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Impact of the Covid-19 Pandemic on Recruitment for a Randomized Controlled Intervention Trial for Children with Functional Abdominal Pain Disorders
Journal of Pediatric Gastroenterology and Nutrition ; 75(Supplement 1):S277-S278, 2022.
Article in English | EMBASE | ID: covidwho-2058223
ABSTRACT

Purpose:

The COVID-19 pandemic affected children and families in multiple ways- schools closed and migrated online and parents altered work schedules and childcare. Our randomized controlled intervention trial for parents of children with Functional Abdominal Pain Disorders (FAPDs) was underway when the pandemic began. This provided the opportunity to examine how the pandemic and mitigation efforts might affect our research. We evaluated differences in recruitment rates and data completion before vs. during the pandemic, hypothesizing that recruitment would be lower and it would take longer for participants to complete baseline measures. Method(s) The number of participants screened, consented, and randomized to the study was captured from February 2019 to November 2021. At baseline, parents of children with FAPD completed a 14-day pain and stool diary, 3-day food diary, and several psychosocial questionnaires. Based on the date of consent, participants were categorized into two groups before or during the COVID-19 pandemic (beginning March 2020). A series of independent sample t-tests was conducted to evaluate differences between the two groups on the number of participants screened, consented, and randomized per month and the number of days it took participants to complete the baseline measures. Result(s) A total of 272 parents of children ages 7-12 years who met Rome IV criteria for FAPD were screened for participation in the study. Of these, 110 eligible parents consented to participate, and 92 were randomized to treatment. There were no differences between the before and during COVID-19 groups on the number of participants screened per month and the number of days to complete the pain and stool diary. We found significant differences between the two groups for the number of participants consented and randomized per month and the number of days to complete the food diary and psychosocial questionnaires (Table 1). Conclusion(s) Our findings indicate that rate of recruitment and baseline data collection differed significantly from before to during the COVID-19 pandemic. While there were no significant differences in the number of families screened, significantly fewer of those eligible agreed to participate and were randomized during the pandemic, as we expected. For those who consented, however, it took significantly fewer days for them to complete several study measures, contrary to our hypotheses. While the overall recruitment rate for the trial did decrease during the COVID-19 pandemic (possibly due to parents feeling overwhelmed by the pandemic), data collection became more efficient for those who were enrolled (perhaps reflecting more time spent at home and online). Overall, our findings suggest that conducting studies involving parents of school-age children during the COVID-19 pandemic may face greater challenges, primarily in recruitment. (Table Presented).
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Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Language: English Journal: Journal of Pediatric Gastroenterology and Nutrition Year: 2022 Document Type: Article

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Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Language: English Journal: Journal of Pediatric Gastroenterology and Nutrition Year: 2022 Document Type: Article