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PubMed1985

Reporting methodology protocols in three acute care journals.

Our study compared the reporting of methodology protocol details in three acute care journals, Annals of Emergency Medicine, Critical Care Medicine, and Journal of Trauma. Eleven criteria previously reported for evaluation of clinical trials in the medical literature were used. These were eligibility criteria, admission before allocation, random allocation, method of randomization, patients' blindness to treatment, blind assessment of outcome, treatment complications, loss to follow-up, statistical methods, statistical analysis, and power. All prospective, interventional, controlled trials appearing in the journals from January 1980 to June 1983 were identified. A total of 45 trials was found. Each study was read independently by two reviewers to determine whether each of the 11 criteria was reported clearly, reported unclearly, or not applicable. Disagreements were resolved by a third reader (adjudicator). The results are reported as the mean proportion of items clearly reported plus or minus the standard deviation: Annals of Emergency Medicine (n = 16), 0.40 +/- 0.18; Journal of Trauma (n = 18), 0.41 +/- 0.24; Critical Care Medicine (n = 11), 0.35 +/- 0.18. A one-way analysis of variance found no statistically significant difference between journals with respect to these proportions (P = .75). The study reveals that these journals, as judged by these criteria, do not report enough methodologic information to allow assessment of bias-reducing techniques and statistical methodology.

Analysis of Variance↗
PubMed2004

Wavelets and functional magnetic resonance imaging of the human brain.

The discrete wavelet transform (DWT) is widely used for multiresolution analysis and decorrelation or "whitening" of nonstationary time series and spatial processes. Wavelets are naturally appropriate for analysis of biological data, such as functional magnetic resonance images of the human brain, which often demonstrate scale invariant or fractal properties. We provide a brief formal introduction to key properties of the DWT and review the growing literature on its application to fMRI. We focus on three applications in particular: (i) wavelet coefficient resampling or "wavestrapping" of 1-D time series, 2- to 3-D spatial maps and 4-D spatiotemporal processes; (ii) wavelet-based estimators for signal and noise parameters of time series regression models assuming the errors are fractional Gaussian noise (fGn); and (iii) wavelet shrinkage in frequentist and Bayesian frameworks to support multiresolution hypothesis testing on spatially extended statistic maps. We conclude that the wavelet domain is a rich source of new concepts and techniques to enhance the power of statistical analysis of human fMRI data.

Algorithms↗
PubMed1981

Statistical power in biological psychiatry.

The use of statistical power and power analysis in both the design and evaluation of experiments in biological psychiatry is described. The possible consequences of low power investigations are discussed, and guidelines are provided to facilitate the application of power analysis. Power curves are provided for sample sizes ranging from 10 to 100 for the Student's t test, and for testing the significance of an obtained Pearson correlation coefficient at both the 0.01 and 0.05 alpha levels. Additionally, difference scales are provided for plasma cortisol and for several neurotransmitter metabolites that are frequently measured in cerebrospinal fluid (CSF). Power evaluation of selected CSF studies measuring neurotransmitter metabolites in depressives and controls suggests the majority had less than a 50% chance of detecting a medium size difference before the experiment was actually performed.

Depressive Disorder↗
PubMed2005

Robust prostate cancer marker genes emerge from direct integration of inter-study microarray data.

MOTIVATION: DNA microarray data analysis has been used previously to identify marker genes which discriminate cancer from normal samples. However, due to the limited sample size of each study, there are few common markers among different studies of the same cancer. With the rapid accumulation of microarray data, it is of great interest to integrate inter-study microarray data to increase sample size, which could lead to the discovery of more reliable markers. RESULTS: We present a novel, simple method of integrating different microarray datasets to identify marker genes and apply the method to prostate cancer datasets. In this study, by applying a new statistical method, referred to as the top-scoring pair (TSP) classifier, we have identified a pair of robust marker genes (HPN and STAT6) by integrating microarray datasets from three different prostate cancer studies. Cross-platform validation shows that the TSP classifier built from the marker gene pair, which simply compares relative expression values, achieves high accuracy, sensitivity and specificity on independent datasets generated using various array platforms. Our findings suggest a new model for the discovery of marker genes from accumulated microarray data and demonstrate how the great wealth of microarray data can be exploited to increase the power of statistical analysis. CONTACT: leixu@jhu.edu.

Algorithms↗
PubMed1994

Cerebral pressure-flow relationship during cardiopulmonary bypass in the dog at normothermia and moderate hypothermia.

We studied cerebral autoregulation by analyzing cerebral pressure-flow curves during cardiopulmonary bypass (CPB) with alpha-stat (alpha-stat) acid-base management at 28 (n = 9) and 37 degrees C (n = 9) in two groups of dogs. Cerebral blood flow (CBF) and cerebral metabolic rate for oxygen (CMRO2) were determined multiple times in each animal over an extensive range of cerebral perfusion pressure (CPP). The CPP was altered by changing perfusion flow rate. The dependence of CBF on CPP during normothermic and moderate hypothermic CPB was assessed using a block design analysis of covariance with CPP as the covariate. We anticipated maximal statistical power with this analysis to define if cerebral autoregulation was intact. This method of statistical analysis was compared with the conventional interpretation by linear regression analysis. Animals were administered sodium thiopental until an isoelectric electroencephalogram was obtained to assure stable depth of anesthesia independently of temperature effects. The animals were randomly assigned to either temperature group. The CBF was determined by injection of radioactive microspheres at each of five target CPPs randomly allocated (50, 60, 70, 80, and 90 mm Hg). The brain oxygen content difference was defined as arterial minus superior sagittal sinus (SSS) oxygen content. No difference in CPP, hemoglobin, arterial carbon dioxide tension, or pH was seen between groups at any time period. In both groups, total CBF (tCBF) increased significantly with increasing CPP (p = 0.012 and 0.017 for normothermic and hypothermic CPB, respectively; CPP as covariate). The between-group difference in slopes (CPP x temperature effect) approached statistical significance (p = 0.059).(ABSTRACT TRUNCATED AT 250 WORDS)

Analysis of Variance↗
PubMed2002

Genetic loci for pathological myopia are not associated with juvenile myopia.

The purpose of this study was to evaluate chromosomal regions previously linked to pathological myopia for linkage to juvenile myopia in a sample of myopic children and their families. Of 125 families with a myopic child participating in the Orinda longitudinal study of myopia, 53 submitted 221 buccal swab samples for genetic analysis. Myopia in proband children was defined as -0.75 D or more myopia in both meridians on cycloplegic autorefraction (1% tropicamide). Affected status in parents and siblings was obtained by survey. DNA was extracted from buccal mucosal cells, amplified by polymerase chain reaction (PCR), and then analyzed with seven markers for chromosome 12 and five markers for chromosome 18 in the regions previously associated with pathological myopia. LOD scores were not significant for any marker tested. The largest positive LOD score was 0.15 for GATA30F04. Model-free methods using a SimIBD approach suggested a possible linkage at one marker, GATA6H09 (P = 0.003), but these results were not supported by transmission disequilibrium test (TDT) analysis. The statistical power to detect LOD scores of > or =1.0, assuming homogeneity, was estimated at 93.2%. We found no confirmatory evidence of linkage between juvenile myopia and regions of chromosomes 12 and 18 previously associated with pathological myopia.

Child↗
PubMed1984

Leisure time sport activities and maximal aerobic power during late adolescence.

The pattern of leisure time sport activity was estimated by retrospective recalls and expressed in terms of an annual sport activity score. The activity score was related to the development of maximal aerobic power during the period of late adolescence in German children. Both girls and boys reduced their activity pattern from 14 to 18 years of age, boys more than girls. At each age boys were more active than girls. A slight tendency towards better fitness with increased habitual physical activity was noticed, but many sedentary children exhibited a good performance capacity and some children with a high level of leisure time sport activity were characterized by a low level of maximal aerobic power. A statistical analysis revealed that the observed tendency to better fitness with increased habitual physical activity could be explained by an age factor with no additional effect of variation in sport activity score.

Adolescent↗
PubMed1984

Intra and inter-hemispheric changes in alpha intensities in EEGs of schizophrenic patients versus matched controls.

62 EEGs of 5 min recordings, over C4-P4, P4-02, C3-P3, P3-01, have been recorded from 31 schizophrenic patients and 31 controls, matched for age (27 years) and sex (males). Patients were clinically classified into 3 sub-groups: paranoid-type P(7), residual type R(10) and others O(14). Controls were statistically classified into 2 sub-groups as high alpha subjects HA(15) or low alpha subjects LA(16). Following computer Fourier statistical analysis, evolutive power spectra, averaged power spectra and spectral variances were obtained for each EEG recording. Date reduction provided for each EEG: Mean frequencies, mean amplitudes in microvolts and percentage asymmetries, resonance, spectral parameters; theta/alpha, with their variabilities. Power spectra were averaged between patients or between subjects for each sub-group. The alpha peak and the mean RMS amplitude was higher over P3-01 than over P4-02 for the residual-type of schizophrenic patients, when compared to his matched control sub-group of high-alpha subjects which presented almost symmetrical occipital alpha peaks and RMS amplitudes. However, the most important changes appear to be intra-hemispheric. The alpha peaks and RMS amplitudes were almost equal between C3-P3 and P3-O1 for the paranoid type of schizophrenic patients in contrast to other sub-groups and especially both control sub-groups. This seems to imply left hemispheric changes in terms of EEG spectral alpha intensities, when tracings of schizophrenics were compared with recordings of volunteers.

Adult↗
PubMed2005

A quality-controlled microarray method for gene expression profiling.

Gene expression profiling on microarrays is widely used to measure the expression of large numbers of genes in a single experiment. Because of the high cost of this method, feasible numbers of replicates are limited, thus impairing the power of statistical analysis. As a step toward reducing technically induced variation, we developed a procedure of sample preparation and analysis that minimizes the number of sample manipulation steps, introduces quality control before array hybridization, and allows recovery of the prepared mRNA for independent validation of results. Sample preparation is based on mRNA separation using oligo(dT) magnetic beads, which are subsequently used for first-strand cDNA synthesis on the beads. cDNA covalently bound to the magnetic beads is used as template for second-strand cDNA synthesis, leaving the intact mRNA in solution for further analysis. The quality of the synthesized cDNA can be assessed by quantitative polymerase chain reaction using 3'- and 5'-specific primer pairs for housekeeping genes such as glyceraldehyde-3-phosphate dehydrogenase. Second-strand cDNA is chemically labeled with fluorescent dyes to avoid dye bias in enzymatic labeling reactions. After hybridization of two differently labeled samples to microarray slides, arrays are scanned and images analyzed automatically with high reproducibility. Quantile-normalized data from five biological replica display a coefficient of variation 45% for 90% of profiled genes, allowing detection of twofold changes with false positive and false negative rates of 10% each. We demonstrate successful application of the procedure for expression profiling in plant leaf tissue. However, the method could be easily adapted for samples from animal including human or from microbial origin.

DNA, Complementary↗
PubMed1998

Clinical efficacy of becaplermin (rhPDGF-BB) gel. Becaplermin Gel Studies Group.

The results of four multicenter, randomized, placebo-controlled, parallel group studies of the efficacy of becaplermin gel are reviewed here. The four studies included a total of 922 patients, all of whom received a standardized regimen of good ulcer care. Patients were randomized to receive placebo gel, 30 or 100 microg/g becaplermin gel, or good ulcer care alone. In Studies 1 and 2, the incidence of complete healing was significantly higher in patients receiving becaplermin gel (30 microg/g, Study 1; 100 microg/g, Study 2) compared with that in patients receiving placebo gel. In Study 3, which was not powered for statistical analysis, the incidence of complete healing in patients treated with 100 microg/g becaplermin gel was approximately twice that of patients treated with good ulcer care alone. In Study 4, there was no significant difference in the incidence of complete healing in patients treated with becaplermin gel versus good ulcer care alone.

Administration, Topical↗
PubMed1996

Association between specific HLA combinations and probability of kidney allograft loss: the taboo concept.

BACKGROUND: HLA matching improves the outcome of cadaveric renal transplantation. However, many allografts function well even in the presence of one or more HLA mismatches, which raises the question of whether some mismatches are better recognised by the recipient's immune system than others. We aimed to identify mismatched HLA donor-recipient combinations that were associated with increased graft loss. METHODS: We selected 2877 first, unrelated renal transplants with a single HLA A, B, or DR mismatch, undertaken between 1982 and 1992, from the Eurotransplant database. To enhance statistical power the analysis was restricted to mismatches of an HLA antigen that occurred in 100 or more donors. 1342 transplants met this criterion and were grouped into a definition set (n = 873) and a validation set (n = 469). In the definition set, we studied further only those recipient HLA antigens that occurred in at least 30 cases within each donor antigen mismatch subset. By a Cox proportional hazards model, donor-recipient combinations that led to significantly higher graft loss than in the whole group were defined. Such combinations were classified as taboo; the remaining combinations were classified as indifferent. FINDINGS: 106 individual recipient antigens were found at least 30 times with a corresponding donor mismatch in the definition set; 11 of the 106 had a significant effect on graft survival. Seven combinations were classified as taboo. Taboo combinations, confirmed as such in the validation set, were associated with graft survival of 81% at one year and 50% at 5 years, significantly lower than the rates in the group with indifferent combinations (89% and 69%; p = 0.04) or among 1190 recipients with no mismatches (89% and 72%; p = 0.03). The findings were substantiated by a multivariate analysis that included the effect of patient immunisation, cold ischaemia time, age, and sex. INTERPRETATION: Mismatched donor antigens are differentially recognised depending on the HLA phenotype of the recipient. The findings may have important clinical consequences for graft survival after transplantation.

Cadaver↗
PubMed2003

Gender differences in pressure pain threshold in healthy humans.

UNLABELLED: AIMS OF INVESTIGATION: To quantify the magnitude of putative gender differences in experimental pressure pain threshold (PPT), and to establish the relevance of repeated measurements to any such differences. METHODS: Two separate studies were undertaken. A pressure algometer was used in both studies to assess PPT in the first dorsal interosseous muscle. Force was increased at a rate of 5 N /s. In study 1, two measurements were taken from 240 healthy volunteers (120 males, 120 females; mean age 25 years) giving a power for statistical analysis of beta=0.80 at alpha=0.01. In study two, 30 subjects (15 males, 15 females mean age 28 years) were randomly selected from study one. Fourteen repeated PPT measurements were recorded at seven, 10 min intervals. Mean PPT data for gender groups, from both studies, were analysed using analysis of covariance with repeated measures, and age as the covariate. RESULTS: The mean PPT for each of the two measurements in study one showed a difference between gender of 12.2 N (f=30.5 N, m=42.7 N) and 12.8 N (f=29.5 N, m=42.3 N), respectively, representing a difference of 28% with females exhibiting a lower threshold. In study two, the mean difference calculated from 14 PPT repeated measurements over a 1h period was comparable to that in study one at 12.3N (range 10.4-14.4 N) again females exhibited the lower threshold. The differences in mean PPT values between gender were found to be significant in both study one, at (P<0.0005, F=37.8, df=1) and study two (P=0.01, F=7.6, df=1). No significant differences were found in either study with repeated measurement (P=0.892 and P=0.280), or on the interaction of gender and repeated measurement after controlling for age (P=0.36 and P=0.62). CONCLUSION: Healthy females exhibited significantly lower mean PPTs in the first dorsal interosseous muscle than males, which was maintained for fourteen repeated measures within a 1 h period. This difference is likely to be above clinically relevant levels of change, and it has clear implications for the use of different gender subjects in laboratory based experimental designs utilising PPT as an outcome measure.

Adult↗
PubMed2001

Occupational status and sleep-disordered breathing in a sample of French males.

Sleep-disordered breathing (SDB) and lower socio-professional status have in common a series of risk factors for ill health such as sedentary lifestyle, weight excess, heavy alcohol and tobacco consumption. We hypothesised that SDB will be more prevalent in lower socio-professional groups. A total of 496 male middle aged subjects (23-66 years) were tested with a protocol including a self-completed structured sleep questionnaire (translation of the Madison sleep cohort study form), anthropometry (including neck, waist and hip girth) and a simple, non-invasive nose-throat examination by a specialist physician. The subjects were classified according to the 10 major groups of the ISCO-88 classification (International Labour Office). Our sampling base did not contain subjects in the major groups 1 (senior officials, legislators), 6 (fishery and agricultural workers), and zero (armed forces), thus these groups were not represented in the analysis. To improve the power of the statistical analysis, groups 3 and 4, 5 and 7, 8 and 9 were merged, the analysis thus including four categories. The differences in demographic data were negligible; as expected, smoking was more prevalent in low socio-occupational groups (difference non-significant). A history of chronic bronchitis was more frequent in low socio-occupational groups, while a low physical job labour was more frequent in higher occupational groups. We did not find any differences in the prevalence of sleep-related respiratory disturbances (snoring, sleep apnoeas). This first study of the possible association between socio-occupational factors and sleep disordered breathing was negative, but we believe further studies, on larger samples, with a more homogeneous distribution of social groups are warranted.

Adult↗
PubMed2004

Epilepsy and pregnancy: lamotrigine as main drug used.

OBJECTIVES: To study the risk of teratogenicity in infants of women with epilepsy. MATERIAL AND METHODS: Prospective data from 1996 to 2000 comprised 147 pregnancies. The most frequent antiepileptic drugs (AEDs) used were lamotrigine (LTG) 35% (n = 51), oxcarbazepine (OXC) 25% (n = 37) and valproate (VPA) 20% (n = 30). Seventy-four per cent (n = 109) received monotherapy. Folic acid supplementation was taken during first trimester by 118 patients (80%). RESULTS: The overall risk of malformations among newborns in the AED-exposed group was 3.1% (n = 4). Two children were born with multiple malformations (VPA monotherapy), two children had ventricular septal defects (one OXC monotherapy, and one OXC and LTG). The risk of malformations was 2.0% in women treated with LTG and 6.7% in women treated with VPA (NS). CONCLUSION: Despite the small number of cases in the study these data indicate that treatment with LTG during pregnancy might be relatively safe. Larger prospective studies are needed to obtain adequate power for statistical analysis.

Abnormalities, Drug-Induced↗
PubMed2003

A randomized, placebo-controlled trial of IGF-1 for delayed graft function: a human model to study postischemic ARF.

BACKGROUND: Insulin-like growth factor (IGF-1) has been shown in animal models to accelerate recovery from acute renal failure (ARF). However, a therapeutic trial of recombinant human (rh) IGF-1 in patients with ARF in the intensive care unit (ICU) failed to demonstrate efficacy [1]. Such patients often had multiple organ failure, recurrent renal injury, and a delay of several days before commencing treatment. METHODS: To circumvent these confounding factors, we randomized recipients of cadaveric renal allografts to immediate (<5 hours) rhIGF-1 versus placebo therapy (100 mg/kg subcutaneously twice a day for 6 days). Preliminary observations 3 hours posttransplantation in an additional 44 patients revealed a creatinine clearance < or = 20 mL/min to predict protracted ARF. Thus, this value was used to determine study eligibility. RESULTS: Creatinine clearance prior to commencing treatment was not significantly different between the two groups (8 +/- 5 mL/min for IGF-1 and 7 +/- 6 mL/min for placebo; P = 0.39). Inulin clearance on day 7, the primary outcome measure, was 21 +/- 22 mL/min and 19 +/- 19 mL/min in the IGF-1 (N = 19) and placebo (N = 24) groups, respectively (P = 0.67). Secondary outcome measures, including nadir serum creatinines after 6 weeks and need for dialysis, also did not differ between the two groups. We performed an analysis of statistical power using the placebo arm of the trial. Defining a twofold increase above placebo in day 7 glomerular filtration rate (GFR) as of meaningful biologic significance, we determined that the modest sample size used in the present study is adequate. CONCLUSION: We, thus, conclude that (1) IGF-1 treatment is unlikely to benefit ARF and (2) the transplanted kidney is a good model to screen new agents for ARF that have demonstrated promise in animal trials.

Acute Kidney Injury↗
PubMed1998

Outcome after general or regional anaesthesia in high-risk patients.

This review is a critical analysis of research design for studies of outcome comparing epidural anaesthesia and analgesia with general anaesthesia and alternative postoperative analgesia regimens. If important advances in knowledge are to be made, appropriately designed multicentre randomized controlled trials are essential. These trials must incorporate strict controls on patient entry, a comprehensive range of carefully defined and clinically significant morbidity endpoints and the previous determination of sample size through a proper analysis of statistical power.

Journal Article↗
PubMed2002

Evaluation of a staging system for infected hip arthroplasty.

A previously reported staging system for prosthetic joint infection was evaluated in 26 consecutive patients with an infected hip arthroplasty. Six patients were treated by a definitive resection arthroplasty whereas the remaining 20 patients received delayed insertion of another hip arthroplasty. Four of the 20 patients (20%) receiving a new prosthesis had reinfection develop. The only variable in common among the patients who had reinfection was the use of a massive femoral structural allograft at reconstruction. Because of the small number of patients in this study, the power of statistical analysis did not allow definitive determination of the effect of the staging system score with respect to recurrent infection. Based on this study, recommendations can be suggested for addition and deletion of certain variables within the existing staging system. Although the concept of a staging system for treatment of an infected hip arthroplasty is promising, the number of patients required to evaluate the use of a staging system will require a multicenter collaborative study.

Adult↗
PubMed1994

The diagnosis of visual field progression in glaucoma.

The detection of true visual field deterioration in glaucoma is of fundamental importance but is limited by inherent variability of the measurements. New techniques have been developed that use powerful statistical regression analysis methods to objectively quantify progression of visual field defects. These have been combined with new methods of graphical presentation to reveal the spatial distribution in the visual field of deterioration. New measurement techniques utilizing blue-on-yellow, flicker, and motion stimuli provide further advantages and may be combined with regression analysis to improve the early detection of real progression of visual field loss.

Glaucoma↗