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What is an “ongoing” clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study
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Pacheco, Rafael Leite

; Martimbianco, Ana Luiza Cabrera

; Riera, Rachel

Sao Paulo Medical Journal

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2024, Volume 142 Nº 1 elocation e20220634

Resumo: En | Texto: En | PDF: En

ABSTRACT BACKGROUND: Although the concept of an “ongoing study” seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of “ongoing clinical trial” across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still “ongoing” during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of “ongoing clinical trials” lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

https://doi.org/10.1590/1516-3180.2022.0634.r2.100523

Most Cochrane systematic reviews and protocols did not adhere to the Cochrane's risk of bias 2.0 tool
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Martimbianco, Ana Luiza Cabrera

; Sá, Kamilla Mayr Martins

; Santos, Giovanna Marcílio

; Santos, Elaine Marcílio

; Pacheco, Rafael Leite

; Riera, Rachel

Revista da Associação Médica Brasileira

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Mar 2023, Volume 69 Nº 3 Páginas 469 - 472

Resumo: En | Texto: En | PDF: En

SUMMARY OBJECTIVE: The aim of this study was to identify the frequency of Cochrane systematic reviews and Cochrane systematic reviews protocols using (or planning to use) the risk of bias 2.0 tool to assess the risk of bias of the included randomized clinical trials. STUDY DESIGN: This is a meta-research study. METHODS: We included Cochrane systematic reviews or Cochrane systematic reviews protocols that planned to include randomized clinical trials. We assessed the Cochrane Database of Systematic Reviews and screened for issues published after the launch of risk of bias 2.0 tool (2019–2022). Two independent investigators performed the study selection and data extraction. RESULTS: We analyzed 440 Cochrane systematic reviews and 536 Cochrane systematic reviews protocols. Overall, 4.8% of the Cochrane systematic reviews and 28.5% of the Cochrane systematic reviews protocols used or planned to use risk of bias 2.0 tool. Although low, adherence is increasing over time. In 2019, 0% of Cochrane systematic reviews used risk of bias 2.0 tool, compared to 24.1% in 2022. In Cochrane systematic reviews protocols, adherence increased from 6.9% in 2019 to 41.5% in 2022. A total of 274 (62.1%) Cochrane systematic reviews had their protocols published before 2018; only one used risk of bias 2.0 tool and reported the change of versions in the “Differences between protocol and revision” section. CONCLUSION: The Cochrane's risk of bias 2.0 tool has low adherence among Cochrane protocols and systematic reviews. Further efforts are necessary to facilitate the implementation of this new tool.

https://doi.org/10.1590/1806-9282.20221593

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

; Perfeito, João Aléssio Juliano

; Pacheco, Rafael Leite

; Latorraca, Carolina de Oliveira Cruz

; Riera, Rachel

Sao Paulo Medical Journal

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2023, Volume 141 Nº 5 elocation e2022543

Resumo: En | Texto: En | PDF: En

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.

https://doi.org/10.1590/1516-3180.2022.0543.r1.01022023

[SciELO Preprints] - Strategies for promoting mental health among residents: scoping review protocol.
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Riera, Rachel Latorraca, Carolina de Oliveira Cruz Padovez, Roberta Carreira Moreira Martimbianco, Ana Luiza Cabrera Simões, Cláudia Marquez Pacheco, Rafael Leite

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Data de publicação: 2022-07-21

Resumo: En

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.

https://doi.org/10.1590/SciELOPreprints.4473

Micro-Costing of a Remotely Operated Referral Management System to Secondary Care in the Unified Health System in Brazil
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Pachito, Daniela Vianna

; Etges, Ana Paula Beck da Silva

; Oliveira, Patrícia Roberta Berithe Pedrosa de

; Basso, Josué

; Bagattini, Ângela Maria

; Riera, Rachel

; Gehres, Luana Gonçalves

; Mallmann, Érica de Brito

; Rodrigues, Átila Szczecinski

; Gadenz, Sabrina Dalbosco

Ciência & Saúde Coletiva

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Mai 2022, Volume 27 Nº 5 Páginas 2035 - 2043

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

Resumo O encaminhamento de casos da atenção primária para a secundária no Sistema Único Brasileiro é uma das questões mais importantes a ser enfrentada. As estratégias de telessaúde têm se mostrado eficazes para evitar encaminhamentos desnecessários. O objetivo deste estudo foi estimar o custo por caso encaminhado por meio de um sistema de gerenciamento de referenciamentos operado remotamente para subsidiar a tomada de decisão sobre o tema. Análise de custo por meio da aplicação de custeio baseado em atividades orientado pelo tempo (time-driven activity-based costing ou TDABC). As análises de custo incluíram comparações entre especialidades médicas, localidades para as quais os encaminhamentos estavam sendo conduzidos e períodos de tempo. O custo por referenciamento em todas as localidades variou entre R$ 5,70 a R$ 8,29. O custo por referenciamento nas especialidades médicas variou entre R$ 1,85 a R$ 8,56. Estratégias para otimizar a gestão dos referenciamentos para a atenção especializada nos sistemas públicos de saúde ainda são necessárias. As estratégias de telessaúde podem ser vantajosas, com estimativas de custo entre as localidades variando entre R$ 5,70 a R$ 8,29, com variabilidade adicional observada relacionada ao tipo de especialidade médica.

Abstract Referral of cases from primary to secondary care in the Brazilian public healthcare system is one of the most important issues to be tackled. Telehealth strategies have been shown effective in avoiding unnecessary referrals. The objective of this study was to estimate cost per referred case by a remotely operated referral management system to further inform the decision making on the topic. Analysis of cost by applying time-driven activity-based costing. Cost analyses included comparisons between medical specialties, localities for which referrals were being conducted, and periods of time. Cost per referred case across localities ranged from R$ 5.70 to R$ 8.29. Cost per referred case across medical specialties ranged from R$ 1.85 to R$ 8.56. Strategies to optimize the management of referral cases to specialized care in public healthcare systems are still needed. Telehealth strategies may be advantageous, with cost estimates across localities ranging from R$ 5.70 to R$ 8.29, with additional observed variability related to the type of medical specialty.

https://doi.org/10.1590/1413-81232022275.07472021

Micro-Costing of a Remotely Operated Referral Management System to Secondary Care in the Unified Health System in Brazil
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Pachito, Daniela Vianna

; Etges, Ana Paula Beck da Silva

; Oliveira, Patrícia Roberta Berithe Pedrosa de

; Basso, Josué

; Bagattini, Ângela Maria

; Riera, Rachel

; Gehres, Luana Gonçalves

; Mallmann, Érica de Brito

; Rodrigues, Átila Szczecinski

; Gadenz, Sabrina Dalbosco

Ciência & Saúde Coletiva

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Mai 2022, Volume 27 Nº 5 Páginas 2035 - 2043

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

https://doi.org/10.1590/1413-81232022275.07472021

Systematic reviews on interventions for COVID-19 have rarely graded the certainty of the evidence
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Martimbianco, Ana Luiza Cabrera

; Pacheco, Rafael Leite

; Latorraca, Carolina de Oliveira Cruz

; Ferreira, Raphael Einsfeld Simões

; Riera, Rachel

Sao Paulo Medical Journal

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Mai 2021, Volume 139 Nº 5 Páginas 511 - 513

Resumo: En | Texto: En | PDF: En

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.

https://doi.org/10.1590/1516-3180.2021.0107.27052021 5 downloads

Tribulus Terrestris for Female Sexual Dysfunction: A Systematic Review
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Martimbianco, Ana Luiza Cabrera

; Pacheco, Rafael Leite

; Vilarino, Fábia Lima

; Latorraca, Carolina de Oliveira Cruz

; Torloni, Maria Regina

; Riera, Rachel

Revista Brasileira de Ginecologia e Obstetrícia

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Jul 2020, Volume 42 Nº 7 Páginas 427 - 435

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

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.

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

https://doi.org/10.1055/s-0040-1712123 1304 downloads

Diretrizes para o tratamento farmacológico da COVID-19. Consenso da Associação de Medicina Intensiva Brasileira, da Sociedade Brasileira de Infectologia e da Sociedade Brasileira de Pneumologia e Tisiologia
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Falavigna, Maicon

; Colpani, Verônica

; Stein, Cinara

; Azevedo, Luciano Cesar Pontes

; Bagattini, Angela Maria

; Brito, Gabriela Vilela de

; Chatkin, José Miguel

; Cimerman, Sergio

; Corradi, Mirian de Freitas Dal Ben

; Cunha, Clovis Arns da

; Medeiros, Flávia Cordeiro de

; Oliveira Junior, Haliton Alves de

; Fritscher, Leandro Genehr

; Gazzana, Marcelo Basso

; Gräf, Débora Dalmas

; Marra, Lays Pires

; Matuoka, Jessica Yumi

; Nunes, Michelle Silva

; Pachito, Daniela Vianna

; Pagano, Cássia Garcia Moraes

; Parreira, Patrícia do Carmo Silva

; Riera, Rachel

; Silva Júnior, Amilton

; Tavares, Bruno de Melo

; Zavascki, Alexandre Prehn

; Rosa, Regis Goulart

; Dal-Pizzol, Felipe

Revista Brasileira de Terapia Intensiva

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Jun 2020, Volume 32 Nº 2 Páginas 166 - 196

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

RESUMO Introdução: Há diversas terapias sendo utilizadas, consideradas ou propostas para o tratamento da COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é fornecer recomendações baseadas nas evidências científicas disponíveis e em sua interpretação transparente, para subsidiar decisões sobre o tratamento farmacológico da COVID-19 no Brasil. Métodos: Um grupo de 27 especialistas e metodologistas integraram a força-tarefa formada pela Associação de Medicina Intensiva Brasileira (AMIB), pela Sociedade Brasileira de Infectologia (SBI) e pela Sociedade Brasileira de Pneumologia e Tisiologia (SBPT). Foram realizadas revisões sistemáticas rápidas, atualizadas até 28 de abril de 2020. A qualidade das evidências e a elaboração das recomendações seguiram o sistema GRADE. As recomendações foram elaboradas nos dias 5, 8 e 13 de maio de 2020. Resultados: Foram geradas 11 recomendações, embasadas em evidência de nível baixo ou muito baixo. Não há indicação para uso de rotina de hidroxicloroquina, cloroquina, azitromicina, lopinavir/ritonavir, corticosteroides ou tocilizumabe no tratamento da COVID-19. Heparina deve ser utilizada em doses profiláticas no paciente hospitalizado, mas não deve ser realizada anticoagulação na ausência de indicação clínica específica. Antibacterianos e oseltamivir devem ser considerados somente nos pacientes em suspeita de coinfecção bacteriana ou por influenza, respectivamente. Conclusão: Até o momento, não há intervenções farmacológicas com efetividade e segurança comprovada que justifiquem seu uso de rotina no tratamento da COVID-19, devendo os pacientes serem tratados preferencialmente no contexto de pesquisa clínica. As recomendações serão revisadas continuamente, de forma a capturar a geração de novas evidências.

ABSTRACT Introduction: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. Methods: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. Results: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. Conclusion: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.

https://doi.org/10.5935/0103-507x.20200039 44293 downloads

10.

Effectiveness and safety of structured exercise vs. no exercise for asymptomatic aortic aneurysm: systematic review and meta-analysis
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Oliveira, Ricardo de Ávila

; Nakajima, Eliza

; Vasconcelos, Vladimir Tonello de

; Riera, Rachel

; Baptista-Silva, José Carlos Costa

Jornal Vascular Brasileiro

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2020, Volume 19 elocation e20190086

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

Resumo Foi realizada revisão sistemática para comparar a efetividade e a segurança de exercícios versus não exercícios em pacientes assintomáticos com aneurisma de aorta. Usamos os termos MeSH aortic aneurysm e exercise para as bases MEDLINE, Embase, CENTRAL, LILACS, PeDRO, CINAHL, clinicaltrials.gov, International Clinical Trials Registry Platform (ICTRP) e OpenGrey. Foram obtidas 1.189 referências. Cinco ensaios clínicos foram incluídos. Não houve morte ou rotura associada ao exercício. Além disso, este não reduziu a velocidade de crescimento do aneurisma em 12 semanas a 12 meses [diferença de médias (DM) −0,05; intervalo de confiança de 95% (IC95%) −0,13 a 0,03]. Seis semanas de exercícios pré-operatórios reduziram complicações clínicas renais e cardíacas (razão de risco 0,54; IC95% 0,31–0,93) e a permanência em unidade de terapia intensiva (DM −1,00; IC95% −1,26 a −0,74). Caminhadas nos períodos pré e pós-operatório reduziram a permanência hospitalar. A evidência foi classificada como de muito baixa qualidade.

Abstract We conducted a systematic review to compare the effectiveness and safety of exercise versus no exercise for patients with asymptomatic aortic aneurysm. We followed the guidelines set out in the Cochrane systematic review handbook. We searched Medline, Embase, CENTRAL, LILACS, PeDRO, CINAHL, clinicaltrials.gov, ICTRP, and OpenGrey using the MeSH terms “aortic aneurysm” and “exercise”. 1189 references were identified. Five clinical trials were included. No exercise-related deaths or aortic ruptures occurred in these trials. Exercise did not reduce the aneurysm expansion rate at 12 weeks to 12 months (mean difference [MD], −0.05; 95% confidence interval [CI], −0.13 to 0.03). Six weeks of preoperative exercise reduced severe renal and cardiac complications (risk ratio, 0.54; 95% CI, 0.31–0.93) and the length of intensive care unit stay (MD, −1.00; 95% CI, −1.26 to −0.74). Preoperative and postoperative forward walking reduced the length of hospital stay (MD, −0.69; 95% CI, −1.24 to −0.14). The evidence was graded as ‘very low’ level.

https://doi.org/10.1590/1677-5449.190086 967 downloads

11.

What do Cochrane systematic reviews say about interventions for age-related macular degeneration?
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Mozetic, Vania

; Pacheco, Rafael Leite

; Latorraca, Carolina de Oliveira Cruz

; Lee, Fernanda Chin Yu Ogasawara

; Gomes, João Victor Borges

; Riera, Rachel

Sao Paulo Medical Journal

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Dez 2019, Volume 137 Nº 6 Páginas 530 - 542

Resumo: En | Texto: En | PDF: En

ABSTRACT BACKGROUND: Age-related macular degeneration (AMD) is the third largest cause of blindness worldwide, accounting for 8.7% of all cases. A considerable number of preventive or therapeutic interventions have been used for AMD. OBJECTIVE: This study presents a critical view of the interventions that have been assessed through Cochrane systematic reviews. DESIGN AND SETTING: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: Review of Cochrane systematic reviews about interventions for AMD. RESULTS: The 18 systematic reviews included assessed the effects of surgical techniques, laser/photo/radiotherapy, intravitreal injections, systemic drugs and phytotherapy/vitamins/supplements. CONCLUSION: The Cochrane systematic reviews found evidence that use of bevacizumab, ranibizumab, pegaptanib, laser photocoagulation, photodynamic therapy and multivitamin compounds may present some benefits for treating AMD. There was insufficient evidence for supporting the use of macular translocation, submacular surgery, steroid implantation, radiotherapy, intravitreal aflibercept, interferon alfa, statins or omega-3 fatty acids for treating AMD; or the use of multivitamin antioxidant vitamins or mineral supplementation for preventing AMD. Future randomized controlled trials are imperative to reduce the uncertainty in several clinical questions regarding AMD.

https://doi.org/10.1590/1516-3180.2019.010317092019 1292 downloads

12.

What do Cochrane systematic reviews say about the management of irritable bowel syndrome?
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Pacheco, Rafael Leite

; Roizenblatt, Arnaldo

; Góis, Aécio Flávio Teixeira de

; Latorraca, Carolina de Oliveira Cruz

; Mota, Carolina Frade Magalhães Girardin Pimentel

; Riera, Rachel

Sao Paulo Medical Journal

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Fev 2019, Volume 137 Nº 1 Páginas 82 - 91

Resumo: En | Texto: En | PDF: En

ABSTRACT BACKGROUND: Irritable bowel syndrome (IBS) is a clinical disorder associated with high socioeconomic burden. Despite its importance, management of IBS remains difficult and several interventions have been hypothesized as beneficial for this condition. This study identified and summarized all Cochrane systematic reviews (SRs) about the effects of interventions for managing IBS patients. DESIGN AND SETTING: Review of systematic reviews, carried out in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: Review of Cochrane SRs addressing interventions for IBS. RESULTS: We included six SRs assessing acupuncture, bulking agents, antispasmodics, antidepressants, herbal medicines, homeopathy, hypnotherapy and psychological therapy for IBS. The certainty of evidence ranged from unknown to moderate, mainly due to imprecision in the estimates and high risk of bias from the primary studies included. There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life, compared with sham acupuncture. There was also very low certainty of evidence that homeopathic asafoetida, used alone or in association with nux, was better than placebo regarding self-reported overall improvement. CONCLUSION: There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life. Further well-designed and well-conducted randomized clinical trials are needed in order to reduce the uncertainties regarding the most commonly used interventions for patients with IBS.

https://doi.org/10.1590/1516-3180.2018.053740119 1756 downloads

13.

What do Cochrane systematic reviews say about interventions for insomnia?
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Melo, Florence de Lucca

; Mendoza, Juan Fulgencio Welko

; Latorraca, Carolina de Oliveira Cruz

; Pacheco, Rafael Leite

; Martimbianco, Ana Luiza Cabrera

; Pachito, Daniela Vianna

; Riera, Rachel

Sao Paulo Medical Journal

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Dez 2018, Volume 136 Nº 6 Páginas 579 - 585

Resumo: En | Texto: En | PDF: En

ABSTRACT CONTEXT AND OBJECTIVE: Insomnia is a frequent complaint that generates more than five million visits to doctors per year in the United States. This study summarizes all Cochrane systematic reviews (SRs) that evaluated interventions to treat insomnia. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A sensitive search was carried out in the Cochrane Database of Systematic Reviews to identify Cochrane SRs that assessed the effects of any type of intervention for people with insomnia. The results, main characteristics of the SRs and the certainty of the evidence obtained from them were synthesized and discussed. RESULTS: Seven SRs were included. They addressed the benefits and harm of acupuncture (n = 1), behavioral interventions (n = 1), music (n = 1), pharmacotherapy (n = 2), phototherapy (n = 1) and physical exercise (n = 1). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Acupuncture, music, physical exercise, paroxetine, doxepin, trimipramine and trazodone seem to present some benefit for patients with insomnia. However, the uncertainty around these results means that no robust and definitive recommendations for clinical practice can be made until the benefits and harms from each intervention for patients with insomnia have been confirmed through further studies.

https://doi.org/10.1590/1516-3180.2018.0380311018 1860 downloads

14.

What do Cochrane systematic reviews say about the use of cannabinoids in clinical practice?
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Latorraca, Carolina de Oliveira Cruz

; Pacheco, Rafael Leite

; Martimbianco, Ana Luiza Cabrera

; Pachito, Daniela Vianna

; Riera, Rachel

Sao Paulo Medical Journal

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Out 2018, Volume 136 Nº 5 Páginas 472 - 478

Resumo: En | Texto: En | PDF: En

ABSTRACT BACKGROUND: The therapeutic effects of cannabinoid compounds have been the center of many investigations. This study provides a synthesis on all Cochrane systematic reviews (SRs) that assessed the use of cannabinoids as a therapeutic approach. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A broad search was conducted in the Cochrane Database of Systematic Reviews to retrieve any Cochrane SRs that assessed the efficacy and safety of cannabinoids as a therapeutic approach. The results and key characteristics of all reviews included were summarized and discussed. RESULTS: Eight SRs were included. They assessed the use of cannabinoids for the following types of conditions: neurological (two SRs), psychiatric (two SRs), rheumatological (one SR), infectious (one SR) and oncological (two SRs). There was moderate-quality evidence showing that the use of cannabinoids reduced nausea and vomiting among adults, compared with placebo. Additionally, there was moderate-quality evidence showing that there was no difference between cannabinoids and prochlorperazine regarding the number of participants who reported vomiting, in this same population. CONCLUSIONS: This review identified eight Cochrane systematic reviews that provided evidence of unknown to moderate quality regarding the use of cannabinoids as a therapeutic intervention. Further studies are still imperative for solid conclusions to be reached regarding practical recommendations.

https://doi.org/10.1590/1516-3180.2018.0313210818 1678 downloads

15.

What do Cochrane systematic reviews say about interventions for treating psoriasis?
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Pacheco, Rafael Leite

; Hosni, Nicole Dittrich

; Latorraca, Carolina de Oliveira Cruz

; Martimbianco, Ana Luiza Cabrera

; Pachito, Daniela Vianna

; Yarak, Samira

; Riera, Rachel

Sao Paulo Medical Journal

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Ago 2018, Volume 136 Nº 4 Páginas 354 - 360

Resumo: En | Texto: En | PDF: En

ABSTRACT CONTEXT AND OBJECTIVE: Psoriasis is a common chronic inflammatory skin disease characterized by abnormal and increased growth of the cells that produce keratin and abnormal functioning of the immune system. We aimed to summarize the evidence available regarding interventions for patients with psoriasis. DESIGN AND SETTING: Review of systematic reviews, developed in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo. METHODS: A systematic search was conducted to identify Cochrane systematic reviews that fulfilled the eligibility criteria. Two authors screened titles and abstracts that had been retrieved through the search strategy. The results from all the Cochrane systematic reviews that were included were summarized and presented in a narrative synthesis. RESULTS: We included six Cochrane systematic reviews assessing interventions for treating psoriasis. The findings from high-quality evidence were that (a) etanercept reduced the psoriasis severity index, compared with placebo and (b) steroids plus vitamin D, compared with vitamin D alone, improved the skin clearance rate, as assessed by investigators, but was associated with a higher proportion of participants who dropped out due to adverse events. For all other comparisons, the quality of the evidence ranged from moderate to very low. CONCLUSION: This review included six Cochrane systematic reviews that provided evidence ranging in quality from unknown to high, regarding management of psoriasis. Further randomized controlled trials are imperative to reduce the uncertainties relating to several treatments that are already used in clinical practice.

https://doi.org/10.1590/1516-3180.0271250618 936 downloads

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