I am conducting a systematic review about a newly developed psychological intervention for children, but all studies available are of exploratory/feasibility nature and I am not sure how to evaluate/analyse their results.
I am wondering if anyone is aware of guidelines or articles regarding the decision process of going from a pilot/feasibility stage to full RCT?
I am sure this is a relevant question in many departments, deciding if the results from exploratory studies justify going further with expensive RCTs.
I have been looking in to Cochrane Library etc. to see how they evaluate evidence, but what I can find is mostly regarding making clinical guidelines based on evidence availible (RCTs and other sources of evidence).
If anyone knows anything about this process, guidelines for going from exploratory to RCTs, I would be immensely grateful since I feel a bit stuck on this question (how to analyse the results from feasibility/exploratory intervention studies, what criteria can be used for deciding to go ahead or not with RCTs etc..)
I doubt that you can find cookie-cutter guidelines or algorithms or decision tools in making/not making the jump from feasibility studies to full-blown RCTs. I say this because I think that such decisions are highly contextualized based on the outcome thresholds and risk tolerance of the study investigators, sponsors/funders and perhaps even the immediate community/participants (potentially) involved. The manner of interpreting the quality and favorability of the results, funding availability and requirements, challenges in recruitment and a lot of other factors may vary widely across settings. Ultimately, I think the process is largely subjective.
Nevertheless, you might want to check the following references:
1. An editorial that describes the distinction between RCTs and preliminary & pilot studies; the content in the table may be of immediate interest to you: Article The Distinction Between Randomized Clinical Trials (RCTs) an...
2. A systematic review that investigated to motivations for the conduct of RCTs across medical specialties: Article The pathway to RCTs: How many roads are there? Examining the...
Unfortunately, there is (as is so often the case in scientific research) no pre-determined answer for your question. You will have to consider, decide and substantiate the criteria for inclusion in your study. You might find this specific part of the Cochrane handbook you already consulted specifically helpful in the process:
https://training.cochrane.org/handbook/current/chapter-03
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