The study design section explains how the study will be conducted. Often study designs can be summarized in a few words, but this section of the protocol is intended to expand on this and explain the procedure. For example, a study might be summarized as a ‘three-arm randomized controlled trial’ with further elaborations as to the activity involved in each ‘arm’ (or ‘branch’) of the trial outlined (prior to being described fully later), and what participants will be required to do, where, when, and for how long. Study design sections often contain a procedure diagram in the form of a flowchart, showing what will happen to participants. The flowchart should give the reader a quick and thorough overview of the study process. A sample flow chart is given in Figure 11.1.
Study participants should be clearly defined to focus the study and avoid biased recruitment. Even if participant groups are very broad, defining features such as location, gender, age range, etc., should be included. For example, ‘people aged 18 or over living within the borough of Camden in London’ or more specifically ‘women aged 18-30 with moderate depression (defined as a score of 11-15 on
Figure 11.1 A sample flow chart showing a study process and mapping participant involvement.
the Hospital Anxiety and Depression Scale)’. For some arts interventions, it may be considered unethical to exclude some people from taking part in an activity because they do not fit the inclusion criteria for a study. However, it may be possible to allow a broader range of people to take part in an activity, perhaps including friends or carers of participants, but with the research only involving those who fit the specific criteria for the study. Alternatively, it may be possible to offer delayed joining options for participants, meaning that the initial few months will be for research participants only, but thereafter the intervention will become freely available to others.