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Effectiveness of poliovirus environmental surveillance in Ghana: an indicator-based performance evaluation across seven regions, 2018-2022

Por: Obodai · E. · Asante Ntim · N. A. · Duker · E. O. · Gberbi · E. · Antwi · C. N. · Mensah · J. Y. · Odame · D. · Boakye · J. D. · Bimpong · S. A. · Agbotse · G. D. · Odoom · N. · Adams · P. L. · Acquah · N. K. · Dickson · A. E. · Odoom · C. · Achempem · K. K. · Baffoe-Nyarko · I. · Egbi
Objective

To evaluate the performance of Ghana’s environmental surveillance (ES) system for poliovirus (PV) detection from 2018 to 2022 using standardised indicators developed by the WHO and the US Centers for Disease Control and Prevention.

Design

A retrospective performance evaluation using 10 key indicators benchmarked against global targets for PV surveillance.

Setting

Seven regions across Ghana, participating in the national ES programme implemented under the Global Polio Eradication Initiative.

Surveillance coverage

Wastewater sampling was conducted at designated ES sites, supported by field collection teams and laboratory personnel responsible for sample acquisition, processing and reporting of PV detection results.

Outcome measures

Detection rates of PV and non-polio enteroviruses (NPEVs), timeliness of sample collection and reporting, data quality and system stability.

Results

A total of 738 wastewater samples were collected. The system demonstrated high sensitivity, detecting circulating vaccine-derived PV type 2 in 51 (6.9%) of samples, Sabin PV types 1 and 3 in 61 (9.5%) and 114 (17.8%), respectively, and NPEVs in 491 (66.5%) of samples. Over 80% of samples met the recommended 21-day collection-to-reporting time frame. Data quality exceeded the ≥80% threshold, and workflows remained stable throughout the evaluation period.

Conclusions

Ghana’s ES system for PV was found to be flexible, stable and effective in generating high-quality data for early detection and public health response. These findings underscore the system’s critical role in supporting polio eradication efforts and highlight its potential as a model for surveillance in similar settings.

Study protocols for the GEPard project: systematic analysis of sex- and gender-specific differences in the efficacy of perioperative pain management - a two-pronged approach

Por: Floren · S. · Segelcke · D. · Machacek · P. A. · Vollert · J. · Norda · H. · Rohde · I. · Gilron · I. · Pogatzki-Zahn · E. M.
Introduction

Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.

Methods and analysis

The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.

Ethics and dissemination

No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.

PROSPERO registration number

The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).

A Remote Nursing‐Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomised Controlled Trial

ABSTRACT

Aim

To assess the impact of a nurse-led remote secondary cardiovascular prevention programme versus usual follow-up in patients who have suffered an acute coronary syndrome in terms of major adverse clinical events (MACE), diet, physical exercise, smoking, emotional state, adherence to medical treatment, cardiometabolic profile and anthropometric parameters within one year of discharge.

Design

Prospective, randomised, open-label, evaluator-blinded, multicentre trial.

Methods

Between October 17, 2017, and February 5, 2023, patients were randomly assigned to either a usual follow-up of two cardiology visits over 12 months or the nurse-led remote secondary cardiovascular prevention programme, which also included 5 nursing visits (one face-to-face and four remote).

Results

At 12 months, the nurse-led remote prevention programme group (interventional group) had lower smoking rates, greater adherence to medication, greater adherence to the Mediterranean diet, more physical activity, and better perceived health status compared to the usual follow-up group. The interventional group demonstrated a reduction in major adverse clinical events (20.7%) compared to the usual follow-up group (12.4%). This reduction was observed particularly in Acute Coronary Syndrome recurrence, all-cause hospitalisation, and hospitalisation for cardiovascular causes.

Conclusions

Patients randomised to the nurse-led remote prevention programme showed a significant reduction of the MACE, improved lifestyle, and medication adherence at 12 months compared to the usual follow-up group.

Implications for the Profession and/or Patient Care

This study illustrates the feasibility and efficacy of a remote secondary cardiovascular prevention programme led by advanced practice nurses in patients who have suffered an Acute Coronary Syndrome.

Reporting Method

CONSORT.

Patient or Public Contribution

None.

Trial Registration

The study was prospectively registered at www.clinicaltrials.gov: NCT03234023

‘We've Taken on a More Advanced Clinical Role’: A Multimethod Study of Community Nurses' Extended Roles in Palliative Care

ABSTRACT

Aim

To explore community nurses' experiences of changes to their roles in palliative and end-of-life care.

Design

An e-survey was followed by focus groups.

Methods

Fifty-one community nurses with recent experience of delivering end-of-life care in the United Kingdom completed a survey about changes to their roles. A purposive sample of 35 respondents participated in focus groups exploring these changes in more depth; thematic analysis was used with constant comparison.

Results

As well as two new roles—prescribing and verifying death—many participants talked about a broader expansion of their role, increasing their leadership in making complex end-of-life care decisions with patients and families. Most nurses expressed pride in their new knowledge and skills, and satisfaction with the care they were providing. Yet many also expressed distress that heavy workloads impaired their capacity both to provide good clinical care and to train junior colleagues. The importance of General Practitioner support with complex cases was often highlighted, but accessing such support was sometimes difficult.

Conclusion

While welcoming the opportunity to extend their palliative care roles, many participants indicated experiencing moral distress.

Implications for the Profession and/or Patient Care

Excessive workloads and patchy medical support threaten the retention of the experienced nurses upon whom community palliative care depends.

Impact

Our findings suggest that new and extended palliative care roles are viewed positively by nurses. To be sustainable, these changes require better workload management and consistent medical back-up.

Reporting

We adhered to relevant EQUATOR guidelines, using the SRQR checklist.

Patient or Public Contribution

Our Public and Clinician Advisory Group helped shape questions and commented on findings.

Social Frailty in Heart Failure: Concept, Impact and Preventive Strategies

ABSTRACT

Aims

To explore the conceptualisation of social frailty and discuss its role in shaping the disease trajectory of heart failure. Based on the discussion, recommendations on how to prevent and manage social frailty in this clinical cohort are delineated.

Design

A discursive paper.

Methods

This paper searched two databases, PubMed and Google Scholar, for a narrative review of the literature related to social frailty and heart failure from 2008 to 2024.

Findings

By integrating the conceptualisation of social frailty from different theoretical paradigms, social frailty is a multi-domain construct that relies on a balance between the availability of environmental resources, social interactions and an individual's ability to maintain and acquire these resources to enhance their well-being. Substantial evidence showed the prognostic impact of social frailty on patient-reported, functional and clinical outcomes of patients with heart failure. The underlying mechanism is still under-investigated, but heart failure-related self-care may mediate its impact. Based on this evidence, improving social frailty may rely on a diagnostic protocol to enhance the person-centred care planning on ways to optimise the social resources to support complex self-care.

Conclusion

Social frailty poses a greater risk to health outcomes in patients with heart failure. Further research is needed to explore determinants and interventions for social frailty in this population.

Implications

This paper increases the awareness of social frailty in heart failure patients and provides important insights on how to combat this social determinant of poor health outcomes among this clinical cohort. A dual-purpose approach of improving social resources and self-care behaviours may have great promise in reducing their social frailty, and this postulation will need to be investigated in future research.

Patient or Public Contribution

There is no involvement of patients or the public in the design or writing of this discursive paper.

Development and evaluation of a modular smoke evacuator for surgical smoke control

by Suksan Kanoksin, Suphakarn Techapongsatorn

Background

Surgical smoke generated during energy-based operations is a known hazard containing particulate matter (PM), volatile organic compounds (VOCs), and biological debris, with insufficient adoption of commercial smoke evacuators due to cost and complexity.

Objective

This study aimed to develop a cost-effective, modular and passive smoke evacuator and evaluate its efficacy in reducing PM and VOC levels during simulated laparoscopic procedures.

Methods

A prototype smoke evacuator incorporating a distilled water bubbling trap, activated carbon filter, and ULPA filter was tested in a sealed chamber simulating laparoscopic surgery using porcine liver tissue. The system was connected to a laparoscopic port through a three-way valve, allowing manual, on-demand smoke evacuation without continuous suction. Air quality metrics, including PM1.0, PM2.5, PM10, VOC, and CO₂, were measured continuously. Results were compared to baseline and performance benchmarks from commercial smoke evacuation systems. Statistical analysis was performed using paired t-tests.

Results

The prototype evacuator reduced PM2.5 levels by >99.5% and VOC concentrations by >95% compared to no-evacuation control trials (p 2.5 and VOC levels were restored to near-baseline values.

Conclusion

The developed modular passive smoke evacuator offers a promising and cost-effective solution to improve air quality and enhance occupational safety in operating rooms. The model represents an idealized simulation of laparoscopic smoke evacuation; further clinical validation in live surgical environments is warranted.

Artificial intelligence-based dairy cattle behavior recognition for estrus detection via ensemble fusion of two camera views

by Panawit Hanpinitsak, Tatpong Katanyukul, Norrawit Tonmitr, Chanon Suntra, Sora-at Tanusilp, Arthit Phuphaphud

Monitoring cattle behavior plays an important role in improving farm productivity, maintaining animal welfare, and supporting efficient management practices. This study presents a multi-view behavior recognition system that uses synchronized top-view and front-view CCTV footage, combined with deep learning techniques. The system includes four main components: cow identification, behavior classification, identity-behavior association using Intersection-over-Union (IoU), and a decision-level ensemble to combine information from both views. YOLOv8 models are applied separately to each camera angle to detect individual cows and classify six key behaviors: drinking, eating, standing, lying, riding, and chin resting, with the latter two being relevant for estrus detection. The system matches cow identities to their behaviors within each view and then integrates the results to produce a final activity label for each cow.

The quality and safety of <i>Rhodiola rosea</i> supplements on the U.S. market: An analysis of biomarkers, heavy metals, and pesticide residues

by Steffen Porwollik, Mahtab Jafari

Rhodiola rosea supplements have become popular in the U.S., with a $3.4 billion market and an annual growth of about 10% in sales in the past few years. While the health benefits of this plant have been evaluated in many scientific studies, the potential differences in quality of these botanical products on the U.S. market have not been studied in detail. Using reversed-phase ultra-performance liquid chromatography, we determined the concentrations of the biomarker molecules, rosavins and salidroside, in a small but representative sample of R. rosea dietary supplement products commercially available in the U.S. Concentrations of rosavins and salidroside ranged from 0.01% to 3.08% and 0.07% to 2.91%, respectively, including substantial aberrations from advertised biomarker amounts. One product showed an undisclosed likely addition of synthetic salidroside. We also assessed heavy metal contaminations via inductively coupled plasma mass spectrometry and pesticide contents by gas chromatography-mass spectrometry or liquid chromatography-mass spectrometry in these botanical products. While pesticide levels were below detection limits, all seven tested capsular products had trace amounts of arsenic, cobalt, and lead. Two of these contained notably elevated levels of cobalt and arsenic, where follow-up arsenic speciation would be required to verify whether they remain within minimal risk levels established by the U.S. Department of Health and Human Services. Overall, these results underscore the need for more stringent quality control in herbal supplements containing R. rosea available in the U.S.

Impact of storage conditions on the stability and biological efficacy of <i>trans</i>-arachidin-1 and <i>trans</i>-arachidin-3

by Ploy Khongrungjarat, Chonnikan Tothong, Chanyanut Pankaew, Suchada Phimsen, Nopawit Khamto, Nutthamon Kijchalao, Warissara Wongkham, Piyathida Wongkham, Wipaporn Chuaymaung, Adsadayu Thonnondang, Apinun Limmongkon

Prenylated stilbenoids, particularly trans-arachidin-1 (Ara-1) and trans-arachidin-3 (Ara-3), have gained attention for their notable bioactivities and potential health-promoting properties. This study presents the first comprehensive investigation into the stability and biological efficacy of these compounds in both peanut hairy root culture crude extracts (PCE) and partially purified fractions derived from elicited peanut hairy root cultures. PCE stored at –20 °C and 4 °C maintained higher antioxidant capacity, total phenolic content compared to samples stored at room temperature. In cytotoxicity assays using SW480 colon cancer cells, the extract stored at –20 °C retained bioactivity with only minor changes in IC₅₀ values over three months, demonstrating superior stability under frozen conditions. Over a six-month period, partially purified fractions of Ara-1 and Ara-3 showed a time-dependent decline in compound content. However, Ara-3 maintained strong cytotoxicity against KKU-100 cholangiocarcinoma cells, while Ara-1 exhibited a significant loss in activity. These findings demonstrate that low-temperature storage, particularly at –20 °C, is crucial for preserving the chemical integrity and bioactivity of stilbenoid-rich extracts. The study underscores the importance of optimizing storage conditions to ensure consistent bioactivity, supporting the potential application of these compounds in the development of stable and effective pharmaceutical or nutraceutical products.

Reliability and Validity of the Italian Translation of the Updated Version of the Pressure Ulcer Knowledge Assessment Tool (PUKAT 2.0)

ABSTRACT

The study aimed to translate the PUKAT 2.0 tool from English to Italian. This was an adaptation and validation study; the validity of the Italian version was determined through content validity, item validity and construct validity. The reliability of the instrument was assessed by conducting a test–retest analysis on a sample of 62 nurses. The I-CVI indices were above the threshold of 0.78 for 91% of the questions, and according to the S-CVI index, 96% of the evaluators agreed that the questionnaire was highly relevant. The overall values for item difficulty were good, with two items being too difficult and none being too easy. The item discriminant index was overall good and reasonable, low for four items. The overall ICC was poor to moderate with a value of 0.48 (95% CI 0.26–0.65). The instrument has proven to be a good starting point although not yet completely reliable, as it clearly requires more basic preparation on the part of the staff, further modifications regarding the reliability and clarity of the questions and more training of the nursing staff if it is to be used in the Italian context.

Prevalence and factors associated with pre-diabetes and undiagnosed diabetes in Cambodia: cross-sectional study based on the World Health Survey Plus 2023

Por: Chhim · S. · Ku · G. V. · Kowal · P. · Te · V. · Sorithisey · M. · Ngor · C. · Walton · P. · Maung · K. T. · Ng · N. · Naidoo · N. · Por · I. · Klipstein-Grobusch · K. · Chhea · C. · Sopheab · H.
Objective

This study aimed to determine the prevalence and factors associated with pre-diabetes and undiagnosed type 2 diabetes (UDD) in Cambodia.

Design

This analysis used data from the WHO World Health Survey Plus, which was collected using a cross-sectional design with a GIS-based, three-stage sampling approach. Multiple logistic regression was used to identify key associated factors, based on a significance level of p

Setting

Data were collected from all 25 provinces in Cambodia between 12 March 2023 and 31 May 2023.

Participants

4427 individuals aged 18 years or older, residing in the selected household for at least 6 months in the past year.

Primary outcome measures

Pre-diabetes (Haemoglobin A1c (HbA1c) 5.7%–6.4%) and UDD (HbA1c≥6.5%), without prior knowledge of having type 2 diabetes (T2D).

Results

The weighted prevalences of pre-diabetes and UDD were 26.4% (95% CI 24.0% to 29.0%) and 9.3% (95% CI 7.9% to 11.0%). Pre-diabetes prevalence was higher in urban areas compared with rural areas (adjusted OR, aOR=1.2, 95% CI 1.0 to 1.4), males (aOR=1.7, 95% CI 1.3 to 2.3), individuals aged 40–49 (aOR=1.8, 95% CI 1.4 to 2.4), individuals aged 50+ years group (aOR=2.9, 95% CI 2.3 to 3.6) compared with the 18–39 years group, overweight individuals (aOR=1.7, 95% CI 1.4 to 2.0), obese (aOR=2.1, 95% CI 1.5 to 3.0) and those with elevated total triglycerides (aOR=1.3, 95% CI 1.1 to 1.5). Similar risk factors were identified for UDD, with the addition of hypertension (aOR=1.6, 95% CI 1.3 to 2.0) and high waist circumference (aOR=2.0, 95% CI 1.5 to 2.7).

Conclusions

The high prevalence of pre-diabetes and UDD in Cambodia is a pressing public health concern. Urgent and intensive interventions are needed to effectively prevent and manage T2D, particularly among urban residents, older persons and individuals with metabolic risk factors.

Does CMR improve aetiological sub-phenotyping beyond echocardiography in patients with elevated LV filling pressure? A prospective registry study (PREFER-CMR)

Por: Bana · A. · Li · R. · Mehmood · Z. · Rogers · C. · Grafton-Clarke · C. · Bali · T. · Hall · D. · Jamil · M. · Ramachenderam · L. · Dudhiya · U. · Spohr · H. · Underwood · V. · Girling · R. · Kasmai · B. · Nair · S. · Matthews · G. · Garg · P.
Objectives

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Design

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

Setting

A single NHS hospital in the UK.

Main outcome measures

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

Results

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

Conclusions

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

Protocol for the development of the WHO gestational weight gain charts

Por: Rangel Bousquet Carrilho · T. · Oladapo · O. T. · Hutcheon · J. A. · Gatica-Dominguez · G. · Rasmussen · K. M. · Flores-Urrutia · M. C. · Kumapley · R. · Tuncalp · O. · Bahya-Batinda · D. · Fayed · A. A. · Bogaerts · A. · Papageorghiou · A. T. · Munoz-Manrique · C. · Farias · D. R
Introduction

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

Methods and analysis

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

Ethics and dissemination

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

Clinical Study on Masquelet Membrane Induction Technique Combined With Free Skin Grafting for the Treatment of Chronic Refractory Wounds With Bone/Tendon Exposure in Aged Patients

ABSTRACT

The treatment of chronic wounds in the Aged is often difficult. Masquelet technique is used for the treatment of infected large segmental bone defects as it provides an adequate blood supply for bone and soft tissue reconstruction. In this study, a two-stage wound management strategy was used, consisting of covering the initial wound with bone cement and skin grafting under induced membranes. From September 2020 to September 2022, 20 Aged patients with chronic refractory wounds of the lower extremities with exposed bone or tendons were recruited in the Department of Wound Repair Surgery of the Second Affiliated Hospital of Wenzhou Medical University. Each patient was reconstructed according to a two-stage process. In the first stage, while treating the patient's underlying disease, several debridements were first performed on the wound; subsequently, the Masquelet technique was applied to seal the wound with antibiotic bone cement. Four to 6 weeks later, the second stage was initiated—after confirming the sufficient formation of wound induced membranes, the bone cement was removed, and free skin grafts were finally used to cover the chronic refractory wounds on the extremities. The area of the defects ranged from 4.5 × 3.0 cm to 15.0 × 6.0 cm, and all soft tissue defects were associated with tendon or bone exposure. After the surgery, patients attended regular outpatient visits and were followed up by telephone and video to observe the healing of the wounds and whether there were any complications in the donor site. The Lower Extremity Function Scale (LEFS) score was used to evaluate the functional recovery of the lower extremities. We found that all implants survived without necrosis or infection. All 20 cases were followed up regularly after surgery for 3 to 12 months, with a mean of 7.6 months. In the first stage, Induced Membranes induction was performed 1–4 times, with an average of (1.3 ± 0.7) times, and in the second stage, free skin grafting was performed on the induction membrane, and all 20 cases of skin grafting survived without necrosis or infection; the appearance and texture of the skin in the grafted area were satisfactory, and the postoperative LEFS score was (69.83 ± 10.82). Finally, our strategy for the management of chronic refractory wounds in the Aged can achieve satisfactory clinical results, reduce surgical risk, be simple and reliable, and be an effective addition to the repair modality.

Three decades of clinical trials in Portuguese-speaking Africa: a comprehensive scoping review protocol

Por: Batista · J. P. B. · Teixeira · M. M. · Torre · C. d. M. · Sepodes · B. · Abecasis · A. · Mota-Filipe · H.
Introduction

Published clinical trials offer valuable insights into the clinical research landscape in Portuguese-speaking African countries (PSAC)—Angola, Cabo Verde, Guinea-Bissau, São Tomé and Príncipe and Mozambique. The objective of this comprehensive scoping review is to systematically map and analyse randomised clinical trials (RCTs) evaluating pharmacological interventions conducted in PSAC from 1995 to 2024, in order to identify research trends, targeted diseases, geographic distribution and evidence gaps to better understand the development and evolution of clinical trials in the region. This is the first comprehensive scoping review to examine the clinical trials landscape in PSAC.

Methods and analysis

This scoping review adheres to the Joanna Briggs Institute methodology for scoping reviews, which builds on the Arksey and O’Malley methodological framework (refined by Levac et al) and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A dual-search strategy will be used, consulting 4 electronic databases (MEDLINE, EMBASE, African Index Medicus, Cochrane Central Register of Clinical Trials) and 3 clinical trials registries platforms (Clinicaltrials.gov, International Clinical Trials Registry Platform, Pan African Clinical Trials Registry). Eligible studies will include RCTs conducted in at least one of the PSAC. Extracted data will include trial characteristics, targeted diseases, phases and designs, funding and ethical compliance. Risk of bias (RoB) will be assessed using the Cochrane RoB tool V.2.0 to evaluate the quality of the evidence included in the scoping review. Conclusions will be drawn upon the comparison between countries and their scope of clinical research, together with comparison with countries from other geographies, considering disease profiles.

Ethics and dissemination

Ethical approval is not required. Results will be disseminated through a peer-reviewed publication, conference presentation and in plain language in social media, both in Portuguese and in English.

PROSPERO registration number

This protocol is registered in the Open Science Framework https://osf.io/5nhc9.

Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (SPEEDY): study protocol for a cluster randomised controlled trial with included health economic and process evaluations

Por: Shaw · L. · Allen · M. · Day · J. · Ford · G. A. · James · M. · McClelland · G. · McMeekin · P. · Mossop · H. · Pope · C. J. · Simmonds · R. L. · White · P. · Wilson · N. · Price · C. I.
Background

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

Methods and analysis

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

Ethics and dissemination

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

Trial registration number

ISRCTN77453332.

Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial

Por: Avancini · A. · Giannarelli · D. · Ugel · S. · Mafficini · A. · Fiorini · P. · Scaglione · I. · Adamoli · G. · Borsati · A. · Belluomini · L. · Eccher · S. · Trestini · I. · Tregnago · D. · Sposito · M. · Insolda · J. · Schena · F. · Scarpa · A. · Derosa · L. · Milella · M. · Novello · S.
Introduction

In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.

Methods and analysis

STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.

Ethics and dissemination

The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Trial registration number

Clinicaltrial.gov: NCT07042724.

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Health and lifestyle in the Iron Age Italian community of Pontecagnano (Campania, Italy, 7th-6th century BCE)

by Roberto Germano, Owen Alexander Higgins, Emanuela Cristiani, Alessia Galbusera, Carmen Esposito, Dulce Neves, Carmine Pellegrino, Alessandra Sperduti, Giorgio Manzi, Luca Bondioli, Alessia Nava

This study investigates health, dental development, diet, and human-environment interactions in individuals buried in the necropolises of Pontecagnano (Campania, Italy, 7th-6th century BCE), using an integrated approach merging dental histomorphometry and calculus micro-residue analysis. The sample consists of 30 permanent teeth (canines, first and second molars) from 10 individuals. Histomorphometric analysis of dental thin sections allowed the estimation of crown formation times, initial cusp formation, crown completion, and enamel extension rates. The prevalence of Accentuated Lines, marking physiological stress events, was analyzed chronologically across tooth classes. Dental calculus analysis was performed on five individuals, identifying plant micro-remains and fungal spores. Crown formation times varied by tooth class, with canines forming the longest (mean = 1,977 ± 295 days), followed by second molars (mean = 1,176 ± 179 days) and first molars (mean = 1,094 ± 154 days). Initial cusp formation values, estimated through chronological overlap between teeth, allowed for a more accurate reconstruction of crown completion timing. Accentuated Lines prevalence peaked at 12 and 44 months, likely reflecting early childhood dietary transitions and the differential recording of stress events across different crown regions. Calculus analysis identified starch granules from cereals (Triticeae) and legumes (Fabaceae), fungal spores (Saccharomyces), and plant fibers, indicating diverse dietary practices, food processing, and extra-masticatory activities. This interdisciplinary approach reinforces the validity of combining histomorphometric and micro-residue analyses to reconstruct childhood health, adult diet, and lifestyle. Our findings align with previous research while emphasizing population-specific variations. This study enhances understanding of Iron Age biocultural adaptations, offering insights into developmental and dietary behaviors in this ancient Italian community.

Placebo and nocebo in clinical practice: An online cross-sectional survey of healthcare professionals from European countries on views, practices and training needs

by Mary O’Keeffe, Nathan Skidmore, Arianna Bagnis, Przemysław Bąbel, Elżbieta A. Bajcar, Alessandra De Palma, Andrea W.M. Evers, Eveliina Glogan, Julia W. Haas, Stefanie H. Meeuwis, Marek Oleszczyk, Antonio Portolés, Johan W.S. Vlaeyen, Katia Mattarozzi, on behalf of PANACEA Consortium

Background

Placebo and nocebo effects significantly influence health outcomes, yet healthcare professionals receive limited training and guidance on their mechanisms and clinical application, creating a gap in education and practical understanding. Conducted within the European PANACEA Consortium, this study evaluated healthcare professionals’ knowledge, attitudes, and practices regarding placebo and nocebo effects, and assessed their needs in further education.

Methods

An online cross-sectional survey among a European multi-country convenience sample of healthcare professionals collected data assessing participants’ knowledge, perceptions, and experiences regarding placebo and nocebo effects; their application and ethical considerations in clinical practice; and investigated educational needs and interest in further training. Quantitative data were analyzed using descriptive statistics, and thematic analysis was applied to the free-text responses.

Results

Amongst 807 participants, 71.7% reported taking advantage of placebo effects in their practice, and over half of participants (55.8%) observing nocebo effects. Participants reported feeling somewhat confident (53.3%) in harnessing placebo effects with 47.5% feeling confident in preventing nocebo effects. The majority of respondents had not received formal training on placebo and nocebo effects, with most expressing an interest in further training in areas such as healthcare education, emphasizing communication skills to enhance placebo effects, and knowledge to recognize and reduce nocebo effects.

Conclusions

There is a significant need for more comprehensive training on placebo and nocebo effects, particularly in early health professional education. These findings informed the development of educational resources and best practice recommendations developed as part of the outcomes from the PANACEA Consortium, improving the understanding and application of these effects among healthcare professionals across Europe.

Effects of breathing exercise and thoracic techniques on pain and disability in low back pain: A systematic review and meta-analysis

by Tahere Seyedhoseinpoor, Ramin Jafari, Zohreh Shafizadegan, Maryam Abbaszadeh-Amirdehi

Purpose

The objective of this study was to systematically review the effectiveness of thoracic-focused interventions, including breathing exercises and thoracic manual techniques (mobilization, high-velocity low-amplitude manipulation, and release techniques), on pain and disability in patients with low back pain (LBP).

Methods

PubMed, Scopus, Web of Sciences, ProQuest, Ovid, Physiotherapy Evidence Database (PEDro), Cochrane Central Register of Controlled Clinical Trials (CENTRAL), and Google Scholar were searched without language restrictions. Clinical trials with control groups on pain and disability in low back pain patients focusing on the efficacy of breathing exercises or thoracic technique were included. In total, 31 studies contributed to the meta-analysis for pain and 24 for disability.

Results

Pooled analyses using Morris’ dppc demonstrated a statistically significant, small effect for pain reduction (dppc = −0.35, 95% CI = −0.46 to −0.23) and a large effect for disability improvement (dppc = −0.71, 95% CI = −0.86 to −0.57) when compared with control groups. Thoracic manual techniques showed larger effects on both pain and disability compare to breathing exercises. However, substantial statistical heterogeneity (I² > 85%) persisted in most analyses.

Conclusion

Breathing and thoracic manual techniques may be effective in reducing disability and, to a lesser extent, pain in patients with LBP, but the overall certainty of evidence is low. However, the quality of the evidence is low. Variability in treatment protocols, study quality, blinding, and outcome measures likely contributed to inconsistencies. Further high-quality trials with standardized protocols are needed to confirm these findings and inform clinical practice.

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