- For Professionals (Shop Floor)
- Clinical Guidelines
- Clinical Standards
- Clinical Audit
- Professional Standards
- Safer Care
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.
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.
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.
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).
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.
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 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”.
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?
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.
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.
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!
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.
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.
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
d) Inclusion and exclusion criteria
f) Outcome measures
g) Data collection
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?