Developing the methods of a study may be one of the most difficult and time-consuming steps of the research process thus far (make sure you have developed a reasonable research question). But, it provides the “recipe” for the action phase of your research study. At this stage, it would be helpful to get some help from someone who already does clinical research (you can get in contact with me here if you do not know anyone else who can help you through this process) – since the details are really important for the rigor of your study and to assure that once you get to the end, regardless of the results, that your results will help other therapists.
First, you need to clarify any ambiguous terms within your research question – for example, if you want to measure “quality of life” what does this mean? How will it be measured? You also need to understand what defines the parameters of a particular intervention (what does it look like, how often is it provided, etc)?
Next, you need to specify the population from whom you will collect data. You will need to decide what characteristics are needed (inclusion criteria) and those characteristics that are not desired (exclusion criteria).
Example: I want to study stroke clients between 1-3 years post-stroke who are between the ages of 25 and 55 years old. Clients will be excluded if they have severe cognitive deficits, flaccid upper extremity, and cannot speak English.
You will then need to decide on the type of study design and
how it will work.
Qualitative methods are those that look deep into a topic and want to provide some information about experience or subjective information about your subjects. For example, “how do patients perceive intervention X provided by occupational therapists while recovering from a stroke?” might be best answered with a qualitative research design.
Quantitative methods, on the other hand, look to provide some type of aggregate data about a group or make some conclusions about whether an intervention works or not. For example, “does intervention X work better than intervention y in clients with cerebral palsy who are transitioning to a worker role?” might be best answered with a quantitative research design.
Finally, you need to decide what the “research” will be, how you will recruit participants, and what data you will collect.
For a qualitative study, you might conduct interviews or focus groups to get the answers you want for your research question.
For a quantitative study, you have to be specific about what type of data you will collect and decide on outcome measures that will answer your research questions. This could include physical measurements (range of motion, BMI) or subjective measures (quality of life) or psychosocial measures (anxiety, depression).
Finally, you need to decide who will collect the data and how it will be analyzed.
All of these details should be written down (it will become your study protocol) – you will use this information to conduct your study. You will also need this information for the next step – ethics board approval!
Cover photo courtesy of http://www.keepcalmandposters.com/poster/5615825_keep_calm_and_follow_protocol