Public involvement and engagement in scientific research and higher education: the only way is ethics?

BACKGROUND: Involving and engaging the public in scientific research and higher education is slowly becoming the norm for academic institutions in the United Kingdom and elsewhere. Driven by a wide range of stakeholders including regulators, funders, research policymakers and charities public involvement and public engagement are increasingly seen as essential in delivering open and transparent activity that is relevant and positively impacts on our society. It is obvious that any activities involving and engaging members of the public should be conducted safely and ethically. However, it is not clear whether conducting activities ethically means they require ethical approval from a research ethics committee. MAIN BODY: Although there is some guidance available from government organisations (e.g. the UK Health Research Authority) to suggest ethical approval is not required for such activities, requests from funders and publishers to have ethical approval in place is commonplace in the authors' experience. We explore this using case studies from our own institution. CONCLUSION: We conclude that any public-facing activity with the purpose to systemically investigate knowledge, attitudes and experiences of members of the public as research and as human participants requires prior approval from an ethics committee. In contrast, engaging and involving members of the public and drawing on lived experience to inform aspects of research and teaching does not. However, lack of clarity around this distinction often results in the academic community seeking ethical approval 'just in case', leading to wasted time and resources and erecting unnecessary barriers for public involvement and public engagement. Instead, ethical issues and risks should be appropriately considered and mitigated by the relevant staff within their professional roles, be it academic or a professional service. Often this can involve following published guidelines and conducting an activity risk assessment, or similar. Moving forward, it is critical that academic funders and publishers acknowledge the distinction and agree on an accepted approach to avoid further exacerbating the problem.

Involving and engaging members of the public is recognised best practice in university research and teaching. Involvement and engagement activities (for instance, working with the public to design a research study) continue to increase in priority and are an important part of an academic's role. However, there is often confusion amongst researchers and educators around whether involving the public in these activities requires prior ethical approval, similar to what would be the case when inviting members of the public to participate in a clinical research study, or to donate samples such as blood for experiments. As an example, sometimes researchers are asked for ethical approval by scientific journals when trying to publish the findings from their public involvement and engagement work, when in fact this is not needed. The ongoing uncertainty about the difference between actual research on one hand and public involvement and engagement on the other hand wastes precious time and resources, and is a barrier for scientists to working with the public. We have developed guidance for academic staff on when ethical approval is and is not required, using examples from our own experience. We wrote this article to bring awareness to this problem; share our views with the wider academic community; encourage discussion around the problem and possible solutions; and ultimately contribute to educating on when research ethics approval is needed, and when not.

Informing evidence-based policy during the COVID-19 pandemic and recovery period: learning from a national evidence centre.

BACKGROUND: The COVID-19 pandemic demonstrated the vital need for research to inform policy decision-making and save lives. The Wales COVID-19 Evidence Centre (WCEC) was established in March 2021 and funded for two years, to make evidence about the impact of the pandemic and ongoing research priorities for Wales available and actionable to policy decision-makers, service leads and the public. OBJECTIVES: We describe the approaches we developed and our experiences, challenges and future vision. PROGRAM IMPLEMENTATION: The centre operated with a core team, including a public partnership group, and six experienced research groups as collaborating partners. Our rapid evidence delivery process had five stages: 1. Stakeholder engagement (continued throughout all stages); 2. Research question prioritisation; 3. Bespoke rapid evidence review methodology in a phased approach; 4. Rapid primary research; and 5. Knowledge Mobilisation to ensure the evidence was available for decision-makers. MAIN ACHIEVEMENTS: Between March 2021-23 we engaged with 44 stakeholder groups, completed 35 Rapid Evidence Reviews, six Rapid Evidence Maps and 10 Rapid Evidence Summaries. We completed four primary research studies, with three published in peer reviewed journals, and seven ongoing. Our evidence informed policy decision-making and was cited in 19 Welsh Government papers. These included pandemic infection control measures, the Action Plan to tackle gender inequalities, and Education Renew and Reform policy. We conducted 24 Welsh Government evidence briefings and three public facing symposia. POLICY IMPLICATIONS: Strong engagement with stakeholder groups, a phased rapid evidence review approach, and primary research to address key gaps in current knowledge enabled high-quality efficient, evidence outputs to be delivered to help inform Welsh policy decision-making during the pandemic. We learn from these processes to continue to deliver evidence from March 2023 as the Health and Care Research Wales Evidence Centre, with a broader remit of health and social care, to help inform policy and practice decisions during the recovery phase and beyond.

Effectiveness and safety of asynchronous telemedicine consultations in general practice: a systematic review.

BACKGROUND: There is a focus on increasing asynchronous telemedicine use, which allows medical data to be transmitted, stored, and interpreted later; however, limited evidence of the quality of care it allows in general practice hinders its use. AIM: To investigate uses and effectiveness of asynchronous telemedicine in general practice, according to the domains of healthcare quality, and describe how the COVID-19 pandemic changed its use. DESIGN & SETTING: Systematic review in general practice. METHOD: A systematic search was carried out across four databases using terms related to general practice, asynchronous telemedicine, uses, and effectiveness, and supported by citation searching. This was followed by screening according to pre-defined criteria, data extraction, and critical appraisal. Narrative synthesis was then undertaken guided by the six domains of healthcare quality and exploring differences in use before and following the COVID-19 pandemic. RESULTS: Searches yielded 6864 reports; 27 reports from 23 studies were included. Asynchronous telemedicine is used by a range of staff and patients across many countries. Safety and equity are poorly reported but there were no major safety concerns. Evidence from other domains of healthcare quality show effectiveness in making diagnoses, prescribing medications, replacing other consultations, providing timely care, and increased convenience for patients. Efficiency is impacted by negative effects on workflow, through poor implementation and patient non-adherence, limiting usability and requiring new administrative approaches from healthcare staff. Asynchronous telemedicine use increased rapidly from March 2020, following the COVID-19 pandemic outbreak. CONCLUSION: Asynchronous telemedicine provides quality care for patients but is limited by reports of increased workload and inefficient workflow compared with face-to-face consultations. Limits of evidence include heterogeneity and small-scale studies. Further research into cost-effectiveness, equity, safety, and sustained implementation will influence future policy and practice.

Analysis of applying a patient safety taxonomy to patient and clinician-reported incident reports during the COVID-19 pandemic: a mixed methods study.

BACKGROUND: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. METHODS: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript. RESULTS: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose. CONCLUSIONS: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems.

Overcoming the disconnect between scientific research and the public.

In biomedical research, there is no situation where public engagement (PE) and public involvement (PI) are not possible, important or even expected. Whether we work in the clinic or in the laboratory, all researchers have a duty to reach out, demonstrate the added value that science brings to society, and make a real difference to the way research is done. Here we outline the benefits of PE and PI for individual researchers and their employers, for members of the public, and for society at large. We offer solutions to overcome major challenges, including a step-by-step guide for researchers to embrace PE and PI in their career, and make a call to action for a cultural shift towards embedding PE and PI in our modern academic environment.

Household Composition and Inequalities in COVID-19 Vaccination in Wales, UK.

The uptake of COVID-19 vaccination in Wales is high at a population level but many inequalities exist. Household composition may be an important factor in COVID-19 vaccination uptake due to the practical, social, and psychological implications associated with different living arrangements. In this study, the role of household composition in the uptake of COVID-19 vaccination in Wales was examined with the aim of identifying areas for intervention to address inequalities. Records within the Wales Immunisation System (WIS) COVID-19 vaccination register were linked to the Welsh Demographic Service Dataset (WDSD; a population register for Wales) held within the Secure Anonymised Information Linkage (SAIL) databank. Eight household types were defined based on household size, the presence or absence of children, and the presence of single or multiple generations. Uptake of the second dose of any COVID-19 vaccine was analysed using logistic regression. Gender, age group, health board, rural/urban residential classification, ethnic group, and deprivation quintile were included as covariates for multivariable regression. Compared to two-adult households, all other household types were associated with lower uptake. The most significantly reduced uptake was observed for large, multigenerational, adult group households (aOR 0.45, 95%CI 0.43-0.46). Comparing multivariable regression with and without incorporation of household composition as a variable produced significant differences in odds of vaccination for health board, age group, and ethnic group categories. These results indicate that household composition is an important factor for the uptake of COVID-19 vaccination and consideration of differences in household composition is necessary to mitigate vaccination inequalities.

Implementing shared decision-making in UK: Progress 2017-2022.

Shared decision making has been on the policy agenda in the UK for at least twelve years, but it lacked a comprehensive approach to delivery. That has changed over the past five years, and we can now see significant progress across all aspects of a comprehensive approach, including leadership at policy, professional and patient levels; infrastructure developments, including the provision of training, tools and campaigns; and practice improvements, such as demonstrations, measurement and coordination. All these initiatives were necessary, but the last, central coordination, would appear to be key to success.

A qualitative exploration of decisions about dental recall intervals - Part 1: attitudes of NHS general dental practitioners to NICE guideline CG19 on the interval between oral health reviews.

Introduction The National Institute for Health and Care Excellence (NICE) Guideline CG19 recommends that the intervals between oral health reviews should be tailored to patients' disease risk. However, evidence suggests that most patients still attend at six-monthly intervals.Aim To explore facilitators and barriers to the implementation of CG19 in general dental practice.Methods Semi-structured telephone interviews were conducted with 25 NHS general dental practitioners (GDPs) in Wales, UK. Transcripts were thematically analysed.Results Dentists described integrating information on clinical risk, patients' social and dental history, and professional judgement when making decisions about recall interval. Although most GDPs reported routinely using risk-based recall intervals, a number of barriers exist to recall intervals at the extremes of the NICE recommendations. Many practitioners were unwilling to extend recall intervals to 24 months, even for the lowest-risk patients. Conversely, dentists described how it could be challenging to secure the agreement of high-risk patients to three-month recalls. In addition, time and workload pressures, the need to meet contractual obligations, pressure from contracting organisations and the fear of litigation also influenced the implementation of risk-based recalls.Conclusions Although awareness of the NICE Guideline CG19 was high, there is a need to explore how risk-based recalls may be best supported through contractual mechanisms.

A qualitative exploration of decisions about dental recall intervals - part 2: perspectives of dentists and patients on the role of shared decision making in dental recall decisions.

Introduction Patients are sensitive to both the frequency and costs of dental recall visits. Shared decision making (SDM) is a principle of patient-centred care, advocated by the National Institute for Health and Care Excellence and policymakers, whereby joint decisions are made between clinicians and patients.Aims To explore NHS dentists' and patients' attitudes towards SDM in decisions about recall interval.Methods Semi-structured telephone interviews were conducted with 25 NHS patients and 25 NHS general dental practitioners in Wales, UK. Transcripts were thematically analysed.Results While many patients would be happy to accept changes to their recall interval, most wanted to be seen at least annually. Most patients were willing to be guided by their dentist in decisions about recall interval, as long as consideration was given to issues such as time, travel and cost. This contrasted with the desire to actively participate in decisions about operative treatment. Although the dentists' understanding of SDM varied, practitioners considered it important to involve patients in decisions about their care. However, dentists perceived that time, patient anxiety and concerns about potential adverse outcomes were barriers to the use of SDM.Conclusions Since there is uncertainty about the most clinically effective and cost-effective dental recall strategy, patient preference may play a role in these decisions.

Barriers and facilitators to shared decision-making in neonatal medicine: A systematic review and thematic synthesis of parental perceptions.

OBJECTIVES: Systematically review parental perceptions of shared decision-making (SDM) in neonatology, identifying barriers and facilitators to implementation. METHODS: Electronic database (Medline, PsycINFO, CINAHL and Scopus) and follow-up searches were conducted to identify qualitative studies. Data were extracted, thematically analysed and synthesised. RESULTS: Searches yielded 2445 papers, of which 25 were included. Thematic analysis identified six key themes. Key barriers included emotional crises experienced in the NICU setting, lack of medical information provided to parents to inform decision-making, inadequate communication of information, poor relationships with caregivers, lack of continuity in care, and perceived power imbalances between HCPs and parents. Key facilitators included clear, honest and compassionate communication of medical information, caring and empathetic caregivers, continuity in care, and tailored approaches that reflected parent's desired level of involvement. CONCLUSION: The highly specialised environment, and the emotional crises experienced by parents impact significantly on their perceived capacity to engage in surrogate decision-making. PRACTICE IMPLICATIONS: Complex and multi-factorial interventions that address the training needs of HCPs, and the emotional, informational and decision support needs of parents are needed. SDM skills training, improved information delivery, and integrated emotional and decisional support could help parents to become more involved in SDM for their infant.

Cohort profile: The UK COVID-19 Public Experiences (COPE) prospective longitudinal mixed-methods study of health and well-being during the SARSCoV2 coronavirus pandemic.

Public perceptions of pandemic viral threats and government policies can influence adherence to containment, delay, and mitigation policies such as physical distancing, hygienic practices, use of physical barriers, uptake of testing, contact tracing, and vaccination programs. The UK COVID-19 Public Experiences (COPE) study aims to identify determinants of health behaviour using the Capability, Opportunity, Motivation (COM-B) model using a longitudinal mixed-methods approach. Here, we provide a detailed description of the demographic and self-reported health characteristics of the COPE cohort at baseline assessment, an overview of data collected, and plans for follow-up of the cohort. The COPE baseline survey was completed by 11,113 UK adult residents (18+ years of age). Baseline data collection started on the 13th of March 2020 (10-days before the introduction of the first national COVID-19 lockdown in the UK) and finished on the 13th of April 2020. Participants were recruited via the HealthWise Wales (HWW) research registry and through social media snowballing and advertising (Facebook®, Twitter®, Instagram®). Participants were predominantly female (69%), over 50 years of age (68%), identified as white (98%), and were living with their partner (68%). A large proportion (67%) had a college/university level education, and half reported a pre-existing health condition (50%). Initial follow-up plans for the cohort included in-depth surveys at 3-months and 12-months after the first UK national lockdown to assess short and medium-term effects of the pandemic on health behaviour and subjective health and well-being. Additional consent will be sought from participants at follow-up for data linkage and surveys at 18 and 24-months after the initial UK national lockdown. A large non-random sample was recruited to the COPE cohort during the early stages of the COVID-19 pandemic, which will enable longitudinal analysis of the determinants of health behaviour and changes in subjective health and well-being over the course of the pandemic.

Managing lower urinary tract symptoms in primary care: qualitative study of GPs' and patients' experiences.

BACKGROUND: Lower urinary tract symptoms (LUTS) are common in males aged ≥40 years and have a considerable impact on quality of life. Management can be complex, and although most LUTS could be treated effectively in primary care, referrals to urology outpatients are increasing. AIM: To explore GPs' experiences of managing LUTS together with patients' experiences of and preferences for treatment in primary care. DESIGN AND SETTING: Telephone interviews were conducted with GPs and male patients presenting to primary care with bothersome LUTS. METHOD: Eleven GPs and 25 male patients were purposively sampled from 20 GP practices in three UK regions: Newcastle upon Tyne, Bristol, and South Wales. Interviews were conducted between May 2018 and January 2019, and were analysed using a framework approach. RESULTS: Difficulty establishing causes and differentiating between prostate and bladder symptoms were key challenges to the diagnosis of LUTS in primary care, often making treatment a process of trial and error. Pharmacological treatments were commonly ineffective and often caused side effects. Despite this, patients were generally satisfied with GP consultations and expressed a preference for treatment in primary care. CONCLUSION: Managing LUTS in primary care is a more accessible option for patients. Given the challenges of LUTS diagnosis, an effective diagnostic tool for use by GPs would be beneficial. Ensuring bothersome LUTS are not dismissed as a normal part of ageing is essential in improving patients' quality of life. Greater exploration of the role of non-pharmacological treatments is needed.

Conducting invasive urodynamics in primary care: qualitative interview study examining experiences of patients and healthcare professionals.

BACKGROUND: Invasive urodynamics is used to investigate the causes of lower urinary tract symptoms; a procedure usually conducted in secondary care by specialist practitioners. No study has yet investigated the feasibility of carrying out this procedure in a non-specialist setting. Therefore, the aim of this study was to explore, using qualitative methodology, the feasibility and acceptability of conducting invasive urodynamic testing in primary care. METHODS: Semi-structured interviews were conducted during the pilot phase of the PriMUS study, in which men experiencing bothersome lower urinary tract symptoms underwent invasive urodynamic testing along with a series of simple index tests in a primary care setting. Interviewees were 25 patients invited to take part in the PriMUS study and 18 healthcare professionals involved in study delivery. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach. RESULTS: Patients generally found the urodynamic procedure acceptable and valued the primary care setting due to its increased accessibility and familiarity. Despite some logistical issues, facilitating invasive urodynamic testing in primary care was also a positive experience for urodynamic nurses. Initial issues with general practitioners receiving and utilising the results of urodynamic testing may have limited the potential benefit to some patients. Effective approaches to study recruitment included emphasising the benefits of the urodynamic test and maintaining contact with potential participants by telephone. Patients' relationship with their general practitioner was an important influence on study participation. CONCLUSIONS: Conducting invasive urodynamics in primary care is feasible and acceptable and has the potential to benefit patients. Facilitating study procedures in a familiar primary care setting can impact positively on research recruitment. However, it is vital that there is a support network for urodynamic nurses and expertise available to help interpret urodynamic results.

What Works in Implementing Patient Decision Aids in Routine Clinical Settings? A Rapid Realist Review and Update from the International Patient Decision Aid Standards Collaboration.

BACKGROUND: Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting. AIM: This review was conducted in response to the IPDAS Collaboration's evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings. METHODS: Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research. RESULTS: We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve. CONCLUSIONS: We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

PRImary care Management of lower Urinary tract Symptoms in men: protocol for development and validation of a diagnostic and clinical decision support tool (the PriMUS study).

INTRODUCTION: Lower urinary tract symptoms (LUTS) is a bothersome condition affecting older men which can lead to poor quality of life. General practitioners (GPs) currently have no easily available assessment tools to help effectively diagnose causes of LUTS and aid discussion of treatment with patients. Men are frequently referred to urology specialists who often recommend treatments that could have been initiated in primary care. GP access to simple, accurate tests and clinician decision tools are needed to facilitate accurate and effective patient management of LUTS in primary care. METHODS AND ANALYSIS: PRImary care Management of lower Urinary tract Symptoms (PriMUS) is a prospective diagnostic accuracy study based in primary care. The study will determine which of a number of index tests used in combination best predict three urodynamic observations in men who present to their GP with LUTS. These are detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity. Two cohorts of participants, one for development of the prototype diagnostic tool and other for validation, will undergo a series of simple index tests and the invasive reference standard (invasive urodynamics). We will develop and validate three diagnostic prediction models based on each condition and then combine them with management recommendations to form a clinical decision support tool. ETHICS AND DISSEMINATION: Ethics approval is from the Wales Research Ethics Committee 6. Findings will be disseminated through peer-reviewed journals and conferences, and results will be of interest to professional and patient stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN10327305.

Public involvement and engagement in primary and emergency care research: the story from PRIME Centre Wales.

BACKGROUND: Policy throughout the United Kingdom promotes involvement of patients and public members in research to benefit patient care and health outcomes. PRIME Centre Wales is a national research centre, developing and coordinating research about primary and emergency care which forms 90% of health service encounters. In this paper, we describe our approach to public involvement and engagement in PRIME Centre Wales (hereafter called PRIME), in particular: how this approach has developed; ways in which public members contribute to PRIME activity; the strengths and limitations of our approach, challenges and future opportunities. PRIME ensures work is relevant to service users, carers, the public and policy makers by incorporating comprehensive patient and public involvement in every phase of our work. APPROACH: PRIME has policies and processes to enable and promote successful public involvement and engagement across research activities. This ensures public perspectives and patient experiences are integrated throughout research development, implementation and dissemination and in managing and delivering PRIME strategy over a 10 year timescale. A public/patient group called SUPER is a key resource providing wide-ranging perspectives via email and face-to-face discussion. We collect information on processes and experiences to assess value and impact, to guide ongoing involvement and engagement. A funded post provides leadership and support to staff and to public/patient contributors to facilitate collaborations. DISCUSSION: A stable, well-resourced structure has provided the timescales to build strong relationships and embed diverse approaches to public involvement and engagement within PRIME. Researchers and public contributors have committed to collaborations, developed knowledge and skills and sustained relationships. Effective approaches incorporate values and actions which, when operating together, strengthen processes and outcomes of public involvement and engagement. CONCLUSION: Supportive context, motivation and time are necessary to foster values and practices that enable effective public involvement and engagement. PRIME has embedded public involvement and engagement across research activities and structures. Central is the public/patient group SUPER offering experience-based expertise to add value to the research cycle. This innovative model, aligned with best practice, enhances relevance and quality of primary and emergency care research to benefit patients and the general population.

"I'd Like to Have More of a Say Because It's My Body": Adolescents' Perceptions Around Barriers and Facilitators to Shared Decision-Making.

PURPOSE: Adolescents living with long-term conditions (LTCs) often feel as though they are left out of discussions and decisions with healthcare professionals, which can give them the impression that their views are not important. Research around decision-making during clinical encounters often fails to represent adolescents' perspectives. This study explores adolescents' perceptions and experiences, focusing on identifying the perceived barriers to, and facilitators for, their involvement in shared decision-making (SDM). METHODS: Nineteen adolescents (aged 13-19 years) with LTCs were recruited from endocrinology, rheumatology, neurology, and nephrology clinics. Participatory qualitative interviews were conducted using life grids and pie charts, and transcripts were analyzed thematically. RESULTS: Four overarching themes and nine sub-themes were identified which describe barriers and facilitators around SDM. Adolescents need to feel, as though their involvement is supported by parents and healthcare professionals, that their contribution to the decision-making process is important and will yield a positive outcome. Adolescents often feel it is their right to be involved in decisions that affect them but also feel as though the adults' contributions to the decisions are considered more valuable. Adolescents need to feel capable of being involved, in terms of being able to understand and process information about the available options and ask appropriate questions. CONCLUSIONS: This work highlights a number of ways SDM can be facilitated between healthcare practitioners and adolescents with LTCs. Identifying the needs of adolescents with LTCs is necessary for optimizing the SDM process and to support them during healthcare consultations.

Ability of observer and self-report measures to capture shared decision-making in clinical practice in the UK: a mixed-methods study.

OBJECTIVES: To examine how observer and self-report measures of shared decision-making (SDM) evaluate the decision-making activities that patients and clinicians undertake in routine consultations. DESIGN: Multi-method study using observational and self-reported measures of SDM and qualitative analysis. SETTING: Breast care and predialysis teams who had already implemented SDM. PARTICIPANTS: Breast care consultants, clinical nurse specialists and patients who were making decisions about treatment for early-stage breast cancer. Predialysis clinical nurse specialists and patients who needed to make dialysis treatment decisions. METHODS: Consultations were audio recorded, transcribed and thematically analysed. SDM was measured using Observer OPTION-5 and a dyadic SureScore self-reported measure. RESULTS: Twenty-two breast and 21 renal consultations were analysed. SureScore indicated that clinicians and patients felt SDM was occurring, but scores showed ceiling effects for most participants, making differentiation difficult. There was mismatch between SureScore and OPTION-5 score data, the latter showing that each consultation lacked at least some elements of SDM. Highest scoring items using OPTION-5 were 'incorporating patient preferences into decisions' for the breast team (mean 18.5, range 12.5-20, SD 2.39) and 'eliciting patient preferences to options' for the renal team (mean 16.15, range 10-20, SD 3.48). Thematic analysis identified that the SDM encounter is difficult to measure because decision-making is often distributed across encounters and time, with multiple people, it is contextually adapted and can involve multiple decisions. CONCLUSIONS: Self-reported measures can broadly indicate satisfaction with SDM, but do not tell us about the quality of the interaction and are unlikely to capture the multi-staged nature of the SDM process. Observational measures provide an indication of the extent to which elements of SDM are present in the observed consultation, but cannot explain why some elements might not be present or scored lower. Findings are important when considering measuring SDM in practice.

A descriptive model of shared decision making derived from routine implementation in clinical practice ('Implement-SDM'): Qualitative study.

OBJECTIVE: Research is needed to understand how Shared Decision-Making (SDM) is enacted in routine clinical settings. We aimed to 1) describe the process of SDM between clinicians and patients; 2) examine how well the SDM process compares to a prescriptive model of SDM, and 3) propose a descriptive model based on observed SDM in routine practice. METHODS: Patients with chronic kidney disease and early stage breast cancer were recruited consecutively via Cardiff and Vale University Health Board (UK) teams. Consultations were audio-recorded, transcribed and thematically analysed. RESULTS: Seventy-six consultations were observed: 26 pre-dialysis consultations and two consultations each for 25 breast cancer patients. Key stages of the 'Three Talk Model' were observed. However, we also observed more elements and greater complexity: a distinct preparation phase; tailored and evolving integrative option conversation; patients and clinicians developing 'informed preferences'; distributed and multi-stage decisions; and a more open-ended planning discussion. Use of decision aids was limited. CONCLUSION: A more complex picture was observed compared with previous portrayals in current theoretical models. PRACTICE IIMPLICATIONS: The model can provide a basis for future training and initiatives to promote SDM, and tackle the gap between what is advocated in policy, but rarely achieved in practice.