Objectives: Conducting longitudinal, multicentre, 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 6-year, multicentre, prospective, longitudinal study of youth with cleft conducted from 2009 to 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 centres in the USA.
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.
Keywords: clinical research; craniofacial anomalies; quality of life; study design.
© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.