| Objective:To introduce Manceval’s PICC-related thrombosis risk assessment scale,test the reliability and validity of the Chinese version of Maneval scale;The Chinese version of the scale was used for the applicability study in domestic tumor patients,and the sensitivity,specificity,positive predictive value,negative predictive value and area under the ROC curve of the scale were tested.The Chinese version of Maneval scale was performed in patients with suspected PICC-associated thrombosis,and P-selectin and D-dimer levels were detected in patients with suspected PICC-related thrombosis.To explore the diagnostic value of clinical score scale,plasma marker single test and combined test in suspected PICC associated thrombus patients.Methods:Part one(1)Translation and cross-cultural debugging of the English version of the Manceval’s PICC-related thrombosis risk assessment scale to form the Chinese version of the Maneval risk assessment scale.(2)The content validity of the Chinese version of Maneval scale was evaluated by experts of nursing education and clinical nursing experts.The content validity evaluation of the scale uses the item level content validity index(I-CVI)and the total item average content validity index(S-CVI/Ave),the scale structure validity evaluation uses exploratory factor analysis.(3)Convenient sampling method was used to select patients with tumors that required PICC catheterization in accordance with the inclusion and exclusion criteria.The PICC-related thrombosis was evaluated.The reliability of the scale was evaluated by Cronbach’s coefficient and the score of the assessor Kappa.Part twoUsing convenient sampling method to select patients with tumors who were eligible for PICC catheterization in 2017.11 to 2018.8 according to the inclusion and exclusion criteria.To test the sensitivity,specificity,positive predictive value,negative predictive value and area under ROC curve of the Chinese version of Maneval risk assessment table.Part threeObjective sampling method was used to select suspected PICC associated thrombosis patients who met the inclusion and exclusion criteria of 2017.11 and 2018.8 as the experimental group.The Maneval risk assessment was performed on the tumor patients with suspected PICC-related thrombosis,and the changes of P-selectin and D-dimer expression in plasma of patients with suspected PICC-associated thrombus were also detected.According to the 1:1 matching method,tumor patients who did not have any PICC-related thrombus symptoms at the same time and had no PICC-related thrombus diagnosed by ultrasonography were selected as the control group.Maneval risk assessment and the detection of P-selectin and D-dimer were performed in the control group.To explore the diagnostic value of Maneval score and P-selectin or D-dimer in the diagnosis of suspected PICC associated thrombosis in tumor patients.Results:Part oneA total of 225 patients with tumors who underwent PICC catheterization according to inclusion and exclusion criteria were included.The I-CVI value of the scale is 0.733 to 1.0,and the S-CVI/Ave value is 0.972.Exploratory factor analysis extracted a total of 5 common factors,the cumulative variance contribution rate was 71.393%,the Cronbach’s a coefficient of the total scale was 0.781,and the Cronbach’s a coefficient of the scale after the entry sensitivity analysis was 0.742-0.781,The scorer Kappa value of each item was 0.615～1.Part twoA total of 260 patients with tumors who underwent PICC catheterization according to inclusion and exclusion criteria were included.The sensitivity,specificity,positive predictive value and negative predictive value of the scale were 0.892,0.845,0.848,0.953and 0.916,respectively,and the Chinese version of the Maneval scale diagnostic threshold was 30.5 points.Part threeA total of 120 patients with tumors who underwent PICC catheterization were included in the study.Sixty 60 patients with suspected PICC-associated thrombosis were included in the experimental group and 60 patients with PICC associated thrombus were selected as the control group who had no PICC associated thrombotic symptoms and were confirmed by ultrasound.(1)Maneval score<10.5 divided into thrombotic impossible group,>10.5 divided into thrombotic possible group The Sensitivity,Specificity,PPV,NPV,AUC was 0.773,0.842,0.739,0.865,0.807,respectively for Maneval scale.(2)The concentration of P-selectin[(30.15±1.03)ng/L]in PICC-associated thrombosis group were significant higher than that in non-thrombosis group[(29.11±1.18)](P=0.001<0.05).There was no significantly different of D-dimer in PICC-associated thrombosis group[(1.04±1.27)ug/mL]and non-thrombosis group[(1.22±0.95)ug/mL](P=0.169>0.05).(3)Making 0.5 ug/mL of D-dimer as the criterion,of 60 suspected patients for PICC-associated thrombosis,46 cases with a positive D-dimer testing and 14 cases with a negative testing.Making 29.575ng/L of P-selectin as the criterion,of 60 suspected patients for PICC-associated thrombosis,28 cases with a positive P-selectin testing and 32 cases with a negative testing.The Sensitivity,Specificity,PPV,NPV,AUC was 0.864,0.289,0.413,0.786,0.577 respectively for D-dimer.0.727,0.684,0.571,0.813,0.706 respectively for P-selectin.(4)The combination of Maneval scale and D-dimer:the Sensitivity,Specificity,PPV,NPV,AUC was 0.969,0.243,0.404,0.769,0.563 respectively for combined test ing parallel or series of testsusing "OR" rules 0.668,0.888,0.773,0.868,0.821 respectively for combined testing parallel or series of testsusing "AND" rules.The combination of Maneval scale and P-selectin:the Sensitivity,Specificity,PPV,N PV,was 0.938,0.576,0.625,0.928,0.797 respectively for combined testing parallel o r series of tests using "OR" rules,0.562,0.951,0.591,0.868,0.730 respectively for combined testing parallel or series of testsusing "AND" rules.Conclusion:Maneval score and P-selectin combination can be safer and more effective in the diagnosis of suspected PICC-related thrombosis,and the specificity of P-selectin was higher than that of D-dimer either in single item or in combination with the scale. |
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