PDF(Pubmed)
Abstract：
BACKGROUND: Intervention fidelity in health services research has been poor with a reported lack of understanding about what constitutes pragmatic adaptation of interventions and what constitutes failure to maintain intervention fidelity. However, the challenges facing those delivering such interventions have not been thoroughly explored. The aims of this study were to critically explore the challenges in maintaining fidelity experienced by physiotherapy staff and support workers when delivering a complex intervention for older people living with frailty.
METHODS: This study is a secondary analysis of data from a process evaluation of a large randomised controlled trial (RCT). The process evaluation employed qualitative methodologies with mixed methods including a variety of data collection methods, including participant observation, semi-structured interviews and documentary analysis. Thematic analysis was used to make sense of the data.
RESULTS: Many therapy staff felt ongoing confusion about what was acceptable to adapt and what needed to follow the protocol exactly. We found that some therapy staff were able to embrace the challenges of pragmatically adapting interventions while maintaining intervention fidelity, others stuck rigidly to the protocol and failed to adapt interventions where it was necessary.
CONCLUSIONS: It was clear that the understanding of fidelity and pragmatism was poor. While pragmatic trials are vital to replicate real world clinical practice, further guidance may need to be developed in order to guide the level of adaptation that is acceptable before fidelity is undermined.
METHODS: This study is a secondary analysis of data from a process evaluation of a large randomised controlled trial (RCT). The process evaluation employed qualitative methodologies with mixed methods including a variety of data collection methods, including participant observation, semi-structured interviews and documentary analysis. Thematic analysis was used to make sense of the data.
RESULTS: Many therapy staff felt ongoing confusion about what was acceptable to adapt and what needed to follow the protocol exactly. We found that some therapy staff were able to embrace the challenges of pragmatically adapting interventions while maintaining intervention fidelity, others stuck rigidly to the protocol and failed to adapt interventions where it was necessary.
CONCLUSIONS: It was clear that the understanding of fidelity and pragmatism was poor. While pragmatic trials are vital to replicate real world clinical practice, further guidance may need to be developed in order to guide the level of adaptation that is acceptable before fidelity is undermined.
摘要：
背景：卫生服务研究中的干预保真度一直很差，据报道缺乏对什么构成干预措施的务实适应以及什么构成无法保持干预保真度的理解。然而,提供此类干预措施的人面临的挑战尚未得到彻底探索。这项研究的目的是批判性地探索在为虚弱的老年人提供复杂的干预措施时，保持理疗人员和支持人员所经历的保真度方面的挑战。
方法：本研究是对一项大型随机对照试验（RCT）过程评估数据的二次分析。过程评估采用定性方法和混合方法，包括各种数据收集方法，包括参与者观察，半结构化访谈和文献分析。使用主题分析来理解数据。
结果：许多治疗人员对适应什么是可接受的，什么是需要严格遵循方案感到困惑。我们发现，一些治疗人员能够接受务实地适应干预措施的挑战，同时保持干预措施的保真度，其他人严格坚持协议，未能在必要时调整干预措施。
结论：很明显，对忠诚和实用主义的理解很差。虽然务实试验对于复制现实世界的临床实践至关重要，可能需要制定进一步的指导，以便在保真度受损之前指导可接受的适应水平。
方法：本研究是对一项大型随机对照试验（RCT）过程评估数据的二次分析。过程评估采用定性方法和混合方法，包括各种数据收集方法，包括参与者观察，半结构化访谈和文献分析。使用主题分析来理解数据。
结果：许多治疗人员对适应什么是可接受的，什么是需要严格遵循方案感到困惑。我们发现，一些治疗人员能够接受务实地适应干预措施的挑战，同时保持干预措施的保真度，其他人严格坚持协议，未能在必要时调整干预措施。
结论：很明显，对忠诚和实用主义的理解很差。虽然务实试验对于复制现实世界的临床实践至关重要，可能需要制定进一步的指导，以便在保真度受损之前指导可接受的适应水平。
