Brigit Chesworth

Icons: identifying continence options after stroke trial: utility of a logic model in the design and implementation of a process evaluation

Background: ICONS is a cluster randomised controlled pilot trial designed to provide preliminary evidence of the effectiveness of a systematic voiding programme (SVP) for the management of continence after stroke. Stroke services were randomised to receive the SVP, the SVP plus supported implementation, or usual care. Process evaluations are designed to evaluate fidelity and provide explanatory evidence around trial outcomes; these need to be underpinned by a theoretical framework to explain linkages between intervention processes and outcomes. Process evaluation: We conducted an evaluation to describe SVP implementation and assist in explaining intervention outcomes. Reflecting best practice in complex intervention research, we developed a logic model to underpin the evaluation representing practitioners’ implementation activities. To increase explanatory power of the model, we synthesised principles from theoretical frameworks underpinning the study (e.g. the Normalisation Process Model) into mechanisms of action to explain conditions necessary for activities to impact on outcomes. Mechanisms were: • Understanding and agreeing: conceptual work associated with the SVP, e.g. increasing awareness. • Driving and aligning: organising systems or processes to align and drive new practice. • Building and supporting: enacting the SVP. • Learning and evaluation: reflecting on performance and progress. Findings: We will discuss the utility of the logic model in explaining conditions necessary for the intervention to work, the success of implementation strategies adopted and variations in patient outcome across trial arms. We will also consider the challenges of synthesising across multiple data sources to understand variation in intervention delivery, maintenance and outcome in cluster trials.

Why does it happen like this?. Consulting with users and providers prior to an evaluation of services for children with life-limiting conditions and their families

Children with life limiting conditions and their families have complex needs. Evaluations must consider their views and perspectives to ensure care is relevant, appropriate and acceptable. We consulted with children, young people, their parents and local professionals to gain a more informed picture of issues affecting them prior to preparing a bid to evaluate services in the area. Multiple methods included focus groups, face-to-face and telephone interviews and participatory activities. Recordings and products from activities were analysed for content to identify areas of relevance and concern. An overarching theme from parents was ‘Why does it happen like this?’ Services did not seem designed to meet their needs. Whilst children and young people expressed ideas related to quality of environment, services and social life, professionals focused on ways of meeting the families’ needs. The theme that linked families’ concerns with those of professionals was ‘assessing individual needs’. Two questions to be addressed by the evaluation are (1) to what extent are services designed to meet the needs of children and families and (2) to what extent are children, young people and their families consulted about what they need? Consultations with families and service providers encouraged us to continue their involvement as partners in the evaluation.

Implementation—The Missing Link in the Research Translation Pipeline: Is It Any Wonder No One Ever Implements Evidence-Based Practice?:

Despite the exponential growth in the evidence base for stroke rehabilitation, there is still a paucity of knowledge about how to consistently and sustainably deliver evidence-based stroke rehabilitation therapies in clinical practice. This means that people with stroke will not consistently benefit from research breakthroughs, simply because clinicians do not always have the skills, authority, knowledge or resources to be able to translate the findings from a research trial and apply these in clinical practice. This “point of view” article by an interdisciplinary, international team illustrates the lack of available evidence to guide the translation of evidence to practice in rehabilitation, by presenting a comprehensive and systematic content analysis of articles that were published in 2016 in leading clinical stroke rehabilitation journals commonly read by clinicians. Our review confirms that only a small fraction (2.5%) of published stroke rehabilitation research in these journals evaluate the implementation of evidence-based interventions into health care practice. We argue that in order for stroke rehabilitation research to contribute to enhanced health and well-being of people with stroke, journals, funders, policy makers, researchers, clinicians, and professional associations alike need to actively support and promote (through funding, conducting, or disseminating) implementation and evaluation research.

Assessing fidelity to complex interventions: the icons experience

Background Assessing fidelity to complex healthcare interventions in clinical trials is a challenging area. ‘ICONS’ is a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP), incorporating bladder training and prompted voiding, to promote post-stroke continence. Here we describe feasibility of one aspect of fidelity assessment: the day-to-day implementation of the SVP through analysis of clinical logs. Methods Nurses completed clinical logs daily, which included documenting: the toileting interval, proposed toileting times and times toileted. Clinical logs were sampled across trial sites. The original intention was to assess fidelity by exploring the degree of concordance between proposed times and times toileted. Initial analysis revealed the unfeasibility of this method due to documentation errors in toileting intervals and proposed times. Consequently, the planned method was changed to identification of key ‘quality indicators’ (QIs) for documentation of practice. Results The need to revise the method of measurement demonstrates the difficulty in assessing fidelity. Assessment of clinical logs revealed low levels of adherence to key quality indicators. However, it is unclear whether this indicates poor fidelity or an imprecise method of fidelity assessment. Conclusion