Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast), in Three Population-Based Case–Control Studies
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{"title"=>"Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast), in Three Population-Based Case–Control Studies", "type"=>"journal", "authors"=>[{"first_name"=>"Banne", "last_name"=>"Nemeth", "scopus_author_id"=>"56995771500"}, {"first_name"=>"Raymond A.van", "last_name"=>"Adrichem", "scopus_author_id"=>"56996184100"}, {"first_name"=>"Astrid van", "last_name"=>"Hylckama Vlieg", "scopus_author_id"=>"56996175000"}, {"first_name"=>"Paolo", "last_name"=>"Bucciarelli", "scopus_author_id"=>"6603790065"}, {"first_name"=>"Ida", "last_name"=>"Martinelli", "scopus_author_id"=>"7006490935"}, {"first_name"=>"Trevor", "last_name"=>"Baglin", "scopus_author_id"=>"18033283300"}, {"first_name"=>"Frits R.", "last_name"=>"Rosendaal", "scopus_author_id"=>"7102172597"}, {"first_name"=>"Saskia le", "last_name"=>"Cessie", "scopus_author_id"=>"14526750900"}, {"first_name"=>"Suzanne C.", "last_name"=>"Cannegieter", "scopus_author_id"=>"6603381281"}], "year"=>2015, "source"=>"PLoS Medicine", "identifiers"=>{"sgr"=>"84949424081", "pmid"=>"26554832", "pui"=>"607211712", "isbn"=>"1549-1277\\r1549-1676", "scopus"=>"2-s2.0-84949424081", "doi"=>"10.1371/journal.pmed.1001899", "issn"=>"15491676"}, "id"=>"9e82222b-0b41-34a9-a5fa-3b319b66fbc4", "abstract"=>"BACKGROUND: Guidelines and clinical practice vary considerably with respect to thrombosis prophylaxis during plaster cast immobilization of the lower extremity. Identifying patients at high risk for the development of venous thromboembolism (VTE) would provide a basis for considering individual thromboprophylaxis use and planning treatment studies. The aims of this study were (1) to investigate the predictive value of genetic and environmental risk factors, levels of coagulation factors, and other biomarkers for the occurrence of VTE after cast immobilization of the lower extremity and (2) to develop a clinical prediction tool for the prediction of VTE in plaster cast patients.\\n\\nMETHODS AND FINDINGS: We used data from a large population-based case-control study (MEGA study, 4,446 cases with VTE, 6,118 controls without) designed to identify risk factors for a first VTE. Cases were recruited from six anticoagulation clinics in the Netherlands between 1999 and 2004; controls were their partners or individuals identified via random digit dialing. Identification of predictor variables to be included in the model was based on reported associations in the literature or on a relative risk (odds ratio) > 1.2 and p ≤ 0.25 in the univariate analysis of all participants. Using multivariate logistic regression, a full prediction model was created. In addition to the full model (all variables), a restricted model (minimum number of predictors with a maximum predictive value) and a clinical model (environmental risk factors only, no blood draw or assays required) were created. To determine the discriminatory power in patients with cast immobilization (n = 230), the area under the curve (AUC) was calculated by means of a receiver operating characteristic. Validation was performed in two other case-control studies of the etiology of VTE: (1) the THE-VTE study, a two-center, population-based case-control study (conducted in Leiden, the Netherlands, and Cambridge, United Kingdom) with 784 cases and 523 controls included between March 2003 and December 2008 and (2) the Milan study, a population-based case-control study with 2,117 cases and 2,088 controls selected between December 1993 and December 2010 at the Thrombosis Center, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy. The full model consisted of 32 predictors, including three genetic factors and six biomarkers. For this model, an AUC of 0.85 (95% CI 0.77-0.92) was found in individuals with plaster cast immobilization of the lower extremity. The AUC for the restricted model (containing 11 predictors, including two genetic factors and one biomarker) was 0.84 (95% CI 0.77-0.92). The clinical model (consisting of 14 environmental predictors) resulted in an AUC of 0.77 (95% CI 0.66-0.87). The clinical model was converted into a risk score, the L-TRiP(cast) score (Leiden-Thrombosis Risk Prediction for patients with cast immobilization score), which showed an AUC of 0.76 (95% CI 0.66-0.86). Validation in the THE-VTE study data resulted in an AUC of 0.77 (95% CI 0.58-0.96) for the L-TRiP(cast) score. Validation in the Milan study resulted in an AUC of 0.93 (95% CI 0.86-1.00) for the full model, an AUC of 0.92 (95% CI 0.76-0.87) for the restricted model, and an AUC of 0.96 (95% CI 0.92-0.99) for the clinical model. The L-TRiP(cast) score resulted in an AUC of 0.95 (95% CI 0.91-0.99). Major limitations of this study were that information on thromboprophylaxis was not available for patients who had plaster cast immobilization of the lower extremity and that blood was drawn 3 mo after the thrombotic event.\\n\\nCONCLUSIONS: These results show that information on environmental risk factors, coagulation factors, and genetic determinants in patients with plaster casts leads to high accuracy in the prediction of VTE risk. In daily practice, the clinical model may be the preferred model as its factors are most easy to determine, while the model still has good predictive performance. These results may provide guidance for thromboprophylaxis and form the basis for a management study.", "link"=>"http://www.mendeley.com/research/venous-thrombosis-risk-after-cast-immobilization-lower-extremity-derivation-validation-clinical-pred", "reader_count"=>34, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>10, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>1, "Student > Master"=>6, "Other"=>1, "Student > Bachelor"=>3, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>10, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>1, "Student > Master"=>6, "Other"=>1, "Student > Bachelor"=>3, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Engineering"=>1, "Biochemistry, Genetics and Molecular Biology"=>3, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>24, "Agricultural and Biological Sciences"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Social Sciences"=>1, "Computer Science"=>1}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>24}, "Social Sciences"=>{"Social Sciences"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>3}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Netherlands"=>1, "Sri Lanka"=>1}, "group_count"=>7}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/2434887", "https://ndownloader.figshare.com/files/2434888", "https://ndownloader.figshare.com/files/2434889", "https://ndownloader.figshare.com/files/2434890", "https://ndownloader.figshare.com/files/2434891", "https://ndownloader.figshare.com/files/2434892"], "description"=>"<div><p>Background</p><p>Guidelines and clinical practice vary considerably with respect to thrombosis prophylaxis during plaster cast immobilization of the lower extremity. Identifying patients at high risk for the development of venous thromboembolism (VTE) would provide a basis for considering individual thromboprophylaxis use and planning treatment studies.</p><p>The aims of this study were (1) to investigate the predictive value of genetic and environmental risk factors, levels of coagulation factors, and other biomarkers for the occurrence of VTE after cast immobilization of the lower extremity and (2) to develop a clinical prediction tool for the prediction of VTE in plaster cast patients.</p><p>Methods and Findings</p><p>We used data from a large population-based case–control study (MEGA study, 4,446 cases with VTE, 6,118 controls without) designed to identify risk factors for a first VTE. Cases were recruited from six anticoagulation clinics in the Netherlands between 1999 and 2004; controls were their partners or individuals identified via random digit dialing. Identification of predictor variables to be included in the model was based on reported associations in the literature or on a relative risk (odds ratio) > 1.2 and <i>p</i> ≤ 0.25 in the univariate analysis of all participants. Using multivariate logistic regression, a full prediction model was created. In addition to the full model (all variables), a restricted model (minimum number of predictors with a maximum predictive value) and a clinical model (environmental risk factors only, no blood draw or assays required) were created. To determine the discriminatory power in patients with cast immobilization (<i>n =</i> 230), the area under the curve (AUC) was calculated by means of a receiver operating characteristic. Validation was performed in two other case–control studies of the etiology of VTE: (1) the THE-VTE study, a two-center, population-based case–control study (conducted in Leiden, the Netherlands, and Cambridge, United Kingdom) with 784 cases and 523 controls included between March 2003 and December 2008 and (2) the Milan study, a population-based case–control study with 2,117 cases and 2,088 controls selected between December 1993 and December 2010 at the Thrombosis Center, Fondazione IRCCS Ca’ Granda–Ospedale Maggiore Policlinico, Milan, Italy.</p><p>The full model consisted of 32 predictors, including three genetic factors and six biomarkers. For this model, an AUC of 0.85 (95% CI 0.77–0.92) was found in individuals with plaster cast immobilization of the lower extremity. The AUC for the restricted model (containing 11 predictors, including two genetic factors and one biomarker) was 0.84 (95% CI 0.77–0.92). The clinical model (consisting of 14 environmental predictors) resulted in an AUC of 0.77 (95% CI 0.66–0.87). The clinical model was converted into a risk score, the L-TRiP(cast) score (Leiden–Thrombosis Risk Prediction for patients with cast immobilization score), which showed an AUC of 0.76 (95% CI 0.66–0.86). Validation in the THE-VTE study data resulted in an AUC of 0.77 (95% CI 0.58–0.96) for the L-TRiP(cast) score. Validation in the Milan study resulted in an AUC of 0.93 (95% CI 0.86–1.00) for the full model, an AUC of 0.92 (95% CI 0.76–0.87) for the restricted model, and an AUC of 0.96 (95% CI 0.92–0.99) for the clinical model. The L-TRiP(cast) score resulted in an AUC of 0.95 (95% CI 0.91–0.99).</p><p>Major limitations of this study were that information on thromboprophylaxis was not available for patients who had plaster cast immobilization of the lower extremity and that blood was drawn 3 mo after the thrombotic event.</p><p>Conclusions</p><p>These results show that information on environmental risk factors, coagulation factors, and genetic determinants in patients with plaster casts leads to high accuracy in the prediction of VTE risk. In daily practice, the clinical model may be the preferred model as its factors are most easy to determine, while the model still has good predictive performance. These results may provide guidance for thromboprophylaxis and form the basis for a management study.</p></div>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598900, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001899.s001", "https://dx.doi.org/10.1371/journal.pmed.1001899.s002", "https://dx.doi.org/10.1371/journal.pmed.1001899.s003", "https://dx.doi.org/10.1371/journal.pmed.1001899.s004", "https://dx.doi.org/10.1371/journal.pmed.1001899.s005", "https://dx.doi.org/10.1371/journal.pmed.1001899.s006"], "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Venous_Thrombosis_Risk_after_Cast_Immobilization_of_the_Lower_Extremity_Derivation_and_Validation_of_a_Clinical_Prediction_Score_L_TRiP_cast_in_Three_Population_Based_Case_8211_Control_Studies_/1598900", "title"=>"Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast), in Three Population-Based Case–Control Studies", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2015-11-10 03:37:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/2434884"], "description"=>"<p>Candidate predictor variables</p>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598897, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001899.t001", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Candidate_predictor_variables_/1598897", "title"=>"Candidate predictor variables", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-11-10 03:37:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/2434882"], "description"=>"<p>Vertical bars represent 95% CIs. Predictors: (1) age, (2) sex, (3) plaster cast and location, (4) prothrombin mutation, (5) current use of oral contraceptives, (6) family history of VTE (first-degree relative), (7) factor VIII activity, (8) bedridden within the past 3 mo, (9) surgery within the past 3 mo, (10) non-O blood type, (11) BMI.</p>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598895, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001899.g002", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_AUC_value_after_addition_of_each_predictor_into_the_restricted_model_/1598895", "title"=>"AUC value after addition of each predictor into the restricted model.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-11-10 03:37:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/2434883"], "description"=>"<p>Distribution of individual L-TRiP(cast) scores in the plaster cast subgroup derived from the MEGA study.</p>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598896, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001899.g003", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Distribution_of_individual_L_TRiP_cast_scores_in_the_plaster_cast_subgroup_derived_from_the_MEGA_study_/1598896", "title"=>"Distribution of individual L-TRiP(cast) scores in the plaster cast subgroup derived from the MEGA study.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-11-10 03:37:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/2434881"], "description"=>"<p>Flowchart of the prediction model derivation process.</p>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598894, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001899.g001", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flowchart_of_the_prediction_model_derivation_process_/1598894", "title"=>"Flowchart of the prediction model derivation process.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-11-10 03:37:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/2434886"], "description"=>"<p>*Presuming a prevalence of VTE in plaster cast patients of 2.5%.</p><p>Predictive performance of the L-TRiP(cast) score in plaster cast patients.</p>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598899, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001899.t005", "stats"=>{"downloads"=>1, "page_views"=>19, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Predictive_performance_of_the_L_TRiP_cast_score_in_plaster_cast_patients_/1598899", "title"=>"Predictive performance of the L-TRiP(cast) score in plaster cast patients.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-11-10 03:37:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/2434885"], "description"=>"<p>This L-TRiP(cast) score was derived from the regression coefficients (betas) of the clinical prediction model: 0.20 < beta ≤ 0.75, 1 point; 0.75 < beta ≤ 1.25, 2 points; 1.25 < beta ≤ 1.75, 3 points; 1.75 < beta ≤ 2.25, 4 points; beta > 2.25, 5 points</p><p>L-TRiP(cast) score based on the clinical risk prediction model.</p>", "links"=>[], "tags"=>["mega", "risk factors", "IRCCS", "Milan study", "planning treatment studies.The", "Venous Thrombosis Risk", "plaster cast immobilization", "auc", "vte", "ci", "Coagulation factors", "cast immobilization", "thrombotic event.ConclusionsThese results show", "plaster cast patients.Methods", "model"], "article_id"=>1598898, "categories"=>["Uncategorised"], "users"=>["Banne Nemeth", "Raymond A. van Adrichem", "Astrid van Hylckama Vlieg", "Paolo Bucciarelli", "Ida Martinelli", "Trevor Baglin", "Frits R. Rosendaal", "Saskia le Cessie", "Suzanne C. Cannegieter"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001899.t004", "stats"=>{"downloads"=>2, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_L_TRiP_cast_score_based_on_the_clinical_risk_prediction_model_/1598898", "title"=>"L-TRiP(cast) score based on the clinical risk prediction model.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-11-10 03:37:58"}

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{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
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