Reporting Guidelines for Medical Research

Overview

A reporting guideline is a checklist, flow diagram or structured text developed using explicit methods to guide authors in reporting a particular type of research [1].

Reporting guidelines aim to make studies:

• complete;
• transparent;
• understandable;
• appraisable;
• reusable.

They do not guarantee:

• good study design;
• correct analysis;
• low risk of bias;
• ethical conduct;
• clinical importance.

The EQUATOR Network provides a searchable library of reporting guidelines and extensions.

Why this matters

Important methodological details are often omitted from manuscripts:

• eligibility criteria;
• participant flow;
• sample-size assumptions;
• outcome definitions;
• missing data;
• analysis populations;
• model-building strategy;
• protocol deviations;
• access to data and code.

Omission prevents readers from judging validity even when the study itself was conducted well.

Using the appropriate guideline from the planning stage can improve protocols, data collection, analysis plans and final reports.

When to use this framework

Use reporting guidelines when:

• developing a protocol;
• designing case-report forms;
• writing an analysis plan;
• preparing a manuscript;
• reviewing a paper;
• updating a published report.

Use the most current guideline applicable to the study design and check for extensions relevant to:

• cluster trials;
• pilot studies;
• non-pharmacological interventions;
• artificial intelligence;
• harms;
• routinely collected data;
• abstracts.

How to select a guideline

Step 1: Identify the study design

Examples:

• randomised trial;
• observational cohort, case–control or cross-sectional study;
• systematic review;
• diagnostic-accuracy study;
• prediction model;
• qualitative study;
• case report;
• animal study.

Step 2: Identify the reporting stage

Is the document:

• protocol;
• completed study;
• abstract;
• secondary analysis;
• extension-specific report?

Step 3: Search EQUATOR

Search by:

• study design;
• specialty;
• intervention;
• report section;
• extension.

Step 4: Verify the latest version

Do not rely on an old downloaded checklist when a guideline has been updated.

Step 5: Use the explanation-and-elaboration paper

The checklist identifies items. The explanation paper provides rationale and examples.

Main reporting guidelines

Core reporting guidelines

published data

Study or document	Main guideline	Current principal version used in this lecture
Randomised trial report	CONSORT	CONSORT 2025
Clinical-trial protocol	SPIRIT	SPIRIT 2025
Observational study	STROBE	STROBE 2007
Systematic review	PRISMA	PRISMA 2020
Diagnostic-accuracy study	STARD	STARD 2015
Clinical prediction model	TRIPOD+AI	TRIPOD+AI 2024
Case report	CARE	CARE guideline
Qualitative interviews or focus groups	COREQ	COREQ
Animal research	ARRIVE	ARRIVE 2.0

Note: Authors should verify current versions and applicable extensions through EQUATOR before submission.

Source: References 1–8

CONSORT 2025

CONSORT 2025 applies to reports of randomised trials. It contains a 30-item checklist, participant-flow diagram and expanded checklist [2].

Key areas include:

• trial design;
• participants;
• interventions;
• outcomes;
• sample size;
• randomisation;
• blinding;
• statistical methods;
• participant flow;
• recruitment;
• baseline data;
• outcome estimates;
• harms;
• protocol and registration;
• open-science information.

The 2025 update includes an open-science section and integrates several items previously covered mainly by extensions.

SPIRIT 2025

SPIRIT 2025 applies to clinical-trial protocols. It contains 34 minimum items and a schedule diagram [3].

It covers:

• administrative information;
• introduction;
• trial design;
• methods;
• interventions;
• outcomes;
• allocation;
• data management;
• statistical methods;
• monitoring;
• ethics;
• dissemination;
• open science.

SPIRIT describes what should be planned and reported before results are known.

STROBE

STROBE applies to cohort, case–control and cross-sectional studies [4].

It supports reporting of:

• setting and participants;
• variables and measurement;
• bias;
• study size;
• quantitative variables;
• statistical methods;
• missing data;
• participant numbers;
• descriptive data;
• outcome data;
• main and sensitivity results;
• limitations and generalisability.

STROBE improves transparency but does not prescribe one correct causal-analysis method.

PRISMA 2020

PRISMA 2020 applies to systematic reviews [5].

It includes:

• a 27-item checklist;
• abstract checklist;
• flow diagram;
• search and selection;
• data collection;
• risk-of-bias methods;
• synthesis methods;
• certainty assessment;
• registration and protocol;
• data, code and materials availability.

PRISMA should not be used to label a review systematic when the methods are not systematic.

STARD 2015

STARD 2015 applies to diagnostic-accuracy studies and has 30 essential items [6].

Important areas include:

• intended use and clinical role;
• target condition;
• index test;
• reference standard;
• participant selection;
• thresholds;
• blinding;
• indeterminate results;
• cross-tabulation;
• accuracy estimates;
• participant flow.

TRIPOD+AI

TRIPOD+AI 2024 updates prediction-model reporting for regression and machine-learning methods [7].

It covers:

• source and participants;
• outcome and predictors;
• sample size;
• missing data;
• model development;
• validation;
• performance;
• fairness;
• availability of data, code and model;
• intended use.

TRIPOD+AI reporting does not establish low risk of bias. PROBAST+AI addresses quality, risk of bias and applicability.

Extensions

A main guideline may have extensions for:

• cluster randomised trials;
• stepped-wedge trials;
• pilot and feasibility trials;
• AI interventions;
• routinely collected data;
• harms;
• abstracts;
• individual participant data;
• diagnostic AI.

The main guideline and extension should be used together.

Worked example

Applying a checklist

What guidelines do not do

A checklist cannot determine:

• whether randomisation was implemented properly;
• whether confounders were measured adequately;
• whether the model is overfitted;
• whether missing-data assumptions are credible;
• whether the study is clinically important.

Use risk-of-bias and critical-appraisal tools separately.

Interpreting guideline compliance

Presenting guideline use

Suggested reporting

State the guideline used and provide the completed checklist, but do not write “the study was conducted according to STROBE” when STROBE is a reporting guideline rather than a conduct standard.

Common mistakes

Knowledge check

What is a reporting guideline?

Answer and reasoning

A systematically developed checklist, flow diagram or structured text that guides complete reporting of a specific research type.

Which guideline applies to a completed randomised trial?

Answer and reasoning

CONSORT 2025, together with any applicable extensions.

Which guideline applies to a clinical-trial protocol?

Answer and reasoning

SPIRIT 2025.

Does STROBE guarantee low risk of bias?

Answer and reasoning

No. It improves reporting of observational studies but does not certify design or analysis quality.

Why use the explanation-and-elaboration paper?

Answer and reasoning

It explains the rationale, meaning and examples behind checklist items.

Key take-home messages

References

1. EQUATOR Network. What is a reporting guideline? Oxford: EQUATOR Network; accessed 3 August 2026. https://www.equator-network.org/about-us/what-is-a-reporting-guideline/
2. 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;389:e081123. https://doi.org/10.1136/bmj-2024-081123
3. Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025;389:e081477. https://doi.org/10.1136/bmj-2024-081477
4. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The STROBE statement: guidelines for reporting observational studies. PLoS Med. 2007;4(10):e296. https://doi.org/10.1371/journal.pmed.0040296
5. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. https://doi.org/10.1136/bmj.n71
6. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527. https://doi.org/10.1136/bmj.h5527
7. Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, et al. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024;385:e078378. https://doi.org/10.1136/bmj-2023-078378