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

Approvals

Revision history

Contents

1. Title and abstract
2. Open science
3. Introduction
4. Methods
5. Results
6. Discussion
7. 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)

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)

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

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)

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)

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)

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)

4.7 Outcomes (item 14)

4.8 Harms (item 15)

4.9 Sample size (items 16a, 16b)

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

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.

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)

4.11 Blinding (items 20a, 20b)

4.12 Statistical methods (items 21a to 21d)

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.

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)

5.4 Baseline data (item 25)

5.5 Numbers analysed, outcomes and estimation (item 26)

For binary outcomes the relative and absolute effects are:

5.6 Harms (item 27)

5.7 Ancillary analyses (item 28)

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:

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.