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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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CONSORT 2025 statement: updated guideline for reporting randomised trials.

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Area of Science:

  • Medical Research Methodology
  • Clinical Trial Reporting Standards

Background:

  • Randomized trials are crucial for healthcare evidence, but reporting quality is often suboptimal.
  • The CONSORT (Consolidated Standards of Reporting Trials) statement aims to enhance trial report quality.
  • Previous versions of CONSORT were published in 1996, 2001, and 2010.

Purpose of the Study:

  • To present the updated CONSORT 2025 statement.
  • To incorporate recent methodological advancements and user feedback into reporting guidelines.
  • To improve the clarity and transparency of randomized trial reporting.

Main Methods:

  • A scoping review and project-specific database were used to identify potential checklist changes.
  • Recommendations from CONSORT extensions, other guidelines (TIDieR), and expert communications were incorporated.
  • A three-round international Delphi survey with 317 participants and an expert consensus meeting with 30 experts were conducted.

Main Results:

  • Substantive revisions were made to the CONSORT checklist, including adding seven new items, revising three, deleting one, and integrating items from extensions.
  • The CONSORT 2025 checklist now includes 30 essential items and a participant flow diagram.
  • A new section on open science was added, and an expanded checklist with implementation details was developed.

Conclusions:

  • Authors, editors, and reviewers should adopt CONSORT 2025 for writing and evaluating randomized trial manuscripts.
  • The updated guidelines promote clearer and more transparent reporting of trial results.
  • CONSORT 2025 facilitates better understanding and utilization of evidence from randomized trials.