Clinical Trial Design and Methodology

This assignment delves into the critical elements of designing and conducting successful clinical trials. It explores various randomization techniques used to ensure unbiased outcomes, emphasizes the importance of appropriate data analysis methods, highlights ethical considerations inherent in research involving human subjects, and discusses effective strategies for maximizing participant retention throughout the trial.

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Evidence Based Practice

Evidence Based Research Practice
Part I
Answer One- Validity of the Trial - Yes
Most interactive aspect in conducting health research is participating in clinical trials which
patents volunteer themselves to participate in the test and ensure the test of efficacy and
safety as new medical interventions, (Baily, 2008). In this case study article the trial
experiment addresses the population of interest which are the hypertensive patients. Effective
research incorporates the use of data and biological aspects collected for disease assessments.
The intervention given here include the uses of drugs like antihypertensive drugs and
subjecting the patients in the research to different exposures and assessing their reaction,
(CHSR, 2008). The outcomes under this study have been established after the completion of
the study the outcomes have been compared with the general population. Thus I agree that the
trail study focused on the trail issue with regards to the population being investigated which
are the hypertensive patients suffering and ailing from hypertension. Normally great deals of
this research entail the analysis of the data, biological samples, (Braunstein et al, 2008). Now
days the research process is conducted through human samples as subjects just like the case
in the study. These clinical trials have shown positive result due to the treatment being
offered to the patients. They help in advancing medical care and ensure that right decisions
and treatments are utilised.
Answer Two- Randomisation of patients- Yes
Randomization in research has been used as the process of making something in random
without following any particular format or way. Random process has been established as the
process of sequence variables whose outcomes do not follow any particular probability
distribution. In experimental research it entails allocating experimental unit’s across the
different groups, (Domanski & Mackinla, 2009).
In this research article , randomization process has been undertaken through the allocated
drug assignment with the key aspects being the two drug regimes under study or being
investigated in the study. Randomization has been found to reduce the chances of
confounding factors occurrences through equalising factors or the independent variables that
may not be accounted for in the initial stage of experimental design process, (Suresh, 2011).
In the article double blinding of randomization process was practised during the trial periods,
however after the trial period elapse, the patients were unblended to the treatment
assignment. Of the 42, 418 subjects, a total of 33, 357 were randomly assigned to
hypertension drug regiment Chlorthalidone. It is evident that the researcher was privy to these
randomised subjects and treatment effect being subjected t them.
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Answer Three – Accountability of trail subjects at closure -Yes
The trial began with treatment of the different groups to different tests and follow up visits
were taken at 1,3,6,9 and 12 months and then after every four months later. It is notable that
outcomes were analysed using the intent to treat approach. After the final close out in the
year 2002, the treatment was discontinued and the participants subjects were unblended with
regard to treatment task.
In this article subjects were not just left alone. Interestingly, subjects were followed even
after four years after the completion of study. The method utilised for the post trial follow ups
was done using National Death index, social Security Administration and Center for
Medicare and Medicaid services so as to get accurate data.
The groups were analysed to the previous randomisation groups. This was evident with the
analyses of the baseline characteristics which were compared after the four years and the
initial characteristics of the subjects. Data of 36 months were utilised in follow up visits for
the subjects in the treatment strata. Hence with this kind of accountability for the subjects it
was easier for in identification and follow up purposes of the subjects, (Zweben et al 2009).
Thus with this kind of follow , the study subjects are worth contributing for further studies as
the subjects characteristics were kept on trail for such a long time thus ability of correlating
hypertensive disease with other state of health of the patients and its correlation to treatment
purposes. Thus this aspects follows effective planning of research protocols, effective data
collection, systematic tracking criteria for subjects which ensures high follow ups was
adopted, (Woolard et al 2004).
Answer four- Blind treatment- Partly
Normally subjects in controlled clinical set up trials often gain experience in studying the
provided treatment they receive through building the efficacy level through raising awareness
levels. However in contrast patients or subjects in blinded control do not learn after they are
included into research what they are being treated for in the study, (Kafantaris et al 2004).
Hence the aspect of ensuring that subjects are kept in blind spot throughout the entire phase is
a key element aspect of methodological process in research process.
In the research article the patients have blind treatment hence they don’t know what they are
being given as the medical treatment for coronary heart disease and it s reduction in the long
run. However, there is no assurance that the health care personnel in the study have been both
blind treat. Further the research personnel have not been blinded for the treatment of the
subjects. The researchers are aware of the treatment to the two groups provided with
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treatment in the study. Studies have shown that keeping the researchers and medical service
providers blinded to the treatment is key aspect in clinical research practice, however they is
need to inform the subjects and medical providers after research may not be beneficial as it
may pose risks and exacerbations of symptoms, thus affecting continual treatment process,
(Bladder 2005).
Answer Five – Similarity of groups - Yes
Randomised controlled trails have been found out to be most efficient methods of
determining cause and effect of relationship that exists between intervention and outcome.
This enables in strengthening the strength of the research process. Its strength normally lies in
the randomisation criterion followed which is unique to the kind of research, (Concarto et al,
2000). In randomised trials subject are randomly assigned to groups which were evident in
this research article. Random allocation is geared towards ensuring that intervention and
control groups are similar in all basis. The treatments in this case are treatment with similarity
but produces different effects.
To ensure this corresponding similarity of the subjects, all participants in the study were
women and men aged over 55 years with either stage 1 or stage 2 hypertensive. All the
subjects had either one additional coronary heart disease factors. Other aspects of similarity
were not highlighted in the research paper. The key aspect of the rearch article is the
randomisation effect which ensures that intervention and control groups are similar in all
aspects.
Answer 6 – Treatment of groups -Yes
The underpinning aims of scientific research are geared at contributing to development of
human knowledge and the rigorous planning and information processing. It entails aspects of
investigation, observations and experiments which uses variety of tools such as group’s
treatments. Group treatment in scientific assessments controls enables the Assesment of the
different effects of tested factors in the experimental study, (Gersten et al., 2005).
In the research article, the groups were given equal treatments in the sense that one group
was given amildopine and similar number of participants was treated with lisinopril, thus this
concludes that the groups were treated equally.
Answer 7 – Treatment Effect
Outcomes effects of treatment process included the analysis of intent to treat approach
outlined four outcomes. the four major outcomes under investigation included all cause
mortality, fatal and non fatal stroke, combined coronary heart disease and combined
Cardiovascular diseases others included end stage renal diseases, cancer diseases occurrences
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Evidence Based Research Practice
and individual aspects of health.
Primary outcomes for the study were not clearly specified however the mentioned broader
aspects were identified with no specific outcome being at the centre of investigation.
Effective developed outcomes in research are essential in ensuring that implications of the
research are clearly articulated. Having a clear outcome objective is essential in ensuring that
the hypothesized treatment effect answers the research questions in the study. Thus collection
of outcome data is essential in ensuring that treatment outcome for the groups are taken into
consideration. Thus for effective outcome measure, there is need for reliability, validity and
variability assessments.
In the research article the results of the four specific outcomes under study included CVD
were significantly higher in the Lisinopril treatment when compared with the other treatment
effect of chlorthalidone, further heart failure cause of mortality among patients were
significant in Lisiniopril treatment at HRs: 1.10, p<0.001 and 1.38, p<0.001 respectively.
Significant effects were felt in Lisinopril treatment rather than the other treatment effect of
chlorthalidone comparison for CVD and CHD mortality with HR=0.88, p=0.04 and 0.84,
p=0.04 respectively.
Answer 8 – Precision of treatment
Precision in experimental research process entails the closeness of measured values to
specific or standards values. Precision hence refers to the reproducibility of set of measures.
Measure of precision is essential in ensuring that the experimental value and actual value
errors are minimised at all costs. Thus in essence it is the accuracy of closeness of a measured
value to its actual value.
In the research article precisions measure entailed the usage of the confidence levels limits.
In measuring the outcomes of treatment effects, confidence intervals of 95 % was
continuously used in the assessing the tests done. The significance for CVD mortality were
that at 95 % CI it was found that it had 0.88, while the CHD for cause mortality it was found
out to be 0.84 at 95% CI.
Answer 9 – Application of results – Yes
In tackling this aspect, there is need to ensure that the results can be replicated and
transferable in other health care settings. Thus in addressing this task, there is need to
consider the implementation of the replica. To do this deliberate replication of the study
procedures forms the key basis and enable the strengthening of evidence and correct
limitations if any. With the confidence levels highlighted in the results analysis, this study
findings can be applied to different settings, as it can adapt effectively.
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This is achieved with the effective follow ups of the study participants for such a long time
which as indicated in the study findings shows more than 6 years follow up and results were
still obtainable for the study. The patients covered in the article are close to 9,800 which is an
adequate representative and average population size. The size differential for this is to
measure effectively the effect of treatment on the population or study participants. This result
can applied to the local population as the confidence level used in data analysis quantifying
the replication and utilization of study findings.
Answer 10 -Importance of clinical outcomes- Yes
The treatment options for the diseases are effective in prevention of CVD, Coronary heart
disease, mental and heart stroke. Other studies have been to affirm what this research has
found out. The international verapamil- Trianolapril in the experimental studies showed that
medical interventions often have sustained strategy to mitigate and prevent death and major
cardiovascular diseases. However in this research article there needs to be incorporation of
the correlation of these major four outcomes of diseases which is under experimental
treatment .Treatment case studies have been found to effective in offering treatment
management. The outcomes found out in the research were thus important in servicing the
general population suffering from such diseases.
Answer 11 benefits are worth harm and cost
Treatment of cardiovascular and other health outcomes are crucial in management of health
outcomes. Care and management process of CVD, CHD and other related disease is essential
in ensuring that health of the population is achieved. Benefits involved are that they help in
ensuring that there is an extended quality of life thereafter for patients diagnosed with
hypertension and other related disease which are related to health care outcomes. Thus the
benefits of understanding the basic action of the drugs are essential in ensuring that the drugs
are effective in managing various outlined diseases such as hypertension and other related
diseases.
Part II
Barriers in implementing and enabling in implementing evidence based practice
The use of evidence based practice has been used as a strategy to integrate and evidences
with regard to well designed studies that inco-operate client assessments which are geared
towards providing safe, better care outcomes which aim at lowering cost of health among
patients diagnosed with hypertension. Thus evidence based approach is a problem based
practice which leads to enhance quality of care which leads to quality care provision, (James
et al., 2014)
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Evidence Based Research Practice
In the provision of this health care service, nurses have been at the fore front in ensuring that
promotion of health care is achieved and better health outcomes are achieved among the
population. The use of scientific evidence and research knowledge has enabled the
integration and ensuring better health outcomes.
Research has shown that organizational challenges have been a challenge in improving the
health outcomes of individuals. Education barriers have been a factor in implementation of
evidence based pr5actice. Barzilay et al, (2012), has shown that academic qualification and
level are important factors in the implementation phase of evidence based practice. Thus
there is need for improving the practical aspects of the nurses to be improved as they are key
towards the implementation of evidence based practices. The nursing role in issue based
practice is effective in delivering health services. This is in-lined with key objective of
improving health services they provide to the patients and the public.
Health care practitioner’s ability to utilise evidence have been occasioned by the lack of the
ability of critical appraisal of research process. This has been evident in the lack of research
evaluation skills, inability to access to journals and inability to get support for those in
hospitals exemplifies the barriers of effective nursing practice. This factor has been
compounded by the inadequate skills in carrying out the research process, lack of support and
the organizational framework of implementing evidence based practices in health care
delivery, (Cushman et al., 2012).
The utilization of the evidence being geared towards increasing precision, relevance and
accuracy, there is need to improve the environmental conditions of providing the car services.
Lack of conducive environment for care provision has been an hindrances in implementation
of evidence based practice. Lack of access to best research evidence with applicable rational
e for health care have been an factor in ensuring that key health practice are implemented.
Often nurses lack the critical skills and reflective purposes in ensuring that rationale
interventions are applied in the health care practice.
Important aspects as it relates to hypertensions medication and the rational used
Care practices are essential in ensuring lowering the elevated in blood pressure and its care
approach is geared towards improving CVD morbidity and mortality. Management practices
have been implemented to ensure care process are offered in ensuring that complications
associated with hypertension are managed. The use of diuretics has been effective approach
in anti hypertensive care. They re essential in lowering the systolic blood pressure in patients.
These drugs help sin eliminating sodium and water from the body, which later decreases the
blood volume so that the heart pumps less blood. The use of Amylodipine has been effective
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in treating blood pressure which is geared towards preventing heart diseases and strokes and
management of angina, (Mancia et al 2009).
Common side effects associated with the drugs compared to the other medication include
experiences of swelling, tiredness, abdominal pain, nausea and lowering blood pressure
among patient. It’s safety with regard to pregnancy or breastfeeding. Thus care is paramount
when administering these drugs especially to liver problems and elderly individuals. Effective
practice has been adopted with the multiple uses through combining Medicare with
combination therapy with other medications,
(James et al 2014).
Contraindications have been observed in provision of these drugs to the patients. In extreme
conditions such as the unstable angina among patients, Amilodopine causes cardiac
contractility. Patients who have hypotension have reduced exacerbated which leads to heart
failure. There is need for indentifying patient with liver function so as to manage
complications.
The use of Chlorthalidone as a thiamine diuretic effect have been found to have longest effect
at therapeutic levels and hypertension and edema . The drug has been used in combination
with other medications in improving the state of antihypertensive drugs and the adjuvant drug
for cardiac insufficiency patients, (ALLHAT, 2002). Chlorthalidone mechanism of action
involves prevention of reabsorption of sodium and chlorides by inhibiting the sodium and
chloride ions, however this has shown to increase reduce of hypo kalemia and hypo
choleramia and mild alkalosis hence showing Chlorthalidone being the best treatment
approach for hypotension and reducing the complications associated with the diseases. This
has been supported by studies which state that the adoption of ALLHAT(Anti Hypertensive
and Lipid Lowering Treatment) and coronary heart diseases are essential therapy in ensuring
that hypertension care is achieved, (Alderman et al., 2016).
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