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AnteayerBMJ Open

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

Por: Barr · L. · Richards · J. · Chapman · G. J.
Introduction

Custom 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 method of foot shape capture used to produce insoles varies throughout orthotic services. This trial aims to investigate the effectiveness of two common shape-capture techniques on patient-reported outcomes in people who require insoles for a foot or ankle pathology.

Methods and analysis

This double-blinded randomised controlled trial will involve two intervention groups recruited from a National Health Service orthotic service. Participants will be randomly assigned to receive a pair of custom CAD/CAM insoles, manufactured either from a direct digital scan or a foam box cast of their feet and asked to wear the insoles for 12 weeks. The primary outcome measure will be the Foot Health Status Questionnaire (FHSQ) pain subdomain, recorded at baseline (immediately after receiving the intervention), 4, 8 and 12 weeks post intervention. Secondary outcome measures will include FHSQ foot function and foot health subdomains recorded at baseline, 4, 8 and 12 weeks. The Orthotic and Prosthetic User Survey Satisfaction with Device will be recorded at 12 weeks. The transit times associated with each arm will be measured as the number of days for each insole to be delivered after foot shape capture. Tertiary outcome measures will include participant recruitment and dropout rates, and intervention adherence measured as the daily usage of the insoles over 12 weeks. The change in FHSQ scores for the subdomains and insole usage will be compared between the groups and time points, and between group differences in time in transit, cost-time analysis and environmental impact will be compared.

Ethics and dissemination

Ethical approval was obtained from the Health Research Authority, London Stanmore Research Ethics Committee (22/LO/0579). Study findings will be submitted for publication in peer-reviewed journals, conference presentations and webinars.

Trial registration number

NCT05444192.

Study protocol for a cross-sectional online survey investigating patient preferences and experiences of waiting for elective cardiac surgery

Por: Russo · M. · Watson · K. · Richards · K. · Olive · R. R. · Krausova · B. · Kumar · R. · Burridge · J. · Goulding · L. · Chua · K.-C. · Hardy · D. · Vassilios · A. · Kamran · B. · Bhudia · S. · Alia · N. · Habib · K. · Sevdalis · N. · Petrou · M.
Introduction

Being on a waiting list for elective (planned) cardiac surgery can be physically and psychologically challenging for patients. Research suggests that stress associated with waiting for surgery is dependent on different individual and contextual factors. However, most data on patients’ experiences of waiting for surgery and preferences for waiting list management derives from non-cardiac clinical populations. The aim of the current study is to explore patients’ experiences of being on a waiting list for elective cardiac surgery, and their views on how the waiting experience could be improved in the future. This work will inform the patient management strategy during the waiting period for surgery across the four major hospitals in London directly involved in this study, and potentially beyond by transferring learning to other services.

Methods and analysis

This is a mixed-methods study that will collect quantitative and qualitative data using a cross-sectional online survey. Patients who are on waiting lists for elective surgery across four major cardiac surgery departments in London hospitals, and are at least 18 years old, will be invited by their healthcare team via text message or letter to complete the survey. The target sample size of non-randomly selected participants will be 268. Bivariable and multivariable regression models will be used to assess associations between survey items measuring the impact of the cardiac condition on specific life domains (eg, daily activities, social and family relationships, hobbies, sexual life), anxiety and depression symptoms as measured by the Patient Health Questionnaire-4 and survey items evaluating experiences of health services. Data on experience and preferences for improvements to the waiting experience will be analysed with qualitative content analysis using an inductive approach.

Ethics and dissemination

This study was reviewed and granted ethical approval by the East of England—East Cambridge Research Ethics Committee. Findings from this study will be disseminated through peer-reviewed journals, a research website and social media and with an online event engaging patients, members of the public, healthcare professionals and other relevant stakeholders.

Trial registration numb

NCT05996640

What might make nurses stay? A protocol for discrete choice experiments to understand NHS nurses preferences at early-career and late-career stages

Por: Ejebu · O.-Z. · Turnbull · J. · Atherton · I. · Rafferty · A. M. · Palmer · B. · Philippou · J. · Prichard · J. · Jamieson · M. · Rolewicz · L. · Williams · M. · Ball · J.
Introduction

Like many countries, England has a national shortage of registered nurses. Employers strive to retain existing staff, to ease supply pressures. Disproportionate numbers of nurses leave the National Health Services (NHS) both early in their careers, and later, as they near retirement age. Research is needed to understand the job preferences of early-career and late-career nurses working in the NHS, so tailored policies can be developed to better retain these two groups.

Methods and analysis

We will collect job preference data for early-career and late-career NHS nurses, respectively using two separate discrete choice experiments (DCEs). Findings from the literature, focus groups, academic experts and stakeholder discussions will be used to identify and select the DCE attributes (ie, job features) and levels. We will generate an orthogonal, fractional factorial design using the experimental software Ngene. The DCEs will be administered through online surveys distributed by the regulator Nursing and Midwifery Council. For each group, we expect to achieve a final sample of 2500 registered NHS nurses working in England. For early-career nurses, eligible participants will be registered nurses who graduated in the preceding 5 years (ie, 2019–2023). Eligible participants for the late-career survey will be registered nurses aged 55 years and above. We will use conditional and mixed logit models to analyse the data. Specifically, study 1 will estimate the job preferences of early-career nurses and the possible trade-offs. Study 2 will estimate the retirement preferences of late-career NHS nurses and the potential trade-offs.

Ethics and dissemination

The research protocol was reviewed and approved by the host research organisation Ethics Committees Research Governance (University of Southampton, number 80610) (https://www.southampton.ac.uk/about/governance/regulations-policies/policies/ethics). The results will be disseminated via conference presentations, publications in peer-reviewed journals and annual reports to key stakeholders, the Department of Health and Social Care, and NHS England/Improvement retention leaders.

Registration details

Registration on OSF http://doi.org/10.17605/OSF.IO/RDN9G.

Exploration of pain assessment and management processes in oncology outpatient services with healthcare professionals: a qualitative study

Por: Robinson · O. C. · Pini · S. · Flemming · K. · Campling · N. · Fallon · M. · Richards · S. H. · Mayland · C. R. · Boland · E. · Swinson · D. · Hurlow · A. · Hartup · S. · Mulvey · M. R.
Objectives

This study explored cancer pain management practices and clinical care pathways used by healthcare professionals (HCPs) to understand the barriers and facilitators for standardised pain management in oncology outpatient services (OS).

Design

Data were collected using semistructured interviews that were audio-recorded and transcribed. The data were analysed using thematic analysis.

Setting

Three NHS trusts with oncology OS in Northern England.

Participants

Twenty HCPs with varied roles (eg, oncologist and nurse) and experiences (eg, registrar and consultant) from different cancer site clinics (eg, breast and lung). Data were analysed using thematic analysis.

Results

HCPs discussed cancer pain management practices during consultation and supporting continuity of care beyond consultation. Key findings included : (1) HCPs’ level of clinical experience influenced pain assessments; (2) remote consulting impeded experienced HCPs to do detailed pain assessments; (3) diffusion of HCP responsibility to manage cancer pain; (4) nurses facilitated pain management support with patients and (5) continuity of care for pain management was constrained by the integration of multidisciplinary teams.

Conclusions

These data demonstrate HCP cancer pain management practices varied and were unstructured. Recommendations are made for a standardised cancer pain management intervention: (1) detailed evaluation of pain with a tailored self-management strategy; (2) implementation of a structured pain assessment that supports remote consultations, (3) pain assessment tool that can support both experienced and less experienced clinicians. These findings will inform the development of a cancer pain management tool to integrate within routine oncology OS.

How did New Zealands regional District Health Board groupings work to improve service integration and health outcomes: a realist evaluation

Por: Penno · E. · Atmore · C. · Maclennan · B. · Richard · L. · Wyeth · E. · Richards · R. · Doolan-Noble · F. · Gray · A. R. · Sullivan · T. · Gauld · R. · Stokes · T.
Objectives

In Aotearoa New Zealand (NZ), integration across the healthcare continuum has been a key approach to strengthening the health system and improving health outcomes. A key example has been four regional District Health Board (DHB) groupings, which, from 2011 to 2022, required the country’s 20 DHBs to work together regionally. This research explores how this initiative functioned, examining how, for whom and in what circumstances regional DHB groupings worked to deliver improvements in system integration and health outcomes and equity.

Design

We used a realist-informed evaluation study design. We used documentary analysis to develop programme logic models to describe the context, structure, capabilities, implementation activities and impact of each of the four regional groupings and then conducted interviews with stakeholders. We developed a generalised context-mechanisms-outcomes model, identifying key commonalities explaining how regional work ‘worked’ across NZ while noting important regional differences.

Setting

NZ’s four regional DHB groupings.

Participants

Forty-nine stakeholders from across the four regional groupings. These included regional DHB governance groups and coordinating regional agencies, DHB senior leadership, Māori and Pasifika leadership and lead clinicians for regional work streams.

Results

Regional DHB working was layered on top of an already complex DHB environment. Organisational heterogeneity and tensions between local and regional priorities were key contextual factors. In response, regional DHB groupings leveraged a combination of ‘hard’ policy and planning processes, as well as ‘soft’, relationship-based mechanisms, aiming to improve system integration, population health outcomes and health equity.

Conclusion

The complexity of DHB regional working meant that success hinged on building relationships, leadership and trust, alongside robust planning and process mechanisms. As NZ reorients its health system towards a more centralised model underpinned by collaborations between local providers, our findings point to a need to align policy expectations and foster environments that support connection and collegiality across the health system.

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis

Por: Willan · K. · Moss · R. H. · Santorelli · G. · Ahern · S. · Bryant · M. · Bywater · T. · Blower · S. L. · Richardson · G. · Hinde · S. · Huo · D. · Wright · J. · Dickerson · J. · Innovation Hub · B. S. B.
Introduction

Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population.

Methods and analysis

An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.

Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.

Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).

Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives’ and women’s perspectives.

Ethics and dissemination

Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings.

Trial registration number

IsRCTNhttps://doi.org/10.1186/ISRCTN31836167

Scabies outbreak management in refugee/migrant camps in Europe 2014-2017: a retrospective qualitative interview study of healthcare staff experiences and perspectives

Por: Richardson · N. A. · Cassell · J. A. · Head · M. G. · Lanza · S. · Schaefer · C. · Walker · S. L. · Middleton · J.
Objectives

Provide insights into the experiences and perspectives of healthcare staff who treated scabies or managed outbreaks in formal and informal refugee/migrant camps in Europe 2014–2017.

Design

Retrospective qualitative study using semistructured telephone interviews and framework analysis. Recruitment was done primarily through online networks of healthcare staff involved in medical care in refugee/migrant settings.

Setting

Formal and informal refugee/migrant camps in Europe 2014–2017.

Participants

Twelve participants (four doctors, four nurses, three allied health workers, one medical student) who had worked in camps (six in informal camps, nine in formal ones) across 15 locations within seven European countries (Greece, Serbia, Macedonia, Turkey, France, the Netherlands, Belgium).

Results

Participants reported that in camps they had worked, scabies diagnosis was primarily clinical (without dermatoscopy), and treatment and outbreak management varied highly. Seven stated scabicides were provided, while five reported that only symptomatic management was offered. They described camps as difficult places to work, with poor living standards for residents. Key perceived barriers to scabies control were (1) lack of water, sanitation and hygiene, specifically: absent/limited showers (difficult to wash off topical scabicides), and inability to wash clothes and bedding (may have increased transmission/reinfestation); (2) social factors: language, stigma, treatment non-compliance and mobility (interfering with contact tracing and follow-up treatments); (3) healthcare factors: scabicide shortages and diversity, lack of examination privacy and staff inexperience; (4) organisational factors: overcrowding, ineffective interorganisational coordination, and lack of support and maltreatment by state authorities (eg, not providing basic facilities, obstruction of self-care by camp residents and non-governmental organisation (NGO) aid).

Conclusions

We recommend development of accessible scabies guidelines for camps, use of consensus diagnostic criteria and oral ivermectin mass treatments. In addition, as much of the work described was by small, volunteer-staffed NGOs, we in the wider healthcare community should reflect how to better support such initiatives and those they serve.

Lifecourse investigation of the cumulative impact of adversity on cognitive function in old age and the mediating role of mental health: longitudinal birth cohort study

Por: Liu · Y. · Patalay · P. · Stafford · J. · Schott · J. M. · Richards · M.
Objective

To investigate the accumulation of adversities (duration of exposure to any, economic, psychosocial) across the lifecourse (birth to 63 years) on cognitive function in older age, and the mediating role of mental health.

Design

National birth cohort study.

Setting

Great Britain.

Participants

5362 singleton births within marriage in England, Wales and Scotland born within 1 week of March 1946, of which 2131 completed at least 1 cognitive assessment.

Main outcome measures

Cognitive assessments included the Addenbrooke’s Cognitive Examination-III, as a measure of cognitive state, processing speed (timed-letter search task), and verbal memory (word learning task) at 69 years. Scores were standardised to the analytical sample. Mental health at 60–64 years was assessed using the 28-item General Health Questionnaire, with scores standardised to the analytical sample.

Results

After adjusting for sex, increased duration of exposure to any adversity was associated with decreased performance on cognitive state (β=–0.39; 95% CI –0.59 to –0.20) and verbal memory (β=–0.45; 95% CI –0.63 to –0.27) at 69 years, although these effects were attenuated after adjusting for further covariates (childhood cognition and emotional problems, educational attainment). Analyses by type of adversity revealed stronger associations from economic adversity to verbal memory (β=–0.54; 95% CI –0.70 to –0.39), with a small effect remaining even after adjusting for all covariates (β=–0.18; 95% CI –0.32 to –0.03), and weaker associations from psychosocial adversity. Causal mediation analyses found that mental health mediated all associations between duration of exposure to adversity (any, economic, psychosocial) and cognitive function, with around 15% of the total effect of economic adversity on verbal memory attributable to mental health.

Conclusions

Improving mental health among older adults has the potential to reduce cognitive impairments, as well as mitigate against some of the effect of lifecourse accumulation of adversity on cognitive performance in older age.

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