Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials.

BACKGROUND AND OBJECTIVES: The current European Stroke Organisation expedited recommendation on tenecteplase (TNK) for acute ischemic stroke (AIS) advocates that TNK 0.25 mg/kg can be used alternatively to alteplase (tissue plasminogen activator [TPA]) for AIS of <4.5 hours duration, based on a meta-analytical approach establishing noninferiority. Since the publication of these guidelines, 4 additional randomized controlled clinical trials (RCTs) have provided further insight. METHODS: We conducted an updated systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of TNK 0.25 mg/kg compared with TPA for the treatment of AIS within 4.5 hours of onset. The primary outcome was defined as the excellent functional outcome at 3 months (modified Rankin Scale [mRS] score 0-1), whereas good functional outcome (mRS score 0-2), reduced disability at 3 months (≥1-point reduction across all mRS scores), symptomatic intracranial hemorrhage (sICH), and 3-month mortality were evaluated as secondary outcomes. Pooled estimates were calculated with random-effects model. A prespecified subgroup analysis was performed stratifying for TNK formulation, that is, original TNK vs biocopy: recombinant human TNK tissue-type plasminogen activator that is available in China and has a different production process. RESULTS: Eleven RCTs were included comprising a total of 3,788 patients treated with TNK vs 3,757 patients treated with TPA. TNK was associated with higher likelihood of excellent functional outcome (risk ratio [RR] 1.05, 95% CI 1.01-1.10; p = 0.012; I2 = 0%; risk difference 2.95%; 95% CI 0.76%-5.14%; p = 0.008; I2 = 0%) and reduced disability at 3 months (common odds ratio 1.10, 95% CI 1.01-1.19; p = 0.034; I2 = 0%) compared with TPA while good functional outcome (RR 1.03, 95% CI 0.99-1.07; p = 0.142; I2 = 28%) was similar between the groups. Regarding safety outcomes, similar rates of sICH (RR 1.12, 95% CI 0.83-1.53; p = 0.456; I2 = 0%) and 3-month mortality (RR 0.97, 95% CI 0.82-1.15; p = 0.727; I2 = 12%) were observed. When stratified for TNK regimen (original vs biocopy), statistical significance in achieving an excellent functional outcome at 3 months was retained for the original TNK (RR 1.05, 95% CI 1.00-1.10; p = 0.044; I2 = 0%). DISCUSSION: The updated meta-analysis confirms similar safety between TNK 0.25 mg/kg and TPA, while showing that TNK is superior to TPA regarding excellent functional outcome and reduced disability at 3 months. These findings support transitioning to TNK in clinical practice.

Most meta-analyses in oral health do not have conclusive and robust results.

OBJECTIVES: In meta-analyses with few studies, between-study heterogeneity is poorly estimated. The Hartung and Knapp (HK) correction and the prediction intervals can account for the uncertainty in estimating heterogeneity and the range of effect sizes we may encounter in future trials, respectively. The aim of this study was to assess the reported use of the HK correction in oral health meta-analyses and to compare the published reported results and interpretation i) to those calculated using eight heterogeneity estimators and the HK adjustment ii) and to the prediction intervals (PIs). METHODS: We sourced systematic reviews (SRs) published between 2021 and 2023 in eighteen leading specialty and general dental journals. We extracted study characteristics at the SR and meta-analysis level and re-analyzed the selected meta-analyses via the random-effects model and eight heterogeneity estimators, with and without the HK correction. For each meta-analysis, we re-calculated the overall estimate, the P-value, the 95 % confidence interval (CI) and the PI. RESULTS: We analysed 292 meta-analyses. The median number of primary studies included in meta-analysis was 8 (interquartile range [IQR] = [5.75-15] range: 3-121). Only 3/292 meta-analyses used the HK adjustment and 12/292 reported PIs. The percentage of statistically significant results that became non-significant varied across the heterogeneity estimators (7.45 %- 16.59 %). Based on the PIs, >60 % of meta-analyses with statistically significant results are likely to change in the future and >40 % of the PIs included the opposite pooled effect. CONCLUSIONS: The precision and statistical significance of the pooled estimates from meta-analyses with at least three studies is sensitive to the HK correction, the heterogeneity variance estimator, and the PIs. CLINICAL SIGNIFICANCE: Uncertainty in meta-analyses estimates should be considered especially when a small number of trials is available or vary notably in their precision. Misinterpretation of the summary results can lead to ineffective interventions being applied in clinical practice.

EAES Multidisciplinary Rapid Guideline: systematic review, meta-analysis, GRADE assessment and evidence-informed recommendations on the surgical management of paraesophageal hernias.

BACKGROUND: New evidence has emerged since latest guidelines on the management of paraesophageal hernia, and guideline development methodology has evolved. Members of the European Association for Endoscopic Surgery have prioritized the management of paraesophageal hernia to be addressed by pertinent recommendations. OBJECTIVE: To develop evidence-informed clinical practice recommendations on paraesophageal hernias, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: We performed three systematic reviews, and we summarized and appraised the certainty of the evidence using the GRADE methodology. A panel of general and upper gastrointestinal surgeons, gastroenterologists and a patient advocate discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost and use of resources, moderated by a Guidelines International Network-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests surgery over conservative management for asymptomatic/minimally symptomatic paraesophageal hernias (conditional recommendation), and recommends conservative management over surgery for asymptomatic/minimally symptomatic paraesophageal hernias in frail patients (strong recommendation). Further, the panel suggests mesh over sutures for hiatal closure in paraesophageal hernia repair, fundoplication over gastropexy in elective paraesophageal hernia repair, and gastropexy over fundoplication in patients who have cardiopulmonary instability and require emergency paraesophageal hernia repair (conditional recommendation). A strong recommendation means that the proposed course of action is appropriate for the vast majority of patients. A conditional recommendation means that most patients would opt for the proposed course of action, and joint decision-making of the surgeon and the patient is required. Accompanying evidence summaries and evidence-to-decision frameworks should be read when using the recommendations. This guideline applies to adult patients with moderate to large paraesophageal hernias type II to IV with at least 50% of the stomach herniated to the thoracic cavity. The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/j7q7Gn . CONCLUSION: An interdisciplinary panel provides recommendations on key topics on the management of paraesophageal hernias using highest methodological standards and following a transparent process. GUIDELINE REGISTRATION NUMBER: PREPARE-2023CN018.

EAES, SAGES, and ESCP rapid guideline: bowel preparation for minimally invasive colorectal resection.

BACKGROUND: Variation exists in practice pertaining to bowel preparation before minimally invasive colorectal surgery. A survey of EAES members prioritized this topic to be addressed by a clinical practice guideline. OBJECTIVE: The aim of the study was to develop evidence-informed clinical practice recommendations on the use of bowel preparation before minimally invasive colorectal surgery, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: This is a collaborative project of EAES, SAGES, and ESCP. We updated a previous systematic review and performed a network meta-analysis of interventions. We appraised the certainty of the evidence for each comparison, using the GRADE and CINeMA methods. A panel of general and colorectal surgeons, infectious diseases specialists, an anesthetist, and a patient representative discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost, and use of resources, moderated by a GIN-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests either oral antibiotics alone prior to minimally invasive right colon resection or mechanical bowel preparation (MBP) plus oral antibiotics; MBP plus oral antibiotics prior to minimally invasive left colon and sigmoid resection, and prior to minimally invasive right colon resection when there is an intention to perform intracorporeal anastomosis; and MBP plus oral antibiotics plus enema prior to minimally invasive rectal surgery (conditional recommendations); and recommends MBP plus oral antibiotics prior to minimally invasive colorectal surgery, when there is an intention to localize the lesion intraoperatively (strong recommendation). The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/LwvKej . CONCLUSION: This guideline provides recommendations on bowel preparation prior to minimally invasive colorectal surgery for different procedures, using highest methodological standards, through a structured framework informed by key stakeholders. Guideline registration number PREPARE-2023CN045.

Do pooled estimates from orthodontic meta-analyses change depending on the meta-analysis approach? A meta-epidemiological study.

BACKGROUND: In meta-analyses involving a few trials, appropriate measures should be employed to assess between-study heterogeneity. When the number of studies is less than five and heterogeneity is evident, the Hartung and Knapp (HK) correction should be used. The aim of this study was to compare the reported estimates of published orthodontic meta-analyses with the pooled effect size estimates and prediction intervals (PI) calculated using eight heterogeneity estimators and corrected using the HK correction. MATERIAL AND METHODS: Systematic reviews (SRs) published between 2017 and 2022 in four orthodontic journals and the Cochrane Database of Systematic Reviews with a meta-analysis of at least three studies were sourced. Study characteristics were extracted at the SR and the outcome/meta-analysis levels. All selected meta-analyses were re-analysed by fitting a random-effects model using eight different heterogeneity estimators, both with and without the HK correction. For each meta-analysis, the overall estimate, along with its standard error, the P-value, and the corresponding 95% confidence interval (CI), the between-study variance (tau2), the I2 statistic, and the PI were calculated. RESULTS: One-hundred-six SRs were analysed. The most prevalent type of SR was non-Cochrane (95.3%), and the most used meta-analyses synthesis model was the random effect (83.0%). The median number of primary studies was 6 (interquartile range: 5, range: 3-45). The between-study variance was reported in most of the eligible meta-analyses (91.5%), but the type of heterogeneity estimator was reported in only one of them (0.9%). In 5 of 106 meta-analyses (4.7%), the HK correction was applied to adjust the CI of the pooled estimate. The percentage of statistically significant results, which became statistically non-significant, ranged from 16.7% to 25%, depending on the heterogeneity estimator. As the number of studies in a meta-analysis increased, the difference between corrected and uncorrected CIs reduced. Based on the PIs, more than half of the meta-analyses having statistically significant results are likely to change in the future, suggesting the result of the meta-analysis is not conclusive. CONCLUSIONS: The statistical significance of pooled estimates from meta-analyses with at least three studies is sensitive to the HK correction, the heterogeneity variance estimator, and PIs. Clinicians should be aware of the clinical implications of not appropriately assessing the effect of the small number of studies and the between-study heterogeneity when interpreting results from meta-analyses.

Exploring the Effectiveness of Self-Management Interventions in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Chronic diseases are a leading cause of global morbidity and mortality. In response to this challenge, self-management interventions (SMIs) have emerged as an essential tool in improving patient outcomes. However, the diverse and complex nature of SMIs pose significant challenges in measuring their effectiveness. This work aims to investigate the comparative effectiveness of SMIs on Type 2 diabetes mellitus (T2DM) outcomes. METHODS: A rigorous analytical framework was employed to assess the relative effectiveness of different SMIs, encompassing both pairwise and network meta-analysis (NMA), as well as component network meta-analysis (CNMA). Various outcomes were considered, including glycated hemoglobin (HbA1c) control, body mass index (BMI) reduction and low-density lipoprotein (LDL) cholesterol. Visualization tools were also utilized to enhance the interpretation of results. RESULTS: SMIs were found promising in improving clinical outcomes and patient-reported measures. However, considerable heterogeneity and inconsistency across studies challenged the validity of NMA results. CNMA along with various visualization tools offered insights into the contributions of individual SMI components, highlighting the complexity of these interventions. DISCUSSION/CONCLUSIONS: SMIs represent a valuable approach to managing chronic conditions, but their effectiveness is context-dependent. Further research is needed to elucidate the contextual factors influencing SMI outcomes. This work contributes to a comprehensive understanding of SMIs' role in T2DM management, aiming to aid decision-makers, clinicians, and patients in selecting tailored interventions.

EAES rapid guideline: systematic review, meta-analysis, GRADE assessment, and evidence-informed European recommendations on appendicitis in pregnancy.

BACKGROUND: Clinical practice recommendations for the management of acute appendicitis in pregnancy are lacking. OBJECTIVE: To develop an evidence-informed, trustworthy guideline on the management of appendicitis in pregnancy. We aimed to address the questions of conservative or surgical management, and laparoscopic or open surgery for acute appendicitis. METHODS: We performed a systematic review, meta-analysis, and evidence appraisal using the GRADE methodology. A European, multidisciplinary panel of surgeons, obstetricians/gynecologists, a midwife, and 3 patient representatives reached consensus through an evidence-to-decision framework and a Delphi process to formulate the recommendations. The project was developed in an online authoring and publication platform (MAGICapp). RESULTS: Research evidence was of very low certainty. We recommend operative treatment over conservative management in pregnant patients with complicated appendicitis or appendicolith on imaging studies (strong recommendation). We suggest operative treatment over conservative management in pregnant patients with uncomplicated appendicitis and no appendicolith on imaging studies (weak recommendation). We suggest laparoscopic appendectomy in patients with acute appendicitis until the 20th week of gestation, or when the fundus of the uterus is below the level of the umbilicus; and laparoscopic or open appendectomy in patients with acute appendicitis beyond the 20th week of gestation, or when the fundus of the uterus is above the level of the umbilicus, depending on the preference and expertise of the surgeon. CONCLUSION: Through a structured, evidence-informed approach, an interdisciplinary panel provides a strong recommendation to perform appendectomy for complicated appendicitis or appendicolith, and laparoscopic or open appendectomy beyond the 20th week, based on the surgeon's preference and expertise. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN210.

AGREE-S: AGREE II extension for surgical interventions: appraisal instrument.

BACKGROUND: The Appraisal of Guidelines Research and Evaluation (AGREE) II instrument was developed to evaluate the quality of clinical practice guidelines. Evidence suggests that development, reporting, and appraisal of guidelines on surgical interventions may be better informed by modification of the instrument. OBJECTIVE: We aimed to develop an AGREE II extension specifically designed for appraisal of guidelines of surgical interventions. METHODS: In a three-part project funded by the United European Gastroenterology and the European Association for Endoscopic Surgery, (i) we identified factors that were associated with higher quality of surgical guidelines, (ii) we statistically calibrated the AGREE II instrument in the context of surgical guidelines using correlation, reliability, and factor analysis, and (iii) we undertook a Delphi consensus process of stakeholders to inform the development of an AGREE II extension instrument for surgical interventions. RESULTS: Several features were prioritized by stakeholders as of particular importance for guidelines of surgical interventions, including development of a guideline protocol, consideration of practice variability and surgical expertise in different settings, and specification of infrastructures required to implement the recommendations. The AGREE-S-AGREE II extension instrument for surgical interventions has 25 items, compared to the 23 items of the original AGREE II instrument, organized into the following 6 domains: Scope and purpose, Stakeholders, Evidence synthesis, Development of recommendations, Editorial independence, and Implementation and update. As the original instrument, it concludes with an overall appraisal of the quality of the guideline and a judgement on whether the guideline is recommended for use. Several items were amended and rearranged among domains, and an item was deleted. The Rigor of Development domain of the original AGREE II was divided into Evidence Synthesis and Development of Recommendations. Items of the AGREE II domain Clarity of Presentation were incorporated in the new domain Development of Recommendations. Three new items were introduced, addressing the development of a guideline protocol, support by a guideline methodologist, and consideration of surgical experience/expertise. CONCLUSION: The AGREE-S appraisal instrument has been developed to be used for assessment of the methodological and reporting quality of guidelines on surgical interventions.

AGREE-S: AGREE II extension for surgical interventions - United European Gastroenterology and European Association for Endoscopic Surgery methodological guide.

BACKGROUND: The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument has been developed to inform the methodology, reporting and appraisal of clinical practice guidelines. Evidence suggests that the quality of surgical guidelines can be improved, and the structure and content of AGREE II can be modified to help enhance the quality of guidelines of surgical interventions. OBJECTIVE: To develop an extension of AGREE II specifically designed for guidelines of surgical interventions. METHODS: In the tripartite Guideline Assessment Project (GAP) funded by United European Gastroenterology and the European Association for Endoscopic Surgery, (i) we assessed the quality of surgical guidelines and we identified factors associated with higher quality (GAP I); (ii) we applied correlation analysis, factor analysis and the item response theory to inform an adaption of AGREE II for the purposes of surgical guidelines (GAP II); and (iii) we developed an AGREE II extension for surgical interventions, informed by the results of GAP I, GAP II, and a Delphi process of stakeholders, including representation from interventional and surgical disciplines; the Guideline International Network (GIN); the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group; the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) initiative; and representation of surgical journal editors and patient/public. RESULTS: We developed AGREE-S, an AGREE II extension for surgical interventions, which comprises 24 items organized in 6 domains; Scope and purpose, Stakeholders, Evidence synthesis, Development of recommendations, Editorial independence, and Implementation and update. The panel of stakeholders proposed 3 additional items: development of a guideline protocol, consideration of practice variability and surgical/interventional expertise in different settings, and specification of infrastructures required to implement the recommendations. Three of the existing items were amended, 7 items were rearranged among the domains, and one item was removed. The domain Rigour of Development was divided into domains on Evidence Synthesis and Development of Recommendations. The new domain Development of Recommendations incorporates items from the original AGREE II domain Clarity of Presentation. CONCLUSION: AGREE-S is an evidence-based and stakeholder-informed extension of the AGREE II instrument, that can be used as a guide for the development and adaption of guidelines on surgical interventions.

Protocol for EHS Rapid Guideline: Systematic Review, Meta-Analysis, GRADE Assessment, and European Recommendations on Parastomal Hernia Prevention.

Background: Parastomal hernia presents frequently after construction of a permanent end colostomy. Previous guidelines recommend using a prophylactic mesh for hernia prevention. Randomized controlled trials (RCTs) published hereafter demonstrate conflicting outcomes. Methods and Analysis: A rapid guideline will be developed and reported in accordance with GRADE, GIN and AGREE-S standards. The steering group will consist of general and colorectal surgeons, members of the EHS Scientific Advisory Board with expertise and experience in guideline development, advanced medical statistics and evidence synthesis, and a certified guideline methodologist. The guideline panel will consist of three general surgeons, three colorectal surgeons, two stoma care nurses, and two patient representatives. A single question will address the safety and efficacy of the use of a prophylactic mesh in patients with a permanent end colostomy, and sensitivity analyses will focus on the use of non-absorbable versus absorbable meshes, and on different anatomical spaces for mesh placement. A systematic review will be conducted and evidence synthesis will be performed by statisticians independently. The results of evidence synthesis will be summarized in summary of findings tables. Recommendation(s) will be finalized through Delphi process of the guideline panel within an evidence-to-decision framework. Ethics and Dissemination: The funding body will not be involved in the development of this guideline. Conflicts of interest, if any, will be addressed by re-assigning functions or replacing participants with direct conflicts, according to Guidelines International Network recommendations.

Guideline Assessment Project II: statistical calibration informed the development of an AGREE II extension for surgical guidelines.

OBJECTIVE: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. METHODS: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. RESULTS: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. CONCLUSIONS: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines.

Insight into the methodology and uptake of EAES guidelines: a qualitative analysis and survey by the EAES Consensus & Guideline Subcommittee.

BACKGROUND: Over the past 25 years, the European Association for Endoscopic Surgery (EAES) has been issuing clinical guidance documents to aid surgical practice. We aimed to investigate the awareness and use of such documents among EAES members. Additionally, we conceptually appraised the methodology used in their development in order to propose a bundle of actions for quality improvement and increased penetration of clinical practice guidelines among EAES members. METHODS: We invited members of EAES to participate in a web-based survey on awareness and use of these documents. Post hoc analyses were performed to identify factors associated with poor awareness/use and the reported reasons for limited use. We further summarized and conceptually analyzed key methodological features of clinical guidance documents published by EAES. RESULTS: Three distinct consecutive phases of methodological evolvement of clinical guidance documents were evident: a "consensus phase," a "guideline phase," and a "transitional phase". Out of a total of 254 surgeons who completed the survey, 72% percent were aware of EAES guidelines and 47% reported occasional use. Young age and trainee status were associated with poor awareness and use. Restriction by colleagues was the primary reason for limited use in these subgroups. CONCLUSIONS: The methodology of EAES clinical guidance documents is evolving. Awareness among EAES members is fair, but use is limited. Dissemination actions should be directed to junior surgeons and trainees.

Assessing the efficacy and safety of laparoscopic antireflux procedures for the management of gastroesophageal reflux disease: a systematic review with network meta-analysis.

BACKGROUND: Despite the extensive literature on laparoscopic antireflux surgery, comparative evidence across different procedures is scarce. The aim of this study was to assess and rank the most efficacious and safe laparoscopic procedures for the management of gastroesophageal reflux disease. METHODS: Medline, Embase, AMED, CINAHL, CENTRAL, and OpenGrey databases were queried for randomized trials comparing two or more laparoscopic antireflux procedures with each other or with medical treatment for the management of gastroesophageal reflux disease. Pairwise meta-analyses were conducted for each pair of interventions using a random-effects model. Network meta-analysis was employed to assess the relative efficacy and safety of laparoscopic antireflux procedures for the management of gastroesophageal reflux disease. RESULTS: Forty-four publications reporting 29 randomized trials which included 1892 patients were identified. The network of treatments was sparse with only a closed loop between different types of wraps; 270°, 360°, anterior 180° and anterior 90°; and star network between 360° and other treatments; and between anterior 180° and other treatments. Laparoscopic 270° (odds ratio, OR 1.19, 95% confidence interval, CI 0.64-2.22), anterior 180°, and anterior 90° were equally effective as 360° for control of heartburn, although this finding was supported by low quality of evidence according to GRADE modification for NMA. The odds for dysphagia were lower after 270° (OR 0.38, 95%, CI 0.24-0.60), anterior 90° (moderate quality evidence), and anterior 180° (low-quality evidence) compared to 360°. The odds for gas-bloat were lower after 270° (OR 0.51, 95% CI 0.27, 0.95) and after anterior 90° compared to 360° (low-quality evidence). Regurgitation, morbidity, and reoperation were similar across treatments, albeit these were associated with very low-quality evidence. CONCLUSION: Laparoscopic 270° fundoplication achieves a better outcome than 360° total fundoplication, especially in terms of postoperative dysphagia, although other types of partial fundoplication might be equally effective. REGISTRATION NO: CRD42017074783.

An observational study of missing data inquiry from randomized trial authors showed a poor response.

BACKGROUND AND OBJECTIVES: The quality of evidence from a meta-analysis might be affected by poor or inadequate reporting of individual randomized controlled trials (RCTs). The results of data request from authors have not been investigated to date. Aim of this study was to quantify these results and propose a bundle of actions for improvement of data retrieval. STUDY DESIGN AND SETTING: After completion of a feasibility trial, the authors of 116 RCTs selected for inclusion in 4 meta-analyses and network meta-analyses were contacted via email to check abstracted data from their studies and/or provide missing data. Univariable and multivariable analyses were performed to investigate the association of response rate with predefined characteristics, including time interval between publication of the RCT and the date of contact, role of the contact author as corresponding author, the number of participating centers, the source of contact email address and risk of bias assessments. RESULTS: The response rate to the primary email invitation was 31.1% (median response time 0 days, interquartile range [IQR]: 0-1). Of the authors who did not respond to the primary invitation, 31.2% responded to the reminder (median response time 1 day, IQR: 0-3). Despite an overall response rate of 41%, both confirmation of data accuracy and supplementation of missing data were provided for 9 RCTs only (7.8%). No association was found between lack of response and predefined characteristics on univariable and multivariable analyses. CONCLUSION: Despite a fair response rate, contacting authors of RCTs to check abstracted data and complete missing items yielded a very low rate of task completion. These findings highlight the importance of endorsing a data-sharing culture among researchers. The role of alternative incentives is yet to be investigated.

Meta-analysis of the accuracy of contrast-enhanced ultrasound for the detection of endoleak after endovascular aneurysm repair.

OBJECTIVE: The purpose of this systematic review and meta-analysis was to investigate the diagnostic accuracy of contrast-enhanced ultrasound (CEUS) for detection of endoleak after endovascular aneurysm repair (EVAR). METHODS: We searched electronic bibliographic databases for original articles comparing concurrent CEUS and computed tomography angiography for detection of endoleak after EVAR. We assessed the methodologic quality of the studies with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. We constructed 2 × 2 contingency tables for all selected studies including true-positive, false-positive, false-negative, and true-negative results for all endoleaks and for type I and type III endoleaks. We used a mixed-effects logistic regression model to estimate summary sensitivity and specificity. We developed hierarchical summary receiver operating characteristic curves and calculated the area under the curve (AUC). RESULTS: We identified 26 studies reporting a total of 2638 paired scans in 2217 patients. The major risk of bias of the selected studies pertained to blinding for the index test and the reference standard. The pooled sensitivity and specificity of CEUS for all endoleaks were 0.94 (95% confidence interval [CI], 0.89-0.97) and 0.93 (95% CI, 0.89-0.96), respectively. The AUC was 0.98 (95% CI, 0.93-0.99). The summary estimate of sensitivity and specificity for type I and type III endoleaks was 0.97 (95% CI, 0.8-1.00) and 1.00 (95% CI, 0.99-1.00), respectively. The AUC was 1.00 (95% CI, 0.99-1.00). CONCLUSIONS: CEUS has a high sensitivity and specificity in the detection of endoleaks after EVAR. CEUS is a useful tool in EVAR surveillance.

Guideline Assessment Project: Filling the GAP in Surgical Guidelines: Quality Improvement Initiative by an International Working Group.

OBJECTIVE: The aim of the study was to identify clinical practice guidelines published by surgical scientific organizations, assess their quality, and investigate the association between defined factors and quality. The ultimate objective was to develop a framework to improve the quality of surgical guidelines. SUMMARY BACKGROUND DATA: Evidence on the quality of surgical guidelines is lacking. METHODS: We searched MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017. We investigated the association between the following factors and guideline quality, as assessed using the AGREE II instrument: number of guidelines published within the study period by a scientific organization, the presence of a guidelines committee, applying the GRADE methodology, consensus project design, and the presence of intersociety collaboration. RESULTS: Ten surgical scientific organizations developed 67 guidelines over the study period. The median overall score using AGREE II tool was 4 out of a maximum of 7, whereas 27 (40%) guidelines were not considered suitable for use. Guidelines produced by a scientific organization with an output of ≥9 guidelines over the study period [odds ratio (OR) 3.79, 95% confidence interval (CI), 1.01-12.66, P = 0.048], the presence of a guidelines committee (OR 4.15, 95% CI, 1.47-11.77, P = 0.007), and applying the GRADE methodology (OR 8.17, 95% CI, 2.54-26.29, P < 0.0001) were associated with higher odds of being recommended for use. CONCLUSIONS: Development by a guidelines committee, routine guideline output, and adhering to the GRADE methodology were found to be associated with higher guideline quality in the field of surgery.

Optimal stump management in laparoscopic appendectomy: A network meta-analysis by the Minimally Invasive Surgery Synthesis of Interventions and Outcomes Network.

BACKGROUND: Laparoscopic appendectomy is the predominant method of treatment of acute appendicitis. There is insufficient evidence on the most effective management of the appendix stump. The aim of this study was to investigate the relative effectiveness and provide a treatment ranking of different options for securing the appendix stump. METHODS: Electronic databases were searched to identify randomized controlled trials comparing ligation methods of the appendix. The primary outcomes were organ/space infection and superficial operative site infection. We performed a network meta-analysis and estimated the pairwise relative treatment effects of the competing interventions using the odds ratio and its 95% confidence interval. We obtained a hierarchy of the competing interventions using rankograms and the surface under the cumulative ranking curve. RESULTS: Forty-three randomized controlled trials were eligible and provided data for >5,000 patients. Suture ligation seemed to be the most effective treatment strategy, in terms of both organ/space infection and superficial operative site infection. Statistical significance was reached for the comparisons of clip versus endoloop (odds ratio 0.56, 95% confidence interval, 0.32-0.96) for organ/space infection; and suture versus clip (odds ratio 0.20, 95% confidence interval 0.08-0.55) and clip versus endoloop (odds ratio 2.22, 95% confidence interval 1.56-3.13) for superficial operative site infection. The network was informed primarily by indirect treatment comparisons. CONCLUSION: The use of suture ligation of the appendix in laparoscopic appendectomy seems to be superior to other methods for the composite parameters of organ/space and superficial operative site infection.