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Real-world data in patients with newly diagnosed multiple myeloma (NDMM) are sparse. Using United States claims databases, we analyzed treatment patterns, clinical outcomes, and health care utilization and costs in patients receiving lenalidomide- and/or bortezomib-containing therapy.Patient claims were obtained from a large commercial and Medicare database (October 2009 to May 2015). Patients with NDMM who received lenalidomide- and/or bortezomib-containing therapy and did not receive stem cell transplant (SCT) were analyzed. Duration of treatment (DOT), time to next treatment (TTNT), and health care utilization and costs were evaluated.Of 3075 patients, 1767 received doublet therapy (814 lenalidomide-dexamethasone [Rd], 953 bortezomib-dexamethasone [Vd]) and 464 received triplet therapy (318 lenalidomide-bortezomib-dexamethasone [RVd], 146 cyclophosphamide-bortezomib-dexamethasone [CyBord]). Rd versus Vd resulted in longer median DOT (12.0 vs. 5.9 months; P .0001) and median TTNT (36.7 vs. 24.4 months; P = .0005). Year 1 costs were greater with Rd versus Vd (Δ = $14,964; P = .0009), primarily owing to higher pharmacy costs; outpatient physician visits and chemotherapy administration costs were lower. Median DOT (14.8 vs. 9.0 months; P .0001) and median TTNT (35.7 vs. 22.3 months; P = .0007) were longer with RVd versus CyBord; year 1 costs were comparable.In this study of patients with NDMM ineligible for transplant, the median duration of therapy was approximately 70% of that in clinical trial observations. Lenalidomide therapy versus Vd and CyBord resulted in longer DOT, which correlated with longer TTNT, and higher pharmacy costs, which were partially offset by lower outpatient and chemotherapy administration costs.

Dose reductions or interruptions may be required to manage treatment-associated adverse events among patients with myelodysplastic syndromes (MDS) treated with lenalidomide; such modifications are recommended to sustain therapy and maximize treatment duration. The aim of this retrospective case-control study was to determine the relationship between lenalidomide dose modification (DM), duration of lenalidomide therapy (DOT), and patient outcomes in patients with MDS. Those patients with database follow-up >20months (n=305) were more likely to have received erythropoiesis-stimulating agents (ESAs) (P=0.004), had longer median DOT (P

Background Real-world analyses of treatments for patients with metastatic breast cancer are limited. We evaluated the comparative effectiveness of nab-paclitaxel vs. paclitaxel in patients with metastatic breast cancer using data from an electronic medical record database from community practices across the USA. Methods We performed a retrospective cohort study using fully de-identified data from an independent US electronic medical record platform of patients with metastatic breast cancer initiating single-agent nab-paclitaxel or paclitaxel as a first- or second-line treatment from December 1, 2010 to October 6, 2014. The clinical efficacy objectives were time to treatment discontinuation (TTD) and time to next treatment (TTNT). Subgroup analyses were performed in patients with 2 types of metastatic breast cancer as follows: 1) hormone receptor-positive and human epidermal growth factor receptor 2 negative, and 2) triple-negative disease. Results This analysis included 925 patients. Patients receiving nab-paclitaxel vs. paclitaxel had significantly longer TTD (median 4.2 vs. 2.8 months, P

Introduction Despite a clinically relevant, statistically significant survival benefit with nab-paclitaxel plus gemcitabine and FOLFIRINOX vs single-agent gemcitabine for metastatic pancreatic cancer (mPC), little is known regarding their real-world effectiveness. We analyzed patients with mPC using a nationally representative electronic medical records database to address this unmet need. Methods This retrospective analysis of the Navigating Cancer database compared outcomes among patients who received first-line nab-paclitaxel plus gemcitabine, FOLFIRINOX, or gemcitabine for mPC. Effectiveness, safety, and supportive care use were examined. nab-Paclitaxel plus gemcitabine was the reference for statistical comparisons. Results Baseline characteristics were similar except age (oldest patients were in the gemcitabine cohort followed by nab-paclitaxel plus gemcitabine, then FOLFIRINOX). Patients receiving nab-paclitaxel plus gemcitabine (n=122) demonstrated similar time to treatment discontinuation (TTD; median, 3.4 vs 3.8 months; P=0.947) and database persistence (DP; median, 8.6 vs 8.6 months; P=0.534) vs FOLFIRINOX (n=80); however, TTD (median, 3.4 vs 2.2 months; P

Fadi Braiteh,1 Manish B Patel,2 Monika Parisi,2 Quanhong Ni,2 Siyeon Park,2,3 Claudio Faria2 1Comprehensive Cancer Centers of Nevada, University of Nevada School of Medicine, Las Vegas, NV, 2Celgene Corporation, Summit, NJ, 3The Ohio State University, Columbus, OH, USA Introduction: Despite a clinically relevant, statistically significant survival benefit with nab-paclitaxel plus gemcitabine and FOLFIRINOX vs single-agent gemcitabine for metastatic pancreatic cancer (mPC), little is known regarding their real-world effectiveness. We analyzed patients with mPC using a nationally representative electronic medical records database to address this unmet need.Methods: This retrospective analysis of the Navigating Cancer database compared outcomes among patients who received first-line nab-paclitaxel plus gemcitabine, FOLFIRINOX, or gemcitabine for mPC. Effectiveness, safety, and supportive care use were examined. nab-Paclitaxel plus gemcitabine was the reference for statistical comparisons.Results: Baseline characteristics were similar except age (oldest patients were in the gemcitabine cohort followed by nab-paclitaxel plus gemcitabine, then FOLFIRINOX). Patients receiving nab-paclitaxel plus gemcitabine (n=122) demonstrated similar time to treatment discontinuation (TTD; median, 3.4 vs 3.8 months; P=0.947) and database persistence (DP; median, 8.6 vs 8.6 months; P=0.534) vs FOLFIRINOX (n=80); however, TTD (median, 3.4 vs 2.2 months; P

BACKGROUND The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) was a series of effectiveness trials. The results of these trials began publication in September 2005. Among other findings, these studies were interpreted to suggest that (1) second-generation antipsychotics might have fewer advantages over first-generation antipsychotics than had been generally thought; (2) among the agents assessed, olanzapine had the best efficacy outcome; and (3) after treatment failure with a second-generation antipsychotic, the most efficacious second-line medication is clozapine. To examine the actual impact on practice of these publications, we looked at change in physician prescribing behavior based on these 3 conclusions before and after publication of CATIE. METHOD Rates of antipsychotic medication prescriptions to 51,459 patients with an ICD-9 code of 295 for schizophrenia were extracted from a Missouri Medicaid claims database. χ² Tests were used to compare the rates of prescribing antipsychotic medications before and after each of 3 key CATIE publications (time 1 was September 2005, time 2 was December 2006, and time 3 was April 2006). RESULTS At all time points, we demonstrated a decrease in prescriptions by all prescribers for olanzapine (P < .0001). One year after time 1, we found an increase in prescriptions by all prescribers for aripiprazole (P < .0001). No statistically significant increases in clozapine prescribing were observed. Also, a small but statistically significant increase was seen in prescriptions of perphenazine (P < .02 at time 3). However, this increase occurred only for prescriptions written by psychiatrists and not other prescribers. CONCLUSIONS We found some evidence in our sample that the publication of the results from CATIE had a small but statistically significant effect on prescribing habits of psychiatrists but not other physicians in our sample population. However, larger changes occurred in prescribing behavior that were largely unrelated to the CATIE trial. We propose a hypothesis to explain the direction of observed changes.

194 Background: Despite improved survival with advanced multiple myeloma (MM) treatments (Tx), 15–20% of pts experience early relapse. We assessed the economic impact of early progression among non-stem-cell transplant NDMM pts. Methods: NDMM pts with ≥ 1 Tx (1st claim date: index date) from 01Jan2011–31Dec2015 were identified from the 100% Medicare database. Eligible pts had ≥ 1 full cycle of therapy and continuous health plan enrollment from 6 months pre-index or first MM diagnosis date until ≥ 12 month post-index date unless pts died < 12 months post-index date. First line of therapy (LOT1) included all Txs prescribed ≤ 60 days post-index date. Among pts who progressed to LOT2, median time to next Tx (TTNT) was estimated from a Kaplan–Meier curve as duration from LOT1 start until the earliest of an addition/switch/restart of non-maintenance MM Tx, or dose increase from maintenance to relapse therapy. Pts who progressed to LOT2 prior to and after median TTNT were included in the early and delayed progression cohorts, respectively. Annual all-cause and MM-related healthcare costs estimated from a generalized linear model were compared between doublet therapy pts in LOT1 in the early and delayed progression cohorts. Results: Of 3,768 MM pts with LOT1, 36.1% progressed to LOT2 with median TTNT of 302 days; 81.3% pts initiated doublet therapy in LOT1, of which 19.2% (n = 589) and 17.3% (n = 533) were included in the early and delayed progression cohorts, respectively. Pts in the early progression cohort were younger and incurred higher all-cause inpatient ($17,332 vs $10,455), outpatient hospital ($18,183 vs $15,097), emergency department ($462 vs $395), office ($37,728 vs $29,174), and total costs ($130,948 vs $108,003) compared with the delayed progression cohort. Similarly, the early progression cohort had higher MM-related total costs ($87,284 vs $72,150) including inpatient and outpatient costs (all P< 0.001). All-cause and MM-related pharmacy costs were similar between cohorts. Conclusions: Early progression after LOT1 is associated with substantially higher economic burden indicating the need for future studies of therapies that delay progression and potentially result in cost savings.

e20041Background: In the US and Europe, lenalidomide (LEN or R) was the first approved drug for post-SCT MT in MM. RVD induction is common in NDMM, but real-world evidence of R-MT after RVD and SCT...

e20040Background: Despite advancements in Multiple Myeloma (MM) treatment (Tx), 10-15% patients (pts) experience early relapse. We assessed the economic impact of early progression in newly diagnos...

Objective To evaluate the impact of onabotulinumtoxinA on individual domains of the quality of life questionnaires in a pooled analysis of two phase 3 trials in overactive bladder patients with urinary incontinence who were inadequately managed by ≥1 anticholinergic. Methods Patients received intradetrusor injections of onabotulinumtoxinA 100U (n = 557) or placebo (n = 548). The proportions of patients with a positive response (condition “greatly improved” or “improved”) on the Treatment Benefit Scale, and changes in Incontinence Quality of Life scores and King's Health Questionnaire domain scores were analyzed in the overall population and subgroups with clean intermittent catheterization use and urinary tract infection status during the first 12 weeks of treatment. Responses to individual King's Health Questionnaire items were also assessed. Results Significantly greater proportions of onabotulinumtoxinA-treated patients achieved positive Treatment Benefit Scale response versus placebo (61.8% vs 28.0%; P

Background Overactive bladder is a prevalent and burdensome condition. Generic utility measures may fail to reflect its full impact on patients’ health status. The Incontinence Utility Index (IUI) is a community-based preference index derived from the Incontinence Quality of Life Questionnaire (I-QOL) developed to value health states related to urinary symptoms in patients with neurogenic detrusor overactivity. This study assessed the measurement properties of the IUI in patients with idiopathic overactive bladder (OAB). Methods Data were used from two clinical trials which recruited patients with OAB whose symptoms were inadequately managed with ≥1 anticholinergic medication. Psychometric evaluation included: Differential Item Functioning (DIF) analysis, concordance between I-QOL and IUI (Intraclass correlation coefficient [ICC], criterion and convergent validity according to relevant patient reported outcomes and clinical variables (Spearman’s correlation coefficient, rho), responsiveness, and agreement between utility measures (ICC and Bland-Altman method). Results A total of 1,105 idiopathic OAB patients were included. Mean age (range) was 60.4 years (18–90), 87.8 % (n = 970) were female. DIF was identified in 3 items, none of which are contained in the IUI. ICC (CI95 %) was 0.944 (0.936–0.950). Statistically significant differences (p |0.6|) were found in the expected direction with daily incontinence, urgency episodes and disease-specific domains of King’s Health Questionnaire (KHQ). Low to moderate correlations (rho

Prehospital management of traumatic brain injury (TBI) and trauma system development and organization are aspects of TBI care that have the potential to significantly impact patient outcome. This multi-center study was conducted to explore the effect of prehospital management decisions on early mortality after severe TBI.This report is based on 1449 patients with severe TBI (GCS9) treated at 22 trauma centers enrolled in a New York State quality improvement (QI) program between 2000 and 2004. The prehospital data collected on these patients include time of injury, time of arrival to the trauma center, mode of transport, type of EMS provider, direct or indirect transport, blood pressure and pulse oximetry values, GCS score, pupillary assessment, and airway management procedures.After exclusion criteria were applied, a total of 1,123 patients were eligible for analysis. The majority of patients were male (75%) with a mean age of 36 years. After controlling for arterial hypotension, age, pupillary status, and initial GCS score, direct transport was found to result in significantly lower mortality than indirect transport. Transport mode, time to admission, and prehospital intubation were not found to be related to 2-week mortality.The present study provides class II evidence that demonstrates a 50% increase in mortality associated with indirect transfer of TBI patients. Patients with severe TBI should be transported directly to a Level I or Level II trauma center with capabilities as delineated in the Guidelines for the Prehospital Management of Traumatic Brain Injury, even if this center may not be the closest hospital.

Aims To identify the self-reported treatment goals of patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO), determine whether patients achieved their goals following onabotulinumtoxinA treatment, and assess impact of neurogenic disease (multiple sclerosis or spinal cord injury) and/or clean intermittent catheterization (CIC) on goal achievement. Methods Data from two Phase III studies of onabotulinumtoxinA 200U (n = 227) or placebo (n = 241) in NDO patients (≥14 UI episodes/week; inadequately managed by anticholinergics) were pooled for analysis. At baseline, patients listed their top two qualitative treatment goals, which were distributed into eight subcategories. Six weeks post-treatment, patients rated whether they achieved their goals (5-point Likert scale). The frequency distribution of goals, the proportion of patients who achieved their goals, and goal achievement by etiology and use/non-use of CIC were assessed. Results At baseline, the most common goals were “be dry” (37.9%), “reduce other urinary symptoms” (26.4%), and “improve quality of life/sleep/emotions” (21.4%). Significantly higher proportions of onabotulinumtoxinA-treated patients achieved their overall goals versus placebo (62.0% vs. 17.2%; P

Haemophilia A and B are rare X-lined hemorrhagic disorders that typically affect men. Women are usually asymptomatic carriers, but may be symptomatic and, rarely, also express severe (factor VIII (FVIII) or factor IX (FIX)

e18130Background: In independent phase III trials, both nab-P + G and FFX demonstrated significantly better OS, PFS, and ORR than G alone as 1L tx for MPAC. Limited real-world data exist on the eff...

e18274Background: nab-P/C and sb-P/C are both recommended as category 1 1L tx options for mNSCLC by NCCN; however there is limited data comparing the total cost of care between the two.This study e...

e18100Background: Based on a randomized clinical trial, MPACT, nab-P+G had superior overall survival (OS) compared to G for the treatment of advanced PAC, but limited data is available comparing th...

293 Background: In a phase III study in MBC, nab-P demonstrated anti-tumor activity across lines of therapy. Eribulin is indicated for the treatment (Tx) of MBC in pts who have previously received ≥ 2 chemotherapeutic regimens. This analysis evaluated Tx patterns and effectiveness of nab-P and eribulin in pts with MBC in a real-world community-based setting. Methods: A retrospective cohort study was performed using fully de-identified data from a US electronic medical record platform of 1300 community oncology physicians. The analysis included women aged ≥ 18 years with MBC who started on nab-P or eribulin monotherapy as 1L or 2L Tx from 12/4/10 to 10/6/14 (≥ 1 cycle of nab-P or eribulin required). The primary objective was to examine duration of Tx (DOT, including time to Tx discontinuation [TTD]; censored if last administration > 30 days from the last date in the database) and time to next Tx (TTNT; day 1 from drug 1 to drug 2). Incidence of adverse events (AEs) and supportive care used during Tx were also examined. Results: Pt characteristics were similar between groups. Mean age was 59 years. Most pts had hormone receptor + (62%), HER2− (82%) disease, and 1L therapy (60%). More pts received nab-P vs eribulin. Slightly more pts receiving nab-P vs eribulin were treated in 1L (63% vs 55%). DOT, TTNT, and TTD were significantly longer in the nab-P vs eribulin group (Table). Thrombocytopenia and anemia were numerically lower in the nab-P vs eribulin group (P = 0.11 for each). Nausea/vomiting was less common with eribulin vs nab-P (P = 0.009). Granulocyte-colony stimulating factor, hydrating agents, and antiemetics were used less often in pts receiving nab-P (P < 0.01 for each). Conclusions: DOT, TTNT, and TTD were significantly longer for pts treated with nab-P vs eribulin. Moreover, pts receiving nab-P experienced fewer hematologic AEs and utilized fewer doses of supportive care. [Table: see text]

433 Background: Both nab-P+G and FFX demonstrated superior overall survival (OS) over gemcitabine monotherapy for the treatment of PDAC; but there is no real-world effectiveness and utilization study of nab-P+G vs. FFX. The objective of this study is to compare real-world treatment patterns of patients receiving nab-P+G vs. FFX as first-line treatment for advanced PDAC. Methods: A retrospective cohort study was performed using fully de-identified data from a nationally representative electronic medical record platform of 1,300 community oncology physicians. Patients diagnosed with PDAC between September 2013 and October 2014 who received either nab-P+G or FFX as 1st line therapy were included in the analysis. We calculated median time to treatment discontinuation (TTD) and database persistence (DP), a proxy for OS, using the Kaplan Meier method, and assessed supportive care usage with Poisson regression. Results: 202 (out of 851) patients met eligibility criteria (nab-P+G, n = 122; FFX, n = 80). Patients on nab-P+G were older than patients on FFX (mean age 67.0 v 61.4; p < 0.01), but other baseline characteristics were comparable. TTD (3.4 v 3.8 mos) and DP (8.6 v 8.6 mos) were not statistically different for nab-P+G and FFX, respectively. The rate of AE-related discontinuation was similar in patients on nab-P+G and FFX (18% v 21%); however patients on nab-P+G utilized less doses of granulocyte-colony stimulating factor (GCSF) agents (2.0 v 4.4; p < 0.01), but needed more doses of erythropoietin-stimulating agents (ESA) (0.9 v 0.1; p < 0.01) and steroids (7.9 v 5.8; p < 0.01) per 100 days. Conclusions: TTD and DP for patients with advanced PDAC did not differ significantly between nab-P+G and FFX, although supportive care medications differed. Patients treated with nab-P+G required fewer doses of GCSF and more doses of ESA and steroids, though AEs leading to discontinuation was not statistically different. Management of chemotherapy related toxicities may incur substantial burden on the U.S. healthcare system, especially if an alternative therapy exists with similar clinical outcomes.

429 Background: Based on a randomized clinical trial (RCT), nab-P+G had superior overall survival (OS) compared to G for the treatment of advanced PDAC, but limited data is available comparing the effectiveness of these treatment options in a real-world setting. The objective of this study is to compare treatment patterns of patients receiving nab-P+G versus G for first-line treatment of PDAC. Methods: A retrospective cohort study was performed using fully de-identified data from a nationally representative electronic medical record platform of 1,300 community oncology physicians. Patients diagnosed with advanced PDAC between September 2013 and October 2014 who received first-line therapy with either nab-P+G or Gm were included in the analysis. We calculated the median time to treatment discontinuation (TTD) and database persistence (DP), a proxy for OS, using the Kaplan Meier method, and assessed supportive care usage with Poisson regression. Results: Out of 851 patients, 168 met eligibility criteria for the analysis (nab-P+G, n=122; G, n=46). Patients in the nab-P+G arm were younger (mean age 67.0 v 72.0; p

Context OnabotulinumtoxinA and mirabegron have recently gained marketing authorisation to treat symptoms of overactive bladder (OAB). Objective To evaluate the relative efficacy of mirabegron and onabotulinumtoxinA in patients with idiopathic OAB. Design Network meta-analysis. Data sources A search of 9 electronic databases, review documents, guidelines and websites. Methods Randomised trials comparing any licensed dose of onabotulinumtoxinA or mirabegron with each other, anticholinergic drugs or placebo were eligible (19 randomised trials were identified). 1 reviewer extracted data from the studies and a second reviewer checked the data. Candidate trials were assessed for similarity and networks were developed for each outcome. Bayesian network meta-analysis was conducted using both fixed-effects and random-effects models. When there were differences in mean baseline values between mirabegron and onabotulinumtoxinA trials they were adjusted for using network meta-regression (NMR). Results No studies directly comparing onabotulinumtoxinA to mirabegron were identified. A network was created for each of the 7 outcomes, with 3–9 studies included in each individual network. The trials included in the networks were broadly similar. Patients in the onabotulinumtoxinA trials had more urinary incontinence and urgency episodes at baseline than patients in the mirabegron trials and these differences were adjusted for using NMR. Both onabotulinumtoxinA and mirabegron were more efficacious than placebo at reducing the frequency of urinary incontinence, urgency, urination and nocturia. OnabotulinumtoxinA was more efficacious than mirabegron (50 and 25 mg) in completely resolving daily episodes of urinary incontinence and urgency and in reducing the frequency of urinary incontinence, urgency and urination. NMR supported the results of the network meta-analysis. Conclusions In the absence of head-to-head trials comparing onabotulinumtoxinA to mirabegron, this indirect comparison indicates that onabotulinumtoxinA may be superior to mirabegron in improving symptoms of urinary incontinence, urgency and urinary frequency in patients with idiopathic OAB.

Background. Despite marked improvement in short-term renal allograft survival rates (GSR) in recent years, improvement in long-term GSR remained elusive. Methods. We analysed the kidney transplant experience at our centre accrued over four decades to evaluate how short-term and long-term GSR had changed and to identify risk factors affecting graft survival. The study included 1476 adult recipients of a deceased-donor kidney transplant who were transplanted between 1963 and 2006 and who had received one of five distinct immunosuppressive protocols. Results. Five-year actual GSR steadily improved over the years as immunosuppressive therapy evolved (22–86%, P < 0.001) in spite of an increasing trend in the transplantation of higher-risk donor–recipient pairings. For those whose grafts functioned for the first year, subsequent 4-year GSR (5-year conditional GSR) also improved significantly (63–92%, P < 0.001). Acute rejection and delayed graft function (DGF) were the most significant risk factors for actual graft survival, while acute rejection was the only significant risk factor for conditional GSR. Use of kidneys from expanded-criteria donors (ECD) was not a risk factor, compared to the use of standard-criteria donor kidneys for either 5-year actual or conditional GSR. There was an impressive decline in the incidence of acute rejection events (77.4–5.8%, P < 0.001). While the DGF rate had decreased, it still remained high (68.7–38.5%, P < 0.001). Conclusions. We found a significant improvement in both short-term and long-term GSR of deceased-donor kidney transplants over the last four decades. These improvements are most likely related to the decreased incidence of acute rejection episodes. Minimizing acute rejection events and preventing DGF could result in further improvement in the GSR. Our experience in the judicious use of ECD kidneys suggests that this source of kidneys could be expanded further.

We evaluated the feasibility of implementing audio computer-assisted self-interviews (ACASI) as part of routine clinical care at two community hospital-based HIV clinics in New York City. Between June 2003 and August 2006, 215 patients completed 1001 ACASI sessions in English or Spanish prior to their scheduled clinical appointments. Topics covered included antiretroviral therapy adherence, depression symptoms, alcohol and drug use, and condom use. Patients and providers received feedback reports immediately after each session. Feasibility was evaluated by quantitative analysis of ACASI responses, medical chart reviews, a brief patient questionnaire administered at the conclusion of each computer session, patient focus groups, and semi-structured provider interviews. ACASI interviews frequently identified inadequate medication adherence and depression symptoms: at baseline, 31% of patients reportedor =95% adherence over the past three days and 52% had symptoms of depression (CES-D scoreor =16). Substance abuse problems were identified less frequently. Patients were comfortable with the ACASI and appreciated it as an additional communication route with their providers; however, expectations about the level of communication achieved were sometimes higher than actual practice. Providers felt the summary feedback information was useful when received in a timely fashion and when they were familiar with the clinical indicators reported. Repeated ACASI sessions did not have a favorable impact on adherence, depression, or substance use outcomes. No improvements in HIV RNA suppression were observed in comparison to patients who did not participate in the study. We conclude that it is feasible to integrate an ACASI screening tool into routine HIV clinical care to identify patients with inadequate medication adherence and depression symptoms. Repeated screening was not associated with improved clinical outcomes. ACASI screening should be considered in HIV clinical care settings to assist providers in identifying patients with the greatest need for targeted psychosocial services including adherence support and depression care.

To evaluate potential side effects of continuous hypertonic 3% saline (CHS) as maintenance fluid in patients with brain injury.Retrospective chart analysis of prospectively collected data.Patients admitted to the neurosurgical intensive care unit for4 days with traumatic brain injury, stroke, or subarachnoid hemorrhage with a Glasgow Coma Scale9 and elevated intracranial pressure (ICP) or at risk of developing elevated ICP were included. Based on physician preference, one group was treated with 3% CHS at a rate of 1.5 mL/kg/bw as maintenance fluid. The other group received 0.9% normal saline (NS). Two percent saline was used in the CHS group to wean patients off 3% CHS or when sodium was above 155. Data on serum sodium, blood urea nitrogen, creatinine, ICP, infection rate, length of stay, rates of deep vein thrombosis, and pulmonary emboli and dural thrombosis were collected prospectively.One hundred seven patients in the CHS group and 80 in the NS group met the inclusion criteria. The incidence of moderate hypernatremia (Na155 mmol/L) and severe hypernatremia (Na160 mmol/L) was significantly higher in the CHS therapy group than in the NS group. No significant relationship between CHS infusion and renal dysfunction was found. Moderate and severe hypernatremia was associated with a higher risk of elevated blood urea nitrogen and creatinine levels. Acute renal failure was not seen in these patients. A total of 53.3% in the CHS group and in 16.3% in the NS group (p0.0001) had raised ICP (25 mm Hg), consistent with the physicians decision to use CHS in patients with elevated ICP.CHS therapy was not associated with an increased rate of infection, deep vein thrombosis, or renal failure. However, there was a significant risk of developing hypernatremia. We conclude that CHS administration in patients with severe injuries is safe as long as sodium levels are carefully monitored.

Object Traumatic brain injury (TBI) remains a serious public health crisis requiring continuous improvement in pre-hospital and inhospital care. This condition results in a hypermetabolic state that increases systemic and cerebral energy requirements, but achieving adequate nutrition to meet this demand has not been a priority in reducing death due to TBI. The effect of timing and quantity of nutrition on death within the first 2 weeks of injury was analyzed in a large prospective database of adult patients with severe TBI in New York State. Methods The study is based on 797 patients with severe TBI (Glasgow Coma Scale [GCS] score < 9) treated at 22 trauma centers enrolled in a New York State quality improvement program between 2000 and 2006. The inhospital section of the prospectively collected database includes information on age, initial GCS score, weight and height, results of CT scanning, and daily parameters such as pupillary status, arterial hypotension, GCS score, and number of calories fed per day. Results Patients who were not fed within 5 and 7 days after TBI had a 2- and 4-fold increased likelihood of death, respectively. The amount of nutrition in the first 5 days was related to death; every 10-kcal/kg decrease in caloric intake was associated with a 30–40% increase in mortality rates. This held up even after controlling for factors known to affect mortality, including arterial hypotension, age, pupillary status, initial GCS score, and CT scan findings. Conclusions Nutrition is a significant predictor of death due to TBI. Together with prevention of arterial hypotension, hypoxia, and intracranial hypertension it is one of the few therapeutic interventions that can directly affect TBI outcome.

HIV prevention has become a new priority for HIV clinicians, as their patients live longer and more sexually active lives. Prevention interventions can be effective in clinical settings, but first patients must be screened and inconsistent condom use must be disclosed. Audio computer-assisted self-interviews (ACASI) are an effective way to elicit this sensitive information. We assessed condom use by ACASI among 198 English- or Spanish-speaking HIV patients at 2 community hospital-based HIV clinics in Queens and the Bronx, New York. Among 120 patients reporting sex with a regular partner in the past 4 weeks, 41 (34%) reported not using a condom every time and 22 (18%) reported never using a condom. Among 81 reporting sex with a casual partner in the past 4 weeks, 21 (26%) reported not using a condom every time and 12 (15%) reported never using a condom. Overall, 24 of 129 sexually active patients (19%) reported never using a condom. In a multivariable model controlling for age, race/ethnicity, gender, and HIV exposure category, depression symptoms (Center for Epidemiological Studies Depression Scale [CES-D] score/= 16; p = 0.03) and self-reported antiretroviral medication non-adherence (/=95% doses in past 3 days; p = 0.03) were significantly associated with never using a condom with a regular or casual partner. ACASI interviews may be an effective way of identifying patients in clinical settings who require prevention counseling as well as other psychosocial services.

Background The causes of severe traumatic brain injury (TBI) vary by age and other demographic characteristics. Mortality after trauma is higher for elderly than younger patients. This study is based on 2779 patients with severe TBI treated at 24 trauma centers enrolled in a New York State quality improvement program. The prospectively collected database includes information on age, sex, mechanism of injury, initial Glasgow Coma Scale score, blood pressure, pupillary assessment, and CT scan findings. This multi-center study was conducted to explore the impact of falls on early mortality from severe TBI among the elderly. Results After exclusion criteria were applied, a total of 2162 patients were eligible for analysis. Falls contributed to 21% of all severe TBI, 12% occurring from > 3 meters and 9% from < 3 meters. Two-week mortality ranged from 18% due to injuries other than falls to 31% due to falls from < 3 meters (p =< 0.0001). Mortality after a severe TBI is much greater among older people, reaching 58% for people 65 years and older sustaining a fall from < 3 meters. Conclusion Among those 65 and older, falls contributed to 61% of all injuries and resulted in especially high mortality among individuals experiencing low falls. Preventive efforts directed toward older people to avoid falls from < 3 meters could have a significant impact on mortality.

According to the CDC’s 2006 National Hemophilia Data Set, females comprise 0.7% of the moderately and severely affected hemophilia A (HA) population and 1.3% of those similarly affected with hemophilia B (HB) in the US. Since no comprehensive data have been published on this patient group since 1978, we conducted this study to collect and analyze epidemiological, clinical, psychosocial, and molecular genetic data on females with severe (s) or moderate (mod) HA or HB. Potential subjects with factor VIII or IX activity levels