Guidelines to write research proposal - Reference MCEM-UK site
Writing A Research Proposal
A
research proposal is an essential pre-requisite to any project. A detailed
proposal is necessary if funding is being sought, while a more brief, general
proposal is required for ethics committee application. However, writing a
proposal has many benefits for the research process itself. It allows problems
to be defined and managed before the project begins, provides guidance while
the research is in process and provides documentary evidence of what analysis
was planned prior to the research commencing.
Once
the proposal is written, a more detailed document – the research protocol,
should be produced. This will outline all the study procedures, including data
collection and planned data analysis.
A
template for writing a research proposal is provided on this website. This
document describes the key steps and can be used to complete the template. It
is best suited to studies evaluating therapeutic interventions but can be
adapted to suit evaluations of diagnostic tests or observation studies of
aetiology or prognosis.
Documents
on this website may be useful in helping you to write your proposal. In
particular, it is worth deciding whether your research is pragmatic or
explanatory, ensuring you have performed a power calculation, and considering issues of ethics, information and
consent.
Project
Title
The
title should describe what is being evaluated and how it is being evaluated.
Avoid long titles. Avoid ambiguous titles.
The
specific research question
This
should be well-defined, important, relevant and answerable by the proposed
methodology. See- Defining Your Research Question.
Background
to the research question
Why
does this research question need to be addressed? Does it relate to a common
emergency problem? Is there substantial associated morbidity or mortality? Are
there important gaps in our current knowledge? This is an essential part of the
proposal. If you are unable to convince the reader that this is an important
research question they are unlikely to read the rest of your proposal. Data
relating to the prevalence of the problem, evidence of unmet health needs,
unexplained variation in practice, or evidence of suboptimal practice are all
worth referencing.
Literature
review
This
is necessary to ensure that the research question is original. What is already
known about this subject? What do we need to know? Previous studies can be used
to ensure that patient selection, interventions, controls, and outcomes are all
appropriate. Although the literature review should be reasonably thorough it
need not be reproduced in detail in the proposal. A brief summary of findings
with key references will suffice.
Study
design
Summarise
the study design in one short sentence. If the optimal design for the study
question is being used (for example, a randomised controlled trial for a
therapeutic intervention) then no further detail is required. If, for ethical
or practical reasons, compromises have been made in the choice of design
then the reasons should briefly be outlined (for example, if a non-randomised
trial is being used to study a therapeutic intervention).
Population
How
is the study population defined and how will it be identified? Selection of the
study population should be guided by the research question. For a pragmatic
trial, the population should be unselected and as similar to “real life practice”
as possible. For an explanatory trial the population may be selected to focus
upon the specific hypothesis under investigation.
How
will the population be sampled and screened for recruitment into the trial? The
recruitment process should ensure that patients recruited into the trial are
representative of the study population. Ideally all consecutive eligible
patients should be recruited according to clear, prespecified criteria. If
recruitment is limited to certain times of the day this should be justified and
explained.
Inclusion
and exclusion criteria
Exclusion
criteria should be explicitly defined. The choice of exclusion criteria should
be determined by scientific and ethical criteria, rather than convenience.
Excluding certain groups of patients may lead to improved compliance and
follow-up rates, but will reduce the potential sample size and may lead to
difficulties generalising results beyond the study population. Exclusion purely
on the basis of age should always be avoided.
Intervention
(and control)
Any
intervention, whether it is a therapeutic intervention, educational intervention,
change in service delivery, or a diagnostic test, should be described in
detail. The specific choice of intervention should be justified in relation to
the existing literature and the research question. Make sure the intervention
is not about to become obsolete!
If
a control group is used, management should be clearly defined and relate to the
study question. As far as possible the control group should receive the best
currently available therapy. Use of a placebo is unethical if an effective treatment
exists.
Outcome
measures
Although
several outcomes may be measured it is usual practice to define one outcome as
the “primary” outcome. It should be the most important and relevant outcome from
the patients perspective.
It is also the outcome used for the power calculation. Secondary outcomes can
be measured to seek other important effects. Clinical outcomes (such as peak
flow rate or blood pressure) are useful for explaining treatment effects but
make poor primary outcome measures, particularly for pragmatic, patient-centred
research. Validated, widely-used outcome measures are ideal (for example, the
SF-36 health-related quality of life index). If you have to create your own
outcome measure try to base it on existing research and make sure you pilot it.
Data
collection
Data
collection procedures and forms should be planned in advance and piloted.
Including data collection forms as an appendix to the proposal may be
worthwhile. They won’t get read but they may impress! Make sure you are going
to be collecting all the data you will need but do not collect data
speculatively, because “it might turn up something interesting”.
Follow-up
When
and how are you going to follow-up study participants? Will follow-up be in a
research clinic, by telephone or by post? How will you ensure a good response
rate?
Planned
analysis
How
will the data be analysed? Who will perform the analysis? How will important
statistical issues be addressed, such as adjustment for confounding and cluster
analysis? If you are considering performing any subgroup analyses, these should
be stated in the proposal, justified, and the study powered to detect
clinically important differences in these subgroups.
Power
calculation
A
clinical trial will require a formal power calculation. Alpha and beta should
be stated for each outcome. The minimal clinically significant difference
should be stated and justified. State the source of estimates of standard
deviation and expected control event rates or proportions.
Although
a formal power calculation is not appropriate for a descriptive study, the
sample size should still be estimated and justified in advance. Use an estimate
of the standard deviation of the value(s) you are measuring to indicate the
precision with which your results will be reported.
Recruitment
and follow-up rates
How
many potential participants will be eligible for your study? What proportion
will actually agree to take part? What proportion of these will complete each
stage of the trial? Your power calculation should be based on the number of
patients expected to be follow-up up to the appropriate outcome measure,not the
number eligible for recruitment. Be realistic, and perhaps a little
pessimistic, in estimating recruitment and follow-up rates. Anticipating 90%
recruitment or follow-up is wishful thinking and will alert any potential
funder, collaborator, or even the ethics committee to the possibility that this
is a poorly planned project. Pilot data that supports your estimates is
invaluable.
Ethical
issues
Any
study that involves altering normal patient management or asking patient to do
anything beyond routine care (even completing a questionnaire) will need ethics
committee approval. Information and consent procedures should be described.
Written information sheets and consent forms can be included as an appendix.
Difficulties with consent are common in the emergency environment and should be
addressed openly. If you think that ethics committee approval is not required
for your study this should be stated and justified. Routine audit projects do
not require ethics committee approval, but then again, why should any journal
publish a routine audit project!
Proposed
timetable
Draw
up a realistic timetable with milestones for- piloting, commencement of recruitment,
completion of recruitment, completion of follow-up, analysis and dissemination
of results. Make sure your timetable for recruitment, anticipated recruitment
rate and sample size estimate are all compatible.
Generalisability
of results
How
will the results be relevant outside your institution? Does the study take
place in a “typical” health services setting, involving “typical” patients and
carers? What difficulties might be encountered in extrapolating the results to
other health care settings?
Benefits
to the NHS and emergency medicine
How
will this study improve patient care? Although this may be a difficult question
to answer, it is vitally important. All research consumes resources, even if it
only your time and energy. Using these resources can only be justified if the
research will ultimately produce some benefit.
Resources
required
Is
any funding being sought for this research? If so, how much and from whom? What
will it be used for? If not, how will the materials required (questionnaires,
data collection sheets, computers, databases etc.) be funded? Whose time will
be consumed? How much of each researchers time can be dedicated to pursuing
this research? Have travel costs been considered? What additional costs will be
required from the NHS (additional clinics, tests, treatments etc)? While
exhaustive details are not required for a general proposal, an assessment of
the potential resource requirements is essential for good research planning. A
proposal that neglects resource use or underestimates the resources required
suggests a poorly thought out project.
Appendices
Adding
a few appendices allows you to show how thoroughly you have prepared you
research project without obliging the reader to wade through all the details. Results
of the literature search, pilot data, data collection forms, patient
information sheets, and consent forms can all be added as appendices.
TEMPLATE
RESEARCH PROPOSAL
1) Research team details
a) Lead researcher- name, post held, institution, address, telephone,
email
b) Research team- name, post held,
institution
2) Project title
3) The specific research question
4) Background to the research question
5) Literature review
6) Plan of investigation
a) Study design
b) Population
c) Recruitment
d) Inclusion and exclusion
criteria
e) Intervention
f) Outcome measures
g) Data collection
h) Follow-up
i) Planned analysis
j) Power calculation
k) Anticipated recruitment and
follow-up rates
7) Ethical approval
8) Proposed timetable
9) Will the results be generalisable?
10) What are the anticipated benefits
of this research to the NHS and to emergency medicine?
11) What resources will be required?
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