Development of a Patient-Reported Outcome Instrument for a Connected Toothbrush

Objectives: This study aimed to develop a Patient Reported Outcome (PRO) instrument to test the effectiveness and acceptability of a new platform for a powered toothbrush connected to a smartphone application.
Methods: The initial development of the PRO measure was based on interviews with 8 participants who used a powered brush connected to an app for 4 weeks. Participants were asked about their experiences with the toothbrush. Subsequently, the PRO measure was included in a randomized clinical trial (RCT) comparing a powered toothbrush connected to an app with an unconnected powered toothbrush. Eighty subjects completed the PRO at baseline, 3 weeks and 6 weeks following randomization. Exit interviews were conducted with a subgroup of 10 subjects in the connected group in order to evaluate patient comprehension and relevance of the PRO items.
Results: Following the initial interviews, the PRO measure was designed to measure brushing patterns, perceived brushing effectiveness, and patient perceptions about brushing (e.g., motivation to brush). In the RCT at 3 weeks, the connected toothbrush users had significantly greater (p<0.05) increases in the following: confidence with the ability to brush, focusing on brushing, the amount of time spent brushing, understanding how to brush and improvement of brushing technique. At 6 weeks, the connected group had significantly higher (p<0.05) values for the amount of time spent brushing and improvement of brushing technique. The findings from qualitative interviews with connected toothbrush users supported the content validity of the PROs Instrument.
Conclusions: The PRO instrument measures aspects of brushing that are relevant and understandable to patients when using a powered toothbrush connected to an app. The measure detected changes in user perceptions and behaviors in an RCT setting. The findings from the RCT suggest that the connected brush may improve brushing behaviors and skills.