Variability on red blood cell transfusion practices among Brazilian neonatal intensive care units

BACKGROUND: Guidelines for red blood cell (RBC) transfusions exist; however, transfusion practices vary among centers. This study aimed to analyze transfusion practices and the impact of patients and institutional characteristics on the indications of RBC transfusions in preterm infants. STUDY DESIGN AND METHODS: RBC transfusion practices were investigated in a multicenter prospective cohort of preterm infants with a birth weight of less than 1500 g born at eight public university neonatal intensive care units of the Brazilian Network on Neonatal Research. Variables associated with any RBC transfusions were analyzed by logistic regression analysis. RESULTS: Of 952 very-low-birth-weight infants, 532 (55.9%) received at least one RBC transfusion. The percentages of transfused neonates were 48.9, 54.5, 56.0, 61.2, 56.3, 47.8, 75.4, and 44.7%, respectively, for Centers 1 through 8. The number of transfusions during the first 28 days of life was higher in Center 4 and 7 than in other centers. After 28 days, the number of transfusions decreased, except for Center 7. Multivariate logistic regression analysis showed higher likelihood of transfusion in infants with late onset sepsis (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.8-4.4), intraventricular hemorrhage (OR, 9.4; 95% CI, 3.3-26.8), intubation at birth (OR, 1.7; 95% CI, 1.0-2.8), need for umbilical catheter (OR, 2.4; 95% CI, 1.3-4.4), days on mechanical ventilation (OR, 1.1; 95% CI, 1.0-1.2), oxygen therapy (OR, 1.1; 95% CI, 1.0-1.1), parenteral nutrition (OR, 1.1; 95% CI, 1.0-1.1), and birth center (p < 0.001). CONCLUSIONS: The need of RBC transfusions in very-low-birth-weight preterm infants was associated with clinical conditions and birth center. The distribution of the number of transfusions during hospital stay may be used as a measure of neonatal care quality.

Comparison of the Rupture and Disintegration Tests for Soft-Shell Capsules

The USP General Chapter < 2040 > Disintegration and Dissolution of Dietary Supplements introduced a rupture test as a performance test of soft-shell capsules. Traditionally, the disintegration test was used for determining the disintegration time of all solid oral dosage forms. The aim of this investigation was to investigate differences between the rupture test and the disintegration test using soft-shell capsules. Five different soft-shell capsule products were chosen based on their filling contents and treated to simulate a production deficiency. The study design compared capsules as received with capsules that were treated by coating them with the liquid contents of another capsule. The capsules were incubated at room temperature and at 40 degrees C. The tests were repeated after two weeks, and at each time point, twelve capsules of each product were tested using the rupture and the disintegration tests. Six capsules were tested untreated, while the other six capsules were treated. Rupture and disintegration times were recorded as dependent variables in each experiment. Thedata were analyzed using ANOVA. According to the USP definition for disintegration, the rupture of a soft-shell capsule can be seen as fulfilling the disintegration criterion if the capsule contents is a semisolid or liquid. Statistical analysis showed no advantage of the rupture test over the disintegration test. On a product-by-product basis, both tests were sensitive to certain investigated parameters. A noticeable difference between both tests was that in most cases, the rupture test reached the defined endpoint faster than the disintegration test. Soft-shell capsules that are subject to a Quality by Design approach should be tested with both methods to determine which performance test is the most appropriate test for a specific product.

Double-blind, randomized, placebo-controlled trial of a cream containing the Stryphnodendron adstringens (Martius) Coville bark extract for suppressing terminal hair growth

Background Excess of terminal hair can be defined as excessive hair that appears in male-like pattern in women. Some experts consider this condition as a result of an atypical relationship between levels of circulating androgens and sensitivity of androgen receptors in hair follicles to circulating androgens. Aims The aim of this research work was to evaluate the efficacy of a topical treatment for suppressing terminal hair growth of a cream containing 6.0% of the Stryphnodendron adstringens bark extract. Study design and subjects Study was randomized, double-blind and placebo-controlled. Subjects with excess of terminal hair were randomized to placebo and to the active treatment (cream with 6.0% of the extract). Evaluation was performed before and after 6 months, and subjects were photographed in each time. Clinical examination was carried out with the same physicians and in accordance with the Ferriman-Gallwey (FG) score. Results Benefits of the cream containing S. adstringens bark extract was observed in 60.98% (P < 0.001) of the subjects. FG score changed from 4 to 3 in the placebo group compared to 4-2 in the active. The cream suppressed the terminal hair growth and diminished the number of terminal hair. Subjects also described the reduction of skin hyperpigmentation, folliculitis and acne. Adverse events were not verified by physicians or patients. Conclusions The cream with 6.0% of the S. adstringens bark extract was effective on the reduction and on the reversion of the terminal hair excess, being considered a new promissory product for such finality.

Quality of Reporting of Observational Longitudinal Research

Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making. However, there are no structured reporting requirements for studies of this design to assist authors, editors, and readers. The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies. The checklist criteria concerned recruitment, data collection, biases, and data analysis and descriptive issues relevant to study rationale, study population, and generalizability. Two raters independently assessed 49 randomly selected articles describing stroke research published from 1999 to 2003 in six journals: American Journal of Epidemiology, Journal of Epidemiology and Community Health, Stroke, Annals of Neurology, Archives of Physical Medicine and Rehabilitation, and American Journal of Physical Medicine and Rehabilitation. On average, 17 of the 33 checklist criteria were reported. Criteria describing the study design were better reported than those related to internal validity. No relation was found between study type (etiologic or prognostic) or word count and quality of reporting. A flow diagram for summarizing participant flow through a study was developed. Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research.

A randomised control trial of exercise and manipulative therapy for cervicogenic headache

Study Design. A multicenter, randomized controlled trial with unblinded treatment and blinded outcome assessment was conducted. The treatment period was 6 weeks with follow-up assessment after treatment, then at 3, 6, and 12 months. Objectives. To determine the effectiveness of manipulative therapy and a low-load exercise program for cervicogenic headache when used alone and in combination, as compared with a control group. Summary of Background Data. Headaches arising from cervical musculoskeletal disorders are common. Conservative therapies are recommended as the first treatment of choice. Evidence for the effectiveness of manipulative therapy is inconclusive and available only for the short term. There is no evidence for exercise, and no study has investigated the effect of combined therapies for cervicogenic headache. Methods. In this study, 200 participants who met the diagnostic criteria for cervicogenic headache were randomized into four groups: manipulative therapy group, exercise therapy group, combined therapy group, and a control group. The primary outcome was a change in headache frequency. Other outcomes included changes in headache intensity and duration, the Northwick Park Neck Pain Index, medication intake, and patient satisfaction. Physical outcomes included pain on neck movement, upper cervical joint tenderness, a craniocervical flexion muscle test, and a photographic measure of posture. Results. There were no differences in headache-related and demographic characteristics between the groups at baseline. The loss to follow-up evaluation was 3.5%. At the 12-month follow-up assessment, both manipulative therapy and specific exercise had significantly reduced headache frequency and intensity, and the neck pain and effects were maintained (P < 0.05 for all). The combined therapies was not significantly superior to either therapy alone, but 10% more patients gained relief with the combination. Effect sizes were at least moderate and clinically relevant. Conclusion. Manipulative therapy and exercise can reduce the symptoms of cervicogenic headache, and the effects are maintained.

Factors influencing wound healing after surgery for metastatic disease of the spine

Study Design, The study group consisted of 53 patients who underwent 75 operations for spine metastases. Patient and tumor demographic factors, preoperative nutritional status, and perioperative adjunctive therapy were retrospectively reviewed. Objective, To determine the risk factors for wound breakdown and infection in patients undergoing surgery for spinal metastases. Summary of Background Data. Spinal Fusion using spine implants may be associated with an infection rate of 5% or more. Surgery for spine metastases is associated with an infection rate of more than 10%. Factors other than the type of surgery performed may account for the greater infection rate. Methods. Data were obtained by reviewing patient records. Age, sex, and neurologic status of the patient; tumor type and site; and surgical details were noted. Adjunctive treatment with corticosteroids and radiotherapy was recorded, Nutritional status was evaluated by determining serum protein and serum albumin concentrations and by total lymphocyte count. Results. Wound breakdown and Infection occurred in 75 of 75 wounds. No patient or tumor demographic factors other than intraoperative blood loss (P < 0.1) were statistically associated with infection; The correlation between preoperative protein deficiency (P < 0.01) or perioperative corticosteroid administration (P < 0.10) and wound infection was significant. There was no statistical correlation between lymphocyte count or perioperative radiotherapy and wound infection. Conclusions, The results indicate that preoperative protein depletion and perioperative administration of corticosteroids are risk factors for wound infection in patients undergoing surgery for spine metastases, Perioperative correction of nutritional depletion and cessation of steroid therapy may reduce wound complications.

Cohort trends in youth suicide in Australia 1964-1997

Objective: This paper examines trends in the rate of suicide among young Australians aged 15-24 years from 1964 to 1997 and presents an age-period-cohort analysis of these trends. Method: Study design consisted of an age-period-cohort analysis of suicide mortality in Australian youth aged between 15 and 24 for the years 1964-1997 inclusive. Data sources were Australian Bureau of Statistics data on: numbers of deaths due to suicide by gender and age at death; and population at risk in each of eight birth cohorts (1940-1944, 1945-1949, 1950-1954, 1955-1959, 1960-1964, 1965-1969, 1970-1974, and 1975-1979). Main outcome measures were population rates of deaths among males and females in each birth cohort attributed to suicide in each year 1964-1997. Results: The rate of suicide deaths among Australian males aged 15-24 years increased from 8.7 per 100 000 in 1964 to 30.9 per 100 000 in 1997, with the rate among females changing little over the period, from 5.2 per 100 000 in 1964 to 7.1 per 100 000 in 1997. While the rate of deaths attributed to suicide increased over the birth cohorts, analyses revealed that these increases were largely due to period effects, with suicide twice as likely among those aged 15-24 years in 1985-1997 than between 1964 and 1969. Conclusions: The rate of youth suicide in Australia has increased since 1964, particularly among males. This increase can largely be attributed to period effects rather than to a cohort effect and has been paralleled by an increased rate of youth suicides internationally and by an increase in other psychosocial problems including psychiatric illness, criminal offending and substance use disorders.

The demise of a planned randomised controlled trial in an urban Aboriginal medical service

To fill a gap in knowledge about the effectiveness of brief intervention for hazardous alcohol use among Indigenous Australians, we attempted to implement a randomised controlled trial in an urban Aboriginal Medical Service (AMS) as a joint AMS-university partnership. Because of low numbers of potential participants being screened, the RCT was abandoned in favour of a two-part demonstration project. Only 16 clients were recruited for follow-up in six-months, and the trial was terminated. Clinic, patient, Aboriginal health worker, and GP factors, interacting with study design factors, all contributed to our inability to implement the trial as designed. The key points to emerge from the study are that alcohol misuse is a difficult issue to manage in an Indigenous primary health care setting; RCTs involving inevitably complex study protocols may not be acceptable or sufficiently adaptable to make them viable in busy, Indigenous primary health care settings; and gold-standard RCT-derived evidence for the effectiveness of many public health interventions in Indigenous primary health care settings may never be available, and decisions about appropriate interventions will often have to be based on qualitative assessment of appropriateness and evidence from other populations and other settings.

Influence of HIV-1 coinfection on effective management of abnormal vaginal discharge

Background: Reports on microbiologic cure rates following syndromic management (SM) of women with nonulcerative sexually transmitted infections (STIs) are limited. Goal. The goal of the study was to determine the effectiveness of the drugs used in SM of nonulcerative STIs and bacterial vaginosis in women and to compare the response among those with and without HIV-1 coinfection. Study Design: This was a cohort study of women with nonulcerative STIs who were treated according to local SM protocols. Results: Of 692 women recruited, 415 (80%) returned 8 to 10 days later, and 290 (70%) consented to a second examination, in which specimens were obtained. Clinical cure was reported by 67%, and microbiologic cure ranged from 80% to 89% for the three discharge-causing STIs and was independent of HIV-1 status. Only 38% of those with bacterial vaginosis were cured, and HIV-1-infected women were less likely to be cured (28% versus 52%; P < 0.001). Conclusions: Clinical and microbiologic response to SM of the nonulcerative STIs was not affected by HIV-1 coinfection, but cure rates for bacterial vaginosis were reduced.

Association between HIV-1 infection, the etiology of genital ulcer disease, and response to syndromic management

Background: Reports on the effect of HIV-1 infection on healing rates of ulcers are conflicting. Goal: The goal was to determine the etiology and response to treatment of genital ulcer disease (GUD) in relation to HIV-1 infection. Study Design: This was a cohort study of patients with GUD treated with local syndromic management protocols. Results: Among the 587 recruited, the prevalences of infections due to HSV, Treponema pallidum, Chlamydia trachomatis (lymphogranuloma venereum [LGV]), Haemophilus ducreyi, Calymmatobacterium granulomatis, and HIV-1 were 48%, 14%, 11%, 10%, 1%, and 75%, respectively. The prevalence of T pallidum was higher among men (P = 0.03), and an association was seen among HIV-1-seronegatives on univariate and multivariate analyses (P < 0.001; P = 0.01). The prevalence of C trachomatis (LGV) was higher among females (P = 0.004), and an association was seen among HIV-1-seropositives on univariate analysis (P = 0.04). At follow-up, 40/407 (10%) showed a decreased healing tendency, not associated with ulcer etiology or HIV-1 seropositivity. Conclusion: Response to syndromic management of GUD was acceptable and not associated with HIV-1 coinfection.

Molecular epidemiology: A multidisciplinary approach to understanding parasitic zoonoses

Sound application of molecular epidemiological principles requires working knowledge of both molecular biological and epidemiological methods. Molecular tools have become an increasingly important part of studying the epidemiology of infectious agents. Molecular tools have allowed the aetiological agent within a population to be diagnosed with a greater degree of efficiency and accuracy than conventional diagnostic tools. They have increased the understanding of the pathogenicity, virulence, and host-parasite relationships of the aetiological agent, provided information on the genetic structure and taxonomy of the parasite and allowed the zoonotic potential of previously unidentified agents to be determined. This review describes the concept of epidemiology and proper study design, describes the array of currently available molecular biological tools and provides examples of studies that have integrated both disciplines to successfully unravel zoonotic relationships that would otherwise be impossible utilising conventional diagnostic tools. The current limitations of applying these tools, including cautions that need to be addressed during their application are also discussed.(c) 2005 Australian Society for Parasitology Inc. Published by Elsevier Ltd. All rights reserved.

Timing of rotator cuff activation during shoulder external rotation in throwers with and without symptoms of pain

Study Design: Fine-wire EMG rotator cuff onset time analysis in 2 matched groups of throwers with and without pain. Objective: To identify if there is a difference in the activation patterns of the rotator cuff muscles during a rapid shoulder external rotation task between throwers with and without pain. Background: The coordinated action of the rotator cuff is recognized as essential for glenohumeral joint control in the throwing athlete. Identification of abnormalities occurring in muscle activation patterns for injured athletes is relevant when prescribing rehabilitative exercises. Methods and Measures: Twelve throwers with shoulder pain were compared to a matched group of 11 asymptomatic throwers. Participants were matched for age, height, body mass, and habitual activity. Fine-wire EMG electrodes were inserted into the subscapularis, supraspinatus, and infraspinatus. EMG activity was measured during a reaction time task of rapid shoulder external rotation in a seated position. The timing of onset of EMG activity was analyzed in relation to visualization of a light (reaction time) and to the onset of infraspinatus activity (relative latency). Results: In the group with shoulder pain, the onset of subscapularis activity was found to be significantly delayed (reaction time, P = .0018; relative latency, P = .0005) from the onset of infraspinatus activity when compared to the control group. Conclusions: The presence of shoulder pain in these athletes was associated with a difference in the onset of subscapularis EMG activity during a rapid shoulder external rotation movement. This was an initial step in the understanding of the joint protection mechanisms of the glenohumeral joint and the problems that occur in throwers. This information may assist in providing future guidelines for more effective rehabilitation and prevention strategies for this condition.

The impact of simple donor education on donor behavioral deferral and infectious disease rates in Sao Paulo, Brazil

BACKGROUND: Studies have shown that human immunodeficiency virus (HIV) residual risk is higher in Brazilian than in US and European blood donors, probably due to failure to defer at-risk individuals in Brazil. This study assessed the impact of an educational brochure in enhancing blood donors` knowledge about screening test window phase and reducing at-risk individuals from donating. STUDY DESIGN AND METHODS: This trial compared an educational intervention with a blood center`s usual practice. The brochure was distributed in alternating months to all donors. After donating, sampled participants completed two questions about their HIV window period knowledge. The impact on HIV risk deferral, leaving without donation, confidential unit exclusion (CUE) use, and test positivity was also analyzed. RESULTS: From August to November 2007 we evaluated 33,940 donations in the main collection center of Fundacao Pro-Sangue/Hemocentro de Sao Paulo in Sao Paulo, Brazil. A significant (p < 0.001) pamphlet effect was found on correct responses to both questions assessing HIV window phase knowledge (68.1% vs. 52.9%) and transfusion risk (91.1% vs. 87.2%). After adjusting for sex and age, the pamphlet effect was strongest for people with more than 8 years of education. There was no significant pamphlet effect on HIV risk deferral rate, leaving without donation, use of CUE, or infectious disease rates. CONCLUSION: While the educational pamphlet increased window period knowledge, contrary to expectations this information alone was not enough to make donors self-defer or acknowledge their behavioral risk.

Chronic Recurrent Multifocal Osteomyelitis Primarily Affecting the Spine Treated With Anti-TNF Therapy

Study Design. A case report describing chronic recurrent multifocal osteomyelitis (CRMO) with initial presentation limited to spine, successfully treated by anti-TNF-alpha therapy after failure of conventional treatment methods. Objective. To describe an unusual manifestation and treatment of a rare disease. Summary of Background Data. CRMO is a rare inflammatory bone disease that should be differentiated from bacterial osteomyelitis. Rarely, it can affect the spine and in this case the most important differential diagnosis is infectious spondylodiscitis. The disease has an unpredictable course with exacerbations and spontaneous remissions. Although the majority of cases remit spontaneously (or after the use of nonsteroidal anti-inflammatory drugs [NSAIDs]), some progressive and resistant cases have been reported. Methods. We describe a case of CRMO with an unusual clinical presentation emphasizing the importance of this finding as a differential diagnosis of spondylodiscitis and comment on the available treatment alternatives. Results. A 17-year-old man presented with debilitating dorsal spine pain. Magnetic resonance imaging of the spine revealed bone lesions at multiple vertebral levels. After failure of antibiotic treatment, the diagnosis of CRMO was suggested. An initial good response to NSAIDs was followed by a recurrent course and involvement of peripheral joints besides the use of corticosteroids and other drugs. The introduction of infliximab was followed by complete remission of the disease. Conclusion. Our observation highlights the need of awareness for the differential diagnosis in suspected cases of osteomyelitis not responding to antibiotics. Anti-TNF-alpha agents should be considered in CRMO refractory cases.

Effect of a continuous regimen of contraceptive combination of ethinylestradiol and drospirenone on lipid, carbohydrate and coagulation profiles

Background: The objective of this study was to evaluate the effects of a contraceptive pill containing ethinylestradiol (30 mcg) and drospirenone (3 mg) in a continuous regimen on lipid, carbohydrate and coagulation parameters. Study Design: This open, prospective, randomized study included 78 participants (mean age 27.8 years) who were randomized into two groups to use the pill continuously for 168 days or for six 28-day cycles with a 7-day hormone-free interval between cycles. Markers of lipid, carbohydrate and coagulation profiles were measured prior to initiation and after the 6 months of pill use. Results: No statistically significant differences were found between the two contraceptive regimens with respect to carbohydrate or lipid profiles or in the parameters related to coagulation. Conclusions: The contraceptive combination of ethinylestradiol and drospirenone used in a continuous regimen was associated with metabolic alterations similar to those found during the traditional cyclic regimen of oral contraceptive use. (C) 2010 Elsevier Inc. All rights reserved.