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  1. Article ; Online: Blinding of interventions in clinical trials helps to prevent selection bias by making the allocation sequence difficult to decipher.

    Pacheco, Rafael Leite / Martimbianco, Ana Luiza Cabrera / Riera, Rachel

    Journal of evaluation in clinical practice

    2022  Volume 28, Issue 6, Page(s) 1050–1052

    MeSH term(s) Humans ; Selection Bias ; Clinical Trials as Topic
    Language English
    Publishing date 2022-04-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 1327355-3
    ISSN 1365-2753 ; 1356-1294
    ISSN (online) 1365-2753
    ISSN 1356-1294
    DOI 10.1111/jep.13682
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: 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.

    Pacheco, Rafael Leite / Martimbianco, Ana Luiza Cabrera / Riera, Rachel

    Sao Paulo medical journal = Revista paulista de medicina

    2023  Volume 142, Issue 1, Page(s) e20220634

    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, ... ...

    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.
    MeSH term(s) Humans ; Brazil ; Cross-Sectional Studies ; Databases, Factual ; Longitudinal Studies ; Clinical Trials as Topic
    Language English
    Publishing date 2023-07-17
    Publishing country Brazil
    Document type Journal Article
    ZDB-ID 1203171-9
    ISSN 1806-9460 ; 1516-3180 ; 0035-0362
    ISSN (online) 1806-9460
    ISSN 1516-3180 ; 0035-0362
    DOI 10.1590/1516-3180.2022.0634.R2.100523
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Let's end "real-world evidence" terminology usage: A study should be identified by its design.

    Pacheco, Rafael Leite / Martimbianco, Ana Luiza Cabrera / Riera, Rachel

    Journal of clinical epidemiology

    2021  Volume 142, Page(s) 249–251

    MeSH term(s) Research Design
    Language English
    Publishing date 2021-11-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2021.11.013
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Methylprednisolone versus dexamethasone for Covid-19 patients

    Rafael Leite Pacheco / Hugo Mamede / Denusa Wiltgen / Airton Stein

    Journal of Evidence-Based Healthcare, Vol

    an analysis of a published clinical trial

    2022  Volume 3

    Keywords Medicine ; R ; Medicine (General) ; R5-920
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Escola Bahiana de Medicina e Saúde Pública
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: The rhetoric of preprints

    Rafael Leite Pacheco / Ana Luiza Cabrera Martimbianco / Rachel Riera

    Journal of Evidence-Based Healthcare, Vol

    2022  Volume 3

    Keywords Preprints. Peer-review. Editorial process. Scientific freedom ; Medicine ; R ; Medicine (General) ; R5-920
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Escola Bahiana de Medicina e Saúde Pública
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: What is an “ongoing” clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends

    Rafael Leite Pacheco / Ana Luiza Cabrera Martimbianco / Rachel Riera

    São Paulo Medical Journal, Vol 142, Iss

    a meta-research study

    2023  Volume 1

    Abstract: 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, ...

    Abstract 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.
    Keywords Randomized controlled trials as topic ; Controlled clinical trials as topic ; Clinical trial [publication type] ; Study classification ; Study category ; Ongoing studies ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2023-07-01T00:00:00Z
    Publisher Associação Paulista de Medicina
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Hydroxychloroquine and chloroquine for COVID-19 infection. Rapid systematic review

    Rafael Leite Pacheco / Rachel Riera

    Journal of Evidence-Based Healthcare, Vol 2, Iss

    2020  Volume 1

    Abstract: CONTEXT: Based on the results of preliminary studies, the off-label use of hydroxychloroquine for COVID-19 infection has been observed in practice. OBJECTIVES: To identify, systematically assess and summarize the best available evidence on the efficacy ... ...

    Abstract CONTEXT: Based on the results of preliminary studies, the off-label use of hydroxychloroquine for COVID-19 infection has been observed in practice. OBJECTIVES: To identify, systematically assess and summarize the best available evidence on the efficacy and safety of the use of hydroxychloroquine and chloroquine for COVID-19 infection. METHODS: Rapid systematic review. RESULTS: After the selection process, 30 studies were included: one open-label randomized trial, one open-label non-randomized trial and 28 ongoing studies. The outcome 'detection of viral load in oral swab' (surrogate outcome) was evaluated by both studies, involving a total of 72 participants. The findings of the studies were discordant: one study observed a higher frequency of negative viral load associated with hydroxychloroquine on day-7, while the other study did not observe any difference between hydroxychloroquine and the control group (standard treatment) on day-6. Both studies have methodological limitations when evaluated by specific tools according to study design (Cochrane Bias Risk Table and ROBINS-I). CONCLUSION: This rapid systematic review identified two clinical studies (with available data), with limited methodological quality, that evaluated the effects of hydroxychloroquine for COVID-19 infection. Based on the findings of these two studies, the efficacy and safety of hydroxychloroquine and chloroquine in patients with COVID-19 is still uncertain (very low evidence certainty) and its routine use for this situation should not be recommended until the results of ongoing studies could provide a proper assessment of their effects.
    Keywords COVID-19. SARS-CoV-2. Coronavirus. Hydroxychloroquine. Chloroquine. Systematic review ; Medicine ; R ; Medicine (General) ; R5-920
    Subject code 150
    Language English
    Publishing date 2020-03-01T00:00:00Z
    Publisher Escola Bahiana de Medicina e Saúde Pública
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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

    Miotto, André / Perfeito, João Aléssio Juliano / Pacheco, Rafael Leite / Latorraca, Carolina de Oliveira Cruz / Riera, Rachel

    Sao Paulo medical journal = Revista paulista de medicina

    2023  Volume 141, Issue 5, Page(s) e2022543

    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 ... ...

    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.
    MeSH term(s) Female ; Humans ; Middle Aged ; Male ; Bronchoscopy/methods ; Brazil ; Biopsy ; Lung Neoplasms/diagnostic imaging
    Language English
    Publishing date 2023-04-17
    Publishing country Brazil
    Document type Meta-Analysis ; Systematic Review ; Journal Article
    ZDB-ID 1203171-9
    ISSN 1806-9460 ; 1516-3180 ; 0035-0362
    ISSN (online) 1806-9460
    ISSN 1516-3180 ; 0035-0362
    DOI 10.1590/1516-3180.2022.0543.R1.01022023
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: The COVID-19 pandemic and a reflection on the conduct of clinical trials in times of war.

    Pacheco, Rafael Leite / Cabrera Martimbianco, Ana Luiza / Riera, Rachel

    Journal of clinical epidemiology

    2020  Volume 132, Page(s) 131–132

    MeSH term(s) Armed Conflicts ; COVID-19 ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/standards ; Humans ; Pandemics ; Research Design ; SARS-CoV-2
    Language English
    Publishing date 2020-12-07
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2020.12.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: EBM in Brazil and the creation of the Oxford-Brazil EBM Alliance.

    Riera, Rachel / Miranda, Enderson / Fontes, Luis Eduardo Santos / Pacheco, Rafael Leite / Nunan, David

    BMJ evidence-based medicine

    2020  

    Language English
    Publishing date 2020-06-18
    Publishing country England
    Document type Letter
    ISSN 2515-4478
    ISSN (online) 2515-4478
    DOI 10.1136/bmjebm-2020-111377
    Database MEDical Literature Analysis and Retrieval System OnLINE

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