Psychometric properties of instruments to measure the well-being of young children: A systematic review protocol

Background@#Child well-being is an important outcome and has received attention from researchers for decades. Until recently, there has been difficulty in drawing conclusions from these studies because of the wide variety of measures used.@*Objective@#This systematic review aims to summarize and assess the measurement properties of existing child well-being instruments presented in the literature.@*Methods@#This systematic review will focus on studies that evaluated the psychometric properties of instruments to measure the well-being of children ages two to seven. The search strategy will aim to locate studies in the English language completed from 2000 to 2023. The databases to be searched include MEDLINE via PubMed, CINAHL Plus, and Psychology & Behavioral Sciences Collection via EBSCOhost. Proquest Dissertations and Theses, Google Scholar, and Research Gate will be used to search unpublished studies. Following the search, all identified citations will be collated in Mendeley. The full text of selected citations will be uploaded to JBI-SUMARI, assessed in detail against the inclusion criteria, and critically appraised using the COSMIN Risk of Bias checklist by two independent reviewers. Data will be extracted using JBI-SUMARI by one reviewer and verified by another. Findings will be reported using a narrative synthesis and tables. If possible, a meta-analysis will be performed. The evidence for each measurement property for each instrument will be compared against acknowledged standards for appropriate measurement characteristics using the COSMIN-proposed "criteria for good measurement properties."@*Expected Results@#This systematic review will provide further evidence regarding the measurement properties of instruments used to measure the well-being of children, specifically in the early years. The findings of this study will be disseminated through a conference presentation and publication in a peer-reviewed journal@*PROSPERO registration number@#CRD4202342T8953

Proposta de Pesquisa Científica para Avaliação da Segurança Microbiológica de Queijos Artesanais fabricados com leite cru e maturados por período inferior a 60 dias produzidos no estado de São Paulo / Scientific Research Proposal for the Microbiological Safety Evaluation of Raw Milk Artisanal Cheeses Ripened for Less than 60 Days in the State of São Paulo

Introdução: No Brasil, a legislação exige maturação mínima de 60 dias para queijos produzidos com leite cru, salvo se houver comprovação científica de que a redução do prazo não compromete a segurança do produto, como ocorreu com alguns queijos artesanais tradicionais de diferentes regiões do estado de Minas Gerais. No estado de São Paulo, onde os produtores seguem formulações e processos específicos individuais, a falta de um padrão de pesquisa validado dificulta a avaliação da segurança microbiológica deste tipo de queijo, pois essas pesquisas são dispendiosas e não há garantia de que os parâmetros estabelecidos pelos pesquisadores seriam aceitos pelos serviços de inspeção. Objetivo: Para abordar este desafio, esta proposta visa estabelecer um modelo de pesquisa científica padronizado para avaliar a segurança de queijos de leite cru maturados por menos de 60 dias. Métodos: Com base na proposta do DIPOA para classificação de Risco de Estabelecimentos, foi criado um checklist para classificação dos estabelecimentos/produtos, considerando risco do produto, volume processado e características de desempenho do estabelecimento em relação às Boas Práticas de Fabricação.  Resultados: A pontuação obtida pela aplicação do checklist na produção do queijo em questão determina o risco do produto como baixo, médio, alto ou muito alto e auxilia no estabelecimento do número mínimo de amostras a serem avaliadas mensalmente. Discussão: Espera-se que essa pesquisa auxilie produtores e órgãos de registro, fiscalização e inspeção no processo de legalização dos queijos artesanais de leite cru, possibilitando o desenvolvimento rural e a fixação de mão de obra no campo. (AU)

Introduction: In Brazil, the legislation requires a minimum ripening period of 60 days for raw milk cheeses, unless scientific evidence shows that the reduction in the ripening time does not compromise food safety, as seen with traditional artisanal cheeses from the state of Minas Gerais. In the state of Sao Paulo, where many producers have developed their own specific formulations and processes, the lack of a standardized validated research protocol for these types of cheese hinders their microbiological safety evaluation, since this type of research is costly and there are no guarantees that the parameters stablished by the researchers would be accepted by the inspection services. Objectives: To address this challenge, this proposal aims to stablish a standardized scientific research protocol for assessing the safety of raw milk cheeses ripened for less than 60 days. Methods: Based on the DIPOA (Department of Inspection of Products of Animal Origin) risk classification model for establishments, a checklist was created to categorize establishments/products, taking into consideration the product's risk, processed volume, and the establishment's performance assessed on the basis of good manufacturing practices. Results: The score obtained through the checklist application determines the final risk level of the product, categorized as low, medium, high, or very high, and helps determining the minimum number of samples to be evaluated monthly. Discussion: This research protocol may help producers, regulatory, inspection, and registration bodies in the legalization process of raw milk artisanal cheeses, enabling rural development and fixation of workforce in rural settings. (AU)

Caracterización preliminar de los protocolos de investigación de residentes de Ciencias Médicas / Preliminary characterization of research protocols of residents in Medical Sciences

Introducción: El conocimiento científico se caracteriza por ser racional, sistemático y verificable, lo que requiere una correcta estructura del protocolo de investigación. La finalidad de un protocolo es la correcta planificación y ejecución del estudio mediante la organización del trabajo de forma lógica, enfocada y eficiente. Objetivo: Describir los protocolos de tesis de los residentes de ciencias médicas. Métodos: Se realizó una investigación descriptiva de corte retrospectivo para la caracterización de 61 protocolos de tesis de los estudiantes de las disciplinas de Medicina general integral y Estomatología general integral del curso 2019-2020. Se confeccionó una planilla para la recolección de los datos extraídos de los protocolos revisados y se elaboró una base de datos para su almacenamiento. Resultados: Del total de protocolos revisados, 36 (59 por ciento) fueron de Medicina general integral y 25 (41 por ciento) de Estomatología general integral. El 90 por ciento de los protocolos de Medicina general integral son estudios observacionales, de estos el 97 por ciento estudios transversales, y de ellos casi el 90 por ciento estudios descriptivos. Los protocolos de Estomatología general integral presentaron resultados similares: el 96 por ciento son estudios observacionales, de estos 92 por ciento transversales y de ellos el 95 por ciento de tipo descriptivo. Acápites tan importantes como la operacionalización de las variables, la descripción de los métodos para la recolección de datos y las consideraciones éticas para el trabajo con humanos se consideran en menos del 25 por ciento de todos los protocolos revisados. Conclusiones: Se demuestra una marcada insuficiencia en la redacción de los protocolos de investigación por parte de los residentes de Medicina general integral y Estomatología general integral(AU)

Introduction: Scientific knowledge is characterized by being rational, systematic and verifiable, for this an adequate initial planning of the research work is required, which is achieved through the correct structure of the research protocol. The planning of a protocol is the correct planning and execution of the study by organizing the work in a logical, focused and efficient way. Objective: To characterize the thesis protocols of the students of the disciplines of comprehensive general medicine and comprehensive general stomatology of the 2019-2020 academic year. Methods: A retrospective descriptive investigation was carried out for the characterization of 61 thesis protocols of the students of the integral general medicine and integral general stomatology disciplines of the 2019-2020 academic year. A spreadsheet was prepared to collect the data extracted from the revised protocols and a database was prepared for storage. Results: Of the total protocols reviewed: 36 (59 percent) from integral general medicine and 25 (41 percent) from integral general stomatology. 90 percent of integral general medicine protocols are observational studies, of these 97 percent cross-sectional studies, and of them almost 90 percent descriptive studies. Regarding the integral general stomatology protocols, the results are similar: 96% are observational studies, of these 92 percent are cross-sectional and 95 percent of them are descriptive. In all, sections as important as the operationalization of the variables, the description of the methods for data collection, and the ethical considerations for working with humans are considered in less than 25 percent of all the protocols reviewed. Conclusions: A marked insufficiency in the writing of the research protocols by the residents of integral general medicine and integral general stomatology is demonstrated(AU)

Mixed methods appraisal tool: strengthening the methodological rigor of mixed methods research studies in nursing / Mixed methods appraisal tool: fortalecimiente del rigor metodológico de investigaciones de métodos mixtos en enfermería / Mixed methods appraisal tool: fortalecimento do rigor metodológico de pesquisas de métodos mistos na enfermagem

ABSTRACT Objective: to describe the use of the Mixed Methods Appraisal Tool to appraise and to strengthen the methodological rigor of mixed methods studies in nursing. Method: a theoretical essay was used to describe the application of Mixed Methods Appraisal Tool to support the development and assessment of mixed methods research in nursing. Four mixed methods articles in nursing were purposely chosen and evaluated based on the Mixed Methods Appraisal Tool criteria. Results: Mixed Methods Appraisal Tool is a tool for evaluating primary mixed methods studies based on five evaluation criteria: 1) justification for adopting mixed methods methodology; 2) integration between the quantitative and qualitative components; 3) interpretation of integrated findings of quantitative and qualitative data; 4) presentation of divergences between quantitative and qualitative results; and 5) compliance with the methodological rigor of each individual approach in mixed methods research. Conclusion: Mixed Methods Appraisal Tool is an instrumental resource that can be used to appraise mixed methods research and strengthen the methodological rigor in planning and conducting future mixed studies in nursing research.

RESUMEN Objetivo: describir el uso de la Mixed Methods Appraisal Tool para evaluación y fortalecimiento del rigor metodológico de estudios de métodos mixtos en enfermería. Método: se utilizó un ensayo teórico para describir la aplicación de la Mixed Methods Appraisal Tool para apoyar el desarrollo y evaluación de la investigación de métodos mixtos en enfermería. Se eligieron y evaluaron intencionalmente cuatro artículos de enfermería de métodos mixtos con base en los criterios del instrumento. Resultados: la Mixed Methods Appraisal Tool es una herramienta para evaluar estudios primarios seleccionados a partir de revisiones de literatura mixta, que evalúa cinco modalidades / categorías metodológicas, incluida la investigación de métodos mixtos. En la evaluación de estudios vinculados al paradigma de investigación mixta, se emplean cinco criterios de evaluación: 1) justificación de la adopción de métodos mixtos; 2) integración entre los componentes cuantitativo y cualitativo; 3) interpretación de la integración entre datos cuantitativos y cualitativos; 4) presentación de divergencias entre resultados cuantitativos y cualitativos; y 5) cumplimiento del rigor metodológico de cada enfoque de investigación mixta, de modo particular. Conclusión: la Mixed Methods Appraisal Tool es un recurso instrumental que puede fortalecer el rigor metodológico en la planificación y realización de estudios mixtos de investigación en Enfermería.

RESUMO Objetivo: descrever o uso da Mixed Methods Appraisal Tool para avaliação e fortalecimento do rigor metodológico de estudos de métodos mistos em enfermagem. Método: foi utilizado um ensaio teórico para descrever a aplicação da Mixed Methods Appraisal Tool no desenvolvimento e avaliação da pesquisa de métodos mistos em enfermagem. Quatro artigos de métodos mistos em enfermagem foram intencionalmente escolhidos e avaliados com base nos critérios do instrumento. Resultados: a Mixed Methods Appraisal Tool é uma ferramenta para avaliar estudos de métodos mistos primários com base em cinco critérios de avaliação: 1) justificativa para a adoção da metodologia de métodos mistos; 2) integração entre os componentes quantitativos e qualitativos; 3) interpretação de resultados integrados de dados quantitativos e qualitativos; 4) apresentação de divergências entre resultados quantitativos e qualitativos; e 5) conformidade com o rigor metodológico de cada abordagem individual na pesquisa de métodos mistos. Conclusão: a Mixed Methods Appraisal Tool é um recurso instrumental que pode ser usado para avaliar a pesquisa de métodos mistos e fortalecer o rigor metodológico no planejamento e na condução de futuros estudos mistos na pesquisa em enfermagem.

Instrumento para evaluar proyectos de investigación que concursan a beca en la Sociedad Argentina de Pediatría: Validación mediante el método Delphi / Instrument to assess research projects that apply for a fellowship by the Argentine Society of Pediatrics: Validation using the Delphi method

El objetivo del presente trabajo fue validar la forma y el contenido, mediante un método de consulta a expertos, como es el método Delphi, del instrumento para evaluar proyectos de investigación que concursan a beca en la Sociedad Argentina de Pediatría. Material y métodos. Un grupo coordinador seleccionó el panel de expertos en investigación pertenecientes a la Sociedad, diseñó y analizó cada una de las rondas de consulta. Los cuestionarios semiestructurados fueron enviados por correo electrónico en forma personalizada. Se estableció como criterio de consenso un acuerdo entre los expertos > 80 %. En cada ronda, se reformularon los aspectos no consensuados y se agregaron nuevos aspectos sugeridos por los expertos. Se consideró como medida de estabilidad para concluir la consulta cuando más del 70 % de los expertos no modificaron su opinión en rondas sucesivas. Resultados. Participaron del proceso 13 expertos en investigación. Luego de 3 rondas, finalizó el método de consulta. El instrumento consensuado contiene 47 ítems. El 10 % de la puntuación total corresponde a presentación general; el 40 %, a calidad metodológica; el 20 %, a relevancia-aplicabilidad; el 20 %, a factibilidad; y el 10 %, a antecedentes del becario y del director. Conclusiones. Se validó la forma y el contenido, mediante consenso de expertos, del instrumento de evaluación de proyectos de investigación que concursan a becas de investigación en la Sociedad y se lograron criterios objetivos de evaluación.

The objective of this study was to validate the format and contents of an instrument to assess research projects that apply for a fellowship by the Sociedad Argentina de Pediatría using an expert consultation technique, such as the Delphi method. Material and methods. A coordinating group selected a panel of research experts who were members of the Sociedad Argentina de Pediatría,designed, and analyzed each of the rounds of consultations. Semistructured questionnaires were sent by personalized e-mail. Agreement among experts > 80 % was established as the criterion for consensus. At each round of consultation, non-consensual aspects were reformulated and new aspects suggested by experts were included. A measure of stability to conclude the consultation was determined when more than 70 % of experts sustained their opinion in successive rounds. Results. Thirteen research experts participated in the process. After 3 rounds, the consultation process was concluded. The consensual instrument contains 47 items. In relation to the total score, 10 % corresponds to the general presentation; 40 %, to methodological quality; 20 %, to relevance and applicability; 20 %, to feasibility; and 10 %, to the fellow's and director's background. Conclusions. The format and contents of the instrument to assess research projects that apply for a fellowship by the Sociedad Argentina de Pediatría were validated based on expert consensus and objective assessment criteria were established.

Study design and implementation for population pharmacokinetics of Chinese medicine: An expert consensus / 中国结合医学杂志

Although many population pharmacokinetics (PPK) researches have been conducted on chemical drugs, few have been in the field of Chinese medicine (CM). Each ingredient in CMs possesses different pharmacokinetic characteristics, therefore, it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations. To develop an expert consensus on study design and implementation for PPK of CM, in August 2013, 6 experts in the field of PPK, CMs pharmacology, and statistics discussed problems on the PPK research protocol of CMs, and a consensus was reached. The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with definite therapeutic effects were selected as indices, and specific time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifies the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment of dosages of CMs.

Protocol and Rationale-The Efficacy of Minocycline as an Adjunctive Treatment for Major Depressive Disorder: A Double Blind, Randomised, Placebo Controlled Trial

While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functional recovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation of novel therapies. Recently depression is conceptualized as an immune-inflammatory and nitro-oxidative stress related disorder. Minocycline is a tetracycline antibiotic that has anti-inflammatory, pro-oxidant, glutamatergic, neurotrophic and neuroprotective properties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctive trial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctive treatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (with a 4 week follow-up post-discontinuation). The primary outcome measure for the study is mean change on the Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcomes including the Social and Occupational Functioning Assessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient Global Impression (PGI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Range of Impaired Functioning Tool (LIFE-RIFT). Biomarker analyses will also be conducted at baseline and week 12. The study has the potential to provide new treatment targets, both by showing efficacy with a new class of 'antidepressant' but also through the analysis of biomarkers that may further inform our understanding of the pathophysiology of unipolar depression.

Writing a research protocol in pediatric oncology / Como elaborar um protocolo de pesquisa de oncologia pediátrica

Children are considered an especially vulnerable population in a clinical trial.Specific research regulations in pediatrics focus on the protection from potential risks. Clinical trials in oncology have become an important step for the researchers to discover new drugs, new combinations of known drugs and new methods. This manuscript aimed to help novice researchers to elaborate protocols in pediatric oncology for clinical trials. This guide describes relevant aspects before writing a research protocol and brings a template of research protocol. Moreover, it showsthe importance of a well-designed research protocol and its appendices – informed consent and informed assent– in a pediatric oncology study.

As crianças são consideradas uma população vulnerável em ensaios clínicos.Normas regulatórias específicas de pesquisa clínica em pediatria estão focadas na proteção de riscos potenciais. Os ensaios clínicos em oncologia tornaram-se um passo importante para os pesquisadores descobrirem novas drogas, novas combinações de drogas conhecidas e novas metodologias. O objetivo deste artigo é ajudar os pesquisadores novatos a elaborar protocolos de pesquisa em oncologia pediátrica. Este guia descreve os aspectos relevantes antes de escrever um protocolo de pesquisa e traz um modelo de protocolo de pesquisa. Além disso, mostra a importância de um protocolo de pesquisa bem delineado e seus apêndices – termo de consentimento livre e informado e termo de assentimento - em um estudode oncologia pediátrica.

Dificultades comunes en la elaboración, procesamiento y análisis de la información en los trabajos de terminación de residencia / Common difficulties in preparing, processing and analyzing information in the final papers of residency

Se expone que durante el asesoramiento para la confección de los protocolos de investigación y revisión de los informes finales de tesis de grado, se detectan muchas deficiencias relacionadas con el diseño, la presentación, la elaboración, el análisis de los resultados y otros aspectos de interés, acerca de los cuales opina el autor de este documento.

It is stated that during counseling for making the research protocols and review of the final reports of thesis many deficiencies related to the design, presentation, processing and analysis of the results, and other aspects of interest are found, on which the author of this document comments.

Calidad de los trabajos de terminación de residencia / Quality of the final papers of residency

Se expone que durante el asesoramiento para la confección de los protocolos de investigación y revisión de los informes finales de tesis de grado, se detectan muchas deficiencias relacionadas con el diseño, la fundamentación y justificación del contenido, la búsqueda bibliográfica pertinente y otros aspectos de interés, acerca de los cuales opina el autor de este documento.

It is stated that during counseling for the preparation of research protocols and review of the final reports of thesis many deficiencies related to the design, rationale and justification of the content are found, as well as relevant literature search and other aspects of interest, on which the author of this document comments.

Partes componentes y elaboración del protocolo de investigación y del trabajo de terminación de la residencia / Constituent parts and drawing up of research protocol and of residence termination work

Se realizan algunas consideraciones y se brindan orientaciones sencillas, simples y precisas de cómo elaborar el protocolo de investigación, según sus componentes y de forma general, cómo redactar el informe final de investigación o trabajo de terminación de la residencia, de forma tal que los residentes puedan inferir al enfrentar esta tarea investigativa la relación existente entre ambos, el protocolo como documento básico y la investigación concluida que es el informe final y contar con las herramientas metodológicas imprescindibles y necesarias para esta función. Se brindan algunas consideraciones que permitirán al residente la confirmación de la calidad metodológica del trabajo realizado

Some considerations are took into account and simple and precise orientations are offered to design a research protocol, according to its components and in general how to write a final report of the research or work of completion residency allowing that residents may to deduce at to confront this research task, the existing relation between both, the protocol as a basic document and the concluded research that is final report and also to count on the methodological tools indispensable and necessary for this function. Author offer some considerations allowing the resident the confirmation of the methodological quality of the work carried out

Metodologia da pesquisa científica: diretrizes para a elaboração de um protocolo de pesquisa / Scientific research methodology: guidelines for elaboration of a research protocol

Objetivo: mostrar os aspectos metodológicos da organização estrutural de um protocolo de pesquisa científica, assim como, discutir os diferentes tipos de pesquisa e as linhas gerais para o desenvolvimento de um projeto científico. Método: para a organização deste estudo, fez-se criterioso levantamento bibliográfico na literatura científica, a partir da compilação de trabalhos publicados em revistas, livros especializados e em bases de dados da rede BIREME. Conclusão: o entendimento dos diferentes tipos de estudos científicos e suas respectivas classificações, assim como, a escolha do método que melhor se aplica à questão da pesquisa e aos seus objetivos, são fundamentais para a obtenção do sucesso na realização de um projeto de pesquisa científica.

Object: to show the methodological aspects of the structural organization of a scientific research protocol, as well as discuss the different types of research and the main aspects of a scientific project development. Method: for the organization of this present review study, a detailed bibliographic research of the scientific literature has been made, from the compilation of papers published in scientific magazines and specialized books, as well as from databases of Bireme?s server. Conclusion: the understanding of the different types of scientific study and their respective classifications, as well as the choice of the method that best applies to the research issue and its objectives, are fundamentals for obtaining success in a scientific research project.