Evidence Based Research Group Project

1. Evidence Based Research Group Project DVT Prophylaxis Best Practice: Compression versus Pharmaceuticals A Review of Research Literature NUR 350 Pamela Dusseau Carly Macklin Natalie Russell Danielle Williams

2. PICO For adult post-operative surgical patients, how successfully does the use of prophylactic oral or subcutaneous anticoagulants reduce the risk of the development of deep vein thrombosis, in comparison with the use of external compression devices (intermittent pneumatic compression stockings, TED hose) for deep vein thrombosis prevention (DVT)?

3. Summary The purpose of this study was to find and analyze literature that has examined prophylacticmeasures taken to prevent postoperative blood clots in patients. Outcomes with the use of subcutaneous and oral anticoagulants and outcomes of the use of only external compression devices were compared.

4. RelevantEvidence Deep Vein Thrombosis (DVT) has been found to be a frequent complication of post-surgical patients that do not receive prophylactic treatment. Emphasizes the importancefor health care facilities to be knowledgeable ofthe best available practices to prevent these adverse complications to its patients. Identifiesthe most effective evidence based practice (EBP) techniques available postsurgical DVTs can be reduced.

5. RelevantEvidence Incidence of DVT reportedly as high as 30% in those without prophylaxis; associated fatality risk of 1%. Combination prophylaxis compared to pharmacological prophylaxis alone significantly reduced the risk of DVT (RR 0.48 [95% CI 0.32 0.72]) with moderate strength of evidence.

6. A Review of the Research The following slides provide a summary of the 4 research articles relating to our PICO which were chosen for critique. Please note that due to limited availability of literature, the focus of the articles may vary, yet all investigate or review the best practice for DVT prevention, comparing mechanical/compression and/or pharmacologic methods.

7. Low-Molecular-Weight Heparin Versus Compression Stockings for Thromboprophylaxis Following Knee Arthroscopy: A Randomized Trial • Conducted in Italy, a four year (2002-2006) randomized trial, published in the Annals of Internal Medicine, sought to evaluate the impact of a 7 day thromboprophylactic regime following knee arthroscopy. • Three groups were analyzed: patients using graduated compression stockings, patients treated with subcutaneous low-molecular-weight heparin (LMWH) for 7 days or 14 days. (The 14 day group ended mid-trial due to safety concerns.) • Patients chosen: low risk factors for bleeding, >18 years old, status post outpatient knee arthroscopy (exploratory or surgical approach). • At the end of 7 days (or 14) the patients underwent a lower extremity ultrasound to evaluate for post-surgical venous thrombosis.

8. Continued: Low-Molecular-Weight Heparin Versus Compression Stockings for Thromboprophylaxis Following Knee Arthroscopy: A Randomized Trial • Results: Occurrence of asymptomatic proximal deep vein thrombosis or a symptomatic venous thromboembolism was 3.2% in the group that wore graduated compression stockings, versus 0.9% of those who underwent 7 days of LMWH. An absolute difference of 2.3%. • Limitations: This study was not double blind due to financial reasons- unable to fit patients with placebo stockings and syringes. Also, lower extremity ultrasound for DVT does leave room for error thus the potential for missed thrombosis. • Recommendation: The authors of this trial, taking the results into consideration, conclude with a recommendation for 7 days of LMWH post arthroscopy for DVT prevention. (Camporese, et al., 2008)

9. Comparative Effectiveness of Combined Pharmacologic and Mechanical Thromboprophylaxis versus Either Method Alone in Major Orthopedic Surgery:A Systematic Review and Meta-analysis • Systematic literature review and meta-analysis published of six Randomized Control Trials (RCT) from January 1980 through March 2011 evaluating the efficacy and safety of pharmacological and mechanical venous thromboembolism (VTE) prevention versus either method alone. • Commissioned by the Agency for Healthcare Research and Quality (AHRQ) to systematically review the state of VTE prophylaxis in major Orthopedic surgery. • Study focus - Major Orthopedic surgery: Total hip replacement, total knee replacement, hip fracture surgery. • Health outcome criteria: Confirmed/major VTE=PE (total, fatal, and non-fatal), mortality (total and d/t bleeding), post-thrombotic syndrome, DVT, health related quality of life.

10. Continued: Comparative Effectiveness of Combined Pharmacologic and Mechanical Thromboprophylaxis versus Either Method alone in Major Orthopedic Surgery:A Systematic Review and Meta-analysis • Results: Risk of DVT decreased with the use of combination prophylaxis versus pharmacological prophylaxis alone in patients undergoing total hip or total knee replacement surgery with a 95% confidence interval. • Limitations: Non-compliance. Insufficient evidence to evaluate all final health outcomes for this comparison of interest. Hip fracture surgery not included. • Recommendations: Further review needed to identify best options that have higher strength of evidence available. (Sobieraj et al, 2013)

11. Mechanical Compression Versus Subcutaneous Heparin Therapy in Postoperative and Post trauma Patients: A Systematic Review and Meta-Analysis • A computerized search as well as manual searches of MEDLINE and EMBASE were completed from 1966 to November 2008, exclusion criteria were added to selectively identify and fully review 41 articles. Sixteenof these studies were selected that met inclusion criteria for post surgical patients that had developed thrombotic complications. • These selected studies used randomized comparisons of the use prophylaxis with mechanical compression versus subcutaneous heparin in patients who had developed a DVT, PE, or bleeding.

12. Continued: Mechanical Compression Versus Subcutaneous Heparin Therapy inPostoperative andPost trauma Patients: A Systematic Review and Meta-Analysis • Conclusions: The findings of this article suggest that,in regards to prevention of postoperative blood clots,both methods of prevention are similarly effective.The findings also suggest that the use of Heparin has a higher rate of side effects associated with bleeding • Limitations: Non-compliance with the use of mechanical compression could have an effect on outcomes. Data was collected without blinding in the primary studies possibility that biases may have played a part in certain elements of this analysis. Variety of study designs. • Recommendation: The use of heparin should be carefully weighed against the increased risk of bleeding in the decision to use heparin rather than mechanical compression in post surgical patients. (Eppsteiner, et al., 2009)

13. Towards Evidence-Based Guidelines for the Prevention of Venous Thromboembolism: Systematic Reviews of Mechanical Methods, Oral Anticoagulation, Dextran and Regional Anaesthesia as Thromboprophylaxis • Conducted by researchers from the Health Care Research Unit at the University of Southampton, UK, and the Clinical Trial Service Unit and Epidemiological Studies Unit at the University of Oxford, UK in 2005to determine the benefits of three types of mechanical compression methods, two pharmacological methods, and a comparison of regional anesthesia versus general anesthesia, in relation to reduction of the incidence of DVT versus risks of bleeding complications with prophylactics use. • Data collected using a systematic search of various electronic databases including EMBASE, MEDLINE, BIOSIS, and Derwent, search of the Antithrombotic Trialists’ Collaboration database, and contacting of medication manufacturers and trialists.

14. Continued: Towards Evidence-Based Guidelines for the Prevention of Venous Thromboembolism: Systematic Reviews of Mechanical Methods, Oral Anticoagulation, Dextran and Regional Anaesthesia as Thromboprophylaxis Results: Meta-analyses of data results demonstrate the use of mechanical compression as a monotherapy reduces patient’s risk of DVT approximately by two-thirds; when used with a pharmacological intervention like low-molecular-weight heparin (LMWH) injections, the risk of DVT is reduced even greater to approximately one-half. Limitations: Only one-third of the trialists contacted by the authors of this study responded; potentially negatively affecting accuracy of study results and source of bias.There is the possibility the meta-analysis conducted in this study may contain hidden biases directly impacting effect sizes, suggesting qualitative findings are more reliable than quantitative.

15. Continued: Towards Evidence-Based Guidelines for the Prevention of Venous Thromboembolism: Systematic Reviews of Mechanical Methods, Oral Anticoagulation, Dextran and Regional Anaesthesia as Thromboprophylaxis • Recommendations: Study identifies the benefits of the use of more than one method of DVT prophylaxis.Future studies be conducted to take into consideration patient compliance with DVT prophylaxis and consideration for patient preferences for the mode of prophylaxis given. • Conclusion: Acombination of prophylactic methods, referred to as adjunct therapy,proves to be most beneficial for patients. (Roderick et al., 2005)

16. Application of Evidence After a thorough review of the four research articles discussed, the authors of this paper identified potential barriers to application of the EBP, developed a plan for implementation of the evidence-based practice (EBP), and discussed recommendations based on research findings. Barriers • Although pneumatic compression devices and subcutaneous anticoagulants have proven to decrease the risk or incidence of patients developing a blood clot postoperatively, barriers have been identified regarding the implementation of the EBP in the clinical setting. • There are rarely medical contraindications preventing patients from using mechanical compression devices, however there are still a number of medical diagnoses contraindicating their use including, peripheral artery disease, diabetic patients with fragile skin, and thrombophlebitis.

17. Continued: Application of Evidence • In regards to the use of LMWH postoperatively, an identified safety risk is patients suffering from a bleeding event. • According to Camporese et al. (2008) research study, 4.4% (29 of 657 patients) who received prophylactic LMWH postoperatively for 7 days suffered from an incidence of bleeding. However, it should be noted none of the bleeding events were life threatening, consisting of hemarthroses that in the worst cases required drainage or a delay in physical activity. Preference When considering the medical use of pneumatic compression devices or anticoagulation injections, the patient’s thoughts or perceptions relating to the proposed treatment can be considered a barrier.

18. Continued: Application of Evidence • Although mechanical compression devices can be very practical, one of the primary complaints reported by patients is leg discomfort; making it more difficult for the patient to agree to wear the PCDs as ordered, with a goal of 18 hours per day, if they find them uncomfortable. • Even after caregivers provide patients with education in relation to the prophylactic benefits of receiving LMWH injections, they may still refuse the medication. • Patients may report LMWH injections to be painful and experience localized bruising at the site of administration; although neither are considered serious side effects, the patient's perception may become negative and conclude the injection unbeneficial.

19. Continued:Application of Evidence • Patients may rationalize the need forLMWH injection based on their activity level; often concluding it may be unnecessary ifthey are out of bed walking. • Ultimately, patients in many situations will choose not to have aninjection based on their fears ofthe discomfort that may result from administration. • When caring for postoperative patients it is essential that the nurse properly educate the patient regarding medications they are going to receive and the treatment plan in entirety in order to ensure the patient can make an educated decision in regards to their plan of care. • Patients need to know the care they are being provided is evidence based and research supports better patient outcomes with the use of prophylaxis to prevent blood clots. (Roderick et al., 2005)

20. Conclusion andRecommendations Despite research results being varied in patient population, study methods and results, the RN in the practice of caring for postoperative adult patients at risk for deep vein thrombosis can still put this evidence into practice! • Multiple studies confirm that combination therapy is best. However, if the patient is at risk for bleeding make sure the physician is aware, ensuring that mechanical methods are still applied. • Ensure that your patient is on some form of thrombophylactic regime as studies show the efficacy of both. If there is no order, call the physician to address this! • Educate your patients with evidence based research on the benefits and success of DVT prevention measures!

21. References Camporese, G., Bernardi, E., Prandoni, P., Noventa, F., Verlato, F., Simioni, P., . . . Andreozzi, G. M. (2008). Low-molecular-weight heparin versus compression stockings for thromboprophylaxis after knee arthroscopy: a randomized trial. Annals of Internal Medicine, 149(2), 73-82. Retrieved April 12, 2013 from http://www.researchgate.net/publication/5226422_Low-molecular-weight_heparin_versus_compression_stockings_for_thromboprophylaxis_after_knee_arthroscopy_a_randomized_trial/file/d912f50c0989a570a8.pdf Eppsteiner, R., Shin, J., Johnson, J. & Van Dam, R. (2010). Mechanical Compression Versus Subcutaneous Heparin Therapy in Postoperative and Post trauma Patients: A Systematic Review and Meta-Analysis. World Journal of Surgery 34, 10-19 DOI 10.1007/s00268-009-0284-z

22. Continued References Roderick, P., Ferris, G., Wilson, K., Halls, H., Jackson, D., Collins, R., & Baigent, C. (2005). Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagualtion, dextran and regional anaesthesia as thromboprophylaxis. Health Technology Assessment, 9(49). Retrieved from https://fsulearn.ferris.edu/courses/1/XLIST_10167.201301/groups/_6633_1//_309275_1/mon949%281%29.pdf Sobieraj, D. M., Coleman, C. I., Tongbram, V., Chen, W., Colby, J., Lee, S., Kluger, J., Makanji, S., Ashaye, A., White, C. M., (2013). Comparative Effectiveness of Combined Pharmacologic and Mechanical Thromboprophylaxis versus Either Method Alone in Major Orthopedic Surgery: A Systematic Review and Meta-analysis. Pharmacotherapy, Volume 33, Number 3, 2013. Retrieved from http://0-onlinelibrary.wiley.com.libcat.ferris.edu/store/10.1002/phar.12