There is no fixed structure for protocols but the following sections outline suitable elements which will guide you: title, abstract, research question, hypothesis or aim, introduction and background, methods, research team, references, timetable, resources and budget, and appendices. Using these headings will give you a structure; however, the list is not exhaustive and may include items that are not relevant to your particular study design. While you are writing you may be unable to complete some sections initially, but this will highlight to you where you need more advice (for example in the analysis section). The draft protocol will be extremely useful to you in getting appropriate and accurate advice from others. Instead of trying to explain your problem you can simply show your advisor the protocol so far indicating which sections you are struggling with. Your advisor will then be able to provide better advice as they have all the information in front of them.

Most importantly there are no word limits for your research protocol; it can be as long as it needs to be. This is a refreshing change from writing up your work, when you will often be severely restricted to specific word limits. This document should be detailed and comprehensive.

The title is important; it is the first thing that is read and should indicate clearly what the project is about. The title needs to be concise, but also contains enough information to say what you are going to do. Typically titles contain the following elements:

study design (such as randomised controlled trial, phenomenology, survey or pilot study)

the problem or patient group (such as depression, patients with type 1 diabetes or fatigue)

the main outcome of the research (such as patients’ experience, better quality of life or improved mobility)

intervention and comparison (if you have one, such as hydrotherapy versus land based exercises or high carbohydrate diet compared to high fat diet)

On the title page include the authors’ names and affiliations, plus a date and version number for the protocol. A version number will ensure any changes you make to the protocol, especially once the research has started, can be tracked and linked to appropriate approvals, such as ethical approval.

Although this is always placed at the start of the document and is the first section anyone will read you must write it last. It should be a summary of what you are going to do, why and what its value is. It is not a summary of the background information; it must include details of the methods, expected outcomes and potential value of the research. Limit yourself to 300–400 words only and write it for a very busy researcher or manager who wants to gain a brief overview of the whole study before looking at the details. Further information on writing abstracts can be found in Chapter 16, Section 16.1.

This bit should be easy since you already have your research question defined (see Chapter 3).

It may be appropriate, particularly for experimental research, to couch your question as a hypothesis. A hypothesis is a statement of what your experiment is attempting to demonstrate. However, in statistics we test what is called a null hypothesis, which is a statement of the situation where there is no difference or association to be found. For example:

Research question: What is the influence of a hospital environment compared to the home environment on patients’ cognitive function and subsequent ability to perform activities of daily living after brain injury?

Hypothesis: Patients with brain injury will demonstrate better cognitive function and improved ability to perform activities of daily living in the home compared to the hospital environment.

Null hypothesis: There will be no difference in the cognitive function of patients with brain injury or their subsequent ability to perform activities of daily living, in the home compared to the hospital environment.

For qualitative or other exploratory research a hypothesis will not be needed but instead it might be useful to state the aims of the research. Your research question may be broken into several parts and these can be made explicit as aims. For example:

Research question: What are the factors that influence obese patients to successfully complete the lifestyle clinic weight loss programme?

Aims:

To establish how patients experience the lifestyle clinic.

To identify factors which promote the successful completion of the programme.

To identify factors that result in patients leaving the programme.

The introduction should be a summary of what research has been done so far in this field, what the gaps in the current knowledge are and how your research will add to the body of knowledge. Try to answer the following questions:

What does the published literature say? Remember, this is where your critical appraisal skills (Chapter 5) are put to use, since you must evaluate each piece of research to judge how sound the information and conclusions are. You need to present an overall picture of the robust and reliable research that is available. Weak and flawed studies do not add much to the knowledge base and should generally be ignored. If you include assumptions based on flawed studies in your reasoning for undertaking your research you leave yourself open to criticism that the basis for your study is unsound. Nevertheless, weaker studies may provide some evidence for your proposed hypothesis and help you justify why your research project is needed.

What are the gaps in the information? You might include here a brief mention of flawed studies to demonstrate you have a comprehensive knowledge of the literature available and recognise which papers do not inform your study and why. You can also highlight the gaps in the knowledge in your particular research area, which will lead on to the next section.

What will this particular piece of work add to the body of research? The summary of the larger body of published research should lead you on to state how your research question will fit into the gaps and add to the general knowledge base.

Why do we need to know this? You need to justify why your particular research idea is important and this will invariably mean showing how it will improve patient health or social care.

What value to patients, the health service, or your profession, will it have? Think carefully about how your work will help patients because, ultimately, that is what we are all trying to do; yet this desire can get lost in the detail. This may include evidence that patients think this research question is important, and that the work links to government guidance, hospital targets or professional research priorities. This information will really strengthen your proposal should you need to obtain funding (more about this in Chapter 9).

In this section you explain exactly how you will carry out the research and you may need to include the following subheadings. The exact headings required will vary depending on your study design, but many of these headings are applicable for all research; qualitative and quantitative.

State the design of your study. Is it prospective or retrospective? Is it observational or experimental? Is it controlled and randomised? What are the philosophical assumptions underlying the research? What strategies of inquiry are to be used (phenomenology, grounded theory etc)? See Chapter 6 for more detail.

Where will you carry out this research? Not only will you state here your organisation and geographical location but also think about which room you can use and the amount of space you need. Writing this section may result in a list of clarifications to make before the research can commence. For example; Who do you need to ask? Who else uses the room? Do you need to share and coordinate with others? Will you need to go to the patient’s own home? Do you need to book rooms for interviews or focus groups?

Who will you include in your study? What are your specific inclusion and exclusion criteria? How many people will you include and how have you arrived at this figure? In quantitative studies you will usually need to justify recruitment figures with a power calculation (see Chapter 8, Section 8.2.3 for details). In qualitative work you will need to explain why you have decided on the recruitment figure and what strategies you have for increasing data collection should you need to.

Describe how you will locate and recruit your subjects (see Chapter 13 for information on recruitment), and demonstrate that you are likely to meet your recruitment target within the proposed time span. For example, if you see on average 100 patients from the group you are interested in each year, and you need to recruit 50 to your study, you need to estimate how long it will take to recruit this number. DO NOT overestimate how many people you can recruit; this is a very common and easy error to make (I’ve made it several times being quite optimistic!). For even the easiest study not everyone will want to take part; for an onerous protocol or a sensitive topic maybe only 10% of screened patients will take part. You have exclusion criteria and so there will be people who are unsuitable to take part; check this carefully with your proposed pool of potential participants, you may be surprised how many people are excluded. Finally, always allow for some people to drop out. 20% is a reasonable drop out figure for most research, but studies including elderly or critical care patients may be higher. Each patient group will differ so it is a good idea to ask someone who has done research in your area.

Outcomes are the changes and effects that happen as a result of the intervention you are testing or the specific information and knowledge gained as a result of your investigation. You need to identify what outcomes you are expecting and looking for.

In quantitative research you will need to identify your most important outcome; the one most pertinent to your research question. This is termed the ‘primary outcome’ and you will use this outcome to calculate how many patients to include in your study (using a power calculation – see Chapter 8, Section 8.2.3). You may also list other outcomes of interest which you will be examining and these are termed ‘secondary outcomes’.

An example of outcomes from a quantitative research hypothesis: