Approximately 250 million children under 5 years of age are at risk of poor development in low-income and middle-income countries. However, existing early childhood development (ECD) interventions can be expensive, labour intensive and challenging to deliver at scale. Mass media may offer an alternative approach to ECD intervention. This protocol describes the planned economic evaluation of a cluster-randomised controlled trial of a radio campaign promoting responsive caregiving and opportunities for early learning during the first 3 years of life in rural Burkina Faso (SUNRISE trial).

The economic evaluation of the SUNRISE trial will be conducted as a within-trial analysis from the provider’s perspective. Incremental costs and health outcomes of the radio campaign will be compared with standard broadcasting (ie, ‘do nothing’ comparator). All costs associated with creating and broadcasting the radio campaign during intervention start-up and implementation will be captured. The cost per child under 3 years old reached by the intervention will be calculated. Incremental cost-effectiveness ratios will be calculated for the trial’s primary outcome (ie, incremental cost per SD of cognitive gain). A cost-consequence analysis will also be presented, whereby all relevant costs and outcomes are tabulated. Finally, an analysis will be conducted to assess the equity impact of the intervention.

The SUNRISE trial has ethical approval from the ethics committees of the Ministry of Health, Burkina Faso, University College London and the London School of Hygiene and Tropical Medicine. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

The SUNRISE trial was registered with ClinicalTrials.gov on 19 April 2019 (identifier: NCT05335395).

Epilepsy is a common neurological disorder characterised by recurrent seizures. Almost half of patients who have an unprovoked first seizure (UFS) have additional seizures and develop epilepsy. No current predictive models exist to determine who has a higher risk of recurrence to guide treatment. Emerging evidence suggests alterations in cognition, mood and brain connectivity exist in the population with UFS. Baseline evaluations of these factors following a UFS will enable the development of the first multimodal biomarker-based predictive model of seizure recurrence in adults with UFS.

200 patients and 75 matched healthy controls (aged 18–65) from the Kingston and Halifax First Seizure Clinics will undergo neuropsychological assessments, structural and functional MRI, and electroencephalography. Seizure recurrence will be assessed prospectively. Regular follow-ups will occur at 3, 6, 9 and 12 months to monitor recurrence. Comparisons will be made between patients with UFS and healthy control groups, as well as between patients with and without seizure recurrence at follow-up. A multimodal machine-learning model will be trained to predict seizure recurrence at 12 months.

This study was approved by the Health Sciences and Affiliated Teaching Hospitals Research Ethics Board at Queen’s University (DMED-2681-22) and the Nova Scotia Research Ethics Board (1028519). It is supported by the Canadian Institutes of Health Research (PJT-183906). Findings will be presented at national and international conferences, published in peer-reviewed journals and presented to the public via patient support organisation newsletters and talks.

NCT05724719.

Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.

The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.

ISRCTN11499185.

An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes.

This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored.

All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement.

NCT03653832.

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Qualitative interviews analysed using thematic analysis.

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

To identify barriers and facilitators to pressure ulcer prevention behaviours in community-dwelling older people and their lay carers.

Theoretically informed qualitative interviews with two-phase, deductive then inductive, thematic analysis.

The study was conducted in one geographical region in the UK, spanning several community National Health Service Trusts.

Community-dwelling older patients at risk of pressure ulcer development (n=10) and their lay carers (n=10).

Six themes and subthemes were identified: (1) knowledge and beliefs about consequences (nature, source, timing and taboo); (2) social and professional role and influences (who does what, conflicting advice and disagreements); (3) motivation and priorities (competing self-care needs and carer physical ability); (4) memory; (5) emotion (carer exhaustion and isolation, carergiver role conflict and patient feelings) and (6) environment (human resource shortage and equipment).

There is minimal research in pressure ulcer prevention in community-dwelling older people. This study has robustly applied the theoretical domains framework to understanding barriers and facilitators to pressure ulcer prevention behaviours. Our findings will support co-design of strategies to promote preventative behaviours and are likely to be transferable to comparable healthcare systems nationally and internationally.

The school food system varies widely between schools and across the UK. There is a need to understand evidence gaps in school food research to allow the development, implementation and evaluation of policies and interventions to support children’s healthy eating at school. This study aimed to conduct a priority setting exercise to co-produce research priorities in relation to the UK school food system.

The James Lind Alliance process informed this priority setting exercise; all key steps engaged a wide range of UK school food stakeholders (including teachers, parents, principals, school governors, policymakers, caterers). An initial online stakeholder survey identified perceived research priorities. In a second survey, stakeholders were asked to rank these priorities. Lastly, an online priority setting workshop with stakeholders elicited the most important research priorities.

In 2021, school food stakeholders (n=1280) completed the first survey, from which 136 research priorities were identified. In the second survey, participants (n=107) ranked these research priorities regarding their importance. Lastly, 30 workshop participants discussed and reached consensus on the research priorities. After final refinement by the research team, 18 priorities resulted, with the top 10 being related to the provision of free school meals (effectiveness of cost-effectiveness of different levels of eligibility, including universal provision), implementation of policy (including improving uptake) and food standards, issues around procurement, leadership, inequalities, social norms, the eating environment, food culture throughout the school setting and healthy eating.

The top 10 research priorities were elicited through a rigorous approach, including a wide range of stakeholders across the UK. These should be considered by policymakers, researchers and others to inform research, evidence-based policy development and, ultimately, improve the UK school food system.

The global population is ageing, and by 2050, there will be almost 2.1 billion people over the age of 60 years. This ageing population means conditions such as diabetes are on the increase, as well as other conditions associated with ageing (and/or diabetes), including those that cause vision impairment, hearing impairment or foot problems. The aim of this scoping review is to identify the extent of the literature describing integration of services for adults of two or more of diabetes, eye, hearing or foot services.

The main database searches are of Medline and Embase, conducted by an information specialist, without language restrictions, for studies published from 1 January 2000 describing the integration of services for two or more of diabetes, eye, hearing and foot health in the private or public sector and at the primary or secondary level of care, primarily targeted to adults aged ≥40 years. A grey literature search will focus on websites of key organisations. Reference lists of all included articles will be reviewed to identify further studies. Screening and data extraction will be undertaken by two reviewers independently and any discrepancies will be resolved by discussion. We will use tables, maps and text to summarise the included studies and findings, including where studies were undertaken, which services tended to be integrated, in which sector and level of the health system, targeting which population groups and whether they were considered effective.

As our review will be based on published data, ethical approval will not be sought. This review is part of a project in Aotearoa New Zealand that aims to improve access to services for adults with diabetes or eye, hearing or foot conditions. The findings will be published in a peer-reviewed journal and presented at relevant conferences.

To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial.

Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change.

Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service.

17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators.

Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists.

Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation.

ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.

The aim was to evaluate whether standardised exercise performance during the incremental shuttle walk test (ISWT) can be used to assess disease severity in children and young people (CYP) with chronic conditions, through (1) identifying the most appropriate paediatric normative reference equation for the ISWT, (2) assessing how well CYP with haemophilia and cystic fibrosis (CF) perform against the values predicted by the best fit reference equation and (3) evaluating the association between standardised ISWT performance and disease severity.

A cross-sectional analysis was carried out using existing data from two independent studies (2018–2019) at paediatric hospitals in London,UK. CYP with haemophilia (n=35) and CF (n=134) aged 5–18 years were included. Published reference equations for standardising ISWT were evaluated through a comparison of populations, and Bland-Altman analysis was used to assess the level of agreement between distances predicted by each equation. Associations between ISWT and disease severity were assessed with linear regression.

Three relevant reference equations were identified for the ISWT that standardised performance based on age, sex and body mass index (Vardhan, Lanza, Pinho). A systematic proportional bias of standardised ISWT was observed in all equations, most pronounced with Vardhan and Lanza; the male Pinho equation was identified as most appropriate. On average, CYP with CF and haemophilia performed worse than predicted by the Pihno equation, although the range was wide. Standardised ISWT, and not ISWT distance alone, was significantly associated with forced expiratory volume in 1 s in CYP with CF. Standardised ISWT in CYP with haemophilia was slightly associated with haemophilia joint health score, but this was not significant.

ISWT performance may be useful in a clinic to identify those with worsening disease, but only when performance is standardised against a healthy reference population. The development of validated global reference equations is necessary for more robust assessment.

Life expectancy and rates of premature death are fundamental markers of health and social equity globally, and measures on which people experiencing homelessness face enormous disparities. However, unlike for other population groups with similar disparities, concerted government action to reduce homeless mortality is rare, partly due to a lack of reliable, timely data. Contemporaneous tracking of homeless deaths is required to render such deaths less invisible and measure trends over time. Drawing on multiple data sources as recommended by the US National Health Care for the Homeless Council’s seminal Homeless Mortality Data Toolkit, we routinely and contemporaneously capture, verify and report on deaths occurring among people who have experienced homelessness in the Australian city of Perth.

Dynamic cohort study.

Perth, Western Australia, Australia, between 2016 and 2022, with deaths examined between 2020 and 2022.

For this study, the cohort comprised 8753 people who experienced homelessness in Perth, with ‘recruitment’ into the cohort governed by engagement with one or more local homelessness services and programmes over the period.

Number and median age-at-death statistics.

There were 360 deaths over the 3-year period, which is likely an undercount. The median age at death was 50 years, >3 decades below the current Australian median age at death of 82 years. Aboriginal people accounted for 30% of the deaths.

The ongoing poor health and premature death of people who have experienced homeless are indictments on our society. Triangulation of multiple data sources is required to identify and monitor deaths among homeless populations. Timely, verified data on homeless mortality are important for galvanising action and accountability, and targets should be set to reduce the observed three-decade life expectancy chasm.

Women with complex health needs are more at risk of having children’s social care involvement with their newborns than other mothers. Around the time of pregnancy, there are opportunities for health services to support women with these needs and mitigate the risk of mother–baby separation. Yet little is known about healthcare professionals’ experiences of providing this support.

We administered an online survey to perinatal healthcare professionals across England (n=70 responders), including midwives, obstetricians, perinatal psychologists/psychiatrists and health visitors. We asked about their experiences of providing care for pregnant women with chronic physical conditions, mental health needs, intellectual/developmental disabilities and substance use disorders, who might be at risk of children’s social care involvement. We conducted a framework analysis.

We constructed five themes from participant data. These include (1) inaccessible healthcare for women with complex needs, (2) the challenges and importance of restoring trust, (3) services focusing on individuals, not families, (4) the necessity and caution around multidisciplinary support and (5) underfunded services inhibiting good practice.

Women who are at risk of children’s social care involvement will likely experience perinatal healthcare inequities. Our findings suggest that current perinatal healthcare provision for this population is inadequate and national guidelines need updated to inform support.

There is a dearth in suicide literature addressing the impact on general practitioners (GPs) of losing a patient. We aimed to examine the personal and professional impact as well as the availability of support and why GPs did or did not use it.

A qualitative study using one-to-one interviews with participants recruited using snowball sampling.

The study was conducted in a primary care setting.

Interviews were held with 19 GPs within primary care in Northern Ireland.

GPs are impacted both personally and professionally when they lose a patient to suicide, but may not access formal help due to commonly held idealised notions of a ‘good’ GP who is regarded as having solid imperturbability. Fear of professional repercussions also plays a major role in deterring help-seeking.

There is a need for a systemic culture shift within general practice which allows doctors to seek support when their physical or mental health require it. This may help prevent stress, burnout and early retirement.

Management of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) improves lung function and health status and reduces COPD exacerbation risk versus monotherapy. This study described treatment use, healthcare resource utilisation (HCRU), healthcare costs and outcomes following initiation of single-device ICS/LABA as initial maintenance therapy (IMT).

Retrospective cohort study.

Primary care, England.

Linked data from the Clinical Practice Research Datalink Aurum and Hospital Episode Statistics datasets.

Patients with COPD and ≥1 single-device ICS/LABA prescription between July 2015 and December 2018 were included.

Treatment pathways, COPD-related HCRU and healthcare costs, COPD exacerbations, time to triple therapy, medication adherence (proportion of days covered ≥80%) and indexed treatment time to discontinuation. Data for patients without prior maintenance therapy history (IMT users) and non-triple users were assessed over a 12-month follow-up period.

Of 13 451 new ICS/LABA users, 5162 were IMT users (budesonide/formoterol, n=1056; beclomethasone dipropionate/formoterol, n=2427; other ICS/LABA, n=1679), for whom at 3 and 12 months post-index, 45.6% and 39.4% were still receiving any ICS/LABA. At >6 to ≤12 months, the proportion of IMT users with ≥1 outpatient visit (10.1%) and proportion with ≥1 inpatient stay (12.6%) had increased from those at 3 months (9.0% and 7.4%, respectively). Inpatient stays contributed most to total COPD-related healthcare costs. For non-triple IMT users, at 3 and 12 months post-index, 4.5% and 13.7% had ≥1 moderate-to-severe COPD exacerbation. Time to triple therapy initiation and time to discontinuation of index medication ranged from 45.9 to 50.2 months and 2.3 to 2.8 months between treatments. Adherence was low across all time points (21.5–27.6%). Results were similar across indexed therapies.

In the year following treatment initiation, ICS/LABA adherence was poor and many patients discontinued or switched therapies, suggesting that more consideration and optimisation of treatment is required in England for patients initiating single-device ICS/LABA therapy.

Canada’s long-term care (LTC) homes were founded on an institutional model that viewed residents as passive recipients of care. Many homes continue to follow this model leaving residents removed from operational decision-making within their homes. However, involving residents in the design of their LTC home’s environment, programmes and operations can improve the residents’ quality of life and other outcomes. This codesign project creates a toolkit/resource for LTC homes to facilitate meaningful resident engagement in their home’s organisational design and governance.

This three-part project consists of a scoping review, qualitative interviews, toolkit/resource development and prototyping. In part 1, we conduct a scoping review to synthesise existing knowledge on approaches to engaging LTC home residents in organisational design and governance of their LTC homes, as well as explore barriers, challenges and facilitators of engagement, considerations for diversity and cognitive change, and approaches to evaluation. In part 2, we will have interviews and focus groups with residents, team members (staff) and administrators to assess community capacity to implement and sustain a programme to engage LTC residents in organisational design and governance of their LTC homes. The third part of our project uses these findings to help codesign toolkit(s)/resource(s) to enable the engagement of LTC residents in the organisational design and governance of their LTC homes.

The project is conducted in partnership with the Ontario Association of Residents’ Councils. We will leverage their communication to disseminate findings and support the use of the codesigned toolkit(s)/resource(S) with knowledge users. We will also publish the study results in an academic journal and present at conferences, webinars and workshops. These results can influence practices within LTC homes by inspiring an organisational culture where residents help shape the place they call home. The interviews and focus groups, conducted in part 2, have been submitted to the University Health Network Research Ethics Board.

The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

NCT05683795.