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  1. Article ; Online: The impact of the COVID pandemic on prematurity rates: Conflicting results, publication ethics and academic frustration.

    Greisen, Gorm / Chalak, Lina / Hansen, Mathias Lühr / Rasmussen, Marie Isabel

    Acta paediatrica (Oslo, Norway : 1992)

    2021  Volume 111, Issue 2, Page(s) 269–271

    MeSH term(s) COVID-19 ; Frustration ; Humans ; Pandemics ; SARS-CoV-2
    Language English
    Publishing date 2021-11-11
    Publishing country Norway
    Document type Journal Article
    ZDB-ID 203487-6
    ISSN 1651-2227 ; 0365-1436 ; 0803-5253
    ISSN (online) 1651-2227
    ISSN 0365-1436 ; 0803-5253
    DOI 10.1111/apa.16164
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Cerebral Oximetry in Preterm Infants-To Use or Not to Use, That Is the Question.

    Greisen, Gorm / Hansen, Mathias Lühr / Rasmussen, Marie Isabel Skov / Vestager, Maria / Hyttel-Sørensen, Simon / Hahn, Gitte Holst

    Frontiers in pediatrics

    2022  Volume 9, Page(s) 747660

    Abstract: The Safeguarding the Brains of our smallest Children (SafeBoosC) project was initially established to test the patient-relevant benefits and harms of cerebral oximetry in extremely preterm infants in the setting of a randomized clinical trial. Extremely ... ...

    Abstract The Safeguarding the Brains of our smallest Children (SafeBoosC) project was initially established to test the patient-relevant benefits and harms of cerebral oximetry in extremely preterm infants in the setting of a randomized clinical trial. Extremely preterm infants constitute a small group of patients with a high risk of death or survival with brain injury and subsequent neurodevelopmental disability. Several cerebral oximeters are approved for clinical use, but the use of additional equipment may disturb and thereby possibly harm these vulnerable, immature patients. Thus, the mission statement of the consortium is "do not disturb-unless necessary." There may also be more tangible risks such as skin breakdown, displacement of tubes and catheters due to more complicated nursing care, and mismanagement of cerebral oxygenation as a physiological variable. Other monitoring modalities have relevance for reducing the risk of hypoxic-ischemic brain injury occurring during acute illness and have found their place in routine clinical care without evidence from randomized clinical trials. In this manuscript, we discuss cerebral oximetry, pulse oximetry, non-invasive electric cardiometry, and invasive monitoring of blood pressure. We discuss the reliability of the measurements, the pathophysiological rationale behind the clinical use, the evidence of benefit and harms, and the costs. By examining similarities and differences, we aim to provide our perspective on the use or non-use of cerebral oximetry in newborn infants during intensive care.
    Language English
    Publishing date 2022-02-02
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2711999-3
    ISSN 2296-2360
    ISSN 2296-2360
    DOI 10.3389/fped.2021.747660
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: The effects of cerebral oximetry in mechanically ventilated newborns

    Maria Linander Vestager / Mathias Lühr Hansen / Marie Isabel Rasmussen / Gitte Holst Hahn / Simon Hyttel-Sørensen / Adelina Pellicer / Anne Marie Heuchan / Cornelia Hagmann / Eugene Dempsey / Gabriel Dimitriou / Gerhard Pichler / Gunnar Naulaers / Hans Fuchs / Jakub Tkaczyk / Jonathan Mintzer / Monica Fumagalli / Saudamini Nesargi / Siv Fredly / Tomasz Szczapa /
    Christian Gluud / Janus Christian Jakobsen / Gorm Greisen

    Trials, Vol 24, Iss 1, Pp 1-

    a protocol for the SafeBoosC-IIIv randomised clinical trial

    2023  Volume 11

    Abstract: Abstract Background The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants’ lives ...

    Abstract Abstract Background The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants’ lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy. The objective of the SafeBoosC-IIIv trial is to evaluate the benefits and harms of cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. Methods/design SafeBoosC-IIIv is an investigator-initiated, multinational, randomised, pragmatic phase-III clinical trial. The inclusion criteria will be newborns with a gestational age more than 28 + 0 weeks, postnatal age less than 28 days, predicted to require mechanical ventilation for at least 24 h, and prior informed consent from the parents or deferred consent or absence of opt-out. The exclusion criteria will be no available cerebral oximeter, suspicion of or confirmed brain injury or disorder, or congenital heart disease likely to require surgery. A total of 3000 participants will be randomised in 60 neonatal intensive care units from 16 countries, in a 1:1 allocation ratio to cerebral oximetry versus usual care. Participants in the cerebral oximetry group will undergo cerebral oximetry monitoring during mechanical ventilation in the neonatal intensive care unit for as long as deemed useful by the treating physician or until 28 days of life. The participants in the cerebral oximetry group will be treated according to the SafeBoosC treatment guideline. Participants in the usual care group will not receive cerebral oximetry and will receive usual care. We use two co-primary outcomes: (1) a composite of death from any cause or moderate to severe neurodevelopmental disability at 2 years of corrected age and (2) the non-verbal cognitive score of the Parent Report of Children’s Abilities-Revised (PARCA-R) at 2 years of ...
    Keywords Randomised clinical trial ; Near infrared spectroscopy ; Protocol ; Mechanical ventilation ; Brain injury ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2023-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Cerebral oximetry monitoring versus usual care for extremely preterm infants

    Marie Isabel Rasmussen / Mathias Lühr Hansen / Adelina Pellicer / Christian Gluud / Eugene Dempsey / Jonathan Mintzer / Simon Hyttel-Sørensen / Anne Marie Heuchan / Cornelia Hagmann / Ebru Ergenekon / Gabriel Dimitriou / Gerhard Pichler / Gunnar Naulaers / Guoqiang Cheng / Jakub Tkaczyk / Hans Fuchs / Monica Fumagalli / Saudamini Nesargi / Siv Fredly /
    Tomasz Szczapa / Anne Mette Plomgaard / Bo Mølholm Hansen / Janus Christian Jakobsen / Gorm Greisen

    Trials, Vol 24, Iss 1, Pp 1-

    a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial

    2023  Volume 11

    Abstract: Abstract Background In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks’ postmenstrual age, ... ...

    Abstract Abstract Background In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks’ postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment. Methods Of the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks’ postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children’s Abilities—Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all. Discussion Follow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. ...
    Keywords Randomised clinical trial ; Preterm ; Near-infrared spectroscopy ; Protocol ; Follow-up ; Neurodevelopment ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2023-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial.

    Vestager, Maria Linander / Hansen, Mathias Lühr / Rasmussen, Marie Isabel / Hahn, Gitte Holst / Hyttel-Sørensen, Simon / Pellicer, Adelina / Heuchan, Anne Marie / Hagmann, Cornelia / Dempsey, Eugene / Dimitriou, Gabriel / Pichler, Gerhard / Naulaers, Gunnar / Fuchs, Hans / Tkaczyk, Jakub / Mintzer, Jonathan / Fumagalli, Monica / Nesargi, Saudamini / Fredly, Siv / Szczapa, Tomasz /
    Gluud, Christian / Jakobsen, Janus Christian / Greisen, Gorm

    Trials

    2023  Volume 24, Issue 1, Page(s) 696

    Abstract: Background: The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants' lives and ... ...

    Abstract Background: The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants' lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy. The objective of the SafeBoosC-IIIv trial is to evaluate the benefits and harms of cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns.
    Methods/design: SafeBoosC-IIIv is an investigator-initiated, multinational, randomised, pragmatic phase-III clinical trial. The inclusion criteria will be newborns with a gestational age more than 28 + 0 weeks, postnatal age less than 28 days, predicted to require mechanical ventilation for at least 24 h, and prior informed consent from the parents or deferred consent or absence of opt-out. The exclusion criteria will be no available cerebral oximeter, suspicion of or confirmed brain injury or disorder, or congenital heart disease likely to require surgery. A total of 3000 participants will be randomised in 60 neonatal intensive care units from 16 countries, in a 1:1 allocation ratio to cerebral oximetry versus usual care. Participants in the cerebral oximetry group will undergo cerebral oximetry monitoring during mechanical ventilation in the neonatal intensive care unit for as long as deemed useful by the treating physician or until 28 days of life. The participants in the cerebral oximetry group will be treated according to the SafeBoosC treatment guideline. Participants in the usual care group will not receive cerebral oximetry and will receive usual care. We use two co-primary outcomes: (1) a composite of death from any cause or moderate to severe neurodevelopmental disability at 2 years of corrected age and (2) the non-verbal cognitive score of the Parent Report of Children's Abilities-Revised (PARCA-R) at 2 years of corrected age.
    Discussion: There is need for a randomised clinical trial to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns.
    Trial registration: The protocol is registered at www.
    Clinicaltrials: gov (NCT05907317; registered 18 June 2023).
    MeSH term(s) Infant ; Child ; Infant, Newborn ; Humans ; Oximetry/methods ; Respiration, Artificial/adverse effects ; Cerebrovascular Circulation ; Brain ; Intensive Care Units, Neonatal ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2023-10-28
    Publishing country England
    Document type Clinical Trial Protocol ; 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/s13063-023-07699-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial.

    Rasmussen, Marie Isabel / Hansen, Mathias Lühr / Pellicer, Adelina / Gluud, Christian / Dempsey, Eugene / Mintzer, Jonathan / Hyttel-Sørensen, Simon / Heuchan, Anne Marie / Hagmann, Cornelia / Ergenekon, Ebru / Dimitriou, Gabriel / Pichler, Gerhard / Naulaers, Gunnar / Cheng, Guoqiang / Tkaczyk, Jakub / Fuchs, Hans / Fumagalli, Monica / Nesargi, Saudamini / Fredly, Siv /
    Szczapa, Tomasz / Plomgaard, Anne Mette / Hansen, Bo Mølholm / Jakobsen, Janus Christian / Greisen, Gorm

    Trials

    2023  Volume 24, Issue 1, Page(s) 653

    Abstract: Background: In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks' postmenstrual age, as ... ...

    Abstract Background: In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks' postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment.
    Methods: Of the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks' postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children's Abilities-Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all.
    Discussion: Follow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. To decrease the risk of generalisation and data-driven biased conclusions, we present a detailed description of the methodology for the SafeBoosC-III follow-up study. As funding is limited, a pragmatic approach is necessary.
    Trial registration: ClinicalTrials.gov NCT05134116 . Registered on 24 November 2021.
    MeSH term(s) Infant ; Child ; Infant, Newborn ; Humans ; Child, Preschool ; Adolescent ; Young Adult ; Adult ; Infant, Extremely Premature ; Oximetry/methods ; Follow-Up Studies ; Cerebrovascular Circulation ; Brain Injuries ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2023-10-07
    Publishing country England
    Document type Clinical Trial Protocol ; 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/s13063-023-07653-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III

    Mathias Lühr Hansen / Marie Isabel Rasmussen / Snorre Rubin / Adelina Pellicer / Guoqiang Cheng / Xin Xu / Yin Zhaoqing / Vibeke Zoffmann / Gorm Greisen

    Trials, Vol 21, Iss 1, Pp 1-

    2020  Volume 13

    Abstract: Abstract Background SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus ... ...

    Abstract Abstract Background SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and monitoring as usual. To ensure high quality of the trial intervention as well as of patient care, we have developed a multilingual web-based training program to train relevant staff and test their competence. As we enter an under-explored area of e-learning, we have conducted a pilot study on the first of the five modules comprising the web-based training program to test the feasibility of developing such a program for an international trial with limited resources. Methods The module in this study focuses on the principles and practice of NIRS monitoring. The pedagogical idea was to integrate training and certification. One-hundred doctors and nurses from five Neonatal Intensive Care Units across China, Spain and Denmark were invited to participate in the pilot study. Upon completion of the NIRS module, participants were invited to evaluate their experience by completing an online survey. Data from closed-ended questions were analysed using descriptive statistics while data from open-ended questions underwent thematic analysis. Results In total, 81 of 100 invited staff members entered the training module and completed the online survey. The median time and the number of questions to pass the module was 15 minutes and seven questions, respectively. Most staff found the academic level of the learning material and quiz appropriate (85% and 93% of all staff members, respectively), as well as agreeing that the module was relevant to prepare them to ‘use the NIRS device’ (90%). Thematic analysis revealed issues such as a discrepancy between learning material and quiz questions, lack of clarity, and technical issues. Conclusion We provide evidence of the feasibility of developing a multilingual web-based training program for an international trial, despite challenges such as low budget, language barriers and possibly differences in the clinical training of staff. Exploring the integration of training and certification for international trials, the positive results of this study motivate further developments. Trial registration ClinicalTrial.gov, NCT03770741 . Registered 10 December 2018.
    Keywords SafeBoosC ; Randomised clinical trial ; Randomized clinical trial ; RCT ; Extremely preterm ; Near-infrared spectroscopy ; Medicine (General) ; R5-920
    Subject code 370
    Language English
    Publishing date 2020-04-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

    Hansen, Mathias Lühr / Rasmussen, Marie Isabel / Rubin, Snorre / Pellicer, Adelina / Cheng, Guoqiang / Xu, Xin / Zhaoqing, Yin / Zoffmann, Vibeke / Greisen, Gorm

    Trials

    2020  Volume 21, Issue 1, Page(s) 356

    Abstract: Background: SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and ... ...

    Abstract Background: SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and monitoring as usual. To ensure high quality of the trial intervention as well as of patient care, we have developed a multilingual web-based training program to train relevant staff and test their competence. As we enter an under-explored area of e-learning, we have conducted a pilot study on the first of the five modules comprising the web-based training program to test the feasibility of developing such a program for an international trial with limited resources.
    Methods: The module in this study focuses on the principles and practice of NIRS monitoring. The pedagogical idea was to integrate training and certification. One-hundred doctors and nurses from five Neonatal Intensive Care Units across China, Spain and Denmark were invited to participate in the pilot study. Upon completion of the NIRS module, participants were invited to evaluate their experience by completing an online survey. Data from closed-ended questions were analysed using descriptive statistics while data from open-ended questions underwent thematic analysis.
    Results: In total, 81 of 100 invited staff members entered the training module and completed the online survey. The median time and the number of questions to pass the module was 15 minutes and seven questions, respectively. Most staff found the academic level of the learning material and quiz appropriate (85% and 93% of all staff members, respectively), as well as agreeing that the module was relevant to prepare them to 'use the NIRS device' (90%). Thematic analysis revealed issues such as a discrepancy between learning material and quiz questions, lack of clarity, and technical issues.
    Conclusion: We provide evidence of the feasibility of developing a multilingual web-based training program for an international trial, despite challenges such as low budget, language barriers and possibly differences in the clinical training of staff. Exploring the integration of training and certification for international trials, the positive results of this study motivate further developments.
    Trial registration: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.
    MeSH term(s) Brain/diagnostic imaging ; China ; Denmark ; Education, Distance/methods ; Education, Medical, Continuing/methods ; Education, Nursing/methods ; Feasibility Studies ; Female ; Humans ; Infant, Extremely Premature/physiology ; Infant, Newborn ; Intensive Care Units, Neonatal ; Male ; Oximetry/methods ; Pilot Projects ; Randomized Controlled Trials as Topic ; Spain ; Spectroscopy, Near-Infrared/methods ; Surveys and Questionnaires
    Keywords covid19
    Language English
    Publishing date 2020-04-23
    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/s13063-020-4206-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Processed meat intake and chronic disease morbidity and mortality: An overview of systematic reviews and meta-analyses.

    Händel, Mina Nicole / Cardoso, Isabel / Rasmussen, Katrine Marie / Rohde, Jeanett Friis / Jacobsen, Ramune / Nielsen, Sabrina Mai / Christensen, Robin / Heitmann, Berit Lilienthal

    PloS one

    2019  Volume 14, Issue 10, Page(s) e0223883

    Abstract: Despite the nutritional value of meat, a large volume of reviews and meta-analyses suggests that processed meat intake is associated with an increased risk of chronic diseases. However, assessments of the quality of these published reviews internal ... ...

    Abstract Despite the nutritional value of meat, a large volume of reviews and meta-analyses suggests that processed meat intake is associated with an increased risk of chronic diseases. However, assessments of the quality of these published reviews internal validity are generally lacking. We systematically reviewed and assessed the quality alongside summarizing the results of previously published systematic reviews and meta-analyses that examined the association between processed meat intake and cancers, type II diabetes (T2D), and cardiovascular diseases (CVD). Reviews and meta-analyses published until May 2018 were identified through a systematic literature search in the databases MEDLINE and EMBASE, and reference lists of included reviews. The quality of the systematic reviews and meta-analyses was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR). All eligible reviews had to comply with two quality requirements: providing sufficient information on quality assessment of the primary studies and a comprehensive search. The results were summarized for T2D, CVD, and each of the different cancer types. The certainty in the estimates of the individual outcomes was rated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method. In total, 22 systematic reviews were eligible and thus included in this review. More than 100 reviews were excluded because quality assessment of the primary studies had not been performed. The AMSTAR score of the included reviews ranged from 5 to 8 indicating moderate quality. Overall, the quality assessments of primary studies of the reviews are generally lacking; the scientific quality of the systematic reviews reporting positive associations between processed meat intake and risk of various cancers, T2D and CVD is moderate, and the results from case-control studies suggest more often a positive association than the results from cohort studies. The overall certainty in the evidence was very low across all individual outcomes, due to serious risk of bias and imprecision.
    MeSH term(s) Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/mortality ; Chronic Disease ; Databases, Factual ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/epidemiology ; Diabetes Mellitus, Type 2/mortality ; Humans ; Meat Products/analysis ; Meat Products/toxicity ; Neoplasms/diagnosis ; Neoplasms/epidemiology ; Neoplasms/mortality ; Risk Factors
    Language English
    Publishing date 2019-10-17
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Systematic Review
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0223883
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: KCNA2 IgG autoimmunity in neuropsychiatric diseases.

    Arlt, Friederike A / Miske, Ramona / Machule, Marie-Luise / Broegger Christensen, Peter / Mindorf, Swantje / Teegen, Bianca / Borowski, Kathrin / Buthut, Maria / Rößling, Rosa / Sánchez-Sendín, Elisa / van Hoof, Scott / Cordero-Gómez, César / Bünger, Isabel / Radbruch, Helena / Kraft, Andrea / Ayzenberg, Ilya / Klausewitz, Jaqueline / Hansen, Niels / Timäus, Charles /
    Körtvelyessy, Peter / Postert, Thomas / Baur-Seack, Kirsten / Rost, Constanze / Brunkhorst, Robert / Doppler, Kathrin / Haigis, Niklas / Hamann, Gerhard / Kunze, Albrecht / Stützer, Alexandra / Maschke, Matthias / Melzer, Nico / Rosenow, Felix / Siebenbrodt, Kai / Stenør, Christian / Dichgans, Martin / Georgakis, Marios K / Fang, Rong / Petzold, Gabor C / Görtler, Michael / Zerr, Inga / Wunderlich, Silke / Mihaljevic, Ivan / Turko, Paul / Schmidt Ettrup, Marianne / Buchholz, Emilie / Foverskov Rasmussen, Helle / Nasouti, Mahoor / Talucci, Ivan / Maric, Hans M / Heinemann, Stefan H / Endres, Matthias / Komorowski, Lars / Prüss, Harald

    Brain, behavior, and immunity

    2024  Volume 117, Page(s) 399–411

    Abstract: Background: Autoantibodies against the potassium voltage-gated channel subfamily A member 2 (KCNA2) have been described in a few cases of neuropsychiatric disorders, but their diagnostic and pathophysiological role is currently unknown, imposing ... ...

    Abstract Background: Autoantibodies against the potassium voltage-gated channel subfamily A member 2 (KCNA2) have been described in a few cases of neuropsychiatric disorders, but their diagnostic and pathophysiological role is currently unknown, imposing challenges to medical practice.
    Design / methods: We retrospectively collected comprehensive clinical and paraclinical data of 35 patients with KCNA2 IgG autoantibodies detected in cell-based and tissue-based assays. Patients' sera and cerebrospinal fluid (CSF) were used for characterization of the antigen, clinical-serological correlations, and determination of IgG subclasses.
    Results: KCNA2 autoantibody-positive patients (n = 35, median age at disease onset of 65 years, range of 16-83 years, 74 % male) mostly presented with cognitive impairment and/or epileptic seizures but also ataxia, gait disorder and personality changes. Serum autoantibodies belonged to IgG3 and IgG1 subclasses and titers ranged from 1:32 to 1:10,000. KCNA2 IgG was found in the CSF of 8/21 (38 %) patients and in the serum of 4/96 (4.2 %) healthy blood donors. KCNA2 autoantibodies bound to characteristic anatomical areas in the cerebellum and hippocampus of mammalian brain and juxtaparanodal regions of peripheral nerves but reacted exclusively with intracellular epitopes. A subset of four KCNA2 autoantibody-positive patients responded markedly to immunotherapy alongside with conversion to seronegativity, in particular those presenting an autoimmune encephalitis phenotype and receiving early immunotherapy. An available brain biopsy showed strong immune cell invasion. KCNA2 autoantibodies occurred in less than 10 % in association with an underlying tumor.
    Conclusion: Our data suggest that KCNA2 autoimmunity is clinically heterogeneous. Future studies should determine whether KCNA2 autoantibodies are directly pathogenic or develop secondarily. Early immunotherapy should be considered, in particular if autoantibodies occur in CSF or if clinical or diagnostic findings suggest ongoing inflammation. Suspicious clinical phenotypes include autoimmune encephalitis, atypical dementia, new-onset epilepsy and unexplained epileptic seizures.
    MeSH term(s) Animals ; Humans ; Male ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Female ; Autoimmunity ; Retrospective Studies ; Autoantibodies ; Seizures ; Autoimmune Diseases of the Nervous System ; Mammals ; Kv1.2 Potassium Channel ; Encephalitis ; Hashimoto Disease
    Chemical Substances Autoantibodies ; KCNA2 protein, human ; Kv1.2 Potassium Channel
    Language English
    Publishing date 2024-02-02
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639219-2
    ISSN 1090-2139 ; 0889-1591
    ISSN (online) 1090-2139
    ISSN 0889-1591
    DOI 10.1016/j.bbi.2024.01.220
    Database MEDical Literature Analysis and Retrieval System OnLINE

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