Preferred Reporting Items for Microbiotherapy (PRIM) Guidelines Across Medical Disciplines: An International Delphi...

Area of Science:

• Microbiology
• Clinical Research Methodology

Background:

• Microbiotherapy shows promise for dysbiosis-related diseases but lacks standardized reporting, hindering result interpretation and safety assessment.
• Existing studies often omit crucial reporting items, impacting transparency and reproducibility.

Purpose of the Study:

• To develop and validate comprehensive reporting guidelines for microbiotherapy studies.
• To enhance the quality, transparency, and comparability of research in microbiotherapy.

Main Methods:

• Phase 1: Developed an initial Preferred Reporting Items for Microbiotherapy (PRIM) checklist and assessed its application in oncology studies (2011-2023).
• Phase 2: Refined and finalized the PRIM guidelines (PRIM 2024) through a Delphi consensus with an international expert panel (22 specialists).

Main Results:

• Only 39.3% of reviewed oncology studies met all initial PRIM checklist items.
• Culture-based microbiotherapy studies scored higher than non-culture-based ones.
• The finalized PRIM 2024 guidelines comprise 10 statements and 18 points covering key aspects of microbiotherapy reporting.
• The panel identified reports meeting less than 80% of PRIM points as low-quality.

Conclusions:

• The PRIM 2024 guidelines provide a standardized framework for reporting microbiotherapy research, including fecal microbiota transplantation, phage therapy, probiotics, and synbiotics.
• Consistent and transparent reporting will facilitate better evaluation, comparison, and implementation of microbiotherapy findings.