Yates Lauren A, Leung Phuong, Orgeta Vasiliki, Spector Aimee, Orrell Martin
North East London Foundation Trust, University College London, London, UK ; Division of Psychiatry, University College London, London, UK.
Division of Psychiatry, University College London, London, UK.
Clin Interv Aging. 2014 Dec 30;10:95-104. doi: 10.2147/CIA.S73844. eCollection 2015.
Adopting a systematic approach to the development of an intervention, supported by robust theoretical, empirical, and clinical rationales represents best practice. The Medical Research Council (MRC) provides a framework for a systematic step-wise approach to the evaluation of complex interventions. This study describes the development phase of the individual cognitive stimulation therapy (iCST) for dementia trial, within this framework.
In the preclinical phase, a recent Cochrane Review of cognitive stimulation for dementia and the current literature on individual cognitive stimulation interventions were examined to establish an evidence base. In addition, people with dementia, carers, and care staff were consulted regarding the acceptability of iCST, and a panel was put together to advise the team on the adaptation of group cognitive stimulation therapy (CST). Phase I (modeling) involved consultations with service users and experts in a series of focus groups, interviews, an online survey, and a consensus conference. Finally, Phase II field testing of the intervention was carried out.
Two drafts of the materials were produced before a final version ready for use in the main randomized controlled trial (RCT). Key changes between the drafts included: editorial amendments to improve the clarity of instructions, emphasize the person centeredness of the approach, and reduce the overall length of the introduction section; the simplification of academic terminology and activities deemed "too difficult"; adjustments made to the monitoring-progress forms and session rating scale to enhance user-friendliness; the addition of a "Getting started" section; amendments made to the content of the toolkit; and clearer distinction made between the level of difficulty of activities.
The rigorous development of the intervention was beneficial as the feasibility of the intervention was explored both in theory and practice, and consulting with service users ensured that materials were appropriately tailored to their needs. A Phase III RCT is currently being conducted to determine the effectiveness of iCST.
采用系统的方法来开发一项干预措施，并辅以强有力的理论、实证和临床依据，这代表了最佳实践。医学研究理事会（MRC）为评估复杂干预措施提供了一个系统的逐步推进的框架。本研究在此框架内描述了针对痴呆症的个体认知刺激疗法（iCST）试验的开发阶段。
在临床前阶段，查阅了最近关于痴呆症认知刺激的Cochrane综述以及当前关于个体认知刺激干预措施的文献，以建立证据基础。此外，就iCST的可接受性咨询了痴呆症患者、护理人员和护理工作人员，并组建了一个专家小组，就团体认知刺激疗法（CST）的调整向团队提供建议。第一阶段（建模）包括在一系列焦点小组、访谈、在线调查和共识会议中与服务使用者及专家进行咨询。最后，进行了干预措施的第二阶段现场测试。
在准备用于主要随机对照试验（RCT）的最终版本之前，制作了两份材料草稿。草稿之间的主要变化包括：进行编辑修改以提高说明的清晰度、强调该方法以患者为中心，并缩短引言部分的总长度；简化学术术语和被认为“太难”的活动；对监测进展表格和课程评分量表进行调整以提高用户友好性；增加一个“入门”部分；对工具包的内容进行修改；以及更清晰地区分活动的难度级别。
对干预措施进行严格开发是有益的，因为在理论和实践中都探索了干预措施的可行性，并且与服务使用者进行咨询确保了材料能够根据他们的需求进行适当调整。目前正在进行第三阶段的随机对照试验，以确定iCST的有效性。
