Differentiating Statistical Output for Data Analysis

Evidence-based practice is widely recognized to improve healthcare quality and patient outcomes. This approach involves the utilization of current research to inform nursing practice as opposed to the traditional methods that rely on beliefs (Chien, 2019). It is essential for nurses to build their body of knowledge to ensure care delivery is standardized. In addition, the utilization of evidence from research can help to improve clinical patient outcomes, and quality of healthcare, and decrease healthcare costs (Chien, 2019). This paper deals with the utilization of evidence from current research to inform clinical decisions. The key sections that will be discussed include the identification of clinical questions, evidence-based quantitative research study, description of the study, evaluation of outcomes, and the application of this evidence to nursing practice.

Identification of Refined Clinical Question

The clinical question of focus in this discussion deals with analyzing the effectiveness of aspirin therapy in managing myocardial infarction. Aspirin is a known drug that has been used to immediately manage symptoms of cardiovascular disease through its action on platelet activation and aggregation (Djarv et al., 2020). Although this drug is supported to manage acute symptoms of cardiac disease including ST-elevation myocardial infarction (STEMI), there is a debate on its early versus late use. Several studies exist to explain the benefits of initiating aspirin therapy before hospitalization while others find it essential to delay aspirin administration. To investigate this problem, a PICOT question was generated, and searching for relevant evidence from Cochrane, PubMed, and the National Institute of Cardiovascular Diseases databases was initiated.

 PICOT Question

In adult patients presenting to the emergency department with suspected myocardial infarction, does the immediate administration of aspirin, compared to delayed administration, result in a decrease in mortality rates and improvement in cardiac outcomes, within the first 24 hours of presentation?

Application of Strategic Leadership and Future Delivery Models

Summary of Database Used

A literature search for relevant articles discussing the use of aspirin in managing myocardial infarction was done using three databases. The first database was the Cochrane Library which is well-known for its publication of systematic reviews and meta-analyses. This database revealed articles that focused on the use of aspirin to manage myocardial infarction at different stages alongside other common medications. For example, the database was used to locate an article that discussed the pretransfer administration of aspirin and the impact of this medication on angiographic outcomes for patients with ST-elevation myocardial infarction. In this single-center observational study involving 326 patients, it was observed that patients who received pre-transfer aspirin had higher rates of achieving TIMI-3 flow at the first angiogram (Yamada et al., 2024). The study showed that pretransfer aspirin therapy was associated with early restoration of coronary blood flow in patients with STEMI.

PubMed is another database that was used to locate research articles focusing on the management of STEMI using aspirin therapy. This database offers a vast repository of research articles, clinical trials, systematic reviews, and meta-analyses. One of the articles found in this database was a systematic review that analyzed early versus late administration of aspirin to manage chest pain related to myocardial infarction. The systematic review showed that early administration of aspirin is associated with increased survival compared to late administration at seven days (Djarv et al., 2020). Another article found in this database discussed the benefits of prehospital administration of aspirin and nitroglycerine in patients with acute coronary syndrome. The systematic review found aspirin therapy to be important in reducing 30-day and one-year mortality compared with no administration (Nakayama et al., 2022). This database provided high-level evidence articles that could be used to inform nursing practice change.

The National Institute of Cardiovascular Diseases is a web resource that promotes clinical research on cardiovascular diseases like myocardial infarction. This database was used to locate the research article dealing with the early use of aspirin to manage ST elevation in patients with myocardial infarction. The prospective study examined 657 patients and found that those who received aspirin before hospitalization experienced decreased length of hospital stay (Mal et al., 2023). These three databases were used to locate relevant literature dealing with the topic of myocardial infarction. The evidence found from these databases was current and sufficient to guide the medical and nursing management of patients with STEMI before and during hospitalization.

Description of the Evidence-Based Article

The identified article is a systematic review that discusses the effects of early versus late administration of aspirin for non-traumatic chest pain. Chest pain is a common symptom that is observed in patients with acute coronary syndrome which entails myocardial infarction. The article begins with the provision of background information about chest pain and how it can manifest in both ST-elevation myocardial infarction and non-ST-elevation acute coronary syndrome. During the management of this problem, the administration of oral antiplatelet agents like aspirin to manage non-traumatic chest pain is well-known. During such episodes, recommendations have it that aspirin should be initiated immediately to manage symptoms and prevent deterioration of the patient’s condition (Djarv et al., 2020). However, there is a debate on early versus in-hospital aspirin administration upon prescription by the doctor or confirmation of STEMI diagnosis.

The systematic review was conducted to establish the effective timing of aspirin administration for non-traumatic chest pain. A PICO question was used to guide the study to ensure outcomes could be measured. The study was designed to answer the question: Among adults with non-traumatic chest pain, does early or first aid administration of aspirin compared to late or in-hospital administration of aspirin change outcomes of survival, complications, incidence of cardiac arrest, cardiac functional outcome, infarction size, or resolution of chest pain? (Djarv et al., 2020). This article is quantitative because of the research question generated and the research methodology employed. For instance, the research used the approach of data collection, statistical analysis, and evaluation of outcomes based on numerical data. The study utilized both randomized controlled studies and non-randomized controlled trials to generate findings.

Errors Analysis

Errors analysis is an approach used to determine the negative aspects of research on the aspects of methodology, analysis, interpretation, and presentation. The methods used in this article are according to the required guidelines. The systematic review was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions, and reporting occurred through the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist (Djarv et al., 2020). In addition, the researchers registered the protocol with The International Prospective Register of Systematic Reviews (PROSPERO). Secondly, the inclusion and exclusion criteria are well-defined and applied consistently in the research. The study included adults aged 18 years and older with non-traumatic chest pain, oral aspirin administration during the first aid phase or administration within two hours from onset of pain, and administration in the late phase which involved two hours after onset of chest pain. The systematic review excluded studies that involved traumatic chest pain, those involving intravenous aspirin therapy, case series studies, and unpublished trials or protocols.

The systematic review used an effective search strategy to locate relevant studies for analysis. The researchers utilized the Medline (OVID interface), Embase (OVID interface), and Cochrane databases to locate articles published until 2019. To eliminate the risk of bias, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used (Djarv et al., 2020). The results of all the studies included were accurately interpreted and their limitations were acknowledged. Overall, the study is well-organized and written without grammatical errors. The tables provided are well-labeled and explained. The researchers have also explained the implications of the study findings among individuals with non-traumatic chest pain.

Summary of the Case Study (RCT)

The randomized controlled trial was conducted to determine the efficacy of aspirin therapy and streptokinase in managing myocardial infarction when given at different stages of treatment. The approach used in the study included the recruitment of patients from different hospitals and countries. The randomization process involved phone calls with no forms (Djarv et al., 2020). Details recorded included the patient’s age, planned hospital treatment, and vital signs. The recruitment process was done using a computer system that determined patients who were in the active treatment pack and placebo group. The eligibility criteria involved patients who were within 24 hours suspected to have myocardial infarction with no clear indication for aspirin or streptokinase therapy (Djarv et al., 2020). The fundamental criteria was that the responsible physician was not sure if a patient was indicated for aspirin therapy or streptokinase.

The study population upon recruitment of patients included 17,187 participants from 417 hospitals in 16 countries. The countries included Germany, Belgium, Spain, Austria, France, and Switzerland among many others. Half of all the patients were allocated randomly to receive aspirin therapy 162.5 mg taken orally while the other half were allocated to receive streptokinase 1.5 million units (Djarv et al., 2020). The aspirin group was further divided into half with one group receiving aspirin therapy while the other received enteric-coated starch tablets as a placebo. The streptokinase group was also divided into two with one group receiving the actual drug and the other group receiving placebo infusion. The study was only to be interrupted if the physician was sure which type of therapy the patient was to receive.

Statistical methods were used during the study to determine the efficacy of treatment. Three specific criteria were used and this included analysis of mortality during the first week of therapy, during the entire period, and the effects of aspirin after one month. The odds of changes in deaths were used to analyze the mortality rate and odds ratio alongside standard deviation calculations used to statistically record findings. The study lasted for two years and it involved a large number of patients which was good for generalization. More positive results were observed in patients who received streptokinase therapy compared to the aspirin group. Focussing on the aspirin therapy group, 94% of the patients continued therapy throughout the hospital stay. The compliance rate of treatment was estimated to be between 90 to 95%. It was observed that the administration of aspirin therapy typically avoided 25 out of 1000 deaths among patients with suspected acute myocardial infarction (Djarv et al., 2020). In addition, continuation of this therapy could further prevent 20 out of 1000 deaths.

Evaluation of Study Outcomes

The outcomes from the randomized controlled trial can be evaluated using specific measures like vascular mortality rates, overall rates of mortality, and risk for adverse events. Given the administration of aspirin therapy to the actual experimental group, vascular deaths occurred in 9.4% of the patients compared to 11.8% of the placebo group (Djarv et al., 2020). The researchers determined these findings to be crucial because they demonstrated a significance of less than 0.00001 with a 95% confidence interval ranging from 15% to 30% (Djarv et al., 2020). The results also indicate that administration of aspirin therapy lowered vascular mortality after hospitalization. There were a total of 25 deaths that occurred in the aspirin group compared to 39 among patients who received the placebo later after treatment.

The second aspect of outcome evaluation focuses on other clinical events that resulted from treatment. Firstly, bleeds requiring transfusion were reported in 0.4% in both the aspirin and placebo groups (Djarv et al., 2020). There were no specific excesses of cerebral hemorrhages that were reported from the study. The administration of aspirin also demonstrated significant effects on the reduction of reinfarction, cardiac arrest, and stroke (Djarv et al., 2020). Early deaths from these adverse effects of myocardial infarction were insignificant. Overall, aspirin administration resulted in a significant reduction in reinfarction and stroke.

The study outcomes can also be evaluated based on the combination of aspirin therapy with streptokinase. The mortality rate among patients allocated the combination of these agents was significantly less compared to the placebo groups. After five weeks of therapy, there were significant differences in vascular mortality, including both early and late deaths (Djarv et al., 2020). Non-vascular deaths were a bit lower in the treatment group compared to the placebo group. Although co-administration of these medications reduced mortality rates, there was no significant data to support co-administration of the drugs. Regarding the aspect of early versus late administration of aspirin therapy, aspirin produced similar-sized reductions in mortality (Djarv et al., 2020). This outcome shows that aspirin can be administered in either stage of treatment during the management of myocardial infarction.

The outcomes from the study indicate varied findings regarding the administration of fibrinolytic therapy and antiplatelet therapy to manage myocardial infarction. The administration of streptokinase led to reduced vascular mortality at five weeks (2p=0.02) and after five weeks (2p=0.004) (Djarv et al., 2020). The study also found a significant reduction in mortality when streptokinase was administered within 6 hours of pain onset compared to later administrations. The use of aspirin therapy indicates that low-dose aspirin started immediately can avoid 25 out of 1000 deaths in patients with suspected myocardial infarction (Djarv et al., 2020). Continuation of antiplatelet therapy also had significant reductions in mortality and other complications of myocardial infarction.

The systematic review supports the findings from the RCT given the inclusion of findings from non-RCT studies with a few deviations. For example, conflicting results were observed for critical outcomes of complications and cardiac arrest. Aspirin therapy was observed to cause in-hospital cardiac arrhythmia, although it did not result in significant deaths. The study also reports outcomes related to overall survival rates within 7 days, 30 days, and 1 year of treatment. The study reports higher survival rates associated with early administration of aspirin compared to late administration at various time points. An outcome that did not have sufficient evidence from all the studies was the recommended dose of aspirin. The studies indicate that the optimal dose of aspirin and frequency of dosing remain uncertain. In the RCT, the administration of 160 mg/day produced similar results to long-term trials that administered 300 to 1500mg/day (Djarv et al., 2020). The study shows that higher doses have severe adverse effects and do not appear to be effective.

Validity and Reliability of the Study

The validity and reliability of the study can be analyzed based on the study methodology, sample size, and outcome measures. The study is a randomized controlled trial which is considered a gold standard approach to evaluating treatment outcomes. Randomization helps to minimize selection bias and ensure that the groups are comparable at the baseline. The use of randomization and minimization techniques helps ensure that treatment groups are balanced concerning important prognostic factors. This enhances the internal validity of the study by reducing confounding variables. Secondly, the study involved a large sample size involving 17,187 patients from different countries. The utilization of the large sample size contributes to the reliability of the study and the follow-up of patients for over three years allowed for assessment of long-term outcomes. The longer follow-up duration enhances the external validity of the study by providing insights into the durability of treatment effects over time.

The statistical analysis of the research is rigorous, with appropriate methods used to analyze data. For example, the odds ratio was used to report changes in the odds of death. The odds ratios were then given at a 95% confidence interval and appropriate standard deviation measures (Djarv et al., 2020). Two-sided p values were cited in both study groups to stress significant outcomes. The reliability of the study can also be represented by reporting of adverse events that occurred upon treatment. For example, the outcome measures include bleeding and cerebral hemorrhage indicating transparency and completeness of the study (Djarv et al., 2020). Lastly, the study population and setting can be used to generalize findings. The study included many patients from several hospitals across many countries ensuring the generalizability of the findings.

Application of Evidence

The initial diagnosis of myocardial infarction and decisions about acute treatment have long depended on the physician’s judgment and clinical expertise. However, evidence from the RCT included in the systematic review shows that aspirin therapy is efficient in managing symptoms of myocardial infarction. The evidence from this study can be used for clinical decision-making to manage non-traumatic chest pain in patients with suspected MI. For example, early administration should be prioritized as part of first aid management to improve patient outcomes in terms of survival rates (Nakayama et al., 2022). The researches indicate that early administration has beneficial effects on the short-term and long-term survival of patients with myocardial infarction.

The findings from this review can be used to guide the refinement of emergency response protocols for patients with chest pain and suspected myocardial infarction. Emergency departments and pre-hospital care settings may consider updating their protocols to emphasize the early administration of aspirin for patients with suspected MI (Mal et al., 2023). In addition, this review provides knowledge to family members and patients regarding the early use of aspirin for non-traumatic chest pain. Apart from these implications that positively affect patients, the evidence from the review can be used to guide further research. For instance, the review indicates that there is no known therapeutic dosage for aspirin and its impact on specific patient populations. The RCT recommends low dose aspirin dosage of about 160mg/day but further research should be done to support this evidence.

Level of Evidence

The certainty of evidence from the review can be rated as high-level because of the RCT. The RCT provides level I evidence making the findings highly reliable. The review also included two non-RCTs that focused on the use of aspirin to manage STEMI. However, the risk for bias observed in these two non-RCTs makes the strength of outcomes questionable.

In conclusion, a study evaluating the use of aspirin to manage myocardial infarction demonstrates robust findings supported by a randomized controlled trial design, large sample size, and rigorous statistical analysis. Early administration of aspirin, particularly within the first two hours of onset of non-traumatic chest pain, may improve survival outcomes in adults suspected of acute myocardial infarction (Djarv et al., 2020). However, further research is warranted to address the identified limitations, and clarify optimal dosing and timing strategies.

References

Chien L. Y. (2019). Evidence-based practice and nursing research. The Journal of             Nursing Research : JNR, 27(4), e29.          https://doi.org/10.1097/jnr.0000000000000346

Djarv, T., Swain, J. M., Chang, W. T., Zideman, D. A., & Singletary, E. (2020). Early or first aid administration versus late or in-hospital administration of aspirin for non-traumatic adult chest pain: A systematic review. Cureus, 12(2), e6862. https://doi.org/10.7759/cureus.6862

Mal, V., Ahmed, R., Asad, A., Batra, M. K., Ammar, A., Kumar, R., Hakeem, A., Khan, N. U., Sial, J. A., & Saghir, T. (2023). Early use of aspirin after symptoms in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention. Pakistan Heart Journal, 56(1), 17-21. https://doi.org/10.47144/phj.v56i1.2393

Nakayama, N., Yamamoto, T., Kikuchi, M., Hanada, H., Mano, T., Nakashima, T., … & Nonogi, H. (2022). Prehospital administration of aspirin and nitroglycerin for patients with suspected acute coronary syndrome―A systematic review―. Circulation reports, 4(10), 449-457.

http://dx.doi.org/10.1253/circrep.CR-22-0060

Yamada, R., Horikoshi, T., Nakamura, T., Uematsu, M., Yamaguchi, K., Kobayahi, T., … & Sato, A. (2024). Pretransfer aspirin administration and its impact on angiographic outcomes for patients with ST-elevation myocardial infarction. International Heart Journal, 65(1), 21-28. https://doi.org/10.1536/ihj.23-389