CONSORT 2025 and SPIRIT 2025: Better Reporting, Better Appraisal?

Critical appraisal depends on knowing what investigators planned, what they did and how they analysed their findings. Incomplete reporting makes these judgements difficult.

The updated CONSORT 2025 statement addresses the reporting of randomised trial results, while SPIRIT 2025 addresses trial protocols. Both place greater emphasis on transparency, including access to protocols and statistical analysis plans, data sharing and disclosure of funding and conflicts of interest.

CONSORT 2025 also strengthens reporting of outcome assessment, harms, missing data and the delivery of interventions and comparators. These details help readers examine whether the reported results provide a credible answer to the research question.

For clinicians, researchers and medical affairs teams, the updates reinforce several practical appraisal questions:

• Were the outcomes and analyses prespecified? Compare the publication with the protocol and statistical analysis plan, examining the timing and justification of changes.
• Who contributed to each analysis? Consider exclusions, treatment-group assignment and the implications of missing outcome data.
• Were benefits and harms assessed adequately? Examine how outcomes were defined, measured and reported.
• Do the conclusions reflect the findings? Consider effect sizes, confidence intervals, methodological limitations and clinical relevance.

However, reporting completeness and methodological quality are distinct. A clearly reported trial may still use an inappropriate comparator, an uninformative endpoint or an analysis based on questionable assumptions. Conversely, an omitted description creates uncertainty about what happened; it does not establish that the method was inadequate.

The value of CONSORT and SPIRIT therefore extends beyond completing a checklist. They help make research sufficiently transparent for meaningful scrutiny. Critical appraisal then requires the reader to judge whether the methods were appropriate and whether the conclusions are justified.

Read the updated statements:
CONSORT 2025 – reporting randomised trials
SPIRIT 2025 – reporting randomised trial protocols

To arrange bespoke training in critical appraisal, trial methodology or research protocol evaluation, contact office@criticalappraisal.com.