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Acceptability and feasibility study of patient-specific ‘tumouroids’ as personalised treatment screening tools: Protocol for prospective tissue and data collection of participants with confirmed or suspected renal cell carcinoma 患者特异性“类肿瘤”作为个性化治疗筛选工具的可接受性和可行性研究:确诊或疑似肾细胞癌参与者的前瞻性组织和数据收集方案
IF 0.9 Q3 SURGERY Pub Date : 2019-01-01 DOI: 10.1016/j.isjp.2019.03.019
Maxine G.B. Tran , Joana B. Neves , Katerina Stamati , Patricia Redondo , Alethea Cope , Chris Brew-Graves , Norman R. Williams , Jack Grierson , Umber Cheema , Marilena Loizidou , Mark Emberton

Introduction

‘Personalised medicine’ aims to tailor interventions to the individual, and has become one of the fastest growing areas of cancer research. One of these approaches is to harvest cancer cells from patients and grow them in the laboratory, which can then be subjected to treatments and the response assessed. We have developed a 3D tumour model with a complex protein matrix that mimics the tumour stroma, cell to cell and cell-matrix interactions seen in vivo, called a tumouroid. In this study, we test the acceptability and feasibility of using this model to establish patient-derived tumouroids.

Methods and analysis

This is a first in-human study using prospective tissue and data collection of adult participants with confirmed or suspected renal cell carcinoma. The goals of the study are to assess patient acceptability to the use of patient-derived tumour models for future treatment decisions, and to assess the feasibility of generating patient-specific renal cancer tumouroids that can be challenged with drugs. These goals will be realised through the collection of tumour samples (expected n = 10), participant-completed questionnaires (expected n = 10), and in-depth semi-structured interviews with patients (expected n = 5). Collected multiregional tumour samples will be dissociated to isolate primary cells which are then expanded in vitro and incorporated into tumouroids. Drug challenge will ensue and the response will be categorised into “responder”, “weak responder”, and “non-responder”. Statistical analysis will be descriptive.

Ethics and dissemination

The study has ethical approval (REC reference 17/LO/1744). Findings will be made available to patients, clinicians, funders, and the National Health Service (NHS) through presentations at national and international meetings, peer-reviewed publications, social media and patient support groups.

Trial registration

Registered on ClinicalTrials.gov (NCT03300102).

“个体化医疗”旨在针对个体量身定制干预措施,并已成为癌症研究中发展最快的领域之一。其中一种方法是从患者身上采集癌细胞并在实验室中培养,然后对其进行治疗并评估其反应。我们已经开发了一种三维肿瘤模型,具有复杂的蛋白质基质,模拟肿瘤基质,细胞间和细胞-基质在体内的相互作用,称为类肿瘤。在本研究中,我们测试了使用该模型建立患者源性类肿瘤的可接受性和可行性。方法和分析这是第一个使用前瞻性组织和数据收集确诊或疑似肾细胞癌成年参与者的人体研究。该研究的目的是评估患者对使用患者衍生肿瘤模型进行未来治疗决策的可接受性,并评估产生可被药物挑战的患者特异性肾癌类肿瘤的可行性。这些目标将通过收集肿瘤样本(预期n = 10)、参与者完成的问卷调查(预期n = 10)和对患者的深入半结构化访谈(预期n = 5)来实现。收集的多区域肿瘤样本将被分离以分离原代细胞,然后在体外扩增并合并到类肿瘤中。随后将出现药物挑战,反应将分为“反应”、“弱反应”和“无反应”。统计分析将是描述性的。该研究已获得伦理批准(REC参考文献17/LO/1744)。研究结果将通过在国内和国际会议、同行评审出版物、社交媒体和患者支持团体上的演讲,提供给患者、临床医生、资助者和国家卫生服务(NHS)。在ClinicalTrials.gov注册(NCT03300102)。
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引用次数: 3
A systematic review and meta-analysis of antibiotic prophylaxis in skin graft surgery: A protocol 植皮手术中抗生素预防的系统回顾和荟萃分析:一项方案
IF 0.9 Q3 SURGERY Pub Date : 2019-01-01 DOI: 10.1016/j.isjp.2019.02.001
Mimi R. Borrelli , Vikram Sinha , Madeleine L. Landin , Maria Chicco , Kezia Echlin , Riaz A. Agha , Alastair MacKenzie Ross

Introduction

There is little evidence-based guidance on the use of prophylactic antibiotics in skin surgery; whilst antibiotics may protect against surgical site infections (SSI), they have associated side effects, increase the risk of adverse events, and can propagate antibiotic resistance. We present a protocol for a systematic review to establish whether the benefit of prophylactic antibiotics overrides the risk, for patients undergoing autograft surgery.

Methods

The systematic review will be registered a priori on researchregistry.com and will be conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). A search strategy will be devised to investigate ‘skin graft surgery and use of antibiotics’. The following electronic databases will be searched, 1979–2018: PubMed, MEDLINE®, EMBASE, SCOPUS, CINAHL, PsychINFO, SciELO, The Cochrane Library, including the Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effect (DARE), the Cochrane Methodology Register, Health Technology Assessment Database, the NHS Economic Evaluation Databases and Cochrane Groups, ClinicalTrials.gov, Current Controlled Trials Database, the World Health Organisation (WHO) International Clinical Trials Registry Platform, UpToDate.com, NHS Evidence and the York Centre for Reviews and Dissemination. Grey literature will be searched. All comparative study designs reporting on the use of antibiotics in skin graft surgery will be considered for inclusion, namely randomized controlled trials (RCTs). Two trained independent teams will screen all titles and abstracts, followed by relevant full texts, for eligibility. Data will be extracted under standardized extraction fields into a preformatted database. Note will be made of the indication for skin graft surgery (traumatic, congenital, malignant, benign), the graft site (head & neck, trunk, upper extremities, lower extremities), type of skin graft (split thickness, full-thickness). The primary outcome will be occurrence of SSI at the donor and/or recipient sites. Secondary outcomes, if reported, will include: length of hospital stay, revision surgery required, cost of medical care, time to wound healing and cosmetic outcome.

Ethics and dissemination

The systematic review will be published in a peer-reviewed journal and presented at national and international meetings within fields of plastic, reconstructive, and aesthetic surgery. The work will be disseminated electronically and in print. Brief reports of the review and findings will be disseminated to interested parties through email and direct communication. The review aims to guide healthcare practice and policy.

关于皮肤手术中预防性抗生素使用的循证指导很少;虽然抗生素可以防止手术部位感染(SSI),但它们有相关的副作用,增加不良事件的风险,并可能传播抗生素耐药性。我们提出了一项系统评价方案,以确定预防性抗生素的益处是否超过风险,对接受自体移植手术的患者。方法系统评价将在researchregistry.com上注册,并按照系统评价和荟萃分析的首选报告项目(PRISMA)进行。将制定一项搜索策略来调查“皮肤移植手术和抗生素的使用”。1979-2018年将检索下列电子数据库:PubMed、MEDLINE®、EMBASE、SCOPUS、CINAHL、PsychINFO、SciELO、Cochrane图书馆,包括Cochrane对照试验中央注册库(Central)、效果评价摘要数据库(DARE)、Cochrane方法学注册库、卫生技术评估数据库、NHS经济评估数据库和Cochrane群组、ClinicalTrials.gov、当前对照试验数据库、世界卫生组织(WHO)国际临床试验注册平台、UpToDate.com、NHS证据和约克中心的审查和传播。灰色文献将被搜索。所有报告在植皮手术中使用抗生素的比较研究设计都将被纳入考虑,即随机对照试验(RCTs)。两个训练有素的独立团队将筛选所有标题和摘要,然后是相关全文,以确定是否合格。数据将在标准化的提取字段下提取到预格式化的数据库中。注意皮肤移植手术的适应证(外伤性、先天性、恶性、良性)、移植部位(头部;颈部,躯干,上肢,下肢),植皮类型(劈厚,全厚)。主要结果将是供体和/或受体部位发生SSI。次要结局,如果报告的话,将包括:住院时间、所需翻修手术、医疗费用、伤口愈合时间和美容结果。该系统综述将发表在同行评议的期刊上,并在整形、重建和美容外科领域的国内和国际会议上发表。这项工作将以电子方式和印刷品传播。本署会以电邮或直接沟通的方式,向有关人士分发有关检讨结果的简短报告。该审查旨在指导医疗保健实践和政策。
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引用次数: 4
The NeST (neoadjuvant systemic therapy in breast cancer) study – Protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer NeST(乳腺癌新辅助全身治疗)研究-一项前瞻性多中心队列研究方案,旨在评估乳腺癌新辅助全身治疗的当前使用情况和短期结果
IF 0.9 Q3 SURGERY Pub Date : 2019-01-01 DOI: 10.1016/j.isjp.2019.10.002
G.W. Irwin , F. Bannon , C.E. Coles , E. Copson , R.I. Cutress , R.V. Dave , M. Grayson , C. Holcombe , S. Irshad , C. O'Brien , R.L. O'Connell , C. Palmieri , A.M. Shaaban , N. Sharma , J. Singh , I. Whitehead , S. Potter , S.A. McIntosh

Introduction

Neoadjuvant systemic therapy (NST) has several potential advantages in the treatment of breast cancer. However, there is currently considerable variation in NST use across the UK. The NeST study is a national, prospective, multicentre cohort study that will investigate current patterns of care with respect to NST in the UK.

Methods and analysis

Phase 1 – a national practice questionnaire (NPQ) to survey current practice.

Phase 2 – a multi-centre prospective cohort study of breast cancer patients, undergoing NST.

Women undergoing NST as their MDT recommended primary breast cancer treatment between December 2017 and May 2018 will be included. The breast surgery and oncological professional associations and the trainee research collaborative networks will encourage participation by all breast cancer centres.

Patient demographics, radiological, oncological, surgical and pathological data will be collected, including complications and the need for further intervention/treatment. Data will be collated to establish current practice in the UK, regarding NST usage and variability of access and provision of these therapies. Prospective data on 600 patients from ~50 centres are anticipated.

Trial registration: ISRCTN11160072.

Ethics and dissemination

Research ethics approval is not required for this study, as per the online Health Research Authority decision tool. The information obtained will provide valuable insights to help patients make informed decisions about their treatment. These data should establish current practice in the UK concerning NST, inform future service delivery as well as identifying further research questions.

This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network and the Association of Breast Surgery. Participating units will have access to their own data and collective results will be presented at relevant conferences and published in appropriate peer-reviewed journals, as well as being made accessible to relevant patient groups.

新辅助全身治疗(NST)在乳腺癌治疗中有几个潜在的优势。然而,目前在整个英国,NST的使用存在相当大的差异。NeST研究是一项全国性的、前瞻性的、多中心队列研究,将调查英国NST目前的护理模式。方法与分析第一阶段-全国实践问卷调查(NPQ),以调查目前的做法。2期-一项针对乳腺癌患者的多中心前瞻性队列研究,接受NST。2017年12月至2018年5月期间接受NST作为MDT推荐的原发性乳腺癌治疗的女性将被纳入其中。乳房外科和肿瘤专业协会以及实习研究合作网络将鼓励所有乳腺癌中心的参与。将收集患者人口统计、放射学、肿瘤学、外科和病理数据,包括并发症和进一步干预/治疗的需要。数据将被整理,以建立在英国的现行做法,关于NST的使用和可变性的获取和提供这些疗法。预计将有来自约50个中心的600名患者的前瞻性数据。试验注册:ISRCTN11160072。伦理和传播根据在线卫生研究权威决策工具,本研究不需要研究伦理批准。获得的信息将提供有价值的见解,帮助患者做出明智的治疗决定。这些数据应该在英国建立有关NST的现行实践,为未来的服务提供提供信息,并确定进一步的研究问题。本协议将通过乳腺学术研究合作组织(MFAC)、再造外科试验网络和乳腺外科协会传播。参与单位将有机会获得自己的数据,集体结果将在相关会议上展示并发表在适当的同行评议期刊上,并向相关患者群体提供。
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引用次数: 7
A nationwide study of clinical variation in the management and outcomes of symptomatic common bile duct stones 一项全国范围内对症状性胆总管结石的处理和结果的临床变化的研究
IF 0.9 Q3 SURGERY Pub Date : 2019-01-01 DOI: 10.1016/j.isjp.2019.03.010
Northern Ireland Surgical Research Collaborative, Aideen Campbell
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引用次数: 0
A protocol for the development of reporting guidelines for IDEAL stage studies 为理想阶段研究制定报告准则的规程
IF 0.9 Q3 SURGERY Pub Date : 2018-01-01 DOI: 10.1016/j.isjp.2018.04.001
Riaz A. Agha , Allison Hirst , Asha Khachane , Peter McCulloch

Background

New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice. We will develop a set of reporting guidelines for each IDEAL stage where deemed necessary through Delphi consensus methodology.

Methods

For each IDEAL stage requiring a new set of reporting guidelines, we will use the following process. We will search for the relevant reporting guidelines already in existence and use principles developed by the IDEAL Collaboration to compile the initial long list of potential checklist items. In each round, the participants will rate the importance of reporting each element on a nine-point Likert scale as proposed by the GRADE group. Sequential rounds and questionnaire administration and completion will take place until a final set of items is produced. There will then be a final consensus meeting of a working group to condense and refine the final recommendations for the reporting guidelines.

新的外科手术、器械和其他复杂干预措施需要对安全性、有效性和有效性进行强有力的评估。理想框架和建议提出了实现这一目标的途径,并就如何报告每个阶段的研究提供了一般指导。然而,研究人员在将理论转化为实践方面需要一些帮助。我们将通过德尔菲共识方法为每个理想阶段制定一套报告指南。对于每个需要一套新的报告指南的IDEAL阶段,我们将使用以下流程。我们将查找现有的相关报告指南,并使用IDEAL协作组织制定的原则来编制潜在检查表项目的初始长清单。在每一轮中,参与者将根据GRADE小组提出的9分李克特量表对报告每个元素的重要性进行评级。在产生最后一套项目之前,将依次进行轮询和问卷管理和填写。然后将举行一个工作组的最后协商一致会议,以精简和完善报告准则的最后建议。
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引用次数: 8
Rectal gastrointestinal stromal tumour: What do we know in 2017? A systematic review protocol 直肠胃肠道间质瘤:2017年我们知道些什么?系统评价方案
IF 0.9 Q3 SURGERY Pub Date : 2018-01-01 DOI: 10.1016/j.isjp.2017.12.001
Surennaidoo Naiken , Ailsa Craig , Noémie Guedj , Nelson Peixoto , Guillaume Zufferey

Introduction

Gastrointestinal stromal tumour is a pathology that originates from the interstitial cells of Cajal and differentiates from other mesenchymal neoplasm by expression of CD117 oncogene on Immunohistochemistry test. Colon and Rectal GISTs constitutes of approximately 5% of all gastrointestinal GISTs. The past decade has witnessed a dramatic change in the treatment of rectal cancer. Preoperative, perioperative and postoperative, management has changed thanks to new chemotherapy regimens and emergence of novel surgical techniques. Our aim is to investigate if same change can be implemented for rectal GISTs management.

Methods and analysis

This protocol is compliant with the Preferred Reporting Items for Systematic Review and Meta-Analysis protocols (PRISMA-P) guidelines. Exclusion and inclusion criteria are outlined within this protocol. Points of interest and objectives are described within this protocol. The search strategy, aims to identify all articles on “Rectal GISTs”.

Discussion

The choice of resection type surgery depends upon the location and size of rectal GIST. Neoadjuvant Imatinib therapy yields tumour shrinkage in at least 50% and is associated with a prolonged disease-free survival for intermediate and high-risk patients. This review will also allow a summary clinicopathological features and prognostic factors of rectal GISTs.

Ethics and dissemination

The Centre for Reviews and Dissemination, University of York acknowledged that this systematic review is within the register scope. This review will be published in a peer-reviewed journal and will be presented at various national and international conferences.

星形肠间质瘤是一种起源于Cajal间质细胞的病理,通过免疫组化检测CD117癌基因的表达与其他间质肿瘤区分开来。结肠和直肠胃肠道间质瘤约占胃肠道间质瘤的5%。在过去的十年里,直肠癌的治疗发生了巨大的变化。由于新的化疗方案和新手术技术的出现,术前、围手术期和术后的治疗已经发生了变化。我们的目的是研究同样的改变是否可以用于直肠胃肠道间质瘤的治疗。方法和分析本方案符合系统评价和荟萃分析方案的首选报告项目(PRISMA-P)指南。排除和纳入标准在本方案中列出。本协议中描述了兴趣点和目标。搜索策略,旨在识别所有关于“直肠gist”的文章。讨论切除手术的选择取决于直肠间质瘤的位置和大小。新辅助伊马替尼治疗可使肿瘤缩小至少50%,并可延长中高危患者的无病生存期。本综述还将总结直肠胃肠道间质瘤的临床病理特征和预后因素。伦理与传播约克大学评论与传播中心承认,该系统评论属于注册范围。这篇综述将发表在同行评议的期刊上,并将在各种国内和国际会议上发表。
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引用次数: 1
Simultaneous resection of colorectal cancer with synchronous liver metastases (RESECT), a pilot study 同时切除伴有同步肝转移的结直肠癌(RESECT),一项试点研究
IF 0.9 Q3 SURGERY Pub Date : 2018-01-01 DOI: 10.1016/j.isjp.2018.01.001
Pablo E. Serrano , Amiram Gafni , Sameer Parpia , Leyo Ruo , Marko Simunovic , Brandon M. Meyers , Harold Reiter , Alice Wei , Steven Gallinger , Paul Karanicolas , Julie Hallet , Nicolás Devaud , Mark Levine

Introduction

The “traditional approach” to resect synchronous colorectal cancer with liver metastases (CRLM) is to perform staged resections. Many institutions perform simultaneous resection. Disadvantages to the simultaneous approach include longer operating room times, which may increase major postoperative complication rates. Data supporting simultaneous resection are limited to retrospective studies that are subject to selection bias. Therefore, we have proposed a single-arm prospective cohort pilot study to evaluate the postoperative complications following simultaneous resection of synchronous CRLM.

Methods and analysis

This single-arm study will be performed in five high-volume hepatobiliary centres to prospectively evaluate the following objectives: (1) To determine the 90-day postoperative complication rate of patients diagnosed with synchronous CRLM undergoing a simultaneous colorectal and liver resection, including major liver resections; (2) To determine the postoperative mortality rate at 90 days following index surgery; (3) To determine change in global health-related Quality of Life (QoL) following simultaneous resection at three months compared to baseline; and (4) To build a costing model for simultaneous resection, We will also evaluate the feasibility of performing combined resection in these patients by evaluating the number of eligible patients enrolled in the study and determining the reasons eligible patients were not enrolled. This protocol has been registered with ClinicalTrials.gov (NCT02954913).

Ethics and dissemination

This study has been provincially approved by the central research ethics board. Study results will inform the design a randomized controlled trial by providing information about the comprehensive complication index in this patient population used to calculate the sample size for the trial.

同步性结直肠癌合并肝转移(CRLM)的“传统方法”是分期切除。许多机构同时进行切除。同时入路的缺点包括较长的手术室时间,这可能增加术后主要并发症的发生率。支持同时切除的数据仅限于受选择偏倚影响的回顾性研究。因此,我们提出了一项单臂前瞻性队列先导研究,以评估同步CRLM同时切除后的术后并发症。该单臂研究将在5个大容量肝胆中心进行,以前瞻性评估以下目标:(1)确定诊断为同步CRLM的患者同时接受结肠和肝脏切除术(包括大肝脏切除术)的90天术后并发症发生率;(2)确定指数手术后90 天的术后死亡率;(3)确定与基线相比,同时切除3个月后全球健康相关生活质量(QoL)的变化;(4)为了建立同时切除的成本模型,我们还将通过评估纳入研究的符合条件的患者的数量和确定不纳入符合条件的患者的原因来评估对这些患者进行联合切除的可行性。该方案已在ClinicalTrials.gov注册(NCT02954913)。伦理与传播本研究已获得省级中央研究伦理委员会批准。研究结果将通过提供用于计算试验样本量的患者群体的综合并发症指数信息,为随机对照试验的设计提供信息。
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引用次数: 7
Prospective mixed-methods study of patients undergoing relaparotomy (ReLap study; DRKS00013001) 剖腹手术患者的前瞻性混合方法研究(ReLap研究;DRKS00013001)
IF 0.9 Q3 SURGERY Pub Date : 2018-01-01 DOI: 10.1016/j.isjp.2018.04.004
Dinh Thien-An Tran , Colette Doerr-Harim , Felix J. Hüttner , Julian C. Harnoss , Phillip Knebel , Martin Schneider , Markus W. Büchler , Markus K. Diener , Pascal Probst

Background

Patients undergoing relaparotomies are underrepresented in clinical trials. Standard of care, relative outcomes compared to primary laparotomy, and the ideal fascial closure technique are unknown.

Objective

The ReLap study has three objectives: First, to determine standard of care and gain evidence of intra-/postoperative outcomes for patients undergoing relaparotomy compared to patients undergoing primary laparotomy. Second, to gain evidence of an association between biomarkers and adhesion grade in a clinical-translational approach in patients undergoing relaparotomy or primary laparotomy. Third, to gain evidence of the feasibility and comparative effectiveness of fascial closure after relaparotomy using the small stitches technique with Monomax 2–0 versus the large stitches technique with PDS 1 loop.

Methods

The ReLap study is a monocentric, prospective, mixed-methods, exploratory study with three steps: health care research, translational research, and randomized controlled trial. All patients scheduled for elective laparotomies or relaparotomies at the University of Heidelberg will be screened for eligibility. There will be five study visits during the hospital stay and one study visit one year after surgery. The clinical course will be followed and outcomes necessary to answer the study objectives will be captured prospectively. Relaparotomy patients eligible for closure with the small and large stitches technique will be randomized intraoperatively to one technique.

Discussion

The ReLap study will bridge a significant knowledge gap regarding patients undergoing relaparotomy. Differences in the standard of care between relaparotomies and primary laparotomies will be determined. The relation between biomarkers and manifestation of adhesions will be explored and evidence for the comparative effectiveness of fascial closure after relaparotomy will be gained.

背景:在临床试验中,接受再剖腹手术的患者数量不足。标准治疗、与初次剖腹手术相比的相对结果和理想的筋膜闭合技术尚不清楚。ReLap研究有三个目的:首先,确定护理标准,并获得剖腹手术患者与初次剖腹手术患者的手术内/术后结果的证据。其次,在接受再开腹手术或初次剖腹手术的患者中,获得临床转化方法中生物标志物与粘连等级之间关联的证据。第三,为了获得证据,证明再开腹手术后使用Monomax 2-0小针技术与使用PDS 1环的大针技术进行筋膜闭合的可行性和比较有效性。方法ReLap研究是一项单中心、前瞻性、混合方法的探索性研究,分为卫生保健研究、转化研究和随机对照试验三步。所有计划在海德堡大学进行择期剖腹手术或再开腹手术的患者将进行资格筛选。住院期间将有五次研究访问,手术后一年将有一次研究访问。将遵循临床过程,并将前瞻性地获取满足研究目标所需的结果。适合小针和大针缝合的再开腹手术患者将在术中随机选择一种缝合技术。ReLap研究将弥合关于接受剖腹手术患者的重要知识差距。再开腹手术和剖腹手术在护理标准上的差异将被确定。将探讨生物标志物与粘连表现之间的关系,并为再开腹手术后筋膜闭合的相对有效性提供证据。
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引用次数: 6
Assessing the compliance of systematic review articles published in leading dermatology journals with the PRISMA statement guidelines: A systematic review protocol 评估发表在主要皮肤病学期刊上的系统评价文章是否符合PRISMA声明指南:一项系统评价方案
IF 0.9 Q3 SURGERY Pub Date : 2018-01-01 DOI: 10.1016/j.isjp.2018.11.001
Buket Gundogan , Alexander Fowler , Riaz Agha

Introduction

Systematic reviews and meta-analyses are methodologically rigorous studies that are said to form the reference standard for summarising evidence to guide health care. Reporting quality of reviews is of critical importance in order to judge the quality and risk of bias in a review to ensure sound healthcare decisions are made. This is particularly important in the field of dermatology due to the growing number of systematic reviews and their key role in informing healthcare decision within dermatology. A contemporary and comprehensive review of the compliance of dermatology systematic reviews and meta-analyses with the PRISMA checklist, in the highest impact factor dermatology journals, has not yet been assessed. To our knowledge, our review represents the most extensive study assessing reporting quality of systematic reviews and meta-analyses published within dermatology to date.

Methods and analysis

Our protocol is reported in line with the Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 guidelines. MEDLINE will be searched to look for systematic reviews and meta-analysis in selected years within the top four highest impact factor dermatology journals in 2017. Records and full texts will be screened independently by five researchers. Data will be extracted onto a standard data extraction database. A training session will take place to ensure accurate data extraction and scoring of studies with the PRISMA checklist. The data will be analysed and outcomes will be determined. Primary outcome will be the compliance of reviews with the PRISMA checklist.

系统评价和荟萃分析是方法学上严格的研究,据说形成了总结证据以指导卫生保健的参考标准。为了判断审查的质量和偏倚风险,以确保做出合理的医疗保健决策,审查的报告质量至关重要。这在皮肤病学领域尤其重要,因为越来越多的系统评价及其在皮肤病学医疗保健决策中的关键作用。在影响因子最高的皮肤学期刊上,对皮肤病学系统评价和meta分析与PRISMA检查表的合规性进行的当代综合评价尚未得到评估。据我们所知,我们的综述代表了迄今为止在皮肤病学领域发表的最广泛的评估系统综述和荟萃分析报告质量的研究。方法和分析本方案的报告符合系统评价和荟萃分析方案(PRISMA-P) 2015指南的首选报告项目。MEDLINE将检索2017年影响因子最高的4种皮肤病学期刊中选定年份的系统综述和荟萃分析。记录和全文将由五位研究人员独立筛选。数据将被提取到标准的数据提取数据库中。将举行一次培训会议,以确保使用PRISMA核对表准确提取数据并对研究进行评分。将对数据进行分析,并确定结果。主要结果将是审查是否符合PRISMA核对表。
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引用次数: 3
Analysis of instability patterns in acute scaphoid fractures by 4-dimensional computed tomographic imaging – A prospective cohort pilot study protocol 用四维计算机断层成像分析急性舟状骨骨折的不稳定模式——一项前瞻性队列先导研究方案
IF 0.9 Q3 SURGERY Pub Date : 2018-01-01 DOI: 10.1016/j.isjp.2018.04.003
M.G.A. de Roo , J.G.G. Dobbe , M.L. Ridderikhof , J.C. Goslings , C.M.A.M. van der Horst , L.F.M. Beenen , G.J. Streekstra , S.D. Strackee

Introduction

A scaphoid fracture is the most common carpal fracture. When healing of the fracture fails (nonunion), a specific pattern of osteoarthrosis occurs, resulting in pain, restricted wrist motion and disability. Scaphoid fracture classification systems recognize fragment displacement as an important cause of nonunion. The fracture is considered unstable if the fragments are displaced. However, whether and how displaced bone fragments move with respect to one another has not yet been investigated in vivo. With a four-dimensional (4D) computed tomographic (CT) imaging technique we aim to analyze the interfragmentary motion patterns of displaced and non-displaced scaphoid fragments. Furthermore, the correlation between fragment motion and the development of a scaphoid nonunion is investigated. We hypothesize that fragment displacement is not correlated to fragment instability; and concurrent nonunion is related to fragment instability and not to interfragmentary displacement.

Methods

In a prospective single-center cohort pilot study, patients with a one-sided acute scaphoid fracture and no history of trauma to the contralateral wrist are illegible for inclusion. Twelve patients with a non-displaced scaphoid fracture and 12 patients with a displaced scaphoid fracture are evaluated. Both wrists are scanned with 4D-CT imaging during active flexion–extension and radio-ulnar deviation motion. The contralateral wrist serves as kinematic reference. Relative displacement of the distal scaphoid fragment with respect to the proximal scaphoid fragment, is described by translations and rotations (the kinematic parameters), as a function of the position of the capitate. Non-displaced scaphoid fractures are treated conservatively, displaced scaphoid fractures receive intraoperative screw fixation. Follow-up with CT scans is conducted until consolidation at 1½, 3 and 6 months. This trial is registered in the Dutch Toetsingonline trial registration system, number: NL60680.018.17.

Ethics

This study is approved by the Medical Ethics Committee of the Academic Medical Center, Amsterdam.

舟状骨骨折是最常见的腕骨骨折。当骨折愈合失败(不愈合)时,会出现特定类型的骨关节病,导致疼痛、手腕活动受限和残疾。舟状骨骨折分类系统认为碎片移位是导致骨不连的重要原因。如果碎片移位,则认为骨折不稳定。然而,移位的骨碎片是否以及如何相互移动尚未在体内进行研究。利用四维计算机断层(CT)成像技术,我们旨在分析移位和非移位舟状骨碎片的碎片间运动模式。此外,碎片运动与舟状骨不愈合发展之间的关系也进行了研究。我们假设碎片位移与碎片不稳定性无关;并发骨不连与骨折块不稳定有关,而与骨折块间移位无关。方法在一项前瞻性单中心队列先导研究中,单侧急性舟状骨骨折且对侧腕部无外伤史的患者难以纳入研究。对12例非移位性舟骨骨折患者和12例移位性舟骨骨折患者进行了评估。在主动屈伸和桡尺偏移运动时,用4D-CT扫描双腕关节。对侧手腕作为运动参考。远端舟状骨碎片相对于近端舟状骨碎片的相对位移,通过平移和旋转(运动学参数)来描述,作为头状骨位置的函数。非移位的舟状骨骨折采用保守治疗,移位的舟状骨骨折采用术中螺钉固定。随访CT扫描,直到1½,3和6 个月的巩固。本试验在荷兰Toetsingonline试验注册系统注册,编号:NL60680.018.17。本研究经阿姆斯特丹学术医学中心医学伦理委员会批准。
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引用次数: 2
期刊
International Journal of Surgery Protocols
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