IDEAL Stage 2a Checklist

A Checklist for planning IDEAL Stage 2a: Development – what you need to consider before beginning.

Title

Identify as a prospective case series of a novel technique include tag IDEAL stage 2a.

Background and objectives

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.

Methods – What are you planning to do?

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

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

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 – You will need to provide a transparent report of all cases in the sequence they were performed, clearly indicating when and why modifications to the technique took place, including visual aids of the technique and modifications (e.g. photographs, videos, etc) when available See example paper
• Outcomes – Clinical and patient-reported outcomes described for each patient, with all available outcome data incorporated into a comprehensive table or graph, whenever possible, to allow for the relationship to be clearly visualized between technique modifications and outcomes
• Harms – Transparently describe all harms or unintended effects for each patient

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

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.

 

 

 

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