Real-world febrile neutropenia rates with same-day versus next-day pegfilgrastim after myelosuppressive chemotherapy.

Aim: To compare the incidence of febrile neutropenia (FN) after same-day versus next-day pegfilgrastim. Materials & methods: This single-institution, real-world, retrospective electronic health record-based study included patients who received chemotherapy and prophylactic same-day or next-day pegfilgrastim/pegfilgrastim-cbqv. Results: In cycle 1, 117 patients received same-day pegfilgrastim and 180 patients received next-day pegfilgrastim. FN episodes in cycle 1 occurred in 6.0 versus 6.7% of patients with same-day versus next-day pegfilgrastim, respectively (p = 0.814). Across all cycles, 8.5 and 9.4% of patients experienced ≥1 FN episode after same-day versus next-day pegfilgrastim, respectively (p = 0.793). In the breast cancer patient subgroup, FN occurred 3.2% of same-day pegfilgrastim cycles versus 1.8% of next-day pegfilgrastim cycles (p = 0.938). Conclusion: No significant differences were detected between same-day and next-day pegfilgrastim administration.

A common side effect of chemotherapy is the unintended killing of important immune cells that can fight infections. Because of this effect, patients with cancer who are treated with chemotherapy can experience a serious, sometimes deadly condition called febrile neutropenia (FN). Pegfilgrastim is a medication that is usually given on the day after chemotherapy to help immune cells grow and prevent FN. Many patients prefer to have pegfilgrastim administered on the same day as chemotherapy to avoid a second clinic visit, but it has not been proven whether this approach is as effective and safe as giving pegfilgrastim a day later. This study from the Utah Cancer Specialists in patients with various tumor types (e.g., breast cancer, lung cancer) showed that similar, low proportions of patients had FN when they were given pegfilgrastim on the same day as or the day after chemotherapy.

Colonoscopy in poorly prepped colons: a cost effectiveness analysis comparing standard of care to a new cleansing technology.

BACKGROUND: The objective of this Markov model lifetime cost-effectiveness analysis was to evaluate a new medical device technology which minimizes redo colonoscopies on the outcomes of cost, quality of life, and aversion of colorectal cancers (CRC). METHODS: A new technology (PureVu® System) which cleans inadequately prepped colons was evaluated using TreeAge 2019 software in patients who presented with inadequate prep in outpatient settings in the US. PureVu was compared to the standard of care (SOC). Peer reviewed literature was used to identify the CRC incidence cancers based on missing polyps. Costs for procedures were derived from 2019 Medicare and from estimated private payer reimbursements. Base case costs, sensitivity analysis and incremental cost effectiveness (ICE) were evaluated. The cost of PureVu was $750. RESULTS: Assuming a national average compliance rate of 60% for colonoscopy, the use of PureVu saved the healthcare system $833-$992/patient depending upon the insurer when compared to SOC. QALYs were also improved with PureVu mainly due to a lower incidence of CRCs. In sensitivity analysis, SOC becomes less expensive than PureVu when compliance to screening for CRC using colonoscopy is ≤ 28%. Also, in order for SOC to be less expensive than PureVu, the list price of PureVu would need to exceed $1753. In incremental cost effectiveness analysis, PureVu dominated SOC. CONCLUSION: Using the PureVu System to improve bowel prep can save the healthcare system $3.1-$3.7 billion per year, while ensuring a similar quality of life and reducing the incidence of CRCs.

Hydration requirements in patients receiving highly emetogenic chemotherapy.

AIM: Chemotherapy-induced nausea and vomiting diminishes quality of life and increases healthcare resource use. This retrospective medical records analysis evaluated hydration requirements with emetogenic chemotherapy. PATIENTS & METHODS: Cancer patients received moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC), and antiemetics palonosetron or granisetron extended-release subcutaneous (GERSC), neurokinin 1 receptor antagonist and dexamethasone. Unscheduled hydration event rates were determined. RESULTS: For 186 patients (92 palonosetron, 94 GERSC) overall, mean hydration rate was significantly higher with palonosetron (0.6 vs 0.2; p = 0.0005). Proportion of patients with ≥1 hydration event was significantly higher with palonosetron overall (54 vs 33%; p = 0.0033) and in cycles 2-4 and the HEC subgroup. CONCLUSION: GERSC within a three-drug antiemetic regimen may reduce unscheduled hydration requirements with MEC or HEC.

Challenges to the Standardization of Trauma Data Collection in Burn, Traumatic Brain Injury, Spinal Cord Injury, and Other Trauma Populations: A Call for Common Data Elements for Acute and Longitudinal Trauma Databases.

OBJECTIVE: Common data elements (CDEs) promote data sharing, standardization, and uniform data collection, which facilitate meta-analyses and comparisons of studies. Currently, there is no set of CDEs for all trauma populations, but their creation would allow researchers to leverage existing databases to maximize research on trauma outcomes. The purpose of this study is to assess the extent of common data collection among 5 trauma databases. DESIGN: The data dictionaries of 5 trauma databases were examined to determine the extent of common data collection. Databases included 2 acute care databases (American Burn Association's National Burn Data Standard and American College of Surgeons' National Trauma Data Standard) and 3 longitudinal trauma databases (Burn, Traumatic Brain Injury, Spinal Cord Injury Model System National Databases). Data elements and data values were compared across the databases. Quantitative and qualitative variations in the data were identified to highlight meaningful differences between datasets. SETTING: N/A. PARTICIPANTS: N/A. INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: N/A. RESULTS: Of the 30 data elements examined, 14 (47%) were present in all 5 databases. Another 9 (30%) elements were present in 4 of the 5 databases. The number of elements present in each database ranged from 23 (77%) to 26 (86%). There were inconsistencies in the data values across the databases. Twelve of the 14 data elements present in all 5 databases exhibited differences in data values. CONCLUSIONS: This study demonstrates inconsistencies in the documentation of data elements in 5 common trauma databases. These discrepancies are a barrier to database harmonization and to maximizing the use of these databases through linking, pooling, and comparing data. A collaborative effort is required to develop a standardized set of elements for trauma research.

Hydration requirements with emetogenic chemotherapy: granisetron extended-release subcutaneous versus palonosetron.

AIM: This retrospective analysis evaluated chemotherapy-induced nausea and vomiting (CINV)-related hydration needs with palonosetron or granisetron extended-release subcutaneous (GERSC), approved in 2016 for CINV prevention. MATERIALS & METHODS: At a community practice, CINV-related hydration per chemotherapy cycle was determined following highly (HEC) or moderately emetogenic chemotherapy (MEC) and a guideline-recommended antiemetic regimen: NK-1 receptor antagonist, dexamethasone and either palonosetron only, GERSC only, or palonosetron switched to GERSC. RESULTS: Palonosetron-only patients (n = 93) had a significantly higher mean (standard deviation) hydration rate (0.9 [1.1]) than GERSC-only patients (n = 91; 0.3 [0.6]; p < 0.0001). Switched patients' (n = 48) hydration rates were significantly higher in the HEC subgroup with palonosetron (0.7 [1.2]) versus GERSC (0.5 [1.0]; p = 0.028). CONCLUSION: GERSC in a three-drug antiemetic regimen may reduce hydration needs following HEC or MEC. [Formula: see text].

Myelo-erythroid commitment after burn injury is under ß-adrenergic control via MafB regulation.

Severely injured burn patients receive multiple blood transfusions for anemia of critical illness despite the adverse consequences. One limiting factor to consider alternate treatment strategies is the lack of a reliable test platform to study molecular mechanisms of impaired erythropoiesis. This study illustrates how conditions resulting in a high catecholamine microenvironment such as burns can instigate myelo-erythroid reprioritization influenced by ß-adrenergic stimulation leading to anemia. In a mouse model of scald burn injury, we observed, along with a threefold increase in bone marrow LSK cells (linneg Sca1+cKit+), that the myeloid shift is accompanied with a significant reduction in megakaryocyte erythrocyte progenitors (MEPs). ß-Blocker administration (propranolol) for 6 days after burn, not only reduced the number of LSKs and MafB+ cells in multipotent progenitors, but also influenced myelo-erythroid bifurcation by increasing the MEPs and reducing the granulocyte monocyte progenitors in the bone marrow of burn mice. Furthermore, similar results were observed in burn patients' peripheral blood mononuclear cell-derived ex vivo culture system, demonstrating that commitment stage of erythropoiesis is impaired in burn patients and intervention with propranolol (nonselective ß1,2-adrenergic blocker) increases MEPs. Also, MafB+ cells that were significantly increased following standard burn care could be mitigated when propranolol was administered to burn patients, establishing the mechanistic regulation of erythroid commitment by myeloid regulatory transcription factor MafB. Overall, results demonstrate that ß-adrenergic blockers following burn injury can redirect the hematopoietic commitment toward erythroid lineage by lowering MafB expression in multipotent progenitors and be of potential therapeutic value to increase erythropoietin responsiveness in burn patients.

Acute Kidney Injury in Burn Patients: Clinically Significant Over the Initial Hospitalization and 1 Year After Injury: An Original Retrospective Cohort Study.

OBJECTIVE: To examine the development of acute kidney injury (AKI) after burn injury as an independent risk factor for increased morbidity and mortality over initial hospitalization and 1-year follow-up. BACKGROUND: Variability in fluid resuscitation and difficulty recognizing early sepsis are major barriers to preventing AKI after burn injury. Expanding our understanding of the burden AKI has on the clinical course of burn patients would highlight the need for standardized protocols. METHODS: We queried the Healthcare Cost and Utilization Project State Inpatient Databases in the states of Florida and New York during the years 2009 to 2013 for patients over age 18 hospitalized with a primary diagnosis of burn injury using ICD-9 codes. We identified and grouped 18,155 patients, including 1476 with burns >20% total body surface area, by presence of AKI. Outcomes were compared in these cohorts via univariate analysis and multivariate logistic regression models. RESULTS: During initial hospitalization, AKI was associated with increased pulmonary failure, mechanical ventilation, pneumonia, myocardial infarction, length of stay, cost, and mortality, and also a lower likelihood of being discharged home. One year after injury, AKI was associated with development of chronic kidney disease, conversion to chronic dialysis, hospital readmission, and long-term mortality. CONCLUSIONS: AKI is associated with a profound and severe increase in morbidity and mortality in burn patients during initial hospitalization and up to 1 year after injury. Consensus protocols for initial burn resuscitation and early sepsis recognition and treatment are crucial to avoid the consequences of AKI after burn injury.

High-volume hemofiltration in adult burn patients with septic shock and acute kidney injury: a multicenter randomized controlled trial.

BACKGROUND: Sepsis and septic shock occur commonly in severe burns. Acute kidney injury (AKI) is also common and often results as a consequence of sepsis. Mortality is unacceptably high in burn patients who develop AKI requiring renal replacement therapy and is presumed to be even higher when combined with septic shock. We hypothesized that high-volume hemofiltration (HVHF) as a blood purification technique would be beneficial in this population. METHODS: We conducted a multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of HVHF on the hemodynamic profile of burn patients with septic shock and AKI involving seven burn centers in the United States. Subjects randomized to the HVHF were prescribed a dose of 70 ml/kg/hour for 48 hours while control subjects were managed in standard fashion in accordance with local practices. RESULTS: During a 4-year period, a total of nine subjects were enrolled for the intervention during the ramp-in phase and 28 subjects were randomized, 14 each into the control and HVHF arms respectively. The study was terminated due to slow enrollment. Ramp-in subjects were included along with those randomized in the final analysis. Our primary endpoint, the vasopressor dependency index, decreased significantly at 48 hours compared to baseline in the HVHF group (p = 0.007) while it remained no different in the control arm. At 14 days, the multiple organ dysfunction syndrome score decreased significantly in the HVHF group when compared to the day of treatment initiation (p = 0.02). No changes in inflammatory markers were detected during the 48-hour intervention period. No significant difference in survival was detected. No differences in adverse events were noted between the groups. CONCLUSIONS: HVHF was effective in reversing shock and improving organ function in burn patients with septic shock and AKI, and appears safe. Whether reversal of shock in these patients can improve survival is yet to be determined. TRIAL REGISTRATION: Clinicaltrials.gov NCT01213914 . Registered 30 September 2010.

Antibiotics and antiseptics for preventing infection in people receiving revision total hip and knee prostheses: a systematic review of randomized controlled trials.

BACKGROUND: Infection rates in revision (second and subsequent) major joint arthroplasty continues to be a significant issue with rates 2-3 times those of primary procedures. The effect of antibiotic and antiseptic prophylaxis on outcomes for this type of surgery has not been adequately reviewed. METHODS: A systematic search of the main databases for randomized controlled trials (RCTs) evaluating antibiotics and antiseptics was conducted to evaluate the predetermined endpoints of infection. RESULTS: There were five (5) RCTs identified that examined the effects of antibiotic and antiseptic prophylaxis on infections after revision total hip arthroplasty [THA] (total of 304 participants) and total knee arthroplasty [TKA] (total of 206 participants). For TKA, preoperative systemic intravenous (IV) antibiotic prophylaxis plus antibiotic cement may be effective in reducing the incidence of infection in revision TKA at 8+ years. These results however should be interpreted with caution due to the significant biases. For revision THA, there is no RCT evidence that antibiotics/antiseptics have any effect on the infection rate. CONCLUSIONS: There is a lack of high quality data demonstrating an effect of antibiotics or antiseptics on infection rates in revision THA/TKA. Considering the rate of infections in revisions is 2-3X that of primary procedures and; there is a consensus recommendation to use similar antibiotic and antiseptic regimens in both primary and revision procedures, there is a need for high quality studies in revision THA/TKA.

APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy.

AIM: APF530, extended-release granisetron, provides sustained release for ≥5 days for acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV). We compared efficacy and safety of APF530 versus ondansetron for delayed CINV after highly emetogenic chemotherapy (HEC), following a guideline-recommended three-drug regimen. METHODS: HEC patients received APF530 500 mg subcutaneously or ondansetron 0.15 mg/kg intravenously, with dexamethasone and fosaprepitant. Primary end point was delayed-phase complete response (no emesis or rescue medication). RESULTS: A higher percentage of APF530 versus ondansetron patients had delayed-phase complete response (p = 0.014). APF530 was generally well tolerated; treatment-emergent adverse event incidence was similar across arms, mostly mild-to-moderate injection-site reactions. CONCLUSION: APF530 versus the standard three-drug regimen provided superior control of delayed-phase CINV following HEC. ClinicalTrials.gov : NCT02106494.

Systematic review and meta-analysis of randomized controlled trials of antibiotics and antiseptics for preventing infection in people receiving primary total hip and knee prostheses.

Infection rates in primary (first-time) major joint arthroplasty continue to be a significant issue. The effect of antibiotic and antiseptic prophylaxis on outcomes for this type of surgery has not been adequately reviewed. A systematic search of the main databases for randomized controlled trials (RCTs) evaluating antibiotics and antiseptics was conducted to evaluate the predetermined endpoints of infection, adverse events, costs, quality of life, and concentration levels of antibiotics. A meta-analysis using pooled effect estimates and fixed-effect and random-effect models of risk ratios (RR), calculated with 95% confidence intervals (CI), was utilized. Thirty (30) RCTs examined the effects of antibiotic and antiseptic prophylaxis on infections after primary total hip arthroplasty (THA) (total of 11,597 participants) and total knee arthroplasty (TKA) (total of 6,141 participants). For THA, preoperative systemic intravenous (i.v.) antibiotic prophylaxis may be effective in reducing the incidence of infection after THA from 6 months to ≥5 years. For TKA, there is no RCT evidence that antibiotics and/or antiseptics have any effect on infection rate. Preoperative systemic antibiotic prophylaxis in primary THA may be effective at reducing infection rate. There is no evidence that timing, route of administration, or concentration levels have an effect on reducing infections, adverse events, or costs in THA or TKA. Many of the trials included in this study were published in the 1980s and 1990s. Thus, it would be important to replicate a number of them based on current patient demographics and incidence of bacterial resistance.

In-office diagnostic arthroscopy for knee and shoulder intra-articular injuries its potential impact on cost savings in the United States.

BACKGROUND: The purpose of this analysis was to determine whether in office diagnostic needle arthroscopy (Visionscope Imaging System [VSI]) can provide for improved diagnostic assessment and; more cost effective care. METHODS: Data on arthroscopy procedures in the US for deep seated pathology in the knee and shoulder were used (Calendar Year 2012). These procedures represent approximately 25-30% of all arthroscopic procedures performed annually. Sensitivities, specificities, positive predictive, and negative predictive values for MRI analysis of this deep seated pathology from systematic reviews and meta-analyses were used in assessing for false positive and false negative MRI findings. The costs of performing diagnostic and surgical arthroscopy procedures (using 2013 Medicare reimbursement amounts); costs associated with false negative findings; and the costs for treating associated complications arising from diagnostic and therapeutic arthroscopy procedures were then assessed. RESULTS: In patients presenting with medial meniscal pathology (ICD9CM diagnosis 836.0 over 540,000 procedures in CY 2012); use of the VSI system in place of MRI assessment (standard of care) resulted in a net cost savings to the system of $151 million. In patients presenting with rotator cuff pathology (ICD9CM 840.4 over 165,000 procedures in CY2012); use of VSI in place of MRI similarly saved $59 million. These savings were realized along with more appropriate care as; fewer patients were exposed to higher risk surgical arthroscopic procedures. CONCLUSIONS: The use of an in-office arthroscopy system can: possibly save the US healthcare system money; shorten the diagnostic odyssey for patients; potentially better prepare clinicians for arthroscopic surgery (when needed) and; eliminate unnecessary outpatient arthroscopy procedures, which commonly result in surgical intervention.

The Affordable Health Care Act annual wellness visits: the effectiveness of a nurse-run clinic in promoting adherence to mammogram and colonoscopy recommendations.

OBJECTIVE: The aim of this study was to determine the effectiveness of the nurse-run annual wellness visit (AWV) in improving adherence to cancer screening recommendations for colonoscopies and/or mammograms. BACKGROUND: The Affordable Health Care Act provides Medicare beneficiaries access to AWVs. Nurse-run AWVs offer individualized education, reinforce health screening recommendations, and may enhance the patients' intent to complete the screenings. METHODS: A nonexperimental comparative study was conducted using data collected from chart audits comparing patients who only attended the AWV, patients who attended the AWV linked with a physician visit, and patients who have not attended an AWV. RESULTS: Patients who attended the AWV showed greater adherence to mammogram completion regardless of the link to the physician follow-up visit. Differences in adherence to colonoscopy recommendations were not significant, likely because of the low number of colonoscopies reported. CONCLUSIONS: Nurse-run AWV clinics are associated with adherence to mammograms and show promise of increasing colonoscopy compliance.

Systematic review and meta-analysis of neurofeedback and its effect on posttraumatic stress disorder.

Background: To date, only one systematic review and meta-analysis of randomized controlled trials (RCTs) has evaluated the effect of neurofeedback in PTSD, which included only four studies and found an uncertainty of the effect of EEG-NF on PTSD symptoms. This meta-analysis is an update considering that numerous studies have since been published. Additionally, more recent studies have included fMRI-NF as well as fMRI-guided or -inspired EEG NF. Methods: Systematic literature searches for RCTs were conducted in three online databases. Additional hand searches of each study identified and of systematic reviews and meta-analyses published were also undertaken. Outcomes evaluated the effect of neurofeedback vs. a control (active, sham, and waiting list) on their effects in reducing PTSD symptoms using various health instruments. Meta-analytical methods used were inverse variance random-effects models measuring both mean and standardized mean differences. Quality and certainty of the evidence were assessed using GRADE. Adverse events were also evaluated. Results: A total of 17 studies were identified evaluating a total of 628 patients. There were 10 studies used in the meta-analysis. Results from all studies identified favored neurofeedback's effect on reducing PTSD symptoms including BDI pretest-posttest [mean difference (MD): 8.30 (95% CI: 3.09 to 13.52; P = 0.002; I 2 = 0%)]; BDI pretest-follow-up (MD: 8.75 (95% CI: 3.53 to 13.97; P < 0.00001; I 2 = 0%); CAPS-5 pretest-posttest [MD: 7.01 (95% CI: 1.36 to 12.66; P = 0.02; I 2 = 86%)]; CAPS-5 pretest-follow-up (MD: 10 (95% CI: 1.29 to 21.29; P = 0.006; I 2 = 77%); PCL-5 pretest-posttest (MD: 7.14 (95% CI: 3.08 to 11.2; P = 0.0006; I 2 = 0%); PCL-5 pretest-follow-up (MD: 14.95 (95% CI: 7.95 to 21.96; P < 0.0001; I 2 = 0%). Other studies reported improvements using various other instruments. GRADE assessments of CAPS, PCL, and BDI demonstrated a moderate/high level in the quality of the evidence that NF has a positive clinical effect. Conclusion: Based on newer published studies and the outcomes measured, NF has demonstrated a clinically meaningful effect size, with an increased effect size at follow-up. This clinically meaningful effect appears to be driven by newer fMRI-guided NF and deeper brain derivates of it.

Inhalation injury severity and systemic immune perturbations in burned adults.

OBJECTIVE: We aimed to determine whether the severity of inhalation injury evokes an immune response measurable at the systemic level and to further characterize the balance of systemic pro- and anti-inflammation early after burn and inhalation injury. BACKGROUND: Previously, we reported that the pulmonary inflammatory response is enhanced with worse grades of inhalation injury and that those who die of injuries have a blunted pulmonary immune profile compared with survivors. METHODS: From August 2007 to June 2011, bronchoscopy was performed on 80 patients admitted to the burn intensive care unit when smoke inhalation was suspected. Of these, inhalation injury was graded into 1 of 5 categories (0, 1, 2, 3, and 4), with grade 0 being the absence of visible injury and grade 4 corresponding to massive injury. Plasma was collected at the time of bronchoscopy and analyzed for 28 immunomodulating proteins via multiplex bead array or enzyme-linked immunosorbent assay. RESULTS: The concentrations of several plasma immune mediators were increased with worse inhalation injury severity, even after adjusting for age and % total body surface area (TBSA) burn. These included interleukin (IL)-1RA (P = 0.002), IL-6 (P = 0.002), IL-8 (P = 0.026), granulocyte colony-stimulating factor (P = 0.002), and monocyte chemotactic protein 1 (P = 0.007). Differences in plasma immune mediator concentrations in surviving and deceased patients were also identified. Briefly, plasma concentrations of IL-1RA, IL-6, IL-8, IL-15, eotaxin, and monocyte chemotactic protein 1 were higher in deceased patients than in survivors (P < 0.05 for all), whereas IL-4 and IL-7 were lower (P < 0.05). After adjusting for the effects of age, % TBSA burn, and inhalation injury grade, plasma IL-1RA remained significantly associated with mortality (odds ratio, 3.12; 95% confidence interval, 1.03-9.44). Plasma IL-1RA also correlated with % TBSA burn, inhalation injury grade, fluid resuscitation, Baux score, revised Baux score, Denver score, and the Sequential Organ Failure Assessment score. CONCLUSIONS: The severity of smoke inhalation injury has systemically reaching effects, which argue in favor of treating inhalation injury in a graded manner. In addition, several plasma immune mediators measured early after injury were associated with mortality. Of these, IL-1RA seemed to have the strongest correlation with injury severity and outcomes measures, which may explain the blunted pulmonary immune response we previously found in nonsurvivors.

Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis.

BACKGROUND: Since the patient's skin is a major source of pathogens that cause surgical-site infection, optimization of preoperative skin antisepsis may decrease postoperative infections. We hypothesized that preoperative skin cleansing with chlorhexidine-alcohol is more protective against infection than is povidone-iodine. METHODS: We randomly assigned adults undergoing clean-contaminated surgery in six hospitals to preoperative skin preparation with either chlorhexidine-alcohol scrub or povidone-iodine scrub and paint. The primary outcome was any surgical-site infection within 30 days after surgery. Secondary outcomes included individual types of surgical-site infections. RESULTS: A total of 849 subjects (409 in the chlorhexidine-alcohol group and 440 in the povidone-iodine group) qualified for the intention-to-treat analysis. The overall rate of surgical-site infection was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group (9.5% vs. 16.1%; P=0.004; relative risk, 0.59; 95% confidence interval, 0.41 to 0.85). Chlorhexidine-alcohol was significantly more protective than povidone-iodine against both superficial incisional infections (4.2% vs. 8.6%, P=0.008) and deep incisional infections (1% vs. 3%, P=0.05) but not against organ-space infections (4.4% vs. 4.5%). Similar results were observed in the per-protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period. Adverse events were similar in the two study groups. CONCLUSIONS: Preoperative cleansing of the patient's skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection after clean-contaminated surgery. (ClinicalTrials.gov number, NCT00290290.)

Antibiotics and antiseptics to prevent infection in cardiac rhythm management device implantation surgery.

BACKGROUND: Surgical site infections (SSIs) resulting from cardiac implantable electronic device (CIED) implantation cause significant morbidity and mortality, and are increasing at a disproportionately higher rate than the rate of CIED implantation. The prophylactic administration of antibiotics and antiseptics can reduce this infection rate. The objective of this systematic review and meta-analysis was to determine whether the prophylactic administration of antibiotics and antiseptics in patients undergoing CIED implantation reduces the incidence of SSI in randomized controlled trials. We searched the Cochrane Wounds Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), Ovid MEDLINE, Ovid EMBASE, and EBSCO CINAHL. No date or language restrictions were applied. METHODS: Two review authors independently screened papers for inclusion, assessed risk of bias, and extracted data using a data collection form. Data were pooled where appropriate. RESULTS: Fifteen studies (3,970 participants) were included in this review. For patients undergoing a CIED implant, perioperative systemic antibiotics (PSA) plus antiseptics delivered 1 hour before the procedure significantly reduced the incidence of SSI compared with no antibiotics (risk ratio [RR] 0.13; 95% confidence interval [CI] 0.05-0.36; P value < 0.00001). Furthermore, PSA plus antiseptics significantly reduced the incidence of postoperative infection compared to antibiotics delivered postoperatively (RR 0.14; 95% CI 0.03-0.60; P value 0.008). CONCLUSION: The evidence strongly suggests that antibiotic prophylaxis within 1 hour before CIED implantation is effective at reducing SSI.

Cemented all-polyethylene acetabular implants vs other forms of acetabular fixation: a systematic review and meta-analysis of randomized controlled trials.

The cost of primary total hip replacement products approaches 65% of the total reimbursement. Durability of total hip replacement resides with the acetabular component. This systematic review and meta-analysis determined if the outcomes of durability, function, and adverse events associated with cemented all-polyethylene acetabular components was similar to other acetabular designs, holding other variables constant. Randomized controlled trials only were evaluated. Two independent reviewers collected the data from 6 randomized controlled trials. Appropriate statistical analysis was performed. There was no statistical difference in regard to the outcomes at various time points (≤3, 4-8, and ≥10 years) in the 907 implants evaluated. There does, however, appear to be a trend toward abject failure with cemented all-polyethylene acetabular component implants consistent with findings of increased radiolucencies more than 10 years out. The issue of increased radiolucencies over time and failure with these types of implants bears closer scrutiny.

Hydroxyapatite (HA) coating appears to be of benefit for implant durability of tibial components in primary total knee arthroplasty.

BACKGROUND: It is unclear whether there is a clinical benefit to adding hydroxyapatite (HA) coatings to total knee implants, especially with the tibial component, where failure of the implant more often occurs. A systematic review of the literature was undertaken to identify all prospective randomized trials for determining whether the overall clinical results (as a function of durability, function, and adverse events) favored HA-coated tibial components. METHODS: A comprehensive literature search was performed for the years 1990 to September 16, 2010. We restricted our search to randomized controlled trials involving participants receiving either an HA-coated tibia or other forms of tibial fixation. The primary outcome measures evaluated were durability, function, and acute adverse events. RESULTS: Data from 926 evaluable primary total knee implants in 14 studies were analyzed. Using an RSA definition for durability, HA-coated tibial components (porous or press-fit) without screw fixation were less likely to be unstable at 2 years than porous and cemented metal-backed tibial components (RR = 0.58, 95% CI: 0.34-0.98; p = 0.04, I(2) = 39%, M-H random effects model). There was no significant difference in durability, as measured from revision and evaluated at 2 and 8-10 years, between groups. Also, functional status using different validated measures showed no significant difference at 2 and 5 years, no matter what measure was used. Lastly, there was no significant difference in adverse events. Limitations included small numbers of evaluable patients (≤ 50) in 7 of the 14 trials identified, and a lack of "hard" evidence of durability with need for replacement (i.e. frank failure, pain, or loss of functionality). INTERPRETATION: In patients > 65 years of age, an HA-coated tibial implant may provide better durability than other forms of tibial fixation. Larger trials should be undertaken comparing the long-term durability, function, and adverse events of HA-coated implants with those of other porous-coated tibial implants in younger, more active OA patients.

Granisetron Extended-Release Subcutaneous Injection versus Palonosetron Infusion for CINV Prevention: Cost Comparison of Unscheduled Hydration.

Background: Granisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Palonosetron is administered intravenously and is indicated for CINV prevention in acute and delayed phases after the use of moderately emetogenic chemotherapy (MEC) and in the acute phase after highly emetogenic chemotherapy (HEC). No data are available regarding the impact of SC granisetron on the cost of unscheduled hydration compared with other antiemetic drugs, specifically the older-generation palonosetron. Objective: To compare the costs of unscheduled hydration associated with breakthrough CINV after SC granisetron versus palonosetron administration in patients receiving MEC or HEC. Methods: This retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. A cost-of-care analysis for SC granisetron and palonosetron was based on the maximum per-unit Medicare reimbursement amounts for the use of unscheduled hydration, administration of rescue antiemetic drugs, laboratory tests, and patient office evaluations. Results: A total of 182 patient records were evaluated, 91 for patients receiving SC granisetron and 91 receiving palonosetron. The mean per-patient cost of care related to unscheduled hydration in patients receiving HEC or MEC was significantly lower with SC granisetron ($296) than palonosetron ($837; P <.0001), including subset analysis of patients requiring additional care (SC granisetron [$691], N = 39; palonosetron [$1058], N = 72; P = .0260). The mean hydration costs per patient receiving HEC or MEC were lower with SC granisetron ($62) than with palonosetron ($253; P <.0001). The hydration costs per patient receiving only HEC were lower with SC granisetron ($66) than palonosetron ($280; P <.0001). The per-patient costs were lower when SC granisetron was administered than when palonosetron was administered as part of the antiemetic regimen, except for the cost of rescue antiemetic drug in patients receiving MEC. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3). Conclusion: The use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events.