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Introducción: Las enfermedades crónicas no transmisibles van en aumento, ocasionando discapacidad y dependencia en quien la padece, así como la necesidad de un cuidador. La cronicidad es un concepto que se ha analizado desde la mirada de la persona que la padece, dejando un vacío en la comprensión del significado para el cuidador. Objetivo: Comprender el significado de la cronicidad para las personas con Enfermedades crónicas no transmisibles y sus cuidadores informales. Materiales y métodos: Investigación cualitativa fenomenológica-hermenéutica según la propuesta de Van Manen, muestreo casual orientado por criterio, participaron 10 personas enfermas y 9 cuidadores. Los criterios de rigor de credibilidad y confirmabilidad, confiabilidad y la transferibilidad, garantizaron la calidad del estudio. Resultados: emergieron los siguientes temas: brindar y recibir cuidado como un acto de amor; unión de la familia; enfrentarse a la dureza; recibir, brindar y buscar apoyo; estar pendiente; cambio de vida; proceso de aprendizaje; una compañía para toda la vida; imponer restricciones, limitaciones y pérdidas. Conclusiones: el significado de la cronicidad para los cuidadores y las personas enfermas es complejo, dinámico y multidimensional; por lo tanto, es necesario realizar intervenciones que ayuden a mitigar el impacto que esta produce en la vida de este binomio.
Introducción: Las enfermeras han brindado cuidados a los pacientes con COVID-19, y muchas tuvieron que lidiar con este virus al ser infectadas. Objetivo: Describir las experiencias de las enfermeras en primera línea contagiadas con COVID-19 que recibieron atención domiciliaria. Método: Investigación cualitativa descriptiva, el tamaño de la muestra fue con 12 enfermeras infectadas con COVID-19 que recibieron tratamiento domiciliario en Chiclayo, Perú. El muestreo fue por la técnica de bola de nieve. Para recolectar los datos se utilizó la entrevista semiestructurada a través de los medios virtuales previo consentimiento informado. Resultados: Surgieron tres categorías: a) Incertidumbre ante modo de contagio, medios de diagnóstico, sintomatología y evolución por la COVID-19, b) Cuidados recuperativos en el hogar: tratamiento médico, uso de medicina tradicional y medidas de bioseguridad, y c) Impacto en la vida familiar, laboral, social, emocional y espiritual al sufrir de la COVID-19. Conclusiones: Las enfermeras presentaron síntomas leves de la COVID-19 y se recuperaron en su domicilio, cumplieron con el tratamiento médico, algunas usaron remedios caseros. Practicaron estrictamente las medidas de bioseguridad para evitar que su familia se contagie. Utilizaron la tecnología digital y reforzaron su fe para afrontar el impacto familiar, emocional y social.
Introducción: El envejecimiento poblacional ha desplegado un nuevo y amplio campo de estudio para la ciencia sanitaria en el que la enfermería debe investigar para garantizar la autonomía en salud de las personas mayores. Objetivo: Visibilizar los Centros de Día Gerontológicos (CDG) y las actividades de los profesionales de enfermería en dichos centros en Huelva. Metodología: Se ha realizado una investigación cualitativa a partir de cuestionarios y entrevistas dirigidas al personal de dirección y enfermería de varios Centros de Día de Huelva y provincia. Resultados: Los CDG son un recurso intermedio con múltiples objetivos y funciones, que ofrecen calidad de vida tanto para los mayores como para sus familiares. Se componen de un equipo básico de profesionales que trabaja de forma no permanente. La figura de la enfermería es esencial, pero cuenta con una situación laboral muy deficiente. Conclusión: Estos centros proporcionan cuidados profesionales y permiten la permanencia en los domicilios habituales favoreciendo la calidad de vida y autonomía de esta población mayor. La bibliografía sobre este tema es escasa, por lo que se considera necesario profundizar en su investigación junto con la puesta en marcha de programas y propuestas de mejora que den a conocer estos centros sociosanitarios.
La relación de la pérdida significativa de un ser querido y el alcoholismo ha minimizado las implicaciones sobre mecanismos de afrontamientos para generar conductas saludables. Este artículo se basa en entrevistas semiestructuradas a profundidad en hombres de entre 30 y 70 años, con más de 10 años en Alcohólicos Anónimos del Estado de Tamaulipas, México. El objetivo fue reflexionar sobre los significados de la pérdida significativa de un ser querido y el alcoholismo. En la búsqueda del significado, se explica que un factor que lleva al alcoholismo no es una sola pérdida significativa de personas queridas, sino un cúmulo también de pérdidas materiales y no materiales, se reflejaron recursos limitados para afrontar las pérdidas, la relación entre la pérdida significativa con el alcoholismo fue mediado por dos principales aspectos, las creencias sobre los efectos que produce el consumo de alcohol como formas de escapar de la realidad y las influencia de la familia al inicio del consumo de alcohol. Por otra parte, la presencia de lo espiritual, la conciencia y las emociones que experimentan durante su proceso de duelo y alcoholismo, los llevó a identificar el problema de la adicción, que permitió influir en el proceso de rehabilitación.
Este estudio tiene como objetivo comprender las prácticas de los cuidadores indígenas en contexto de cambio cultural. Parte de la idea de la necesidad de construir bases etnográficas que sirvan de insumos para la implementación de los enfoques de salud intercultural y enfermería transcultural, así como parte de la evidencia que facilite las prácticas de salud, a partir de descripciones competentes que ayuden a comprender la diversidad cultural de las poblaciones humanas. El abordaje metodológico se realizó desde la investigación cualitativa, con enfoque etnográfico, combinando revisión documental y entrevistas semiestructuradas a 44 personas. Se identificaron códigos, agrupados en subcategorías y categorías. Se encontraron varios tipos de cuidadores, de los cuales, se consideraron relevantes el médico tradicional y la partera. Sus prácticas se basan en saberes de la dimensión material y espiritual, entre las que se destaca el uso de plantas medicinales, rezo, interpretación de los sueños y ceremonias colectivas. Además, su labor depende del reconocimiento social, estatus del cuidador y rol en la organización social. Los modelos interculturales deben tener en cuenta a los cuidadores, en el marco de estrategias basadas en el diálogo de saberes y la participación.
La función del ajuar funerario para el viaje al más allá forma parte esencial de los ritos y rituales funerarios de Oaxaca. La ideología de la iglesia es que una vez que estás muerta, el alma va directa al cielo, al purgatorio o al infierno. Los pueblos indígenas de Oaxaca tienen una visión mucho más compleja y matizada. La sombra, no el alma, sigue presente en estado liminal, observadora consciente. Hay pocos estudios sobre prácticas funerarias de rituales del ajuar funerario y la cosmovisión en regiones indígenas. El objetivo es describir prácticas funerarias en comunidades indígenas del sur de Oaxaca y su sentido simbólico. Se realizaron entrevistas en profundidad con 73 personas mayores indígenas quien describieran los objetos enterrados, sus propósitos, el viaje durante la novena y el final, la Tierra de los Muertos. El conocimiento de las creencias y prácticas representa un acercamiento a las estrategias cognitivas y emocionales de las comunidades. Nos permite adentrarnos en el conocimiento y respeto de su organización social y cosmovisión. La enseñanza y práctica no pueden ser adecuada sin una conciencia de las diversidades en las creencias sobre la muerte, el viaje al más allá y la Tierra de los Muertos.
Introducción: La intersexualidad comprende condiciones infrecuentes donde una persona nace con una anatomía sexual diferente del binario hombre-mujer; esto supone habitar un cuerpo fuera de lo inteligible y estigmatizado. Históricamente, desde la heteronorma, el modelo biomédico ha buscado normalizarles quirúrgicamente para asignar precoz y arbitrariamente un sexo-género armónico con la genitalidad. Desde los Derechos Humanos, estas prácticas son cuestionadas por colectivos Intersex. Materiales y método: Estudio de caso, entre años 2019 y 2020; técnica de entrevista en profundidad a dos usuarios adultos de los Policlínicos de Urología y Endocrinología de un hospital público en Santiago, Chile; se utilizó la fenomenología de Husserl para comprender la experiencia en el sistema de salud de las personas intersex. El análisis de la información se basó en la propuesta de Colaizzi. Resultados: Se reconocieron unidades de significado principales e imbricadas, cuyas esencias permitieron describir el fenómeno de: ser niño y habitar el espacio hospitalario, vivir con la condición actualmente, y la experiencia de utilizar el sistema de salud siendo adulto. Conclusiones: Se identificaron diversas estrategias de agencia tanto en el espacio hospitalario como el cotidiano, mediante un proceso personal y silencioso de aprendizajes sobre las implicancias de ser intersexual.
The elimination of mother-to-child transmission (MTCT) of syphilis has been set as a public health priority. However, an instrument to predict the MTCT of syphilis is not available. We aimed to develop and validate an intuitive nomogram to predict the individualised risk of MTCT in pregnant women with syphilis in China.
Retrospective cohort study.
Data was acquired from the National Information System of Prevention of MTCT of Syphilis in Guangdong province between 2011 and 2020.
A total of 13 860 pregnant women with syphilis and their infants were included and randomised 7:3 into the derivation cohort (n=9702) and validation cohort (n=4158).
Congenital syphilis.
Among 13 860 pregnant women with syphilis and their infants included, 1370 infants were diagnosed with congenital syphilis. Least absolute shrinkage and selection operator regression and multivariable logistic regression showed that age, ethnicity, registered residence, marital status, number of pregnancies, transmission route, the timing of syphilis diagnosis, stage of syphilis, time from first antenatal care to syphilis diagnosis and toluidine red unheated serum test titre were predictors of MTCT of syphilis. A nomogram was developed based on the predictors, which demonstrated good calibration and discrimination with an area under the curve of the receiver operating characteristic of 0.741 (95% CI: 0.728 to 0.755) and 0.731 (95% CI: 0.710 to 0.752) for the derivation and validation cohorts, respectively. The net benefit of the predictive models was positive, demonstrating a significant potential for clinical decision-making. We have also developed a web calculator based on this prediction model.
Our nomogram exhibited good performance in predicting individualised risk for MTCT of syphilis, which may help guide early and personalised prevention for MTCT of syphilis.
Social status, which encompasses various psychosocial dimensions, such as income, education and social relationships, can have a significant impact on physical and mental health outcomes. The study aims to explore the association among subjective social status, health and well-being among individuals aged 55 years and older in China and South Korea.
Sample population included individuals aged 55 years and older: China (n=1779) and South Korea (n=421).
Outcome measures included self-reported health status and well-being which were assessed by life satisfaction and general happiness.
The percentage of participants who reported a ‘very good’ health condition was higher in South Korea (14.5%) than in China (11.0%). The percentage of participants who reported feeling very satisfied (14.7%) with their life was lower in South Korea (11.8%). In China, 6.7% of the respondents reported their health as ‘very bad’ (rating 5), while in South Korea, this percentage was higher at 18.1%. Regression analysis revealed an inverse association among higher social status and poorer health, lower life satisfaction and lower happiness levels. For example, individuals who placed themselves in the highest social status category had 0.26 times lower odds (95% CI=0.13 to 0.55) of reporting poorer self-rated health status than those in the lowest category. Similarly, compared with individuals who place themselves in the lowest social status category, those who place themselves in the highest social status category have 0.03 times lower odds of reporting lower life satisfaction (95% CI=0.02 to 0.07).
Overall, the results highlight a significant association among social status, subjective health, life satisfaction and general happiness in both the countries. Health policymakers should identify effective strategies to promote healthy ageing and reduce disparities in health and well-being outcomes among older adults from different social backgrounds.
Acute heart failure (AHF) is a critical, costly condition with high mortality rates, affecting millions annually. Despite advances in cardiovascular care, AHF treatment lacks robust evidence. AHF commonly manifests with sudden heart failure symptoms such as pulmonary congestion, and the pathophysiology involves fluid overload. Initial treatment is based on intravenous diuretics typically, but the optimal combination of drugs remains uncertain.
We will systematically review randomised controlled trials enrolling patients with AHF and volume overload undergoing in-hospital diuretic treatment. We aim to investigate any diuretic intervention. Our search strategy includes the following databases: Embase, Medline, Latin American and Caribbean Health Sciences Literature, Web of Science and the Cochrane Central Register of Controlled Trials. The primary outcome is all-cause mortality. Secondary outcomes are serious adverse events, hospital readmission and kidney failure. Study results reported at the most extended follow-up will be used for all outcomes. If appropriate, we will conduct meta-analysis, trial sequential analysis and network meta-analysis.
No ethics approval is required for this study. The results will be published in a peer-reviewed journal in this field.
CRD42023463979.
Due to the high risks of postoperative complications brought on by gastric cancer, traditional Chinese medicine (TCM) as a commonly used therapy, has exerted its vital role in postoperative recovery care. In this sense, this meta-analysis was conducted to explore the related documents about TCM's impact on gastric cancer postoperative recovery. During the research, we explored a total of 1549 results from databases PubMed, China National Knowledge Infrastructure (CNKI), Embase, Cochrane Library and Web of Science (WoS). Thirty-two clinical randomized trials (RCTs) were then selected and analysed for this meta-analysis by using the software RevMan 5.4 (under PRISMA 2020 regulations), with a population of 3178 patients. Data prove that TCM therapy reduced the risks for postoperative complications exposure by an estimated average of 19% (95% CI). Among the complications, TCM therapy suppressed the risks of wound infection and incisional infections by 53% and 48% respectively. Meanwhile, the patient's wound healing duration exhibited a significant reduction compared to those without TCM treatment, with a difference at around 0.74 days (95% CI). TCM also exerted its potential to strengthen the patient's immune and health conditions, leading to a significantly promoted gastrointestinal function in the patients with a shorter duration to release first exhaustion and defecation compared to those with no TCM therapy. In addition, similar promoted phenomena also exist in those patients with TCM therapy in terms of their immunity and nutritional conditions. These facts all indicate a positive impact of TCM therapy in clinical applications.
Cardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet is the first diet with cardiovascular benefits, a healthy dietary pattern that fits Chinese food culture that can effectively reduce the risk of CMD has not been found.
The study is a single-centre, open-label, randomised controlled trial aimed at evaluating the effect of the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern in reducing the risk of CMDs in people with dyslipidaemia and providing a reference basis for constructing a dietary pattern suitable for the prevention of CMDs in the Chinese population. Participants are men and women aged 35–45 years with dyslipidaemia in Tianjin. The target sample size is 100. After the run-in period, the participants will be randomised to the RCMDR dietary pattern intervention group or the general health education control group with a 1:1 ratio. The intervention phases will last 12 weeks, with a dietary intervention of 5 working days per week for participants in the intervention group. The primary outcome variable is the cardiometabolic risk score. The secondary outcome variables are blood lipid, blood pressure, blood glucose, body composition indices, insulin resistance and 10-year risk of cardiovascular diseases.
The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants. The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). The results from the study will be disseminated through publications in a peer-reviewed journal.
Chinese Clinical Trial Registry (ChiCTR2300072472).
Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.
The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.
Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes.
We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres.
The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.
Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.
A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.
Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.
Australian New Zealand Clinical Trials Registry—ACTRN12622001010785.
To explore the role of health communication in Shared Decision-Making (SDM) between nursing staff and older people in the community setting.
Society and healthcare services are marked by an exponentially ageing population, leading to a significant proportion of patients being older adults with highly demanding care needs. Scientific literature supports shared decision-making as a process that engages patients in their care. However, the increasing use of technology and the consequences of the COVID-19 pandemic have influenced how nurses communicate with older patients. Therefore, it is crucial to understand how to develop health communication to reach effective, shared decision-making processes.
Whittemore and Knafl's integrative review method, the literature search comprised five databases: PubMed, CINALH, Web of Science, Scopus and PsycINFO.
The 12 included studies were synthesised into three study patterns: (1) nurse–older patient health communication relationship, (2) older patients' perspectives and (3) nontherapeutic communication in end-of-life care.
This review underscored the crucial role of effective health communication in shaping SDM dynamics between nursing staff and older people in the community setting. Key elements included transparent information exchange, establishing trust and maintaining communication channels with informal caregiving networks. SDM actions were aligned with preserving older people's autonomy, but communication challenges persisted, particularly in end-of-life situations. Advanced care planning was recommended to address these shortcomings and improve communication among older people, healthcare professionals and families.
Implementing educational measures based on verbal and nonverbal health communication in nursing training could be beneficial. Nursing research could continue to develop and refine specific communication strategies adapted to the social determinants of health for diverse clinical situations regarding older adults in the community setting.
The authors have adhered to relevant EQUATOR guidelines through the PRISMA 2020 checklist.
No Patient or Public Contribution.
Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.
Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.
The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.
NCT05575128,
Newborn bloodspot screening (NBS) is a highly successful public health programme that uses biochemical and other assays to screen for severe but treatable childhood-onset conditions. Introducing genomic sequencing into NBS programmes increases the range of detectable conditions but raises practical and ethical issues. Evidence from prospectively ascertained cohorts is required to guide policy and future implementation. This study aims to develop, implement and evaluate a genomic NBS (gNBS) pilot programme.
The BabyScreen+ study will pilot gNBS in three phases. In the preimplementation phase, study materials, including education resources, decision support and data collection tools, will be designed. Focus groups and key informant interviews will also be undertaken to inform delivery of the study and future gNBS programmes. During the implementation phase, we will prospectively recruit birth parents in Victoria, Australia, to screen 1000 newborns for over 600 severe, treatable, childhood-onset conditions. Clinically accredited whole genome sequencing will be performed following standard NBS using the same sample. High chance results will be returned by genetic healthcare professionals, with follow-on genetic and other confirmatory testing and referral to specialist services as required. The postimplementation phase will evaluate the feasibility of gNBS as the primary aim, and assess ethical, implementation, psychosocial and health economic factors to inform future service delivery.
This project received ethics approval from the Royal Children’s Hospital Melbourne Research Ethics Committee: HREC/91500/RCHM-2023, HREC/90929/RCHM-2022 and HREC/91392/RCHM-2022. Findings will be disseminated to policy-makers, and through peer-reviewed journals and conferences.
When children with head and neck cancer receive radiation therapy as part of their treatment, a considerable frequency of hypopituitarism has been recognised. However, in adults, it has been little studied and it is possible that patients may be inadvertently affected. The objective is to estimate the incidence of anterior pituitary dysfunction in adults undergoing radiotherapy for head and neck cancer.
A total of five databases will be used to perform the document search: PubMed, Scopus, Web of Science (Core Collection), Ovid-MEDLINE and Embase. Cohort studies will be included without restriction by language or date. The main outcome will be the incidence of adenohypophyseal dysfunction for each axis: prolactin, growth hormone, thyroid-stimulating hormone, adrenocorticotropic hormone, luteinising hormone and follicle-stimulating hormone. Incidence meta-analysis will be performed using the Freeman-Tukey double arcsine method. In addition, a random-effects model will be used along with a 95% CI. Subgroup analyses will be performed according to tumour location, radiation dose and endocrine assessment time. Meta-regression will be applied according to patient’s age and time elapsed until diagnosis.
Since this will be a systematic review of published data, no ethics committee approval is required. The results will be presented at conferences and finally published in a peer-reviewed journal.
CRD42021235163.
Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation.
We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway.
This is a prospective, pragmatic, observational cohort study. Children (aged 0–17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9–15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value.
The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective.
FreshRSS