NIHR open research最新文献

Introduction: Trauma-informed care (TIC) has attracted considerable attention globally as a framework for addressing the profound impacts of trauma on individuals and communities. Despite its widespread adoption, the definition and operationalisation of TIC remain inconsistent across contexts, including the United Kingdom. TIC represents a systemic shift in healthcare and social care practices, moving from a focus on immediate issues to addressing the underlying effects of violence, childhood adversity, and trauma. This approach is particularly pertinent in the UK, where there is growing interest in TIC across the health, social care, and criminal justice sectors.This systematic scoping review aims to shed light on how TIC is defined and applied in the UK. By synthesising existing literature, it seeks to clarify the conceptualisation of TIC, identify gaps in implementation, and contribute to ongoing efforts to standardise trauma-informed approaches. The review is motivated by the UK's proactive yet fragmented adoption of TIC, as evidenced by recent initiatives and sector-specific adaptations. By examining these developments, the review aims to inform policy and practice, ultimately enhancing the delivery of trauma-informed care in the UK.

Methods: We systematically searched for primary studies in PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Medline to explore how TIC is defined in the UK. Grey documents that described TIC principles, evaluation, and implementation within mental health care services in the UK were selected. Data from selected studies and grey documents, including handbooks, policies, or training materials, were systematically extracted, focusing on the document characteristics, TIC principles, implementation strategies and evaluation methods. Studies were then selected in English from the last 15 years of work, focusing on TIC practices within the mental health care system in the UK. Data were then analysed to describe TIC principles within mental health care services, identify important concepts of TIC and explore implementation and evaluation methods. This would enable us to understand the broader components of how TIC is defined.

Ethics and dissemination: This systematic scoping review did not require ethical approval. The findings will be disseminated through peer-reviewed publications in academic journals specialising in mental health, trauma, and healthcare management, conference presentations, online platforms such as the research team's website, social media channels, community organisations, advocacy groups, or patients.

Introduction: Cutaneous leishmaniasis (CL) remains a major public health challenge, especially in endemic regions like Ethiopia, where an estimated 40,000 new cases occur annually. Effective treatment evaluation for CL relies on consistent clinical assessments, yet variability in lesion descriptions can complicate reliable outcome measures.

Methods: We conducted an inter-reliability study of clinicians' evaluations of CL lesion morphology and size at ALERT Hospital, Addis Ababa. Twelve clinicians independently examined 12 patients with parasitologically confirmed CL, each clinician assessing lesion morphology, size, and severity.

Results: We found high consistency in reporting major morphological categories (e.g., plaques) but significant variability in secondary features like dyspigmentation and scale, as well as mucosal involvement. Lesion size measurements showed limited variability, suggesting its reliability as a potential measure for future clinical trials. Disparities in severity assessments highlight the need for a standardized scoring system in CL.

Discussion: Our findings underscore the importance of training for consistent, high-quality clinical evaluations of CL and suggests that lesion size could be a reproducible outcome measure in treatment efficacy trials.

Background: The evidence and infrastructure needed to access and deliver cardiac rehabilitation (CR) services are absent or lacking in low and middle-income countries (LMICs), resulting in a substantial loss of potential health and socio-economic benefits. Home-based programmes provide an affordable model of delivery that can leverage a scalable increase in CR access in LMICs. ACROSS (Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study) seeks to co-develop (with patients, caregivers, clinicians, and service commissioners) a culturally and contextually applicable and affordable home-based programme for people with the multimorbidity of coronary heart disease and/or heart failure with co-existing depression and/or anxiety and evaluate the acceptability, clinical effectiveness, and cost-effectiveness of its implementation in Bangladesh, India, and Pakistan and to determine its scalability and sustainability.

Methods: Four linked work packages (WPs). WP1 (cultural adaptation/refinement of home-based rehabilitation): examine rehabilitation implementation barriers/enablers from multiple stakeholder perspectives and co-develop a feasible and acceptable culturally & contextually adapted home-based programme, extended to take account of co-existing depression and/or anxiety; WP2 (external pilot): assess feasibility/acceptability of the co-developed rehabilitation intervention and study design and processes necessary for a full-scale trial; WP3: (multicentre/multi-country hybrid effectiveness and implementation randomised trial) determine the clinical and cost-effectiveness of a culturally adapted home-based rehabilitation intervention for people with coronary heart disease and/or heart failure and depression and/or anxiety; WP4 (capacity building): build research and rehabilitation delivery capacity.

Conclusions: The ACROSS programme overarching goal is to develop a clinically and cost-effective CR model in low-resource settings for people in Bangladesh, India, and Pakistan with a multimorbidity of heart disease and depression and/or anxiety with the potential for substantial health and socio-economic benefits.

Background: Progress in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) research is being slowed by the relatively small-scale studies being performed whose results are often not replicated. Progress could be accelerated by analyses of large population-scale projects, such as UK Biobank (UKB), which provide extensive phenotype and genotype data linked to both ME/CFS cases and controls.

Methods: Here, we analysed the overlap and discordance among four UKB-defined ME/CFS cohorts, and additional questionnaire data when available.

Results: A total of 5,354 UKB individuals were linked to at least one piece of evidence of MECFS, a higher proportion (1.1%) than most prevalence estimates. Only a third (36%; n=1,922) had 2 or more pieces of evidence for MECFS, in part due to data missingness. For the same UKB participant, ME/CFS status defined by ICD-10 (International Classification of Diseases, Tenth Revision) code G93.3 (Post-viral fatigue syndrome) was most likely to be supported by another data type (72%); ME/CFS status defined by Pain Questionnaire responses is least likely to be supported (43%), in part due to data missingness.

Conclusions: We conclude that ME/CFS status in UKB, and potentially other biobanks, is best supported by multiple, and not single, lines of evidence. Finally, we raise the estimated ME/CFS prevalence in the UK to 410,000 using the most consistent evidence for ME/CFS status, and accounting for those who had no opportunity to participate in UKB due to being bed- or house-bound.

Background: During pregnancy, labour and early motherhood, most women in the UK receive care from different midwives. The National Health Service (NHS) policy change in England sought to introduce a model of care whereby each woman is cared for by the same midwife throughout antenatal, intrapartum and postnatal periods, supported by a small team of midwives to cover off-duty periods. This model is called the Midwifery Continuity of Carer (MCoC). The aim of this study is proposes to evaluate the implementation and delivery of MCoC across England, aiming to better understand the factors that result in different rates of progress with MCoC implementation.

Aim: To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?

Methods: A sequential mixed-methods study, informed by implementation science frameworks will be delivered over three work packages. Work package 1: Following a literature review of the challenges and successes of previous attempts to implement MCoC. Work package 2: six case studies in NHS Trusts will be undertaken to better understand different rates of progress with MCoC implementation and people's experiences of MCoC implementation through: interview and questionnaire (maternity services staff); interviews (service-users); observation of relevant implementation meetings and organisational documentation collection. Interviews will be undertaken with national and regional stakeholders relevant to MCoC implementation. Work package 3: Data analysis will be conducted both inductively and deductively, informed by implementation science constructs.

Dissemination: Study findings will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the public, clinical and policy stakeholders in the UK and will be disseminated accordingly.

Objectives: Abbreviated breast MRI (abMRI) is being introduced into breast screening practice worldwide. Increased provision of abMRI will require mammogram readers to learn abMRI-interpretation and the implementation of abMRI-reading into clinical practice. The present study explores the acceptability of the implementation of developed reader training, and the barriers and facilitators to training programme participation and subsequently to reading the training programme assessment task of abMRI images in a work/NHS context familiar to the individual participants.

Methods: Fourteen NHS Breast Screening Programme mammogram readers, who were undertaking abMRI interpretation training, participated in semi-structured interviews. Template analysis using the a priori implementation framework, COM-B (Capability, Opportunity, Motivation, Behaviour) was undertaken.

Results: The training day was well received. Participants identified that their varying ranges of knowledge and experience (capability) was accounted for. Participation in the research was appreciated by all, but especially those new to reading MRI.Radiographers commented that learning to read and understand the abMRI images was motivational, and this helped drive implementation. It was noted that organisational leadership is needed to fully enable change in practice. COVID-19 was commented on in relation to its impact on image reading.

Conclusions: The project demonstrates that production of training for reading abMRI images and subsequent implementation of changes to practice needs to be carefully planned. Changes must be led by the needs of staff undertaking the tasks. When this is achieved the engagement in training is positive and the barriers are more readily removed or mitigated for both individuals and organisations.

Critical relevance statement: AbMRI is part of the solution to reducing waiting times for MRI within the NHS, however, training for reading abMRI images and implementation to practice needs to be carefully planned.

Background: Chronic migraine is a disabling condition that can substantially impact on quality of life. People with chronic migraine have headaches on at least 15 days of every month. Preventative medications aiming to reduce number of days with migraine are available, but high-quality randomised evidence is lacking for many drugs, and it is unclear which medications should be prioritised for research. There is also no existing evidence about patient and clinicians' priorities for research.

Methods: We undertook a consensus workshop with patient and healthcare professional stakeholders, using nominal group technique, to understand these stakeholders' priorities for future randomised controlled trials. We reached a consensus on a set of research recommendations for the field.

Results: Eight people with chronic migraine and eleven healthcare professionals took part in an online workshop. Comparisons of calcitonin gene-related peptide monoclonal antibodies (CGRP MAbs) and OnabotulinumtoxinA (BTA) were a top priority for our group. Candesartan and Flunarizine were the top drugs the group wanted to compare against placebo.

Conclusions: These research recommendations should guide researchers in the field, and funders when prioritising commissioned research and assessing funding applications. Particular areas to explore further are Candesartan or Flunarizine versus placebo, and comparing and combining CGRP MAbs with other medications.

Background: Venous leg ulceration (VLU) is the most severe form of venous disease and an important burden to patients and society. Many treatments for VLU exist, including wound therapies, medications, and surgical interventions. However, high-level randomized trial data supporting leg ulcer treatments are lacking, limiting their adoption in clinical practice. We developed a platform trial assessing multiple interventions for VLU comprising multiple multi-arm multi-stage trials.

Methods: Scoping reviews, surveys, meetings, and focus groups were conducted over five work streams to inform the development of the proposed platform trial. We involved international experts in venous disease, patients with a lived experience of VLU, healthcare professionals with an interest in VLU care, methodologists, industry partners, and other key stakeholders to help inform priority research areas and methodology, and finalize the proposed trial design.

Results: Based on this feedback, the proposed multi-arm multi-stage (MAMS) platform trial will be delivered across three patient domains: patients with active ulceration present for less than six months (Domain 1), patients with active ulceration present for more than six months (Domain 2), and patients with healed ulceration (Domain 3). Interventions included wound care, medication, intervention for superficial venous reflux, and surveillance strategies delivered across community, primary, and secondary care.

Conclusions: Our MAMS platform trial development highlighted many challenges and opportunities in methodology development and the potential delivery of such a study. The work performed in our work streams will help inform future research in this field.

Background: Usual airway clearance management in critically ill patients with acute respiratory failure includes suctioning, humidification, use of isotonic saline, and respiratory physiotherapy techniques. Escalation to use of mucoactives occurs when secretions are difficult to clear. Use of mucoactives in clinical practice for this patient population is extensive, yet empirical and variable. Carbocisteine and hypertonic saline are the most used agents, but evidence for their effectiveness is absent or minimal. The lack of existing large-scale randomised trials comparing mucoactives to usual airway clearance management alone in critically ill patients with acute respiratory failure highlights the urgency and necessity of this study.

Aim: To determine whether the use of mucoactives in critically ill patients with acute respiratory failure improves clinical outcomes and is cost effective, compared to usual airway clearance management alone.

Methods: A UK multi-centre, 2x2 factorial, randomised, controlled, open-label, Phase 3, pragmatic, clinical and cost effectiveness trial with internal pilot. The target sample is 1956 critically ill adults. Participants will be equally allocated across four trial arms. All participants will receive usual airway clearance management. In three intervention groups, participants will receive either carbocisteine, hypertonic saline, or a combination of carbocisteine and hypertonic saline. In the fourth comparator group, participants will receive usual airway clearance management alone. The primary outcome is the duration of mechanical ventilation with secondary clinical, safety, and health resource utilisation outcomes. The trial will be reported in accordance with CONSORT guidelines. Ethical approval was granted by Leeds East (Yorkshire & The Humber) Research Ethics Committee (reference 21/YH/0234) on 28 ^th October 2021. All participants will provide written, informed consent via either Personal or Professional Legal Representatives, and subsequently directly once capacity is regained.

Trial registration: Main trial: ISRCTN17683568, https://www.isrctn.com/ISRCTN17683568, 25 ^th November 2021Study Within A Trial: ISRCTN16675252, https://www.isrctn.com/ISRCTN16675252, 3 ^rd November 2021EudraCT Number, 2021-003763-94.

Background: Opioids are frequently prescribed for short-term acute pain following surgery. Used appropriately, opioids deliver extremely favourable pain relief. Used longer than 90-days, however, can result in health complications, including unintentional overdose and addiction. Globally, >40 million people are dependent on opioids and annually >100,000 die from opioid misuse. With >4.7 million surgical procedures occurring annually in the United Kingdom it is imperative that opioid-use is managed upon discharge. A declining General Practitioner (GP) workforce and increased patient numbers, however, means gaps in healthcare during transfer of care. Here we report a mixed-methods protocol to understand the feasibility, and acceptability of a clinical pharmacist (CP)-led early opioid deprescribing intervention for discharged surgical patients.

Methods: DESCALE is a multicentre, non-randomised, pragmatic feasibility study. Participants aged ≥18 years who have undergone a surgical procedure at a single NHS trust in Southeast England and discharged with opioids and without a history of long-term opioid use, cancer diagnosis or study contraindications will be offered a Medicines Use Review (MUR) within 7-10 days of discharge. The MUR will be delivered by CPs at participating GP practices. Feasibility outcomes will focus on recruitment, fidelity of CPs to deliver the MUR, and barriers within primary care that affect delivery of the intervention, with a maximum sample size of 100. Clinical outcomes will focus on the number of participants that reduce or stop opioid use within 91 days. Prescribing, medical, surgical, and demographic data for individual participants will be collected and analysed to inform future trial design. Qualitative interviews with participants and associated healthcare professionals will explore acceptability and implementation of the intervention.

Conclusion: Data collected with respect to opioid use post-surgery, feasibility and acceptability of the intervention, patient experience and outcome data will inform the design of future research and larger clinical trials.