Identify as a prospective case series of a novel technique include tag IDEAL stage 2a.
Review literature on the topic. Refer to IDEAL Stage 1 reports in previous publications, if applicable. Clarify specific objectives of study including refining the new technique and progressing toward stability.
Describe study design (e.g. sequentially reported prospective case series)
P Consider how you will select 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 or refer to a prior stage paper, 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 measures that are standardized and validated. Provide rationale for the outcome measure(s) used
Assess whether the technique and outcomes have reached stability in the hands of the current team (e.g. you do not intend to make further major modifications to the technique, and patient outcomes are stable). You will be able to establish whether the technique is ready for evaluation in a prospective, multi-centre IDEAL Stage 2b study.