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La mayoría de las preguntas de investigación (PI), conducirán a un proyecto que apunta a generar nuevo conocimiento, sin embargo el escenario, la población a estudio y la metodología pueden ser muy diferentes, lo que determinará que los resultados obtenidos y por ende, el nivel de evidencia (NE) y el grado de recomendación (GR) puedan variar notablemente. El objetivo de este artículo fue proporcionar recomendaciones para formular una PI asociada al NE y respectivos GR que se pueden desprender a partir de los resultados generados. Este artículo entregará algunos conocimientos sobre la PI y su relación con los NE y GR de la evidencia generada a partir de resultados obtenidos por un proceso de investigación en diferentes escenarios de investigación.

SUMMARY: Most research questions (RQ) will lead to a project that aims to generate new knowledge. However, the setting, study population and methodology may be very different, which will determine the results obtained and therefore, the level of evidence (LOE) and the grade of recommendation (GOR) may vary significantly. The aim of this study was to provide recommendations to formulate a RQ associated with the LOE and respective GOR that can be derived from the generated results. This article will provide some knowledge about the RQ and its relationship with the LEO and GOR of the generated evidence from results obtained by a research process in different research scenarios.

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BACKGROUND AND OBJECTIVE: The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is a systematic method for assessing the certainty of evidence (CoE) and strength of recommendations in health care. We aimed to verify the effects of an online-based GRADE course on multirater consistency in the evaluation of the CoE in systematic reviews (SRs) analysis. STUDY DESIGN AND SETTINGS: Sixty-five Brazilian methodologists and researchers participated in an online course over 8 weeks. Asynchronous lessons and weekly synchronous meetings addressed the GRADE system in the context of CoE assessment. We asked participants to evaluate the CoE of random SRs (two before and another two after the course). Analyzes focused on the multirater agreement with a standard response, in the interrater agreement, and before-after changes in the proportion of participants that rated down the domains. RESULTS: 48 individuals completed the course. Participants presented improvements in the raters' assessment of the CoE using the GRADE approach after the course. The multirater consistency of indirectness, imprecision, and the overall CoE increased after the course, as well as the agreement between raters and the standard response. Furthermore, interrater reliability increased for risk of bias, inconsistency, indirectness, publication bias, and overall CoE, indicating progress in between-raters consistency. After the course, approximately 78% of individuals rated down the overall CoE to a low/very low degree, and participants presented more explanations for the judgment of each domain. CONCLUSION: An online GRADE course improved the consistency and agreement of the CoE assessment by Brazilian researchers. Online training courses have the potential to improve skills in guideline methodology development.

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Objective: To evaluate the efficacy and safety of nonpharmacological topical interventions for treating breastfeeding nipple pain. Methods: Randomized clinical trials (RCTs) assessing lactating women suffering from breastfeeding painful nipples were included. Primary outcomes were pain, healing process, and adverse events. A comprehensive search was conducted on June 02, 2023, without date or language restrictions. Methodological quality was assessed using the Cochrane risk of bias tool and the certainty of the evidence, the GRADE approach. Results: Nineteen RCTs with unclear to high risk of bias were included. There was uncertain evidence regarding the effects of photobiomodulation versus placebo on pain reduction (mean difference [MD] -0.15; 95% confidence interval [95% CI] -1 0.49 to 1.19; 139 participants, 2 RCTs). There are uncertainties concerning the effects of lanolin versus breast milk on pain (MD -1.80; 95% CI -2.43 to -1.17; 1 RCT; 180 participants), wound healing (MD 0.10; 95% CI -0.26 to -0.46; 1 RCT; 180 participants), and any adverse events (zero events in both groups). Similar effects were observed by the other interventions assessed. Conclusion: The evidence of nonpharmacological topical interventions for painful nipples is imprecise, and future RCTs with higher methodological quality are needed to support recommendations. Considering the accessibility and low cost of these alternative treatments, the findings of this evidence synthesis could support clinical decision-making and guide future research. PROSPERO CRD42020170320.

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La investigación en salud es la base del conocimiento médico y de las recomendaciones en los sistemas de salud. Por ello, la elección de desenlaces apropiados en estudios de intervenciones terapéuticas es un paso fundamental en la producción de evidencia y, posteriormente, para la toma de decisiones. En este artículo proponemos tres factores clave para la elección de desenlaces: la inclusión de desenlaces reportados por pacientes, ya que ponen el foco del efecto de la intervención en la percepción que tienen los propios pacientes de su estado de salud y calidad de vida; la consideración de desenlaces clínicamente relevantes, los cuales son mediciones directas del estado de salud del paciente y, por ende serán determinantes en la toma de decisiones; y la utilización de herramienta que estandariza y permite la homogeneización en la medición e interpretación de desenlaces, facilitando la producción y posterior síntesis de evidencia apropiada para el ecosistema de evidencia. La correcta elección de los desenlaces permitirá que la evidencia generada de estos estudios ayude a los tomadores de decisiones en salud y los profesionales clínicos a entregar cuidados apropiados centrados en el paciente y a optimizar el uso de recursos en salud e investigación clínica.

Health research is the foundation of medical knowledge and healthcare system recommendations. Therefore, choosing appropriate outcomes in studies of therapeutic interventions is a fundamental step in producing evidence and, subsequently, for decision-making. In this article, we propose three key factors for the choice of outcomes: the inclusion of patient-reported outcomes, since they focus on the patient's perception of their health status and quality of life; the consideration of clinically relevant outcomes, which are direct measurements of the patient's health status and, therefore, will be decisive in decision-making; and the use of core outcome sets, a tool that standardizes the measurement and interpretation of outcomes, facilitating the production and synthesis of appropriate evidence for the evidence ecosystem. The correct choice of outcomes will help health decision-makers and clinicians deliver appropriate patient-centered care and optimize the use of resources in healthcare and clinical research.

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Health research is the foundation of medical knowledge and healthcare system recommendations. Therefore, choosing appropriate outcomes in studies of therapeutic interventions is a fundamental step in producing evidence and, subsequently, for decision-making. In this article, we propose three key factors for the choice of outcomes: the inclusion of patient-reported outcomes, since they focus on the patient's perception of their health status and quality of life; the consideration of clinically relevant outcomes, which are direct measurements of the patient's health status and, therefore, will be decisive in decision-making; and the use of core outcome sets, a tool that standardizes the measurement and interpretation of outcomes, facilitating the production and synthesis of appropriate evidence for the evidence ecosystem. The correct choice of outcomes will help health decision-makers and clinicians deliver appropriate patient-centered care and optimize the use of resources in healthcare and clinical research.

La investigación en salud es la base del conocimiento médico y de las recomendaciones en los sistemas de salud. Por ello, la elección de desenlaces apropiados en estudios de intervenciones terapéuticas es un paso fundamental en la producción de evidencia y, posteriormente, para la toma de decisiones. En este artículo proponemos tres factores clave para la elección de desenlaces: la inclusión de desenlaces reportados por pacientes, ya que ponen el foco del efecto de la intervención en la percepción que tienen los propios pacientes de su estado de salud y calidad de vida; la consideración de desenlaces clínicamente relevantes, los cuales son mediciones directas del estado de salud del paciente y, por ende serán determinantes en la toma de decisiones; y la utilización de herramienta que estandariza y permite la homogeneización en la medición e interpretación de desenlaces, facilitando la producción y posterior síntesis de evidencia apropiada para el ecosistema de evidencia. La correcta elección de los desenlaces permitirá que la evidencia generada de estos estudios ayude a los tomadores de decisiones en salud y los profesionales clínicos a entregar cuidados apropiados centrados en el paciente y a optimizar el uso de recursos en salud e investigación clínica.

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Patient Blood Management (PBM) is a multidimensional approach that seeks to optimize the use of blood and its components in patients. This matter emerged as a response to the need to reduce unnecessary exposure to blood transfusions and their potential risks. In the past, blood transfusion was often overused resulting in complications and high costs. The advent of Patient Blood Management has caused a paradigm shift, highlighting anemia prevention, bleeding control and maximizing the production of blood cells by the organism itself. Patient Blood Management guidelines include the early identification of anemia, strategies to minimize blood loss during surgery, intraoperative blood conservation techniques, preoperative hemoglobin optimization and evidence-based approaches to the rational use of blood transfusions. Aiming to improve clinical outcomes, decrease transfusion-related complications and reduce associated costs, this multidisciplinary approach counts on doctors, nurses, pharmacists and other healthcare professionals. Based on research and clinical evidence, Patient Blood Management continues to evolve thereby promoting safer, more effective patient-centered practices. Its implementation has proven beneficial in various medical contexts thereby contributing to improvements in the quality of care provided to patients. Our goal with this Consensus is to present readers with a broad and diverse view of Patient Blood Management so that they have the building blocks to implement this new technique.

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The use of strategies to reduce blood loss and transfusions is essential in the treatment of surgical patients, including in complex cardiac surgeries and those that use cardiopulmonary bypass. Antifibrinolytics, such as epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA), are widely used in these procedures, as well as in other types of surgeries. These medicines are included in the World Health Organization (WHO) list of 'essential medicines'. Scientific evidence demonstrates the effectiveness of EACA in reducing bleeding and the need for transfusions in heart surgery. EACA is highly recommended for use in heart surgery by the American Society of Anesthesiology Task Force on Perioperative Blood Management. Regarding the safety of EACA, there is no robust evidence of any significant thrombotic potential. TXA has also been shown to be effective in reducing the use of blood transfusions in cardiac and non-cardiac surgeries and is considered safer than other antifibrinolytic agents. There is no evidence of any increased risk of thromboembolic events with TXA, but doses greater than 2 g per day have been associated with an increased risk of seizures. It is also important to adjust the dose in patients with renal impairment. In conclusion, antifibrinolytics, such as EACA and TXA, are effective in reducing blood loss and transfusion use in cardiac and non-cardiac surgeries, without causing serious adverse effects.

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INTRODUCTION: Clinical trials on tyrosine kinase inhibitors (TKI) treatment have shown an improvement in overall and progression-free survival in patients with advanced differentiated thyroid cancer. However, it is necessary to evaluate these studies to assess methodological biases and inconsistencies that may impact the effects. OBJECTIVE: To map and assess the methodological quality of randomized clinical trials (RCTs) regarding randomization, allocation concealment, blinding, and selective reporting bias. METHODS: RCTs assessing the efficacy and safety of TKI for the treatment of advanced differentiated thyroid cancer were included. The search was performed in the MEDLINE database. The included RCTs were assessed for the adequacy of the methodological steps, as recommended by the Cochrane Risk of Bias tool. RESULTS: Nine studies were analyzed, of which 77.7% were classified as low risk of bias regarding selective reporting and 33.3% as high risk of reporting bias. The mean time between protocol registration and study publication was approximately 5.11 years. Moreover, 66.7% were classified as low risk of bias for randomization and allocation concealment, and 33.3% did not specify the randomization process and allocation concealment in a way that would allow the identification of occurrences of bias. Concerning blinding of participants and outcome assessors, 77.8% of the RCTs reported adequate blinding and were classified as having a low risk of bias, 11.1% had a high risk of bias, and 11.1% had insufficient information and were classified as having unclear risk of bias. Regarding the blinding of the outcome assessors, 33.3% did the blinding correctly, 11.1% did not blind, and 55.6% did not provide enough information. CONCLUSION: Overall, the assessed RCTs were predominantly at low risk of bias. The critical evaluation of these studies is essential to have confidence in the treatment estimated effect that will support clinical decision-making and provide information to preclude future clinical study flaws.

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