Division of Neonatology, Center for Pediatric and Adolescent Medicine, University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
DFG-Research Training Group "Life Sciences - Life Writing", Institute for the History, Philosophy and Ethics of Medicine, University Medical Center of the Johannes Gutenberg-University Mainz, Am Pulverturm 13, 55131, Mainz, Germany.
Trials. 2021 Dec 6;22(1):884. doi: 10.1186/s13063-021-05796-3.
One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients' perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing.
To explore parents' preferences concerning prognostic framing and its effects on parent-reported outcomes and experiences. To identify predictors (demographic, psychological) of parents' communication preferences.
DESIGN, SETTING, PARTICIPANTS: Unblinded, randomized controlled crossover trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2010 and 2019 with a birth weight < 1500 g. Inclusion of up to 204 families is planned, with possible revision according to a blinded sample size reassessment.
Embedded in an online survey and in pre-specified order, participants will watch two video vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos.
At baseline and after each video, participants complete a two-part online questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with prognostic framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician.
This RCT will explore parents' preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists, and ethicists.
German Clinical Trials Register DRKS00024466 . Registered on April 16, 2021.
早产儿给父母和医生带来的众多挑战之一是预后告知。预后是基于科学证据和医学经验的。它们需要进行个体评估，并且通常对于个体来说仍然不确定。这可能导致预后框架的差异，从而影响接受者的看法。在新生儿学中，关于预后框架效果的相关数据很少。特别是，目前尚不清楚父母是否更喜欢更乐观或更悲观的预后框架。
探讨父母对预后框架的偏好及其对父母报告结果和体验的影响。确定父母沟通偏好的预测因素（人口统计学、心理学）。
设计、地点、参与者：德国美因茨大学医学中心新生儿科的非盲、随机对照交叉试验（RCT），纳入 2010 年至 2019 年间出生体重<1500g 的早产儿的德语母语父母或监护人。计划纳入多达 204 个家庭，并根据盲法样本量重新评估进行修订。
嵌入在线调查中并按预定顺序，参与者将观看两个视频片段，描绘对早产儿父母进行预后告知时更乐观与更悲观的框架。除了预后框架外，两位视频中的所有其他方面的医生与父母沟通都是标准化的。
在基线和每次视频后，参与者完成一份在线问卷的两部分（基线和干预后）。主要结果是对更乐观或更悲观的预后框架的偏好。次要结果包括状态焦虑（STAI-SKD）变化、对预后框架的满意度、预后评估、未来乐观和希望、对共同决策的准备程度（使用定制问题评估）以及一般印象（定制问题）、咨询医生的专业性（改编自 GMC 患者问卷）和同情心（医生同情心问卷）。
这项 RCT 将探讨父母对预后框架的偏好及其对医生与父母沟通的影响。结果可能有助于更好地了解父母在预后告知方面的需求，并为广大临床医生、科学家和伦理学家提供帮助。
德国临床试验注册中心 DRKS00024466。注册于 2021 年 4 月 16 日。
