Healthcare resource utilization and costs by age and joint location among osteoarthritis patients in a privately insured population.

AIMS: To compare healthcare resource utilization and costs between patients aged 18-64 years with osteoarthritis (OA) and matched controls without OA in a privately insured population. METHODS: Patients with OA were selected from de-identified US-based employer claims (Q1:1999-Q3:2011). The index date was defined as the first OA diagnosis indicated by ICD-9-CM codes. One year before and after the index date were defined as the baseline and study periods, respectively. A second OA diagnosis during the study period was also required. Patients with OA were matched one-to-one on age, gender, index date, and minimum length of follow-up to controls without OA. Baseline characteristics and study period resource utilization and costs (2016 USD) were compared between cohorts. RESULTS: This study identified 199,539 patients with OA (knee: 87,271, hip: 19,953, hand: 15,670, spine: 12,496). The average age was 54 years, and 58% were female. OA patients had higher healthcare resource utilization than matched controls in inpatient, emergency room, and outpatient settings (p < .001 for all). Further, patients with OA had 4-times the excess total medical costs of their matched controls ($14,521 vs $3,629; p < .001). Patients with hip OA had the highest medical costs among all joint locations. Outpatient and pharmacy costs were similar among patients with knee, hip, and hand OA, but higher in patients with spine OA. In sub-group analyses, older patients (45-64 years old) had higher costs. LIMITATIONS: This sample, obtained using claims data, only includes patients who were actively seeking care for OA and were likely symptomatic. Asymptomatic patients would likely not be captured in this analysis. CONCLUSIONS: Patients with OA incur greater healthcare resource utilization and costs than patients without OA, with substantial variation by joint location.

Comparative effectiveness of everolimus and axitinib as second targeted therapies for metastatic renal cell carcinoma in the US: a retrospective chart review.

Background Second targeted therapies for metastatic renal cell carcinoma (mRCC) include mammalian target of rapamycin inhibitors (mTORis) and tyrosine kinase inhibitors (TKIs). This observational study compares overall survival (OS) and progression-free survival (PFS) of patients treated with everolimus (an mTORi) and axitinib (a TKI) following first TKI, and assesses the impact of type and duration of first TKI on the relative effectiveness of these second targeted therapies. Methods Retrospective reviews of medical records were conducted by medical oncologists or hematologists/oncologists recruited from a nationwide panel. Included patients with mRCC were required to have discontinued a first TKI (sunitinib, sorafenib, or pazopanib) for medical reasons, and to have initiated everolimus or axitinib as second targeted therapy between February 2012 and January 2013. OS and PFS were compared between patients treated with everolimus vs. axitinib using multivariable Cox proportional hazards regression models. Comparative results were also stratified by type and duration of first TKI. Results Included patients (n = 325 for everolimus and n = 127 for axitinib) had a mean age of 61 years and 31% were female. Sunitinib was the most commonly used first TKI (73%). After adjusting for patient characteristics, no statistically significant differences were observed in OS or PFS between everolimus and axitinib. When stratifying by type and duration of first TKI, there was no statistically significant difference in OS between everolimus and axitinib in all subgroups except for patients with <6 months on sunitinib or sorafenib as first TKI. No significant difference in PFS was observed in any subgroup. Limitations Important limitations include potential missing or inaccurate data in medical charts, and confounding due to unobserved factors. Conclusions In this retrospective chart review, no significant differences were detected in OS or PFS between axitinib and everolimus as second targeted therapy. Longer duration of first TKI was not associated with increased effectiveness of subsequent axitinib compared to everolimus.

Real-World Effectiveness of Everolimus Subsequent to Different First Targeted Therapies for the Treatment of Metastatic Renal Cell Carcinoma: Synthesis of Retrospective Chart Reviews.

BACKGROUND: The effect of first targeted therapy on outcomes with second targeted therapy for metastatic renal cell carcinoma is not well known. The purpose of this study was to compare outcomes for patients receiving a second targeted therapy with everolimus by type of first targeted therapy. PATIENTS AND METHODS: Data were drawn from 3 separate retrospective chart reviews conducted in 2011, 2012, and 2014. Inclusion criteria and study design were similar across the 3 studies. To be included in this analysis, patients had to meet the following criteria: aged ≥ 18 years; received first targeted therapy with pazopanib, sunitinib, or sorafenib; and received second targeted therapy with everolimus. Overall survival, time to treatment failure, and time to treatment discontinuation outcomes were measured from second targeted therapy initiation. Outcomes were compared among treatment groups by Cox proportional hazard models adjusting for demographic and clinical characteristics. Hazard ratios for overall survival, time to treatment failure, and time to treatment discontinuation obtained from the 3 chart reviews were synthesized in meta-analyses. RESULTS: Of 696 patients treated with everolimus as second targeted therapy, 605 patients received first targeted therapy with sunitinib/sorafenib and 91 with pazopanib. After synthesizing the hazard ratios from all studies in meta-analyses, there were no significant differences in study outcomes between patients receiving sunitinib/sorafenib versus those receiving pazopanib as first targeted therapy. CONCLUSION: There were no significant differences among outcomes while receiving second targeted therapy with everolimus for patients treated with pazopanib versus sunitinib/sorafenib as first targeted therapy.

Real-world dosing and drug costs with everolimus or axitinib as second targeted therapies for advanced renal cell carcinoma: a retrospective chart review in the US.

OBJECTIVE: To describe dosing patterns and to compare the drug costs per month spent in progression-free survival (PFS) among patients with advanced renal cell carcinoma (aRCC) treated with everolimus or axitinib following a first tyrosine kinase inhibitor (TKI). METHODS: A medical record retrospective review was conducted among medical oncologists and hematologists/oncologists in the US. Patient eligibility criteria included: (1) age ≥18 years; (2) discontinuation of first TKI (sunitinib, sorafenib, or pazopanib) for medical reasons; (3) initiation of axitinib or everolimus as a second targeted therapy during February 2012-January 2013. Real-world dosing patterns were summarized. Dose-specific drug costs (as of October 2014) were based on wholesale acquisition costs from RED BOOK Online. PFS was compared between everolimus and axitinib using a multivariable Cox proportion hazards model. Everolimus and axitinib drug costs per month of PFS were compared using multivariable gamma regression models. RESULTS: A total of 325 patients received everolimus and 127 patients received axitinib as second targeted therapy. Higher proportions of patients treated with axitinib vs everolimus started on a higher than label-recommended starting dose (14% vs 2%) or experienced dose escalation (11% vs 1%) on second targeted therapy. The PFS did not differ significantly between patients receiving everolimus or axitinib (adjusted hazard ratio (HR) = 1.16; 95% confidence interval [CI] = 0.73-1.82). After baseline characteristics adjustment, axitinib was associated with 17% ($1830) higher drug costs per month of PFS compared to everolimus ($12,467 vs $10,637; p < 0.001). LIMITATIONS: Retrospective observational study design and only drug acquisition costs considered in drug costs estimates. CONCLUSIONS: Patients with aRCC receiving axitinib as second targeted therapy were more likely to initiate at a higher than label-recommended dose and were more likely to dose escalate than patients receiving everolimus. With similar observed durations of PFS, drug costs were significantly higher-by 17% per month of PFS-with axitinib than with everolimus.

Change in forced vital capacity and associated subsequent outcomes in patients with newly diagnosed idiopathic pulmonary fibrosis.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare and serious disease characterized by progressive lung-function loss. Limited evidence has been published on the impact of lung-function loss on subsequent patient outcomes. This study examined change in forced vital capacity (FVC) across IPF patients in the 6 months after diagnosis and its association with clinical and healthcare resource utilization (HRU) outcomes in a real-world setting in the U.S. METHODS: A retrospective chart review was conducted of patients diagnosed with IPF by U.S. pulmonologists. Patient eligibility criteria included: 1) 40 years or older with a confirmed date of first IPF diagnosis with high-resolution computed tomography and/or lung biopsy between 01/2011 and 06/2013; 2) FVC results recorded at first diagnosis (±1 month) and at 6 months (±3 months) following diagnosis. Based on relative change in FVC percent predicted (FVC%), patients were categorized as stable (decline <5%), marginal decline (decline ≥5% and <10%), or significant decline (decline ≥10%). Physician-reported clinical and HRU outcomes were assessed from ~6 months post-diagnosis until the last contact date with the physician and compared between FVC% change groups. Multivariable Cox proportional-hazards models were constructed to assess risk of mortality, suspected acute exacerbation (AEx), and hospitalization post-FVC% change. Generalized estimating equations were used to account for multiple patients contributed by individual physicians. RESULTS: The sample included 490 IPF patients contributed by 168 pulmonologists. The mean (SD) age was 61 (11) years, 68% were male, and the mean (SD) baseline FVC% was 60% (26%). 250 (51%) patients were categorized as stable, 98 (20%) as marginal decline, and 142 (29%) as significant decline. The mean (SD) observation time was 583 (287) days. In both unadjusted analysis and multivariable models, significantly worse clinical outcomes and increased HRU were observed with greater lung-function decline. CONCLUSIONS: These findings suggest that nearly half of IPF patients experienced decline in FVC% within ~6 months following IPF diagnosis. Greater FVC% decline was associated with an increased risk of further IPF progression, suspected AEx, mortality, and higher rate of HRU. Management options that slow FVC decline may help improve future health outcomes in IPF.

Association of early suspected acute exacerbations of idiopathic pulmonary fibrosis with subsequent clinical outcomes and healthcare resource utilization.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) may be complicated by episodes of acute exacerbation. This study quantified the association between occurrence of suspected acute exacerbations of IPF (AEx-IPF) in the 6 months post-IPF diagnosis with clinical outcomes and IPF-related healthcare resource utilization (HRU). METHODS: U.S. pulmonologists participated in a retrospective chart review of IPF patients. Patient eligibility criteria included: 1) ≥40 years of age and a confirmed date of first IPF diagnosis with HRCT and/or lung biopsy between January 2011-June 2013; 2) 2 separate FVC results recorded around first diagnosis and 6 months post-diagnosis. Patients with a suspected AEx-IPF within 6 months post-diagnosis were categorized as "early AEx-IPF." Subsequent clinical outcomes and IPF-related HRU were assessed from 6 months post-diagnosis until the latest physician contact date. RESULTS: The sample included 490 IPF patients from 168 pulmonologists; 72 (15%) patients had a suspected early AEx-IPF. At IPF diagnosis, the mean (SD) age was 61 (11) years, 68% were male, and the mean FVC percent predicted was 60% (26%). Compared to patients without a suspected early AEx-IPF, patients with an early AEx-IPF had higher mortality risk (HR = 2.87, p < 0.001) and higher rates of subsequent suspected AEx-IPF (IRR = 3.87, p < 0.001), outpatient visits (IRR = 1.46, p < 0.001), ER visits (IRR = 4.39, p < 0.001), hospitalizations (IRR = 7.96, p < 0.001), and ICU stays (IRR = 9.74, p < 0.001). CONCLUSIONS: Using a large sample of IPF patients from varied practice settings, we found a strong relationship between suspected early AEx-IPF and worse subsequent clinical outcomes and increased IPF-related HRU. This relationship was particularly pronounced for acute resource use.

One-year and long-term molecular response to nilotinib and dasatinib for newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison.

BACKGROUND: Nilotinib and dasatinib have shown superior rates of molecular response (MR) compared to imatinib for the treatment of newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CP). This study indirectly compares MR in patients taking nilotinib 300 mg bid with that in those taking dasatinib 100 mg qd by 12 months and through 48 months. METHODS: Patients in ENESTnd were re-weighted to match published baseline characteristics reported for DASISION using a propensity score model. After matching, differences in rates of major MR (MMR, measured as a 3 log reduction on the International Scale [IS]), MR(4.0) (4 log reduction on IS), and MR(4.5) (4.5 log reduction on IS) relative to imatinib were indirectly compared between nilotinib and dasatinib. Hazard ratios (HRs) were used to indirectly compare MR outcomes between nilotinib and dasatinib through 48 months of follow-up, while rate differences were used to compare progression to AP/BC between nilotinib and dasatinib by 48 months. RESULTS: After matching, rates of MR by 12 months were higher with nilotinib vs dasatinib by 11.7% for MMR (p = 0.045), 8.2% for MR(4.0) (p = 0.029), and 8.5% for MR(4.5) (p < 0.001). Higher rates of MMR (HR = 1.44, p = 0.018) and MR(4.0) (HR = 1.58, p = 0.013) achievement were maintained with nilotinib compared to dasatinib through 48 months of follow-up. No statistically significant differences were observed for MR(4.5) through 48 months or progression to AP/BC by 48 months. LIMITATIONS: LIMITATIONS include comparisons based solely on indirect evidence and HRs for MR(4.0) and MR(4.5) from the DASISION trial being extracted from cumulative incidence curves. CONCLUSIONS: This indirect comparison suggests that nilotinib is associated with higher rates of achieving MMR, MR(4.0), and MR(4.5) by 12 months compared to dasatinib for the treatment of newly diagnosed CML-CP. In addition, higher rates of MR achievement with nilotinib were also maintained through 48 months of follow-up.

Major molecular response during the first year of dasatinib, imatinib or nilotinib treatment for newly diagnosed chronic myeloid leukemia: a network meta-analysis.

OBJECTIVE: No randomized trials have directly compared dasatinib with nilotinib for the treatment of newly diagnosed chronic myeloid leukemia in the chronic phase. The objective of this study was to indirectly compare these therapies using evidence from randomized trials versus imatinib, the current standard of care. METHODS: Randomized trials that included either dasatinib or nilotinib as first-line treatment for chronic myeloid leukemia were identified in a systematic review. Inclusion and exclusion criteria, baseline characteristics and endpoint definitions were compared across trials. The outcome of interest was major molecular response by or at 12 months. A network meta-analysis was conducted to compare rates of major molecular response among therapies while adjusting for measurement of response by or at 12 months. RESULTS: One trial of nilotinib versus imatinib (ENESTnd) and two trials of dasatinib versus imatinib (DASISION and the S0325 Intergroup Trial) were identified. Major molecular response was reported by and at 12 months in ENESTnd, by 12 months in DASISION, and at 12 months in the S0325 Intergroup Trial. In the network meta-analysis, nilotinib had a 97% chance of having the highest rate of major molecular response compared to dasatinib and imatinib, corresponding to absolute rates of major molecular response by month 12 of 55.2%, 44.8% and 26.7%, respectively. CONCLUSIONS: In this network meta-analysis, nilotinib was associated with the highest rate of major molecular response, compared to dasatinib and imatinib, during the first year of treatment in patients with newly diagnosed chronic myeloid leukemia in the chronic phase.

Impact of misspecifying the distribution of a prognostic factor on power and sample size for testing treatment interactions in clinical trials.

BACKGROUND: Interaction in clinical trials presents challenges for design and appropriate sample size estimation. Here we considered interaction between treatment assignment and a dichotomous prognostic factor with a continuous outcome. Our objectives were to describe differences in power and sample size requirements across alternative distributions of a prognostic factor and magnitudes of the interaction effect, describe the effect of misspecification of the distribution of the prognostic factor on the power to detect an interaction effect, and discuss and compare three methods of handling the misspecification of the prognostic factor distribution. METHODS: We examined the impact of the distribution of the dichotomous prognostic factor on power and sample size for the interaction effect using traditional one-stage sample size calculation. We varied the magnitude of the interaction effect, the distribution of the prognostic factor, and the magnitude and direction of the misspecification of the distribution of the prognostic factor. We compared quota sampling, modified quota sampling, and sample size re-estimation using conditional power as three strategies for ensuring adequate power and type I error in the presence of a misspecification of the prognostic factor distribution. RESULTS: The sample size required to detect an interaction effect with 80% power increases as the distribution of the prognostic factor becomes less balanced. Misspecification such that the actual distribution of the prognostic factor was more skewed than planned led to a decrease in power with the greatest loss in power seen as the distribution of the prognostic factor became less balanced. Quota sampling was able to maintain the empirical power at 80% and the empirical type I error at 5%. The performance of the modified quota sampling procedure was related to the percentage of trials switching the quota sampling scheme. Sample size re-estimation using conditional power was able to improve the empirical power under negative misspecifications (i.e. skewed distributions) but it was not able to reach the target of 80% in all situations. CONCLUSIONS: Misspecifying the distribution of a dichotomous prognostic factor can greatly impact power to detect an interaction effect. Modified quota sampling and sample size re-estimation using conditional power improve the power when the distribution of the prognostic factor is misspecified. Quota sampling is simple and can prevent misspecification of the prognostic factor, while maintaining power and type I error.

Estimating the burden of total knee replacement in the United States.

BACKGROUND: In the last decade, the number of total knee replacements performed annually in the United States has doubled, with disproportionate increases among younger adults. While total knee replacement is a highly effective treatment for end-stage knee osteoarthritis, total knee replacement recipients can experience persistent pain and severe complications. We are aware of no current estimates of the prevalence of total knee replacement among adults in the U.S. METHODS: We used the Osteoarthritis Policy Model, a validated computer simulation model of knee osteoarthritis, and data on annual total knee replacement utilization to estimate the prevalence of primary and revision total knee replacement among adults fifty years of age or older in the U.S. We combined these prevalence estimates with U.S. Census data to estimate the number of adults in the U.S. currently living with total knee replacement. The annual incidence of total knee replacement was derived from two longitudinal knee osteoarthritis cohorts and ranged from 1.6% to 11.9% in males and from 2.0% to 10.9% in females. RESULTS: We estimated that 4.0 million (95% confidence interval [CI]: 3.6 million to 4.4 million) adults in the U.S. currently live with a total knee replacement, representing 4.2% (95% CI: 3.7% to 4.6%) of the population fifty years of age or older. The prevalence was higher among females (4.8%) than among males (3.4%) and increased with age. The lifetime risk of primary total knee replacement from the age of twenty-five years was 7.0% (95% CI: 6.1% to 7.8%) for males and 9.5% (95% CI: 8.5% to 10.5%) for females. Over half of adults in the U.S. diagnosed with knee osteoarthritis will undergo a total knee replacement. CONCLUSIONS: Among older adults in the U.S., total knee replacement is considerably more prevalent than rheumatoid arthritis and nearly as prevalent as congestive heart failure. Nearly 1.5 million of those with a primary total knee replacement are fifty to sixty-nine years old, indicating that a large population is at risk for costly revision surgery as well as possible long-term complications of total knee replacement.

Missed opportunities: refusal to confirm reactive rapid HIV tests in the emergency department.

BACKGROUND: HIV infection remains a major US public health concern. While HIV-infected individuals now benefit from earlier diagnosis and improved treatment options, progress is tempered by large numbers of newly diagnosed patients who are lost to follow-up prior to disease confirmation and linkage to care. METHODOLOGY: In the randomized, controlled USHER trial, we offered rapid HIV tests to patients presenting to a Boston, MA emergency department. Separate written informed consent was required for confirmatory testing. In a secondary analysis, we compared participants with reactive results who did and did not complete confirmatory testing to identify factors associated with refusal to complete the confirmation protocol. PRINCIPAL FINDINGS: Thirteen of 62 (21.0%, 95% CI (11.7%, 33.2%)) participants with reactive rapid HIV tests refused confirmation; women, younger participants, African Americans, and those with fewer HIV risks, with lower income, and without primary care doctors were more likely to refuse. We projected that up to four true HIV cases were lost at the confirmation stage. CONCLUSIONS: These findings underscore the need to better understand the factors associated with refusal to confirm reactive HIV testing and to identify interventions that will facilitate confirmatory testing and linkage to care among these populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT00502944; NCT01258582.

Lifetime risk and age at diagnosis of symptomatic knee osteoarthritis in the US.

OBJECTIVE: To estimate the incidence and lifetime risk of diagnosed symptomatic knee osteoarthritis (OA) and the age at diagnosis of knee OA based on self-reports in the US population. METHODS: We estimated the incidence of diagnosed symptomatic knee OA in the US by combining data on age-, sex-, and obesity-specific prevalence from the 2007-2008 National Health Interview Survey, with disease duration estimates derived from the Osteoarthritis Policy (OAPol) Model, a validated computer simulation model of knee OA. We used the OAPol Model to estimate the mean and median ages at diagnosis and lifetime risk. RESULTS: The estimated incidence of diagnosed symptomatic knee OA was highest among adults ages 55-64 years, ranging from 0.37% per year for nonobese men to 1.02% per year for obese women. The estimated median age at knee OA diagnosis was 55 years. The estimated lifetime risk was 13.83%, ranging from 9.60% for nonobese men to 23.87% in obese women. Approximately 9.29% of the US population is diagnosed with symptomatic knee OA by age 60 years. CONCLUSION: The diagnosis of symptomatic knee OA occurs relatively early in life, suggesting that prevention programs should be offered relatively early in the life course. Further research is needed to understand the future burden of health care utilization resulting from earlier diagnosis of knee OA.

The changing demographics of total joint arthroplasty recipients in the United States and Ontario from 2001 to 2007.

BACKGROUND: The rates of total joint arthroplasty (TJA) of the hip and knee have increased in North America over the last decade. While initially designed for elderly patients (>70 years of age), several reports suggest that an increasing number of younger patients are undergoing joint replacements. This suggests that more people are meeting the indication for TJA earlier in their lives. Alternatively, it might indicate a broadening of the indications for TJA. METHODS: We used the administrative databases available at the Healthcare Cost and Utilization Project (HCUP) and the Institute for Clinical Evaluative Sciences (ICES) to determine the rates of TJA of the hip and knee in the United States, and Ontario, Canada, respectively. We determined the crude rates of THA and TKA in both areas for four calendar years (2001, 2003, 2005 and 2007). We also calculated the age- and sex-standardised rates of THA and TKA in both areas for each time period. We compared the age distribution of TJA recipients between the US and Ontario, and within each area over time. RESULTS: The crude and standardised rates of THA and TKA increased over time in both the US and Ontario. The crude rates of THA were higher in the US in 2001 and 2003, but were not significantly different from the rate in Ontario in 2005 and 2007. The crude rates of TKA were consistently higher in the US for all time periods. In addition, the US consistently had more THA and TKA recipients in 'younger' age categories (<60 years of age). While the age- and sex-standardised rates of TKA were greater in the US in all time periods, the relative increase in rates from 2001 to 2007 was greater in Ontario (US - 59%, Ontario - 73%). For both the US and Ontario, there was a significant shift in the demographic of THA and TKA recipients to younger patients (p < 0.0001). CONCLUSIONS: The utilisation of primary hip and knee arthroplasty has increased substantially in both the US and Ontario in the period from 2001 to 2007. This increase has been predominantly in knee replacements. The demographics of joint replacement recipients has become younger, with substantial increases in the prevalence of patients <60 years old amongst TJA recipients, and significant increases in the incidence of TJA in these age groups in the general population, in both the US and Ontario.

Acceptability of fingerstick versus oral fluid rapid HIV testing: results from the universal screening for HIV infection in the emergency room (USHER Phase II) randomized controlled trial.

BACKGROUND: Oral rapid HIV testing has been reported to have a lower sensitivity and specificity than rapid HIV testing with whole blood and has been associated with clusters of false-positive results. Patient preference for oral rapid HIV testing compared with more invasive whole blood fingerstick may influence the acceptance of rapid HIV testing. OBJECTIVE: To compare HIV test acceptance rates among patients routinely offered fingerstick compared with those routinely offered oral fluid screening in an urban hospital emergency department. METHODS: The Universal Screening for HIV Infection in the Emergency Room Phase II was a single-center, prospective, randomized controlled trial that randomized subjects to either fingerstick or oral rapid HIV screening in an urban academic emergency department. From May 5, 2009, to January 4, 2010, eligible patients aged 18-75 years were invited to participate in the trial. The primary outcome measure was HIV test acceptance rate. RESULTS: : 2012 eligible patients were approached, of whom 1651 (82%) consented to trial participation and enrolled. Among those enrolled, 830 and 821 were randomized to the fingerstick and oral fluid arms, respectively. Acceptance of rapid HIV testing was similar in both arms; 67% (553 of 830) of subjects accepted fingerstick testing compared with 69% (565 of 821) who accepted oral (P = 0.34). CONCLUSIONS: Although fingerstick rapid HIV testing is more invasive than oral fluid testing, test acceptance rates did not differ. Given the option, preference should therefore be given to fingerstick testing because of its slightly superior test characteristics. System factors such as ease of staff use, necessary Clinical Laboratory Improvement Amendments waivers, laboratory capacity, and HIV prevalence should also be considered.

The relationship between hand osteoarthritis and serum leptin concentration in participants of the Third National Health and Nutrition Examination Survey.

INTRODUCTION: Leptin has been suspected to contribute to the development of osteoarthritis (OA). However, this hypothesis has not been tested in large-scale hand OA cohorts. Our study aimed to determine whether there is a cross-sectional relationship between serum leptin levels and hand OA in a population-based sample of US adults. METHOD: We used the Third National Health and Nutrition Examination Survey (NHANES III), a national cross-sectional population-based survey, to study the relationship between hand OA and serum leptin concentration. We applied previously established classification criteria for hand OA. Patients with rheumatoid arthritis were excluded. Potential confounders included sex, body mass index, the presence of polyarticular OA, diabetes, and total cholesterol. We estimated unadjusted mean leptin concentration by hand OA status and by all confounders. We further developed a linear regression model to assess mean leptin levels, adjusted for appropriate confounders. RESULTS: Of 2,477 subjects in the NHANES III sample that had a hand examination and did not have rheumatoid arthritis, 1,056 (42.6%) had a leptin measurement and were included in the analysis. Subjects with and without leptin measurement had similar demographic characteristics. We did not find any significant differences in mean serum leptin levels in subjects with symptomatic hand OA (7.38 ng/ml in males (95% confidence interval (CI) = 5.31, 9.46) and 21.55 ng/ml in females (95% CI = 17.08, 26.02)), asymptomatic hand OA (6.69 ng/ml in males (95% CI = 5.19, 8.18) and 17.09 ng/ml in females (95% CI = 15.00, 19.18)), and no hand OA (8.22 ng/ml in males (95% CI = 7.47, 8.97) and 20.77 ng/ml in females (95% CI = 18.01, 23.53)) in the unadjusted analysis. In a multivariable linear regression model that included variables of hand OA status, age, race/ethnicity, and obesity status, we found no statistically significant association between serum leptin and hand OA status. CONCLUSIONS: In this cross-sectional study of a large representative US cohort, we did not find any evidence to support the hypothesis that serum leptin is associated with hand OA.

Emergency provider attitudes and barriers to universal HIV testing in the emergency department.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) recently published recommendations for routine, voluntary human immunodeficiency virus (HIV) testing of adults in all health care settings, including the emergency department (ED). STUDY OBJECTIVE: The objective of this study was to examine the willingness of ED providers to offer HIV testing, as well as their perceived barriers to implementation of these guidelines. METHODS: Before the establishment of a routine HIV testing program in the ED, a 21-item survey was used to assess ED providers' knowledge, attitudes, and perceived challenges to HIV testing. Six months after program initiation, the identical survey was re-administered to determine whether HIV testing program experience altered providers' perceptions. RESULTS: There were 108 of 146 (74%) providers who completed both the pre- and post-implementation surveys. Although the majority of emergency providers at 6 months were supportive of an ED-based HIV testing program (59/108 [55%]), only 38% (41/108) were willing to offer the HIV test most or all of the time. At 6 months, the most frequently cited barriers to offering a test were: inadequate time (67/108 [62%]), inadequate resources (65/108 [60%]), and concerns regarding provision of follow-up care (64/108 [59%]). CONCLUSIONS: After the implementation of a large-scale HIV testing program in an ED, the majority of emergency providers were supportive of routine HIV testing. Nevertheless, 6 months after program initiation, providers were still reluctant to offer the test due to persistent barriers. Further studies are needed to identify feasible implementation strategies that minimize barriers to routine HIV testing in the ED.

Estimation of the prevalence of undiagnosed and diagnosed HIV in an urban emergency department.

OBJECTIVE: To estimate the prevalence of undiagnosed HIV, the prevalence of diagnosed HIV, and proportion of HIV that is undiagnosed in populations with similar demographics as the Universal Screening for HIV in the Emergency Room (USHER) Trial and the Brigham and Women's Hospital (BWH) Emergency Department (ED) in Boston, MA. We also sought to estimate these quantities within demographic and risk behavior subgroups. METHOD: We used data from the USHER Trial, which was a randomized clinical trial of HIV screening conducted in the BWH ED. Since eligible participants were HIV-free at time of enrollment, we were able to calculate the prevalence of undiagnosed HIV. We used data from the Massachusetts Department of Public Health (MA/DPH) to estimate the prevalence of diagnosed HIV since the MA/DPH records the number of persons within MA who are HIV-positive. We calculated the proportion of HIV that is undiagnosed using these estimates of the prevalence of undiagnosed and diagnosed HIV. Estimates were stratified by age, sex, race/ethnicity, history of testing, and risk behaviors. RESULTS: The overall expected prevalence of diagnosed HIV in a population similar to those presenting to the BWH ED was 0.71% (95% CI: 0.63%, 0.78%). The prevalence of undiagnosed HIV was estimated at 0.22% (95% CI: 0.10%, 0.42%) and resultant overall prevalence was 0.93%. The proportion of HIV-infection that is undiagnosed in this ED-based setting was estimated to be 23.7% (95% CI: 11.6%, 34.9%) of total HIV-infections. CONCLUSIONS: Despite different methodology, our estimate of the proportion of HIV that is undiagnosed in an ED-setting was similar to previous estimates based on national surveillance data. Universal routine testing programs in EDs should use these data to help plan their yield of HIV detection.

Resource utilization and cost-effectiveness of counselor- vs. provider-based rapid point-of-care HIV screening in the emergency department.

BACKGROUND: Routine HIV screening in emergency department (ED) settings may require dedicated personnel. We evaluated the outcomes, costs and cost-effectiveness of HIV screening when offered by either a member of the ED staff or by an HIV counselor. METHODS: We employed a mathematical model to extend data obtained from a randomized clinical trial of provider- vs. counselor-based HIV screening in the ED. We compared the downstream survival, costs, and cost-effectiveness of three HIV screening modalities: 1) no screening program; 2) an ED provider-based program; and 3) an HIV counselor-based program. Trial arm-specific data were used for test offer and acceptance rates (provider offer 36%, acceptance 75%; counselor offer 80%, acceptance 71%). Undiagnosed HIV prevalence (0.4%) and linkage to care rates (80%) were assumed to be equal between the screening modalities. Personnel costs were derived from trial-based resource utilization data. We examined the generalizability of results by conducting sensitivity analyses on offer and acceptance rates, undetected HIV prevalence, and costs. RESULTS: Estimated HIV screening costs in the provider and counselor arms averaged $8.10 and $31.00 per result received. The Provider strategy (compared to no screening) had an incremental cost-effectiveness ratio of $58,700/quality-adjusted life year (QALY) and the Counselor strategy (compared to the Provider strategy) had an incremental cost-effectiveness ratio of $64,500/QALY. Results were sensitive to the relative offer and acceptance rates by strategy and the capacity of providers to target-screen, but were robust to changes in undiagnosed HIV prevalence and programmatic costs. CONCLUSIONS: The cost-effectiveness of provider-based HIV screening in an emergency department setting compares favorably to other US screening programs. Despite its additional cost, counselor-based screening delivers just as much return on investment as provider based-screening. Investment in dedicated HIV screening personnel is justified in situations where ED staff resources may be insufficient to provide comprehensive, sustainable screening services.

Counselor- versus provider-based HIV screening in the emergency department: results from the universal screening for HIV infection in the emergency room (USHER) randomized controlled trial.

OBJECTIVE: We compare rates of rapid HIV testing, test offer, and acceptance in an urban emergency department (ED) when conducted by dedicated HIV counselors versus current members of the ED staff. METHODS: The Universal Screening for HIV Infection in the Emergency Room [USHER] trial is a prospective randomized controlled trial that implemented an HIV screening program in the ED of an urban tertiary medical center. ED patients were screened and consented for trial enrollment by an USHER research assistant. Eligible subjects were randomized to rapid HIV testing (oral OraQuick) offered by a dedicated counselor (counselor arm) or by an ED provider (provider arm). In the counselor arm, counselors-without other clinical responsibilities-assumed nearly all testing-related activities (consent, counseling, delivery of test results). In the provider arm, trained ED emergency service assistants (nursing assistants) consented and tested the participant in the context of other ED-related responsibilities. In this arm, ED house officers, physician assistants, or attending physicians provided HIV test results to trial participants. Outcome measures were rates of HIV testing and test offer among individuals consenting for study participation. Among individuals offered the test, test acceptance was also measured. RESULTS: From February 2007 through July 2008, 8,187 eligible patients were approached in the ED, and 4,855 (59%) consented and were randomized to trial participation. The mean age was 37 years, 65% were women, and 42% were white. The overall testing rate favored the counselor arm (57% versus 27%; P<.001); 80% (1,959/2,446) of subjects in the counselor arm were offered an HIV test compared with 36% (861/2,409) in the provider arm (P<.001). HIV test acceptance was slightly higher in the provider arm (counselor arm 71% versus provider arm 75%; P = .025). CONCLUSION: Routine rapid HIV testing in the ED was accomplished more frequently by dedicated HIV counselors than by ED staff in the course of routine clinical work. Without dedicated staff, HIV testing in this setting may not be truly routine.

Patient satisfaction with rapid HIV testing in the emergency department.

OBJECTIVE: Patient satisfaction with HIV screening is crucial for sustainable implementation of the Centers for Disease Control and Prevention (CDC) HIV testing recommendations. This investigation assesses patient satisfaction with rapid HIV testing in the emergency department (ED) of an urban tertiary academic medical center. METHODS: After receiving HIV test results, participants in the Universal Screening for HIV Infection in the Emergency Room (USHER) randomized controlled trial were offered a patient satisfaction survey. Questions concerned overall satisfaction with ED visit, time spent on primary medical problem, time spent on HIV testing, and test provider's ability to answer HIV-related questions. Responses were reported on a 4-point Likert scale, ranging from very dissatisfied to very satisfied (defined as optimal satisfaction). RESULTS: Of 4,860 USHER participants, 2,025 completed testing and were offered the survey: 1,616 (79.8%) completed the survey. Overall, 1,478 (91.5%) were very satisfied. Satisfaction was less than optimal for 34.5% (10 of 29) of participants with reactive results and for 7.5% (115 of 1,542) with nonreactive results. The independent factors associated with less than optimal satisfaction were reactive test result, aged 60 years or older, black race, Hispanic/Latino ethnicity, and testing by ED provider instead of HIV counselor. CONCLUSION: Most participants were very satisfied with the ED-based rapid HIV testing program. Identification of independent factors that correlate with patient satisfaction will help guide best practices as EDs implement CDC recommendations. It is critical to better understand whether patients with reactive results were negatively affected by their results or truly had concerns about the testing process.