Abstract
Purpose
The success of prospective randomized trials relies on voluntary participation, which has been perceived as a barrier for successful trials in children who rely on parental permission. We sought to identify the reasons parents decline child participation to understand potential limitations in the consent process.
Methods
A prospective observational study was conducted in 92 patients asked to participate in prospective randomized trials between 2012 and 2015. Parental reasons for refusal were documented.
Results
The 92 refusals were distributed between studies investigating the management of circumcision, gastroschisis, pectus excavatum, appendicitis, pyloric stenosis, undescended testicles, abdominal abscess and gastroesophageal reflux. Reasons for refusal included preference of treatment path (37 %), inability to follow up (21 %), unspecified resistance to participate in research (18 %), preference to maintain independent surgeon decision (16 %), and desire for historically standard treatment (8 %). Of the families who opted to pursue a specific treatment arm rather than randomization, 35 % had prior experience with that treatment, 32 % had researched the procedure, 18 % wished to pursue the minimal intervention and 15 % did not specify.
Conclusions
Parental preference of therapy is the most common reason for refusal of study participation. This variable could be influenced with more effective explanation of study rationale and existing equipoise.
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Acknowledgments
We would like to acknowledge the following categorical pediatric surgery and research fellows who have helped contribute to not only this study but the success of recent prospective randomized trials completed at Children’s Mercy Hospital: Corey W. Iqbal, Sohail Shah, Pablo Aguayo, Jason Fraser, Jeff Dehmer, E. Marty Knott, Tolulope Oyetunji, Frankie Fike, Vincent Mortellaro, Alessandra C. Gasior, Janine N. Pettiford, Priscilla Thomas, Nicole Sharp, and Hanna Alemayehu. We would also like to thank our research coordinator Kathy Johnson for her assistance.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study formal consent is not required.
Conflict of interest
The authors declare that they have no conflict of interest.
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Gonzalez, K.W., Adibe, O.O., Dalton, B.G. et al. Understanding parental refusal of permission for child participation in surgical prospective trials. Pediatr Surg Int 32, 505–508 (2016). https://doi.org/10.1007/s00383-016-3878-1
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DOI: https://doi.org/10.1007/s00383-016-3878-1