Selective outcome reporting concerning antibiotics and third molar surgery.

OBJECTIVES: This study evaluates the selective outcome reporting (SOR) in clinical trials on antibiotic use in third molar surgeries. It explores how SOR may bias results and affect systematic reviews, potentially leading to misinterpretations of intervention efficacy. MATERIALS AND METHODS: A search was conducted on "ClinicalTrials.gov", "Brazilian Registry of Clinical Trials", "International Clinical Trials Registry Platform" and "European Union Clinical Trials Register" using the terms "third molar" and "antibiotics" up to December 2024. Two independent researchers selected eligible clinical trials. Data were extracted from registered protocols and corresponding publications. Discrepancies were analyzed using established criteria, and the risk of bias of published articles was assessed with Risk of Bias2. RESULTS: Discrepancies between protocols and publications were found in 87.5% of cases, affecting outcomes in 68.7% of studies. SOR significantly influenced results in studies with one or more discrepancies. 75% of studies assess pain post-antibiotic therapy; of those, 50% found significant results. Only 31,25% of studies showed significant reductions in trismus or edema with antibiotic use. The risk of bias varied significantly across studies. CONCLUSIONS: The high rate of selective reporting stresses the need for transparent studies to clarify the role of antibiotics in the perioperative period. Researchers should adhere to best clinical practices, including protocol registration, accurate sample size calculations, and precision in reporting. Journals and reviewers must prioritize transparency to reduce bias and improve research quality. CLINICAL RELEVANCE: This study emphasizes the impact of SOR in clinical trials using antibiotics in third molar surgery. Clinicians should be more cautious in reading evidence based on randomized clinical trials with SORs.

The need for more pragmatic trials in glaucoma research.

AIM: There have been a number of clinical trials in glaucoma research published in the past two decades. Most of these trials were designed to evaluate very specific issues in selected populations placing them in the explanatory end of the pragmatic-explanatory continuum. The purpose of this study was to assess the level of pragmatism of published randomized controlled trials in glaucoma. METHODS: A PubMed search using 'glaucoma' from 1995 to 2022 and randomized controlled trial (RCT) article type was done. Each study was assessed by three independent examiners using the Pragmatic-Explanatory Continuum Indicator Summary version 2 (PRECIS-2) toolkit. Scores were calculated for each study to determine the level of pragmatism. A summed score ≥36 was indicative of a very pragmatic study. RESULTS: Thirty-two different articles were included in the analysis. These papers represented 13 different landmark trials. The median PRECIS-2 score was 32 (range, 25 for the Early Manifest Glaucoma Trial (EMGT) to 34 to the Collaborative Normal Tension Glaucoma Study (CNTGS) and the Ocular Hypertension Treatment Study). The Treatment of Advanced Glaucoma Study (TAGS), was considered very pragmatic and scored 33 points. CONCLUSION: Despite the number of RCTs in glaucoma, there is still a need for more pragmatic studies.

Effectiveness of early childhood education interventions to improve complementary feeding practices in children 4 to 36 months of age: a systematic review protocol.

OBJECTIVE: This review will analyze the effectiveness of early childhood education interventions to improve complementary feeding practices in children aged 4 to 36 months. INTRODUCTION: Healthy eating habits, which start with food introduction, can influence children's growth and development. Educational actions carried out at school for children who are beginning to eat, involving families and school staff who attend daycare centers, can serve as strategies to improve complementary feeding practices. INCLUSION CRITERIA: The review will consider randomized clinical trials, cluster-randomized clinical trials, and controlled clinical trials that evaluate the effectiveness of early childhood education interventions involving children aged 4 to 36 months, their families, or school staff to improve complementary feeding. In their absence, observational cohort, case-control, and cross-sectional studies may be considered. METHODS: This review will be conducted in line with the JBI methodology for systematic reviews of effectiveness. The search for relevant studies will be conducted in PubMed, Embase (Ovid), BIREME, Scopus, the Cochrane Library (Cochrane Central Register of Controlled Trials CENTRAL and Cochrane Database of Systematic Reviews), CINAHL (EBSCOhost), and the ProQuest Databases (ProQuest Central). No date or language limitations will be applied. Two independent reviewers will select studies by screening titles, abstracts, and keywords against the inclusion criteria. This will be followed by full-text screening. Two independent reviewers will then evaluate the quality of the sources and perform data extraction. GRADEpro will be used to assess the certainty in the findings, which will be reported in the systematic review and, if possible, grouped in a meta-analysis. REVIEW REGISTRATION: PROSPERO CRD42022384704.

Rosa dos Ventos Multicenter Cohort Study of Patients with Reduced or Mildly Reduced Ejection Fraction Heart Failure in Brazil: Rationale and Design. / Delineamento e Racional do Estudo Rosa dos Ventos: Estudo Multicêntrico do Tipo Coorte de Pacientes com Insuficiência Cardíaca com Fração de Ejeção Reduzida ou Moderadamente Reduzida no Brasil.

BACKGROUND: Brazil is a country with different biomes and social disparities. There are limited data available on regional differences and prognosis of heart failure (HF) in the country. OBJECTIVE: The Rosa dos Ventos study aims to investigate regional differences and the current prognosis of HF outpatients with reduced or mildly reduced ejection fraction in Brazil. METHODS: This is a prospective, multicenter, observational cohort study that will include outpatients older than 18 years with HF and an ejection fraction < 50% in 30 public and private centers distributed in all Brazilian regions. A total of 2,500 patients will be enrolled from June 2021 and October 2023, with a 12-month follow-up period. We will collect data on socioeconomic and clinical status, medical prescription and results of cardiology tests. Follow-up phone calls will be made at 6 and 12 months after inclusion to collect information regarding emergency room visits, hospitalization and mortality. CONCLUSION: The Rosa dos Ventos study will allow a more accurate characterization of chronic HF in Brazil. This initiative will provide relevant information for the development of effective management strategies to mitigate the impact of this condition on patients and the healthcare system.

Sustainability of Interprofessional Education: Protocol for a Scoping Review.

BACKGROUND: Interprofessional education (IPE) is an approach that can improve health care quality, contribute to the qualification of health care professionals, and train undergraduate students. Although this strategy has made significant progress in the last decade, integration, sustainability, and institutional growth are still priorities worldwide. Thus, maintaining strategies is essential for their full development and evolution. OBJECTIVE: This study aimed to identify discussions about the sustainability of IPE and map its actions or strategies (or both). METHODS: The scoping review will follow the Joanna Briggs Institute methodology. This scoping review protocol follows the JBI Reviewers' Manual, with 6 stages: identifying the research question; identifying relevant studies; study selection; data extraction and coding; analysis and interpretation of results; and consultation with stakeholders. Two independent and blind reviewers will evaluate and select studies available in English, Portuguese, and Spanish based on the eligibility criteria. Searches will be conducted on LILACS, Embase, Scopus, PubMed/MEDLINE, ERIC, Web of Science, CINAHL, Google Scholar databases; ProQuest Dissertations & Theses Global, and Brazilian Digital Library of Theses and Dissertations. The main research question is as follows: What have been the sustainability strategies for IPE actions? This scoping review will incorporate studies (empirical or theoretical-reflective) that address strategies or actions (or both) for IPE sustainability. They must present a quantitative, qualitative, or mixed methods approach and be available in full text. Data on strategies or actions for IPE sustainability will be extracted and inserted into a spreadsheet for analysis. Quantitative data will be analyzed using descriptive statistics, while qualitative analysis will identify meanings and patterns through thematic analysis. Thus, the aim is to present the compiled findings in tables and charts. RESULTS: The database search was conducted on March 22, 2024. In April and May 2024, duplicate studies were excluded. From July to November 2024, study selection will be carried out. In December 2024, data extraction and tabulation will take place, as well as consultation with stakeholders. The aim is to publish the results in scientific journals in January 2025. CONCLUSIONS: This protocol will guide this scoping review to identify discussions on the sustainability of IPE and map its actions or strategies (or both); summarize the definitions and institutions that develop or promote IPE; and present the main recommendations for the area under study. Additionally, possible research gaps can be identified to guide future studies. This review will shed light on existing knowledge gaps and the current state of research, which could provide support for future research, programs, and policy responses to foster collaboration and interprofessional practice and, consequently, improve the quality of user care. This information will be useful in supporting decision-making by government officials, managers, teachers, facilitators, and students in the implementation, maintenance, and development of IPE. TRIAL REGISTRATION: Open Science Framework 5VNJS; https://osf.io/5vnjs/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60763.

Childhood early oral ageing syndrome: prevalence and association with possible aetiological factors and consequences for the vertical dimension of occlusion: protocol for a cross-sectional study.

INTRODUCTION: Childhood early oral ageing syndrome (CEOAS) is a condition involving oral abnormalities resulting from systemic diseases of different origins that are related to the current lifestyle of the paediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the early loss of tooth structure at an accelerated pace, with negative impacts on function, aesthetics and quality of life. The aim of the study is to identify the prevalence of early tooth wear in childhood and its severity using the CEOAS index, which is a tool for the diagnosis of the condition and for epidemiological surveys, involving the investigation of abnormalities of the oral cavity in the paediatric population and possible factors associated with the severity of the condition. METHODS AND ANALYSIS: Children aged 3-6 years will be recruited from the paediatric clinic of Universidade Nove de Julho. Children with amelogenesis imperfecta, dentinogenesis imperfecta and genetic syndromes, as well as those undergoing orthodontic treatment will be excluded. A questionnaire will be administered addressing general health, sleep quality, dietary habits, oral hygiene habits and parafunctional habits. Clinical examinations will then be performed using the novel CEOAS index to assess tooth wear (scores 0-3) and determine the occurrence of enamel defects (scores I-III). The vertical dimension of occlusion (VDO) will also be measured. The CEOAS scores will be computed for the deciduous dentition and analysed statistically, with the significance level set at 5% (p<0.05). ETHICS AND DISSEMINATION: This protocol has been approved by the institutional review board of Universidade Nove de Julho (process number: 6.713.724. Approved on 20 March 2024). The results will be submitted to international peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: www. CLINICALTRIALS: gov, NCT06381414. Registered 23 April 2024.

Exploring the effects of climate change on child malnutrition: protocol for a scoping review.

INTRODUCTION: Rapid climate changes in the early 21st century have triggered a global syndemic intertwining obesity, undernutrition and climate change, profoundly affecting health, especially children. Despite increasing research, a significant gap persists in understanding the mechanisms linking climate change to child malnutrition, particularly in children under 5 years old. This protocol proposes a scoping review to address this gap, with the aim of mapping the available evidence on the relationship between climate change and malnutrition among children under 5 years old. METHODS AND ANALYSIS: This scoping review will be conducted according to the Joanna Briggs Manual for Evidence Synthesis, and the results will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist to ensure a replicable process. The search will be conducted using MEDLINE (PubMed), Web of Science, Scopus and Embase databases. The studies to be included will be selected according to the inclusion and exclusion criteria defined based on the Population, Concept and Context technique. The study population will consist of children under 5 years old, with a focus on examining the impact of climate change on health outcomes related to nutrition, obesity and undernutrition. Original articles in English, Spanish and Portuguese will be selected without any restrictions on the publication year. Two researchers will independently select the articles and extract the data. The results will be presented through narrative synthesis. ETHICS AND DISSEMINATION: This study relies on analysing existing scientific literature and does not require ethical approval. The outcomes of this scoping review will be submitted for publication in a peer-reviewed journal, with a preference for open access. STUDY REGISTRATION: OSF (osf.io/swt4b).

Can resistance exercise prevent breast cancer-related lymphoedema? A systematic review and metanalysis protocol.

INTRODUCTION: Evidence shows that resistance training (RT) reduces lymphoedema in patients with breast cancer-related lymphoedema (BRCL), making it a safe and efficient intervention. However, it is uncertain if RT is safe and effective in patients at risk of developing BRCL. This systematic review (SR) protocol aims to describe all methodological aspects in order to evaluate the short-, medium- and long-term effects of RT on the prevention of BCRL. MATERIALS AND METHODS: Throughout 2024, randomised clinical trials (RCTs) will be identified in electronic databases MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, PEDro and LILACS. Only studies in English, Spanish and Portuguese will be included. Grey literature and clinical trial registration will also be reviewed. The primary outcome will be the occurrence of lymphoedema and quality of life. Second, pain intensity, upper limb function, range of movement, grip strength and adverse events will be considered. The individual studies' risk of bias will be evaluated using the Cochrane Risk of Bias 2.0 tool. Pairwise meta-analyses using a frequentist approach and random effects model will be conducted. The Grading of Recommendations Assessment, Development and Evaluation system will be used to evaluate the certainty of the evidence. ETHICS AND DISSEMINATION: This protocol does not require the approval of an ethics committee, as it is a secondary study. The results will be disseminated through peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42023455720.

Do randomised clinical trials on dental caries adopt Open Science practices?

BACKGROUND: Open Science Practices (OSPs) are essential when assessing research integrity and quality of Randomised Clinical Trials (RCTs). As dental caries represents a significant oral health burden, our objective was to identify and analyse the adoption of OSPs within RCTs focused on addressing this disease. METHODS: We searched PubMed to retrieve RCTs related to dental caries published from January 2000 to March 2022. Two independent researchers assessed a random sample of these articles to evaluate their eligibility until reaching the minimum sample size. Then, the same examiners reviewed the included texts regarding the OSPs adopted in the articles. The collected variables related to OSPs were reporting guidelines, protocol registration, detailed methodology available, open-source software, statistical analysis code sharing, statistical analysis plan, data sharing, open peer review, and open access. Association analyses using logistic regression were conducted considering the publication year, the continent of the first author, impact factor and open-access policy of the journals (explanatory variables), and adoption of at least one OSP or one OSP other than open access (outcomes). The recommendations for adopting OSPs were assessed by reviewing the "Instructions for Authors" section of the most frequently used journals where the included papers were published. RESULTS: 64.8% of the articles (95% Confidence Interval = 59.3-70.1%) adopted at least one OSP. However, no individual OSP was adopted by more than 50% of the articles. The most adopted practices were protocol registration (37.1%), the use of reporting guidelines (33.1%) and publishing open access (37.3%). These are also the OSPs most often recommended by journals in the Instructions for Authors. A few articles adopted other practices. Older articles presented a lower frequency of adopting these practices, and articles published in higher impact factor journals were positively associated with both outcomes. CONCLUSION: The RCTs published on dental caries demonstrate a low frequency of adoption of most OSPs. However, a trend toward increased adoption of these practices has been notable in recent years.

Exploring the role of health applications in promoting health among older adults: a scoping review protocol.

INTRODUCTION: Evidence on the use of health apps to support healthcare and promote the health of individuals aged 55 and older is limited. Older adults face challenges with literacy, usability and accessibility of digital tools. This scoping review aims to explore how digital health apps promote healthy living and self-empowerment while identifying successful applications for older adults METHODS AND ANALYSIS: This study will adopt the JBI methodology for scoping reviews, guided by the (Population, Concept, Context) framework. The results will be comprehensively reported in the final scoping review and illustrated using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The inclusion criteria include studies from 2016 to 2024 that investigate the use of health applications within healthcare services for older adults. ETHICS AND DISSEMINATION: Ethical approval is not required for this scoping review. The findings will highlight potential directions for future research and improve knowledge among professionals, researchers and the public. The results will be published in a peer-reviewed journal and disseminated through professional networks. Data will be available from the Open Science Framework.

Types of statistical analysis in prognostic studies.

Prognostic studies may have a descriptive exploratory objective on an outcome or a comparative objective in the search for factors associated with it. A second objective is explanatory to determine the effect of a particular prognostic factor adjusted for its confounders, with or without the intention of establishing causality. The third objective is the construction of a predictive prognostic scale. For each of these objectives, there are recommended statistical methods for clarification and validity. In this article, the methods and application examples are presented. The proper selection of analytical methods allows for clear and valid communication of the results of a prognostic study.

Los estudios pronósticos pueden tener un objetivo exploratorio descriptivo sobre un desenlace o comparativo en la búsqueda de factores asociados al mismo. Un segundo objetivo es explicativo para determinar el impacto de un factor pronóstico en particular ajustado a sus confusores con o sin la intención de establecer rutas causales. El tercero es la construcción de una escala pronóstica predictiva. Para cada uno de estos objetivos existen métodos estadísticos recomendados para su clarificación y validez, los cuales fueron revisados en una publicación previa. En este artículo presentamos los métodos y ejemplos de aplicación. La adecuada selección de los métodos analíticos permite una comunicación clara y válida de los resultados de un estudio pronóstico.

Key elements for understanding and developing qualitative research for health professionals. / Elementos clave para la comprensión y desarrollo de investigaciones cualitativas para profesionales de la salud.

Qualitative research plays an essential role in health sciences, aiming to achieve a deep understanding of phenomena, experiences, perceptions, and behaviors in their natural contexts. In this article, we outline essential aspects to consider when conducting qualitative research, starting from formulating the research question to analyzing and reporting the obtained data. We present the main qualitative design methods and sampling techniques, emphasizing the importance of reaching data saturation and the data production methods. This article offers a roadmap for conducting qualitative research in health care, contributing to a more humanized and evidence-based clinical practice.

La investigación cualitativa juega un papel crucial en las ciencias de la salud, centrándose en comprender profundamente fenómenos, experiencias, percepciones y comportamientos en sus contextos naturales. Este artículo aborda aspectos esenciales para llevar a cabo un estudio cualitativo, desde la formulación de preguntas de investigación hasta el análisis y reporte de los datos. Se resalta la reflexibilidad de la metodología cualitativa. Se presentan los principales diseños cualitativos: etnográfico, fenomenológico, teoría fundamentada y biográfico; las técnicas de muestreo: teórico, en cadena y por conveniencia, subrayando la importancia de alcanzar la saturación teórica. También se examinan métodos de producción de datos como la observación, entrevistas, grupos focales, grupos de discusión y técnicas documentales. El análisis de datos comienza con la transcripción íntegra de los audios y se continúa con la generación de códigos y agrupaciones de los mismos. El análisis puede ser tanto de contenido como del discurso, buscando interpretaciones profundas de la información recopilada. Este artículo es parte de una serie metodológica destinada a la formación de estudiantes en bioestadística y epidemiología clínica, destacando la colaboración entre instituciones de Chile y Argentina. El objetivo es ofrecer una guía completa para la implementación efectiva de investigaciones cualitativas en el ámbito de la salud, contribuyendo a una práctica clínica más humanizada y basada en la evidencia.

Protocol for an ambidirectional cohort study on long COVID and the healthcare needs, use and barriers to access health services in a large city in Southeast Brazil.

INTRODUCTION: Post-COVID-19 condition, or syndrome, also known as long COVID, is an infection-associated chronic condition that can develop after a SARS-CoV-2 infection and last at least 3 months to years. Despite representing a high burden for the Unified Health System (SUS), which has affected millions of Brazilians, it has received limited attention in Brazil. Prevalence studies to date have failed to include a broad representation of the population, and there has been insufficient exploration of the impact on people's lives and the burden of and barriers to accessing health services. This article presents the research protocol for the quantitative component of a mixed methods project to produce evidence to inform SUS's provision of care for long COVID. The protocol was designed to study long COVID in SUS patients hospitalised for COVID-19 in a large city in Southeast Brazil to capture symptoms and factors associated with the syndrome, effects on quality of life and employment, health needs, use of health services and barriers to accessing necessary healthcare. METHODS AND ANALYSIS: An ambidirectional cohort study to capture data retrospectively and prospectively from adults previously discharged from SUS hospitals for COVID-19. The study involves up to two telephone surveys with the patients or proxies selected from a sampling plan for population estimates. Survey questions include baseline and follow-up data on demographic, socioeconomic, comorbidities, work status, health-related quality of life, vaccination status, long COVID symptoms, healthcare needs, use and barriers to access. Descriptive and appropriate multivariable analyses will be employed. ETHICS AND DISSEMINATION: The project was approved by the Research Ethics Committees of participant institutions and by the Brazilian National Research Ethics Commission. All participants provided verbal consent. We plan to publish articles in scientific journals and multimedia resources for SUS professionals and the general population.

Commercial fisheries as non-designed experiments.

Commercial fisheries data often lacks the controlled environment of traditional experiments. In this note, we explore the limitations and strengths of observational and quasi-experimental approaches in fisheries science, discussing the challenges of establishing causality, space-time pseudo-replication, and the impact of fishing-induced evolution.

Predictive factors associated with Bile culture positivity And phenotypiCal antIbiogram resistance patterns in patients taken to LaparOscopic cholecystectomy (BACILO): protocol for a prospective observational cohort study and development of a prognostic prediction model.

INTRODUCTION: Bile fluid is aseptic under normal conditions; however, in the presence of cholecystitis, its susceptibility to bacterial colonisation varies, with reported rates of 20%-70% of cases. This process is referred to as bactibilia and/or bacteriobilia and can be considered a secondary complication of biliary stasis and cholecystitis in general. In the management of acute cholecystitis, the antibiotic regimen should be prescribed based on the presumed pathogens involved, taking into consideration the risk factors for resistance patterns according to demographics and local exposure. The aim of this study is to determine the predictive factors for bile culture positivity and antibiotic resistance in patients who underwent laparoscopic cholecystectomy in the Méderi Hospital Network. We hope to develop a predictive model that allows us to better guide antibiotic therapy. METHODS AND ANALYSIS: This is a prospective observational cohort study with prognostic prediction model. Patients who will undergo laparoscopic cholecystectomy and have bile cultures taken in the Méderi Hospital Network during the study period will be included. The dependent variables will be positive bile culture and antibiotic resistance, and the predictive variables will be age, presence of diabetes, diagnosis of choledocholithiasis, diagnosis of cholecystitis and severity of cholecystitis according to the Tokyo criteria. The minimum sample size has been calculated at 703 patients. Follow-up will continue until a control appointment 15 days after the procedure. The primary outcomes are bile culture positivity and phenotypical antibiogram resistance. For each outcome, a multivariate logistic regression will be performed using frequentist and Bayesian prediction techniques. ETHICS AND DISSEMINATION: This study was approved by the Méderi network research department committee (CIMED) and by Universidad del Rosario's Research Ethics Committee (CEI-UR; DVO005 2555-CV1837). Written informed consent is required for participation. The results will be disseminated through the submission of an academic article to a high-impact scientific journal, presentations at academic conferences, and sharing with our institution's faculty to inform antimicrobial therapy management based on local epidemiological data. TRIAL REGISTRATION NUMBER: NCT06314399.

Clasificación de los estudios que aplican al área de cirugía / Classification of studies that apply to the area of surgery

Introducción. La investigación clínica nos provee de herramientas para desarrollar proyectos en los cuales se muestre nuestra actividad en el campo profesional, pero requiere de una apropiada metodología, que siga los lineamientos del método científico. Una de las cuestiones básicas en el inicio de un proyecto de investigación es realizar un diseño adecuado para cada tipo de estudio propuesto. Métodos. Se hizo una revisión de la literatura disponible y se presenta de forma narrativa los aspectos más relevantes relacionados con los tipos de estudios que aplican al área de cirugía. Resultados. Según la relación entre el momento en que se realiza el estudio y los hechos evaluados, los estudios pueden ser prospectivos o retrospectivos. Desde el punto de vista de la temporalidad, pueden ser longitudinales o transversales. De acuerdo con la unidad de análisis, los estudios se pueden enfocar a nivel de los individuos o de las poblaciones. Vistos desde la intervención, los estudios epidemiológicos pueden tener un diseño experimental o no. Conclusión. Los ensayos clínicos controlados son considerados el "estándar de oro" de los diseños de investigación porque proporcionan la evidencia más convincente de la relación entre exposición y resultado. Sin embargo, en el área de cirugía, la ejecución de estudios experimentales no es fácil porque se enfrentan a serios problemas éticos y mayores riesgos de sesgos. Por eso, es necesario conocer otros tipos de estudios que aplican.

Introduction. Clinical research provides us with tools to develop projects in which our activity in the professional field is shown, but requires an appropriate methodology that follows the guidelines of the scientific method. One of the basic questions at the beginning of a research project is to carry out an appropriate design for each type of study proposed. Methods. A review of the available literature was performed and the most relevant aspects related to the types of studies that apply to the area of surgery are presented in a narrative form. Results. Depending on the relationship between the time in which the study is done and the facts evaluated, studies can be prospective or retrospective. From the point of view of temporality, they can be longitudinal or transversal. Depending on the unit of analysis, studies can be focused at the level of individuals or populations. Seen from the intervention, epidemiological studies may or may not have an experimental design. Conclusion. Controlled clinical trials are considered the gold standard of research designs because they provide the most convincing evidence of the relationship between exposure and outcome. However, in the area of surgery, performing experimental studies is not easy because they face serious ethical problems and greater risks of bias. Therefore, it is necessary to know other types of studies that apply.

Botulinum toxin for the management of bruxism: an overview of reviews protocol.

INTRODUCTION: Bruxism is characterised by a repetitive activity in the masticatory muscles that involves teeth clenching or grinding and/or forceful mandibular movements. Its management is typically initiated when individuals start experiencing the adverse effects of the condition. One of the available intervention forms is the administration of botulinum toxin type A (BoNT-A). Numerous systematic reviews have addressed the use of BoNT-A to manage bruxism; however, the results are controversial. The current overview aims to determine BoNT-A's effectiveness for managing bruxism in relation to placebo, the absence of treatment or alternative interventions in the adult population. METHODS AND ANALYSIS: This study will include systematic reviews (SRs), with or without meta-analysis, aiming to evaluate the efficacy of BoNT-A for bruxism in adults. A broad literature search will be carried out on Cochrane Library, EMBASE, LILACS, Livivo, PubMed/MEDLINE, Scopus, Web of Science and the grey literature. Experts in the topic and reference lists of included SRs will also be consulted. The study selection will be conducted in two phases by two independent reviewers. Data collection will be performed by one author and cross-checked by another. The methodological quality of included SRs will be evaluated using AMSTAR-II. A narrative synthesis will be employed as the formal method to combine individual study data. The overlap across studies will be quantified by the corrected covered area and illustrated by the Graphical Representation of Overlap for Overviews. ETHICS AND DISSEMINATION: This overview does not require ethics approval, as it uses secondary data from previously published studies. The results will be disseminated through the publication in a high-impact journal. OSF OF REGISTRATION: DOI: 10.17605/OSF.IO/RB45T.

At the intersections: operationalizing intersectional thematic analysis in HIV prevention. / Nas intersecções: operacionalizando análise temática interseccional em prevenção ao HIV.

OBJECTIVE: This study aims to provide theoretical and methodological tools to assist in producing thematic analyses guided by an intersectional approach in empirically-based qualitative health studies. It argues that combining an intersectional perspective with thematic analysis can update the latter-which is quite popular in qualitative health investigations-regarding meaningful discussions about multiple and interconnected patterns of privilege and oppression that operate structurally and institutionally, producing experiences of relative disadvantage in individuals according to their gender, race/ethnicity, class, sexuality, generation, among other positions. METHODS: Based on an article that analyzed qualitative empirical data from a longitudinal demonstrative study on pre-exposure prophylaxis for HIV (PrEP) in adolescents and young people aged 15 to 19 years in two Brazilian capitals, this study discusses the limitations, challenges, and potentialities of the theoretical and methodological efforts undertaken by those authors. Additionally, this research that offers a proposal for operationalizing thematic analysis with intersectional sensitivity. RESULTS: It observed that triangulating techniques can enhance thematic analysis with intersectional sensitivity to produce qualitative data. Adopting an a priori intersectional proposal, starting from the research design phase, construction, and application of data production instruments with intersectional intentionality, enables the recognition of the relations between social markers in analytical categories. DISCUSSION: However, the absence of an intersectional theoretical-methodological perspective to conceive research and produce data fails to render intersectionality as a methodological tool unfeasible, although it may limit result analysis and discussion. Such limitations can be addressed by proposing intersectional assumptions and comparing the results with literature related to the theme and object of study.

OBJETIVO: Este artigo objetiva fornecer instrumentação teórica e metodológica inicial para auxiliar a produção de análises temáticas sob orientação interseccional em estudos qualitativos de base empírica em saúde. Argumenta-se que o encontro da perspectiva interseccional com a análise temática tem o potencial de atualizar essa última - bastante popular nas investigações qualitativas no campo da saúde - acerca das importantes discussões sobre os múltiplos e relacionados padrões de privilégio e opressão que operam nos níveis estrutural e institucional e produzem experiências de desvantagem relativa nos indivíduos segundo suas posições de gênero, raça/cor, classe, sexualidade, geração, entre outras. MÉTODO: Este trabalho, com caráter ensaístico e metodológico, foi realizado a partir de um artigo que analisou dados empíricos qualitativos de um estudo longitudinal demonstrativo da Profilaxia Pré-Exposição sexual ao HIV (PrEP) entre jovens de 15 a 19 anos em três capitais brasileiras. Foram discutidas as limitações, os desafios e as potencialidades dos esforços teóricos e metodológicos empreendidos pelos seus autores, e apresentada uma proposta de operacionalização da análise temática com sensibilidade interseccional. RESULTADOS: Observou-se que a análise temática com sensibilidade interseccional pode ser potencializada com a utilização de triangulação de técnicas para a produção de dados qualitativos. A proposição inicial, desde a etapa do desenho da pesquisa, da construção e da aplicação dos instrumentos de produção de dados com intencionalidade interseccional favorece e viabiliza o reconhecimento das relações entre marcadores sociais nas categorias analíticas. DISCUSSÃO: O fato de a perspectiva teórico-metodológica da interseccionalidade não estar presente desde a concepção da pesquisa e a fase de produção dos dados não inviabiliza a utilização da interseccionalidade como ferramenta metodológica, embora possa implicar algumas limitações em termos de análise e discussão dos resultados. Tais limitações podem ser contornadas com a proposição de pressupostos de caráter interseccional e o cotejamento dos resultados com a literatura referente ao tema e objeto de estudo.

Preventive interventions for diabetic foot ulcer adopted in different healthcare settings: A scoping review protocol.

BACKGROUND: Diabetic foot ulcers are challenging to heal, increase the risk of lower extremity amputation, and place a significant burden on patients, families, and healthcare systems. Prioritizing preventive interventions holds the promise of reducing patient suffering, lowering costs, and improving quality of life. This study describes a scoping review protocol that will be used to delineate the preventive interventions for diabetic foot ulcers employed in different healthcare settings. METHODS: The scoping review methodology was formulated in accordance with the PRISMA extension guidelines for scoping reviews and informed by the procedural insights provided by the JBI methodology group. Studies with participants diagnosed with type 1 and type 2 diabetes, aged 18 years or older, without an active ulcer at baseline, and studies of preventive interventions for foot ulcers in various healthcare settings will be screened. The search strategy was developed in collaboration with a research librarian using the PRESS checklist and no time or language limitations were applied. Data will be analyzed and summarized descriptively, including characteristics of studies, participants, and interventions. DISCUSSION: Understanding the strategies and gaps in diabetic foot ulcer prevention is critical. The literature can provide valuable insights for developing tailored interventions and strategies to effectively address these gaps, potentially accelerating progress toward improved outcomes in diabetic foot ulcer prevention. REVIEW REGISTRATION: Open Science Framework DOI 10.17605/OSF.IO/FRZ97 [June 19, 2023].

Virtual simulation for teaching cardiology in nursing: a scoping review protocol.

INTRODUCTION: Virtual simulation (VS) can be an effective learning strategy in the context of nursing education on cardiovascular disease; however, its use in teaching cardiology in nursing is less studied. The objective of this scoping review is to map the use of VS for teaching cardiology in nursing. METHODS AND ANALYSIS: This scoping review will be conducted according to the Joanna Briggs Institute methods, and the results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Eight databases will be searched: MEDLINE (NCBI/PubMed), Cumulative Index to Nursing and Allied Health Literature, Web of Science, Latin American and Caribbean Literature in Health Sciences, Spanish Bibliographic Index of Health Sciences, Database of Nursing, EMBASE and Google Scholar from inception to 31 July 2024. This study will include any existing peer-reviewed literature and grey literature. There will be no time or language restrictions. Two reviewers will screen and select the articles independently, and when there are differences, they will be resolved with a third opinion. When appropriate, broad themes and categories derived from the review questions will be accompanied by other illustrative formats (eg, tables or graphs, word clouds and infographics). ETHICS AND DISSEMINATION: This research project does not require ethical committee approval. The study is part of a cooperative research project between researchers from the Federal University of Piauí, Northeast of Brazil, and Queen's University, Ontario, Canada, to develop and seek evidence of content validity of a VS game about valvular heart disease. The protocol and review will be published in peer-reviewed journals. REGISTRATION DETAILS: Open Science Framework (https://doi.org/10.17605/OSF.IO/S3UMH).