IDEAL Stage 1 Checklist

13th April 2021

A Checklist for planning IDEAL Stage 1: Idea – what you need to consider before beginning.


Identify the technique or device in the title and state IDEAL Stage 1 or ‘first in human’

Background and objectives

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.

Methods – What are you planning to do?

About the study (consider PICO elements – patients, intervention, comparator, outcomes where relevant)

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.

Consider what data you will collect and how you will report/analyze it

  • Baseline Data – eg, baseline demographic and clinical characteristics for each patient. How many patients were assessed for treatment and a description of which patients were included, excluded, or refused, and why (to be displayed in a flow diagram format, when appropriate)
  • Intervention – Technical feasibility of technique, including visual aids (e.g. photographs, videos, etc) when available
  • Outcomes – what are appropriate clinical outcomes?
  • Harms – Transparently describe all harms or unintended effects for each patient

By the end of the study you will be able to:

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.

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