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PubMed1986

The Clinical Linguistic and Auditory Milestone Scale (CLAMS). Identification of cognitive defects in motor-delayed children.

The Clinical Linguistic and Auditory Milestone Scale (CLAMS) and Bayley Scales of Infant Development (BSID) were independently administered to 43 children with mild-to-moderate motor delay at 15, 21, and 27 months of age. Highly significant correlations were noted for each examination. Sex, race, and age at time of examination did not significantly influence the relationship between a CLAMS quotient and a Bayley ratio quotient (BRQ). On the first examination gestational age exerted an effect that carried over to the total population. The initial CLAMS quotient also correlated with the results of the CLAMS and BSID administered 12 months later. The CLAMS identified children with a delayed BRQ (less than 70) as follows: sensitivity, 0.66; specificity, 0.79; predictive value of a positive test, 0.80; and predictive value of a negative test, 0.65. The CLAMS provides the pediatrician with a language assessment instrument that adequately detects cognitive deficits in motor-delayed children.

Child Language↗
PubMed1998

Concurrent validity of the GMS-AGECAT (A3) package in a Danish nursing home population.

AIM: To validate the Danish version of the GMS-AGECAT (A3), the Standardized Mini Mental State Examination (SMMSE) and the Geriatric Depression Scale-15 (GDS-15) by comparing them to clinical ICD-10 criteria in a Danish nursing home population. METHODS: With a participation of 91%, the study included 100 residents. All residents were interviewed with the GMS-AGECAT (A3), SMMSE and GDS-15 by an MD and then blindly diagnosed by a consultant geriatric psychiatrist. All residents approached for an interview were included, also those who were not able to communicate (the non-accessibles). RESULTS: The prevalence of clinical psychiatric ICD-10 main diagnoses was 56%. The non-accessibles had significantly higher psychiatric morbidity and lower ADL scores (modified Barthel ADL index) compared to those who were able to communicate. With the non-accessibles (N = 100) included, the optimal screening and diagnostic cutpoint for the GMS-AGECAT organic diagnoses was 2/3, with 96% sensitivity, 73% specificity, 77% predictive value of a positive test and 95% predictive value of a negative test. The SMMSE and GDS-15 had better screening properties compared to the GMS-AGECAT but only 60% of the residents were able to complete the SMMSE and 78% were able to complete the GDS-15. CONCLUSION: The Danish version of the GMS-AGECAT has relevant diagnostic and screening properties for organic disorders in Danish nursing home populations.

Aged↗
PubMed1992

Factors influencing fine-needle aspiration cytology in the management of recurrent gynecologic malignancies.

Over a period of 6.5 years (January 1983 through August 1989) 124 fine-needle aspirations (FNAs) were performed on 95 patients with prior documented primary malignancies of the cervix, ovary, endometrium, and vulva. The significance of clinicopathologic factors which influenced the FNA results was analyzed by statistical methods. The factors studied included the initial patient clinical stage, the time interval between staging and disease recurrence, the treatment modalities, the neoplasm type, the aspiration site, the target lesion size, and the type of radiologic guidance. Primary aspiration sites were pelvic wall and organs (40%), lymph nodes (36%), and liver (21%); 64% were positive, 5% suspicious, 15% negative, and 16% unsatisfactory. The specificity was 100%; sensitivity, 96.3%; predictive value of a positive test, 100%; and predictive value of a negative test, 84.2%. Statistically significant clinicopathologic factors which influenced the FNA results included the target lesion size (P = 0.026) and the aspiration site (P = 0.033). The primary neoplasm type, the time interval between staging and disease recurrence, the initial patient clinical stage, the treatment modalities, and the type of radiologic guidance were not statistically significant. FNA is a reliable procedure in the management of gynecologic malignancy and its results are influenced by clinicopathologic factors.

Adult↗
PubMed1996

Prognostic value of the galactose test in predicting survival of patients with cirrhosis evaluated for liver transplantation. A prospective multicenter Italian study. AISF Group for the Study of Liver Transplantation. Associazione Italiana per lo Studio del Fegato.

AIMS/METHODS: The present study aimed to examine whether the galactose elimination capacity can be used to predict the survival of patients with advanced liver disease. We studied 194 patients with cirrhosis, belonging to Child class B and C, for 2 years each. RESULTS: The overall probability of survival was 79% at 6 months, 72% at 1 year and 62% at 2 years. Variables significantly associated with the duration of survival, as assessed by univariate analysis, were the Child-Pugh score, presence of ascites, size of esophageal varices, prothrombin time, albumin, bilirubin, urea, creatinine, glucose and galactose elimination capacity. By a multivariable analysis, only Pugh score (p = 0.005), creatinine (p < 0.001), varices (p = 0.001) and galactose elimination capacity (p < 0.001) were independent predictors of mortality. The galactose elimination capacity was even more sensitive when the end-point was limited to deaths due to liver failure and hepatorenal syndrome. A new score obtained by summing the Pugh score with a score derived from galactose elimination capacity was quite simple and accurate for predicting survival. CONCLUSIONS: The quantitative measurement of liver function as the galactose elimination capacity could be of use to identify patients with cirrhosis and probable short survival who might benefit most from urgent transplantation.

Adolescent↗
PubMed1991

Value of combined phenotypic markers in identifying inheritance of familial adenomatous polyposis.

Familial adenomatous polyposis is an autosomal dominant disease characterised by the development of hundreds of colorectal adenomas in young adults. Occult radio-opaque jaw lesions and pigmented ocular fundus lesions (formerly called congenital hypertrophy of the retinal pigment epithelium) are extraintestinal phenotypic markers for this disorder. We evaluated the usefulness of the combination of these markers for identifying patients who have inherited familial adenomatous polyposis. Forty three affected patients and 12 unaffected first degree relatives from 24 families with familial adenomatous polyposis, including four families without extraintestinal manifestations, were examined for both phenotypic markers. Thirty three of the 43 patients (77%) with familial adenomatous polyposis were positive for both markers, including patients from two families without extraintestinal manifestations. By contrast, only one of 12 (8%) unaffected first degree relatives over 35 years of age had both markers. The sensitivity of the combination of these markers in identifying patients who inherited familial adenomatous polyposis was 77%, the specificity 92%, the predictive value of a positive test 97%, the predictive value of a negative test 52%, and the efficacy 80%. The combined markers had improved efficacy over either marker alone (70% for occult radio-opaque jaw lesions and 67% for pigmented ocular fundus lesions). We conclude that the presence of both occult radio-opaque jaw lesions and pigmented ocular fundus lesions in a person at risk indicates a high probability of inheritance and expression of familial adenomatous polyposis.

Adenomatous Polyposis Coli↗
PubMedDate not supplied

Evaluation of the PAPNET system for prescreening triage of cervicovaginal smears.

OBJECTIVE: To assess the PAPNET System for prescreening triage of cervical smears. STUDY DESIGN: We prospectively prescreened 5,170 consecutive cervicovaginal smears with the PAPNET System. The slides were then manually screened by cytotechnologists blinded to the PAPNET diagnoses. Cases identified as abnormal by either PAPNET or manual screening were reviewed by a cytopathologist. The PAPNET and manual diagnoses were correlated. RESULTS: Diagnostic concordance between PAPNET and manual screening was seen in 4,340 (84%) of the cases (3,167 negative, 1,038 abnormal and 135 unsatisfactory). Noncorrelation between PAPNET and manual diagnosis occurred in 794 cases (543 abnormal by PAPNET and negative manually, 228 negative by PAPNET and abnormal manually, 8 abnormal by PAPNET and unsatisfactory manually, 29 unsatisfactory by PAPNET and negative manually, 7 negative by PAPNET and unsatisfactory manually). The diagnostic sensitivity of the PAPNET System was 82%, diagnostic specificity 85%, predictive value of a positive test 66% and predictive value of a negative test 93.4%. The false negative fraction of PAPNET was 6.4% for low grade squamous intraepithelial lesion and above. CONCLUSION: PAPNET performed effectively for prescreening triage, increasing the accuracy of screening and reducing the screening time.

Evaluation Studies as Topic↗
PubMed2006

Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens II. Further analysis of mammalian cell results, relative predictivity and tumour profiles.

One of the consequences of the low specificity of the in vitro mammalian cell genotoxicity assays reported in our previous paper [D. Kirkland, M. Aardema, L. Henderson, L. Muller, Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. I. Sensitivity, specificity and relative predictivity, Mutat. Res. 584 (2005) 1-256] is industry and regulatory agencies dealing with a large number of false-positive results during the safety assessment of new chemicals and drugs. Addressing positive results from in vitro genotoxicity assays to determine which are "false" requires extensive resources, including the conduct of additional animal studies. In order to reduce animal usage, and to conserve industry and regulatory agency resources, we thought it was important to raise the question as to whether the protocol requirements for a valid in vitro assay or the criteria for a positive result could be changed in order to increase specificity without a significant loss in sensitivity of these tests. We therefore analysed some results of the mouse lymphoma assay (MLA) and the chromosomal aberration (CA) test obtained for rodent carcinogens and non-carcinogens in more detail. For a number of chemicals that are positive only in either of these mammalian cell tests (i.e. negative in the Ames test) there was no correlation between rodent carcinogenicity and level of toxicity (we could not analyse this for the CA test as insufficient data were available in publications), magnitude of response or lowest effective positive concentration. On the basis of very limited in vitro and in vivo data, we could also find no correlation between the above parameters and formation of DNA adducts. Therefore, a change to the current criteria for required level of toxicity in the MLA, to limit positive calls to certain magnitudes of response, or to certain concentration ranges would not improve the specificity of the tests without significantly reducing the sensitivity. We also investigated a possible correlation between tumour profile (trans-species, trans-sex and multi-site versus single-species, single-sex and single-site) and pattern of genotoxicity results. Carcinogens showing the combination of trans-species, trans-sex and multi-site tumour profile were much more prevalent (70% more) in the group of chemicals giving positive results in all three in vitro assays than amongst those giving all negative results. However, single-species, single-sex, single-site carcinogens were not very prevalent even amongst those chemicals giving three negative results in vitro. Surprisingly, when mixed positive and negative results were compared, multi-site carcinogens were highly prevalent amongst chemicals giving only a single positive result in the battery of three in vitro tests. Finally we extended our relative predictivity (RP) calculations to combinations of positive and negative results in the genotoxicity battery. For two out of three tests positive, the RP for carcinogenicity was no higher than 1.0 and for 2/3 tests negative the RP for non-carcinogenicity was either zero (for Ames+MLA+MN) or 1.7 (for Ames+MLA+CA). Thus, all values were less than a meaningful RP of two, and indicate that it is not possible to predict outcome of the rodent carcinogenicity study when only 2/3 genotoxicity results are in agreement.

Animals↗
PubMed1992

[The role of clinical, biochemical and echographic data in identifying the biliary pathogenesis of acute pancreatitis].

The role of clinical (biliary pain and/or jaundice), laboratory (discriminant function (DF) calculated using AST, ALT, AlkPh and GGT serum values) and ultrasonographic (US)(dilation and/or stone of common bile duct (CBD)) findings in identification of the biliary etiology of acute pancreatitis (AP) was studied in 60 patients. AP biliary etiology was defined by ERCP executed in the early phase of the disease (lithiasis and/or stenosis of CBD; endoscopic features of forced papilla in patients with gallstone). US showed the best values of sensitivity (84.6%) and diagnostic efficacy (76.7%); DF showed the best results of specificity (62.5%) and of test positive predictive value (92.8%). The statistical evaluation (McNemar test) showed a significant increase of sensitivity for US vs clinical findings and of specificity for DS vs clinical findings (p less than 0.05). The sensitivity, specificity, accuracy, test negative and positive predictive value were improved to 96.1, 87.5, 96.6, 77.1 and 92% by the combination of US and DF. Therefore the association of US and DF can provide the best non invasive method in rapidly detecting CBD pathology as an etiological factor in AP and then the enough accurate indication to early operative ERCP.

Abdomen↗
PubMed1988

Evaluation of a latex agglutination test for herpes simplex virus.

We evaluated a new commercial latex agglutination test for herpes simplex virus antigen detection (Virogen Herpes Slide Test, Wampole Laboratories, Cranbury, N.J.). In testing of eluates from 100 lesion swabs, mostly from genital sites, the following test parameters were ascertained: sensitivity, 73%; specificity, 89%; positive predictive value, 89%; negative predictive value, 72%. Testing was also performed on 160 supernatants from 153 cell cultures inoculated with clinical samples. In this application, sensitivity and specificity were each 100%, provided supernatants were sampled for testing when the cytopathic effect involved at least 25% of the cell monolayer.

Antigens, Viral↗
PubMed1992

Cholesterol palmitate in amniotic fluid: confirmation of a simple, rapid, inexpensive, and reliable indicator of fetal pulmonary maturity.

The cholesterol test was previously described and preliminary experience suggested it might be a rapid, inexpensive, and reliable indicator of fetal lung maturity. In this expanded series of 1342 patients delivered of infants within 72 hours of amniotic fluid analysis, the predictive value for mature test was 98.6%. Predictive value for immature test was 55.4%. For the phospholipid profile the predictive value was 97.0% for a mature test result, 31.2% for an immature result. These observations, coupled with its methodologic simplicity, make the cholesterol palmitate test a good first step in a cascade scheme of tests for fetal lung maturity and a valuable test in a facility where the phospholipid profile is not available 24 hours a day.

Amniocentesis↗
PubMed1992

Value of exercise stress test, radionuclide angiography and coronary angiography in predicting new coronary events in asymptomatic patients after a first episode of myocardial infarction.

One-hundred-and-fifty-five consecutive symptom-free patients underwent maximal treadmill exercise testing, rest and stress radionuclide angiography at least two months after an uncomplicated acute myocardial infarction; of these, 90 underwent coronary angiography. All patients were followed-up for a mean of 32 +/- 13 months regarding the prediction of hard (death and reinfarction) and soft (angina and coronary surgery) coronary events. The specificity, sensitivity, positive and negative predictive value of exercise stress test were 47%, 76% and 41% for any coronary events; none of the patients who incurred a hard coronary event showed ischemia during electrocardiographic exercise tests. Sensitivity, specificity and positive predictive value for failure to increase the ejection fraction of at least 5% were 60%, 45% and 30% for any coronary event and 25%, 49% and 2% for any hard coronary event. The presence of multivessel disease at coronary angiography showed a sensitivity of 62% for any coronary event and of 67% for hard coronary events; specificities were 66% and 57%, and predictive values were 52% and 10%, respectively. It is concluded that electrocardiographic exercise testing, radionuclide angiography and coronary angiography are not helpful two months after an episode of uncomplicated myocardial infarction in order to identify patients who will suffer a new coronary event.

Adult↗
PubMed2004

How does susceptibility prevalence impact on the performance of disk diffusion susceptibility testing?

Antimicrobial disk diffusion susceptibility testing, devoted in a clinical context to predicting whether an antibiotic regimen will be effective, should be evaluated through predictive values. This approach implies that the susceptibility prevalence (frequency of susceptible, intermediate, and resistant isolates) affects the predictive value of a result. We quantified the influence of the susceptibility prevalence variation on the disk diffusion method performance through a modeling approach. Simulations based on a resampling procedure from two distinct minimum inhibitory concentration/diameter data sets were performed. Experimental variability on minimum inhibitory concentration and diameters was taken into account in the simulations. Results show that the susceptibility prevalence impact depends on the antibiotic and may be significant when prevalence variation is high enough. Consequences of these results on zone diameter breakpoint determination policy are discussed. This implies that the following should be done: (i) consider more rigorously the susceptibility prevalence in studies dealing with zone diameter breakpoint determination and performance evaluation, (ii) re-evaluate disk diffusion breakpoint consistency when the weight of prevalence variation is noteworthy, (iii) estimate consequences of a breakpoint international consensus on prediction quality and appropriate patient management.

Agar↗
PubMed2002

Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus.

OBJECTIVE: To compare the lumbar infusion test and the cerebrospinal fluid (CSF) tap test for predicting the outcome of shunt surgery in patients with suspected normal pressure hydrocephalus. METHODS: 68 patients with suspected normal pressure hydrocephalus were studied. The absence of preceding history indicated idiopathic disease in 75% of these. All patients were assessed twice with walking and psychometric tests before lumbar infusion test and tap test assessments. The lumbar infusion test was done using a constant infusion rate (0.80 ml/min) and regarded as positive if the steady state CSF plateau pressure reached levels of > 22 mm Hg (resistance to outflow > 14 mm Hg/ml/min). The tap test was regarded as positive if two or more of four different test items improved after CSF removal. As the variability in baseline test results was large, the better of two evaluations was used in comparisons with the results after CSF removal, as well as to evaluate the outcome after shunt surgery. Only patients with a positive lumbar infusion test or a positive tap test had surgery. RESULTS: The results of the CSF tap test and the lumbar infusion test agreed in only 45% of the patients. Of the total cohort, 47 (69%) had positive test results and were operated on; 45 (96%) of these reported subjective improvement, and postoperative assessments verified the improvements in 38 (81%). Improvements were highly significant in walking, memory, and reaction time tests (p < 0.001). Most of the patients improved by surgery (84%) were selected by a positive lumbar infusion test, and only 42% by a positive tap test. Positive predictive values were 80% for lumbar infusion test and 94% for tap test. The false negative predictions in the operated group were much higher (58%) with the tap test than with the lumbar infusion test (16%). CONCLUSIONS: Both the lumbar infusion test and the tap test can predict a positive outcome of shunt operations in unselected patients with suspected normal pressure hydrocephalus. The two tests are complementary and should be used together for optimal patient selection.

Adult↗
PubMed1996

Individual, ethnic and seasonal variability in irritant susceptibility of skin: the implications for a predictive human patch test.

Since irritants are the major cause of contact dermatitis, it is important to identify those chemicals that possess significant ability to cause skin irritation. This process must then be followed by risk assessment and risk management. Historically, animal tests have played a major rôle in this process, but human volunteer studies are of increasing importance in this field. Where the appropriate safety and ethical controls are in place, human testing can give data that identifies skin irritation hazard. To be of widest value, these human studies must not be flawed due to inter-individual, inter-ethnic or seasonal variation. We conducted a large dose-response study and studied the impact of summer and winter weather on a predictive human assay. Sodium dodecyl sulphate (SDS) was tested at 0.1%-20% in 3 national groups of approximately 100 volunteers, using 25 mm Hill Top chambers loaded with 0.2 ml, solution and applied to the upper outer arm for 4 h. Reactions were scored at 24, 48 and/or 72 h after patch application. The German and Chinese studies were completed in a few weeks under similar winter conditions, whereas the UK work was spread fairly evenly over about a 15-month period. Some relatively minor differences were observed in the dose-response curves obtained, probably due to weather conditions. The effect of the weather on the intensity, but not the pattern, of irritant reactivity was also evident in the smaller specific study that assessed reactions to SDS in summer and in winter. Whereas 45% of the panel reacted to 20% SDS in summer, 91% reacted in the winter. However, in both studies, substantial inter-individual variations in response to SDS dominated the pattern of response. When designing a human patch test to discriminate skin irritant substances from those that are of minimal effect, it is this inter-individual variability, rather than any small inter-ethnic or seasonal variation, which must be taken into account. This can be achieved by the routine inclusion of a suitable positive irritant control, which then calibrates each human volunteer panel.

Adult↗
PubMed1989

A computerized program of skin test evaluation and its predictive value in immunotherapy.

The present study describes a computerized methodology for the assessment of specific skin testing which is both sensitive and reproducible. We evaluated the predictive value of this technique in identifying patients at great risk for developing undesirable reactions during hyposensitization. In 11 of 93 patients we were able to detect an unusual dermal response in the patients who developed either generalized or local generalized adverse reactions.

Adolescent↗