What really is nontokenistic fully inclusive patient and public involvement/engagement in research?

Patient and public involvement and engagement (PPIE) is critically important in healthcare research. A useful starting point for researchers to understand the scope of PPIE is to review the definition from the National Institute for Health and Care Research (NIHR) as, 'research being carried out "with" or "by" members of the public rather than "to", "about" or "for" them'. PPIE does not refer to participation in research, but to actively shaping its direction. The 'Effectiveness of a decision support tool to optimise community-based tailored management of sleep for people living with dementia or mild cognitive impairment (TIMES)' study is funded through the NIHR programme grant for applied research. TIMES has thoroughly embraced PPIE by ensuring the person's voice is heard, understood, and valued. This editorial showcases how the TIMES project maximised inclusivity, and we share our experiences and top tips for other researchers. We base our reflections on the six key UK standards for public involvement; Inclusive Opportunities, Working Together, Support and Learning, Communications, Impact and Governance. We present our work, which had been co-led by our PPIE leads, academics and partners including, together in dementia everyday, Innovations in Dementia, The UK Network of Dementia Voices (Dementia Engagement & Empowerment Project) and Liverpool Chinese Wellbeing. We have a Lived Experience Advisory Forum on Sleep, which includes people with dementia, family carers, representatives of the South Asian Community and the Chinese community.

Can PPI be used to improve epistemic justice in health research for marginalised groups?

BACKGROUND: The principle of epistemic justice (EJ) recognises the need for a person's voice to be both heard (testimonial) and understood (hermeneutic) in the generation of meaning. Funding bodies now require all research to have embedded patient and public involvement (PPI) - an active partnership between patients, carers, and the public with researchers, which influences and shapes research. AIM: Current PPI initiatives potentially enable testimonial justice - ensuring voices are heard. But do they adequately support hermeneutical justice? METHOD: First, a scoping review of published PPI guidance was carried out to describe a current best-practice framework. The framework was then critically reviewed using key concepts described by an EJ understanding of optimising healthcare research for marginalised groups, to consider the potential role of current PPI guidance in supporting epistemically just health research. RESULTS: Analysis is ongoing, but the study's findings describe whether and how current PPI guidelines support and enable the voice of marginalised patient groups to not only be included in research but also to have meaningful impact, including what factors enable and disable tailored care. CONCLUSION: This study suggests ways in which current PPI methods can be used to best advantage. The authors' ongoing research is discussed to understand further how EJ concepts might help shape the future of PPI in health research.

Sleep disturbance in people living with dementia or mild cognitive impairment: a realist review of general practice.

BACKGROUND: Sleep disturbance is a prevalent condition among people living with dementia (PLwD) or mild cognitive impairment (MCI). Its assessment and management within primary care is complex because of the comorbidities, older age, and cognitive impairment typical of this patient group. AIM: To explore how primary care clinicians assess, understand, and manage sleep disturbance for PLwD or MCI; if and why such initiatives work; and how people and their carers experience sleep disturbance and its treatment. DESIGN AND SETTING: A realist review of existing literature conducted in 2022. METHOD: Six bibliographic databases were searched. Context-mechanism-outcome configurations (CMOCs) were developed and refined. RESULTS: In total, 60 records were included from 1869 retrieved hits and 19 CMOCs were developed. Low awareness of and confidence in the treatment of sleep disturbance among primary care clinicians and patients, combined with time and resource constraints, meant that identifying sleep disturbance was difficult and not prioritised. Medication was perceived by clinicians and patients as the primary management tool, resulting in inappropriate or long-term prescription. Rigid nursing routines in care homes were reportedly not conducive to good-quality sleep. CONCLUSION: In primary care, sleep disturbance among PLwD or MCI is not adequately addressed. Over-reliance on medication, underutilisation of non-pharmacological strategies, and inflexible care home routines were reported as a result of low confidence in sleep management and resource constraints. This does not constitute effective and person-centred care. Future work should consider ways to tailor the assessment and management of sleep disturbance to the needs of individuals and their informal carers without overstretching services.

Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia-a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial.

BACKGROUND: Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and ß-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing). METHODS: BioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC). The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking. The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed. DISCUSSION: The BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship. TRIAL REGISTRATION: ISRCTN11633399. Registered 24/06/2022.

Prevention of alcohol related harm though preconception care: A scoping review of barriers and enablers.

Objective: To understand the perspectives of healthcare practitioners and women of reproductive age regarding addressing prevention of an alcohol exposed pregnancy before conception. Methods: A scoping review of mixed methods, qualitative and quantitative research was conducted. Medline, CINAHL, EMBASE and PsychInfo databases were searched for literature published by March 2022. Data were extracted and synthesized. Results: Twenty-three studies were included. Views varied between healthcare practitioners and women about addressing alcohol with women before pregnancy. Healthcare practitioners agreed prevention was important but believed they were ill-prepared to provide support, and that it might be intrusive if women were not contemplating pregnancy. Whereas women would welcome advice from healthcare practitioners, particularly if offered during appointments or visits for services related to reproductive health. A knowledge deficit about pregnancy and fetal harms from alcohol was expressed by both healthcare practitioners and women. Conclusions: Investment in alcohol education and skills training for healthcare professionals is required to ensure a coherent message is communicated across services, and that shared decision making about healthcare between service users and health professionals is facilitated. Future research should explore implementation of interventions to prevent alcohol exposed pregnancy in settings where women are seeking reproductive health support.