Department of Pediatrics, Division of Neonatology, Children's Hospital of Eastern Ontario and The Ottawa Hospital, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
J Pediatr. 2019 Jul;210:41-47.e1. doi: 10.1016/j.jpeds.2019.03.005. Epub 2019 Apr 17.
To identify barriers and enablers that may influence parents' and neonatologists' participation in clinical trials of mesenchymal stromal cells for bronchopulmonary dysplasia.
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.
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.
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.
确定可能影响父母和新生儿科医生参与间充质基质细胞治疗支气管肺发育不良临床试验的障碍和促进因素。
这是一项定性研究，对 18 名极早产儿的父母和 16 名新生儿科医生进行了一对一的半结构化访谈。访谈指南和定向内容分析是根据理论领域框架构建的，这是一种专门为实施研究开发的工具，用于确定对行为的影响。
父母面临的主要障碍包括他们对临床试验流程、干细胞的一般知识不足，以及对其风险和副作用的担忧。重要的是，父母希望在分娩前或出生后 1 或 2 周内由新生儿科医生直接联系他们参与招募。然而，大多数新生儿科医生认为，招募父母不是他们职责的一部分。新生儿科医生报告说，竞争的优先事项、时间承诺、成本和缺乏机构支持是他们招募患者的能力的重大障碍。
通过在间充质基质细胞治疗临床试验的早期将利益相关者整合进来，我们确定并可以解决入组的重要障碍。一些已确定的障碍是意料之外的，如果没有通过这项研究发现，它们可能会影响招募。我们建议，这种方法可以更广泛地用于儿科的其他早期临床试验。
