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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
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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
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Zs.A 4464: Show issues

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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
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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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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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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
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Article ; Online: Definition and reporting of composite outcomes are often inadequate in randomized clinical trials on pharmacological interventions for coronary artery disease.

Mozetic de Barros, Valéria / Pacheco, Rafael Leite / Cabrera Martimbianco, Ana Luiza / Mozetic, Vânia / Junior, Sebastião Castilho / Riera, Rachel

Journal of clinical epidemiology

2023 Volume 165, Page(s) 111212

Abstract: Objectives: To estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease.: Study design and setting: A metaresearch study. A ... ...

Abstract	Objectives: To estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease. Study design and setting: A metaresearch study. A search strategy was developed to retrieve references from MEDLINE. We considered articles, published from 1st January 2020, to December 31, 2021, reporting results of clinical primary outcomes from randomized clinical trials which assessed pharmacological interventions, used alone or in combination, for the treatment or secondary prevention (previous coronary event) of coronary artery disease. Results: From the 34 included studies, 28 (82.35%) had a primary composite outcome. Thirteen unique composite primary outcomes were used with the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term major adverse cardiac events was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. From the included studies, 60.71% (17/28) reported the estimates for each individual component and the direction of the effect was consistent between all components and the composite outcomes in 58.82% (10/17) of them. Additionally, no included study discussed potential limitations and/or related advantages of the composite outcomes. Conclusion: In randomized clinical trials on pharmacological interventions for coronary artery disease, composite outcomes are frequently used, but the definition of their components is very heterogeneous. The estimate for individual components within the composite outcome is often not fully reported, which prevents a complete analysis of their adequacy for clinical practice. The term major adverse cardiac events was used inconsistently and to refer to different set of components, which can also be misleading and confusing.
MeSH term(s)	Humans ; Coronary Artery Disease/drug therapy ; Myocardial Infarction/drug therapy ; Randomized Controlled Trials as Topic ; Stroke/prevention & control
Language	English
Publishing date	2023-11-07
Publishing country	United States
Document type	Journal Article ; Meta-Analysis
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2023.11.002
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Article ; Online: Quality of systematic reviews on the treatment of vesiculobullous skin diseases. A meta-epidemiological study.

Sá, Kamilla Mayr Martins / Rodrigues, Juliana Cavaleiro / da Silva, Lígia Borges / Santos, Giovanna Marcılio / Colovati, Mileny Esbravatti Stephano / Martimbianco, Ana Luiza Cabrera

Anais brasileiros de dermatologia

2023 Volume 99, Issue 2, Page(s) 223–232

Abstract: Background: Systematic reviews of Randomized Controlled Trials (RCTs) are considered high-level evidence to support a decision on therapeutic interventions, and their methodological quality is essential to provide reliable and applicable results.: ... ...

Abstract	Background: Systematic reviews of Randomized Controlled Trials (RCTs) are considered high-level evidence to support a decision on therapeutic interventions, and their methodological quality is essential to provide reliable and applicable results. Objective: This meta-epidemiological study aimed to map and critically appraise systematic reviews assessing treatments for vesiculobullous skin diseases. Methods: We conducted a comprehensive search strategy on MEDLINE (via Pubmed) in December 2022 without restrictions to find systematic reviews evaluating pharmacological interventions for vesiculobullous skin diseases. The methodological quality was assessed using the AMSTAR-2 tool, and additional information was extracted. We identified nine systematic reviews published between 2002 and 2021, seven assessing pemphigus. Results: According to the AMSTAR-2 tool, 55.6% were classified as critically low quality, 22.2% as moderate quality, 11.1% as low and 11.1% as high quality. No review assessed the certainty of the evidence (GRADE); 86% of pemphigus reviews had at least two overlapping RCTs. There were some limitations regarding methodological flaws and the AMSTAR-2 tool use CONCLUSIONS: These findings reveal a frail methodological quality of systematic reviews about vesiculobullous diseases treatment that may impact the results. Therefore, methodological rigor is mandatory for future systematic reviews to avoid duplication of effort and increase the certainty of the evidence supporting decision-making.
MeSH term(s)	Humans ; Pemphigus/drug therapy ; Pemphigus/epidemiology ; Systematic Reviews as Topic ; Epidemiologic Studies
Language	English
Publishing date	2023-11-18
Publishing country	Spain
Document type	Journal Article
ZDB-ID	433655-0
ISSN	1806-4841 ; 0365-0596
ISSN (online)	1806-4841
ISSN	0365-0596
DOI	10.1016/j.abd.2023.06.003
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Zs.A 359: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Efficacy and safety of therapeutic use of cannabis derivatives and their synthetic analogs: Overview of systematic reviews.

Riera, Rachel / Pacheco, Rafael Leite / Bagattini, Ângela Maria / Martimbianco, Ana Luiza Cabrera

Phytotherapy research : PTR

2021 Volume 36, Issue 1, Page(s) 5–21

Abstract: The debate on the use of cannabinoids for therapeutic purposes is constantly on the rise. This overview aimed to map the evidence on the therapeutic effects of cannabis derivatives and their synthetic analogs. Systematic reviews (SRs) of randomized ... ...

Abstract	The debate on the use of cannabinoids for therapeutic purposes is constantly on the rise. This overview aimed to map the evidence on the therapeutic effects of cannabis derivatives and their synthetic analogs. Systematic reviews (SRs) of randomized trials were identified through a comprehensive search in several databases, and their methodological quality were evaluated with AMSTAR-2. The results for main outcomes are presented, prioritizing those from updated and better quality SRs. Finally, 68 SRs, addressing 37 different health conditions, were included. The methodological quality was high for eight SRs. The evidence certainty (GRADE) for the effects of cannabinoids is not high for any of the outcomes identified. Evidence certainty was moderate for the following: (a) cannabidiol appears to be beneficial for quality of life but increases the risk of adverse events in ulcerative colitis; (b) cannabinoids in general appear to have no clinically important benefit for chronic non-oncologic pain, spasticity-related pain in multiple sclerosis, or for acute post-operative pain; (c) cannabinoids in general appear to have a benefit in reducing chemotherapy-related nausea and vomiting. For all other outcomes from remaining comparisons, the evidence certainty was low, very low, or not evaluated, which prevents recommendations for or against their routine use.
MeSH term(s)	Cannabinoids/adverse effects ; Cannabis ; Chronic Pain ; Humans ; Quality of Life ; Systematic Reviews as Topic
Chemical Substances	Cannabinoids
Language	English
Publishing date	2021-11-29
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	639136-9
ISSN	1099-1573 ; 0951-418X
ISSN (online)	1099-1573
ISSN	0951-418X
DOI	10.1002/ptr.7263
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Article ; Online: Most Cochrane systematic reviews and protocols did not adhere to the Cochrane's risk of bias 2.0 tool.

Martimbianco, Ana Luiza Cabrera / Sá, Kamilla Mayr Martins / Santos, Giovanna Marcílio / Santos, Elaine Marcílio / Pacheco, Rafael Leite / Riera, Rachel

Revista da Associacao Medica Brasileira (1992)

2023 Volume 69, Issue 3, Page(s) 469–472

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Humans ; Bias ; Randomized Controlled Trials as Topic ; Systematic Reviews as Topic
Language	English
Publishing date	2023-02-20
Publishing country	Brazil
Document type	Journal Article ; Review
ZDB-ID	731969-1
ISSN	1806-9282 ; 0104-4230 ; 0004-5241 ; 0102-843X
ISSN (online)	1806-9282
ISSN	0104-4230 ; 0004-5241 ; 0102-843X
DOI	10.1590/1806-9282.20221593
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