Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden.
The Stockholm Sjukhem Foundation, Stockholm, Sweden.
BMC Geriatr. 2021 Feb 1;21(1):96. doi: 10.1186/s12877-021-02031-1.
Process evaluations provide contextual insight into the way in which interventions are delivered. This information is essential when designing strategies to implement programs into wider clinical practice. We performed a process evaluation of the HiBalance effectiveness trial investigating the effects of a 10-week of highly challenging and progressive balance training for mild-moderate Parkinson's disease (PD). Study aims were to investigate i) the quality and quantity of intervention delivery and ii) barriers and facilitators for implementation.
Process outcomes included; Fidelity; Dose (delivered and received) Recruitment and Reach. Investigation of barriers and facilitators was guided by the Consolidated Framework for Implementation Research. Program delivery was assessed across four neurological rehabilitation sites during a two-year period. Data collection was mixed-methods in nature and quantitative and qualitative data were merged during the analysis phase.
Thirteen program trainers delivered the intervention to 12 separate groups during 119 training sessions. Trainer fidelity to program core components was very high in 104 (87%) of the sessions. Participant responsiveness to the core components was generally high, although adherence to the home exercise program was low (50%). No significant context-specific differences were observed across sites in terms of fidelity, dose delivered/ received or participant characteristics, despite varying recruitment methods. Facilitators to program delivery were; PD-specificity, high training frequency and professional autonomy. Perceived barriers included; cognitive impairment, absent reactional balance among participants, as well a heterogeneous group in relation to balance capacity.
These findings provide corroborating evidence for outcome evaluation results and valuable information for the further adaptation and implementation of this program. Important lessons can also be learned for researchers and clinicians planning to implement challenging exercise training programs for people with mild-moderate PD.
ClinicalTrials.gov, NCT02727478 , registered 30 march, 2016 - Retrospectively registered.
过程评估提供了干预措施实施方式的背景洞察力。当设计将方案实施到更广泛的临床实践中的策略时,这些信息是必不可少的。我们对 HiBalance 有效性试验进行了过程评估,该试验研究了为期 10 周的高挑战性和渐进性平衡训练对轻度至中度帕金森病(PD)的影响。研究目的是调查 i)干预措施的质量和数量的交付情况,ii)实施的障碍和促进因素。
过程结果包括:保真度;剂量(交付和接收);招募和覆盖范围。对障碍和促进因素的调查遵循实施研究的综合框架。在两年期间,在四个神经康复地点评估了计划的交付情况。数据收集本质上是混合方法的,并且在分析阶段合并了定量和定性数据。
13 名计划培训师在 119 次培训课程中向 12 个不同的小组提供了干预措施。在 104 次(87%)的课程中,培训师对计划核心组件的保真度非常高。尽管对家庭锻炼计划的依从性较低(50%),但参与者对核心组件的反应通常较高。尽管招募方法不同,但在保真度,交付/接收剂量或参与者特征方面,各个地点之间没有明显的特定于上下文的差异。促进计划交付的因素包括:PD 特异性、高培训频率和专业自主权。感知到的障碍包括:认知障碍、参与者缺乏反应性平衡,以及与平衡能力相关的异质群体。
这些发现为结果评估结果提供了佐证证据,并为进一步改编和实施该计划提供了有价值的信息。对于计划为轻度至中度 PD 患者实施挑战性运动训练计划的研究人员和临床医生来说,也可以吸取重要的经验教训。
ClinicalTrials.gov,NCT02727478,注册于 2016 年 3 月 30 日 - 回顾性注册。