Efficacy and cost analysis of transrectal ultrasound-guided prostate biopsy under monitored anesthesia

Sedation may result in reduction in pain during transrectal ultrasound （TRUS）-guided prostate biopsies. We aimed to evaluate the efficacy and safety of a combination of propofol and remifentanil infusion during TRUS-guided prostate biopsy and the related increases in health care costs. From January to September 2010, 100 men undergoing a transrectal prostate biopsy were randomized into two groups. In Group 1, 50 patients received a combined infusion of propofol and remifentanil; in Group 2, 50 patients received lidocaine jelly. After TRUS-guided biopsies were performed, pain and patient satisfaction were evaluated by a lO-point visual analog scale （VAS）, and a cost-related patient satisfaction questionnaire was completed by all patients. Patients were also asked whether they would be willing to undergo repeat biopsy by the same method. Patients in Group I showed a significantly lower VAS score than those in Group 2 （mean VAS score： 0.9± 1.1 versus 6.3±2.5; P〈0.001）. In addition, the patient satisfaction scale was significantly higher in Group 1 （P=0.002）. Although the overall cost was significantly higher in Group 1 （P=0.006）, patient satisfaction scales considering cost were also higher in this group （P=0.009）. A combination of propofol and remifentanil is a safe and effective way to decrease patient pain and increase patient satisfaction during TRUS-guided prostate biopsy. Although the costs were higher in the group that received sedation, as expected, the patients exhibited heightened satisfaction and willingness to repeat biopsies by the same method.

Targeted-cryosurgical ablation of the prostate with androgen deprivation therapy:quality of life in high-risk prostate cancer patients

Aim： To present preliminary results on health-related quality of life （QoL）, prostate-associated symptoms and therapeutic effects of targeted-cryosurgical ablation of the prostate （TCSAP） with androgen deprivation therapy （ADT） in high-risk prostate cancer （PCa） patients. Methods： Thirty-four men with high-risk PCa features underwent TCSAP, and ADT was added to improve the treatment outcomes. High-risk parameters were defined as either prostate-specific antigen （PSA） ≥ 10ng/mL, or Gleason score 〉 8, or both. The Genito-Urinary Group of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 （EORTC QLQ-C30） with prostate-cancer-specific module （QLQ-PR25） was used for evaluating morbidities and PSA levels were recorded every 3 months. PSA failure was defined as the inability to reach a nadir of 0.4 ng/mL or less. Results： Although it was not statistically significant, the global health status scores increased after TCSAP with ADT. The scores for five functional scales also became higher after treatment. The most prominent symptom after treatment was sexual dysfunction, followed by treatment-related and irritative voiding symptoms. Conclusion： TCSAP with ADT appears to be minimally invasive with high QoL except for sexual dysfunction. Long-term follow-up of PSA data and survival is necessary before any conclusions can be made on the efficacy of this promising new therapeutic modality in the treatment of PCa.

The biochemical efficacy of primary cryoablation combined with prolonged total androgen suppression compared with radiotherapy on high-risk prostate cancer： a 3-year pilot study

To gain beneficial effects in the management of high-risk prostate cancer, an integrated approach that combines local therapy and androgen deprivation therapy （ADT） was used. We compared biochemical responses between primary cryosurgical ablation of the prostate （CSAP） combined with prolonged ADT and radiation combined with ADT, which is the established modality in high-risk disease. A total of 33 high-risk patients received CSAP combined with ADT for 3 months before and up to 24 months after treatment. This patient group was matched with another 33 patients who had undergone three-dimensional conformal radiation therapy （3D-CRT） with the same protocol for ADT. Biochemical recurrence （BCR） was assessed by the American Society for Therapeutic Radiation Oncology （ASTRO） definition, the Phoenix definition and a prostate-specific antigen （PSA） cutoff of 0.5 ng mL^-1. Median follow-up was 61.0 ± 11.9 months for the CSAP ＋ ADT group and 86.0±15.8 months for the 3D-CRT ＋ ADT group. In the CSAP group, major complications including rectourethral fistula and incontinence were not noted. In the CSAP ＋ ADT group, 57.0% had BCR using the ASTRO definition, 21.2% using the Phoenix definition and 54.5% using a PSA cutoff of 0.5 ng mL^-1. In the 3D-CRT ＋ ADT group, 54.5%, 21.2% and 54.5% had BCR using the ASTRO, Phoenix and PSA definition, respectively. In the CSAP ＋ ADT group, the BCR-free survival （BRFS） was 54 ± 10 months using the ASTRO definition, 65 ± 5 months using the Phoenix definition and 51 ± 4 months using a PSA cutoff of 0.5 ng mL-1. In the 3D-CRT ＋ ADT group, the BRFS was 68 ± 12, 93 ± 19 and 70 ± 18 months using the ASTRO, Phoenix and PSA definition, respectively. By the log-rank test, the BRFS values for each group were not statistically different. This intermediate-term result indicated that primary CSAP combined with prolonged ADT offers a parallel biochemical response compared with radiotherapy in high-risk prostate cancer.

The optimal timing of post-prostate biopsy magnetic resonance imaging to guide nerve-sparing surgery

The goal of our study was to evaluate the impact of the interval between prostate biopsy and magnetic resonance imaging （MRI） on the accuracy of simple tumor localization, which is essential information that enables nerve-sparing surgery. We also sought to determine the optimal timing of a post-biopsy MRI, A total of 184 patients who had undergone MRI before radical prostatectomy at an institution without a predetermined schedule for MRI after a prostate biopsy were enrolled. The mean interval from the biopsy to the MRI was 30.8 ± 18.6days. The accuracy of the MRI for simplified tumor location （right, left, bilateral and none） was 44.6%. In the group with discordant pathologic and MRI findings, the most common reason recorded was ＇MRI predicted a unilateral lesion, but pathology revealed bilateral lesions＇ （58.3%）, followed by ＇MRI predicted no lesion, but pathology revealed the presence of a lesion＇ （32.0%）. Multivariable analysis showed that the discordant group had a shorter interval （25.0 ± 14.3 vs 38.1 ± 20.6days, P 〈 0.01） preceding the MRI and a higher rate of hemorrhage as observed by MRI （80.4% vs 54.8%, P 〈 0.01） in comparison with the accordant group. In receiver operating characteristics analysis, the area under the curve of the MRI interval in accurate prediction of the tumor location was 0.707 （P 〈 0.001）. At the MRI interval＇s cutoff of 28.5days, the sensitivity was 73.2% and the specificity was 63.7%. When the MRI was performed within 28days, the accumulated accuracy was only 26.1% （23/88）; however, when it was performed after 28days, the reversely accumulated accuracy was 61.5% （59/96）. These data support a waiting period of at least 4weeks after a biopsy before performing an MRI for the purposes of surgical refinement.

A comparison of short-term postoperative outcomes including nutritional status between gastrectomy with simultaneous cholecystectomy and gastrectomy only in patients with gastric cancer

Objective: We aimed to evaluate the effect of simultaneous cholecystectomy on the short-term postoperative outcomes and nutritional status in patients with gastric cancer.Methods: We retrospectively reviewed data from 4,820 patients with gastric cancer who underwent gastrectomy from January 2011 to December 2016. Patients who underwent only gastrectomy(N=4,578) were matched to those who underwent simultaneous cholecystectomy during gastrectomy(N=242) at a 1:1 ratio using propensity score matching analysis. The nutritional status and inflammatory responses preoperatively and postoperatively and postoperative outcomes were compared between the groups.Results: The simultaneous cholecystectomy group showed more intraoperative blood loss and a longer operative time than the gastrectomy only group [150.0(100.0, 200.0) m L vs. 100.0(100.0, 200.0) m L, P=0.006;176.0(150.0,210.0) min vs. 155.0(128.0, 188.0) min, P<0.001, respectively]. Intraoperative event rate, postoperative complication rate, and postoperative recovery did not differ between the groups. All parameters including body weight, the hemoglobin level, absolute lymphocyte count, total protein level, albumin level, fasting glucose level,and prognostic nutritional index excluding the cholesterol level were not significantly different between the groups,and their changing patterns were similar. Although the cholesterol level was significantly lower in the simultaneous cholecystectomy group than in the gastrectomy only group at all follow-up points, the mean value of the decreased cholesterol level was within normal range.Conclusions: In gastric cancer patients with gallbladder disease, simultaneous cholecystectomy is safe and not associated with additional nutritional loss.

The predictability of T3 disease in staging MRI following prostate biopsy decreases in patients with high initial PSA and Gleason score

To obtain improved accuracy in predicting extracapsular extension （ECE） and seminal vesicle invasion （SVI）, we evaluated the variables affecting the predictability of staging magnetic resonance imaging （MRI, phased-array coil） and estimated their impact on accuracy between preoperative MRI staging and histological outcome. A total of 121 patients with localized or locally advanced prostate cancer who underwent robotic radical prostatectomy （RALP） were included. Following transrectal biopsy, all enrolled patients had undergone MRI for staging work-up. After RALP, only 43.8% （53/121） of the patients were matched with the MRI predicted stage. Compared to the matched group in the prediction of ECE, the unmatched group had significantly higher initial prostate-specific antigen （PSA, 12.8 ng m1-1 versus 8.1 ng m1-1, P=0.048）. In the prediction of SVI, initial PSA （8.1 ng ml- 1 versus 17.3 ng ml- 1, P=0.009） and biopsy Gleason score （6.5 versus 7.6, P=0.035） were significantly higher in the unmatched group. When applying clinical cutoffs of initial PSA of 10 and 20 ng ml-1, the accuracy of MRI in the prediction of ECE was decreased in the group with PSA over 20 ng ml- 1 （75.6, 64.5 and 37.5%, P=0.01）, and this group had significantly decreased accuracy of MRI in the prediction of SVI （91.5, 77.4 and 37.5%, P〈0.01）. Applying the clinical cutoff of a Gleason score of 7, the accuracy of MRI in the prediction of SVI was decreased in the higher G leason score group （93.9, 82.1 and 62.9%, P= 0.01）. Thus, for these patient groups, to obtain margin negativity during radical prostatectomy, operative findings, rather than post-biopsy MRI images, may provide substantial information, implying a clinical advantage in conducting MRI before prostate biopsy.

Does robot-assisted laparoscopic radical prostatectomy enable to obtain adequate oncological and functional outcomes during the learning curve?From the Korean experience

To estimate the short-term results of robot-assisted laparoscopic radical prostatectomy(RALRP)during the learning curve,in terms of surgical,oncological and functional outcomes,we conducted a prospective survey on RALRP.From July 2007,a single surgeon performed 63 robotic prostatectomies using the same operative technique.Perioperative data,including pathological and early functional results of the patient,were collected prospectively and analyzed.Along with the accumulation of the cases,the total operative time,setup time,console time and blood loss were significantly decreased.No major complication was present in any patient.Transfusion was needed in six patients;all of them were within the initial 15 cases.The positive surgical margin rate was 9.8%(5/51)in pT2 disease.The most frequent location of positive margin in this stage was the lateral aspect(60%),but in pT3 disease multiple margins were the most frequent(41.7%).Overall,53(84.1%)patients had totally continent status and the median time to continence was 6.56 weeks.Among 17 patients who maintained preoperative sexual activity(Sexual Health Inventory for Men≥17),stage below pT2,followed up for>6 months with minimally one side of neurovascular bundle preservation procedure,12(70.6%)were capable of intercourse postoperatively,and the mean time for sexual intercourse after operation was 5.7 months.In this series,robotic prostatectomy was a feasible and reproducible technique,with a short learning curve and low perioperative complication rate.Even during the initial phase of the learning curve,satisfactory results were obtained with regard to functional and oncological outcome.

High-dose dietary zinc promotes prostate intraepithelial neoplasia in a murine tumor induction mode

To evaluate the role of high-dose dietary zinc in the process of prostate malignancy,60 Sprague-Dawley rats were randomly divided into four groups：tumor induction with carcinogen and hormone （group 1）,oral zinc administration without tumor induction （group 2）,oral zinc administration with tumor induction （group 3） and a control without zinc administration or tumor induction （group 4）. Zinc was supplied orally in the form of zinc sulfate heptahydrate dissolved in drinking water to groups 2 and 3 for 20 weeks. Although the serum level of zinc measured at 20 weeks was maintained similarly in each group （P = 0.082）,intraprostatic zinc concentrations were statistically different. Group 1 prostates contained the least amount of zinc in both the dorsolateral and ventral lobes at levels of 36.3 and 4.8 μg g^-1,respectively. However,in group 3,zinc levels increased in both lobes to 59.3 and 12.1 μg g^-1,respectively,comparable with that of group 4 （54.5±14.6 and 14.1±2.4 μg g^-1）. In spite of these increases in zinc concentration,the prevalence of prostate intraepithelial neoplasm was rather increased in group 3 （53.3% and 46.7%） compared with group 1 （33.3% and 33.3%） in both dorsolateral and ventral prostate lobes. Although prostate intraepithelial neoplasm did not develop in any prostate in group 4,zinc administration did induce prostate intraepithelial neoplasm in group 2 （46.7% and 40.0%）. Thus,although high dietary zinc increased intraprostatic zinc concentrations,it promoted,instead of preventing,prostate intraepithelial neoplasm in a murine prostate malignancy induction model.

Extragastrointestinal stromal tumor presenting as a scrotal mass： an unusual case

We describe an unusual case of extragastrointestinal stromal tumor （EGIST） presenting as a scrotal mass. A 71- year-old man presented with a gradually enlarging scrotal mass with a 20-year duration. Physical examination re vealed a huge （as large as volleyball）, round, nontender mass occupying the whole scrotum, which was resected completely. Clinical and radiological findings did not comply with any other primary site disease. Under histological examination, the tumor showed a spindle cell pattern with low cellularity, absence of necrotic and mitotic features. Immunohistochemical anlaysis revealed the tumor reactive for CD117 and CD34, while negative for smooth muscle actin, desmin and S-100 protein. To our knowledge, this is the first reported case of an EGIST involving the scrotum.

手指辅助牵张技术在剖宫产中的应用

Objective: To compare the perioperative outcomes of two cesarean section methods, the finger- assisted stretching technique (FAST), based on a modified Joel- Cohen method, with the traditional technique. Methods: A retrospective review of the records of 416 women who underwent cesarean sections at Guro Hospital, Seoul, Korea, between May 1993 and December 2001 was performed. Of the 416 women, 283 underwent cesarean sections with FAST and 133 with the traditional technique. Results: Operative time was significantly shorter with FAST (15.3 vs. 42.6 min, P < .05), and FAST was associated with lower blood loss (601 vs. 928 mL, P < .05) and shorter hospital stay (3.7 vs. 6.5 days, P < .05). There were no significant differences in wound infection, voiding difficulty, and postoperative adhesions between the two methods. Conclusion: These results suggest that FAST may be the better technique.

Analysis of COVID-19 Guideline Quality and Change of Recommendations:A Systematic Review

Background.Hundreds of coronavirus disease 2019(COVID-19)clinical practice guidelines(CPGs)and expert consensus statements have been developed and published since the outbreak of the epidemic.However,these CPGs are of widely variable quality.So,this review is aimed at systematically evaluating the methodological and reporting qualities of COVID-19 CPGs,exploring factors that may influence their quality,and analyzing the change of recommendations in CPGs with evidence published.Methods.We searched five electronic databases and five websites from 1 January to 31 December 2020 to retrieve all COVID-19 CPGs.The assessment of the methodological and reporting qualities of CPGs was performed using the AGREE II instrument and RIGHT checklist.Recommendations and evidence used to make recommendations in the CPGs regarding some treatments for COVID-19(remdesivir,glucocorticoids,hydroxychloroquine/chloroquine,interferon,and lopinavir-ritonavir)were also systematically assessed.And the statistical inference was performed to identify factors associated with the quality of CPGs.Results.We included a total of 92 COVID-19 CPGs developed by 19 countries.Overall,the RIGHT checklist reporting rate of COVID-19 CPGs was 33.0%,and the AGREE II domain score was 30.4%.The overall methodological and reporting qualities of COVID-19 CPGs gradually improved during the year 2020.Factors associated with high methodological and reporting qualities included the evidence-based development process,management of conflicts of interest,and use of established rating systems to assess the quality of evidence and strength of recommendations.The recommendations of only seven(7.6%)CPGs were informed by a systematic review of evidence,and these seven CPGs have relatively high methodological and reporting qualities,in which six of them fully meet the Institute of Medicine(IOM)criteria of guidelines.Besides,a rapid advice CPG developed by the World Health Organization(WHO)of the seven CPGs got the highest overall scores in methodological(72.8%)and reporting qualities(83.8%).Many CPGs covered the same clinical questions(it refers to the clinical questions on the effectiveness of treatments of remdesivir,glucocorticoids,hydroxychloroquine/chloroquine,interferon,and lopinavirritonavir in COVID-19 patients)and were published by different countries or organizations.Although randomized controlled trials and systematic reviews on the effectiveness of treatments of remdesivir,glucocorticoids,hydroxychloroquine/chloroquine,interferon,and lopinavir-ritonavir for patients with COVID-19 have been published,the recommendations on those treatments still varied greatly across COVID-19 CPGs published in different countries or regions,which may suggest that the CPGs do not make sufficient use of the latest evidence.Conclusions.Both the methodological and reporting qualities of COVID-19 CPGs increased over time,but there is still room for further improvement.The lack of effective use of available evidence and management of conflicts of interest were the main reasons for the low quality of the CPGs.The use of formal rating systems for the quality of evidence and strength of recommendations may help to improve the quality of CPGs in the context of the COVID-19 pandemic.During the pandemic,we suggest developing a living guideline of which recommendations are supported by a systematic review for it can facilitate the timely translation of the latest research findings to clinical practice.We also suggest that CPG developers should register the guidelines in a registration platform at the beginning for it can reduce duplication development of guidelines on the same clinical question,increase the transparency of the development process,and promote cooperation among guideline developers all over the world.Since the International Practice Guideline Registry Platform has been created,developers could register guidelines prospectively and internationally on this platform.

Investigation and evaluation of randomized controlled trials for interventions involving artificial intelligence

Objective Complete and transparent reporting is of critical importance for randomized controlled trials(RCTs).The present study aimed to determine the reporting quality and methodological quality of RCTs for interventions involving artificial intelligence(AI)and their protocols.Methods We searched MEDLINE(via PubMed),Embase,Web of Science,CBMdisc,Wanfang Data,and CNKI from January 1,2016,to November 11,2020,to collect RCTs involving AI.We also extracted the protocol of each included RCT if it could be obtained.CONSORT-AI(Consolidated Standards of Reporting Trials-Artificial Intelligence)statement and Cochrane Collaboration’s tool for assessing risk of bias(ROB)were used to evaluate the reporting quality and methodological quality,respectively,and SPIRIT-AI(The Standard Protocol Items:Recommendations for Interventional Trials-Artificial Intelligence)statement was used to evaluate the reporting quality of the protocols.The associations of the reporting rate of CONSORT-AI with the publication year,journal’s impact factor(IF),number of authors,sample size,and first author’s country were analyzed univariately using Pearson’s chi-squared test,or Fisher’s exact test if the expected values in any of the cells were below 5.The compliance of the retrieved protocols to SPIRIT-AI was presented descriptively.Results Overall,29 RCTs and three protocols were considered eligible.The CONSORT-AI items“title and abstract”and“interpretation of results”were reported by all RCTs,with the items with the lowest reporting rates being“funding”(0),“implementation”(3.5%),and“harms”(3.5%).The risk of bias was high in 13(44.8%)RCTs and not clear in 15(51.7%)RCTs.Only one RCT(3.5%)had a low risk of bias.The compliance was not significantly different in terms of the publication year,journal’s IF,number of authors,sample size,or first author’s country.Ten of the 35 SPIRIT-AI items(funding,participant timeline,allocation concealment mechanism,implementation,data management,auditing,declaration of interests,access to data,informed consent materials and biological specimens)were not reported by any of the three protocols.Conclusions The reporting and methodological quality of RCTs involving AI need to be improved.Because of the limited availability of protocols,their quality could not be fully judged.Following the CONSORT-AI and SPIRIT-AI statements and with appropriate guidance on the risk of bias when designing and reporting AI-related RCTs can promote standardization and transparency.

Overall rate, location, and predictive factors for positive surgical margins after robot-assisted laparoscopic radical prostatectomy for high-risk prostate cancer

We report the overall rate, locations and predictive factors of positive surgical margins （PSMs） in 271 patients with high-risk prostate cancer. Between April 2008 and October 2011, we prospectively collected data from patients classified as D＇Amico high-risk who underwent robot-assisted laparoscopic radical prostatectomy. Overall rate and location of PSMs were reported. Stepwise logistic regression models were fitted to assess predictive factors of PSM. The overall rate of PSMs was 25.1% （68 of 271 patients）. Of these PSM, 38.2% （26 of 68） were posterolateral （PL）, 26.5% （18 of 68） multifocal, 16.2% （11 of 68） in the apex, 14.7% （10 of 68） in the bladder neck, and 4.4% （3/68） in other locations. The PSM rate of patients with pathological stage pT2 was 8.6% （12 of 140）, 26.6% （17 of 64） of pT3a, 53.3% （32/60） of pT3b, and 100% （7 of 7） of pT4. In a logistic regression model including pre-, intra-, and post-operative parameters, body mass index （odds ratio [OR]. 1.09; 95% confidence interval [CI]： 1.01-1.19, P = 0.029）, pathological stage （pT3b or higher vs pT2; OR： 5.14; 95% Ch 1.92-13.78; P = 0.001） and percentage of the tumor （OR： 46.71; 95% CI： 6.37-342.57; P 〈 0.001） were independent predictive factors for PSMs. The most common location of PSMs in patients at high-risk was the PL aspect, which reflects the reported tumor aggressiveness. The only significant predictive factors of PSMs were pathological outcomes, such as percentage of the tumor in the specimen and pathological stage.