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Article ; Online: Availability of results of interventional studies assessing colorectal cancer from 2013 to 2020

Anna Pellat / Isabelle Boutron / Philippe Ravaud

PLoS ONE, Vol 17, Iss

2022 Volume 4

Abstract: 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 ... ...

Abstract	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 searched for results posted on the ClinicalTrials.gov registry and/or published in a full-text article. Our primary outcome was the proportion of CRC interventional studies with available results (i.e. posted on the ClinicalTrials.gov registry and/or published in a full-text article). Secondary outcomes were 1) median time between primary completion and earliest date of results availability, 2) the cumulative percentage of interventional studies with results available over time 3) the cumulative percentage of interventional studies with results posted on the ClinicalTrials.gov registry over time and 4) the percentage of results available in open access. We identified 763 eligible interventional studies in ClinicalTrials.gov, which included 679 198 patients. Of these, 286 (37%) trials, including 270 845 (40%) patients, did not have any results available. Median time for results availability was 32.6 months (IQ 16.1-unreached). The cumulative percentage of interventional studies with available results was 17% at 12 months, 39% at 24 months and 55% at 36 months. Results were more likely available for trials that were randomized, completed, had one trial site in the United States, and with mixed funding. The cumulative percentage of interventional studies with results posted on ClinicalTrials.gov was 2% at 12 months. Results were available in open access for 420 (420/477 = 88%) trials. Our results highlight an important waste in research for interventional studies studying CRC.
Keywords	Medicine ; R ; Science ; Q
Subject code	028
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Availability of results of interventional studies assessing colorectal cancer from 2013 to 2020.

Anna Pellat / Isabelle Boutron / Philippe Ravaud

PLoS ONE, Vol 17, Iss 4, p e

2022 Volume 0266496

Abstract	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 searched for results posted on the ClinicalTrials.gov registry and/or published in a full-text article. Our primary outcome was the proportion of CRC interventional studies with available results (i.e. posted on the ClinicalTrials.gov registry and/or published in a full-text article). Secondary outcomes were 1) median time between primary completion and earliest date of results availability, 2) the cumulative percentage of interventional studies with results available over time 3) the cumulative percentage of interventional studies with results posted on the ClinicalTrials.gov registry over time and 4) the percentage of results available in open access. We identified 763 eligible interventional studies in ClinicalTrials.gov, which included 679 198 patients. Of these, 286 (37%) trials, including 270 845 (40%) patients, did not have any results available. Median time for results availability was 32.6 months (IQ 16.1-unreached). The cumulative percentage of interventional studies with available results was 17% at 12 months, 39% at 24 months and 55% at 36 months. Results were more likely available for trials that were randomized, completed, had one trial site in the United States, and with mixed funding. The cumulative percentage of interventional studies with results posted on ClinicalTrials.gov was 2% at 12 months. Results were available in open access for 420 (420/477 = 88%) trials. Our results highlight an important waste in research for interventional studies studying CRC.
Keywords	Medicine ; R ; Science ; Q
Subject code	028
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: COVID-19-related perceptions, context and attitudes of adults with chronic conditions

Viet-Thi Tran / Philippe Ravaud

PLoS ONE, Vol 15, Iss 8, p e

Results from a cross-sectional survey nested in the ComPaRe e-cohort.

2020 Volume 0237296

Abstract: Background To avoid a surge of demand on the healthcare system due to the COVID-19 pandemic, we must reduce transmission to individuals with chronic conditions who are at risk of severe illness with COVID-19. We aimed at understanding the perceptions, ... ...

Abstract	Background To avoid a surge of demand on the healthcare system due to the COVID-19 pandemic, we must reduce transmission to individuals with chronic conditions who are at risk of severe illness with COVID-19. We aimed at understanding the perceptions, context and attitudes of individuals with chronic conditions during the COVID-19 pandemic to clarify their potential risk of infection. Methods A cross-sectional survey was nested in ComPaRe, an e-cohort of adults with chronic conditions, in France. It assessed participants' perception of their risk of severe illness with COVID-19; their context (i.e., work, household, contacts with external people); and their attitudes in situations involving frequent or occasional contacts with symptomatic or asymptomatic people. Data were collected from March 23 to April 2, 2020, during the lockdown in France. Analyses were weighted to represent the demographic characteristics of French patients with chronic conditions. The subgroup of participants at high risk according to the recommendations of the French High Council for Public Health was examined. Results Among the 7169 recruited participants, 63% patients felt at risk because of severe illness. About one quarter (23.7%) were at risk of infection because they worked outside home, had a household member working outside home or had regular visits from external contacts. Less than 20% participants refused contact with symptomatic people and <20% used masks when in contact with asymptomatic people. Among patients considered at high risk according to the recommendations of the French High Council for Public Health, 20% did not feel at risk, which led to incautious attitudes. Conclusion Individuals with chronic conditions have distorted perceptions of their risk of severe illness with COVID-19. In addition, they are exposed to COVID-19 due to their context or attitudes.
Keywords	Medicine ; R ; Science ; Q ; covid19
Subject code	300
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Course of post COVID-19 disease symptoms over time in the ComPaRe long COVID prospective e-cohort

Viet-Thi Tran / Raphaël Porcher / Isabelle Pane / Philippe Ravaud

Nature Communications, Vol 13, Iss 1, Pp 1-

2022 Volume 6

Abstract: Long-term complications and persistent symptoms occur following COVID-19, but the nature and duration of the long-term symptoms are not fully characterised. Here the authors report the evolution of post COVID-19 symptoms using a validated self-reported ... ...

Abstract	Long-term complications and persistent symptoms occur following COVID-19, but the nature and duration of the long-term symptoms are not fully characterised. Here the authors report the evolution of post COVID-19 symptoms using a validated self-reported questionnaire assessing 53 symptoms over time in the ComPaRe long COVID prospective e-cohort.
Keywords	Science ; Q
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Impact of an interactive web tool on patients’ intention to receive COVID-19 vaccination

Viet-Thi Tran / Stéphanie Sidorkiewicz / Clarisse Péan / Philippe Ravaud

BMC Medical Informatics and Decision Making, Vol 21, Iss 1, Pp 1-

a before-and-after impact study among patients with chronic conditions in France

2021 Volume 7

Abstract: Abstract Objectives In France, about 30% of the population refuses COVID-19 vaccination outright, and 9 to 40% are hesitant. We developed and evaluated an interactive web tool providing transparent and reliable information on the benefits and risks of ... ...

Abstract	Abstract Objectives In France, about 30% of the population refuses COVID-19 vaccination outright, and 9 to 40% are hesitant. We developed and evaluated an interactive web tool providing transparent and reliable information on the benefits and risks of COVID-19 vaccination. Methods The most recent scientific data at the time of the study were implemented into an interactive web tool offering individualized information on the risks of COVID-19 infection-related events versus vaccination-related serious adverse events. The tool was evaluated during a before-and-after impact study nested in ComPaRe, a French e-cohort of adult patients with chronic conditions. Primary outcome was the proportion of patients intending to receive vaccination after using the tool, among those not intending to receive it at baseline. Results Between January 8 and 14, 2021, we enrolled 3152 patients in the study [mean age 55.2 (SD: 16.9), 52.9% women and 63% with ≥ 2 chronic conditions]. Before consulting the tool, 961 (30.5%) refused to be vaccinated until further data on efficacy/safety was obtained and 239 (7.5%) outright refused vaccination. Among these 1200 patients, 96 (8.0%, number needed to treat: 12.5) changed their mind after consulting the tool and would subsequently accept vaccination. Conclusions Our interactive web tool represents a scalable method to help increase the intent to receive COVID-19 vaccination among patients with chronic conditions and address vaccine hesitancy. Since April 2021, our tool has been embedded on the official webpage of the French Government for COVID-19 information.
Keywords	COVID-19 ; Vaccine ; Decision aids ; Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	306
Language	English
Publishing date	2021-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Blockchain technology for improving clinical research quality

Mehdi Benchoufi / Philippe Ravaud

Trials, Vol 18, Iss 1, Pp 1-

2017 Volume 5

Abstract: Abstract Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and ... ...

Abstract	Abstract Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community. Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transparent, decentralised, secure “trustless” manner at the top of the Blockchain (in fact, there is trust, but it is hardcoded in the Blockchain protocol via a complex cryptographic algorithm). Therefore, users have a high degree of control over and autonomy and trust of the data and its integrity. Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, prevents a posteriori reconstruction and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders. In this commentary article, we explore the core functionalities of Blockchain applied to clinical trials and we illustrate concretely its general principle in the context of consent to a trial protocol. Trying to figure out the potential impact of Blockchain implementations in the setting of clinical trials will shed new light on how modern clinical trial methods could evolve and benefit from Blockchain technologies in order to tackle the aforementioned challenges.
Keywords	Blockchain ; Transparency ; Reproducibility ; Data sharing ; Privacy ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2017-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Patients’ views of wearable devices and AI in healthcare

Viet-Thi Tran / Carolina Riveros / Philippe Ravaud

npj Digital Medicine, Vol 2, Iss 1, Pp 1-

findings from the ComPaRe e-cohort

2019 Volume 8

Abstract: Abstract Wearable biometric monitoring devices (BMDs) and artificial intelligence (AI) enable the remote measurement and analysis of patient data in real time. These technologies have generated a lot of “hype,” but their real-world effectiveness will ... ...

Abstract	Abstract Wearable biometric monitoring devices (BMDs) and artificial intelligence (AI) enable the remote measurement and analysis of patient data in real time. These technologies have generated a lot of “hype,” but their real-world effectiveness will depend on patients’ uptake. Our objective was to describe patients’ perceptions of the use of BMDs and AI in healthcare. We recruited adult patients with chronic conditions in France from the “Community of Patients for Research” (ComPaRe). Participants (1) answered quantitative and open-ended questions about the potential benefits and dangers of using of these new technologies and (2) participated in a case-vignette experiment to assess their readiness for using BMDs and AI in healthcare. Vignettes covered the use of AI to screen for skin cancer, remote monitoring of chronic conditions to predict exacerbations, smart clothes to guide physical therapy, and AI chatbots to answer emergency calls. A total of 1183 patients (51% response rate) were enrolled between May and June 2018. Overall, 20% considered that the benefits of technology (e.g., improving the reactivity in care and reducing the burden of treatment) greatly outweighed the dangers. Only 3% of participants felt that negative aspects (inadequate replacement of human intelligence, risks of hacking and misuse of private patient data) greatly outweighed potential benefits. We found that 35% of patients would refuse to integrate at least one existing or soon-to-be available intervention using BMDs and AI-based tools in their care. Accounting for patients’ perspectives will help make the most of technology without impairing the human aspects of care, generating a burden or intruding on patients’ lives.
Keywords	Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	616
Language	English
Publishing date	2019-06-01T00:00:00Z
Publisher	Nature Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials

Carolina Graña Possamai / Philippe Ravaud / Lina Ghosn / Viet-Thi Tran

BMC Medicine, Vol 18, Iss 1, Pp 1-

a methodological systematic review

2020 Volume 11

Abstract: Abstract Background Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense ... ...

Abstract	Abstract Background Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements. Methods Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE and completed a page-by-page hand search in five leading medical journals between January 1, 2018, and December 31, 2018. Three reviewers independently extracted all primary and secondary outcomes collected using BMDs, and assessed (1) the definitions used to summarize BMD outcome data; (2) whether the validity, reliability, and responsiveness of sensors was reported; (3) the discrepancy with outcomes prespecified in public clinical trial registries; and (4) the methods used to manage missing and incomplete BMD outcome data. Results Of the 4562 records screened, 75 RCTs were eligible. Among them, 24% tested a pharmacological intervention and 57% used an inertial measurement sensor to measure physical activity. Included trials involved 464 outcomes (average of 6 [SD = 8] outcomes per trial). In total, 35 trials used a BMD to measure a primary outcome. Several issues affected the value and transparency of trials using BMDs to measure outcomes. First, the definition of outcomes used in the trials was highly heterogeneous (e.g., 21 diabetes trials had 266 outcomes and 153 had different unique definitions to measure diabetes control), which limited the combination and comparison of results. Second, information on the validity, reliability, and responsiveness of sensors used was lacking in 74% of trials. Third, half (53%) of the outcomes measured with BMDs had not been prespecified, with a high risk of outcome reporting bias. Finally, reporting on the management of incomplete outcome data (e.g., due ...
Keywords	Clinical trials ; Outcomes ; Wearable devices ; Medicine ; R
Subject code	610
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Risk of bias in observational studies using routinely collected data of comparative effectiveness research

Van Thu Nguyen / Mishelle Engleton / Mauricia Davison / Philippe Ravaud / Raphael Porcher / Isabelle Boutron

BMC Medicine, Vol 19, Iss 1, Pp 1-

a meta-research study

2021 Volume 14

Abstract: Abstract 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 ... ...

Abstract	Abstract 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 therapeutic interventions using routinely collected data published in high impact factor journals from 01/06/2018 to 30/06/2020. We assessed the reporting of the study design (i.e., eligibility, treatment assignment, and the start of follow-up). The risk of selection bias and immortal time bias was determined by assessing if the time of eligibility, the treatment assignment, and the start of follow-up were synchronized to mimic the randomization following the target trial emulation framework. Result Seventy-seven articles were identified. Most studies evaluated pharmacological treatments (69%) with a median sample size of 24,000 individuals. In total, 20% of articles inadequately reported essential information of the study design. One-third of the articles (n = 25, 33%) raised some concerns because of unclear reporting (n = 6, 8%) or were at high risk of selection bias and/or immortal time bias (n = 19, 25%). Only five articles (25%) described a solution to mitigate these biases. Six articles (31%) discussed these biases in the limitations section. Conclusion Reporting of essential information of study design in observational studies remained suboptimal. Selection bias and immortal time bias were common methodological issues that researchers and physicians should be aware of when interpreting the results of observational studies using routinely collected data.
Keywords	Observational studies ; Routinely collected data ; Emulated trial ; Meta-research ; Risk of bias ; Medicine ; R
Subject code	306
Language	English
Publishing date	2021-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Designs of trials assessing interventions to improve the peer review process

Amytis Heim / Philippe Ravaud / Gabriel Baron / Isabelle Boutron

BMC Medicine, Vol 16, Iss 1, Pp 1-

a vignette-based survey

2018 Volume 11

Abstract: Abstract Background We aimed to determine the best study designs for assessing interventions to improve the peer review process according to experts’ opinions. Furthermore, for interventions previously evaluated, we determined whether the study designs ... ...

Abstract	Abstract Background We aimed to determine the best study designs for assessing interventions to improve the peer review process according to experts’ opinions. Furthermore, for interventions previously evaluated, we determined whether the study designs actually used were rated as the best study designs. Methods Study design: A series of six vignette-based surveys exploring the best study designs for six different interventions (training peer reviewers, adding an expert to the peer review process, use of reporting guidelines checklists, blinding peer reviewers to the results (i.e., results-free peer review), giving incentives to peer reviewers, and post-publication peer review). Vignette construction: Vignettes were case scenarios of trials assessing interventions aimed at improving the quality of peer review. For each intervention, the vignette included the study type (e.g., randomized controlled trial [RCT]), setting (e.g., single biomedical journal), and type of manuscript assessed (e.g., actual manuscripts received by the journal); each of these three features varied between vignettes. Participants: Researchers with expertise in peer review or methodology of clinical trials. Outcome: Participants were proposed two vignettes describing two different study designs to assess the same intervention and had to indicate which study design they preferred on a scale, from − 5 (preference for study A) to 5 (preference for study B), 0 indicating no preference between the suggested designs (primary outcome). Secondary outcomes were trust in the results and feasibility of the designs. Results A total of 204 experts assessed 1044 paired comparisons. The preferred study type was RCTs with randomization of manuscripts for four interventions (adding an expert, use of reporting guidelines checklist, results-free peer review, post-publication peer review) and RCTs with randomization of peer reviewers for two interventions (training peer reviewers and using incentives). The preferred setting was mainly several biomedical journals from different publishers, and the preferred type of manuscript was actual manuscripts submitted to journals. However, the most feasible designs were often cluster RCTs and interrupted time series analysis set in a single biomedical journal, with the assessment of a fabricated manuscript. Three interventions were previously assessed: none used the design rated first in preference by experts. Conclusion The vignette-based survey allowed us to identify the best study designs for assessing different interventions to improve peer review according to experts’ opinion. There is gap between the preferred study designs and the designs actually used.
Keywords	Peer review ; Randomized controlled trials ; Design ; Quality ; Validity ; Medicine ; R
Subject code	310
Language	English
Publishing date	2018-10-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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