Randomised Controlled Trial Report Template (CONSORT 2025)

Randomised trial report following the 30 CONSORT 2025 items: open science, PPI, methods, flow diagram, results, harms

과학 연구전체CONSORT 2010clinical trial report diagram math업데이트됨 2026. 10. 20.

사용법: Use when writing up a completed randomised trial for a journal or clinical study report. Fill the open science items (registration, protocol, data sharing, funding) and the participant flow first, and complete the official checklist page numbers as you go. The main pitfall is numbers that do not reconcile between abstract, flow diagram and tables.

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Randomised Trial Report: [Short title of the trial]

Report template for a randomised controlled trial. The sections follow the topics and order of the CONSORT 2025 Statement (title and abstract, open science, introduction, methods, results, discussion), which replaced CONSORT 2010 and has 30 checklist items plus a participant flow diagram. Topics are written in original words for this collection; use the template with the official CONSORT 2025 checklist and flow diagram from consort-spirit.org. This is a reporting format, not clinical, statistical or regulatory advice. Replace every [bracketed] value and every row marked Example.

Document control

Field	Value
Document ID	[CTR-TRIAL-001]
Trial acronym	[ACRONYM]
Trial registration	[Registry name and number, e.g. ISRCTN / NCT / EUCT]
Protocol version reported against	[Protocol v3.0, YYYY-MM-DD]
Statistical analysis plan	[SAP v1.1, YYYY-MM-DD]
Reporting guideline	CONSORT 2025 [plus extensions used, e.g. cluster, non-inferiority]
Version	[0.1]
Status	[Draft / In review / Approved]
Owner	[@chief-investigator]
Approvers	[@trial-statistician], [@trial-steering-committee-chair]
Last updated	YYYY-MM-DD
Classification	[Confidential until publication]

Approvals

Role	Name	Decision	Date
Chief investigator	[@name]	[Approved]	YYYY-MM-DD
Trial statistician	[@name]	[Approved]	YYYY-MM-DD
Trial steering committee chair	[@name]	[Approved]	YYYY-MM-DD
Sponsor representative	[@name]	[Approved]	YYYY-MM-DD

Revision history

Version	Date	Author	Change summary
0.1	YYYY-MM-DD	[@name]	First draft after database lock
0.2	YYYY-MM-DD	[@name]	Example: Added per-protocol sensitivity analysis requested by steering committee
1.0	YYYY-MM-DD	[@name]	Approved for journal submission

Title and abstract
Open science
Introduction
Methods
Results
Discussion
Appendices

1. Title and abstract

The title and structured abstract let readers identify the study as a randomised trial and grasp its design, methods, results and conclusions.

1.1 Title (item 1a)

The title identifies the study as a randomised trial and names the intervention, comparator, population and main outcome.

[Intervention] versus [comparator] for [condition] in [population]: a [multicentre, double-blind] randomised controlled trial

1.2 Structured abstract (item 1b)

Heading	Content
Background	[One or two sentences on the problem and the gap]
Objective	[Primary objective in one sentence]
Design	[Parallel-group, allocation ratio, blinding, number of centres, country]
Participants	[Key eligibility criteria and setting]
Interventions	[Intervention and comparator, dose, duration]
Main outcome	[Primary outcome and time point]
Randomisation and blinding	[Method in a few words; who was blinded]
Results	Example: 412 participants randomised (206 per group); 389 analysed. Mean change in [outcome] was -8.1 vs -4.9 points (difference -3.2, 95% CI -5.0 to -1.4). Serious adverse events: 9 vs 7.
Conclusions	[One sentence that matches the primary result, without overstating]
Registration	[Registry and number]
Funding	[Funder and grant number]

2. Open science

These items let readers compare the report with the registered plan, find the underlying materials and judge potential conflicts.

2.1 Trial registration (item 2)

Registry: [name]; registration number: [number]; registry URL: [link]; date registered: [YYYY-MM-DD]; [prospectively / retrospectively] registered. If registration was retrospective, explain why.

2.2 Protocol and statistical analysis plan (item 3)

The full protocol can be accessed at [journal reference / registry / repository link]. The statistical analysis plan (version [x.y], finalised [YYYY-MM-DD], [before / after] unblinding) is available at [link].

2.3 Data sharing (item 4)

Material	Available?	Where	When	Access conditions
De-identified individual participant data	Example: Yes	[Repository name and DOI]	6 months after publication	Approved proposal and data use agreement
Data dictionary	[Yes / No]	[Link]	[When]	[Conditions]
Statistical analysis code	Example: Yes	[Code repository link and commit]	At publication	Open licence [MIT / CC BY]
Other materials (case report forms, intervention manual)	[Yes / No]	[Link]	[When]	[Conditions]

2.4 Funding and conflicts of interest (items 5a, 5b)

Item	Detail
Funder	[Funder name, grant number]
Other support	[Supply of drugs or devices, for example by manufacturer]
Role of funder	Example: The funder had no role in design, conduct, analysis, interpretation, writing or the decision to publish
Conflicts of interest of authors	[Financial and non-financial interests per author, or reference to disclosure forms]

3. Introduction

The introduction tells the reader what was already known and why this trial was justified.

3.1 Background and rationale (item 6)

[Describe the condition, its burden and current management. Summarise the existing evidence for the intervention, ideally from a systematic review, and state the specific uncertainty this trial addresses.]

3.2 Objectives (item 7)

ID	Objective	Hypothesis	Type
OBJ-01	Example: Compare [intervention] with [comparator] on [primary outcome] at 12 weeks	[Intervention] reduces [outcome] by at least 3 points more than [comparator]	Primary, benefit, superiority
OBJ-02	[Secondary objective]	[Hypothesis]	Secondary, benefit
OBJ-03	Compare the frequency of [specified harms] between groups	Descriptive, no formal hypothesis	Harms

4. Methods

The methods describe the trial as it was actually conducted, in the order of the CONSORT 2025 checklist.

4.1 Patient and public involvement (item 8)

Stage	Who was involved	How	Effect on the trial
Design	Example: 6 people living with [condition] in a lived-experience panel	Two workshops on outcomes and visit burden	Primary outcome changed to a patient-reported measure; visits reduced from 6 to 4
Conduct	[Who]	[For example review of participant materials]	[Effect]
Interpretation and reporting	[Who]	[For example co-writing the plain-language summary]	[Effect]

4.2 Trial design (item 9)

[Describe the design, for example: a multicentre, parallel-group, double-blind, placebo-controlled superiority trial with 1:1 allocation, conducted at [n] sites in [country or countries].]

4.3 Changes to trial protocol (item 10)

Change	Date	Reason	Approved by
Example: Upper age limit raised from 70 to 80 years	YYYY-MM-DD	Slow recruitment; no safety concern in older adults	Research ethics committee, amendment 2
[Change]	YYYY-MM-DD	[Reason]	[Body]

4.4 Trial setting (item 11)

Settings: [type of centres, for example university hospitals and community clinics]. Locations: [countries and number of sites per country]. A list of sites is in appendix B.

4.5 Eligibility criteria (items 12a, 12b)

Participants: inclusion criteria

[Age range, diagnosis confirmed by method, severity threshold]
[Ability to give informed consent]

Participants: exclusion criteria

[Contraindication to the intervention]
[Concurrent participation in another interventional trial]

Sites and intervention providers (if applicable): [for example sites needed at least 20 eligible patients a year; physiotherapists needed two years' experience and completed a one-day training course].

4.6 Intervention and comparator (item 13)

Element	Intervention group	Comparator group
What	[Drug, device, procedure, programme]	[Placebo, usual care, active comparator]
Dose and schedule	Example: 20 mg orally once daily for 12 weeks	Matching placebo once daily for 12 weeks
Delivered by	[Profession and training]	[Profession and training]
Setting	[Outpatient clinic / home]	[Same]
Tailoring or modification rules	[Dose reduction rules]	[Same]
Additional materials	[Intervention manual, link]	[Link]

4.7 Outcomes (item 14)

ID	Outcome	Variable	Analysis metric	Aggregation	Time point
OUT-P1	Example: Symptom severity (primary)	[Validated scale, 0-50]	Change from baseline	Mean	12 weeks
OUT-S1	[Secondary outcome]	[Variable]	[Metric]	[Proportion]	[Time point]
OUT-S2	[Secondary outcome]	[Variable]	[Metric]	[Aggregation]	[Time point]

4.8 Harms (item 15)

Aspect	Approach
Definition	Example: Adverse events coded with MedDRA [version]; severity graded with [CTCAE version]
Systematic collection	[Structured questionnaire at weeks 2, 6 and 12 for prespecified events]
Non-systematic collection	[Spontaneous reports at any time]
Assessor	[Site investigator, blinded to allocation]

4.9 Sample size (items 16a, 16b)

For a two-group comparison of means with equal allocation, the number of participants per group is:

n = \frac{2\,\sigma^{2}\,\left(z_{1-\alpha/2} + z_{1-\beta}\right)^{2}}{\Delta^{2}}

where $\sigma$ is the standard deviation of the outcome, $\Delta$ the minimal clinically important difference, $\alpha$ the two-sided significance level and $1-\beta$ the power.

Example: With $\sigma = 10$ , $\Delta = 5$ , $\alpha = 0.05$ ( $z = 1.96$ ) and 90% power ( $z = 1.28$ ), $n = 2 \times 100 \times 3.24^{2} / 25 \approx 85$ per group. Allowing for 10% loss to follow-up, $85 / 0.9 \approx 95$ per group, 190 in total.

Parameter	Value	Source
Minimal important difference $\Delta$	[5 points]	[Reference]
Standard deviation $\sigma$	[10 points]	[Pilot study / prior trial]
Alpha (two-sided)	[0.05]	Convention
Power	[90%]	[Rationale]
Expected attrition	[10%]	[Prior trial]
Target sample size	[190]	Calculated

Interim analyses and stopping guidelines (item 16b): [None planned / describe, including the boundary used, for example O'Brien-Fleming, and who saw interim results].

4.10 Randomisation (items 17 to 19)

The randomisation process is reported in three parts.

4.10.1 Sequence generation (items 17a, 17b)

[Who generated the sequence and the method used, for example an independent statistician using computer-generated permuted blocks of random size 4 and 6, stratified by centre and baseline severity.]

4.10.2 Allocation concealment mechanism (item 18)

[Mechanism used to conceal the sequence until interventions were assigned, for example a central web-based system accessed after eligibility was confirmed and consent recorded.]

4.10.3 Implementation (item 19)

Task	Performed by	Access to sequence?
Generated the sequence	Example: Independent statistician at [clinical trials unit]	Yes
Enrolled participants	[Site research nurses]	No
Assigned participants to interventions	[Central randomisation system]	System only

4.11 Blinding (items 20a, 20b)

Group	Blinded?	How
Participants	[Yes / No]	Example: Identical capsules in appearance, taste and packaging
Care providers	[Yes / No]	[Method]
Outcome assessors	[Yes / No]	[Method]
Data analysts	[Yes / No]	[Groups coded A and B until analysis was complete]

4.12 Statistical methods (items 21a to 21d)

Item	Approach
Methods for outcomes, including harms (21a)	Example: Linear mixed model with baseline score, stratification factors and centre as covariates; harms compared descriptively with risk differences
Analysis populations (21b)	Example: All randomised participants analysed in the group to which they were allocated
Effect measure	[Mean difference / risk ratio / hazard ratio] with 95% confidence interval
Missing data (21c)	[Multiple imputation under missing at random, 50 imputations; sensitivity analysis under missing not at random]
Additional analyses (21d)	[Prespecified subgroups with interaction tests; per-protocol and complete-case sensitivity; post hoc analyses labelled as such]
Multiplicity	[Correction method or rationale for none]
Software	[R 4.x / Stata / SAS version]

5. Results

This section reports what happened to participants and what the trial found.

5.1 Participant flow (items 22a, 22b)

The diagram shows the numbers of participants assessed, randomised, allocated, followed up and analysed.

Stage	Intervention	Comparator	Reasons
Excluded before randomisation	[108 total]		Example: 71 did not meet criteria, 29 declined, 8 other
Received allocated intervention	[201]	[204]	[Reasons for not receiving]
Discontinued intervention	[12]	[9]	[Adverse event, withdrawal]
Lost to follow-up	[10]	[13]	[Moved, unreachable]
Excluded from analysis after randomisation	[0]	[0]	[Reasons]
Analysed (primary)	[196]	[193]

5.2 Recruitment (items 23a, 23b)

Participants were recruited from [YYYY-MM-DD] to [YYYY-MM-DD]; follow-up for benefits and harms was completed on [YYYY-MM-DD]. [The trial ended as planned / was stopped early because of ...].

5.3 Intervention and comparator delivery (items 24a, 24b)

Aspect	Intervention	Comparator
Delivered as intended (fidelity)	Example: 94% of sessions met the fidelity checklist	97%
Adherence	Example: Median 92% of doses taken (IQR 81-98)	93% (84-99)
Delivered by	[Profession, number of providers]	[Same]
Concomitant care	[Rescue medication used by 18 (8.7%)]	[27 (13.1%)]

5.4 Baseline data (item 25)

Characteristic	Intervention (n = [206])	Comparator (n = [206])
Age, years, mean (SD)	Example: 54.2 (11.8)	53.7 (12.1)
Female, n (%)	[112 (54.4)]	[108 (52.4)]
Baseline [primary outcome], mean (SD)	[31.4 (6.2)]	[31.0 (6.5)]
[Key prognostic factor], n (%)	[Value]	[Value]

5.5 Numbers analysed, outcomes and estimation (item 26)

Outcome	Group	n analysed	n with data	Result	Effect (95% CI)
OUT-P1, change at 12 weeks, mean (SD)	Intervention	206	Example: 196	-8.1 (7.4)	Mean difference -3.2 (-5.0 to -1.4)
	Comparator	206	193	-4.9 (7.9)
OUT-S1, responders, n (%)	Intervention	[196]	[196]	[92 (46.9)]	RR [1.48 (1.15 to 1.91)]; RD [15.3% (5.8 to 24.8)]
	Comparator	[193]	[193]	[61 (31.6)]

For binary outcomes the relative and absolute effects are:

\text{RR} = \frac{a/(a+b)}{c/(c+d)}, \qquad \text{RD} = \frac{a}{a+b} - \frac{c}{c+d}

5.6 Harms (item 27)

Event	Intervention n (%)	Comparator n (%)
Any adverse event	[118 (58.7)]	[103 (50.5)]
Serious adverse events	Example: 9 (4.5)	7 (3.4)
Discontinuation due to adverse event	[6 (3.0)]	[2 (1.0)]
[Specific event of interest]	[Value]	[Value]
Deaths	[0]	[0]

5.7 Ancillary analyses (item 28)

Analysis	Prespecified?	Result	Interpretation
Example: Subgroup by baseline severity	Yes	Interaction P = 0.41	No evidence of differential effect
Per-protocol	Yes	MD [-3.6 (-5.5 to -1.7)]	Consistent with primary
[Analysis]	[Yes / No, post hoc]	[Result]	[Interpretation]

6. Discussion

The discussion places the findings in context and is honest about what the trial can and cannot show.

6.1 Interpretation (item 29)

[Give an interpretation consistent with the results, balancing benefits and harms, and relate the findings to other relevant evidence, ideally an updated systematic review.]

6.2 Limitations (item 30)

[Bias: for example loss to follow-up higher in the comparator group, and its likely effect]
[Imprecision: for example wide confidence interval for the harms outcome]
[Generalisability: how far participants, settings and interventions resemble routine practice]
[Multiplicity: number of secondary outcomes tested and how it affects interpretation]

7. Appendices

Supporting material for reviewers:

Appendix	Content
A	Completed CONSORT 2025 checklist with page numbers
B	Full eligibility criteria and list of sites
C	Statistical analysis plan
D	Additional tables (all adverse events, sensitivity analyses)
E	Plain-language summary for participants
F	Glossary of abbreviations: [CI confidence interval, ITT intention to treat, MD mean difference, PPI patient and public involvement, RR risk ratio, SAE serious adverse event]

Standard and licence note

Based on the CONSORT 2025 Statement: Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al., CONSORT 2025 statement: updated guideline for reporting randomised trials, BMJ 2025;388:e081123 (https://doi.org/10.1136/bmj-2024-081123) and parallel publications, with the checklist at https://www.consort-spirit.org. The CONSORT 2025 statement and checklist are published open access under the Creative Commons Attribution licence (CC BY 4.0, https://creativecommons.org/licenses/by/4.0/). This template follows the order of its 30 items (including the open science section and the patient and public involvement item new in 2025), paraphrased in original text, and reproduces no checklist wording; use the official checklist and its explanation and elaboration for the normative items. CONSORT 2025 replaces CONSORT 2010. This is a reporting format, not clinical, statistical or regulatory advice; follow local privacy law and your institution's documentation policy. Template licence: MIT.