首页 > 最新文献

International Journal of Surgery Protocols最新文献

英文 中文
Management and Outcomes of Low-Grade Gliomas in Africa: A Scoping Review Protocol. 非洲低级别胶质瘤的治疗和结果:一项范围审查方案。
IF 0.9 Q3 SURGERY Pub Date : 2022-02-02 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.171
Setthasorn Zhi Yang Ooi, Rosaline de Koning, Abdullah Egiz, David Ulrich Dalle, Moussa Denou, Marvin Richie Dongmo Tsopmene, Mehdi Khan, Régis Takoukam, Jay Kotecha, Dawin Sichimba, Yao Christian Hugues Dokponou, Ulrick Sidney Kanmounye, Nourou Dine Adeniran Bankole

Background: Over the last decade, many advancements have been made in the management of low-grade gliomas (LGGs). Overall survival outcomes are correlated with factors such as postoperative residual volumes and specific tumor biomolecular profiles such as IDH mutation status. It is unclear whether these advancements have benefited LGG patients in Africa. This scoping review protocol outlines how the authors will evaluate the epidemiology, presentations, management and outcomes of LGGs in Africa.

Methods: MEDLINE, Embase and African Journals Online will be searched from database inception to date in order to identify the relevant studies. Patients of all ages with histologically and/or radiologically confirmed LGGs that were managed in an African country will be included. Surgical and chemoradiation management of LGG tumours will be considered. Original research, reviews, commentaries, editorials and case reports will be included.

Results: Primary outcomes of the review will include LGG management, morbidity and mortality. Secondary outcomes include epidemiology and recurrence of LGGs.

Discussion: This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research as well as health system strengthening efforts by policymakers and stakeholders.

Scoping review registration: The protocol has been registered on the Open Science Framework (OSF; registration link: https://doi.org/10.17605/OSF.IO/E732G).

Highlights: LGGs account for 17% to 22% of total brain tumours and have a median survival time between 5.6 and 13.3 years.Despite many recent advancements in the management of LGGs, there is a paucity in the data within the African landscape.This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research and policymaking efforts.

背景:在过去的十年中,低级别胶质瘤(LGGs)的治疗取得了许多进展。总体生存结果与术后残留体积和特定肿瘤生物分子特征(如IDH突变状态)等因素相关。目前尚不清楚这些进展是否使非洲的LGG患者受益。这份范围审查方案概述了作者将如何评估非洲LGGs的流行病学、介绍、管理和结果。方法:检索MEDLINE、Embase和African Journals Online从数据库建立至今的相关研究。所有年龄的、经组织学和/或放射学证实在非洲国家治疗过的lgg患者将被纳入研究范围。将考虑LGG肿瘤的手术和放化疗管理。原创性研究、评论、评论、社论和病例报告将包括在内。结果:本综述的主要结局将包括LGG管理、发病率和死亡率。次要结局包括流行病学和lgg的复发。讨论:这次范围审查将首次评估非洲LGG管理的现状和成果,突出可用于指导进一步研究以及决策者和利益攸关方加强卫生系统努力的相关主题。范围审查注册:该方案已在开放科学框架(OSF;注册链接:https://doi.org/10.17605/OSF.IO/E732G).Highlights: LGGs占所有脑肿瘤的17%至22%,中位生存时间在5.6至13.3年之间。尽管最近在LGGs管理方面取得了许多进展,但非洲境内的数据仍然缺乏。这一范围审查将首次评估非洲地方政府集团管理的现状和成果,突出可能用于指导进一步研究和决策工作的相关主题。
{"title":"Management and Outcomes of Low-Grade Gliomas in Africa: A Scoping Review Protocol.","authors":"Setthasorn Zhi Yang Ooi,&nbsp;Rosaline de Koning,&nbsp;Abdullah Egiz,&nbsp;David Ulrich Dalle,&nbsp;Moussa Denou,&nbsp;Marvin Richie Dongmo Tsopmene,&nbsp;Mehdi Khan,&nbsp;Régis Takoukam,&nbsp;Jay Kotecha,&nbsp;Dawin Sichimba,&nbsp;Yao Christian Hugues Dokponou,&nbsp;Ulrick Sidney Kanmounye,&nbsp;Nourou Dine Adeniran Bankole","doi":"10.29337/ijsp.171","DOIUrl":"https://doi.org/10.29337/ijsp.171","url":null,"abstract":"<p><strong>Background: </strong>Over the last decade, many advancements have been made in the management of low-grade gliomas (LGGs). Overall survival outcomes are correlated with factors such as postoperative residual volumes and specific tumor biomolecular profiles such as IDH mutation status. It is unclear whether these advancements have benefited LGG patients in Africa. This scoping review protocol outlines how the authors will evaluate the epidemiology, presentations, management and outcomes of LGGs in Africa.</p><p><strong>Methods: </strong>MEDLINE, Embase and African Journals Online will be searched from database inception to date in order to identify the relevant studies. Patients of all ages with histologically and/or radiologically confirmed LGGs that were managed in an African country will be included. Surgical and chemoradiation management of LGG tumours will be considered. Original research, reviews, commentaries, editorials and case reports will be included.</p><p><strong>Results: </strong>Primary outcomes of the review will include LGG management, morbidity and mortality. Secondary outcomes include epidemiology and recurrence of LGGs.</p><p><strong>Discussion: </strong>This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research as well as health system strengthening efforts by policymakers and stakeholders.</p><p><strong>Scoping review registration: </strong>The protocol has been registered on the Open Science Framework (OSF; registration link: <i>https://doi.org/10.17605/OSF.IO/E732G</i>).</p><p><strong>Highlights: </strong>LGGs account for 17% to 22% of total brain tumours and have a median survival time between 5.6 and 13.3 years.Despite many recent advancements in the management of LGGs, there is a paucity in the data within the African landscape.This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research and policymaking efforts.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"1-6"},"PeriodicalIF":0.9,"publicationDate":"2022-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8815446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39642251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Reporting Modifications in Surgical Innovation: A Systematic Scoping Review Protocol. 报告外科创新的修改:一个系统的范围审查方案。
IF 0.9 Q3 SURGERY Pub Date : 2021-11-12 eCollection Date: 2021-01-01 DOI: 10.29337/ijsp.167
Christin Hoffmann, Sina Hossaini, Sian Cousins, Natalie Blencowe, Angus G K McNair, Jane M Blazeby, Kerry N L Avery, Shelley Potter, Rhiannon Macefield

Introduction: Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation.

Materials and methods: A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices.

Highlights: This work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.

引言:外科手术的创新推动了患者护理的改善。新的外科手术程序和设备在引入临床实践过程中,通常会经过一系列的改进。理想情况下,这些变化应该在外科医生创新者之间报告和分享,以促进高效、安全和透明的创新。目前,对于如何定义、概念化和分类修改,以便能够高效透明地报告和共享,还缺乏一致意见。这篇综述的目的是检查和总结现有的关于外科手术/器械修改的定义、看法和分类的文献,包括关于如何测量和报告它们的观点。这些发现将为未来的工作提供信息,以标准化手术创新修改的报告和共享。材料和方法:将根据PRISMA ScR指南进行系统的范围界定审查。收录的文章将集中在与临床实践中引入的新外科手术或器械的修改相关的综述文章和意见文章上。识别相关文献的方法包括MEDLINE(Ovid版本)中的系统搜索、有针对性的互联网搜索(Google Scholar)和滚雪球搜索。两阶段筛选过程(标题/摘要/关键词和全文)将使用指定的排除/纳入标准来确定符合条件的文章。将逐字提取关于修改i)定义、ii)感知和iii)分类的数据,以及iv)关于修改应如何衡量和报告的观点的数据。将酌情对提取的数据进行归纳专题分析。结果将以叙述性总结的形式呈现,包括所收录文章的描述性特征。研究结果将为初步概念框架提供信息,以促进系统报告和共享对新程序和装置的修改。亮点:这项工作将深入了解目前如何定义、感知和分类修改,以及在外科创新的背景下如何报告修改的观点。将采用严格和全面的搜索方法来确定广泛多样的数据来源,以纳入审查。总结现有的修改相关文献是制定透明、实时报告框架的必要步骤,并在未来的创新侵入性程序/设备研究中共享修改。
{"title":"Reporting Modifications in Surgical Innovation: A Systematic Scoping Review Protocol.","authors":"Christin Hoffmann, Sina Hossaini, Sian Cousins, Natalie Blencowe, Angus G K McNair, Jane M Blazeby, Kerry N L Avery, Shelley Potter, Rhiannon Macefield","doi":"10.29337/ijsp.167","DOIUrl":"10.29337/ijsp.167","url":null,"abstract":"<p><strong>Introduction: </strong>Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation.</p><p><strong>Materials and methods: </strong>A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices.</p><p><strong>Highlights: </strong>This work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"25 1","pages":"250-256"},"PeriodicalIF":0.9,"publicationDate":"2021-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8588892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9156630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Protocol for a Systematic Review Assessing Surgery versus Primary Endocrine Therapy in Operable Breast Cancer. Prep for Pandemic 评估手术与原发性内分泌治疗在可手术乳腺癌中的系统评价方案。为大流行做准备
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.003
Sacha Roberts, Aram Rojas, Mahir Gachabayov, Maria Castaldi

Introduction

In COVID-19 pandemic epicenters cancer care was severely impacted. All elective and semi-elective procedures, as well as select urgent cases, were postponed in order to preserve resources and protect patients and staff from SARS-CoV-2 exposure. Structured decision making for breast cancer treatment resulted in deferment of surgery with initiation of endocrine therapy. Moreover, the waitlist for elective breast cancer procedures after mitigation is a challenge for prioritization.

Objective and significance

We aim to summarize the current body of evidence, comparatively evaluate oncological outcomes of surgery versus primary endocrine therapy (PET), and determine whether PET is a viable long-term alternative to surgery in the context of crisis management strategy for early, operable hormone receptor positive (HRP) breast cancer. PET could potentially be an acceptable bridging or maintenance therapy in select patients during pandemic crisis or for those choosing to forgo surgery in the treatment of breast cancer.

Methods and analysis

The database search includes PubMed, EMBASE, and MEDLINE (via Ovid). This systematic review includes women 18 years or older undergoing one of two interventions for HRP breast cancer: surgery (with or without endocrine therapy post-surgery) or solely PET. Studies comparing one of the two interventions of interest to a non-relevant intervention and studies reporting only descriptive data will not be included in the quantitative synthesis of data. After selection of eligible studies based on title and abstract, these studies will be further screened through full text articles by two independent reviewers, with a third as an arbitrator. Eligible studies will be critically appraised at the study level for methodological quality. Cochrane methodology will be utilized for meta-analysis.

Ethics and dissemination

This study does not require an institutional review board approval given its summary design nature. Findings of this systematic review will be published in a peer-reviewed journal.

在COVID-19大流行中心,癌症治疗受到严重影响。所有选择性和半选择性手术以及部分紧急病例都被推迟,以保留资源并保护患者和工作人员免受SARS-CoV-2暴露。乳腺癌治疗的结构化决策导致手术延迟开始内分泌治疗。此外,缓解后的选择性乳腺癌手术的等待名单是优先排序的挑战。目的和意义我们旨在总结目前的证据,比较评估手术与原发性内分泌治疗(PET)的肿瘤学结果,并确定在早期可手术的激素受体阳性(HRP)乳腺癌的危机管理策略中,PET是否是一种可行的长期替代手术。在大流行危机期间,PET可能是一种可接受的桥接或维持治疗,对于那些选择放弃手术治疗乳腺癌的患者。方法与分析数据库检索包括PubMed, EMBASE和MEDLINE(通过Ovid)。本系统综述包括18岁或以上接受两种干预措施之一治疗HRP乳腺癌的妇女:手术(术后伴或不伴内分泌治疗)或单纯PET。将两种相关干预措施中的一种与非相关干预措施进行比较的研究以及仅报告描述性数据的研究将不包括在数据的定量综合中。在根据标题和摘要选出符合条件的研究后,这些研究将由两名独立审稿人进一步通过全文文章进行筛选,第三名作为仲裁员。合格的研究将在研究水平上对方法学质量进行严格评价。meta分析将采用Cochrane方法学。伦理和传播考虑到其概要设计的性质,本研究不需要机构审查委员会的批准。本系统综述的结果将发表在同行评议的期刊上。
{"title":"Protocol for a Systematic Review Assessing Surgery versus Primary Endocrine Therapy in Operable Breast Cancer. Prep for Pandemic","authors":"Sacha Roberts,&nbsp;Aram Rojas,&nbsp;Mahir Gachabayov,&nbsp;Maria Castaldi","doi":"10.1016/j.isjp.2020.10.003","DOIUrl":"10.1016/j.isjp.2020.10.003","url":null,"abstract":"<div><h3>Introduction</h3><p>In COVID-19 pandemic epicenters cancer care was severely impacted. All elective and semi-elective procedures, as well as select urgent cases, were postponed in order to preserve resources and protect patients and staff from SARS-CoV-2 exposure. Structured decision making for breast cancer treatment resulted in deferment of surgery with initiation of endocrine therapy. Moreover, the waitlist for elective breast cancer procedures after mitigation is a challenge for prioritization.</p></div><div><h3>Objective and significance</h3><p>We aim to summarize the current body of evidence, comparatively evaluate oncological outcomes of surgery versus primary endocrine therapy (PET), and determine whether PET is a viable long<strong>-</strong>term alternative to surgery in the context of crisis management strategy for early, operable hormone receptor positive (HRP) breast cancer. PET could potentially be an acceptable bridging or maintenance therapy in select patients during pandemic crisis or for those choosing to forgo surgery in the treatment of breast cancer.</p></div><div><h3>Methods and analysis</h3><p>The database search includes PubMed, EMBASE, and MEDLINE (via Ovid). This systematic review includes women 18 years or older undergoing one of two interventions for HRP breast cancer: surgery (with or without endocrine therapy post-surgery) or solely PET. Studies comparing one of the two interventions of interest to a non-relevant intervention and studies reporting only descriptive data will not be included in the quantitative synthesis of data. After selection of eligible studies based on title and abstract, these studies will be further screened through full text articles by two independent reviewers, with a third as an arbitrator. Eligible studies will be critically appraised at the study level for methodological quality. Cochrane methodology will be utilized for meta-analysis.</p></div><div><h3>Ethics and dissemination</h3><p>This study does not require an institutional review board approval given its summary design nature. Findings of this systematic review will be published in a peer-reviewed journal.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"24 ","pages":"Pages 36-38"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.10.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38689866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Adult cardiac surgical cost variation around the world: Protocol for a systematic review 世界各地成人心脏手术费用变化:系统评价方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.004
Dominique Vervoort , Camila R. Guetter , Lena Trager , Priyansh Shah , Carlos Eduardo Diaz-Castrillon , Eric W. Etchill , Rawn Salenger

Introduction

Globally, over one million cardiac operations occur each year, whereas cardiac surgery is expensive and largely inaccessible without insurance or philanthropic support. Substantial cost variation has been reported within cardiac surgery in the United States and among non-cardiac surgical procedures globally, but little is known on the global procedural cost variation for common adult cardiac surgical procedures.

Objectives and significance

This review seeks to assess variation in procedural costs of coronary artery bypass grafting (CABG), mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures between and within countries. Results may give insights in the scope and drivers of cost variation around the world, posing cost reduction lessons. Results may further inform the potential of economies of scale in reducing procedural costs, benefiting patients, hospitals, governments, and insurers.

Methods and analysis

A systematic review will be performed using the EconLit, Embase, PubMed/MEDLINE, Web of Science, and WHO Global Index Medicus databases to identify articles published between January 1, 2000 and June 1, 2020. Studies describing procedural costs for CABG, mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures will be identified. Articles describing other types of cardiac surgery, concomitant aortic surgery, only describing costs related to non-surgical care, or with incomplete cost data will be excluded from the analysis. No exclusion will be based solely on article type or language. Identified costs will be converted to 2019 USD to account for local currency unit inflation and exchange fluctuations.

Ethics and dissemination

This study protocol has been prospectively registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols. This review requires no institutional review board approval. Results of this study will be summarized and disseminated in a peer-review journal.

在全球范围内,每年有超过100万例心脏手术,而心脏手术是昂贵的,而且在没有保险或慈善支持的情况下,大部分人无法进行心脏手术。据报道,美国心脏手术和全球非心脏手术的成本差异很大,但对普通成人心脏手术的全球成本差异知之甚少。目的和意义本综述旨在评估各国之间冠状动脉旁路移植术(CABG)、二尖瓣修复、二尖瓣置换术、主动脉瓣修复、主动脉瓣置换术以及冠状动脉-二尖瓣或冠状动脉-主动脉瓣联合手术的手术成本差异。结果可能会对世界各地成本变化的范围和驱动因素提供见解,提出降低成本的经验教训。结果可能进一步说明规模经济在降低程序成本方面的潜力,使患者、医院、政府和保险公司受益。方法和分析将使用EconLit、Embase、PubMed/MEDLINE、Web of Science和WHO Global Index Medicus数据库进行系统评价,以确定2000年1月1日至2020年6月1日期间发表的文章。研究将描述冠状动脉搭桥、二尖瓣修复、二尖瓣置换术、主动脉瓣修复、主动脉瓣置换术以及冠状动脉搭桥-二尖瓣或冠状动脉搭桥-主动脉瓣联合手术的手术成本。描述其他类型心脏手术、合并主动脉手术、仅描述与非手术护理相关的费用或费用数据不完整的文章将被排除在分析之外。排除将不会仅仅基于文章类型或语言。已确定的费用将转换为2019年美元,以考虑当地货币单位通货膨胀和汇率波动。伦理和传播本研究方案已在国际系统评价和荟萃分析方案注册平台上前瞻性注册。这项审查不需要机构审查委员会的批准。本研究结果将在同行评议期刊上进行总结和传播。
{"title":"Adult cardiac surgical cost variation around the world: Protocol for a systematic review","authors":"Dominique Vervoort ,&nbsp;Camila R. Guetter ,&nbsp;Lena Trager ,&nbsp;Priyansh Shah ,&nbsp;Carlos Eduardo Diaz-Castrillon ,&nbsp;Eric W. Etchill ,&nbsp;Rawn Salenger","doi":"10.1016/j.isjp.2020.07.004","DOIUrl":"10.1016/j.isjp.2020.07.004","url":null,"abstract":"<div><h3>Introduction</h3><p>Globally, over one million cardiac operations occur each year, whereas cardiac surgery is expensive and largely inaccessible without insurance or philanthropic support. Substantial cost variation has been reported within cardiac surgery in the United States and among non-cardiac surgical procedures globally, but little is known on the global procedural cost variation for common adult cardiac surgical procedures.</p></div><div><h3>Objectives and significance</h3><p>This review seeks to assess variation in procedural costs of coronary artery bypass grafting (CABG), mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures between and within countries. Results may give insights in the scope and drivers of cost variation around the world, posing cost reduction lessons. Results may further inform the potential of economies of scale in reducing procedural costs, benefiting patients, hospitals, governments, and insurers.</p></div><div><h3>Methods and analysis</h3><p>A systematic review will be performed using the EconLit, Embase, PubMed/MEDLINE, Web of Science, and WHO Global Index Medicus databases to identify articles published between January 1, 2000 and June 1, 2020. Studies describing procedural costs for CABG, mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures will be identified. Articles describing other types of cardiac surgery, concomitant aortic surgery, only describing costs related to non-surgical care, or with incomplete cost data will be excluded from the analysis. No exclusion will be based solely on article type or language. Identified costs will be converted to 2019 USD to account for local currency unit inflation and exchange fluctuations.</p></div><div><h3>Ethics and dissemination</h3><p>This study protocol has been prospectively registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols. This review requires no institutional review board approval. Results of this study will be summarized and disseminated in a peer-review journal.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"23 ","pages":"Pages 11-14"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38269949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CRC COVID: Colorectal cancer services during COVID-19 pandemic. Study protocol for service evaluation CRC COVID: COVID-19大流行期间的结直肠癌服务。服务评估的研究方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.005
Alona Courtney , Ann-Marie Howell , Najib Daulatzai , Nicos Savva , Oliver Warren , Sarah Mills , Shahnawaz Rasheed , Goel Milind , Nicholas Tekkis , Matthew Gardiner , Tinglong Dai , Bashar Safar , Jonathan E Efron , Ara Darzi , Paris Tekkis , Christos Kontovounisios

Introduction

COVID-19 has had an impact on the provision of colorectal cancer care. The aim of the CRC COVID study is to describe the changes in colorectal cancer services in the UK and USA in response to the pandemic and to understand the long-term impact.

Methods and analysis

This study comprises 4 phases. Phase 1 is a survey of colorectal units that aims to evaluate adherences and deviations from the best practice guidelines during the COVID-19 pandemic. Phase 2 is a monthly prospective data collection of service provision that aims to determine the impact of the service modifications on the long-term cancer specific outcomes compared to the national standards. Phase 3 aims to predict costs attributable to the modifications of the CRC services and additional resources required to treat patients whose treatment has been affected by the pandemic. Phase 4 aims to compare the impact of COVID-19 on the NHS and USA model of healthcare in terms of service provision and cost, and to propose a standardised model of delivering colorectal cancer services for future outbreaks.

Ethics and dissemination

This study is a service evaluation and does not require HRA Approval or Ethical Approval in the UK. Local service evaluation registration is required for each participating centre. In the USA, Ethical Approval was granted by the Research and Development Committee. The results of this study will be disseminated to stakeholders, submitted for peer review publications, conference presentations and circulated via social media.

Registration details

Nil.

covid -19对结直肠癌护理的提供产生了影响。CRC COVID研究的目的是描述英国和美国应对大流行的结直肠癌服务的变化,并了解其长期影响。方法与分析本研究分为四个阶段。第一阶段是对结直肠单位的调查,旨在评估在COVID-19大流行期间遵守和偏离最佳实践指南的情况。第二阶段是每月收集服务提供的前瞻性数据,旨在确定与国家标准相比,服务修改对长期癌症特定结果的影响。第三阶段的目的是预测由于CRC服务的改变而产生的费用,以及治疗受大流行影响的患者所需的额外资源。第4阶段旨在比较COVID-19对NHS和美国医疗保健模式在服务提供和成本方面的影响,并提出一种为未来疫情提供结直肠癌服务的标准化模式。伦理和传播本研究是一项服务评估,在英国不需要HRA批准或伦理批准。每个参与中心都需要进行本地服务评估注册。在美国,研究与发展委员会批准了伦理批准。这项研究的结果将分发给利益相关者,提交同行评审出版物、会议报告,并通过社交媒体传播。登记detailsNil。
{"title":"CRC COVID: Colorectal cancer services during COVID-19 pandemic. Study protocol for service evaluation","authors":"Alona Courtney ,&nbsp;Ann-Marie Howell ,&nbsp;Najib Daulatzai ,&nbsp;Nicos Savva ,&nbsp;Oliver Warren ,&nbsp;Sarah Mills ,&nbsp;Shahnawaz Rasheed ,&nbsp;Goel Milind ,&nbsp;Nicholas Tekkis ,&nbsp;Matthew Gardiner ,&nbsp;Tinglong Dai ,&nbsp;Bashar Safar ,&nbsp;Jonathan E Efron ,&nbsp;Ara Darzi ,&nbsp;Paris Tekkis ,&nbsp;Christos Kontovounisios","doi":"10.1016/j.isjp.2020.07.005","DOIUrl":"10.1016/j.isjp.2020.07.005","url":null,"abstract":"<div><h3>Introduction</h3><p>COVID-19 has had an impact on the provision of colorectal cancer care. The aim of the CRC COVID study is to describe the changes in colorectal cancer services in the UK and USA in response to the pandemic and to understand the long-term impact.</p></div><div><h3>Methods and analysis</h3><p>This study comprises 4 phases. Phase 1 is a survey of colorectal units that aims to evaluate adherences and deviations from the best practice guidelines during the COVID-19 pandemic. Phase 2 is a monthly prospective data collection of service provision that aims to determine the impact of the service modifications on the long-term cancer specific outcomes compared to the national standards. Phase 3 aims to predict costs attributable to the modifications of the CRC services and additional resources required to treat patients whose treatment has been affected by the pandemic. Phase 4 aims to compare the impact of COVID-19 on the NHS and USA model of healthcare in terms of service provision and cost, and to propose a standardised model of delivering colorectal cancer services for future outbreaks.</p></div><div><h3>Ethics and dissemination</h3><p>This study is a service evaluation and does not require HRA Approval or Ethical Approval in the UK. Local service evaluation registration is required for each participating centre. In the USA, Ethical Approval was granted by the Research and Development Committee. The results of this study will be disseminated to stakeholders, submitted for peer review publications, conference presentations and circulated via social media.</p></div><div><h3>Registration details</h3><p>Nil.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"23 ","pages":"Pages 15-19"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38295734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol B-MaP-C研究:COVID-19大流行期间乳腺癌管理途径研究协议
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.003
Alona Courtney , Rachel O'Connell , Tim Rattay , Baek Kim , Ramsey I. Cutress , Cliona C. Kirwan , Ashu Gandhi , Patricia Fairbrother , Nisha Sharma , Christopher W.J. Cartlidge , Kieran Horgan , Stuart A. McIntosh , Daniel R. Leff , Raghavan Vidya , Shelley Potter , Chris Holcombe , Ellen Copson , Charlotte E. Coles , Rajiv V. Dave

Introduction

Approximately 55,000 women in the United Kingdom are diagnosed with new breast cancer annually. Since emerging in December 2019, SARS-CoV-2 (coronavirus disease 2019, COVID-19) has become a global pandemic, affecting healthcare delivery worldwide. In response to the pandemic, multiple guidelines were issued to assist with rationalising breast cancer care. The primary aim of the B-MaP-C study is to audit and describe breast cancer management of patients newly diagnosed with breast cancer during the COVID-19 pandemic against pre-COVID-19 management practice in the UK. The implications of changes to management will be determined and the impact of a COVID-19 diagnosis on the patient’s breast cancer management will be determined.

Methods and analysis

This is a multi-centre collaborative audit of consecutive breast cancer patients undergoing treatment decisions during the acute and recovery phases of the COVID-19 pandemic. All patients with newly diagnosed primary breast cancer, whose treatment was decided in a multidisciplinary meeting from the 16th March 2020, are eligible for inclusion.

Ethics and dissemination

As this is an audit ethical approval is not required. Each participating centre is required to register the study locally and obtain local governance approvals prior to commencement of data collection. Local audit data will be available to individual participating units for governance purposes. The results of the data analysis will be submitted for publication, as well as disseminated via the ABS newsletter and a webinar. All data will be presented at national and international conferences, circumstances permitting.

Registration details

Each participating centre received local governance audit registration.

在英国,每年大约有55,000名女性被诊断为新发乳腺癌。自2019年12月出现以来,SARS-CoV-2(2019冠状病毒病,COVID-19)已成为全球大流行,影响了全球的医疗保健服务。为应对这一流行病,发布了多项准则,以协助使乳腺癌护理合理化。B-MaP-C研究的主要目的是审计和描述在2019冠状病毒病大流行期间新诊断为乳腺癌的患者的乳腺癌管理与英国COVID-19前的管理实践。将确定管理变化的影响,并确定COVID-19诊断对患者乳腺癌管理的影响。方法和分析这是一项对2019冠状病毒病大流行急性期和恢复期连续接受治疗决策的乳腺癌患者的多中心协作审计。所有在2020年3月16日起的多学科会议上决定治疗的新诊断原发性乳腺癌患者都有资格纳入研究。道德和传播由于这是审计,不需要道德批准。每个参与中心都必须在当地注册研究,并在开始数据收集之前获得当地政府的批准。本地审计数据将提供给各个参与单位用于治理目的。数据分析的结果将提交出版,并通过ABS通讯和网络研讨会进行传播。如果情况允许,所有数据将在国家和国际会议上提交。各参与中心已接受本地管治审核注册。
{"title":"The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol","authors":"Alona Courtney ,&nbsp;Rachel O'Connell ,&nbsp;Tim Rattay ,&nbsp;Baek Kim ,&nbsp;Ramsey I. Cutress ,&nbsp;Cliona C. Kirwan ,&nbsp;Ashu Gandhi ,&nbsp;Patricia Fairbrother ,&nbsp;Nisha Sharma ,&nbsp;Christopher W.J. Cartlidge ,&nbsp;Kieran Horgan ,&nbsp;Stuart A. McIntosh ,&nbsp;Daniel R. Leff ,&nbsp;Raghavan Vidya ,&nbsp;Shelley Potter ,&nbsp;Chris Holcombe ,&nbsp;Ellen Copson ,&nbsp;Charlotte E. Coles ,&nbsp;Rajiv V. Dave","doi":"10.1016/j.isjp.2020.07.003","DOIUrl":"10.1016/j.isjp.2020.07.003","url":null,"abstract":"<div><h3>Introduction</h3><p>Approximately 55,000 women in the United Kingdom are diagnosed with new breast cancer annually. Since emerging in December 2019, SARS-CoV-2 (coronavirus disease 2019, COVID-19) has become a global pandemic, affecting healthcare delivery worldwide. In response to the pandemic, multiple guidelines were issued to assist with rationalising breast cancer care. The primary aim of the B-MaP-C study is to audit and describe breast cancer management of patients newly diagnosed with breast cancer during the COVID-19 pandemic against pre-COVID-19 management practice in the UK. The implications of changes to management will be determined and the impact of a COVID-19 diagnosis on the patient’s breast cancer management will be determined.</p></div><div><h3>Methods and analysis</h3><p>This is a multi-centre collaborative audit of consecutive breast cancer patients undergoing treatment decisions during the acute and recovery phases of the COVID-19 pandemic. All patients with newly diagnosed primary breast cancer, whose treatment was decided in a multidisciplinary meeting from the 16th<!--> <!-->March 2020, are eligible for inclusion.</p></div><div><h3>Ethics and dissemination</h3><p>As this is an audit ethical approval is not required. Each participating centre is required to register the study locally and obtain local governance approvals prior to commencement of data collection. Local audit data will be available to individual participating units for governance purposes. The results of the data analysis will be submitted for publication, as well as disseminated via the ABS newsletter and a webinar. All data will be presented at national and international conferences, circumstances permitting.</p></div><div><h3>Registration details</h3><p>Each participating centre received local governance audit registration.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"24 ","pages":"Pages 1-5"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38302944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
The effectiveness of low-level laser therapy combined with facial expression exercises in patients with moderate-to-severe Bell's palsy: A study protocol for a randomised controlled trial 低水平激光治疗结合面部表情练习对中重度贝尔氏麻痹患者的有效性:一项随机对照试验的研究方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.11.001
Praveen Kumar Kandakurti , Sukumar Shanmugam , Shaikh Altaf Basha , Sampath Kumar Amaravadi , Prathap Suganthirababu , Kumaraguruparan Gopal , Geovinson Stephen George

Background

Even though corticosteroid therapy and facial expression exercises were found to be effective, still 30% of participants with bell’s palsy achieve incomplete recovery from the facial paralysis. The study objective was to evaluate the effectiveness of low-level laser therapy (LLLT) combined with progressive facial expression exercises in participants with moderate to severe bell’s palsy.

Methodology

A total of 120 participants with idiopathic bell’s palsy to be equally allocated in three groups. LLLT, electrical stimulation and corticosteroid/antiviral therapy will be performed respectively in the group I, group II and Group III and facial expression exercises as a common intervention. First two groups to be treated with respective interventions weekly 3 days for 6 consecutive weeks and third group will receive prescribed doses of medications and facial expression exercise for 6 weeks. The functional recovery will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks using the Facial Disability Index and House-Brackmann Scale. The overall within and between group differences in the clinical outcomes to be reported based on the Friedman Repeated Measures ANOVA and Kruskal-Wallis test. Whereas Wilcoxon Signed Rank and Mann-Whitney-U tests will be performed to report the within and between groups timeline differences.

Discussion

Based on the dearth of evidence for the effective treatment of moderate to severe bell’s palsy, we framed a most appropriate LLLT dosage along with facial expression exercises. Our study’s intervention protocol designed with equal duration and number of interventions for all three groups. Even the comparator groups such as electrical muscle stimulation and Corticosteroids therapy will be receiving similar facial expression exercises. We believe that this intervention protocol would benefit by promoting the complete facial function recovery in patients with moderate to severe bell’s palsy.

Dissemination

We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.

尽管皮质类固醇治疗和面部表情练习被发现是有效的,但仍有30%的贝尔氏麻痹患者从面瘫中完全恢复。研究目的是评估低水平激光治疗(LLLT)结合渐进式面部表情练习对中度至重度贝尔氏麻痹患者的有效性。方法将120例特发性铃性麻痹患者平均分为三组。在I组、II组和III组分别进行LLLT、电刺激和皮质类固醇/抗病毒治疗,面部表情练习作为常见干预。前两组采用各自的干预措施,每周3天,连续6周;第三组采用规定剂量的药物治疗和面部表情练习,连续6周。使用面部残疾指数和House-Brackmann量表在基线、3周、6周和12周评估功能恢复情况。根据Friedman重复测量方差分析和Kruskal-Wallis检验报告临床结果的组内和组间总体差异。而Wilcoxon sign Rank和Mann-Whitney-U检验将用于报告组内和组间时间线差异。基于缺乏有效治疗中度至重度贝尔氏麻痹的证据,我们制定了最合适的LLLT剂量以及面部表情练习。本研究的干预方案为三组设计了相同的干预时间和数量。即使是比较组,如肌肉电刺激和皮质类固醇治疗,也将接受类似的面部表情练习。我们相信这种干预方案将有利于促进中度至重度贝尔氏麻痹患者面部功能的完全恢复。我们计划在同行评议的期刊上发表这篇综述。我们也可能在地方和/或国家会议上介绍这篇综述。
{"title":"The effectiveness of low-level laser therapy combined with facial expression exercises in patients with moderate-to-severe Bell's palsy: A study protocol for a randomised controlled trial","authors":"Praveen Kumar Kandakurti ,&nbsp;Sukumar Shanmugam ,&nbsp;Shaikh Altaf Basha ,&nbsp;Sampath Kumar Amaravadi ,&nbsp;Prathap Suganthirababu ,&nbsp;Kumaraguruparan Gopal ,&nbsp;Geovinson Stephen George","doi":"10.1016/j.isjp.2020.11.001","DOIUrl":"10.1016/j.isjp.2020.11.001","url":null,"abstract":"<div><h3>Background</h3><p>Even though corticosteroid therapy and facial expression exercises were found to be effective, still 30% of participants with bell’s palsy achieve incomplete recovery from the facial paralysis. The study objective was to evaluate the effectiveness of low-level laser therapy (LLLT) combined with progressive facial expression exercises in participants with moderate to severe bell’s palsy.</p></div><div><h3>Methodology</h3><p>A total of 120 participants with idiopathic bell’s palsy to be equally allocated in three groups. LLLT, electrical stimulation and corticosteroid/antiviral therapy will be performed respectively in the group I, group II and Group III and facial expression exercises as a common intervention. First two groups to be treated with respective interventions weekly 3 days for 6 consecutive weeks and third group will receive prescribed doses of medications and facial expression exercise for 6 weeks. The functional recovery will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks using the Facial Disability Index and House-Brackmann Scale. The overall within and between group differences in the clinical outcomes to be reported based on the Friedman Repeated Measures ANOVA and Kruskal-Wallis test. Whereas Wilcoxon Signed Rank and Mann-Whitney-<em>U</em> tests will be performed to report the within and between groups timeline differences.</p></div><div><h3>Discussion</h3><p>Based on the dearth of evidence for the effective treatment of moderate to severe bell’s palsy, we framed a most appropriate LLLT dosage along with facial expression exercises. Our study’s intervention protocol designed with equal duration and number of interventions for all three groups. Even the comparator groups such as electrical muscle stimulation and Corticosteroids therapy will be receiving similar facial expression exercises. We believe that this intervention protocol would benefit by promoting the complete facial function recovery in patients with moderate to severe bell’s palsy.</p></div><div><h3>Dissemination</h3><p>We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"24 ","pages":"Pages 39-44"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.11.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38707496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Feasibility study of stem-cell enriched autologous lipotransfer to treat oro-facial fibrosis in systemic sclerosis (Sys-Stem): Protocol for open-label randomised controlled trial 干细胞富集自体脂肪移植治疗系统性硬化症(system - stem)患者口面部纤维化的可行性研究:开放标签随机对照试验方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.002
Faith Hyun Kyung Jeon , Michelle Griffin , Christopher Paul Denton , Peter Edward Michael Butler

Introduction

Oro-facial fibrosis is a common and disabling manifestation of systemic sclerosis (SSc), causing a plethora of functional, aesthetic and social compromise, yet is without effective treatment. Autologous lipotransfer is an established minimally invasive surgical procedure that is postulated to exert anti-fibrotic effects by adipose-derived stem cells, and presents a novel method in the treatment of fibrotic conditions. This study aims to assess the safety and efficacy of autologous lipotransfer for facial involvement in SSc.

Methods and analysis

This is the first randomised controlled study with an open label design to assess autologous lipotransfer for oro-facial involvement in systemic sclerosis. The goals of this study are to assess the feasibility of using a range of quantitative and qualitative outcome measures to effectively measure disease severity and treatment outcome, and to assess patient acceptability for future multi-centre trials. A total of 50 participants will be randomised to a treatment or control group. The treatment group will receive autologous fat transfer to the peri-oral region by a single surgeon. Dermal fibroblasts and adipose-derived stem cells will be isolated from tissue samples. All outcome measures will be taken at baseline, then at 6 weeks, 3 months and 6 months from the time of intervention in the treatment arm, or from baseline in the control arm.

Ethics and dissemination

The study has ethical approval (REC reference 19/LO/0718). Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.

Trial registration

Registered on ISRCTN registry (ISRCTN17793055).

面部纤维化是系统性硬化症(SSc)的一种常见且致残的表现,导致过多的功能、美学和社会损害,但目前尚无有效的治疗方法。自体脂肪移植是一种已建立的微创外科手术,被认为可以通过脂肪来源的干细胞发挥抗纤维化作用,是治疗纤维化疾病的一种新方法。本研究旨在评估自体脂肪移植治疗SSc面部受损伤的安全性和有效性。方法和分析:这是首个采用开放标签设计的随机对照研究,旨在评估自体脂肪移植治疗累及全身硬化症患者的口腔-面部。本研究的目的是评估使用一系列定量和定性结果测量来有效测量疾病严重程度和治疗结果的可行性,并评估患者对未来多中心试验的可接受性。总共50名参与者将被随机分配到治疗组或对照组。治疗组由一名外科医生将自体脂肪移植到口腔周围。将从组织样本中分离出真皮成纤维细胞和脂肪来源的干细胞。所有结果测量将在基线时进行,然后在治疗组进行干预后6周、3个月和6个月,或在对照组进行基线时进行。该研究已获得伦理批准(REC参考19/LO/0718)。研究结果将通过在国家和国际风湿病学会议上的报告以及在同行评议期刊上的发表,提供给患者、患者用户群体、临床医生和公众。试验注册在ISRCTN注册表(ISRCTN17793055)上注册。
{"title":"Feasibility study of stem-cell enriched autologous lipotransfer to treat oro-facial fibrosis in systemic sclerosis (Sys-Stem): Protocol for open-label randomised controlled trial","authors":"Faith Hyun Kyung Jeon ,&nbsp;Michelle Griffin ,&nbsp;Christopher Paul Denton ,&nbsp;Peter Edward Michael Butler","doi":"10.1016/j.isjp.2020.07.002","DOIUrl":"10.1016/j.isjp.2020.07.002","url":null,"abstract":"<div><h3>Introduction</h3><p>Oro-facial fibrosis is a common and disabling manifestation of systemic sclerosis (SSc), causing a plethora of functional, aesthetic and social compromise, yet is without effective treatment. Autologous lipotransfer is an established minimally invasive surgical procedure that is postulated to exert anti-fibrotic effects by adipose-derived stem cells, and presents a novel method in the treatment of fibrotic conditions. This study aims to assess the safety and efficacy of autologous lipotransfer for facial involvement in SSc.</p></div><div><h3>Methods and analysis</h3><p>This is the first randomised controlled study with an open label design to assess autologous lipotransfer for oro-facial involvement in systemic sclerosis. The goals of this study are to assess the feasibility of using a range of quantitative and qualitative outcome measures to effectively measure disease severity and treatment outcome, and to assess patient acceptability for future multi-centre trials. A total of 50 participants will be randomised to a treatment or control group. The treatment group will receive autologous fat transfer to the peri-oral region by a single surgeon. Dermal fibroblasts and adipose-derived stem cells will be isolated from tissue samples. All outcome measures will be taken at baseline, then at 6 weeks, 3 months and 6 months from the time of intervention in the treatment arm, or from baseline in the control arm.</p></div><div><h3>Ethics and dissemination</h3><p>The study has ethical approval (REC reference 19/LO/0718). Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.</p></div><div><h3>Trial registration</h3><p>Registered on ISRCTN registry (ISRCTN17793055).</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"23 ","pages":"Pages 6-10"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38270012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women: A protocol study 设计普拉提对孕妇妊娠结局影响的干预方案:一项协议研究
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.004
Bahareh Mothaghi Dastenaei , Fereshteh Aein , Faranak Safdari , Zohreh Karimiankakolaki

Background

Pregnancy is a pleasure for most women, it is often considered as a stressful period with physiological, anatomical, biochemical, and psychological changes. Pilates exercise improved quality of life in women. Therefore, the present study targeted at designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women.

Methods

In this protocol, a clinical intervention will be designed in three phases. In the first phase of the study, a researcher-made checklist will be used to evaluate the pregnancy and neonatal outcomes based on the literature review. In the second phase, an intervention program of Pilates exercise will be conducted according to different studies and viewpoints of a panel of reproductive health and physical activity specialists. The exercises will include two sessions of 30 minutes per week for 12 weeks conducted under the supervision of a qualified trainer. The third phase of the intervention will include the pre-test and post-test using a standard questionnaire and a researcher-made checklist for the two intervention groups and one control group.

Discussions

The present study provides useful data regarding the design of a Pilates exercise intervention program for pregnant women with the aim of influencing pregnancy and neonatal outcomes, reducing depression, low back pain and improving maternal mental health. It can also reduce their medical and treatment costs. The strategies of this program could be important and cost effective, and therefore we hope that the success of such a program is a step forward in improving reproductive health status.

怀孕对大多数女性来说是一件快乐的事,它通常被认为是生理、解剖、生化和心理变化的紧张时期。普拉提运动提高了女性的生活质量。因此,本研究旨在设计一个干预方案,以了解普拉提对孕妇妊娠结局的影响。方法本方案将临床干预设计分为三个阶段。在研究的第一阶段,将根据文献综述,使用研究者制作的检查表来评估妊娠和新生儿结局。在第二阶段,将根据一组生殖健康和体育活动专家的不同研究和观点,实施普拉提运动的干预方案。练习将包括在合格教练的监督下进行的每周30分钟的两次练习,为期12周。干预的第三阶段将包括使用标准问卷和研究人员为两个干预组和一个对照组制作的检查表进行前测试和后测试。本研究为孕妇普拉提运动干预方案的设计提供了有用的数据,旨在影响妊娠和新生儿结局,减少抑郁、腰痛和改善产妇心理健康。它还可以减少他们的医疗和治疗费用。这一方案的战略可能是重要的和具有成本效益的,因此我们希望这一方案的成功是在改善生殖健康状况方面向前迈出的一步。
{"title":"Designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women: A protocol study","authors":"Bahareh Mothaghi Dastenaei ,&nbsp;Fereshteh Aein ,&nbsp;Faranak Safdari ,&nbsp;Zohreh Karimiankakolaki","doi":"10.1016/j.isjp.2020.10.004","DOIUrl":"10.1016/j.isjp.2020.10.004","url":null,"abstract":"<div><h3>Background</h3><p>Pregnancy is a pleasure for most women, it is often considered as a stressful period with physiological, anatomical, biochemical, and psychological changes. Pilates exercise improved quality of life in women<strong>.</strong> Therefore, the present study targeted at designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women.</p></div><div><h3>Methods</h3><p>In this protocol, a clinical intervention will be designed in three phases. In the first phase of the study, a researcher-made checklist will be used to evaluate the pregnancy and neonatal outcomes based on the literature review. In the second phase, an intervention program of Pilates exercise will be conducted according to different studies and viewpoints of a panel of reproductive health and physical activity specialists. The exercises will include two sessions of 30 minutes per week for 12 weeks conducted under the supervision of a qualified trainer. The third phase of the intervention will include the pre-test and post-test using a standard questionnaire and a researcher-made checklist for the two intervention groups and one control group.</p></div><div><h3>Discussions</h3><p>The present study provides useful data regarding the design of a Pilates exercise intervention program for pregnant women with the aim of influencing pregnancy and neonatal outcomes, reducing depression, low back pain and improving maternal mental health. It can also reduce their medical and treatment costs. The strategies of this program could be important and cost effective, and therefore we hope that the success of such a program is a step forward in improving reproductive health status.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"24 ","pages":"Pages 27-30"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.10.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38304441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Face, content, construct validity and training effect of touch surgery™ as a surgical decision-making trainer for novices in open appendicectomy touch surgery™作为开放性阑尾切除术新手手术决策培训课程的内容、内容、结构效度及培训效果
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.05.002
Chi Lap Nicholas Tsang , Jerry Cao , Kapil Sugand , Jacqui Chiu , Franz Casper Pretorius

Background

Laparoscopic surgery has become the gold standard for many operations with significant benefits in morbidity and hospital recovery time. One such procedure is appendicectomy, which is overwhelmingly performed using the laparoscopic approach in the modern era. This has also meant that the number of cases involving traditional open appendicectomy has declined despite surgeons being expected to be able to convert to the open technique if required. One method to rehearse for theatre is the use of software applications. This paper investigates the validity of Touch Surgery™ as an education tool for surgical decision-making for novices, as well as its training effect in open appendicectomy.

Method

70 participants will be recruited, consisting of 60 medical students (novices) and 10 surgical consultants (experts). For face, content, and construct validity, first attempt scores on the Touch Surgery™ Open Appendicectomy Test Module will be compared between novices and experts. For the training effect and knowledge decline elements of the study, novices will be further randomised into either the low intervention (control) group who will complete the simulation once, or to the high intervention group who will complete the simulation six times, with both novice groups asked to repeat the test one week later. All participants will also be requested to complete questionnaires regarding the stimulation.

腹腔镜手术已成为许多手术的金标准,在发病率和住院恢复时间方面具有显著的优势。其中一种手术是阑尾切除术,在现代,这种手术绝大多数采用腹腔镜方法。这也意味着传统的开放式阑尾切除术的病例数量已经下降,尽管外科医生被期望能够在需要时转换为开放式技术。为戏剧排练的一种方法是使用软件应用程序。本文探讨Touch Surgery™作为新手手术决策教育工具的有效性,以及其在阑尾开腹切除术中的培训效果。方法招募70名参与者,包括60名医学生(新手)和10名外科顾问(专家)。对于面部、内容和结构效度,将比较新手和专家在Touch Surgery™开放式阑尾切除术测试模块上的第一次尝试分数。为了研究的训练效果和知识下降因素,新手将进一步随机分为低干预(对照)组,他们将完成一次模拟,或高干预组,他们将完成六次模拟,两组新手都被要求在一周后重复测试。所有参与者还将被要求完成关于刺激的问卷调查。
{"title":"Face, content, construct validity and training effect of touch surgery™ as a surgical decision-making trainer for novices in open appendicectomy","authors":"Chi Lap Nicholas Tsang ,&nbsp;Jerry Cao ,&nbsp;Kapil Sugand ,&nbsp;Jacqui Chiu ,&nbsp;Franz Casper Pretorius","doi":"10.1016/j.isjp.2020.05.002","DOIUrl":"10.1016/j.isjp.2020.05.002","url":null,"abstract":"<div><h3>Background</h3><p>Laparoscopic surgery has become the gold standard for many operations with significant benefits in morbidity and hospital recovery time. One such procedure is appendicectomy, which is overwhelmingly performed using the laparoscopic approach in the modern era. This has also meant that the number of cases involving traditional open appendicectomy has declined despite surgeons being expected to be able to convert to the open technique if required. One method to rehearse for theatre is the use of software applications. This paper investigates the validity of Touch Surgery™ as an education tool for surgical decision-making for novices, as well as its training effect in open appendicectomy.</p></div><div><h3>Method</h3><p>70 participants will be recruited, consisting of 60 medical students (novices) and 10 surgical consultants (experts). For face, content, and construct validity, first attempt scores on the Touch Surgery™ Open Appendicectomy Test Module will be compared between novices and experts. For the training effect and knowledge decline elements of the study, novices will be further randomised into either the low intervention (control) group who will complete the simulation once, or to the high intervention group who will complete the simulation six times, with both novice groups asked to repeat the test one week later. All participants will also be requested to complete questionnaires regarding the stimulation.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"22 ","pages":"Pages 19-23"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.05.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38157388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
期刊
International Journal of Surgery Protocols
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1