Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts.

BACKGROUND/AIMS: The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University's Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration. METHODS: We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper. RESULTS: Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies. CONCLUSIONS: Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit's experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

Watch Me Play!: protocol for a feasibility study of a remotely delivered intervention to promote mental health resilience for children (ages 0-8) across UK early years and children's services.

BACKGROUND: Half of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement and attention to the child to promote social-emotional well-being and thereby mental health resilience. Originally developed in the context of a local authority mental health service for children in care, it is now also delivered online as a low intensity, scalable, preventative intervention. Although WMP shows promise and is already used in some services, we do not yet know whether it is effective. METHODS: A non-randomised single group feasibility study with embedded process evaluation. We propose to recruit up to 40 parents/carers of children aged 0-8 years who have been referred to early years and children's services in the UK. WMP involves a parent watching the child play and talking to their child about their play (or for babies, observing and following signals) for up to 20 min per session. Some sessions are facilitated by a trained practitioner who provides prompts where necessary, gives feedback, and discusses the child's play with the caregiver. Services will offer five facilitated sessions, and parents will be asked to do at least 10 additional sessions on their own with their child in a 5-week period. Feasibility outcomes examined are as follows: (i) recruitment, (ii) retention, (iii) adherence, (iv) fidelity of delivery, (v) barriers and facilitators of participation, (vi) intervention acceptability, (vii) description of usual care, and (viii) data collection procedures. Intervention mechanisms will be examined through qualitative interview data. Economic evaluation will be conducted estimating cost of the intervention and cost of service use for child and parents/carers quality-adjusted life years. DISCUSSION: This study will address feasibility questions associated with progression to a future randomised trial of WMP. TRIAL REGISTRATION: ISRCTN13644899 . Registered on 14th April 2023.

Developing a model for decision-making around antibiotic prescribing for patients with COVID-19 pneumonia in acute NHS hospitals during the first wave of the COVID-19 pandemic: qualitative results from the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients (PEACH Study).

OBJECTIVE: To explore and model factors affecting antibiotic prescribing decision-making early in the pandemic. DESIGN: Semistructured qualitative interview study. SETTING: National Health Service (NHS) trusts/health boards in England and Wales. PARTICIPANTS: Clinicians from NHS trusts/health boards in England and Wales. METHOD: Individual semistructured interviews were conducted with clinicians in six NHS trusts/health boards in England and Wales as part of the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients study, a wider study that included statistical analysis of procalcitonin (PCT) use in hospitals during the first wave of the pandemic. Thematic analysis was used to identify key factors influencing antibiotic prescribing decisions for patients with COVID-19 pneumonia during the first wave of the pandemic (March to May 2020), including how much influence PCT test results had on these decisions. RESULTS: During the first wave of the pandemic, recommendations to prescribe antibiotics for patients with COVID-19 pneumonia were based on concerns about secondary bacterial infections. However, as clinicians gained more experience with COVID-19, they reported increasing confidence in their ability to distinguish between symptoms and signs caused by SARS-CoV-2 viral infection alone, and secondary bacterial infections. Antibiotic prescribing decisions were influenced by factors such as clinician experience, confidence, senior support, situational factors and organisational influences. A decision-making model was developed. CONCLUSION: This study provides insight into the decision-making process around antibiotic prescribing for patients with COVID-19 pneumonia during the first wave of the pandemic. The importance of clinician experience and of senior review of decisions as factors in optimising antibiotic stewardship is highlighted. In addition, situational and organisational factors were identified that could be optimised. The model presented in the study can be used as a tool to aid understanding of the complexity of the decision-making process around antibiotic prescribing and planning antimicrobial stewardship support in the context of a pandemic. TRIAL REGISTRATION NUMBER: ISRCTN66682918.

Acceptability and feasibility of a planned preconception weight loss intervention in women with long-acting reversible contraception: the Plan-it mixed-methods study.

BACKGROUND: Women with overweight (a body mass index of ≥ 25 kg/m2) or obesity (a body mass index of ≥ 30 kg/m2) are at greater risk of experiencing complications during pregnancy and labour than women with a healthy weight. Women who remove their long-acting reversible contraception (i.e. coils or implants) are one of the few groups of people who contact services as part of their preparation for conception, creating an opportunity to offer a weight loss intervention. OBJECTIVES: The objectives were to understand if routine NHS data captured the pathway from long-acting reversible contraception removal to pregnancy and included body mass index; to identify the suitable components of a preconception weight loss intervention; and to engage with key stakeholders to determine the acceptability and feasibility of asking women with overweight/obesity to delay the removal of their long-acting reversible contraception in order to take part in a preconception weight loss intervention. DESIGN: This was a preparatory mixed-methods study, assessing the acceptability and feasibility of a potential intervention, using routine NHS data and purposefully collected qualitative data. PARTICIPANTS: The NHS routine data included all women with a long-acting reversible contraception code. There were three groups of participants in the surveys and interviews: health-care practitioners who remove long-acting reversible contraception; weight management consultants; and women of reproductive age with experience of overweight/obesity and of using long-acting reversible contraception. SETTING: UK-based health-care practitioners recruited at professional meetings; and weight management consultants and contraceptive users recruited via social media. DATA SOURCES: Anonymised routine data from UK sexual health clinics and the Clinical Practice Research Datalink, including the Pregnancy Register; and online surveys and qualitative interviews with stakeholders. RESULTS: The records of 2,632,871 women aged 16-48 years showed that 318,040 had at least one long-acting reversible contraception event, with 62% of records including a body mass index. Given the identified limitations of the routine NHS data sets, it would not be feasible to reliably identify women with overweight/obesity who request a long-acting reversible contraception removal with an intention to become pregnant. Online surveys were completed by 100 health-care practitioners, four weight management consultants and 243 contraceptive users. Ten health-care practitioners and 20 long-acting reversible contraception users completed qualitative interviews. A realist-informed approach generated a hypothesised programme theory. The combination of weight discussions and the delay of long-acting reversible contraception removal was unacceptable as an intervention to contraceptive users for ethical and practical reasons. However, a preconception health intervention incorporating weight loss could be acceptable, and one potential programme is outlined. LIMITATIONS: There was very limited engagement with weight management consultants, and the sample of participating stakeholders may not be representative. CONCLUSIONS: An intervention that asks women to delay long-acting reversible contraception removal to participate in a preconception weight loss intervention would be neither feasible nor acceptable. A preconception health programme, including weight management, would be welcomed but requires risk communication training of health-care practitioners. FUTURE WORK: Work to improve routine data sets, increase awareness of the importance of preconception health and overcome health-care practitioner barriers to discussing weight as part of preconception care is a priority. TRIAL REGISTRATION: This trial is registered as ISRCTN14733020. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 1.

If a woman has overweight or obesity when she is pregnant, then there is a greater risk of health problems for her and her baby. About half of women of childbearing age have overweight or obesity, so we need to find ways of supporting women to lose weight before they become pregnant (described here as 'preconception'). This can be difficult because women do not usually talk to a health-care practitioner (e.g. general practitioners, sexual health doctors, nurses) about becoming pregnant, but one group of women who do are those who need to have a long-acting reversible contraceptive (e.g. a coil or an implant) removed. This study was designed as preparatory work for a potential future study of a preconception weight loss intervention. We wanted to answer three questions: (1) would women with experience of overweight and of using a long-acting reversible contraceptive think that it would be acceptable to ask women to delay having their long-acting reversible contraceptive removed to take part in a weight loss intervention before pregnancy; (2) what did health-care practitioners think about that idea, and would they be happy to ask women to take part; and (3) can NHS information (routine data) tell us how many women might potentially take part in such an intervention? We looked at NHS routine data and the research on preconception weight loss interventions. A total of 100 health-care practitioners and 243 users of long-acting reversible contraceptives completed surveys, and 10 health-care practitioners and 20 users of long-acting reversible contraceptives took part in interviews. We found that routine data could not be used to identify people reliably. Designing a weight loss intervention that needed women to delay the removal of a long-acting reversible contraceptive was not acceptable to women. A population-based preconception weight loss intervention with a positive focus was acceptable, but, for such a programme to be delivered by the NHS, health-care practitioners need more knowledge, skills and confidence in talking about weight with patients.

The acceptability of asking women to delay removal of a long-acting reversible contraceptive to take part in a preconception weight loss programme: a mixed methods study using qualitative and routine data (Plan-it).

BACKGROUND: Having a body mass index (BMI) which is classified as overweight (BMI ≥ 25) or obese (BMI ≥ 30) increases the risk of complications during pregnancy and labour. Weight-management interventions which target excess gestational weight gain during pregnancy have had limited success. Women who use long-acting reversible contraception (LARC) are in contact with services as part of their preparation for conception, creating a potential opportunity to offer a preconception weight-loss intervention. The aims of this mixed methods study were to assess the acceptability and practicability of a weight-loss intervention which asked people to delay LARC removal in order to lose weight before conceiving. METHODS: Routine UK NHS data were analysed to identify pathways from LARC removal to pregnancy. Qualitative surveys and advisory group discussions with service providers and LARC users with experience of being overweight were conducted and analysed thematically. RESULTS: Three hundred fifteen thousand seven hundred fifty-five UK women aged 16-48 years between 2009-2018 had at least one LARC-related event (e.g. insertion, removal) and 1.7% of those events were recorded as related to planning a pregnancy. BMI was included in 62% of women's records, with 54% of those BMI being classified as overweight or obese. Online surveys were completed by 100 healthcare practitioners and 243 LARC users. Stakeholders identified facilitators and barriers associated with the proposed intervention including sensitivities of discussing weight, service-user past experiences, practitioner skills, the setting and ethical implications of the proposed intervention. CONCLUSIONS: Although women and service providers recognised potential benefits, a preconception weight-loss intervention asking people to delay LARC removal posed many barriers, due mainly to the acceptability of such an intervention to women and healthcare practitioners. Weight-loss interventions that target the general population, together with a focus on improving public knowledge of preconception health, may be more acceptable than interventions which solely focus on LARC users. Many of the barriers identified, including communication, understanding and beliefs about weight and risk, appointment systems and the limitations of routine datasets also have relevance for any preconception weight-loss intervention. Work to improve routine datasets and reducing communication barriers to discussing weight are priorities. TRIAL REGISTRATION: ISRCTN14733020 registered 10.05.2019.

Inequalities in older LGBT people's health and care needs in the United Kingdom: a systematic scoping review.

The hostile environment that older lesbian, gay, bisexual and transgender (LGBT) people faced at younger ages in the United Kingdom (UK) may have a lasting negative impact on their health. This systematic scoping review adds to the current knowledge base through comprehensively synthesising evidence on what is known about the extent and nature of health and care inequalities, as well as highlighting gaps in the evidence which point the way towards future research priorities. We searched four databases, undertook manual searching, and included studies which presented empirical findings on LGBT people aged 50+ in the UK and their physical and mental health or social care status. From a total of 5,738 records, 48 papers from 42 studies were eligible and included for data extraction. The synthesis finds that inequities exist across physical and mental health, as well as in social care, exposure to violence and loneliness. Social care environments appeared as a focal point for inequities and formal care environments severely compromised the identity and relationships that older LGBT people developed over their lifecourse. Conversely, the literature demonstrated how some older LGBT people successfully negotiated age-related transitions, e.g. emphasising the important role of LGBT-focused social groups in offsetting social isolation and loneliness. While there exist clear policy implications around the requirement for formal care environments to change to accommodate an increasingly diverse older population, there is also a need to explore how to support older LGBT people to maintain their independence for longer, reducing the need for formal care.

Prevalence and determinants of loneliness in people living with dementia: Findings from the IDEAL programme.

OBJECTIVE: To establish the prevalence and determinants of loneliness among people living with dementia. METHODS: Using data from the baseline wave of the Improving the experience of Dementia and Enhancing Active Life (IDEAL) cohort study, we examined the prevalence and predictors of loneliness in 1547 people with mild-to-moderate dementia. Loneliness was assessed using the six-item De Jong Gierveld loneliness scale. RESULTS: About 30.1% of people with dementia reported feeling moderately lonely and 5.2% severely lonely. Depressive symptoms and increased risk of social isolation were associated with both moderate and severe loneliness. Those living alone were more likely to experience severe loneliness as were those reporting poorer quality of life. Marital status was not associated with loneliness nor were dementia diagnosis or cognitive function. CONCLUSIONS: This is one of the few large-scale studies to explore the prevalence of and determinants of loneliness among people living with dementia. Social isolation, depression and living alone were associated with experiencing loneliness. Longitudinal studies are needed to determine the directionality of these associations.

"Overwhelmed and out of my depth": Responses from early career midwives in the United Kingdom to the Work, Health and Emotional Lives of Midwives study.

BACKGROUND: Efforts to resolve the longstanding and growing staffing crisis in midwifery in the United Kingdom have been hampered by very poor retention rates, with early career midwives the most likely to report burnout and intention to leave the profession. AIMS: To establish the key, self-described factors of satisfaction and dissatisfaction at work for early career midwives in the United Kingdom, and suggest appropriate and effective retention strategies. METHODS: Thematic analysis was undertaken on a subset of free text responses from midwives who had been qualified for five years or less, collected as part of the United Kingdom arm of the Work, Health and Emotional Lives of Midwives project. FINDINGS: Midwives described feeling immense pressure caused by an unremittingly heavy workload and poor staffing. Where relationships with colleagues were strong, they were described as a protective factor against stress; conversely, negative working relationships compounded pressures. Despite the challenges, many of the midwives reported taking great pleasure in their work, describing it as a source of pride and self-esteem. Midwives valued being treated as individuals and having some control over their shift pattern and area of work. DISCUSSION: These results, which reveal the strain on early career midwives, are consistent with the findings of other large studies on midwives' wellbeing. All available levers should be used to retain and motivate existing staff, and recruit new staff; in the meantime, considerable creativity and effort should be exercised to improve working conditions. CONCLUSION: This analysis provides a 'roadmap' for improving staff wellbeing and potentially retention.

Midwives in the United Kingdom: Levels of burnout, depression, anxiety and stress and associated predictors.

OBJECTIVE: The overall study aim was to explore the relationship between the emotional wellbeing of UK midwives and their work environment. Specific research questions were to: assess levels of burnout, depression, anxiety and stress experienced by UK midwives; compare levels of burnout, depression, anxiety and stress identified in this sample of UK midwives, with levels reported in Australia, New Zealand and Sweden; identify demographic and work-related factors associated with elevated levels of burnout, depression, anxiety and stress. DESIGN: Cross sectional research design using an online survey. The WHELM survey tool was developed within the Australian maternity context and includes a number of validated measures: The Copenhagen Burnout Inventory (CBI), Depression, Anxiety and Stress Scale (DASS-21), as well as items from the Royal College of Midwives (RCM) 'Why Midwives Leave' study (Ball et al., 2002). SETTING: United Kingdom. PARTICIPANTS: An on-line survey was distributed via the RCM to all full midwife members in 2017 (n = 31,898). DATA ANALYSIS: The demographic and work-related characteristics of the sample were analysed using descriptive analyses. Levels of depression, anxiety, stress and burnout, measured by the CBI and DASS scores, were analysed using non-parametric statistical tests. Comparisons were made between groups based on demographic and work characteristics. Mann-Whitney U tests were used for two group comparisons, and Kruskal Wallis tests were used for groups with 2+ groups. Given the large number of analyses undertaken, statistically significant comparisons were identified with a conservative alpha level (p < .01). FINDINGS: A total of 1997 midwives responded to the survey, representing 16% of the RCM membership. The key results indicate that the UK's midwifery workforce is experiencing significant levels of emotional distress. 83% (n = 1464) of participants scored moderate and above for personal burnout and 67% (n = 1167) recorded moderate and above for work-related burnout. Client-related burnout was low at 15.5% (n = 268). Over one third of participants scored in the moderate/severe/extreme range for stress (36.7%), anxiety (38%) and depression (33%). Personal and work-related burnout scores, and stress, anxiety and depression scores were well above results from other countries in which the WHELM study has been conducted to date. Midwives were more likely to record high levels of burnout, depression, anxiety and stress if they were aged 40 and below; reported having a disability; had less than 10 years' experience; worked in a clinical midwifery setting, particularly if they worked in rotation in hospital and in integrated hospital/community settings. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Many UK midwives are experiencing high levels of stress, burnout, anxiety and depression, which should be of serious concern to the profession and its leaders. NHS employed clinical midwives are at much greater risk of emotional distress than others surveyed, which has serious implications for the delivery of high quality, safe maternity care. It is also of serious concern that younger, more recently qualified midwives recorded some of the highest burnout, stress, anxiety and depression scores, as did midwives who self-reported a disability. There is considerable scope for change across the service. Proactive support needs to be offered to younger, recently qualified midwives and midwives with a disability to help sustain their emotional wellbeing. The profession needs to lobby for systems level changes in how UK maternity care is resourced and provided. Making this happen will require support and commitment from a range of relevant stakeholders, at regional and national levels.

Conducting sexualities research: an outline of emergent issues and case studies from ten Wellcome-funded projects.

This letter seeks to synthesise methodological challenges encountered in a cohort of Wellcome Trust-funded research projects focusing on sexualities and health. The ten Wellcome Trust projects span a diversity of gender and sexual orientations and identities, settings; institutional and non-institutional contexts, lifecourse stages, and explore a range of health-related interventions.  As researchers, we originate from a breadth of disciplinary traditions, use a variety of research methods and data sources. Despite this breadth, four common themes are found across the projects: (i) inclusivity, representations and representativeness, (ii) lumping together of diverse groups, (iii) institutions and closed settings (iv) ethical and governance barriers.