Identification of the novel technique/device being investigated and the type of study conducted (e.g. multi-centre, prospective cohort or feasibility RCT), including the IDEAL stage.
Review literature on the topic. Refer to IDEAL Stage 1 and 2a reports in previous publications, if available. Clarify specific objectives of study including reaching consensus on aspects necessary to conduct an RCT, or consensus that an RCT is not appropriate or feasible
Describe study design (e.g. multi-centre study design, with prospective collection of standard data across centres). Consider holding a consensus meeting at end to determine if an RCT is feasible?
P Identify the patient group, 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 a detailed description of the new technique, including necessary pre- and post-procedure care or reference to it in prior publication, including an assessment measure for quality of adherence to the technique for operators/teams
I If addressed be able to describe or reference your learning curve assessment of operators/team using pre-defined objective quality metrics
I Will you include patient safety monitoring methods and safeguards? Describe these.
O Description of pre-specified primary and secondary outcome measures selected 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
Describe the statistical methods you will use to describe baseline characteristics and evaluate primary and secondary outcomes, when appropriate, including methods for additional analysis (e.g. learning curve analysis, pre-specified subgroup analysis)
Will you attempt to evaluate patient and surgeon preferences and values relevant to future RCT trial design and conduct? How will you do this? Include any qualitative work planned to ascertain views about randomization.
Interpret results and analyze the appropriateness of progressing to RCT or pilot/feasibility study ie,
Consider how will ensure potential harms from learning curves are addressed by training and mentoring prior to Stage 3.