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PubMed2001

Monitoring universal leucodepletion performance: the current issues within components production and testing.

The UK NBS completed the introduction of universal leucodepletion in November 1999. This involved the implementation of new methods of production, testing and monitoring, the development of which is still ongoing. Whilst important lessons have been learnt, much remains to be achieved in respect of quality improvement through standardisation of procedures, processes and product modifications to improve safety/efficacy of therapeutic blood components. Since the introduction of universal leucodepletion, many changes in component production and testing have occurred. The primary goal of this report is to review the level of standardisation and harmonisation currently achieved for low leucocyte counting within the NBS and discuss remedial actions undertaken to improve the standard of blood component production and quality monitoring and to highlight some of the related issues which are currently being worked on. The following issues are discussed.

Blood Component Removal↗
PubMed1996

Overview of substance abuse acupuncture treatment research.

The research on the efficacy of acupuncture substance abuse treatment is generally still in an early stage. The methodological weaknesses found in the acupuncture research can be found in most substance abuse research. Sufficient early trial, empirical findings suggest that there are positive treatment effects. Certainly, use of the treatment is popular and widespread. Overall, the research has progressed beyond early clinical trials, and the method has been documented to be safe and potentially useful.

Acupuncture Therapy↗
PubMed2003

The Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ): an instrument to assess outcomes of schizophrenia care.

Advances in treatment technologies and development of evidence-based standards of care demand better methods for routine assessment of outcomes for schizophrenia in systems of care. This article describes the development and psychometrics of a new instrument to assess outcomes of routine care for persons with schizophrenia in service systems. Candidate items for the Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) were drawn from existing measures. Domains covered include disease outcomes (symptoms, subjective medication effects, substance abuse), functional status, health status, quality of life, and public safety. A sample of 1,584 patients with schizophrenia or schizoaffective disorder who were recruited into a large prospective, naturalistic study on the course of treatment for schizophrenia completed the SCAP-HQ at baseline and 1 year later (n = 434), providing data for factor analysis, assessment of internal consistency, convergent validity, and responsiveness to change. A subsample of 121 patients completed a test-retest protocol. Fifteen scales were derived by factor analysis from 55 outcome items on the SCAP-HQ. These factors covered psychiatric symptoms, life satisfaction, instrumental activities of daily living, health-related disability, subjective medication side effects, vitality, legal problems, social relations, mental health-related disability, suicidality, drug and alcohol use, daily activities, victimization, violence, and employment. For most scales, standard psychometric parameters, including internal consistency and test-retest reliability, convergent validity, and responsiveness to change, were acceptable for application to large sample evaluations of care systems. This new measure represents an advance in the development of outcome measures for schizophrenia for use in large-scale studies of routine care.

Activities of Daily Living↗
PubMed1994

Community health nursing in the 1990s--risky business?

The atmosphere in which community health nurses (CHNs) work in city, suburban, and rural neighborhoods has become increasingly dangerous. Using Neuman's Systems Theory, four graduate students surveyed CHNs from three certified home health agencies to ascertain the real and perceived safety risks which these workers face daily. The response from all three agencies was similar as the nurses identified several situations in which they felt that their safety was compromised. As a result of the information gathered, a Community Risk-Reduction Plan was formulated.

Community Health Nursing↗
PubMed2002

Entry-into-humans study with tezosentan, an intravenous dual endothelin receptor antagonist.

The purpose of this study was to investigate the tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of tezosentan, an IV dual endothelin receptor antagonist, during first administration in humans. Tezosentan infused at doses of 5, 20, 50, 100, 200, 400, and 600 mg for 1 h was administered to sequential groups of six male subjects in a randomized, placebo-controlled, double-blind design. Recording of vital signs, electrocardiogram, adverse events, and clinical laboratory parameters monitored tolerability and safety. Blood samples were collected frequently for pharmacokinetic determinations and measurement of plasma endothelin-1 concentrations. Tezosentan was well tolerated at all dose levels. Headache was the most frequently reported adverse event and occurred at a higher incidence than with placebo at doses of > or = 100 mg. No clinically relevant changes in vital signs, electrocardiographic, or clinical laboratory parameters occurred. Plasma concentrations of tezosentan rapidly approached steady state and could be described by a two-compartment model. The volume of distribution at steady state (approximately 16 l) and the clearance (approximately 30 l/h) were considered independent of dose, in view of the wide dose range explored. A pronounced and rapid disposition phase (half-life 6 min), accounting for the major part of the elimination, was followed by a slower phase (half-life 3 h), probably caused by distribution from tissues. Endothelin-1 concentrations increased in a dose- and concentration-dependent fashion and returned slowly to baseline after termination of the infusion. Tezosentan warrants further clinical development in view of its tolerability and pharmacokinetic profile, which appears advantageous for application in emergency situations.

Adult↗
PubMed2004

The use of a locked plate in the treatment of ununited femoral shaft fractures.

BACKGROUND: Sixteen patients with ununited fractures of the femur were treated by locked plate. There were 14 men and 2 women. The youngest patient was 18 years old and the oldest was 48 years (average, 32.9 years). Two fractures were infected and 14 were noninfected. METHODS: Time between injury and operation varied from 4 to 26 months (average, 8.2 months). A standard broad dynamic compression plate and AO washers and nuts were used to construct a locked plate. Follow-up ranged from 6 to 24 months. RESULTS: All fractures have healed after this operation; bone graft was not used in any of them. Time until healing ranged from 4 to 6 months (average, 4.9 months). Shortening after surgery ranged from 0 to 5 cm (average, 1.8 cm). There was no metal failure or recurrence of infection. Two patients were readmitted 1 year after operation for metal removal, knee arthrolysis, and quadricepsplasty to improve the range of motion of the knee. CONCLUSION: Locked plate fixation is rigid enough for bone healing and to allow early postoperative mobilization, with good functional outcome.

Accidental Falls↗
PubMed2003

Efficacy and safety of itraconazole prophylaxis for fungal infections after orthotopic liver transplantation: a prospective, randomized, double-blind study.

BACKGROUND: There is significant morbidity and mortality related to fungal infections in the solid-organ transplant population. METHODS: A prospective, randomized, double-blind, placebo-controlled, restricted sequential design trial was performed in 71 adults undergoing orthotopic liver transplantation. Patients were randomly assigned to receive either itraconazole (5.0 mg/kg orally, preoperatively, 2.5 mg/kg orally, two times a day, postoperatively) or placebo. Therapy continued for a maximum of 56 days or until patient was discharged from hospital or met a predefined endpoint. Measurements included incidence of fungal colonization, superficial or systemic fungal infections requiring systemic therapy, adverse events, and mortality rate. RESULTS: This trial design supported the superiority of itraconazole in preventing fungal infections; nine patients in the placebo group (24%; 95% confidence interval, 0.118-0.412) and one patient in the itraconazole group (4%; 95% confidence interval, 0.001-0.204) developed fungal endpoints requiring therapy with amphotericin B (P=0.04, Fisher's exact test). At the time of enrollment, fungal colonization occurred in 40% and 37% of itraconazole and placebo patients (P=0.43), respectively. Adverse events were reported by 97% and 100% of the intraconazole and placebo groups, respectively, and one itraconazole and six placebo-group patients died within the study period. There was no relation to trial medication for serious adverse events. CONCLUSION: Prophylaxis with itraconazole reduces fungal infections in patients undergoing orthotopic liver transplantation and is well tolerated.

Administration, Oral↗
PubMed2007

12-month safety and efficacy of everolimus with reduced exposure cyclosporine in de novo renal transplant recipients.

The proliferation signal inhibitor everolimus (Certican), has demonstrated efficacy with full-dose cyclosporine (CsA) (Neoral). Two multicenter randomized controlled studies were performed to compare 12-month efficacy and safety of everolimus 1.5 and 3.0 mg/day with reduced-dose CsA. Study 1 enrolled 237 de novo renal allograft recipients, randomizing 222 nonblack patients to either everolimus 1.5 or 3.0 mg/day, with the Neoral) dose guided by C(2) (monitoring of CsA concentration 2 h after dosing). Study 2 had a similar protocol, with basiliximab included, enrolling 256 recipients and randomizing 243 nonblack patients. In Study 1, there was a lower incidence of acute rejection in nonblack patients on 3 mg/day (16.4%) compared with 1.5 mg/day (25.9%), P = 0.08. In Study 2, the inclusion of basiliximab lowered the overall incidence of acute rejection; 14.3% of nonblack patients (3 mg/day) and 13.6% of nonblack patients (1.5 mg/day) had acute rejection by 12 months (P =0.891). Renal function was preserved throughout the study, with no differences observed between groups within studies. Everolimus was well tolerated with no significant differences between doses. Everolimus, in combination with reduced-dose Neoral), demonstrated efficacy and was well tolerated. Basiliximab allows for utilization of lower doses of everolimus with reduced dosing of Neoral).

Adult↗
PubMedDate not supplied

Co-bedding versus traditional bedding of multiple-gestation infants in the NICU.

This study was part of a large departmental performance improvement initiative to implement and evaluate developmental and family-centered care as "best practice" in the neonatal intensive care unit (NICU). The goal was to evaluate the safety, effect on infant clinical and developmental outcomes, and maternal satisfaction of co-bedding of multiple-gestation infants compared to traditionally bedded infants/mothers. A secondary purpose was to evaluate co-bedding and American Academy of Pediatrics-recommended "back to sleep" behaviors in the same infants/mothers after discharge. A retrospective, comparative, descriptive design was used. Chart reviews and mailed written surveys were used to collect study data. Findings showed no significant differences in demographic variables or clinical and developmental outcomes between the total traditionally bedded and co-bedded groups. All mothers reported positive experiences with the NICU. Co-bedding may promote maternal bonding and has no negative clinical or developmental outcomes. Once policies and education are in place, parents should be offered the option to co-bed multiple-gestation infants in the NICU. There is a performance improvement opportunity regarding the education provided to parents of multiple-gestation infants before discharge on the "back to sleep" recommendations.

Benchmarking↗
PubMed1997

A descriptive analysis of children's playground injuries in the United States 1990-4.

OBJECTIVES: To review playground injury statistics over a five year period in order to develop an awareness of how and where children in the United States are being injured. METHODS: All data are based on the United States Consumer Product Safety Commission's National Electronic Injury Surveillance System (NEISS) for playground related injuries during 1990-4. The surveillance data includes injuries recorded in more than 90 hospital emergency departments located throughout the United States. RESULTS: Each year there are roughly 211,000 preschool or elementary school-children in the United States who receive emergency department care for injuries associated with playground equipment. On average, 17 of these cases result in death. 70% of all injuries occur on public playgrounds, with nearly one third classified as severe. Swings, climbers, and slides are the pieces of playground equipment associated with 88% of all NEISS reported injuries. Falls to the surface are responsible for 70%. CONCLUSIONS: NEISS playground injury statistics contribute to our understanding of playground injuries. By identifying where and how children are injured, suggestions can be made in an attempt to make playgrounds safer.

Adolescent↗
PubMed2001

Agricultural Disability Awareness and Risk Education (AgDARE) for high school students.

OBJECTIVE: Develop and test a farm health and injury prevention educational intervention for high school agriculture students. SETTING: Twenty one high schools in Kentucky, Iowa, and Mississippi. METHODS: A quasiexperimental crossover design was used to test the effectiveness of two sets of instructional materials designed through participatory action research with agriculture teachers and students. Narrative simulations based on farm work stories and simulations of farm work while students pretended to have a disability were completed in 14 schools (n = 373) over the academic year. Students in seven control schools (n = 417) received no intervention but completed, in the same time frame as students in the treatment schools, demographic surveys and premeasures and post-measures of farm safety attitudes and intent to change safety behaviors. One year after the intervention, 29 students from the treatment group received farm visits to measure their farm safety behaviors. RESULTS: Students engaged in hazardous work on farms. Thirty two were involved in tractor overturns and 11 had received injuries from rotating power take-off mechanisms. One fourth reported hearing problems, and 21% had respiratory symptoms after working in dusty farm surroundings. Students who completed at least two physical and two narrative simulations of the Agricultural Disability Awareness and Risk Education (AgDARE) curriculum showed statistically significant positive changes in farm safety attitude and intent to change behaviors. CONCLUSIONS: Adolescents engage in farm work that places them at risk for injury and illness. The AgDARE curriculum may be an effective and efficient method of teaching farm safety in high school agriculture classes.

Accident Prevention↗
PubMed2002

Effects of state helmet laws on bicycle helmet use by children and adolescents.

OBJECTIVE: To evaluate the effectiveness of state helmet laws in increasing the use of bicycle helmets by children and adolescents under age 16. SETTING: United States. METHODS: A cross sectional study of factors associated with the likelihood of helmet use by children and adolescents. Data were derived from a national random digit dial telephone survey of bicycle riders. A multiple logistic regression analysis was used to quantify the independent effect of the state helmet laws on helmet use. RESULTS: Helmet use was systematically related to the presence of state helmet laws (odds ratio 2.65; 95% confidence interval (CI) 1.29 to 5.44). The increase in the average probability of helmet use attributable to state helmet laws was 18.4% (95% CI 17.8% to 19.0%). CONCLUSIONS: State helmet laws significantly increase helmet use by children and play an important part in any comprehensive effort designed to achieve this goal.

Adolescent↗
PubMed2006

A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement.

BACKGROUND: Rivaroxaban (BAY 59-7939)--an oral, direct Factor Xa inhibitor--could be an alternative to heparins and warfarin for the prevention and treatment of thromboembolic disorders. METHODS AND RESULTS: This randomized, double-blind, double-dummy, active-comparator-controlled, multinational, dose-ranging study assessed the efficacy and safety of once-daily rivaroxaban relative to enoxaparin for prevention of venous thromboembolism in patients undergoing elective total hip replacement. Patients (n=873) were randomized to once-daily oral rivaroxaban doses of 5, 10, 20, 30, or 40 mg (initiated 6 to 8 hours after surgery) or a once-daily subcutaneous enoxaparin dose of 40 mg (given the evening before and > or = 6 hours after surgery). Study drugs were continued for an additional 5 to 9 days; mandatory bilateral venography was performed the following day. The primary end point (composite of any deep vein thrombosis, objectively confirmed pulmonary embolism, and all-cause mortality) was observed in 14.9%, 10.6%, 8.5%, 13.5%, 6.4%, and 25.2% of patients receiving 5, 10, 20, 30, and 40 mg rivaroxaban, and 40 mg enoxaparin, respectively (n=618, per-protocol population). No significant dose-response relationship was found for efficacy (P=0.0852). Major postoperative bleeding was observed in 2.3%, 0.7%, 4.3%, 4.9%, 5.1%, and 1.9% of patients receiving 5, 10, 20, 30, and 40 mg rivaroxaban, and 40 mg enoxaparin, respectively (n=845, safety population), representing a significant dose-response relationship (P=0.0391). CONCLUSIONS: Rivaroxaban showed efficacy and safety similar to enoxaparin for thromboprophylaxis after total hip replacement, with the convenience of once-daily oral dosing and without the need for coagulation monitoring. When both efficacy and safety are considered, these results suggest that 10 mg rivaroxaban once daily should be investigated in phase III studies.

Administration, Oral↗
PubMed2006

Active commuting to school: Associations with environment and parental concerns.

PURPOSE: This study examined the association of objective and perceived neighborhood environmental characteristics and parent concerns with active commuting to school, investigated whether parental concerns varied by environmental characteristics, and compared the association of the perceived environment, parental concerns, and objective environment on the outcome active commuting to school. METHODS: Randomly selected parents of children (aged 5-18 yr), in neighborhoods chosen for their variability in objectively measured walkability and income, completed questionnaires about their neighborhood environment, concerns about children walking to school, and children's behavior (N = 259). Objective measures of the environment were available for each participant and each neighborhood. Logistic regression analyses were used to investigate the relationships among environment, parental concerns, and walking or biking to or from school at least once a week. RESULTS: A parental concerns scale was most strongly associated with child active commuting (odds ratio: 5.2, 95% CI: 2.71-9.96). In high-income neighborhoods, more children actively commuted in high-walkable (34%) than in low-walkable neighborhoods (23%) (odds ratio: 2.1, 95% CI: 1.12-3.97), but no differences were noted in low-income neighborhoods. Parent concerns and neighborhood aesthetics were independently associated with active commuting. Perceived access to local stores and biking or walking facilities accounted for some of the effect of walkability on active commuting. CONCLUSION: Both parent concerns and the built environment were associated with children's active commuting to school. To increase active commuting to school, interventions that include both environmental change and education campaigns may be needed.

Adolescent↗