IDEAL Stage 2b Checklist

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

Title

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.

Background and objectives

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

Methods – What are you planning to do?

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

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.

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)

• Report of learning curve assessment results for operators/team based on pre-defined objective quality metrics, including statistical analysis, if feasible

• Describe results of each pre-specified outcome measure, including patient reported outcome measures, where appropriate
• Transparent account of all harms or unintended effects reported
• Stakeholder Values – Report findings of attempts to evaluate patient and surgeon preferences and values relevant to future RCT trial design and conduct, including any qualitative work done to ascertain views about randomization

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

Interpret results and analyze the appropriateness of progressing to RCT or pilot/feasibility study ie,

• Has agreement been reached about standard technique, including accepted variants, and quality standards based on operator/team experience during this stage?
• Has agreement been reached for appropriate target patient population and indications, including identification of subgroups for which the applicability of the technique is considered uncertain?
• Has agreement been reached regarding appropriate outcome measure(s) for a trial, including an estimated power calculation of the primary outcome for a future trial?
• Has agreement been reached regarding the appropriate comparator treatment for a trial?
• Are operators and patients willing to accept randomization between the proposed treatments (establishing equipoise)?

Consider how will ensure potential harms from learning curves are addressed by training and mentoring prior to Stage 3.

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