Health Research Authority Research Articles

Effects of implementation of a care bundle on rates of necrotising enterocolitis and own mother’s milk feeding in the East Midlands: protocol for a mixed methods impact and process evaluation study

IntroductionPrevention of necrotising enterocolitis (NEC) is vital for improving neonatal outcomes. Feeding own mother’s milk helps prevent NEC. Rates of own mother’s milk feeding in the East Midlands are lower...

Understanding Longitudinal Population Study Data and the Law

BackgroundUK Longitudinal Linkage Collaboration (UK LLC) is the national Trusted Research Environment for the UK's longitudinal studies. The need for a clear way to communicate Longitudinal Population Study (LPS) participants’ rights was identified through public contributor consultations. UK LLC gathered public views to inform meaningful discussion with NHS England, the National Data Guardian’s Office, and the Health Research Authority to develop a new framework for agreeing consistency in assessment of the legal basis for linking participant self-reported data to participants' health records. The consultation flagged that the legislation around LPS data is complex, confusing, and often inaccessible. This means that it may prove difficult for LPS participants to fully understand who is allowed to access their data, for what purposes, under what circumstances and what their rights are. IntroductionThe legal basis for using LPS data is complex. Of particular importance are the UK GDPR (General Data Protection Regulations), Common Law Duty of Confidentiality, Digital Economy Act (DEA) 2017 and Section 251 of the NHS Act 2016. Our vision was to produce transparency materials to help LPS participants understand LPS data and the law. MethodsWe surveyed public contributors from UK LLC, Health Data Research UK and DATAMIND to establish current understanding. We worked in partnership with UK LLC’s Public Advisory Group (PAG) and external organisations to produce a series of infographics (over time also available in audio, BSL and additional languages) to reach as wide an audience as possible. We collaborated with DATAMIND throughout the project sharing insights and ideas. ResultsA total of 56 people participated in the survey, most of whom lived in England: 30% were LPS participants; 55% were aged 55 and over; and 18% identified as belonging to an ethnic minority group. Survey results showed that the levels of awareness of the laws/legal principles relating to the use of LPS data is generally low. The DEA was least well-known, with 11% of people aware of this legislation. The most well-known among the infographic topics was GDPR, with 88% awareness. We co-developed key messages for LPS participants on what they should be aware of as individuals, including what they should expect from their LPS. This was not a straightforward process due to the exemptions and conditions under each law/legal principle. This led to focus on highlighting the practical implications for participants rather than explaining the laws/legal principles. Across the series, participants are directed to official organisations for further information. ConclusionsThis series of transparency materials provides a more accessible and easy-to-understand way for LPS participants to fully understand who is allowed to access their data, for what purposes, under what circumstances and what their rights are.

A qualitative study to explore the knowledge and perceptions of vitamin D deficiency in women of Bengali origin living in the UK

A study into the determinants influencing Vitamin D supplementation among women of Bengali descent in the UK Background: The prevalence of Vitamin D deficiency is widespread, particularly among South Asian women residing in temperate climates such as the United Kingdom. Contributory factors encompass dietary habits and conservative dressing practices. Aims: This study aims to delineate the knowledge, perceptions, and determinants influencing Vitamin D supplementation among women of Bengali descent in the UK. Methods: The study employed semi-structured interviews with women of Bengali origin at a general practice in London. A deductive thematic analysis was conducted utilizing the COM-B model to identify behavioural determinants. The study was approved by the Health Research Authority. Findings: Key determinants to behaviours associated with Vitamin D supplementation encompassed awareness, cultural practices, healthcare advice, and personal convictions. Notwithstanding awareness of its criticality, actual intake was minimal due to factors like forgetfulness, cultural norms, and perceptions regarding the necessity of supplementation. Conclusion: Although there is an overarching recognition of the significance of Vitamin D, adherence to supplementation regimens remains erratic. This study underscores the imperative for tailored health interventions that account for these elements to enhance Vitamin D supplementation among high-risk populations.

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain

IntroductionGestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs...

Determination of factors influencing the retention in HIV care of adolescents during the Covid-19 pandemic in Lusaka Zambia

Background: Adolescents (ages 18-24) living with HIV are prone to disengagement from care, risking health deterioration and viral transmission. Identifying key barriers to adolescent retention is crucial for intervention development. This study aims to explore barriers and facilitators to adolescent HIV care retention. In Zambia, where 32% of 15–17-year-olds and 60% of 18–19-year-olds are sexually active, with low condom use rates, the risk of HIV and STIs is high. Despite Ministry of Health strategies, many HIV-positive adolescents in Zambia struggle with adherence. This study sought to investigate how various factors interact to influence HIV retention among adolescents in Lusaka, Zambia, employing an adapted Andersen framework. Its objectives include understanding factors impacting HIV retention, analysing predisposing factors, and examining health system influences on adolescent HIV care retention in Lusaka, Zambia. Methods: The study was conducted at University Teaching Hospital (UTH), Chilenje Hospital, and Chawama, Mtendere, and Kalingalinga) clinics in Lusaka, Zambia. Non-probability sampling, specifically purposive sampling, was employed. Semi-structured questionnaires were used for data collection and the quantitative data was analyzed using STATA 16.0. Findings will be disseminated through healthcare community, policy circles, among stakeholders and shared with UNZA's library. Ethical approval was obtained from The University of Zambia Biomedical Research Ethics Committee (UNZABREC) and permission from the Zambia National Health Research Authority (ZNHRA). Informed consent was obtained from participants, emphasizing voluntariness and the right to withdraw. Anonymity, confidentiality, and privacy was strictly upheld throughout the study. Results: The results highlight the nuanced nature of factors influencing adolescent retention in HIV care, emphasizing the importance of predictors such as education level, alcohol intake, belief in HIV cure through prayers, and perception of HIV as a significant life problem. The findings align with prior studies, warranting further exploration of support networks and experiences of non-engaged adolescents. Conclusion: In summary, this study makes a significant contribution to public health research by delving into the intricate factors impacting adolescent retention in HIV care in Lusaka, Zambia. The findings, aligned with research inquiries and existing literature, shed light on education, substance use, and psychosocial aspects. These insights lay the groundwork for tailored interventions, highlighting the significance of patient-centered strategies. Moreover, the study emphasizes the necessity for continued exploration of support networks, disclosure challenges, and broader societal dynamics affecting healthcare engagement. This insight informs future research endeavors aimed at enhancing the well-being of adolescents living with HIV. Recommendations include improve medication access through mobile services, provide financial aid integrated with counseling, personalize adherence plans, involve social networks, respect religious beliefs, address geographic disparities, monitor long-term health, and pilot targeted interventions. Policies should establish guidelines for medication access and financial assistance.

Protocol for a Randomized Controlled Trial to Evaluate a Permissive Blood Pressure Target Versus Usual Care in Critically Ill Children with Hypotension (PRESSURE).

Management of hypotension is a fundamental part of pediatric critical care, with cardiovascular support in the form of fluids or vasoactive drugs offered to every hypotensive child. However, optimal blood pressure (BP) targets are unknown. The PRotocolised Evaluation of PermiSSive BP Targets Versus Usual CaRE (PRESSURE) trial aims to evaluate the clinical and cost-effectiveness of a permissive mean arterial pressure (MAP) target of greater than a fifth centile for age compared with usual care. Pragmatic, open, multicenter, parallel-group randomized control trial (RCT) with integrated economic evaluation. Eighteen PICUs across the United Kingdom. Infants and children older than 37 weeks corrected gestational age to 16 years accepted to a participating PICU, on mechanical ventilation and receiving vasoactive drugs for hypotension. Adjustment of hemodynamic support to achieve a permissive MAP target greater than fifth centile for age during invasive mechanical ventilation. Randomization is 1:1 to a permissive MAP target or usual care, stratified by site and age group. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred until after randomization. The primary clinical outcome is a composite of death and days of ventilatory support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of BP and organ support, and discharge outcomes. This RCT received Health Research Authority approval (reference 289545), and a favorable ethical opinion from the East of England-Cambridge South Research Ethics Committee on May 10, 2021 (reference number 21/EE/0084). The trial is registered and has an International Standard RCT Number (reference 20609635). Trial findings will be disseminated in U.K. national and international conferences and in peer-reviewed journals.

Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial

IntroductionCustom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The...

Exploratory study of using Magnetic resonance Prognostic Imaging markers for Radiotherapy In Cervix cancer (EMPIRIC): a prospective cohort study protocol

IntroductionRadical chemoradiotherapy represents the gold standard for locally advanced cervical cancer. However, despite significant progress in improving local tumour control, distant relapse continues to impact overall survival. The development of...

Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme

IntroductionBetween 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are...

Motiv8: a study protocol for a cluster-randomised feasibility trial of a weight management intervention for adults with severe mental illness in secure forensic services

IntroductionPeople with severe mental illness have physical comorbidities which result in significant reductions in quality of life and premature mortality. Effective interventions are required that are suitable for people in secure forensic mental health services. We conducted pilot work of a multidisciplinary weight management intervention (Motiv8) which showed improvements in physical and mental health and high levels of satisfaction. We aim to test the feasibility of Motiv8 under cluster randomised conditions, with an aim to investigate the acceptability, feasibility and potential effectiveness of this intervention to supplement standard secure care.Methods and analysisA randomised waitlist-controlled feasibility trial of a lifestyle intervention (Motiv8) + TAU compared with TAU (+ Motiv8 waitlist) for adults on secure mental health units will be conducted. Thirty-two people (4 cohorts) will be recruited from secure services in Greater Manchester Mental Health NHS Foundation Trust. Participants will be randomly allocated to Motiv8 or TAU + Motiv8 waitlist. All participants will receive Motiv8 during the trial. Assessor-blinded physical/mental health and lifestyle assessments will be conducted at baseline, 10 weeks (post-intervention/waitlist), and after 12 weeks (post-waitlist intervention/follow-up). Motiv8 is a multidisciplinary intervention including exercise sessions, cooking/nutrition classes, physical health education, psychology sessions, sleep hygiene, peer support and medication review by pharmacy. A nested qualitative study will be conducted with a subsample of participants (n = 10) to explore their experiences of taking part. The analysis will focus on feasibility outcomes and tabulated success indicators of the study (e.g. Recruitment rates, retention rates, follow-up retention and response rates, attendance at sessions, the experience of involvement in the trial and delivery of the intervention, assessment of safety, development of a manualised intervention). Thematic analysis will be conducted through qualitative interviews. The analysis will aim to inform the development of a definitive trial.Ethics and disseminationThe trial has been granted ethical approval from the NHS Health Research Authority and adopted onto the UK Clinical Research Network Portfolio. Findings will be disseminated via peer-reviewed publications, professional and public networks, conferences and clinical services.Trial registrationISRCTN13539285.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients’ musculoskeletal pain and enablement

IntroductionEffective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in...

Co-design and evaluation of a youth-informed organisational tool to enhance trauma-informed practices in the UK public sector: a study protocol

IntroductionA trauma-informed approach (TIA) means working with awareness that people’s histories of trauma may shape the way they engage with services, organisations or institutions. Young people with adverse childhood experiences...

A study protocol to investigate if acipimox improves muscle function and sarcopenia: an open-label, uncontrolled, before-and-after experimental medicine feasibility study in community-dwelling older adults

IntroductionSarcopenia is the age-associated loss of muscle mass and strength. Nicotinamide adenine dinucleotide (NAD) plays a central role in both mitochondrial function and cellular ageing processes implicated in sarcopenia. NAD...

Protocol for VIVALDI social care: Pilot study to reduce infections, outbreaks and antimicrobial resistance in care homes for older adults.

Care home residents are vulnerable to severe outcomes from infections such as COVID-19 and influenza. However, measures to control outbreaks, such as care home closures to visitors and new admissions, have a detrimental impact on their quality of life. Many infections and outbreaks could be prevented but the first step is to measure them reliably. This is challenging in care homes due to the lack of data and research infrastructure. During the pandemic, the VIVALDI study measured COVID-19 infections in residents and staff by partnering with care providers and using routinely collected data. This study aims to establish sentinel surveillance and a research database to enable observational and future interventional studies in care homes. The project has been co-produced with care providers, staff, residents, relatives, and researchers. The study (October 2023 to March 2025) will explore the feasibility of establishing a network of 500-1500 care homes for older adults in England that is underpinned by a linked data platform. No data will be collected from staff. The cohort will be created by regularly extracting resident identifiers from Digital Social Care Records (DSCR), followed by pseudonymisation and linkage to routinely collected datasets. Following extensive consultation, we decided not to seek informed consent from residents for data collection, but they can 'opt out' of the study. Our goal is to be inclusive, and it is challenging to give every resident the opportunity to 'opt in' due to cognitive impairment and the requirement for consultees. The project, and all requests to use the data will be overseen by relatives, residents, staff, and care providers. The study has been approved by the Health Research Authority Confidentiality Advisory Group (23/CAG/0134&0135) and the South-West Frenchay Research Ethics Committee (23/SW/0105). It is funded by the UK Health Security Agency.

Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians

BackgroundStatisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard for the conduct of clinical trials research. Statisticians are required to undertake training on GCP but existing training is generic and, crucially, does not cover statistical activities. This results in statisticians undertaking training mostly unrelated to their role and variation in awareness and implementation of relevant regulatory requirements with regards to statistical conduct. The need for role-relevant training is recognised by the UK NHS Health Research Authority and the Medicines and Healthcare products Regulatory Agency (MHRA).MethodsThe Good Statistical Practice (GCP for Statisticians) project was instigated by the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Statisticians Operational Group and funded by the National Institute for Health and Care Research (NIHR), to develop materials to enable role-specific GCP training tailored to statisticians. Review of current GCP training was undertaken by survey. Development of training materials were based on MHRA GCP. Critical review and piloting was conducted with UKCRC CTU and NIHR researchers with comment from MHRA. Final review was conducted through the UKCRC CTU Statistics group.ResultsThe survey confirmed the need and desire for the development of dedicated GCP training for statisticians. An accessible, comprehensive, piloted training package was developed tailored to statisticians working in clinical research, particularly the clinical trials arena. The training materials cover legislation and guidance for best practice across all clinical trial processes with statistical involvement, including exercises and real-life scenarios to bridge the gap between theory and practice. Comprehensive feedback was incorporated. The training materials are freely available for national and international adoption.ConclusionAll research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders.

Study of Whole blood in Frontline Trauma (SWiFT): implementation study protocol

IntroductionUncontrolled bleeding is a major cause of death for patients with major trauma. Current transfusion practices vary, and there is uncertainty about the optimal strategy. Whole blood (WB) transfusion, which...

Sleep and motor learning in stroke (SMiLES): a longitudinal study investigating sleep-dependent consolidation of motor sequence learning in the context of recovery after stroke

IntroductionThere is growing evidence that sleep is disrupted after stroke, with worse sleep relating to poorer motor outcomes. It is also widely acknowledged that consolidation of motor learning, a critical...

Developing a core outcome set for the health outcomes for children and adults with congenital oesophageal atresia and/or tracheo-oesophageal fistula: OCELOT task group study protocol

IntroductionHeterogeneity in reported outcomes of infants with oesophageal atresia (OA) with or without tracheo-oesophageal fistula (TOF) prevents effective data pooling. Core outcome sets (COS) have been developed for many conditions...

Implementation of Body Worn Camera: Practical and Ethical Considerations

Body-worn cameras are increasingly being used as a violence prevention tool in inpatient mental health wards. However, there remains a limited understanding of this technology from an implementation perspective, such as protocols and best practice guidance if cameras are to be used in these settings. This study explores the perspectives of patients, mental health staff, and senior management to understand the practical and ethical issues related to the implementation of body-worn cameras. Semi-structured interviews (n = 64) with 24 patients, 25 staff from acute wards, six Mental Health Nursing Directors, and 9 community-based patients were conducted. Interviews were analysed using reflexive thematic analysis. Ethical approval was granted by the Health Research Authority. Findings from this study show that the implementation of BWC in healthcare settings requires careful consideration. The perspectives of patients and staff demonstrate the complex reality of implementation alongside the consideration of practical and ethical issues around implementation that are essential to ensures that wards recognise the need to assess their capacity to use the cameras in a way that is fair and consistent for all involved. The findings further highlight wider questions around power and autonomy in mental health care.

The UK research ethics committee: Making the case for better serving the underserved – can we do better?

Research ethics committees exist internationally to review research proposals to protect the rights and safety of human participants and researchers involved in research. These committees recruit a panel of expert and lay members, mostly on an unpaid voluntary basis, with relevant scientific experience to appraise these studies. Contemporary data in the UK show that women and people over 55 years old are overrepresented in these committee panels in the Health Research Authority, suggesting that there are potential barriers to inclusivity and participation. A variety of global approaches to tackle these barriers include targeting specific populations, such as faith or community leaders, or implementing quotas have been adopted. Further research is needed to understand likely barriers preventing participation in research ethics committees in the UK and how they may be overcome.