Basu Anna Purna, Pearse Janice Elizabeth, Rapley Tim
Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK.
Department of Paediatric Neurology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE7 7DN, UK.
Trials. 2017 Jan 9;18(1):5. doi: 10.1186/s13063-016-1757-7.
Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed.
Triallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.
开放科学是“使科学研究、数据及传播能为求知社会的各个层面所获取的运动”。本着开放科学运动的精神，生物医学中心、《英国医学杂志》开放版及其他机构目前都在倡导提前发表临床试验方案。与此同时，参与者在获取和分享与试验及健康相关信息方面变得越来越积极。虽然在已发表的试验结果之外获取方案有明显益处，但对于复杂行为干预试验而言，提前发表试验方案可能存在问题。在本文中，我们举例说明这如何可能导致盲法被破坏、干预组与对照组之间的“污染”以及参与者对评估结果的蓄意偏向。我们讨论了潜在的解决方案，并表明有必要就如何最佳处理这一问题展开公众辩论。
试验者可能仍在低估参与者对信息的兴趣。这种情况需要改变：需要与公众进行联合且开放的讨论，以便为我们应如何推进提供信息。
