Skip to main content

Research Repository

Advanced Search

Professor ED JUSZCZAK's Outputs (84)

E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan (2020)
Journal Article
Bell, J. L., Hardy, P., Greenland, M., Juszczak, E., Cole, C., Maheshwari, A., Bhattacharya, S., & Linsell, L. (2020). E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan. Trials, 21(1), Article 596. https://doi.org/10.1186/s13063-020-04441-9

Background: The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial. Methods and de... Read More about E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.

Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report (2020)
Preprint / Working Paper
Horby, P., Lim, W. S., Emberson, J., Mafham, M., Bell, J., Linsell, L., Staplin, N., Brightling, C., Ustianowski, A., Elmahi, E., Prudon, B., Green, C., Felton, T., Chadwick, D., Rege, K., Fegan, C., Chappell, L. C., Faust, S. N., Jaki, T., Jeffery, K., …RECOVERY Collaborative Group. Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report

Background Coronavirus disease 2019 (COVID-19) is associated with diffuse lung damage. Corticosteroids may modulate immune-mediated lung injury and reducing progression to respiratory failure and death.

Methods The Randomised Evaluation of COVID-1... Read More about Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report.

Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT) (2020)
Journal Article
Tahir, W., Monahan, M., Dorling, J., Hewer, O., Bowler, U., Linsell, L., Partlett, C., Berrington, J. E., Boyle, E., Embleton, N., Johnson, S., Leaf, A., McCormick, K., McGuire, W., Stenson, B. J., Juszczak, E., & Roberts, T. E. (2020). Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT). Archives of Disease in Childhood. Fetal and Neonatal Edition, 105(6), 587-592. https://doi.org/10.1136/archdischild-2019-318346

Objective: To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants.
Design: Within-trial economic evaluation alongside a multicentre, two-arm parallel group,... Read More about Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).

Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT (2019)
Journal Article
Knight, M., Chiocchia, V., Partlett, C., Rivero-Arias, O., Hua, X., Bowler, U., Gray, J., Gray, S., Hinshaw, K., Khunda, A., Moore, P., Mottram, L., Owino, N., Pasupathy, D., Sanders, J., Sultan, A. H., Thakar, R., Tuffnell, D., Linsell, L., & Juszczak, E. (2019). Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT. Health Technology Assessment, 23(54), 1-54. https://doi.org/10.3310/hta23540

Background
Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence’s guid... Read More about Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT.

Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants (2019)
Journal Article
Dorling, J., Abbott, J., Berrington, J., Bosiak, B., Bowler, U., Boyle, E., Embleton, N., Hewer, O., Johnson, S., Juszczak, E., Leaf, A., Linsell, L., McCormick, K., McGuire, W., Omar, O., Partlett, C., Patel, M., Roberts, T., Stenson, B., & Townend, J. (2019). Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants. New England Journal of Medicine, 381(15), 1434-1443. https://doi.org/10.1056/NEJMoa1816654

Background
Observational data have shown that slowly advancing enteral feeds in preterm infants is associated with reduced risk for necrotizing enterocolitis but increased risk for late onset sepsis. However, randomized trial data are limited.
Me... Read More about Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants.

Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT (2019)
Journal Article
Yates, H., Chiocchia, V., Linsell, L., Orsi, N., Juszczak, E., Johnson, K., Chetcuti, P., Illingworth, C., Hardy, P., Monk, V., Newell, S., & Turner, M. (2019). Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. Efficacy and Mechanism Evaluation, 6(8), 1-52. https://doi.org/10.3310/eme06080

Background:
Postnatal corticosteroids are used to improve lung function and reduce the incidence of bronchopulmonary dysplasia (BPD) in preterm babies. However, corticosteroids may be associated with adverse neurodevelopment. Despite a lack of evide... Read More about Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT.

The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial (2019)
Journal Article
Gale, C., Modi, N., Jawad, S., Culshaw, L., Dorling, J., Bowler, U., Forster, A., King, A., McLeish, J., Linsell, L., Turner, M. A., Robberts, H., Stanbury, K., Van Staa, T., & Juszczak, E. (2019). The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial. BMJ Open, 9(9), Article e033543. https://doi.org/10.1136/bmjopen-2019-033543

Introduction Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell trans... Read More about The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial.

Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial (2019)
Journal Article
Chappell, L. C., Brocklehurst, P., Green, M. E., Hunter, R., Hardy, P., Juszczak, E., Linsell, L., Chiocchia, V., Greenland, M., Placzek, A., Townend, J., Marlow, N., Sandall, J., Shennan, A., Agarwal, U., Ahmed, I., Ajay, B., Alfirevic, Z., Arya, R., Bambridge, G., …Wu, P. (2019). Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. Lancet, 394(10204), 1181-1190. https://doi.org/10.1016/s0140-6736%2819%2931963-4

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease... Read More about Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial.

Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial (2019)
Journal Article
Chappell, L. C., Bell, J. L., Smith, A., Linsell, L., Juszczak, E., Dixon, P. H., Chambers, J., Hunter, R., Dorling, J., Williamson, C., Thornton, J. G., Ahmed, I., Arya, R., Beckett, V., Bhide, A., Brown, H., Bugg, G., Cameron, H., Deole, N., Dey, M., …Tan, B. (2019). Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet, 394(10201), 849-860. https://doi.org/10.1016/s0140-6736%2819%2931270-x

Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation (2019)
Journal Article
Maheshwari, A., Bhattacharya, S., Bowler, U., Brison, D., Child, T., Cole, C., Coomarasamy, A., Cutting, R., Harbottle, S., Hardy, P., Juszczak, E., Khalaf, Y., Kurinczuk, J. J., Lavery, S., Lewis-Jones, C., Macklon, N., Raine-Fenning, N. J., Rajkohwa, M., Scotland, G., & Troup, S. (2019). Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation. Reproductive Health, 16, 1-11. https://doi.org/10.1186/s12978-019-0737-2

Background: Infertility affects one in seven couples; many of these need in vitro fertilisation (IVF). IVF involves external hormones to stimulate a woman's ovaries to produce eggs which are harvested surgically. Embryos, created in the laboratory by... Read More about Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation.

Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial (2019)
Journal Article
Knight, M., Chiocchia, V., Partlett, C., Rivero-Arias, O., Hua, X., Hinshaw, K., Tuffnell, D., Linsell, L., & Juszczak, E. (2019). Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial. Lancet, 393(10189), 2395-2403. https://doi.org/10.1016/S0140-6736%2819%2930773-1

Background
Risk factors for maternal infection are clearly recognised, including caesarean section and operative vaginal birth. Antibiotic prophylaxis at caesarean section is widely recommended because there is clear systematic review evidence that... Read More about Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial.

Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement (2019)
Journal Article
Juszczak, E., Altman, D. G., Hopewell, S., & Schulz, K. (2019). Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. Journal of the American Medical Association, 321(16), 1610-1620. https://doi.org/10.1001/jama.2019.3087

© 2019 AMA. All rights reserved. Importance: The quality of reporting of randomized clinical trials is suboptimal. In an era in which the need for greater research transparency is paramount, inadequate reporting hinders assessment of the reliability... Read More about Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement.

Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol (2019)
Journal Article
Clarke, P., Craig, J. V., Wain, J., Tremlett, C., Linsell, L., Bowler, U., Juszczak, E., & Heath, P. T. (2019). Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol. BMJ Open, 9(2), Article e028022. https://doi.org/10.1136/bmjopen-2018-028022

Introduction
Catheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care ‘bundles’ has reduced the incidence of catheter-related seps... Read More about Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol.

Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial) (2019)
Journal Article
Chappell, L. C., Green, M., Marlow, N., Sandall, J., Hunter, R., Robson, S., Bowler, U., Chiocchia, V., Hardy, P., Juszczak, E., Linsell, L., Placzek, A., Brocklehurst, P., & Shennan, A. (2019). Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial). Trials, 20(1), Article 85. https://doi.org/10.1186/s13063-018-3150-1

Background: Pre-eclampsia is a pregnancy disorder, characterised by hypertension and multisystem complications in the mother. The adverse outcomes of pre-eclampsia include severe hypertension, stroke, renal and hepatic injury, haemorrhage, fetal grow... Read More about Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial).

Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial (2019)
Journal Article
Griffiths, J., Jenkins, P., Vargova, M., Bowler, U., Juszczak, E., King, A., Linsell, L., Murray, D., Partlett, C., Patel, M., Berrington, J., Dorling, J., Embleton, N. D., Heath, P. T., Oddie, S., McGuire, W., Ainsworth, S., Boyle, E., Clarke, P., Craig, S., …Manjunatha, C. (2019). Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial. Lancet, 393(10170), 423-433. https://doi.org/10.1016/s0140-6736%2818%2932221-9

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Infections acquired in hospital are an important cause of morbidity and mortality in very preterm infants. Several small tri... Read More about Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial.

Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial (2018)
Journal Article
Hartley, C., Moultrie, F., Hoskin, A., Green, G., Monk, V., Bell, J. L., King, A. R., Buckle, M., van der Vaart, M., Gursul, D., Goksan, S., Juszczak, E., Norman, J. E., Rogers, R., Patel, C., Adams, E., & Slater, R. (2018). Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. Lancet, 392(10164), 2595-2605. https://doi.org/10.1016/S0140-6736%2818%2931813-0

Background: Infant pain has immediate and long-term effects but is undertreated because of a paucity of evidence-based analgesics. Although morphine is often used to sedate ventilated infants, its analgesic efficacy is unclear. We aimed to establish... Read More about Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials (2018)
Journal Article
Stenson, B. J., Donoghoe, M., Brocklehurst, P., Davis, P. G., Juszczak, E., Marschner, I. C., Simes, J., & Tarnow-Mordi, W. O. (2019). Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials. Journal of Pediatrics, 204, 301-304.E2. https://doi.org/10.1016/j.jpeds.2018.08.033

Infants in the Australian and UK Benefits of Oxygen Saturation Targeting-II trials treated using revised oximeters spent more time within their planned pulse oximeter saturation target ranges than infants treated using the original oximeters (P < .00...

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration (2018)
Journal Article
Askie, L. M., Darlow, B. A., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., Davis, P. G., Carlo, W. A., Brocklehurst, P., Davies, L. C., Das, A., Rich, W., Gantz, M. G., Roberts, R. S., Whyte, R. K., Costantini, L., Poets, C., Asztalos, E., Battin, M., Halliday, H. L., …for the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. (2018). Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. Journal of the American Medical Association, 319(21), 2190–2201. https://doi.org/10.1001/jama.2018.5725

IMPORTANCE There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen.

OBJECTIVE To compare the effects of different target ranges for oxygen saturation asmeasured b... Read More about Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration.

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials (2017)
Journal Article
Gamble, C., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Doré, C., Williamson, P. R., Altman, D. G., Montgomery, A., Lim, P., Berlin, J., Senn, S., Day, S., Barbachano, Y., & Loder, E. (2017). Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Journal of the American Medical Association, 318(23), 2337-2343. https://doi.org/10.1001/jama.2017.18556

© 2017 American Medical Association. All rights reserved. IMPORTANCE While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support tr... Read More about Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.