Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, USA; Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
University of Massachusetts Medical School, Worcester, MA, USA.
Contemp Clin Trials. 2021 Sep;108:106510. doi: 10.1016/j.cct.2021.106510. Epub 2021 Jul 16.
Few evidence-based public health interventions are adopted in practice, in part due to a disconnect between the outcomes measured in clinical trials and the outcomes important to stakeholders that determine implementation in real-world practice. AsthmaLink is a school-supervised asthma therapy program which partners pediatric providers, school nurses, and families. To inform the design of a cluster randomized controlled trial of AsthmaLink, we elicited systems-level stakeholder input.
Maximum variation sampling was used to recruit 18 stakeholders to participate in semi-structured interviews that were recorded, transcribed, and open coded: Department of Public Health officials (n = 4), school officials (n = 4), pediatric practice managers (n = 3), health insurance officials (n = 4), and legislators (n = 3). Thematic analysis was used to identify common themes related to stakeholder priorities for clinical trial design and perceived barriers to AsthmaLink adoption.
Stakeholder groups identified common priorities for the clinical trial design, including examination of the extent to which AsthmaLink (1) reduces health care utilization, (2) is cost effective (2) addresses health disparities, (3) reduces school absenteeism, and (4) educates families about asthma. Stakeholder groups reported potential barriers to AsthmaLink adoption, including challenges pertaining to (1) securing resources, staffing, and reimbursement, (2) variability across school districts, and (3) standing out amidst multiple programs vying for resources.
Systems-level stakeholder input informed refinements to the clinical trial design of a school-supervised therapy program including outcome and implementation measures and choice of study population. Incorporating systems-level stakeholder perspectives into clinical trial design is critical to achieve adoption of evidence-based interventions into practice.
由于临床试验中测量的结果与决定实际实践中实施的利益相关者重视的结果之间存在脱节，因此，很少有基于证据的公共卫生干预措施在实践中得到采用。AsthmaLink 是一个由学校监督的哮喘治疗计划，它与儿科医生、学校护士和家庭合作。为了为 AsthmaLink 的一项整群随机对照试验设计提供信息，我们征求了系统层面的利益相关者的意见。
采用最大变异抽样法招募了 18 名利益相关者参加半结构式访谈，访谈内容被记录、转录和开放编码：公共卫生部门官员（n=4）、学校官员（n=4）、儿科实践管理人员（n=3）、医疗保险官员（n=4）和立法者（n=3）。采用主题分析法确定了与临床试验设计的利益相关者优先事项和对 AsthmaLink 采用的障碍有关的共同主题。
利益相关者群体确定了临床试验设计的共同优先事项，包括检查 AsthmaLink （1）在多大程度上减少医疗保健的利用，（2）是否具有成本效益，（2）是否解决健康差距，（3）减少学校缺勤，以及（4）教育家庭有关哮喘的知识。利益相关者群体报告了 AsthmaLink 采用的潜在障碍，包括（1）在资源、人员配备和报销方面面临的挑战，（2）学区之间的差异，以及（3）在多个竞争资源的项目中脱颖而出。
系统层面的利益相关者的意见为学校监督的治疗计划的临床试验设计提供了信息，包括结果和实施措施以及研究人群的选择。将系统层面的利益相关者观点纳入临床试验设计对于实现基于证据的干预措施在实践中的采用至关重要。
