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Role of Devine gastric partitioning in locally advanced gastric cancer: palliation and bridge to definitive care-protocol for a systematic review

Por: Gomes · A. · Reis · M. I. · Costa · B. · Nunes · V.
Background

Gastric outlet obstruction syndrome (GOOS) is a clinically significant condition often associated with advanced malignancies, particularly gastric and pancreatic cancers. Management strategies focus on symptom relief, nutritional improvement and quality of life enhancement. Surgical gastrojejunostomy (GJ), especially laparoscopic GJ, is commonly recommended for patients with good functional status and life expectancy exceeding 2 months. The modified Devine partial stomach-partitioning gastrojejunostomy (PSPG) was introduced to address functional limitations of conventional GJ, including duodenogastric reflux and afferent loop syndrome. However, PSPG has not been widely adopted, and its role in malignant GOOS remains unclear.

This systematic review aims to synthesise the available evidence on the application, functional outcomes and oncological implications of the modified Devine technique in malignant GOOS.

Methods and analysis

This review follows Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The PICO framework was employed to define eligibility criteria, focusing on studies examining PSPG for malignant GOOS as palliative surgery or a bridge to resection. Literature searches were conducted across Medline, EMBASE, Cochrane Library, ClinicalTrials.gov and grey literature sources using a prospectively registered search strategy, between August and October 2025, following protocol submission. Two independent reviewers will screen articles, extract data and assess quality using the Newcastle-Ottawa Scale where applicable. Data will be synthesised narratively.

Ethics and dissemination

As this study is a systematic review of published literature, formal ethical approval was not strictly required. In accordance with institutional policy, the protocol was submitted to the Institutional Review Board of Hospital Prof. Doutor Fernando Fonseca, which confirmed that the study met criteria for ethical exemption. Findings will be disseminated through peer-reviewed publication.

Registration

This study is registered in PROSPERO (CRD42024593540). Search strategy is registered in searchRxiv https://doi.org/10.1079/searchRxiv.2025.00838.

Systematic review registration

PROSPERO CRD42024593540

Search strategy registration

https://doi.org/10.1079/searchRxiv.2025.00838.

Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial

Por: Nunes · S. M. · Rizzo · R. R. · Franco · M. R. · Ferreira · F. R. · Barros · L. J. G. · Maciel · I. T. · Santos · R. L. · Nascimento · R. R. · Couto · A. J. · Quaresma · L. S. · Fontes · R. M. · Ferreira · E. M. R. · Maher · C. G. · McAuley · J. H. · Pinto · R. Z.
Introduction

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

Methods and analysis

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

Trial registration number

NCT05953155.

Organ donation for research purposes: a qualitative focus group study on the views of donor families, transplant recipients and heart failure patients in the UK

Por: Louca · J. O. · Asemota · N. · Thren · J. · Manara · A. · Bhagra · S. · Wang · L. · Bargehr · J. · Burton · N. · Burton · S. · Rockell · K. · Nunes · J. P. · White · P. · Berman · M. · Pettit · S. · Rubino · A. · Reyahi · A. · Large · S. · Sinha · S. · Wilson · C.
Background

Declined donor organs and explanted recipient organs may hold considerable value for biomedical research, particularly in advancing knowledge of disease mechanisms and supporting drug development. However, public perceptions of such use, and preferences for how consent should be obtained, remain underexplored.

Methods

Four workshops were held across the UK to examine the views of organ donor families and transplant recipients regarding the use of human organs in research, with a focus on myocardial regeneration. Each workshop included three brief presentations on transplantation and cardiac regeneration, followed by facilitated small-group discussions. Observational notes were taken to capture participants’ perspectives on the use of organs unsuitable for transplantation. A follow-up survey generated both quantitative and qualitative data, the latter analysed using thematic analysis.

Results

Participants expressed strong support for the use of declined donor and explanted recipient organs in research. Transplant recipients frequently cited a desire to give back to the National Health Service (NHS), while donor families viewed research use as a meaningful way to honour their loved ones when transplantation was not possible.

Conclusion

This exploratory study highlights widespread support for using non-transplantable organs in research among individuals with personal experience of transplantation. The findings suggest a need for further research into how best to support and inform potential donors and families. Participants emphasised the importance of sensitive communication, clear consent processes and transparency regarding the use of donated organs.

Clusters of adolescent pregnancies and neonatal deaths in Sao Paulo state, Brazil: a population-based spatial analysis with a socioeconomic approach

Objective

Adolescent pregnancy is a global issue. Early childbearing is strongly linked to poverty and negative health outcomes, including increased neonatal death risk. This study explores spatial patterns of adolescent pregnancies and neonatal deaths and their association with socioeconomic characteristics.

Design

This population-based study used spatial analysis techniques to investigate the geographical distribution of adolescent pregnancies, socioeconomic characteristics and neonatal mortality rate (NMR).

Setting

The 645 municipalities of State of Sao Paulo, Brazil.

Participants

All live births to mothers residing in the State of Sao Paulo, Brazil, between 2004 and 2020.

Primary and secondary outcome measures

The socioeconomic indicators used were: municipal human development index and per capita income (PCI). Spatial patterns were assessed for spatial autocorrelation (Moran’s I, LISA), and smoothed using local Bayesian estimation. Spearman’s correlation was used to ascertain the relationship between the percentage of live births to adolescent mothers and socioeconomic indexes. This calculation was also undertaken between different maternal age groups of NMR.

Results

The study analysed over 10 million live births, with 14.3% attributed to adolescent mothers. Spatial analysis revealed significant clustering of adolescent pregnancies, strongly associated with lower socioeconomic indicators. NMR also exhibited spatial clustering, particularly after smoothing. Statistically significant differences were observed in PCI medians between high–high and low–low clusters for adolescent births. High and low incidence areas of NMR, both in all maternal ages and stratified by adolescent and non-adolescent mothers, demonstrated considerable overlap.

Conclusion

The results indicated the existence of clustering areas of adolescent pregnancy and neonatal deaths and suggested that the prevalence of births to adolescent mothers is not distributed equally and is higher in lower socioeconomic developed areas.

Readiness to reduce primary care-associated carbon emissions in England: a cross-sectional survey of clinical and non-clinical staff views

Por: Geddes · O. · Twohig · H. · Dahlmann · F. · Eccles · A. · Karaba · F. · Nunes · A. R. · Spencer · R. · Dale · J.
Objectives

To describe current levels of interest and action around decarbonisation in general practice settings, and awareness and use of currently available materials designed to support general practice teams undertake decarbonisation activity.

Design

Cross-sectional, mixed methods, online survey.

Setting

473 general practices in three Integrated Care Board regions in England.

Participants

Multiprofessional general practice staff.

Results

There were 328 responses from 163 (34.5%) practices. Most respondents were general practitioner (GP) partners (98; 29.9%), other clinical staff (93; 28.3%) or managerial staff (76; 23.2%). 229 (69.8%) respondents felt that acting to reduce carbon emissions from primary care is a legitimate part of general practice activity. However, only 44 (13.4%) felt that there is sufficient training and resources to support such activity, and only 59 (18.0%) agreed that there was sufficient leadership from higher levels within the health service to enable this. 58 (35.6%) practices had a lead for sustainability, generally managerial staff (22; 37.9%) or GP partners (17; 29.3%). Compared to other practices, those with a decarbonisation lead reported increased levels of decarbonisation actions currently being undertaken (mean = 5.2 vs 3.1; t(161) = 7.7, p2=31.9, p2=32.3, p

Conclusions

This survey provides insight into how English general practices and their staff regard decarbonisation activities. The findings highlight the importance of leadership, resources and incentives in driving such activities and have implications for initiatives to help achieve wider decarbonisation goals in healthcare.

Influence of concurrent oral calcium carbonate supplementation on steady-state pharmacokinetics of once daily oral raltegravir in persons with HIV: a protocol for a prospective open-label non-randomised study in Canada

Por: Teixeira Nunes Porto · L. L. · Doyle · M.-A. · Zhang · G. · Tremblay · N. · Yazji · B. · Kanji · S. · Cameron · D. W.
Introduction

Raltegravir is a potent HIV-integrase strand transfer inhibitor (INSTI). Despite its strong activity against HIV-1 strains resistant to other antiretroviral drug classes, it is usually used in combination with other antiretroviral drugs due to the empirical requirement for anti-HIV drug combinations to ensure effective anti-retroviral therapy (ART). As an early-arriving INSTI, raltegravir is clinically familiar for its safety, tolerability and treatment effectiveness. High-dose calcium carbonate formulated as an antacid (as opposed to a supplement formulation) taken orally together with raltegravir is known to reduce systemic raltegravir exposure due to chelation and reduced absorption. This study aims to assess the effect of daily calcium carbonate antacid as TUMS Ultra Strength (US) administration in lower doses, as currently used for oral calcium supplementation, on the steady-state pharmacokinetics (PKs) of once-daily oral raltegravir.

Methods and analysis

This is an open-label, three-treatment series in three periods in a single group, fixed-sequence PK study in 12 healthy adult volunteers with HIV on ART. Subjects will take 1200 mg of raltegravir single QD oral dose alone for 7 days (period one), then raltegravir 1200 mg with calcium carbonate 500 mg from day 8 to day 14 (period two) and raltegravir 1200 mg with calcium carbonate 1000 mg from day 15 to day 22 (period three). We will conduct serial PK sampling from observed dosing on days 7, 14 and 21, with 24-hour PK sampling scheduled for days 8, 15 and 22. Follow-up will continue until day 51.

Ethics and dissemination

This study will adhere to the ICH GCP Guidelines and the Declaration of Helsinki. Ethics approval was obtained from the Ottawa Health Science Network Research Ethics Board under study ID 20190750–01 hour. Informed consent will be obtained from all participants prior to enrolment. This protocol will be published in a peer-reviewed journal prior to the study’s completion and closure. Results generated from this activity will also be reported in a peer-reviewed journal.

Trial registration number

NCT04258475.

AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modelling

Por: Follet · C. · Dumont · A. · Roussel · M. · Gillibert · A. · Boedard · C. · Quillard · M. · Ruault · S. · Vallin · F. · Donnadieu · N. · Nunes Ferreira · D. · Pereira · T. · Joly · L.-M. · Lvovschi · V. · Duflot · T.
Introduction

Pain accounts for approximately 80% of emergency department admissions. While intravenous morphine titration is commonly used for severe pain, non-invasive alternatives that bypass intravenous access are needed. Nebulised fentanyl, combined with pupillometry for objective monitoring of opioid impregnation, may offer a rapid and safe alternative for pain management.

Methods and analysis

This phase I, open-label, randomised, exploratory, crossover, single-centre prospective controlled trial will employ pharmacokinetic–pharmacodynamic (PK–PD) modelling to assess the variability in bioavailability of nebulised fentanyl administered via intranasal route versus facial aerosol. 20 healthy volunteers will receive three repeated administrations of fentanyl over two visits. At each visit, blood samples (n=11) will be collected for fentanyl quantification by liquid chromatography–tandem mass spectrometry, and pupillary unrest in ambient light (PUAL) measurements (n=9) will be recorded. The resulting data will be analysed using Monolix 2024R1 to model PK–PD relationships, perform Monte Carlo simulations and determine the optimal dosing and timing required to achieve a reduction of more than 30% in PUAL, while also evaluating safety, comfort and tolerance.

Ethics and dissemination

The study has been approved by the Ethic Committee Île-de-France VII (approval reference number: 000216, February 2024) and will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications, conference presentations and appropriate data-sharing platforms to support further research and clinical application.

Trial registration number

This trial is registered at ClinicalTrials.gov (Identifier: NCT06281951).

El juicio clínico de las enfermeras sobre el empoderamiento del cuidador

Objetivo principal: Identificar los factores que subyacen al juicio clínico de las enfermeras sobre el empoderamiento del cuidador. Metodología: Estudio cualitativo y exploratorio. Los participantes fueron 10 enfermeras expertas que pertenecían a un grupo que apoya a sus colegas en el diseño de los cuidados apoyados en modelos teóricos y enfermeras expertas en el empoderamiento de los cuidadores, en un hospital universitario. Se realizaron entrevistas semiestructuradas con grabación de audio. Los datos se analizaron mediante la técnica de análisis de contenido. Resultados principales: Emergieron tres temas, las enfermeras, los cuidadores y las dificultades y limitaciones, que se subdividieron en ocho subtemas. Se identificaron factores facilitadores, así como limitaciones y dificultades asociadas a la asunción y gestión del rol de cuidador. Conclusión principal: El empoderamiento del cuidador es un proceso complejo, en el que los cuidados de enfermería se centran más en la persona dependiente y menos en el cuidador, lo que demuestra que es un área que requiere mayor atención y conceptualización por parte de las enfermeras.

Eventos adversos en la atención de pacientes en hemodiálisis en unidades de cuidados intensivos

Objetivo principal: El objetivo fue identificar y analizar eventos adversos en la atención de pacientes en hemodiálisis en la Unidad de Cuidados Intensivos. Metodología: Estudio descriptivo y retrospectivo desarrollado en una clínica de hemodiálisis, que subcontrata el servicio de hemodiálisis a 10 unidades de cuidados intensivos en hospitales de Goiânia, Goiás, Brasil. Se realizó una evaluación de los indicadores de evaluación de los servicios de hemodiálisis con el fin de elevar los eventos adversos en los últimos seis meses. Resultados principales: La mayoría de los pacientes fueron sometidos a hemodiálisis mediante catéter venoso central de doble lumen, con predominio del sexo masculino y mayores de 60 años. En los seis meses se identificaron 1.988 sesiones de hemodiálisis, 228 eventos adversos que generaron interrupción del tratamiento, producto de fallas en tecnología sanitaria, fallas en el acceso vascular, alteración hemodinámica y metabólica del paciente o por orden médica. Conclusión principal: Los eventos adversos identificados en la atención de pacientes en hemodiálisis en una unidad de cuidados intensivos provocaron la interrupción de la sesión de tratamiento de diálisis. Fueron: fallas en la tecnología de la salud, fallas en el acceso vascular y cambios hemodinámicos y metabólicos.

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