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All Outputs (73)

Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial (2022)
Journal Article
Beardmore-Gray, A., Greenland, M., Linsell, L., Juszczak, E., Hardy, P., Placzek, A., …the PHOENIX Study Group. (2022). Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology, 129(10), 1654-1663. https://doi.org/10.1111/1471-0528.17167

Objective: We evaluated the best time to initiate delivery in late preterm pre-eclampsia in order to optimise long-term infant and maternal outcomes. Design: Parallel-group, non-masked, randomised controlled trial. Setting: Forty-six maternity units... Read More about Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial.

Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT (2022)
Journal Article
Maheshwari, A., Bari, V., Bell, J. L., Bhattacharya, S., Bhide, P., Bowler, U., …Troup, S. (2022). Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT. Health Technology Assessment, 26(25), 1-142. https://doi.org/10.3310/AEFU1104

Background Freezing all embryos, followed by thawing and transferring them into the uterine cavity at a later stage (freeze-all), instead of fresh-embryo transfer may lead to improved pregnancy rates and fewer complications during in vitro fertilisa... Read More about Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT.

The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure (2022)
Journal Article
Gordon, A. L., Rick, C., Juszczak, E., Montgomery, A., Howard, R., Guthrie, B., …Tate, V. (2022). The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure. Age and Ageing, 51(3), Article afac052. https://doi.org/10.1093/ageing/afac052

The COVID-19 pandemic resulted in catastrophic levels of morbidity and mortality for care home residents. Despite this, research platforms for COVID-19 in care homes arrived late in the pandemic compared with other care settings. The Prophylactic The... Read More about The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure.

Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2022)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Mafham, M., Peto, L., Campbell, M., Pessoa-Amorim, G., …Landray, M. J. (2022). Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10325), 665-676. https://doi.org/10.1016/S0140-6736%2822%2900163-5

Background: Casirivimab and imdevimab are non-competing monoclonal antibodies that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike glycoprotein, blocking viral entry into host cells. We aimed to evaluate the efficac... Read More about Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze) (2022)
Journal Article
Maheshwari, A., Bell, J. L., Bhide, P., Brison, D., Child, T., Chong, H. Y., …Bhattacharya, S. (2022). Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze). Human Reproduction, 37(3), 476-487. https://doi.org/10.1093/humrep/deab279

STUDY QUESTION: Does a policy of elective freezing of embryos, followed by frozen embryo transfer result in a higher healthy baby rate, after first embryo transfer, when compared with the current policy of transferring fresh embryos? SUMMARY ANSWER:... Read More about Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze).

First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis (2022)
Journal Article
Karim, J. N., Bradburn, E., Roberts, N., Papageorghiou, A. T., Alfirevic, Z., Chudleigh, T., …Yaz, G. (2022). First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis. Ultrasound in Obstetrics and Gynaecology, 59(1), 11-25. https://doi.org/10.1002/uog.23740

Objectives: To determine the diagnostic accuracy of ultrasound at 11–14 weeks' gestation in the detection of fetal cardiac abnormalities and to evaluate factors that impact the detection rate. Methods: This was a systematic review of studies evaluati... Read More about First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis.

An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial (2021)
Journal Article
Rochat, T. J., Dube, S., Herbst, K., Hoegfeldt, C. A., Redinger, S., Khoza, T., …Stein, A. (2021). An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial. Trials, 22(1), Article 914. https://doi.org/10.1186/s13063-021-05672-0

Background: The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Peri... Read More about An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial.

Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Pessoa-Amorim, G., Staplin, N., Emberson, J. R., Campbell, M., …Landray, M. J. (2022). Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10320), 143-151. https://doi.org/10.1016/S0140-6736%2821%2901825-0

Background Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19. Methods In this randomised,... Read More about Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Horby, P. W., Campbell, M., Spata, E., Emberson, J. R., Staplin, N., Pessoa-Amorim, G., …Landray, M. J. (2021). Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Respiratory Medicine, 9(12), 1419-1426. https://doi.org/10.1016/s2213-2600%2821%2900435-5

Background: Colchicine has been proposed as a treatment for COVID-19 based on its anti-inflammatory actions. We aimed to evaluate the efficacy and safety of colchicine in patients admitted to hospital with COVID-19. Methods: In this streamlined, rand... Read More about Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial (2021)
Journal Article
Fleminger, J., Duhig, K., Seed, P. T., Brocklehurst, P., Green, M., Juszczak, E., …Chappell, L. (2021). Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial. Pregnancy Hypertension, 26, 91-93. https://doi.org/10.1016/j.preghy.2021.10.002

This secondary analysis of the PHOENIX trial (evaluating planned delivery against expectant management in late preterm preeclampsia) demonstrates that in women who started induction of labour, 63% of women delivered vaginally (56% at 34 weeks’ gestat... Read More about Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial.

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results (2021)
Journal Article
Mc Cord, K. A., Imran, M., Rice, D. B., McCall, S. J., Kwakkenbos, L., Sampson, M., …Hemkens, L. G. (2022). Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. Journal of Clinical Epidemiology, 141, 175-186. https://doi.org/10.1016/j.jclinepi.2021.09.012

Objective: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries. Study Design and... Read More about Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results.

Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement (2021)
Journal Article
McCall, S. J., Imran, M., Hemkens, L. G., Mc Cord, K., Kwakkenbos, L., Sampson, M., …Juszczak, E. (2022). Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement. Journal of Clinical Epidemiology, 141, 198-209. https://doi.org/10.1016/j.jclinepi.2021.09.011

Objective To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using... Read More about Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement.

Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases (2021)
Journal Article
Langan, S. M., Imran, M., Mc Cord, K., McCall, S. J., Kwakkenbos, L., Sampson, M., …Thombs, B. D. (2022). Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases. Journal of Clinical Epidemiology, 141, 187-197. https://doi.org/10.1016/j.jclinepi.2021.09.010

Objective: We evaluated reporting completeness and transparency in randomized controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTIN... Read More about Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases.

Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (Trials, (2021), 22, 1, (368), 10.1186/s13063-021-05324-3) (2021)
Journal Article
Bell, J. L., Gupta, S., Juszczak, E., Hardy, P., & Linsell, L. (2021). Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (Trials, (2021), 22, 1, (368), 10.1186/s13063-021-05324-3). Trials, 22, Article 609. https://doi.org/10.1186/s13063-021-05409-z

Following the publication of the original article [1], It has come to the authors’ attention that some wording was changed prior to publication of the Statistical Analysis Plan from the original SAP which will be used in their analysis of data.

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT (2021)
Journal Article
Juszczak, E., Hewer, O., Partlett, C., Hurd, M., Bari, V., Bowler, U., …Stenson, B. (2021). Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT. Trials, 22(1), Article 554. https://doi.org/10.1186/s13063-021-05515-y

Background: Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, leading to potentially biased and... Read More about Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT.

A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: awaiting peer review] (2021)
Journal Article
McCarthy, E., O'Keeffe, L., Williamson, P. R., Sydes, M. R., Farrin, A., Lugg-Widger, F., …Kearney, P. M. (2021). A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: awaiting peer review]. HRB Open Research, 4, 1-7. https://doi.org/10.12688/hrbopenres.13314.1

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (2021)
Journal Article
Bell, J. L., Gupta, S., Juszczak, E., Hardy, P., & Linsell, L. (2021). Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes. Trials, 22, Article 368. https://doi.org/10.1186/s13063-021-05324-3

Background: The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analy... Read More about Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes.

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial (2021)
Journal Article
Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zyengi, S. (2021). Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet, 397(10289), 2049-2059. https://doi.org/10.1016/s0140-6736%2821%2900897-7

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This ran... Read More about Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zuriaga-Alvaro, A. (2021). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10285), 1637-1645. https://doi.org/10.1016/s0140-6736%2821%2900676-0

Background: We evaluated the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19... Read More about Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.