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  • 1
    Online Resource
    Online Resource
    Development of a neonatal adverse event severity scale through a Delphi consensus approach
    BMJ ; 2019
    In:  Archives of Disease in Childhood Vol. 104, No. 12 ( 2019-12), p. 1167-1173
    Details
    In: Archives of Disease in Childhood, BMJ, Vol. 104, No. 12 ( 2019-12), p. 1167-1173
    Abstract: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. Methods A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. Results Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. Discussion The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.
    Type of Medium: Online Resource
    ISSN: 0003-9888 , 1468-2044
    URL: Article
    DOI: 10.1136/archdischild-2019-317399
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 1481191-1
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  • 2
    Online Resource
    Online Resource
    Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development
    Wiley ; 2019
    In:  Clinical Pharmacology & Therapeutics Vol. 105, No. 6 ( 2019-06), p. 1462-1470
    Details
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 105, No. 6 ( 2019-06), p. 1462-1470
    Abstract: The objective of this study was to evaluate the predictive performance of population models to predict renal clearance in newborns and infants. Pharmacokinetic (PK) data from eight drugs in 788 newborns and infants were used to evaluate the predictive performance of the population models based on postmenstrual age (PMA), postnatal age, gestational age, and body weight. For the PMA model, the average fold error for clearance (CL) predicted /CL observed was within a twofold range for each drug in all subgroups. For drugs with 〉  90% renal elimination, the prediction bias ranged from 0.7−1.3. For drugs with 60–80% renal elimination, the prediction bias ranged 0.6–2.0. Our results suggest that PMA‐based sigmoidal maximum effect (E max ) model, in combination with bodyweight‐based scaling and kidney function assessment, can be used in population PK (PopPK) modeling for drugs that are primarily eliminated via renal pathway to inform initial dose selection for newborns and infants with normal renal function in clinical trials.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    URL: Article
    DOI: 10.1002/cpt.2019.105.issue-6
    DOI: 10.1002/cpt.1332
    RVK:
    XA 36900
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2040184-X
    SSG: 15,3
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  • 3
    Online Resource
    Online Resource
    Biodiversity Offsets and the Challenge of Achieving No Net Loss
    Wiley ; 2013
    In:  Conservation Biology Vol. 27, No. 6 ( 2013-12), p. 1254-1264
    Details
    In: Conservation Biology, Wiley, Vol. 27, No. 6 ( 2013-12), p. 1254-1264
    Abstract: Los negocios, gobiernos e instituciones financieras adoptan cada vez más una política de no pérdida neta de biodiversidad para el desarrollo de actividades. La meta de la no pérdida neta está enfocada en ayudar a aliviar la tensión entre la conservación y el desarrollo al permitir que se obtengan ganancias económicas sin pérdidas de biodiversidad acompañantes. Los balances de biodiversidad representan un componente necesario de una estrategia de mitigación mucho más amplia para obtener una no pérdida neta siguiendo la aplicación previa de evitación, minimización y medidas de remediación. Sin embargo, han surgido dudas sobre el uso apropiado de los balances de biodiversidad. Examinamos lo que implica una no pérdida neta como un resultado de conservación deseable y revisamos las condiciones que determinan si, y bajo cuales circunstancias, los balances de biodiversidad pueden ayudar a obtener dicha meta. Propusimos un marco de trabajo conceptual para sustituir las aproximaciones seguidas y ad hoc en muchas iniciativas de balances de biodiversidad. La relevancia de los balances de biodiversidad hacia la no pérdida neta yace sobre dos premisas fundamentales. Primero, los balances rara vez son adecuados para obtener la no pérdida neta por sí sola. Segundo, algunos efectos de desarrollo pueden ser muy difíciles o riesgosos, o incluso imposibles, para el balance. Para ayudar a obtener no pérdida neta a través de los balances de biodiversidad, las ganancias de biodiversidad deben ser comparables con las pérdidas, estar sumadas a las ganancias de conservación que pueden haber ocurrido en la ausencia de los balances y ser duraderas y estar protegidas del riesgo de fracaso. La adhesión a estas condiciones requiere una consideración del contexto de paisaje más amplio de desarrollo y de las actividades del balance, la sincronización de la obtención del balance, medida de la biodiversidad, procedimientos de aseguramiento y juegos de reglas usados para calcular las pérdidas y ganancias de biodiversidad y guías en el diseño de balances, y aproximaciones al manejo de riesgo. La adopción de este marco de trabajo hará más fuerte el potencial para que los balances proporcionen un mecanismo defendible ecológicamente que pueda ayudar a reconciliar a la conservación con el desarrollo.
    Type of Medium: Online Resource
    ISSN: 0888-8892 , 1523-1739
    URL: Issue
    URL: Article
    DOI: 10.1111/cobi.2013.27.issue-6
    DOI: 10.1111/cobi.12118
    Language: English
    Publisher: Wiley
    Publication Date: 2013
    detail.hit.zdb_id: 2020041-9
    SSG: 12
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  • 4
    Online Resource
    Online Resource
    A process for assessing the offsetability of biodiversity impacts
    Wiley ; 2013
    In:  Conservation Letters Vol. 6, No. 5 ( 2013-09), p. 376-384
    Details
    In: Conservation Letters, Wiley, Vol. 6, No. 5 ( 2013-09), p. 376-384
    Abstract: Biodiversity offsetting is increasingly being used to reconcile the objectives of conservation and development. It is generally acknowledged that there are limits to the kinds of impacts on biodiversity that can or should be offset, yet there is a paucity of policy guidance as to what defines these limits and the relative difficulty of achieving a successful offset as such limits are approached. In order to improve the consistency and defensibility of development decisions involving offsets, and to improve offset design, we outline a general process for evaluating the relative offsetability of different impacts on biodiversity. This process culminates in a framework that establishes the burden of proof necessary to confirm the appropriateness and achievability of offsets, given varying levels of: conservation concern for affected biodiversity; residual impact magnitude; opportunity for suitable offsets; and feasibility of offset implementation in practice. Rankings for biodiversity conservation concern are drawn from existing conservation planning tools and approaches, including the IUCN Red List, Key Biodiversity Areas, and international bank environmental safeguard policies. We hope that the proposed process will stimulate much‐needed scientific and policy debate to improve the integrity and accountability of both regulated and voluntary biodiversity offsetting.
    Type of Medium: Online Resource
    ISSN: 1755-263X , 1755-263X
    URL: Issue
    URL: Article
    DOI: 10.1111/conl.2013.6.issue-5
    DOI: 10.1111/conl.12002
    Language: English
    Publisher: Wiley
    Publication Date: 2013
    detail.hit.zdb_id: 2430375-6
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