Identify the technique or device in the title and state IDEAL Stage 1 or ‘first in human’
Review literature on the topic. Be able to provide a clear explanation of the rationale for the new technique. Is there an unmet clinical need. Outline details of pre-clinical development of the technique, including efforts to avoid harm. Explain if innovation arose in emergency situation.
Describe study design (e.g. case report or very small case series)
P Consider how you will select the first/few patients, with explicit detail about inclusion and exclusion criteria
P Clarify your informed consent process (include explanation of risks and acknowledgement of level of experience with technique/device)
Describe setting, location, and timeframe of when and where the novel technique will be performed, including hospital characteristics, details regarding the operator/team (e.g. experience)
I Be able to provide clear and detailed description of the new technique/device, including necessary pre- and post-procedure care
I Will you include patient safety monitoring methods and safeguards? Describe these.
O How will you select outcome measure(s) and how they will be assessed, including patient reported outcome measures, preferably use measures that are standardized and validated. Provide rationale for the outcome measure(s) used.
Evaluate if it is worthwhile to pursue in further patients and discuss risks and suggestions to avoid them in future cases based on initial experience.
