Benefits Of Prophylactic Use Research Articles

A Study on Sensitivity of Angiogenic Factors as Predictors of Preeclampsia and Role of Aspirin in Preventing Preterm Preeclampsia

Background Preeclampsia is one of the hypertensive disorders of pregnancy causing maternal and perinatal mortality and morbidity. The global burden of Pre-eclampsia and eclampsia is 5-10. The prevalence of preeclampsia-complicating pregnancy in India is 7.8. Early prediction of preeclampsia and prophylactic use of aspirin reduces morbidity and mortality.Objectives To study the role of angiogenic factors and biophysical markers to identify women at high risk for developing preterm preeclampsia. To study the diagnostic value of angiogenic factors as predictors of preterm preeclampsia in early pregnancy. To compare the benefits of prophylactic use of 150mg of Aspirin versus 75mg of Aspirin from 11-16 weeks of gestation in reducing the incidences of preterm preeclampsia.Methods It was a two year study conducted at Rajarajeswari Medical College and Hospital. Data for the study was collected from women attending antenatal clinics at 11 weeks 0days to 13weeks 6days after taking informed consent. Screening for preeclampsia was done using biophysical and biochemical tests. Screen-positive women were grouped randomly into Group A and Group B. They were given 7mg and 150mg aspirin and maternal and fetal outcome was analysed.Results In our study 489.6 women were screened positive for preeclampsia. There were no significant differences between the 75mg aspirin group and the 150mg aspirin group with regard to demographic characteristics. Pre-eclampsia occurred in 27.2 of participants in the 75mg aspirin group compared with 4.1 in the 150 mg aspirin group. There was a significant difference in the incidence of PE p0.0293 its severity and the period of gestation at delivery in the two groups. The positive predictive value of the screening method in our study is 12.7 and the negative predictive value is 91.6.Conclusion Our study showed that screening test was beneficial in identifying high-risk cases but the study population was very less. Early screening and use of prophylactic aspirin reduce the development preterm preeclampsia. Aspirin is a safe economical and easily available drug.

Incidence and Risk Factors for Surgical Site Infections Following Oromaxillofacial Oncologic Surgery in Dogs.

Antibiotic stewardship in veterinary medicine is essential to help prevent resistant bacterial infections. Critical evaluation into the benefits of prophylactic use of antibiotics during veterinary surgical procedures is under reported and additional investigation is warranted. The objectives of this paper were to determine the incidence of surgical site infection in dogs that underwent oromaxillofacial oncologic surgery and to identify risk factors for the development of surgical site infection. In this retrospective cohort study including 226 dogs surgically treated for oromaxillofacial tumors between January 1, 1997 and December 31, 2018, the incidence of surgical site infection was determined to be 7.5%. Univariable logistical regression models were used to evaluate potential risk factors for development of surgical site infections including signalment, tumor type, antibiotic protocol, time under anesthesia, location of surgical procedure (dental suite vs. sterile operating room), specific comorbidities, and surgical margins obtained. Anesthetic events lasting greater than 6 h were significantly associated with development of infection. Signalment, comorbidities, administration of anti-inflammatory and immunosuppressive medications, tumor type, histological margin evaluation, surgical procedure location, and antibiotic protocols were not significant contributors to development of infection. Use of antibiotic therapy in this cohort was not protective against development of infection and may not be routinely indicated for all oromaxillofacial oncologic surgeries despite common promotion of its use and the contaminated nature of the oral cavity. Anesthetic time significantly contributed towards the development of infection and use of perioperative antibiotics for surgical procedures lasting >6 h may be routinely warranted.

Phenotypic and Transcriptomic Lymphocytes Changes in Allograft Recipients After Intravenous Immunoglobulin Therapy in Kidney Transplant Recipients.

High dose intravenous immunoglobulin (IVIG) are widely used after kidney transplantation and its biological effect on T and B cell phenotype in the context of maintenance immunosuppression was not documented yet. We designed a monocentric prospective cohort study of kidney allograft recipients with anti-HLA donor specific antibodies (DSA) without acute rejection on screening biopsies treated with prophylactic high-dose IVIG (2 g/kg) monthly for 2 months. Any previous treatment with Rituximab was an exclusion criterion. We performed an extensive analysis of phenotypic and transcriptomic T and B lymphocytes changes and serum cytokines after treatment (day 60). Twelve kidney transplant recipients who completed at least two courses of high-dose IVIG (2 g/kg) were included in a median time of 45 (12–132) months after transplant. Anti-HLA DSA characteristics were similar before and after treatment. At D60, PBMC population distribution was similar to the day before the first infusion. CD8+ CD45RA+ T cells and naïve B-cells (Bm2+) decreased (P = 0.03 and P = 0.012, respectively) whereas Bm1 (mature B-cells) increased (P = 0.004). RORγt serum mRNA transcription factor and CD3 serum mRNA increased 60 days after IVIG (P = 0.02 for both). Among the 25 cytokines tested, only IL-18 serum concentration significantly decreased at D60 (P = 0.03). In conclusion, high dose IVIG induced limited B cell and T cell phenotype modifications that could lead to anti-HLA DSA decrease. However, no clinical effect has been isolated and the real benefit of prophylactic use of IVIG after kidney transplantation merits to be questioned.

Efficacy of nepafenac ophthalmic suspension 0.1% in improving clinical outcomes following cataract surgery in patients with diabetes: an analysis of two randomized studies.

ObjectiveTo assess the efficacy of nepafenac 0.1% ophthalmic suspension in improving the clinical outcomes following cataract surgery (CS) in patients with nonproliferative diabetic retinopathy.MethodsIn two similar multicenter, randomized studies, patients received either nepafenac 0.1% or vehicle, instilled three times daily starting a day prior to surgery and continuing for 90 days postoperatively. A post hoc analysis of these two studies was conducted to assess 1) the likelihood for development of postoperative macular edema (ME), based on the percentage of patients who developed ME (≥30% increase from preoperative baseline in central subfield macular thickness) within 90 days following CS and 2) best-corrected visual acuity (BCVA) endpoints, including the percentage of patients with a BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90. Results for individual studies and their pooled estimates (only visual acuity endpoints) are reported. Primary inference was based on odds ratio (OR).ResultsThis post hoc analysis included 411 patients (nepafenac 0.1%: 205; vehicle: 206). The incidence of postoperative ME within 90 days of CS was notably lower in the nepafenac-treated patients than in vehicle-treated patients (study 1: 3.2% vs 16.7%; OR =0.2, 95% confidence interval [CI] =0.1, 0.5, P=0.001; study 2: 5.0% vs 17.5%; OR =0.2, 95% CI =0.1, 0.8, P=0.018). A higher percentage of nepafenac-treated patients than vehicle-treated patients gained ≥15 letters from preoperative baseline to Day 14, which was maintained through Day 90 (study 1: 38.4% vs 21.4%; OR =2.4, 95% CI =1.4, 4.2, P=0.003; study 2: 35.0% vs 25.0%; OR =1.6, 95% CI =0.8, 3.2, P=0.172; pooled: 37.1% vs 22.8%; OR =2.0, 95% CI =1.3, 3.1, P=0.001). The odds of >5-letter and >10-letter loss in BCVA from postoperative Day 7 were higher in vehicle-treated than in nepafenac-treated patients.ConclusionThese results support the clinical benefit of prophylactic use of nepafenac 0.1% for reducing the risk of postoperative ME and for improvement in BCVA outcomes following CS in patients with nonproliferative diabetic retinopathy.

The influence of probiotics for preterm neonates on the incidence of atopic dermatitis-results from a historically controlled cohort study.

Probiotic supplementation is a promising preventive strategy for atopic dermatitis (AD). To help clarifying the significance of timing with respect to prevention of AD, we here evaluate the benefit of prophylactic use of probiotic supplementation in neonates younger than 30 weeks of gestation. Preterm children from the Department of Neonatology, Rigshospitalet, Denmark from two different admission periods were included in a historically controlled cohort study. Neonates from January 2007 to February 2010, not treated with and neonates from March 2010 to February 2013 treated with probiotic were enrolled. Main outcome was prevalence of AD, and secondary outcomes were use of topical corticosteroids, and number of skin-related visits to GPs and dermatologists. 527 preterm neonates were included in the study, 249 treated and 278 not treated with probiotics. Response rate for the two cohorts was 76.7 and 77.7% respectively. The prevalence of AD was similar in the two groups (20.9% in the probiotic treated group versus 17.1% in the not treated group, p = 0.33). No significant differences were found between the groups with respect to treatment with topical corticosteroids, or visits at GPs or dermatologist. We found no indication that probiotics may prevent AD when administered to neonates <30 gestation weeks from birth until discharge home. Factors influencing the early maturation of the immune system have been assumed to be of particular importance in atopic dermatitis, and hence, our unique cohorts contribute information on how probiotic supplementation may affect the extremely immature immune systems of preterm infants.

INFLUENCE VIOLATIONS FORMATION OF INTESTINAL FLORA, INTESTINAL BARRIER FUNCTION IN NEWBORNS OF INFECTIOUS AND INFLAMMATORY DISEASES AND THE IMPORTANCE OF PROBIOTICS IN THEIR PREVENTION

The article presents of modern data on the role of probiotics in the development of mature digestive tract, the effect of probiotics in prevention of inflammatory and infectious diseases of the digestive tract in newborns, especially premature, frequency of necrotizing enterocolitis in premature infants, late neonatal sepsis.The discussed main factors of worsen or slow down the process of formation of physiological microbiocenosis in newborns. These sow modern evidence-based recommendations for the study of the practical aspects of the use of probiotic microorganisms in neonatal practice. The modern scheme of probiotic microorganisms in neonatal wards submitted. These evidence-based benefits of prophylactic use of L. Reuteri DSM 17938, L. Reuteri ATCC 55730 in reducing the frequency of food intolerance, death, development of necrotizing enterocolitis, late neonatal sepsis. The potential prospects highlights for studying the role of Bacillus clausii in the maturation of the immune system and promoting the formation of a physiological intestinal microbiota in infants.

One Against All: A Broadly Influenza Neutralizing Man-made Monoclonal Antibody Passes Phase I

One Against All: A Broadly Influenza Neutralizing Man-made Monoclonal Antibody Passes Phase I

397P Benefits of prophylactic use of personalized insoles for patients treated with regorafenib

397P Benefits of prophylactic use of personalized insoles for patients treated with regorafenib

Prophylactic antibiotics versus post- operative antibiotics in herniorraphy

Postoperative surgical site infections are a major source of illness. Infection results in longer hospital stay and higher costs. Uses of preoperative antibiotics have been standardized and are being used routinely in most clinical surgeries and include controversial areas like breast surgery and herniorraphy. Objective of the study is to find out the benefit of prophylactic use of antibiotics in the management of herniorraphy.This project was carried out in a multispeciality tertiary care teaching hospital from 1 st -30 th April in 2002. Group 1 patients were treated prophylactically half an hour before surgery with single dose of I.V. antibiotics (injection. Ampicillin 1gm + injection. Gentamicin 80mg). Group 2 patients were treated post surgery with capsule. Ampicillin 500mg 4 times a day for 7 days and injection. Gentamicin twice a day for first 4 days. In case of group 1 patients only one out of 20 patients (5%) was infected. Whereas in-group 2 patients 5 out of 20 patients (25%) were infected. The cost of prophylactic antibiotic treatment was Rs. 25.56 per patient. The postoperative antibiotic treatment cost was Rs. 220.4 per patient. That means postoperative treatment is around 8.62 times costlier than prophylactic treatment. From this study it is evident that prophylactic (preoperative) treatment is better than postoperative treatment with antibiotics.

Use of Probiotics as Prophylaxis for Postoperative Infections of Under- 5 Children Following Gastrointestinal Surgery

Background: Bacterial infection is a frequent complication following operations in the gastrointestinal tract. Despite prophylactic administration of antibiotics the incidence of postoperative infections ranges from 10%–30% in resection surgery.1 Most infections are caused by bacteria of enteric origin.2 In spite of restricted use of prophylactic antibiotics, the emergence of antibiotic resistance has increased significantly.3 Probiotics when consumed in adequate amounts, confer a health benefit on the host. In vitro, studies suggest that probiotics potentially act favorably on the host through several different mechanisms. They have an antimicrobial effect. Furthermore, administration of probiotics suppresses growth of potentially pathogenic microorganisms, e.g., E. coli and Enterobacteriaceae. The effects of these agents may go beyond the gastrointestinal tract to distant areas, such as the urogenital and respiratory mucosa. It has been hypothesized by several authors that these characteristics can be used in a clinical setting of preoperative prophylaxis for reduction of postoperative infections. Preoperative antibiotic prophylaxis constitutes more than 10% of antibiotic usage in surgery and a reduction could lead to a reduced pressure on development of antibiotic resistance. It may therefore be of interest to study if probiotics may be used in the preoperative preparation of patients undergoing gastrointestinal operations.Objective: The overall objective of this study is to evaluate the effectiveness of probiotics as prophylaxis for post operative infections in under-5 children undergoing gastrointestinal surgery. Materials and methods: We are conducting a prospective comparative study with the intention to observe the postoperative periods of 60 purposively selected patients of gastrointestinal surgery in the Department of Pediatric surgery, Dhaka Medical College Hospital (DMCH), Dhaka, over a period of 18 months from October, 2013 to March, 2015. The patients are going to be divided into 2 groups by random sampling- Group A (Control group- without probiotics) and Group B (Study group- with probiotics). Under-5 children are planned to be selected as study subjects. All children are subjected to investigate for white blood cell (WBC) count and Creactive protein (CRP) preoperatively and on 5th postoperative day (POD) in addition to routine investigations. Structured questionnaire is used to collect information regarding fever, surgical site infection, WBC and CRP count before operation and 5 days after operation (i.e. on 5th POD). Informed written consent from parents or legal guardian is taken after describing the study objectives. Ethical clearance has been sought from the Ethical Committee of Dhaka Medical CollegeResults: Total 8 patients are studied till now, 4 in each group. From this limited data we have observed that there has been apparently minimum difference between the cases and controls regarding postoperative infections.Discussion: Post operative wound infections are quite common and an important reason for administering antibiotics for prolonged periods.13 Probiotics given preoperatively tends to reduce the incidence of post operative infection, though the accurate mechanism is not known. The use in patients undergoing colorectal surgery does not seem to show any benefit.18 The result of our study until now has not demonstrated any added benefit of prophylactic use of probiotis in the specified age group. So up to now the available data is compatible with the various data seen in other studies.18 In our study, it is very early to comment on the results.Conclusion: This is an on-going study. Definite conclusion could not be drawn at this preliminary stageJ. Paediatr. Surg. Bangladesh 4(2): 38-43, 2013 (July)

Prophylactic Aspirin has Favorable Benefit–Harm Profile

* In the general population, the benefits of prophylactic use of aspirin outweigh the risks. * Excess bleeding is the most important harm resulting from aspirin use.

SS-2 - Benefits of Prophylactic Use of Personalized Insoles for Patients Treated with Regorafenib

Background: Regorafenib is an oral multi-kinase inhibitor that was approved for treatment of colorectal cancer in Japan in 2013. It has characteristic side effects of skin damage, especially of hands and feet, which can lead to suspension of treatment. We had one patient who suffered from severe foot damage and we managed to relieve her symptoms using personalized insoles. These insoles allowed us to continue her Regorafenib treatment for over six months without foot damage. Based on this case, we started a study to evaluate the benefits of prophylactic use of personalized insoles.Aim: To evaluate the benefits of prophylactic use of personalized insoles for patients treated with Regorafenib.Method: We prepared personalized insoles before the start of the treatment. The quality of fit of the insoles was evaluated and adjusted by baropodometry; a system for measurement of plantar pressure. The insoles were to be worn all the time, outside as well as at home. Foot damage in all patients who could complete more than 1 course of Regorafenib treatment was evaluated using the CTCAE v4.0 scale.Results: Since Nov. 2013, 10 patients with metastatic colorectal cancer participated in this study. 2 patients stopped Regorafenib during the 1st course due to intolerable toxicities other than foot damage. Foot damage was evaluated in the 8 remainingPatients: all could walk normally during the whole treatment and none had foot damage CTCAE grade 2 or higher.Conclusion: Personalized insoles could prevent foot damage by Regorafenib and could increase its compliance and so also the efficacy of treatment.

Evaluation of a Therapeutic Vaccine for the Prevention of Recurrent Urinary Tract Infections Versus Prophylactic Treatment With Antibiotics

Urinary tract infections (UTIs) are common bacterial infections. Women are 8 to 30 times more likely to have this infection than men. The majority of women report at least 1 UTI in their lifetime. Within a year, about 25% or more of these patients will have a recurrence, and 22% will have recurrent UTIs (RUTIs). Continuous prophylaxis with antibiotics is commonly recommended as initial treatment for RUTIs. However, there is high risk for the development of multiresistance with their continuous use; in some regions of the world, more than 40% of the bacterial strains are already resistant to available antibiotics. Moreover, there is a high incidence of adverse reactions. To address these problems, preventive strategies such as vaccine use have been investigated that reinforce the natural mechanisms of pathogen defense. One such vaccine, Uromune, is an inactivated bacterial cell suspension composed of selected strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis. The aim of this multicenter retrospective observational study was to compare the clinical benefit of prophylactic use of Uromune with that of the currently accepted prophylactic treatment, sulfamethoxazole/trimethoprim (SMX/TMP) to prevent RUTIs. The authors reviewed the clinical history of 319 women who presented with RUTIs (defined as at least 2 episodes of UTI in the last 6 months or 3 in the last 12 months). Data collected before the initiation of the corresponding treatment and after 3, 9, and 15 months included number of UTIs and time of evolution of RUTIs before initiation of treatment. Patients in group A (n = 159) received prophylactic treatment with Uromune for a period of 3 months, and patients in group B (n = 160) received oral doses of SMX/TMP (200/40 mg/d) as prophylactic treatment for a period of 6 months. The data showed that patients in group A experienced a highly significant reduction in the mean number of infections in the first 3 months compared with patients in group B: 0.36 versus 1.60, P < 0.0001, respectively. There was also a significant reduction after 9 and 15 months (P < 0.0001). Significantly more patients in group A than in group B did not suffer any UTI at 3, 9, and 15 months: 101, 77, and 55 patients in group A versus 9, 4, and 0 patients in group B (P < 0.000). These data show that the use of this bacterial-based therapeutic vaccine could be an effective strategy to reduce frequency, duration, severity, and costs of RUTIs.

Foreword

von Willebrand disease (VWD) is probably the most common congenital bleeding disorder while haemophilia, although relatively rare, remains the best characterized. Advances in the prevention and treatment of bleeding episodes in both conditions have translated into improved quality of life and survival across all age groups. However, improved survival does not come without its own side effect. As patients advance in age, several previously unrecognized morbidities continue to manifest. In this supplement, we highlight the most relevant complications in the ageing population and overview current approaches to their management, while realizing areas of unmet needs. The other focus of the supplement is to shed light upon persisting challenges in the prophylactic treatment of bleeding episodes in patients with haemophilia and VWD, within all age groups. Since the middle of the last century, clotting factor replacement for persons with haemophilia has evolved from plasma cryoprecipitate to plasma protein-free recombinant factor. Reactionary focus on pathogen transmission was addressed in the late 1980s with viral reduction measures for plasma-derived clotting factor (pd-CF) and the development of recombinant clotting factor (rCF) concentrates. What has resurfaced is the unsolved dilemma of inhibitor development in a substantial number of individuals with haemophilia A, and possibly a differential inhibitor induction rate among recipients of pd-CF containing von Willebrand factor (VWF) and rCF. In addition, renewed attention on the profile of the inhibitor patient has incriminated genetic predispositions, timing and intensity of exposure to CFs and temporally associated immunological danger signals. Cogent studies to address these questions, in the United States and internationally, include SIPPET, the CDC Inhibitor Study and the Haemophilia Inhibitor Genetics Study (HIGS). In addition, the means by which these inhibitors can be eradicated using ITI procedures are under investigation. Prophylactic treatment has been recommended for children with severe haemophilia in view of its efficacy in reducing the number of bleeds and therefore preventing the development of haemophilic arthropathy. Nonetheless, the ideal age for starting prophylaxis and the optimal dosing schedule, remain unclear. Moreover, the fact that primary prophylactic treatment with clotting factor has dramatically preserved the joints of younger persons with haemophilia brings into question whether the whole of this benefit continues throughout the adult life of haemophilia patients. It is not known whether intensive episodic or prolonged regular prophylaxis contributes to ageing-related disorders, such as ischaemic heart disease or renal disease, or prevents osteoporosis, in persons with haemophilia; a new focus for the community of haemophilia clinicians and scientists to address. Various investigator-initiated studies are underway in the US, keeping in mind that prospective collaborations are necessary to study this important subset of individuals with haemophilia. Plasma-derived concentrates containing both VWF and coagulation factor VIII (FVIII) have been available since the early 1980s for the treatment of severe VWD with proven haemostatic efficacy and safety. Several clinical studies are also ongoing to evaluate the efficacy and safety of novel recombinant products or single VWF replacement without FVIII, and the benefits of prophylactic use in this patient population. Nonetheless, establishing specific management guidelines, while utilizing the longstanding experience from patients with haemophilia, is warranted. A special focus on women affected with VWD is also called for, as they can experience significant gynaecological and obstetrical bleeding episodes that not only affect their physical health but also their psychosocial well-being. The author received an honorarium from Grifols S.A. for participating in the symposium and production of the article. The author thanks Content Ed Net for providing valuable editorial assistance in the preparation of the article; funding for this assistance was provided by Grifols S.A.

Can Early Echocardiographic Findings Predict Patent Ductus Arteriosus?

Background: Prophylactic treatment with prostaglandin synthetase inhibitors (PSI) is potentially harmful. Moreover, long-term benefits of prophylactic use of indomethacin or ibuprofen are not proven. Early treatment of a high-risk population is alternative to the routine prophylactic use of PSI, but it remains unclear which newborn is at greatest risk for patent ductus arteriosus (PDA). Objective: Evaluation of the prognostic value of early echocardiographic studies with respect to PDA in later life. Methods: Sixty preterm infants with a mean birth weight of 1,087 g and mean gestational age of 28.5 weeks were included in a prospective study. Cardiac scans were performed in all newborns on entry into the study (within 12–48 h after birth) and further in case of clinical suspicion of PDA or obligatorily on the 7th and 28th days of life. There was no prophylactic or treatment use of any PSI during the study period. Newborns were divided into 2 cohorts: with significant left to right shunt requiring surgical ligation of PDA (n = 16) or without significant PDA during follow-up (control group, n = 44). Results: On entry, the mean internal diameter of the ductus arteriosus (2.6 vs. 0.91 mm/kg; p < 0.01), mean cardiac index across aortic valve (2.96 vs. 2.37 l/min/m²; p < 0.01) and early filling peak velocity (43.1 vs. 33.7; p = 0.01) were significantly higher in babies who later needed surgical ligation of PDA. There was no difference in the mean values of the other echocardiographic parameters studied. An early ductal diameter of >1.5 mm/kg predicted symptomatic PDA with a sensitivity of 94% and a specificity of 73%, and its positive predictive value equaled 57% and negative predictive value amounted to 97%. Conclusions: Early echocardiographic studies possess negative predictive value and may decrease unnecessary surgical ligation of PDA in very low birth weight infants.

Estimates of the likely prophylactic effect of tamoxifen in women with high risk BRCA1 and BRCA2 mutations.

The development of breast cancer control strategies in women at high genetic risk of breast cancer is an important issue. The likely benefit of chemopreventive approaches is of particular interest. Tamoxifen tends to be more effective in both prevention and treatment of oestrogen receptor positive tumours than oestrogen receptor negative. In this study, we combine the oestrogen-receptor specific effects of tamoxifen from randomized preventive or therapeutic trials with the oestrogen receptor status of tumours in BRCA1 and BRCA2 mutation positive women from published tumour surveys to obtain estimates of the likely effect of tamoxifen administration in mutation carriers. We used a simple two-stage procedure to estimate the benefit as a weighted average of the effect on oestrogen receptor positive tumours and oestrogen receptor negative, and using a more complex hierarchical modelling approach. Using the simple procedure and deriving the estimates of benefit from both primary prevention and therapeutic trials, we obtain an estimated reduction in risk of breast cancer from administration of tamoxifen in BRCA1 mutation positive women of 13% (RR=0.87, 95% CI 0.68–1.11). The corresponding estimated reduction in BRCA2 mutation positive women was 27% (RR=0.73, 95% CI 0.59–0.90). Using the more complex models gave essentially the same results. Using only the primary prevention trials gave smaller estimates of benefit in BRCA1 carriers but larger estimates in BRCA2, in both cases with wider confidence intervals. The benefit of prophylactic use of tamoxifen in BRCA1 mutation carriers is likely to be modest, and the effect in BRCA2 mutation carriers somewhat greater.British Journal of Cancer (2002) 86, 218–221. DOI: 10.1038/sj/bjc/6600064 www.bjcancer.com© 2002 The Cancer Research Campaign

Prophylactic Use of Factor VIII: an Economic Evaluation

Since the introduction of exogenous factor VIII therapy, several studies have explored the clinical benefits of prophylactic use of factor VIII. Little research, though, has focused on the economic aspects of this regimen. We conducted a cost analysis using data from the Orthopedic Outcomes Study, a prospective, cross-national study of the clinical outcomes associated with different patterns of factor VIII utilization to examine the health care costs incurred and expenditures averted in patients receiving on-demand versus prophylactic use of factor VIII in hemophilia. 831 patients with severe hemophilia aged 1 to 31 years, from 19 centers around the world were included in the cost analysis. Patients were categorized into three groups according to the number of weeks during the study years in which they received prophylactic regimens of factor VIII. For each subject, we estimated the costs of hospitalization, surgery, days lost from school or work, and factor VIII utilization. Costs were then stratified by age and by joint score to assess confounding, and a multivariate model developed to determine the relationship between use of factor VIII prophylaxis and total costs, while controlling for potential confounders. Patients who received factor VIII episodically incurred substantially greater disability-related costs (days lost from school or work, days hospitalized due to hemophilia, surgery) than patients who received factor VIII prophylactically for some or all of the study period. For all treatment regimens, most disability-related costs were accounted for by hospitalization for hemophilia-related conditions. The cost of factor VIII itself was substantial in all treatment categories but was highest among patients who received year-round prophylaxis, exceeding the savings resulting from reduced disability and other health care expenditures. Reductions in non-factor health care costs and disability associated with prophylactic use of factor VIII in hemophilia were substantial and helped somewhat to offset the much higher costs of this regimen. For certain subgroups, frequent episodic treatment may be more expensive than full-time prophylaxis. However, because of the very high cost of year-round prophylactic use of factor VIII, total health care expenditures were highest among patients receiving this therapeutic regimen. However, because prophylaxis clearly offers important clinical benefits, this approach may be warranted on medical rather than economic grounds.

OSHA's Final Bloodborne Pathogens Standard

The Bloodborne Pathogens Standard has specific requirements for employee hazard communication and training as well as management of regulated waste, contaminated laundry, and housekeeping procedures. OSHA recognizes the benefits of prophylactic use of hepatitis B vaccine and requires that it be made available, at no charge, to all employees who have occupational exposure to blood or other potentially infectious materials. The goal of the Bloodborne Pathogens Standard is to reduce the occupational risk of morbidity and mortality associated with diseases such as hepatitis B and human immunodeficiency virus (HIV).