Mireille Guillot1, Sarah Asad2, Manoj M Lalu3, Brigitte Lemyre4, Gisell Castillo2, Bernard Thébaud5, Justin Presseau6. 1. Department of Pediatrics, Division of Neonatology, Children's Hospital of Eastern Ontario and The Ottawa Hospital, Ottawa, Ontario, Canada. Electronic address: mireille.guillot.1@ulaval.ca. 2. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 3. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Regenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada. 4. Department of Pediatrics, Division of Neonatology, Children's Hospital of Eastern Ontario and The Ottawa Hospital, Ottawa, Ontario, Canada. 5. Department of Pediatrics, Division of Neonatology, Children's Hospital of Eastern Ontario and The Ottawa Hospital, Ottawa, Ontario, Canada; Regenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada; Molecular Biomedicine, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada. 6. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Abstract
OBJECTIVE: To identify barriers and enablers that may influence parents' and neonatologists' participation in clinical trials of mesenchymal stromal cells for bronchopulmonary dysplasia. STUDY DESIGN: This qualitative study involved one-on-one semistructured interviews with parents of extremely preterm infants (n = 18) and neonatologists (n = 16). Interview guides and directed content analysis were framed using the theoretical domains framework, a tool specifically developed for implementation research to identify influences on behavior. RESULTS: Key barriers for parents included their lack of knowledge about clinical trial processes in general, stem cells, and concerns about their risks and side effects. Importantly, parents preferred to be approached for recruitment directly by a neonatologist, either before delivery or 1 or 2 weeks after birth. However, the majority of neonatologists felt that approaching parents was not part of their role. Neonatologists reported competing priorities, time commitment, costs, and lack of institutional support as significant barriers to their ability to recruit patients. CONCLUSIONS: By integrating stakeholders early into the development of a clinical trial of mesenchymal stromal cell therapy, we identified and can address important barriers to enrollment. Some identified barriers were unanticipated and could have compromised recruitment had they not been identified by this study. We suggest that this approach can be used more broadly for other early phase clinical trials in pediatrics.
OBJECTIVE: To identify barriers and enablers that may influence parents' and neonatologists' participation in clinical trials of mesenchymal stromal cells for bronchopulmonary dysplasia. STUDY DESIGN: This qualitative study involved one-on-one semistructured interviews with parents of extremely preterm infants (n = 18) and neonatologists (n = 16). Interview guides and directed content analysis were framed using the theoretical domains framework, a tool specifically developed for implementation research to identify influences on behavior. RESULTS: Key barriers for parents included their lack of knowledge about clinical trial processes in general, stem cells, and concerns about their risks and side effects. Importantly, parents preferred to be approached for recruitment directly by a neonatologist, either before delivery or 1 or 2 weeks after birth. However, the majority of neonatologists felt that approaching parents was not part of their role. Neonatologists reported competing priorities, time commitment, costs, and lack of institutional support as significant barriers to their ability to recruit patients. CONCLUSIONS: By integrating stakeholders early into the development of a clinical trial of mesenchymal stromal cell therapy, we identified and can address important barriers to enrollment. Some identified barriers were unanticipated and could have compromised recruitment had they not been identified by this study. We suggest that this approach can be used more broadly for other early phase clinical trials in pediatrics.
Authors: Bernard Thébaud; Manoj Lalu; Laurent Renesme; Sasha van Katwyk; Justin Presseau; Kednapa Thavorn; Kelly D Cobey; Brian Hutton; David Moher; Roger F Soll; Dean Fergusson Journal: Stem Cells Transl Med Date: 2021-02-11 Impact factor: 6.940
Authors: Gisell Castillo; Manoj M Lalu; Sarah Asad; Madison Foster; Natasha Kekre; Dean A Fergusson; Terry Hawrysh; Harold Atkins; Kednapa Thavorn; Joshua Montroy; Stuart Schwartz; Robert A Holt; Raewyn Broady; Justin Presseau Journal: BMJ Open Date: 2021-03-19 Impact factor: 2.692
Authors: Katie Gillies; Jamie Brehaut; Taylor Coffey; Eilidh M Duncan; Jill J Francis; Spencer P Hey; Justin Presseau; Charles Weijer; Marion K Campbell Journal: Trials Date: 2021-12-04 Impact factor: 2.279
Authors: Manoj M Lalu; Madison Foster; Justin Presseau; Dar Dowlatshahi; Gisell Castillo; Analyssa Cardenas; Whitney Tam; Jennifer Zlepnig; Deborah Timpson; Yuan Yi Dong; Pascale Juneau; Dean A Fergusson Journal: BMJ Open Date: 2020-03-19 Impact factor: 2.692