Thrombosis and thromboembolism: Brighton collaboration case definition and guidelines for data collection,analysis, and presentation of immunization safety data

This is a Brighton Collaboration case definition of thrombosis and thromboembolism to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected expert reviewers prior to submission.     

Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

Gynecologic Malignancy-Associated Venous Thromboembolism and Predictive Tool at Thammasat University Hospital

Objectives: Aims were to investigate the prevalence and risk factors of venous thromboembolism (VTE) in gynecologic malignancy cases. Value of screening tool (Caprini) for prediction of VTE was also assessed. Study design: A retrospective study of gynecologic malignancy subjects who underwent major gynecological operation via exploratory laparotomy at Thammasat University Hospital, Pathum Thani, Thailand from January 2015 to December 2020. Participants were categorized into VTE and non-VTE groups. Caprini score, associated laboratory and clinical factors of both groups were evaluated. Results: A total of 392 subjects were recruited into the study. Prevalence of VTE was 7.4 (29/392) percent. VTE was diagnosed in subjects with endometrial, ovarian and cervical cancer at percentage of 7.8 (15/192), 7.9 (11/138) and 5.7 (3/53), respectively. Demographic characters of both groups were comparable. VTE group had significant more Caprini score, platelets count and platelet lymphocyte ratio (PLR) than non-VTE group. Modified Caprini score (2 multiply Caprini score plus 1 multiply PLR) was generated for better VTE prediction. Sensitivity and specificity of Caprini (≥5.5) and modified Caprini scores (≥22.8) were 72.4 vs 39.4, and 79.3 vs 52.1 percent, respectively. Conclusion: Prevalence of VTE among gynecologic malignancy cases was 7.4 percent. The modified Caprini score was an alternative VTE predictive tool. Cut-off point of modified Caprini score at equal or more than 22.8 was proposed.     

Riesgo de recurrencia tras retirada de la anticoagulación en pacientes con enfermedad tromboembólica venosa no provocada: validación externa del nomograma de Viena y del modelo predictivo DASH

IntroductionScales for predicting venous thromboembolism (VTE) recurrence are useful for deciding the duration of the anticoagulant treatment. Although there are several scales, the most appropriate for our setting has not been identified. For this reason, we aimed to validate the DASH prediction score and the Vienna nomogram at 12 months.MethodsThis was a retrospective study of unselected consecutive VTE patients seen between 2006 and 2014. We compared the ability of the DASH score and the Vienna nomogram to predict recurrences of VTE. The validation was performed by stratifying patients as low-risk or high-risk, according to each scale (discrimination) and comparing the observed recurrence with the expected rate (calibration).ResultsOf 353 patients evaluated, 195 were analyzed, with an average age of 53.5 ± 19 years. There were 21 recurrences in 1 year (10.8%, 95% CI: 6.8%-16%). According to the DASH score, 42% were classified as low risk, and the rate of VTE recurrence in this group was 4.9% (95% CI: 1.3%-12%) vs. the high-risk group that was 15% (95% CI: 9%-23%) (p <.05). According to the Vienna nomogram, 30% were classified as low risk, and the rate of VTE recurrence in the low risk group vs. the high risk group was 4.2% (95% CI:0.5%-14%) vs. 16.2% (95% CI: 9.9%-24.4%) (p <.05).ConclusionsOur study validates the DASH score and the Vienna nomogram in our population. The DASH prediction score may be the most advisable, both because of its simplicity and its ability to identify more low-risk patients than the Vienna nomogram (42% vs. 30%).     

Biomarker directed chronic wound therapy – A new treatment paradigm

AimTo develop a treatment paradigm for chronic leg ulcers that incorporates new biomarkers of wound healing with currently available therapies.MethodsRecently published data on GM-CSF and MMP-13 as biomarkers of venous leg ulcer (VLU) healing status with accuracies of 92% and 78% respectively, was reviewed along with the wound bed preparation (WBP) theoretical framework for treatment of chronic wounds. The broad categories of wound treatments that align with the WBP concepts were identified. These were then considered in a hierarchical order that initially improves the wound bed and subsequently incorporates more complex advanced wound therapies. Identification of the non-healing status of the wound is the driver to advance through the different treatments.ResultsA point of care test of wound healing status is the key to the systematic use of currently available therapies for chronic leg ulcers in a timely fashion. The different therapies address – debridement, moisture control, bacterial contamination, protease inhibition, formation of granulation tissue, application of growth factors, application of matrix constructs, and application of cellular components. Progression through this hierarchical order of therapies is directed by the leg ulcer remaining in a non-healing state with the previous therapies having been implemented.ConclusionCombining a validated point of care test of wound healing with a systematic approach to wound therapies, has the potential to create a new paradigm of chronic leg ulcer treatment - biomarker directed wound therapy.     

临床护理路径在心血管患者静脉留置针中的研究分析

目的:提高静脉留置针使用有效期,保证心血管患者得到及时用药,有效开放静脉抢救通道。方法:建立了心血管患者静脉留置针的临床护理路径(Clinical Nursing Pathway,CNP)。选择我院2018年1-12月期间接诊的静脉留置针心血管患者为研究对象,共100例,随机分组,即对照组(50例,常规护理)与实验组(50例,在常规护理基础上辅以临床护理路径),比较两组护理效果,包括留置时间、不良反应情况、患者满意度等。结果:护理后,两组患者留置时间无明显差异,但实验组不良反应发生率、静脉炎发生率低于对照组,差异有统计学意义(P<0.05);实验组满意度、一次性置管成功率高于对照组,而非计划性拔管率则低于对照组,差异有统计学意义(P<0.05)。结论:心血管患者静脉留置针护理中辅以临床护理路径,可减少不良反应,预防静脉炎,延长置管时间,提高护理满意度,值得优选。     

脑静脉畸形的MRI表现及其诊断价值

目的 探讨脑静脉畸形的MRI表现，评价各成像序列的诊断价值。资料与方法 搜集经临床手术证实的脑静脉畸形8例进行回顾性分析，所有患者均进行了常规MRI平扫及3D-MOTSA MRA检查。6例行Gd-DTPA增强T1WI，其中3例行3D-MOTSA增强MRA检查。结果 小脑4例，额叶、顶叶、枕叶共4例。5例MRI平扫引流静脉为长T1短T2流空信号，3例呈长T1低信号、长T2高信号。扩张的髓静脉为网状及条状长T1低信号、长T2高信号，增强扫描呈“海蛇头”样改变，即多条髓静脉呈辐射状汇入粗大的引流静脉。3D-MOTSA MRA检查显示部分引流静脉，髓静脉显示较少。3D-MOTSA增强MRA检查引流静脉全程显示，髓静脉显示数目多。结论 MRI能明确诊断脑静脉畸形的合并症，弥补脑血管造影的不足，3D-MOTSA增强MRA检查可取代脑血管造影。     

压力梯度长袜和间歇充气装置预防恶性肿瘤患者术后下肢深静脉血栓形成的效果

目的 观察单纯应用压力梯度长袜（CS）或与间歇充气装置（IPC）联合使用预防恶性肿瘤患者术后下肢深静脉血栓（DVT）形成的效果及可能的机制。方法 胸科、泌尿外科、肝胆外科恶性肿瘤根治手术患者240例，随机分为4组：对照组、单纯CS组、CS＋IPC全程组、CS＋IPC术后组，每组60例。术后3～8d内行双下肢深静脉超声检查，记录DVT例数及血栓发生部位（大腿或小腿）。随机选择对照组和CS＋IPC全程组各15例患者，分别于术前、切皮后2h及术后24h各采集外周静脉血2ml，测定D-二聚体（D-D）、纤溶酶原激活物抗原（tPA-Ag）、纤溶酶原激活物抑制物（PAI）、血管性血友病因子（vWF）、凝血酶原时间（PT）和活化部分凝血活酶时间（APTT）。结果 术后3-8d对照组、CS＋IPC全程组、CS＋IPC术后组和单纯CS组DVT发生率分别为49．3％、15．0％、23．3％和30．0％（P〈0．05）。所有发生DVT患者中，除CS组发现1例近端DVT外，其余均为远端DVT。发生DVT患者年龄、卧床时间、危险因素个数等与未发生血栓患者相比差异有统计学意义（P〈0．05）。凝血，纤溶指标：与对照组比较，切皮后2h，CS＋IPC全程组vWF升高，D-D、tPA-Ag降低（P〈0．05），术后24h对照组和cs＋IPC全程组间D—D、vWF、tPA-Ag及PAI差异无统计学意义。结论 CS＋IPC全程或术后使用均能降低高危患者术后DVT的发生，其中CS＋IPC全程使用预防效果最好，可能与IPC增加纤溶活性有关。