ILI and DSE after 4 years. CONCLUSIONS A 4-year weight loss intervention was significantly associated with a modest increase in bone loss at the hip in men but not in women.

Background/Rationale: Alzheimer's disease (AD) represents a serious public health issue affecting approximately 5.4 million individuals in the United States and is projected to affect up to 16 million by 2050. This study examined health care resource utilization (HCRU), costs, and comorbidity burden immediately preceding new diagnosis of AD and 2 years after diagnosis. Methods: This study utilized a claims-based, retrospective cohort design. Medicare Advantage members newly diagnosed with AD (n = 3374) were compared to matched non-AD controls (n = 6748). All patients with AD were required to have 12 months of continuous enrollment prior to AD diagnosis (International Classification of Diseases, Clinical Modification [ICD-9] 331.0), during which time no diagnosis of AD, a related dementia, or an AD medication was observed. Non-AD controls demonstrated no diagnosis of AD, a related dementia, or a prescription claim for an AD medication treatment during their health plan enrollment. Medical and pharmacy claims data were used to measure HCRU, costs, and comorbidity burden over a period of 36 months (12 months pre-diagnosis and 24 months post-diagnosis). Results: The HCRU and costs were greater for AD members during the year prior to diagnosis and during postdiagnosis years 1 and 2 compared to controls. The AD members also displayed greater comorbidity than their non-AD counterparts during postdiagnosis years 1 and 2, as measured by 2 different comorbidity indices. Conclusions: Members newly diagnosed with AD demonstrated greater HCRU, health care costs, and comorbidity burden compared to matched non-AD controls.

AIMSOur study aims were to determine the frequency of MODY mutations (HNF1A, HNF4A, glucokinase) in a diverse population of youth with diabetes and to assess how well clinical features identify youth with maturity-onset diabetes of the young (MODY).METHODSThe SEARCH for Diabetes in Youth study is a US multicenter, population-based study of youth with diabetes diagnosed at age younger than 20 years. We sequenced genomic DNA for mutations in the HNF1A, HNF4A, and glucokinase genes in 586 participants enrolled in SEARCH between 2001 and 2006. Selection criteria included diabetes autoantibody negativity and fasting C-peptide levels of 0.8 ng/mL or greater.RESULTSWe identified a mutation in one of three MODY genes in 47 participants, or 8.0% of the tested sample, for a prevalence of at least 1.2% in the pediatric diabetes population. Of these, only 3 had a clinical diagnosis of MODY, and the majority was treated with insulin. Compared with the MODY-negative group, MODY-positive participants had lower FCP levels (2.2 ± 1.4 vs 3.2 ± 2.1 ng/mL, P < .01) and fewer type 2 diabetes-like metabolic features. Parental history of diabetes did not significantly differ between the 2 groups.CONCLUSIONS/INTERPRETATIONIn this systematic study of MODY in a large pediatric US diabetes cohort, unselected by referral pattern or family history, MODY was usually misdiagnosed and incorrectly treated with insulin. Although many type 2 diabetes-like metabolic features were less common in the mutation-positive group, no single characteristic identified all patients with mutations. Clinicians should be alert to the possibility of MODY diagnosis, particularly in antibody-negative youth with diabetes.

Approximately 15 million Americans provide unpaid care for individuals with Alzheimer's disease (AD). Over 5 million Americans have AD, and the prevalence is projected to increase dramatically in the coming decades. The impact of AD on family members can be substantial and can impact their well-being. The objective of this research is to compare health-related outcomes among household members (HHMs) of patients with AD to HHMs of individuals without AD. This study is a retrospective cohort study based on administrative claims data collected between January 1, 2007 and December 31, 2011. Non-dual eligible Medicare Advantage Prescription Drug (MAPD) plan members with a diagnosis of AD (ICD-9-CM 331.0) were selected and linked via telephone and address to a HHM in order to form patient-household member dyads. AD dyads were then matched to non-AD dyads, and health-related endpoints including health conditions, service utilization, and direct healthcare costs were measured during 36 months of continuous health plan enrollment. A total of 1,861 individuals with AD were linked to 1,861 household members, and these AD dyads were matched to 1,861 non-AD patient-household member dyads. HHMs in both groups were primarily female (n = 1,080 for both groups, 58.0%), and the mean age was 75 years. The vast majority (n= 1,759, 94.5%) of HHMs linked to subjects with AD were opposing gender. AD HHMs had greater number of health conditions compared to non-AD HHMs, and medical conditions including mood disorders, anxiety disorders, insomnia, substance abuse or dependence, cardiovascular disease, and rheumatoid arthritis were more prevalent among AD HHMs. Compared to non-AD HHMs, emergency department and outpatient utilization was more common among HHMs of individuals with AD, and AD HHMs had greater healthcare costs. Household members of individuals diagnosed with AD demonstrated greater health condition burden, healthcare service utilization, and direct healthcare costs compared to non-AD HHMs. These findings demonstrate the significant clinical and financial impact of AD among household member of patients with AD. Household members and other potential caregivers of individuals with AD should be counseled on the importance of caring for their own physical and psychological well-being.

OBJECTIVE: Because of concerns about the safety and environmental impact of mercury, aneroid sphygmomanometers have replaced mercury-filled devices for blood pressure (BP) measurements. Despite this change, few studies have compared BP measurements between the 2 devices. METHODS: The SEARCH for Diabetes in Youth Study conducted a comparison of aneroid and mercury devices among 193 youth with diabetes (48% boys, aged 12.9 ± 3.7 years; 89% type 1). Statistical analyses included estimating Pearson correlation coefficients, Bland-Altman plots, paired t tests, and fitting regression models, both overall and stratified by age (<10 vs ≥10–18 years). RESULTS: Mean mercury and aneroid systolic and diastolic BPs were highly correlated. For the entire group, there was no significant difference in mean systolic BP using the aneroid device, but there was a −1.53 ± 5.06 mm Hg difference in mean diastolic BP. When stratified by age, a lower diastolic BP (−1.78 ± 5.2 mm Hg) was seen in those ≥10 to 18 years using the aneroid device. No differences in systolic BP were observed, and there were no differences in BP by device in individuals <10 years. Regression analyses did not identify any explanatory variables. CONCLUSIONS: Although a small discrepancy between diastolic BP measurements from aneroid versus mercury devices exists, this variation is unlikely to be clinically significant, suggesting that either device could be used in research or clinical settings.

Diabet. Med. 29, 1148–1152 (2012)AbstractAims The aim of this pilot study was to generate an initial estimate of the prevalence and correlates of diabetic retinopathy in a racially and ethnically diverse sample of youth with Type 1 and Type 2 diabetes mellitus.Methods A pilot study was conducted among 222 individuals with Type 1 diabetes (79% non‐Hispanic white, 21% other) and 43 with Type 2 diabetes (28% non‐Hispanic white, 72% other), all of > 5 years duration (mean duration 6.8 years) who participated in the SEARCH for Diabetes in Youth study. Diabetic retinopathy was assessed using non‐mydriatic retinal photography of both eyes.Results The prevalence of diabetic retinopathy was 17% for Type 1 diabetes and 42% for Type 2 diabetes (odds ratio 1.50, 95% CI 0.58–3.88; P = 0.40 adjusted for age, duration, gender, race/ethnicity, parental education and HbA1c. HbA1c was significantly higher among those with any diabetic retinopathy (adjusted mean 79 mmol/mol, 9.4%) vs. no diabetic retinopathy (adjusted mean 70 mmol/mol, 8.6%) (P = 0.015). LDL cholesterol was also significantly higher among those with any diabetic retinopathy (adjusted mean 107.2 mg/dl) compared with those without diabetic retinopathy (adjusted mean 97.9 mg/dl) (P = 0.04).Conclusions The prevalence of diabetic retinopathy in contemporary young individuals was substantial, particularly among minority youth and those with Type 2 diabetes. Further long‐term study of diabetic retinopathy in youth is needed.

Purpose:To assess correlates of physical activity, and to examine the relationship between physical activity and physical functioning, in 160 older (66 ± 6 years old), overweight/obese (mean body mass index = 33.5 ± 3.8 kg/m2), sedentary (less than 30 mins of activity, 3 days a week) individuals with knee osteoarthritis.Methods:Physical activity was measured with accelerometers and by self-report. Physical function was assessed by 6-min walk distance, knee strength, and the Short Physical Performance Battery. Pain and perceived function were measured by questionnaires. Pearson correlations and general linear models were used to analyze the relationships.Results:The mean number of steps taken per day was 6209 and the average PAEE was 237 ± 124 kcal/day. Participants engaged in 131 ± 39 minutes of light physical activity (LPA) and 10.6 ± 8.9 minutes of moderate-vigorous physical activity (MPA/VPA). Total steps/day, PAEE, and minutes of MPA/VPA were all negatively correlated with age. The 6-min walk distance and lower extremity function were better in those who had higher total steps/day, higher PAEE, higher minutes of MPA/VPA, and a higher PASE score.Conclusions:This study demonstrates that a population who has higher levels of spontaneous activity have better overall physical function than those who engage in less activity.

Persons with type 1 diabetes are at increased risk of developing vascular disease. Adiponectin concentrations may play an intermediate role in this process. We sought to determine whether adiponectin is correlated with vascular stiffness in adolescents with type 1 diabetes. Plasma adiponectin, pulse wave velocity (PWV), augmentation index (AIx-75), and brachial distensibility (BrachD) were collected in 225 adolescents. Outcomes were evaluated by sex, and regression models were used to determine whether adiponectin was an independent determinant of arterial stiffness. Males had lower adiponectin levels and stiffer vessels (lower BrachD, p < 0.01) than females. Unadjusted correlations revealed that adiponectin was correlated with BrachD (p < 0.01) but not PWV and AIx-75. After adjustment, adiponectin was not a significant predictor of BrachD. The most consistent predictors of increased stiffness were age, male sex, blood pressure, obesity, and total cholesterol (p < 0.05). Adiponectin's contributions to arterial stiffness appear to be masked by other cardiovascular risk factors in persons with type 1 diabetes.

Background Many factors have been identified that influence the recruitment of African Americans into clinical trials; however, the influence of eligibility criteria may not be widely appreciated. We used the experience from the Look AHEAD (Action for Health in Diabetes) trial screening process to examine the differential impact eligibility criteria had on the enrollment of African Americans compared to other volunteers. Methods Look AHEAD is a large randomized clinical trial to examine whether assignment to an intensive lifestyle intervention designed to produce and maintain weight loss reduces the long-term risk of major cardiovascular events in adults with type 2 diabetes. Differences in the screening, eligibility, and enrollment rates between African Americans and members of other racial/ethnic groups were examined to identify possible reasons. Results Look AHEAD screened 28,735 individuals for enrollment, including 6226 (21.7%) who were self-identified African Americans. Of these volunteers, 12.9% of the African Americans compared to 19.3% of all other screenees ultimately enrolled (p < 0.001). African Americans no more often than others were lost to follow-up or refused to attend clinic visits to establish eligibility. Furthermore, the enrollment rates of individuals with histories of cardiovascular disease and diabetes therapy did not markedly differ between the ethnic groups. Higher prevalence of adverse levels of blood pressure, heart rate, HbA1c, and serum creatinine among African American screenees accounted for the greater proportions excluded (all p < 0.001). Conclusions Compared to non-African Americans, African American were more often ineligible for the Look AHEAD trial due to comorbid conditions. Monitoring trial eligibility criteria for differential impact, and modifying them when appropriate, may ensure greater enrollment yields.