Engaging Stakeholders in Patient-Centered Outcomes Research Regarding School-Based Sealant Programs

Donald L Chi; Peter Milgrom; Jane Gillette

Purpose: The purpose of this study was to use qualitative methods to describe the key lessons learned during the stakeholder engagement stage of planning a randomized clinical trial comparing outcomes of silver diamine fluoride (SDF) as an alternative to pit-and-fissure sealants in a school-based delivery system.Methods: Eighteen caregivers and community-based stakeholders with involvement in the school-based sealant program Sealants for Smiles from the state of Montana, were recruited for this qualitative study. United States (U.S.) Patient-Centered Outcomes Research Institute (PCORI) methodology standards were used to develop two semi-structured interview guides consisting of 6 questions. One interview guide was used for telephone interviews with caregivers and the second was used for a stakeholder focus group. Content analytic methods were used to analyze the data.Results: All participants believed that a study comparing SDF and sealants was clinically relevant. Non-caregiver stakeholders agreed with the proposed primary outcome of the study (caries prevention) whereas caregivers also emphasized the importance of child-centered outcomes such as minimizing dental anxiety associated with dental care. Stakeholders described potential concerns associated with SDF such as staining and perceptions of safety and discussed ways to address these concerns through community engagement, appropriate framing of the study, proper consent procedures, and ongoing safety monitoring during the trial. Finally, stakeholders suggested dissemination strategies such as direct communication of findings through professional organizations and encouraging insurance plans to incentivize SDF use by reimbursing dental providers.Conclusions: Involving key stakeholders in early planning is essential in developing patient-centered research questions, outcomes measures, study protocols, and dissemination plans for oral health research involving a school-based delivery system.

Engaging Stakeholders in Patient-Centered Outcomes Research Regarding School-Based Sealant Programs

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