Why English? | Reporting CONSORT Pilot and Feasibility Trials Through Feasibility Objectives, Progression Criteria, Recruitment, Unintended Consequences and Next Steps

ORIENTATION

What this guide owns

Current fact check

The 2016 extension applies to randomised studies in which a future definitive trial, or part of it, is conducted on a smaller scale. It does not directly cover an internal pilot built into the main trial, a non-randomised feasibility study or a phase II study, although some principles may still help.

Canonical boundary

This article owns reporting of randomised pilot and feasibility trials conducted before a future definitive randomised trial. The education-policy pilots article owns system scaling, while the CONSORT 2025 article owns general completed-trial reporting.

Worked example

Every chapter returns to a fictional pilot in eight secondary schools testing whether a future trial of a reading-conference programme can recruit schools, train teachers, retain students and collect the planned comprehension outcome. It is fictional, low-stakes and educational; it does not report a real school, clinical decision or guaranteed outcome.

Warm up with eduKate’s guides to explaining scientific evidence and asking better questions in class.

CHAPTER 1 OF 13

1. Identify the Study as a Randomised Pilot or Feasibility Trial

Back to contents

Why this move matters

Use the title and abstract to name the study correctly and identify the future definitive trial it prepares.

Return to the feasibility question

Use the title and abstract to name the study correctly and identify the future definitive trial it prepares. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The title says pilot cluster randomised trial rather than only randomised trial. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

The word pilot is not a synonym for small, early or low quality. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Identify the Study as a Randomised Pilot or Feasibility Trial”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 2 OF 13

2. State the Future Definitive Trial and the Feasibility Uncertainties

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Why this move matters

Describe the intended design, intervention, comparator, population and outcomes, then name what is uncertain enough to require the pilot.

Return to the feasibility question

Describe the intended design, intervention, comparator, population and outcomes, then name what is uncertain enough to require the pilot. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The team is unsure whether schools can be recruited and whether teachers can deliver the programme consistently. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A list of activities is not a set of answerable feasibility objectives. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “State the Future Definitive Trial and the Feasibility Uncertainties”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 3 OF 13

3. Separate Feasibility Objectives From Effectiveness Objectives

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Why this move matters

Write specific questions about recruitment, retention, acceptability, delivery, data collection or analysis systems and avoid confirmatory efficacy language.

Return to the feasibility question

Write specific questions about recruitment, retention, acceptability, delivery, data collection or analysis systems and avoid confirmatory efficacy language. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The objective estimates outcome completion, not whether the programme raises scores. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A confidence interval around a preliminary effect does not create confirmatory power. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Separate Feasibility Objectives From Effectiveness Objectives”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 4 OF 13

4. Describe How Participants and Sites Were Identified

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Why this move matters

Report settings, eligibility, screening routes, invitations, gatekeepers, consent and whether recruitment procedures themselves were tested.

Return to the feasibility question

Report settings, eligibility, screening routes, invitations, gatekeepers, consent and whether recruitment procedures themselves were tested. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The report states how schools and students entered the screening denominator. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

Reporting only those randomised hides whether the recruitment route was workable or selective. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Describe How Participants and Sites Were Identified”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 5 OF 13

5. Describe the Intervention and Trial Procedures Being Rehearsed

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Why this move matters

Give delivery, training, comparator, randomisation, masking, follow-up and data systems in enough detail to show what the pilot actually tested.

Return to the feasibility question

Give delivery, training, comparator, randomisation, masking, follow-up and data systems in enough detail to show what the pilot actually tested. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: Teachers rehearse the same training and lesson sequence proposed for the future trial. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A simplified pilot procedure may not establish feasibility of the definitive version. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Describe the Intervention and Trial Procedures Being Rehearsed”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 6 OF 13

6. Prespecify Progression Criteria and Decision Responsibility

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Why this move matters

State quantitative or qualitative criteria, thresholds or traffic-light zones, who will judge them, how uncertainty and context enter, and what actions are possible.

Return to the feasibility question

State quantitative or qualitative criteria, thresholds or traffic-light zones, who will judge them, how uncertainty and context enter, and what actions are possible. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: Green, amber and red recruitment ranges are set before enrolment with an independent review route. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A threshold invented after results cannot be a prespecified progression criterion. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Prespecify Progression Criteria and Decision Responsibility”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 7 OF 13

7. Justify Sample Size for Feasibility Precision

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Why this move matters

Explain the number of sites and participants using the feasibility objective, desired precision, practical range or other rationale rather than a definitive-effect power calculation.

Return to the feasibility question

Explain the number of sites and participants using the feasibility objective, desired precision, practical range or other rationale rather than a definitive-effect power calculation. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The sample supports a useful confidence interval around the retention rate. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

Convenience alone can leave a pilot unable to answer its own feasibility question. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Justify Sample Size for Feasibility Precision”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 8 OF 13

8. Report Recruitment, Retention and Flow With Denominators

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Why this move matters

Show sites and people approached, eligible, consenting, randomised, receiving intervention, assessed and analysed, with timing and reasons.

Return to the feasibility question

Show sites and people approached, eligible, consenting, randomised, receiving intervention, assessed and analysed, with timing and reasons. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The flow diagram separates school refusal from student non-consent and later loss. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A percentage without the screened denominator can make recruitment look easier than it was. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Report Recruitment, Retention and Flow With Denominators”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 9 OF 13

9. Report Each Feasibility Outcome With Uncertainty

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Why this move matters

Present observed rates, process measures, qualitative findings and precision against the planned target or question.

Return to the feasibility question

Present observed rates, process measures, qualitative findings and precision against the planned target or question. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: Recruitment is 72% with a confidence interval and an explanation of delays. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A target crossed by one observation may still leave substantial uncertainty. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Report Each Feasibility Outcome With Uncertainty”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 10 OF 13

10. Report Harms and Other Unintended Consequences

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Why this move matters

Describe expected and unexpected effects of the intervention and trial procedures on participants, staff, sites, workload, privacy and access.

Return to the feasibility question

Describe expected and unexpected effects of the intervention and trial procedures on participants, staff, sites, workload, privacy and access. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: Teachers report that one data form duplicates existing records and increases workload. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

Operational harm can matter even when no clinical adverse event occurs. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Report Harms and Other Unintended Consequences”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 11 OF 13

11. Explain the Progression Decision and Proposed Modifications

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Why this move matters

Compare results with criteria, state who decided, identify deviations, explain judgement and list changes to design, procedures or intervention.

Return to the feasibility question

Compare results with criteria, state who decided, identify deviations, explain judgement and list changes to design, procedures or intervention. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The team proceeds with a simpler data form and a longer school-recruitment window. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

An amber result is not automatically a hidden green result. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Explain the Progression Decision and Proposed Modifications”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 12 OF 13

12. Interpret Preliminary Outcomes Without Claiming Effectiveness

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Why this move matters

Report any intervention-effect estimates as exploratory or descriptive, with uncertainty and the study’s lack of confirmatory purpose.

Return to the feasibility question

Report any intervention-effect estimates as exploratory or descriptive, with uncertainty and the study’s lack of confirmatory purpose. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The score difference is shown to test measurement and analysis, not to declare success. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

Statistical significance in a small pilot can be unstable and misleading. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “Interpret Preliminary Outcomes Without Claiming Effectiveness”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

CHAPTER 13 OF 13

13. State What Happens Next and What Remains Unknown

Back to contents

Why this move matters

Explain whether a future trial is planned, what will change, what additional work is needed and how the pilot limits transfer.

Return to the feasibility question

Explain whether a future trial is planned, what will change, what additional work is needed and how the pilot limits transfer. Ask whether the item helps decide if or how a future definitive trial should proceed, not whether the intervention has already been proved effective.

Test one progression decision

Worked example: The report names the unresolved recruitment question for smaller schools before a definitive trial. Trace the target, observed result, uncertainty, traffic-light or other rule, contextual judgement and proposed modification.

Separate learning from efficacy

Report recruitment, retention, acceptability, delivery, measurement and data processes as feasibility evidence. Treat clinical or educational outcomes as descriptive unless the study was designed for confirmatory inference.

Protect the next study

A feasible trial is not the same as a feasible intervention at scale. A pilot can expose practical failure and improve design; it cannot guarantee that a larger trial will succeed or that the intervention works.

Student, parent and career transfer

Make one evidence card for “State What Happens Next and What Remains Unknown”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports education research, clinical trials, implementation science, programme evaluation, trial management and research funding without promising a grade, admission, funding decision or job.

PRACTICE LAB

Build a feasibility-progression decision trail

Student route

1. Choose one original report inside this guide’s scope.
2. Copy its objective and underline actor, action, context, evidence and intended decision.
3. Draw the specific reasoning chain used in this article.
4. Mark each step reported, inferred, contested or unknown.
5. Rewrite the conclusion so it preserves the narrowest important limitation.

Parent or teacher route

Ask the learner to explain CONSORT Pilot and Feasibility’s central reporting method twice: once to a classmate and once to a method specialist. Praise a precise correction and a well-stated unknown; both show disciplined attention to evidence.

Early-career route

Create a one-page CONSORT Pilot and Feasibility audit with source link, date checked, scope, method logic, decisive wording, contrary evidence, limit and next action. A colleague should be able to continue without guessing.

Continue with eduKate’s guides to reading course and career information and giving useful feedback in group projects.

USEFUL NEXT READING

Connect this narrow owner to its neighbour

Read the CONSORT 2025 trial-reporting guide for a related but different reader job. Return here when the question is specifically how to report a smaller preparatory trial without pretending it has already answered the definitive question. This boundary keeps one canonical owner per intent.

For English practice across research, school and career communication, visit the English at work and in public life guide.

FREQUENTLY ASKED QUESTIONS

Questions students and parents often ask

What is the main question in a pilot trial?

Whether and how a future definitive trial can proceed, not whether the intervention is already proven.

Must progression criteria be numerical?

No. They may combine quantitative thresholds and qualitative judgement, but the process should be prespecified and transparent.

Can a pilot estimate an intervention effect?

It can provide an exploratory estimate, but it is usually not designed for confirmatory effectiveness conclusions.

Why report unintended consequences?

Trial procedures can create burden, exclusion or workflow problems that affect the next study.

Does feasibility guarantee a successful larger trial?

No. It reduces selected uncertainties but cannot remove all future risk.

Which core guideline applies now?

Use CONSORT 2025 with the existing specialised extension until an aligned update is published.