Comparison Of Efficacy Of Antiplatelets And Anticoagulants In Reducing Recurrence Of Stroke

Discuss about the Nursing Interventions and Clinical Skills.

Accountability of all patients at end of trial

The article discussed a Randomized Controlled Trial on the comparison of the efficacy of antiplatelets and anticoagulants in the reduction of the recurrence of stroke. The trial sought to find out whether one approach of treatment was more effective than the other in reducing the recurrence of stroke. The discussion provided a clearly focused issue of research whereby the problem under study, the intervention, the comparison, and the outcome of the trial was clearly discussed (Amonette, English and Kraemer, 2016). The problem under the study trial was stroke in individuals with extracranial carotid and vertebral artery dissection. The intervention and the comparison were antiplatelets and anticoagulants respectively. The two remedies of stroke equally fitted the trial because the study aimed at finding a solution in reducing the recurrence of stroke. Additionally, prevention of recurrent stroke was clearly discussed as the outcome of the study trial. From the discussion above, it is clear that the discussion in this article provided a clear information regarding the PICO components (Perry, Potter and Ostendorf, 2016). Since all the components of PICO were vividly discussed, the results of the trial can be considered valid.

Patients who had intracranial carotid or vertebral artery dissection with the occurrence of symptoms within the last seven days were enrolled into the study trial. Equally patients who had experienced stroke or transient ischemic episodes were included in the study. Evidence of dissection had to be done by MRI or magnetic resonance angiography or CT angiography. Randomization of the patients was based on the evidence of imaging of the dissection. The patients in the trial were allocated randomly to the treatment of either antiplatelet therapy or anticoagulant therapy. The randomisation of the assignment of the treatment was done by telephone randomisation service that was automated. The use of an automated telephone for random allocation of treatment ensured adequate concealment. According to O’Brien and Broughton-Pipkin (2017) the employment of randomisation study design in a study trial reduces bias. Therefore, since this study employed randomization design, the study can be said to be valid.

The study trial was conducted within a period of three months and the study was done to completion. Every participant in the trial was accounted for at the end of the study. The initial plan of the study was to enrol 250 participants who were all included in the intention-to-treat population. Before the database was locked, imaging of the study population was done for all the participants and dissection was confirmed in 198 patients. The 198 patients were included in the per protocol analysis although there was 1 drop out case reducing the number to 197 patients. The 1 drop out case was due to delayed randomisation because of a technical error. The accountability of the 1 drop-out case was well documented in the report. The report does not indicate any further drop-out case apart from the one above. The study does not indicate any case of the study participants not remaining in their randomized groups hence analysis of all the patients was done in their specific randomized groups. Crary and Groher (2016) discuss that accountability of all patients at the end of the trial reduces biasness thereby leading to a higher level of confidence of the study. Therefore, due to the very low drop-out case and the fact that the participants remained in the randomised groups during analysis, unbiased comparison of both the therapies was possible.  

Precision of the estimate of the treatment effect

Both the clinical personnel and the patients were aware of which drug allocation was given. Therefore, there was no binding for the clinical personnel. However, binding was done to the adjudication committee that was responsible for assessment of all primary and secondary endpoints. The absence of binding to the clinical personnel and the patients could pose a potential systemic bias and therefore interfere with the overall results (Scott-Brown, Gleeson and Browning, 2016). Equally, the knowledge of the allocated therapy by the patients and the clinical staff could lead to an intentional or unintentional change in the behaviour and attitude of both. The binding of the adjudication committee was necessary to avoid subjective evaluation and assessment of the results (Boutron, Ravaud and Moher, 2016).

Basement characteristics such as age, presentation of signs and symptoms, dissection site, period between symptoms, diagnostic imaging, and randomization were similar in all the groups. Similarity of groups at the beginning of the trial study is very key in preventing selection bias and to provide statistically significant results. The clinical and demographic features of the groups under study at the onset of the research are essential in giving comparability of additional information of the groups. If baseline characteristics are not similar, then comparison of the groups would not be easy and the validity of the results could be questioned (Carney and Gallen, 2014). Additionally, the possibility of implementing the evidence in a clinical set-up may be difficult if comparison cannot be done between the groups under study. Even if the comparison group is insignificant statistically, if the size of the sample is very small, the differences in the basement characteristics can be pertinent clinically.

Away from the experimental trial, the groups were treated equally. The follow-ups were done equally at 3 months after randomization. At this period, there was recording of data for the outcome and the occurrence of recurrent stroke and ischaemic attack in both the groups. Whenever it was possible, at the 3-month follow-ups, imaging was repeated by using magnetic resonance angiography or CT angiography to asses vessel recanalization for both the groups. The equal treatment in follow-ups was important because it ensured there was no possible bias. The authors reported that the clinical personnel had contacts with the patients because there was no blinding. The absence of blinding of both the patients and the clinicians could have posed a potential bias in the treatment of the groups (Faries et al., 2014). One group maybe be prone to better treatment than the other group because of the lack of blinding. Since it was at the discretion of the clinician to make a choice of which drug to administered to any patient, unequal treatment of the study groups could occur for example special attention may be given to one group against the other for some reasons.

The trial measured the primary endpoints and the secondary endpoints. The primary endpoint was evidently specified whereby ipsilateral stroke or death of any cause occurred within a period of 3 months of randomization in the intention-to-treat population. Secondary endpoints included; ipsilateral transient ischaemic attack, stroke, or death, or major bleeding. In the intention-to-treat population, ipsilateral stroke recurred in four (2%) of 250 patients: three in the antiplatelet group and one in the anticoagulant group. There was no occurrence of death and therefore the primary endpoint of occurrence of ipsilateral stroke was in three (2%) of 126 patients in the antiplatelet therapy and one (1%) of 124 patients of the anticoagulant therapy (odds ratio 0.335, 95% CI 0.006-4.233; p=0.63). In the per-protocol population, occurrence of stroke was in four (2%) of 196 patients and in four (3%) of 151 patients that presented with stroke. In the intention-to-treat group, ipsilateral transient ischaemic stroke occurred in one (1%) of 126 patients in the antiplatelet group and four (3%) 0f 124 patients in the anticoagulant therapy group.

The secondary endpoints did not significantly differ between the therapy groups because findings obtained from both the intention-to-treat population and the per-protocol group were similar. One major haemorrhage and additional two minor bleed occurred in the anticoagulant therapy group but not in the antiplatelet group. From the results obtained from the trial it is evident that the treatment effect was large and hence the trial can be relied upon (Doherty et al., 2016).

The exact confidence intervals (CIs) were calculated using the exact method of binomial (Clopper-Pearson). The effect of treatment of each group was compared by exact logistic regression (Strata, version 13). Other analyses were done with SPSS (version 20). Power calculations to approximate the size of sample for a conclusive third phase trial was done with the data obtained from the per-protocol group using an online power calculator. The calculations were based on both the primary and secondary endpoint of stroke, death, and major haemorrhage with a power of 0.8 and a p value of 0.05. With the power of 0.8 and confidence level of 0.05, it was calculated that a sample size of 4876 would be needed in each group. The estimate of the effect of treatment was precise in this study trial (Waljee, 2014). From the assessment of the size of sample and the precision of the effect of treatment, it is clear enough that this trial study is reliable and valid (Le et al., 2014).

Inasmuch as the critical appraisal of study trial indicates that the study was valid and reliable, the clinical outcome in the comparison of the efficacy of antiplatelets and anticoagulants showed that there was no significant difference between the two therapies. Despite the fact that there was more occurrence of strokes in the antiplatelet therapy group than the anticoagulant group, the difference was offset by a massive haemorrhage in the anticoagulant treatment group. However, with the small difference, the study can still be applied to local population. The study records very few limitations such as lack of inclusion of patients within 24hours of onset of symptoms as opposed to of 3.4 days because it would help in capturing strokes that were recurring early. The biases associated with Randomized Controlled Trials such as selection and systematic bias were hugely reduced (Guyatt et al., 2014). The study only records bias that could be caused by lack of blinding of the patients and the clinical personnel.

All clinically significant outcomes were considered in the trial. The clinical outcome of the study was that there is no significant difference in the comparison of the efficacy of the antiplatelets and anticoagulants. The authors reported that since the recurrence of stroke was very rare, a larger population size would be needed for a definitive study. The power calculation of the sample size based on the per-protocol data needed a very huge total sample size of approximately 10,000 patients which would be almost impossible to recruit. The authors further stated that the calculated sample size should be considered a rough approximation since the outcomes of the study were rare and the 95% confidence intervals for the endpoints were huge. The information given by the authors about the sample size could be an indication that a smaller sample size was used for this study which would have influenced the outcome. (Alshryda, Huntley and Banaszkiewicz, 2016). With the information above, it is clear that if other similar studies were done, then the outcome would significantly differ with the outcome of this current study.

Due to the fact that there was no significant difference in the comparison of the efficacy of antiplatelets and anticoagulants in this study, the study may as well not be used in the local population. The study cannot be applied to the local population because the outcome did not provide any new information to the area of research (Lipscomb, 2016). Clinical personnel may continue to employ any type of therapy that they have been using. There was no any treatment benefit and therefore the study was not worth the harms and cost. The huge haemorrhage by one patient in the study was not worth it.

Evidence-based practice is an essential part in clinical settings and should be embraced and implemented in practices whenever possible. Whereas implementing evidence-based practice in a clinical setting is essential, there are certain barriers and enablers that could influence the implementation of EBP. One factor that may influence the implementation of evidence at workplace is the type of culture present at the work place. Optimistic staffs that exhibit positive attitude, staffs that are supportive and ready for change are able to influence the implementation of evidence in practice (Hallberg and Richards, 2015). The ability of the staffs to access and asses evidence-based information is equally a contributing factor in implementation of evidencee (Douglas, Pacquiao and Purnell, 2018). When the staff is competent enough to be able to critically appraise a research paper, then introducing evidence to practice is probable.

The skills of the clinicians may affect the implementation of evidence whereby effecting change may take too long as the clinicians acquire new skills regarding the evidence. Another factor that may be potential barrier or enabler to implementing EBP is the availability of funds and resources (Guidet, Valentin and Flaatten, 2016). When funds are not available or enough in the clinical setting, new treatments may not be implemented. Local environment also plays an important role in the implementation of evidence-based practice in health care. Cases such as the advancement of local policy may affect the change needed in a clinical setting. Finally, the ethics, prospects, and concerns of patients may be potential barriers of enablers to implementation. Patients may refuse to use new treatments due to their cultural beliefs or spiritual beliefs.

My search question was to determine whether aspirin was more effective than heparin in the prevention of an occurrence of stroke. The study was a Randomized Controlled Trial whereby two different groups of patients were either treated to antiplatelets or anticoagulants therapy to determine the recurrence of stroke (Harvey and Land, 2016). The study was helpful in understanding the uncertainty that was presented concerning the type of therapy that was more beneficial compared to the other. Based on the critical appraisal of the paper, none of the therapies was beneficial over the other. The study outcome indicated that there was no significant difference in the comparison of the efficacy of antiplatelets and anticoagulants.

However, with further critical analysis of the paper, the authors noted that the calculated sample that would be used for a definitive study would consequently need a very large sample of approximately 10.000. The huge figure was dependent on the rare outcomes of the study and the huge 95% confidence intervals of the endpoints (VanderWeele, 2015). The information given by the authors about the sample size suggests that the study had a small sample (Chowell and Hyman, 2016). Based upon the fact that the smaller sample size may have influenced the outcome of the study, there may be a significant difference between the two treatment options if another research paper with a larger sample size was appraised.

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