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Introducción: La calidad de los datos facilita garantizar la fiabilidad de los estudios observacionales. Objetivo: Describir el aseguramiento y el control de calidad para mantener la fiabilidad y la validez del dato en un estudio de cohorte. Métodos: Presentar el manejo de datos implementado dentro de un seguimiento de enfermos renales crónicos cuya exposición fue un programa de protección renal comparado con el tratamiento convencional y su asociación con desenlaces clínicos. Se evaluó el cambio en la frecuencia de errores después de implementar el plan y la reproducibilidad del ingreso de registros a las bases de datos. Resultados: Se documentó una disminución progresiva en los errores cometidos en la captación de datos. El valor de Kappa entre los recolectores de la información para las variables clínicas más importantes fue 0,960 para la depuración de creatinina 150 mg/dL; 0,730 para la alteración del sedimento urinario; 0,956 para la asignación de estadio al ingreso. Los coeficientes de correlación intraclase para la identificación de las cifras de presión arterial sistólica fue 0,996; para la de presión arterial diastólica 0,993 y para los niveles de creatinina sérica al diagnóstico 0,995. Discusión: La calidad de los datos comienza con el reconocimiento de los retos y dificultades que implica su responsable captación, de ahí el aporte de la estandarización de los procesos y el personal que los lleve a cabo en forma idónea. Estudios evidencian que muchos procesos de mejora surgen en el desarrollo de la investigación sin protocolos preestablecidos. Conclusión: La reducción en la proporción y el tipo de error durante el proceso de captación de datos se debe a su identificación temprana y la corrección de instructivos, del instrumento de control de diligenciamiento y de la capacitación continua del personal. El análisis mostró una buena concordancia interevaluador.

Introduction: Data quality makes it easier to ensure that observational studies are reliable. Objective: To describe assurance and quality control to maintain data reliability and validity in a cohort study. Methodology: We present the data management strategies implemented in a study that followed patients of chronic kidney disease who were in a renal protection program and compared them with those undergoing conventional treatment to observe its association with clinical outcomes. We assessed the changes in error frequency after implementing the plan along with the reproducibility of the strategies for entering records into the databases. Results: We documented a progressive decrease of data collection errors. The Kappa values among data collectors for the most important variables were: 0.960 for creatinine clearance 150 mg/dl; 0.730 for urinary sediment alteration and 0.956 for stage allocation upon admission. The intraclass correlation coefficient for the identification of systolic blood pressure was 0.996; for diastolic blood pressure, the coefficient was 0.993 and for serum creatinine levels at diagnosis, the value was 0.995. Discussion: Data quality begins with the recognition of the challenges and difficulties involved in responsible data collection, hence the contribution of standardized processes and personnel to carry them out in a suitable manner. Studies show that many improvement processes arise in the development of research without pre-established protocols. Conclusion: The reduction in error ratio and type during the data collection process are the result of the early identification of erroneously entered or missing data, the correction of the guidelines for completing forms as well as of the instruments for detecting errors and continuous training of the staff. The analysis showed good inter-rater reliability.

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INTRODUCTION: There is still no community consensus regarding strategies for data quality review in liquid chromatography mass spectrometry (LC-MS)-based untargeted metabolomics. Assessing the analytical robustness of data, which is relevant for inter-laboratory comparisons and reproducibility, remains a challenge despite the wide variety of tools available for data processing. OBJECTIVES: The aim of this study was to provide a model to describe the sources of variation in LC-MS-based untargeted metabolomics measurements, to use it to build a comprehensive curation pipeline, and to provide quality assessment tools for data quality review. METHODS: Human serum samples (n=392) were analyzed by ultraperformance liquid chromatography coupled to high-resolution mass spectrometry (UPLC-HRMS) using an untargeted metabolomics approach. The pipeline and tools used to process this dataset were implemented as part of the open source, publicly available TidyMS Python-based package. RESULTS: The model was applied to understand data curation practices used by the metabolomics community. Sources of variation, which are often overlooked in untargeted metabolomic studies, were identified in the analysis. New tools were used to characterize certain types of variations. CONCLUSION: The developed pipeline allowed confirming data robustness by comparing the experimental results with expected values predicted by the model. New quality control practices were introduced to assess the analytical quality of data.

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RESUMO Objetivo Realizar a validação de conteúdo de um protocolo de decanulação de pacientes adultos traqueostomizados. Método Para a validação de conteúdo do protocolo elaborado por fonoaudiólogas foi utilizada a técnica Delphi. Os 11 itens do protocolo foram julgados por peritos, por meio de rodadas via e-mail e foram classificados como adequados, parcialmente adequados ou inadequados, além de fornecerem comentários e sugestões sobre cada item. Foram convidados 30 fonoaudiólogos, 30 fisioterapeutas respiratórios e 30 médicos responsáveis pelo procedimento de traqueostomia e decanulação. O percentual de concordância adotado foi ≥ 80% e o processo foi interrompido quando obtido esse percentual em todos os itens. Resultados Ao final do processo, 24 profissionais participaram da terceira rodada, sendo 46% fonoaudiólogos, 29% fisioterapeutas e 25% médicos. Após as sugestões e comentários dos peritos, dois itens foram mantidos como estavam no protocolo inicial, sete foram reformulados, seis incluídos e dois excluídos. A versão final do protocolo incluiu: identificação, ausência de secreções abundantes, características da secreção, tosse eficaz, capacidade para remover secreções, tolera o balonete desinsuflado, aptidão no processo de decanulação, nível de consciência, troca de cânula para menor calibre, ausência de infecção vigente/ ativa, deglutição espontânea e eficaz de saliva, uso de válvula de fala, aptidão à oclusão da cânula, avaliação da aptidão para decanulação e exames objetivos. Conclusão Por meio da Técnica Delphi houve a validação do conteúdo do instrumento, ocorrendo mudanças substanciais. A próxima etapa de validação do instrumento é a obtenção de evidências de validade em relação a estrutura interna.

ABSTRACT Purpose Perform content validation of a decannulation protocol for tracheostomized adult patients. Methods To validate the content of the protocol developed by speech therapists, the Delphi technique was used. The 11 items of the protocol were judged by experts through rounds via e-mail and were classified as adequate, partially adequate or inadequate, in addition to providing comments and suggestions on each item. 30 speech therapists, 30 respiratory physiotherapists and 30 physicians responsible for the tracheostomy and decannulation procedure were invited. The percentage of agreement adopted was ≥ 80% and the process was interrupted when this percentage was obtained in all items. Results At the end of the process, 24 professionals participated in the third round, being 46% speech therapists, 29% physiotherapists and 25% physicians. After the experts' suggestions and comments, two items were kept as they were in the initial protocol, seven were reformulated, six were included and two were excluded. The final version of the protocol included: identification, absence of abundant secretions, characteristics of the secretion, effective cough, ability to remove secretions, tolerate the deflated cuff, aptitude in the decannulation process, level of consciousness, change of cannula to a smaller caliber, absence of current/active infection, spontaneous and effective swallowing of saliva, use of a speech valve, aptitude for occlusion of the cannula, assessment of aptitude for decannulation and objective examinations. Conclusion Through the Delphi Technique, the content of the instrument was validated, with substantial changes occurring. The next stage of instrument validation is obtaining evidence of validity in relation to the internal structure.

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Background: A significant proportion of the clinical record is in free text format, making it difficult to extract key information and make secondary use of patient data. Automatic detection of information within narratives initially requires humans, following specific protocols and rules, to identify medical entities of interest. Aim: To build a linguistic resource of annotated medical entities on texts produced in Chilean hospitals. Material and Methods: A clinical corpus was constructed using 150 referrals in public hospitals. Three annotators identified six medical entities: clinical findings, diagnoses, body parts, medications, abbreviations, and family members. An annotation scheme was designed, and an iterative approach to train the annotators was applied. The F1-Score metric was used to assess the progress of the annotator's agreement during their training. Results: An average F1-Score of 0.73 was observed at the beginning of the project. After the training period, it increased to 0.87. Annotation of clinical findings and body parts showed significant discrepancy, while abbreviations, medications, and family members showed high agreement. Conclusions: A linguistic resource with annotated medical entities on texts produced in Chilean hospitals was built and made available, working with annotators related to medicine. The iterative annotation approach allowed us to improve performance metrics. The corpus and annotation protocols will be released to the research community.

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Preprocessing data in a reproducible and robust way is one of the current challenges in untargeted metabolomics workflows. Data curation in liquid chromatography-mass spectrometry (LC-MS) involves the removal of biologically non-relevant features (retention time, m/z pairs) to retain only high-quality data for subsequent analysis and interpretation. The present work introduces TidyMS, a package for the Python programming language for preprocessing LC-MS data for quality control (QC) procedures in untargeted metabolomics workflows. It is a versatile strategy that can be customized or fit for purpose according to the specific metabolomics application. It allows performing quality control procedures to ensure accuracy and reliability in LC-MS measurements, and it allows preprocessing metabolomics data to obtain cleaned matrices for subsequent statistical analysis. The capabilities of the package are shown with pipelines for an LC-MS system suitability check, system conditioning, signal drift evaluation, and data curation. These applications were implemented to preprocess data corresponding to a new suite of candidate plasma reference materials developed by the National Institute of Standards and Technology (NIST; hypertriglyceridemic, diabetic, and African-American plasma pools) to be used in untargeted metabolomics studies in addition to NIST SRM 1950 Metabolites in Frozen Human Plasma. The package offers a rapid and reproducible workflow that can be used in an automated or semi-automated fashion, and it is an open and free tool available to all users.

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This paper presents the extract-transform-and-load (ETL) process from the Electronic Patient Records (ePR) at the Heart Institute (InCor) to the OMOP Common Data Model (CDM) format. We describe the initial database characterization, relational source mappings, selection filters, data transformations and patient de-identification using the open-source OHDSI tools and SQL scripts. We evaluate the resulting InCor-CDM database by recreating the same patient cohort from a previous reference study (over the original data source) and comparing the cohorts' descriptive statistics and inclusion reports. The results exhibit that up to 91% of the reference patients were retrieved by our method from the ePR through InCor-CDM, with AUC=0.938. The results indicate that the method that we employed was able to produce a new database that was both consistent with the original data and in accordance to the OMOP CDM standard.

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ABSTRACT Objective: report the experience of applying the theoretical data saturation technique in qualitative research with schoolchildren. Method: critical reading of primary sources and compilation of raw data, followed by thematic grouping through colorimetric codification and allocation of themes/types of statements in charts to find theoretical saturation for each grouping. Results: colorimetric codification occurred according to previously established themes: bodily hydration; physical activities and play; handling of sickle-cell disease; feeding and clothing. On the eleventh interview, it was possible to reach the theoretical saturation of themes, with four additional interviews being performed. Conclusion: this experience report enabled the description of the five sequential steps for identification of theoretical data saturation in qualitative research conducted with schoolchildren.

RESUMEN Objetivo: Relatar la experiencia en la aplicación técnica de saturación teórica de datos en investigación cualitativa con escolares. Método: Lectura crítica de fuentes primarias y compilación de datos brutos, continuadas por agrupado temático mediante codificación colorimétrica y ubicación de los temas/tipos de enunciado en un cuadro para constatación de saturación teórica de cada grupo. Resultados: La codificación colorimétrica se realizó según los temas previamente establecidos: hidratación corporal; bromas y actividades físicas; manejo de la enfermedad falciforme, alimentación y ropas utilizadas. En la decimoprimera entrevista fue posible alcanzar la saturación teórica de los temas, realizándose luego cuatro entrevistas más. Conclusión: Este relato de experiencia permitió describir los cinco pasos seguidos secuencialmente para la identificación de saturación teórica de datos en una investigación cualitativa desarrollada con escolares.

RESUMO Objetivo: relatar a experiência na aplicação técnica de saturação teórica dos dados em pesquisa qualitativa com escolares. Método: leitura crítica das fontes primárias e compilação dos dados brutos, seguidas do agrupamento temático por meio da codificação colorimétrica e alocação dos temas/tipos de enunciados em um quadro para constatação da saturação teórica de cada agrupamento. Resultados: a codificação colorimétrica ocorreu de acordo com os temas estabelecidos previamente: hidratação corporal; brincadeiras e atividades físicas; manejo da doença falciforme; alimentação e roupas utilizadas. Na décima primeira entrevista foi possível alcançar a saturação teórica dos temas, sendo, após, realizadas mais quatro entrevistas. Conclusão: este relato de experiência permitiu descrever os cinco passos percorridos sequencialmente para identificação da saturação teórica dos dados em uma pesquisa qualitativa desenvolvida com escolares.

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ABSTRACT Objective: to generate a translated and validated version of the Clavien-Dindo Classification of Surgical Complications (CDC) to Brazilian Portuguese (CDC-BR). Methods: the process of translation and adaptation followed the guideline of Beaton et al., 2000. We divided 76 participating surgeons, in different levels of experience, from the Department Surgery of the Hospital de Clínicas de Porto Alegre, into two groups: Group I applied the original version (CDC, n=36);r Group II used the modified version (CDC-BR, n=40). Each group classified 15 clinical cases of surgical complications. We compared performance between the groups (Mann-Whitney test) relating to the level of experience of the surgeon (Kruskal-Wallis test), considering p value <0.05 as significant. Results: the performance of the Group II (CDC-BR) was higher, with 85% accuracy, compared with 79% of Group I (CDC), p-value =0.012. The performance of the groups as for surgeons experience displayed p=0.171 for Group I, p=0.528 for Group II, and p=0.135 for overall performance. Conclusion: we produced a translated and validated version of the CDC for Brazilian Portuguese. The instrument will be a useful tool in the production of evidence on surgical outcomes.

RESUMO Objetivo: gerar uma versão traduzida e validada da Classificação de Complicações Cirúrgicas de Clavien-Dindo (CCD) para o Português-Brasileiro (CCD-BR). Métodos: o processo de tradução e adaptação seguiu a diretriz de Beaton et al., de 2000. Formaram-se dois grupos, Grupo I, que utilizou a versão original (CCD, n=36) testado em relação ao Grupo II, com a versão modificada (CCD-BR, n=40), com um total de 76 cirurgiões participantes em níveis de experiência distintos do Departamento de Cirurgia do Hospital de Clínicas de Porto Alegre. Quinze casos clínicos de complicações cirúrgicas foram classificados em cada grupo. Comparou-se o desempenho entre grupos (teste de Mann-Whitney) relacionando ao nível de experiência dos cirurgiões (teste de Kruskal-Wallis). Valor de p<0,05 como significativo. Resultados: o desempenho do Grupo II (CCD-BR) foi superior, com 85% de acertos, contra 79% do Grupo I (CCD), p-valor=0,012 do teste de Mann-Whitney. O desempenho dos grupos em relação à experiência dos cirurgiões foi p-valor=0,171 para o Grupo I, p-valor=0,528 para o Grupo II, e p-valor=0,135 para o desempenho geral, teste de Kruskal-Wallis. Conclusão: foi produzida uma versão traduzida e validada da CCD para o Português-Brasileiro. O instrumento produzido será ferramenta útil na produção de evidências sobre os resultados cirúrgicos.

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