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ABSTRACT OBJECTIVE This study aims to propose a comprehensive alternative to the Bland-Altman plot method, addressing its limitations and providing a statistical framework for evaluating the equivalences of measurement techniques. This involves introducing an innovative three-step approach for assessing accuracy, precision, and agreement between techniques, which enhances objectivity in equivalence assessment. Additionally, the development of an R package that is easy to use enables researchers to efficiently analyze and interpret technique equivalences. METHODS Inferential statistics support for equivalence between measurement techniques was proposed in three nested tests. These were based on structural regressions with the goal to assess the equivalence of structural means (accuracy), the equivalence of structural variances (precision), and concordance with the structural bisector line (agreement in measurements obtained from the same subject), using analytical methods and robust approach by bootstrapping. To promote better understanding, graphical outputs following Bland and Altman's principles were also implemented. RESULTS The performance of this method was shown and confronted by five data sets from previously published articles that used Bland and Altman's method. One case demonstrated strict equivalence, three cases showed partial equivalence, and one showed poor equivalence. The developed R package containing open codes and data are available for free and with installation instructions at Harvard Dataverse at https://doi.org/10.7910/DVN/AGJPZH. CONCLUSION Although easy to communicate, the widely cited and applied Bland and Altman plot method is often misinterpreted, since it lacks suitable inferential statistical support. Common alternatives, such as Pearson's correlation or ordinal least-square linear regression, also fail to locate the weakness of each measurement technique. It may be possible to test whether two techniques have full equivalence by preserving graphical communication, in accordance with Bland and Altman's principles, but also adding robust and suitable inferential statistics. Decomposing equivalence into three features (accuracy, precision, and agreement) helps to locate the sources of the problem when fixing a new technique.

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Abstract This study aimed to assess whether dentists correctly understand the benefit of a dental treatment when it is presented using absolute numbers or relative risk reduction (RRR). This parallel-group randomized controlled trial recruited dentists from 3 postgraduate courses in Rio de Janeiro, Brazil. Participants received, in sequentially numbered sealed opaque envelopes, the description of a hypothetical scenario of the benefit (avoidance of multiple tooth loss) of nonsurgical periodontal treatment without or with antibiotics. Treatment benefit was presented in 2 different formats: absolute numbers or RRR. Dentists were given 10 minutes to read the treatment scenario and answer 5 questions. The final sample for analysis included 101 dentists. When asked to estimate the number of patients out of 100 who would avoid multiple tooth loss without antibiotics, 17 dentists (33%) in the absolute numbers group and 12 (25%) in the RRR group provided the correct response (p = 0.39). Regarding treatment with antibiotics, 26 dentists (50%) in the absolute numbers group and 14 (29%) in the RRR group provided the correct response (p = 0.04). Only 16 dentists (31%) in the absolute numbers group and 12 (25%) in the RRR group gave correct answers for both questions (p = 0.51). Most dentists did not correctly understand the benefit of the treatment, irrespective of the format it was presented. Slightly more dentists correctly understood the benefit of the treatment when it was presented as absolute numbers than as RRR.

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Introducción: Es objetivo fundamental de la medicina, determinar las causas que producen las enfermedades; para llevar a cabo este estudio, a finales del siglo XX se emplearon técnicas estadísticas multivariadas confiables en el análisis simultáneo de diferentes variables independientes sobre un desenlace. Objetivo: Determinar la aplicación de la validez racional y de apariencia en la metodología empleada para el estudio de la causalidad en salud. Métodos: Para evaluar si la metodología se correspondía con los requerimientos de la investigación, se aplicó la validez de apariencia para valorar los resultados obtenidos en su aplicación, específicamente, si las reglas reflejan verazmente, lo que ocurre en la práctica médica, mediante el empleo de la validez racional. Resultados: Los usuarios potenciales de la metodología la consideraron aceptable en los aspectos medidos sobre la regresión logística binaria. El mayor porcentaje de las reglas analizadas está en correspondencia con lo planteado en la literatura, pocas plantean aspectos que no se dan necesariamente en la práctica médica, pero tampoco se contradicen con la literatura. Los resultados de la validez de apariencia no fueron favorables, pues la metodología no había sido empleada antes en el contexto. En cuanto a la validez racional, se verificó un alto porcentaje de correspondencia entre lo planteado por las reglas y la literatura. Es importante tener en cuenta, que el hallazgo de algo conocido reafirma la validez de esa regla. Conclusiones: Las reglas obtenidas de la aplicación de la metodología reflejan, en general, lo que ocurre en la práctica médica.

Introduction: the fundamental objective of medicine is to determine the causes that produce diseases. At the end of the 20th century, multivariate statistical techniques were used as reliable in the simultaneous analysis of different independent variables on an outcome. Objective: to determine the application of appearance and rational validity of a methodology to study causality in health. Methods: to evaluate whether the methodology corresponded to the research requirements, appearance validity was applied to assess the results obtained in its application, specifically, if the rules accurately reflect what happens in medical practice, through the use of rational validity. Results: the potential users of the methodology considered it acceptable in the measured aspects of the binary logistic regression. The highest percentage of the rules analyzed is in correspondence with what is stated in the literature; few raise aspects that do not necessarily occur in medical practice, but they do not contradict the literature either. The results of face validity were not favourable, since the methodology had not been used before in the context. A high percentage of correspondence regarding rational validity was verified between what was stated by the rules and the literature. It is important to note that finding something known reaffirms the validity of that rule. Conclusions: the rules obtained from the application of the methodology reflect, in general, what happens in medical practice.

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Objective. Within the context of evidence-based practice, this article exposes the reflection on the understanding and usefulness of the information provided by the research findings shared in reports and research publications, exposing differences based on the interpretation of statistical significance and clinical significance. Content synthesis. Basic aspects of the meaning and use of the information reported by research on p value (statistical significance) and the value and usefulness of these results are analyzed and exemplified, contrasting the value for the practice of an additional judgment on clinical significance. In addition to establishing conceptual differences, the need is highlighted for nurses to have the competencies to differentiate and apply each of them according to the clinical contexts of their potential implementation. Conclusion. The real usefulness of research about interventions within the context of nursing care is given by its real application and reach for the practice and benefit for patients. For this to occur, nurses must interpret adequately the information provided by scientific publications and other research reports.

Objetivo. En el contexto de una práctica basada en evidencia, este artículo expone la reflexión sobre la comprensión y utilidad de la información que proveen los hallazgos de investigación reportados en informes y publicaciones de investigación, exponiendo las diferencias a partir de la interpretación de la significancia estadística y significancia clínica. Síntesis del contenido. Se analizan y ejemplifican aspectos básicos sobre el significado y uso de la información que reportan las investigaciones sobre valor p (significancia estadística) y el valor y utilidad de estos resultados contrastando el valor para la práctica de un juicio adicional sobre significancia clínica. Además de establecer diferencias conceptuales, se resalta la necesidad de que las enfermeras tengan las competencias para diferenciar y aplicar cada uno de ellos según los contextos clínicos de su potencial implementación. Conclusión. La real utilidad de la investigación sobre intervenciones en el contexto del cuidado de enfermería está dada por su real aplicación y alcance para la práctica y el beneficio para los pacientes. Para que ello ocurra, las enfermeras deben interpretar adecuadamente la información que proveen las publicaciones científicas y otros reportes de investigación.

Objetivo. No contexto de uma prática baseada em evidências, este artigo apresenta a reflexão sobre a compreensão e utilidade da informação fornecida pelos resultados da investigação relatados em relatórios de investigação e publicações, expondo as diferenças com base na interpretação da significância estatística e da significância clínica. Síntese de conteúdo. Aspectos básicos sobre o significado e uso das informações relatadas pelas pesquisas sobre valor p (significância estatística) e o valor e utilidade desses resultados são analisados e exemplificados, contrastando o valor para a prática de um julgamento adicional sobre significância clínica. Além de estabelecer diferenças conceituais, destaca-se a necessidade de o enfermeiro ter competências para diferenciar e aplicar cada uma delas de acordo com os contextos clínicos de seu potencial implementação. Conclusão. A real utilidade da investigação sobre intervenções no contexto dos cuidados de enfermagem é dada pela sua real aplicação e âmbito de prática e benefício para os pacientes. Para que isso ocorra, os enfermeiros devem interpretar adequadamente as informações fornecidas pelas publicações científicas e outros relatórios de pesquisa.

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Multiple drugs currently used in clinical practice have been approved by regulatory agencies based on studies that utilize composite endpoints. Composite endpoints are appealing because they reduce sample size requirements, follow-up periods, and costs. However, interpreting composite endpoints can be challenging, and their misuse is not uncommon. Incorrect interpretation of composite outcomes can lead to misleading conclusions that impact patient care. To correctly interpret composite outcomes, several important questions should be considered. Are the individual components of the composite outcome equally important to patients? Did the more and less important endpoints occur with similar frequency? Do the component endpoints exhibit similar relative risk reductions? If these questions receive affirmative answers, the use and interpretation of the composite endpoint would be appropriate. However, if any component of the composite endpoint fails to satisfy the aforementioned criteria, interpretation can become difficult, necessitating additional steps. Regulatory agencies acknowledge these challenges and have specific considerations when approving drugs based on studies employing composite endpoints. In conclusion, composite endpoints are valuable tools for evaluating the efficacy and net clinical benefit of interventions; however, cautious interpretation is advised.

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Oral conditions represent a critical public health challenge, and together with descriptive and predictive epidemiology, causal inference has a crucial role in developing and testing preventive oral health interventions. By identifying not just correlations but actual causes of disease, causal inference may quantify the average effect of interventions and guide policies. Although authors are not usually explicit about it, most oral health studies are guided by causal questions. However, methodological deficiencies limit their interpretability and the implementation of their findings. This manuscript is a call to action on the use of causal inference in oral research. Its application starts with asking theoretically sound questions and being explicit about causal relationships, defining the estimates to evaluate, and measuring them properly. Beyond promoting causal analytical approaches, we emphasize the need for more causal thinking to promote thoughtful research questions and the use of appropriate methods to answer them. Causal inference relies on the plausibility of assumptions underlying the data analysis and the quality of the data, and we argue that high-quality observational studies can be used to estimate average causal effects. Although individual efforts to embrace causal inference in dentistry are essential, they will not yield substantial results if not led by a systematic and structural change in the field. We urge scientific societies, funding bodies, dental schools, and journals to promote transparency in research, causal thinking, and causal inference projects to move the field toward more meaningful studies. It is also time for researchers to move forward and connect with the community, co-produce investigations and translate their findings, and engage in interventions that impact public health. We conclude by highlighting the importance of triangulating results from different data sources and methods to support causal inference and inform decision-making on interventions to effectively improve population oral health.

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Resumo O objetivo deste estudo foi analisar a literatura científica da área de saúde bucal coletiva quanto ao cálculo, apresentação e discussão do tamanho do efeito em estudos observacionais. A literatura cientifica na área (2015 a 2019) foi analisada quanto: a) informações gerais (periódico e diretrizes aos autores, número de variáveis e desfechos), b) objetivo e coerência com o cálculo amostral apresentado; c) tamanho do efeito (apresentação, medida utilizada e coerência com a discussão dos dados e conclusão). Foram analisados 123 artigos, de 66 periódicos. A maioria dos artigos avaliados apresenta um único desfecho (74%) e não menciona a realização de cálculo amostral (69,9%). Dentre os que realizaram, para 70,3% havia coerência entre o cálculo amostral utilizado e o objetivo. Apenas 3,3% dos artigos mencionam o termo tamanho do efeito e 24,4% não o consideram na discussão dos resultados, apesar de terem calculado. A regressão logística foi a metodologia estatística mais utilizada (98,4%) e o Odds Ratio a medida de tamanho do efeito mais utilizada (94,3%), embora não tenha sido citada e discutida como uma medida de tamanho do efeito na maioria dos estudos (96,7%). Os pesquisadores, em sua maioria, restringiram a discussão dos resultados apenas à significância estatística encontrada nas associações testadas.

Abstract The objective of this study was to analyze the scientific literature in public oral health regarding calculation, presentation, and discussion of the effect size in observational studies. The scientific literature (2015 to 2019) was analyzed regarding: a) general information (journal and guidelines to authors, number of variables and outcomes), b) objective and consistency with sample calculation presentation; c) effect size (presentation, measure used and consistency with data discussion and conclusion). A total of 123 articles from 66 journals were analyzed. Most articles analyzed presented a single outcome (74%) and did not mention sample size calculation (69.9%). Among those who did, 70.3% showed consistency between sample calculation used and the objective. Only 3.3% of articles mentioned the term effect size and 24.4% did not consider that in the discussion of results, despite showing effect size calculation. Logistic regression was the most commonly used statistical methodology (98.4%) and Odds Ratio was the most commonly used effect size measure (94.3%), although it was not cited and discussed as an effect size measure in most studies (96.7%). It could be concluded that most researchers restrict the discussion of their results only to the statistical significance found in associations under study.

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Objective: Within the context of evidence-based practice, this article exposes the reflection on the understanding and usefulness of the information provided by the research findings shared in reports and research publications, exposing differences based on the interpretation of statistical significance and clinical significance. Content synthesis: Basic aspects of the meaning and use of the information reported by research on p value (statistical significance) and the value and usefulness of these results are analyzed and exemplified, contrasting the value for the practice of an additional judgment on clinical significance. In addition to establishing conceptual differences, the need is highlighted for nurses to have the competencies to differentiate and apply each of them according to the clinical contexts of their potential implementation. Conclusion: The real usefulness of research about interventions within the context of nursing care is given by its real application and reach for the practice and benefit for patients. For this to occur, nurses must interpret adequately the information provided by scientific publications and other research reports.

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RESUMO Objetivo: O ensaio TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) visa avaliar se uma intervenção complexa por telemedicina em unidades de terapia intensiva, que se concentra em rondas multidisciplinares diárias realizadas por intensivistas a distância, reduzirá o tempo de permanência na unidade de terapia intensiva em comparação com os cuidados habituais. Métodos: O TELESCOPE é um ensaio nacional, multicêntrico, controlado, aberto, randomizado em cluster. O estudo testa a eficácia de rondas multidisciplinares diárias realizadas por um intensivista por meio de telemedicina em unidades de terapia intensiva brasileiras. O protocolo foi aprovado pelo Comitê de Ética em Pesquisa local do centro coordenador do estudo e pelo Comitê de Ética em Pesquisa local de cada uma das 30 unidades de terapia intensiva, de acordo com a legislação brasileira. O ensaio está registado no ClinicalTrials.gov (NCT03920501). O desfecho primário é o tempo de internação na unidade de terapia intensiva, que será analisado considerando o período basal e a estrutura dos dados em cluster, sendo ajustado por covariáveis predefinidas. Os desfechos exploratórios secundários incluem a classificação de desempenho da unidade de terapia intensiva, a mortalidade hospitalar, a incidência de infecções nosocomiais, o número de dias sem ventilação mecânica aos 28 dias, a taxa de pacientes que recebem alimentação oral ou enteral, a taxa de pacientes sob sedação leve ou em alerta e calmos e a taxa de pacientes sob normoxemia. Conclusão: De acordo com as melhores práticas do ensaio, divulgamos nossa análise estatística antes de bloquear a base de dados e iniciar as análises. Esperamos que essa prática de notificação evite o viés das análises e aprimore a interpretação dos resultados apresentados. Registro no ClinicalTrials.gov:NCT03920501

ABSTRACT Objective: The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care. Methods: The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia. Conclusion: According to the trial's best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results. ClinicalTrials.gov registration:NCT03920501