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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.
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Apendicite , Laparoscopia , Gravidez , Feminino , Humanos , Apendicite/cirurgia , Abordagem GRADE , Apendicectomia/métodos , Laparoscopia/métodos , Doença AgudaRESUMO
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.
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Reprodutibilidade dos Testes , Consenso , HumanosRESUMO
BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.
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Colecistectomia Laparoscópica , Coledocolitíase , Cálculos Biliares , Humanos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Colecistectomia Laparoscópica/métodos , Abordagem GRADE , Metanálise em Rede , Filmes Cinematográficos , Coledocolitíase/cirurgia , Cálculos Biliares/cirurgia , Ducto Colédoco/cirurgiaRESUMO
BACKGROUND: There are several options for the surgical management of GERD in adults. Previous guidelines and systematic reviews have compared the effects of total fundoplication versus pooled effects of different techniques of partial fundoplication. OBJECTIVE: To develop evidence-informed, trustworthy, pertinent recommendations on the use of total, posterior partial and anterior partial fundoplications for the management of GERD in adults. METHODS: We performed an update systematic review, network meta-analysis, and evidence appraisal using the GRADE and the Confidence in Network Meta-Analysis methodologies. An international, multidisciplinary panel of surgeons, gastroenterologists, and a patient representative reached unanimous consensus through an evidence-to-decision framework to select among multiple interventions, and a Delphi process to formulate the recommendation. The project was developed in an online authoring and publication platform (MAGICapp), and was overseen by an external auditor. RESULTS: We suggest posterior partial fundoplication over total posterior or anterior 90° fundoplication in adult patients with GERD. We suggest anterior >90° fundoplication as an alternative, although relevant comparative evidence is limited (weak recommendation). The guideline, with recommendations, evidence summaries and decision aids in user friendly formats can also be accessed in MAGICapp: https://app.magicapp.org/#/guideline/j20X4n. CONCLUSION: This rapid guideline was developed in line with highest methodological standards and provides evidence-informed recommendations on the surgical management of GERD. It provides user-friendly decision aids to inform healthcare professionals' and patients' decision making.
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Abordagem GRADE , Refluxo Gastroesofágico , Humanos , Metanálise em Rede , Refluxo Gastroesofágico/cirurgiaRESUMO
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.
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Gastroenterologia , Endoscopia , Análise Fatorial , HumanosRESUMO
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.