Validation of a Patient-Completed Caprini Risk Score for Venous Thromboembolism Risk Assessment

Abstract

Introduction Individualized risk assessment for venous thromboembolism (VTE) using the Caprini risk score (CRS), coupled with targeted prophylaxis based on the score, is effective in reducing postoperative VTE. Critics contend that using this tool is time consuming for health care providers. We decided to create a patient-completed CRS and conducted a prospective study to compare the scores calculated by a patient with those calculated by a blinded physician for the same patient.

Methods In phase 1, we interviewed patients in our deep vein thrombosis (DVT) support group who had a history of thrombosis and included their family members to determine areas of misunderstanding in the original CRS. We created a patient-completed form based on these interviews. In phase 2, we further optimized the questions after a CRS-trained, blinded physician scored 20 hospitalized patients during the pilot study. In the final (third) phase, we measured the agreement level between the new form filled out by the trained physicians and those filled out by the patients. The study was approved by our local institutional review board. Using PASS version 11, we determined that a sample size of 37 individuals achieves a power of 80%, to detect a 0.1 difference between the null hypothesis correlation of 0.5 and the alternative hypothesis correlation of 0.7 using a two-sided hypothesis test with a significance level of 0.05. We tabulated the individuals' answers and categorized the scores by using SPSS version 23 to estimate the kappa value, linear correlation, and the Bland–Altman test. A kappa value greater than 0.8 indicated an “almost perfect agreement.”

Results We tested the first patient-completed CRS version (phase 2) in a 20-patient pilot study. A poor agreement was observed with the body mass index (BMI) responses in multiple iterations, and so we excluded the BMI calculation from the final patient-completed CRS form. We recruited 42 patients with an average age of 55, mostly female (45%), who completed less than college education (62%) to fill out the updated CRS form (phase 3). An almost perfect agreement was found for both the individual questions and the overall score comparing physician and patient answers, resulting in a high correlation (r = 0.95). In Bland–Altman, we did not find any trend for extreme values.

Conclusion We created and validated a patient-completed CRS form that has an excellent agreement level with the physician-completed form. From the results, the physician only needs to calculate the BMI. The average time for a patient to complete the form was 5 minutes. The average time for the physician to finalize the score was approximately 6 minutes. Implementation studies are needed to assess the correlation of the aggregated score, derived from this form, with the occurrence of perioperative VTE.

Keywords

Caprini score - venous thromboembolism - risk assessment model - thrombosis prophylaxis - patient-centered communication

• References

• 1 Wickham N, Gallus AS, Walters BN, Wilson A. ; NHMRC VTE Prevention Guideline Adaptation Committee. Prevention of venous thromboembolism in patients admitted to Australian hospitals: summary of National Health and Medical Research Council clinical practice guideline. Intern Med J 2012; 42 (06) 698-708
• 2 Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA 2003; 290 (14) 1868-1874
• 3 Guyatt GH, Eikelboom JW, Gould MK. , et al. Approach to outcome measurement in the prevention of thrombosis in surgical and medical patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2, Suppl): e185S-e194S
• 4 Shojania KG, Duncan BW, McDonald KM, Wachter RM, Markowitz AJ. Making health care safer: a critical analysis of patient safety practices. Evid Rep Technol Assess (Summ) 2001; 43 (43) 1-668
• 5 Caprini JA. Thrombosis risk assessment as a guide to quality patient care. Dis Mon 2005; 51 (2-3): 70-78
• 6 Bahl V, Hu HM, Henke PK, Wakefield TW, Campbell Jr DA, Caprini JA. A validation study of a retrospective venous thromboembolism risk scoring method. Ann Surg 2010; 251 (02) 344-350
• 7 Hewes PD, Hachey KJ, Zhang XW. , et al. Evaluation of the Caprini model for venothromboembolism in esophagectomy patients. Ann Thorac Surg 2015; 100 (06) 2072-2078
• 8 Shuman AG, Hu HM, Pannucci CJ, Jackson CR, Bradford CR, Bahl V. Stratifying the risk of venous thromboembolism in otolaryngology. Otolaryngol Head Neck Surg 2012; 146 (05) 719-724
• 9 Stroud W, Whitworth JM, Miklic M. , et al. Validation of a venous thromboembolism risk assessment model in gynecologic oncology. Gynecol Oncol 2014; 134 (01) 160-163
• 10 Weber B, Seal A, McGirr J, Fielding K. Case series of elective instrumented posterior lumbar spinal fusions demonstrating a low incidence of venous thromboembolism. ANZ J Surg 2016; 86 (10) 796-800
• 11 Macht R, Gardner I, Talutis S, Rosenkranz P, Doherty G, McAneny D. Evaluation of a standardized risk-based venous thromboembolism prophylaxis protocol in the setting of thyroid and parathyroid surgery. J Am Coll Surg 2017; 224 (06) 1029-1035
• 12 Gould MK, Garcia DA, Wren SM. , et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2, Suppl): e227S-e277S
• 13 Maynard G, Stein J. Designing and implementing effective venous thromboembolism prevention protocols: lessons from collaborative efforts. J Thromb Thrombolysis 2010; 29 (02) 159-166
• 14 Popoola VO, Lau BD, Shihab HM. , et al. Patient preferences for receiving education on venous thromboembolism prevention—a survey of stakeholder organizations. PLoS One 2016; 11 (03) e0152084
• 15 Venous Resource Center. Are you at risk for DVT? Available at: http://venousdisease.com/caprini-dvt-risk-assessment/ . Accessed September 20, 2017
• 16 Andersen MR, Urban N. Involvement in decision-making and breast cancer survivor quality of life. Ann Behav Med 1999; 21 (03) 201-209
• 17 Epstein RM, Fiscella K, Lesser CS, Stange KC. Why the nation needs a policy push on patient-centered health care. Health Aff (Millwood) 2010; 29 (08) 1489-1495
• 18 McCormack LA, Treiman K, Rupert D. , et al. Measuring patient-centered communication in cancer care: a literature review and the development of a systematic approach. Soc Sci Med 2011; 72 (07) 1085-1095
• 19 Morse JM. Approaches to qualitative-quantitative methodological triangulation. Nurs Res 1991; 40 (02) 120-123
• 20 Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1 (8476): 307-310
• 21 Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33 (01) 159-174
• 22 Alikhan R, Cohen AT, Combe S. , et al. Prevention of venous thromboembolism in medical patients with enoxaparin: a subgroup analysis of the MEDENOX study. Blood Coagul Fibrinolysis 2003; 14 (04) 341-346
• 23 Pannucci CJ, Bailey SH, Dreszer G. , et al. Validation of the Caprini risk assessment model in plastic and reconstructive surgery patients. J Am Coll Surg 2011; 212 (01) 105-112
• 24 Lobastov K, Barinov V, Schastlivtsev I, Laberko L, Rodoman G, Boyarintsev V. Validation of the Caprini risk assessment model for venous thromboembolism in high-risk surgical patients in the background of standard prophylaxis. J Vasc Surg Venous Lymphat Disord 2016; 4 (02) 153-160
• 25 Kucher N, Koo S, Quiroz R. , et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med 2005; 352 (10) 969-977
• 26 Barbar S, Noventa F, Rossetto V. , et al. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost 2010; 8 (11) 2450-2457
• 27 Rogers Jr SO, Kilaru RK, Hosokawa P, Henderson WG, Zinner MJ, Khuri SF. Multivariable predictors of postoperative venous thromboembolic events after general and vascular surgery: results from the patient safety in surgery study. J Am Coll Surg 2007; 204 (06) 1211-1221
• 28 Cassidy MR, Rosenkranz P, McAneny D. Reducing postoperative venous thromboembolism complications with a standardized risk-stratified prophylaxis protocol and mobilization program. J Am Coll Surg 2014; 218 (06) 1095-1104
• 29 Pannucci CJ, Swistun L, MacDonald JK, Henke PK, Brooke BS. Individualized venous thromboembolism risk stratification using the 2005 Caprini Score to identify the benefits and harms of chemoprophylaxis in surgical patients: a meta-analysis. Ann Surg 2017; 265 (06) 1094-1103
• 30 McAdams MA, Van Dam RM, Hu FB. Comparison of self-reported and measured BMI as correlates of disease markers in US adults. Obesity (Silver Spring) 2007; 15 (01) 188-196
• 31 Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford) 2008; 47 (03) 345-349
• 32 Pincus T, Amara I, Koch GG. Continuous indices of core data set measures in rheumatoid arthritis clinical trials: lower responses to placebo than seen with categorical responses with the American College of Rheumatology 20% criteria. Arthritis Rheum 2005; 52 (04) 1031-1036
• 33 Pincus T, Chung C, Segurado OG, Amara I, Koch GG. An index of patient reported outcomes (PRO-Index) discriminates effectively between active and control treatment in 4 clinical trials of adalimumab in rheumatoid arthritis. J Rheumatol 2006; 33 (11) 2146-2152
• 34 Pincus T, Strand V, Koch G. , et al. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003; 48 (03) 625-630
• 35 Catterick D, Hunt BJ. Impact of the national venous thromboembolism risk assessment tool in secondary care in England: retrospective population-based database study. Blood Coagul Fibrinolysis 2014; 25 (06) 571-576