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Module contents:
Writing your protocol: why we have them, what to put in the Background section, and defining the question
Learning objectives
Why bother with protocols?
Can I change my protocol?
Writing your protocol
Defining the question
Building up your table of comparisons
Next module

Writing your protocol

You will probably have several versions of the protocol as you agree on the content with your co-reviewers and review group. Many people prefer to do this in a word-processing package they know well, rather than put it straight into RevMan. If you plan to do this, it is easy to copy and paste text directly into RevMan after you have written it in another piece of software. However, fancy fonts, formatting, tables, etc don't paste across well, so keep the text simply formatted.

You should also remember that the target audience for your review is the same as for a general medical journal. So try to imagine the audience when you're writing, and write for them. If they cannot understand what you are proposing in your protocol, they might not be able to understand the results and conclusions of your review.

The Title

The title of your review is important. When someone using The Cochrane Library is browsing through a list of reviews, it is the first thing they will see. So the title has to provide enough information to help the reader decide if the review is relevant to them.

The reader will need some succinct information about the participants and interventions that are the focus of the review. They won't want to be distracted with unnecessary words. The Cochrane Collaboration has decided on a standard format for titles which helps to convey information as quickly as possible:

[Intervention] for [problem] in [category]

The last of these three parts is not always needed. Here are some examples:


Try to write out your title in this format

Acupuncture for chronic asthma
Antihistamines versus aspirin for itching in late pregnancy
Case management for people with severe mental disorders

Try writing out your title in this format. Try it out on some people and see if they understand what your review is about. You'll get further help from your review group in deciding on the title.

 

By the time a reader finishes your Background section s/he should be able to understand why you are asking the question

The Background section

In the Background section you need to explain to people reading your review why you are asking the review question. Don't forget to write this section in plain English. Here's a list of the sort of things you might like to cover:

  • how important is the problem?
  • is there any uncertainty about how to deal with the problem?
  • why do people think this intervention might work?
  • what is the intervention supposed to achieve?
The background should cover the size of the problem, uncertainty about dealing with it, why the intervention might work, and what it is supposed to achieve

When you discuss the importance of the health problem addressed by your review, you should cover how common the problem is and what effect it has on people or communities. For example, the common cold affects millions of people, has only minor effects on most people, but is responsible for a lot of time off work which costs the economy money. Multiple sclerosis is not very common, but affects some people very severely. You should try to attach some numbers to these types of statement (and reference them), and also consider how the situation might vary around the world.

Many people undertake reviews because they know there is uncertainty about how to deal with the health problem. If you know of evidence of uncertainty, put it here. For example, you might be aware of a survey showing that different doctors use different drugs in the same situation.


Read section 3.2 of the Reviewers' Handbook

It's not always obvious why people think an intervention might work, or why people tried it in the first place. So include some explanation of the reasoning behind the use of the intervention. For drugs, this might be some biological information about how the drug acts on a cell; for other interventions it might be psychological or sociological theory. However, don't get too technical! This section of a review should be understandable to a wide readership. If you think there needs to be some very detailed information for expert readers, you could put a section at the end of the Background with a subheading called 'technical information'.


Try to explain to someone who doesn't know much about the topic what your review is about. Give yourself a time limit of 5 minutes and try to get all the important points in.

Finally, you should explain what the intervention is supposed to achieve. Is it supposed to cure the problem, or help with a specific symptom?

At the end of this section, the reader should understand why you are asking the review question, and the next part of the review shouldn't come as a surprise. A good way to see if your background contains the right information is to use it to explain to someone what your review is about.


Write out the main questions your review addresses in a few sentences

Objectives

In this section you should write down the main questions to be addressed in your review. This should only take a sentence or two. Try it now…..

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