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Article ; Online: Definitions of digital biomarkers: a systematic mapping of the biomedical literature.

Macias Alonso, Ana Karen / Hirt, Julian / Woelfle, Tim / Janiaud, Perrine / Hemkens, Lars G

BMJ health & care informatics

2024 Volume 31, Issue 1

Abstract: Background: Technological devices such as smartphones, wearables and virtual assistants enable health data collection, serving as digital alternatives to conventional biomarkers. We aimed to provide a systematic overview of emerging literature on ' ... ...

Abstract	Background: Technological devices such as smartphones, wearables and virtual assistants enable health data collection, serving as digital alternatives to conventional biomarkers. We aimed to provide a systematic overview of emerging literature on 'digital biomarkers,' covering definitions, features and citations in biomedical research. Methods: We analysed all articles in PubMed that used 'digital biomarker(s)' in title or abstract, considering any study involving humans and any review, editorial, perspective or opinion-based articles up to 8 March 2023. We systematically extracted characteristics of publications and research studies, and any definitions and features of 'digital biomarkers' mentioned. We described the most influential literature on digital biomarkers and their definitions using thematic categorisations of definitions considering the Food and Drug Administration Biomarkers, EndpointS and other Tools framework (ie, data type, data collection method, purpose of biomarker), analysing structural similarity of definitions by performing text and citation analyses. Results: We identified 415 articles using 'digital biomarker' between 2014 and 2023 (median 2021). The majority (283 articles; 68%) were primary research. Notably, 287 articles (69%) did not provide a definition of digital biomarkers. Among the 128 articles with definitions, there were 127 different ones. Of these, 78 considered data collection, 56 data type, 50 purpose and 23 included all three components. Those 128 articles with a definition had a median of 6 citations, with the top 10 each presenting distinct definitions. Conclusions: The definitions of digital biomarkers vary significantly, indicating a lack of consensus in this emerging field. Our overview highlights key defining characteristics, which could guide the development of a more harmonised accepted definition.
MeSH term(s)	Humans ; Biomarkers ; Biomedical Research
Chemical Substances	Biomarkers
Language	English
Publishing date	2024-04-08
Publishing country	England
Document type	Journal Article ; Review
ISSN	2632-1009
ISSN (online)	2632-1009
DOI	10.1136/bmjhci-2023-100914
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Meta-research on pragmatism of randomized trials: rationale and design of the PragMeta database.

Hirt, Julian / Janiaud, Perrine / Düblin, Pascal / Hemkens, Lars G

Trials

2023 Volume 24, Issue 1, Page(s) 437

Abstract: Background: Pragmatic trials provide decision-oriented, real-world evidence that is highly applicable and generalizable. The interest in real-world evidence is fueled by the assumption that effects in the "real-world" are different to effects obtained ... ...

Abstract	Background: Pragmatic trials provide decision-oriented, real-world evidence that is highly applicable and generalizable. The interest in real-world evidence is fueled by the assumption that effects in the "real-world" are different to effects obtained under artificial, controlled, research conditions as often used for traditional explanatory trials. However, it is unknown which features of pragmatism, generalizability, and applicability would be responsible for such differences. There is a need to provide empirical evidence and promote meta-research to answer these fundamental questions on the pragmatism of randomized trials and real-world evidence. Here, we describe the rationale and design of the PragMeta database which pursues this goal ( www.PragMeta.org ). Methods: PragMeta is a non-commercial, open data platform and infrastructure to facilitate research on pragmatic trials. It collects and shares data from published randomized trials that either have a specific design feature or other characteristic related to pragmatism or they form clusters of trials addressing the same research question but having different aspects of pragmatism. This lays the foundation to determine the relationship of various features of pragmatism, generalizability, and applicability with intervention effects or other trial characteristics. The database contains trial data actively collected for PragMeta but also allows to import and link existing datasets of trials collected for other purposes, forming a large-scale meta-database. PragMeta captures data on (1) trial and design characteristics (e.g., sample size, population, intervention/comparison, outcome, longitudinal structure, blinding), (2) effects estimates, and (3) various determinants of pragmatism (e.g., the use of routinely collected data) and ratings from established tools used to determine pragmatism (e.g., the PRagmatic-Explanatory Continuum Indicator Summary 2; PRECIS-2). PragMeta is continuously provided online, inviting the meta-research community to collaborate, contribute, and/or use the database. As of April 2023, PragMeta contains data from > 700 trials, mostly with assessments on pragmatism. Conclusions: PragMeta will inform a better understanding of pragmatism and the generation and interpretation of real-world evidence.
MeSH term(s)	Humans ; Randomized Controlled Trials as Topic ; Databases, Factual ; Routinely Collected Health Data ; Sample Size
Language	English
Publishing date	2023-06-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07474-y
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review.

Hirt, Julian / Janiaud, Perrine / Hemkens, Lars G

BMJ evidence-based medicine

2022 Volume 27, Issue 6, Page(s) 334–344

Abstract: Objective: We aimed at providing a systematic overview of randomised trials assessing non-pharmaceutical interventions (NPIs) to prevent COVID-19.: Design: Scoping review.: Methods: We included all randomised trials assessing NPIs to prevent COVID- ...

Abstract	Objective: We aimed at providing a systematic overview of randomised trials assessing non-pharmaceutical interventions (NPIs) to prevent COVID-19. Design: Scoping review. Methods: We included all randomised trials assessing NPIs to prevent COVID-19 in any country and setting registered in ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform using the COVID-evidence platform (until 17 August 2021). We searched for corresponding publications in MEDLINE/PubMed, Google Scholar, the Living Overview of Evidence platform, and the Cochrane COVID-19 registry as well as for results posted in registries (until 14 November 2021). Descriptive statistics using numbers and percentages were used in the narrative synthesis of the results. Results: We identified 41 randomised trials. Of them, 12 were completed (29.3%) including 9 with published results. The 41 trials planned to recruit a median of 1700 participants (IQR 588-9500, range 30-35 256 399) with a median planned duration of 8 months (IQR 3-14, range 1-24). Most came from the USA (n=11, 26.8%). The trials mostly assessed protective equipment (n=11, 26.8%), COVID-19-related information and education programmes (n=9, 22.0%), access to mass events under specific safety measures (n=5, 12.2%), testing and screening strategies (n=5, 12.2%) and hygiene management (n=5, 12.2%). Conclusions: Worldwide, 41 randomised trials assessing NPIs have been initiated with published results available to inform policy decisions for only 9 of them. A long-term research agenda including behavioural, environmental, social and systems level interventions is urgently needed to guide policies and practices in the current and future public health emergencies.
MeSH term(s)	Humans ; COVID-19/prevention & control ; Randomized Controlled Trials as Topic ; Public Health
Language	English
Publishing date	2022-01-27
Publishing country	England
Document type	Review ; Journal Article
ISSN	2515-4478
ISSN (online)	2515-4478
DOI	10.1136/bmjebm-2021-111825
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Clinical trial research agenda on COVID-19 - the first two years in Germany and beyond.

Hirt, Julian / Janiaud, Perrine / Hemkens, Lars G

Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen

2022 Volume 174, Page(s) 32–42

Abstract: Background: We have followed the COVID-19 clinical trial research agenda from the beginning using the COVID-evidence.org platform. Now, two years after the COVID-19 pandemic started, our aim was to re-examine this research agenda with the latest data to ...

Abstract	Background: We have followed the COVID-19 clinical trial research agenda from the beginning using the COVID-evidence.org platform. Now, two years after the COVID-19 pandemic started, our aim was to re-examine this research agenda with the latest data to provide a global perspective on the research landscape with a focus on Germany. Methods: We reviewed and updated previously published data on the COVID-19 clinical research agenda as of 28February 2022 focusing on randomized trials. We used the COVID-evidence.org platform including registry entries from ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform as well as publications from the Living OVerview of Evidence platform for COVID-19 (L·OVE). Results: Two years on from the pandemic outbreak, there were 4,673 registered trials. The majority of these trials have remained small with a median of 120 planned participants (IQR 60-320). In the first hundred days of the pandemic most of them (50%) had been registered in China. More than two years later, the five countries with the most registered trials (alone or within a framework of international collaborations) were the USA (825 trials; 18%), Iran (619 trials; 13%), India (566 trials; 12%), China (353 trials; 8%), and Spain (309 trials; 7%). Only 119 trials were reported to have a study site in Germany (2.5% of the registered trials). Of the 4,673 trials registered, 15% (694 trials) had published their results by February 2022. The clinical research agenda has been marked by both successes, such as the large RECOVERY trial providing evidence on 10 treatments for COVID-19 including over 45,000 patients as of February 2022, and failures: worldwide only 57 randomized trials have been registered over two years that aimed to assess non-pharmaceutical interventions (e.g., face mask policies and lockdown measures) to prevent COVID-19, and only 11 of them had published results informing decisions that have an impact on the life of billions of people worldwide. Conclusions: The COVID-19 clinical research agenda has highlighted the substantial effort of the research community but also the challenges of the clinical research ecosystem. Most importantly, it has shed light on the ability to circumvent traditional barriers and to make trials more useful even under extraordinary conditions. The time to learn our lessons and apply them is now, and the time to demonstrate how we have improved the system is before the next pandemic.
MeSH term(s)	Humans ; Pandemics/prevention & control ; COVID-19/epidemiology ; SARS-CoV-2 ; Ecosystem ; Germany ; Communicable Disease Control
Language	English
Publishing date	2022-09-28
Publishing country	Netherlands
Document type	Review ; Journal Article
ZDB-ID	2412512-X
ISSN	2212-0289 ; 1865-9217
ISSN (online)	2212-0289
ISSN	1865-9217
DOI	10.1016/j.zefq.2022.08.003
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Conference proceedings: Impact of pragmatic trial design features on treatment effect estimates: rationale and design of the PragMeta database

Hirt, Julian / Janiaud, Perrine / Düblin, Pascal / Hemkens, Lars G.

2023 , Page(s) 23ebmPSII–3–01

Event/congress	24. Jahrestagung des Netzwerks Evidenzbasierte Medizin; Gesundheit und Klima – EbM für die Zukunft; Potsdam; Netzwerk Evidenzbasierte Medizin e.V.; 2023
Keywords	Medizin, Gesundheit
Publishing date	2023-03-21
Publisher	German Medical Science GMS Publishing House; Düsseldorf
Document type	Conference proceedings
DOI	10.3205/23ebm066
Database	German Medical Science

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Article ; Online: Meta-research on pragmatism of randomized trials

Julian Hirt / Perrine Janiaud / Pascal Düblin / Lars G. Hemkens

Trials, Vol 24, Iss 1, Pp 1-

rationale and design of the PragMeta database

2023 Volume 8

Abstract: Abstract Background Pragmatic trials provide decision-oriented, real-world evidence that is highly applicable and generalizable. The interest in real-world evidence is fueled by the assumption that effects in the “real-world” are different to effects ... ...

Abstract	Abstract Background Pragmatic trials provide decision-oriented, real-world evidence that is highly applicable and generalizable. The interest in real-world evidence is fueled by the assumption that effects in the “real-world” are different to effects obtained under artificial, controlled, research conditions as often used for traditional explanatory trials. However, it is unknown which features of pragmatism, generalizability, and applicability would be responsible for such differences. There is a need to provide empirical evidence and promote meta-research to answer these fundamental questions on the pragmatism of randomized trials and real-world evidence. Here, we describe the rationale and design of the PragMeta database which pursues this goal ( www.PragMeta.org ). Methods PragMeta is a non-commercial, open data platform and infrastructure to facilitate research on pragmatic trials. It collects and shares data from published randomized trials that either have a specific design feature or other characteristic related to pragmatism or they form clusters of trials addressing the same research question but having different aspects of pragmatism. This lays the foundation to determine the relationship of various features of pragmatism, generalizability, and applicability with intervention effects or other trial characteristics. The database contains trial data actively collected for PragMeta but also allows to import and link existing datasets of trials collected for other purposes, forming a large-scale meta-database. PragMeta captures data on (1) trial and design characteristics (e.g., sample size, population, intervention/comparison, outcome, longitudinal structure, blinding), (2) effects estimates, and (3) various determinants of pragmatism (e.g., the use of routinely collected data) and ratings from established tools used to determine pragmatism (e.g., the PRagmatic–Explanatory Continuum Indicator Summary 2; PRECIS-2). PragMeta is continuously provided online, inviting the meta-research community to ...
Keywords	Pragmatic clinical trial [MeSH] ; Real-world clinical trials ; Naturalistic randomized clinical trial ; Databases ; Bibliographic [MeSH] ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Registrering av forskning baserad på nationella hälsoregister.

Axfors, Cathrine / Fröbert, Ole / Janiaud, Perrine / Zavalis, Emmanuel / G Hemkens, Lars / P A Ioannidis, John

Lakartidningen

2024 Volume 121

Abstract: In medical research as a whole, frequent inaccurate or biased findings are of international concern. One measure against reporting biases is study registration before the start of data collection (preregistration), preferably together with the ... ...

Title translation	Registration of national health registry-based research.
Abstract	In medical research as a whole, frequent inaccurate or biased findings are of international concern. One measure against reporting biases is study registration before the start of data collection (preregistration), preferably together with the statistical analysis plan. This meta-research study systematically evaluated registration of Swedish observational research based on national health registries. In a random sample of registry-based observational studies published 2010-2022, very few were preregistered with a publicly available analysis plan (<1 procent). Ideas from the meta-research literature can be leveraged to strengthen the brand of Swedish registry-based observational studies and counteract reporting bias.
MeSH term(s)	Humans ; Registries ; Data Collection ; Research Design ; Sweden/epidemiology ; Biomedical Research
Language	Swedish
Publishing date	2024-04-08
Publishing country	Sweden
Document type	Observational Study ; English Abstract ; Journal Article
ZDB-ID	391010-6
ISSN	1652-7518 ; 0023-7205
ISSN (online)	1652-7518
ISSN	0023-7205
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Clinical trial evidence of quality-of-life effects of disease-modifying therapies for multiple sclerosis: a systematic analysis.

Hirt, Julian / Dembowska, Kinga / Woelfle, Tim / Axfors, Cathrine / Granziera, Cristina / Kuhle, Jens / Kappos, Ludwig / Hemkens, Lars G / Janiaud, Perrine

Journal of neurology

2024

Abstract: Background: Increasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis ( ...

Abstract	Background: Increasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis (PwMS). Methods: Randomized trials assessing approved DMTs in PwMS with results for at least one outcome referred to as "quality of life" were searched in PubMed and ClinicalTrials.gov. Results: We identified 38 trials published between 1999 and 2023 with a median of 531 participants (interquartile range (IQR) 202 to 941; total 23,225). The evaluated DMTs were mostly interferon-beta (n = 10; 26%), fingolimod (n = 7; 18%), natalizumab (n = 5; 13%), and glatiramer acetate (n = 4; 11%). The 38 trials used 18 different QoL instruments, with up to 11 QoL subscale measures per trial (median 2; IQR 1-3). QoL was never the single primary outcome. We identified quantitative QoL results in 24 trials (63%), and narrative statements in 15 trials (39%). In 16 trials (42%), at least one of the multiple QoL results was statistically significant. The effect sizes of the significant quantitative QoL results were large (median Cohen's d 1.02; IQR 0.3-1.7; median Hedges' g 1.01; IQR 0.3-1.69) and ranged between d 0.14 and 2.91. Conclusions: Certain DMTs have the potential to positively impact QoL of PwMS, and the assessment and reporting of QoL is suboptimal with a multitude of diverse instruments being used. There is an urgent need that design and reporting of clinical trials reflect the critical importance of QoL for PwMS.
Language	English
Publishing date	2024-04-16
Publishing country	Germany
Document type	Journal Article ; Review
ZDB-ID	187050-6
ISSN	1432-1459 ; 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
ISSN (online)	1432-1459
ISSN	0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
DOI	10.1007/s00415-024-12366-5
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Article ; Online: Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently?

Janiaud, Perrine / Hemkens, Lars G / Ioannidis, John P A

The Canadian journal of cardiology

2021 Volume 37, Issue 9, Page(s) 1353–1364

Abstract: The COVID-19 crisis led to a flurry of clinical trials activity. The COVID-evidence database shows 2814 COVID-19 randomized trials registered as of February 16, 2021. Most were small (only 18% have a planned sample size > 500) and the rare completed ones ...

Abstract	The COVID-19 crisis led to a flurry of clinical trials activity. The COVID-evidence database shows 2814 COVID-19 randomized trials registered as of February 16, 2021. Most were small (only 18% have a planned sample size > 500) and the rare completed ones have not provided published results promptly (only 283 trial publications as of February 2021). Small randomized trials and observational, nonrandomized analyses have not had a successful track record and have generated misleading expectations. Different large trials on the same intervention have generally been far more efficient in producing timely and consistent evidence. The rapid generation of evidence and accelerated dissemination of results have led to new challenges for systematic reviews and meta-analyses (eg, rapid, living, and scoping reviews). Pressure to regulatory agencies has also mounted with massive emergency authorizations, but some of them have had to be revoked. Pandemic circumstances have disrupted the way trials are conducted; therefore, new methods have been developed and adopted more widely to facilitate recruitment, consent, and overall trial conduct. On the basis of the COVID-19 experience and its challenges, planning of several large, efficient trials, and wider use of adaptive designs might change the future of clinical research. Pragmatism, integration in clinical care, efficient administration, promotion of collaborative structures, and enhanced integration of existing data and facilities might be several of the legacies of COVID-19 on future randomized trials.
MeSH term(s)	COVID-19/therapy ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/standards ; Clinical Trials as Topic/statistics & numerical data ; Drug Repositioning ; Humans ; Pandemics ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/standards ; Randomized Controlled Trials as Topic/statistics & numerical data ; Research Design/standards ; SARS-CoV-2
Language	English
Publishing date	2021-05-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	632813-1
ISSN	1916-7075 ; 0828-282X
ISSN (online)	1916-7075
ISSN	0828-282X
DOI	10.1016/j.cjca.2021.05.009
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Conference proceedings: Definitions and applications of digital biomarkers: a systematic mapping of the biomedical literature

Karen Macias Alonso, Ana / Hirt, Julian / Haji Abukar, Saido / Janiaud, Perrine / Hemkens, Lars G.

2023 , Page(s) 23ebmPSI–6–04

Event/congress	24. Jahrestagung des Netzwerks Evidenzbasierte Medizin; Gesundheit und Klima – EbM für die Zukunft; Potsdam; Netzwerk Evidenzbasierte Medizin e.V.; 2023
Keywords	Medizin, Gesundheit
Publishing date	2023-03-21
Publisher	German Medical Science GMS Publishing House; Düsseldorf
Document type	Conference proceedings
DOI	10.3205/23ebm062
Database	German Medical Science

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