Minimally invasive interventions for biopsy of malignancy-suspected pulmonary nodules: a systematic review and meta-analysis.

BACKGROUND: Imaging tests are important for diagnosis during the management of pulmonary nodules; however, biopsy is required to confirm the malignancy. OBJECTIVES: To compare the effects of different techniques used for the biopsy of a pulmonary nodule. DESIGN AND SETTING: Systematic review and meta-analysis were conducted using Cochrane methodology in São Paulo, São Paulo, Brazil. METHODS: We conducted a systematic review of randomized controlled trials (RCTs) on minimally invasive techniques, including tomography-guided percutaneous biopsy (PERCUT), transbronchial biopsies with fluoroscopy (FLUOR), endobronchial ultrasound (EBUSR), and electromagnetic navigation (NAVIG). The primary outcomes were diagnostic yield, major adverse events, and need for another approach. RESULTS: Seven RCTs were included (913 participants; 39.2% female, mean age: 59.28 years). Little to no increase was observed in PERCUT over FLUOR (P = 0.84), PERCUT over EBUSR (P = 0.32), and EBUSR over NAVIG (P = 0.17), whereas a slight increase was observed in NAVIG over FLUOR (P = 0.17); however, the evidence was uncertain. EBUSR may increase the diagnostic yield over FLUOR (P = 0.34). PERCUT showed little to no increase in all bronchoscopic techniques, with uncertain evidence (P = 0.02). CONCLUSION: No biopsy method is definitively superior to others. The preferred approach must consider availability, accessibility, and cost, as safety and diagnostic yield do not differ. Further RCTs planned, conducted, and reported with methodological rigor and transparency are needed, and additional studies should assess cost and the correlation between nodule size and location, as well as their association with biopsy results. SYSTEMATIC REVIEW REGISTRATION: PROSPERO database, CRD42018092367 -https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=92367.

Sentidos subjetivos atribuídos às reações de familiares após comunicação de más notícias em um pronto-socorro / Subjective meanings attributed to family reactions after communication of bad news in an emergency room / Sentidos subjetivos atribuidos a las reacciones familiares tras la comunicación de malas noticias en servicio de urgencias

INTRODUÇÃO: No cotidiano do hospital, inevitavelmente, a equipe de saúde se relaciona com pacientes e familiares que receberam algum tipo de má notícia. Constituindo-se como uma tarefa árdua, porém fundamental, a comunicação de más notícias é um importante tema de estudo na área da saúde. OBJETIVOS: O objetivo é descrever e analisar quais são os sentidos subjetivos atribuídos pelos profissionais às reações da família a uma comunicação de más notícias. Os objetivos específicos foram: identificar processos simbólicos e práticas reguladoras da produção de sentidos; analisar como se apresenta a emocionalidade dos profissionais envolvidos nas situações de comunicação de más notícias; e analisar como o contexto de pronto socorro atua enquanto mediador de produções simbólico-emocionais dos profissionais. MÉTODO: Participaram deste estudo profissionais de um pronto socorro de um hospital universitário da cidade de São Paulo. Foram apresentadas três vinhetas de casos clínicos que retratam diferentes reações de familiares de pacientes após uma comunicação de más notícias, no Pronto Socorro. A partir de uma pergunta disparadora, conduziu-se uma entrevista semi-estruturada. RESULTADOS: Evidenciou-se que ausência da instrumentalização para a comunicação de más notícias durante a graduação em medicina e enfermagem repercute em diversos âmbitos da experiência do profissional, desde como administram suas próprias emoções até o modo como lidam com as múltiplas reações emocionais dos familiares dos pacientes. CONSIDERAÇÕES FINAIS: Este estudo sugere, então, a relevância de haver, durante a formação profissional, maior espaço para estudo e discussão sobre os temas que emergem em um contexto de comunicação de más notícias.

INTRODUCTION: In the daily routine of the hospital, inevitably, the health team interacts with patients and family members who have received some kind of bad news. Constituting itself as an arduous but fundamental task, the communication of bad news is an important topic of study in the health area. OBJECTIVES: We aim to describe and analyze what are the subjective sense attributed by professionals to the family's reactions to a communication of bad news. The specific objectives were: to identify symbolic processes and regulatory practices of the sense make; to analyze how the emotionality of the professionals involved in the communication of bad news is presented; and to analyze how the emergency department context acts as a mediator of symbolic-emotional productions of professionals. METHOD: Professionals from an emergency department of a university hospital in the city of São Paulo participated in this study. Three vignettes of clinical cases were presented that depict different reactions of patients' relatives after a communication of bad news, in the emergency department. From a triggering question, a semi-structured interview was conducted. RESULTS: It was evidenced that the absence of instrumentalization for the communication of bad news during graduation in medicine and nursing has repercussions in several areas of the professional's experience, from how they manage their own emotions to the way they deal with the multiple emotional reactions of patients' family members. FINAL CONSIDERATIONS: This study suggests, therefore, the importance of having, during professional training, greater space for study and discussion on the themes that emerge in a context of communication of bad news.

INTRODUCCIÓN: En el día a día del hospital, inevitablemente, el equipo de salud interactúa con pacientes y familiares que han recibido algún tipo de mala noticia. Constituyéndose en una tarea ardua pero fundamental, la comunicación de malas noticias es un importante tema de estudio en el área de la salud. OBJECTIVO: El objetivo general de este estudio fue describir y analizar cuáles son los sentidos subjetivos atribuidos por los profesionales a las reacciones de la familia ante una comunicación de malas noticias. Los objetivos específicos fueron: identificar procesos simbólicos y prácticas reguladoras de la producción de significados; analizar cómo se presenta la emotividad de los profesionales involucrados en la comunicación de malas noticias; y analizar cómo el contexto de urgencias actúa como mediador de las producciones simbólico-emocionales de los profesionales. MÉTODO: Participaron de este estudio profesionales del servicio de urgencias de un hospital universitario de la ciudad de São Paulo. Se presentaron tres viñetas de casos clínicos que muestran diferentes reacciones de los familiares de los pacientes después de una comunicación de malas noticias, en el servicio de urgencias. A partir de una pregunta desencadenante, se realizó una entrevista semiestructurada. RESULTADOS: Se evidenció que la ausencia de instrumentalización para la comunicación de malas noticias durante la graduación en medicina y enfermería repercute en varias áreas de la experiencia del profesional, desde cómo maneja sus propias emociones hasta la forma en que lidia con las múltiples reacciones emocionales de los familiares de los pacientes. CONSIDERACIONES FINALES: Por lo tanto, este estudio sugiere, la importancia de tener, durante la formación profesional, mayor espacio de estudio y discusión sobre los temas que emergen en un contexto de comunicación de malas noticias.

Is Evening Carbohydrate Intake in Healthy Individuals Associated with Higher Postprandial Glycemia and Insulinemia When Compared to Morning Intake? A Systematic Review and Meta-Analysis of Randomized Crossover Studies.

This systematic review aimed to summarize randomized clinical trials that compared the postprandial glycemic and insulinemic metabolic response after eating isocaloric and standardized carbohydrate meals consumed at two moments: morning versus night, in healthy individuals who were not shift workers. The search strategy consisted of an electronic search using the following electronic databases: MEDLINE (via PubMed), EMBASE (via Elsevier), LILACs (Virtual Health Library - VHL), Cochrane Registers of Clinical Trials (CENTRAL, via Wiley) and gray literature (Opengray.eu). The PICO strategy was used to define the search terms (P: healthy adults, I: nocturnal intake, C: morning intake, O: area under the curve (AUC) of the postprandial glucose and insulin response). This review was reported according to the PRISMA statement. From the 3757 articles found, 412 were duplicates and excluded, totaling 3345 that had their titles and abstracts read. A total of 42 articles met the inclusion criteria and were read in full, and eight studies were included in the systematic review. The certainty of the evidence was assessed using GRADE. The results showed, with moderate quality of evidence, a postprandial response with higher glycemic values in the evening compared to the morning (SMD = 1.30; 95% CI, 1.01 to 1.59; I2 = 0%; p < 0.00001; 8 studies and 116 participants). No differences were found between insulin values at night and in the morning (SMD = 0.19; 95% CI, -0.10 to 0.49; 6 studies and 90 participants). We concluded that the intake of carbohydrates at night leads to higher glycemic, but not insulinemic, postprandial values. Revision Record: PROSPERO number CRD42019137862 available at: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019137862 Key teaching points and nutritional relevanceThis systematic review summarized randomized clinical trials that compared the postprandial glycemic and insulinemic response after eating carbohydrate meals in the morning versus at night.A total of eight studies were included in the systematic review; the results showed a postprandial response with higher glycemic values in the evening compared to the morning.No differences were found between insulin values at night and in the morning;• The intake of carbohydrates at night leads to higher glycemic, but not insulinemic, postprandial values.

Efficacy and safety of hemodialysis strategies for pregnant women with chronic kidney disease: Systematic review.

Pregnancy in chronic kidney disease (CKD) women is relatively rare, and the less risky choice of hemodialysis is unknown. The objective of this systematic review was to identify, systematically evaluate and summarize the available evidence on the efficacy and safety of hemodialysis strategies for pregnant CKD women. Sensitive search strategies were applied to six databases without data or language restrictions. Comparative (randomized and non-randomized) studies were prioritized. Two reviewers independently selected, extracted, and critically evaluated data from studies. The risk of bias assessment was performed using the ROBINS-I tool, considering the study design (non-randomized comparative observational studies). The certainty of the evidence was assessed using the GRADE approach. From 7210 references identified, six retrospective cohort studies were included (576 women). The effects of intensive hemodialysis (over 20 h/week) are uncertain for maternal and neonatal mortality (Peto odds ratio [OR] 0.85; 95% confidence interval [95% CI] 0.26-2.80), miscarriage (Peto OR 0, 38; 95% CI 0.12-1.23), stillbirths (Peto OR 0, 56; 95% CI 0.13-2.31), preterm birth (Peto OR 0.87; 95% CI 0.33-2.28), low birth weight (Peto OR 0.71; 95% CI 0.20-2.50) and congenital anomalies rates. The certainty of the evidence was very low due to studies methodological limitations and effect estimates imprecision. The uncertainty about intensive versus conventional hemodialysis effects for pregnant women with CKD and the imprecision in the estimated effects precludes any recommendation. The strategy choice must consider treatment availability, costs, and maternal social aspects until future studies provide more reliable evidence. PROSPERO CRD42021259237.

Supporting Decisions of the Brazilian Regulatory Agency for Supplementary Healthcare: A Case Study.

OBJECTIVES: This study aimed to report implementation and partial results of the project "Supporting the Brazilian regulatory agency for supplementary healthcare through health technology assessment actions" conducted at Hospital Sírio-Libanês, Brazil, from 2020 to 2023, through Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde, a Brazilian Ministry of Health initiative. METHODS: This was a case study conducted at Health Technology Center, Hospital Sírio-Libanês. RESULTS: From its inception, in 2020, to July 2022, the following activities and products were completed: 59 technical-methodological reports assessing the efficacy, safety, cost-effectiveness, and budget impact of technologies received by Agência Nacional de Saúde Suplementar (ANS) to compose its catalog of drugs products and services; 50 analyses of society contributions from public consultation; 34 methodological or clinical tutorial sessions to support ANS team; 2 templates to systematize the update process of ANS catalog; and one training course on systematic reviews and meta-analysis for ANS team. CONCLUSION: The project has contributed to increasing ANS autonomy in the health technology assessment, collaborating to efficiency in technologies offer to the users. By adopting and fostering evidence-based knowledge construction, the project reinforces its bridging role for supporting the consonance between public and supplementary healthcare sectors in Brazil.

Minimally invasive interventions for biopsy of malignancy-suspected pulmonary nodules: a systematic review and meta-analysis

ABSTRACT BACKGROUND: Imaging tests are important for diagnosis during the management of pulmonary nodules; however, biopsy is required to confirm the malignancy. OBJECTIVES: To compare the effects of different techniques used for the biopsy of a pulmonary nodule. DESIGN AND SETTING: Systematic review and meta-analysis were conducted using Cochrane methodology in São Paulo, São Paulo, Brazil. METHODS: We conducted a systematic review of randomized controlled trials (RCTs) on minimally invasive techniques, including tomography-guided percutaneous biopsy (PERCUT), transbronchial biopsies with fluoroscopy (FLUOR), endobronchial ultrasound (EBUSR), and electromagnetic navigation (NAVIG). The primary outcomes were diagnostic yield, major adverse events, and need for another approach. RESULTS: Seven RCTs were included (913 participants; 39.2% female, mean age: 59.28 years). Little to no increase was observed in PERCUT over FLUOR (P = 0.84), PERCUT over EBUSR (P = 0.32), and EBUSR over NAVIG (P = 0.17), whereas a slight increase was observed in NAVIG over FLUOR (P = 0.17); however, the evidence was uncertain. EBUSR may increase the diagnostic yield over FLUOR (P = 0.34). PERCUT showed little to no increase in all bronchoscopic techniques, with uncertain evidence (P = 0.02). CONCLUSION: No biopsy method is definitively superior to others. The preferred approach must consider availability, accessibility, and cost, as safety and diagnostic yield do not differ. Further RCTs planned, conducted, and reported with methodological rigor and transparency are needed, and additional studies should assess cost and the correlation between nodule size and location, as well as their association with biopsy results. SYSTEMATIC REVIEW REGISTRATION: PROSPERO database, CRD42018092367 -https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=92367.

Strategies for promoting mental health among residents: scoping review protocol.

Health professionals are encouraged to attend a residency period of two to seven years after graduating. The typical demands of this in-service training modality have been associated with reduced sleep quality, decreased exercise frequency, and detachment from family and social relationships, leading to an increased diagnosis of anxiety, depression, and burnout syndrome. Therefore, conducting a scoping review to identify strategies aimed at promoting mental health and wellbeing among residents from different health areas is essential to support any forthcoming preventive action.

Estratégias de comunicação de evidências em saúde para gestores e para a população: revisão de escopo / Projeto ESPIE / Health evidence communication strategies for managers and the population: scope review / ESPIE Project

O avanço das mídias digitais e sociais reformulou o conceito de comunicação em saúde, e diferentes estratégias têm sido desenvolvidas para aumentar o entendimento sobre os resultados das pesquisas científicas direcionadas aos gestores e à população. O mapeamento por meio de uma revisão de escopo é necessário para identificar e avaliar a natureza e a extensão da literatura relacionada a essas abordagens para cada público e contexto. Os resultados identificados poderão subsidiar a tomada de decisão de setores envolvidos na promoção do uso do conhecimento científico nos processos decisórios no que se refere à comunicação de evidências no contexto das Políticas Informadas por Evidências (PIE). Foi realizada busca ampla e sensível em bases e repositórios de dados, além de buscas não estruturadas em outras fontes e busca manual para identificação de estudos, de qualquer delineamento metodológico, e documentos publicados a partir de 1o de janeiro de 2000, sobre estratégias para comunicação de evidências científicas para gestores de saúde e/ou população, em nível individual ou populacional, no âmbito da saúde pública ou suplementar, em qualquer nível de assistência. As estratégias foram classificadas e apresentadas narrativamente de acordo com as categorias: comunicação de risco/benefício, comunicação de incerteza, modelos de síntese de evidências e outros documentos em linguagem acessível, orientações para elaboração/avaliação de produtos de comunicação de evidências científicas e ensino/aprendizagem. Esta revisão de escopo identificou 80 estudos, relatórios ou outras formas de apresentação de informações, que abordaram 78 estratégias ou conjuntos de estratégias de comunicação de evidências científicas em saúde para a população e/ou gestores. As estratégias mais frequentes eram de comunicação de risco e benefícios em saúde, apresentaram abordagem. de apoio à Formulação e Implementação de Políticas de Saúde Informadas por Evidências - ESPIE de entrega textual e tinham o status de implementadas e, de alguma forma, avaliadas. Entre as estratégias avaliadas e que parecem apresentar algum benefício estão: • comunicação de risco/benefício: maior compreensão de frequências naturais do que de porcentagens; maior compreensão de risco absoluto, do que riscos relativos e número necessário para tratar; maior compreensão e mudança de comportamento com comunicação numérica do que nominal; maior compreensão de mortalidade do que de sobrevida; comunicações com teor negativo ou de perdas parecem ser mais eficazes para compreensão, satisfação e mudança de comportamento do que comunicações com teor positivo ou de ganho; comunicação nominal pode levar à superestimativa do risco de eventos adversos e pode levar os pacientes a tomarem decisões inadequadas sobre o uso ou não do medicamento. • modelos de síntese de evidências e outros documentos e linguagem acessível: plain languages summaries para comunicar os resultados de revisões sistemáticas Cochrane para a população foram percebidos como mais confiáveis, mais fáceis de encontrar e de compreender e melhores para apoiar as decisões do que os resumos originais. • ensino/aprendizagem: os recursos da iniciativa Informed Health Choices para comunicação e aprendizagem de conceito-chave evidências em saúde parecem ser eficazes em melhorar a habilidade em pensamento crítico em saúde logo após sua utilização, mas estes efeitos não foram observados após um ano; o treinamento teórico-prático para parlamentares sobre evidências científicas em saúde parece ser uma estratégia com potencial de sensibilizar e melhorar a compreensão deste subgrupo de gestores sobre evidências em saúde. Esta revisão de escopo identificou 78 estratégias ou conjuntos para estratégias de comunicação de evidências em saúde para gestores e população. Algumas delas foram implementadas, avaliadas e parecem ter algum benefício para melhorar a compreensão destes públicos sobre conceitos de evidências e resultados em saúde. Os achados desta revisão têm um importante potencial de aplicabilidade na área de políticas informadas por evidências. Esforços futuros são necessários para padronizar e estimular o relato destas estratégias e avaliar seus efeitos em desfechos clínicos relevantes para o indivíduo, para a sociedade e para os sistemas de saúde.

Efficacy and safety of home-based intravenous antibiotic therapy among adults: a systematic review.

The aim of this study was to identify, systematically assess and summarise the available evidence about the efficacy and safety of intravenous home antibiotic therapy. In this systematic review, we considered studies of adults with any kind of infection and recommended intravenous antibiotic therapy. We included studies comparing therapy given at the patient's home versus any other setting (other levels of healthcare services or sites). We performed wide and sensitive literature searches with strategies adjusted for each of the electronic databases, including CINAHL, ClinicalTrials.gov, Cochrane Library, Embase, Epistemonikos, Health System Evidence, LILACS, MEDLINE and grey literature (OpenGrey). We used the Cochrane risk-of-bias and GRADE tools to evaluate the risk of bias and the certainty of evidence. At least two reviewers, working independently, selected the studies, extracted data and critically evaluated the evidence. We performed random-effects meta-analyses where possible. From 20 099 references initially identified, we included 6 randomised controlled trials (RCTs) with 616 participants. We considered the certainty of the body of evidence as low to very low regarding infection resolution after 6 weeks, risk of adverse events, mortality and clinical status. Based on six RCTs with considerable risk of bias, this systematic review found low or very low evidence about the advantages of intravenous antibiotic therapy at home. The imprecision of the results does not allow us to recommend or contraindicate the use of this strategy in clinical practice. [PROSPERO register: this review protocol was prospectively submitted at the PROSPERO register base at 31 January 2021 (submission no. 42021234454)].

Is self-reported short sleep duration associated with obesity? A systematic review and meta-analysis of cohort studies.

CONTEXT: A possible association between self-reported short sleep duration and risk of obesity has been studied. OBJECTIVE: To analyze the association between sleep duration and obesity. METHODS: The LILACS, Medline, Central, Embase, and OpenGrey databases were searched from inception until July 2020. Two authors screened the studies independently according to the PECO strategy, as follows: participants: > 18 years old; exposure: short sleep duration; control: regular sleep; outcome: obesity). Only cohort studies were included. A total of 3286 studies were retrieved with the search strategy, but only 36 were included. Disagreements were resolved by a third author. The quality of studies was assessed with Newcastle-Ottawa Quality Assessment Form for Cohort Studies. The certainty of the evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation. RESULTS: Thirty-six studies were included, and 22 contributed quantitative data. Most of the studies (n = 27) assessed sleep by self-report. The meta-analysis showed a significant association between self-reported short sleep and development of obesity, and the chances of developing obesity increased when self-reported sleep duration decreased. CONCLUSIONS: Self-reported short sleep was significantly associated with a higher incidence of obesity, with moderate quality of evidence. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42019130143.

Hypofractionated radiotherapy for newly diagnosed elderly glioblastoma patients: A systematic review and network meta-analysis.

OBJECTIVE: To evaluate different hypofractionated radiotherapy (HRT) regimens for newly diagnosed elderly glioblastoma (GBM) patients. METHODS: We performed a systematic review with network meta-analysis (NMA), including searches on CENTRAL, Medline, EMBASE, CINAHL, clinical trial databases and manual search. Only randomized clinical trials (RCTs) were included. Primary outcomes: overall survival (OS) and adverse events (AE). Secondary outcomes: progression-free-survival (PFS) and quality of life (QoL). We used the Cochrane Risk of Bias (RoB) table for assessing individual studies and CINeMA for evaluating the certainty of the final body of evidence. RESULTS: Four RCTs (499 patients) were included. For OS, the estimates from NMA did not provide strong evidence of a difference between the HRTs: 40 Gray (Gy) versus 45 Gy (HR: 0.89; CI 95%: 0.42, 1.91); 34 Gy versus 45 Gy (HR: 0.85; CI 95% 0.43, 1.70); 25 Gy versus 45 Gy (HR: 0.81; CI 95% 0.32, 2.02); 34 Gy versus 40 Gy (HR: 0.95; CI 95% 0.57, 1.61); and 25 Gy versus 34 Gy (HR: 0.95; CI 95% 0.46, 1.97). We performed qualitative synthesis for AE and QoL due to data scarcity and clinical heterogeneity among studies. The four studies reported a similar QoL (assessed by different methods) between arms. One RCT reported grade ≥ 3 AE, with no evidence of a difference between arms. PFS was reported in one study (25 Gy versus 40 Gy), with no evidence of a difference between arms. CONCLUSION: This review found no evidence of a difference between the evaluated HRTs for efficacy and safety.

Route of oxytocin administration for preventing blood loss at caesarean section: a systematic review with meta-analysis.

OBJECTIVES: Assess the effects of different routes of prophylactic oxytocin administration for preventing blood loss at caesarean section (CS). DESIGN: Systematic review and meta-analysis. METHODS: Medline, EMBASE, CINAHL, Cochrane Library, BVS, SciELO and Global Index Medicus were searched through 24 May 2020 for randomised controlled trials (RCTs) comparing different routes of prophylactic oxytocin administration during CS. Study selection, data extraction and quality assessment were conducted by two investigators independently. We pooled results in fixed effects meta-analyses and calculated average risk ratio (RR), mean difference (MD) and 95% CI. We used GRADE to assess the overall quality of evidence for each outcome. RESULTS: Three trials (180 women) were included in the review. All studies compared intramyometrial (IMY) versus intravenous oxytocin in women having prelabour CS. IMY compared with intravenous oxytocin administration may result in little or no difference in the incidence of postpartum haemorrhage (RR 0.14, 95% CI 0.01 to 2.70; N=100 participants; 1 RCT), hypotension (RR 1.00, 95% CI 0.29 to 3.45; N=40; 1 RCT), headache (RR 3.00, 95% CI 0.13 to 69.52; N=40; 1 RCT) or facial flushing (RR 0.50, 95% CI 0.05 to 5.08; N=40; 1 RCT); IMY oxytocin may reduce nausea/vomiting (RR 0.13, 95% CI 0.02 to 0.69; N=140; 2 RCTs). We are very uncertain about the effect IMY versus intravenous oxytocin on the need for additional uterotonics (RR 0.82; 95% CI 0.25 to 2.69; N=140; 2 RCTs). IMY oxytocin may reduce blood loss slightly (MD -57.40 mL, 95% CI -101.71 to -13.09; N=40; 1 RCT). CONCLUSIONS: There is limited, low to very low certainty evidence on the effects of IMY versus intravenous oxytocin at CS for preventing blood loss. The evidence is insufficient to support choosing one route over another. More trials, including studies that assess intramuscular oxytocin administration, are needed on this relevant question. PROSPERO REGISTRATION NUMBER: CRD42020186797.

High frequency of spin bias in controlled trials of cannabis derivatives and their synthetic analogues: A meta-epidemiologic study.

OBJECTIVE: To investigate the frequency and perform a qualitative analysis of spin bias in publications of controlled trials assessing the therapeutic use of cannabis derivatives and their synthetic analogues. STUDY DESIGN AND SETTING: Meta-epidemiologic study carried out at the Universidade Federal de São Paulo, Brazil. RESULTS: A total of 65 publications with at least one efficacy primary outcome were considered. The results analysis for the primary outcome indicated statistically significant effects in 44.6% (29/65) of the publications, and 70.7% (45/65) of the conclusions were considered favorable to the intervention. Among the 36 publications that found statistically nonsignificant results for the primary outcome, 44.4% (16/36) presented conclusions favorable to or recommending the intervention, which represents spin bias according to the definition adopted in this study. Qualitative analysis of the 16 studies with spin bias showed selective outcomes reporting (elevating secondary outcomes that had positive results or reporting only subgroup results), deviations from the planned statistical analysis, and failure to consider or report uncertainty in the estimates of treatment effects. CONCLUSION: The frequency of spin bias among publications of controlled trials with statistically nonsignificant results assessing the therapeutic use of cannabis derivatives and their synthetic analogues reached 44.4%. When not observed by readers, such deviation can lead to misconduct in clinical practice through the adoption of interventions that are not effective or whose effectiveness is uncertain.

Systematic reviews on interventions for COVID-19 have rarely graded the certainty of the evidence.

BACKGROUND: Numerous systematic reviews on coronavirus disease-19 (COVID-19) treatment have been developed to provide syntheses of the large volume of primary studies. However, the methodological quality of most of these reviews is questionable and the results provided may therefore present bias. OBJECTIVE: To investigate how many systematic reviews on the therapeutic or preventive options for COVID-19 assessed the certainty of the evidence through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. METHODS: We conducted a sensitive search in MEDLINE (via PubMed) and included all systematic reviews that assessed any intervention for COVID-19. The systematic reviews included were examined to identify any planned and/or actual assessment using the GRADE approach (or absence thereof) regarding the certainty of the evidence. RESULTS: We included 177 systematic reviews and found that only 37 (21%; 37/177) assessed and reported the certainty of the evidence using the GRADE approach. This number reduced to 27 (16.2%; 27/167) when Cochrane reviews (n = 10), in which an evaluation using GRADE is mandatory, were excluded. CONCLUSION: Most of the systematic reviews on interventions relating to COVID-19 omitted assessment of the certainty of the evidence. This is a critical methodological omission that must not be overlooked in further research, so as to improve the impact and usefulness of syntheses relating to COVID-19.

Timing of oxytocin administration to prevent post-partum hemorrhage in women delivered by cesarean section: A systematic review and metanalysis.

BACKGROUND: There is no consensus on the best timing for prophylactic oxytocin administration during cesarean section (CS) to prevent post-partum hemorrhage (PPH). OBJECTIVES: Assess the effects of administrating prophylactic oxytocin at different times during CS. METHODS: We searched nine databases to identify relevant randomized controlled trials (RCT). We pooled results and calculated average risk ratios (RR), mean differences (MD), and 95% confidence intervals (CI). We used GRADE to assess the overall evidence certainty. RESULTS: We screened 13,389 references and included four trials. We found no statistically significant differences between oxytocin given before versus after fetal delivery on PPH (RR 0.60, 95%CI 0.15-2.47; 1 RCT, N = 300) or nausea/vomiting (RR 1.21, 95%CI 0.69-2.13; 1 RCT, N = 300). There was a significant reduction in the need for additional uterotonics when oxytocin was given immediately before uterine incision versus after fetal delivery (RR 0.37, 95%CI 0.18-0.73; I2 = 0%; 2 RCTs; N = 301). Oxytocin given before fetal delivery significantly reduced intra-operative blood loss (MD -146.77mL, 95%CI -168.10 to -125.43; I2 = 0%; 3 RCTs, N = 601) but did not change the incidence of blood transfusion (RR 0.50, 95%CI 0.13-1.95; I2 = 0%; 2 RCTs, N = 301) or hysterectomy (RR 3.00; 95%CI 0.12-72.77; I2 = 0%; 2 RCTs, N = 301). One trial (N = 100) compared prophylactic oxytocin before versus after placental separation and found no significant differences on PPH, additional uterotonics, or nausea/vomiting. CONCLUSIONS: In women having pre-labor CS, there is limited evidence indicating no significant differences between prophylactic oxytocin given before versus after fetal delivery on PPH, nausea/vomiting, blood transfusion, or hysterectomy. Earlier oxytocin administration may reduce the volume of blood loss and need for additional uterotonics. There is very limited evidence suggesting no significant differences between prophylactic oxytocin given before versus after placental separation on PPH, need for additional uterotonic, or nausea/vomiting. The overall certainty of the evidence was mostly low or very low due to imprecision. Protocol: CRD42020186797.

Systematic reviews on interventions for COVID-19 have rarely graded the certainty of the evidence

ABSTRACT BACKGROUND: Numerous systematic reviews on coronavirus disease-19 (COVID-19) treatment have been developed to provide syntheses of the large volume of primary studies. However, the methodological quality of most of these reviews is questionable and the results provided may therefore present bias. OBJECTIVE: To investigate how many systematic reviews on the therapeutic or preventive options for COVID-19 assessed the certainty of the evidence through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. METHODS: We conducted a sensitive search in MEDLINE (via PubMed) and included all systematic reviews that assessed any intervention for COVID-19. The systematic reviews included were examined to identify any planned and/or actual assessment using the GRADE approach (or absence thereof) regarding the certainty of the evidence. RESULTS: We included 177 systematic reviews and found that only 37 (21%; 37/177) assessed and reported the certainty of the evidence using the GRADE approach. This number reduced to 27 (16.2%; 27/167) when Cochrane reviews (n = 10), in which an evaluation using GRADE is mandatory, were excluded. CONCLUSION: Most of the systematic reviews on interventions relating to COVID-19 omitted assessment of the certainty of the evidence. This is a critical methodological omission that must not be overlooked in further research, so as to improve the impact and usefulness of syntheses relating to COVID-19.

Methodological quality and redundancy of systematic reviews that compare endarterectomy versus stenting for carotid stenosis.

A review of systematic reviews (SRs) and a critical appraisal study was conducted at Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). The objectives of this review are (1) to identify all published SRs comparing the effectiveness and safety of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) for carotid artery stenosis, (2) to assess their methodological quality and (3) to compare the primary studies contained in each SR. We included 17 SRs published between 2005 and 2017. None of the SRs fulfilled all items of AMSTAR-2. The overall confidence in the results was graded as critically low for 16 SRs (94%) and low for 1 SR (6%). Five items were judged inadequate in all SRs: reference to a published protocol, explanation to the selection of study design, comprehensive search of the literature, methods for statistical combination of findings and consideration of the risk of bias on the results of meta-analysis. In total, 15 randomised clinical trials (RCTs) were included at least in one SR. The number of included RCTs in each SR was inconsistent (4 to 15) and was not related to the year of publication of the SR. Our study found redundant and low methodological quality SR comparing CAS versus CEA for carotid stenosis.

Tribulus Terrestris for Female Sexual Dysfunction: A Systematic Review.

OBJECTIVE: We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). DATA SOURCES: We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. SELECTION OF STUDIES: We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. DATA COLLECTION: Data extraction was performed by two reviewers with a preestablished data collection formulary. DATA SYNTHESIS: Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, which means that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. CONCLUSION: More RCTs are needed to support or refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process.Number of Protocol registration in PROSPERO database: CRD42019121130.

OBJETIVO: Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF). FONTES DE DADOS: Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. SELEçãO DOS ESTUDOS: Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos. EXTRAçãO DE DADOS: O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. SíNTESE DE DADOS: Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTADOS: Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona em mulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas. CONCLUSãO: Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.

Tribulus terrestris for female sexual dysfunction: a systematic review / Tribulus terrestris para disfunção sexual feminina: uma revisão sistemática

Abstract Objective We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). Data sources We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO,WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. Selection of studies We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. Data collection Data extraction was performed by two reviewers with a preestablished data collection formulary. Data synthesis Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Results After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, whichmeans that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. Conclusion MoreRCTs are needed to supportor refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process. Number of Protocol registration in PROSPERO database: CRD42019121130

Resumo Objetivo Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF). Fontes de dados Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. Seleção dos estudos Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos. Extração de dados O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. Síntese de dados Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Resultados Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona emmulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas. Conclusão Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.