Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study.

BACKGROUND: It is crucial to include a wide range of the population in clinical trials for the outcome to be applicable in real-world settings. Existing literature indicates that under-served groups, including disabled people, have been excluded from participating in clinical trials without justification. Exclusion from clinical trials exacerbates disparities in healthcare and diminishes the benefits for excluded populations. Therefore, this study was conducted to investigate potential obstacles that prevent disabled people from participating in clinical trials in the United Kingdom (UK). METHODS: The study was carried out through an explanatory sequential mixed methods design. The Imperial Clinical Trials Unit devised and implemented an online questionnaire-based survey (with open/closed-ended questions) and an online focus group discussion. The target population were disabled people, family members/carers of disabled people and staff involved in clinical trials, whereupon the sample was recruited by convenience sampling methods via posters and emails through various networks. The Qualtrics XM survey system was used as the host platform for the online survey, and Microsoft Teams was used for an online focus group discussion. The focus group discussion was conducted to gain a deeper understanding of the themes identified from the survey responses. We analysed responses to the survey via descriptive analysis and used thematic analysis to synthesise the free-text answers from the survey and focus group discussion. RESULTS: We received 45 responses to the survey questionnaire and 5 disabled people took part in a focus group discussion. Our findings highlighted the differences between the perspectives of researchers and those "being researched" and different types of barriers experienced by disabled people: opportunity barriers (inadequate recruitment strategy and ambiguous eligibility criteria), awareness barriers (perception of disability) and acceptance/refusal barriers (available support and adjustment, and sharing of trial results). CONCLUSION: Our findings support perspectives drawn from the Ford Framework regarding the need to consider all barriers, not just up to the point of enrolment into trials but also beyond the point of inclusion in clinical trials. We support calls for the introduction of legislation on including disabled people in clinical trials, implementation of industry/community-wide participatory approaches and the development of guidelines, a combined public-private approach.

'Building bridges': reflections and recommendations for co-producing health research.

BACKGROUND: Co-produced research is when all stakeholders, including experts by experience and researchers, work together to conceptualise, design, deliver and disseminate research to enhance understanding and knowledge. This type of participatory inquiry is being increasingly used across health research; however, it continues to be a complex area to navigate given existing institutional structures. MAIN BODY: We collaborated across three independent co-produced research studies to share insights, reflections, and knowledge of our work in the fields of HIV, mental health, and disability research. We co-designed and delivered a three-hour online workshop at a conference to share these reflections using the metaphor of 'building bridges' to describe our co-production journey. We generated key principles of co-production from our different experiences working in each individual research project as well as together across the three projects. Our principles are to: (1) be kind, have fun and learn from each other; (2) share power (as much as you can with people); (3) connect with people you know and don't know; (4) remain connected; and (5) use clear and simple language. CONCLUSION: We recommend that co-produced research needs additional funding, resource, and flexibility to remain impactful and ethical. Co-produced research teams need to be mindful of traditional power structures and ensure that the process is transparent, fair, and ethical. Addressing equality, diversity, and inclusion of traditionally underrepresented groups in research is essential as are the skills, expertise, and experiences of all members of the co-production team.

Co-produced research occurs when a range of people, including researchers and people with lived experience of a topic work together on all stages of a piece of research, from design to publication, to improve understanding of a topic. This methodology has become increasingly popular in the field of health research, however ­ it can be difficult to undertake because of how health institutions are structured. As a team, we examined three co-produced studies (focusing on HIV, mental health, and disability research) to share our insights and reflections. We then shared these reflections through a co-designed online workshop at a conference. We used the metaphor of 'building bridges' to describe our teamwork. From our experiences on these studies, we came up with five key suggestions for co-production in research: (1) be kind, have fun and learn from each other; (2) share power as much as possible with everyone; (3) connect with people you know and those you don't; (4) stay connected; (5) use clear and simple language. To achieve ethical and impactful co-produced research, we suggest that it needs more funding, resources, and flexibility. Teams who are conducting co-produced research must be fair and clear about how they do so, and ensure that everyone, especially groups who are often unheard, get a chance to be part of research so that everyone's skills and experiences are equally considered.

"I'd rather wait and see what's around the corner": A multi-perspective qualitative study of treatment escalation planning in frailty.

INTRODUCTION: People living with frailty risk adverse outcomes following even minor illnesses. Admission to hospital or the intensive care unit is associated with potentially burdensome interventions and poor outcomes. Decision-making during an emergency is fraught with complexity and potential for conflict between patients, carers and clinicians. Advance care planning is a process of shared decision-making which aims to ensure patients are treated in line with their wishes. However, planning for future care is challenging and those living with frailty are rarely given the opportunity to discuss their preferences. The aim of the ProsPECT (Prospective Planning for Escalation of Care and Treatment) study was to explore perspectives on planning for treatment escalation in the context of frailty. We spoke to people living with frailty, their carers and clinicians across primary and secondary care. METHODS: In-depth online or telephone interviews and online focus groups. The topic guide explored frailty, acute decision-making and planning for the future. Data were thematically analysed using the Framework Method. Preliminary findings were presented to a sample of study participants for feedback in two online workshops. RESULTS: We spoke to 44 participants (9 patients, 11 carers and 24 clinicians). Four main themes were identified: frailty is absent from treatment escalation discussions, planning for an uncertain future, escalation in an acute crisis is 'the path of least resistance', and approaches to facilitating treatment escalation planning in frailty. CONCLUSION: Barriers to treatment escalation planning include a lack of shared understanding of frailty and uncertainty about the future. Emergency decision-making is focussed on survival or risk aversion and patient preferences are rarely considered. To improve planning discussions, we recommend frailty training for non-specialist clinicians, multi-disciplinary support, collaborative working between patients, carers and clinicians as well as broader public engagement.

Personalising clinical pathways in a London breast cancer service.

Using interview and observational data from a busy and research-intensive breast cancer service in the United Kingdom, we discuss recent developments in personalised medicine. Specifically, we show how clinical and research practices meet in clinical pathways that are reconfigured in response to changing approaches of diagnosing, monitoring, treating and understanding cancers. Clinical pathways are increasingly sensitive to changes in evidence deduced through new technologies and therapies as well as decisions based on intensive, iterative analysis of data collected across a range of platforms. We contribute to existing research by showing how the organisation of clinical pathways both maintains established clinical practices and responds to new research evidence, managing a threshold between evidence-based and experimental medicine. Finally, we invite comparisons with other forms of personalisation to understand how they depend on the 'real time' collection, analysis and application of data.

A qualitative exploration of participant and investigator perspectives from the TRED-HF trial.

AIMS: We explored the experiences and motivations of participants and staff who took part in the TRED-HF trial (Therapy withdrawal in REcovered Dilated cardiomyopathy). METHODS AND RESULTS: We conducted a qualitative study, using semi-structured interviews, with participants (n = 12) and the research team (n = 4) from the TRED-HF trial. Interviews were carried out in 2019 and were audio-recorded and transcribed. Data were managed using NVivo and analysed using framework analysis. A patient representative provided guidance on the interpretation of findings and presentation of themes to ensure these remained meaningful, and an accurate representation, to those living with dilated cardiomyopathy. Three key themes emerged from the data: (i) perception of health; (ii) experiences and relationships with healthcare services and researchers; and (iii) perception of risk. Study participants held differing perceptions of their health; some did not consider themselves to have a heart condition or disagreed with the medical term 'heart failure'. Relationships between participants, research staff, and clinical management teams influenced participants' experiences and decision making during the trial, including following clinical advice. There were differences in participants' perceptions of risk and their decisions to take heart failure medication after the trial was completed. Although the original TRED-HF trial did not provide the results many had hoped for, a strong motivator for taking part was the opportunity to withdraw medication in a safely monitored environment which had been previously considered by some participants before. Investigators acknowledged that the insights gained from the study can now be used to support evidence-based conversations with patients. CONCLUSIONS: For people whose dilated cardiomyopathy is in remission, decisions to continue, reduce, or stop their medication are influenced by perceptions of personal health, perceive risk and the important of work, employment, recreation, relationships, and long-term plans. The unique relationship between patient and cardiologist provides opportunities to promote honest discussion about adherence to medication and personalized long-term management.

Experience of primary care for people with HIV: a mixed-method analysis.

BACKGROUND: Advances in treatment have transformed HIV into a long-term condition (LTC), presenting fresh challenges for health services, HIV specialists, and GPs. AIM: To explore the experience of people living with HIV (PLHIV) regarding consulting their GPs. DESIGN & SETTING: A mixed-method analysis using data from two sources: a nationally-representative survey of PLHIV and a qualitative study with London-based PLHIV. METHOD: Univariate logistic regression was used for quantitative data and framework analysis for qualitative data. RESULTS: The survey had 4422 participants; the qualitative study included 52 participants. In both studies, registration with a GP and HIV status disclosure were high. Similar to general population trends, recent GP use was associated with poor self-rated health status, comorbidities, older age, and lower socioeconomic status. Two-thirds reported a good experience with GPs; a lower proportion felt comfortable asking HIV-related questions. Actual or perceived HIV stigma were consistently associated with poor satisfaction. In the interviews, participants with additional LTCs valued sensitive and consistent support from GPs. Some anticipated, and sometimes experienced, problems relating to HIV status, as well as GPs' limited experience and time to manage their complex needs. Sometimes they took their own initiative to facilitate coordination and communication. For PLHIV, a 'good' GP offered continuity and took time to know and accept them without judgment. CONCLUSION: The authors suggest clarification of roles and provision of relevant support to build the confidence of PLHIV in GPs and primary care staff to care for them. As the PLHIV population ages, there is a strong need to develop trusting patient-GP relationships and HIV-friendly GP practices.

From activism to secrecy: Contemporary experiences of living with HIV in London in people diagnosed from 1986 to 2014.

BACKGROUND: Successes in biomedicine have transformed HIV from a debilitating and frequently fatal infection to a chronic, manageable condition. OBJECTIVE: To explore how the contemporary metanarrative of HIV as a chronic condition is understood by patients and how it varies depending on when they were diagnosed. DESIGN: Qualitative interviews with 52 people living with HIV who were diagnosed during different phases in the history of the epidemic. SETTING AND PARTICIPANTS: Participants were recruited from two HIV clinics in London to include four "HIV generations": generation 1 were those who had been diagnosed pre-1997 (pre-ART), generation 2 from 1997 to 2005 (complex ART), generation 3 from 2006 to 2012 (simpler ART) and generation 4 diagnosed in the year before the study (2013-2014). RESULTS: Participants in all HIV generations took their medication as prescribed, attended clinic appointments and were well informed about their immunological biomarkers. While the pre-treatment generation had been engaged in community endeavours such as activism, public education and use of support groups, those more recently diagnosed had little experience of collective activities and their HIV was essentially a private matter, separate from their social identity. These strategies worked for some; however, those experiencing clinical or social problems related to HIV or wider issues often relied exclusively on their HIV clinic for wider support. CONCLUSION: The loss of public conversation around HIV, the imperative for patients to take on greater individual responsibility for HIV management and the streamlining of HIV services alongside reductions in ancillary support services may expose some people to suboptimal health outcomes.

Patient perspectives on the HIV continuum of care in London: a qualitative study of people diagnosed between 1986 and 2014.

OBJECTIVES: To describe the experiences of the HIV treatment cascade of diagnosis, engagement with care and initiation of treatment from the perspective of patients; we explored whether this differed according to the year of their diagnosis, for example, whether they had experienced HIV care in the pretreatment era. DESIGN: Qualitative interview study with framework analysis. SETTING: Two large HIV adult outpatient clinics in central London. PARTICIPANTS: 52 HIV-positive individuals, 41 men, 11 women, purposively sampled to include people who had been diagnosed at different stages in the history of the epidemic classified as four 'generations': pre-1996 (preantiretroviral therapy (ART)), 1997-2005 (complex ARTs), 2006-2012 (simpler ARTs) and 2013 onwards (recent diagnoses). RESULTS: Some important differences were identified; for earlier generations, the visible illness and deaths from AIDS made it harder to engage with care following diagnosis. Subsequent decisions about starting treatment were deeply influenced by the fear of severe side effects from early ART. However, despite improvements in ART and life expectancy over the epidemic, we found a striking similarity across participants' accounts of the key stages of the care continuum, regardless of when they were diagnosed. Diagnosis was a major traumatic life event for almost everyone. Fear of testing positive or having low self-perceived risk affected the timing of testing and diagnosis. Engaging with care was facilitated by a flexible approach from services/clinicians. Initiating treatment was a major life decision. CONCLUSION: We found patients' experiences are influenced by when they were diagnosed, with earliest cohorts facing substantial challenges. However, being diagnosed with HIV and starting treatment continue to be significant life-altering events even in the era of effective, simple treatments. Despite the advances of biomedical treatment, services should continue to recognise the needs of patients for whom the diagnosis and treatment remain significant challenges.

Nurse handover: patient and staff experiences.

AIM AND OBJECTIVES: to understand the purpose, impact and experience of nurse handover from patient and staff perspectives. BACKGROUND: poor communication is increasingly recognised as a major factor in healthcare errors. Handover is a key risk point. Little consensus exists regarding the practice in nursing but the trend is towards bedside handover. Research on patient and staff experiences of handover is limited. DESIGN: a qualitative and observational study on two acute wards in a large urban hospital in the UK. METHODS: interviews conducted with patients and staff and observation of handovers, ward rounds and patient-staff interactions. RESULTS: diverse forms of nurse handover were found, used in combination: office based (whole nursing team), nurse in charge (NIC) to NIC, and bedside. Patients' and nurses' views concurred on the purpose of bedside handover--transference of information about the patient between two nurses--and about the medical ward round, which was seen as a discussion with the patient. Views diverged regarding the purpose and value of office handover. Bedside handover differed in style, content, and place of delivery, often driven by concerns regarding confidentiality and talking over patients, and there were varied views on the benefits of patient involvement in bedside handover. Nurses worked beyond their shift end to complete handover. Communication problems within the clinical team were identified by staff and patients. CONCLUSIONS: while it is important to agree the purpose of handover and develop appropriate structure, content and style, it need not be a uniform process in all clinical areas. Nurse training to deliver bedside handover and patient information on the purpose of handover and the patient's role would be beneficial.

"In reality, it is complex and difficult": UK nurses' perspectives on "treatment as prevention" within HIV care.

Globally, clinical guidelines for HIV treatment are being altered to reflect new research showing that successful treatment with antiretroviral therapies (ART) can prevent the onward transmission of HIV. As a result, health care services are being challenged to find ways to roll out "treatment as prevention" (TasP) as a public health measure. In theory, TasP requires individuals to start ART as soon as they are diagnosed - for public health reasons - which may be some time before ART for that individual is required for clinical reasons. There is currently little research on the acceptability of TasP from a patient or provider perspective. This paper reports findings from a qualitative study that sought to explore UK nurses' views and experiences of TasP in HIV care. Ten HIV specialist nurses, purposively selected from across the country, were interviewed. Results suggest that, although positive about TasP in principle, nurses hold several reservations about its implementation in practice. Perceived benefits of TasP include reassurance for patients that their loved ones are protected and that immediate care is available. Concerns include the possibility of sexual dis-inhibition or coercion within sexual relationships. In the UK context, decisions around TasP are still being made on a highly individualised patient by patient basis, within a philosophy of holistic care and partnership working. As such, the research participants called for more resources to support information giving, risk assessment and decision-making. The results show that translating a public health treatment approach into individual patient care is complex, potentially time-consuming and may alter traditional provider-patient dynamics. The findings from this study suggest that in-depth research is needed to understand better the patient, community and provider experience as TasP becomes more widely rolled out.

Support for practitioners switching work environments mid-career.

Patterns of healthcare demand are changing, so services are increasingly being located in communities. Nurses and nurse managers must. therefore, prepare themselves for mid-career transitions into new roles or working environments. This article explains how these transitions can best be made and offers some tips for nurses and nurse managers who are about to make them, or who want to help colleagues make them, successfully.