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Phase II multicentre double-blind randomised controlled trial of a Bivalent VaccInation against Salmonella Typhi and Paratyphi A (BiVISTA) using a controlled human infection model of paratyphoid A infection: study protocol

Por: Paganotti Vicentine · M. · McCann · N. · Hennigan · O. · Maria · N. · Juarez Molina · C. I. · Koleva · S. · Islam · M. K. · Jones · E. · Flaxman · A. · Day · N. · MacDonald · A. · Adnan · M. · Singh · N. · Vernon · S. · Wilson · E. · Potey · A. V. · Dharmadhikari · A. · Gaidhane · S. · Kul
Introduction

Enteric fever, primarily caused by Salmonella enterica Typhi and Salmonella enterica Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may address this gap. Although field efficacy trials are not considered feasible, controlled human infection models (CHIMs) offer an alternative pathway for evaluating vaccine efficacy. This will be the first efficacy study of a bivalent vaccine against typhoid and paratyphoid A using a paratyphoid CHIM.

Methods and analysis

This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18–55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control.

Ethics and dissemination

The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings.

Trial registration number

ISRCTN65855590.

Implementation strategies for the WHO Safe Childbirth Checklist: a scoping review

Por: Gama · Z. A. d. S. · Semrau · K. E. A. · Rosendo · T. M. S. d. S. · Freitas · M. R. d. · Saraiva · C. O. P. d. O. · Westgard · C. M. · Mita · C. · Tuller · D. E. · Freitas · K. d. M. S. · Molina · R. L.
Background

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

Objectives

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

Eligibility criteria

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

Sources of evidence

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

Charting methods

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

Results

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

Conclusions

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Registration

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

Retrospective validation of an artificial intelligence system for diagnostic assessment of prostate biopsies on the ProMort cohort: study protocol

Por: Ji · X. · Zelic · R. · Aspegren · O. · Mulliqi · N. · Fiorentino · M. · Giunchi · F. · Molinaro · L. · Boman · S. E. · Szolnoky · K. · Liu · L. X. · Pettersson · A. · Vincent · P. H. · Eklund · M. · Akre · O. · Kartasalo · K.
Introduction

Prostate cancer diagnosis and treatment planning depend on accurate histopathological assessment of needle biopsies, particularly through the Gleason scoring system. The inherently subjective nature of the grading creates variability between pathologists, potentially resulting in suboptimal patient management decisions. These reproducibility challenges extend beyond Gleason scoring to encompass other critical diagnostic and prognostic markers, including cancer volume quantification and detection of cribriform morphology patterns and perineural invasion. Artificial intelligence (AI) applications in digital pathology have emerged as promising solutions for enhancing diagnostic consistency and accuracy, with recent research demonstrating that automated systems can match expert-level performance in prostate biopsy evaluation. Nevertheless, comprehensive validation studies have revealed concerning limitations in model generalisability when deployed across different clinical environments and patient populations. Recent systematic reviews revealed widespread risk-of-bias limitations and insufficient external validation in AI diagnostic studies, highlighting critical needs for accumulated evidence supporting generalisability before clinical implementation. Rigorous external validation with preregistered protocols using independent datasets from diverse clinical settings remains essential to establish the reliability and safety of AI-assisted prostate pathology systems.

Methods and analysis

This study protocol establishes a framework for the retrospective external validation of an AI system developed for prostate biopsy assessment, to be conducted on the case-control samples of the National Prostate Cancer Register of Sweden, ProMort study (1998-2015). The primary aim is to evaluate the AI model’s diagnostic accuracy and Gleason grading performance using completely independent datasets separate from any model development or previously used validation cohorts. The diversity of the validation samples, spanning multiple geographic regions, temporal collection periods and reference standards, allows evaluation of model robustness across varied clinical contexts. Secondary aims encompass evaluating AI performance in cancer length estimation and detection of cribriform patterns and perineural invasion. This protocol delineates procedures for data collection, reference standard clarification and prespecified statistical analyses, ensuring comprehensive validation and reliable performance assessment. The study design conforms to established reporting guidelines Checklist for Artificial Intelligence in Medical Imaging (CLAIM) and Standards for Reporting Diagnostic Accuracy Studies using Artificial Intelligence (STARD-AI), and recognised best practices for AI validation in medical imaging.

Ethics and dissemination

Data collection and usage were approved by the Swedish Regional Ethics Review Board and the Swedish Ethical Review Authority (permits 2012/1586-31/1, 2016/613-31/2, 2019-01395, 2019-05220). The study adheres to the Declaration of Helsinki principles, and findings will be made available in open access peer-reviewed publications.

Is a change in mouth opening associated with improvements in quality of life in children with type 1 obstructive sleep apnoea after adenotonsillectomy? Protocol for the JawChild prospective cohort study

Por: Akkari · M. · Lopez · R. · Jaussent · I. · Vidal · C. · Skinner · S. · Jaffuel · D. · Molinari · N.
Introduction

Adenotonsillectomy is the primary treatment for type 1 obstructive sleep apnoea (OSA1). Although polysomnography (PSG) remains the gold standard for measuring Apnoea-Hypopnoea Index, it is a labour-intensive procedure and does not correlate with improvements in quality of life postadenotonsillectomy. Mouth breathing is associated with poorer quality of life in children. Mandibular movement (MM), which measures mouth opening, is a validated measure of respiratory effort that can be easily and safely assessed in children using the JAWAC technology. This study aims to evaluate the relationship between changes in quality of life and changes in mouth opening in children with OSA1 after undergoing adenotonsillectomy. Secondary objectives include evaluating changes in quality of life, clinical symptoms and other MM and PSG metrics in the same population.

Methods and analysis

This exploratory, non-randomised, monocentric, prospective cohort study with a non-blinded single arm will include 50 children aged 3–7 years, undergoing adenotonsillectomy at the Clinique Saint Jean, Montpellier, France. Quality of life will be measured using the parent version of the Paediatric Quality of Life Inventory and MM metrics will be measured during PSG using the JAWAC system during the inclusion visit and 3 months after adenotonsillectomy. The primary outcome will be the correlation between the changes in quality of life and mouth opening (1/10 mm) postadenotonsillectomy. Secondary analyses will evaluate changes in clinical symptoms, PSG measures and other MM metrics including respiratory effort, as well as the associations between these measures.

Ethics and dissemination

This study was approved by an independent ethics committee (Comité de Protection des Personnes Est) on 24 March 2025 (2024-A02761-46) and will be conducted in accordance with French law, good clinical practice and the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

Trial registration number

NCT06973928.

Understanding and reframing clinical errors through just culture: protocol for the DECIDE mixed-methods study in Spanish healthcare and community contexts

Por: Mira · J. J. · Lorenzo · S. · Aranaz-Andres · J. M. · Macias-Maroto · M. · Cobos-Vargas · A. · Moreno Campoy · E. E. · Perez-Perez · P. · Trillo-Lopez · P. · Corpas-Nogales · E. · Gea Velazquez de Castro · M. T. · Arencibia-Jimenez · M. · Asencio · A. · Diez Herrero · D. · Molina
Introduction

Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.

Methods and analysis

A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.

Ethics and dissemination

This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.

ClinicalTrials.gov identifier

NCT06835517.

Comparing high-flow nasal cannula oxygen and non-invasive ventilation to standard oxygenation in non-selected intensive care unit patients admitted for acute hypoxaemic respiratory failure: protocol for the KISS (Key oxygenation Interventions in Surgical

Por: Jaber · S. · Huguet · H. · Molinari · N. · De Jong · A.
Introduction

Hypoxaemic acute respiratory failure (ARF) in intensive care unit (ICU) patients is associated with high mortality. Three main devices are used to provide oxygen to hypoxaemic ARF patients: non-invasive ventilation (NIV), high-flow nasal cannula oxygen (HFNO) and standard oxygen (first-attempt device in usual care). To date, no multicentre randomised controlled study has compared NIV and HFNO to standard oxygen with day 28 mortality rate as primary outcome in hypoxaemic ARF in non-selected patients. Our hypothesis is that NIV and/or HFNO is superior to standard oxygen to reduce day 28 mortality rate in hypoxaemic ARF.

Methods and analysis

The Key oxygenation Interventions in Surgical and non-Surgical patients (KISS) trial is an adaptive investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system–based randomisation. Patients with hypoxaemic ARF were randomly assigned to one of three groups: the ‘NIV-group’ to receive curative NIV combined with HFNO delivered between NIV trials, or the ‘HFNO’ group to receive HFNO alone, or the ‘standard oxygen-group’ to receive oxygen therapy alone.

The primary endpoint is day 28 all-cause mortality. The main secondary endpoint is intubation rate at day 28. The exploratory endpoints are intubation rates at day 3 and day 7; oxygenation up to day 7; need for other rescue oxygen therapy up to day 7; ICU and hospital length of stay; and mortality rates in ICU, hospital and at day 90.

The main objective is to assess if NIV and/or HFNO is superior to standard oxygen to reduce day 28 mortality rate in hypoxaemic ARF. Additional comparisons between predefined stratum following randomisation will be performed: (1) medical versus postoperative admissions, (2) among medical (immunocompromised vs non-immunocompromised) and (3) among postoperative (abdominal vs cardio-thoracic).

An adaptive design will be used. Two interim analyses will be performed after 700 and 1400 included patients among the 2100 planned.

Ethics and dissemination

The study project has been approved by the appropriate ethics committee ‘Comité-de-Protection-des-Personnes Sud-Est V-23-CHUM-01 Cat2 2022-A02761-42/1’. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If NIV and/or HFNO reduce the mortality at day 28, NIV and/or HFNO could be proposed to become one of the first-line therapies in hypoxaemic ARF patients.

Trial registration number

NCT05812911.

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

Por: Marques · T. · Forsyth · C. · Barreira · F. · Lombas · C. · Blum de Oliveira · B. · Laserna · M. · Molina · I. · Bangher · M. d. C. · Javier Fernandez · R. · Lloveras · S. · Fernandez · M. L. · Scapellato · P. · Patterson · P. · Garcia · W. · Ortiz · L. · Schijman · A. · Moreira · O. C.
Introduction

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

Methods and analysis

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

Ethics and dissemination

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

Trial registration number

NCT04897516.

Study protocol for the HONIVAH trial: a single-centre randomised study assessing high-flow oxygen therapy versus non-invasive ventilation on lung volumes and the upper airway in hypoxemic critically ill patients

Por: Monet · C. · Piron · L. · Pressac · M. · Molinari · N. · De Jong · A. · Guiu · B. · Jaber · S.
Introduction

In non-intubated patients, symptomatic treatment of hypoxaemic respiratory failure is still debated, with different options: (1) standard oxygen therapy (SOT), (2) high-flow nasal cannula oxygen therapy (HFNC) and (3) non-invasive ventilation (NIV). The objective of this study is to compare the effects of HFNC and NIV on lung volumes assessed by CT scan to allow a better understanding of their effectiveness.

Methods and analysis

The HONIVAH study (High-flow Oxygen therapy and Non-Invasive ventilation on lung Volumes and on upper Airway in Hypoxemic critically ill patients) is an investigator-initiated, prospective, single-centre, physiological, randomised, parallel-group, unblinded trial with an electronic system-based randomisation. Patients with hypoxaemic respiratory failure, defined as the need for SOT flow ≥3 L/min to maintain a pulsed oxygen saturation ≥95%, and a CT scan prescribed by the physician in charge of the patient, will be randomly assigned to the HFNC group or the NIV group. Two inspiratory thoracic CT scans will be performed, one with SOT as part of the routine patient management and a second thoracic CT scan with HFNC or NIV, depending on the allocation group. The primary outcome is the comparison of the relative variation in ‘poorly aerated’ and ‘non-aerated’ lung volumes before and after the intervention between the HFNC group and NIV group, assessed by thoracic CT scan. Secondary outcomes included the variation in tracheal cross-sectional upper airway area, lung volumes, gas exchange and patient comfort.

Ethics and dissemination

The study project has been approved by the appropriate ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-mer 1, France, 2022-A02458-35). Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration

ClinicalTrials.gov identifier: NCT05643911.

LDL-C achievement in patients with coronary artery disease: a study protocol for the EDHIPO-MARCA retrospective registry

Por: Cordoba-Melo · B. D. · Arango-Ibanez · J. P. · Posso-Marin · S. · Ruiz · A. J. · Molina · D. I. · Gomez-Mesa · J. E.
Introduction

Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.

Methods and analysis

This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.

Ethics and dissemination

This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.

Flow cytometric lyophilised reagent tube assay for peripheral blood neutrophil myeloperoxidase expression to rule out myelodysplastic neoplasms at a university hospital: a diagnostic accuracy study

Por: Planta · C. · Scheffen · L. · Jacob · M.-C. · Szymanski · G. · Chevalier · S. · Tondeur · S. · Bulabois · B. · Meunier · M. · Lefebvre · C. · Gonnet · N. · Garban · F. · Molina · L. · Paradis · C. · Seigneurin · A. · Chiriac · R. · Merle · R. · Labarere · J. · Park · S. · Raskovalova · T.
Objectives

Although flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression can accurately rule out myelodysplastic neoplasms (MDS), it lacks reliability and efficiency due to the practical limitations of laboratory-developed liquid reagent-based assays. This study aimed to quantify the agreement and comparative discriminatory accuracy between a single-use flow cytometric lyophilised reagent tube (BD Lyotube Stain 468) and its laboratory-developed liquid reagent counterpart.

Design

Cross-sectional diagnostic accuracy study of two index tests against a reference diagnosis.

Setting

A university hospital in France.

Participants

Consecutive adult patients with an indication for bone marrow aspiration due to suspected MDS and unexplained peripheral blood cytopenia.

Primary outcome

MDS confirmed by cytomorphological evaluation of the bone marrow aspirate performed in duplicate by experienced haematopathologists blinded to the index test.

Results

Of 103 participants enrolled between July 2020 and August 2021, 37 had MDS (prevalence, 36%). The median intra-individual robust coefficient of variation (RCV) for myeloperoxidase expression was 30.9% using the BD Lyotube Stain 468 and 31.2% using the laboratory-developed liquid reagent assay, with an intraclass correlation coefficient of 0.94 (95% CI 0.91 to 0.96). The areas under the receiver operating characteristic curves were 0.83 (95% CI 0.74 to 0.90) and 0.82 (95% CI 0.73 to 0.89), respectively. Using a prespecified threshold of 30.0%, the corresponding sensitivity estimates were 89% (95% CI 75% to 97%) and 95% (95% CI 82% to 99%).

Conclusion

BD Lyotube Stain 468 performs as well as its laboratory-developed liquid reagent counterpart for the quantification of myeloperoxidase expression by peripheral blood neutrophils. It may obviate the need for invasive bone marrow aspiration in up to 40% of patients with suspected MDS.

Trials registration number

NCT04399018.

Perspectivas de enfermería en atención primaria y promoción de salud en los adolescentes durante la pandemia

Sr. Director: A inicios de la pandemia por la enfermedad de coronavi-rus (Covid‑19), producida por el virus SARS-CoV-2, las autoridades en salud emitieron recomendaciones a todos los países a fin de salva-guardar la integridad física de la población [Fragmento de texto].

Percepción de los profesionales sanitarios sobre cómo afecta la luz y ruido al sueño/descanso de los pacientes en el Servicio de Urgencias

Objetivo principal: Mejorar la calidad del sueño y descanso de los pacientes en el servicio de urgencias mediante la participación y cono-cimiento de las percepciones de los profesionales sanitarios. Metodología: Un total de 173 profesionales sanitarios (79 enfermeras/os, 33 TCAE, 29 médicos/as y 32 celadores/as) cumplimentaron el cuestionario ad hoc de percepción de los profesionales sobre cómo afecta la luz y ruido al sueño y descanso de los pacientes. Resultados principales: Aspectos relacionados con la organización y dinámicas de trabajo, las competencias, habilidades y cuidados llevados a cabo por los profesionales daban lugar a distinciones en la participación de responder al cuestionario y en las percepciones de los profesionales sobre cómo la luz y ruido afecta al sueño y descanso de los pacien-tes, lo cual remarcaba la necesidad de evaluar factores perturbadores ambientales y establecer estrategias, medidas, intervenciones y cuidados para mejorar la calidad de sueño de los pacientes. Por tanto, los resultados de este trabajo aportaban nuevos datos en compa-ración con los datos de escasos estudios sobre la necesidad de conocer la percepción de los profesionales sanitarios sobre factores perturbadores ambientales que afectan al sueño/descanso de los pacientes, particularmente en el servicio de urgencias. Conclusión principal: Existe una variabilidad de las diferentes categorías de profesionales sanitarios en relación a la participación en contestar al cuestionario ad hoc, así como diferencias significativas entre las percepciones sobre cómo afecta la luz y ruido sobre el sueño/descanso de los pacientes. Por tanto, se plantean perspectivas de futuro y se alude a estrategias dirigidas a los pacientes, profesionales y organi-zación/entorno de trabajo para mejorar la calidad de sueño de los pacientes en el servicio de urgencias.

Cuidado de enfermería con terapia cognitiva conductual en la depresión postparto

Esta narrativa describe el cuidado que brinda una enfermera matrona, entrenada en terapia cognitivo conductual a una mujer con depresión postparto, con la cual establece una relación terapéutica. Previo consentimiento escrito, se planificaron sesiones terapéuticas basándose en la teoría de Aaron Beck, y durante las mismas, se logró que la puérpera reconociera y plasmara en un papel sus pensam-ientos negativos, reconociera las conexiones entre pensamiento, afecto y conducta, examinara las evidencias que están a favor o en contra de sus pensamientos, corrigiera sus distorsiones, sustituyera los pensamientos negativos por interpretaciones más objetivas y aprendiera a identificar los esquemas condicionantes y los autoesquemas, que predisponen a distorsionar sus experiencias. La capacitación y sensibilidad de la matrona, le permitió atender a la puérpera, y reconocer que más allá de la consulta por mastitis, su demanda inicial, había una depresión, ante la cual debía actuar.

Convivir con el Síndrome del Intestino Irritable

En este relato bibliográfico se cuenta la experiencia de una persona que sufre de la patología crónica del síndrome del intestino irritable, cómo es su afrontamiento desde el primer contacto con ella a cómo ha ido adaptándose progresivamente hasta hacerla partícipe de su vida. El objetivo es abordar cómo se vive con la patología del SII, la experiencia propia de esta persona. También se pretende dar a conocer esta patología, así como presentarla desde la subjetividad de esta persona. Para ello se escoge la metodología cualitativa y se lleva a cabo mediante una entrevista en profundidad y su posterior transcripción a un relato bibliográfico. Se observó que le causó un gran impacto a nivel psicológico pero también se detecta una actitud valerosa y finalmente de aceptación, control hacia la patología.

Intervenciones y cuidados de enfermería en la mejora del sueño/descanso de los pacientes hospitalizados

Introducción: los pacientes en el hospital están expuestos a factores clínicos, ambientales y emocionales que contribuyen a la inquietud, miedo, incertidumbre y a reducir y fragmentar el sueño/descanso. Por ello, una intervención y cuidados de enfermería adecuados por parte de los profesionales de la salud, llevando a cabo medidas específicas para atenuar el impacto del ingreso en el hospital, es funda-mental para mejorar el bienestar y la rápida recuperación de los pacientes. Objetivo: revisar cuales son las intervenciones y cuidados de enfermería más eficaces para mejorar el sueño/descanso. Material y métodos: se llevó a cabo una búsqueda bibliográfica en las princi-pales bases de datos primarias y secundarias como Google Académico®, Pubmed®, CINAHL®, Cochrane® y CUIDEN® de los últimos 10 años, fundamentalmente para conseguir una revisión reciente de la literatura, tanto a nivel nacional como internacional en relación al tema de estudio. El presente trabajo está enfocado como una revisión narrativa descriptiva crítica para aportar datos basados en la evi-dencia. Resultados: se obtuvo un gran número de artículos, de los cuales se seleccionaron los que fueron más relevantes según el obje-tivo de esta revisión narrativa crítica. Discusión y conclusiones: la literatura aporta que unas intervenciones y cuidados de enfermería específicos acordes a la actividad rutinaria en el hospital favorece el sueño/descanso de los pacientes teniendo incidencia en su recupe-ración.

Repercusión de la luz y ruido sobre el sueño/descanso en los pacientes hospitalizados

Introducción: los pacientes que se encuentran hospitalizados sufren un conjunto de reacciones y sentimientos que conlleva generalmente proble-mas de sueño en el hospital, donde el trabajo es continuo en relación a los cuidados que requieren los pacientes y donde es necesario considerar la tecnología que caracteriza a las diferentes unidades, por el ruido que se produce y la luz que requieren los profesionales para llevar a cabo el trabajo. El ruido y la luz son los factores ambientales que afectan en mayor medida a los pacientes hospitalizados. El objetivo es comprobar, identifi-car y discutir cuales son los factores perturbadores ambientales que afectan al sueño/descanso de los pacientes ingresados en el hospital. Material y métodos: se llevó a cabo una búsqueda bibliográfica en las principales bases de datos primarias y secundarias como Pubmed®, CINAHL®, Coch-rane® y Google Acádemico® de los últimos 10 años. Resultados: se obtuvo un gran número de artículos, de los cuales se seleccionaron los que fueron más relevantes según el objetivo de esta revisión narrativa crítica. Discusión y conclusiones: existe una gran complejidad y variabilidad en las metodologías de los diferentes estudios relacionados con factores perturbadores ambientales, pero también en los últimos años se está prestando mayor atención a la investigación sobre los factores que afectan a sueño y descanso de los pacientes ingresados en el hospital. Se puede concluir que el ruido y la luz son los factores perturbadores ambientales principales que afectan al sueño/descanso de los pacientes hospitalizados y que se necesita más investigación de alta calidad para superar las limitaciones y dificultades de estudios previos y fortalecer los cuidados de enfermería basados en la evidencia.

El adecuado producto en el baño preoperatorio

Objetivo principal: Describir que productos son los adecuados para el baño o ducha preoperatoria. Metodología: Se ha realizado una revisión narrativa, a través de la búsqueda en bases de datos electrónicas, que sintetiza la información de los estudios acerca del tema en concreto. Finalmente, tras aplicar criterios de selección y quitar duplicados se obtuvo un total de 12 artículos. Resultados: Se analizaron los estudios considerando que producto (gluconato de clorhexidina al 4%-2%, jabón, povidona yodada o sin producto) se utilizaba para el baño preoperatorio, dado que un correcto abordaje de esta actividad reduce el número de microorganismos de la piel y así minimizar el riesgo de infección de la herida quirúrgica. Conclusión principal: La mayoría de estudios afirman en realizar una ducha preoperatoria, pero hay variedad en el producto a administrar siendo el antiséptico de gluconato de clorhexidina al 4% el más adecuado.

El papel de enfermería en cirugía de colon según el programa de rehabilitación multimodal

Objetivo principal: Describir el programa de rehabilitación multimodal, destacando las actividades en las que participa el profesional de enfermería en el preoperatorio y postoperatorio de cirugía de colon. Metodología: Se ha realizado una revisión narrativa, a través de la búsqueda en bases de datos electrónicas, que sintetiza la información de los estudios acerca del tema en concreto. Finalmente, tras aplicar criterios de selección y quitar duplicados se obtuvo un total de 26 artículos. Resultados: Se analizaron los estudios considerando las etapas prequirúrgicas y postquirúrgicas obteniendo una relación de cuidados de enfermería necesarios para realizar un correcto abordaje al paciente según el programa de rehabilitación multimodal. Conclusión principal: Se ha elaborado un “checklist” basado en los resultados del estudio, para orientar, verificar la cantidad y tipo de cuidados que deben de llevarse a cabo en el programa de rehabilitación multimodal.

WITHDRAWN: Post-traumatic stress disorder-related perinatal factors after the first postpartum year

This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause.
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