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Preferred Reporting Items for Microbiotherapy (PRIM) Guidelines Across Medical Disciplines: An International Delphi
Faming Zhang1, Michael A Kamm2, Xia Wu1
1Department of Microbiota Medicine and Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Abstract:
Microbiotherapy has opened new avenues for managing dysbiosis-related diseases. However, many studies did not cover all the necessary reporting items for microbiotherapy making the interpretation of results, safety assessment, technology extension, and even the transparency of legitimacy difficult. This project consisted of 2 phases. First, we proposed an initial preferred reporting items for microbiotherapy (PRIM) checklist and applied it to oncology studies from 2011 to 2023 according to Meta-Analyses guideline. Only 39.3% (n = 64) of these studies (n = 163) met all PRIM checklist items. The culture-based microbiotherapy (CMT) studies had higher score than non-culture-based (NMT) ones (p = 0.018). In the second phase, the expert panel consisting of 22 specialists from eight countries across Asia, Australia, Europe, and North America refined and finalized the PRIM guidelines (named as PRIM 2024) through Delphi consensus. The PRIM 2024 guidelines conclude 10 statements and 18 points on diagnosis, delivery route, source, classification, preparation, dosage, state, concomitant treatment, efficacy, and safety. The panel defined less than 80% of all PRIM points (14 points) as low-quality reports. These guidelines are recommended for reporting on microbiotherapy in clinical studies and reports on compassionate use, including but not limited to fecal microbiota transplantation, phage therapy, probiotics, and synbiotics. These consistent and transparent reporting items can help researchers and practitioners better evaluate, compare, implement research findings in microbiotherapy.
Insights
Reporting guidelines for microbiotherapy (PRIM 2024) were developed to improve study transparency and evaluation. These guidelines ensure consistent reporting for fecal microbiota transplantation, phage therapy, probiotics, and synbiotics.
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.
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