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Fallopian tube tissue obtained at Pomeroy sterilization of 75 normally cycling women, 75 women 2 to 3 days postpartum, and 75 asymptomatic women who had used a nonmedicated IUD for at least a year was examined histologically. There was an increased frequency of tissue edema and congestion in the postpartum group only. The frequency and extent of acute inflammatory changes in the three groups was not significantly different.
BACKGROUND: We used polymerase chain reaction to search for nucleic acid sequences of several viruses in DNA and RNA extracted from brain tissues of schizophrenic and control subjects. METHODS: We extracted DNA and RNA templates from frozen brain specimens of 31 patients with schizophrenia and 23 nonschizophrenic control patients with other diseases. The extracts were subjected to polymerase chain reaction with oligonucleotide primers for 12 different viruses (cytomegalovirus, Epstein-Barr virus, herpes simplex virus type 1, human herpesvirus type 6, varicellazoster virus, measles virus, mumps virus, rubella virus, the picornavirus group, influenza A virus, human T-cell lymphotropic virus type I, and St Louis encephalitis virus), several of which have been suspected of involvement in schizophrenia. Nested primers were used to increase the sensitivity of the method. RESULTS: No amplified nucleic acid sequences encoded by the selected viral genomes were detected in extracts of any brain specimens from either schizophrenic or control patients. CONCLUSIONS: These data agree with previous studies that failed to find sequences of a number of viruses in the cerebrospinal fluid or selected areas of the brains of schizophrenic patients. Additional efforts should be undertaken to identify other known and unknown pathogens in schizophrenia, sampling more areas of the brain from subjects with a variety of clinical types of schizophrenia.
The cellular compatibility of each of several brands of urinary catheters available on the Australian market was measured by means of cell-culture methods, a rabbit intramuscular implant test, and the traditional mouse systemic toxicity test. Good agreement was obtained between the in-vitro tests and the rabbit implant tests (although the cell-culture tests were simpler, more rapid, more sensitive, and quantitative). The mouse systemic toxicity test was insensitive, and detected no toxic samples. The cell-culture and rabbit-implant test results indicated that some urinary catheters can release substances harmful to mammalian cells. Such substances may contribute to the clinical reactions of urethritis and strictures after urethral catheterization.
Evolving statistical concepts and innovative trial designs for heart failure (HF) clinical trials seek to improve the conduct, efficiency, and likelihood of meaningful evidence generation crucial for advancing therapeutic development and optimizing patient care. HF trials with conventional statistical frameworks often require large sample sizes, long follow-up times, and high cost to generate sufficient evidence. Novel statistical methodologies would be of interest if they could address these issues while retaining or enhancing the clinical relevance and reliability of results. The HFC (Heart Failure Collaboratory), comprising clinical investigators, clinicians, statisticians, patients, government representatives, payors, and industry collaborators, leads efforts to improve HF research methodologies. HFC discussions have included statistical concepts such as the estimand framework, HR drift, and analytic methods, including the win ratio and restricted mean survival time, that have not been used frequently in HF trials. The estimand framework encourages precise definition and alignment of trial objectives with trial design. The win ratio method attempts to incorporate and prioritize multiple clinically meaningful outcomes by using a hierarchy of clinical importance. The restricted mean survival time provides an alternative to the HR as a measure of therapeutic effect by quantifying the mean time gained or lost during a fixed time after randomization. This paper provides a critical review of some evolving HF trial design methodologies and statistical concepts for the HF community as discussed within the HFC. Our goal is to foster collaboration among diverse stakeholders and advance the development of effective treatments and improve patient care outcomes.
Antibiotic dipping with gentamicin sulfate by means of the temperature-differential method was effective in reducing but not completely eliminating Arizona hinshawii (7:1, 7, 8) from artificially infected turkey hatching eggs. Embryonic development was well maintained. The antibiotic dip solution intake was variable from egg to egg. Removal of cuticle by means of either 0.2 N HCl or a 10% disodium salt of ethylene diamine tetraacetic acid enhanced egg weight gains and maintained good embryonic development. Complete elimination of A. hinshawii was achieved in one experiment out of four. Correlation studies between egg weight gains and gentamicin concentrations of the contents of the turkey hatching eggs indicated a statistically significant relationship between these two parameters.
Six centers participated in comparative studies of female sterilization conducted by the international Fertility Research Program. The incidence of technical failures (or failed attempts) was compared between patients sterilized with the tubal ring and those sterilized with other tubal occlusion techniques. The tubal ring was associated with a higher failure rate than electrocoagulation, the Rocket clip, or the modified Pomeroy technique. Of 1,035 tubal ring sterilizations, there were 38 technical failures. Reasons given by the operators for the failures, by frequency of occurrence, were surgical complications, conditions preexisting in the patients, and problems with the instruments. Most of these failures were remedied by changing to other techniques. In two patients, the procedure was completed by changing the approach from laparoscopy to laparotomy. In five others, sterilization was not completed. Case-control analysis was performed and three risk factors were delineated: obesity, prior use of an intrauterine contraceptive device and previous abdominal operations.
Biocompatibility tests have been compared for their suitability as routine safety tests for urinary catheters. Latex catheters from five manufacturers were tested by each of the following four methods: (1) a cell culture cytotoxicity assay of catheter extracts, (2) intracutaneous injection of the extracts into rabbits, (3) intramuscular implant of catheter pieces into rabbits, (4) catheterization of sheep (mucous membrane irritation). The rabbit intracutaneous and intramuscular tests are both current pharmacopoeial methods for ascertaining the suitability of polymers for medical use. The four tests each showed a cell or tissue response ranging from no detectable change to severe damage, according to the catheter batch or brand, and they each identified the same samples as most toxic and least toxic. However, they differed in sensitivity. The sheep test and the cell culture assay discriminated between catheters of intermediate toxicity and ranked as toxic catheters not identified as such by the two pharmacopoeial tests. The sheep test most closely approximates clinical usage, but is impractical for routine use. The cell culture assay is a suitable alternative. It also has the advantages of a clearly defined endpoint, good sensitivity, reproducibility, speed, and reduced animal usage.
Studies of the role of leptin in patients with anorexia nervosa and bulimia nervosa have conflicted in their data and interpretation. Such differences may be a result of the assay methods used or the way results are compared with those from normal controls. To investigate these possibilities, we analyzed serum leptin levels in anorexic, bulimic, obese, and control individuals, thereby spanning the full range of human body weights, using three frequently employed commercial kits. Kits from Linco (St Louis, MO) and DSL (Webster, TX) employ a radioimmunoassay method, and the R&D Systems kit (Minneapolis, MN) uses an enzyme-linked immunosorbent assay. We found that the three kits provide results that are highly linearly correlated with each other and remarkably linearly related to percent ideal body weight (%IBW) over more than three orders of magnitude (Linco, r = 0.90; R&D, r = 0.87; DSL, r = 0.86). For very low leptin levels, the more sensitive kits from R&D and Linco appeared to give more reliable results. Measurement method does not appear to explain the literature conflicts. We found that patients with anorexia nervosa have serum leptin values that lie above the line extrapolated from the %IBW/leptin curve generated from analysis of all non-anorexic patients. Therefore, in anorexia nervosa, inappropriately high leptin levels for %IBW may contribute to a blunted physiologic response to underweight and consequent resistance to dietary treatment. By contrast, most bulimic patients have leptin levels significantly below those predicted from the same %IBW/leptin curve. The relative leptin deficiency in bulimic subjects may contribute to food-craving behavior. We propose that using the %IBW/ leptin curve can facilitate identification of true pathophysiologic abnormalities in eating-disordered individuals and provide a basis for the design of therapeutic interventions or monitoring of response to treatment.
OBJECTIVE: (1) To find the inter-rater and intra-rater reliability of raters using GaitMat II to measure tempo-spatial gait parameters of stroke patients. (2) To find if reliability is related to abnormality of footprint patterns. DESIGN: A prospective agreement study. SETTING: A movement analysis laboratory. SUBJECTS: Nineteen adults who were at least six months after stroke and able to walk 4 metres with or without assistance participated as subjects in this study. There were five raters. METHODS: Subjects completed at least two walks along GaitMat II. The raw footprint data were analysed independently by each of the five raters. RESULTS: Mean intraclass correlation coefficients (ICCs) for each rater within subject ranged from 0.8398 to 0.9318. However eight of the 17 parameters tested showed significant differences between raters (p = 0.0029 to p < 0.0001). When the most inexperienced rater was excluded, differences between experienced raters (n = 4) was found to be statistically insignificant for all parameters. The association of the mean score and standard deviation of experienced raters was significant for nine parameters (r values 0.5087 to 0.9459), i.e., as walking pattern became more abnormal, variation in scoring between raters increased. CONCLUSIONS: GaitMat II may have acceptable inter-rater reliability if raters have experience of gait analysis but disagreement may increase when stroke patients exhibit more abnormal gait patterns.
OBJECTIVE: To describe neuropsychological functioning (with a specific focus on cognition and memory) after surgical treatment of craniopharyngiomas. METHODS: Sixteen patients who were between 6 and 15 years of age at the time of surgery comprised the sample. Each child had been treated for a craniopharyngioma with surgery only, on Dana-Farber Cancer Institute Protocol 92-077. RESULTS: The overall level of cognitive functioning was well within the average range, with both language and visuospatial functioning being generally intact; however, specific memory problems, in both the language and visuospatial domains, were evident. CONCLUSION: Although general cognitive functioning was intact after the surgical treatment of craniopharyngiomas, difficulties in the retrieval of learned information were observed. Neuropsychological assessments, with a focus on memory recall, should be a component of the medical management plan for each child.
We studied cerebral lesions in the streptozotocin-diabetic rat, an established model of diabetic retinopathy. A group of diabetic rats all had cerebral lesions, but showed no gross abnormalities of the brain or signs of effects on the central nervous system. Light and electron microscopy of horizontal brain sections stained by a variety of methods showed focal accumulation of collagen fibrils in the basement membranes of arteriole and capillary walls, slight degeneration of random neuronic cells (mainly in the brain stem), and no evidence of perivascular myelin pallor plaques. A marked tendency toward platelet aggregation, which leads to thrombosis, was also seen. There was no difference between results from rats killed 9 and 12 months after streptozotocin injection. The brain lesions bore a close resemblance to those seen in a nutritional encephalopathy known to be induced by a diet deficient in tocopherol and rich in oxidized oil, but differed from that encephalopathy in that the peculiar hypertrophic cerebral astroglia associated with diabetes resembled Alzheimer Type II astroglia. The differences between these cerebral astroglia and the retinal Müller cells may account for the difference in degree between the effects of diabetes on the brain and the retina.
BACKGROUND: Latinos have low representation in cancer prevention trials and intervention studies. Culturally appropriate recruitment strategies are needed to address this issue. OBJECTIVE: To describe and summarize the effectiveness of recruitment strategies used by the Latin American Cancer Research Coalition (LACRC). DESIGN: Descriptive report of recruitment methods. PARTICIPANTS: Uninsured Latino immigrants (N=1,170; 77% female, 23% male) from Central and South America recruited to 7 cancer control studies. APPROACH: The LACRC recruitment model involved inclusion of Latino researchers and providers, and use of culturally acceptable materials released through culturally appropriate outlets such as Latino radio stations. RESULTS: The overall participation rate was high-96% of patients identified as eligible agreed to participate. Women were excellent referrals for recruiting men to research studies. Additionally, a local Latino radio program was used to efficiently recruit eligible study participants. CONCLUSIONS: Latinos are interested and willing to participate in cancer control studies when culturally relevant approaches are used. Research teams that partner with Latino researchers and with Latino service providers are important in educating Latinos about cancer control and encouraging participation in research.
BACKGROUND: Older women remain predominantly sedentary despite potential health benefits and reduced risks of cardiovascular disease associated with regular exercise. Primary care interventions to increase exercise need to focus on constructs amenable to intervention that predict exercise behavior. PURPOSE: The study tested an explanatory model of older women's exercise behavior using concepts from social cognitive theory, the transtheoretical model, and the theory of planned behavior (self-efficacy, outcome expectancy, perceived exercise barriers, processes of change, perceived health, and age). METHODS: Data were collected by interviews with 203 older community-dwelling women physically capable of some exercise. Ordinary least squares regression results were used to determine the direct and indirect effects in a path model. FINDINGS: All concepts and 13 hypothesized paths were retained in the trimmed model. The constructs accounted for 46% of the variance in exercise behavior. Outcome expectancy had the largest total effect. Processes of change had the largest direct effect on exercise behavior. Exercise self-efficacy and perceived exercise barriers accounted for similar amounts of variance in exercise behavior, whereas age and health had only modest effects. CONCLUSION: Important constructs for future exercise model testing and intervention research should include outcome expectancy, processes of change, exercise self-efficacy, and perceived barriers to exercise. Primary care interventions designed to increase older women's exercise should focus on these same constructs.
BACKGROUND: the central tenet of the neurofacilitatory approach to stroke therapy is that muscle tone needs to be normal before normal movement can occur. A reliable clinical measure of the full spectrum of muscle tone is needed to test: (i) the purported relationship between muscle tone, other motor impairments and disability, and (ii) the effectiveness of stroke therapy to restore movement. AIM: the purpose of the study was to test the inter-rater reliability of clinical categorization of muscle tone (spastic/normal/flaccid) and also a visual analogue scale with anchor points of 'lowest tone possible' (score 0) and 'highest tone possible' (score 100). METHODS: four independent raters assessed tone of elbow flexors and knee extensors of 14 stroke rehabilitation inpatients using the categorical scale. Six independent raters assessed tone of elbow flexors and knee extensors of 25 chronic stroke patients and two healthy volunteers using the visual analogue scale. All assessment orders were randomized. RESULTS: both scales were unreliable, with K coefficients for the categorical scale ranging from -0.046 to 0.56 for the categorical scale, and intra-class correlation coefficients for the visual analogue scale of 0.595 for elbow flexors and 0.451 for knee extensors. Assessment order effects for the visual analogue scale were non-significant for elbow flexors (P= 0.545) and knee extensors (P= 0.911). CONCLUSIONS: these results, and those of earlier studies, suggest that clinical measures of muscle tone are consistently unreliable. Systematic investigation of the therapy rationale for planning and evaluating treatment is required before relevant clinical measures can be developed.
PURPOSE: Stratification of risk in patients with medulloblastoma remains a challenge. As clinical parameters have been proven insufficient for accurately defining disease risk, molecular markers have become the focus of interest. Outcome predictions on the basis of microarray gene expression profiles have been the most accurate to date. We ask in a multivariate model whether clinical parameters enhance survival predictions of gene expression profiles. PATIENTS AND METHODS: In a cohort of 55 young patients (whose medulloblastoma samples have been analyzed previously for gene expression profile), associations between clinical and gene expression variables and survival were assessed using Cox proportional hazards models. Available clinical variables included age, stage (ie, the presence of disseminated disease at diagnosis), sex, histologic subtype, treatment, and status. RESULTS: Univariate analysis demonstrated expression profiles to be the only significant clinical prognostic factor (P=.03). In multivariate analysis, gene expression profiles predicted outcome independent of other criteria. Clinical criteria did not significantly contribute additional information for outcome predictions, although an exploratory analysis noted a trend for decreased survival of patients with metastases at diagnosis but favorable gene expression profile. CONCLUSION: Gene expression profiling predicts medulloblastoma outcome independent of clinical variables. These results need to be validated in a larger prospective study.
PURPOSE: Assessment of dysarthria has traditionally been based on perceptual methods. The purpose of this study was to examine the feasibility of using 2D kinematic analysis to measure lip closure during normal speech. METHOD: Retroflective markers (4 mm diameter) were placed on the midline of each lip of three healthy male, caucasian volunteers aged 69 years who repeated the sentence 'My mother made me an apple and blackberry pie' six times. Videorecordings were analysed using the Ariel Performance Analysis System to calculate the distance between the lips before, during and after the sentence. RESULTS: The graphs produced from the data objectively measured the distance between the lips and identified the eight bilabial sounds. However, in spite of stringent study criteria to minimize differences linked to age, gender and race, differences were found between participants. CONCLUSION: Kinematic 2D analysis may have potential for the objective measurement of lip closure in dysarthria in the context of meaningful speech. These results justify further pilot work to explore: the possible variability within defined populations; and the usefulness of 2D kinematic analysis in the measurement of disordered lip closure in dysarthria.
Conditions required for optimal assay of low levels of activity of hepatic delta-aminolevulinic acid synthetase have been studied, comparing dilute homogenates of mouse, rat, and human livers. The assay method used was a modification of that described by Ebert et al. (Biochim, Biophys, Acta (1970) 208, 236-250), and livers were studied from both untreated animal and human subjects and subjects pretreated with porphyrinogenic compounds. In homogenates of mouse and human but not rat liver, maximal rates of delta-aminolevulinic acid formation required addition to the incubation mixture of an exogenous system for succinyl-CoA generation. The requirement for this generating system was increased if livers from pretreated subjects were frozen and stored prior to assay, suggesting that the endogenous capacity for succinyl-CoA generation was more labile than delta-aminolevulinic acid synthetase under these conditions. Of the metabolic inhibitors tested (F-, malonate, and arsenite), only F- (100 mM final concentration) enhanced activity. Increasing the permeability of mitochondria by quick freeze-thawing of fresh homogenates just before assay did not increase the rate of delta-aminolevulinic acid formation.
BACKGROUND: Although the mortality rate among children with bacterial meningitis has decreased dramatically in recent decades, some patients are left with neurologic sequelae. It has not been clearly established which features of the acute illness predict the chronic neurologic sequelae, including late seizures or epilepsy. METHODS: We followed 185 infants and children prospectively during and after acute bacterial meningitis. The mean duration of follow-up was 8.9 years (range, 0.1 to 15.5). During the first six years standard neurologic examinations were performed; telephone interviews were conducted thereafter. RESULTS: One month after meningitis, 69 children (37 percent) had neurologic abnormalities. Many of these signs resolved within a year, leaving only 26 children (14 percent) with persistent deficits: 18 (10 percent) had only sensorineural hearing loss, and 8 (4 percent) had multiple neurologic deficits. Thirteen children (7 percent) had one or more late seizures not associated with fever. The presence of persistent neurologic deficits indicative of cerebral injury was the only independent predictor of late afebrile seizures (P less than 0.001). CONCLUSIONS: After bacterial meningitis only children with permanent neurologic deficits are at high risk for epilepsy. Those with normal examinations after the acute illness have an excellent change of escaping serious neurologic sequelae, including epilepsy.