Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study.

BACKGROUND: Improved responsiveness to erythropoiesis stimulating agents (ESAs) in patients on on-line post-dilution hemodiafiltration (Post-HDF) compared with conventional hemodialysis (HD) was reported by some authors but challenged by others. This prospective, cross-over randomized study tested the hypothesis that an alternative infusion modality of HDF, mixed-dilution HDF (Mixed HDF), could further reduce ESAs requirement in dialysis patients compared to the traditional Post-HDF. METHODS: One-hundred-twenty prevalent patients from 6 Dialysis Centers were randomly assigned to two six-months treatment sequences: A-B and B-A (A, Mixed HDF; B, Post-HDF). Primary outcome was comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance. Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters were monitored. RESULTS: In sequence A, darbepoetin requirement decreased during Mixed HDF from 29.5 to 23.7 µg/month and increased significantly during Post-HDF (32.3 µg/month at 6th month) while, in sequence B, it increased during Post-HDF from 38.2 to 43.7 µg/month and decreased during Mixed HDF (23.9 µg/month at 6th month). Overall, EPO doses at 6 months on Mixed and Post-HDF were 23.8 and 38.4 µg/month, respectively, P < 0.01. A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods. CONCLUSIONS: Mixed HDF decreased darbepoetin-alfa requirement in dialysis patients. This might help preventing the untoward side effects of high ESA doses, besides having a remarkable economic impact. Additional evidence is needed to confirm this potential benefit of Mixed-HDF.

Pharmacogenomic Approach to Selecting Antiplatelet Therapy in Patients With Acute Coronary Syndromes: The PHARMCLO Trial.

BACKGROUND: Although clopidogrel is still frequently used in patients with acute coronary syndromes (ACS), its efficacy is hampered by interpatient response variability caused by genetic polymorphisms associated with clopidogrel's metabolism. OBJECTIVES: The goal of this study was to evaluate whether selecting antiplatelet therapy (clopidogrel, prasugrel, or ticagrelor) on the basis of a patient's genetic and clinical characteristics leads to better clinical outcomes compared with the standard of care, which bases the selection on clinical characteristics alone. METHODS: Patients hospitalized for ACS were randomly assigned to standard of care or the pharmacogenomic arm, which included the genotyping of ABCB1, CYP2C19*2, and CYP2C19*17 using an ST Q3 system that provides data within 70 min at each patient's bedside. The patients were followed up for 12 ± 1 month for the primary composite endpoint of cardiovascular death and the first occurrence of nonfatal myocardial infarction, nonfatal stroke, and major bleeding defined according to Bleeding Academic Research Consortium type 3 to 5 criteria. RESULTS: After enrolling 888 patients, the study was prematurely stopped. Clopidogrel was used more frequently in the standard-of-care arm (50.7% vs. 43.3%), ticagrelor in the pharmacogenomic arm (42.6% vs. 32.7%; p = 0.02), and prasugrel was equally used in both arms. The primary endpoint occurred in 71 patients (15.9%) in the pharmacogenomic arm and in 114 (25.9%) in the standard-of-care arm (hazard ratio: 0.58; 95% confidence interval: 0.43 to 0.78; p < 0.001). CONCLUSIONS: A personalized approach to selecting antiplatelet therapy for patients with ACS may reduce ischemic and bleeding events. (Pharmacogenetics of Clopidogrel in Patients With Acute Coronary Syndromes [PHARMCLO]; NCT03347435).

Psychomotor Development in Cri du Chat Syndrome: Comparison in Two Italian Cohorts with Different Rehabilitation Methods.

The Cri du Chat syndrome (CdC) is a rare genetic disorder caused by variable size deletions of the short arm of chromosome 5 (5p-). It is well known that home-reared patients show better performances as compared to institutionalised cases, and it was reported that continuous educational intervention can ameliorate their performances. To assess the efficacy of educational intervention and to develop new CdC oriented programs of rehabilitation, we compare the results obtained for many developmental skills in two groups of CdC patients undergoing two different rehabilitation programs. Using data on the development of a group of CdC patients obtained by validated Italian translation for the Denver Developmental Screening Test II, we compared a group of 13 patients undergoing an educational program developed for CdC patients, the Mayer Project (MP), with a second group of 15 cases in whom caring was not specifically oriented. A positive impact of the MP was reported by parents, observing an improvement in social skills obtained, even if no significant differences were observed when the items of the Denver Test are studied. The need for personalized care in CdC patients and the choice of different methods to compare the results are also discussed.

A comparison of methods for the analysis of binomial clustered outcomes in behavioral research.

BACKGROUND: In behavioral research, data consisting of a per-subject proportion of "successes" and "failures" over a finite number of trials often arise. This clustered binary data are usually non-normally distributed, which can distort inference if the usual general linear model is applied and sample size is small. A number of more advanced methods is available, but they are often technically challenging and a comparative assessment of their performances in behavioral setups has not been performed. METHOD: We studied the performances of some methods applicable to the analysis of proportions; namely linear regression, Poisson regression, beta-binomial regression and Generalized Linear Mixed Models (GLMMs). We report on a simulation study evaluating power and Type I error rate of these models in hypothetical scenarios met by behavioral researchers; plus, we describe results from the application of these methods on data from real experiments. RESULTS: Our results show that, while GLMMs are powerful instruments for the analysis of clustered binary outcomes, beta-binomial regression can outperform them in a range of scenarios. Linear regression gave results consistent with the nominal level of significance, but was overall less powerful. Poisson regression, instead, mostly led to anticonservative inference. COMPARISON WITH EXISTING METHODS: GLMMs and beta-binomial regression are generally more powerful than linear regression; yet linear regression is robust to model misspecification in some conditions, whereas Poisson regression suffers heavily from violations of the assumptions when used to model proportion data. CONCLUSIONS: We conclude providing directions to behavioral scientists dealing with clustered binary data and small sample sizes.

Long-term facial improvement after repeated BoNT-A injections and mirror biofeedback exercises for chronic facial synkinesis: a case-series study.

BACKGROUND: Only few studies have considered the effects of the combined treatment with onabotulinumtoxinA (BoNT-A) injections and biofeedback (BFB) rehabilitation in the recovery of postparetic facial synkinesis (PPFS). AIM: To explore the presence of a persistent improvement in facial function out of the pharmacological effect of BoNT-A in subjects with established PPFS, after repeated sessions of BoNT-A injections combined with an educational facial training program using mirror biofeedback (BFB) exercises. Secondary objective was to investigate the trend of the presumed persistent improvement. STUDY DESIGN: Case-series study. SETTING: Outpatient Clinic of Physical Medicine and Rehabilitation Unit. POPULATION: Twenty-seven patients (22 females; mean age 45±16 years) affected by an established peripheral facial palsy, treated with a minimum of three BoNT-A injections in association with mirror BFB rehabilitation. The interval between consecutive BoNT-A injections was at least five months. METHODS: At baseline and before every BoNT-A injection+mirror BFB session (when the effect of the previous BoNT-A injection had vanished), patients were assessed with the Italian version of Sunnybrook Facial Grading System (SB). The statistical analysis considered SB composite and partial scores before each treatment session compared to the baseline scores. RESULTS: A significant improvement of the SB composite and partial scores was observed until the fourth session. Considering the "Symmetry of Voluntary Movement" partial score, the main improvement was observed in the muscles of the lower part of the face. CONCLUSIONS: In a chronic stage of postparetic facial synkinesis, patients may benefit from a combined therapy with repeated BoNT-A injections and an educational facial training program with mirror BFB exercises, gaining an improvement of the facial function up to the fourth session. This improvement reflects the acquired ability to use facial muscle correctly. It doesn't involve the injected muscles but those trained with mirror biofeedback exercises and it persists also when BoNT-A action has vanished. CLINICAL REHABILITATION IMPACT: The combined therapy with repeated BoNT-A injections and an educational facial training program using mirror BFB exercises may be useful in the motor recovery of the muscles of the lower part of the face not injected but trained.

Evaluation outcomes of a sex education strategy in high schools of Pavia (Italy).

AIM: We aimed to provide process and effectiveness evaluations of a sex education intervention realized with interactive techniques in high schools of Pavia (Italy). METHODS: Six public high schools, divided into 'treated' and 'control' units, voluntarily joined this mixed-methods study. Only second-year classes were enrolled: treated adolescents followed a sex education course, performed by trained 'near-peer educators' (undergraduate medical students) with interactive techniques. All adolescents compiled an anonymous effectiveness evaluation questionnaire at baseline (pre-test) and 3 months later (post-test). Sexual knowledge and reported behavioural changes were compared between the two groups through linear mixed-effects models. The process was assessed through a satisfaction questionnaire for treated students, monitoring cards for working group members and cards/diaries for educators. RESULTS: The final sample consisted of 547 treated and 355 control adolescents (mean age = 15.28 ± 0.61 years). Highly significant changes (p < 0.001) from pre-test to post-test, with strong improvements of treated adolescents, were evident for all knowledge items. No significant changes for behavioural items were reported. Process evaluation showed positive results in adolescents' satisfaction, highlighting the need for more youth gathering places. Working group members and educators generally provided positive evaluations, although difficult communication was perceived. CONCLUSIONS: The intervention was effective in improving adolescents' sexual knowledge. The present work highlighted that in Italy sex education in adolescence is still neglected: this could encourage misinformation and health-risk behaviour. Young people perceive the need for a serious health-promoting action in which they could play an active role, spreading educational messages with organized interactive methods.

The Prognosis of Patients with Liver Metastases from Colorectal Cancer still Depends on Anatomical Presentation more than on Treatments.

BACKGROUND: The best management of liver metastases from colorectal cancer is still debated and little is known about the true impact of treatments on survival. MATERIALS AND METHODS: The study involved 122 patients (77 males), aged 64.0 ± 11.0 years (range: 27.8-86.1) at diagnosis of liver metastatization (synchronous in 59). All underwent chemotherapy and at least one procedure of radiofrequency ablation; 53 also had partial hepatic resections. Demographics, tumor characteristics and survival outcomes from liver metastatization were analyzed with univariate and multivariate techniques. This analysis was performed also taking into account relative survival as the best estimate of specific survival. RESULTS: The analysis with observed survival selected the categorized number of involved lymph nodes in the colorectal specimens as the only statistically significant predictor, while the analysis with relative survival also showed site of the primary tumor (above the sigmoid colon or otherwise) and number of liver metastases as significant factors. The standardized mortality ratio was 9.673 (95% CI: 7.668-11.663) and a total of 201.85 years of life were lost in comparison with the survival of the reference population. CONCLUSIONS: The computation of relative survival ­ better than observed survival ­ selected a more adequate number of predictors, making investigation of even limited series of patients with confounding factors reliable. The finding that prognosis was mainly dependent on the anatomical presentation of the primary tumor and of liver metastases ­ instead of treatments ­ could explain the still contrasting opinions on the role of the available therapies in this field.

Genotype-phenotype correlation in Pompe disease, a step forward.

BACKGROUND: Pompe's disease is a progressive myopathy caused by mutations in the lysosomal enzyme acid alphaglucosidase gene (GAA). A wide clinical variability occurs also in patients sharing the same GAA mutations, even within the same family. METHODS: For a large series of GSDII patients we collected some clinical data as age of onset of the disease, presence or absence of muscular pain, Walton score, 6-Minute Walking Test, Vital Capacity, and Creatine Kinase. DNA was extracted and tested for GAA mutations and some genetic polymorphisms able to influence muscle properties (ACE, ACTN3, AGT and PPARα genes).We compared the polymorphisms analyzed in groups of patients with Pompe disease clustered for their homogeneous genotype. RESULTS: We have been able to identify four subgroups of patients completely homogeneous for their genotype, and two groups homogeneous as far as the second mutation is defined "very severe" or "potentially less severe". When disease free life was studied we observed a high significant difference between groups. The DD genotype in the ACE gene and the XX genotype in the ACTN3 gene were significantly associated to an earlier age of onset of the disease. The ACE DD genotype was also associated to the presence of muscle pain. CONCLUSIONS: We demonstrate that ACE and ACTN3 polymorphisms are genetic factors able to modulate the clinical phenotype of patients affected with Pompe disease.

Platysma synkinesis in facial palsy and botulinum toxin type A.

OBJECTIVES/HYPOTHESIS: Facial synkinesis is a well-known disabling occurrence following severe facial palsy. Platysma muscle, innervated by the facial nerve, can be involved in synkinesis as well, but thus far has been little investigated. The aim of our study is to evaluate the presence of platysma synkinesis and its clinical evolution after onabotulinumtoxinA (BoNT-A) (Botox(®) ; Allergan Pharmaceuticals, Irvine, CA) injections. STUDY DESIGN: Retrospective study. METHODS: Sixty-nine patients were treated for synkinesis following facial palsy. Of those, 45 were affected by platysma synkinesis and thus were injected in the platysma muscle. The total number of sessions was 124. The Sunnybrook Facial Grading System (SFGS) and a specific platysmal evaluation for the presence and severity of synkinesis and local symptoms were performed before and after BoNT-A treatments. RESULTS: Platysma synkinesis was present in 65.2% of the sample and was associated with subjective complaints in 85.5% of the cases. The facial expressions more related to platysma synkinesis were snarl, followed by open-mouth smile and lip pucker. After each BoNT-A treatment, there was an improvement in facial symmetry at rest and during voluntary movements, a global reduction of synkinesis, and a specific reduction of synkinesis and symptoms related to the platysma. No adverse reaction to BoNT-A occurred. CONCLUSION: Platysma involvement represents a recurring and symptomatic problem in patients affected by synkinetic recovery following facial palsy. After BoNT-A injections, there is a reduction in platysma synkinesis and related symptoms. LEVEL OF EVIDENCE: 4.

Drug attitude in adolescents: a key factor for a comprehensive assessment.

OBJECTIVE: Very few studies have evaluated the subjective experience (SE) in children and adolescents treated with antipsychotics. The present study aimed to evaluate the SE of antipsychotics in adolescents diagnosed with different psychiatric conditions and to identify explanatory variables of adolescents' SE and compliance with treatment. METHODS: The Drug Attitude Inventory (DAI) was used to evaluate SE in 67 adolescents in 2 different countries (Italy and United Kingdom). Compliance was measured using a Likert scale completed by both patients and parents. To evaluate other parameters correlated to the SE, the following scales were administered: Clinical Global Impression Scale, Children's Global Assessment Scale, Extrapyramidal Symptoms Rating Scale, Barnes Akathisia Rating Scale, and EuroQoL (for quality of life). Multiple and logistic regression analyses were applied. RESULTS: No significant difference in drug attitude was found between psychotic and nonpsychotic patients. Our results showed a highly significant association between DAI and compliance (Spearman index, 0.33; P = 0.005); for all other variables, DAI associated significantly only with quality of life (r = 0.25; P = 0.03). The multivariable analysis confirmed the presence of a strong association between compliance and DAI (P = <0.001). In our sample, drug attitude was the only variable found to be correlated with the compliance, whereas extrapyramidal adverse effects showed an only marginally significant association. CONCLUSIONS: Our observations provide confirmation, also in adolescents, that drug attitude is strongly correlated with treatment compliance and underline the need in clinical assessments to always consider the patient's viewpoint.

Quantitative measurement of evolution of postparetic ocular synkinesis treated with botulinum toxin type A.

BACKGROUND: The Sunnybrook Facial Grading System is considered one of the best scales available to grade facial motility and postparetic synkinesis. To measure facial landmarks and movement excursion, a new software, the Facial Assessment by Computer Evaluation, has been proposed. The aim of this study was to quantify eye synkinesis improvement after botulinum toxin type A injections using the new software and to compare this method with the Sunnybrook grading system. METHODS: The study included 40 injection sessions on 29 Caucasian outpatients with facial synkinesis. Before and 2 weeks after the injection, patients were evaluated using the Italian version of the Sunnybrook system. Eyelid fissure size at rest, during lip puckering, and while smiling was measured with the new software. RESULTS: After botulinum infiltration, the Sunnybrook grading system showed a global facial improvement with reduction of synkinesis and increase of static and dynamic symmetry. The Facial Assessment software detected an increase of ocular fissure measure at rest, during lip puckering, and especially during smiling, and the improvement was positively correlated with initial asymmetry. A single point of the Sunnybrook system synkinesis score corresponded to a mean difference of 0.77 mm during smiling and 1.0 mm during lip puckering. CONCLUSIONS: The Facial Assessment by Computer Evaluation measure allowed the authors to quantify the improvement of eye synkinesis after botulinum toxin type A injection. The Sunnybrook Facial Grading System provided an immediate instrument with which to monitor treatment in routine clinical practice, whereas the Facial Assessment system gave a more accurate quantitative assessment. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, II.

Inpatient rehabilitation outcome: a matter of diagnosis?

BACKGROUND: Patients with comorbidities are becoming more and more common in Italian rehabilitative wards. These comorbidities are considered a major problem for inpatient rehabilitation, due to the fact that they cause longer lengths of stay, higher costs, and lower functional results. METHODS: To investigate the possible relationships between comorbidity, functional impairment, age, and type of discharge in patients hospitalized in postacute rehabilitation facilities, we planned an observational study. A total of 178 consecutive inpatients (average age: 78 years [range: 39-99]) from postacute rehabilitation facilities were recruited. Primary diagnosis, comorbidity rating (Cumulative Illness Rating Scale - Geriatric version, CIRS-G) and functional impairment score (Functional Independence Measure, FIM™) were evaluated at admission. The FIM™ rating was also assessed at hospital discharge. RESULTS: A total of 178 of the 199 enrolled patients completed the rehabilitation treatment (89.4%). The average length of stay was 46 ± 24 days. CIRS-G showed an average comorbidity score for each patient of 4.45 ± 1.69. The average FIM™ rating was 79 ± 24.88 at admission, and 91.9 ± 25.7 at discharge. Diagnosis at admission (grouped according to the International Classification of Diseases 9-CM) seemed to correlate with functional results, since lower rehabilitative efficiency was obtained for patients who had a history of stroke. CONCLUSION: The number and type of comorbidities (CIRS-G) in rehabilitation inpatients do not seem to affect functional outcomes of treatment. The determining factor for a lower level of functional recovery seems to be the diagnosis at admission.

The prognostic role of time to diagnosis and presenting symptoms in patients with pancreatic cancer.

BACKGROUND: The aim of this study was to investigate the prognostic role of diagnostic delay and clinical presentation (regarding pain, jaundice, and weight loss) in pancreatic carcinoma. METHODS: One hundred and seventy patients with pancreatic cancer were diagnosed and treated in the decade 2001-2010 (100 males and 70 females, with a mean age of 65.8 years [range, 36-91]). Patients were staged with spiral computed tomography and 75% were found to have advanced disease (28 stage III, 99 stage IV disease). Ductal adenocarcinoma was diagnosed in 147 cases, other subtypes of carcinoma in the remaining 23. Fifty patients were operated with radical intent, 19 had palliative surgery, 101 were considered inoperable because of advanced disease or heavy anesthesiologic risk; 31 of these inoperable patients underwent biliary decompression by insertion of an endoluminal or percutaneous stent. Gemcitabine-containing regimens were administered to 143 patients and radiotherapy was combined in 19. Overall and relative survival were the parameters studied. Multivariate analysis was performed by multiple regressions applied to proportional-hazards model. RESULTS: From all the clinical, pathological and therapeutical factors evaluated the statistically significant ones were time to diagnosis and surgery. Among symptoms pain was related to the shortest mean time to diagnosis, weight loss to the longest, with corresponding differences in survival. These differences of observed survival were substantially confirmed in terms of relative survival. CONCLUSIONS: The poor prognosis of pancreatic carcinoma seems to depend, in part, on diagnostic delay and this, in turn, is influenced by the type of presenting symptoms.

[An update on several indicators of the quality of data flow in a cancer registry in Vercelli (Piedmont, Italy)]. / L'incidenza oncologica nell'ASL VC di Vercelli dal 2002 al 2009: aggiornamento indicatori di qualità del flusso informativo.

The first estimates of cancer incidence in the city of Vercelli in Piedmont (Italy) are now available for the years 2002 to 2005 and preliminary data are also available up to 2009. With respect to previously published results, the cancer database has been integrated with information from additional data sources to ensure that it will become, in the near future, a sound basis of information upon which to build an accredited cancer registry. An evaluation was therefore performed of two indicators of the quality of data flow: the proportion of cases with histological confirmation of diagnosis and cancer mortality to incidence (M/I) ratios. Both show an improvement with respect to 2005 but need to be significantly improved to reach the levels of excellence and accuracy that a registry must necessarily possess. Local health authorities will need to ensure staff availability and facilitate access to key data sources to fully evaluate cancer epidemiology in the area.

Influence of lingual bracket position on microbial and periodontal parameters in vivo.

OBJECTIVE: Lingual orthodontics is becoming more popular in dental practice. The purpose of the present investigation was to compare plaque formation on teeth bonded with the same bracket onto buccal or lingual surface, with non-bonded control teeth, via an in vivo growth experiment over a 30-day period. MATERIAL AND METHODS: A randomized controlled trial with split-mouth design was set up enrolling 20 dental students. Within each subject sites with buccal and lingual brackets and control sites were followed. Clinical periodontal parameters (periodontal pocket depth: PPD; bleeding on probing: BOP) were recorded at baseline and on days 1, 7 and 30. Microbiological samples were taken from the brackets and the teeth on days 1, 7 and 30 to detect colony-forming units (CFU). Total CFU, streptococci CFU and anaerobe CFU were measured. RESULTS: No significant differences (P>0.05) were found between buccal and lingual brackets in terms of clinical periodontal parameters and microbiological values. CONCLUSION: Bracket position does not have significant impact on bacterial load and on periodontal parameters.

A long diagnostic delay in patients with Hereditary Haemorrhagic Telangiectasia: a questionnaire-based retrospective study.

BACKGROUND: The difficulty in establishing a timely correct diagnosis is a relevant matter of concern for several rare diseases. Many rare-disease-affected patients suffer from considerable diagnostic delay, mainly due to their poor knowledge among healthcare professionals, insufficient disease awareness among patients' families, and lack of promptly available diagnostic tools. Hereditary Haemorrhagic Telangiectasia (HHT) is an autosomal-dominantly inherited vascular dysplasia, affecting 1:5,000-10,000 patients. HHT is characterized by high variability of clinical manifestations, which show remarkable overlapping with several common diseases. AIM: To perform a detailed analysis concerning the diagnostic time lag occurring in patients with HHT, defined as the time period spanning from the first clinical manifestation to the attainment of a definite, correct diagnosis. METHODS: A questionnaire was administered to the HHT patients previously recruited from 2000 and 2009. Clinical onset, first referral to a physician for disease manifestations, and first correct diagnosis of definite HHT were collected. Eventual misdiagnosis at first referral and serious complications occurring throughout the time elapsing between disease onset and definite diagnosis were also addressed. RESULTS: In the 233 respondents, the clinical onset of disease occurred at an age of 14.1 yrs, while the age of first referral and the age of first definite diagnosis of HHT were 29.2 yrs and 40.1 yrs, respectively. Only 88/233 patients received a correct diagnosis at first counseling. Thus, the diagnostic time lag, represented by the time elapsing from disease onset and first definite diagnosis of HHT, proved to be 25.7 yrs. Twenty-two patients suffered from severe complications during this time interval. The diagnostic delay was significantly longer (p < 0.001) in index patients (first patients who attained definite HHT diagnosis in a given family) than in non-index patients (relative of index patients). The diagnostic time lag was also significantly associated with education grade (p < 0.001). CONCLUSIONS: Our data report for the first time a systematic inquiry of diagnostic delay in HHT showing that patients receive a definite diagnosis only after nearly three decades from disease onset. Concerted efforts are still to be made to increase awareness of this disease among both families and physicians.

Cervical human papillomavirus infection and shedding of human immunodeficiency virus in cervicovaginal fluids: a cross-sectional study.

We evaluated the association between human papillomavirus cervical infection and HIV shedding in cervicovaginal lavage fluid (CVL), studying 89 HIV-infected women recruited at the Department of Infectious Diseases of Brescia (Italy). HIV shedding in CVL was found in a similar proportion of women with (30%; 21/70) and without (31.6%; 6/19) cervical human papillomavirus infection. A statistically significant correlation was found between HIV viral load in serum and CVL among the 27 women with detectable HIV in CVL (r = 0.4; P = 0.04). However, women on highly active antiretroviral therapy were more likely to have detectable HIV-RNA in CVL despite negative viremia (80% vs. 8%; P < 0.005).

Influence of lingual bracket position on microbial and periodontal parameters in vivo

OBJECTIVE: Lingual orthodontics is becoming more popular in dental practice. The purpose of the present investigation was to compare plaque formation on teeth bonded with the same bracket onto buccal or lingual surface, with non-bonded control teeth, via an in vivo growth experiment over a 30-day period. MATERIAL AND METHODS: A randomized controlled trial with split-mouth design was set up enrolling 20 dental students. Within each subject sites with buccal and lingual brackets and control sites were followed. Clinical periodontal parameters (periodontal pocket depth: PPD; bleeding on probing: BOP) were recorded at baseline and on days 1, 7 and 30. Microbiological samples were taken from the brackets and the teeth on days 1, 7 and 30 to detect colony-forming units (CFU). Total CFU, streptococci CFU and anaerobe CFU were measured. RESULTS: No significant differences (P>0.05) were found between buccal and lingual brackets in terms of clinical periodontal parameters and microbiological values. Conclusion: Bracket position does not have significant impact on bacterial load and on periodontal parameters.

Accuracy of a novel risk index combining degree of stenosis of the carotid artery and plaque surface echogenicity.

BACKGROUND AND PURPOSE: The purpose of this study was to determine the accuracy of a risk index in symptomatic or asymptomatic carotid stenoses. METHODS: Consecutive patients presenting 50% to 99% carotid stenoses were included. A semiautomated gray scale-based color mapping (red, yellow, and green) of the whole plaque and of its surface was achieved. Surface was defined as the region located between the lumen (Level 0) and, respectively, 0.5, 1, 1.5, and 2 mm. Risk index was based on a combination of degree of stenosis and the proportion of the red color (reflecting low echogenicity) on the surface or on the whole plaque. RESULTS: There were 67 (36%) symptomatic and 117 (64%) asymptomatic carotid stenoses. Risk index values were higher among symptomatic stenoses (0.46 mean versus 0.29; P<0.0001); on receiver operating characteristic curves, risk index presented a stronger predictive power compared with degree of stenosis or surface echogenicity alone. Also, in a regression model including age, gender, degree of stenosis, surface echogenicity, gray median scale of the whole plaque, and risk index, risk index measured within the surface region located at 0.5 mm from the lumen was the only parameter significantly associated with the presence of symptoms (OR, 4.89; 95% CI, 2.7-8.7; P=0.0000002). The best criterion to differentiate between symptomatic and asymptomatic stenoses was a risk index value >0.36 (sensitivity and specificity of 78% and 65%, respectively). CONCLUSIONS: Risk index was significantly higher in the presence of symptoms and could therefore be a valuable tool to assess the clinical risk of a carotid plaque.

Advantages of the lognormal approach to determining reference change values for N-terminal propeptide B-type natriuretic peptide.

BACKGROUND: Serial measurement of NT-proBNP is performed routinely in the monitoring and assessment of the effectiveness of therapy in patients being treated for chronic heart failure (CHF). Intra-individual changes in NT-proBNP levels over time are compared typically to a reference change value (RCV) determined using either a standard [i.e., nested analysis of variance (nANOVA)] or a lognormal approach. The RCV defines the minimum percent change in serial analyte values that exceeds the percent change expected due to biological variation alone. Currently, there is no consensus on which approach (nANOVA or lognormal) to determining RCV is better. AIMS: Based on these considerations, we aimed to illustrate the impact of data transformation on the calculation of the biological variation of NT-proBNP and discuss the utility of logarithmic transformation in monitoring patients with heart failure. METHODS: 15 healthy subjects were enrolled after informed consent; 5 blood specimens were collected twice a week. Nested ANOVA from replicate analyses was applied to obtain components of biological variation, on the raw data and after data transformation. RESULTS: NT-proBNP distribution being highly skewed required data transformation. Natural log transformation yielded normalization. An example demonstrates that for untransformed values the RCV was overestimated for low concentrations of NT-proBNP and underestimated for higher concentrations. CONCLUSIONS: Log-transformed data are often used in the establishment of reference intervals for evaluating laboratory tests results in clinical practice, especially when the reference interval data are not Gaussian distributed. As log-normal approach is the best approach to determining RCV values we encourage its use assessing the clinical utility of NT-proBNP serial testing. We propose that the log-normal approach becomes the standard approach to determining RCV and replaces the use of nANOVA.