Objectives
Conducting longitudinal, multi-center, multidisciplinary research for
individuals with chronic conditions can be challenging. Despite careful
planning, investigative teams must adapt to foreseen and unforeseen
problems. Our objective is to identify challenges encountered and solutions
sought in a recently completed observational, longitudinal study of youth
with cleft lip and palate as well as their caregivers.
Methods
Data for analysis were derived from a six-year, multi-center,
prospective, longitudinal study of youth with cleft conducted from
2009–2015 that examined oral health-related quality of life and
other related clinical observations over time in youth who had cleft-related
surgery compared to those who did not. Youth and their caregivers
participating in this study were followed at one of six geographically
diverse, multidisciplinary cleft treatment centers in the United States.
Results
Establishing effective communication, ensuring protocol adherence,
safeguarding data quality, recognizing and managing differences across
sites, maximizing participant retention, dealing with study personnel
turnover, and balancing/addressing clinical and research tasks were
particularly exigent issues that arose over the course of the study.
Attending to process, ongoing communication within and across sites, and
investigator and clinician commitment and flexibility were required to
achieve the stated aims of the research.
Conclusion
Studying children with cleft and their caregivers over time created
both foreseen and unforeseen challenges. Solutions to these challenges are
presented to aid in the design of future longitudinal research in
individuals with chronic conditions.