Total Point Score Research Articles

MD Anderson Cancer Center (MDACC) Score Adds Prognostic Information To The Distinction Between High COUNT Monoclonal B-CELL Lymphocytosis (HC-MBL) and RAI STAGE 0 Chronic Lymphocytic Leukemia (CLL)

Immunogenetic characteristics and clinical outcome findings suggest that high-count monoclonal B-cell lymphocytosis (HC-MBL) (i. e, more than 0.5 x 10E9 clonal B cells/L in peripheral blood) and Rai stage 0 CLL (i. e, more than 5.0 x 10E9 clonal B cells/L in peripheral blood) are similar entities. However, it is not clear whether prognostic variables generally useful to forecast the likelihood of transformation to an active phase of disease requiring therapy of patients with early CLL can be applied to subjects with HC-MBL. We therefore analyzed clinical outcome of a multi-institutional, prospective cohort including 94 subjects with HC CLL-like (i.e., CD19-, CD5-, CD23-positivity, and CD20dim expression) MBL and 158 Rai stage 0 CLL patients diagnosed at different Italian hematologic institution between January 2006 and December 2010 (O-CLL1 protocol; clini- caltrial.gov identifier NCT00917540). In this cohort we wondered whether the new prognostic index proposed by MD Anderson Cancer Center (MDACC) which includes either clinical (i.e., number of lymph node sites involved, lymph node size in neck, LDH) or biological (i.e., mutational status of IGHV, presence of 11q or 17p deletion by FISH) variables could add prognostic information to that afforded by distinction between HC-MBL and Rai stage 0.Using time to first treatment (TTFT) as endpoint, we found that likelihood to receive therapy was significantly lower for subject with HC-MBL in comparison to patients in Rai stage 0 (P<0.001). Furthermore, a total point score of 25, used as threshold, identified two different patterns of TTFT among either subjects with HC-MBL (P=0.02) or patients with Rai stage 0 CLL (P<0.001). We then stratified our cohort taking into account either the distinction between HC-MBL and Rai stage 0 or MDACC prognostic index. Accordingly, 4 groups were identified: 1. HC-MBL with MDACC total point score lower than 25 (n=66); 2. HC-MBL with MDACC total point score equal or higher than 25(n=28); 3. Rai stage 0 with MDACC total point score lower than 25 (n=74); 4. Rai stage 0 with MDACC total point score equal or higher than 25 (n=84). The probability of remaining free from therapy at 5 years was 97% for subjects with HC-MBL and MDACC score lower than 25 while it was 20% for patients with Rai stage 0 and score equal or higher than 25. In between there were HC-MBL subjects with MDACC total point scorre equal or higher than 25 and Rai stage 0 patients with MDACC total point score lower than 25. Curves of TTFT of these two groups virtually overlapped and 5-year probability of remaining free from therapy was 68% for both.In conclusion, we demonstrated that MDACC score adds information to the distinction between HC-MLB and Rai stage 0 leading to the identification of three significantly different patterns of TTFT on the basis of objective data of clinical outcome (P<0.0001) (Fig1). These results support the idea that HC-MBL and Rai stage 0 are a mixture of real patients whose clinical outcome is affected by the disease but also of individuals who will never develop clinical signs and symptoms. [Display omitted] Disclosures:No relevant conflicts of interest to declare.

A dermatology surgical safety checklist: an objective resident performance tool

A dermatology surgical safety checklist: an objective resident performance tool

Diagnostika úrovně výkonnostních předpokladů tenistek (longitudinální studie)

The contribution deals with the issues of judging the level and evolution trends of somatic and motor performance preconditions in tennis. In contemporary world tennis, there is an obvious tendency to the physically demanding game and that is why the diagnostics of the level of performance preconditions is an important part of the training process. The research intent was to perform a longitudinal observation of the level of somatic and motor preconditions in two female tennis players, who have reached a high international level of performance in their adult age, to evaluate evolution trends and to compare the found data with a population of female tennis players. The research had the character of a longitudinal study and the data were gathered using the test battery TENDIAG1 containing three somatic and six motor items. The results of both observed female players clearly show that the total point score in the test battery was above the boundary of the average level of the female tennis players’population. The results proved that the level of somatic and motor preconditions of both female players was mostly above average. The results confirm the importance of somatic, conditioning, and coordination preconditions for tennis.

Development of a risk index for prediction of mortality after open aortic aneurysm repair

Open infrarenal abdominal aortic aneurysm (oAAA) repair is associated with significant morbidity and mortality. Although there has been a shift toward endovascular repair, many patients continue to undergo an open repair due to anatomic considerations. Tools currently existing for estimation of periprocedural risk in patients undergoing open aortic surgery have certain limitations. The objective of this study was to develop a risk index to estimate the risk of 30-day perioperative mortality after elective oAAA repair. Patients who underwent elective oAAA repair (n = 2845) were identified from the American College of Surgeons' 2007 to 2009 National Surgical Quality Improvement Program (NSQIP), a prospective database maintained at >250 centers. Univariable and multivariable analyses were performed to evaluate risk factors associated with 30-day mortality after oAAA repair and a risk index was developed. The 30-day mortality after oAAA repair was 3.3%. Multivariable analysis identified six preoperative predictors of mortality, and a risk index was created by assigning weighted points to each predictor using the β-coefficients from the regression analysis. The predictors included dyspnea (at rest: 8 points; on moderate exertion: 2 points; none: 0 points), history of peripheral arterial disease requiring revascularization or amputation (3 points), age >65 years (3 points), preoperative creatinine >1.5 mg/dL (2 points), female gender (2 points), and platelets <150,000/mm(3) or >350,000/mm(3) (2 points). Patients were classified as low (<7%), intermediate (7%-15%), and high (>15%) risk for 30-day mortality based on a total point score of <8, 8 to 11, and >11, respectively. There were 2508 patients (88.2%) patients in the low-risk category, 278 (9.8%) in the intermediate-risk category, and 59 (2.1%) in the high-risk category. This risk index has excellent predictive ability for mortality after oAAA repair and awaits validation in subsequent studies. It is anticipated to aid patients and surgeons in informed patient consent, preoperative risk assessment, and optimization.

The utility of two prognostic models for predicting time to first treatment in early chronic lymphocytic leukemia patients: Results of a comparative analysis

The use of both traditional and novel prognostic parameters combined in a statistical model for predicting patient clinical outcome has been recently proposed by both MD Anderson Cancer Center (MDACC) and German chronic lymphocytic leukemia (CLL) group. Using time to first treatment (TTFT) as end-point, we performed a comparative external validation of MDACC score versus a modified version of German score, which excluded thymidine kinase measurement, in a prospective, multicenter, community-based cohort consisting of 328 patients who had asymptomatic, early stage CLL. With both models a significant correlation between higher score and shorter TTFT could be found. As a matter of fact, patients with total point score ≥25 according to MDACC model (HR, 3.27; 95% CI, 2.07–5.18; P<0.0001) or ≥2 according to modified German model (HR, 2.02; 95% CI, 1.29–3.16; P=0.002) were more likely to receive therapy. Both models provided similar results in terms of sensitivity (MDACC score, 61.5%; modified German score, 57.7%; P=0.79), whereas specificity was significantly higher for MDACC score (72.1% versus 63%; P=0.02). The prognostic utility of either MDACC or modified German score was assessed by time-dependent Receiver Operating Characteristic (ROC) analysis. Results of this comparative analysis showed that after the 2nd year area under curve (AUC) for TTFT was higher than 0.60 for both models and kept unmodified this trend over the time. Results of this study suggest that in CLL both MDACC and modified German score group should be considered the benchmarking of comparison for any novel prognostic proposal having as endpoint TTFT in CLL and including both traditional and newer prognostic parameters.

A Risk Scoring System to Identify Emergency Department Patients With Heart Failure at High Risk for Serious Adverse Events

There are no validated guidelines to guide physicians with difficult disposition decisions for emergency department (ED) patients with heart failure (HF). The authors sought to develop a risk scoring system to identify HF patients at high risk for serious adverse events (SAEs). This was a prospective cohort study at six large Canadian EDS that enrolled adult patients who presented with acute decompensated HF. Each patient was assessed for standardized clinical and laboratory variables as well as for SAEs defined as death, intubation, admission to a monitored unit, or relapse requiring admission. Adjusted odds ratios for predictors of SAEs were calculated by stepwise logistic regression. In 559 visits, 38.1% resulted in patient admission. Of 65 (11.6%) SAE cases, 31 (47.7%) occurred in patients not initially admitted. The multivariate model and resultant Ottawa Heart Failure Risk Scale consists of 10 elements, and the risk of SAEs varied from 2.8% to 89.0%, with good calibration between observed and expected probabilities. Internal validation showed the risk scores to be very accurate across 1,000 replications using the bootstrap method. A threshold of 1, 2, or 3 total scores for admission would be associated with sensitivities of 95.2, 80.6, or 64.5%, respectively, all better than current practice. Many HF patients are discharged home from the ED and then suffer SAEs or death. The authors have developed an accurate risk scoring system that could ultimately be used to stratify the risk of poor outcomes and to enable rational and safe disposition decisions.

External validation on a prospective basis of a nomogram for predicting the time to first treatment in patients with chronic lymphocytic leukemia

A nomogram that incorporates traditional and newer prognostic factors to identify patients with chronic lymphocytic leukemia (CLL) who are at high risk of receiving therapy was developed by investigators at The University of Texas M. D. Anderson Cancer Center (MDACC). Because the model required validation before its extensive use could be recommended, the authors sought to externally validate the nomogram in an independent, community-based cohort of patients with CLL. In total, 328 previously untreated patients with newly diagnosed, asymptomatic, Binet stage A CLL from different primary hematology centers who were registered on a prospective basis during 2006 to 2010 on an observational database of the Italian Lymphoma Study Group were considered suitable for external validation of the model. A total point score was calculated for each patient using a formula proposed by MDACC investigators, and the median score was 19.9 (range, 0-69.5). Furthermore, when the score was evaluated as continuous variable (ie, by measuring the risk of each point increase), the total point score was associated with the time to first treatment (hazard ratio [HR], 1.04; 95% confidence interval [CI], 1.02-1.05; P < .0001). Receiver operating characteristic analysis identified a point score of 25 (area under curve; 0.64; sensitivity, 61.5; specificity, 72.1; P < .0001) as the best threshold capable of separating patients who needed therapy from patients who did not (HR, 3.27; 95% CI, 2,07-5.18; P < .0001). The prognostic index category also remained a predictor of the time to first treatment when the analysis was limited to patients with Rai stage 0 disease (HR, 4.05; 95% CI, 2.25-7.52; P < .0001). Finally, a goodness-of-fit test demonstrated that the nomogram model had a significantly good fit at 2 years (correlation coefficient [r(2) ] = 0.966; P = .002). The current results confirmed the ability of a newly developed prognostic index to predict the time to first treatment among previously untreated patients with CLL who had early disease and extended the utility of the model to those with Rai stage 0 disease. In addition, the actual and predicted time to first treatment outcomes revealed good agreement, suggesting that, externally, the results provided by the model are well calibrated. Cancer 2013. © 2012 American Cancer Society.

BOTH MD Anderson Cancer Center MODEL and German Score Work in Predicting Time to First Treatment in EARLY Chronic Lymphocytic Leukemia: Results of an External Validation Analysis

AbstractAbstract 3934In chronic lymphocytic leukemia (CLL) there has been a limited published work on the development of models predicting time to first treatment that incorporate traditional and novel prognostic factors. We wondered whether the nomogram recently proposed by M D Anderson Cancer Center (MDACC) investigators that includes clinical and newer prognostic variables (i.e., three or more involved lymph node sites, increased size of cervical lymph nodes, presence of 17p deletion or 11q deletion by FISH, increased serum LDH, and unmutated IGHV mutation status) could work when applied to a prospective community-based CLL patient cohort.We considered suitable for the purpose of this study 328 previously untreated patients with newly diagnosed asymptomatic Binet stage A CLL from different primary hematology centers registered on a prospective basis during the period 2006–2010 on an observational database of Gruppo Italiano Studio Linfomi (GISL).Using the formula proposed by Wierda et a total point score was calculated for each patient. A value ranging between 0 and 69.5 (median, 19.9) - therefore similar to total point scores reported by the MDACC group (median, 21.0; range, 0 – 87.4) – was found. As a continuous variable (i.e., measuring the risk of each point increase), total point score was associated with time to first treatment (HR 1.04; 95% CI 1.02–1.05; P < 0.0001). Receiver Operating Characteristic analysis identified a point score of 25 [area under curve (AUC) 0.64, sensitivity 61.5 specificity 72.1; P<0.0001)] as the best threshold capable of separating patients who needed therapy from patients who did not (HR, 3.27; 95% CI, 2,07–5.18; P<0.0001). The prognostic index category remained a predictor of time to first treatment also when analysis was limited to patients in Rai stage 0 (HR,4.05; 95% CI: 2.25–7.52; P<0.0001). Finally, the goodness of fit showed that the nomogram model had significant good fit at 2 years (r2=0.966; P=0.002).We next wondered whether the German score based on 7 prognostic variables (i.e., age, gender, b2-microglobulin, sTK, IGVH mutational status, ECOG performance status and hierachic type of FISH abnormalities) and originally designed for predicting overall survival could forecast time to first treatment in patients with early disease. Since sTK was not available a slightly modified version of German model based on 6 prognostic variables was used. The risk score calculated in each patient by summing single ratings of adverse factors, allowed the identification of two different risk categories scoring respectively 0–2 and 3–5 whose clinical outcomes were different with respect to time to first treatment (HR 2.19, 95% CI: 1.15–2.20; P=0.005).In conclusion, this analysis shows that both models proposed by MDACC investigators and German group provide interchangeable tool for assessing time to first treatment. Interestingly, in this validation analysis the pattern of distribution of patients into a low and high-risk category revealed a high degree of concordance between models (P<0.0001; Mann-Whitney test). Disclosures:Morabito:Celgene: Honoraria.

Risk index for predicting perioperative stroke, myocardial infarction, or death risk in asymptomatic patients undergoing carotid endarterectomy

The latest guidelines recommend performance of carotid endarterectomy (CEA) on asymptomatic patients with high-grade carotid stenosis, only if the combined perioperative stroke, myocardial infarction (MI), or death risk is ≤3%. Our objective was to develop and validate a risk index to estimate the combined risk of perioperative stroke, MI, or death in asymptomatic patients undergoing elective CEA. Asymptomatic patients who underwent an elective CEA (n= 17,692) were identified from the 2005-2010 National Surgical Quality Improvement Program, a multicenter, prospective database. Multivariable logistic regression analysis was performed with primary outcome of interest being the composite of any stroke, MI, or death during the 30-day periprocedural period. Bootstrapping was used for internal validation. A risk index was created by assigning weighted points to each predictor using the β-coefficients from the regression analysis. Fifty-eight percent of the patients were men with a median age of 72 years. Thirty-day incidences of stroke, MI, and death were 0.9% (n= 167), 0.6% (n= 108), and 0.4% (n= 72), respectively. The combined 30-day stroke, MI, or death incidence was 1.8% (n= 324). On multivariable analysis, six independent predictors were identified and a risk index created by assigning weighted points to each predictor using the β-coefficients from the regression analysis. The predictors included age in years (<60: 0 point; 60-69: -1 point; 70-79: -1 point; ≥80: 2 points), dyspnea (2 points), chronic obstructive pulmonary disease (3 points), previous peripheral revascularization or amputation (3 points), recent angina within 1 month (4 points), and dependent functional status (5 points). Patients were classified as low (<3%),intermediate (3%-6%), or high (>6%) risk for combined 30-day stroke, MI, or death, based on a total point score of<4, 4-7, and >7, respectively. There were 15,249 patients (86.2%) in the low-risk category, 2233 (12.6%) in the intermediate-risk category, and 210 (1.2%) in the high-risk category. The validated risk index can help identify asymptomatic patients who are at greatest risk for 30-day stroke, MI, and death after CEA, thereby aiding patient selection.

Follow-up of unilateral cleft-lip nose deformity after secondary repair with a modified reverse-U method

Emphasis of secondary repair for unilateral cleft-lip has been placed on correction of the cleft-lip nasal deformity by translocation of the alar cartilage with its attached vestibular lining into a normal position, thereby establishing the normal vault and shape of the cartilage. We have managed cleft-lip deformities employing a modified reverse-U method. We present our modified technique and the obtained results. Eighty-nine patients with unilateral cleft-lip nasal deformity underwent surgical repair between 1998 and 2007 by one surgeon. These patients were divided into two groups based on their previous operative histories. Group A comprised 52 patients who underwent primary cheiloplasty using a modified Tajima technique. No other surgery had been performed prior to our modified reverse-U method in these cases. Group B consisted of 37 patients receiving the primary operation and/or more than one rhinoplasty at another hospital before our method was employed. The ages of our patients at the time of the secondary operation ranged from 4 to 40 years (average, 8.1 years; 4.2 years in group A and 13.4 years in group B). The follow-up period ranged from 2 to 11 years (average 7.2 years). For objective evaluation, points on the nasal dome and alar crease were measured on patient photographs. The results were retrospectively distinguished to three levels by total point score: Excellent, Good and Fair. Excellent or Good results were obtained in 74 cases, while 15 had Fair results. Eighty-one percent of all cases maintained acceptable results without relapse. Fair results were attributed to an unclear alar crease or relapse. In conclusion, rigid fixation and release of nasal cartilage are very important. We believe our modified reverse-U method to be very useful for achieving symmetry of the unilateral cleft-lip nose in the long term.

Clinical Trial of Lutein in Patients With Retinitis Pigmentosa Receiving Vitamin A

To determine whether lutein supplementation will slow visual function decline in patients with retinitis pigmentosa receiving vitamin A. Randomized, controlled, double-masked trial of 225 nonsmoking patients, aged 18 to 60 years, evaluated over a 4-year interval. Patients received 12 mg of lutein or a control tablet daily. All were given 15,000 IU/d of vitamin A palmitate. Randomization took into account genetic type and baseline serum lutein level. The primary outcome was the total point score for the Humphrey Field Analyzer (HFA) 30-2 program; prespecified secondary outcomes were the total point scores for the 60-4 program and for the 30-2 and 60-4 programs combined, 30-Hz electroretinogram amplitude, and Early Treatment Diabetic Retinopathy Study acuity. No significant difference in rate of decline was found between the lutein plus vitamin A and control plus vitamin A groups over a 4-year interval for the HFA 30-2 program. For the HFA 60-4 program, a decrease in mean rate of sensitivity loss was observed in the lutein plus vitamin A group (P = .05). Mean decline with the 60-4 program was slower among those with the highest serum lutein level or with the highest increase in macular pigment optical density at follow-up (P = .01 and P = .006, respectively). Those with the highest increase in macular pigment optical density also had the slowest decline in HFA 30-2 and 60-4 combined field sensitivity (P = .005). No significant toxic effects of lutein supplementation were observed. Lutein supplementation of 12 mg/d slowed loss of midperipheral visual field on average among nonsmoking adults with retinitis pigmentosa taking vitamin A. Application to Clinical Practice Data are presented that support use of 12 mg/d of lutein to slow visual field loss among nonsmoking adults with retinitis pigmentosa taking vitamin A. ClinicalTrials.gov Identifier: NCT00346333.

Comorbidity of fibromyalgia and cervical myofascial pain syndrome

The aims of this study are to determine the frequency of fibromyalgia syndrome (FMS) in patients with chronic cervical myofascial pain (CMP) and to investigate the FMS characteristics in CMP patients. Ninty-three patients with CMP and 30 age-matched healthy women were included in this study. Main outcome measures included visual analog scale (VAS), Beck Depression Inventory (BDI), and pain pressure thresholds. CMP patients were evaluated for the existence of FMS. The severity of FMS was assessed with total myalgic score (TMS) and control point score (CPS). Most common clinical characteristics of FMS were noted. Of the 93 CMP subjects, 22 (23.6%) patients fulfilled the classification criteria for FMS. Number of tender points were higher (p=0.0), while TMS (p=0.0) and CPS (p=0.0) values were lower in comorbid CMP and FMS patients than regional CMP group. There were statistically significant differences between regional CMP patients and comorbid CMP and FMS patients regarding presence of fatigue (p=0.0) and irritable bowel syndrome (p=0.022). There was no statistically significant difference between patient groups regarding VAS values (p>0.05). BDI values of the regional CMP were significantly lower than comorbid CMP and FMS patients (p=0.011). In conclusion, we found that nearly a quarter of CMP patients were comorbid with FMS, and psychological and comorbid symptoms were more prominent in comorbid patients. We thought that, these two syndromes might be overlapping conditions and as a peripheral pain generator or inducer of central sensitisation, MPS might lead to FMS or precipitate and worsen the FMS symptoms.

The inter-rater reliability of the Pulmonary Embolism Severity Index

The Pulmonary Embolism Severity Index (PESI) is a validated clinical prognostic model for patients with acute pulmonary embolism (PE). Our goal was to assess the PESI's inter-rater reliability in patients diagnosed with PE. We prospectively identified consecutive patients diagnosed with PE in the emergency department of a Swiss teaching hospital. For all patients, resident and attending physician raters independently collected the 11 PESI variables. The raters then calculated the PESI total point score and classified patients into one of five PESI risk classes (I-V) and as low (risk classes I/II) versus higher-risk (risk classes III-V). We examined the inter-rater reliability for each of the 11 PESI variables, the PESI total point score, assignment to each of the five PESI risk classes, and classification of patients as low versus higher-risk using kappa (κ) and intra-class correlation coefficients (ICC). Among 48 consecutive patients with an objective diagnosis of PE, reliability coefficients between resident and attending physician raters were > 0.60 for 10 of the 11 variables comprising the PESI. The inter-rater reliability for the PESI total point score (ICC: 0.89, 95% CI: 0.81-0.94), PESI risk class assignment (κ: 0.81, 95% CI: 0.66-0.94), and the classification of patients as low versus higher-risk (κ: 0.92, 95% CI: 0.72-0.98) was near perfect. Our results demonstrate the high reproducibility of the PESI, supporting the use of the PESI for risk stratification of patients with PE.

Evaluation of the clinical efficacy of conservative treatment in the management of carpal tunnel syndrome

Carpal tunnel syndrome (CTS) is impingement of the median nerve at the wrist. The aim of this study was to compare the effectiveness of tendon and nerve gliding exercises with standard conservative treatment (SCT), which consists of splinting and local steroid injections, in the treatment of CTS. This study was a prospective, randomized, single-blind trial. Patients were randomized into three groups: treatment with SCT (Group 1); SCT and tendon and nerve gliding exercises (Group 2); tendon and nerve gliding exercises only (Group 3). A symptom total point score was obtained from five symptoms: hand pain, tingling, numbness, nocturnal numbness, and interrupted sleep. The functional status of the hand was determined by assessing seven daily living activities: writing, buttoning clothes, gripping a telephone receiver, opening jars, doing housework, carrying grocery bags, and bathing. Standard physical examinations (Tinel's test, Phalen's test, reverse Phalen's test, and the compression test) were also performed. A total of 111 patients who were diagnosed with intermediate-stage CTS were included in the study. At the end of treatment, significant improvements in symptoms and functionality were detected in all groups. However, the recovery of patients in Groups 1 (n=41) and 2 (n=35) were found to be significantly greater than that of patients in Group 3 (n=35; P<0.001). Patient satisfaction was investigated a mean of 11 months after treatment. Percentages of asymptomatic patients in Group 1 and Group 2 were significantly higher than in Group 3 (P=0.02 and P=0.04, respectively). In the intermediate stage of CTS, SCT was an effective treatment to improve symptoms and functional status. Tendon and nerve gliding exercises alone were inferior to either SCT alone or SCT in combination with gliding exercises.

Multivariate Analysis of Prognostic Factors in CLL: A Study on 431 Patients Showing Usefulness of Novel Biological and Old Clinical Parameters in Predicting Shorter Survival: An Italian Multicentric Study

B-cell chronic lymphocytic leukaemia (B-CLL) is a heterogeneous disease with highly variable clinical courses. Recently, besides classical clinical parameters, including Rai/Binet's staging system, novel biological factors acquired prognostic relevance especially for risk-adapted therapeutic strategies: IgVH mutational status, ZAP-70 and CD38 expression, chromosome aberration (del13q, trisomy 12, del11q, del17p) detected by FISH analysis. In a recent report, Wierda et al constructed a prognostic nomogram predictive for overall survival based on clinical and routine laboratory characteristic of 1674 CLL patients: age, beta2 microglobulin, absolute lymphocyte count, sex, Rai stage and number of involved lymph node groups. Biological prognostic features were not considered in this model but the authors concluded that “future works will focus on incorporation of new prognostic factors into this prognostic model. Actually, unlike other haematological malignancies, there is no a standard Prognostic Index that can be used to group CLL patients according clinical and new biological prognostic parameters and to guide the choice of treatment. To assess which factors give independent contribution in predicting shorter survival we collected 784 patients data from 4 laboratories. All variables were measured at diagnosis or before start of therapy; they included: age above 65 years, male sex, Rai stage >0, beta2 microglobulin >2.5 mg/L, absolute lymphocyte count (ALC), involvement of 3 or more nodal groups, high risk FISH cytogenetics (17p- or 11q-), IgVH mutational status, ZAP-70 and CD38 expression. Survival was measured from diagnosis until death from any cause. A sample of 431 patients was obtained after deleting cases with missing values. Median follow-up was 60 months (54–65). There were 63 deaths (15%) during follow-up, with a not reached median survival at 250 months. During follow-up 43% of patients were treated. Cox proporzional hazard model was used for univariate and multivariate analysis. P <0.05 was considered to be statistically significant. Multivariate model was developed including those variables statistically significant in univariate analysis and further variables were eliminated from the final model by backward selection. IgVH, ZAP-70, CD38, ALC, male sex were not significant in univariate analysis. In multivariate analysis the following variables predicted for shorter survival (table 1): age>65 years, Rai stage>0, beta2>2.5mg/L, high risk FISH. In a larger subset of patients (568), selected with all variables except beta2 microglobulin, the above results were confirmed, in particular no independent contribution was given by IgVH, ZAP-70 and CD38, even if they turned out significant in univariate analysis. Beta2 microglobulin and high risk FISH or only high risk FISH retained prognostic power respectively in a subset of 198 patients under 65 years of age and in a subset of 252 patients with Rai stage 0. In conclusion age>65 years, B2 microglobulin> 2,5 mg/L, Rai stage >0, and high risk FISH abnormalities (del 17p or 11q) will be considered by clinician because of independent prognostic factor of OS. A nomogram will developed to predict for survival using the independent covariates identified in multivariate analysis. This weighted prognostic model will permit to obtain a total point score predictive for median survival of each patient, based on clinical and biological characteristic.Table 1: MULTIVARIATE ANALYSIS (COX MODEL, p = Wald test)Variableshazard ratio (confidence interval)p-valueAge>652.19 (1.26–3.79)0,0052Nodal sites involved >= 3rrBeta-2 microglobulin >2.5mg/L1.87 (1.06–3.28)0,03Rai stage > 02.13 (1.26–3.62)0,0051FISH 17p- or 11q-2.41 (1.42–4.08)0,0011r = removed by bacward selection

Efficacy and safety of galantamine (reminyl) for dementia in patients with Parkinson's disease (an open controlled trial)

An open controlled trial of the use of galantamine at a maximum dose of 16 mg/day included 41 patients with Parkinson's disease with dementia randomized to a galantamine treatment group (21 patients) and a control group (20 patients). Cognitive, neuropsychiatric, and motor symptoms were assessed clinically before the trial and at 4, 12, and 24 weeks, using the Mini Mental State Examination (MMSE), the cognitive Alzheimer's Disease Assessment Scale (ADAS-cog), the clock drawing test, the Frontal Assessment Battery (FAB), and the Neuropsychiatric Inventory (NPI) with assessment of distress in relatives. Patients treated with galantamine had better scores on the MMSE (p < 0.05),ADAS-cog (p < 0.05), the clock drawing test (p < 0.05), and the FAB (p < 0.01) at the end of the study period as compared with the control group. Changes in total point scores on the NPI-12 at the ends of weeks 12 and 24, as compared with the beginning of the trial, were in favor of the group treated with galantamine, with significant changes in the hallucinations (p = 0.0002), anxiety (p = 0.04), sleep disturbance (p = 0.04), and apathy (p = 0.006) sections. Galantamine treatment was accompanied by decreases in the level of distress in patients' relatives (p = 0.007) and improvements in daily activity (p = 0.003). Improvements in gait and decreases in freezing and falls were seen in the galantamine treatment group. However, two patients of this group showed minor increases in tremor. Side effects (drooling, postural hypotension, nausea, dysuria) occurred in seven patients (30%).

Preoperative Assessment of the Risk Factors that Help to Predict the Prognosis After Living Donor Liver Transplantation

The purpose of this study was to analyze various risk factors and to assess the preoperative risk score, which can predict the prognosis after living donor liver transplantation (LDLT). From February 2002 to August 2007, 84 adult to adult living donor liver transplantation donors and recipients were analyzed. First, the donor, recipient, and intraoperative factors were examined by univariate and multivariate analyses. We then gave a score of one point for each significant marginal factor (total point scores were called "risk score") and each risk score was examined by univariate analyses. Recipients with the donor age 50 years or older, Model for End-Stage Liver Disease (MELD) score (> or =21), and hepatitis C virus-positive status had a significantly poor survival. Recipients between the risk score of 0 vs. scores of 2 + 3 (p < 0.001, log-rank) and risk score of 1 vs. scores of 2 + 3 (p = 0.003, log-rank) had significantly different survival. Preoperative assessment of the risk score might help to predict recipient outcomes after living donor liver transplantation.

Deep muscle pain, tender points and recovery in acute whiplash patients: A 1-year follow-up study

Local sensitization to noxious stimuli has been previously described in acute whiplash injury and has been suggested to be a risk factor for chronic sequelae following acute whiplash injury. In this study, we prospectively examined the development of tender points and mechano-sensitivity in 157 acute whiplash injured patients, who fulfilled criteria for WAD grade 2 ( n = 153) or grade 3 ( n = 4) seen about 5 days after injury (4.8 ± 2.3) and who subsequently had or had not recovered 1 year after a cervical sprain. Tender point scores and stimulus–response function for mechanical pressure were determined in injured and non-injured body regions at specific time-points after injury. Thirty-six of 157 WAD grade 2 patients (22.9%) had not recovered, defined as reduced work capacity after 1 year. Non-recovered patients had higher total tender point scores after 12 ( p < 0.05), 107 ( p < 0.05) and 384 days ( p < 0.05) relative to those who recovered. Tenderness was found in the neck region and in remote areas in non-recovered patients. The stimulus–response curves for recovered and non-recovered patients were similar after 12 days and 107 days after the injury, but non-recovered patients had steeper stimulus–response curves for the masseter ( p < 0.02) and trapezius muscles ( p < 0.04) after 384 days. This study shows early mechano-sensitization after an acute whiplash injury and the development of further sensitization in patients with long-term disability.

Predicting Response of Vitreous Hemorrhage after Intravitreous Injection of Highly Purified Ovine Hyaluronidase (Vitrase) in Patients with Diabetes

To develop a predictive model for patients with diabetes who are most likely to have vitreous hemorrhage clearing by 3 months after a single, intravitreous injection of highly purified, preservative-free, ovine hyaluronidase (Vitrase; ISTA Pharmaceuticals, Inc., Irvine, CA). Post hoc data analysis was performed on two randomized, double-masked, placebo-controlled, phase 3 clinical trials of a single intravitreous injection of Vitrase for severe vitreous hemorrhage. Vitreous hemorrhage density was scored using a 0 to 4 vitreous hemorrhage grading scale in 12 radial segments of the fundus ("clock hours"). Reduction in total hemorrhage point score (DeltaTHPS) between baseline and 1 month after injection was analyzed as a predictor of vitreous hemorrhage outcome at 3 months. A strong predictive model was demonstrated by receiver operating characteristic (ROC) curve analysis; area under the curve (AUC) = 0.845 (P < 0.0001). The DeltaTHPS was higher in hyaluronidase-treated subjects than in saline-treated control subjects. Median DeltaTHPS was 8.0 and 6.0 in subjects treated with 55 IU (68 USP) and 75 IU (93 USP) of hyaluronidase respectively, versus 2.0 in saline control subjects (P < 0.0001). discussion. The DeltaTHPS at 1 month provides quantitative guidance for predicting the outcome of a single intravitreous ovine hyaluronidase injection in patients with diabetes and severe vitreous hemorrhage (ClinicalTrials.gov numbers, NCT00198510 and NCT00198497).

Self and social function: Art therapy in a therapeutic community prison

This paper shows how suitability to engage in group therapeutic work can be ascertained from an analysis of the art work of inmates at a therapeutic prison. Ten pieces of artwork were rated on a scale of one to ten against seven features, and scores were totalled for each out of a maximum of 70 points. A total point score of 35 or more was thought to denote the kind of adjustment (gregariousness, awareness of how they are situated in time, emotionality, mental capacity to engage with relevant concepts) that would allow the subject to make a positive response to group work. According to this analysis, five of the ten subjects were deemed unsuitable, and five suitable, for group work. In actual fact, all five subjects whose work was deemed unsuitable and one on the borderline of suitability, left the prison within a year of the assessment. The remaining four deemed to be suitable for group work are still at the prison after three years. Since decisions about the respondents were made in isolation from the art therapeutic assessments, and since remaining at the prison is a sign of suitability for group work (the main function of the prison), the art therapeutic assessments showed high levels of validity. The extent to which a piece of graphic expression can convey the aspects of its creator is revealed by this experiment. These findings may be relevant to brand managers and creators seeking to gain analytical tools to measure the personality concepts in graphic expression, with a view to ensuring a match with the self-concept of consumers.