In some of the Phd dissertations, I see randomized controlled mixed methods study is conducted applying only feasibility phase with 3-5 participants as a pilot trial. Then the main study is started. Is this method ok? I think they should conduct a pilot trial first which includes feasibility and represents main study including randomized controlled trial design. For example 30 intervention and 30 control groups. How a new developed health education program could be designed best ? Which of the quidelines should be followed ?
Thank you so much for your response in advance!
For a survey questionnaire, 3-5 participants might be adequate for a pilot study, but I doubt whether such a small sample would be adequate for an intervention.
Can you say more about what your goals are for your pilot study?
Dear Professor David L Morgan ,
First of all, I would like to thank you for your response. I would like to further detail my question as follows.
I am considering developing an person-centered education program based on a model and comparing it with standard public health education. Since there is no research based on this approach in my field of study, I am thinking of designing the new education program I will develop as a pilot study to assess its feasibility and potential impact. And I plan to do this using a mixed-method approach. When I reviewed some doctoral theses, I saw that they tested the feasibility of a newly developed program, "for example, a web-based health education program", on only 3-5 people and then directly conducted the main study to measure the effectiveness of the intervention. However, is it correct to measure the effectiveness of a newly developed program without conducting a pilot study first? Additionally, the literature recommends including 10-30 participants in each arm for pilot studies. This situation has confused me. Is my method correct?
Kind regards,
It sounds like you are doing something similar to an exploratory sequential mixed methods design, where you use a preliminary qualitative study to help create a larger quantitative project.
If so, that is rather different from pilot testing. I recommend that you take a look at the textbook by Creswell and Plano-Clark on mixed methods, which has a chapter on exploratory sequential designs.
Since it is a person-centered education program, I would suggest a few points. B F Skinner's ABC Theory may help conceptualize the model better. The Central Limit Theorem will help you in sample size selection. A Longitudinal Study will give a better outcome as it is a training/education-related module. Hope the inputs help you in your study.
Conducting a randomized controlled mixed-method pilot and feasibility study involves a thoughtful approach to address key research questions. Here’s a methodological guidance for integrating quantitative and qualitative methods within such studies:
Joash Sande Please credit Chat-GTP or the equivalent AI when you re-post responses from it.