Agenda setting in the clinical encounter: what is it, and is it measureable?

The term agenda setting has been used variably across the healthcare literature, in particular in writings on doctor-patient communication, medical education, and behaviour change. No attempt has yet been made to integrate these different conceptualisations. This impacts both investigation and teaching of this communication skill. The studies in this thesis aim to clarify a conceptual foundation, and to develop a measure of agenda setting, for use in teaching clinicians. A context of long-term condition management was selected. In these clinical encounters clinician and patient agendas naturally intersect and may disagree, and patient participation is essential to effective management. Phase 1 of this thesis involved a structured literature review, and focus group study with clinicians in primary and secondary care to map components of agenda setting. These were refined through a consensus group study involving patients, clinicians, researchers and educators. An integrated model of agenda setting is proposed that adopts new terminology: agenda mapping involves establishing shared focus, and agenda navigation involves tracking natural shifts in focus throughout an interaction. Agenda mapping includes six core domains: (1) identifying patient talk topics, (2) identifying clinician talk topics, (3) agreeing shared priorities, (4) agreeing focus, (5) collaboration, and (6) engagement. Clarifying these domains established a foundation for measurement. Phase 2 of this thesis addresses measurement of agenda mapping. A review of measures confirmed that no existing measure includes all agenda mapping domains. The Evaluation of AGenda mapping skiL Instrument (EAGL-I) was developed, and tested in a study with third year medical students. EAGL-I scores were shown to represent reliable and valid assessment of agenda mapping. Conditions, under which reliable assessment may occur, are also discussed. Educators and researchers now have a tool for use in teaching agenda mapping to clinicians. Further investigation of agenda mapping in long-term condition management may also now progress. Key words: agenda setting, agenda mapping, healthcare communication, motivational interviewing, focusing, measurement, psychometric, teaching, training, education, long term conditions, behaviour chang

Comment on Rishu et al. Time required to initiate outbreak and pandemic observational research

We applaud the work of Rishu and colleagues in tracking the timelines to initiation of outbreak and pandemic observational research. Through this work they highlight the challenges in being prepared with a clinical research response in the next pandemic. Pandemics are unpredictable but also recurrent. Recent experience of Ebola and Zika outbreaks highlight the devastating impact these outbreaks have on the health, economy and security of communities for generations to come

Is a motivational interviewing based lifestyle intervention for obese pregnant women across Europe implemented as planned? Process evaluation of the DALI study

Background: Process evaluation is an essential part of designing and assessing complex interventions. The vitamin D and lifestyle intervention study (DALI) study is testing different strategies to prevent development of gestational diabetes mellitus among European obese pregnant women with a body mass index ≥29kg/m2. The intervention includes guidance on physical activity and/or healthy eating by a lifestyle coach trained in motivational interviewing (MI). The aim of this study was to assess the process elements: reach, dose delivered, fidelity and satisfaction and to investigate whether these process elements were associated with changes in gestational weight gain (GWG). Methods: Data on reach, dose delivered, fidelity, and satisfaction among 144 participants were collected. Weekly recruitment reports, notes from meetings, coach logs and evaluation questionnaires (n=110) were consulted. Fidelity of eight (out of twelve) lifestyle coach practitioners was assessed by analysing audio recorded counselling sessions using the MI treatment integrity scale. Furthermore, associations between process elements and GWG were assessed with linear regression analyses. Results: A total of 20% of the possible study population (reach) was included in this analysis. On average 4.0 (of the intended 5) face-to-face sessions were delivered. Mean MI fidelity almost reached \u27expert opinion\u27 threshold for the global scores, but was below \u27beginning proficiency\u27 for the behavioural counts. High variability in quality of MI between practitioners was identified. Participants were highly satisfied with the intervention, the lifestyle coach and the intervention materials. No significant associations were found between process elements and GWG. Conclusion: Overall, the intervention was well delivered and received by the study population, but did not comply with all the principles of MI. Ensuring audio recording of lifestyle sessions throughout the study would facilitate provision of individualized feedback to improve MI skills. A larger sample size is needed to confirm the lack of association between process elements and GWG. Trial registration: ISRCTN registry: ISRCTN70595832 ; Registered 12 December 2011

Implementation of the Family Nurse Partnership programme in England: experiences of key health professionals explored through trial parallel process evaluation

Background The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context. The aim of the focus groups was to investigate views of key health professionals towards the integration and delivery of FNP programme in England. Methods Focus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011–2012. Transcripts from audio-recordings were analysed thematically. Results A total of 122 professionals participated in one of 19 focus groups. Family Nurses were confident in the effectiveness of FNP, although they experienced practical difficulties meeting programme fidelity targets and considered that programme goals did not sufficiently reflect client or community priorities. Health Visitors and Midwives regarded FNP as well-resourced and beneficial to clients, describing their own services as undervalued and struggling. They wished to work closely with Family Nurses, but felt excluded from doing so by practical barriers and programme protection. Conclusion FNP was described as well-resourced and delivered by highly motivated and well supported Family Nurses. FNP eligibility, content and outcomes conflicted with individual client and community priorities. These factors may have restricted the potential effectiveness of a programme developed and previously tested in a different social milieu. Building Blocks ISRCTN23019866 Registered 20/04/2009

'Focusing' in motivational interviewing: development of a training tool for practitioners

Rationale, aims and objectives: Motivational Interviewing (MI) is an individual-level approach to behaviour change that has been evaluated in over 600 randomised clinical trials across multiple settings. Increasingly, research efforts focus on how MI works and how it can best be integrated into public health and clinical programmes. As the application of MI expands, a key integration challenge involves specifying the focus of a conversation such that a practitioner might ignite and intensify a patient’s internal motivation for change related to that focus. At present, this challenge is poorly conceptualised. We aimed to clarify the construct of “focusing” and to develop a practical tool that can be used to develop and assess practitioner competence. Method: First we reviewed validated MI measures to elucidate current conceptualisations of focusing. Second, we identified practitioner speech acts that led to topic transitions. We then drafted the first version of MIFI. A gold standard rater, together with one expert MI and 3 non-expert MI raters, each used MIFI to coded 20 audio recordings from a feasibility study of MI and breastfeeding maintenance (n=170 observations). Internal consistency and inter-rater reliability analyses were conducted. Results: Published MI measures include ‘focusing’ as a strategy to agree a target change or to hold attention on that change target. We observed practitioners create or shift focus using 4 skills: questions, listening statements, giving information or meta-statements. Moderate to strong correlations were demonstrated between 4 of 5 global measures on the MIFI. Reliability estimates were good to excellent overall (5 coder ICCs>0.65), fair to excellent for the non-expert coding group (ICCs>0.55) and for the best coding pair (MI expert and non-expert ICCs >0.52). Conclusion: We offer conceptual clarity about focusing in MI and have developed a tool to train practitioners in “focusing” when integrating MI into healthcare and public health interventions

Development and Delivery of a Physical Activity Intervention for People With Huntington Disease:Facilitating Translation to Clinical Practice

Background and Purpose: We studied the development and delivery of a 14-week complex physical activity intervention for people with Huntington disease, where detailed information about the intervention was fully embedded in the trial design process. Methods: Intervention Development: The intervention was developed through a series of focus groups. The findings from the focus groups informed the development of a logic model for the physical activity intervention that was broadly consistent with the framework of self-determination theory. Intervention Delivery: Key components underpinning the delivery of the intervention were implemented including a defined coach training program and intervention fidelity assessment methods. Training of coaches (physical therapists, occupational therapists, research nurses, and exercise trainers) was delivered via group and 1:1 training sessions using a detailed coach's manual, and with ongoing support via video calls, and e-mail communication as needed. Detailed documentation was provided to determine costs of intervention development and coach training. Results: Intervention delivery coaches at 8 sites across the United Kingdom participated in the face-to-face training. Self-report checklists completed by each of the coaches indicated that all components of the intervention were delivered in accordance with the protocol. Mean (standard deviation) intervention fidelity scores (n = 15), as measured using a purpose-developed rating scale, was 11 (2.4) (out of 16 possible points). Coaches' perceptions of intervention fidelity were similarly high. The total cost of developing the intervention and providing training was [pounds]30,773 ($47,042 USD). Discussion and Conclusions: An important consideration in promoting translation of clinical research into practice is the ability to convey the detailed components of how the intervention was delivered to facilitate replication if the results are favorable. This report presents an illustrative example of a physical activity intervention, including the development and the training required to deliver it. This approach has the potential to facilitate reproducibility, evidence synthesis, and implementation in clinical practice

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.

BACKGROUND: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these. METHODS: A scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data. RESULTS: Of 2678 articles screened, 76 were included. Most presented data relating to the 2014-2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated. CONCLUSIONS: To strengthen global preparedness and response to the COVID-19 pandemic and future epidemics, identified solutions for rapid clinical research deployment, delivery, and dissemination must be implemented. Improvements are urgently needed to strengthen collaborations, funding mechanisms, global and national research capacity and capability, targeting regions vulnerable to epidemics and pandemics. Solutions need to be flexible to allow timely adaptations to context, and research led by governments of affected regions. Research communities globally need to evaluate their activities and incorporate lessons learnt to refine and rehearse collaborative outbreak response plans in between epidemics

Developing a whole-school mental health and wellbeing intervention through pragmatic formative process evaluation: A case-study of innovative local practice within the School Health Research Network

The evidence-base for whole school approaches aimed at improving student mental health and wellbeing remains limited. This may be due to a focus on developing and evaluating de-novo, research led interventions, while neglecting the potential of local, contextually-relevant innovation that has demonstrated acceptability and feasibility. This study reports a novel approach to modelling and refining the theory of a whole-school restorative approach, alongside plans to scale up through a national educational infrastructure in order to support robust scientific evaluation. A pragmatic formative process evaluation was conducted of a routinized whole-school restorative approach aimed at improving student mental health and wellbeing in Wales. The study reports seven phases of the pragmatic formative process evaluation that may be undertaken in the development and evaluation of interventions already in routine practice: 1) identification of innovative local practice; 2) scoping review of evidence-base to identify existing intervention programme theory; outcomes; and contextual characteristics that influence programme theory and implementation; 3) establishment of a Transdisciplinary Action Research (TDAR) group; 4) co-production of an initial intervention logic model with stakeholders; 5) confirmation of logic model with stakeholders; 6) planning for intervention refinement; and 7) planning for feasibility and outcome evaluation. The phases of this model may be iterative and not necessarily sequential. Formative, pragmatic process evaluations support researchers, policy-makers and practitioners in developing a robust scientific evidence-base for acceptable and feasible local innovation that does not have a clear evidence base. The case of a whole-school restorative approach provides a case example of how such an evaluation may be undertaken.Wellcome Trust Institutional Strategic Support Fund, Cardiff University, grant no. 510564

A mixed methods pilot of Beat the Bugs: a community education course on hygiene, self-care and antibiotics

Background: e-Bug is an international health education resource which support World Health Organization (WHO) public health recommendations by educating young people about microbes, hygiene and antibiotics use. The e-Bug team collaborated with Kingfisher Treasure Seekers to develop a six-session course for community groups called Beat the Bugs covering: microbes; hygiene; antibiotic use; and self-care. A pilot was used to inform further development and evaluation. Methods: Pilot courses with 9–12 adults with learning difficulties and young parents were delivered by community leaders and observed by researchers. Participants completed before and after knowledge questionnaires. Two participant focus groups and two course leader interviews explored views on the course and retention of knowledge. Results: Completed questionnaires and qualitative results showed an improvement in participant knowledge in each session; microbes and antibiotics sessions showed the greatest knowledge improvement. Self-care showed the greatest knowledge retention and participants reported behaviour change including an increase in appropriate hand-washing and tooth-brushing. Conclusion: The Beat the Bugs course is a useful intervention for communities to give individuals the knowledge and confidence to manage their own infection and change behaviour around hygiene, self-care and antibiotics. Beat the Bugs is freely available to download