Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child's Viewpoint: Evolution of Study Protocol.

backgroundOutdoor play and risk-taking behaviors, including play at heights, are important to children's physical, social, and cognitive development. These aspects of play are important to consider when informing prevention policies for serious injuries that commonly occur on play structures. Supracondylar fractures of the humerus (SCH) are the most common type of elbow fractures that result from falls on an outstretched hand among healthy children. Despite being one of the leading causes of admission to the hospital and surgical intervention, the details surrounding the cause of these injuries are often not recorded. Previous research has correlated decreased overall playground safety with higher rates of SCH fractures. Play structure height and the type of undersurface have been identified as potential risk factors for severe injuries, including SCH fractures, in part due to low compliance with safety standards. This paper explores the challenges we encountered designing the study and the resulting insights and methodological modifications we made.

objectiveThe aim of this paper is to discuss the challenges related specifically to clinical research in pediatrics and strategies developed to conduct a study that prioritizes the engagement and perspective of children and their families.

methodsTo explore the link between the severity of SCH fractures and children's behavioral, environmental, and mechanistic factors, we conducted a mixed-methods study.

resultsDuring phase 1 (the original methodology) from April 2017 to July 2018, there were 58 eligible study participants and 17 were recruited. For phase 2 (the revised methodology) between October 2018 and October 2019, there were 116 eligible participants and 47 were recruited.

conclusionsThe changes in methodology made following the first phase of data collection were effective in our ability to recruit participants. By identifying and addressing challenges pertaining to recruitment and resource limitations, we were able to collect data in a concise manner while not compromising the quality of the data and make for an easily adoptable methodology for other sites interested in participating in the study. We hope that future studies that plan to employ a similar methodology can gain insight through the methodological challenges we have encountered and the way we adapted the methodology to build a more pragmatic approach. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21816.