Research is a tool for answering questions. Unless you know what your question is, you will be unable to design your research. Novice researchers are often unable to frame a question to illustrate their research interest, even after repeated prompting. For example, a researcher at a conference reported that his question was ‘to demonstrate the effectiveness of herbal medicine for cystitis’; another cited a wish ‘to investigate massage for cancer patients’. These are clearly not questions.

There are three general guidelines for defining a research question: (1) questions should be in four parts; (2) questions should be focused; (3) questions should be explicit.

Research, like a ‘journey of a thousand miles’, goes one step at a time. Broad questions such as ‘Does hypnosis work?’ or ‘What are the effects of patient expectations on outcome?’ will not be resolved by a single research study. The researcher needs to break down large, global questions into manageable stages: a series of questions each associated with a single study.

Science is a cumulative enterprise. A review of the background can help you define a study topic, identify appropriate research designs and avoid the mistakes of previous workers. Locate as many studies as possible on both the therapy and the condition under investigation and look up other examples of the type of research that you would like to conduct (have a look at some classic surveys if you want to conduct a survey, for instance). Indepth reading of the research literature is one of the most important preparatory steps for a prospective researcher.

Given that research will almost inevitably turn out much more complicated than you could possibly imagine, it is a good idea to keep things simple to start with. Studies involving multiple endpoints, complex designs or large numbers of participants should be avoided by all but the most experienced researchers.

One ‘red flag’ to watch out for: if anyone comes up to you while you are planning your research and says ‘wouldn’t it be nice to know …’, panic! Of course it would be ‘interesting to know’ all sorts of things. The point is that you cannot answer all of them in your research. This seems a particular problem in questionnaire surveys, where the temptation is always to add just one more question. The problem is that, the longer a questionnaire is, the less likely you are to get good-quality data from any particular respondent.

The importance of keeping things simple is often inadequately recognized at present in the medical research community. For example, a first-time researcher was recently told by a funding committee to change a simple comparison of a physical therapy technique to no extra treatment to a complex three-way trial of the physical therapy technique, contact with the physical therapist but no use of the technique, and no contact. This was on the grounds that ‘it would be interesting to know’ which components of the physical therapy technique were of value: was it the actual technique itself or just the time and touch of the teacher? This more than doubled the cost of the trial, and because the funding committee was unwilling to provide the extra money, the trial was never conducted. My own view is that the initial two-arm trial should have been funded with further research questions addressed subsequently.

A study protocol is a precise description of all methodologically pertinent features of a study. An example of a protocol is given in the further reading section, below. The point of a protocol is that it should provide a complete guide to all aspects of trial management and analysis. It should be extremely detailed and explicit: a protocol I recently wrote, for instance, was nearly 8000 words long. As an illustration, here is a short section, chosen more or less at random, which describes the rules for data entry if data are ambiguous:

Many protocols are inadequately detailed, particularly the plan for statistical analysis. Examples I have seen recently include: ‘we expect to measure the proportion experiencing pain relief of at least 35–50%’ and ‘the main outcome measure will be forced expiratory volume’. Compare this to ‘the primary outcome measure will be the change in mean daily headache score between baseline and the 1-year follow-up’. This is an absolutely explicit guide: you do not have to guess whether to choose 35% or 50% as a cut-off nor guess at which follow-up point forced expiratory volume should be assessed.

In centres conducting many studies, certain aspects of methodology can be defined by standard operating procedures (SOPs). SOPs describe certain aspects of research, such as how to chase up missing data by telephone, or how to deal with ambiguous data. The SOPs can be summarized in a single, standalone document that is then referred to in protocols.

A good way to make sure that you have incorporated all appropriate detail in your protocol is to use a methodological checklist. An example of a checklist, in this case for clinical trials, is given in Box 15.1. One useful trick is to go through the checklist a second time, this time asking ‘who?’ rather than ‘what?’ (e.g. ‘What measurements will be taken before treatment?’ becomes ‘Who will take measurements on participants before treatment?’).