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2.
BMJ Open ; 14(5): e084583, 2024 May 07.
Artículo en Inglés | MEDLINE | ID: mdl-38719288

RESUMEN

INTRODUCTION: The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts. METHODS AND ANALYSIS: This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia's Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC. ETHICS AND DISSEMINATION: The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse. TRIAL REGISTRATION NUMBER: https://doi.org/10.17605/OSF.IO/RWY27.


Asunto(s)
Lista de Verificación , Organización Mundial de la Salud , Humanos , Femenino , Embarazo , Parto , Parto Obstétrico/normas , Proyectos de Investigación , Recién Nacido
3.
Am J Med Qual ; 39(3): 118-122, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38713599

RESUMEN

Electrolyte replacement protocols are routinely used in intensive care units (ICU) to guide magnesium replacement. Guided by serum levels, these protocols include no patient-specific factors despite a literature showing ICU patients routinely have significant deficits despite normal serum levels. The authors developed a checklist to help identify patients requiring more aggressive magnesium replacement than the electrolyte replacement protocol would provide. The checklist included risk factors for having significant magnesium deficits and for developing arrhythmias. The checklist was retrospectively applied to 364 medical ICU patients. Diabetic patients prescribed outpatient diuretics were defined as the highest-risk population. A total of 88% of patients in this subgroup had normal magnesium levels. Despite averaging 3.4 risk factors per patient, only 3 of 32 patients received magnesium. Applying the checklist would have suggested additional repletion for at least 85% of patients. A checklist can help identify ICU patients who may require more aggressive magnesium supplementation than protocols will provide.


Asunto(s)
Lista de Verificación , Unidades de Cuidados Intensivos , Magnesio , Humanos , Unidades de Cuidados Intensivos/organización & administración , Estudios Retrospectivos , Femenino , Masculino , Persona de Mediana Edad , Magnesio/administración & dosificación , Magnesio/sangre , Anciano , Factores de Riesgo , Deficiencia de Magnesio , Fluidoterapia/métodos
4.
Adv Tech Stand Neurosurg ; 49: 73-94, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38700681

RESUMEN

Enhanced recovery after surgery (ERAS) proposes a multimodal, evidence-based approach to perioperative care. ERAS pathways have been shown to help reduce complications, hospital length of stay (LOS), 30-day readmission rates, pain scores, and ultimately surgical costs, while improving patient satisfaction scores and outcomes in multiple surgical subspecialties [1-6]. Numerous specialties have implemented ERAS programs across the globe, providing a foundation for spine surgeons to begin the process themselves. Over the last few years, a significant number of papers have been addressing ERAS pathways for spinal surgery [7-19]. The majority have addressed the lumbar spine [9, 20-26]. The number of cervical ERAS pathways has been limited [27-29]. Many spine programs have begun the implementation of ERAS pathways, incorporating principles and interventions to various spine surgical procedures. Although differences in implementation across programs exist, there are a few common elements that promote a successful enhanced recovery approach [11, 16, 23, 25, 30-33]. All spinal ERAS pathways have three major elements, which are preoperative, perioperative, and postoperative phases. Within these phases some common elements include preoperative and intraoperative surgical checklists. Intraoperative checklist in addition to the "surgical time out" has been integrated into the workflow of most hospitals doing surgeries and have become a standard of care. The surgical checklist is designed to help reduce surgical errors and prevent wrong site/patient surgeries. Several surgical checklists have been developed throughout the years. Despite these safety protocols wrong site/level and other surgical errors continue to occur. Many cases of wrong level spine surgery (WLSS) still occur even when intraoperative imaging is performed [34, 35]. One survey reported that about 50% of spine surgeons have performed at least one WLSS during their career [36, 37]. Another survey reported that 36% of spine surgeons had performed at least one WLSS that was not recognized intraoperatively [38]. On a similar account, about 30% of spine surgery fellows have experienced wrong-site surgery [39]. From raw incidence rates, WLSS may seem rare, but these surveys show that the experience of WLSS is rather common among spine surgeons. WLSS is not yet a "never event." This may be due to poor quality of the intraoperative images, hindering subsequent level identification [34, 35, 38, 40]. Errors in interpretation of the imaging may also occur, including inconsistency in numbering vertebrae, inconsistency in landmark usage for level counting, and problems with numbering vertebrae due to lumbosacral transitional vertebrae (LSTV) and other anatomical variants [34, 38, 41-43]. This chapter will describe a framework for the development and implementation of ERAS pathway for patients undergoing spine surgery. In addition, we will propose preoperative imaging guidelines and a comprehensive spine surgical checklist to incorporate into the perioperative phase to help reduce further surgical errors and WLSS.


Asunto(s)
Lista de Verificación , Recuperación Mejorada Después de la Cirugía , Atención Perioperativa , Humanos , Recuperación Mejorada Después de la Cirugía/normas , Atención Perioperativa/normas , Atención Perioperativa/métodos , Columna Vertebral/cirugía , Procedimientos Neuroquirúrgicos/métodos , Procedimientos Neuroquirúrgicos/normas , Vías Clínicas/normas
5.
J Healthc Qual ; 46(3): 188-195, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38697096

RESUMEN

BACKGROUND/PURPOSE: Documentation of resuscitation preferences is crucial for patients undergoing surgery. Unfortunately, this remains an area for improvement at many institutions. We conducted a quality improvement initiative to enhance documentation percentages by integrating perioperative resuscitation checks into the surgical workflow. Specifically, we aimed to increase the percentage of general surgery patients with documented resuscitation statuses from 82% to 90% within a 1-year period. METHODS: Three key change ideas were developed. First, surgical consent forms were modified to include the patient's resuscitation status. Second, the resuscitation status was added to the routinely used perioperative surgical checklist. Finally, patient resources on resuscitation processes and options were updated with support from patient partners. An audit survey was distributed mid-way through the interventions to evaluate process measures. RESULTS: The initiatives were successful in reaching our study aim of 90% documentation rate for all general surgery patients. The audit revealed a high uptake of the new consent forms, moderate use of the surgical checklist, and only a few patients for whom additional resuscitation details were added to their clinical note. CONCLUSIONS: We successfully increased the documentation percentage of resuscitation statuses within our large tertiary care center by incorporating checks into routine forms to prompt the conversation with patients early.


Asunto(s)
Documentación , Mejoramiento de la Calidad , Humanos , Documentación/normas , Documentación/estadística & datos numéricos , Lista de Verificación , Órdenes de Resucitación , Cirugía General/normas , Resucitación/normas
6.
JMIR Res Protoc ; 13: e52572, 2024 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-38771621

RESUMEN

BACKGROUND: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs). OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs' implementation in CQRs, which is the aim of the broader project. METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs' implementation will be extracted. A narrative synthesis of included publications will be conducted. RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024. CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs' implementation in CQRs. TRIAL REGISTRATION: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52572.


Asunto(s)
Lista de Verificación , Medición de Resultados Informados por el Paciente , Humanos , Proyectos de Investigación/normas , Guías como Asunto
7.
BMC Med Res Methodol ; 24(1): 117, 2024 May 20.
Artículo en Inglés | MEDLINE | ID: mdl-38769533

RESUMEN

BACKGROUND: Although randomized trials and systematic reviews provide the best evidence to guide medical practice, many permanent neonatal diabetes mellitus (PNDM) studies have been published as case reports. However, the quality of these studies has not been assessed. The purpose of this study was to assess the extent to which the current case reports for PNDM comply with the Case Report (CARE) guidelines and to explore variables associated with the reporting. METHOD: Six English and four Chinese databases were searched from their inception to December 2022 for PNDM case reports. The 23 items CARE checklist was used to measure reporting quality. Primary outcome was the adherence rate of each CARE item and second outcome was total reporting score for each included PNDM case report. Linear and logistic regression analyses were used to examine the connection between five pre-specified predictor variables and the reporting quality. The predictor variables were impact factor of the published journal (<3.4 vs. ≥3.4, categorized according to the median), funding (yes vs. no), language (English vs. other language), published journal type (general vs. special) and year of publication (>2013 vs. ≤ 2013). RESULT: In total, 105 PNDM case reports were included in this study. None of the 105 PNDM case reports fulfilled all 23 items of the CARE checklist. The response rate of 11 items were under 50%, including prognostic characteristics presentation (0%), patient perspective interpretation (0%), diagnostic challenges statement (2.9%), clinical course summary (21.0%), diagnostic reasoning statement (22.9%), title identification (24.8%), case presentation (33.3%), disease history description (34.3%), strengths and limitations explanation (41.0%), informed consent statement (45.7%), and lesson elucidation (47.6%). This study identified that the PNDM case reports published in higher impact factor journals were statistically associated with a higher reporting quality. CONCLUSION: The reporting of case reports for PNDM is generally poor. As a result, this information may be misleading to providers, and the clinical applications may be detrimental to patient care. To improve reporting quality, journals should encourage strict adherence to the CARE guidelines.


Asunto(s)
Diabetes Mellitus , Humanos , Estudios Transversales , Diabetes Mellitus/diagnóstico , Recién Nacido , Lista de Verificación , Informe de Investigación/normas , Femenino , Adhesión a Directriz/estadística & datos numéricos , Masculino , Proyectos de Investigación/normas , Factor de Impacto de la Revista
8.
J Med Internet Res ; 26: e52508, 2024 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-38696776

RESUMEN

The number of papers presenting machine learning (ML) models that are being submitted to and published in the Journal of Medical Internet Research and other JMIR Publications journals has steadily increased. Editors and peer reviewers involved in the review process for such manuscripts often go through multiple review cycles to enhance the quality and completeness of reporting. The use of reporting guidelines or checklists can help ensure consistency in the quality of submitted (and published) scientific manuscripts and, for example, avoid instances of missing information. In this Editorial, the editors of JMIR Publications journals discuss the general JMIR Publications policy regarding authors' application of reporting guidelines and specifically focus on the reporting of ML studies in JMIR Publications journals, using the Consolidated Reporting of Machine Learning Studies (CREMLS) guidelines, with an example of how authors and other journals could use the CREMLS checklist to ensure transparency and rigor in reporting.


Asunto(s)
Aprendizaje Automático , Humanos , Guías como Asunto , Pronóstico , Lista de Verificación
9.
Eur J Psychotraumatol ; 15(1): 2333222, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38699832

RESUMEN

Background: The changes DSM-5 brought to the diagnostic criteria for posttraumatic stress disorder (PTSD) resulted in revising the most widely used instrument in assessing PTSD, namely the Posttraumatic Checklist for DSM-5 (PCL-5).Objective: This study examined the psychometric properties of the Romanian version of the PCL-5, tested its diagnostic utility against the Structured Clinical Interview for DSM-5 (SCID-5), and investigated the latent structure of PTSD symptoms through correlated symptom models and bifactor modelling.Method: A total sample of 727 participants was used to test the psychometric properties and underlying structure of the PCL-5 and 101 individuals underwent clinical interviews using SCID-5. Receiver operating characteristic curve (ROC) analyses were performed to test the diagnostic utility of the PCL-5 and identify optimal cut-off scores based on Youden's J index. Confirmatory Factor Analyses (CFAs) and bifactor modelling were performed to investigate the latent structure of PTSD symptoms.Results: Estimates revealed that the PCL-5 is a valuable tool with acceptable diagnostic accuracy compared to SCID-5 diagnoses, indicating a cut-off score of >47. The CFAs provide empirical support for Anhedonia, Hybrid, and bifactor models. The findings are limited by using retrospective, self-report data and the high percentage of female participants.Conclusions: The PCL-5 is a psychometrically sound instrument that can be useful in making provisional diagnoses within community samples and improving trauma-informed practices.


This study offers an in-depth analysis of the Romanian version of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), exploring its psychometric properties, diagnostic utility, and latent structure.An optimal cut-off score was identified for PTSD diagnosis using the SCID-5, providing essential insights into the diagnostic process and enhancing its utility in clinical assessments.Using bifactor modelling and other statistical methods, various PTSD models were compared to offer valuable guidance for future research, assessment, and interventions in this field.


Asunto(s)
Psicometría , Trastornos por Estrés Postraumático , Humanos , Psicometría/normas , Psicometría/instrumentación , Femenino , Masculino , Trastornos por Estrés Postraumático/diagnóstico , Adulto , Reproducibilidad de los Resultados , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Lista de Verificación , Análisis Factorial , Escalas de Valoración Psiquiátrica/normas , Persona de Mediana Edad , Encuestas y Cuestionarios/normas
10.
J Nurs Educ ; 63(5): 320-327, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38729143

RESUMEN

BACKGROUND: Accuracy is needed with medication administration, a skill that involves rule-based habits and clinical reasoning. This pilot study investigated the use of an evidence-based checklist for accuracy with oral medication administration and error reporting among prelicensure nursing students. Checklist items were anchored in the mnemonic C-MATCH-REASON© (Client, Medication, ADRs, Time, Client History, Route, Expiration date, Amount, Site, Outcomes, Notation). METHOD: Nineteen participants randomly assigned to crossover sequence AB or BA (A: checklist; B: no checklist) practiced simulation scenarios with embedded errors. Nursing faculty used an observation form to track error data. RESULTS: Using the C-MATCH-REASON© checklist compared with not using the checklist supported rule adherence (p = .005), knowledge-based error reduction (p = .011), and total error reduction (p = .010). The null hypothesis was not rejected for errors found (p = .061) nor reported (p = .144), possibly due to sample size. CONCLUSION: C-MATCH-REASON© was effective for error reduction. Study replication with a larger sample is warranted. [J Nurs Educ. 2024;63(5):320-327.].


Asunto(s)
Lista de Verificación , Competencia Clínica , Errores de Medicación , Femenino , Humanos , Masculino , Competencia Clínica/normas , Educación Basada en Competencias , Estudios Cruzados , Bachillerato en Enfermería , Errores de Medicación/prevención & control , Investigación en Educación de Enfermería , Proyectos Piloto , Estudiantes de Enfermería/estadística & datos numéricos
11.
Eur Radiol Exp ; 8(1): 72, 2024 May 14.
Artículo en Inglés | MEDLINE | ID: mdl-38740707

RESUMEN

Overall quality of radiomics research has been reported as low in literature, which constitutes a major challenge to improve. Consistent, transparent, and accurate reporting is critical, which can be accomplished with systematic use of reporting guidelines. The CheckList for EvaluAtion of Radiomics research (CLEAR) was previously developed to assist authors in reporting their radiomic research and to assist reviewers in their evaluation. To take full advantage of CLEAR, further explanation and elaboration of each item, as well as literature examples, may be useful. The main goal of this work, Explanation and Elaboration with Examples for CLEAR (CLEAR-E3), is to improve CLEAR's usability and dissemination. In this international collaborative effort, members of the European Society of Medical Imaging Informatics-Radiomics Auditing Group searched radiomics literature to identify representative reporting examples for each CLEAR item. At least two examples, demonstrating optimal reporting, were presented for each item. All examples were selected from open-access articles, allowing users to easily consult the corresponding full-text articles. In addition to these, each CLEAR item's explanation was further expanded and elaborated. For easier access, the resulting document is available at https://radiomic.github.io/CLEAR-E3/ . As a complementary effort to CLEAR, we anticipate that this initiative will assist authors in reporting their radiomics research with greater ease and transparency, as well as editors and reviewers in reviewing manuscripts.Relevance statement Along with the original CLEAR checklist, CLEAR-E3 is expected to provide a more in-depth understanding of the CLEAR items, as well as concrete examples for reporting and evaluating radiomic research.Key points• As a complementary effort to CLEAR, this international collaborative effort aims to assist authors in reporting their radiomics research, as well as editors and reviewers in reviewing radiomics manuscripts.• Based on positive examples from the literature selected by the EuSoMII Radiomics Auditing Group, each CLEAR item explanation was further elaborated in CLEAR-E3.• The resulting explanation and elaboration document with examples can be accessed at  https://radiomic.github.io/CLEAR-E3/ .


Asunto(s)
Lista de Verificación , Humanos , Europa (Continente) , Radiología/normas , Diagnóstico por Imagen/normas , Radiómica
12.
Food Res Int ; 183: 114201, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38760134

RESUMEN

Food services, which must meet the sanitary standards for food production, needed to adapt to COVID-19 protocols in times of pandemic. In this context, the study of food safety assessment tools and sanitary protocols can contribute to the systematization of sanitary control actions and to the understanding how services have adapted to the new requirements. Thus, the present study aims to evaluate the relationships among the results of the assessment tools for food safety and adherence to the sanitary protocol for coping with COVID-19 in food services. Sanitary inspections were performed in 40 food services located in the center of the city of São Paulo - Brazil. Data were collected through the application of four checklists to evaluate the following: i. risk for FBD; ii. Good Handling Practices; iii. the structural requirements; and iv. The implementation of the COVID-19 sanitary protocol. The risk assessment tool was interpreted using a risk score, with each item weighted according to the risk for FBD. The results of the other tools were evaluated using the overall percentage of violated items. The results showed the predominance of high risk of GHP in the food services evaluated and a high percentage of violation of Good Handling Practices and structural requirements. The percentage of violation of the COVID-19 health protocol was moderate in most establishments. The degree of risk showed a high positive correlation with Good Handling Practices violations (Spearman ρ = 0.73; p < 0.001) and structural requirements (Spearman ρ = 0.63; p < 0.001). Regarding the tool for assessing adherence to the COVID-19 sanitary protocol, a moderate correlation was found with the violations of Good Handling Practices (Spearman ρ = 0.65; p < 0.001), with an emphasis on the thematic block relevant to food handlers. This discussion of the relationships among the results of the evaluation tools and their measurements may therefore be useful for improving the application of these tools by professionals involved in inspection activities, allowing the greater systematization of sanitary control actions and contributing to reduced risk of FBD.


Asunto(s)
COVID-19 , Manipulación de Alimentos , Inocuidad de los Alimentos , Servicios de Alimentación , SARS-CoV-2 , COVID-19/prevención & control , COVID-19/epidemiología , Humanos , Brasil , Medición de Riesgo , Manipulación de Alimentos/métodos , Adhesión a Directriz , Lista de Verificación , Pandemias
13.
J Pak Med Assoc ; 74(4 (Supple-4)): S85-S89, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38712414

RESUMEN

The Operating Room Black Box (ORBB) is a relatively recent technology that provides a comprehensive solution for assessing technical and non-technical skills of the operating team. Originating from aviation, the ORBB enables real-time observation and continuous recording of intraoperative events allowing for an in-depth analysis of efficiency, safety, and adverse events. Its dual role as a teaching tool enhances transparency and patient safety in surgical training. In comparison to traditional methods, like checklists that have limitations, the ORBB offers a holistic understanding of clinical and non-clinical performances that are responsible for intraoperative patient outcomes. It facilitates systematic observation without additional personnel, allowing for review of numerous surgical cases. This review highlights the potential benefits of the ORBB in enhancing patient safety, its role as a surgical training tool, and addresses barriers especially in resource-constrained settings. It signifies a transformative step towards global surgical practices, emphasizing transparency and improved surgical outcomes.


Asunto(s)
Quirófanos , Seguridad del Paciente , Humanos , Quirófanos/normas , Lista de Verificación , Competencia Clínica , Cirugía General/educación
14.
BMJ Open ; 14(5): e081155, 2024 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-38772889

RESUMEN

INTRODUCTION: Large language model (LLM)-linked chatbots are being increasingly applied in healthcare due to their impressive functionality and public availability. Studies have assessed the ability of LLM-linked chatbots to provide accurate clinical advice. However, the methods applied in these Chatbot Assessment Studies are inconsistent due to the lack of reporting standards available, which obscures the interpretation of their study findings. This protocol outlines the development of the Chatbot Assessment Reporting Tool (CHART) reporting guideline. METHODS AND ANALYSIS: The development of the CHART reporting guideline will consist of three phases, led by the Steering Committee. During phase one, the team will identify relevant reporting guidelines with artificial intelligence extensions that are published or in development by searching preprint servers, protocol databases, and the Enhancing the Quality and Transparency of health research Network. During phase two, we will conduct a scoping review to identify studies that have addressed the performance of LLM-linked chatbots in summarising evidence and providing clinical advice. The Steering Committee will identify methodology used in previous Chatbot Assessment Studies. Finally, the study team will use checklist items from prior reporting guidelines and findings from the scoping review to develop a draft reporting checklist. We will then perform a Delphi consensus and host two synchronous consensus meetings with an international, multidisciplinary group of stakeholders to refine reporting checklist items and develop a flow diagram. ETHICS AND DISSEMINATION: We will publish the final CHART reporting guideline in peer-reviewed journals and will present findings at peer-reviewed meetings. Ethical approval was submitted to the Hamilton Integrated Research Ethics Board and deemed "not required" in accordance with the Tri-Council Policy Statement (TCPS2) for the development of the CHART reporting guideline (#17025). REGISTRATION: This study protocol is preregistered with Open Science Framework: https://doi.org/10.17605/OSF.IO/59E2Q.


Asunto(s)
Lista de Verificación , Humanos , Proyectos de Investigación , Técnica Delphi
15.
Drug Saf ; 47(6): 575-584, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38713346

RESUMEN

BACKGROUND AND AIM: Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts. METHODS: We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting. RESULTS: Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts. CONCLUSIONS: The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Farmacovigilancia , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos/normas , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Técnica Delphi , Lista de Verificación , Consenso , Guías como Asunto
16.
Pediatr Neurol ; 155: 62-67, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38603983

RESUMEN

BACKGROUND: The TAND (Tuberous Sclerosis Complex [TSC]-Associated Neuropsychiatric Disorders) Checklist was developed as a clinical screener for neurodevelopmental disorders in TSC. Most studies have described patterns in older children and adults. This study sought to better understand behavioral concerns as measured by the TAND Checklist in young children with TSC. METHODS: We examined patterns of caregiver responses to the TAND Checklist in 90 toddlers with TSC (12 to 23 months n = 60; 24 to 36 months n = 30) through data collected during baseline visits across two TSC early intervention studies. RESULTS: Over 90% of caregivers reported at least one behavioral concern related to TAND. The number of concerns increased with age. Delayed language was the most frequently reported concern across ages (12 to 23 months: 58.3%, 24 to 36 months: 86.7%). Questions related to behavioral concerns were largely relevant in this age range, but questions in other areas, such as neuropsychological or academic function, were not. CONCLUSIONS: TAND symptoms are very common in toddlers with TSC, and these symptoms may increase with age. The TAND Checklist is a useful tool for identifying behavioral concerns efficiently, but several items and sections are not suited to younger children. Results support the development of an abbreviated form of the TAND Checklist for toddlers.


Asunto(s)
Lista de Verificación , Esclerosis Tuberosa , Humanos , Esclerosis Tuberosa/complicaciones , Esclerosis Tuberosa/diagnóstico , Lactante , Masculino , Femenino , Preescolar , Lista de Verificación/normas , Discapacidades del Desarrollo/etiología , Discapacidades del Desarrollo/diagnóstico
17.
BMC Psychiatry ; 24(1): 254, 2024 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-38570753

RESUMEN

Traumatic experiences in childhood can lead to trauma symptoms and impaired mental health, especially when children are exposed to war and political violence. Despite significant attention to child's exposure to traumas, few instruments to detect potentially traumatic events have been validated psychometrically. Our study aimed to develop, adapt and validate a user-friendly traumatic events checklist in Palestinian children living in three areas affected by low-intensity war and ongoing political and military violence. 965 Palestinian children (494 males and 471 females) living in the Gaza Strip, West Bank and East Jerusalem were administered with a tailor-made Traumatic Events checklist, Children Impact of Events scale, and Strengths and Difficulties Scale. Exploratory and Confirmatory factor analysis was run to detect the factorial structure of the checklist. Furthermore, ANOVA was performed to identify statistically significant demographic differences among participants. A three factors structure emerged with Political violence-related traumatic experiences (PVTE), military violence against individuals (MVI), and military violence against individuals and families (MVF). Gaza children and adolescents resulted in being the most exposed to potentially traumatic events. The instrument can clearly portray potentially traumatic experiences in children exposed to violent events and adverse childhood experiences.


Asunto(s)
Trastornos por Estrés Postraumático , Guerra , Masculino , Niño , Femenino , Adolescente , Humanos , Trastornos por Estrés Postraumático/diagnóstico , Trastornos por Estrés Postraumático/etiología , Trastornos por Estrés Postraumático/psicología , Árabes/psicología , Lista de Verificación , Violencia/psicología
18.
BMJ Open ; 14(4): e081394, 2024 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-38569702

RESUMEN

INTRODUCTION: Mental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL. This systematic review will examine and compare the measurement properties of the MHLS in different languages, enabling academics, clinicians and policymakers to make informed judgements regarding its use in assessments. METHODS AND ANALYSIS: The review will adhere to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of patient-reported outcome measures and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and will be presented following the Preferred Reporting Items for Systematic reviews and Meta-Analysis 2020 checklist. The review will be conducted in four stages, including an initial search confined to PubMed, a search of electronic scientific databases PsycINFO, CINAHL, Scopus, MEDLINE, Embase (Elsevier), PubMed (NLM) and ERIC, an examination of the reference lists of all papers to locate relevant publications and finally contacting the MHLS original author to identify validation studies that the searches will not retrieve. These phases will assist us in locating studies that evaluate the measurement properties of MHLS across various populations, demographics and contexts. The search will focus on articles published in English between May 2015 and December 2023. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, and a comprehensive qualitative and quantitative data synthesis will be performed. ETHICS AND DISSEMINATION: Ethics approval is not required. The publication will be in peer-reviewed journals and presented at national and international conferences. PROSPERO REGISTRATION NUMBER: CRD42023430924.


Asunto(s)
Alfabetización en Salud , Humanos , Psicometría/métodos , Revisiones Sistemáticas como Asunto , Salud Mental , Lista de Verificación
19.
Syst Parasitol ; 101(3): 28, 2024 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-38568286

RESUMEN

A checklist of 113 monogenean species parasitizing marine fishes (60 species) from different localities in Egypt is provided. The list is supplemented by eight newly collected monogenean species from Red Sea fishes, off Safaga and El-Quseir. Five of these species are new Egyptian records: Calydiscoides euzeti Justine, 2007, Calydiscoides rohdei Oliver, 1984, Lethrinitrema austrosinense (Li & Chen, 2005) Sun, Li & Yang, 2014, Pseudohaliotrema sphincteroporus Yamaguti, 1953, and Pentatres sphyraenae Euzet & Razarihelisoa, 1959. Furthermore, Lutjanus ehrenbergii (Peters), Lethrinus nebulosus (Forsskål), Lethrinus mahsena (Forsskål), Siganus stellatus (Forsskål), and Sphyraena flavicauda Rüppell represent new host records. The current study also lists nine monogenean species from the Gulf of Aqaba for which the coordinates of the sampling localities were not clearly defined, but which could also belong to the Egyptian fauna as the gulf is part of the Red Sea basin. Dactylogyrus aegyptiacus Ramadan, 1983 is transferred to Ecnomotrema Kritsky, 2023 as E. aegyptiacum (Ramadan, 1983) n. comb. Entobdella aegyptiacus Amer, 1990, Polylabroides aegyptiacus Mahmoud & Shaheed 1998, Gotocotyla sigani Abdel Aal, Ghattas & Badawy, 2001, Neohexostoma epinepheli Abdel Aal, Ghattas & Badawy, 2001, Neothoracocotyle commersoni Abdel Aal, Ghattas & Badawy, 2001, Acleotrema maculatum Morsy, El Fayoumi & Fahmy, 2014, Diplectanum harid Morsy, El Fayoumi, Al Shahawy & Fahmy, 2014, and Pseudorhabdosynochus chlorostigma Morsy, El Fayoumi, Al Shahawy & Fahmy, 2014, are considered species inquirendae. Paranaella diplodae Bayoumy, Abd El-Hady & Hassanain, 2007 is considered incertae sedis. Allencotyla lutini El-Dien, 1995 and Lamellodiscus diplodicus Bayoumy, 2003 are regarded as nomina nuda.


Asunto(s)
Lista de Verificación , Peces , Animales , Humanos , Egipto , Especificidad de la Especie
20.
JAMA Netw Open ; 7(4): e246813, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38625701

RESUMEN

Importance: Posttraumatic stress disorder (PTSD) is marked by the contrasting symptoms of hyperemotional reactivity and emotional numbing (ie, reduced emotional reactivity). Comprehending the mechanism that governs the transition between neutral and negative emotional states is crucial for developing targeted therapeutic strategies. Objectives: To explore whether individuals with PTSD experience a more pronounced shift between neutral and negative emotional states and how the intensity of emotional numbing symptoms impacts this shift. Design, Setting, and Participants: This cross-sectional study used hierarchical bayesian modeling to fit a 5-parameter logistic regression to analyze the valence ratings of images. The aim was to compare the curve's slope between groups and explore its association with the severity of emotional numbing symptoms. The study was conducted online, using 35 images with a valence range from highly negative to neutral. The rating of these images was used to assess the emotional responses of the participants. The study recruited trauma-exposed individuals (witnessed or experienced life-threatening incident, violent assault, or someone being killed) between January 17 and March 8, 2023. Participants completed the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) (PCL-5). Exposure: On the basis of DSM-5 criteria (endorsing at least 1 symptom from clusters B and C and 2 from D and E), participants were categorized as having probable PTSD (pPTSD) or as trauma-exposed controls (TECs). Main Outcomes and Measures: The main outcome was the slope parameter (b) of the logistic curve fitted to the valence rating. The slope parameter indicates the rate at which emotional response intensity changes with stimulus valence, reflecting how quickly the transition occurs between neutral and negatively valenced states. The secondary outcome was the association between emotional numbing (PCL-5 items 12-14) and the slope parameter. Results: A total of 1440 trauma-exposed individuals were included. The pPTSD group (n = 445) was younger (mean [SD] age, 36.1 [10.9] years) compared with the TEC group (mean [SD] age, 41.5 [13.3] years; P < .001). Sex distribution (427 women in the TEC group vs 230 in the pPTSD group) did not significantly differ between groups (P = .67). The pPTSD group exhibited a steeper slope (mean slope difference, -0.255; 89% highest posterior density [HPD], -0.340 to -0.171) compared with the controls. Across all individuals (n = 1440), a robust association was found between the slope and emotional numbing severity (mean [SD] additive value, 0.100 [0.031]; 89% HPD, 0.051-0.15). Additional analysis controlling for age confirmed the association between emotional numbing and transition sharpness (mean [SD] additive value, 0.108 [0.032]; 89% HPD, 0.056-0.159), without evidence of an age-related association (mean [SD] additive value, 0.031 [0.033]; 89% HPD, -0.022 to 0.083). Conclusions and Relevance: These findings support that individuals with PTSD undergo rapid transitions between neutral and negative emotional states, a phenomenon intensified by the severity of emotional numbing symptoms. Therapeutic interventions aimed at moderating these swift emotional transitions could potentially alleviate PTSD symptoms.


Asunto(s)
Trastornos por Estrés Postraumático , Femenino , Humanos , Adulto , Teorema de Bayes , Estudios Transversales , Emociones , Lista de Verificación , Convulsiones
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