Institute of Population Health Sciences, University of Liverpool, Room 223, Second Floor, Block B, Waterhouse Building, 1-5 Dover Street, Liverpool, L3 5DA, UK.
Bristol Medical School, University of Bristol, Bristol, UK.
BMC Pediatr. 2020 Mar 30;20(1):140. doi: 10.1186/s12887-020-02040-w.
Recruiting patients to paediatric trials can be challenging, especially in trials that compare markedly different management pathways and are conducted in acute settings. We aimed to enhance informed consent and recruitment in the CONTRACT trial (CONservative TReatment of Appendicitis in Children a randomised controlled Trial; ISRCTN15830435) - a feasibility trial that compared non-operative treatment (antibiotics) versus appendicectomy for uncomplicated acute appendicitis.
Qualitative study embedded within CONTRACT and conducted across three UK children's hospitals. Data were transcribed audio-recordings of 85 CONTRACT recruitment consultations with 58 families; and semi-structured interviews with 35 health professionals and 28 families (34 parents, 14 children) invited to participate in CONTRACT. Data analysis drew on thematic approaches. Throughout CONTRACT, we used findings from the ongoing qualitative analysis to inform bespoke communication training for health professionals recruiting to CONTRACT. Before and after training we also examined qualitative changes in communication during consultations and quantitative changes in recruitment rates.
Bespoke communication training focussed on presenting the trial arms in a balanced way, emphasising clinical equipoise, exploring family treatment preferences and managing families' expectations about the trial's treatment pathways. Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%. However, they remained reluctant to explore families' treatment preferences and respond with further information to balance these preferences. Analyses of interviews identified the time constraints of the urgent care setting, concerns about coercion, and reservations about exposing children to conversations about treatment risks as reasons for this reluctance. Interviews with families indicated the importance of clear explanations of trial treatment timings and sensitive communication of treatment allocation for both recruitment and retention.
Following bespoke training based on the qualitative analyses, health professionals presented CONTRACT to families in clearer and more balanced ways and this was associated with an increase in the recruitment rate. Despite training, health professionals remained reluctant to explore families' treatment preferences. We provide several recommendations to enhance communication, informed consent, recruitment and retention in future trials in urgent care settings.
招募儿科试验的患者可能具有挑战性，特别是在比较明显不同的管理途径且在急性环境中进行的试验中。我们旨在增强 CONSERVATIVE TReatment of Appendicitis in Children a randomised controlled Trial（CONTRACT，儿童阑尾炎保守治疗随机对照试验）中的知情同意和招募，这是一项可行性试验，比较了非手术治疗（抗生素）与阑尾切除术治疗单纯性急性阑尾炎的效果。
这项嵌入在 CONTRACT 中的定性研究在英国的三家儿童医院进行。数据来源于 85 次 CONTRACT 招募咨询的音频记录，涉及 58 个家庭；以及对 35 名卫生专业人员和 28 个受邀参加 CONTRACT 的家庭（34 名家长，14 名儿童）的半结构化访谈。数据分析采用了主题方法。在整个 CONTRACT 过程中，我们利用正在进行的定性分析结果为参与 CONTRACT 的卫生专业人员提供了专门的沟通培训。在培训前后，我们还检查了咨询过程中沟通的定性变化和招募率的定量变化。
专门的沟通培训侧重于以平衡的方式呈现试验组，强调临床均衡，探索家庭的治疗偏好，并管理家庭对试验治疗途径的期望。对招募咨询的分析表明，培训后卫生专业人员对治疗组的介绍变得越来越平衡（例如避免不平衡的术语），招募率从 38%上升到 62%。然而，他们仍然不愿意探索家庭的治疗偏好，并提供更多信息来平衡这些偏好。对访谈的分析确定了紧急护理环境的时间限制、对强制的担忧以及对让儿童参与治疗风险对话的保留，是这种不情愿的原因。对家庭的访谈表明，清楚解释试验治疗时间和敏感沟通治疗分配对招募和保留都很重要。
根据基于定性分析的专门培训，卫生专业人员以更清晰、更平衡的方式向家庭介绍 CONTRACT，这与招募率的提高有关。尽管经过培训，卫生专业人员仍然不愿意探索家庭的治疗偏好。我们为未来紧急护理环境中的试验提供了一些增强沟通、知情同意、招募和保留的建议。
