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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 Medicine 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。
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引用次数: 1
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 Medicine 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。
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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 Medicine 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。
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引用次数: 4
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 Medicine 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。
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引用次数: 4
Venous thromboembolic events after bariatric surgery: Protocol for a systematic review and meta-analysis 减肥手术后静脉血栓栓塞事件:系统回顾和荟萃分析的方案
IF 0.9 Q3 Medicine Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.06.001
Walid El Ansari , Brijesh Sathian , Ayman El-Menyar

Introduction

Considerably large numbers of bariatric surgery (BS) procedures are undertaken globally, and are projected to increase with the obesity epidemic. Venous thromboembolic events (VTE) comprise an important cause of postoperative morbidity and mortality after BS and an important issue with wide clinical and financial repercussions. Yet, a precise extent of the prevalence of VTE after BS for obesity and its mortality remains uncertain.

Methods and analysis

In order to respond to this knowledge gap, we will conduct a systematic review and meta-analysis of the prevalence of and mortality associated with VTE after BS. This protocol outlines the methodology that will be used and the search strategies and eligibility criteria that will be utilized to identify and select studies, as well as the method by which data from the selected studies will be extracted for analysis. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), WHO International Clinical Trials Registry Platform, Cochrane Library, MEDLINE, Scopus, clinicaltrials.gov and Google scholar will be searched from 01 January 1990 through 10th April 2020, for original studies written in English that provided prevalence estimates of VTE after BS. Articles will also be searched for mortality estimates of VTE after BS. STROCSS (Strengthening the Reporting of Cohort Studies in Surgery) criteria will evaluate the methodological quality of the selected studies. The use of fixed effect or random effects model will be subject to the findings of the statistical tests for heterogeneity. Publication bias will be visually estimated by inspecting the funnel plots. Pooled estimates will be computed. Th current protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines and has been submitted to the PROSPERO International Prospective Register of systematic reviews. No ethical clearance is required for this study. This systematic review and meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.

在全球范围内进行了大量的减肥手术(BS),并且预计随着肥胖的流行而增加。静脉血栓栓塞事件(VTE)是BS术后发病率和死亡率的重要原因,也是一个具有广泛临床和经济影响的重要问题。然而,肥胖BS后静脉血栓栓塞的确切流行程度及其死亡率仍不确定。方法和分析为了应对这一知识空白,我们将对BS后静脉血栓栓塞的患病率和死亡率进行系统回顾和荟萃分析。本方案概述了将用于识别和选择研究的方法学、检索策略和资格标准,以及从所选研究中提取数据进行分析的方法。从1990年1月1日至2020年4月10日,将检索PubMed、Cochrane中央对照试验注册中心(Central)、世卫组织国际临床试验注册平台、Cochrane图书馆、MEDLINE、Scopus、clinicaltrials.gov和Google scholar,以查找提供BS后VTE患病率估计的英文原始研究。文章也将搜索静脉血栓栓塞后BS的死亡率估计。STROCSS(加强外科队列研究报告)标准将评估所选研究的方法学质量。使用固定效应或随机效应模型将取决于异质性的统计检验结果。发表偏倚将通过检查漏斗图进行视觉估计。将计算汇总估计。目前的方案符合系统评价和荟萃分析(PRISMA)指南的首选报告项目,并已提交给普洛斯彼罗国际前瞻性系统评价登记册。本研究不需要伦理许可。这一系统综述和荟萃分析将发表在同行评议的期刊上,并在国家和国际会议上发表。
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引用次数: 2
Management and outcomes following emergency surgery for traumatic brain injury – A multi-centre, international, prospective cohort study (the Global Neurotrauma Outcomes Study) 外伤性脑损伤急诊手术后的处理和结果——一项多中心、国际、前瞻性队列研究(全球神经创伤结局研究)
IF 0.9 Q3 Medicine Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.02.001
David Clark , Alexis Joannides , Omar Ibrahim Abdallah , Amos Olufemi Adeleye , Abdul Hafid Bajamal , Tom Bashford , Arnold Bhebhe , Hagos Biluts , Natalia Budohoska , Karol Budohoski , Iype Cherian , Niklas Marklund , Rocio Fernandez Mendez , Tony Figaji , Deepak Kumar Gupta , Corrado Iaccarino , Ali Ilunga , Mathew Joseph , Tariq Khan , Tsegazeab Laeke , Peter Hutchinson

Introduction

Traumatic brain injury (TBI) accounts for a significant amount of death and disability worldwide and the majority of this burden affects individuals in low-and-middle income countries. Despite this, considerable geographical differences have been reported in the care of TBI patients. On this background, we aim to provide a comprehensive international picture of the epidemiological characteristics, management and outcomes of patients undergoing emergency surgery for traumatic brain injury (TBI) worldwide.

Methods and analysis

The Global Neurotrauma Outcomes Study (GNOS) is a multi-centre, international, prospective observational cohort study. Any unit performing emergency surgery for TBI worldwide will be eligible to participate. All TBI patients who receive emergency surgery in any given consecutive 30-day period beginning between 1st of November 2018 and 31st of December 2019 in a given participating unit will be included. Data will be collected via a secure online platform in anonymised form. The primary outcome measures for the study will be 14-day mortality (or survival to hospital discharge, whichever comes first). Final day of data collection for the primary outcome measure is February 13th. Secondary outcome measures include return to theatre and surgical site infection.

Ethics and dissemination

This project will not affect clinical practice and has been classified as clinical audit following research ethics review. Access to source data will be made available to collaborators through national or international anonymised datasets on request and after review of the scientific validity of the proposed analysis by the central study team.

外伤性脑损伤(TBI)在世界范围内造成大量死亡和残疾,这一负担主要影响低收入和中等收入国家的个人。尽管如此,据报道,在TBI患者的护理方面存在相当大的地理差异。在此背景下,我们的目标是提供一个全面的国际流行病学特征,管理和世界范围内接受创伤性脑损伤(TBI)急诊手术患者的结局。全球神经创伤结局研究(GNOS)是一项多中心、国际、前瞻性观察队列研究。全球任何进行TBI急诊手术的单位都有资格参加。所有在2018年11月1日至2019年12月31日期间在特定参与单位连续30天内接受紧急手术的TBI患者都将被纳入其中。数据将通过一个安全的在线平台以匿名形式收集。本研究的主要结局指标为14天死亡率(或存活至出院,以先到者为准)。主要结果测量数据收集的最后一天是2月13日。次要结局指标包括返回手术室和手术部位感染。伦理与传播本项目不影响临床实践,在研究伦理审查后已被归类为临床审核。应要求并在中央研究小组审查拟议分析的科学有效性之后,将通过国家或国际匿名数据集向合作者提供对源数据的访问。
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引用次数: 9
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 Medicine 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。
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引用次数: 2
Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE) 患者首次手术前使用l<s:1> beck工具箱课程进行目标导向微创手术模拟训练的效果:一项多中心随机对照验证试验的研究方案(新手)
IF 0.9 Q3 Medicine Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.02.004
Michael Thomaschewski , Tilman Laubert , Markus Zimmermann , Hamed Esnaashari , Reinhard Vonthein , Tobias Keck , Claudia Benecke

Background

Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents’ skills in performing their first MIS procedures on patients.

Method

The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the Lübeck Toolbox curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).

Discussion

The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.

背景:微创手术(MIS)需要特殊的精神运动技能。这些MIS基本技能的学习通常是在手术室(OR)进行的。这在经济上是低效的,在患者安全方面可以得到改善。在这个问题的背景下,各种MIS模拟器被开发出来,用于培训手术室外的MIS基本技能。本研究的目的是评估资讯系统训练计划和模拟程序在多大程度上提高住院医师对病人进行第一次资讯系统手术的技能。方法目前的多中心随机对照试验将在没有MIS积极经验的外科住院医师中进行(n = 14)。在参与者完成第一次腹腔镜胆囊切除术作为基线评估(CHE I)后,他们将被随机分为两组:1)干预组将执行贝克工具箱课程,而2)对照组将不接受任何MIS培训。6 周后,两组均进行第二次腹腔镜CHE (CHE II)。根据全球腹腔镜手术技能评估(GOALS)评分(主要终点)分析和评估手术表现(CHE I和CHE II之间)的变化或改善。多中心随机对照试验将有助于确定手术室外MIS培训的价值。实践转移的有效性证明对于将MIS培训计划整合到外科教育中具有相当大的相关性。
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引用次数: 1
Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis 使用基于移动电话的(mHealth)方法与传统口腔检查方法进行口腔癌筛查,具有成本-效果分析的聚类随机研究方案
IF 0.9 Q3 Medicine Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.001
Krishnakumar Thankappan , Praveen Birur , Manu Raj , Sandjar Djalalov , Sujha Subramanian , Subramania Iyer , Moni Abraham Kuriakose

Introduction

Oral cancer is a significant health problem in India. Diagnosis is often delayed. The effectiveness of conventional oral screening has been shown in the Trivandrum oral cancer screening study. The present study will be a step forward to test a mobile phone-based (the mHealth approach) comparing it with the conventional approach. The purpose of this paper is to report the protocol for this study. The primary objective will be to compare both methods in diagnosing oral potentially malignant disorders and cancers. The secondary objective would be to study the cost-effectiveness.

Methods and analysis

This will be a cluster-randomized clinical trial of the population in Ernakulam district of Kerala state in India. They will undergo oral cancer screening by community health workers, who will be pre-assigned to the randomly allotted intervention (mHealth) or control (conventional method) clusters. We will enrol a minimum of 9696 subjects from all 6 clusters over 18 months. The cost-effectiveness of the two strategies for oral screening will be determined using data from this randomized controlled trial. The incremental cost per oral cancer/high-risk dysplasia detected, and the incremental cost per life saved will be reported. We will conduct sensitivity and scenario analysis to evaluate the robustness of the findings.

Ethics and dissemination

When completed, this will be the first cluster randomized population-based study to test the technology-based approach in India. The knowledge from this study will indicate whether specialists can make a remote diagnosis of oral lesions accurately based on the information gathered using a mobile phone health application and whether the mHealth strategy will be cost-effective in Oral cancer screening. The study will follow the ethical guidelines and will be published in an indexed journal.

口腔癌在印度是一个严重的健康问题。诊断常常被延误。Trivandrum口腔癌筛查研究显示了传统口腔筛查的有效性。目前的研究将向前迈出一步,测试一种基于移动电话的(移动健康方法),并将其与传统方法进行比较。本文的目的是报告本研究的方案。主要目的是比较两种诊断口腔潜在恶性疾病和癌症的方法。第二个目标是研究成本效益。方法和分析这将是印度喀拉拉邦Ernakulam地区人群的一项集群随机临床试验。他们将接受社区卫生工作者的口腔癌筛查,这些卫生工作者将被预先分配到随机分配的干预(移动健康)或控制(传统方法)组。我们将在18个月内从所有6个组中招募至少9696名受试者。这两种口腔筛查策略的成本效益将根据这项随机对照试验的数据来确定。将报告每个检测到的口腔癌/高危不典型增生的增量成本,以及每个挽救生命的增量成本。我们将进行敏感性和情景分析,以评估研究结果的稳健性。伦理和传播完成后,这将是第一个在印度测试基于技术的方法的基于人群的随机研究。来自本研究的知识将表明专家是否可以根据使用手机健康应用程序收集的信息准确地对口腔病变进行远程诊断,以及移动健康策略在口腔癌筛查中是否具有成本效益。该研究将遵循伦理准则,并将发表在索引期刊上。
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引用次数: 4
Effectiveness of proprioceptive training versus conventional exercises on postural sway in patients with early knee osteoarthritis – A randomized controlled trial protocol 本体感觉训练与常规运动对早期膝关节骨关节炎患者体位摇摆的有效性-一项随机对照试验方案。
IF 0.9 Q3 Medicine Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.09.002
Ashish John Prabhakar , Abraham M. Joshua , Srikanth Prabhu , Yogeesh Dattakumar Kamat

Introduction

In recent times, ‘early osteoarthritis’ (EOA) has achieved recognition as a disease entity. The importance of defining EOA is in the fact that a variety of joint preservation treatments are available. Development of the sense of proprioception is a known vital element of most exercise rehabilitation programmes. Postural sways have been found to be prevalent in arthritic patients. It follows therefore that correction of early postural aberrations should help patients with EOA. The current study aims to determine the effectiveness of such proprioceptive training versus conventional exercises in patients with EOA.

Method

This study is a randomized controlled trial. A total of 100 participants between the age of 20–45 years will be recruited. Participants will be randomly assigned to conventional or interventional group. Participants in both the groups will receive 12 session of treatment over a period of four weeks. Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.

Results

Data collected will be analyzed by mean, SD and 2 factor ANOVA for repeated measure, followed by Bonferroni post hoc analysis. Data will be analyzed using SPSS package version 17.0, p < 0.05 will be considered as significant.

Conclusion

The authors hope to determine whether proprioceptive training improves outcome better than conventional exercise therapy and hope to contribute to an improved targeted treatment for patients with Early osteoarthritis.

近年来,“早期骨关节炎”(EOA)已被公认为一种疾病实体。确定EOA的重要性在于,有多种关节保存治疗方法可供选择。本体感觉的发展是大多数运动康复计划的重要组成部分。体位摇晃在关节炎患者中很普遍。因此,早期体位异常的纠正应该有助于EOA患者。目前的研究旨在确定这种本体感觉训练与传统运动在EOA患者中的有效性。方法:采用随机对照试验。总共将招募100名年龄在20-45岁之间的参与者。参与者将被随机分为常规组和干预组。两组的参与者将在四周的时间内接受12次治疗。考虑的结果测量是压力偏移中心、关节位置感、手持测功机、视觉模拟量表和膝关节损伤和骨关节炎功能结果评分。结果:收集的数据将采用均值、标准差和重复测量的2因素方差分析进行分析,然后进行Bonferroni事后分析。结论:作者希望确定本体感觉训练是否比常规运动疗法更好地改善预后,并希望为早期骨关节炎患者的靶向治疗做出贡献。
{"title":"Effectiveness of proprioceptive training versus conventional exercises on postural sway in patients with early knee osteoarthritis – A randomized controlled trial protocol","authors":"Ashish John Prabhakar ,&nbsp;Abraham M. Joshua ,&nbsp;Srikanth Prabhu ,&nbsp;Yogeesh Dattakumar Kamat","doi":"10.1016/j.isjp.2020.09.002","DOIUrl":"10.1016/j.isjp.2020.09.002","url":null,"abstract":"<div><h3>Introduction</h3><p>In recent times, ‘early osteoarthritis’ (EOA) has achieved recognition as a disease entity. The importance of defining EOA is in the fact that a variety of joint preservation treatments are available. Development of the sense of proprioception is a known vital element of most exercise rehabilitation programmes. Postural sways have been found to be prevalent in arthritic patients. It follows therefore that correction of early postural aberrations should help patients with EOA. The current study aims to determine the effectiveness of such proprioceptive training versus conventional exercises in patients with EOA.</p></div><div><h3>Method</h3><p>This study is a randomized controlled trial. A total of 100 participants between the age of 20–45 years will be recruited. Participants will be randomly assigned to conventional or interventional group. Participants in both the groups will receive 12 session of treatment over a period of four weeks. Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.</p></div><div><h3>Results</h3><p>Data collected will be analyzed by mean, SD and 2 factor ANOVA for repeated measure, followed by Bonferroni post hoc analysis. Data will be analyzed using SPSS package version 17.0, p &lt; 0.05 will be considered as significant.</p></div><div><h3>Conclusion</h3><p>The authors hope to determine whether proprioceptive training improves outcome better than conventional exercise therapy and hope to contribute to an improved targeted treatment for patients with Early osteoarthritis.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.09.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38517205","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: 8
期刊
International Journal of Surgery Protocols
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