PICOT Question
For women with diabetes (P), does the use of low-dose aspirin on a daily basis (I) reduce the risk of cardiovascular events (O) within several years (T) in comparison with no usage of low-dose aspirin (C)?
Article 1.
| Full reference for article (APA Format) | Zheng, S. L., & Roddick, A. J. (2019). Association of aspirin use for primary prevention with cardiovascular events and bleeding events: A systematic review and meta-analysis. JAMA, 321(3), 277–287. Web. |
| Purpose | In their article, Zheng and Roddick (2019) examine the association of aspirin with cardiovascular and bleeding events in patients without cardiovascular disease in past medical history. The significance of their research is determined by the considerably high mortality rates from myocardial infarction and stroke in the United States (Zheng & Roddick, 2019). In addition, the investigation of the impact of aspirin for the primary prevention of cardiovascular events is significant as the potential benefits of this medication may be limited by an increased risk of bleeding. |
| Evidence Type | In general, this research implies the systematic review and meta-analysis of 13 trials. |
| Sample, Sample Size, and Setting | Trials involved 164 225 randomized senior patients without any cardiovascular events in past medical history (Zheng & Roddick, 2019).Every trial enrolled no less than 1000 participants with and without diabetes and had a follow-up period of at least 12 months (Zheng & Roddick, 2019). |
| Data Collection | A systematic search of Embase and PubMed by both authors was conducted on the Cochrane Central Register of Controlled Trials (CENTRAL) (Zheng & Roddick, 2019). The investigators examined and extracted data independently, and the final list of studies with the comparison of the aspirin therapy with no treatment was approved after discussion between them. |
| Study Findings | According to the results of the research, the use of aspirin reduces the risk of cardiovascular events and considerably increases the risk of bleeding events in comparison with the absence of treatment. |
| Limitations (State why the limitations) | The absence of information concerning the precise dosage of aspirin and poorly reported cardiovascular and bleeding events in patients with diabetes negatively affect the accuracy of the research. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. The findings of this comprehensive and detailed research are highly beneficial for health care providers who may inform patients about the consequences of the aspirin therapy for the primary prevention of cardiovascular events in order to improve the quality of treatment. |
Article 2.
| Full reference for article (APA Format) | Newman, J. D., Schwartzbard, A. Z., Weintraub, H. S., Goldberg, I. J., & Berger, J. S. (2017).Primary prevention of cardiovascular disease in diabetes mellitus. Journal of the American College of Cardiology, 70(7), 883-893. Web. |
| Purpose | The article by Newman, et al. (2017) is dedicated to the examination of various measures for the primary prevention of cardiovascular disease in patients with type 2 diabetes mellitus. In general, the authors summarize all guidelines and evidence for lifestyle and the management of cardiovascular disease risk factors for the prevention of cardiovascular events that may be regarded as the main cause of death in diabetes (Newman, et al., 2017). The impact of the use of low-dose aspirin was investigated in the domain of the prevention and risk reduction of cardiovascular disease in individuals with type 2 diabetes. |
| Evidence Type | The section of this research dedicated to low-dose aspirin may be defined as a clinical review of three major trials that examined the impact of this medication for the primary prevention of cardiovascular events. |
| Sample, Sample Size, and Setting | Three trials (the Early Treatment of Diabetic Retinopathy Study, the Prevention of Arterial Disease and Diabetes trial, and the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes trial) involved 3,700, 1,276, and 2,539 participants, respectively (Newman, et al., 2017). The population for all trials implied both male and female patients with type 2 diabetes mellitus, with and without cardiovascular events in past medical history. All studies compare the impact of aspirin therapy and no treatment and have a follow-up period of no less than 4 years. |
| Data Collection | All scientific statements end evidence were synthesized from the American Heart Association (AHA), the American Diabetes Association (ADA), and the American College of Cardiology (ACC) (Newman, et al., 2017). |
| Study Findings | According to the results of the research, for primary prevention, low-dose aspirin is beneficial for patients with diabetes with an increased 10-year risk of cardiovascular disease and without a substantial risk of gastrointestinal bleeding. |
| Limitations (State why the limitations) | Although the research may be regarded as comprehensive and detailed due to its focus on all measures that may be effective for the primary prevention of cardiovascular disease, the number of analyzed trials is considerably limited for reliable results. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. It may be substantively useful for clinicians who provide health care to patients with diabetes to improve the quality of treatment. |
Article 3.
| Full reference for article (APA Format) | The ASCEND Study Collaborative Group. (2018). Effects of aspirin for primary prevention in persons with diabetes mellitus. The New England Journal of Medicine, 379(16), 1529-1539. Web. |
| Purpose | The ASCEND Study Collaborative Group (2018) conducted the research dedicated to the use of low-dose aspirin for the prevention of initial cardiovascular events in patients with diabetes mellitus. The significance of this research is determined by the necessity to investigate the impact of aspirin for primary prevention that remains unclear in order to balance benefits and hazards. |
| Evidence Type | The quantitative research implies the description of a conducted trial. |
| Sample, Sample Size, and Setting | The trial focused on the comparison of aspirin therapy with placebo treatment and had a follow-up period of 7.4 years (The ASCEND Study Collaborative Group, 2018). Results were received from 15,480 participants randomly chosen from general practices or regional diabetes registers around the United Kingdom (The ASCEND Study Collaborative Group, 2018). All patients were with diabetes mellitus and without cardiovascular events in past medical history. |
| Data Collection | The trial was “designed and conducted by independent investigators in the Clinical Trial Service Unit at the University of Oxford” (The ASCEND Study Collaborative Group, 2018, p. 1530). During the follow-up period of the experiment, participants had been receiving appropriate capsules and tablets and questionnaires to record their condition and all adverse effects every six months. After 2,5 years, measures of weight and blood pressure and urine and blood samples were requested from 1800 randomly selected patients for statistical analysis (The ASCEND Study Collaborative Group, 2018). |
| Study Findings | The use of low-dose aspirin for primary prevention in people with diabetes helps to prevent serious vascular events. However, no evidence of the efficiency of aspirin for the prevention of cardiovascular disease was received at trial entry (The ASCEND Study Collaborative Group, 2018). At the same time, the medication caused major gastrointestinal bleeding events. |
| Limitations (State why the limitations) | Despite the fact that this research may be regarded as highly comprehensive, the accuracy of data may be challenged due to a “lack of full adherence to the regimen during the trial” from some participants (The ASCEND Study Collaborative Group, 2018, p. 1537). |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. Its results underestimate the efficiency of aspirin for primary prevention and may initiate positive changes in advanced medical practice. |
Article 4.
| Full reference for article (APA Format) | Kokoska, L. A., Wilhelm, S. M., Garwood, C. L., & Berlie, H. D. (2016). Aspirin for primary prevention of cardiovascular disease in patients with diabetes: A meta-analysis. Diabetes Research and Clinical Practice, 120, 31-39. Web. |
| Purpose | In this article, Kokoska, et al. (2016) examine the impact of aspirin on patients with diabetes to evaluate its efficacy and safety for the primary prevention of cardiovascular events, including myocardial infarction, stroke, transient ischemic attack, revascularization, and peripheral artery disease. |
| Evidence Type | The authors’ work implies the meta-analysis of six trials dedicated to the comparison of aspirin use with placebo treatment. |
| Sample, Sample Size, and Setting | Six trials involved 10,117 randomly chosen male and female participants with diabetes mellitus and without cardiovascular disease in past medical history (Kokoska, et al., 2016). The follow-up periods of studies ranged from 3,6 to 10,1 years (Kokoska, et al., 2016). |
| Data Collection | The search of the literature was conducted by the investigators with the use of theme-related terms (aspirin, cardiovascular disease, diabetes mellitus) to identify appropriate trials. Ischemic and bleeding events and study sample size were extracted and analyzed with the use of RevMan 5.2.7. (Kokoska, et al., 2016). |
| Study Findings | According to the results of trials, there were no differences in rates of atherosclerotic events, all-cause mortality, hemorrhagic stroke, and gastrointestinal bleeding between groups. The efficiency of aspirin for the primary prevention of cardiovascular disease in patients with diabetes remained unclear. |
| Limitations (State why the limitations) | This research did not provide innovative findings. In addition, the changing dosage of aspirin in different trials does not allow to make a relevant conclusion. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. It may initiate additional investigations to supplement the available researches and improve the quality of medical practice. |
Article 5.
| Full reference for article (APA Format) | Huang, W., Saver, J. L., Wu, Y., Lin, C., Lee, M., & Ovbiagele, B. (2019). Frequency of intracranial hemorrhage with low-dose aspirin in individuals without symptomatic cardiovascular disease: A systematic review and meta-analysis. JAMA Neurology, 76(8), 906-914. Web. |
| Purpose | The purpose of the research conducted by Huang, et al. (2019) is the assessment of the potential risk of intracranial bleeding associated with the use of low-dose aspirin for the primary prevention of cardiovascular events. Patients with cardiovascular risk factors, including diabetes, elderly age, and a low body mass index, are particularly vulnerable to the occurrence of cardiovascular disease (Huang, et al., 2019). |
| Evidence Type | The research implies the systematic review and meta-analysis of 13 trials that compare the impact of low-dose aspirin on the risk of major bleeding (Huang, et al., 2019). |
| Sample, Sample Size, and Setting | Randomized clinical trials involved 134,446 patients without cardiovascular disease in past medical history (Huang, et al., 2019). |
| Data Collection | Data were collected from the Cochrane Central Register of Controlled Trials, PubMed, Embase, and ClinicalTrials.gov databases (Huang, et al., 2019). A random-effect estimate was computed on the basis of the Mantel-Haenszel method (Huang, et al., 2019). |
| Study Findings | According to the results of this meta-analysis, the use of low-dose aspirin for the primary prevention of cardiovascular events increases the risk of intracranial hemorrhage, intracranial bleeding, intracerebral hemorrhage, subdural or extradural hemorrhage, and subarachnoid hemorrhage (Huang, et al., 2019). |
| Limitations (State why the limitations) | This meta-analysis requires an additional examination of the impact of low-dose aspirin in patients with cardiovascular risk factors, including diabetes, for more reliable results. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article may be regarded as useful for the examination of the PICOT question. Its results underestimate the efficiency of aspirin for primary prevention and may initiate positive changes in advanced medical practice to improve the quality of treatment and health care delivery. |
Article 6.
| Full reference for article (APA Format) | Lin, M., Lee, C., Lin, C., Zou, Y., Lu. C., Hsieh, C., & Lee, C. (2019). Low-dose aspirin for the primary prevention of cardiovascular disease in diabetic individuals: A meta-analysis of randomized control trials and trial sequential analysis. Journal of Clinical Medicine, 8(5), 1-13. Web. |
| Purpose | In their article, Lin, et al. (2019) examine the efficiency and safety of low-dose aspirin for the primary prevention of cardiovascular events in patients with diabetes. This severe chronic disease requires specific measures as cardiovascular disease is the major cause of mortality in these patients. |
| Evidence Type | The research implies sequential trial analysis and the meta-analysis of randomized control clinical trials (279 studies). |
| Sample, Sample Size, and Setting | Trials included 29,814 randomly chosen participants with type 1 and type 2 diabetes and without previous cardiovascular events and had a follow-up period of no less than 12 months (Lin, et al., 2019). |
| Data Collection | Data were extracted by two investigators from the Cochrane Library, Embase, and Medline databases according to a predetermined protocol and with the use of the Grading of Recommendation and Cochrane standards (Lin, et al., 2019). |
| Study Findings | According to the results of the research, aspirin may be regarded as beneficial for the primary prevention of stroke in senior patients (Lin, et al., 2019). At the same time, it increases the potential risk of non-fatal myocardial infarction, intracranial hemorrhage, and gastrointestinal bleeding (Lin, et al., 2019). |
| Limitations (State why the limitations) | Despite the comprehensiveness and reliability of the results of this research, its findings cannot be regarded as innovative. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. Its finding may be used by clinicians who provide diabetes treatment to improve its quality. |
Article 7.
| Full reference for article (APA Format) | Patrono, C., & Baigent, C. (2019). Role of aspirin in primary prevention of cardiovascular disease. Nature Reviews Cardiology,16,675–686. Web. |
| Purpose | In their article, Patrono and Baigent (2019) investigate the efficiency of low-dose aspirin for the primary prevention of cardiovascular events. The benefits of this medication for secondary prevention is clearly established as its efficiency outweighs all potential risks. However, low-dose aspirin therapy is frequently applied for the primary prevention of cardiovascular disease in patients with risk factors, such as diabetes, as well. That is why the evaluation of risks and benefits of aspirin is highly essential to reduce the negative consequences of treatment. |
| Evidence Type | The article implies the critical review of the results of three major trials (the ASPREE trial, the ASCEND trial, and the ARRIVE trial) related to the evaluation of the impact of aspirin use for primary prevention (Patrono & Baigent, 2019). |
| Sample, Sample Size, and Setting | All trials focused on the comparison of aspirin therapy and placebo treatment and had a follow-up period of no less than 4 years. They involved randomly chosen male and female patients with diabetes mellitus, elderly people, and individuals with multiple cardiovascular disease risk factors, though without cardiovascular events in past medical history (Patrono & Baigent, 2019). |
| Data Collection | Data for the analysis was extracted by investigators from the results of trials, and risk scores for major extracranial bleeds and vascular events were used to classify the results received from individual participants. |
| Study Findings | According to the results of all trials, low-dose aspirin therapy for primary prevention considerably increases gastrointestinal bleeding and negatively influences all-cause mortality (Patrono & Baigent, 2019). At the same time, the prevention of cardiovascular events remains insignificant. |
| Limitations (State why the limitations) | The number of analyzed trials is considerably limited for the reliable results of this research. In addition, the results cannot be regarded as innovative. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. It contributes to the development of new approaches to the treatment of cardiovascular events. For instance, coronary imaging and gastroprotectant therapy may be combined to reduce the potential risk of bleeding. |
Article 8.
| Full reference for article (APA Format) | Christiansen, M., Grove, E. L., & Hvas, A. (2019). Primary prevention of cardiovascular events with aspirin: Toward more harm than benefit – a systematic review and meta-analysis. Seminars in Thrombosis and Hemostasis, 45(5), 478-489. Web. |
| Purpose | Christiansen, et al. (2019) conducted their research in order to compare the safety and efficacy of aspirin for the primary prevention of cardiovascular events in healthy people and patients with diabetes. |
| Evidence Type | This study implies the meta-analysis and systematic review of 20 randomized clinical trials that examined the impact of low-dose for the primary prevention of cardiovascular events (Christiansen, et al., 2019). |
| Sample, Sample Size, and Setting | Trials included 144,930 healthy individuals with and without cardiovascular risk factors and 20,326 male and female patients with diabetes (Christiansen, et al., 2019). All participants did not have cardiovascular disease in past medical history. |
| Data Collection | Trials for the research was collected from the Medline database and reference lists without time restrictions. For analysis, data on safety (major bleeding) and efficacy (non-fatal myocardial infarction and cardiovascular death) were extracted. |
| Study Findings | In healthy individuals, aspirin substantially reduced the potential risk of non-fatal myocardial infarction, though increased major bleeding and had no effect on cardiovascular death (Christiansen, et al., 2019). In patients with diabetes, aspirin had no effect on non-fatal myocardial infarction and cardiovascular death though it considerably increased the risk of major bleeding (Christiansen, et al., 2019). According to the results of the research, aspirin could not be used by individuals, especially with diabetes, on a routine basis. |
| Limitations (State why the limitations) | Despite the comprehensiveness and reliability of the results of this research, its findings cannot be regarded as innovative. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. It may initiate additional investigations to supplement the available researches and improve the quality of medical practice. |
Article 9.
| Full reference for article (APA Format) | Capodanno, D., & Angiolillo, D. J. (2016). Aspirin for primary cardiovascular risk prevention and beyond in diabetes mellitus. Circulation, 134(20), 1579-1594. Web. |
| Purpose | Capodanno and Angiolillo (2016) conducted the research dedicated to the examination of the impact of low-dose aspirin for the prevention of ischemic stroke, non-fatal myocardial infarction, and other events in patients with diabetes. |
| Evidence Type | The study implies the critical, descriptive review of studies related to the use of low-dose aspirin for the primary and secondary prevention of cardiovascular events. |
| Sample, Sample Size, and Setting | The authors examined several randomized clinical trials dedicated to first and second prevention that compared aspirin therapy with placebo treatment. |
| Data Collection | Trials involved randomly chosen participants with and without cardiovascular events in past medical history. |
| Study Findings | According to the results of the review, the efficiency and safety of aspirin for primary prevention remained unclear as this medication has no effect on the reduction of myocardial infarction, ischemic stroke, and other cardiovascular events. In turn, low-dose aspirin is highly beneficial for second prevention as its efficacy overweighs potential bleeding. |
| Limitations (State why the limitations) | The articles’ periods of research were not specified, and that is why their results may be outdated. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article may be regarded as useful for the examination of the PICOT question. Its results are beneficial for advanced medical practice and may improve the quality of treatment and health care delivery. |
Article 10.
| Full reference for article (APA Format) | Santilli, F., Pignatelli, P., Violi, F., & Davi, G. (2015). Aspirin for primary prevention in diabetes mellitus: from the calculation of cardiovascular risk and risk/benefit profile to personalised treatment. Thrombosis and Haemostasis, 114(5), 876-882. Web. |
| Purpose | Santilli, et al. (2015) organized and conducted highly comprehensive research dedicated to the impact of low-dose aspirin for antiplatelet prophylaxis and the primary prevention of cardiovascular disease in patients with type 2 diabetes mellitus. |
| Evidence Type | This research implies the comprehensive critical review of available literature, including randomized clinical trials, retrospective analyses, meta-analyses, and prospective cohort studies. In general, more than 100 studies with approximately 800,000 participants were analyzed (Santilli, et al.,2015). |
| Sample, Sample Size, and Setting | Trials dedicated to the examination of the impact of aspirin therapy for primary prevention involved randomly chosen prevalently senior male and female patients with diabetes mellitus and without cardiovascular disease in past medical history (Santilli, et al.,2015). |
| Data Collection | Data was collected from the PubMed database with the use of theme-related terms (aspirin, primary prevention, prophylaxis, antiplatelet therapy, cardiovascular disease, diabetes mellitus). In addition, identified references were subsequently hand-searched in order to identify the location of other potentially useful sources (Santilli, et al.,2015). |
| Study Findings | For primary prevention, low-dose aspirin is beneficial for the reduction of the risk of non-fatal myocardial infarction (Santilli, et al.,2015). It has no effect on vascular mortality and stroke, and insignificantly increases major intracranial and gastrointestinal bleeding. In general, aspirin for the primary prevention of cardiovascular events in patients with diabetes may be regarded as the medication of choice (Santilli, et al.,2015). |
| Limitations (State why the limitations) | Despite extended follow-up and large sample size, a considerable number of trials addressed different aspirin regimens, widely different populations, and low event rates and could not provide reliable results. |
| Relevance to the PICOT and Implications for Advanced Nursing Practice | This article is relevant to the PICOT question as it includes the examination of all elements of the question. Its finding may be used by clinicians who provide diabetes treatment to improve its quality. |