# 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*.

<!--
Guidance: How to use this template
- Download the official CONSORT 2025 checklist (and the expanded checklist
  with its explanation and elaboration) and fill in the page number for
  every item as you write; journals usually require it at submission.
- The "Item" references in this template (for example "item 8") point to
  the CONSORT 2025 checklist numbers so you can complete it quickly.
- Report what was done, not what was planned. Every change from the
  registered protocol belongs in section 3.3 with a reason.
- Keep numbers consistent across the abstract, flow diagram, tables and text;
  reviewers check that the counts reconcile.
- Never include identifying participant data. Follow local privacy law
  (for example HIPAA or GDPR), your ethics approval conditions and your
  institution's documentation policy.
-->

## Document control

<!-- Guidance: Track the manuscript or clinical study report as a controlled document. Status moves Draft -> In review -> Approved. -->

| 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

<!-- Guidance: Record each circulated draft. Note which analyses changed between versions so co-authors can re-check them. -->

| 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 |

## Contents

<!-- Guidance: Keep in sync with the headings below. -->

1. [Title and abstract](#1-title-and-abstract)
2. [Open science](#2-open-science)
3. [Introduction](#3-introduction)
4. [Methods](#4-methods)
5. [Results](#5-results)
6. [Discussion](#6-discussion)
7. [Appendices](#7-appendices)

## 1. Title and abstract

<!-- Guidance: Readers and search engines decide from the title and abstract alone. State "randomised" in the title (item 1a). Use the CONSORT for Abstracts guidance for the structured summary (item 1b). -->

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)

<!-- Guidance: Keep to the journal word limit (often 250-300 words). Give the primary outcome result with effect size and confidence interval, not only a P value, and include harms. -->

| 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

<!-- Guidance: CONSORT 2025 groups the transparency items in a dedicated "open science" section near the start of the checklist: registration, protocol and analysis plan access, data sharing, and funding and conflicts of interest. Journals may place some of these at the end of the article; keep the content complete wherever it appears. -->

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)

<!-- Guidance: State what will be shared, where, when, with whom and how to request it. Data sharing must respect participant consent, ethics approval and privacy law; "available on request" without detail is weak. -->

| 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

<!-- Guidance: Explain why the trial was needed, citing a systematic review where one exists. End with the objectives, covering both benefits and harms. -->

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)

<!-- Guidance: Use the same wording as the registered protocol. State the framework (superiority, non-inferiority, equivalence) and include objectives about harms, not only benefits. -->

| 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

<!-- Guidance: Give enough detail for another team to replicate the trial. Cite the published protocol rather than repeating it in full, but report every deviation here. -->

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)

<!-- Guidance: New in CONSORT 2025. Say who was involved (patients, carers, members of the public), at which stages (design, conduct, analysis, interpretation, reporting) and what changed as a result. If there was no involvement, say so plainly. -->

| 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)

<!-- Guidance: Name the design (parallel, crossover, factorial, cluster), the allocation ratio and the framework (superiority, non-inferiority, equivalence, exploratory). -->

[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)

<!-- Guidance: List every important change after the trial started, including outcomes or analyses that were not prespecified, with the date and the reason. Changes made after unblinding need special justification. -->

| 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)

<!-- Guidance: Give eligibility criteria as applied, not as hoped. CONSORT 2025 also asks, where relevant, for criteria applied to sites and to the people delivering the interventions. -->

**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)

<!-- Guidance: Describe each group with enough detail to replicate it: what, who delivered it, how, where, when, how much, and how adherence was supported. Point to an intervention manual if one exists. TIDieR can help structure this. -->

| 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)

<!-- Guidance: Define each prespecified outcome completely: the measurement variable, the analysis metric (change from baseline, final value, time to event), the method of aggregation (mean, proportion) and the time point. -->

| 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)

<!-- Guidance: CONSORT 2025 asks how harms were defined and assessed, including whether they were collected systematically (for example a structured checklist at each visit) or non-systematically (spontaneous reports). -->

| 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)

<!-- Guidance: Show the full calculation: assumed effect, variability, alpha, power, allocation ratio and attrition. Cite the source of each assumption. Explain any interim analyses and stopping guidelines. -->

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)

<!-- Guidance: Report the three components separately: how the sequence was generated, how it was concealed until assignment, and who did what. Concealment is not the same as blinding. -->

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)

<!-- Guidance: Say who was blinded after assignment (participants, care providers, outcome assessors, data analysts) and how. If blinding was not possible, explain how bias was limited. Describe how similar the interventions looked. -->

| 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)

<!-- Guidance: Describe the methods for primary and secondary outcomes including harms, who was included in each analysis and in which group, how missing data were handled, and additional analyses, separating prespecified from post hoc. -->

| 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

<!-- Guidance: Present results in the order of the outcomes in section 4.7. Give absolute numbers for every group and avoid reporting only percentages or P values. -->

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

### 5.1 Participant flow (items 22a, 22b)

<!-- Guidance: The flow diagram is strongly recommended. For each group give the numbers randomised, receiving the intended intervention and analysed for the primary outcome, plus losses and exclusions after randomisation with reasons. Replace this sketch with the official CONSORT 2025 diagram in the final manuscript. -->

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

```mermaid
flowchart TD
    A["Assessed for eligibility (n = 520)"] --> B["Excluded (n = 108)"]
    A --> C["Randomised (n = 412)"]
    C --> D["Allocated to intervention (n = 206)"]
    C --> E["Allocated to comparator (n = 206)"]
    D --> F["Lost to follow-up (n = 10)"]
    E --> G["Lost to follow-up (n = 13)"]
    D --> H["Analysed (n = 196)"]
    E --> I["Analysed (n = 193)"]
```

| 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)

<!-- Guidance: New emphasis in CONSORT 2025: report what was actually delivered, by whom, adherence and fidelity, and the concomitant care each group received. -->

| 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)

<!-- Guidance: Show baseline demographic and clinical characteristics for each group. Do not test baseline differences for significance; any differences after randomisation are due to chance. -->

| 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)

<!-- Guidance: For each primary and secondary outcome and each group, give the number included in the analysis, the number with available data at the time point, the result per group and the effect estimate with its precision. For binary outcomes give both absolute and relative effects. -->

| 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)

<!-- Guidance: Report all harms or unintended events in each group, not only those above a frequency threshold, and say how they were collected (section 4.8). Put full tables in a supplement if long. -->

| 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)

<!-- Guidance: Report any other analyses, including subgroup and sensitivity analyses, and say which were prespecified and which were post hoc. -->

| 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

<!-- Guidance: Interpret results in light of the objectives and the wider evidence. Avoid claiming benefit from secondary outcomes when the primary outcome is negative. -->

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)

<!-- Guidance: Address sources of potential bias, imprecision, generalisability and, where relevant, multiplicity of analyses. Name the direction in which each limitation might move the result. -->

- [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

<!-- Guidance: Keep supporting material here or in supplementary files. -->

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.