Implementation of Medical Homes in Federally Qualified Health Centers.

BACKGROUND: From 2011 through 2014, the Federally Qualified Health Center Advanced Primary Care Practice Demonstration provided care management fees and technical assistance to a nationwide sample of 503 federally qualified health centers to help them achieve the highest (level 3) medical-home recognition by the National Committee for Quality Assurance, a designation that requires the implementation of processes to improve access, continuity, and coordination. METHODS: We examined the achievement of medical-home recognition and used Medicare claims and beneficiary surveys to measure utilization of services, quality of care, patients' experiences, and Medicare expenditures in demonstration sites versus comparison sites. Using difference-in-differences analyses, we compared changes in outcomes in the two groups of sites during a 3-year period. RESULTS: Level 3 medical-home recognition was awarded to 70% of demonstration sites and to 11% of comparison sites. Although the number of visits to federally qualified health centers decreased in the two groups, smaller reductions among demonstration sites than among comparison sites led to a relative increase of 83 visits per 1000 beneficiaries per year at demonstration sites (P<0.001). Similar trends explained the higher performance of demonstration sites with respect to annual eye examinations and nephropathy tests (P<0.001 for both comparisons); there were no significant differences with respect to three other process measures. Demonstration sites had larger increases than comparison sites in emergency department visits (30.3 more per 1000 beneficiaries per year, P<0.001), inpatient admissions (5.7 more per 1000 beneficiaries per year, P=0.02), and Medicare Part B expenditures ($37 more per beneficiary per year, P=0.02). Demonstration-site participation was not associated with relative improvements in most measures of patients' experiences. CONCLUSIONS: Demonstration sites had higher rates of medical-home recognition and smaller decreases in the number of patients' visits to federally qualified health centers than did comparison sites, findings that may reflect better access to primary care relative to comparison sites. Demonstration sites had larger increases in emergency department visits, inpatient admissions, and Medicare Part B expenditures. (Funded by the Centers for Medicare and Medicaid Services.).

Characteristics of Chiropractic Patients Being Treated for Chronic Low Back and Neck Pain.

OBJECTIVES: Chronic low back pain (CLBP) and chronic neck pain (CNP) are the most common types of chronic pain, and chiropractic spinal manipulation is a common nonpharmacologic treatment. This study presents the characteristics of a large United States sample of chiropractic patients with CLBP and CNP. METHODS: Data were collected from chiropractic patients using multistage systematic stratified sampling with 4 sampling levels: regions and states, sites (ie, metropolitan areas), providers and clinics, and patients. The sites and regions were San Diego, California; Tampa, Florida; Minneapolis, Minnesota; Seneca Falls and Upstate New York; Portland, Oregon; and Dallas, Texas. Data were collected from patients through an iPad-based prescreening questionnaire in the clinic and emailed links to full screening and baseline online questionnaires. The goal was 20 providers or clinics and 7 patients with CLBP and 7 with CNP from each clinic. RESULTS: We had 6342 patients at 125 clinics complete the prescreening questionnaire, 3333 patients start the full screening questionnaire, and 2024 eligible patients completed the baseline questionnaire: 518 with CLBP only, 347 with CNP only, and 1159 with both. In general, most of this sample were highly-educated, non-Hispanic, white females with at least partial insurance coverage for chiropractic care who have been in pain and using chiropractic care for years. Over 90% reported high satisfaction with their care, few used narcotics, and avoiding surgery was the most important reason they chose chiropractic care. CONCLUSIONS: Given the prevalence of CLBP and CNP, the need to find effective nonpharmacologic alternatives for chronic pain, and the satisfaction these patients found with their care, further study of these patients is worthwhile.

A history of chronic opioid usage prior to kidney transplantation may be associated with increased mortality risk.

Chronic opioid usage (COU) for analgesia is common among patients with end-stage renal disease. In order to test whether a prior history of COU negatively affects post-kidney transplant outcomes, we retrospectively examined clinical outcomes in adult kidney transplant patients. Among 1064 adult kidney transplant patients, 452 (42.5%) reported the presence of various body pains and 108 (10.2%) reported a prior history of COU. While the overall death or kidney graft loss was not statistically different between patients with and without a history of COU, the cumulative mortality rate at 1, 3, and 5 years after transplantation, and during the entire study period, appeared significantly higher for patients with than without a history of COU (6.5, 18.5, and 20.4 vs. 3.2, 7.5, and 12.7%, respectively). Multivariate Cox regression analysis adjusted for potential confounding factors in entire cohorts and Cox regression analysis in 1:3 propensity-score matched cohorts suggest that a positive history of COU was significantly associated with nearly a 1.6- to 2-fold increase in the risk of death (hazard ratio 1.65, 95% confidence interval 1.04-2.60, and hazard ratio 1.92, 95% confidence interval 1.08-3.42, respectively). Thus, a history of chronic opioid usage prior to transplantation appears to be associated with increased mortality risk. Additional studies are warranted to confirm the observed association and to understand the mechanisms.

Inactivity on the kidney transplant wait-list is associated with inferior pre- and post-transplant outcomes.

BACKGROUND: The majority of kidney transplant (KT) candidates spend some time on the transplant wait-list (WL) prior to kidney transplantation. We examined the impact of WL inactivity on clinical outcomes. METHODS: All adult KT candidates first actively wait-listed between January 1, 1996, and December 31, 2005, in the United States were grouped by frequency of inactivity on the WL. Transplantation rate, pre- and post-transplant patient survival and death-censored kidney graft survival were compared. RESULTS: Of 159,774 candidates who were placed on the WL, 48,598 (30.4%) experienced one or more periods of inactivity. Candidates with inactivity once or more on the WL had 42% and 27% less likelihood of KT, respectively (HR 0.58, 95% CI 0.57, 0.59 and HR 0.73, 95% CI 0.71, 0.75). WL inactivity once or more was associated with a higher likelihood of death (HR 1.94, 95% CI 1.88, 2.00 and HR 2.13, 95% CI 2.02, 2.24). Among KT recipients, inactivity more than once on the WL was associated with a higher risk of death (HR 1.14, 95% CI 1.05, 1.23). CONCLUSIONS: Periods of inactivity on the WL predict increased mortality pre- and post-transplantation. A better understanding of the reasons for WL inactivity is essential to improve WL management and post-transplant outcomes.

Racial/Ethnic Inequities in Use of Diabetes Technologies Among Medicare Advantage Beneficiaries With Type 1 Diabetes.

CONTEXT: Racial/ethnic inequities have been observed in diabetes care. OBJECTIVE: To measure changes in prevalence of continuous glucose monitoring (CGM) and insulin pump therapy among Medicare Advantage beneficiaries with type 1 diabetes by race/ethnicity and to determine the impact of socioeconomic factors on racial/ethnic inequities. DESIGN: The prevalence of CGM and pump use was assessed by race/ethnicity for Medicare Advantage beneficiaries annually from 2017 through 2020. Models predicting technology use by year, race/ethnicity, age, sex, endocrinology visits, and measures of socioeconomic status were fit. SETTING: Community. PATIENTS OR OTHER PARTICIPANTS: Beneficiaries with type 1 diabetes and 2 or more claims with a diabetes diagnosis in the coverage year. INTERVENTION(S): Insulin pump or CGM therapy. MAIN OUTCOME MEASURE(S): Use of diabetes technology by racial/ethnic group. RESULTS: Technology use increased from 2017 through 2020 in all racial/ethnic groups. The absolute difference in use between White and Black beneficiaries from 2017 to 2020 remained stable for insulin pumps (10.7% to 10.8%) and increased for CGM (2.6% to 11.1%). The differences in pump use from 2017 to 2020 narrowed between White and Hispanic beneficiaries (12.3% to 11.4%) and White and Asian beneficiaries (9.7% to 6.6%), whereas the opposite occurred for CGM use (3.0% to 15.5% for White vs Hispanic beneficiaries; 1.5% to 8.0% for White vs Asian beneficiaries). Racial/ethnic inequities persisted (P < .0001) after adjusting for other characteristics. CONCLUSIONS: Differences in diabetes technology use between racial/ethnic groups often persisted from 2017 through 2020 and could not be explained by demographics, socioeconomic status, or endocrinology visits.

Fluid overload and fluid removal in pediatric patients on extracorporeal membrane oxygenation requiring continuous renal replacement therapy.

OBJECTIVE: In pediatric patients, fluid overload at continuous renal replacement therapy initiation is associated with increased mortality. The aim of this study was to characterize the association between fluid overload at continuous renal replacement therapy initiation, fluid removal during continuous renal replacement therapy, the kinetics of fluid removal and mortality in a large pediatric population receiving continuous renal replacement therapy while on extracorporeal membrane oxygenation. DESIGN: Retrospective chart review. SETTING: Tertiary children's hospital. PATIENTS: Extracorporeal membrane oxygenation patients requiring continuous renal replacement therapy from July 2006 to September 2010. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Overall intensive care unit survival was 34% for 53 patients that were initiated on continuous renal replacement therapy while on extracorporeal membrane oxygenation during the study period. Median fluid overload at continuous renal replacement therapy initiation was significantly lower in survivors compared to nonsurvivors (24.5% vs. 38%, p = .006). Median fluid overload at continuous renal replacement therapy discontinuation was significantly lower in survivors compared to nonsurvivors (7.1% vs. 17.5%, p = .035). After adjusting for percent fluid overload at continuous renal replacement therapy initiation, age, and severity of illness, the change in fluid overload at continuous renal replacement therapy discontinuation was not significantly associated with mortality (p = .212). Models investigating the rates of fluid removal in different periods, age, severity of illness, and fluid overload at continuous renal replacement therapy initiation found that fluid overload at continuous renal replacement therapy initiation was the most consistent predictor of survival. CONCLUSIONS: Our data demonstrate an association between fluid overload at continuous renal replacement therapy initiation and mortality in pediatric patients receiving extracorporeal membrane oxygenation. The degree of fluid overload at continuous renal replacement therapy discontinuation is also associated with mortality, but appears to reflect the effect of fluid overload at initiation. Furthermore, correction of fluid overload to ≤ 10% was not associated with improved survival. These results suggest that intervening prior to the development of significant fluid overload may be more clinically effective than attempting fluid removal after significant fluid overload has developed. Our findings suggest a role for earlier initiation of continuous renal replacement therapy in this population, and warrant further clinical studies.

Fluid overload at initiation of renal replacement therapy is associated with lack of renal recovery in patients with acute kidney injury.

BACKGROUND: Patients with acute kidney injury (AKI) requiring initiation of renal replacement therapy (RRT) have poor short- and long-term outcomes, including the development of dialysis dependence. Currently, little is known about what factors may predict renal recovery in this population. METHODS: We conducted a single-center, retrospective analysis of 170 hospitalized adult patients with AKI attributed to acute tubular necrosis who required inpatient initiation of RRT. Data collection included patient characteristics, laboratory data, details of hospital course and degree of fluid overload at RRT initiation. The primary outcome was recovery of renal function to dialysis independence. RESULTS: Within 1 year of RRT initiation, 35.9% (61/170) of patients reached the primary end point of renal recovery. The median (interquartile range) duration of RRT was 11 (3-33) days and 83.6% (51/61) recovered prior to hospital discharge. Recovering patients had significantly less fluid overload at the time of RRT initiation compared to non-recovering patients (3.5 versus 9.3%, P = 0.004). In multivariate Cox proportional hazard regression analysis, a rise in percent fluid overload at dialysis initiation remained a significant negative predictor of renal recovery (hazard ratio 0.97, 95% confidence interval 0.95-1.00, P = 0.024). CONCLUSIONS: In patients with AKI, a higher degree of fluid overload at RRT initiation predicts worse renal recovery at 1 year. Clinical trials are needed to determine whether interventions targeting fluid overload may improve patient and renal outcomes.

Delayed graft function requiring more than one-time dialysis treatment is associated with inferior clinical outcomes.

Delayed graft function (DGF) is a common complication of deceased donor kidney transplantation with negative impact on clinical outcomes. In a single-center retrospective analysis, we compared patient and kidney survival, early renal function, and the incidence of acute rejection during the first year among all adult deceased donor kidney transplant patients without DGF, with DGF requiring one-time and/or more than one-time dialysis treatment between January 1, 2000, and December 31, 2008. Of 831 adult kidney transplant patients, 74 (8.9%) required one-time and 134 (16.1%) more than one-time dialysis treatment post-transplantation, respectively. While DGF patients with one-time dialysis treatment had comparable clinical outcomes to that of patients without DGF, patients with DGF requiring more than one-time dialysis treatment had a 45% increased risk for death (HR 1.45, 95% CI 1.02, 2.05, p = 0.04) after adjustment for the differences in demographic and baseline characteristics. Furthermore, DGF patients with more than one-time dialysis requirement displayed significantly lower renal function after recovery (OR 0.32, 95% CI 0.21, 0.49, p < 0.001, for eGFR ≥ 60 mL/min) and higher incidence of acute rejection during the first year (OR 1.66, 95% CI 1.11, 2.49, p = 0.015). Additional studies of therapeutic approaches to manage patients with prolonged DGF are needed.

The time interval between kidney and pancreas transplantation and the clinical outcomes of pancreas after kidney transplantation.

Pancreas after kidney (PAK) transplantation is one of the accepted pancreas transplant modalities. We studied the impact of time interval between kidney and pancreas transplantation on the outcomes of PAK transplantation. Using OPTN/SRTR data, we included 1853 PAK transplants performed between 1996 and 2005 with follow-up until November 1, 2008. Kaplan-Meier survival and multivariate Cox regression analyses were performed using the time interval between kidney and pancreas transplantation either as a categorical (less than one yr, between one and less than three yr, and greater than or equal to three yr) or as a continuous variable (months) to assess kidney graft and patient survival. Patients who received a pancreas transplant three yr or later after kidney transplantation had higher risk of death-censored kidney graft loss (HR 1.56, 95% CI 1.04, 2.32, p = 0.03). Each month beyond three yr between kidney and pancreas transplantation incurred 1% higher risk of subsequent death-censored kidney graft loss (HR 1.01, 95% CI 1.001, 1.02, p = 0.03). In conclusion, time interval between pancreas and kidney transplantation is an independent risk factor of kidney graft loss following pancreas transplantation. Shortening the time interval between pancreas and kidney transplantation to less than three yr may reduce the risk of kidney graft loss in qualified PAK transplant candidates.

Measuring the Appropriateness of Spinal Manipulation for Chronic Low Back and Chronic Neck Pain in Chiropractic Patients.

STUDY DESIGN: RAND/UCLA Appropriateness Method (RUAM) applied to chiropractic manipulation for patients with chronic low-back pain (CLBP) and chronic neck pain (CNP). OBJECTIVE: Determine the rate of appropriate care provided by US chiropractors. SUMMARY OF BACKGROUND DATA: Spinal manipulation has been shown effective for CLBP and CNP but may not be appropriate for all patients with these conditions. METHODS: Ratings of the appropriateness of spinal and cervical manipulation previously developed by two RUAM expert panels were applied to data abstracted from random samples of patient charts from chiropractors in six US regions to determine the appropriateness of manipulation for each patient. RESULTS: Of 125 chiropractors sampled, 89 provided charts that could be abstracted. Of the 2128 charts received, 1054 were abstracted. Charts received but not abstracted included 460 that were unusable (e.g., illegible), and 555 did not have CLBP or CNP. Across the abstracted charts 72% had CLBP, 57% had CNP, and 29% had both; 84% of patients with CLBP and 86% with CNP received manipulation. Patients with CLBP who had minor neurologic findings, sciatic nerve irritation, or no joint dysfunction were significantly less likely to receive manipulation. Patients with CNP who had substantial trauma etiology, no joint dysfunction, or no radiographs were significantly less likely to receive manipulation. Most manipulation for CLBP (64%) was appropriate and most manipulation for CNP (93%) was for patients where appropriateness was uncertain or equivocal. The proportions of patients receiving inappropriate manipulation for either condition were low (1%-3%) as were the numbers of patients presenting to these chiropractors for which manipulation was inappropriate. CONCLUSION: Chiropractors in this US sample tend to provide manipulation to very few patients with CLBP or CNP for which it is inappropriate. However, more research is needed to determine which patients with CNP benefit from manipulation.Level of Evidence: 4.

Patient Willingness to Pay for Reductions in Chronic Low Back Pain and Chronic Neck Pain.

Many recommended nonpharmacologic therapies for patients with chronic spinal pain require visits to providers such as acupuncturists and chiropractors. Little information is available to inform third-party payers' coverage policies regarding ongoing use of these therapies. This study offers contingent valuation-based estimates of patient willingness to pay (WTP) for pain reductions from a large (n = 1,583) sample of patients using ongoing chiropractic care to manage their chronic low back and neck pain. Average WTP estimates were $45.98 (45.8) per month per 1-point reduction in current pain for chronic low back pain and $37.32 (38.0) for chronic neck pain. These estimates met a variety of validity checks including that individuals' values define a downward-sloping demand curve for these services. Comparing these WTP estimates with patients' actual use of chiropractic care over the next 3 months indicates that these patients are likely "buying" perceived pain reductions from what they believe their pain would have been if they didn't see their chiropractor-that is, they value maintenance of their current mild pain levels. These results provide some evidence for copay levels and their relationship to patient demand, but call into question ongoing coverage policies that require the documentation of continued improvement or of experienced clinical deterioration with treatment withdrawal. PERSPECTIVE: This study provides estimates of reported WTP for pain reduction from a large sample of patients using chiropractic care to manage their chronic spinal pain and compares these estimates to what these patients do for care over the next 3 months, to inform coverage policies for ongoing care.

Cost-effectiveness of collaborative care for depression and PTSD in military personnel.

OBJECTIVES: Collaborative care is an effective approach for treating posttraumatic stress disorder (PTSD) and depression within the US Military Health System (MHS), but its cost-effectiveness remains unstudied. Our objective was to evaluate the costs and cost-effectiveness of centrally assisted collaborative telecare (CACT) versus optimized usual care (OUC) for PTSD and depression in the MHS. STUDY DESIGN: A randomized trial compared CACT with OUC. Routine primary care screening identified active-duty service members with PTSD or depression. Eligible participants (N = 666) were randomized to CACT or OUC and assessed at 3, 6, and 12 months. OUC patients could receive care management and increased behavioral health support. CACT patients could receive these services plus stepped psychosocial treatment and routine centralized team monitoring. METHODS: Quality-adjusted life-years (QALYs) were derived from the 12-Item Short Form Health Survey. Claims and case management data were used to estimate costs. Cost-effectiveness analyses were conducted from a societal perspective. RESULTS: Data from 629 patients (320 CACT and 309 OUC) with sufficient follow-up were analyzed. CACT patients gained 0.02 QALYs (95% CI, -0.001 to 0.03) relative to OUC patients. Twelve-month costs, including productivity, were $987 (95% CI, -$3056 to $5030) higher for CACT versus OUC. CACT was estimated to cost $49,346 per QALY gained compared with OUC over 12 months. There is a 58% probability that CACT is cost-effective at a $100,000/QALY threshold. CONCLUSIONS: Despite its higher costs, CACT appears to be a cost-effective strategy relative to OUC for managing PTSD and depression in the MHS.

Adjusting Medicare Advantage star ratings for socioeconomic status and disability.

OBJECTIVES: Studies have identified potential unintended effects of not adjusting clinical performance measures in value-based purchasing programs for socioeconomic status (SES) factors. We examine the impact of SES and disability adjustments on Medicare Advantage (MA) plans' and prescription drug plans' (PDPs') contract star ratings. These analyses informed the development of the Categorical Adjustment Index (CAI), which CMS implemented with the 2017 star ratings. STUDY DESIGN: Retrospective analyses of MA and PDP performance using 2012 Medicare beneficiary-level characteristics and performance data from the Star Rating Program. METHODS: We modeled within-contract associations of beneficiary SES (Medicaid and Medicare dual eligibility [DE] or receipt of a low-income subsidy [LIS]) and disability with performance on 16 clinical measures. We estimated variability in contract-level DE/LIS and disability disparities using mixed-effects regression models. We simulated the impact of applying the CAI to adjust star ratings for DE/LIS and disability to construct the 2017 star ratings. RESULTS: DE/LIS was negatively associated with performance for 12 of 16 measures and positively associated for 2 of 16 measures. Disability was negatively associated with performance for 11 of 15 measures and positively associated for 3 of 15 measures. Adjusting star ratings using the CAI resulted in half-star rating increases for 8.5% of MA and 33.3% of PDP contracts that exceeded 50% DE/LIS beneficiaries. CONCLUSIONS: Increases in star ratings following adjustment of clinical performance for SES and disability using the CAI focused on contracts with higher percentages of DE/LIS beneficiaries. Adjustment for enrollee characteristics may improve the accuracy of quality measurement and remove incentives for providers to avoid caring for more challenging patient populations.

Center-level variation in infection rates after coronary artery bypass grafting.

BACKGROUND: Health-care-acquired infections (HAIs) are a leading cause of morbidity and mortality after cardiac surgery. Prior work has identified several patient-related risk factors associated with HAIs. We hypothesized that rates of HAIs would differ across institutions, in part attributed to differences in case mix. METHODS AND RESULTS: We analyzed 20 896 patients undergoing isolated coronary artery bypass grafting surgery at 33 medical centers in Michigan between January 1, 2009, and June 30, 2012. Overall HAIs included pneumonia, sepsis/septicemia, and surgical site infections, including deep sternal wound, thoracotomy, and harvest/cannulation site infections. We excluded patients presenting with endocarditis. Predicted rates of HAIs were estimated using multivariable logistic regression. Overall rate of HAI was 5.1% (1071 of 20 896; isolated pneumonia, 3.1% [n=644]; isolated sepsis/septicemia, 0.5% [n=99]; isolated deep sternal wound infection, 0.5% [n=96]; isolated harvest/cannulation site, 0.5% [n=97]; isolated thoracotomy, 0.02% [n=5]; multiple infections, 0.6% [n=130]). HAI subtypes differed across strata of center-level HAI rates. Although predicted risk of HAI differed in absolute terms by 2.8% across centers (3.9-6.7%; min:max), observed rates varied by 18.2% (0.9-19.1%). CONCLUSIONS: There was a 18.2% difference in observed HAI rates across medical centers among patients undergoing isolated coronary artery bypass grafting surgery. This variability could not be explained by patient case mix. Future work should focus on the impact of other factors (eg, organizational and systems of clinical care) on risk of HAIs.

Geographic variability in potentially discretionary red blood cell transfusions after coronary artery bypass graft surgery.

OBJECTIVE: A number of established regional quality improvement collaboratives have partnered to assess and improve care across their regions under the umbrella of the Cardiac Surgery Quality Improvement (IMPROVE) Network. The first effort of the IMPROVE Network has been to assess regional differences in potentially discretionary transfusions (<3 units red blood cells [RBCs]). METHODS: We examined 11,200 patients undergoing isolated nonemergent coronary artery bypass graft surgery across 56 medical centers in 4 IMPROVE Network regions between January 2008 and June 2012. Each center submitted the most recent 200 patients who received 0, 1, or 2 units of RBC transfusion during the index admission. Patient and disease characteristics, intraoperative practices, and percentage of patients receiving RBC transfusions were collected. Region-specific transfusion rates were calculated after adjusting for pre- and intraoperative factors among region-specific centers. RESULTS: There were small but significant differences in patient case mix across regions. RBC transfusions of 1 or 2 units occurred among 25.2% of coronary artery bypass graft procedures (2826 out of 11,200). Significant variation in the number of RBC units used existed across regions (no units, 74.8% [min-max, 70.0%-84.1%], 1 unit, 9.7% [min-max, 5.1%-11.8%], 2 units, 15.5% [min-max, 9.1%-18.2%]; P < .001). Variation in overall transfusion rates remained after adjustment (9.1%-31.7%; P < .001). CONCLUSIONS: Delivery of small volumes of RBC transfusions was common, yet varied across geographic regions. These data suggest that differences in regional practice environments, including transfusion triggers and anemia management, may contribute to variability in RBC transfusion rates.

Identification of a protein signature in renal allograft rejection.

PURPOSE: Serum creatinine functions as a poor surrogate marker of renal allograft dysfunction and long-term graft survival. By measuring multiple proteins simultaneously in the serum of transplant patients, we can identify unique protein signatures of graft dysfunction. EXPERIMENTAL DESIGN: We utilized training and validation cohorts composed of healthy and volunteer subjects, stable renal transplant patients, and renal transplant patients experiencing acute allograft rejection. Utilizing our antibody microarray, we measured 108 proteins simultaneously in these groups. RESULTS: Using Mann-Whitney tests with Bonferroni correction, we identified ten serum proteins from 19 renal transplant patients with stable renal function, which are differentially expressed, compared to healthy control subjects. In addition, we identified 17 proteins that differentiate rejecting renal transplant recipients from stable renal transplant. Validation cohorts substantiated these findings. CONCLUSION AND CLINICAL RELEVANCE: Our preliminary results support that a specific pattern of protein expression or "protein signature" may be able to differentiate between stable transplant patients from those with rejection. Future studies will focus on other etiologies of renal allograft dysfunction and the effect of treatment on protein expression and long-term outcome.

Update on kidney transplantation in HIV-infected recipients.

HIV infection has historically been a contraindication to kidney transplantation. Prior to the era of potent antiretroviral therapy, the survival of HIV-infected patients was too poor to justify transplantation. In the last 15 years there has been substantial improvement in antiretroviral medications, such that HIV-positive patients are living longer and developing chronic diseases such as end-stage renal disease. The improvement in survival of HIV-positive patients has resulted in transplant centers increasingly considering infected patients appropriate for kidney transplantation. Recently, the results of the first prospective multicenter trial of kidney transplantation into HIV-positive candidates were released, showing the success and challenges of transplantation into this population. In light of the multicenter findings as well as national registry data, kidney transplantation should be considered the standard-of-care renal replacement therapy for HIV-positive end-stage renal disease patients and they should be referred and evaluated for kidney transplantation accordingly.

Implications of different fluid overload definitions in pediatric stem cell transplant patients requiring continuous renal replacement therapy.

PURPOSE: In critically ill pediatric patients, fluid overload (FO) >10% has been identified as a threshold for possible interventions, including initiation of continuous renal replacement therapy (CRRT). However, multiple definitions have been reported, and there remains no consensus method for FO calculation. The goal of this study was to compare different methods of FO determination and to assess their relative value in predicting outcomes. METHODS: This is a retrospective single-center review of 21 pediatric stem cell transplant patients (PSCT) that required CRRT from 2004 to 2009. We compared eight definitions (4 weight-based and 4 fluid-balance based) that varied by baseline weights. Outcome measures were pediatric intensive care unit (PICU) mortality and pediatric logistic organ dysfunction (PELOD) scores. RESULTS: The number of patients identified as having >10% FO varied significantly according to the definition used, from 14 to 48% (p = 0.002). Significant intra-subject variability was observed; the median difference between individual minimum and maximum %FO scores was 11.4% (IQR 6.8, 17.1%). %FO was not significantly associated with PICU mortality, but five of eight FO definitions were predictive of higher subsequent PELOD scores. CONCLUSION: Our study is one of the first to compare different FO definitions and the impact on predicting outcomes. Our findings suggest that depending on the FO definition used, there is significant variability in the calculated %FO in PSCT patients, and this has important implications for clinical decision-making. Further studies are necessary to determine an optimal FO definition that is clinically relevant and predictive of important outcomes.

Universal prophylaxis is cost effective in cytomegalovirus serology-positive kidney transplant patients.

BACKGROUND: The economic merit of universal prophylaxis and preemptive therapy in the management of cytomegalovirus (CMV) infection for serology positive (R+) kidney transplant patients remains undefined. We performed cost effectiveness and cost utility modeling comparing these two approaches. METHODS: The incidence of CMV infection under universal prophylaxis and preemptive therapy was determined among 653 R+ patients from our institution and 416 R+ patients from various clinic trials, respectively. Standardized decision tree analysis and Markov transitional models were used to calculate cost and quality-adjusted life years (QALYs) from the prototypical clinical data and published literature. Incremental cost effectiveness and cost utility were calculated as dollars for one case of infection avoided and one QALY gained over 10 years, respectively. One- and two-way sensitivity analyses were performed. RESULTS: The incidence of CMV infection was 4.1% and 55.5% within the first year after transplant for universal prophylaxis and preemptive therapy, respectively. Compared with preemptive therapy, universal prophylaxis incurred $1464 more in direct cost while saving $7309 in indirect cost, and resulted in a net gain of 0.209 in QALYs per patient over a 10-year period. Thus, universal prophylaxis dominates over preemptive therapy with a cost saving of $27,967 for 1 QALY gained. This cost saving was sensitive to the variation in the rate of CMV infection and disease with each approach. CONCLUSION: Universal prophylaxis in CMV R+ kidney transplant patients is clinically effective and cost saving. It should be considered as the preferred approach.