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Biomedical subjects

S Black

Publications and source records attributed to S Black.

At least 55 records · Page 3Linked to original sources

A simple model to help distinguish necrotizing fasciitis from nonnecrotizing soft tissue infection.

BACKGROUND: Necrotizing fasciitis (NF) has been associated with certain "hard" clinical signs (hypotension, crepitance, skin necrosis, bullae, and gas on x-ray), but these may not always be present. Using results of a previous study, we developed a simple model to serve as an adjunctive tool in diagnosing NF (admission WBC > 15.4 x 10(9)/L or serum sodium [Na] < 135 mmol/L) and determined its ability to distinguish between patients with NF and nonnecrotizing soft tissue infection (non-NF). STUDY DESIGN: A retrospective review was conducted of consecutive NF (n=31) and non-NF patients (n= 328) treated at a single institution during an 11-month period. Comparison of admission vital signs, physical examination findings, radiology results, and number of patients meeting model criteria was performed. RESULTS: Ninety percent of NF patients and 24% of non-NF patients met model criteria (p < 0.0001). The model had a sensitivity of 90%, a specificity of 76%, a positive predictive value of 26%, and a negative predictive value of 99% for diagnosing NF. Nineteen (61%) NF patients had no "hard" signs of NF; the model correctly classified 18 (95%) of these patients. CONCLUSIONS: Admission WBC greater than 15.4 x 10(9)/L and serum Na less than 135mmol/L are useful parameters that may help to distinguish NF from non-NF infection, particularly when classic "hard" signs of NF are absent.

Adult↗

Incidence of venous air embolism during craniectomy for craniosynostosis repair.

BACKGROUND: Investigations to determine the incidence of venous air embolism in children undergoing craniectomy for craniosynostosis repair have been limited, although venous air embolism has been suspected as the cause of hemodynamic instability and sometimes death. A precordial Doppler ultrasonic probe is an accepted method for detection of venous air embolism and is readily available at most institutions. METHODS: A prospective study was conducted using a precordial Doppler ultrasonic probe in children undergoing craniectomy for craniosynostosis repair. The Doppler signal was continuously monitored intraoperatively for characteristic changes of venous air embolism. A recording was made of the precordial Doppler probe pulses, which was later reviewed by a neuroanesthesiologist, blinded to the intraoperative events. This information was correlated with the intraoperative events and episodes of venous air embolism were graded. RESULTS: Twenty-three patients were enrolled in the study during the 2-yr study period. Nineteen patients (82.6%) demonstrated 64 episodes of venous air embolism; six patients (31.6%) had hypotension associated with venous air embolism. Thirty-two episodes of hypotension were demonstrated in eight patients (34.7%). None of the patients developed cardiovascular collapse. CONCLUSION: The incidence of venous air embolism in our study of 23 children undergoing craniectomy for craniosynostosis was 82.6%. Though most episodes of venous air embolism during craniosynostosis repair are without hemodynamic consequences, the preemptive placement of a precordial Doppler ultrasonic probe is a noninvasive, economic, and safe method for the detection of venous air embolism. Prompt recognition may allow for the early initiation of therapy, thereby decreasing morbidity and mortality rates related to venous air embolism.

Child↗

Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group.

OBJECTIVE: To determine the efficacy, safety and immunogenicity of the heptavalent CRM197 pneumococcal conjugate vaccine against invasive disease caused by vaccine serotypes and to determine the effectiveness of this vaccine against clinical episodes of otitis media. METHODS: The Wyeth Lederle Heptavalent CRM197 (PCV) was given to infants at 2, 4, 6 and 12 to 15 months of age in a double blind trial; 37,868 children were randomly assigned 1:1 to receive either the pneumococcal conjugate vaccine or meningococcus type C CRM197 conjugate. The primary study outcome was invasive disease caused by vaccine serotype. Other outcomes included overall impact on invasive disease regardless of serotype, effectiveness against clinical otitis media visits and episodes, impact against frequent and severe otitis media and ventilatory tube placement. In addition the serotype-specific efficacy against otitis media was estimated in an analysis of spontaneously draining ears. RESULTS: In the interim analysis in August, 1998, 17 of the 17 cases of invasive disease caused by vaccine serotype in fully vaccinated children and 5 of 5 of partially vaccinated cases occurred in the control group for a vaccine efficacy of 100%. Blinded case ascertainment was continued until April, 1999. As of that time 40 fully vaccinated cases of invasive disease caused by vaccine serotype had been identified, all but 1 in controls for an efficacy of 97.4% (95% confidence interval, 82.7 to 99.9%), and 52 cases, all but 3 in controls in the intent-to-treat analysis for an efficacy of 93.9% (95% confidence interval, 79.6 to 98.5%). There was no evidence of any increase of disease caused by nonvaccine serotypes. Efficacy for otitis media against visits, episodes, frequent otitis and ventilatory tube placement was 8.9, 7.0, 9.3 and 20.1% with P < 0.04 for all. In the analysis of spontaneously draining ears, serotype-specific effectiveness was 66.7%. CONCLUSION: This heptavalent pneumococcal conjugate appears to be highly effective in preventing invasive disease in young children and to have a significant impact on otitis media.

Bacterial Vaccines↗

Efficacy of pneumococcal conjugate vaccines in large scale field trials.

BACKGROUND: Each year Streptococcus pneumoniae causes approximately 1.2 million deaths worldwide from pneumonia. In the United States S. pneumoniae is estimated to cause 500,000 cases of pneumonia and 7 million episodes of acute otitis media annually. CONJUGATE VACCINES: The current pneumococcal polysaccharide vaccine is ineffective in children <2 years old and may not produce an adequate antibody response until children reach the age of 5 years. Pneumococcal conjugate vaccines are immunogenic after primary and booster vaccination in young children and in children and adults with immunodeficiencies. Immunization with conjugate vaccines also induces a strong and rapid anamnestic response and enhanced functional activity of antibodies. Two large scale field trials of pneumococcal conjugate vaccines were initiated in 1995, 1 in California and 1 in Finland. The California trial, involving 37,868 children, evaluated the efficacy of a 7-valent conjugate for the prevention of invasive pneumococcal disease and secondarily evaluated its efficacy for acute otitis media and pneumonia. RESULTS: Preliminary results indicate 94% efficacy against invasive pneumococcal disease caused by serotypes included in the vaccine in fully or partially vaccinated children. Preliminary evidence from large scale field trials indicates that pneumococcal conjugate vaccines are effective in reducing invasive pneumococcal disease as well as acute otitis media and pneumonia in children and represents a significant advance in the prevention of childhood infectious diseases.

Adult↗

The diagnosis of "mixed" dementia in the Consortium for the Investigation of Vascular Impairment of Cognition (CIVIC).

If vascular risk factors are risk for Alzheimer's disease (AD), and if "pure" vascular dementia (VaD) is less common than has been thought, what do we make of the diagnosis of mixed dementia? We report characteristics of those with mixed dementia in a prospective, seven center, clinic-based Canadian study. Of 1,008 patients, 372 were diagnosed with AD, 149 with vascular cognitive impairment (VCI) including 76 with mixed AD/VaD, and 82 with other types of dementia. The mean age of patients with mixed AD/VaD was 78.0 +/- 7.6 years; 49% were female. These proportions differed significantly between dementia diagnosis subgroup (p < 0.001) showing a trend which is evident in all comparisons--AD/VaD patients fall in between AD and VaD. Vascular risk factors were present significantly more often in mixed AD/VaD than in AD (p < 0.001). More mixed AD/VaD (20%) than AD patients (4%) had focal signs, compared with 38% of those with vascular dementia and 12% with other types of dementia. Between the initial clinical diagnosis and the final diagnosis (which utilized neuroimaging and neuropsychological data) AD/VaD was the least stable diagnosis. Neuroimaging of ischemic lesions was the most common reason for reassignment from AD to the mixed AD/VaD diagnosis (17 cases). These data suggest that an operational definition of mixed AD/VaD can be proposed on presentation and clinical/radiographic findings, but indifferent to vascular risk factors. The concept of mixed dementia should be extended to include vascular dementia in combination with dementias, other than Alzheimer's disease.

Aged↗

A rural perspective on home care communication about elderly patients after hospital discharge.

Little is known about home health agencies (HHA) and their integration in the continuum of care in rural areas. The aims of this study are to describe the amount and type of patient-related data transferred by discharging hospitals to rural HHAs and to explore the influence of selected organizational factors on that communication process using a previously tested model of interorganizational communication. In this study, 446 closed-case, elderly patient records at three rural HHAs were reviewed using the Referral Data Inventory. Rural HHAs receive about half of the literature-recommended referral data, characterized primarily by background data, some medical data, and almost no psychosocial or nursing-care data. Referrals transmitted by telephone and written data were superior to referrals transferred by a telephone call only. Hospital-affiliated HHAs received significantly greater amounts and richer types of referral data than did free-standing HHAs. Findings suggest that cost-saving measures in the referral process need investigation.

Aged↗

Over-expression of Candida albicans mitochondrial ribosomal protein S9 (MrpS9p) disturbs mitochondrial function in Saccharomyces cerevisiae.

A Candida albicans mitochondrial ribosomal protein S9 (MRPS9) cDNA was identified in a screen for sequences whose expression induce galactose lethality in Saccharomyces cerevisiae. MRPS9 appears to encode a protein of 346 amino acids with an N-terminal mitochondrial targeting sequence and an internal S9 signature that is conserved amongst eukaryotic mitochondrial and prokaryotic ribosomal protein S9 sequences. Expression of a GAL1-CaMRPS9 fusion in S. cerevisiae caused the slow development of a galactose-negative phenotype upon repeated subculturing, and this correlated with an increased frequency of petite mutant formation. Therefore, over-expression of CaMRPS9 interferes with S. cerevisiae mitochondrial function, which accounts for the inhibition of growth on galactose.

Amino Acid Sequence↗

Somatosensory-evoked potentials during aortic coarctation repair.

OBJECTIVE: To determine the incidence of somatosensory-evoked potential (SSEP) changes and the interventions based on these changes during aortic coarctation repair. DESIGN: Retrospective review. SETTING: Single-institution, university hospital. PARTICIPANTS: Eighty-four children who had undergone surgical repair of aortic coarctation from January 1984 to May 1996. INTERVENTIONS: SSEPs were monitored in all patients throughout the procedure. A persistent decrease in amplitude greater than 50% from baseline was considered significant. Duration of SSEP changes in relation to the time course of surgical repair and whether a surgical or anesthetic intervention resulted from a change in SSEPs were documented. MEASUREMENTS AND MAIN RESULTS: Eighty-four patients underwent 87 surgical procedures. SSEP changes occurred in 40% of the procedures: 38.5% with repair and 15% with test clamp, with 9% occurring during both test clamp and repair. Interventions, which included repositioning the aortic cross-clamp, elevating blood pressure, and aborting surgery, occurred in 26.4% of all procedures based on SSEP changes. No patient sustained a neurologic deficit. CONCLUSION: This is the largest series to date describing the use of SSEPs in aortic coarctation repair. These SSEP changes were often immediately amenable to changes in surgical and anesthetic management. SSEP changes and interventions based on these changes occurred with a considerable frequency.

Adolescent↗

Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers.

OBJECTIVES: The objectives of this study were (1) to determine the safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate (PNCRM7) vaccine in infants and (2) to determine the effect of concurrent hepatitis B immunization during the primary series and the effect of concurrent diphtheria and tetanus toxoid and acellular pertussis [DTaP (ACEL-IMUNE)] and conjugate CRM197 Haemophilus influenzae type b [HbOC (HibTITER) immunization at time of the booster dose on the safety and immunogenicity of PNCRM7and these other concurrently administered vaccines. METHODS: This was a randomized double-blinded study in 302 healthy infants in the Northern California Kaiser Permanente (NCKP) Health Plan. Infants received either PNCRM7 vaccine or meningococcal group C conjugate vaccine as a control at 2, 4 and 6 months of age and a booster at 12 to 15 months of age. Study design permitted the evaluation of immunology and safety of concurrent administration of routine vaccines. Antibody titers were determined on blood samples drawn before and 1 month after the primary series and the booster dose. RESULTS: After the third dose of PNCRM7 geometric mean concentrations (GMCs) ranged from 1.01 for serotype 9V to 3.72 microg/ml for serotype 14. More than 90% of all subjects had a post-third dose titer of > or =0.15 microg/ml for all serotypes, and the percentage of infants with a post-third dose titer of > or =1.0 microg/ml ranged from 51% for type 9V to 89% for type 14. After the PNCRM7 booster dose, the GMCs of all seven serotypes increased significantly over both post-Dose 3 and pre-Dose 4 antibody levels. In the primary series there were no significant differences in GMCs of pneumococcal antibodies between the subjects given PN-CRM7 alone or concurrently with hepatitis B vaccine. At the toddler dose concurrent administration of PNCRM7 and DTaP and HbOC resulted in a near conventional threshold for statistical significance of a post-Dose 4 GMC for serotype 23F [alone 6.75 mirog/ml vs. concurrent 4.11 microg/ml (P = 0.057)] as well as significantly lower antibody GMCs for H. influenza polyribosylribitol phosphate, diphtheria toxoid, pertussis toxin and filamentous hemagglutinin. For all antigens there were no differences between study groups in defined antibody titers that are considered protective. CONCLUSION: We conclude that PNCRM7 vaccine was safe and immunogenic. When this vaccine was administered concurrently at the booster dose with DTaP and HbOC vaccines, lower antibody titers were noted for some of the antigens when compared with the antibody response when PNCRM7 was given separately. Because the GMCs of the booster responses were all generally high and all subjects achieved similar percentages above predefined antibody titers, these differences are probably not clinically significant.

Antibodies, Bacterial↗

Postmarketing evaluation of the safety and effectiveness of varicella vaccine.

BACKGROUND: The Oka strain of live attenuated varicella virus was licensed for use in healthy children in the United States in March, 1995. We report a postmarketing evaluation of the short term safety of this vaccine within Kaiser Permanente. METHODS: After licensure varicella vaccination was introduced into the preventive care program of the Northern California Kaiser Permanente Medical Care Program. Potential adverse events after vaccination with varicella vaccine were identified from automated clinical databases of hospitalizations, emergency room visits and clinic visits. Deaths were identified from automated clinical databases at Kaiser as well as from the State death records for California. To evaluate safety, rates of diagnosis-specific events in the risk periods were compared with the rates of such diagnosis-specific events in two self control and one historical control period. RESULTS: During the study period of April 1, 1995, to December 31, 1996, a total of 89753 adults and children received varicella vaccine. A total of 3200 relative risks were calculated, and of these 5 hospital diagnostic categories, 9 emergency visit diagnostic categories and 30 outpatient diagnostic categories demonstrated at least 1 relative risk with a P value of <0.05 in 1 or more age groups and in comparisons with 1 control period or more. The p value for these tests was not adjusted for multiple comparisons. Of these categories 14 demonstrated an increased risk either in more than 1 age group or against more than 1 comparison group. These categories included elective procedures, febrile seizure, febrile illness, well child, acute gastroenteritis, varicella, congenital anomaly, "rule out sepsis," trauma, viral syndrome, apnea, back pain, congenital valvular heart disease and vision evaluation for glasses. Of these the outcomes of elective procedure, congenital anomaly, congenital valvular heart disease, well child and vision evaluation for glasses were judged not to have a biologically plausible association with vaccination. A second diagnostic grouping included febrile illness, viral illness, febrile seizure and "rule out sepsis." In an analysis of these events which adjusted for the concomitant administration of M-M-R(II) vaccine, none of the associations was statistically associated with receipt of varicella vaccine. The diagnostic category of "rule out sepsis" still had a relative risk of 1.95 with P = 0.02. None of the children in the "rule out sepsis" category had positive bacteriologic cultures from any other normally sterile site. Because of the large number of gastroenteritis cases, we reviewed a random sample of 100 exposed and 100 unexposed cases. From this review no consistent time association or clustering of any of these events was seen in the exposed follow-up time interval. Only gastroenteritis and negative evaluations for sepsis were thought to be possibly associated with receipt of varicella vaccine. Although there was a statistically significant increased risk over the entire 30 day-period, there was no clustering of these events within the 30-day window. CONCLUSION: In this study population of 89753 children and adults, the varicella vaccine (Oka strain, Merck) appeared to have a favorable safety profile. In addition rates of varicella-like rash and of breakthrough cases were both low and consistent with the rates observed in prelicensure studies.

Adult↗

Blood loss and transfusion practice in the perioperative management of craniosynostosis repair.

During the past 5 years, the surgical repair for sagittal synostosis has been modified to a more complex and involved procedure. This led to a retrospective evaluation of the current transfusion practice in a large series of craniosynostosis repairs. The charts of 76 patients (81 surgical procedures) undergoing craniosynostosis repair from January 1990 to November 1996 were examined. The calculated volume of blood loss (BL) was determined for each surgical procedure and related to the estimated blood volume (EBV) and acceptable blood loss (ABL). The anesthesiologist's ability to estimate BL was compared with the calculated blood loss (CBL). In most surgical procedures for craniosynostosis, especially in the complex sagittal repairs, CBL was underestimated and exceeded ABL. Packed red blood cell transfusion occurred in 96.3% of the patients and was appropriate for most procedures based on ABL. Thus, transfusion for craniosynostosis repair is almost inevitable, and the preventive preparation of blood on the order of the mean estimated blood loss (EBL) plus 2 SD is appropriate. With the increased complexity of sagittal repair and its performance in a younger population, the cosmetic benefit of surgical repair has major implications for management of blood and fluids.

Age Factors↗

Comparative safety of two recombinant hepatitis B vaccines in children: data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD).

BACKGROUND: Preliminary review of data from the Vaccine Adverse Event Reporting System (VAERS), 1991-1994, revealed that more serious adverse events were reported in children who received a specific brand of recombinant hepatitis B (HepB) vaccine. OBJECTIVE: To compare the post-marketing safety experience of the two recombinant HepB vaccines licensed for use in infants and children in the United States. DESIGN: Review of a case series derived from passive surveillance data in the national VAERS. A retrospective cohort study using data from one health maintenance organization participating in Vaccine Safety Datalink (VSD), a computerized record linkage system. POPULATIONS STUDIED: U.S. children, ages birth-10 years for whom adverse events after HepB vaccine were reported to VAERS, 1991-1994. Children, ages birth-6 years, who received HepB vaccine at Kaiser Permanente Medical Care Program, Northern California, 1991-1994. MAIN OUTCOME MEASURES: VAERS reporting rates for each vaccine by manufacturer were calculated from the numbers of reported events occurring within 30 days of HepB vaccination and the number of doses distributed by the manufacturers. VSD event rates for each vaccine were calculated from the numbers of hospitalization or emergency room visits within 30 days of HepB vaccination and the number of vaccine doses administered to the cohort. RESULTS: In VAERS, higher rates of serious events (i.e., life threatening or resulting in hospitalization or permanent disability) were reported in children who received Vaccine A vs. Vaccine B (relative risk [RR]: 3.13-8.18, P < 0.01), particularly by those vaccinated in the private (RR: 7.62-28.58, P < 0.01), but not public sector (RR: 2.12, P = 0.19). Similar types of events were reported in recipients of both vaccines. In contrast, analysis of VSD data showed no significant difference in rates of hospitalization or ER visits in children who received either HepB vaccine (RR: 0.96-1.25, P > 0.05). CONCLUSIONS: Our investigation reveals that it is unlikely there is a true difference between rates of serious events temporally associated with the two HepB vaccines in children. This study demonstrates the dual roles played by VAERS and VSD in providing a more complete picture of the post-marketing safety profile of childhood vaccines, and underscores the importance of using other analytic studies to evaluate findings from passive surveillance systems of adverse events.

Adverse Drug Reaction Reporting Systems↗

Ocular search during line bisection. The effects of hemi-neglect and hemianopia.

We examined ocular fixations during line bisection in five patients with left hemianopia, two patients with right hemianopia, nine patients with left hemi-neglect and nine normal control subjects. Compared with measures in control subjects, the median fixation, and left- and rightmost fixations were shifted contralaterally in patients with hemianopia alone and ipsilaterally in patients with hemi-neglect. The fixation with the longest duration and the bisection point were also shifted contralaterally with hemianopia and ipsilaterally with hemi-neglect. However, the number of fixations and the spatial range spanned by fixations did not differ between the groups, showing that ocular exploration was not truncated in any group. Only some patients showed a previously reported directional search bias. Overall, there was no directional bias in saccadic number or amplitude. The distribution of fixations was most dense at the centre of the line in normal subjects, while hemianopic patients fixated most frequently at the ends of lines in their contralateral (blind) hemispace and at a central locus that was biased slightly contralaterally, as was their bisection judgement. This contralateral bias may reflect either an adaptive contralateral attentional gradient or a non-veridical spatial representation within the remaining normal hemifield. Hemi-neglect patients had a broad distribution of fixation peaks in the ipsilateral hemispace. Of two hemi-neglect patients with many fixations, one clustered fixations at a position right of centre, as if a normal fixation pattern was shifted rightward, while the other had two fixation peaks: one to the far right and the other near the centre of the line, reminiscent of the dual peaks of activity seen in some recent hemi-neglect models. These data reveal a heterogeneity in the routes by which right-biased judgements of spatial centre are reached by hemi-neglect patients.

Adult↗

Failure to awaken after general anesthesia due to cerebrovascular events.

Failure to awaken after general anesthesia is a rare complication that may be caused by residual drug effect, systemic abnormalities, or neurologic injury. Failure to awaken often is initially attributed to residual drug effect, potentially delaying correct diagnosis. Three cases of failure to awaken because of neurologic injury are reviewed. Differential diagnosis of failure to awaken is discussed, and the importance of distinguishing pathologic causes from residual anesthetic is stressed.

Aged↗

Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria.

OBJECTIVE: To improve clinical recognition and provide research diagnostic criteria for three clinical syndromes associated with frontotemporal lobar degeneration. METHODS: Consensus criteria for the three prototypic syndromes-frontotemporal dementia, progressive nonfluent aphasia, and semantic dementia-were developed by members of an international workshop on frontotemporal lobar degeneration. These criteria build on earlier published clinical diagnostic guidelines for frontotemporal dementia produced by some of the workshop members. RESULTS: The consensus criteria specify core and supportive features for each of the three prototypic clinical syndromes and provide broad inclusion and exclusion criteria for the generic entity of frontotemporal lobar degeneration. The criteria are presented in lists, and operational definitions for features are provided in the text. CONCLUSIONS: The criteria ought to provide the foundation for research work into the neuropsychology, neuropathology, genetics, molecular biology, and epidemiology of these important clinical disorders that account for a substantial proportion of cases of primary degenerative dementia occurring before the age of 65 years.

Dementia↗