by Sarah J. Wright, Michele J. Grimm
The brachial plexus is a set of nerves that innervate the upper extremity and may become injured during the birthing process through an injury known as Neonatal Brachial Plexus Palsy. Studying the mechanisms of these injuries on infant cadavers is challenging due to the justifiable sensitivity surrounding testing. Thus, these specimens are generally unavailable to be used to investigate variations in brachial plexus injury mechanisms. Finite Element Models are an alternative way to investigate the response of the neonatal brachial plexus to loading. Finite Element Models allow a virtual representation of the neonatal brachial plexus to be developed and analyzed with dimensions and mechanical properties determined from experimental studies. Using ABAQUS software, a two-dimensional brachial plexus model was created to analyze how stresses and strains develop within the brachial plexus. The main objectives of this study were (1) to develop a model of the brachial plexus and validate it against previous literature, and (2) to analyze the effect of stress on the nerve roots based on variations in the angles between the nerve roots and the spinal cord. The predicted stress for C5 and C6 was calculated as 0.246 MPa and 0.250 MPa, respectively. C5 and C6 nerve roots experience the highest stress and the largest displacement in comparison to the lower nerve roots, which correlates with clinical patterns of injury. Even small (+/- 3 and 6 degrees) variations in nerve root angle significantly impacted the stress at the proximal nerve root. This model is the first step towards developing a complete three-dimensional model of the neonatal brachial plexus to provide the opportunity to more accurately assess the effect of the birth process on the stretch within the brachial plexus and the impact of biological variations in structure and properties on the risk of Neonatal Brachial Plexus Palsy.The objective was to map the experiences and needs of patients presenting with symptoms of suspected cancer in the primary care interval (from when they first present to primary care to their first appointment or referral to a secondary or tertiary level healthcare facility).
This was a scoping review.
Studies or reports written in English which included primary data on the primary care interval experiences and/or needs of adult patients presenting with new symptoms of suspected cancer were eligible. Studies which only included patients with secondary or recurring cancer, conference abstracts and reviews were excluded. No date limits were applied.
The Joanna Briggs Institute method for Scoping Reviews guided screening, report selection and data extraction. At least two independent reviewers contributed to each stage. Medline, CINAHL, PsychInfo, Embase and Web of Science were searched and several grey literature resources. Relevant quantitative findings were qualitised and integrated with qualitative findings. A thematic analysis was carried out.
Of the 4855 records identified in the database search, 18 were included in the review, along with 13 identified from other sources. The 31 included studies were published between 2002 and 2023 and most (n=17) were conducted in the UK. Twenty subthemes across four themes (patient experience, interpersonal, healthcare professional (HCP) skills, organisational) were identified. No studies included patient-reported outcome measures. Patients wanted (1) to feel heard and understood by HCPs, (2) a plan to establish what was causing their symptoms, and (3) information about the next stages of the diagnostic process.
Scoping review findings can contribute to service planning as the cancer diagnostic pathway for symptomatic presentation of cancer evolves. The effectiveness of this pathway should be evaluated not only in terms of clinical outcomes, but also patient-reported outcomes and experience, along with the perspectives of primary care HCPs.
Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.
To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.
Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (
Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p
There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.
Coal-fired power plants are major sources of air pollution which impact human health. Coal combustion byproducts released into the air include particulate matter, nitrogen oxides and sulphur dioxide. Exposure to fine particulate matter is associated with increased risk of mortality. This scoping review will examine and summarise the current literature on the health risks of exposure to air pollution in areas in which coal-fired power plants exist.
This scoping review will be conducted according to the Joanna Briggs Institute methodological framework and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Five electronic databases (PubMed, ScienceDirect, Scopus, Web of Science and Google Scholar) will be searched for relevant articles. Studies will be included up until 31 January 2024. There will be no restriction on geographical area. The searches will be limited to studies published in English. Title, abstract, full-text screening and data extraction of relevant articles will be done by two independent reviewers. Discrepancies will be resolved by group discussion. The findings will be presented in tables with a narrative summary. This review will consider epidemiological studies and grey literature that report on the health risks of exposure to air pollution in areas where coal-fired power plants exist.
All data will be collected from published and grey literature. Ethics approval is therefore not required. We will submit our findings for publication in a peer-reviewed journal.
Young people aged 18–24 years old are a key demographic target for eliminating HIV transmission globally. Pre-exposure prophylaxis (PrEP), a prevention medication, reduces HIV transmission. Despite good uptake by gay and bisexual men who have sex with men, hesitancy to use PrEP has been observed in other groups, such as young people and people from ethnic minority backgrounds. The aim of this study was to explore young people’s perceptions and attitudes to using PrEP.
A qualitative transcendental phenomenological design was used.
A convenience sample of 24 young people aged between 18 and 24 years was recruited from England.
Semistructured interviews and graphical elicitation were used to collect data including questions about current experiences of HIV care, awareness of using PrEP and decision-making about accessing PrEP. Thematic and visual analyses were used to identify findings.
Young people had good levels of knowledge about HIV but poor understanding of using PrEP. In this information vacuum, negative stigma and stereotypes about HIV and homosexuality were transferred to using PrEP, which were reinforced by cultural norms portrayed on social media, television and film—such as an association between using PrEP and being a promiscuous, white, gay male. In addition, young people from ethnic minority communities appeared to have negative attitudes to PrEP use, compared with ethnic majority counterparts. This meant these young people in our study were unable to make decisions about when and how to use PrEP.
Findings indicate an information vacuum for young people regarding PrEP. A strength of the study is that theoretical data saturation was reached. A limitation of the study is participants were largely from Northern England, which has low prevalence of HIV. Further work is required to explore the information needs of young people in relation to PrEP.
Children with cerebral palsy (CP) are prescribed home exercise programmes (HEPs) to increase the frequency of movement practice, yet adherence to HEPs can be low. This paper outlines the protocol for a single-case experimental design (SCED) with alternating treatments, using a new home therapy exercise application, Bootle Boot Camp (BBCamp), offered with and without movement tracking feedback. This study will explore the impact of feedback on engagement, movement quality, lower limb function and family experiences to help understand how technology-supported HEPs should be translated and the added value, if any, of movement tracking technology.
In this explanatory sequential mixed-methods study using a SCED, 16 children with CP (aged 6–12 years, Gross Motor Function Classification System levels I–II) will set lower limb goals and be prescribed an individualised HEP by their physiotherapist to complete using BBCamp on their home television equipped with a three-dimensional camera-computer system. Children will complete four weekly exercise sessions over 6 weeks. Children will be randomised to 1 of 16 alternating treatment schedules where BBCamp will provide or withhold feedback during the first 4 weeks. The version of BBCamp that results in the most therapeutic benefit will be continued for 2 final weeks. Goals will be re-evaluated and families interviewed. The primary outcome is adherence (proportion of prescribed exercise repetitions attempted) as a measure of behavioural engagement. Secondary outcomes are affective and cognitive engagement (smiley face ratings), exercise fidelity, lower limb function, goal achievement and participant experiences. SCED data will be analysed using visual and statistical methods. Quantitative and qualitative data will be integrated using joint displays.
Ethical approval was obtained from the Research Ethics Boards at Bloorview Research Institute and the University of Toronto. Results will be distributed through peer-reviewed journals and scientific conferences.
NCT05998239; pre-results.
Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.
The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.
Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.
To understand patients’ experiences with diabetes care during the COVID-19 pandemic, with an emphasis on rural, medically underserved, and/or minoritised racial and ethnic groups in the Midwestern USA.
Community-engaged, semi-structured interviews were conducted by medical student researchers trained in qualitative interviewing. Transcripts were prepared and coded in the language in which the interview was conducted (English or Spanish). Thematic analysis was conducted, and data saturation was achieved.
The study was conducted in communities in Eastern and Western Iowa.
Adults with diabetes (n=20) who were fluent in conversational English or Spanish were interviewed. One-third of participants were residents of areas designated as federal primary healthcare professional shortage areas and/or medically underserved areas, and more than half were recruited from medical clinics that offer care at no cost.
Themes across both English and Spanish transcripts included: (1) perspectives of diabetes, care providers and care management; (2) challenges and barriers affecting diabetes care; and (3) participant feedback and recommendations. Participants reported major constraints related to provider availability, costs of care, access to nutrition counselling and mental health concerns associated with diabetes care during the pandemic. Participants also reported a lack of shared decision-making regarding some aspects of care, including amputation. Finally, participants recognised systems-level challenges that affected both patients and providers and expressed a preference for proactive collaboration with healthcare teams.
These findings support enhanced engagement of rural, medically underserved and minoritised groups as stakeholders in diabetes care, diabetes research and diabetes provider education.
The objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients.
Patients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves.
Ethics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request.
Australian New Zealand Clinical Trials Registry (ACTRN 12622000659707).
The objective of this trial is to evaluate a CHN intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes.
Since the introduction of pneumococcal conjugate vaccines, pneumococcal disease rates have declined for many vaccine-type serotypes. However, serotype 3 (SPN3) continues to cause significant disease and is identified in colonisation epidemiological studies as one of the top circulating serotypes in adults in the UK. Consequently, new vaccines that provide greater protection against SPN3 colonisation/carriage are urgently needed. The Experimental Human Pneumococcal Challenge (EHPC) model is a unique method of determining pneumococcal colonisation rates, understanding acquired immunity, and testing vaccines in a cost-effective manner. To enhance the development of effective pneumococcal vaccines against SPN3, we aim to develop a new relevant and safe SPN3 EHPC model with high attack rates which could be used to test vaccines using small sample size.
This is a human challenge study to establish a new SPN3 EHPC model, consisting of two parts. In the dose-ranging/safety study, cohorts of 10 healthy participants will be challenged with escalating doses of SPN3. If first challenge does not lead into colonisation, participants will receive a second challenge 2 weeks after. Experimental nasopharyngeal (NP) colonisation will be determined using nasal wash sampling. Using the dose that results in ≥50% of participants being colonised, with a high safety profile, we will complete the cohort with another 33 participants to check for reproducibility of the colonisation rate. The primary outcome of this study is to determine the optimal SPN3 dose and inoculation regime to establish the highest rates of NP colonisation in healthy adults. Secondary outcomes include determining density and duration of experimental SPN3 NP colonisation and characterising mucosal and systemic immune responses to SPN3 challenge.
This study is approved by the NHS Research and Ethics Committee (reference 22/NW/0051). Findings will be published in peer-reviewed journals and reports will be made available to participants.
The prevalence of type 2 diabetes (T2D) is increasing in the Latinx community. Despite telehealth and technology becoming more available, these resources are not reaching the Latinx population. Diabetes education is a cornerstone of treatment; however, access to culturally tailored content is a barrier to the Latinx population. Real-time continuous glucose monitoring (RT-CGM) is a patient-empowering tool that can improve glycaemic control, but it is not readily available for Latinx patients with T2D. We aim to evaluate a culturally tailored diabetes self-management education and support (DSMES) curriculum, using a team-based approach to improve glycaemic control, promote healthy behaviours and enhance patient access with the use of telehealth in Latinx individuals. The primary aim of the study is to evaluate the additive effectiveness of RT-CGM on glycaemia and behavioural changes among Latinx patients undergoing a culturally tailored DSMES. A sub aim of the study is to evaluate family members’ change in behaviours.
We propose a randomised controlled trial of blinded versus RT-CGM with 100 Latinx participants with T2D who will receive DSMES via telemedicine over 12 weeks (n=50 per group). The study will be conducted at a single large federally qualified health centre system. The control group will receive culturally tailored DSMES and blinded CGM. The intervention group will receive DSMES and RT-CGM. The DSMES is conducted by community health educators weekly over 12 weeks in Spanish or English, based on participant’s language preference. Patients in the RT-CGM group will have cyclical use with a goal of 50 days wear time. The primary outcomes are changes in haemoglobin A1c and CGM-derived metrics at 3 and 6 months. The secondary outcomes include participants’ self-management knowledge and behaviour and household members’ change in lifestyle.
The study proposal was approved by the University of Washington ethics/institutional review board (IRB) Committee as minimal risk (IRB ID: STUDY00014396) and the Sea Mar IRB committee.
ClinicalTrials.gov identifier: NCT05394844
This study aims to map existing literature describing how people with lived experience of self-harm have engaged in codesigning self-harm interventions, understand barriers and facilitators to this engagement, and how the meaningfulness of codesign has been evaluated.
Scoping review by Joanna Briggs Institute methodology. A protocol was published online (http://dx.doi.org/10.17605/OSF.IO/P52UD).
PubMed, Embase, PsycINFO, Web of Science, Cochrane Library, PROSPERO, ClinicalTrials.gov and relevant websites were searched on 24 December 2022 (repeated 4 November 2023).
We included studies where individuals with lived experience of self-harm (first-hand or caregiver) have codesigned self-harm interventions.
Results were screened at title and abstract level, then full-text level by two researchers independently. Prespecified data were extracted, charted and sorted into themes.
We included 22 codesigned interventions across mobile health, educational settings, prisons and emergency departments. Involvement varied from designing content to multistage involvement in planning, delivery and dissemination. Included papers described the contribution of 159 female, 39 male and 21 transgender or gender diverse codesigners. Few studies included contributors from a minoritised ethnic or LGBTQIA+ group. Six studies evaluated how meaningfully people with lived experience were engaged in codesign: by documenting the impact of contributions on intervention design or through postdesign reflections. Barriers included difficulties recruiting inclusively, making time for meaningful engagement in stretched services and safeguarding concerns for codesigners. Explicit processes for ensuring safety and well-being, flexible schedules, and adequate funding facilitated codesign.
To realise the potential of codesign to improve self-harm interventions, people with lived experience must be representative of those who use services. This requires processes that reassure potential contributors and referrers that codesigners will be safeguarded, remunerated, and their contributions used and valued.
by Timothy R. Elliott, Yu-Yu Hsiao, Kathleen Randolph, Randall J. Urban, Melinda Sheffield-Moore, Richard B. Pyles, Brent E. Masel, Tamara Wexler, Traver J. Wright
Debilitating symptoms of fatigue and accompanying “brain fog” are observed among patients with various chronic health conditions. Unfortunately, an efficient and psychometrically sound instrument to assess these co-occurring symptoms is unavailable. Here, we report the development and initial psychometric properties of the Fatigue and Altered Cognition Scale (the FACs), a measure of self-reported central fatigue and brain fog. Traumatic brain injury (TBI) was chosen to model and develop the FACs due to research team expertise and established links between TBI and the symptom complex. Potential items were generated by researchers and clinicians with experience treating these symptoms, drawing from relevant literature and review of patient responses to measures from past and current TBI studies. The 20 candidate items for the FACs—ten each to assess altered cognition (i.e., brain fog) and central fatigue–were formatted on an electronic visual analogue response scale (eVAS) via an online survey. Demographic information and history of TBI were obtained. A total of 519 participants consented and provided usable data (average age = 40.23 years; 73% female), 204 of whom self-reported a history of TBI (75% reported mild TBI). Internal consistency and reliability values were calculated. Confirmatory factor analysis (CFA) examined the presumed two-factor structure of the FACs and a one-factor solution for comparison. A measurement invariance test of the two latent constructs (altered cognition, fatigue) among participants with and without TBI was conducted. All items demonstrated normal distribution. Cronbach’s alpha coefficients indicated good internal consistency for both factors (α’s = .95). Omega reliability values were favorable (α’s = .95). CFA supported the presumed two-factor model and item loadings which outperformed the one-factor model. Measurement invariance found the two-factor structure was consistent between the two groups. Implications of these findings, study limitations, and potential use of the FACs in clinical research and practice are discussed.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.
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.
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.
Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines.
This is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient–participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient–participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned.
The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations.
ACTRN12622001505796.
by Shannon E. Wright, Caroline Palmer
Accurate perception and production of auditory rhythms are key for human behaviors such as speech and music. Auditory rhythms in music range in their complexity: complex rhythms (based on non-integer ratios between successive tone durations) are more difficult to perceive and produce than simple rhythms (based on integer ratios). The physiological activity supporting this behavioral difference is not well understood. In a within-subjects design, we addressed how rhythm complexity affects cardiac dynamics during auditory perception and production. Musically trained adults listened to and synchronized with simple and complex auditory rhythms while their cardiac activity was recorded. Participants identified missing tones in the rhythms during the Perception condition and tapped on a keyboard to synchronize with the rhythms in the Synchronization condition. Participants were equally accurate at identifying missing tones in simple and complex rhythms during the Perception condition. Tapping synchronization was less accurate and less precise with complex rhythms than with simple rhythms. Linear cardiac analyses showed a slower mean heart rate and greater heart rate variability during perception than synchronization for both simple and complex rhythms; only nonlinear recurrence quantification analyses reflected cardiac differences between simple and complex auditory rhythms. Nonlinear cardiac dynamics were also more deterministic (predictable) during rhythm perception than synchronization. Individual differences during tapping showed that greater heart rate variability was correlated with poorer synchronization. Overall, these findings suggest that linear measures of musicians’ cardiac activity reflect global task variability while nonlinear measures additionally reflect stimulus rhythm complexity.