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PubMed2000

A simple method to quantify staphylococcal protein A in the presence of human or animal IgG in various samples.

Immunoassays designed to measure low concentrations of staphylococcal protein A (SPA) that have been leached into antibody preparations intended for therapeutic use are subject to differing degrees of interference. Methods established to quantify SPA in murine antibody preparations are not accurate in the presence of human or humanized IgG. We report the development of an enzyme-linked immunosorbent assay (ELISA) for SPA with a detection limit of 7 pg/ml and the optimization of a method that permits complete dissociation of SPA-immunoglobulin-complexes. This assay is a modification of our heat-mediated dissociation (HD-SD) treatment with sodium dodecyl sulfate (SDS) and diethylenetriaminepentacetic acid (DTPA) for total immune-complex dissociation, in which the heat treatment has been prolonged and the diluent is characterized by increased protein content and buffering capacity. The diluent developed contains SDS, DTPA and bovine serum albumin dissolved in a 0.1 M phosphate buffer (pH 7.2). To validate the efficiency of this novel method, a series of samples have been assayed, including samples reconstituted in vitro, samples of purified antibodies, and plasma from patients. The described method has been shown to be generally efficient in quantitating all native and recombinant SPA in samples containing up to 50 mg/ml of human IgG. These data demonstrate the utility of this technique in determining SPA contamination of recombinant immunoglobulin therapeutic products.

Antibodies↗
PubMed2006

Quality of life, social participation, appraisals and coping post spinal cord injury: a review of four community samples.

STUDY DESIGN: Cross-sectional or psychotherapy, questionnaire. OBJECTIVES: To examine the community needs of people with spinal cord injury (SCI) across four European countries and to identify areas of unmet needs. It is intended that this information will be of use to rehabilitation professionals in fostering greater social participation among SCI individuals. SETTING: United Kingdom, Germany, Austria and Switzerland. METHODS: Self-report questionnaires were sent to 1000 people with SCI resident in the community in the UK, Germany, Austria and Switzerland. Questionnaires measured current needs, community integration, mood, appraisals, coping strategies, functional independence and perceived manageability. RESULTS: Occupation, sexual activity and pain relief were areas indicative of highest community needs in all four countries. Most participants were psychologically well adjusted and socially integrated into the community. Well-addressed needs were skin management, wheelchair needs and accommodation. Some differences that occurred in certain areas across the four countries were found. CONCLUSION: This study has highlighted that the main areas of unmet needs for a European community sample of people with SCI includes levels of occupation, sexual activity and pain relief. The findings will be of interest to those involved in rehabilitation of newly as well as long-term injured people and demonstrate the need to consistently re-address such issues as part of a person's long-term rehabilitation in order to achieve and maximise effective social participation.

Adaptation, Psychological↗
PubMed2006

Temporally and spectrally resolved sampling imaging with a specially designed streak camera.

We present a novel sampling imaging technique capable of performing simultaneous two-dimensional measurements of the temporal and spectral characteristics of light-emission processes by use of a specially designed streak camera. A proof-of-principle experiment was performed with a homemade multifocal multiphoton fluorescence microscope. The system was calibrated with a Fabry-Perot etalon and a standard fluorophore solution (rhodamine 6G in ethanol) and was shown to have temporal and spectral resolution of 6.5 ps and 3 nm, respectively, as well as high accuracy and reproducibility in lifetime and spectrum measurement. Temporally and spectrally resolved images of 4 x 4 foci on the sample can be obtained with a snapshot.

Equipment Design↗
PubMed1987

Optimal restricted two-stage designs.

The fixed sample p value at the final stage of a group sequential design may be "significant" while the overall p value for the trial as designed may be "nonsignificant." This can lead to confusion in reporting and interpreting final stage results. Two-stage designs are presented that allow acceptance, rejection, or continuation at the first stage while retaining the fixed sample critical value at the second stage. The designs are optimized under this restriction to minimize the expected sample size under the null hypothesis, the expected sample size under a specific alternative hypothesis, or the maximum expected sample size. These restricted designs are almost fully efficient when compared to optimal unrestricted two-stage designs. Additionally, one can interpret the results of hypothesis tests at the final stage as though a fixed sample design had been used. Examples are given which illustrate the use of these restricted plans in the design and analysis of clinical trials.

Biometry↗
PubMed1993

Determinants of non-spatial working memory deficits in rats given intraventricular infusions of the NMDA antagonist AP5.

Two series of experiments using rats assessed the effects of intraventricular administration of the NMDA antagonist AP5 on performance of non-spatial working memory tasks. The first series used a continuous delayed non-matching to sample (DNMS) design; the second series used a discrete trial delayed matching to sample (DMS) design. Performance was assessed at retention intervals ranging from approximately 5 to 90 sec. The subjects had acquired the behavioural tasks before drug testing commenced. In the DNMS series, minipumps containing vehicle, 5, 10 or 15 nM D-AP5 were implanted. Every 10 days, each rat's minipump was removed and replaced with a fresh pump containing a new drug dose in a counterbalanced design, so that all rats were tested under all four conditions. There were no drug effects on performance at any retention interval. In the DMS series, there were three different basic task variants. Minipumps filled either with 15 mM D-AP5 or vehicle solution were implanted. Vehicle rats performed at approximately pre-operative levels; AP5 rats were impaired only on task variants using repeated stimulus presentations within session. There was no interaction between retention interval and drug treatment. This pattern of results closely resembles that seen following hippocampectomy or fornicotomy, as would be expected if this drug, administered intraventricularly, selectively affected hippocampal function.

2-Amino-5-phosphonovalerate↗
PubMed1995

A test to measure lift capacity of physically impaired adults. Part 2--Reactivity in a patient sample.

STUDY DESIGN: Test reactivity is the based on the idea that experience with a test may affect performance on subsequent tests, independent of what the test purports to measure. The reactivity of a test of lift capacity was studied in a single-blind randomized clinical trial was studied in a single-blind randomized clinical trial in which subjects were assigned to one or two groups. One group received lift testing before and after a therapeutic trial, while the other group received lift testing only at the conclusion of the therapeutic trial. OBJECTIVE: To measure the reactivity of a lift capacity test over the course of treatment. SUMMARY OF BACKGROUND DATA: The reactivity of a test is an important criterion by which an outcome measure must be judged. Change in response to treatment is assumed to be independent of changes resulting from the evaluee's experience with the test, although this is rarely addressed. METHODS: The EPIC Lift Capacity test was administered to 55 patients with low back pain in a treatment program after they were randomized into a pre-test/post-test and a post-test only group. Additional measures were taken on a pre-test/post-test basis for all subjects. RESULTS: Analyses of variance demonstrated no difference between the randomized groups after treatment. However, the pre-test/post-test group demonstrated significant improvement over the course of treatment. Other measures of outcome were similarly affected. CONCLUSION: The reactivity of the EPIC Lift Capacity test was negligible over an 8-week treatment regimen that did not include lifting tasks.

Adult↗
PubMed1996

Quantified pain drawing in subacute low back pain. Validation in a nonselected outpatient industrial sample.

STUDY DESIGN: The criterion and construct validities of pain drawing, quantified by a simple total body area score of pain extent (area raw extent assessment score), were analyzed prospectively on consecutive patients (n = 103), drawn from a predefined blue collar worker population, all sick listed for 6 weeks as a result of low back pain. OBJECTIVES: To evaluate the validity of pain drawing as a screening tool in the secondary prevention of subacute low back pain. SUMMARY OF BACKGROUND DATA: Pain drawings have been used clinically for more than 40 years as a complement to a patient's verbal pain descriptions. The main objectives have been to differentiate functional pain from organic pain and to identify meaningful features in spatial-anatomic pain distribution. The ability of the pain drawing to delineate concurrent psychopathology correctly has been questioned. There is no consensus on which scoring method should be used. METHODS: The area raw extent assessment score was analyzed concurrently against the penalty point system and predictively against return to work and absenteeism over a period of 2 years. Content and construct validity assessed the relative influence of medical, psychologic, and subjective disability as well as psychosocial factors. RESULTS: Criterion validation of the area raw extent assessment score showed significant correlations, both concurrently against the penalty point score (r = 0.86, P < 0.001, with explained variance R2 = 0.75, P < 0.001) and predictively against occupational handicap (r = 0.48, P < 0.001). In construct validation, the highest explained variance was shown for medical (R2 = 0.46, P < 0.001) and psychologic factors (R2 = 0.46, P < 0.001) and psychologic factors (R2 = 0.34, P < 0.001) and for subjective disability (R2 = 0.32, P < 0.001). Variance in the area raw extent assessment score also was explained by psychosocial factors (R2 = 0.19, P < 0.01). CONCLUSIONS: Pain drawing quantification of the extent of pain shows high criterion and construct validity for the area raw extent assessment score. Content validity could be shown for significant clinical aspects of the disability experience--assets preferred for a screening tool in secondary prevention.

Activities of Daily Living↗
PubMed2006

Worker recovery expectations and fear-avoidance predict work disability in a population-based workers' compensation back pain sample.

STUDY DESIGN: Prospective, population-based cohort study. OBJECTIVES: To examine whether worker demographic, pain, disability, and psychosocial variables, assessed soon after work-related back pain disability onset, predict 6-month work disability. SUMMARY OF BACKGROUND DATA: Greater age, pain, and physical disability, and certain psychosocial characteristics may be risk factors for prolonged back pain-related work disability, although many studies have been small, findings have been inconsistent, and some psychosocial variables have not been examined prospectively. METHODS: Workers (N = 1,068) completed telephone interviews assessing demographic, pain, disability, and psychosocial variables 18 days (median) after submitting Workers' Compensation back pain disability claims. Administrative measures of work disability 6 months after claim submission were obtained. RESULTS: At 6 months, 196 workers (18.4%) were receiving work disability compensation. Age, race, education, and baseline pain and disability were significant predictors of 6-month disability. Adjusting for baseline demographics, pain, disability, and other psychosocial variables, high work fear-avoidance (odds ratio, 4.6; 95% confidence interval, 1.6-13.7) and very low recovery expectations (odds ratio, 3.1, 95% confidence interval, 1.5-6.5) were significant independent predictors. CONCLUSIONS: Among individuals with acute work-related back pain, high pain and disability, low recovery expectations, and fears that work may increase pain or cause harm are risk factors for chronic work disability.

Adolescent↗
PubMed1989

A program for the computation of power and determination of sample size in hierarchical experimental designs.

We have devised a program that allows computation of the power of F-test, and hence determination of appropriate sample and subsample sizes, in the context of the one-way hierarchical analysis of variance with fixed effects. The power at a fixed alternative is an increasing function of the sample size and of the subsample size. The program makes it easy to obtain the power of F-test for a range of values of sample and subsample sizes, and therefore the appropriate sizes based on a desired power. The program can be used for the 'ordinary' case of the one-way analysis of variance, as well as for hierarchical analysis of variance with two stages of sampling. Examples are given of the practical use of the program.

Analysis of Variance↗
PubMed2004

The effect of HMOs on the inpatient utilization of medicare beneficiaries.

OBJECTIVE: To determine the effect of joining HMOs (health maintenance organizations) on the inpatient utilization of Medicare beneficiaries. DATA SOURCES: We linked enrollment data on Medicare beneficiaries to patient discharge data from the California Office of Statewide Health Planning and Development (OSHPD) for 1991-1995. DESIGN AND SAMPLE: A quasi-experimental design comparing inpatient utilization before and after switching from fee-for-service (FFS) to Medicare HMOs; with comparison groups of continuous FFS and HMO beneficiaries to adjust for aging and secular trends. The sample consisted of 124,111 Medicare beneficiaries who switched from FFS to HMOs in 1992 and 1993, and random samples of 108,966 continuous FFS beneficiaries and 18,276 continuous HMO enrollees yielding 1,227,105 person-year observations over five years. MAIN OUTCOMES MEASURE: Total inpatient days per thousand per year. PRINCIPAL FINDINGS: When beneficiaries joined a group/staff HMO, their total days per year were 18 percent lower (95 percent confidence interval, 15-22 percent) than if the beneficiaries had remained in FFS. Total days per year were reduced less for beneficiaries joining an IPA (independent practice association) HMO (11 percent; 95 percent confidence interval, 4-19 percent). Medicare group/staff and IPA-model HMO enrollees had roughly 60 percent of the inpatient days per thousand beneficiaries in 1995 as did FFS beneficiaries (976 and 928 versus 1,679 days per thousand, respectively). In the group/staff model HMOs, our analysis suggests that managed care practices accounted for 214 days of this difference, and the remaining 489 days (70 percent) were due to favorable selection. In IPA HMOs, managed care practices appear to account for only 115 days, with 636 days (85 percent) due to selection. CONCLUSIONS: Through the mid-nineties, Medicare HMOs in California were able to reduce inpatient utilization beyond that attributable to the high level of favorable selection, but the reduction varied by type of HMO.

Aged↗
PubMed2003

Prospective evaluation of a 21-sample needle biopsy procedure designed to improve the prostate cancer detection rate.

OBJECTIVES: To evaluate prospectively the diagnostic yield of a 21-sample ultrasound-guided needle biopsy procedure for prostate cancer in patients with elevated serum prostate-specific antigen and/or abnormal digital rectal examination findings. METHODS: Between December 2000 and May 2002, 303 patients underwent 21-sample needle biopsy under local anesthesia, comprising sextant biopsies at a 45 degrees angle, 3 biopsies in each peripheral zone at an 80 degrees angle, 3 biopsies in each transition zone (TZ), and 3 biopsies in the midline peripheral zone. Morbidity was assessed clinically. A short questionnaire was filled out by 90 consecutive patients. RESULTS: The cancer detection rate using 6 biopsy samples (sextant biopsies only), 12 samples (sextant plus lateral biopsies), 18 samples (sextant plus lateral plus TZ biopsies), and 21 samples (sextant plus lateral plus TZ, plus midline biopsies) was 22.7%, 28.3%, 30.7%, and 31.3%, respectively. The 21-sample procedure statistically improved the cancer detection rate by 37.9% relative to the 6-sample procedure. The improvement was most marked in patients with a prostate volume of more than 40 cm(3) (48.3%), patients with Stage T1c prostate disease (44.9%), patients undergoing repeat biopsy (66.2%), and patients with prostate-specific antigen levels greater than 10 ng/mL (38.5%). Adverse effects were infrequent (3%), consisting of prostatitis in 3 patients, acute urinary retention in 6 patients, and rectal bleeding requiring hospitalization in 1 patient taking aspirin. Using the questionnaire, 84% of patients reported macroscopic hematuria for an average of 3.4 days and hematospermia for 12.8 days, and 45% reported minor rectal bleeding lasting 1.1 days. The mean pain score, with a visual analog scale ranging between 0 (no pain) and 10 (intense pain), was 4.56. CONCLUSIONS: A 21-sample needle biopsy procedure increased the prostate cancer detection rate relative to a 6-sample procedure, without increasing morbidity. Patients with elevated prostate-specific antigen values should undergo sextant biopsies and at least 6 additional biopsies in the peripheral zone and 6 in the TZ.

Aged↗
PubMedDate not supplied

Construction and evaluation of an aerosol generating apparatus for combustion products from polyurethane foam.

A system has been constructed and evaluated for generating aerosols from combustion or pyrolysis of various cross-linked polymers. The system consists of an aerosol generator and an aerosol chamber with a sampling compartment designed for various samplers and sampling probes. A geared electric motor assembly is used to lower a polymer strip into the controlled atmosphere of a quartz-lined furnace. The polymer used in this investigation was a polyurethane foam (PUF) based on toluene diisocyanate (TDI). Combustion of the PUF was conducted in filtered air at a temperature of 300 degrees C. The particle number concentration of the generated aerosol was measured by light scattering in the particle size range from 0.1 micron to greater than 5 microns. Air samples were collected periodically in impinger flasks using dibutylamine (DBA) in toluene as derivatization reagent. The TDI-DBA derivatives from the impinger samples were analyzed with high performance liquid chromatography. The aerosol generating system was found to generate a stable, reproducible, and predictable concentration of particles and TDI monomer. Three partial least squares models were created to evaluate the generator. The investigated responses were the TDI concentration, the particle number concentration, and the stability of the particle number concentration during the generating process. The factor with most impact on the concentrations of the generated aerosol was found to be the interaction between linear feeding rate of the polymer strip and the flow rate of combustion gas. For stability the linear feeding rate was the most important.

Aerosols↗
PubMed1999

Classifier design for computer-aided diagnosis: effects of finite sample size on the mean performance of classical and neural network classifiers.

Classifier design is one of the key steps in the development of computer-aided diagnosis (CAD) algorithms. A classifier is designed with case samples drawn from the patient population. Generally, the sample size available for classifier design is limited, which introduces variance and bias into the performance of the trained classifier, relative to that obtained with an infinite sample size. For CAD applications, a commonly used performance index for a classifier is the area, Az, under the receiver operating characteristic (ROC) curve. We have conducted a computer simulation study to investigate the dependence of the mean performance, in terms of Az, on design sample size for a linear discriminant and two nonlinear classifiers, the quadratic discriminant and the backpropagation neural network (ANN). The performances of the classifiers were compared for four types of class distributions that have specific properties: multivariate normal distributions with equal covariance matrices and unequal means, unequal covariance matrices and unequal means, and unequal covariance matrices and equal means, and a feature space where the two classes were uniformly distributed in disjoint checkerboard regions. We evaluated the performances of the classifiers in feature spaces of dimensionality ranging from 3 to 15, and design sample sizes from 20 to 800 per class. The dependence of the resubstitution and hold-out performance on design (training) sample size (Nt) was investigated. For multivariate normal class distributions with equal covariance matrices, the linear discriminant is the optimal classifier. It was found that its Az-versus-1/Nt curves can be closely approximated by linear dependences over the range of sample sizes studied. In the feature spaces with unequal covariance matrices where the quadratic discriminant is optimal, the linear discriminant is inferior to the quadratic discriminant or the ANN when the design sample size is large. However, when the design sample is small, a relatively simple classifier, such as the linear discriminant or an ANN with very few hidden nodes, may be preferred because performance bias increases with the complexity of the classifier. In the regime where the classifier performance is dominated by the 1/Nt term, the performance in the limit of infinite sample size can be estimated as the intercept (1/Nt= 0) of a linear regression of Az versus 1/Nt. The understanding of the performance of the classifiers under the constraint of a finite design sample size is expected to facilitate the selection of a proper classifier for a given classification task and the design of an efficient resampling scheme.

Computer Simulation↗
PubMed2005

Coping strategies and anxiety in caregivers of people with Alzheimer's disease: the LASER-AD study.

BACKGROUND: Caregivers of people with dementia (CGPD) frequently have anxiety symptoms but little is known about the relationship of anxiety with coping strategies. METHOD: 126 people with Alzheimer's disease (AD) and their family caregivers living in the community were recruited from local psychiatric services, the voluntary sector and care homes. Sampling was designed to ensure that the sample was epidemiologically representative in terms of dementia severity, gender and care setting. We used the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) to measure anxiety and the Brief COPE to measure coping strategies. RESULTS: Use of dysfunctional coping strategies (Wald = 7.3, p = 0.007) and HADS depression caseness (Wald = 14.0, p < 0.001) were the only factors that predicted HADS anxiety caseness on logistic regression. LIMITATIONS: Anxious caregivers may be more likely to report their coping strategies negatively; these results do not clarify direction of causality. CONCLUSIONS: Dysfunctional coping strategies and depression appear to be the most important factors predicting caregiver anxiety. Addressing coping strategies may be a helpful intervention for managing caregiver anxiety.

Adaptation, Psychological↗
PubMed2005

Improvement of cytomegalovirus avidity testing by adjusting the concentration of CMV-specific IgG in test samples.

BACKGROUND: Human cytomegalovirus (CMV) is the most common cause of viral intrauterine infection. Primary CMV infection in early pregnancy bears a high risk of fetal damage. Accurate measurement of CMV-specific IgG avidity may help to improve the serodiagnosis of CMV-infected women by determining the time of infection and fetal outcome. OBJECTIVES: To study the performance of the CMV avidity assay with the fully automated Vidas analyzer (bioMérieux) as a function of the concentration of CMV-specific IgG present in the serum sample. STUDY DESIGN: Eighty-two serum samples were investigated from 3 clinical scenarios: 18 individuals with sera negative for CMV-specific IgG and IgM (control group), 20 pregnant women (44 samples) containing CMV-specific IgG- and IgM-antibodies suggesting acute or recent primary infection and 20 patients with evidence of past infection (CMV-IgG positive and CMV-IgM negative). RESULTS: In the group with presumed acute or recent primary infection 12 of 44 sera had CMV-specific IgG values above 100 arbitrary units (AU, bioMérieux)/ml and in these cases an increase in AI was measurable upon dilution of the serum sample. In two cases, AI's were shifted towards or above the cut-off value of AI>or=0.8, indicative of past infection. Dilution of sera which were CMV-specific IgM positive and had specific IgG concentrations of <or=100 AU/ml produced only minor changes in AI. In individuals with serology indicative of past infection, dilution effects similar to the group of acute or recently infected individuals were observed and if CMV-specific IgG was above 100 AU/ml an increase in AI to above or equal to the cut-off could only be calculated after serum dilution. CONCLUSIONS: The results obtained from undiluted patients' sera with high CMV-IgG concentrations indicate that falsely low avidity indices are obtained if these sera are not diluted to below an empirically determined CMV-specific IgG concentration. In addition, the cut-off value for this commercial CMV-IgG avidity assay should be revised.

Antibodies, Viral↗
PubMedDate not supplied

Morphologic characteristics of p16INK4a-positive cells in cervical cytology samples.

OBJECTIVE: Overexpression of p16INK4a has been proposed as a biomarker helpful for the identification of dysplastic cervical epithelial cells on histologic slides as well as in cervical smears. Since a few nontransformed cells in the genital tract in some instances may also express p16INK4a, we evaluated whether applying established morphologic criteria for cervical dysplasia allows a distinction of dysplastic from nondysplastic p16INK4a-stained cells in cytologic samples. STUDY DESIGN: Liquid-based cytology samples were obtained from a screening population (n=50), and from patients attending a dysplasia clinic (n=40). Slides prepared from these samples were stained with the conventional Papanicolaou stain procedure. From each specimen, a second slide was prepared in parallel and immunostained for p16INK4a. Cytologic diagnoses for most patients attending the dysplasia clinic could be compared to the reported histologic diagnoses on punch biopsy samples taken from the patients at the time of colposcopy. This allowed a comparison of the cytology and p16INK4a immunostaining results with subsequent hematoxylin and eosin-based histologic diagnoses. RESULTS: Overall, in 10% of slides obtained from patients with nonsuspicious smears, few p16INK4a-positive cells were found. Using established morphologic criteria and applying these criteria on cells showing any p16INK4a immunoreactivity, p16INK4a-positive normal or metaplastic cells could be discriminated from p16INK4a-expressing dysplastic cells. In 21 of 22 cases (95%) of high grade lesions (cervical intraepithelial neoplasia 2 or higher in follow-up histology), easily recognizable p16INK4a-positive dysplastic cells could be detected, with the remaining case lacking dysplastic cells in the thin-layer slide used for p16INK4a immunostaining. CONCLUSION: Established morphologic criteria for cervical dysplasia can be readily applied to p16INK4a-immunostained cytologic specimens. Thus, p16INK4a immunostaining may help to avoid ambiguities in the interpretation of cervical cytology samples and facilitate more rapid diagnosis and possibly even automated screening of cytologic slides.

Aged↗
PubMedDate not supplied

Evaluation of fine needle capillary sampling in superficial and deep-seated lesions. An analysis of 670 cases.

OBJECTIVE: To study the efficacy and merits of a simplified cytologic technique of fine needle capillary (FNC) sampling in 670 cases. STUDY DESIGN: FNC sampling was tested on a consecutive series of 600 superficial palpable masses and 70 deep-seated lesions during the period January 1993-September 1993. Among superficial masses, sampling was done on 380 lymph nodes, 88 breast lesions, 56 thyroids, 12 salivary glands and 64 miscellaneous sites. Fifty-five lung lesions were sampled using 8 computed tomography, while 15 abdominal masses were sampled using ultrasonography. Cell samples were assessed as diagnostically adequate or inadequate. RESULTS: The diagnostic adequacy in lymph node, breast and thyroid lesions was 95%, 91.07% and 90.09%, respectively. The diagnostic adequacy for deep-seated lesions was 91.42%. CONCLUSION: The procedure gives a better perception of tumor consistency and control of the hand. FNC resulted in a high yield of good-quality material with retention of cellular architecture. It is recommended that the operator become familiar with the macroscopic slide appearance of a cellular smear. Doubts persist with respect to fibrotic and cystic lesions.

Adult↗