Hello, this is Sam from Ref-n-write. In this video, I will explain how to write
a clinical trial research paper. We will go through the basic components
that make up a good clinical paper. The title of our research paper is ‘The Effects of Vitamin D Supplements on Obesity: A Randomized Clinical Trial Study’. I must insist that this is
not an actual research paper. This is just an example research paper
we put together for the purposes of teaching. Before we move on to the video, if you still haven’t installed
Ref-n-write software, please do it now. It comes with Referencing tools, Paraphrasing Tools
and Academic phrasebank And a lot of other useful features to help
you write your research papers and theses. You can sign up for free Using the link below in the description. Now let's get back to the paper. Let's start
with the introduction paragraph. This is the place where you tell you readers
what is your topic and why it is important? It is a good idea to start
your intro paragraph with a hook A hook is a powerful opening statement
designed to grab the reader’s attention. This can be a fact, a statistic
or a question. Since our study is about obesity,
let’s give an interesting statistic about obesity. After starting with a broad statement,
the next step is to narrow down the topic. Here, we are dropping a hint that
our paper is to do with vitamin D and obesity. With the next statement we are
establishing the importance of the topic. and vitamin D is causing a lot of health issues,
so we must do something about it. We are saying that a lot of people
are dying due to obesity, Then in the final statement
of the intro paragraph, we explain how conducting research
in this field will benefit the community. In our case, doctors will be able to prescribe
better treatment options for obese patients. That concludes the introduction paragraph
of our research paper. Let's move on to literature review. This is where you provide a comprehensive summary
of previous research on this topic. Let’s start with a broad statement
summarizing the research in the area. Here we are saying that many studies have confirmed
some sort of link between vitamin D and obesity. Now let's move on to specific studies. Here we are reporting the results of
a specific study that came out recently that talks about the link between vitamin D
and obesity in western countries. Now let’s talk about some mixed evidence that casts
some doubt on the current understanding of the topic. We are saying that some studies have
shown that obesity causes vitamin D deficiency, whereas other studies have shown that it is
in fact vitamin D causes obesity issues among people. Now it's time to establish
the research gap. The previous statements
we made nicely lead on to this statement. We are saying that we are lacking clear evidence
linking vitamin D to obesity. We are also saying that most of the existing studies were conducted on subjects with preexisting health conditions, so there is a research gap to be filled. Now you must define your
research question and explain how it addresses the research gap
you established in the literature review. We're saying here that the main
aim of this study is to investigate the effect of vitamin D on weight loss
among healthy population. We are also defining
a specific hypothesis that we will either prove or disprove
towards the end of the paper. Let's move on to
materials and methods. The materials and methods is one of the
most important parts of your paper. This section should have enough detail
so that another researcher can reproduce
your experiments and results. Let's start with study design. In clinical trial papers, you must explain about the
study design you have employed in your work. In our case, it was a
randomized double-blinded placebo trial. Then you can talk about the location and
period in which the clinical trial was conducted. Then provide details about the ethical approval
that was obtained for the study. Nowadays it is mandatory to register your
clinical trial on the website, clinicaltrial.org before you start recruiting
patients for your study. You must also include
the registration number. I must warn you that many journals will
refuse to publish the results of your paper if the clinical trial is unregistered. Good clinical practice (GCP) is a set of
internationally recognized quality standards that must be followed when conducting
clinical trials involving people. It is a good idea to provide information about who is
responsible for monitoring this for your trial. It is very important to define the inclusion
and exclusion criteria used for the study. The inclusion criteria define the characteristics
that will make subjects eligible for the study. In our case, we only included non smoking and
non diabetic subjects with BMI greater than 25. In our case, we are excluding subjects
participating in weight loss programs and taking dietary supplements. In our case, we recruited
50 subjects in the age range 15-60. Let’s provide some information
about the recruitment procedure. In our case, there was a face to face
interview to confirm eligibility. And also, the eligible participants
were asked to fill in a questionnaire so that we can gather
demographic information. Another important part of recruitment process
is to get informed consent from the participants. The participants should be given
all the information about the trial including the benefits and risks, so that they can make an informed decision
as to whether to participate in the trial or not. Let’s explain how the participants were
grouped into different groups. In our study the participants were randomly
split to into intervention and control groups, and the control group was given a placebo. Our study is double blinded, it means neither the participants nor the
researchers knew which group they belong to. Let's talk about the follow up period. It is very important to choose a good
follow up period for your study. Because a shorter follow up period will result in
an underestimation of the effects you are measuring. Whereas with a long follow up period, there is
a risk of subjects dropping out of the study. In our case we have chosen
a follow up period of 12 months, and the measurements
were performed every 6 months. Then we have to explain what parameters we are measuring on the participants during the course of the study. In our case, we measured BMI,
waist circumference and blood pressure. BMI is the primary outcome. It means it is
the most important outcome and we will analyze the changes in BMI values
to either prove or disprove our hypothesis. The secondary outcomes such as waist circumference
and BP are additional measurements that we perform to provide supporting evidence for the main finding. Let’s talk about the statistical analysis and
statistical tools used for the study. In our case, we are using an independent
sample t-test for statistical analysis. The independent sample t-test
compares the means of two groups, in our case, vitamin D group
and placebo group. We also specify the definition
of statistical significance. if p value is less than 0.05 then we will
consider the difference to be statistically significant. We also give the format of the
data presented in the paper. in our case, all the data will be represented
in the format, plus or minus standard error. Let’s move on the results section. This is where you present the
core findings of your study. You have to present your
results in a logical sequence. Do not interpret the results here. Save them for the discussion
section later. Before jumping into results, you have to first let the audience know if you did
any preprocessing or data clean up before the analysis. In our case, 4 participants had to be
excluded from the study due to health issues. And two participants dropped out
due to personal reasons. So it means that we are dealing with
a slightly small sample size than we initially set out. Try to present your data
in figures and tables, and only elaborate the most
important results in the main text. In our case, we are presenting the characteristics of both groups in a table. And we are plotting the change in BMI over time
as a graph and presenting it as a figure in the paper. Now let's start with the main finding. In our case,
we found a significant drop in the BMI among the cohort
taking vitamin D supplements. Since we use the word significant,
we have to provide a p-value. Let's move on to the next result. we are reporting that there is no significant difference
in blood pressure between two groups. We are also providing
actual values in the text. We've already mentioned in methods section
that the data will be in the format mean plus or minus standard error. Let's move on to discussion. This is where you
interpret your findings and compare your results with
previously published work in this domain. This is the place to talk about limitations
and future direction of your work. It is a good idea to start
with the main result. In our case, we found that vitamin D
reduces the BMI supporting the main hypothesis. Let’s also mention how these findings
fits into existing research in the domain. In our case, these findings are in line with results
of previous studies published on this topic. Now let's move
on to a negative result. In our case, we observed a negative association
between waist circumference and vitamin D. Now give your interpretation
of this negative result. We think it is because of
he shorter duration of the study. Let's report an
unexpected result. In our case, we found that the blood pressure
was bit on the higher side with the cohort taking
vitamin D supplements. Let’s give our
interpretation of the result. We believe it is
because of limited data. Let’s talk about
the implications of our research. This is where you describe
the significance of your findings. You can also explain how your
findings contribute to the existing body of knowledge and impact future research
in the area. Then add one or two lines about
the novelty of your research. Explain what is so
unique about your research? In our case, this is the first study
to be conducted on a healthy population. Let's move on to limitations. Every study has limitations. If your hide your limitations, I can guarantee you that
reviewers will reject your paper. Be honest about the limitations,
and explain how future studies can rectify
the shortcomings of your work. In our case,
the major limitation is that our study uses a small number
of participants. Let's move on to the
final statement of the paper. Finish your paper with
one or two lines about the possible future direction
of your research. In our case, we can
conduct a much bigger study to reconfirm our findings
in the future. I hope you found this
presentation useful. If you have any questions,
please drop a message below. We will answer it
as soon as possible. If you like this video
and would like to learn more about
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