Louise Caffrey

Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre

BackgroundIn the UK, the recruitment of patients into clinical research is a national health research and development policy priority. There has been limited investigation of how national level factors operate as barriers or facilitators to recruitment work, particularly from the perspective of staff undertaking patient recruitment work. The aim of this study is to identify and examine staff views of the key organisational barriers and facilitators to patient recruitment work in one clinical research group located in an NHS Academic Health Science Centre.MethodsA qualitative study utilizing in-depth, one-to-one semi-structured interviews with 11 purposively selected staff with particular responsibilities to recruit and retain patients as clinical research subjects. Thematic analysis classified interview data by recurring themes, concepts, and emergent categories for the purposes of establishing explanatory accounts.ResultsThe findings highlight four key factors that staff perceived to be most significant for the successful recruitment and retention of patients in research and identify how staff located these factors within patients, studies, the research centre, the trust, and beyond the trust. Firstly, competition for research participants at an organisational and national level was perceived to undermine recruitment success. Secondly, the tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs. Thirdly, staff perceived an imbalance between personal patient burden and benefit. Ethical committee regulation, designed to protect patients, was perceived by some staff to detract from clarification and systematisation of incentivisation strategies. Finally, the structure and relationships within clinical research teams, in particular the low tacit status of recruitment skills, was seen as influential.ConclusionsThe results of this case-study, conducted in an exemplary NHS academic research centre, highlight current systematic challenges to patient recruitment and retention in clinical studies more generally as seen from the perspective of staff at the sharp end’ of recruiting. Staff experience is that, beyond individual clinical research design and protocol factors, wider organisational and extra-organisational norms, structures, and processes operate as significant facilitators or hindrances in the recruitment of patients as research subjects.

Gender equity programmes in academic medicine: a realist evaluation approach to Athena SWAN processes

Objectives Gender inequity has persisted in academic medicine. Yet equity is vital for countries to achieve their full potential in terms of translational research and patient benefit. This study sought to understand how the gender equity programme, Athena SWAN, can be enabled and constrained by interactions between the programme and the context it is implemented into, and whether these interactions might produce unintended consequences. Design Multimethod qualitative case studies using a realist evaluation approach. Setting 5 departments from a university medical school hosting a Translational Research Organisation. Participants 25u2005hours of observations of gender equality committee meetings, 16 in-depth interviews with Heads of Departments, Committee Leads and key personnel involved in the initiative. 4 focus groups with 15 postdoctoral researchers, lecturers and senior lecturers. Results The implementation of Athena SWAN principles was reported to have created social space to address gender inequity and to have highlighted problematic practices to staff. However, a number of factors reduced the programmes potential to impact gender inequity. Gender inequity was reproduced in the programmes enactment as female staff was undertaking a disproportionate amount of Athena SWAN work, with potential negative impacts on individual womens career progression. Early career researchers experienced problems accessing Athena SWAN initiatives. Furthermore, the impact of the programme was perceived to be undermined by wider institutional practices, national policies and societal norms, which are beyond the programmes remit. Conclusions Gender equity programmes have the potential to address inequity. However, paradoxically, they can also unintentionally reproduce and reinforce gender inequity through their enactment. Potential programme impacts may be undermined by barriers to staff availing of career development and training initiatives, and by wider institutional practices, national policies and societal norms.

Embedding research in health systems: lessons from complexity theory

BackgroundInternationally, there has been increasing focus on creating health research systems. This article aims to investigate the challenges of implementing apparently simple strategies to support the development of a health research system. We focus on a case study of an English National Health Service Hospital Trust that sought to implement the national recommendation that health organisations should introduce a statement about research on all patient admission letters.MethodsWe apply core concepts from complexity theory to the case study and undertake a documentary analysis of the email dialogue between staff involved in implementing this initiative.ResultsThe process of implementing a research statement in patient admission letters in one clinical service took 1xa0year and 21xa0days. The length of time needed was influenced firstly by adaptive self-organisation, underpinned by competing interests. Secondly, it was influenced by the relationship between systems, rather than simply being a product of issues within those systems. The relationship between the health system and the research system was weaker than might have been expected. Responsibilities were unclear, leading to confusion and delayed action.ConclusionsConventional ways of thinking about organisations suggest that change happens when leaders and managers change the strategic vision, structure or procedures in an organisation and then persuade others to rationally implement the strategy. However, health research systems are complex adaptive systems characterised by high levels of unpredictability due to self-organisation and systemic interactions, which give rise to ‘emergent’ properties. We argue for the need to study how micro-processes of organisational dynamics may give rise to macro patterns of behaviour and strategic organisational direction and for the use of systems approaches to investigate the emergent properties of health research systems.

Embracing model-based designs for dose-finding trials.

Background:Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM).Methods:We carried out a literature review of dose-finding designs and conducted a survey to identify perceived barriers to their implementation.Results:We describe the benefits of model-based designs (flexibility, superior operating characteristics, extended scope), their current uptake, and existing resources. The most prominent barriers to implementation of a model-based design were lack of suitable training, chief investigators’ preference for algorithm-based designs (e.g., 3+3), and limited resources for study design before funding. We use a real-world example to illustrate how these barriers can be overcome.Conclusions:There is overwhelming evidence for the benefits of CRM. Many leading pharmaceutical companies routinely implement model-based designs. Our analysis identified barriers for academic statisticians and clinical academics in mirroring the progress industry has made in trial design. Unified support from funders, regulators, and journal editors could result in more accurate doses for later-phase testing, and increase the efficiency and success of clinical drug development. We give recommendations for increasing the uptake of model-based designs for dose-finding trials in academia.

A systems approach to policy evaluation

There is growing interest in evaluating policy implementation in ways that grapple with the complexity of the process. This article offers an example of using systems methodology to explore how the child protection policy in child contact centres has functioned in practice. Rather than just asking the traditional evaluation question ‘is it working?’ this study sought to understand how the policy was working and how it was interpreted as it interacted with other systems, producing conflicts, local variation and emergent effects. It illustrates how the systems concepts of ‘emergence’, ‘local rationality’, ‘socio-technical systems’ and ‘feedback for learning’ can contribute new knowledge and understanding to a complex policy evaluation problem.

The strange resilience of new public management: the case of medical research in the UK’s national health service

ABSTRACT Whether New Public Management (NPM) ideas and practices have remained resilient or are now in decline remains a topic of contention. We investigate the case of a national system, introduced in 2006, for performance managing medical research in the United Kingdom’s National Health System (NHS). We argue that the system conforms to traditional NPM, providing empirical evidence of its late adoption and resilience. We highlight potential conflicts in the adoption of NPM in this context and demonstrate for the first time the potential for this NPM-style system to produce unintended and unwanted consequences in the context of medical research.

Patient-initiated recruitment for clinical research: Evaluation of an outpatient letter research statement

UK Hospital Trusts are charged with increasing patients’ research awareness and willingness to take part in research. This includes implementing strategies to encourage patient‐initiated enquiries about participation.

The BMJ’s stance on qualitative research is epistemologically naïve

A response to Greenhalgh and colleagues’ appeal for more