Shifting from Traditional to Pragmatic Randomized Controlled Trials: Insights and Lessons Learned from the Toddler Oral Health Intervention.

Purpose: This article examines the implementation of the Toddler Oral Health Intervention (TOHI) protocol, emphasizing feasibility, recruitment, retention, and protocol adherence rather than clinical outcomes. It discusses encountered challenges, necessary adjustments, and key lessons learned during the shift from a traditional randomized controlled trial (RCT) to a pragmatic RCT, thereby offering guidance for future research on similar complex interventions. Methods: The methods of the RCT study protocol are presented, including (1) recruitment of well-baby clinics and oral health coaches, (2) recruitment of the study population; (3) implementation of the intervention and (4) outcome measures, alongside with the process of implementation and gathered feedback needed for required adjustments. A systematic analysis identified key protocol elements, modifications made, and lessons learned. Results: Specific protocol modifications, including adjustments due to the COVID-19 pandemic, demonstrate how a traditional RCT can be adapted to real-world conditions without compromising outcome reliability. Key lessons include the necessity of robust contingency planning to manage unforeseen disruptions, effective recruitment and retention strategies to sustain participant and interventionists engagement, and the adoption of standardized data collection processes to ensure data integrity. These findings underscore the importance of addressing practical and contextual factors alongside measuring effectiveness, ensuring that study outcomes are both applicable and useful in clinical practice. Conclusion: The findings demonstrate that carefully planned and documented pragmatic adjustments not only preserve scientific rigor but also enhance the relevance and applicability of the results, maintaining the methodological robustness expected of traditional RCTs.