Use of the pragmatic-explanatory continuum indicator summary tool in low- and middle-income country settings: Systematic review.

ObjectiveTo systematically review and characterize the literature on using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS) tools in low- and middle-income countries (LMICs), focusing on successes, challenges, and potential improvements to enhance applicability across diverse settings.Study design and settingA systematic search of PubMed to identify peer-reviewed articles applying PRECIS tools to LMIC-based research. Data extraction focused on trial characteristics, modifications, and use of PRECIS tools. Narrative synthesis was used to outline successes, challenges, and recommendations.ResultsA total of 40 articles met the selection criteria. The PRECIS tools were mostly (n=39, 97.5%) used for purposes other than trial design. Significant variation was seen in methods of use and reporting. Most (n=32, 80%) used PRECIS-2, valued for its reliability, ability to quantify pragmatism, assess trial design, and identify research gaps. Challenges included the tools' subjectivity, absence of information needed for scoring, interpretation of scores, and application to non-Western contexts and multinational trials. Recommendations for improvement included refining scoring criteria, translating guidance, and developing additional educational resources.ConclusionThe PRECIS tools have successfully supported research globally and are perceived as reliable research tools with multiple strengths. Further guidance and refinement would enable consistent application and reporting, particularly as the tools have frequently been used for purposes other than their original intention. Most challenges were similar to high-income settings, however, translation and application of the tools to traditional medicine, international trials and research-naïve settings were highlighted as LMIC-focused issues requiring consideration.