Repeat resection in recurrent glioblastoma (3rGBM) Trial: A randomized care trial

BackgroundThe prognosis for patients with recurrent glioblastoma (GBM) is dismal, and the question of repeat surgery at time of recurrence is common. Re-operation in the management of these patients remains controversial, as there is no randomized evidence of benefit. An all-inclusive pragmatic care trial is needed to evaluate the role of repeat resection.Methods3rGBM is a multicenter, pragmatic, prospective, parallel-group randomized care trial, with 1:1 allocation to repeat resection or standard care with no repeat resection. To test the hypothesis that repeat resection can improve overall survival by at least 3 months (from 6 to 9 months), 250 adult patients with prior resection of pathology-proven glioblastoma for whom the attending surgeon believes repeat resection may improve quality survival will be enrolled. A surrogate measure of quality of life, the number of days outside of hospital/nursing/palliative care facility, will also be compared. Centers are invited to participate without financial compensation and without contracts. Clinicians may apply to local authorities to approve an investigator-led in-house trial, using a common protocol, web-based randomization platform, and simple standardized case report forms.DiscussionThe 3rGBM trial is a modern transparent care research framework with no additional risks, tests, or visits other than what patients would encounter in normal care. The burden of proof remains on repeat surgical management of recurrent GBM, because this management has yet to be shown beneficial. The trial is designed to help patients and surgeons manage the uncertainty regarding optimal care.Clinical Trial Registrationhttp://www.clinicaltrials.gov. Unique identifier: NCT04838782.     

A seven-year study on an integrated hospital-community diabetes management program in Chinese patients with diabetes

Aims

To assess whether an integrated hospital-community diabetes management program could improve major cardiovascular risk factor control among patients with diabetes in real-world clinical settings.

Association between Oral vitamin C supplementation and serum uric acid: A meta-analysis of randomized controlled trials

IntroductionResults from recent trials assessing the effect of oral vitamin C supplementation on serum uric acid (SUA) have been inconsistent.ObjectivesThe purpose of this study was to explore the association between oral vitamin C supplementation and serum uric acid.MethodsPUBMED, EMBASE, CNKI, Web of Science, and CENTRAL of Cochrane library databases were searched to identify relevant articles published up to February 2020. Heterogeneity was evaluated using I-square (I²) statistics. Random-effects model was used to pool weighted mean differences (WMD) and 95 % confidence interval (CI) as summary effect sizes.ResultsThe total sixteen eligible randomized controlled trials (RCTs) containing 1,013 participants were included in this meta-analysis. The pooled findings showed that vitamin C supplementation had a significant effect of lowering SUA. The subgroup analyses showed that the effect of vitamin C supplementation on SUA has positive association with mean age of participants <65 years old, the use of placebo or blank control, duration of trials <1 month and high-quality studies. In addition, sensitivity analysis showed that the results of this study were stable. Both Egger’s test and Begg’s test demonstrated that no evidence of significant publication bias.ConclusionsThe results of present meta-analysis have demonstrated that vitamin C supplementation could make a reduction of SUA. The use of placebo, duration of intervention, age of the subjects and study quality have an impact on the effect of oral vitamin C, but the baseline of SUA not.     

Adherence of Randomized Controlled Trials to Consolidated Standards of Reporting Trials 2010 Guidelines: A Survey of Randomized Controlled Trials Published in 2011-2016 in 3 Periodontology Journals

ObjectiveTo assess the quality of reporting of randomized controlled trials (RCTs) in the Journal of Clinical Periodontology (JCP), Journal of Periodontology (JOP), and Journal of Periodontal Research (JPR), published in the years 2011 until 2016, using Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.MethodsA thorough search of PubMed for RCTs published between January 2011 and December 2016 in the three journals was carried out. The CONSORT 2010 checklist (36 questions) was used to evaluate the adherence of these RCTs to these guidelines. A modified CONSORT score was calculated and categorized as “perfect” (100%), “excellent” (80%-99%), “good” (60%-79%), “modest” (40%-59%), and “poor” (<40%).ResultsA total of 369 RCTs were published in the three periodontology journals from 2011 until 2016. Based on the modified CONSORT score among all the RCTs, title, abstract, and introduction sections of the included RCTs showed good adherence to the CONSORT 2010 guidelines (60%-79%), whereas the adherence was poor for half the items in methodology (<40%), results (<40%), and discussion (40%). The highest modified CONSORT score was obtained for the trials published in the JCP from 2011 to 2016, whereas the lowest score was achieved by the RCTs in the JPR. Overall, none of the RCTs in any of the journals were perfect in reporting the trials as per the guidelines. Almost half of the RCTs in the JCP showed good adherence (51.1%), whereas almost three-fourths of the RCTs in the JOP (72%) and JPR (82.7%) showed modest to poor adherence as per the reporting guidelines (P < .001).ConclusionAmong the three periodontology journals assessed, the JCP showed better adherence than the JOP and JPR from 2011 until 2016.     

Predictors of ethical approval and informed consent in orthodontic RCTs

Abstract

Objectives: Determine the number of orthodontic randomized controlled trials (RCTs) published in four key orthodontic journals from 1 January 2001 to 31 December 2010, whether details about ethical approval (EA) and/or informed consent (IC) were reported and identify predictors for reporting EA and IC in orthodontic RCTs.

Design: Retrospective observational study.

Setting: American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) from 2001 to 2010.

Interventions: AJODO, AO, EJO and JO were handsearched to identify all RCTs published from 1 January 2001 to 31 December 2010.

Main outcome measure: The RCTs were assessed to identify: inclusion of details about EA and IC, publication journal, number of authors, number and location of centres involved, perceived statistician involvement, publication year and inclusion of random* in either the title, abstract or body of the text.

Results: 218 RCTs were published. 109 (48·6%) had reported both EA and IC, 59 (27·1%) neither and 53 (12·9%) either EA or IC. Factors associated with an RCT reporting obtaining EA and IC: number of authors (P<0·001), random* in title (P<0·001), random* in abstract but not title (P<0·001), location of origin (P?=?0·001), publication year (P?=?0·003), journal of publication (P?=?0·004) and number of centres (P?=?0·008). Logistic regression suggested the most significant indicators of reporting EA and IC were: publication in the JO (P?=?0·018), >6 authors (P<0·001), random* in the abstract but not title (P?=?0·004) and publication after 2004 (P?=?0·001).

Conclusions: RCTs were most likely to have reported EA and IC when published in the JO, after 2004 while having more than six authors and random* in the abstract but not title.     

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Background

Patients with acute deep vein thrombus (DVT) can safely be treated as outpatients. However the role of outpatient treatment in patients diagnosed with a pulmonary embolism (PE) is controversial. We sought to determine the safety of outpatient management of patients with acute symptomatic PE.

Materials and Methods

A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Pooled proportions for the different outcomes were calculated.

Results

A total of 1258 patients were included in the systematic review. The rate of recurrent venous thromboembolism (VTE) in patients with PE managed as outpatients was 1.47% (95% CI: 0.47 to 3.0%; I²: 65.4%) during the 3 month follow-up period. The rate of fatal PE was 0.47% (95% CI: 0.16 to 1.0%; I²: 0%). The rates of major bleeding and fatal intracranial hemorrhage were 0.81% (95% CI: 0.37 to 1.42%; I²: 0%) and 0.29% (95% CI: 0.06 to 0.68%; I²: 0%), respectively. The overall 3 month mortality rate was 1.58% (95% CI: 0.71 to 2.80%; I²: 45%). The event rates were similar if employing risk stratification models versus using clinical gestalt to select appropriate patients for outpatient management.

Conclusions

Independent of the risk stratification methods used, the rate of adverse events associated with outpatient PE treatment seems low. Based on our systematic review and pooled meta-analysis, low-risk patients with acute PE can safely be treated as outpatients if home circumstances are adequate.     

硝苯地平和坦索罗新治疗下段输尿管结石的meta分析

目的比较硝苯地平与坦索罗新两种药物在药物排石治疗中的疗效及安全性。方法计算机检索Pubmed、Cochrane和Embase等数据库,查找所有比较硝苯地平与坦索罗新治疗下段输尿管结石的临床随机对照试验（RCT）,检索时限为建库至2014年1月16日。同时手检纳入文献的参考文献。按纳入排除标准由两人独立进行RCT的筛选、资料提取和质量评价后,采用Rev Man 5.2软件进行meta分析,并采用证据质量分级和推荐强度（GRADE）系统进行证据质量评价。结果共纳入5个研究,3 708例患者。meta分析结果显示：1在有效性方面：5个研究均比较了排石率,坦索罗新组排石率高于硝苯地平组,差异有统计学意义（RR为0.77,95%CI为0.75-0.80,P=0.02）。4个研究比较了排石时间（d）,其中1个研究显示两者差异无统计学意义（P=0.2）,另外3个研究均显示两者差异有统计学意义（均P〈0.01）,坦索罗新组排石时间较硝苯地平组短。5个研究均比较了镇痛效果,其中1个研究显示两者双氯芬酸使用剂量差异无统计学意义（P〉0.05）,另外4个研究均显示两者治疗双氯芬酸使用剂量差异有统计学意义（P〈0.01）。2在安全性方面：两组在轻微不良反应发生率和严重不良反应发生率上差异均无统计学意义（RR为1.61,95%CI为0.59-4.38,P=0.35;RR为0.43,95%CI为0.06-2.89,P=0.38）。结论硝苯地平跟坦索罗新相比,坦索罗新组排石率高于硝苯地平组,而两者不良反应发生率相似;此外,坦索罗新组在缩短排石时间和减少镇痛剂使用量方面优于硝苯地平组。下段输尿管结石的药物治疗首选坦索罗新。     

Effects of cardiac contractility modulation by non-excitatory electrical stimulation on exercise capacity and quality of life: An individual patient's data meta-analysis of randomized controlled trials

Background

Although cardiac contractility modulation (CCM) has emerged as a promising device treatment for heart failure (HF), the effect of CCM on functional capacity and quality of life has not been the subject of an individual patient data meta-analysis to determine its effect on measures of functional capacity and life quality. This meta-analysis is aimed at systematically reviewing the latest available randomized evidence on the effectiveness of CCM on functional capacity and quality of life indexes in patients with HF.

Methods

The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in May 2013 to identify eligible randomized controlled trials comparing CCM with sham treatment or usual care. Primary outcomes of interest were peak oxygen consumption, 6-minute walk test distance and quality of life measured by Minnesota Living With Heart Failure Questionnaire. There was no sufficient information to address safety. Mean difference and 95% confidence intervals (C.I.s) were calculated for continuous data using a fixed-effects model.

Results

Three studies enrolling 641 participants were identified and included. Pooled analysis showed that, compared to control, CCM significantly improved peak oxygen consumption (mean difference + 0.71, 95% C.I. 0.20 to 1.21 mL/kg/min, p = 0.006), 6-minute walk test distance (mean difference + 13.92, 95% C.I. − 0.08 to 27.91 m, p = 0.05) and quality of life measured by Minnesota Living With Heart Failure Questionnaire (mean difference − 7.17, 95% C.I. − 10.38 to − 3.96, p < 0.0001).

Conclusions

Meta-analysis of individual patient data from randomized trials suggests that CCM has significant if somewhat modest benefits in improving measures of functional capacity and quality of life.     

Summary of knowledge gaps related to quality and efficacy of current influenza vaccines

Influenza viruses are a public health threat, as they are pathogenic, highly transmissible and prone to genetic changes. For decades vaccination strategies have been based on trivalent inactivated vaccines, which are regulated by specific guidelines. The progress in scientific knowledge and the lessons learned from the A(H1N1)2009 pandemic have highlighted further the need to improve current guidelines, including the immunogenicity criteria set by the CHMP in 1997, and to promote the discussion on the shortcomings encountered, e.g. the evaluation of vaccine efficacy in the paediatric and elderly populations, the measurement of the naivety of a population, the impact of prior immunity on subsequent vaccinations, and the technical issues with the serological assays for detection of immunity and immunogenicity.     

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting

ObjectiveTo describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials.Study Design and SettingThe AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009.ResultsOf the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011–2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable.ConclusionTrials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.