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  1. Article ; Online: Consider pregnancy in COVID-19 therapeutic drug and vaccine trials.

    Whitehead, Clare L / Walker, Susan P

    Lancet (London, England)

    2020  Volume 395, Issue 10237, Page(s) e92

    MeSH term(s) Betacoronavirus ; COVID-19 ; COVID-19 Vaccines ; Clinical Trials as Topic ; Coronavirus Infections/drug therapy ; Coronavirus Infections/prevention & control ; Female ; Humans ; Pandemics/prevention & control ; Patient Selection ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/prevention & control ; Pregnancy ; Pregnant Women ; SARS-CoV-2 ; Viral Vaccines
    Chemical Substances COVID-19 Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-05-13
    Publishing country England
    Document type Letter
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(20)31029-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Statistical analyses of ordinal outcomes in randomised controlled trials: a scoping review.

    Selman, Chris J / Lee, Katherine J / Ferguson, Kristin N / Whitehead, Clare L / Manley, Brett J / Mahar, Robert K

    Trials

    2024  Volume 25, Issue 1, Page(s) 241

    Abstract: Background: Randomised controlled trials (RCTs) aim to estimate the causal effect of one or more interventions relative to a control. One type of outcome that can be of interest in an RCT is an ordinal outcome, which is useful to answer clinical ... ...

    Abstract Background: Randomised controlled trials (RCTs) aim to estimate the causal effect of one or more interventions relative to a control. One type of outcome that can be of interest in an RCT is an ordinal outcome, which is useful to answer clinical questions regarding complex and evolving patient states. The target parameter of interest for an ordinal outcome depends on the research question and the assumptions the analyst is willing to make. This review aimed to provide an overview of how ordinal outcomes have been used and analysed in RCTs.
    Methods: The review included RCTs with an ordinal primary or secondary outcome published between 2017 and 2022 in four highly ranked medical journals (the British Medical Journal, New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association) identified through PubMed. Details regarding the study setting, design, the target parameter, and statistical methods used to analyse the ordinal outcome were extracted.
    Results: The search identified 309 studies, of which 144 were eligible for inclusion. The most used target parameter was an odds ratio, reported in 78 (54%) studies. The ordinal outcome was dichotomised for analysis in 47 (
    Conclusions: The results of this review indicate that in RCTs that use an ordinal outcome, there is variation in the target parameter and the analytical approaches used, with many dichotomising the ordinal outcome. Few studies provided assurance regarding the appropriateness of the assumptions and methods used to analyse the ordinal outcome. More guidance is needed to improve the transparent reporting of the analysis of ordinal outcomes in future trials.
    MeSH term(s) United States ; Humans ; Research Design ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2024-04-06
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-024-08072-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Statistical analyses of ordinal outcomes in randomised controlled trials: protocol for a scoping review.

    Selman, Chris J / Lee, Katherine J / Whitehead, Clare L / Manley, Brett J / Mahar, Robert K

    Trials

    2023  Volume 24, Issue 1, Page(s) 286

    Abstract: Introduction: Randomised controlled trials (RCTs) aim to assess the effect of one (or more) unproven health interventions relative to other reference interventions. RCTs sometimes use an ordinal outcome, which is an endpoint that comprises of multiple, ... ...

    Abstract Introduction: Randomised controlled trials (RCTs) aim to assess the effect of one (or more) unproven health interventions relative to other reference interventions. RCTs sometimes use an ordinal outcome, which is an endpoint that comprises of multiple, monotonically ordered categories that are not necessarily separated by a quantifiable distance. Ordinal outcomes are appealing in clinical settings as specific disease states can represent meaningful categories that may be of clinical importance to researchers. Ordinal outcomes can also retain information and increase statistical power compared to dichotomised outcomes and can allow multiple clinical outcomes to be comprised in a single endpoint. Target parameters for ordinal outcomes in RCTs may vary depending on the nature of the research question, the modelling assumptions and the expertise of the data analyst. The aim of this scoping review is to systematically describe the use of ordinal outcomes in contemporary RCTs. Specifically, we aim to: [Formula: see text] Identify which target parameters are of interest in trials that use an ordinal outcome, and whether these parameters are explicitly defined. [Formula: see text] Describe how ordinal outcomes are analysed in RCTs to estimate a treatment effect. [Formula: see text] Describe whether RCTs that use an ordinal outcome adequately report key methodological aspects specific to the analysis of the ordinal outcome. Results from this review will outline the current state of practice of the use of ordinal outcomes in RCTs. Ways to improve the analysis and reporting of ordinal outcomes in RCTs will be discussed.
    Methods and analysis: We will review RCTs that are published in the top four medical journals (British Medical Journal, New England Journal of Medicine, The Lancet and the Journal of the American Medical Association) between 1 January 2012 and 31 July 2022 that use an ordinal outcome as either a primary or a secondary outcome. The review will identify articles through a PubMed-specific search strategy. Our review will adhere to guidelines for scoping reviews as described in the PRISMA-ScR checklist. The study characteristics and details of the study design and analysis, including the target parameter(s) and statistical methods used to analyse the ordinal outcome, will be extracted from eligible studies. The screening, review and data extraction will be conducted using Covidence, a web-based tool for managing systematic reviews. The data will be summarised using descriptive statistics.
    MeSH term(s) Humans ; Checklist ; Randomized Controlled Trials as Topic ; Research Design ; Review Literature as Topic ; United States
    Language English
    Publishing date 2023-04-21
    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/s13063-023-07262-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Consider pregnancy in COVID-19 therapeutic drug and vaccine trials

    Whitehead, Clare L / Walker, Susan P

    The Lancet

    2020  Volume 395, Issue 10237, Page(s) e92

    Keywords General Medicine ; covid19
    Language English
    Publisher Elsevier BV
    Publishing country us
    Document type Article ; Online
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/s0140-6736(20)31029-1
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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  6. Article ; Online: Obesity: Maternal obesity and congenital anomalies - risk and diagnosis.

    Dodd, Jodie M / Whitehead, Clare L

    Nature reviews. Endocrinology

    2017  Volume 13, Issue 9, Page(s) 504–506

    MeSH term(s) Cohort Studies ; Female ; Humans ; Obesity ; Overweight ; Pregnancy
    Language English
    Publishing date 2017-08-04
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 2489381-X
    ISSN 1759-5037 ; 1759-5029
    ISSN (online) 1759-5037
    ISSN 1759-5029
    DOI 10.1038/nrendo.2017.100
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Author Correction: Pre-eclampsia.

    Dimitriadis, Evdokia / Rolnik, Daniel L / Zhou, Wei / Estrada-Gutierrez, Guadalupe / Koga, Kaori / Francisco, Rossana P V / Whitehead, Clare / Hyett, Jon / da Silva Costa, Fabricio / Nicolaides, Kypros / Menkhorst, Ellen

    Nature reviews. Disease primers

    2023  Volume 9, Issue 1, Page(s) 35

    Language English
    Publishing date 2023-07-03
    Publishing country England
    Document type Published Erratum
    ISSN 2056-676X
    ISSN (online) 2056-676X
    DOI 10.1038/s41572-023-00451-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: High-affinity tamoxifen analogues retain extensive positional disorder when bound to calmodulin.

    Milanesi, Lilia / Trevitt, Clare R / Whitehead, Brian / Hounslow, Andrea M / Tomas, Salvador / Hosszu, Laszlo L P / Hunter, Christopher A / Waltho, Jonathan P

    Magnetic resonance (Gottingen, Germany)

    2021  Volume 2, Issue 2, Page(s) 629–642

    Abstract: Using a combination of NMR and fluorescence measurements, we have investigated the structure and dynamics of the complexes formed between calcium-loaded calmodulin (CaM) and the potent breast cancer inhibitor idoxifene, a derivative of tamoxifen. High- ... ...

    Abstract Using a combination of NMR and fluorescence measurements, we have investigated the structure and dynamics of the complexes formed between calcium-loaded calmodulin (CaM) and the potent breast cancer inhibitor idoxifene, a derivative of tamoxifen. High-affinity binding (
    Language English
    Publishing date 2021-08-13
    Publishing country Germany
    Document type Journal Article
    ISSN 2699-0016
    ISSN (online) 2699-0016
    DOI 10.5194/mr-2-629-2021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Risk of recurrent shoulder dystocia: are we any closer to prediction?

    Al-Hawash, Shadha / Whitehead, Clare L / Farine, Dan

    The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

    2018  Volume 32, Issue 17, Page(s) 2928–2934

    Abstract: Objective: ...

    Abstract Objective:
    MeSH term(s) Birth Weight ; Cohort Studies ; Delivery, Obstetric/adverse effects ; Delivery, Obstetric/statistics & numerical data ; Female ; Humans ; Pregnancy ; Recurrence ; Risk Factors ; Shoulder Dystocia/diagnosis ; Shoulder Dystocia/epidemiology ; Shoulder Dystocia/prevention & control
    Language English
    Publishing date 2018-03-27
    Publishing country England
    Document type Journal Article ; Systematic Review
    ZDB-ID 2077261-0
    ISSN 1476-4954 ; 1057-0802 ; 1476-7058
    ISSN (online) 1476-4954
    ISSN 1057-0802 ; 1476-7058
    DOI 10.1080/14767058.2018.1450382
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Reduction in spontaneous and iatrogenic preterm births in twin pregnancies during COVID-19 lockdown in Melbourne, Australia: a multicenter cohort study.

    Manno, Juliana M / Marzan, Melvin B / Rolnik, Daniel L / Potenza, Stephanie / Pritchard, Natasha / Said, Joanne M / Palmer, Kirsten R / Whitehead, Clare L / Sheehan, Penelope M / Ford, Jolyon / Mol, Ben W / Walker, Susan P / Hui, Lisa

    BMC pregnancy and childbirth

    2023  Volume 23, Issue 1, Page(s) 846

    Abstract: Background: Melbourne, Australia, recorded one of the longest and most stringent pandemic lockdowns in 2020, which was associated with an increase in preterm stillbirths among singleton pregnancies. Twin pregnancies may be particularly susceptible to ... ...

    Abstract Background: Melbourne, Australia, recorded one of the longest and most stringent pandemic lockdowns in 2020, which was associated with an increase in preterm stillbirths among singleton pregnancies. Twin pregnancies may be particularly susceptible to the impacts of pandemic disruptions to maternity care due to their higher background risk of adverse perinatal outcomes.
    Methods: Multicenter retrospective cohort study of all twin pregnancies birthing in public maternity hospitals in Melbourne. Multivariable log-binomial regression models were used to compare perinatal outcomes between a pre-pandemic group to women in whom weeks 20
    Results: Total preterm births < 37 weeks were significantly lower in exposure 1 compared with the pre-pandemic period (63.1% vs 68.3%; adjusted risk ratio 0.92 95% CI 0.87-0.98, p = 0.01). This was mainly driven by fewer spontaneous preterm births (18.9% vs 20.3%; adjusted risk ratio 0.95 95% CI 0.90-0.99, p = 0.04). There were also lower rates of preterm birth < 34 weeks (19.9% vs 23.0%, adjusted risk ratio 0.93 95% CI 0.89-0.98 p = 0.01) and total iatrogenic births for fetal compromise (13.4% vs 20.4%; adjusted risk ratio 0.94 95% CI 0.89-0.98, p = 0.01). There were fewer special care nursery admissions (38.5% vs 43.4%; adjusted risk ratio 0.91 95% CI 0.87-0.95, p < 0.001) but no significant changes in stillbirth (1.5% vs 1.6%; adjusted risk ratio 1.00 95% CI 0.99-1.01, p = 0.82). Compared with the pre-pandemic period, there were more preterm births < 28 weeks and neonatal intensive care unit admissions in exposure 2.
    Conclusions: Melbourne's first lockdown-exposure period was associated with lower preterm births in twins without significant differences in adverse newborn outcomes. Our findings provide insights into the influences on preterm birth and the optimal timing of delivery for twins.
    MeSH term(s) Pregnancy ; Female ; Infant, Newborn ; Humans ; Premature Birth/epidemiology ; Pregnancy, Twin ; Retrospective Studies ; COVID-19/epidemiology ; COVID-19/prevention & control ; Communicable Disease Control ; Maternal Health Services ; Stillbirth/epidemiology ; Iatrogenic Disease ; Pregnancy Outcome/epidemiology
    Language English
    Publishing date 2023-12-11
    Publishing country England
    Document type Multicenter Study ; Journal Article
    ZDB-ID 2059869-5
    ISSN 1471-2393 ; 1471-2393
    ISSN (online) 1471-2393
    ISSN 1471-2393
    DOI 10.1186/s12884-023-06137-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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