Palmetto Health Richland

About: Palmetto Health Richland is a healthcare organization based out in Columbia, South Carolina, United States. It is known for research contribution in the topics: Pharmacy & Health care. The organization has 110 authors who have published 119 publications receiving 3704 citations.

Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia.

Abstract: Sixty-five boys younger than 30 months of age were randomly assigned to prophylaxis (32 boys) or enhanced episodic therapy (33 boys). When the boys reached 6 years of age, 93% of those in the prophylaxis group and 55% of those in the episodic-therapy group were considered to have normal index-joint structure on MRI (P = 0.006). The relative risk of MRI-detected joint damage with episodic therapy as compared with prophylaxis was 6.1 (95% confidence interval, 1.5 to 24.4). The mean annual numbers of joint and total hemorrhages were higher at study exit in the episodic-therapy group than in the prophylaxis group (P<0.001 for both comparisons). High titers of inhibitors of factor VIII developed in two boys who received prophylaxis; three boys in the episodic-therapy group had a life-threatening hemorrhage. Hospitalizations and infections associated with central-catheter placement did not differ significantly between the two groups. Conclusions Prophylaxis with recombinant factor VIII can prevent joint damage and decrease the frequency of joint and other hemorrhages in young boys with severe hemophilia A. (ClinicalTrials.gov number, NCT00207597.)

Refractive Outcomes Following Bevacizumab Monotherapy Compared With Conventional Laser Treatment: A Randomized Clinical Trial

Abstract: Importance Children born prematurely who develop retinopathy of prematurity (ROP) often develop myopia, and those who require laser treatment may develop very high myopia, which has considerable clinical consequences. Objective To report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage 3+ ROP or aggressive posterior ROP (APROP). Design, Setting, and Participants All infants received intravitreal bevacizumab or laser therapy in a prospective, stratified, randomized, controlled, masked, multicenter clinical trial, Bevacizumab Eliminates the Angiogenic Threat for ROP (BEAT-ROP). Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial, with treatment randomized by infant, underwent cycloplegic retinoscopic refraction at a mean age of 2½ years. Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level 3 neonatal intensive care units in academic centers with institutional review board approval were included in the trial. Of the originally enrolled 150 infants (300 eyes) in the BEAT-ROP clinical trial, 13 infants (26 eyes) died (6 received intravitreal bevacizumab; 7 received laser) and 19 eyes had intraocular surgery (6 infants bilaterally). Thus, 45 eyes (19 infants bilaterally) were excluded, leaving 131 infants (255 eyes, including 21 eyes that received a successful second treatment for recurrence). Interventions Follow-up of the BEAT-ROP cohort. Main Outcomes and Measures Spherical equivalent refractive outcomes and their distribution by ROP zone and treatment. Results Refractions were available for 109 of 131 eligible infants (83.2%) and 211 of 255 eyes (82.7%). Mean (SD) spherical equivalent refractions were as follows: zone I, −1.51 (3.42) diopters (D) in 52 eyes that received intravitreal bevacizumab and −8.44 (7.57) D in 35 eyes that received laser treatment ( P P P P Conclusions and Relevance More very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab. This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment. Trial Registration clinicaltrials.gov Identifier:NCT00622726

Neutralizing antibodies against adeno-associated virus examined prospectively in pediatric patients with hemophilia.

Abstract: Recombinant adeno-associated virus (rAAV) is a promising gene delivery vector and has recently been used in patients with hemophilia. One limitation of AAV application is that most humans have experienced wild-type AAV serotype 2 exposure, which frequently generates neutralizing antibodies (NAbs) that may inhibit rAAV2 vector transduction. Employing alternative serotypes of rAAV vectors may circumvent this problem. We investigated the development of NAbs in early childhood by examining sera gathered prospectively from 62 children with hemophilia A, participating in a multi-institutional hemophilia clinical trial (the Joint Outcome Study). Clinical applications in hemophilia therapy have been suggested for serotypes AAV2, AAV5 and AAV8, therefore NAbs against these serotypes were serially assayed over a median follow-up of 4 years. NAbs prevalence increased during early childhood for all serotypes. NAbs against AAV2 (43.5%) were observed more frequently and at higher titers compared with both AAV5 (25.8%) and AAV8 (22.6%). NAbs against AAV5 or AAV8 were rarely observed in the absence of co-prevalent and higher titer AAV2 NAbs, suggesting that NAbs to AAV5 and AAV8 were detected following AAV2 exposure due to partial cross-reactivity of AAV2-directed NAbs. The results may guide rational design of clinical trials using alternative AAV serotypes and suggest that younger patients who are given AAV gene therapy will benefit from the lower prevalence of NAbs.

Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop.

Abstract: Envenomation by crotaline snakes (rattlesnake, cottonmouth, copperhead) is a complex, potentially lethal condition affecting thousands of people in the United States each year. Treatment of crotaline envenomation is not standardized, and significant variation in practice exists. A geographically diverse panel of experts was convened for the purpose of deriving an evidence-informed unified treatment algorithm. Research staff analyzed the extant medical literature and performed targeted analyses of existing databases to inform specific clinical decisions. A trained external facilitator used modified Delphi and structured consensus methodology to achieve consensus on the final treatment algorithm. A unified treatment algorithm was produced and endorsed by all nine expert panel members. This algorithm provides guidance about clinical and laboratory observations, indications for and dosing of antivenom, adjunctive therapies, post-stabilization care, and management of complications from envenomation and therapy. Clinical manifestations and ideal treatment of crotaline snakebite differ greatly, and can result in severe complications. Using a modified Delphi method, we provide evidence-informed treatment guidelines in an attempt to reduce variation in care and possibly improve clinical outcomes.

Is after-hours orthopaedic surgery associated with adverse outcomes? A prospective comparative study.

Abstract: Background: Treatment of fractures is sometimes performed after normal daytime operating hours and in such instances may be performed under less than ideal conditions. The consequence of performing operations under such conditions is largely unknown and was therefore studied in the context of intramedullary nail fixation of tibial and femoral shaft fractures. Methods: Two hundred and three consecutive patients with either a femoral or tibial shaft fracture (Orthopaedic Trauma Association classification 32 or 42) treated with intramedullary nail fixation were included in a prospective, multicenter, nonrandomized study. Patients were divided into an after-hours group defined as an operation beginning from 4:00 P.M. to 6:00 A.M. or a daytime group defined as an operation beginning from 6:00 A.M. to 4:00 P.M. These groups were further divided on the basis of the injured bone into the following subgroups: after-hours femoral fracture (fifty-five patients), daytime femoral fracture (forty-four patients), after-hours tibial fracture (forty-eight patients), and daytime tibial fracture (fifty-six patients). The demographic and fracture characteristics were similar among the subgroups. All patients were treated with the same type of femoral antegrade, femoral retrograde, or tibial nail fixation with reaming. Data for fracture-healing, complications, operative time, and fluoroscopy time were collected prospectively. Results: The healing rates were similar between daytime and after-hours surgery groups for both the tibial and femoral nailing. On the basis of univariate analysis, operative times were shorter in the after-hours group compared with the daytime group for both the tibial and femoral nail fixation groups (p 0.05). The after-hours group had more unplanned reoperations than the daytime group (p < 0.02). Removal of painful hardware was more frequent in the after-hours femoral fracture group (27%) than in the daytime femoral fracture group (3%) (p < 0.02), and after-hours surgery was an independent variable associated with the need for removal of painful femoral fracture hardware (p < 0.05). Conclusions: Rates of nonunion, infectious complications, and radiation exposure are similar for after-hours and daytime surgery for intramedullary nail fixation of both femoral and tibial fractures. After-hours femoral nail fixation was associated with an increased frequency for removal of painful hardware, which may be related to technical errors associated with nonideal conditions and shorter operative times. An increase in the allocated amount of daytime operative time for orthopaedic trauma surgery has the potential to reduce minor complication rates for intramedullary nail fixation. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.