How to Write a Research Protocol Tutorial

Wednesday 3:00pm 4:00pm | 04 May 2016 | Dr Aroni

General Updates
1. Exam
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Reduced number of questions in the exam

Exam deemed fair

2. Community Organisation Profile

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No essay
Only poster

3. Research Protocol
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Examples of published protocols were given

o A lot more detailed
This standard not expected
Only small literature review
No discussion in protocol; but still require detail in the background, rationale and
method section; Need to produce research question based on that, and come up with a
design that is suitable to answer the research question

Research Protocol
General Points
1. Dr Aroni does not have a preference in research design; only expect that the design
match the research question. This is a key element.
2. Except for bench science any research will be fine; The reason is many students are
from biomedical background, giving them an advantage
3. If youre not finding anything, may be using inadequate search terms
HOW TO START
1. Consider your search strategy
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Need to identify a topic area

Lets look at your clinical science stuff/studies or clinical placements; What was my
interest in that or in a particular area? What sort of questions can I ask? What sort of
questions could I note from stuff from reproductive health or an area Im particularly
interested in?
o Eg. cardiovascular health, oncology, health policies, medical education

To get your topic area, find something that youre interested in that we dont already
know;
o Dont bother with the things we know the answer to ie physical exercise reducing
risk of cardiovascular disease
So when youre looking through the literature, dont try and cover the entire planet on
that topic
Dont try to answer everything in the one question
Reduce it to the first step in a series because it needs to be simple/doable
o Find a small thing that has not been answered and focus on a small/easiest
aspect of it
o Break it down into manageable pieces

TOPIC AREA DECIDED

Once you have decided on a topic area, find the thing about it that has not been
answered ie the gap

There may be different types (variation) of gaps in the area

o One type is there is conflict in the area and people have not agreed on what
they think. Eg. Could be in relation to the way in which you deal with heart
diseases in women and getting them to emergency/recognising symptoms of a
heart attack. There are different models of how you train the community or how
you engage in good work so people present to ED before they die; OR the other
thing we have in health system is where women, once theyre in ED; may not get
recognised as having an immediate cardiac event because of staffing
issues/practice. This may be just one domain of examining competing models
o Another gap will be that the research question has been asked, but only in
certain populations. Population outcomes may not be the same as health
systems may treat different populations differently;
o A third way to think about it, is where you see limitations to studies youre
reading; and in the limitation session, they say we think we could have done or if
we did differently we would have potentially have a better study; but we couldnt
do this. Now some of those limits are unavoidable, but some you can fix by
changing the design; In the literature it has said that blah would have been a
good thing to do, but we didnt have the funding or we didnt notice it until it was
too late, or we had restrictions from ethics/whatever else. So we can re-ask this
question and reduce the limitations and perhaps find something different (by
changing our study design/shifting our question slightly)

These are other forms of finding gaps in the literature as oppose to just oh we dont
know the answer

may conflict where ppl have not agreed

Ie the method of tx in which you deal with heart attack in women
o When to go to ED
o There may be different models of how you train the community to get to ED;
o How you train/educate the community
o How the staff perceive women in ED, they may not pick up that these ppl will
have potential EDs
Health outcomes may not be the same in differnet health systems;

What forms of gaps exist in the literature as oppose to what we dont know
HOW DO WE WRITE THIS THING?
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Essentially you start with a background

Why is it an issue? Why is anything an issue in this particular area?

o eg. CVD national health priority area high death rates in the community
o eg. Is this a Cinderella disease (the one that is neglected) is not research
extensively because not a lot of members in the population experience it so
less funding for cures or treatment; these are ripe areas for research (as there
are not enough research done); This is another domain to find a topic area

GET ONTO THE LIBRARY PAGE

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Dont just rely on Pubmed or Google Scholar,

o These are not sufficient, as the people who write the program for these search
engines operate slightly differently (whatever this means?!)
Pubmed and Medline will provide the bulk of what typical medical journals put out, but
its still not sufficient
Try EMBASE another software/search engine that is broader than Medline;
Try SCOPUS gives you again a slightly different spectrum
Try CINAHL (nursing database) often have a lot of material that is skipped over in
medical database

UQ has their own library combined search engine you can use it, but dont rely on it;
cause they may miss things

LITERATURE REVIEW
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Youre not doing a systematic review;

What were doing is a narrative review, decent search which is not a detailed/full
systematic review process
2-4 pages (max) on the background to reduce the strain;
BUT you still need to do a decent discussion in the background

So what is expected?
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Find the relevant search terms

Have a particular interest area and start reading (lol)

You then go to another area in the library website (eg. the COCHRANE library), and then
you have a look at it. So Cochrane library will give you systematic review; but is will only
use the hierarchy that the Cochrane review has provided (which misses out on a lot);
But the Cochrane Review is a good way to start your search to see what has been done;
o Ie Gives you good references
From the reference list you can expand

Also, a number of studies are cited by everybody, look at these ones; as they are the
key ones done in the domain; will give you basic knowledge that everyone knows in that
area (so cite them)

The other thing that people do to set up your background, eg CVD go to Australian
Institute of Health & Welfare, Australian Bureau of Statistics or National Health Priorities
Government Sites to state figures/stats ie we know this already, and why is it of
interest this whole field
o Morbidity in the community
o We know that the figure is this in 2015

Reference List/In text Reference

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Each domain has its own preference but dont worry, just be consistent ie stick to one
style (eg. if using Vancouver stick to Vancouver throughout; or Harvard then do Harvard
throughout etc)
If youre using Endnote, even though you correctly insert into it, you will still get errors
in your reference list; please fix them otherwise you will lose marks

BACKGROUND OF LIT REVIEW

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Background or lit review is putting forward a case

What is known about this topic area? We need to establish this.
Youre also establishing how do we know this
o Well we have this evidence and that evidence and theyve done this and this
study;
o And this study and that study had this and this limitations;
o OR there are a bundle of studies that have been done on this issue and they
looked at it in this way and there are other studies that have focus on this aspect
of an issue
So when you write numerous studies have said (cite numerous studies) and talk about
it, cant just make generalisation; as you are providing evidence to support your

argument (ie that this is what we know, this is how we know and this next stage is what
we dont know)
Next Stage
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This is what we dont know because not enough studies have been done about this
issue or some studies have raised this but have not found something conclusive or even
correlations but have suggested there may be an issue here
So this is the next step of the argument (we are using the intro to set up our argument)
There are different ways to structure this background section
o Some of you can use narratives others prefer headings; it is fine to use either;

YOUR RESEARCH QUESTION

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Get in touch with Dr Aroni if unsure,

Wording of questions is important, cant just say Im doing a hypothesis
o Even when you do hypothesis in satandard RCT model, you still need in a
protocol, to state your question as a question; you may then have hypotheses
that you wish to test as part of the your answer to the question
Hypothesis are part of your design, they are not your research question; Do not put a
statement in and claim that that is your question
o You must frame it as a proper question, ie have a question mark at the end;
o Can you articulate a clear concise well worded research question;
o It needs to make sense in the area that you wish to study;
o Needs to make common sense, should be able to be read by anybody not doing
medicine and understood cause its clearly articulated, and in specialty areas of
medicine, someone outside the area should be able to understand it

(If we use NHMRC as an example, when they do review of grant applications, they will
have load of people on the panels, have people review your protocol, and they will not
be experts, and maybe have 2 people on the field to assess protocol that are experts; so
the way you frame and phrase everything needs to be understood by everyone)

In your design you can go into specifics; BUT background and research question has to
be able to be understood be anybody
So people who are experts in ophthalmology may not be experts in ENT but they may
review it;
Need to convince them that the question is worth asking, that it hasnt been answered,
and that its important to answer it. The reason you want it to answer is that it will
change clinical practice and let you have a further understanding in the field of your
chosen topic

Wording of research question is really important; and Dr Aroni would like to check that
our research question is on the right track
Dont try to answer the research question in the way you frame the question or they try
and cover everything;
Dont try and answer the question in your background;

Even if its awkwardly worded in the first instance, put it down; Youve done degree, you
know how to do this stuff??!?!

Try and limit it to one aspect of the research, if youre doing a quantitative study, try not
to find something that you have to look at 1000 confounding variables, itll take your 20
years to do;
Try and focus on a small simple area, dont make it complex; where the complexity will
lie, is in the design you will produce ie like taking into account some of the confounding
variables (cohort studies, RCTs)

FOUND YOUR GAP, HAVE YOUR QUESTION

Eg. Trying to look the way in which members of the LGTB community health with dealing
with smoking cessation and the problems of increase weight at the same time
o The literature in health promotion tells us very clearly that often when people are
trying to stop smoking they put on weight
o Is this the same or are there any similar issues that come up in the LGTB
community?
Eg. Some people with mental illness (eg schizophrenics) often smokes, this reduce some
of their symptoms but we tell them not to smoke;
o So theres dilemmas in clinical practice might be a way for you to get your
research questions;

DESIGN OF STUDY
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The design (huge options) is tied to the Question

The nature of the Question asked will determine the design you should be using
If you are asking questions about the meaning of events, why something is happening,
more often than not, you will be doing QUALITATIVE study design
If you are asking about pattern, trends, correlations, causality then youre looking at
QUANTITATIVE designs
These are pretty standard/well known combinations

You may opt for a mix method design, where youre using both;

Sequential mix-method design

o What those patterns and trends are and why they occur?
o OR you dont know much about an area, but youre trying to figure out the
patterns and trends

Concurrent mix method designs

o Might send out questionnaires to 1000 people, then pick a sample of those to
conduct in depth interviews with them, to understand why they answered in the
way they did
o Or you might conduct interviews with the group that you want to get
measurement of their mental health; you might want them to fill in dietary diary.
This is a mix method design

So when youre labelling your design, you need to know what youre talking about
o Is it cross sectional/longitudinal
o How you work this out will depend on the question that youre asking
o Also depend on the way in which you think it will work, can you find the answer
to that question by doing this study
o Eg If you want to find out how many people exercise in the morning vs how many
exercise at night and whether they have weight loss at the end of two months.
No point setting up in-depth interviews or doing a QUALITATIVE study. You will be
doing a QUANTITATIVE study.
o Eg. If you want to find out why people choose to exercise in the morning vs at
night, then you might do a QUALITATIVE study to find out their reasoning. You
might do a simple questionnaire or there are lots of research in that field

SAMPLING STRATEGY & SAMPLING FRAME

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After you state what design you will do, you need to go into the details
Who are you including? Why are they necessary?

Next part is recruitment with your sampling strategy and sampling frame and
sampling size;
o What is your recruitment strategy? What is reasonable? How do we get them?
o When we talked about focus groups what can you offer them to come along;
o Specialists in hospitals you offer them breakfast/dinner; ie hot meals were
attractive to specialists

With GPs they want a fee (enticement)

DATA COLLECTION METHOD

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This is the way the questionnaire has been developed to conduct this research
Based on questionnaire x and questionnaire y from studies by so and so however we
have adapted that to the Australian/US/HK context or wherever in order to make it
amenable to the local circumstance
OR we have developed this from scratch and we are using it as there has been no
instrument developed into this area
And you can attached whatever you have in your questionnaire in your appendix??!?!
If you go down the QUALITATIVE design, then you are doing the same process, providing
sampling strategy, sampling frame and sampling size, data collection techniques and
recruiting strategy
What might be different in your protocol would be, typically, you may not be able to give
a rationale for the sample size
Whereas in QUANTITATIVE models, sample size is often dictated by the population,
relationship in the population and working out whether if you can do the stats (from
EBM from last years - do an estimate of the sample size that you will need)
For instance if you were looking at Chinese migrants to Australia from China over the
last 5 years
o In this context look up the local Government area stats and say this is what the
total potential population would be for men with Type 2 diabetes
o And in order to have a reasonable sample size, I would potentially need x (a
rough estimate)

With a QUALITATIVE sample size, it may not be that easy because you need to find a
justification for the sample size, which is typically smaller; not because you need a small
sample size, but it is expensive with a larger sample size
o Therefore qualitative research is limited by funding, too expensive if big sample
size; sometimes that will change; So need to work out what is a reasonable
sample size. Cant just say 40 or 50, need to justify.
o Perhaps you start with x number, or how many focus groups do you have, or
cluster sampling, but need to justify
o Are you recruiting through community groups, GP records, hospital records,
these are things you need to figure out based on your question, based on your
reading of the literature;
o They are not that complex once you have done your reading; what are the
potential options, if youre not sure get in touch;

I have these options, how do I make the judgment, get advice (Life skills @_@)

INDEPTH INTERVIEWS & FOCUS GROUP

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So now that you have your research question, your methodology, what youre going to
do, and you are going to do (example) an in-depth interview or focus group. Then we
need to have an interview schedule;
Need to know what this is if talking about it.
We are trying to teach you a skill this is not an MCQ Exam

WORK OUT DATA COLLECTION

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Is it a tool like a questionnaire?

Depression instrument, Quality of Life (QOL) instrument, or standard health
questionnaires about your sense of wellbeing and health
There are lots of different versions of these

In the literature you review, you will see which one is being used, ie COPD do a 6 min
walk test, with lung impairment; there are specific test that are standard in the
industry
There are tests that are used as standards in clinic or therapy
And there are other tests which we use because we know that everyone in the world has
used it, so we want to make our stuff comparable, so that when we publish it can be
compared;

DATA ANALYSIS
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QUANTITATIVE data analysis and QUALITATIVE (NB look at these lectures again)
It isnt that complex, theres a table with stat tests that you can use with diff forms of
data you have;
These are the data that might be collected. You are not collecting data. Youre just
devising what can be collected; You are planning to do this!
Your language is all future tense, it is not past tense; it is not yet done, it is plan to; we
will plan to use questionnaire x and questionnaire y
We are piloting this and we plan on implementing this;
Uni-variant or multi-variant?
With the QUALITATIVE ones, discourse analysis (fairly straight forward)
For QUANTITATIE data, may talk about using a particular software package to assist you
o May use SPSS or STATA, or SASS;
With the QUALITATIVE
o May use ETHNOGRAFT, ATLAS T, INVIVO??
QUANTITATIVE data analysis talk about doing certain calculations that would be
required to give you answers to your original question; that would give meaningful
answers
With your QUALITATITVE, you dont talk about the calculations, you talk about coding
and category (the categorisation of your data), talk about your narrative data,
transcribing from your audio or from your visual;
Talk about transcription and data analysis following that

ETHICS CLEARANCE
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Key ethical dilemma that are likely to arise

QUALITATIVE research put up sick people by asking them issues they would not want
to conjure; so provide counselling services
Informed consent & Confidentiality

LIMITATIONS
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Finish off with what are the limitations of your design

Inherent strengths of your design and limitations