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  1. Article ; Online: Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development

    Fiona A. Quirke / Patricia Healy / Elaine Ní Bhraonáin / Mandy Daly / Linda Biesty / Tim Hurley / Karen Walker / Shireen Meher / David M. Haas / Frank H. Bloomfield / Jamie J. Kirkham / Eleanor J. Molloy / Declan Devane

    Trials, Vol 22, Iss 1, Pp 1-

    a randomised trial

    2021  Volume 9

    Abstract: Abstract Background The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants’ survey ... ...

    Abstract Abstract Background The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants’ survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy. Methods One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects. Discussion This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods. Trial registration NCT04471103 . Registered on 14 July 2020.
    Keywords Real-Time Delphi ; Multi-Round Delphi ; Core outcome sets ; Methodology ; Randomised trial ; Medicine (General) ; R5-920
    Language English
    Publishing date 2021-02-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: COHESION

    Fiona A. Quirke / Patricia Healy / Elaine Ní Bhraonáin / Mandy Daly / Linda Biesty / Tim Hurley / Karen Walker / Shireen Meher / David M. Haas / Frank H. Bloomfield / Jamie J. Kirkham / Eleanor J. Molloy / Declan Devane

    Trials, Vol 22, Iss 1, Pp 1-

    core outcomes in neonatal encephalopathy (protocol)

    2021  Volume 11

    Abstract: Abstract Background Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or ... ...

    Abstract Abstract Background Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. Methods We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a “Real-Time” Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). Discussion More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve ...
    Keywords Core outcome set ; High-income countries ; Low- to middle-income countries ; Delphi ; Real-time Delphi ; PPI ; Medicine (General) ; R5-920
    Language English
    Publishing date 2021-02-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: What is the definition of acute episodic and chronic pain in critically ill neonates and infants? A global, four-stage consensus and validation study

    Marsha Campbell-Yeo / Mandy Daly / Verity Pacey / Vibhuti Shah / Kaye Spence / Kanwaljeet J S Anand / Bonnie J Stevens / Mats Eriksson / Laura Brown / Emre Ilhan / Christ-jan van Ganzewinkel / Rebecca Pillai Riddell / Carlo Bellieni / Celeste Johnston / Julia Hush

    BMJ Open, Vol 12, Iss

    2022  Volume 3

    Keywords Medicine ; R
    Language English
    Publishing date 2022-03-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Protocol for the development of a core outcome set for neonatal sepsis (NESCOS)

    Petek Eylul Taneri / Jamie J. Kirkham / Eleanor J. Molloy / Linda Biesty / Richard A. Polin / James L. Wynn / Barbara J. Stoll / Niranjan Kissoon / Kondwani Kawaza / Mandy Daly / Aoife Branagan / Lívia Nagy Bonnard / Eric Giannoni / Tobias Strunk / Magdalena Ohaja / Kenneth Mugabe / Denise Suguitani / Fiona Quirke / Declan Devane

    PLoS ONE, Vol 18, Iss

    2023  Volume 12

    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Protocol for the development of a core outcome set for neonatal sepsis (NESCOS).

    Petek Eylul Taneri / Jamie J Kirkham / Eleanor J Molloy / Linda Biesty / Richard A Polin / James L Wynn / Barbara J Stoll / Niranjan Kissoon / Kondwani Kawaza / Mandy Daly / Aoife Branagan / Lívia Nagy Bonnard / Eric Giannoni / Tobias Strunk / Magdalena Ohaja / Kenneth Mugabe / Denise Suguitani / Fiona Quirke / Declan Devane

    PLoS ONE, Vol 18, Iss 12, p e

    2023  Volume 0295325

    Abstract: Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for ... ...

    Abstract Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients' parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.
    Keywords Medicine ; R ; Science ; Q
    Subject code 306
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Core Outcome Set for GROwth restriction

    Patricia Healy / Sanne Gordijn / Wessel Ganzevoort / Irene Beune / Ahmet Baschat / Asma Khalil / Louise Kenny / Frank Bloomfield / Mandy Daly / Aris Papageorghiou / Declan Devane

    Trials, Vol 19, Iss 1, Pp 1-

    deVeloping Endpoints (COSGROVE)

    2018  Volume 7

    Abstract: Abstract Background Foetal growth restriction (FGR) refers to a foetus that does not reach its genetically predetermined growth potential. It is well recognised that growth-restricted foetuses are at increased risk of stillbirth, foetal compromise, early ...

    Abstract Abstract Background Foetal growth restriction (FGR) refers to a foetus that does not reach its genetically predetermined growth potential. It is well recognised that growth-restricted foetuses are at increased risk of stillbirth, foetal compromise, early neonatal death and neonatal morbidity. Later in life, they are prone to health problems, including increased risk of cardiovascular diseases and neurodevelopmental disorders. Interventions for preventing and treating FGR have been studied in many trials, but evidence is often difficult to synthesise and compare because of differences in the selection and definition of outcomes. To enable future trials to measure similar, meaningful outcomes, we are developing two core outcome sets (COS) – one for prevention and the other for treatment of FGR. Methods We will review the literature to identify previously reported outcomes. An international panel of relevant stakeholders who have experience of FGR (parent or carer of a baby that was growth restricted, health professional involved in the care of mothers and babies affected by FGR, a person with expertise in FGR research) will rate the importance of each of those outcomes in a series of three sequential online rounds of a Delphi study. Participants will be able to add items to the proposed list in round 1. A final face-to-face consensus meeting will be held with representatives of each stakeholder group at which a final list of outcomes for inclusion in the COS will be agreed. Discussion The development of COSs in FGR will ensure the collection and reporting of a minimum dataset agreed by stakeholder consensus and will reduce inconsistencies in the reporting of outcomes across relevant trials. Such standardisation in the reporting of outcomes will improve synthesis of evidence and generalisability of knowledge in the future by reducing heterogeneity in outcomes between trials and thus improve the results of systematic reviews and meta-analyses. Ultimately, we hope that the COSs will lead to an improvement in the ...
    Keywords Core outcome sets ; Delphi ; Methodology ; Foetal growth restriction ; Pregnancy ; Medicine (General) ; R5-920
    Subject code 300
    Language English
    Publishing date 2018-08-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: The international Perinatal Outcomes in the Pandemic (iPOP) study

    Sarah J. Stock / Helga Zoega / Meredith Brockway / Rachel H. Mulholland / Jessica E. Miller / Jasper V. Been / Rachael Wood / Ishaya I. Abok / Belal Alshaikh / Adejumoke I. Ayede / Fabiana Bacchini / Zulfiqar A. Bhutta / Bronwyn K. Brew / Jeffrey Brook / Clara Calvert / Marsha Campbell-Yeo / Deborah Chan / James Chirombo / Kristin L. Connor /
    Mandy Daly / Kristjana Einarsdóttir / Ilaria Fantasia / Meredith Franklin / Abigail Fraser / Siri Eldevik Håberg / Lisa Hui / Luis Huicho / Maria C. Magnus / Andrew D. Morris / Livia Nagy-Bonnard / Natasha Nassar / Sylvester Dodzi Nyadanu / Dedeke Iyabode Olabisi / Kirsten R. Palmer / Lars Henning Pedersen / Gavin Pereira / Amy Racine-Poon / Manon Ranger / Tonia Rihs / Christoph Saner / Aziz Sheikh / Emma M. Swift / Lloyd Tooke / Marcelo L. Urquia / Clare Whitehead / Christopher Yilgwan / Natalie Rodriguez / David Burgner / Meghan B. Azad / iPOP Study Team

    Wellcome Open Research, Vol

    protocol [version 1; peer review: 2 approved]

    2021  Volume 6

    Abstract: Preterm birth is the leading cause of infant death worldwide, but the causes of preterm birth are largely unknown. During the early COVID-19 lockdowns, dramatic reductions in preterm birth were reported; however, these trends may be offset by increases ... ...

    Abstract Preterm birth is the leading cause of infant death worldwide, but the causes of preterm birth are largely unknown. During the early COVID-19 lockdowns, dramatic reductions in preterm birth were reported; however, these trends may be offset by increases in stillbirth rates. It is important to study these trends globally as the pandemic continues, and to understand the underlying cause(s). Lockdowns have dramatically impacted maternal workload, access to healthcare, hygiene practices, and air pollution - all of which could impact perinatal outcomes and might affect pregnant women differently in different regions of the world. In the international Perinatal Outcomes in the Pandemic (iPOP) Study, we will seize the unique opportunity offered by the COVID-19 pandemic to answer urgent questions about perinatal health. In the first two study phases, we will use population-based aggregate data and standardized outcome definitions to: 1) Determine rates of preterm birth, low birth weight, and stillbirth and describe changes during lockdowns; and assess if these changes are consistent globally, or differ by region and income setting, 2) Determine if the magnitude of changes in adverse perinatal outcomes during lockdown are modified by regional differences in COVID-19 infection rates, lockdown stringency, adherence to lockdown measures, air quality, or other social and economic markers, obtained from publicly available datasets. We will undertake an interrupted time series analysis covering births from January 2015 through July 2020. The iPOP Study will involve at least 121 researchers in 37 countries, including obstetricians, neonatologists, epidemiologists, public health researchers, environmental scientists, and policymakers. We will leverage the most disruptive and widespread “natural experiment” of our lifetime to make rapid discoveries about preterm birth. Whether the COVID-19 pandemic is worsening or unexpectedly improving perinatal outcomes, our research will provide critical new information to shape prenatal care ...
    Keywords Medicine ; R ; Science ; Q
    Subject code 306
    Language English
    Publishing date 2021-02-01T00:00:00Z
    Publisher Wellcome
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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