Division of Mental Health and Psychology, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Health Technol Assess. 2017 Oct;21(55):1-240. doi: 10.3310/hta21550.
Participation in the UK Newborn Bloodspot Screening Programme (NBSP) requires parental consent but concerns exist about whether or not this happens in practice and the best methods and timing to obtain consent at reasonable cost.
To collate all possible modes of prescreening communication and consent for newborn (neonatal) screening (NBS); examine midwives', screening professionals' and users' views about the feasibility, efficiency and impact on understanding of each; measure midwives' and parents' preferences for information provision; and identify key drivers of cost-effectiveness for alternative modes of information provision.
Six study designs were used: (1) realist review - to generate alternative communication and consent models; (2) qualitative interviews with parents and health professionals - to examine the implications of current practice for understanding and views on alternative models; (3) survey and observation of midwives - to establish current costs; (4) stated preference surveys with midwives, parents and potential future parents - to establish preferences for information provision; (5) economic analysis - to identify cost-effectiveness drivers of alternative models; and (6) stakeholder validation focus groups and interviews - to examine the acceptability, views and broader impact of alternative communication and consent models.
Providers and users of NBS in England.
Study 2: 45 parents and 37 health professionals; study 3: 22 midwives and eight observations; study 4: 705 adults aged 18-45 years and 134 midwives; and study 6: 12 health-care professionals and five parents.
The realist review identified low parental knowledge and evidence of coercive consent practices. Interview, focus group and stated preference data suggested a preference for full information, with some valuing this more than choice. Health professionals preferred informed choice models but parents and health professionals queried whether or not current consent was fully informed. Barriers to using leaflets effectively were highlighted. All studies indicated that a 'personalised' approach to NBS communication, allowing parents to select the mode and level of information suited to their learning needs, could have added value. A personalised approach should rely on midwife communication and should occur in the third trimester. Overall awareness was identified as requiring improvement. Starting NBS communication by alerting parents that they have a choice to make and telling them that samples could be stored are both likely to enhance engagement. The methods of information provision and maternal anxiety causing additional visits to health-care professionals were the drivers of relative cost-effectiveness. Lack of data to populate an economic analysis, confirmed by value of information analysis, indicated a need for further research.
There are some limitations with regard to the range of participants used in studies 2 and 3 and so caution should be exercised when interpreting some of the results.
This project highlighted the importance of focusing on information receipt and identified key communication barriers. Health professionals strongly preferred informed consent, which parents endorsed if they were made aware of sample storage. Uniform models of information provision were perceived as ineffective. A choice of information provision was supported by health professionals and parents, which both enhances cost-effectiveness and improves engagement, understanding and the validity of consent. Remaining uncertainties suggest that more research is needed before new communication modes are introduced into practice. Future research should measure the impact of the suggested practice changes (informing in third trimester, information toolkits, changed role of midwife).
Current Controlled Trials ISRCTN70227207.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 55. See the NIHR Journals Library website for further project information.
参与英国新生儿血斑筛查计划（NBSP）需要家长同意，但人们担心实际上是否会这样做，以及以合理的成本获得同意的最佳方法和时间。
整理新生儿筛查（NBS）所有可能的预筛沟通和同意模式；检查助产士、筛查专业人员和用户对每种模式的可行性、效率和对理解的影响的看法；衡量助产士和父母对信息提供的偏好；并确定替代信息提供模式的成本效益的关键驱动因素。
使用了六种研究设计：（1）现实审查——生成替代沟通和同意模型；（2）对父母和卫生专业人员进行定性访谈——检查当前实践对理解和替代模型看法的影响；（3）调查和观察助产士——确定当前成本；（4）对助产士、父母和潜在未来父母进行陈述偏好调查——确定信息提供偏好；（5）经济分析——确定替代模型的成本效益驱动因素；（6）利益相关者验证焦点小组和访谈——检查替代沟通和同意模型的可接受性、看法和更广泛的影响。
英格兰 NBS 的提供者和使用者。
研究 2：45 名父母和 37 名卫生专业人员；研究 3：22 名助产士和 8 次观察；研究 4：705 名 18-45 岁的成年人和 134 名助产士；和研究 6：12 名卫生保健专业人员和 5 名父母。
现实审查确定了父母知识水平低和存在强制同意做法的证据。访谈、焦点小组和陈述偏好数据表明，人们更倾向于充分的信息，而有些人则更看重信息的选择。卫生专业人员更喜欢知情选择模式，但父母和卫生专业人员质疑当前的同意是否完全知情。还突出了有效使用传单的障碍。所有研究都表明，一种针对 NBS 沟通的“个性化”方法，允许父母选择适合他们学习需求的模式和信息水平，可以增加价值。个性化方法应该依赖于助产士的沟通，并且应该在第三个三个月进行。总体意识被认为需要提高。通过提醒父母他们有选择的权利，并告知他们样本可以储存，开始 NBS 沟通，这两者都有可能增强参与度。信息提供方式和导致母亲焦虑的方法导致额外访问卫生保健专业人员是相对成本效益的驱动因素。由于缺乏数据来进行经济分析，价值信息分析也证实了这一点，这表明需要进一步研究。
研究 2 和 3 的参与者范围存在一些限制，因此在解释某些结果时应谨慎。
该项目强调了关注信息接收的重要性，并确定了关键的沟通障碍。卫生专业人员强烈支持知情同意，如果父母意识到样本储存，他们也会认可。统一的信息提供模式被认为是无效的。卫生专业人员和父母都支持信息提供的选择，这既提高了成本效益，又提高了参与度、理解度和同意的有效性。仍然存在不确定性，表明在引入新的沟通模式之前，还需要进行更多的研究。未来的研究应该衡量建议的实践变化（在第三个三个月告知、信息工具包、助产士角色的变化）的影响。
当前对照试验 ISRCTN70227207。
本项目由英国国家卫生与保健优化研究所健康技术评估计划资助，并将在 ；第 21 卷，第 55 期全文发表。请访问英国国家卫生与保健优化研究所期刊图书馆网站以获取进一步的项目信息。
