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  1. Article ; Online: Medicina Clínica: A commitment to improvement.

    Cobo, Erik

    Medicina clinica

    2024  

    Title translation Medicina Clínica: un compromiso con la mejora.
    Language Spanish
    Publishing date 2024-02-19
    Publishing country Spain
    Document type Editorial
    ZDB-ID 411607-0
    ISSN 1578-8989 ; 0025-7753
    ISSN (online) 1578-8989
    ISSN 0025-7753
    DOI 10.1016/j.medcli.2023.12.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.279: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Magnitud del efecto

    Erik Cobo

    Medicina Clínica Práctica, Vol 4, Iss , Pp 100295- (2021)

    2021  

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher Elsevier España
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Valorar la predicción

    Erik Cobo

    Medicina Clínica Práctica, Vol 4, Iss , Pp 100296- (2021)

    2021  

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher Elsevier España
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Significados de prospectivo y retrospectivo

    Erik Cobo

    Medicina Clínica Práctica, Vol 4, Iss , Pp 100293- (2021)

    2021  

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher Elsevier España
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Buenas prácticas en la metodología de la investigación clínica

    Erik Cobo

    Medicina Clínica Práctica, Vol 4, Iss , Pp 100290- (2021)

    2021  

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher Elsevier España
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Description of survival with numerical and graphic indicators. Basics and mistakes to avoid.

    Gómez Melis, Guadalupe / Cortés Martínez, Jordi / Cobo Valeri, Erik

    Cirugia espanola

    2022  Volume 100, Issue 9, Page(s) 587–589

    Language English
    Publishing date 2022-06-10
    Publishing country Spain
    Document type Journal Article
    ISSN 2173-5077
    ISSN (online) 2173-5077
    DOI 10.1016/j.cireng.2021.11.021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Heterogeneity of treatment response to beta-blockers in the treatment of portal hypertension: A systematic review.

    Alsaeid, Mohammad / Sung, Shuen / Bai, Wayne / Tam, Matthew / Wong, Yu Jun / Cortes, Jordi / Cobo, Erik / Gonzalez, Jose Antonio / Abraldes, Juan G

    Hepatology communications

    2024  Volume 8, Issue 2

    Abstract: Background: It has been suggested that a relevant proportion of patients do not respond to nonselective beta-blockers (NSBB)s, which raises questions regarding the need for individualized therapy. The existence of potential heterogeneity in the ... ...

    Abstract Background: It has been suggested that a relevant proportion of patients do not respond to nonselective beta-blockers (NSBB)s, which raises questions regarding the need for individualized therapy. The existence of potential heterogeneity in the treatment response can be assessed using the variability ratio (VR) of the outcome measurement (in this case, HVPG) between the treated and placebo groups. We conducted a systematic review and meta-analysis of randomized controlled trials to assess the potential heterogeneity in the portal pressure response to NSBBs.
    Methods: After a systematic search, we quantified the heterogeneity of treatment response with the VR between the treatment and control groups, with VR > 1 indicating potential heterogeneity. We used a similar approach to compare carvedilol with propranolol and statins with placebo.
    Results: We identified 18 studies that included 965 patients. A comparison between beta-blockers and placebo showed a pooled VR of 0.99 (95% CI:0.87-1.14), which suggests a homogeneous HVPG response to NSBB at the individual patient level (ie, no evidence to support that some patients responded to beta-blockers and others did not). For the comparison between carvedilol and propranolol, pooled VR was 0.97 (95% CI 0.82-1.14), suggesting that carvedilol achieves a greater average response (rather than an increase in the proportion of responders). There was no evidence of a heterogeneous response to statins.
    Conclusion: Our analysis did not support the existence of a heterogeneous patient-by-patient response to NSBBs in cirrhosis. These findings challenge the concept of personalized therapy based on portal pressure response and indicate that routine portal pressure measurement may not be necessary to guide NSBB therapy.
    MeSH term(s) Humans ; Propranolol/therapeutic use ; Carvedilol/therapeutic use ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Adrenergic beta-Antagonists/therapeutic use ; Hypertension, Portal/drug therapy
    Chemical Substances Propranolol (9Y8NXQ24VQ) ; Carvedilol (0K47UL67F2) ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Adrenergic beta-Antagonists
    Language English
    Publishing date 2024-01-29
    Publishing country United States
    Document type Meta-Analysis ; Systematic Review ; Journal Article
    ISSN 2471-254X
    ISSN (online) 2471-254X
    DOI 10.1097/HC9.0000000000000321
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

    Schütz, Helmut / Burger, Divan A / Cobo, Erik / Dubins, David D / Farkás, Tibor / Labes, Detlew / Lang, Benjamin / Ocaña, Jordi / Ring, Arne / Shitova, Anastasia / Stus, Volodymyr / Tomashevskiy, Michael

    The AAPS journal

    2024  Volume 26, Issue 3, Page(s) 50

    Abstract: Comparative bioavailability studies often involve multiple groups of subjects for a variety of reasons, such as clinical capacity limitations. This raises questions about the validity of pooling data from these groups in the statistical analysis and ... ...

    Abstract Comparative bioavailability studies often involve multiple groups of subjects for a variety of reasons, such as clinical capacity limitations. This raises questions about the validity of pooling data from these groups in the statistical analysis and whether a group-by-treatment interaction should be evaluated. We investigated the presence or absence of group-by-treatment interactions through both simulation techniques and a meta-study of well-controlled trials. Our findings reveal that the test falsely detects an interaction when no true group-by-treatment interaction exists. Conversely, when a true group-by-treatment interaction does exist, it often goes undetected. In our meta-study, the detected group-by-treatment interactions were observed at approximately the level of the test and, thus, can be considered false positives. Testing for a group-by-treatment interaction is both misleading and uninformative. It often falsely identifies an interaction when none exists and fails to detect a real one. This occurs because the test is performed between subjects in crossover designs, and studies are powered to compare treatments within subjects. This work demonstrates a lack of utility for including a group-by-treatment interaction in the model when assessing single-site comparative bioavailability studies, and the clinical trial study structure is divided into groups.
    MeSH term(s) Humans ; Biological Availability ; Research Design ; Cross-Over Studies
    Language English
    Publishing date 2024-04-17
    Publishing country United States
    Document type Journal Article
    ISSN 1550-7416
    ISSN (online) 1550-7416
    DOI 10.1208/s12248-024-00921-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: An iterative method to protect the type I error rate in bioequivalence studies under two-stage adaptive 2×2 crossover designs.

    Molins, Eduard / Labes, Detlew / Schütz, Helmut / Cobo, Erik / Ocaña, Jordi

    Biometrical journal. Biometrische Zeitschrift

    2020  Volume 63, Issue 1, Page(s) 122–133

    Abstract: Bioequivalence studies are the pivotal clinical trials submitted to regulatory agencies to support the marketing applications of generic drug products. Average bioequivalence (ABE) is used to determine whether the mean values for the pharmacokinetic ... ...

    Abstract Bioequivalence studies are the pivotal clinical trials submitted to regulatory agencies to support the marketing applications of generic drug products. Average bioequivalence (ABE) is used to determine whether the mean values for the pharmacokinetic measures determined after administration of the test and reference products are comparable. Two-stage 2×2 crossover adaptive designs (TSDs) are becoming increasingly popular because they allow making assumptions on the clinically meaningful treatment effect and a reliable guess for the unknown within-subject variability. At an interim look, if ABE is not declared with an initial sample size, they allow to increase it depending on the estimated variability and to enroll additional subjects at a second stage, or to stop for futility in case of poor likelihood of bioequivalence. This is crucial because both parameters must clearly be prespecified in protocols, and the strategy agreed with regulatory agencies in advance with emphasis on controlling the overall type I error. We present an iterative method to adjust the significance levels at each stage which preserves the overall type I error for a wide set of scenarios which should include the true unknown variability value. Simulations showed adjusted significance levels higher than 0.0300 in most cases with type I error always below 5%, and with a power of at least 80%. TSDs work particularly well for coefficients of variation below 0.3 which are especially useful due to the balance between the power and the percentage of studies proceeding to stage 2. Our approach might support discussions with regulatory agencies.
    MeSH term(s) Cross-Over Studies ; Humans ; Research Design ; Sample Size ; Therapeutic Equivalency
    Language English
    Publishing date 2020-10-01
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 131640-0
    ISSN 1521-4036 ; 0323-3847 ; 0006-3452
    ISSN (online) 1521-4036
    ISSN 0323-3847 ; 0006-3452
    DOI 10.1002/bimj.201900388
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Bonn / Germany

    Z 1267: Show issues

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  10. Article ; Online: Taking advantage of unexpected WebCONSORT results.

    Cobo, Erik / González, José Antonio

    BMC medicine

    2016  Volume 14, Issue 1, Page(s) 204

    Abstract: To estimate treatment effects, trials are initiated by randomising patients to the interventions under study and finish by comparing patient evolution. In order to improve the trial report, the CONSORT statement provides authors and peer reviewers with a ...

    Abstract To estimate treatment effects, trials are initiated by randomising patients to the interventions under study and finish by comparing patient evolution. In order to improve the trial report, the CONSORT statement provides authors and peer reviewers with a guide of the essential items that would allow research replication. Additionally, WebCONSORT aims to facilitate author reporting by providing the items from the different CONSORT extensions that are relevant to the trial being reported. WebCONSORT has been estimated to improve the proportion of reported items by 0.04 (95% CI, -0.02 to 0.10), interpreted as "no important difference", in accordance with the scheduled desired scenario of a 0.15 effect size improvement. However, in a non-scheduled analysis, it was found that, despite clear instructions, around a third of manuscripts selected for trials by the editorial staff were not actually randomised trials. We argue that surprises benefit science, and that further research should be conducted in order to improve the performance of editorial staff.Please see related research: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0736-x.
    MeSH term(s) Biomedical Research/standards ; Guidelines as Topic ; Peer Review/standards ; Periodicals as Topic/standards ; Randomized Controlled Trials as Topic/standards ; Reproducibility of Results
    Language English
    Publishing date 2016-12-05
    Publishing country England
    Document type Editorial
    ISSN 1741-7015
    ISSN (online) 1741-7015
    DOI 10.1186/s12916-016-0758-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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