Feasibility of conducting a prospective cohort study in pediatric surgery: introducing the Caregiver Quality of Life of pediatric patients referred for feeding tube insertion (CARE) study

INTRODUCTION: High-quality prospective cohort studies are needed to answer research questions focused on prognosis. To determine the feasibility of conducting this type of research, a prospective cohort study focused on investigating health-related quality of life (HRQoL) of caregivers of children who require a gastrostomy (G) tube at the McMaster Children's Hospital was piloted from November 2009 to May 2011. METHODS: Recruitment began after research ethics board approval. Feasibility data were collected on all caregivers of patients assessed for G tube placement by a pediatric surgeon including recruitment status, protocol compliance, and HRQoL. Data were collected at 1 month and 2 weeks before surgery and 2 weeks and 3, 6, 9, and 12 months after surgery. Health-related quality of life measures included the Short Form 36v2, the Caregiver Strain Index, and the Parent Experience of Childhood Illness. RESULTS: A total of 117 G procedures were conducted, and 39 caregivers met eligibility criteria. Thirty-one caregivers were enrolled (79.5% recruitment rate), 8 parents were not interested, and 26 were missed. Protocol adherence to the follow-up schedule is high (91.3%). CONCLUSION: Conducting high-level research with long-term follow-up in pediatric surgery is challenging. Factors including low prevalence of patients and competing priorities for busy clinicians indicate that multicenter collaboration is essential to research success in this field.