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PubMed1999

Laboratory tests for heparin-induced thrombocytopenia: a multicenter study.

A multicenter clinical trial of the thrombin inhibitor argatroban (Novastan; Texas Biotechnology, Houston, TX; Smith-Kline Beecham Pharmaceuticals, Philadelphia, PA) was recently conducted in patients with heparin-induced thrombocytopenia (HIT) and HIT that had progressed to thrombosis (HITTS). In patients defined by the inclusion/exclusion criteria, the utility of three diagnostic HIT assays was investigated: the platelet aggregation assay, the serotonin release assay (SRA), and the enzyme-linked immunosorbent assay (ELISA) for the antibody to the heparin-platelet factor 4 (H-PF4) complex. Confirmation was made in 26%, 55%, and 64% of the patients, respectively (n = 199 patients; 512 to 606 samples; P < .001 platelet aggregation assay v SRA v ELISA). Patients who progressed to HITTS (n = 98) were more often confirmed than were HIT patients without associated thrombosis (n = 101) (P < .05). Confirmation by platelet aggregation assay and SRA results generally was associated with a higher antibody titer. However, a minimum critical titer could not be identified, because all patterns of positive and negative results by the platelet aggregation assay, SRA, and ELISA were observed, and clinically ill patients had a wide range of antibody titers. Over a 30-day period, the percentage of positive responses did not change. Although multiple testing over several days enhanced the chance of confirmation, this difference was not significant. Combined results of the three assays enhanced the positive response to 83% of the total population (P < .005). These data demonstrate that there is no direct correlation between the positive response of these assays, and that clinically positive HIT patients can be missed by all three assays. With these limitations, the combination of platelet aggregation assay, SRA, and ELISA testing with multiple samples offers the best chance of confirming a positive HIT patient. Caution is advised, however, in interpreting all assay results, as no assay is optimal.

Acute Disease↗

PubMed1998

Multiple comparison procedures updated.

1. A common statistical flaw in articles submitted to or published in biomedical research journals is to test multiple null hypotheses that originate from the results of a single experiment without correcting for the inflated risk of type 1 error (false positive statistical inference) that results from this. Multiple comparison procedures (MCP) are designed to minimize this risk. The present review focuses on pairwise contrasts, the most common sort of multiple comparisons made by biomedical investigators. 2. In an earlier review a variety of MCP were described and evaluated. It was concluded that an effective MCP should control the risk of family-wise type 1 error, so as to ensure that not more than one hypothesis within a single family is falsely rejected. One-step procedures based on the Bonferroni or Sidák inequalities do this. For continuous data and under normal distribution theory, so does the Tukey-Kramer procedure for all possible pairwise contrasts of means and the Dunnett procedure for all possible pairwise contrasts of means with a control mean. 3. There is now a new class of MCP, based on the Bonferroni or Sidák inequalities but performed in a step-wise fashion. The members of this class have certain desirable properties. They: (i) control the family-wise type 1 error rate as effectively as the one-step procedures; (ii) are more powerful than the one-step Bonferroni or Sidák procedures, especially when hypotheses are logically related; and (iii) can be applied not only to continuous data but also to ordinal or categorical data. 4. Of the new step-wise MCP, Holm's step-down procedures are commended for their combination of accuracy, power and versatility. They also have the virtue of simplicity. Given the raw P values that result from conventional tests of significance, the adjustments for multiple comparisons can be made by hand or hand-held calculator. 5. Despite the corrective abilities of the new step-wise MCP, investigators should try to design their experiments and analyses to test a single, global hypothesis rather than multiple ones.

Analysis of Variance↗

PubMed2006

Prevalence and risk factors of non-adherence with immunosuppressive medication in kidney transplant patients.

Non-adherence with immunosuppressive regimen is a major risk factor for poor outcome after kidney transplantation. Identifying patients at risk for non-adherence requires understanding the risk factors for non-adherence. This prospective study included a convenience sample of 249 adult kidney transplant patients >1 year post-transplant. Non-adherence was monitored electronically using MEMS(R). Selected socio-economic, therapy-, patient-, condition- and healthcare team-related risk factors for non-adherence were assessed. Period prevalences were expressed as the percent of prescribed doses taken (taking adherence), the percent of correctly dosed days (dosing adherence), the percentage of inter-dose intervals not exceeding 25% of the prescribed interval (timing adherence), and the number of drug holidays per 100 days (no intake for > 48 h if once daily or for > 24 h if twice daily intake). Testing occurred by simple mixed logistic regression analysis. Factors significant after correction for multiple testing were entered into a multiple logistic regression model. Mean taking, dosing, timing adherence, and drug holidays were 98%, 96%, 93%, and 1.1 days, respectively. Non-adherence was associated with lower self-efficacy, higher self-reported non-adherence, no pillbox usage, and male gender. Adherence declined between Monday and Sunday. This study provides a framework for identifying patients at risk for non-adherence and for developing adherence-enhancing interventions.

Adult↗

PubMed1988

Evaluating diagnostic performance of clinical tests by spreadsheet modeling. Bayesian analysis using Ri/Cj ratio as a unifying concept.

We present a general spreadsheet model for evaluating diagnostic performance of clinical tests. Our model depicts test results as an r X c matrix, with r possible test results and c possible clinical states. Analysis of this matrix is based on the Ri/Cj ratio, calculated as a number of subjects having a specified result Ri within a given clinical state Cj, divided by total subjects within this clinical state. From this model, we can identify three special cases: (1) a 2 X c matrix, with two possible test results of T+ or T-, over c possible clinical states; (2) an r X 2 matrix, with r possible test results, over two possible clinical states of D+ or D-; and (3) a 2 X 2 matrix, with two possible test results over two possible clinical states. Application of the Ri/Cj ratio to the r X c matrix provides a useful approach to graphic analysis of multiple test results over multiple clinical states. The Ri/Cj ratio also provides a general approach to Bayesian analysis, in which likelihood ratio, relative operating characteristic analysis, sensitivity, and specificity represent special cases or special applications.

Bayes Theorem↗

PubMed1986

A relationship between gonadotropins and visuospatial function.

Follicle Stimulating Hormone (FSH) levels were negatively correlated with visuospatial function in two successive testing sessions in 32 young adult men. Men with high concentrations of FSH performed poorly on three-dimensional tests and tests of point localization. Men with low concentrations tended to perform better. Luteinizing Hormone (LH) tended to correlate positively with verbal/sequential skills and with two of the visuospatial skills for one session; testosterone was positively correlated with one spatial test. Multiple regression between the average performance on visuospatial tests and the three hormones produced Rs of 0.67 and 0.60, accounting for 39% and 29% of the variance, respectively, in Sessions 1 and 2. In women, the hormonal/behavior relationships were less clear although in many ways similar. For example, FSH was negatively correlated with one visuospatial test but only after the effects of estradiol and progesterone were partialled out. FSH was positively correlated with word fluency as was LH. With respect to sex differences women were poorer than men on the visuospatial tests and better on verbal fluency which is consistent with women's generally higher FSH levels and the negative relationship between FSH and visuospatial skills and the positive relationship with fluency.

Adolescent↗

PubMed2004

Effect of chemical disinfectants on the transverse strength of heat-polymerized acrylic resins submitted to mechanical and chemical polishing.

STATEMENT OF PROBLEM: Immersion in chemical solutions used for cleansing and disinfecting prostheses can decrease the strength of denture base resins, making them more prone to fracture during use. PURPOSE: The purpose of this study was to assess the effect of immersion in different chemical disinfectants for varying time periods on the transverse strength of 3 mechanically or chemically polished heat-polymerized acrylic resins. MATERIAL AND METHODS: A total of 630 rectangular specimens (65 x 10 x 3 mm), 210 per resin (Classico, Lucitone 550, and QC-20), were fabricated. One side of each specimen was not polished and the other was either mechanically (n=300) or chemically (n=300) polished, and immersed for 10, 20, 30, 45, or 60 minutes in either 1%, 2.5%, or 5.25% sodium hypochlorite or 2% glutaraldehyde. Mechanically polished (n=15) and chemically polished (n=15) control specimens were immersed only in distilled water. The transverse strength (N/mm 2 ) was tested for failure in a universal testing machine, at a crosshead speed of 5 mm/min. Data were statistically analyzed using 2-way ANOVA and Student t test. Multiple comparisons were performed using Tukey and Scheffe tests (alpha=.05). RESULTS: There was significant difference (P < .01) between types of polishing, with chemical polishing resulting in lower transverse strength. ANOVA identified significant differences (P < .01) in strength between mechanically polished Lucitone 550 and QC-20, and among all 3 chemically polished resins. No significant differences were observed between resins submitted to both types of polishing or between different immersion periods (10 to 60 minutes), disinfectants, or interaction. CONCLUSIONS: Lucitone 550 resin presented the greatest transverse strength values with both types of polishing. Among the mechanically and chemically polished specimens, transverse strength was not affected after immersion in the disinfectants for the immersion periods tested (10 to 60 minutes). Chemically polished control and experimental (immersed in all solutions) QC-20 specimens showed significant differences in transverse strength values.

Acrylic Resins↗

PubMed1997

Role of pharyngeal length in patients with a lack of overbite.

Anterior open bites may be localized dental manifestations, which are caused by habits or skeletal disharmony, with or without functional aberration. Previous studies suggest various associations between open bites and underlying etiologic factors. We hypothesize that respiratory efficiency may be associated with anterior open bites. Under the assumption that breathing efficiency of the oropharynx and hypopharynx may be related to pharyngeal airway length, a cephalometric variable, vertical airway length (VAL), was measured on lateral cephalograms obtained from a total of 58 subjects with, so called, "open bite tendencies" (hereafter, open bite tendency). By means of the variable VAL, the association between pharyngeal length and open bite was investigated. In addition, the difference between actual open bite and open bite tendencies was also examined. The samples were randomly collected under stringent selection criteria from an existing database. A series of statistical analyses, such as unpaired t test, multiple regression, and discriminant analysis, was used to test the proposed hypothesis. The study found that none of the open bite tendency indicators used can segregate open bite subjects from nonopen bite subjects. The obtained discriminant function clearly divides the samples into two groups, i.e., open bite group and nonopen bite group, which were based on VAL and lower facial height. The study concludes that, first, an open bite tendency may be a different entity from an actual open bite or may be a misconceptualized term. Second, pharyngeal length may be a convenient indicator to diagnose open bite. We speculate that open bite may be different from an open bite tendency in pharyngeal length.

Adolescent↗

PubMed1998

Testing for differences in multiple quality of life dimensions: generating hypotheses from the experience of hospital staff.

In clinical trials with a quality of life (QoL) component, it is usual to monitor several QoL dimensions at several points in time. Multiple significance tests without formal hypotheses are problematic. It is not always feasible to specify a priori hypotheses for all variables. Can such studies be used to generate hypotheses for testing in later research only? We developed a method which can allow for formal hypothesis testing on a data set collected without a priori hypotheses in the protocol. We surveyed experienced physicians and nurses treating patients, to obtain independent expectations about differences in QoL dimensions. These 'staff expectations' will be used in the analysis of QoL data collected from breast cancer patients taking part in three randomized trials of adjuvant therapy. We propose frameworks for the informal and formal use of the experience of the staff in testing for group differences in patients' QoL scores. The method described here is anticipated to be useful for QoL studies in general, even when a priori hypotheses were specified before the studies were initiated.

Bayes Theorem↗

PubMed2002

Pelvic fracture in the elderly is associated with increased mortality.

OBJECTIVE: The elderly population is currently the fastest growing sector in America. The purpose of this study was to examine the age-related outcome in patients after blunt pelvic injury. METHODS: All patients admitted with a pelvic fracture during a 5-year period were identified from the trauma registry. Data retrieval included: demographics, shock (BP < 90 mm Hg) on admission, injury severity score (ISS), abbreviated injury score (AIS) for head, chest, and abdomen, intensive care unit (ICU) length of stay (LOS), hospital LOS, and mortality. All pelvic fracture patterns were classified. Patient data were then stratified by age for comparison: young (< 55 years) and elderly (> or = 55 years). Statistical analysis was performed using the Student t test, Wilcoxon rank-sum test, multiple logistic regression analysis, and chi-square test with significance set at P <.05. RESULTS: Three hundred five patients sustained a pelvic fracture (young [n = 248, 81.3%]; elderly [n = 57, 18.7%]). The only predictor of mortality was age. The 2 groups differed by gender (elderly = 54.4% females; young = 62.5% males) but not frequency of shock, ISS, or AIS for head, chest, and abdomen. Motor vehicle collision was the most common mechanism of injury (elderly = 68.4%; young = 73.8%). Lateral compression was the most common fracture pattern in both groups (elderly = 54.4%; young = 45.6%). There was no difference in transfusion (elderly = 2.5 +/- 0.7 vs young = 2.0 +/- 0.3; ns) but the elderly group was more frequently admitted to the ICU (elderly = 61.4% vs young = 46.8%; P =.065). Significantly more of the elderly group had a diagnosis of cardiovascular disease (43.9% vs 10.1%, P <.001) and diabetes mellitus (10.5% vs 2.4%, P <.014). Mortality was significantly greater in the elderly group (12.3% vs 2.3%). CONCLUSION: Elderly patients sustaining a pelvic fracture were more likely to have a lateral compression fracture pattern, longer hospital LOS, and die despite aggressive resuscitation. This difference in outcome should help trauma surgeons recognize that the elderly patient sustaining a pelvic fracture is at increased risk of death.

Adult↗

PubMed1986

Evaluation of different assay systems for identification of environmental Aeromonas strains.

Important biochemical reactions in conventional tests were compared with counterpart reactions in two multiple test systems, API-20E (Analytab Products, Plainview, N.Y.) and Aeromonas hydrophila medium, to evaluate their accuracy for the identification of motile Aeromonas spp. isolated from fish. In a total of 49 Aeromonas spp. isolates and 10 A. hydrophila reference strains, false-negative or -positive reactions were detected in the Voges-Proskauer test, indole production, gelatinase activity, production of gas, fermentation of arabinose, and lysine decarboxylase reaction. A good correlation was found, among the three identification systems, for the fermentation of mannitol and inositol as well as for the arginine dihydrolase and ornithine decarboxylase tests. The failure of A. hydrophila medium in the detection of gas indicates that this medium is not entirely suitable for defining aerogenic or anaerogenic strains. From the results of the present study, we consider that of the identification method and taxonomic scheme to be adopted for environmental Aeromonas spp. must be standardized.

Journal Article↗

PubMed2002

Evidence for a novel type 1 diabetes susceptibility locus on chromosome 8.

Type 1 diabetes results from a combination of genetic susceptibility and environmental exposures. Susceptibility loci other than HLA and the insulin gene remain to be identified to account for the degree of familial clustering observed in this disorder. Early genome-wide scans provided suggestive evidence of linkage on chromosome 8q, prompting detailed analysis of this region. A total of 20 microsatellite markers spanning an 88-cM region of 8q11-24 were genotyped in 24 type 1 diabetes pedigrees from Wisconsin that contained 39 affected sib-pairs. Multipoint linkage analyses provided close to suggestive evidence of linkage, with a multipoint logarithm of odds score (MLS) of 2.4 and Genehunter nonparametric logarithm of odds score (NPL) of 2.7 (P = 0.003). There is also evidence of linkage disequilibrium at peak marker D8S1823 for the 217bp allele (P = 0.037) using the pedigree disequilibrium test. Although our sample size was small, the multiple tests were consistent and our preliminary results suggested that 8q24 may harbor a novel population-specific type 1 diabetes susceptibility gene. Continued investigation of this region for a novel type 1 diabetes susceptibility gene appears justified.

Chromosome Mapping↗

PubMed1992

Statistical tests in medical research.

Various propositions have been made to improve the statistical quality of medical journals: using statistical referees, promoting better collaboration between statisticians and researchers, and teaching of basic statistics to clinicians. The most frequent errors found in medical articles are misinterpretation of p-values or non-significant results and confusion between statistical and clinical significance, inappropriate use of tests requiring precise assumptions, inappropriate or not controlled multiple testing and particularly testing of post hoc hypotheses, and overemphasis on p-values. Many errors arising from the misinterpretation of results of statistical hypothesis tests, the basic principles of this methodology are emphasized, and the usual fallacies found in the medical literature are reviewed.

Research↗

PubMed1985

A critical appraisal of impedance plethysmography in the diagnosis of acute deep venous thrombosis.

Compulsive performance of the test is paramount to obtaining good results. Sequential multiple tests with prolongation of the filling time to maximize venous filling and ultimately reaching a plateau is essential. Increase in venous filling by increasing the cuff pressure in the proximal lower thigh occluding cuff to 60 instead of 45 centimeters of water is helpful in obtaining optimum venous filling. Unrecognized patient apprehension or muscle contraction may be a reason for false-positive IPGs. Patient relaxation, local heat application or even electromyography attachment may be helpful. The IPG can be repeated after a few hours if a false-positive test result is suspected. If a test falls above the stop line, the NPV is so high that no repetition of the test is necessary and the limb is read out as showing no proximal venous thrombosis. If a test is normal or borderline, the test may be repeated with sequential testing until the test points seem to group together or a clear divergence of either normal or abnormal is achieved. If the contralateral limb is clearly normal and an abnormal test result is obtained in the suspected limb, the test is likely to be reliable. Bilateral abnormal IPGs, especially in the presence of congestive heart failure or severe edema, may indicate a false-positive test finding. Increased edema in the extremity decreases electrical resistivity and balancing the machine may become a technical problem.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗

PubMed1983

Do preoperative laboratory tests predict blood transfusion needs in cardiac operations?

We retrospectively compared preoperative prothrombin (PT), partial thromboplastin (PTT), dilute whole blood clot lysis and bleeding times, fibrinogen level, and platelet count with subsequent blood component administration in 92 patients who had undergone cardiac operations with cardiopulmonary bypass (CPB). Abnormal results for one or more tests were found in 34% of 71 adults and 81% of 21 children and teenagers. The patients with abnormal test(s) received no more whole blood and packed red cell units, platelets, or plasma than those with normal tests in either age group. No individual or multiple test abnormalities predicted excess blood component transfusion, even when low-grade abnormalities were excluded. The high rate of abnormal tests in patients less than 20 years of age was not due to polycythemia and may indicate a need for age-specific reference ranges. Baseline PT, PTT, and platelet count may aid in the evaluation of the potential for subsequent development of coagulopathy, but we conclude that further preoperative testing may be reserved for infants, polycythemic individuals, or others in whom history or drug use suggests potential bleeding problems.

Adolescent↗

PubMed1984

Multiple Sleep Latency Test findings in Kleine-Levin syndrome.

Multiple Sleep Latency Test (MSLT) findings in a case of Kleine-Levin syndrome are reported for the first time. MSLT data indicate sleepiness as severe as in narcolepsy or obstructive sleep apnea and the occurrence of four sleep onset rapid eye movement (REM) periods, with a greater REM propensity at 2:00 p.m. and 4:00 p.m. than at 10:00 a.m. and 12:00 noon. The replication of such findings might suggest that Kleine-Levin syndrome could be considered a form of periodic REM sleep disinhibition. Therefore, the traditional hypothesis of diencephalic dysfunction may require modification to include the role of more caudal brain stem structures specifically activated during REM sleep.

Adult↗

PubMedDate not supplied

[Use of psychopathometric procedures in diagnosis of dementia exemplified by a comparison between the Mini-Mental State and the MWT/KAI (Multiple-Choice Vocabulary/General Intelligence Test Short-Form) test system].

Different definitions of dementia have resulted in various psychopathometric diagnostic instruments. For that reason, the validity of the test or test battery is related to the originating definition of dementia. There are short tests which can be easily handled (e.g., Mini-Mental State or the test battery Multiple-Choice-Vocabulary-Intelligence Test/Short Test for General Intelligence). These tests can be used for the verification of a severe intellectual and mnemonic deterioration or a relative decrease of the mental capacity. For their objectivity, reliability and validity they are suitable for diagnostic routine. However, two aspects should be taken into consideration: Before using psychopathometric tests which aim at objectifying a decrease of mental capacity and indicating the degree of severity, it is necessary to make a differential diagnosis for particularly excluding so-called pseudodementia. It is also a fact that a single test is not sufficient for registering each degree of severity. The Mini-Mental State test can be used for documenting moderate to severe cases of dementia. The test battery Multiple-Choice-Vocabulary-Intelligence Test (MWT)/Short Test for General Intelligence (KAI) is suitable for the diagnosis and follow-up of mild to moderate cases.

Aged↗

PubMed1997

Multiple-time-point dissolution specifications for a sampling acceptance plan.

In dissolution testing, multiple dissolution measurements at specific time points are used to obtain the dissolution characteristics for most extended-release and some immediate-release drug products. This paper presents a general procedure for defining specifications by a multivariate confidence region or by simultaneous confidence limits on the dissolution values of individual time points. The confidence regions and simultaneous confidence limits were estimated using two approaches: the first approach assumed a multivariate normal distribution on the multiple dissolution values and the second approach used the bootstrap resampling method. The multivariate confidence region was constructed using the Hotelling's T2 statistic (equivalently, Mahalanobis distance D2), and the simultaneous confidence limits were based on the Mahalanobis statistic as well as on the Bonterroni adjustment. The Mahalanobis simultaneous confidence limits specification criteria have the overall false out-of-specification rate too low in both parametric and bootstrap approaches.

Chemistry, Pharmaceutical↗

PubMed2006

Endoscopic ultrasound as a first test for diagnosis and staging of lung cancer: a prospective study.

RATIONALE: Multiple tests are required for the management of lung cancer. OBJECTIVES: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was evaluated as a single test for the diagnosis and staging (thoracic and extrathoracic) of lung cancer. METHODS: Consecutive subjects with computed tomography (CT) findings of a lung mass were enrolled for EUS and results were compared with those from CT and positron emission tomography scans. RESULTS: Of 113 subjects with lung cancer, EUS was performed as a first test (after CT scan) for diagnosis in 93 (82%) of them. EUS-FNA established tissue diagnosis in 70% of cases. EUS-FNA, CT, and positron emission tomography detected metastases to the mediastinal lymph nodes with accuracies of 93, 81, and 83%, respectively. EUS-FNA was significantly better than CT at detecting distant metastases (accuracies of 97 and 89%, respectively; p = 0.02). Metastases to lymph nodes at the celiac axis (CLNs) were observed in 11% of cases. The diagnostic yields of EUS-FNA and CT for detection of metastases to the CLNs were 100 and 50%, respectively (p < 0.05). EUS was able to detect small metastases (less than 1 cm) often missed by CT. Metastasis to the CLNs was a predictor of poor survival of subjects with non-small cell lung cancer, irrespective of the size of the CLNs. Of 44 cases with resectable tumor on CT scan, EUS-FNA avoided thoracotomy in 14% of cases. CONCLUSIONS: EUS-FNA as a first test (after CT) has high diagnostic yield and accuracy for detecting lung cancer metastases to the mediastinum and distant sites. Metastasis to the CLNs is associated with poor prognosis. EUS-FNA is able to detect occult metastasis to the CLNs and thus avoids thoracotomy.

Aged↗