Models for predicting venous thromboembolism in ambulatory patients with lung cancer: a systematic review protocol.
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ABSTRACT: Introduction
Venous thromboembolism (VTE) is a common complication in patients with cancer and has a determining role in the disease prognosis. The risk is significantly increased with certain types of cancer, such as lung cancer. Partly due to difficulties in managing haemorrhage in outpatient settings, anticoagulant prophylaxis is only recommended for ambulatory patients at high risk of VTE. This requires a precise VTE risk assessment in individual patients. Although VTE risk assessment models have been developed and updated in recent years, there are conflicting reports on the effectiveness of such risk prediction models in patient management. The aim of this systematic review is to gain a better understanding of the available VTE risk assessment tools for ambulatory patients with lung cancer and compare their predictive performance.Methods and analysis
A systematic review will be conducted using MEDLINE, Cochrane Library, CINAHL, Scopus and Web of Science databases from inception to 30 September 2021, to identify all reports published in English describing VTE risk prediction models which have included adult ambulatory patients with primary lung cancer for model development and/or validation. Two independent reviewers will conduct article screening, study selection, data extraction and quality assessment of the primary studies. Any disagreements will be referred to a third researcher to resolve. The included studies will be assessed for risk of bias and applicability. The Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies will be used for data extraction and appraisal. Data from similar studies will be used for meta-analysis to determine the incidence of VTE and the performance of the risk models.Ethics and dissemination
Ethics approval is not required. We will disseminate the results in a peer-reviewed journal.Prospero registration number
CRD42021245907.
SUBMITTER: Yan AR
PROVIDER: S-EPMC8638451 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionHospital-acquired thrombosis accounts for a large proportion of all venous thromboembolism (VTE), with significant morbidity and mortality. This subset of VTE can be reduced through accurate risk assessment and tailored pharmacological thromboprophylaxis. This systematic review aimed to determine the comparative accuracy of risk assessment models (RAMs) for predicting VTE in patients admitted to hospital.MethodsA systematic search was performed across five electronic databases (including MEDLINE, EMBASE and the Cochrane Library) from inception to February 2021. All primary validation studies were eligible if they examined the accuracy of a multivariable RAM (or scoring system) for predicting the risk of developing VTE in hospitalised inpatients. Two or more reviewers independently undertook study selection, data extraction and risk of bias assessments using the PROBAST (Prediction model Risk Of Bias ASsessment Tool) tool. We used narrative synthesis to summarise the findings.ResultsAmong 6355 records, we included 51 studies, comprising 24 unique validated RAMs. The majority of studies included hospital inpatients who required medical care (21 studies), were undergoing surgery (15 studies) or receiving care for trauma (4 studies). The most widely evaluated RAMs were the Caprini RAM (22 studies), Padua prediction score (16 studies), IMPROVE models (8 studies), the Geneva risk score (4 studies) and the Kucher score (4 studies). C-statistics varied markedly between studies and between models, with no one RAM performing obviously better than other models. Across all models, C-statistics were often weak (<0.7), sometimes good (0.7-0.8) and a few were excellent (>0.8). Similarly, estimates for sensitivity and specificity were highly variable. Sensitivity estimates ranged from 12.0% to 100% and specificity estimates ranged from 7.2% to 100%.ConclusionAvailable data suggest that RAMs have generally weak predictive accuracy for VTE. There is insufficient evidence and too much heterogeneity to recommend the use of any particular RAM.Prospero registration numberSteve Goodacre, Abdullah Pandor, Katie Sworn, Daniel Horner, Mark Clowes. A systematic review of venous thromboembolism RAMs for hospital inpatients. PROSPERO 2020 CRD42020165778. Available from https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=165778https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=165778.
| S-EPMC8323381 | biostudies-literature
Project description:BackgroundVenous thromboembolism (VTE) increases the risk of death or adverse outcomes in patients with lung cancer. Therefore, early identification and treatment of high-risk groups of VTE have been the research focus. In this systematic review, the risk assessment tools of VTE in patients with lung cancer were systematically analyzed and evaluated to provide a reference for VTE management.MethodsRelevant studies were retrieved from major English databases (The Cochrane Library, Embase, Web of Science, PubMed, Scopus, Medline) and Chinese databases (China National Knowledge Infrastructure [CNKI] and WanFang Data) until July 2023 and extracted by two researchers. This systematic review was registered at PROSPERO (no. CRD42023409748).ResultsFinally, two prospective cohort studies and four retrospective cohort studies were included from 2019. There was a high risk of bias in all included studies according to the Prediction Model Risk of Bias Assessment tool (PROBAST). In the included studies, Cox and logistic regression were used to construct models. The area under the receiver operating characteristic curve (AUC) of the model ranged from 0.670 to 0.904, and the number of predictors ranged from 4 to 11. The D-dimer index was included in five studies, but significant differences existed in optimal cutoff values from 0.0005 mg/L to 2.06 mg/L. Then, three studies validated the model externally, two studies only validated the model internally, and only one study validated the model using a combination of internal and external validation.ConclusionVTE risk prediction models for patients with lung cancer have received attention for no more than 5 years. The included model shows a good predictive effect and may help identify the risk population of VTE at an early stage. In the future, it is necessary to improve data modeling and statistical analysis methods, develop predictive models with good performance and low risk of bias, and focus on external validation and recalibration of models.
| S-EPMC10834197 | biostudies-literature
Project description:BackgroundVitamin K antagonists (VKA) are the most widely used anticoagulants, and bridging is commonly administered during periprocedural VKA interruption. Given the unclear benefits and risks of periprocedural bridging in patients with previous venous thromboembolism, we aimed to assess recurrent venous thromboembolism and bleeding outcomes with and without bridging in this population.MethodsWe performed a systematic review searching the PubMed and Embase databases from inception to December 7, 2017 for randomized and nonrandomized studies that included adults with previous venous thromboembolism requiring VKA interruption to undergo an elective procedure, and that reported venous thromboembolism or bleeding outcomes. Quality of evidence was graded by consensus.ResultsWe included 28 cohort studies (20 being single-arm cohorts) with, overall, 6915 procedures for analysis. In 27 studies reporting perioperative venous thromboembolism outcomes, the pooled incidence of recurrent venous thromboembolism with bridging was 0.7% (95% confidence interval [CI], 0.4%-1.2%) and 0.5% (95% CI, 0.3%-0.8%) without bridging. Eighteen studies reported major or nonmajor bleeding outcomes. The pooled incidence of any bleeding was 3.9% (95% CI, 2.0%-7.4%) with bridging and 0.4% (95% CI, 0.1%-1.7%) without bridging. In bridged patients at high thromboembolic risk, the pooled incidence for venous thromboembolism was 0.8% (95% CI, 0.3%-2.5%) and 7.5% (95% CI, 3.1%-17.4%) for any bleeding. Quality of available evidence was very low, primarily due to a high risk of bias of included studies.ConclusionsPeriprocedural bridging increases the risk of bleeding compared with VKA interruption without bridging, without a significant difference in periprocedural venous thromboembolism rates.
| S-EPMC6588421 | biostudies-literature
Project description:IntroductionVenous thromboembolism (VTE) is among the three major causes of cardiovascular diseases worldwide after ischaemic heart disease and stroke. Knowledge on the global epidemiology of this condition is deficient in Africa. Accurate data are needed to evaluate the burden of VTE in Africa to design effective preventive and treatment strategies. This systematic review and meta-analysis aims to summarise epidemiological data on VTE in Africa and to evaluate the use of prophylaxis in African patients at risk of VTE.Methods and analysisMedline, Embase, Scopus and African Journal Online will be searched for relevant abstracts of studies published between 1 January 1986 and 5 December 2016, without language restriction. After a screening of abstracts, study selection, data extraction and assessment of the risk of bias, we shall assess studies individually for clinical and statistical heterogeneity. Appropriate meta-analytic technics will then be used to pool studies judged to be clinically homogeneous. Funnel-plots analysis and Egger's test will be used to detect publication bias. Results will be presented by geographical region (Central, Eastern, Northern, Southern and Western Africa). This systematic review will be reported according to the Meta-analysis of Observational Studies in Epidemiology Guidelines.Ethics and disseminationThe current study will be based on published data, and thus ethics consideration is not required. This review is expected to provide relevant data to help in quantifying the magnitude of this disease in Africa. The final report of this study will be published in a peer-reviewed journal and the findings will be submitted to relevant health authorities.Trial registration numberThe protocol for this review has been published in the International Prospective Register of systematic reviews (http://www.crd.york.ac.uk/PROSPERO), registration number: PROSPERO CRD42017056253.
| S-EPMC5652565 | biostudies-literature
Project description:BackgroundA reliable venous thromboembolism (VTE) risk assessment model (RAM) can assist surgeons in identifying patients who would benefit from VTE prophylaxis. This systematic review was aimed at summarising the current available evidence on VTE RAMs used in aesthetic plastic surgery.MethodsA comprehensive search was performed in the PubMed, EMBASE and Cochrane databases to include primary studies describing VTE RAMs in aesthetic plastic surgery from 1946 to February 2019. The objective was to compare the different VTE RAMs described for aesthetic plastic surgery to recommend a reliable model to stratify patients.ResultsOf the 557 articles identified in the PubMed, EMBASE and Cochrane databases, six articles were included in the final review. Five different RAMs were used in the included studies: Caprini 2005 RAM, Caprini 2010 RAM, Davison-Caprini 2004 RAM, the American Society of Anaesthesiologist's (ASA) physical status grading system and a tool developed by Wes et al. The difference in risk weightage amongst the tools along with the VTE incidences for different categories was compared. The Caprini 2005 RAM was the most widely reported tool and validated in plastic surgery patients.ConclusionAmongst the five different tools currently used, the Caprini 2005 RAM was the most widely reported. This tool was validated in plastic surgery patients and reported to be a sensitive and reliable tool for VTE risk stratification; therefore, current data support its use until further higher quality evidence becomes available. Because of the heterogeneity of the data and low quality of the current evidence, a definitive recommendation cannot be made on the best VTE RAM for patients undergoing aesthetic plastic surgery. This paper highlights the need for randomised controlled trials evaluating the various RAMs which are essential to support future recommendations and guidelines.
| S-EPMC8427088 | biostudies-literature
Project description:IntroductionVenous thromboembolism (VTE) is a serious life-threatening complication in patients with gastric cancer. Abnormal coagulation function and tumour-related treatment may contribute to the occurrence of VTE. Many guidelines considered that surgical treatment would put patients with cancer at high risk of VTE, so positive prevention is needed. However, there are no studies that have systematically reviewed the postoperative risk and distribution of VTE in patients with gastric cancer. We thus conduct this systematic review to determine the risk of VTE in patients with gastric cancer undergoing surgery and provide some evidence for clinical decision-making.Methods and analysisStudies reporting the incidence of VTE after gastric cancer surgery will be included. Primary studies of randomised controlled trials, cohort studies, population-based surveys and cross-sectional studies are eligible for this review and only studies published in Chinese and English will be included. We will search the Medline, Embase, Web of Science, CBM, CNKI and Wanfang data from their inception to November 2019. Two reviewers will independently select studies and extract data. The quality of each included study will be assessed with tools corresponding to their study design. Meta-analysis will be used to pool the incidence data from included studies. Heterogeneity of the estimates across studies will be assessed, if necessary, a subgroup analysis will be performed to explore the source of heterogeneity. The Grades of Recommendation, Assessment, Development and Evaluation method is applied to assess the level of evidence obtained from this systematic review.Ethics and disseminationThis proposed systematic review and meta-analysis is based on published data, and thus ethical approval is not required. The results of this review will be sought for publication.Prospero registration numberCRD42019144562.
| S-EPMC6955495 | biostudies-literature
Project description:Venous thromboembolism (VTE) is a chronic disease, with fatal recurrences occurring in 5% to 9% of patients, yet it is also one of the best examples of preventable disease. Prognostic models that utilise multiple prognostic factors (demographic, clinical and laboratory patient characteristics) in combination to predict individual outcome risk may allow the identification of patients who would benefit from long-term anticoagulation therapy, and conversely those that would benefit from stopping such therapy due to a low risk of recurrence. The study will systematically review the evidence on potential prognostic models for the recurrence of VTE or adverse outcomes following the cessation of therapy, and synthesise and summarise each model's prognostic value. The review has been registered with PROSPERO (CRD42013003494).Articles will be sought from the Cochrane library (CENTRAL, CDSR, DARE, HTA databases), MEDLINE and EMBASE. Trial registers will be searched for ongoing studies, and conference abstracts will be sought. Reference lists and subject experts will be utilised. No restrictions on language of publications will be applied. Studies of any design will be included if they examine, in patients ceasing therapy after at least three months' treatment with an oral anticoagulant therapy, whether more than one factor in combination is associated with the risk of VTE recurrence or another adverse outcome. Study quality will be assessed using appropriate guidelines for prognostic models. Prognostic models will be summarised qualitatively and, if tested in multiple validation studies, their predictive performance will be summarised using a random-effects meta-analysis model to account for any between-study heterogeneity.The results of the review will identify prognostic models for the risk of VTE recurrence or adverse outcome following cessation of therapy for a first unprovoked VTE. These will be informative for clinicians currently treating patients for a first unprovoked VTE and considering whether to stop treatment or not for particular individuals. The conclusions of the review will also inform the potential development of new prognostic models and clinical prediction rules to identify those at high or low risk of VTE recurrence or adverse outcome following a first unprovoked VTE.
| S-EPMC3852155 | biostudies-other
Project description:Despite evidence-based guidelines for venous thromboembolism prevention, substantial variability is found in practice. Many economic evaluations of new drugs for thromboembolism prevention do not occur prospectively with efficacy studies and are sponsored by the manufacturers, raising the possibility of bias. We performed a systematic review of economic analyses of venous thromboembolism prevention in hospitalized patients to inform clinicians and policy makers about cost-effectiveness and the potential influence of sponsorship.We searched MEDLINE, EMBASE, Cochrane Databases, ACP Journal Club, and Database of Abstracts of Reviews of Effects, from 1946 to September 2011. We extracted data on study characteristics, quality, costs, and efficacy.From 5,180 identified studies, 39 met eligibility and quality criteria. Each addressed pharmacologic prevention: low-molecular-weight heparins versus placebo (five), unfractionated heparin (12), warfarin (eight), one or another agents (five); fondaparinux versus enoxaparin (11); and rivaroxaban and dabigatran versus enoxaparin (two). Low-molecular-weight heparins were most economically attractive among most medical and surgical patients, whereas fondaparinux was favored for orthopedic patients. Fondaparinux was associated with increased bleeding events. Newer agents rivaroxaban and dabigatran may offer additional value. Of all economic evaluations, 64% were supported by manufacturers of a "new" agent. The new agent had a favorable outcome in 38 (97.4%) of 39 evaluations [95% confidence interval [CI] (86.5 to 99.9)]. Among studies supported by a pharmaceutical company, the sponsored medication was economically attractive in 24 (96.0%) of 25 [95% CI, 80.0 to 99.9)]. We could not detect a consistent bias in outcome based on sponsorship; however, only a minority of studies were unsponsored.Low-molecular-weight heparins and fondaparinux are the most economically attractive drugs for venous thromboembolism prevention in hospitalized patients. Approximately two thirds of evaluations were supported by the manufacturer of the new agent; such drugs were likely to be reported as economically favorable.
| S-EPMC3964799 | biostudies-other
Project description:BackgroundVenous thromboembolism (VTE) may complicate the course of Coronavirus Disease 2019 (COVID-19).ObjectivesTo evaluate the incidence of VTE in patients with COVID-19.MethodsMEDLINE, EMBASE, and PubMed were searched up to 24th June 2020 for studies that evaluated the incidence of VTE, including pulmonary embolism (PE) and/or deep vein thrombosis (DVT), in patients with COVID-19. Pooled proportions with corresponding 95% confidence intervals (CI) and prediction intervals (PI) were calculated by random-effect meta-analysis.Results3487 patients from 30 studies were included. Based on very low-quality evidence due to heterogeneity and risk of bias, the incidence of VTE was 26% (95% PI, 6%-66%). PE with or without DVT occurred in 12% of patients (95% PI, 2%-46%) and DVT alone in 14% (95% PI, 1%-75%). Studies using standard algorithms for clinically suspected VTE reported PE in 13% of patients (95% PI, 2%-57%) and DVT in 6% (95% PI, 0%-60%), compared to 11% (95% PI, 2%-46%) and 24% (95% PI, 2%-85%) in studies using other diagnostic strategies or patient sampling. In patients admitted to intensive care units, VTE occurred in 24% (95% PI, 5%-66%), PE in 19% (95% PI, 6%-47%), and DVT alone in 7% (95% PI, 0%-69%). Corresponding values in general wards were respectively 9% (95% PI, 0%-94%), 4% (95% PI, 0%-100%), and 7% (95% CI, 1%-49%).ConclusionsVTE represents a frequent complication in hospitalized COVID-19 patients and often occurs as PE. The threshold for clinical suspicion should be low to trigger prompt diagnostic testing.
| S-EPMC7420982 | biostudies-literature
Project description:ObjectivesTo assess the comparative accuracy of risk assessment models (RAMs) to identify women during pregnancy and the early postnatal period who are at increased risk of venous thromboembolism (VTE).DesignSystematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Data sourcesMEDLINE, Embase, Cochrane Library and two research registers were searched until February 2021.Eligibility criteriaAll validation studies that examined the accuracy of a multivariable RAM (or scoring system) for predicting the risk of developing VTE in women who are pregnant or in the puerperium (within 6 weeks post-delivery).Data extraction and synthesisTwo authors independently selected and extracted data. Risk of bias was appraised using PROBAST (Prediction model Risk Of Bias ASsessment Tool). Data were synthesised without meta-analysis.ResultsSeventeen studies, comprising 19 externally validated RAMs and 1 internally validated model, met the inclusion criteria. The most widely evaluated RAMs were the Royal College of Obstetricians and Gynaecologists guidelines (six studies), American College of Obstetricians and Gynecologists guidelines (two studies), Swedish Society of Obstetrics and Gynecology guidelines (two studies) and the Lyon score (two studies). In general, estimates of sensitivity and specificity were highly variable with sensitivity estimates ranging from 0% to 100% for RAMs that were applied to antepartum women to predict antepartum or postpartum VTE and 0% to 100% for RAMs applied postpartum to predict postpartum VTE. Specificity estimates were similarly diverse ranging from 28% to 98% and 5% to 100%, respectively.ConclusionsAvailable data suggest that external validation studies have weak designs and limited generalisability, so estimates of prognostic accuracy are very uncertain.Prospero registration numberCRD42020221094.
| S-EPMC9562726 | biostudies-literature