Cohort Study in Healthcare Research: Ethical Considerations

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Healthcare Research: Principles and Practice

Table of Contents
Introduction......................................................................................................................................3
Section A.........................................................................................................................................4
A new medical phenomenon has recently emerged, and researchers are interested in following a
group of patients who have the illness to see how it progresses. A cohort study will be done.
Critically evaluate the key features of cohort studies and discuss why a cohort study would be
suitable for investigating the new medical phenomenon.................................................................5
What ethical issues would you need to consider when undertaking research with vulnerable
groups? Critically discuss how you would overcome the challenge of informed consent for one
of these vulnerable groups...............................................................................................................7
Section B..........................................................................................................................................8
a) Calculate the mean value of insulin administered to each patient...............................................8
b) Calculate the median value of insulin administered to each patient...........................................9
c) Explain what Standard Deviation (SD) is and what it represents. What do the SDs given in
Table 1 tell us about the variations in the data?...............................................................................9
d) Which test would you use to see if there were any significant differences between patients in
the total amount of quick acting insulin they received per mmol of blood glucose? Give the
characteristics required of the data in order to perform this test.....................................................9
Conclusion.....................................................................................................................................10
Reference List................................................................................................................................11
2

Introduction
Conducting a research is often considered as a hectic procedure, which is juxtaposition with
different types of assessment techniques and use of tools. It is observed that the research
management process is often checked with the methodologies that not only have to be proficient
but effective from the context of aim of the research. Quantitative, qualitative and other research
data can be considered in this process to make a proper deduction of the research aim. This helps
in understanding the issues associated with the research and addressing them becomes more
effective as well. The following segment will help in making a proper deduction of the situation
and the most appropriate research technique deduction.
3

Section A
A researcher wishes to explore people’s experiences of undertaking a course of
motivational interviewing for medication adherence. Describe the main similarities and
differences between quantitative and qualitative research characteristics and critically
discuss how these might dictate whether the researcher conducts a quantitative or
qualitative piece of research for the proposed study.
The researchers often face a dilemma associated with process consideration. The different types
of approaches like quantitative, qualitative has their own contribution to a certain project, and it
is seen that researchers often choose between quantitative or qualitative approach. There are
many differences between quantitative and qualitative approaches and the following segment is
going to have few of those to elucidate on the emancipation of the data analysis process. The
difference is helpful in analysis of which kind of research technique is necessary for better
conduction of a research.
Similarities of Quantitative and Qualitative research
Conduction of a primary researcher be it quantitative of qualitative the participants are necessary
and they have to be totally unbiased it is a process which is going to help in analysis of the
situation that may have a major impact on the research management process. On the other hand,
both the data analysis processes require proper understanding of the management tool
identification and proper use of it, because this is going to make a significant contribution to the
result of the research. Using the tools in a proper manner is not only required but imperative as
well.
Differences of Quantitative and Qualitative research
Quantitative Research Qualitative Research
The quantitative research is mainly responsible
for quantification of the problem, which has
been bought. It is mainly focused on the
research assessment process by considering
The process is an exploratory research, which
primarily looks for the insider information in a
detailed manner where elaborate opinion is
highly necessary for better understanding of
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statistical data representation. the situation.
It is a structured process and has a straight way
approach in which interpretation of statistical
database is an important thing.
It is considered to a semi-structured process
where interpretation of data can change the
result of the research.
The process needs to have a high amount of
respondents to minimize the possibility of
errors in the end.
The process does not need to have a high
amount of respondents, in contrary to this the
respondents have be selective and rational
while detailing their opinion about certain
problems presented to them.
Table 1: Difference of Quantitative and Qualitative research
(Source: Created by learner)
In order to have opinions of people and proper justification associated with that, the service
providers need to make sure that they are getting the job done significantly. In accordance with
Brannen (2017), quantitative approach is a structured process that lacks inner depth of the
thought process that instigated one respondent to give a reply like that. On the other hand
Bryman (2017), states that, the processes have to be well monitored to extract the authentic
information to make decisions regarding the approach of the research. In a healthcare research,
where the service seekers might have their opinions regarding the services they are getting,
taking a qualitative approach is the best option. Qualitative approach will be a vivifying
difference maker.
A new medical phenomenon has recently emerged, and researchers are interested in
following a group of patients who have the illness to see how it progresses. A cohort study
will be done. Critically evaluate the key features of cohort studies and discuss why a cohort
study would be suitable for investigating the new medical phenomenon.
In context to analyze the medical phenomenon that are being observed in the recent days, the
possibility of having a better kind of ideas of the phenomenon will be magnified with the process
of understanding the problems that have risen. In accordance with Goodkin et al. (2017), Cohort
study is mainly done in order to make a logical deduction of a medical situation or illness; this
specialty makes it more acceptable. In a supportive response Gray et al. (2015), elucidates that a
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proper group is necessary and the respondents must have something in common to segregate
them from the rest to conduct a proper analysis. Therefore, it can be stated that the research is
related with the selection of the people who are efficient enough to respond to the questions in a
proper manner. On the other hand Brown et al. (2016.), the opinion of the researcher is not
irrational because the Cohort Study needs to have a specific group of people who have one
certain aspect common but the process of analysis needs to be unidirectional to emancipate the
benefits of the research process. In accordance with Hayashi et al. (2017), the main aspect is to
make sure that the problem is sorted in a specific manner in order to ensure a prognostic
approach proficiently. In accordance with Wang et al. (2018), it is evident that the approach
becomes monotonous as well and hence the rational sense of a researcher is hampered. This is a
major factor to consider for better deduction of issues in a specific process. In comparison to the
case-control studies, the selection of Cohort Studies will be beneficial because the approach is
more segmental and effective in nature.
The process is going to be the most beneficial option to consider because it is going to have a
better approach that will magnify the chances of authentic result presentation. Cohort study is a
segregated process of approach, which is going to make a certain change that will help in
nullifying the issues associated with the data tampering with irrelevant information. In
accordance with Kraschnewski et al. (2016), analysis of particular issues will be proficient
enough if the samples are selected based on similar illness. From the viewpoint of Johansson et
al. (2018), it is seen that in a study associated with abdominal aortic aneurysm needs to have
patients who only have this particular issue to have a better result. This signifies that the cohort
study is a necessary process to consider but; what necessary is to have a set of proportional
samples with similar desires to make changes in the situation (Mazidi et al., 2019). Investigating
a new issue and illness is associated with proper analysis of the matters that are related with it. In
accordance with Ducassou et al. (2017), it is imperative to consider the reality that a single
diversion can be harmful for a research and hence it is important to be strict while selecting
samples during health care research. This makes cohort study appropriate for the research.
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What ethical issues would you need to consider when undertaking research with vulnerable
groups? Critically discuss how you would overcome the challenge of informed consent for
one of these vulnerable groups.
During conduction of a research, it is highly important to consider the safety and other aspects of
the people who are getting involved in the research. In accordance with Bracken-Roche et al.
(2017), if the research considers opinion of the vulnerable group then the safe guarding process
has to be increased to a level where violation of rule must be penalized with legal consequences.
According to Ellard-Gray et al. (2015), the risk management process needs to be strengthened in
order to have better kind of effects. depending upon the level of vulnerability the researchers has
to consider the best kind of safe guarding processes that can make sure that the people who are
in the research are not in any kind of danger. On the other hand, the best option is to make sure
that the management policies are associated with managing the issues that are related with the
condition of the vulnerable group.
The researchers have to make sure that they are monitoring the plans in association with the Data
Safety Monitoring Committee. This is a major factor to consider in order making significant
analysis of the situation. According to Neaton et al., (2018), these have to be included in the
initial and in the trail phase in order to ensure that, the researchers are not harming the vulnerable
parties.
The vulnerable groups have to be safeguarded from the willing violation of Good Clinical
Practices (GCP). This process of making a significant modification can be managed with proper
kind of analysis of the situation. The risks have to be analyzed on the risk benefit scale in order
to make a proper and productive change in the situation. This is going to change this will help in
analysis of the matters in a significant process as well. From the viewpoint of Murphy et al.
(2018), a researcher needs to follow the Stringent reporting guidelines in order to channelize any
issues associated with research conduction. The guidelines help in maintaining the database,
which is going to validate the safety data dissemination proficiently.
For a physically challenged person the informed consent is going to provide a better kind of
analytical detail, which is going to help in identifying the issues associated with the process of
patient (Spatz et al., 2016). The informed consent helps in finding the issues that are associated
with the process is database management by a permitted disclosure of the data associated with
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the patient’s health condition (Riordan et al., 2015). In a situation like this, the permission needs
to be accessed by one person only and with the job ethics; the person has to keep highly secret
things to himself. Only those data can be disclosed which is related with the issue mitigation
process and this is going to help in making certain changes that are associated with the care
providing process. according to (McNamara et al., 2018), the best option is to consider secrecy
and non-disclosure of certain data that are not important for other people to know this is the
process which will help in better situation management.
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Section B
a) Calculate the mean value of insulin administered to each patient.
The mean value of
Patient A is 43,
Patient B is 40.42
Patient C is 43.28
Patient D is 62.57
Patient E is 59.57
Patient F is 57.28
Patient G is 49.28
Patient H is 72.85
b) Calculate the median value of insulin administered to each patient.
The median value for Patient A is 43, Patient B is 40, Patient C is 50, Patient D is 72.5, Patient E
is 53, Patient F is 54, Patient G is 45, and Patient H is 74.
c) Explain what Standard Deviation (SD) is and what it represents. What does the SDs
given in Table 1 tell us about the variations in the data?
The standard deviation of a set of numbers is nothing but quantifying the amount of variations
present in the data set. If the standard deviation is low then it can be stated that the number is
closer to mean and if that is high, then the numbers are spread over the entire set of numbers
from which it has been considered (McGrath et al., 2019).
As per the given data in the Table 1, it can be stated that the patients are given with a dose of
insulin and it is necessary to ensure that the patients are getting proper treatment. The SD given
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in the table signifies the risk level of the patients. In case of the given table, it can be stated that
the patient A has a SD of 2.45. The difference of higher dose and the lower amount of dose of
the Patient is not that high and in the end, this patient is not going to face major threats
associated with high blood glucose level (Huey et al., 2018). The highest amount of SD can be
seen in Patient G where the highest dose amount is 80 and the lowest amount is 35. This means
the Patient is facing issues related with blood sugar level alteration. The risk level for the patient
is higher than expectation and a sudden fall in the sugar level can be threatening for the
individual.
d) Which test would you use to see if there were any significant differences between
patients in the total amount of quick acting insulin they received per mmol of blood
glucose? Give the characteristics required of the data in order to perform this test.
In this process, the t-test is going to be considered to find the significant difference among the
patients level of received quick acting insulin per mol of blood glucose level. This will help in
making a significant difference among the level of administered insulin.
Characteristics of the required data
 If the groups of patients have been made then a high amount of t-scores tells that the
groups are different and low amounts of difference tell that they are similar.
 There should be high variation of data to make a significant difference of results.
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Conclusion
From the given detail it can be stated that the possibility of having issues in the health care
related research is higher than expectation. The healthcare process needs to be in line with the
demand of the patients in order to give them the best treatment. The patients need to be provided
with high amount of care to ensure that the blood sugar fluctuation is not harming them. On the
other hand if research related concerns are taken into consideration then it can be stated that there
will be some benefits and drawbacks of a particular kind of research but the researcher should
ensure a proficient analysis of the situation and then select one in order to meet the requirements
of the service.
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Reference List
Bracken-Roche, D., Bell, E., Macdonald, M.E. and Racine, E., 2017. The concept of
‘vulnerability’in research ethics: an in-depth analysis of policies and guidelines. Health research
policy and systems, 15(1), p.8.
Brannen, J., 2017. Mixing methods: Qualitative and quantitative research. Routledge.
Brown, J.B., Gestring, M.L., Stassen, N.A., Forsythe, R.M., Billiar, T.R., Peitzman, A.B. and
Sperry, J.L., 2016. Geographic variation in outcome benefits of helicopter transport for trauma in
the United States: a retrospective cohort study. Annals of surgery, 263(2), p.406.
Bryman, A., 2017. Quantitative and qualitative research: further reflections on their integration.
In Mixing methods: Qualitative and quantitative research (pp. 57-78). Routledge.
Ducassou, S., Leverger, G., Fernandes, H., Chambost, H., Bertrand, Y., Armari‐Alla, C., Nelken,
B., Monpoux, F., Guitton, C., Leblanc, T. and Fisher, A., 2017. Benefits of rituximab as a
second‐line treatment for autoimmune haemolytic anaemia in children: a prospective French
cohort study. British journal of haematology, 177(5), pp.751-758.
Ellard-Gray, A., Jeffrey, N.K., Choubak, M. and Crann, S.E., 2015. Finding the hidden
participant: Solutions for recruiting hidden, hard-to-reach, and vulnerable
populations. International Journal of Qualitative Methods, 14(5), p.1609406915621420.
Goodkin, K., Miller, E.N., Cox, C., Reynolds, S., Becker, J.T., Martin, E., Selnes, O.A., Ostrow,
D.G., Sacktor, N.C. and Study, M.A.C., 2017. Effect of ageing on neurocognitive function by
stage of HIV infection: evidence from the Multicenter AIDS Cohort Study. The Lancet
HIV, 4(9), pp.e411-e422.
Gray, S.L., Anderson, M.L., Dublin, S., Hanlon, J.T., Hubbard, R., Walker, R., Yu, O., Crane,
P.K. and Larson, E.B., 2015. Cumulative use of strong anticholinergics and incident dementia: a
prospective cohort study. JAMA internal medicine, 175(3), pp.401-407.
Hayashi, T., Yamashita, T., Terashima, T., Suda, T., Okada, H., Asahina, Y., Hayashi, T., Hara,
Y., Nio, K., Sunagozaka, H. and Takatori, H., 2017. Serum cytokine profiles predict survival
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