Navigating the Complexities of Artificial Intelligence-Enabled Real-World Data Collection for Oncology Pharmacovigilance.

This new editorial discusses the promise and challenges of successful integration of natural language processing methods into electronic health records for timely, robust, and fair oncology pharmacovigilance.

The impact of electronic versus paper-based data capture on data collection logistics and on missing scores in thyroid cancer patients.

PURPOSE: The purpose of this study was to investigate the impact of the type of data capture on the time and help needed for collecting patient-reported outcomes as well as on the proportion of missing scores. METHODS: In a multinational prospective study, thyroid cancer patients from 17 countries completed a validated questionnaire measuring quality of life. Electronic data capture was compared to the paper-based approach using multivariate logistic regression. RESULTS: A total of 437 patients were included, of whom 13% used electronic data capture. The relation between data capture and time needed was modified by the emotional functioning of the patients. Those with clinical impairments in that respect needed more time to complete the questionnaire when they used electronic data capture compared to paper and pencil (ORadj 24.0; p = 0.006). This was not the case when patients had sub-threshold emotional problems (ORadj 1.9; p = 0.48). The odds of having the researcher reading the questions out (instead of the patient doing this themselves) (ORadj 0.1; p = 0.01) and of needing any help (ORadj 0.1; p = 0.01) were lower when electronic data capture was used. The proportion of missing scores was equivalent in both groups (ORadj 0.4, p = 0.42). CONCLUSIONS: The advantages of electronic data capture, such as real-time assessment and fewer data entry errors, may come at the price of more time required for data collection when the patients have mental health problems. As this is not uncommon in thyroid cancer, researchers need to choose the type of data capture wisely for their particular research question.

The Hawthorne Effect: Quality and Outcomes in Neurosurgery.

Measure something, and it gets better-this is what is called as the Hawthorne effect (also known as the observer effect). The Hawthorne factory experiments in 1920s were remarkable industrial data collection and analysis exercises that lead to Edwards Deming's quality revolution. The Harvard Medical Practice Study (1991), Leape's "Error in Medicine" (1994), and the Bristol pediatric cardiac report (2001) are among many documents that have revealed the huge gap between best practices and actual medical practice. Alarmed by the poor standards of quality at the most respected institutions, the medical fraternity therefore began visiting facilities in different fields and observing their quality assessment processes. The next leap for neurosurgery is to realize that it is unacceptable to treat patients with no regard for the standard of clinical outcomes. The traditional neurosurgery residency training has long ignored the most important issues of self-assessment, reappraisal, relearning, and measurement of skill and surgical outcomes. However, the experience taken from disparate fields, especially cardiac surgery, may encourage research and progress in measurement and improvement of quality in neurosurgery. Like cardiac surgeons, neurosurgeons must examine and analyze the results of their interventions. The concept of quality measurement is the most important single advance we can make in neurosurgery practice. Meticulous and precise measurement of outcomes will allow future progress of our specialty.

Current state of rare disease registries and databases in Australia: a scoping review.

BACKGROUND: Rare diseases (RDs) affect approximately 8% of all people or > 400 million people globally. The Australian Government's National Strategic Action Plan for Rare Diseases has identified the need for a national, coordinated, and systematic approach to the collection and use of RD data, including registries. Rare disease registries (RDRs) are established for epidemiological, quality improvement and research purposes, and they are critical infrastructure for clinical trials. The aim of this scoping review was to review literature on the current state of RDRs in Australia; to describe how they are funded; what data they collect; and their impact on patient outcomes. METHODS: We conducted a literature search on MEDLINE, EMBASE, CINAHL and PsychINFO databases, in addition to Google Scholar and grey literature. Dissertations, government reports, randomised control trials, conference proceedings, conference posters and meeting abstracts were also included. Articles were excluded if they did not discuss RDs or if they were written in a language other than English. Studies were assessed on demographic and clinical patient characteristics, procedure or treatment type and health-related quality of life captured by RDRs or databases that have been established to date. RESULTS: Seventy-four RDRs were identified; 19 were global registries in which Australians participated, 24 were Australian-only registries, 10 were Australia and New Zealand based, and five were Australian jurisdiction-based registries. Sixteen "umbrella" registries collected data on several different conditions, which included some RDs, and thirteen RDRs stored rare cancer-specific information. Most RDRs and databases captured similar types of information related to patient characteristics, comorbidities and other clinical features, procedure or treatment type and health-related quality of life measures. We found considerable heterogeneity among existing RDRs in Australia, especially with regards to data collection, scope and quality of registries, suggesting a national coordinated approach to RDRs is required. CONCLUSION: This scoping review highlights the current state of Australian RDRs, identifying several important gaps and opportunities for improvement through national coordination and increased investment.

[Evaluation of thyroid cancer data completeness and quality at a population-based cancer registry, Algeria]. / Évaluation de l'exhaustivité et de la qualité des données du cancer de la thyroïde dans un registre du cancer dans la population algérienne.

BACKGROUND: Over the last three decades the incidence of thyroid cancer (TC) has increased in many regions of the world, however little is known about TC incidence and trends in Algeria. MATERIAL AND METHODS: Using data from the Oran cancer registry (OCR) we assessed TC incidence and trends in Oran for the period 1996-2013 with the historical data method. The incidence curves were unstable and did not show any clear trend. Therefore, we actively collected data on TC for the period 1996-2013 using the multisource approach and the independent case ascertainment method. RESULTS: Analysis of actively collected and validated data showed a significant increase in the incidence of TC. We compared the two databases to identify differences. There were 558 TC cases during the period 1996-2013 in the OCR, while our active data collection enabled us to find 1,391 TC cases during the same period. The completeness rate in the OCR was 40.1%. These differences were due to our approach that consisted in the inclusion of a greater number of health facilities and laboratories (44 versus 23 in the OCR), and the active data collection in the nuclear medicine facility of the University Hospital of Tlemcen that we undertook. CONCLUSIONS: The application of the recommendations of the International Agency for Research on Cancer (IARC) to enhance data completeness and quality, and an active collection of TC data in the nuclear medicine facility of the University Hospital of Tlemcen should make the OCR an essential tool for decision-making in public health and for directing health policy towards health priorities.

"Tabela falante" como estratégia de integração de dados em uma pesquisa de métodos mistos / "Tabla parlante" como estrategia de integración de datos en una investigación de métodos mixtos / "Talking table" as a data integration strategy in mixed methods research

RESUMO Objetivo relatar a utilização da tabela falante como estratégia de integração e análise de dados em estudo de abordagem mista. Método trata-se de um relato de utilização de uma estratégia metodológica de integração e análise dos dados em pesquisa de método misto. São apresentados dados de um estudo longitudinal analítico, que acompanhou 151 lactentes prematuros no primeiro ano de vida. O estudo abordou aspectos das condições de saúde dessa população e integrou dados quantitativos, coletados por meio de instrumento de avaliação de condições de saúde e dados qualitativos oriundos de entrevista semiestruturada. Resultados a integração dos dados em estudos mistos é uma exigência metodológica que requer dos pesquisadores a utilização de estratégias que possibilitem e facilitem esse processo analítico. A tabela falante, por meio da integração visual dos dados quantitativos expressos em tabelas e suas convergências e divergências analíticas com os enunciados qualitativos, favorece a leitura e interpretação integrada. Conclusão e implicações para a prática considera-se a tabela falante uma ferramenta analítica de integração de dados quantitativos e qualitativos que contribui na formulação de metainferências em pesquisas com métodos mistos.

RESUMEN Objetivo relatar el uso de la mesa parlante como estrategia de análisis e integración de datos en un estudio de enfoque mixto. Método este es un informe sobre el uso de una estrategia metodológica para la integración y el análisis de datos en la investigación de método mixto. Se presentan los datos de un estudio longitudinal analítico que siguió a 151 bebés prematuros en el primer año de vida. Nuestro estudio abordó aspectos de las condiciones de salud de esta población e integró datos cuantitativos, recolectados a través de un instrumento para evaluar las condiciones de salud y datos cualitativos de una entrevista semiestructurada. Resultados la integración de datos en estudios mixtos es un requisito metodológico que obliga a los investigadores a utilizar estrategias que habiliten y faciliten este proceso analítico. La mesa parlante, a través de la integración visual de datos cuantitativos expresados en tablas y sus convergencias y divergencias analíticas con enunciados cualitativos, favorece la lectura e interpretación integradas. Conclusión e implicaciones para la práctica: la mesa de diálogo es considerada como una herramienta analítica para la integración de datos cuantitativos y cualitativos que contribuyen a la formulación de meta-inferencias en investigaciones con métodos mixtos.

ABSTRACT Objective to report the use of a talking table as a data analysis and integration strategy in a mixed approach study. Method this is a report on the use of a methodological strategy for data integration and analysis in mixed methods research. Data from an analytical longitudinal study that followed 151 preterm infants in the first year of life are presented. The study addressed aspects of the health conditions of this population and integrated quantitative data, collected through an instrument to assess health conditions and qualitative data from a semi-structured interview. Results data integration in mixed studies is a methodological requirement that requires researchers to use strategies that enable and facilitate this analytical process. A talking table, through the visual integration of quantitative data expressed in tables and their analytical convergences and divergences with qualitative statements, favors integrated reading and interpretation. Conclusion and implications for practice: a talking table is considered an analytical tool for quantitative and qualitative data integration, which contribute to developing meta-inferences in mixed methods research.

Comparación de cuatro métodos para contar peces en una bahía tropical: el caso del Área Marina de Manejo Bahía Santa Elena en el Pacífico de Costa Rica / Comparison of four methods to count fish in a tropical bay: the case of the Santa Elena Bay Marine Management Area in the Pacific of Costa Rica

Resumen Introducción: La naturaleza tropical está experimentando una amenaza sin precedentes que incluye comunidades de peces costeros que requieren un constante seguimiento de la presencia de especies. El uso simultáneo de varios métodos de monitoreo debería reducir el sesgo causado por la selectividad de cada método. Objetivo: Este estudio uso cuatro diferentes métodos de muestreo a lo largo de dos años para evaluar y comparar los ensamblajes de peces en el Área Marina de Manejo Bahía Santa Elena, Pacífico de Costa Rica. Métodos: Examinamos los cambios en la riqueza y composición de especies entre épocas de afloramiento y no afloramiento entre julio de 2019 y febrero de 2020. Aplicamos censos visuales, cámaras remotas submarinas; líneas de fondo; y pesca deportiva. Resultados: Identificamos 140 especies de peces (54 familias); las cámaras submarinas remotas detectaron el 83 %, seguido por los censos visuales submarinos (65 %), la pesca deportiva (16 %) y las líneas de fondo (14 %). Solo el método de pesca deportiva detectó diferencias en la riqueza y composición de especies entre temporadas. Conclusión: Las cámaras remotas parecen ser el mejor método para el conteo de especies y la pesca deportiva para detectar diferencias estacionales en las costas tropicales similares a la aquí estudiada.

Abstract Introduction: Tropical nature is experiencing an unprecedented threat that includes coastal fish communities that requires a close monitoring of species presence. The simultaneous use of several monitoring methods should reduce the bias caused by the selectivity of each method. Objective: This study used four different sampling methods over two years to assess and compare fish assemblages in the Santa Elena Bay Marine Management Area (AMM-BSE), North Pacific of Costa Rica. Methods: We examined changes in species richness and composition between upwelling and non-upwelling seasons from July 2019 and February 2020. We applied visual censuses, underwater remote cameras; bottom lines; and sport fishing. Results: We identified 140 species of fish (54 families); remote underwater cameras detected 83 %, followed by underwater visual censuses (65 %), sport-fishing (16 %) and bottom lines (14 %). Only the sport-fishing method detected differences in species richness and composition between seasons. Conclusion: Remote cameras appear to be the best method for species counts, and sport-fishing to detect seasonal differences in tropical coasts similar to the one studied here.

Using real world data to advance the provision of supportive cancer care: mucositis as a case study.

PURPOSE OF REVIEW: For decades, clinical decision making and practice has been largely informed by data generated through randomized clinical trials (RCTs). By design, RCTs are highly restricted in both scope and scale, resulting in narrow indications and iterative advances in clinical practice. With the transition to electronic health records, there are now endless opportunities to utilize these 'real world' data (RWD) to make more substantive advances in our understanding that are, by nature, more applicable to reality. This review discusses the current paradigm of using big data to advance and inform the provision of supportive cancer care, using mucositis as a case study. RECENT FINDINGS: Global efforts to synthesize RWD in cancer have almost exclusively focused on tumor classification and treatment efficacy, leveraging on routine tumor pathology and binary response outcomes. In contrast, clinical notes and billing codes are not as applicable to treatment side effects which require integration of both clinical and biological data, as well as patient-reported outcomes. SUMMARY: Cancer treatment-induced toxicities are heterogeneous and complex, and as such, the use of RWD to better understand their etiology and interaction is challenging. Multidisciplinary cooperation and leadership are needed to improve data collection and governance to ensure the right data is accessible and reliable.

Making decisions about health information on social media: a mouse-tracking study.

Health misinformation is a problem on social media, and more understanding is needed about how users cognitively process it. In this study, participants' accuracy in determining whether 60 health claims were true (e.g., "Vaccines prevent disease outbreaks") or false (e.g., "Vaccines cause disease outbreaks") was assessed. The 60 claims were related to three domains of health risk behavior (i.e., smoking, alcohol and vaccines). Claims were presented as Tweets or as simple text statements. We employed mouse tracking to measure reaction times, whether processing happens in discrete stages, and response uncertainty. We also examined whether health literacy was a moderating variable. The results indicate that information in statements and tweets is evaluated incrementally most of the time, but with overrides happening on some trials. Adequate health literacy scorers were equally certain when responding to tweets and statements, but they were more accurate when responding to tweets. Inadequate scorers were more confident on statements than on tweets but equally accurate on both. These results have important implications for understanding the underlying cognition needed to combat health misinformation online.

Challenges in developmental psychology research during the COVID-19 pandemic / Desafios da pesquisa em psicologia do desenvolvimento durante a pandemia da COVID-19 / Desafíos de la investigación en psicología del desarrollo durante la pandemia de COVID-19

The COVID-19 pandemic brought a series of restructurings necessary for research in Developmental Psychology. The aim of the manuscript is to discuss adaptations we made in our research in this context during the COVID-19 pandemic and to present strategies to adequate research protocols originally designed to occur in person. Although some contexts do not allow the continuity of studies, research at this time can bring essential contributions in this extreme period. This article explores the strategies for adapting recruitment procedures, suggesting dissemination platforms, and using social networks for this purpose. Guidelines are suggested for conducting non-face-to-face interviews with caregivers, ways of assessing the interaction of the mother-child pairs, and problematizing ethical issues. The procedures for returning the results, an ethical researcher commitment, may be improved by resources such as automatic reports. Besides, strategies for better dissemination of the results for the participants are suggested. (AU)

A pandemia COVID-19 trouxe uma série de reestruturações necessárias à pesquisa em Psicologia do Desenvolvimento. O objetivo deste artigo é discutir as adaptações que realizamos em pesquisas neste contexto durante a pandemia de COVID-19 e apresentar estratégias para adequação de protocolos de pesquisa originalmente planejados para ocorrer de forma presencial. Embora alguns contextos não permitam a continuidade dos estudos, pesquisas nesse momento podem trazer importantes contribuições sobre este período ímpar. No presente artigo são exploradas estratégias de adaptação dos procedimentos de recrutamento, sugeridas plataformas de divulgação e como melhor usar as redes sociais para esse fim. Também são descritos procedimentos para realização de entrevistas não presenciais com responsáveis, formas de avaliação da interação das duplas mãe-criança e problematizadas questões éticas. Os procedimentos de devolução dos resultados, um compromisso ético dos pesquisadores, podem ser facilitados por recursos como relatórios automáticos. Além disso, sugerimos estratégias para melhor divulgação dos resultados ao público participante. (AU)

La pandemia del COVID-19 trajo una serie de reestructuraciones necesarias para la investigación en Psicología del Desarrollo. El objetivo de este artículo es discutir las adaptaciones realizadas en las investigaciones en este contexto durante la pandemia de COVID-19 y presentar algunas estrategias para la adaptación de los protocolos de investigación originalmente planeados para ser presenciales. Si bien algunos contextos no permitan la continuidad de los estudios, la investigación en este momento puede aportar importantes avances sobre estos tiempos de crisis. Este artículo explora las estrategias para adaptar los procedimientos de contratación, sugiriendo algunas plataformas de difusión y la mejor manera de utilizar las redes sociales para este fin. También se describen los procedimientos para la realización de entrevistas no presenciales con padres o tutores legales, las formas de evaluar la interacción madre-hijo y las cuestiones éticas. Los procedimientos para la devolución de los resultados, un compromiso ético de los investigadores, pueden verse facilitados por funciones como informes automáticos. Además, se recomienda estrategias para una mejor difusión de los resultados al público participante. (AU)

Data resource: Children receiving care and support and children in need, administrative records in Wales.

Introduction: In Wales, the Children in Need (CIN) dataset includes information relating to needs of children and social care support. Before the Social Services and Well-being (Wales) Act 2014 came into force in April 2016, this data collection was named the Children in Need census, changing to Children Receiving Care and Support (CRCS) after this date to reflect better the children eligible for inclusion. This paper describes these datasets, their potential for research and their limitations. We describe data that researchers can access via the Secure Anonymised Information Linkage (SAIL) Databank and exploratory linkages made to health records. Methods: CIN and CRCS data were transferred to the SAIL Databank using a standardised approach to provide de-identified data with Anonymised Linking Fields (ALF) for successfully matched records. The linkage method relies on the use of Unique Pupil Numbers (UPN). As such, no records are currently available for children without a UPN, which includes most under age three. ALFs enabled linkage to individual-level health data within SAIL. Health service use was compared to non-CIN/CRCS populations. Results: CRCS data held within the SAIL Databank comprises 25,972 records, 81% of the total number of records reported by the Welsh Government. The CIN data contains 108,449 records, 79% of the Welsh Government's records for this data collection. Health service use of children in need, and children receiving care and support, was roughly equal to that of the non-CIN/CRCS population, except GP visits, where children in need had fewer consultations, and children receiving care and support had more consultations than the comparison population. Conclusion: Researchers can access Welsh CIN and CRCS datasets through the SAIL Databank, enabling research opportunities. Work is ongoing to improve records and to understand better the health and health service use among children captured by CIN and CRCS censuses.

Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies.

INTRODUCTION: Real-world data (RWD) can contextualize findings from single-arm trials when randomized comparative trials are unethical or unfeasible. Findings from single-arm trials alone are difficult to interpret and a comparison, when feasible and meaningful, to patient-level information from RWD facilitates the evaluation. As such, there have been several recent regulatory applications including RWD or other external data to support the product's efficacy and safety. This paper summarizes some lessons learned from such contextualization from 20 notable new drug or biologic licensing applications in oncology and rare diseases. METHODS: This review focuses on 20 notable new drug or biologic licensing applications that included patient-level RWD or other external data for contextualization of trial results. Publicly available regulatory documents including clinical and statistical reviews, advisory committee briefing materials and minutes, and approved product labeling were retrieved for each application. The authors conducted independent assessments of these documents focusing on the regulatory evaluation, in each case. Three examples are presented in detail to illustrate the salient issues and themes identified across applications. RESULTS: Regulatory decisions were strongly influenced by the quality and usability of the RWD. Comparability of cohort attributes such as endpoints, populations, follow-up, index and censoring criteria, as well as data completeness and accuracy of key variables appeared to be essential to ensure the quality and relevance of the RWD. Given adequate sample size of the clinical trials or external control, the use of appropriate analytic methods to properly account for confounding, such as regression or matching, and pre-specification of these methods while blinded to patient outcomes seemed good strategies to address baseline differences. DISCUSSION: Contextualizing single-arm trials with patient-level RWD appears to be an advance in regulatory science; however, challenges remain. Statisticians and epidemiologists have long focused on analytical methods for comparative effectiveness but hurdles in use of RWD have often occurred upstream of the analyses. More specifically, we noted hurdles in evaluating data quality, justifying cohort selection or initiation of follow-up, and demonstrating comparability of cohorts and endpoints.

Lobectomía por cirugía torácica videoasistida en el Centro Nacional de Cirugía de Mínimo Acceso / Lobectomy for Video-Assisted Thoracic Surgery at the National Center for Minimal Invasive Surgery

Introducción: La tasa de mortalidad de los tumores malignos de tráquea, bronquios y pulmón ocupa el segundo lugar en hombres y el primero en las mujeres. Según el anuario estadístico, hubo 5580 muertes por esta causa en 2020, con una tasa de mortalidad general en los hombres de 61,6 y de 38,1 en la mujer por 100 000 habitantes. Para el tratamiento del cáncer pulmonar en estadios tempranos la cirugía torácica videoasistida ha demostrado su seguridad y efectividad, con una baja morbilidad y una menor estancia posoperatoria. Objetivo: Mostrar los resultados de la lobectomía por cirugía torácica videoasistida en el Centro Nacional de Cirugía de Mínimo Acceso. Métodos: Se realizó un estudio prospectivo en una serie consecutiva de 29 pacientes operados con el diagnóstico de nódulo pulmonar. Para la obtención de la información se confeccionó una planilla de recolección para este fin y en todo momento se contó con el consentimiento informado de los pacientes. Se evaluaron las variables durante el pre, intra y posoperatorio. Resultados: Del total de 57 casos portadores de nódulos pulmonares, se realizó lobectomía por cirugía torácica videoasistida en 29, para un 50,9 por ciento; el 80 por ciento estaban en etapas I y II según el pTNM. Hubo un 31 por ciento de complicaciones y el índice de conversión fue del 20,7 por ciento. Conclusiones: La lobectomía por cirugía torácica video asistida es una técnica segura y de eficacia demostrada, factible de generalizar en nuestro medio(AU)

Introduction: The mortality rate of malignant tumors of the trachea, bronchi and lung ranks second in men and first in women. According to the Health Statistics Yearbook, there were 5,580 deaths from this cause in 2020, with a general mortality rate for men of 61.6 and 38.1 for women per 100,000 inhabitants. For the treatment of lung cancer in early stages, video-assisted thoracic surgery has demonstrated its safety and effectiveness, with low morbidity and a shorter postoperative stay. Objective: To show the results of video-assisted thoracic surgery lobectomy at the National Center for Minimal Invasive Surgery. Methods: A prospective study was carried out in a consecutive series of 29 patients operated on with a diagnosis of pulmonary nodule. A collection form was prepared to obtain the information and the informed consent of the patients was obtained at all times. The variables were evaluated during the pre, intra and postoperative period. Results: Fifty seven (57) cases with pulmonary nodules formed the total of this study. Twenty nine of them (29) underwent lobectomy by video-assisted thoracic surgery (50.9 percent). 80 percent were in stages I and II according to pTNM. There were 31 percent complications and the conversion rate was 20.7 percent. Conclusions: Video-assisted thoracic surgery lobectomy is a safe and proven technique, which is feasible to generalize in our setting(AU)

A Framework for Using Real-World Data and Health Outcomes Modeling to Evaluate Machine Learning-Based Risk Prediction Models.

OBJECTIVES: We propose a framework of health outcomes modeling with dynamic decision making and real-world data (RWD) to evaluate the potential utility of novel risk prediction models in clinical practice. Lung transplant (LTx) referral decisions in cystic fibrosis offer a complex case study. METHODS: We used longitudinal RWD for a cohort of adults (n = 4247) from the Cystic Fibrosis Foundation Patient Registry to compare outcomes of an LTx referral policy based on machine learning (ML) mortality risk predictions to referral based on (1) forced expiratory volume in 1 second (FEV1) alone and (2) heterogenous usual care (UC). We then developed a patient-level simulation model to project number of patients referred for LTx and 5-year survival, accounting for transplant availability, organ allocation policy, and heterogenous treatment effects. RESULTS: Only 12% of patients (95% confidence interval 11%-13%) were referred for LTx over 5 years under UC, compared with 19% (18%-20%) under FEV1 and 20% (19%-22%) under ML. Of 309 patients who died before LTx referral under UC, 31% (27%-36%) would have been referred under FEV1 and 40% (35%-45%) would have been referred under ML. Given a fixed supply of organs, differences in referral time did not lead to significant differences in transplants, pretransplant or post-transplant deaths, or overall survival in 5 years. CONCLUSIONS: Health outcomes modeling with RWD may help to identify novel ML risk prediction models with high potential real-world clinical utility and rule out further investment in models that are unlikely to offer meaningful real-world benefits.

Impact of Intraoperative Data on Risk Prediction for Mortality After Intra-Abdominal Surgery.

BACKGROUND: Risk prediction models for postoperative mortality after intra-abdominal surgery have typically been developed using preoperative variables. It is unclear if intraoperative data add significant value to these risk prediction models. METHODS: With IRB approval, an institutional retrospective cohort of intra-abdominal surgery patients in the 2005 to 2015 American College of Surgeons National Surgical Quality Improvement Program was identified. Intraoperative data were obtained from the electronic health record. The primary outcome was 30-day mortality. We evaluated the performance of machine learning algorithms to predict 30-day mortality using: 1) baseline variables and 2) baseline + intraoperative variables. Algorithms evaluated were: 1) logistic regression with elastic net selection, 2) random forest (RF), 3) gradient boosting machine (GBM), 4) support vector machine (SVM), and 5) convolutional neural networks (CNNs). Model performance was evaluated using the area under the receiver operator characteristic curve (AUROC). The sample was randomly divided into a training/testing split with 80%/20% probabilities. Repeated 10-fold cross-validation identified the optimal model hyperparameters in the training dataset for each model, which were then applied to the entire training dataset to train the model. Trained models were applied to the test cohort to evaluate model performance. Statistical significance was evaluated using P < .05. RESULTS: The training and testing cohorts contained 4322 and 1079 patients, respectively, with 62 (1.4%) and 15 (1.4%) experiencing 30-day mortality, respectively. When using only baseline variables to predict mortality, all algorithms except SVM (area under the receiver operator characteristic curve [AUROC], 0.83 [95% confidence interval {CI}, 0.69-0.97]) had AUROC >0.9: GBM (AUROC, 0.96 [0.94-1.0]), RF (AUROC, 0.96 [0.92-1.0]), CNN (AUROC, 0.96 [0.92-0.99]), and logistic regression (AUROC, 0.95 [0.91-0.99]). AUROC significantly increased with intraoperative variables with CNN (AUROC, 0.97 [0.96-0.99]; P = .047 versus baseline), but there was no improvement with GBM (AUROC, 0.97 [0.95-0.99]; P = .3 versus baseline), RF (AUROC, 0.96 [0.93-1.0]; P = .5 versus baseline), and logistic regression (AUROC, 0.94 [0.90-0.99]; P = .6 versus baseline). CONCLUSIONS: Postoperative mortality is predicted with excellent discrimination in intra-abdominal surgery patients using only preoperative variables in various machine learning algorithms. The addition of intraoperative data to preoperative data also resulted in models with excellent discrimination, but model performance did not improve.

Coleta on-line de dados em pesquisa qualitativa sobre Educação Permanente em Saúde no Brasil: um estudo metodológico / Recopilación de datos on-line en investigación cualitativa sobre Educación Permanente en Salud en Brasil: un estudio metodológico / On-line data collection in qualitative research on Permanent Education in Health in Brazil: a methodological study

Objetivou-se analisar a coleta de dados on-line em uma pesquisa qualitativa sobre Educação Permanente em Saúde. Estudo metodológico sobre a coleta de dados com roteiro com questões abertas, difundido pela Internet para 28 Superintendências e/ou Gerências Regionais de Saúde do estado de Minas Gerais, Brasil. A análise das respostas de 40 trabalhadores que atuam na gestão de projetos e de programas de saúde ocorreu pela Análise de Conteúdo Temática. O foco foi para a resposta sobre a experiência de participar de pesquisa qualitativa remotamente, respondendo um instrumento on-line. A coleta de dados on-line atingiu diferentes profissionais, das regiões de saúde do estado; instigou-lhes reflexões sobre o cotidiano dos serviços e permitiu o alcance dos objetivos da pesquisa qualitativa, obtendo-se a análise da visão de gestores de saúde sobre a Política de Educação Permanente e das limitações que estes encontram para aplicá-la na gestão. Participantes com acesso à Internet e destreza no manuseio de tecnologias de informação consideraram a experiência de responder à pesquisa remotamente rápida e fácil. Embora responder questões abertas on-line demande tempo e elimine a interação presencial pesquisador-participante, possibilita coletar dados com participantes distantes e significativos à análise de questões sobre políticas públicas em vasta extensão territorial(AU)

El objetivo fue analizar la recolección de datos en línea en una investigación cualitativa sobre Educación Permanente en Salud. Estudio metodológico sobre recolección de datos con un guion de preguntas abiertas, difundido por Internet a 28 Superintendencias y/o Gerencias Regionales de Salud en el estado de Minas Gerais, Brasil. El análisis de las respuestas de 40 trabajadores que laboran en la gestión de proyectos y programas de salud se realizó a través del Análisis de Contenido Temático. La atención se centró en responder la experiencia de participar en una investigación cualitativa de forma remota, respondiendo a un instrumento en línea. La recolección de datos en línea llegó a diferentes profesionales de las regiones de salud del estado; instigó reflexiones sobre la cotidianidad de los servicios y permitió el logro de los objetivos de la investigación cualitativa, se obtuvo un análisis de la visión de los gestores de salud sobre la Política de Educación Permanente y las limitaciones que encuentran para aplicarla en la gestión. Los participantes con acceso a Internet y habilidades en el manejo de tecnologías de la información, consideraron que la experiencia de responder a la encuesta de forma remota es rápida y fácil. Si bien responder a preguntas abiertas en línea lleva tiempo y elimina la interacción cara a cara investigador-participante, permite recolectar datos con participantes distantes y significativos en el análisis de preguntas sobre políticas públicas en un vasto territorio(AU)

The objective was to analyze the online data collection of a qualitative research on permanent education in health. A methodological study about the data collection with an open questions script, distributed online to 28 Superintendencies and/or Minas Gerais, Brazil state Regional Health Managements. The analysis of the answers from 40 workers who act in project and health programs management was done through Thematic Analysis. The focus was on the answer to the question about the experience of participating in a remote qualitative research, answering an online instrument. The data collection reached different professionals from different health regions of the state; it instigated them reflections around their service daily routine and allowed reaching the qualitative research goals, acquiring the analysis of managers point of view over the Permanent Education in Health and the limitations they faced when applying it in their management. Participants with Internet access and experience in handling information technologies found the experience of answering the research remotely to be fast and easy. Although answering open questions online demands time and rules out the researcher-participant face to face interaction, it allows distant participants to contribute with significant data collection to the analysis of questions about public politics in vast territorial extensions(AU)

Shame from Smiling and Speaking Due to Oral Health Problems in Brazilian Adolescents: A Nationwide Population-Based Study

Abstract Objective: To investigate the association between oral health problems and being ashamed of smiling or speaking among Brazilian adolescents. Material and Methods: This was a population-based cross-sectional study carried out with secondary data from 7,328 12-year-old Brazilian adolescents from the latest Brazilian national oral health survey (SB Brasil 2010). The question "In the previous 6 months, have you been ashamed of smiling or speaking due to your teeth?" was the outcome variable. Calibrated examiners performed clinical examinations on adolescents for the diagnosis of dental caries (DMF-T), dental trauma, dental fluorosis and occlusal alterations. Data were analyzed descriptively and by Poisson unadjusted and adjusted Poisson regression analysis (p<0.05). The final model was controlled by family income. Results: The prevalence of being ashamed of smiling or speaking was 13.6%. The following variables were associated with the outcome: female sex (PR= 1.33; 95% CI: 1.17-1.53), cavitated dental caries on upper incisors (PR= 1.81; 95% CI: 1.51-2.15), dental trauma (PR= 1.36; 95% CI:1.16-1.60), increased maxillary overjet (PR= 1.36; 95% CI:1.18-1.57), dental crowding (PR= 1.60; 95% CI:1.40-1.83), midline diastema (PR= 1.30; 95% CI:1.11-1.44), tooth loss (PR= 1.45; 95% CI:1.16-1.80), mild/questionable dental fluorosis (PR= 1.23; 95% CI:1.06-1.44) and moderate/severe dental fluorosis (PR= 1.67; 95% CI:1.15-2.44). Conclusion: Oral health problems that impact dental aesthetics were predisposing factors for being ashamed of smiling or speaking in Brazilian adolescents (AU).

Internal consistency of the Sport Motivation Scale-II Questionnaire in the Brazilian context: potentialities and limitations

Abstract Aim: The purpose of this paper was to analyze the internal consistency of the Sport Motivation Scale-II (SMS-II) questionnaire based on three studies with sports practitioners in the Brazilian college context. Methods: All the three studies i) were carried out with students enrolled in higher education and engaged in sports training by their institution (n1 = 304; n2 = 441; n3 = 310); ii) used SMS-II as an instrument for data collection; iii) used the online procedure for data collection. The Confirmatory Factor Analysis was performed and Cronbach's Alpha (α), McDonald's Omega (Ω), and the correlation between items were used to assess internal consistency. Results: As potentialities, five dimensions of the SMS-II presented high values of internal reliability (α and Ω > 0.60). As a limitation, the dimension of introjected regulation showed low reliability (α and Ω < 0.40) in the three studies conducted by our group. The exclusion of item 16 enabled an increase in alpha, but without achieving satisfactory reliability in Study 1 (α = 0.46) and Study 2 (α = 0.31). In Study 3, the exclusion of item 7 improved the internal reliability of the dimension (α = 0.43) also without reaching satisfactory values of internal consistency. It was not possible to identify a problematic item, given that each item had a different influence in the three studies. Conclusion: We found good values of validity and internal consistency for the Brazilian version of the SMS-II. However, we suggest attention to the introjected regulation dimension when using the instrument in the Brazilian college context.

Atos de criação como processo vivo em pesquisa acadêmica / Acts of creation as a living process within academic research / Actos de creación como proceso vivo en investigación académica

Este artigo apresenta os múltiplos processos de criação vividos durante uma pesquisa de mestrado. Propõe instigar a inovação da investigação e da documentação acadêmica, mostrando a relevância da articulação entre arte, escrita e cuidado no contexto da formação de profissionais de saúde e da produção de conhecimento. Pretende dar visibilidade à pesquisa cartográfica, que se afirma como um processo de criação em si, gerando objetos agenciadores da conexão entre o pesquisador e o campo pesquisado, permitindo ao pesquisador aprofundar o vínculo com o tema e com todos os encontros intrínsecos à pesquisa. O campo de produção de dados aconteceu durante oficinas com práticas de expressão corporal, oral e escrita, envolvendo a criação de uma obra de arte grupal, um e-book com textos dos participantes e um livro-objeto, que materializa o devir da pesquisa científica em pesquisa-arte.(AU)

This article presents multiple creation processes experienced during the research process for a master's thesis. It proposes to instigate innovation in research and academic documentation, showing the relevance of articulation between art, writing and care in the context of health professional training and education and knowledge production. It intends to give visibility to cartographic research, which asserts itself as a process of creation in itself, generating objects that mediate the connection between the researcher and the field of research, enabling him or her to create a deeper bond with the theme and the encounters that are intrinsic to the study. The data were collected during workshops involving bodily, oral, and written expression practices and the creation of a group work of art, an e-book made up of texts written by the participants, and an object book, materializing the transformation of scientific research into art-based research.(AU)

Este artículo presenta los múltiples procesos de creación vividos durante un proceso de investigación de maestría. Propone instigar la innovación de la investigación y documentación académica, mostrando la relevancia de la articulación entre arte, escritura y cuidado en el contexto de la formación de profesionales de salud y de la producción de conocimiento. Pretende dar visibilidad a la investigación cartográfica, que se afirma como un proceso de creación en sí, generando objetos que agencian la conexión entre el investigador y el campo investigado, permitiendo que el investigador profundice el vínculo con el tema y con todos los encuentros intrínsecos a la investigación. El campo de producción de datos tuvo lugar durante talleres con prácticas de expresión corporal, oral y escrita, envolviendo la creación de una obra de arte grupal, un e-book con textos de los participantes y un libro-objeto, que materializa el devenir de la investigación-científica en investigación-arte.(AU)

[DESCAR-T, a nationwide registry for patient treated by CAR-T Cells in France]. / DESCAR-T, le registre national des patients traités par CAR-T Cells.

CAR-T Cells have opened new doors for cellular immunotherapies and provides new therapeutic options for patients with refractory B-cell malignancies, B-cell acute lymphoblastic leukemia and diffuse large B-cel lymphoma. CAR-T Cells have benefited from an accelerated approval procedure in many countries. Indeed, The French health authorities have approved the specialties Tisacel ® and Axicel ®, but additional data including the use of CAR-T Cells in real life were also mandatory. In regard to the scientific interest of the project, LYSA-LYSARC committed itself to prospectively and retrospectively collect information on patients eligible for CAR-T Cells as required by French health authorities. Other academic cooperating groups (GRAALL, IFM, SFCE, FILO and the scientific society SFGM-TC) were associated to this initiative which aims to build a nationwide CAR-T Cells devoted registry, so-called DESCART (Dispositif d'Enregistrement et Suivi des patients traités par CAR-T cells). DESCAR-T is a real-life multicentric registry set up in French sites qualified for CAR-T Cells treatment. DESCAR-T objective is to describe the use of CAR-T Cells in real life. All paediatric and adult patients with hematological malignancy fulfilling CAR-T Cells approval criteria and for whom a CAR-T Cells therapy has been discussed are included from 1 July 2018. Clinical data are directly collected from medical records and patients are treated according to the centers' routine practices. One of the distinctive features of DESCAR-T is its link with HTA for CAR-T Cells s reimbursement by the French public health system. DESCAR-T is the first national registry promoted by an academic group allowing centralized data collection for both academic and HTA/health authorities' purposes.