Isabelle Boutron

• Université Paris Cité

Importance The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in...

Importance The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in...

Importance The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in...

Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of report...

Importance Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of repor...

Importance Retractions are rising in the scientific literature, increasing the risk of reusing unreliable results. Objectives To identify reports of systematic reviews that included retracted studies in their meta-analyses, and to assess the impact of these retracted studies on the results. Design, Setting, and Participants In this systematic rev...

Background Researchers explore the biology of painful experiences not primarily felt in the body (‘non-physical pain’), sometimes referred to as mental, social or emotional pain. A critical challenge lies in how to operationalise this subjective experience for biological research, a crucial process for translating findings into clinical practice....

Objectives We aimed to determine to what extent systematic reviewers and post-preprint and post-publication peer review identified methodological and reporting issues in COVID-19 trials that could be easily resolved by the authors. Design Qualitative study. Data sources COVID-NMA living systematic review ( covid-nma.com ), PubPeer, medRxiv, Resea...

Background Peer review may improve the quality of research manuscripts and aid in editorial decisions, but reviewers can have conflicts of interest that impact on their recommendations. Objectives The objective was to systematically map and describe the extent and nature of empirical research on peer reviewers’ conflicts of interest in biomedical...

Objective To examine the characteristics of comparative non-randomised studies that assess the effectiveness or safety, or both, of drug treatments. Design Cross sectional study. Data sources Medline (Ovid), for reports published from 1 June 2022 to 31 August 2022. Eligibility criteria for selecting studies Reports of comparative non-randomised...

Background Resveratrol is a natural compound found in red wine. It has demonstrated anti-inflammatory properties in preclinical models. We compared the effect of oral resveratrol in a new patented formulation to oral placebo for individuals with painful knee osteoarthritis. Methods and findings ARTHROL was a double-blind, randomized, placebo-contr...

"Spin" refers to misleading reporting, interpretation, and extrapolation of findings in primary and secondary research (such as in systematic reviews). The study of spin primarily focuses on beneficial outcomes. The objectives of this research were threefold: first, to develop a framework for identifying spin associated with harms in systematic rev...

Background: Systematic reviews are performed manually despite the exponential growth of scientific literature. Objective: To investigate the sensitivity and specificity of GPT-3.5 Turbo, from OpenAI, as a single reviewer, for title and abstract screening in systematic reviews. Design: Diagnostic test accuracy study. Setting: Unannotated bibl...

Introduction An important mechanism of research waste is inadequate incorporation of, and references to, previous relevant research. Identifying references for a research manuscript can be challenging, in part due to the exponential rise in potentially relevant literature to consider. For large research projects, such as developing or updating repo...

Background This study examined the synthesis methods used in meta-analyses pooling data from observational studies (OSs) and randomised controlled trials (RCTs) from various medical disciplines. Methods We searched Medline via PubMed to identify reports of systematic reviews of interventions, including and pooling data from RCTs and OSs published...

Background Preprints are increasingly used to disseminate research results, providing multiple sources of information for the same study. We assessed the consistency in effect estimates between preprint and subsequent journal article of COVID-19 randomized controlled trials. Methods The study utilized data from the COVID-NMA living systematic revi...

Importance: Systematic reviews are time-consuming and are still performed predominately manually by researchers despite the exponential growth of scientific literature. Objective: To investigate the sensitivity, specificity and estimate the avoidable workload when using an AI-based large language model (LLM) (Generative Pre-trained Transformer [GPT...

Our aim was to describe the research practices of doctoral students facing a dilemma to research integrity and to assess the impact of inappropriate research environments, i.e. exposure to (a) a post-doctoral researcher who committed a Detrimental Research Practice (DRP) in a similar situation and (b) a supervisor who did not oppose the DRP. We con...

Objective: Preprints became a major source of research communication during the COVID-19 pandemic. We aimed to evaluate whether summary treatment effect estimates differ between preprint and peer-reviewed journal trials. Study design and setting: A meta-epidemiological study. Data were derived from the COVID-NMA living systematic review (covid-n...

Objective: To compare the contemporary Cochrane review approach for retrieving information on trial funding and researchers' conflicts of interest with a structured approach for information retrieval. Study design and setting: Methodological study of 100 Cochrane reviews from October to December 2020 and one randomly selected trial from each rev...

Background: It has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for...

Importance: Numerous studies have shown that adherence to reporting guidelines is suboptimal. Objective: To evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles. Design, setting, and participants: Two parallel-group,...

Purpose: To assess the completeness of reporting in abstracts of published randomized controlled trials (RCTs) assessing interventional radiology (IR) for liver disease; to assess whether publication of the 2017 CONSORT update for nonpharmacological treatments (NPT) resulted in changes in abstract reporting; and to identify factors associated with...

This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access.

Outputs from living evidence syntheses projects have been used widely during the pandemic by guideline developers to form evidence-based recommendations. However, the needs of different stakeholders cannot be accommodated by solely providing pre-defined non amendable numerical summaries. Stakeholders also need to understand the data and perform the...

Objectives: As part of an effort to develop an extension of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 statement for living systematic reviews (LSRs), we discuss conceptual issues relevant to the reporting of LSRs and highlight a few challenges. Methods: Discussion of conceptual issues based on a scoping...

Objective: To examine the methodological characteristics of systematic reviews and meta-analyses including observational studies (OSs) and randomized controlled trials (RCTs), in various medical disciplines. Study design and setting: We searched Medline via PubMed to identify systematic reviews of interventions including RCTs and OSs published i...

A systematic review identifies, appraises and synthesises all the empirical evidence from studies that meet prespecified eligibility criteria to answer a specific research question. As part of the appraisal, researchers use explicit methods to assess risk of bias in the results’ from included studies that contribute to the review’s findings, to imp...

Objectives: To identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modi...

Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional...

Background: Different forms of vaccines have been developed to prevent the SARS-CoV-2 virus and subsequent COVID-19 disease. Several are in widespread use globally. OBJECTIVES: To assess the efficacy and safety of COVID-19 vaccines (as a full primary vaccination series or a booster dose) against SARS-CoV-2. Search methods: We searched the Cochra...

Objectives: Ranking metrics in network meta-analysis (NMA) are computed separately for each outcome. Our aim is to 1) present graphical ways to group competing interventions considering multiple outcomes and 2) use conjoint analysis for placing weights on the various outcomes based on the stakeholders' preferences. Study design and setting: We u...

Objective: To identify, summarise, and analyse comments on the core reporting guidelines for protocols of randomised trials (SPIRIT 2013) and for completed trials (CONSORT 2010), with special emphasis on suggestions for guideline modifications.Methods: We included documents written in English and published after 2010 that explicitly commented on SP...

Background In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all prepri...

Results from clinical trials can be deemed trustworthy only if they are properly conducted and their methods are fully reported. The SPIRIT and CONSORT checklists, which have improved clinical trial design, conduct and reporting, are being updated to reflect recent advances and improve the assessment of healthcare interventions.

Objective To our knowledge, the effect of front-of-pack nutrition labels such as the Nutri-Score on food purchases has never been assessed among individuals suffering from nutrition-related chronic diseases specifically, while dietary modifications are generally part of their care. This study aimed to investigate the effect of the Nutri-Score on th...

Cancer guidelines are ideally based on high levels of evidence (LOE). We aim to evaluate the LOE supporting recommendations in United States (US) guidelines on pancreatic adenocarcinoma (PDAC) treatment and its evolution over time. We searched for current guidelines from the American Society of Clinical Oncology (ASCO) and National Comprehensive Ca...

Background Pancreatic adenocarcinoma (PDAC) is a lethal cancer with few therapeutic options. Availability of results is a crucial step in interventional research. Our aim was to evaluate results availability for trials in patients with PDAC and explore associated factors. Materials and Methods We performed a retrospective cohort study and searched...

Purpose The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlle...

Question Although mental pain is present in many mental disorders and is a predictor of suicide, it is rarely investigated in research or treated in care. A valid tool to measure it is a necessary first step towards better understanding, predicting and ultimately relieving this pain. Study selection and analysis Following the Preferred Reporting I...

Well-designed and properly executed randomized controlled trials provide the most reliable evidence on the efficacy of healthcare interventions. However, there is overwhelming evidence that the quality of reporting of randomized trials is not always optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial f...

Objective: to visualize the evolution of all registered COVID-19 vaccines trials STUDY DESIGN AND SETTING: as part of the living mapping of the COVID-NMA initiative, we identify biweekly all COVID-19 vaccine trials and automatically extract data from the EU clinical trials registry, ClinicalTrials.gov, IRCT and the WHO International Clinical Trial...

Colorectal cancer (CRC) is one of the most frequent cancers worldwide. Our aim was to evaluate the availability of results of interventional studies studying CRC. We searched the ClinicalTrials.gov registry for all interventional studies on CRC management in adults completed or terminated between 01/01/2013 and 01/01/2020. To identify results, we s...

Background Colorectal cancer (CRC) is currently one of the most frequently diagnosed cancers. Our aim was to evaluate transparency and selective reporting in interventional trials studying CRC. Methods First, we assessed indicators of transparency with completeness of reporting, according to the CONSORT statement, and data sharing. We evaluated a...

Importance: Multidisciplinary prehabilitation before total knee replacement (TKR) for osteoarthritis may improve outcomes in the postoperative period. Objective: To compare multidisciplinary prehabilitation with usual care before TKR for osteoarthritis in terms of functional independence and activity limitations after surgery. Design, setting,...

Background The Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled tria...

Randomized controlled trials (RCTs) are essential to support clinical decision making. We assessed the transparency, completeness and consistency of reporting of 244 reports (120 peer-reviewed journal publications; 124 preprints) of RCTs assessing pharmacological interventions for the treatment of COVID-19 published the first 17 months of the pande...

Background: Interleukin-1 (IL-1) blocking agents have been used for treating severe coronavirus disease 2019 (COVID-19), on the premise that their immunomodulatory effect might be beneficial in people with COVID-19. Objectives: To assess the effects of IL-1 blocking agents compared with standard care alone or with placebo on effectiveness and sa...

Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low...

Uvod: Preporučene smjernice za izvještavanje u sustavnim pregledima i metaanalizama (engl. Preferred Reporting Items for Systematic reviews and Meta-Analyses, PRISMA) prvi su put objavljene 2009. godine kako bi autorima sustavnih pregleda omogućile transparentno izvještavanje o predmetu istraživanja, korištenim metodama i dobivenim rezultatima. Tij...

Objective: To describe the bias assessment practice in recently published systematic reviews of mediation studies and to evaluate the quality of different bias assessment tools for mediation analysis proposed in the literature. Method: We conducted an overview of systematic reviews by searching MEDLINE (OvidSP), PsycINFO (OvidSP), Cochrane Datab...

Background To assess the completeness of reporting, research transparency practices, and risk of selection and immortal bias in observational studies using routinely collected data for comparative effectiveness research. Method We performed a meta-research study by searching PubMed for comparative effectiveness observational studies evaluating the...

"Living" evidence synthesis is of primary interest for decision-makers to overcome the COVID-19 pandemic. The COVID-NMA provides open-access living meta-analyses assessing different therapeutic and preventive interventions. Data are posted on a platform (https://covid-nma.com/) and analyses are updated every week. However, guideline developers and...

Objectives: To assess the sensitivity of two secondary electronic sources of COVID-19 studies: 1) the Cochrane COVID-19 Study Register (https://covid-19.cochrane.org/); and, 2) the Living Overview of the Evidence (L•OVE) COVID-19 platform (https://iloveevidence.com/). Study design and setting: We identified reports of randomized controlled trial...

In Reply As correctly pointed out by Licciardone, our study¹ involved nonphysician osteopathic practitioners and represented practice settings in France. According to French usage, osteopathic manipulative treatment (OMT) can be delivered by health and nonhealth professionals. In 2021, this latter category represented 21 000 (60%) of 35 000 osteopa...

Importance Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modific...

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome da...

Preprints promote the open and fast communication of non-peer reviewed work. Once a preprint is published in a peer-reviewed venue, the preprint server updates its web page: a prominent hyperlink leading to the newly published work is added. Linking preprints to publications is of utmost importance as it provides readers with the latest version of...

BACKGROUND Information about patients’ preferences of the way a trial is organised could inform the trial planning to enhance participation rate. OBJECTIVE To describe patients’ preferences on the organisation of a randomised controlled trial (RCT) (visits on site or remotely) and evaluate the potential impact of fulfilling preferences on their wi...

Background Patients’ participation is crucial to the success of randomized controlled trials (RCTs). However, recruiting and retaining patients in trials remain a challenge. Objective This study aims to describe patients’ preferences for the organization of RCTs (visits on- site or remotely) and evaluate the potential impact of fulfilling preferen...

Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm d...

Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routi...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

Background: Interleukin 6 (IL-6) blocking agents have been used for treating severe coronavirus disease 2019 (COVID-19). Their immunosuppressive effect might be valuable in patients with COVID-19 characterised by substantial immune system dysfunction by controlling inflammation and promoting disease tolerance. Objectives: To assess the effect of...

Importance Osteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations. Objective To compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecifi...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

Background The Nutri-Score, a front-of-pack nutrition label, has been adopted in 2017 in France but its impact on low-income populations is unknown, and they are more at risk of having unhealthy diets. The present study assessed the effects of the Nutri-Score on the nutritional quality of purchasing intentions among low-income individuals, compared...

Objectives To describe the processes used to update the PRISMA 2009 statement for reporting systematic reviews, present results of a survey conducted to inform the update, summarise decisions made at the PRISMA update meeting, and describe and justify changes made to the guideline. Methods We reviewed 60 documents with reporting guidance for syste...

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluat...

Objectives Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluate...

Abstract Background The increasing use of preprints to disseminate evidence on the effect of interventions for the coronavirus disease 2019 (COVID-19) can lead to multiple evidence sources for a single study, which may differ in the reported evidence. We aim to describe the proportion of evidence on the effect of interventions for COVID-19 from pre...

Objectives The objective of this review is to identify all preprint platforms with biomedical and medical scope and to compare and contrast the key characteristics and policies of these platforms. Study design and setting Preprint platforms that were launched up to 25 June 2019 and have a biomedical and medical scope according to MEDLINE’s journal...

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To provide a living mapping of registered randomized trials, and to assess and rank where appropriate the relative effects of interventions for the prevention and treatment of COVID-19. Our approach has been described in Boutron 2020 and Nguyen 2020...