Department of Social Work, Education and Community Wellbeing, Northumbria University, Coach Lane Campus West, Newcastle upon Tyne, NE7 7XA, UK.
Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle-upon-Tyne, NE2 4AX, UK.
BMC Med Res Methodol. 2018 Nov 15;18(1):133. doi: 10.1186/s12874-018-0590-y.
BACKGROUND: Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants. METHODS: An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument. RESULTS: We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items. CONCLUSION: The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.
背景:理解和衡量实施过程是实施研究人员面临的一个关键挑战。本研究借鉴了规范化进程理论(NPT),开发了一种工具,可用于评估、监测或衡量实施参与者视角下可能影响规范化的因素。
方法:采用以下方法进行工具开发的迭代过程:理论阐述、项目生成和项目缩减(团队研讨会);项目评估(QAS-99);与复杂干预团队进行认知测试;与 NPT 专家进行理论验证;以及仪器的试点测试。
结果:我们最初生成了 112 个潜在的问卷项目;通过团队研讨会和项目评估将其减少到 47 个。在项目评估过程中,没有对项目措辞和结构提出任何担忧。我们与参与复杂干预的开发、评估、提供或接收的专业人员(n=30)进行了三轮认知访谈。我们发现一些项目措辞方面的小问题;如何在干预的不同时间点与不同的人接触的普遍问题;以及仪器应针对哪些类型的人设计的概念问题。我们通过添加额外的项目(n=6)和包括一套新的选项来解决这些问题:“现阶段不相关”、“与我的角色不相关”和“与这项干预不相关”,并决定为那些提供或接收干预的人设计一种仪器。该版本的仪器有 53 个项目。23 名对 NPT 有深入了解的人员审查了这些项目的理论偏差。与 NPT 子结构显示出较差一致性的项目被删除(n=8),其他项目被修订或合并(n=6)。最终仪器,共有 43 个项目,成功地对五个人进行了试点,项目完成率达到 100%。
结论:在理论翻译、项目生成、认知测试和理论(重新)验证的循环中不断前进的过程对于在 NPT 概念的理论完整性和预期受访者回答问题的便利性之间保持平衡至关重要。最终的仪器易于理解和完成,同时保留理论有效性。NoMAD 代表了一种可以用来理解实施参与者体验的测量工具。它旨在作为一种可以与衡量实施活动其他维度(如实施保真度、采用和准备度)的工具一起使用的测量工具。
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