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An analysis of risk factors for biochemical progression in patients with seminal vesicle invasion: validation of Kattan's nomogram in a pathological subgroup.

OBJECTIVE: To assess the ability of a recently published nomogram to predict failure after radical retropubic prostatectomy (RRP) in a cohort of patients with seminal vesicle invasion (SVI) of the resected specimen, widely regarded as a very poor prognostic factor in patients with prostate cancer. PATIENTS AND METHODS: Men with SVI after RRP were analysed retrospectively; patients with positive lymph nodes, adjuvant radiotherapy or hormone therapy were excluded. Age, race, baseline prostate specific antigen (PSA) level, clinical stage, Gleason score, margin status, perineural invasion, capsular invasion, laterality and route of invasion were recorded. Biochemical recurrence was defined as one PSA measurement of 0.4 ng/mL. Biochemical disease-free survival probability was plotted using the Kaplan-Meier method. Kattan's nomogram was applied to each patient and a receiver-operator characteristic (ROC) curve produced to assess the test's reliability. RESULTS: In all, 67 patients with SVI were identified (mean age 64.6 years, sd 5.9; median follow-up 30.5 months). Biochemical disease-free survival was significantly better for men with negative margins, unilateral SVI and perineural invasion. No other significant factors were detected. The median (95% confidence limit) area under the ROC curve was 0.739 (0.604-0.847). CONCLUSION: There were significant prognostic differences for three of the factors assessed. Although components of the Kattan nomogram were not significant in this group its predictive value approached that found originally, suggesting that it can be applied to patients with SVI in helping to direct adjuvant therapy and guide postoperative counselling.

Disease Progression↗

Nomogram for estimating an individual's risk of having a fetus with open spina bifida.

A nomogram indicating the risk of having a fetus with open spina bifida in relation to a particular maternal serum and amniotic fluid alpha-fetoprotein (AFP) level is described. The nomogram is designed for counselling patients with borderline amniotic fluid AFP results, who on average are only marginally at risk of having a fetus with open spina bifida. The use of the nomogram will refine the estimate of risk for a particular woman by combining the estimate derived from the amniotic fluid AFP level with that derived from the maternal serum AFP level. Details are also given for further refining the estimate risk by using information from an amniotic fluid gel acetylcholinesterase determination.

Amniotic Fluid↗

A new method of haemodynamic assessment of mitral stenosis in atrial fibrillation: construction of a nomogram.

Accurate haemodynamic assessment of mitral stenosis by hydraulic formulas requires measurement of the mean valve gradient and the cardiac output. The calculation is laborious, particularly in the presence of atrial fibrillation when averaged values obtained from multiple beat-to-beat determinations must be used. The relations between valve area, end diastolic gradient, and heart rate in 20 patients with mitral stenosis and atrial fibrillation were examined. In each patient the end diastolic pressure gradient for each cardiac cycle was related linearly to the RR interval of that cycle, and this relation was unchanged on exercise. The slope (S) and intercept (I) of this relation correlated with the degree of mitral stenosis as measured by the Gorlin valve area. The regression equations describing these relations were then used to construct a nomogram relating end diastolic pressure gradient to mitral valve area at different heart rates. When the nomogram was applied to catheterisation data from a further 30 patients the results correlated well with direct calculation of valve area by the Gorlin formula. The nomogram is simple to use, does not require measurement of cardiac output, and is independent of heart rate so that it is unnecessary for the patient to exercise during catheterisation.

Atrial Fibrillation↗

Plasma protein osmotic pressure equations and nomogram for sheep.

The equations developed by Landis and Pappenheimer (Handbook of Physiology. Circulation, 1963, p. 961-1034) for calculating the protein osmotic pressure of human plasma proteins have been frequently used for other animal species without regard to the fractional albumin concentration or correction for protein-protein interaction. Using an electronic osmometer, we remeasured the protein osmotic pressure of purified sheep albumin and sheep plasma partially depleted of albumin. We measured protein osmotic pressures of serial dilutions over the concentration range 0-180 g/l for albumin and 0-100 g/l for the albumin-depleted proteins at room temperature (26 degrees C). Using a nonlinear least squares parameter-fitting computer program, we obtained the equation of best fit for purified albumin, and then we used that equation together with the measured albumin fraction to obtain the best-fit equation for the nonalbumin proteins. The equation for albumin is IIcmH2O,39 degrees C = 0.382C + 0.0028C2 + 0.000013C3, where C is albumin concentration in g/l. The equation for the nonalbumin fraction is IIcmH2O,39 degrees C = 0.119C + 0.0016C2. Up to 200- and 100-g/l protein concentration, respectively, these equations give the least standard error of the estimate for each of the virial coefficients. The computed number-average molecular weight for the nonalbumin proteins is 222,000. Using the new equations, we constructed a nomogram, based on the one of Nitta and co-workers (Tohoku J. Exp. Med. 135: 43-49, 1981). We tested the nomogram using 144 random samples of sheep plasma and lymph from 31 sheep. We obtained a correlation coefficient of 0.99 between the measured and nomogram estimates of protein osmotic pressure.

Animals↗

Randomized assessment of a warfarin nomogram for initial oral anticoagulation after venous thromboembolic disease.

Standard treatment for venous thromboembolism is parenteral heparin followed by warfarin. In this study we assess whether a standardized method of ordering warfarin reduces the duration of hospitalization. Consecutive patients were randomized to receive warfarin managed by attending physicians or by a nomogram. Patients were stratified according to primary or secondary venous thromboembolism. Prothrombin times were measured daily and heparin was given for a minimum of 5 days and stopped when the International Normalized Ratio was >1.9. Patients were followed for 3 months. There were 111 patients, 80 with primary and 31 with secondary venous thromboembolism. Overall there were no differences between the two warfarin groups with respect to length of admission. Given the prolonged duration of admission in many patients with secondary venous thromboembolism, a subset analysis was conducted on the 80 patients with primary venous thromboembolism. Patients in the standard group stayed significantly longer than patients in the nomogram group (6.0 vs. 5.6 days, p = 0.02). The warfarin nomogram as tested is safe and leads to a significantly shorter length of stay for patients with primary venous thromboembolism as compared to standard practice.

Administration, Oral↗

Predictability of phenytoin serum levels by nomograms and clinicians.

On the basis of a reliable steady state phenytoin serum concentration on one (lower) dose, the serum concentration on a second (higher) dose was predicted in 28 patients (32 levels) by two previously reported nomograms and 3 physicians who had clinical experience with phenytoin therapy. Both nomograms and all 3 physicians on the average underestimated the serum concentration on the higher dose. Except for 1 physician, this bias was statistically significant (p < 0.05). The mean and SD of the prediction errors (difference between predicted and measured serum concentration) were -2.2 +/- 4.2 and -3.1 +/- 3.6 for the two nomograms and -1.0 +/- 4.0, -2.1 +/- 4.1 and -1.8 +/- 4.2 for the 3 physicians, respectively. Thus, independent of the method used, there was a large uncertainty in the prediction; the approximate 68% confidence interval of the prediction error (mean +/- SD) was almost as large as the therapeutic range of the drug. Because prediction of phenytoin serum levels based on one serum concentration measurement was found unreliable in this study, it is proposed that every patient whose dose had been increased should be under close observation until a new steady state has been confirmed.

Adult↗

A guideline nomogram to control intraoperative haemodilution in cardiac surgery.

Intraoperative blood collection prior to cardiopulmonary bypass (CPB) is a common procedure in cardiac surgery. Its aims are to obtain fresh whole blood to be infused after CPB, to use autologous blood in the prime or to avoid too high levels of haematocrit (HCT) during CPB. Calculations to determine the amount of blood to be collected are generally based on theoretical assumptions. In this paper we have set up and controlled, on a clinical basis, a nomogram to be used in order to obtain a standard pre-CPB HCT equal to 38%, using a moderately hypervolaemic haemodilution based on blood collection simultaneous with fluid replacement. Thirty adult patients were evaluated in order to settle the nomogram; subsequently, the nomogram validity was checked on 100 adult patients. Statistical analysis revealed the good clinical usefulness of this instrument.

Adult↗

A nomogram for predicting the likelihood of additional nodal metastases in breast cancer patients with a positive sentinel node biopsy.

BACKGROUND: The standard of care for breast cancer patients with sentinel lymph node (SLN) metastases includes complete axillary lymph node dissection (ALND). However, many question the need for complete ALND in every patient with detectable SLN metastases, particularly those perceived to have a low risk of non-SLN metastases. Accurate estimates of the likelihood of additional disease in the axilla could assist greatly in decision-making regarding further treatment. METHODS: Pathological features of the primary tumor and SLN metastases of 702 patients who underwent complete ALND were assessed with multivariable logistic regression to predict the presence of additional disease in the non-SLNs of these patients. A nomogram was created using pathological size, tumor type and nuclear grade, lymphovascular invasion, multifocality, and estrogen-receptor status of the primary tumor; method of detection of SLN metastases; number of positive SLNs; and number of negative SLNs. The model was subsequently applied prospectively to 373 patients. RESULTS: The nomogram for the retrospective population was accurate and discriminating, with an area under the receiver operating characteristic (ROC) curve of 0.76. When applied to the prospective group, the model accurately predicted likelihood of non-SLN disease (ROC, 0.77). CONCLUSIONS: We have developed a user-friendly nomogram that uses information commonly available to the surgeon to easily and accurately calculate the likelihood of having additional, non-SLN metastases for an individual patient.

Adult↗

A nomogram for planning respiratory therapy.

A nomogram is presented which aids in monitoring and selecting therapy in the treatment of the patient with hypoxemia. It facilitates accurate bedside determination of total shunt fraction and estimation of the arterial oxygen tension (PaO2) attainable at inspired oxygen concentrations of 21 percent to 100 percent. The nomogram permits rapid consideration of changes in hemoglobin concentration, arteriovenous oxygen content difference, and shunt fraction on the PaO2. The uses of the nomogram in several therapeutic contexts are discussed.

Carbon Dioxide↗

Nomogram for estimating creatinine clearance.

Several methods have been published for estimating creatinine clearance from serum creatinine concentrations. Such estimates of creatinine clearance are widely used for dosage adjustments of drugs which are primarily eliminated through the kidneys in patients with reduced renal function. Most of these methods involve the use of equations, requiring a few steps of calculations. A simple and easy-to-use nomogram is presented for estimating creatinine clearance from serum creatinine concentration, plus the age, sex, and bodyweight of the individual patient. This nomogram is based on the linear relationship between creatinine clearance and the reciprocal value of the serum creatinine concentration, where the slope of this relationship is determined by the rate of creatinine production. The rate of creatinine production, however, is related to age, sex, and bodyweight. These physical characteristics are therefore used to scale the slopes of the relationships between creatinine clearance and serum creatinine concentration. The validity of the nomogram was tested in 50 consecutive hospitalised patients for which creatinine clearance was measured. There was an excellent correlation (r = 0.903) between predicted and observed creatinine clearance values.

Creatinine↗

Nomograms for the prediction of pathologic stage of clinically localized prostate cancer in Korean men.

We analyzed the prostate cancer data of 317 Korean men with clinically localized prostate cancer who underwent radical prostatectomy at Asan Medical Center between June 1990 and November 2003 to construct nomograms predicting the pathologic stage of these tumors, and compared the outcome with preexisting nomograms. Multinomial log-linear regression was performed for the simultaneous prediction of organ-confined disease (OCD), extracapsular extension (ECE), seminal vesicle invasion (SVI) and lymph node metastasis (LNM) using serum prostate-specific antigen (PSA), Gleason score and clinical stage. Nomograms representing percent probabilities were constructed and compared with those presented by Partin et al. by calculating areas under the receiver operating characteristics (ROC) curves. Median serum PSA at surgery was 10.8 ng/mL, and median biopsy Gleason score was 7. Overall OCD, ECE, SVI and LNM rates were 59.6%, 20.5%, 11.7% and 8.2%, respectively, and areas under the curves were 0.724, 0.626, 0.662, and 0.794, respectively. Pathologic stage of localized prostate cancer in Korean men may be predicted using the Partin table, with acceptable accuracy for OCD and LNM, but less so for ECE and SVI.

Adult↗

Biomarker-Based Nomogram to Predict Neoadjuvant Chemotherapy Response in Muscle-Invasive Bladder Cancer.

Background/Objectives: The aim of this study was to identify response prediction and prognostic biomarkers in muscle-invasive bladder cancer (MIBC) patients undergoing neoadjuvant chemotherapy (NAC). Methods: A retrospective multicentre study including 191 patients with MIBC who received NAC previous to radical cystectomy (RC) between 1996 and 2013. Gene expression patterns were analysed in 34 samples from transurethral resection of the bladder (TURB) using Illumina microarrays. The expression levels of 45 selected differentially expressed genes between responders and non-responders to NAC were validated by quantitative PCR in an independent cohort of 157 patients. Regression analysis was used to identify predictors of downstaging and relapse. A nomogram for predicting downstaging and relapse-including clinicopathological and gene expression variables-was developed. Results: The expression levels of 1352 transcripts differed between responders and non-responders to NAC. A nomogram based on the most predictive clinical variables (age, Tis (in situ), gender, history of NMIBC, and lymphadenopathy) and genes selected following the Akaike information criterion (AIC) (CBTB16, CHMP6, DDX54, CASP8, LOR, and PLEC) was then created. In addition, a three-gene expression prognostic model to predict tumour relapse was generated. This model was able to discriminate between two groups of patients with a significantly different probability of tumour relapse (HR: 2.11; CI: 1.16-3.83, p = 0.01). Conclusions: Our nomogram based on gene expression and clinical data is a useful tool to predict downstaging and tumour relapse after NAC in MIBC patients. Further validation is warranted.

bladder cancer↗

Comparative results between standard and bitoric nomograms for astigmatism correction.

PURPOSE: To investigate results of excimer laser correction for mixed astigmatism, using two kinds of corneal photoablation; bitoric nomograms for cylinder and standard monotoric procedures. METHODS: Intrastromal photoablation was performed with the Nidek EC-5000 excimer laser and a lamellar keratotomy was created with the Hansatome microkeratome. We selected 46 cases with mixed astigmatism. The first group included 28 eyes (average cylinder 4.15 +/- 0.86 D, sphere 1.37 +/- 0.18 D). In this group, procedures were performed using bitoric nomograms. The second group included 18 eyes (average cylinder 4.05 +/- 0.64 D, sphere 1.67 +/- 0.23 D). In this group ablation was performed with monotoric nomograms. RESULTS: After 6 months in the bitoric group, average residual cylinder was 1.49 +/- 0.24 D, and sphere was -0.57 +/- 0.31 D. In seven cases (25%), re-ablations for astigmatism correction were needed. In the monotoric group, average postoperative cylinder was 1.89 +/- 0,39 D, and sphere was 0.77 +/- 0.28 D. In eight cases (44%), retreatments were planned. CONCLUSION: Bitoric ablations for astigmatic corrections resulted in a decreased frequency of reablation as compared to standard monotoric procedures.

Adult↗

Laser in situ keratomileusis results of DOS and windows software versions for the Nidek EC-5000 excimer laser using the same nomogram.

PURPOSE: To compare the results of laser in situ keratomileusis (LASIK) correction for myopia and myopic astigmatism between the previous DOS software version and the Windows software version for the Nidek EC-5000 excimer laser, using the same nomogram. METHODS: This retrospective review included 2021 eyes (980 patients) after LASIK using the Nidek EC-5000 excimer laser. Of these, 1,632 eyes were corrected with the DOS software version and the other 389 eyes were corrected with the Windows software version of the laser. Both groups were treated with the same surgical nomogram. Minimum follow-up time was 6 months. Patients were classified into range of myopia: low, moderate, and high. RESULTS: Postoperative uncorrected visual acuity was not statistically significantly different between the two groups in any range of refractive error. There was no loss of best spectacle-corrected visual acuity for any patient. Uncorrected visual acuity equal to or better than 20/40 was achieved in 96.3% of eyes in the Windows version group and 94.9% in the DOS version. CONCLUSION: Results for the correction of myopia or myopic astigmatism were similar using the Nidek EC-5000 excimer laser with either the DOS software version or Windows software version, with the same surgical nomogram.

Adolescent↗

Sample size nomograms for interpreting negative clinical studies.

In recent years there has been increasing attention to the appropriate interpretation of a clinical study. One special concern has been the difficulty inherent in interpreting studies that were not statistically significant: Was the sample size sufficient to detect a clinically important effect if, in fact, it existed? This concern is further complicated because readers may have differing opinions of what size effect is clinically important. A pair of sample size nomograms has been developed, using common levels of statistical significance, to assist in this interpretation. The nomograms are intended to provide the clinician with a handy and easy-to-use reference for ascertaining whether an apparently negative study has a sample size adequate to detect reliably any difference between treatment groups that the clinician believes is clinically important. Examples are provided to show these principles and the use of the nomograms in interpreting negative studies.

Clinical Trials as Topic↗

Nomograms of the fetal lateral ventricles using transvaginal sonography.

Nomograms of the fetal lateral ventricles were obtained by the transvaginal approach. Three hundred low-risk women with no sonographically apparent fetal anomalies were scanned prospectively in a cross-sectional study. Three measurements in the parasagittal plane, three in the midline coronal plane, and two in the posterior coronal plane were used to generate seven nomograms. Two additional nomograms reflecting two calculated ratios also were created. A mean regression line and the 5th and 95th confidence intervals were determined. We concluded that transvaginal sonography of the fetal brain generates images of both hemispheres of good enough resolution to allow several precise and reproducible measurements.

Anthropometry↗

Sonographic nomogram of the leptomeninges (pia-glial plate) and its usefulness for evaluating bacterial meningitis in infants.

BACKGROUND AND PURPOSE: To our knowledge, the upper limits of the thickness of normal meninges on neurosonograms are not known. We therefore established a nomogram for sonographic measurements of the leptomeninges (pia-glial plate) and assessed its usefulness in neurosonographic examinations of children with bacterial meningitis. METHODS: The pia mater-cortical glia limitans complex on the surface of the brain and in the sulcus of a frontal gyrus was measured on neurosonograms in 100 infants without meningeal disease in order to establish a nomogram of the thickness of this pia-glial plate, referred to as the leptomeninx. Effects of prematurity, age, sex, and single-layer (surface) versus double-layer (sulcus) measurements were analyzed. Meningeal thicknesses derived from a retrospective analysis of the neurosonograms of 33 patients with purulent meningitis and a prospective study of 22 patients with bacterial meningitis were compared with the nomograms. Clinical outcomes of children with meningeal thickening were compared with those of affected children with normal meninges. RESULTS: The distribution of sulci measurements was significantly asymmetrical around the mean. Statistical data showed no influence of prematurity and sex, but showed surface measurements to be more consistent than sulcal measurements. Older chronological age was related to slightly larger sulci, but did not influence the surface measurements. In children with bacterial meningitis, the surface meninges were less frequently thickened than were the sulci. Sulcal enlargement occurred often in combination with echogenic deposits in the sub-arachnoid space. CONCLUSION: Leptomeninges are best measured on the surface of a gyrus rather than in a sulcus, as the normal thickness of the sulci shows much more variability. Clinical outcome of bacterial meningitis cannot be predicted by presence or absence of meningeal thickening as the only sonographic abnormality.

Echoencephalography↗

A birthweight nomogram for Africa, as a malaria-control indicator.

Low birthweight (LBW) attributable to malaria in pregnancy is a significant risk for millions in Africa. Infants born to primigravidae are at greatest risk and it is proposed that this excess risk can be used as a simple indicator of malaria transmission and exposure in pregnant women in Africa. Birthweight data from different regions in 11 malarious and three non-malarious African countries were investigated. A regression analysis of the excess risk of low birthweight in first pregnancies, compared with later ones, was completed and interpreted in relation to malaria-transmission intensities. The aim was to develop a simple birthweight chart (nomogram) as a tool for monitoring malaria transmission or malaria control in pregnancy. Low-birthweight risk in first pregnancies was associated with levels of malaria-transmission intensity amongst different African countries. The nomogram distinguished longitudinal changes in malaria exposure, related to season and changes in antimalarial-drug policy. Malaria is one of the most important causes of LBW in first pregnancies in Africa. As birthweight and parity are routinely recorded in many delivery centres across Africa, the nomogram provides a simple, available and inexpensive tool for monitoring malaria transmission and exposure in pregnant women and the effectiveness of malaria-control activities for this high-risk group.

Africa↗