Background The introduction of ‘Freedom to Speak Up Guardians’ into every NHS trust in England was intended to support workers and trusts to better raise, respond to and learn from speaking-up concerns. However, only broad guidance was provided on how to implement the role. As a result, there is the potential for important local differences to emerge as the role is implemented across England. Objectives The overall aim of this study was to better understand the implementation of Guardians in acute trusts and mental health trusts. Design The Freedom to Speak Up Guardian role was conceptualised as a complex intervention consisting of several interacting and interlocking components spanning the macro level (national organisations), the meso level (individual trusts) and the micro level (employees, teams and wards/units). A mixed-methods study was designed, which consisted of three work packages: (1) a systematic narrative review of the international literature regarding interventions promoting ‘speaking up’ by health-care employees; (2) semistructured telephone interviews with Guardians working in acute hospital trusts and mental health trusts; and (3) qualitative case studies of Freedom to Speak Up Guardian implementation, consisting of observations and interviews undertaken in four acute trusts and two mental health trusts. Interviews were also undertaken with national stakeholders. Setting Acute trusts and mental health NHS trusts in England. Participants Work package 2: Freedom to Speak Up Guardians (n = 87) were interviewed. Work package 3: 116 interviews with key stakeholders involved in pre-implementation and early implementation decision-making, workers who had spoken up to the Guardian, and national stakeholders. Results Wide variability was identified in how the Guardian role had been implemented, resourced and deployed by NHS trusts. ‘Freedom to Speak Up Guardian’ is best considered an umbrella term, and multiple versions of the role exist simultaneously across England. Any comparisons of Guardians’ effectiveness are likely to be possible or meaningful only when this variability is properly accounted for. Many Freedom to Speak Up Guardians identified how a lack of available resources, especially time scarcity, negatively and significantly affected their ability to effectively respond to concerns; their opportunities to collect, analyse and learn from speaking-up data; and, more generally, the extent to which they developed their role and speak-up culture. Limitations It is possible that those whom we interviewed were more receptive of Freedom to Speak Up Guardians or may have been biased by ‘socially desirability’, and their answers may not always have represented respondents’ true perceptions. Conclusions Optimal implementation of the Guardian role has five components: (1) establishing an early, collaborative and coherent strategy congruent with the values of Freedom to Speak Up fosters the implementation of (2) policies and robust, yet supportive, practices (3) informed by frequent and reflexive monitoring of Freedom to Speak Up implementation that is (4) underpinned by sufficient time and resource allocation that leads to (5) a positive implementation climate that is congruent with Freedom to Speak Up values and is well placed to engender positive and sustainable Freedom to Speak Up culture and the well-being of a Guardian. Future work The following recommendations for future research are considered to be of equal priority. Studies of the speaking-up experiences of minority communities and ‘seldom-heard’ workforce groups are a priority requirement. There is also value in undertaking a similar study in non-hospital settings and where peripatetic working is commonplace, such as in ambulance services and in primary care settings. The role of human resources and ‘middle managers’ in the management of concerns is an area requiring further research, especially regarding concerns relating to unprofessional and transgressive behaviours. Devolved administrations in Scotland and Wales have adopted different approaches to speaking up; research undertaken in these contexts would offer valuable comparative insights. Researching the Guardian role ≥ 5 years post implementation is recommended to understand the medium-term impact and the longer-term sustainability of the role and well-being of Guardians. Study registration This study is registered as ISRCTN38163690 and has the study registration CRD42018106311. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 23. See the NIHR Journals Library website for further project information.
In genomics, the clinical application of Next Generation Sequencing technologies (such as Whole Genome or Exome Sequencing) has attracted considerable attention from UK policymakers, interested in the benefits such technologies could bring the National Health Service. However, this boosterism plays little attention to the challenges raised by a kind of result known as a Variant of Uncertain Significance, or VUS, which require clinical geneticists and related colleagues to classify ambiguous genomic variants as ‘benign’ or ‘pathogenic’. With a rigorous analysis based on data gathered at 290 clinical meetings over a two-year period, this paper presents the first ethnographic account of decision-making around NGS technology in a NHS clinical genomics service, broadening our understanding of the role formal criteria play in the classification of VUS. Drawing on Stefan Timmermans’ concept of ‘reflexive standardisation’ to explore the way in which clinical genetics staff classify such variants this paper explores the application of a set of criteria drafted by the American College of Medical Genetics and Genomics, highlighting the flexible way in which various resources – variant databases, computer programmes, the research literature – are drawn on to reach a decision. A crucial insight is how professionals’ perception of, and trust in, the clinical practice at other genomics centres in the NHS, shapes their own application of criteria and the classification of a VUS as either benign or pathogenic.
This article draws on 2 years’ worth of ethnographic observation of team meetings to explore decision‐making in an NHS clinical genomics service. The focus of discussions was on ambiguous genomic results known as VUS or Variants of Uncertain Significance, which may be pathogenic but which also may turn out to be benign. In examining decision‐making around such results, we note how, in contrast to much policy and promotional material in this area, clinicians in these meetings (clinical geneticists and genetic counsellors) place great emphasis on parental phenotypes and whether the parents of a patient share the symptoms and signs of the suspected condition. This information is then combined with the result of genomic tests to decide whether the variant a patient has is responsible for their condition. This article explores the way in which clinicians attempt to flexibly enrol parents into genomic explanations through informal diagnosis of their possible phenotypes and the way in which actually meeting parents allows some clinicians to trump explanations based on documentary or photographic data. The paper sheds light on the way that earlier scholarly understandings of such decisions (around, say dysmorphology) remain relevant and explores claims that laboratory tests overrule clinical decision‐making.
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