Unpacking the Cinderella black box of complex intervention development through the Partners at Care Transitions (PACT) programme of research

Introduction: Complex intervention development has been described as the ‘Cinderella’ black box in health services research. Greater transparency in the intervention development process is urgently needed to help reduce research waste. Methods: We applied a new consensus‐based framework for complex intervention development to our programme of research, in which we developed an intervention to improve the safety and experience of care transitions for older people. Through this process, we aimed to reflect on the framework's utility for intervention development and identify any important gaps within it to support its continued development. Findings: The framework was a useful tool for transparent reporting of the process of complex intervention development. We identified potential ‘action’ gaps in the framework including ‘consolidation of evidence’ and ‘development of principles’ that could bracket and steer decision‐making in the process. Conclusions: We consider that the level of transparency demonstrated in this report, aided through use of the framework, is essential in the quest for reducing research waste. Patient or Public Contribution: We have involved our dedicated patient and public involvement group in all work packages of this programme of research. Specifically, they attended and contributed to co‐design workshops and contributed to finalizing the intervention for the pilot evaluation. Staff also participated by attending co‐design workshops, helping us to prioritize content ideas for the intervention and supporting the development of intervention components outside of the workshops

How to analyse longitudinal data from multiple sources in qualitative health research : the pen portrait analytic technique

BACKGROUND: Longitudinal qualitative research is starting to be used in applied health research, having been popular in social research for several decades. There is potential for a large volume of complex data to be captured, over a span of months or years across several different methods. How to analyse this volume of data - with its inherent complexity - represents a problem for health researchers. There is a previous dearth of methodological literature which describes an appropriate analytic process which can be readily employed. METHODS: We document a worked example of the Pen Portrait analytic process, using the qualitative dataset for which the process was originally developed. RESULTS: Pen Portraits are recommended as a way in which longitudinal health research data can be concentrated into a focused account. The four stages of undertaking a pen portrait are: 1) understand and define what to focus on 2) design a basic structure 3) populate the content 4) interpretation. Instructive commentary and guidance is given throughout with consistent reference to the original study for which Pen Portraits were devised. The Pen Portrait analytic process was developed by the authors, borne out of a need to effectively integrate multiple qualitative methods collected over time. Pen Portraits are intended to be adaptable and flexible, in order to meet the differing analytic needs of qualitative longitudinal health studies. CONCLUSIONS: The Pen Portrait analytic process provides a useful framework to enable researchers to conduct a robust analysis of multiple sources of qualitative data collected over time

UK consensus guidelines for the delivery of unexpected news in obstetric ultrasound: The ASCKS framework

Background: Studies indicate there is a need to improve the delivery of unexpected news via obstetric ultrasound, but there have been few advances in this area. One factor preventing improvement has been a lack of consensus regarding the appropriate phrases and behaviours which sonographers and ultrasound practitioners should use in these situations. Aims: To develop consensus guidelines for unexpected news delivery in Early Pregnancy Unit and Fetal Anomaly Screening Programme NHS settings. Methods: A workshop was conducted to identify priorities and reach consensus on areas of contention. Contributors included interdisciplinary healthcare professionals, policy experts, representatives from third-sector organisations, lay experts and academic researchers (n = 28). Written and verbal feedback was used to draft initial guidance which was then circulated amongst the wider writing group (n = 39). Revisions were undertaken until consensus was reached. Results: Consensus guidelines were developed outlining the behaviours and phrases which should be used during scans where unexpected findings are identified. Specific recommendations included that: honest and clear communication should be prioritised, even with uncertain findings; technical terms should be used, but these should be written down together with their lay interpretations; unless expectant parents use other terminology (e.g. ‘foetus’), the term ‘baby’ should be used as a default, even in early pregnancy; at the initial news disclosure, communication should focus on information provision. Expectant parents should not be asked to make decisions during the scan. Conclusions: These recommendations can be used to develop and improve news delivery interventions in obstetric ultrasound settings. The full guidelines can be accessed online as supplemental material and at https://doi.org/10.5518/100/24

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Background Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation. Methods/Design A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4–6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A ‘study within a trial’ (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation. Discussion This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention. Trial Registration ISRCTN38920246. Registered 22 June 2016

‘More like a partnership’: A qualitative evaluation of Communication Coaching for Sonographers (CCS) in obstetric ultrasound

Introduction:Sonographers are required to deliver unexpected news to expectant parents in real time during obstetric ultrasound scans. The complexity of these interactions requires sonographers to conduct the clinical task while communicating their findings and managing the expectant parent’s response within the designated appointment time. Communication coaching for sonographers (CCS) is a tailored intervention that has previously been associated with improvements in confidence and news delivery practice. The current study explored the views and experiences of sonographers who completed CCS to evaluate and inform future delivery of this intervention.Methods:Nine sonographers participated in semi-structured qualitative interviews after completing CCS. We analysed data using a Reflexive Thematic Analysis (RTA) approach.Results:Participants reported CCS to be valuable and informative. The key themes identified included (1) innovating the path: tailored and novel training for sonographers, (2) humanising care: honouring the self, service-users and relevant others in the delivery of compassion-focused care and (3) making space: considerations for successfully delivering coaching. Participants said the coaching provided practical suggestions and was experienced as a ‘safe space’ for reflective practice that helped to enhance their capacity to identify and respond to emotion in others. There were practical challenges to taking part in CCS and organisational factors could act as a barrier; managerial championing of the intervention was crucial to uptake and completion.Conclusions:Participants viewed CCS positively. To implement CCS, there needs to be organisational coordination. Further controlled studies will be needed to establish the effectiveness of CCS