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Abstract：
The study design and protocol that underpin a randomised controlled trial (RCT) are critical for the ultimate success of the trial. Although RCTs are considered the gold standard for research, there are multiple threats to their validity such as participant recruitment and retention, identifying a meaningful change, and non-adherence to the protocol. For clinical RCTs, involving patients and clinicians in protocol design provides the opportunity to develop research protocols that are meaningful to their target audience and may help overcome some of the inherent threats in conducting RCTs. However, the majority of protocols do not describe the methodology underpinning their development, limiting the amount of learned experience shared between research groups.
With the purpose of reporting a collaborative approach towards developing a protocol, we present the findings from three sequential workshops that were conducted with the aim of developing a protocol to investigate the feasibility of adding a computerised test of attention, impulsivity and activity (QbTest) to medication management of children and young people with Attention deficit hyperactivity disorder (ADHD). Based on previous qualitative interviews with clinicians and families, each workshop prioritised topics for focused discussion. Information from the workshops was fed back to the participants for reflection in advance of the next workshop.
The workshops involved 21 multi-disciplinary ADHD experts, including clinicians, patient and public involvement (PPI) members, parents of young people with ADHD and researchers. The consensus workshops addressed key research issues such as: the most relevant outcome measures/ resource drivers; methods and time points for data collection; and the clinical protocol for utilising the QbTest, including when best to use this within the medication management process. The resulting protocol details a feasibility RCT design describing these factors.
Protocols which are co-developed may help overcome some of the risks associated with RCT completion (e.g. recruitment, retention, protocol adherence) and help prioritise outcomes of greater relevance to the populations under study. The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design.
Clinicaltrials.gov NCT03368573, 11th December 2017 (retrospectively registered).
With the purpose of reporting a collaborative approach towards developing a protocol, we present the findings from three sequential workshops that were conducted with the aim of developing a protocol to investigate the feasibility of adding a computerised test of attention, impulsivity and activity (QbTest) to medication management of children and young people with Attention deficit hyperactivity disorder (ADHD). Based on previous qualitative interviews with clinicians and families, each workshop prioritised topics for focused discussion. Information from the workshops was fed back to the participants for reflection in advance of the next workshop.
The workshops involved 21 multi-disciplinary ADHD experts, including clinicians, patient and public involvement (PPI) members, parents of young people with ADHD and researchers. The consensus workshops addressed key research issues such as: the most relevant outcome measures/ resource drivers; methods and time points for data collection; and the clinical protocol for utilising the QbTest, including when best to use this within the medication management process. The resulting protocol details a feasibility RCT design describing these factors.
Protocols which are co-developed may help overcome some of the risks associated with RCT completion (e.g. recruitment, retention, protocol adherence) and help prioritise outcomes of greater relevance to the populations under study. The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design.
Clinicaltrials.gov NCT03368573, 11th December 2017 (retrospectively registered).
摘要：
支持随机对照试验（RCT）的研究设计和方案对于该试验的最终成功至关重要。虽然RCT被认为是研究的黄金标准，其有效性存在多种威胁，如参与者招募和保留，确定有意义的变化，和不遵守协议。对于临床随机对照试验，让患者和临床医生参与方案设计,为制定对目标受众有意义的研究方案提供了机会,这些研究方案可能有助于克服进行RCT时的一些固有威胁.然而,大多数协议没有描述支撑其发展的方法论，限制研究小组之间分享的学习经验的数量。
为了报告制定协议的协作方法，我们介绍了三个连续研讨会的结果，这些研讨会的目的是制定一项协议，以调查添加计算机化注意力测试的可行性，冲动和活动（QbTest）对患有注意缺陷多动障碍（ADHD）的儿童和年轻人的药物管理。根据以前对临床医生和家庭的定性访谈，每个研讨会都优先讨论主题。讲习班的信息已反馈给参与者，以便在下一次讲习班之前进行思考。
研讨会有21名多动症多学科专家参加，包括临床医生,患者和公众参与(PPI)成员，患有多动症的年轻人的父母和研究人员。共识研讨会讨论了关键研究问题，例如：最相关的结果度量/资源驱动因素；数据收集的方法和时间点；以及使用QbTest的临床方案，包括何时在药物管理过程中最好使用它。由此产生的协议详述了描述这些因素的可行性RCT设计。
共同开发的协议可能有助于克服与完成RCT相关的一些风险(例如，保留,协议遵守)，并帮助优先考虑与研究人群更相关的结果。该方法对研究人员和组织制定临床指南具有潜在价值，并提供了对PPI对试验设计的宝贵影响的见解。
Clinicaltrials.govNCT03368573，2017年12月11日（回顾性注册）。
为了报告制定协议的协作方法，我们介绍了三个连续研讨会的结果，这些研讨会的目的是制定一项协议，以调查添加计算机化注意力测试的可行性，冲动和活动（QbTest）对患有注意缺陷多动障碍（ADHD）的儿童和年轻人的药物管理。根据以前对临床医生和家庭的定性访谈，每个研讨会都优先讨论主题。讲习班的信息已反馈给参与者，以便在下一次讲习班之前进行思考。
研讨会有21名多动症多学科专家参加，包括临床医生,患者和公众参与(PPI)成员，患有多动症的年轻人的父母和研究人员。共识研讨会讨论了关键研究问题，例如：最相关的结果度量/资源驱动因素；数据收集的方法和时间点；以及使用QbTest的临床方案，包括何时在药物管理过程中最好使用它。由此产生的协议详述了描述这些因素的可行性RCT设计。
共同开发的协议可能有助于克服与完成RCT相关的一些风险(例如，保留,协议遵守)，并帮助优先考虑与研究人群更相关的结果。该方法对研究人员和组织制定临床指南具有潜在价值，并提供了对PPI对试验设计的宝贵影响的见解。
Clinicaltrials.govNCT03368573，2017年12月11日（回顾性注册）。
