Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

We aim to use an agent-based model to accurately predict the spread of COVID-19 within multiple US state prisons.

We developed a semistochastic transmission model of COVID-19.

Five regional state-owned prisons within North Carolina.

Several thousand incarcerated individuals.

We measured (1) the observed and simulated average daily infection rate of COVID-19 for each prison studied in 30-day intervals, (2) the observed and simulated average daily recovery rate from COVID-19 for each prison studied in 30-day intervals, (3) the mean absolute percentage error (MAPE) of each prison’s summary statistics and the simulated results and (4) the parameter estimates of key predictors used in the model.

The COVID-19 pandemic disparately affected incarcerated populations in the USA, with severe morbidity and infection rates across the country. In response, many predictive models were developed to help mitigate risk. However, these models did not feature the systemic factors of prisons, such as vaccination rates, populations and capacities (to determine overcrowding) and design and were not generalisable to other prisons.

An agent-based model that used geospatial contact networks and compartmental transmission dynamics was built to create predictive microsimulations that simulated COVID-19 outbreaks within five North Carolinian regional prisons between July 2020 and June 2021. The model used the characteristics of an outbreak’s initial case size, a given facility’s capacity and its incarcerated vaccination rate as additional parameters alongside traditional susceptible-exposed-infected-recovered transmission dynamics. By fitting the model to each prison’s data using approximate Bayesian computation methods, we derived parameter estimates that reasonably modelled real-world results. These individualised estimates were then averaged to produce generalised parameter estimates for North Carolina state prisons overall.

Our model had a mean average MAPE score of 23.0 across all facilities, meaning that it reasonably forecasted facilities’ average daily positive and recovery rates of COVID-19. Our model estimated an average incarcerated vaccination rate of 54% across all prisons (with a 95% CI of ±0.12). In addition, the prisons of this study were estimated to be operating at 90% of their capacity on average (95% CI ±0.16). Given the high levels of COVID-19 observed in these prisons, which averaged over one-third positive tests on respective 1-day maxima, we conclude that vaccination levels were not sufficient in curbing COVID-19 outbreaks, and high occupancy levels likely exacerbated the spread of COVID-19 within prisons.

In addition, data gaps in facilities without recorded daily testing resulted in poor spread predictions, demonstrating how important consistent data release practices are in incarcerated settings for accurate tracking and prediction of outbreaks.

The findings of this study better quantify how spatial contact networks and facility-level characteristics unique to congregate living facilities can be used to predict infectious disease spread. Our approach also highlights the need for increased vaccination efforts and potential capacity reductions to mitigate COVID-19 transmission in prisons.

Health literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.

In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.

This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.

Despite the high prevalence of chronic low back pain (cLBP), its underlying mechanisms remain poorly understood. Addressing modifiable psychosocial resources and health behaviours such as physical activity offers a promising avenue for reducing the impact of cLBP. Furthermore, although the relationship between physical activity and pain is theorised as a within-person process, previous research has primarily focused on between-person differences. In this article, we present the protocol for the prospective observational study PRIA (Psychologie und Rückengesundheit im Alltag), which is part of a larger interdisciplinary research consortium investigating preventive, diagnostic and therapeutic aspects of cLBP. Drawing on theories from health and pain psychology, the outlined study examines the interplay between different dimensions of cLBP and back health, physical activity and their psychosocial determinants within individuals in their everyday lives.

This prospective longitudinal study combines online questionnaires with ecological momentary assessment of health behaviours, cognitions, affect, social support and pain using a smartphone-based app (movisensXS) and continuous measurement of physical activity by accelerometry (movisens Move 4). Parameters will be recorded at baseline (T0), daily for the following 14 days (five times per day at 09:00, 12:00, 15:00, 18:00 and 21:00, resulting in up to 70 measurement occasions), 3 and 6 months later (T1 and T2). A total of 230 participants (115 individuals with cLBP and 115 without cLBP) aged 18–64 years will be enrolled. The associations between cLBP and the measured parameters will be examined using multilevel models.

The university’s ethics committee at the MSB Medical School Berlin approved the study on 8 March 2021 (approval number MSB-2021/59, amendment approved on 10 November 2023, amendment number MSB-2023/145). Ethical approval for the FOR 5177 initial screening was granted by Charité – Universitätsmedizin Berlin (EA1/058/21). All participants provided written informed consent. The results of this research will be published in peer-reviewed international journals, presented at national and international conferences, and reported to the German Research Foundation.

DRKS00032978.

To determine whether hormonal contraceptives are associated with subsequent risks of suicidal behaviour and depression among women of reproductive age.

Nationwide register-based study.

Swedish national population using health and death registers. Nationwide registries provided individual-level information about the use of hormonal contraception, suicidal behaviour, depression and potential confounders.

All women in Sweden from 1 January 2006 to 31 December 2013.

Suicidal behaviour events or registered deaths due to suicide were identified through the National Patient Register and Cause of Death Register, respectively. Clinical diagnoses of depression were obtained from the patient register. Cox regression models were used to estimate HRs with 95% CIs of suicidal behaviour and depression in women using hormonal contraceptives.

We followed more than two million women for a median of 6.8 years (12.4 million person-years in total). No increased risk was observed among women using oral contraceptives or non-oral combined oestrogen/progestin formulations. Non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour using both population-based (HR=1.17, 95% CI 1.13 to 1.21) and within-individual (HR=1.16, 95% CI 1.11 to 1.21) analyses. Age-stratified analyses revealed that during late adolescence (age 15–18), use of oral contraceptives or non-oral combined formulations was associated with an increased risk of suicidal behaviour (range of HRs: 1.09–1.35), an effect that was not observed in adulthood. In contrast, non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour during both late adolescence and adulthood.

We found no overall increased risk of suicidal behaviour among women using oral contraceptives or non-oral combined formulations. However, the observed increased risk associated with hormonal contraceptive use during adolescence, as well as with non-oral progestin-only contraception—particularly gonane-containing formulations—across the entire reproductive window warrants attention and further investigation.

To evaluate adherence to National Health Service (NHS) patient registration ID guidelines among General Practitioners’ (GP) practices.

A mystery shopper study, including website reviews and phone calls.

Rural and urban parts of the United Kingdom’s West Midlands.

85 randomly selected GP practices.

In January–April 2024, GP’s websites were reviewed before phone calls in which our ‘mystery shopper’ was asked to register without photo ID and proof of address.

Of 85 GP practices, 60 (71%) breached NHS guidance either online or over the phone, with only 25 (29%) consistently following NHS guidance. Phone calls to rural (vs urban) GP practices were more likely to yield refusal of registration without photo ID and proof of address, despite rural (vs urban) GP practices making similar statements online. During some phone calls, practices sought to negotiate a compromise by requesting less robust ‘documentation’, such as an addressed parcel.

GP practices commonly refuse registration to people without photo ID or proof of address, thus creating ‘sludge’ and undermining access to healthcare especially for poor, vulnerable patients, including immigrants. Changing GP practices’ websites would not address this problem if erroneous information is still provided over the phone. GPs and practice managers should ensure that all staff follow NHS guidance to allow registration without these documents.

The aetiology of eating disorders (EDs) is complex, involving an interplay of genetic and environmental factors. Children at familial high risk (FHR) for EDs demonstrate increased risk of developing EDs themselves compared with children born to parents without EDs, though the majority remain unaffected. The BLOOM study is an FHR study that aims to identify biological, neurocognitive and psychosocial risk and protective pathways to EDs. Results of this study will help identify trait markers of EDs, inform targeted preventive intervention strategies and clarify how to mitigate genetic risk of EDs.

This prospective cohort study will enrol 510 children aged 8–10 years, including 360 at FHR for developing EDs (comprising 120 children each from mothers with anorexia nervosa, bulimia nervosa and binge ED) and 150 children not at FHR. Participants will be recruited over 2 years and followed up every 2 years. Data collection will include dual X-ray absorptiometry scans to evaluate body composition, saliva samples for genotyping, neurocognitive testing, self and parent-reported questionnaires and semistructured diagnostic interviews of psychopathology and well-being. Optional data collection will include fasting blood samples, stool samples and brain MRI scans. Mothers and secondary caregivers will complete questionnaires regarding family functioning and their mental health.

The study has been approved by the Danish Data Protection Agency (p-2023-14826) and the Regional Ethics Committee of Health Research of the Capital Region of Denmark (H-23043100). Written consent will be obtained from all participants. Results will be disseminated at scientific conferences, in peer-reviewed publications, PhD dissertations and to relevant stakeholders.

To inform about behavioural gender and age differences in compliance with hand hygiene recommendations during the COVID-19 pandemic in Switzerland.

Observational study (24–25 June and 1–3 July 2020); validation study (4 December 2020); gender and age group estimated by observers.

Observations occurred in five supermarkets.

All customers entering the supermarkets during a 3-hour period per day (n=8245 main study) and during 1 day (n=1918 validation study).

We observed whether people disinfected their hands.

The study reveals considerable differences with respect to gender and age: For women, 58.7% (95% CI 57.3 to 60.0%) were disinfecting their hands vs 50.4% (95% CI 48.6 to 52.2%) of men. With respect to age, we identified a steep increase across age groups up to the age of 60 years and older with 35.5% (95% CI 30.7 to 40.5%) of youth (12-17 yrs) disinfecting their hands, 50.5% (95% CI 49.1 to 51.9%) of adults (18-59 yrs) vs 69.0% (95% CI 67.1 to 70.9%) of the golden age group (60-74 yrs) and 67.2% (95% CI 61.1 to 72.9%) of people older than 75 years. The validation study confirmed these differences.

The study documents substantial differences in hand hygiene compliance between gender and age groups. This should be considered in the design of protective measures to ensure clean and safe hands.

Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

To examine trends in preconception and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, obstetric interventions, and the impact of COVID-19, and to forecast future disease burden.

A multi-centre retrospective cohort study.

A large hospital network with three maternity hospitals serving ethnically diverse populations in Melbourne, Australia.

Pregnant women who gave birth between 2016 and 2022.

Trends in cardiometabolic conditions, birth complications and obstetric interventions.

Over 7 years, 63 232 women were included, of whom 40% were nulliparous, and 60.9% were born overseas from 167 countries. From 2016–2022, maternal age (30.2–31.3 years), obesity (21.0%–26.2%), gestational diabetes mellitus (GDM) (15.9%–28.1%) and caesarean delivery (28.5%–37.6%) increased, while average gestational weight gain, premature births and special care admissions declined from 12.6–11.6 kg, 6.3%–4.9% and 24.2%–14.1%, respectively; and was statistically significant (p

Prepregnancy and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, and obstetric interventions increased markedly over 7 years. Despite this, offspring complications, including special care admissions, stillbirths and prematurity, decreased, while pregnancy complications peaked during COVID-19. GDM is forecasted to increase to 43.0% by 2028, posing an unsustainable health and economic burden that necessitates urgent public health initiatives.

Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.

UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).

This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.

NCT06112977; ISRCTN17470747.

Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.

The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.

The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.

ISRCTN14591444.

This study aimed to examine how older adults form beliefs about their memory and how these beliefs are influenced by their level of concern about dementia. Inaccurate beliefs and excessive worrying, indicative of erroneous metacognition, are associated with negative health outcomes. This research can help identify mitigation for these harmful effects.

Qualitative focus groups; thematic analysis.

Focus group discussion with healthy older adults hosted at a university in central London.

35 healthy older individuals (women=29) without any psychiatric or neurological diagnoses, over the age of 65 years (mean 75.31, SD: 6.15). 13 participants were identified as having a high level of worry about dementia and 22 as having low worry. Groups were matched for cognitive performance on the Telephone Mini Addenbrooke’s cognitive assessment (Tele-MACE).

Participants were assigned to a focus group depending on their level of worry about dementia. During focus groups, a vignette prompted discussion around lifespan changes in memory and how this affected concerns around memory. This allowed investigation of the differences in beliefs about memory.

Thematic analysis revealed two key themes. First, older adults appear to base their definition of ‘normality’ of their own memory on comparisons. These comparisons were between themselves and others and between themselves now and their own past self. Despite similar strategies to define ‘normality’, those with high dementia worry had stricter definitions of what they determined as normal. The second theme described narratives around the ‘self’ and the ‘other’. There was a difference between those with high versus low worry; those with high worry had a strong focus on the ‘self’, while those with low dementia worry focused on ‘others’.

Comparison is a common metacognitive strategy used in forming beliefs about memory. Targeting the use of comparison is potentially valuable in interventions aiming to alleviate older adults’ memory concerns. Addressing self-focused thinking, for example, with cognitive behavioural therapy, could improve harmful levels of high worry.