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Proficiency score as a predictor of early trifecta achievement during the learning curve of robot-assisted radical prostatectomy for high-risk prostate cancer:Results of a multicentric series

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Current Urology 2024年第2期18卷 110-114页

作者： Umberto Anceschi Rocco Simone Flammia Antonio Tufano Michele Morelli Antonio Galfano Lorenzo Giuseppe Luciani Leonardo Misuraca Paolo Dell’Oglio Gabriele Tuderti Aldo Brassetti Maria Consiglia Ferriero Alfredo Maria Bove Riccardo Mastroianni Francesco Prata Isabella Sperduti Giovanni Petralia SilviaSecco Ettore Di Trapani DanieleMattevi Tommaso Cai Aldo Massimo Bocciardi Giuseppe Simone department of Urology IRCCS“Regina Elena”National Cancer InstituteRomeItaly Urologic Clinic Department of Maternal-Child and Urologic SciencesSapienza University of RomeItaly Ospedale Niguarda Ca’Granda Department of UrologyMilanItaly department of Urology APSS Santa Chiara Regional HospitalTrentoItaly department of biostatistical unit IRCCS Regina Elena National Cancer InstituteRomeItaly

Background:Recently,an innovative tool called“proficiency score”was introduced to assess the learning curve for robot-assisted radical prostatectomy(RARP).However,the initial study only focused on patients with low-risk prostate cancer forwhompelvic lymph node dissection(PLND)was not *** address this issue,we aimed to validate proficiency scores of a contemporarymulticenter cohort of patients with high-risk prostate cancer treated with RARP plus extended PLND by trainee *** andmethods:Between 2010 and 2020,4 Italian institutional prostate-cancer datasets weremerged and queried for“RARP”and“high-risk prostate cancer.”High-risk prostate cancer was defined according to the most recent European Association of Urology guidelines as follows:prostate-specific antigen>20 ng/mL,International Society ofUrological Pathology≥4,and/or clinical stage(cT)≥2c on preoperative *** selected cohort(n=144)included clinical cases performed by trainee surgeons(n=4)after completing their RARP learning curve(50 procedures for low-risk prostate cancer).The outcome of interest,the proficiency score,was defined as the coexistence of all the following criteria:a comparable operation time to the interquartile range of the mentor surgeon at each center,absence of any significant perioperative complications Clavien-Dindo Grade 3–5,no perioperative blood transfusions,and negative surgical margins.A logistic binary regression model was built to identify the predictors of 1-year trifecta achievement in the trainee *** all statistical analyses,a 2-sided p<0.05 was considered ***:A proficiency score was achieved in 42.3%*** univariable level,proficiency score was associated with 1-year trifecta achievement(odds ratio,8.77;95%confidence interval,2.42–31.7;p=0.001).After multivariable adjustments for age,nerve-sparing,and surgical technique,the proficiency score independently predicted 1-year trifecta achievement(odds ratio,9.58;95%confidence i

关键词： Trifecta Learning curve Robot-assisted radical prostatectomy High-risk prostate cancer

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A systematic review and meta-analysis of clinical trials implementing aromatase inhibitors to treat male infertility

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Asian Journal of Andrology 2020年第4期22卷 360-367页

作者： Francesco Del Giudice Gian Maria Busetto Ettore De Berardinis Isabella Sperduti Matteo Ferro Martina Maggi Martin S Gross Alessandro Sciarra Michael L Eisenberg department of Urology Sapienza Rome UniversityPoliclinico Umberto IRome 00161Italy biostatistical unit IRCCSRegina Elena National Cancer InstituteRome 00128Italy Division of Urology European Institute of OncologyMilan 20141Italy Section of Urology Dartmouth-Hitchcock Medical CenterLebanonNH 03766USA department of Urology Stanford UniversitySchool of MedicineStanfordCA 94305USA

Aromatase activity has commonly been associated with male infertility characterized by testicular dysfunction with low serum testosterone and/or testosterone to estradiol *** this subset of patients,and particularly in those with hypogonadism,elevated levels of circulating estradiol may establish a negative feedback on the hypothalamic–pituitary–testicular axis by suppressing follicle-stimulating hormone(FSH)and luteinizing hormone(LH)production and impaired *** manipulation via different agents such as selective estrogen modulators or aromatase inhibitors to increase endogenous testosterone production and improve spermatogenesis in the setting of infertility is an off-label option for *** carried out a systematic review and meta-analysis of the literature of the past 30 years in order to evaluate the benefits of the use of aromatase inhibitors in the medical management of infertile/hypoandrogenic ***,eight original articles were included and critically *** steroidal(Testolactone)or nonsteroidal(Anastrozole and Letrozole)aromatase inhibitors were found to statistically improve all the evaluated hormonal and seminal outcomes with a safe tolerability *** the evidence is promising,future prospective randomized placebo-controlled multicenter trials are necessary to better define the efficacy of these medications.

关键词： aromatase inhibitor hypogonadism male infertility meta-analysis systematic review

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Clinicopathological differences and correlations between right and left colon cancer

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World Journal of Clinical Cases 2020年第8期8卷 1424-1443页

作者： Ioannis Kalantzis Afroditi Nonni Kitty Pavlakis Eumorphia-Maria Delicha Konstantinos Miltiadou Christos Kosmas Nikolaos Ziras Konstantinos Gkoumas Harikleia Gakiopoulou department of Gastroenterology Korgialenio-Mpenakeio Hellenic Red Cross HospitalAthens 11526Greece department of Oncology Metaxa Anticancer HospitalPiraeus 18537Greece First department of Pathology National and Kapodistrian University of AthensMedical SchoolAthens 11527Greece Independent biostatistical Consultant ASTATStatistics in Clinical ResearchGlyfada 16675Greece Hepatogastroenterology unit Second Department of Internal MedicineAttikon University General HospitalAthens 12462Greece

BACKGROUND The differences in histopathology and molecular biology between right colon cancer(RCC)and left colon cancer(LCC)were first reported in the literature by Bufill in *** then,a large number of studies have confirmed their differences in epidemiology,clinical presentation,comorbidities and biological behaviours,which may be related to the difference in prognosis and overall survival(OS)between the two *** To investigate statistically significant differences between Greek patients with LCC and *** The present observational study included 144 patients diagnosed with colon cancer of any stage who received chemotherapy in a Greek tertiary oncology hospital during a 2.5-year *** information,comorbidities,histopathologic characteristics and molecular biomarkers were collected from the patients’medical records retrospectively,while administered chemotherapy regimens,targeted agents,progression-free survival(PFS)periods with first-and second-line chemotherapy and OS were recorded retroactively and *** analysis was performed with the SPSS statistical *** Eighty-six males and 58 females participated in the *** hundred(69.4%)patients had a primary lesion in the left colon,and 44(30.6%)patients had a primary lesion in the right *** with RCC were more likely to display anaemia than patients with LCC[odds ratio(OR)=3.09],while LCC patients were more likely to develop rectal bleeding(OR=3.37)and a feeling of incomplete evacuation(OR=2.78)than RCC *** comorbidities,RCC patients were more likely to suffer from diabetes(OR=3.31)and coronary artery disease(P=0.056)than LCC *** mucinous differentiation rate was higher in the right-sided group than in the left-sided group(OR=4.49),as was the number of infiltrated lymph nodes(P=0.039),while the percentage of high-grade differentiation was higher in the group of patients with left-sided colon cancer than in RCC patients(OR=2.78)

关键词： Colorectal neoplasm Epidermal growth factor Vascular endothelial growth factor Histology Molecular biology Metabolic syndrome

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Statistical models for predicting number of involved nodes in breast cancer patients

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Health 2010年第7期2卷 641-651页

作者： Alok Kumar Dwivedi Sada Nand Dwivedi Suryanarayana Deo Rakesh Shukla Center for biostatistical Services Department of Environmental Health College of Medicine University of Cincinnati Cincinnati USA.

Clinicians need to predict the number of involved nodes in breast cancer patients in order to ascertain severity, prognosis, and design subsequent treatment. The distribution of involved nodes often displays over-dispersion—a larger variability than expected. Until now, the negative binomial model has been used to describe this distribution assuming that over-dispersion is only due to unobserved heterogeneity. The distribution of involved nodes contains a large proportion of excess zeros (negative nodes), which can lead to over-dispersion. In this situation, alternative models may better account for over-dispersion due to excess zeros. This study examines data from 1152 patients who underwent axillary dissections in a tertiary hospital in India during January 1993-January 2005. We fit and compare various count models to test model abilities to predict the number of involved nodes. We also argue for using zero inflated models in such populations where all the excess zeros come from those who have at some risk of the outcome of interest. The negative binomial regression model fits the data better than the Poisson, zero hurdle/inflated Poisson regression models. However, zero hurdle/inflated negative binomial regression models predicted the number of involved nodes much more accurately than the negative binomial model. This suggests that the number of involved nodes displays excess variability not only due to unobserved heterogeneity but also due to excess negative nodes in the data set. In this analysis, only skin changes and primary site were associated with negative nodes whereas parity, skin changes, primary site and size of tumor were associated with a greater number of involved nodes. In case of near equal performances, the zero inflated negative binomial model should be preferred over the hurdle model in describing the nodal frequency because it provides an estimate of negative nodes that are at “high-risk” of nodal involvement.

关键词： Nodal Involvement Count Models Breast Cancer

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Clinical outcomes of endoscopic papillectomy of ampullary adenoma: A multi-center study

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World Journal of Gastroenterology 2022年第17期28卷 1845-1859页

作者： Seong Ji Choi Hong Sik Lee Jiyeong Kim Jung Wan Choe Jae Min Lee Jong Jin Hyun Jai Hoon Yoon Hyo Jung Kim Jae Seon Kim Ho Soon Choi department of Internal Medicine Hanyang University College of MedicineSeoul 04763South Korea Division of Gastroenterology and Hepatology Department of Internal MedicineKorea University College of MedicineSeoul 02841South Korea Lab of biostatistical Consulting and Research Medical Research Collaborating CenterIndustry-University Cooperation FoundationHanyang UniversitySeoul 04763South Korea

BACKGROUND Ampullary adenoma is a rare premalignant lesion,but its incidence is *** papillectomy has become the first treatment of choice for ampullary adenomas due to its safety and effectiveness,thereby replacing surgical ***,recurrence rates and adverse events after endoscopic papillectomy were reported in up to 30%of *** To review the long-term outcomes of endoscopic papillectomy and investigate the factors that affect these *** We retrospectively analyzed the data of patients who underwent endoscopic papillectomy for ampullary adenoma at five tertiary hospitals between 2013 and *** evaluated clinical outcomes and their risk *** definitions of outcomes were as follow:(1)curative resection:complete endoscopic resection without recurrence;(2)endoscopic success:treatment of ampullary adenoma with endoscopy without surgical intervention;(3)early recurrence:reconfirmed adenoma at the first endoscopic surveillance;and(4)late recurrence:reconfirmed adenoma after the first endoscopic *** A total of 106 patients were included for *** the included patients,81(76.4%)underwent curative resection,99(93.4%)had endoscopic success,showing that most patients with noncurative resection were successfully managed with *** patients(15.1%)had piecemeal resection,22 patients(20.8%)had shown positive/uncertain resection margin,11 patients(16.1%)had an early recurrence,13 patients(10.4%)had a late recurrence,and 6 patients(5.7%)had a *** multivariate analysis,a positive/uncertain margin[Odds ratio(OR)=4.023,P=0.048]and piecemeal resection(OR=6.610,P=0.005)were significant risk factors for early and late recurrence,*** resection was also a significant risk factor for non-curative resection(OR=5.424,P=0.007).Twenty-six patients experienced adverse events(24.5%).CONCLUSION Endoscopic papillectomy is a safe and effective treatment for ampullary ***

关键词： Endoscopic papillectomy Ampullary adenoma Clinical outcome Recurrence Adverse event

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Short Term Evaluation of a Novel Eletronic Transanal Irrigation System in Patients with Neurogenic Bowel Dysfunction Previously Exposed to Transanal Irrigation Systems

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Journal of Pharmacy and Pharmacology 2018年第4期6卷 380-394页

作者： Passananti V. Emmanuel A. Nordin M. Storie J. Gripenland j. Astrom M. Hultling C. GI Physiology unit University College London Hospital and National Hospital for Neurology & Neurosurgery London NW1 2BU UK Karolinska University Hospital Department of Neurology Stoekholml 41 86 Sweden biostatistical department StatCons Malm6 126 18 Sweden

Introduction： Neurogenic bowel dysfunction is one of the most distressing consequences of the spinal cord injury. Transanal irrigation has proven to be a treatment for many such individuals, but there are some patients with sub-optimal response to it. Our aim was to evaluate the satisfaction, safety, perception and compliance of a new transanal irrigation device, Navina Smart system featuring an electronically driven pump with a digital control. Material and methods： Twenty-eight patients who had previously used, or were currently using transanal irrigation were enrolled. They were trained to use the Navina Smart system and were thereafter treated for four weeks. Patient perception, compliance and level of satisfaction were assessed at baseline and at the end of treatment. Results： At the end of treatment 68% of patients were still using the system and 50% of ITT （intended to treat） wished to continue using the system. Navina Smart was well tolerated with no adverse effects in the cohort. Patient perception of the Navina Smart system was positive in 67%. Conclusions： Navina Smart system was shown to be safe, tolerable and effective in two-thirds of patients who were unsatisfied with their previous bowel care and was associated with an increase in the patient＇s independence.

关键词： NavinaTM Smart system neurogenic bowel dysfuction transanal irrigation.

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Magnifying endoscopy for the diagnosis of specialized intestinal metaplasia in short-segment Barrett's esophagus

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World Journal of Gastroenterology 2013年第41期19卷 7089-7096页

作者： Nam Seok Ham Jae Young Jang Sung Woo Ryu Ji Hye Kim Eui Ju Park Woong Cheul Lee Kwang Yeun Shim Soung Won Jeong Hyun Gun Kim Tae Hee Lee Sung Ran Jeon Jun Hyung Cho Joo Young Cho So Young Jin Ji Sung Lee Institution for Digestive Research Digestive Disease CenterDepartment of Internal MedicineSoonchunhyang University HospitalSeoul 140-743South Korea department of Pathology Soonchunhyang University HospitalSeoul 140-743South Korea biostatistical Consulting unit Soonchunhyang University HospitalSeoul 140-743South Korea

AIM:To determine whether magnified observation of short-segment Barrett’s esophagus(BE)is useful for the detection of specialized intestinal metaplasia(SIM).METHODS:Thirty patients with suspected short-segment BE underwent magnifying endoscopy up to×*** magnified images were analyzed with respect to their pit-patterns,which were simultaneously classified into five epithelial types[Ⅰ(small round),Ⅱ(straight),Ⅲ(long oval),Ⅳ(tubular),Ⅴ(villous)]by Endo’s ***,a 0.5%solution of methylene blue(MB)was sprayed over columnar *** patterns of the magnified image and MB staining were *** were obtained from the regions previously observed by magnifying endoscopy and MB ***:Three of five patients with a typeⅤ(villous)epithelial pattern had SIM,whereas 21 patients with a non-typeⅤepithelial patterns did not have *** sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of pit-patterns in detecting SIM were 100%,91.3%,92.3%,60%and100%,respectively(P=0.004).Three of the 12 patients with positive MB staining had SIM,whereas 14patients with negative MB staining did not have *** sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of MB staining in detecting SIM were 100%,60.9%,65.4%,25%and100%,respectively(P=0.085).The specificity and accuracy of pit-pattern evaluation were significantly superior compared with MB staining for detecting SIM by comparison with the exact McNemar’s test(P=0.0391).CONCLUSION:The magnified observation of a shortsegment BE according to the mucosal pattern and its classification can be predictive of SIM.

关键词： Short-segment Barrett’s esophagus Magnifying endoscopy Methylene blue chromoendoscopy Specialized intestinal metaplasia Dysplasia Esophageal adenocarcinoma Diagnosis

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Evidence that chronic hypoxia causes reversible impairment on male fertility

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Asian Journal of Andrology 2008年第4期10卷 602-606页

作者： Vittore Verratti Francesco Berardinelli Camillo Di Giulio Gerardo Bosco Marisa Cacchio Mario Pellicciotta Michele Nicolai Stefano Martinotti Raffaele Tenaglia department of Medicine and Aging Science University of Chieti Chieti 66013 Italy department of Basic and Applied Medical Sciences University of Chieti Chieti 66013 Italy biostatistical Office Regina Elena Institute Rome 00144 Italy Laboratorio di Patologia Clinica H University of Chieti Chieti 66013 Italy

Aim： To evaluate the effect of chronic hypoxia on human spermatogenic parameters and their recovery time. Methods： Seminological parameters of six male healthy mountain trekkers were evaluated in normoxia at sea level. After 26 days exposure to altitude （ranging from 2 000 m to 5 600 m, Karakorum Expedition） the same parameters were again evaluated after returning to sea level. These parameters were once again evaluated after 1 month and then again after 6 months. Results： Sperm count was found to be lower immediately after returning to sea level （P = 0.0004） and again after a month （P = 0.0008）. Normal levels were reached after 6 months. Spermatic motility （%） shows no reduction immediately after returning to sea level （P = 0.0583）, whereas after 1 month this reduction was significant （P = 0.0066）. After 6 months there was a recovery to pre-hypoxic exposure values. Abnormal or immature spermatozoa （%） increased immediately after returning to sea level （P = 0.0067） and then again after 1 month （P = 0.0004）. After 6 months there was a complete recovery to initial values. The total number of motile sperm in the ejaculate was found to be lower immediately after returning to sea level （P = 0.0024） and then again after 1 month （P = 0.0021）. After 6 months there was a recovery to pre-hypoxic exposure values. Conclusion： Chronic hypoxia induces a state of oligospermia and the normalization of such seminological parameters at the restoration of previous normoxic conditions after 6 months indicate the influence of oxygen supply in physiological mechanisms of spermatogenesis and male fertility.

关键词： male fertility hypoxia seminological parameters high altitude

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Carotid Intima-media Thickness Measurements： Relations with Atherosclerosis, Risk of Cardiovascular Disease and Application in Randomized Controlled Trials

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Chinese Medical Journal 2016年第2期129卷 215-226页

作者： Michiel L Bots Gregory W Evans Charles H Tegeler Rudy Meijer Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands department of biostatistical Sciences and Neurology Wake Forest School of Medicine Winston-Salem NC USA department of Neuiology Ward A Riley Ultrasound Center Wake Forest School of Medicine Medical Center Boulevard Winston-Salem NC USA

Cardiovascular disease （CVD） is the leading cause of death worldwide and contributes considerably to morbidity The underlying cause is atherosclerosisThe development of new preventive therapies is one of the steps to control the CVD epidemic. It is increasingly demanded that promising therapies be evaluated in trials using cardiovascular （CV） morbidity and mortality （M and M） as a primary outcome.

关键词： Atherosclerosis Cardiovascular Disease Prevention Trials

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An epidemiological study on delay in treatment initiation of cancer patients

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Health 2012年第2期4卷 66-79页

作者： Alok Kumar Dwivedi Sada Nand Dwivedi Suryanarayana Deo Rakesh Shukla Arvind Pandey Durgesh Kumar Dwivedi Center for biostatistical Services Division of Biostatistics and Epidemiology Department of Environmental Health College of Medicine University of Cincinnati Cincinnati USA department of Biostatistics All India Institute of Medical Sciences New Delhi India department of NMR & MRI Facility All India Institute of Medical Sciences New Delhi India department of Surgical Oncology All India Institute of Medical Sciences New Delhi India National Institute of Medical Statistics Indian Council of Medical Research New Delhi India

Early diagnosis and timely initiation of treatment of cancer patients may improve survival and quality of life. Various measures of delay can be made during diagnosis and treatment initiation. Most of the studies were based on single type of cancer with different definitions and measurements of delay in diagnosis and treatment. Thus, it has been difficult to synthesize results and generalize to other types of cancer. The study proposes to measure total duration between onsets of symptom to start of treatment into three components, namely primary, secondary and tertiary delays. Primary delay is defined as onset of symptoms to contacting the first medical person, secondary delay is from first medical contact to confirmed diagnosis, and tertiary delay is from confirmed diagnosis to treatment initiation. The aim of this study is to determine factors associated with primary, secondary and tertiary delays in cancer patients. This study was planned as a cross-sectional study. Data was collected from patients admitted to the surgical wards of department of Surgical Oncology, Institute Rotary Cancer Hospital, New Delhi during 2006-2007. Gamma regression and quantile regressions at 25th, 50th and 75th percentile of each of the delays were used to determine related factors. A total of 403 patients were included in the analysis. The median tertiary delay was found almost two folds (59;Interquartile range: 26 - 101 days) than the primary and secondary delays. Extremity cancer patients had longest primary, secondary and tertiary delays. Shortest primary, secondary and tertiary delays were observed for gastrointestinal cancer, breast and genitourinary cancer respectively. There is an urgent need and scope to reduce delay at each level primary, secondary and tertiary delay. Intervention studies are needed through information, education and communication/screening programs to reduce the diagnostic and treatment delays in cancer patients.

关键词： Delay Cancer Log Gamma Regression Quantile Regression

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