Introduction
PICO is a structure for formulating a sound clinical research topic before conducting a study. It is a short word for the four components of a practical interventional foreground question. According to Harris and Turner (2018), the topic should specify the patient or demography to be studied, the treatment or intervention to be used, a correlation of one treatment to another (if relevant), and the anticipated consequence. These four components constitute the PICO model’s four aspects: Patient / Issue, Intervention, Comparison, and Outcome. The PICO process begins with a possible situation, where a question is derived that is pertinent to the situation and is defined so that discovering a solution is facilitated (Harris & Turner, 2018). After developing a well-framed question, scholars will be prepared to conduct a literature survey for facts to substantiate their initial PICO question.
Clinical Case
During a volleyball match, a 38-year-old female semi-professional athlete sustained a left lower extremity popliteal fracture. She was referred for diagnostic testing after being confirmed with a potentially painful deep vein thrombosis (DVT). After a duplex Doppler ultrasonography revealed DVT, the patient was hospitalized for anticoagulation (Warfarin, unfractionated heparin). After leaving the hospital, the patient maintained taking oral warfarin for 32 weeks. She went to her family doctor for sequential coagulation tests and ultrasonography scans periodically. The traumatic fracture was her sole main thrombotic health concern. After 12 months since the first DVT, the patient resumed contact sports, but she still had sporadic complaints of left lower leg discomfort and left knee swelling.
The patient’s previous clinical and familial history did not reveal a tendency of thrombotic or its associated risk factors. All these were considered non-contributory to the patient’s current problem. A magnetic resonance scan (MRI) of the left knee was performed several days following admission to confirm the presence of a fractured left knee meniscal ligament. This problem had been diagnosed previously. The final MRI radiological report revealed moderate joint edema with a bursal abscess.
Athletes frequently sustain vascular lesions when participating in a range of games. Trauma is among the most prominent etiology of deep vein thrombosis in the lower extremities. On the other hand, Athletic traumas concerning lower extremity painful DVT are rarely addressed, although this is not the case with the patient. Overall, during the preliminary medical evaluation, this assessment and the related risk factors should be explored.
Background
Joint replacement is a popular surgical intervention in orthopedics and among the most successful therapies for terminal hip joint dysfunction, especially among aging populations. Total hip arthroplasty (THA) is primarily used to relieve joint discomfort and impairment from hip joint illness, such as osteoarthritis (Yu, Wu & Ning, 2021). Every year, thousands of individuals worldwide have mechanical joint replacements due to osteoarthritis, bone cancers, and other disorders (Mazzolai et al., 2018). In other words, it is possible to reduce joint discomfort, enhance joint functionality, and repair deformities with mechanical hip replacement. The client’s hip joint functionality can satisfy the necessities of everyday living and enhance the quality of life with suitable postoperative physical activity.
Deep venous thrombosis (DVT) is a typical side effect following a hip replacement. According to Streiff et al. (2018), with an occurrence rate of up to 60%. DVT development in the lower limbs may worsen individuals’ symptoms, lengthen hospital stay, and raise medical costs (Al-Samkari & Connors, 2018). It can lead to pulmonary embolism if it slips free, and severe forms can result in fatality. According to the clinical recommendations, individuals who have had major surgeries like hip arthroplasty and have no evident bleeding susceptibility should take anticoagulant medicines within 24.
Anticoagulant therapy is recommended as it is non-invasive, cures the majority of clients without any apparent physical symptoms of DVT, has a minimal risk of side effects, and has efficacy statistics that show a reduction in disease and fatality. Unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) have been found to have reduced susceptibility to; recurrent DVT, pulmonary embolism (PE), and severe bleeding in meta-analyses of randomized studies (Cohen et al., 2019). Anticoagulant therapy can be administered orally or through injections. The efficacy of either form of intervention remains contentious, but subcutaneous injections have proven simple to administer with immediate impacts.
Accordingly, this PICO question seeks to investigate whether oral anticoagulants are as effective as subcutaneous injections in lowering susceptibility to deep vein thrombosis (DVT) after a joint placement. From this PICO question, I hope to determine whether DVT patients prefer oral anticoagulants to subcutaneous injections. If patients prefer the former to the latter, I hope to understand the reasons why. For example, current literature associates this with increased effectiveness in DVT treatment or ease of administration (self-management or self-care). The main search terms I intend to use include deep vein thrombosis, pulmonary embolism, hip/joint arthroplasty, hip/joint replacement, heparin, oral anticoagulants, and subcutaneous injections. I utilized three databases to identify the journals for the PICO question. These were: BioMed Central (BMC), Pubmed Central (PMC), and ScienceDirect.
Findings
There are numerous anticoagulant drugs used to treat DVT, most of which cause bleeding and other complications. In this regard, Nutescu et al. (2016) undertook a study to investigate the pharmacological properties of several anticoagulant medications used to treat DVT patients. The researchers intended to discover information that would help guide the selection of anticoagulant medicines based on their relevant risks, advantages, and pharmacologic properties. Because UFH is poorly metabolized orally, the researchers determined that subcutaneous (SC) injection or intravenous (IV) infusion are the optimal methods of delivery (Nutescu et al., 2016). They also discovered that IV treatment (with a bolus dosage) generates therapeutic plasma levels quickly and is the ideal route of dosing when anticoagulation is needed urgently.
Furthermore, Nutescu et al. (2016) discovered that contingent on the dosage, the bioavailability of UFH if administered SC varies from 30 to 70%. Thus, if the SC treatment method is employed to administer therapeutic amounts of the drug, larger doses of UFH should be administered. When UFH is administered by SC injection, the start of anticoagulation is prolonged by 1–2 hours; however, when administered IV, the start is quick (seconds to minutes) (Nutescu et al., 2016). The half-life of UFH depends on the dose and varies from 30 to 90 minutes, although large concentrations can last more than two hours. Similarly, the bioavailability of LMWHs after subcutaneous injection reaches 100%, according to the study (Nutescu et al., 2016). To this end, these findings provide evidence that while oral administration of anticoagulation has an immediate impact, it has a poor absorption rate compared to SC or IV delivery.
The research provides an adequate level of evidence that helps to answer the question. The opinions refer to medical practice standards that are evidence-based and based on systematic evaluations of RCTs, hence level 1. The researchers have compared many types of anticoagulation agents, including unfractionated heparin, low molecular weight heparins, warfarin, direct oral anticoagulants, direct thrombin inhibitors (DTIs), and factor Xa inhibitors. The study discusses these drugs extensively, including their subagents. Presently, few studies discuss various anticoagulants and their subagents. In this context, this research has added crucial information in an area that many scholars have ignored. A classic example is factor Xa inhibitors, whose effectiveness has not been researched extensively but included in the study. In this way, the study’s findings regarding oral and SC administration of anticoagulants are relevant in patients who develop DVT after hip replacement.
In contrast to healthy patients, anticoagulation in malignancy patients with DVT poses serious concerns, such as a higher bleeding risk and resurgence of DVT. Accordingly, Al-Samkari and Connors (2018) conducted a study to confirm emerging evidence indicating that direct oral anticoagulants (DOACs) are viable treatment alternatives for cancer patients. Based on their finds, when it comes to averting reoccurring DVT, DOACs are just as efficacious as LMWH (Al-Samkari & Connors, 2018). According to the researchers, some studies reported that subcutaneous injections of LMWH limited self-care. That is, while “they are the benchmark of care for the treatment of cancer-related DVT, their use necessitates once or twice daily subcutaneous injections, which can be a considerable burden for most malignancy patients who frequently need long-term anticoagulation” (Al-Samkari & Connors, 2018, p.1). DOACs provided the instantaneous start of the action, with the only disadvantage being their short half-lives. To this end, the researchers concluded that direct oral anticoagulants are the preferred treatment alternatives for cancer patients compared to subcutaneous injections.
Concerning the PICOT question, bone cancer patients are often at an increased risk of developing DVT. That aside, cancer patients and their families often experience a lot of burdens associated with expensive treatment costs. For this patient population, therapeutic interventions should simplify care and not complicate it. The researchers examined several randomized, open-label, meta-analyses, controlled, and multicenter trials on the topic. As a result, the level of evidence can be categorized as level 1. These studies use diverse methodologies such as RCTs and meta-analyses, which are based on different samples sizes. The researchers show that subcutaneous injections increase the treatment burden because they are administered at least once every day. This can be stressful for patients, which would potentially exacerbate their conditions. Thus, compared to the previous study, this study presents strong evidence that helps to support the PICOT question. They are highly relevant and beneficial since they provide evidence for the treatment and management of DVT using various anticoagulants among cancer patients.
The effectiveness of medical interventions can be affected by the level of patient compliance. Consistently, Di Benedetto et al. (2016) carried out a study to examine treatment adherence with orally delivered novel oral anticoagulants against subcutaneous injection following major orthopedic surgery. At the same time, the researchers aimed to determine the patient choice for oral vs. subcutaneous dosing. Two new drugs were rivaroxaban and dabigatran, whereas fondaparinux was the subcutaneously administered drug (Di Benedetto et al., 2016). The intake of the orally administered drugs was reported as the duty of the patient. This study’s findings revealed a high degree of adherence to medications taken orally and injected subcutaneously. Oral delivery was observed to be the chosen mode of treatment for 88 percent and 84 percent of patients, respectively, taking the new drugs. Interestingly, over 70% of individuals taking fondaparinux via subcutaneous injection preferred this approach over oral delivery (Di Benedetto et al., 2016). What this means is that each group favored its respective method of medication administration.
The study findings suggest no distinctive differences in the effectiveness of oral administration or subcutaneous injection of anticoagulants. From the study’s methodology and findings, it can be categorized as level 1 evidence. Essentially, the study is a randomized clinical study that sought to determine the rate of patients’ compliance with a given therapeutic intervention. To this end, the study findings can be generalized to the PICOT because it focuses on postoperative patients who are usually at an increased risk of DVT.
Conclusion
The evidence above shows that scholars are divided on whether oral Anticoagulants are as effective as subcutaneous injections in lowering the risk of deep vein thrombosis (DVT) after a joint placement. This can be attributed to the different methodologies and samples used in the studies. Nonetheless, none of the three studies explicitly proved that oral Anticoagulants are ineffective. To summarize, the incidence of DVT following THA is linked to a range of outcomes. The focus must be devoted to identifying the risk factors that cause DVT to enhance active intervention in medical practice. The health care practitioner should implement appropriate risk factor-targeted actions promptly. They should also assist patients in undertaking physical activities promptly to limit the occurrence of DVT. In this way, they boost the effectiveness of THA and raise patients’ life quality.
References
Al-Samkari, H., & Connors, J. M. (2018). The role of direct oral anticoagulants in treatment of cancer-associated thrombosis. Cancers, 10(8), 271.
Cohen, A. T., Berger, S. E., Milenković, D., Hill, N. R., & Lister, S. (2019). Anticoagulant selection for patients with VTE—Evidence from a systematic literature review of network meta-analyses. Pharmacological Research, 143, 166-177.
Di Benedetto, P., Vetrugno, L., De Franceschi, D., Gisonni, R., Causero, A., & Della Rocca, G. (2016). Patient compliance with new oral anticoagulants after major orthopedic surgery: Rivaroxaban and dabigatran compared with subcutaneous injection of fondaparinux. Joints, 4(04), 214-221.
Harris, C., & Turner, T. (2018). Evidence-Based Answers to Clinical Questions for Busy Clinicians. In Centre for Clinical Effectiveness, (pp. 1-32). Monash Health.
Mazzolai, L., Aboyans, V., Ageno, W., Agnelli, G., Alatri, A., Bauersachs, R.,… & Brodmann, M. (2018). Diagnosis and management of acute deep vein thrombosis: a joint consensus document from the European Society of Cardiology working groups of aorta and peripheral vascular diseases and pulmonary circulation and right ventricular function. European heart journal, 39(47), 4208-4218.
Nutescu, E. A., Burnett, A., Fanikos, J., Spinler, S., & Wittkowsky, A. (2016). Pharmacology of anticoagulants used in the treatment of venous thromboembolism. Journal of thrombosis and thrombolysis, 41(1), 15-31.
Streiff, M. B., Agnelli, G., Connors, J. M., Crowther, M., Eichinger, S., Lopes, R., McBane, R. D., Moll, S., & Ansell, J. (2016). Guidance for the treatment of deep vein thrombosis and pulmonary embolism. Journal of thrombosis and thrombolysis, 41(1), 32–67.
Yu, X., Wu, Y., & Ning, R. (2021). The deep vein thrombosis of lower limb after total hip arthroplasty: what should we care. BMC Musculoskeletal Disorders, 22(1), 1-6.