Professor ED JUSZCZAK's Outputs (84)

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., Jawad, S., Zwarenstein, M., Relton, C., Langan, S. M., Moher, D., Fröbert, O., Thombs, B. D., Gale, C., & 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 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., Fröbert, O., Gale, C., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., Thombs, B. D., & 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 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., Fröbert, O., Gale, C., Hemkens, L. G., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., & 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., Linsell, L., Dorling, J., Berrington, J., Boyle, E., Embleton, N., Hewer, O., Johnson, S., King, A., Leaf, A., Linsell, L., McCormick, K., McGuire, W., Murray, D., Roberts, T., & 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, M., O'Keeffe, L., Williamson, P. R., Sydes, M. R., Farrin, A., Lugg-Widger, F., Davies, G., Avery, K., Chan, A.-W., Kwakkenbos, L., Thombs, B. D., Watkins, A., Hemkens, L. G., Gale, C., Zwarenstein, M., Langan, S. M., Thabane, L., Juszczak, E., Moher, D., & 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

Background:Protocols are an essential document for conducting randomised controlled trials (RCTs).However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of sta... Read More about 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].

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., Abbott, A., Abdallah, N., Abdelaziz, A., Abdelfattah, M., Abdelqader, B., Abdo, D., Abdul, B., Abdul Rasheed, A., Abdulakeem, A., Abdul-Kadir, R., Abdulle, A., Abdulmumeen, A., Abdul-Raheem, R., Abdulshukkoor, N., …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., Abbott, A., Abdallah, N., Abdelaziz, A., Abdelfattah, M., Abdelqader, B., Abdul, B., Abdul Rasheed, A., Abdulakeem, A., Abdul-Kadir, R., Abdulmumeen, A., Abdul-Raheem, R., Abdulshukkoor, N., Abdusamad, K., Abed El Khaleq, Y., …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.

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration (2021)
Journal Article
Kwakkenbos, L., Imran, M., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., Zwarenstein, M., Relton, C., Rice, D. B., Langan, S. M., Benchimol, E. I., Thabane, L., Campbell, M. K., Sampson, M., Erlinge, D., Verkooijen, H. M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., …Thombs, B. D. (2021). CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 373, Article n857. https://doi.org/10.1136/bmj.n857

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the t... Read More about CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) (2021)
Journal Article
Imran, M., Kwakkenbos, L., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., Zwarenstein, M., Relton, C., Rice, D. B., Langan, S. M., Benchimol, E. I., Thabane, L., Campbell, M. K., Sampson, M., Erlinge, D., Verkooijen, H. M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., …Thombs, B. D. (2021). Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). BMJ Open, 11(4), Article e049093. https://doi.org/10.1136/bmjopen-2021-049093

Objectives
Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated St... Read More about Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

Paediatric research in the times of COVID-19 (2021)
Journal Article
Fleming, P. F., Gale, C., Molloy, E. J., Faust, S. N., Costeloe, K., Juszczak, E., & Roehr, C. C. (2021). Paediatric research in the times of COVID-19. Pediatric Research, 90, 267–271. https://doi.org/10.1038/s41390-021-01479-6

The COVID-19 pandemic poses many direct and indirect consequences for children's health and associated research. Direct consequences include participation of children in COVID-19 research trials, pausing other research in children and the potential i... Read More about Paediatric research in the times of COVID-19.

Compression stockings for preventing deep vein thrombosis in airline passengers (2021)
Journal Article
Clarke, M. J., Broderick, C., Hopewell, S., Juszczak, E., & Eisinga, A. (2021). Compression stockings for preventing deep vein thrombosis in airline passengers. Cochrane Database of Systematic Reviews, 2021(4), https://doi.org/10.1002/14651858.cd004002.pub4

Background: Air travel might increase the risk of deep vein thrombosis (DVT). It has been suggested that wearing compression stockings might reduce this risk. This is an update of the review first published in 2006. Objectives: To assess the effects... Read More about Compression stockings for preventing deep vein thrombosis in airline passengers.

Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial (2021)
Journal Article
Gupta, S., Juszczak, E., Hardy, P., Subhedar, N., Wyllie, J., Kelsall, W., Sinha, S., Johnson, S., Roberts, T., Hutchison, E., Pepperell, J., Linsell, L., Bell, J. L., Stanbury, K., Laube, M., Edwards, C., Field, D., & on behalf of the ‘The Baby-OSCAR Collaborative Group. (2021). Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatrics, 21, Article 100. https://doi.org/10.1186/s12887-021-02558-7

Background
The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks’ gestation are born in the... Read More about Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.

Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abaleke, E., Abbas, M., Abbasi, S., Abbott, A., Abdelaziz, A., Abdelbadiee, S., Abdelfattah, M., Abdul, B., Abdul Rasheed, A., Abdul-Kadir, R., Abdulmumeen, A., Abdulshukkoor, N., Abdusamad, K., Abed El Khaleq, Y., Abedalla, M., Abeer Ul Amna, A. U., Aboaba, A., Abo-Leyah, H., Abou-Haggar, A., Abouibrahim, M., …Zuriaga-Alvaro, A. (2021). Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10274), 605-612. https://doi.org/10.1016/s0140-6736%2821%2900149-5

Summary
Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory
actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.

Methods In t... Read More about Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial (2020)
Journal Article
Fleminger, J., Seed, P., Smith, A., Dixon, P., Juszczak, E., Chambers, J., Dorling, J., Williamson, C., Thornton, J., & Chappell, L. (2021). Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial. BJOG: An International Journal of Obstetrics and Gynaecology, 128(6), 1066-1075. https://doi.org/10.1111/1471-0528.16567

Objective: To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA). Design: Secondary analysis of the P... Read More about Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 (2020)
Journal Article
The RECOVERY Collaborative Group, Horby, P., Mafham, M., Linsell, L., Bell, J. L., Staplin, N., Emberson, J. R., Wiselka, M., Ustianowski, A., Elmahi, E., Prudon, B., Whitehouse, T., Felton, T., Williams, J., Faccenda, J., Underwood, J., Baillie, J. K., Chappell, L. C., Faust, S. N., Jaki, T., …Landray, M. J. (2020). Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. New England Journal of Medicine, 383(21), 2030-2040. https://doi.org/10.1056/NEJMoa2022926

BACKGROUND Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials. METHODS In this randomized, cont... Read More about Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.

Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2020)
Journal Article
The Recovery Collaborative Group, Horby, P. W., Mafham, M., Bell, J. L., Linsell, L., Staplin, N., Emberson, J., Palfreeman, A., Raw, J., Elmahi, E., Prudon, B., Green, C., Carley, S., Chadwick, D., Davies, M., Wise, M. P., Baillie, J. K., Chappell, L. C., Faust, S. N., Jaki, T., …Landray, M. J. (2020). Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 396(10259), 1345-1352. https://doi.org/10.1016/s0140-6736%2820%2932013-4

Summary
Background Lopinavir–ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity,
preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir–ri... Read More about Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT) (2020)
Journal Article
Richards, J., Rankin, J., Juszczak, E., Dorling, J., McGuire, W., & Embleton, N. D. (2021). Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT). Archives of Disease in Childhood. Fetal and Neonatal Edition, 106(1), 84-87. https://doi.org/10.1136/archdischild-2020-319031

Objective
To explore parents’ perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study.

Design
A qualitative study involving 17 in-depth semistructured interviews, with parents who ha... Read More about Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT).

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report (2020)
Journal Article
Horby, P., Lim, W. S., Emberson, J. R., Mafham, M., Bell, J. L., 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., …Landray, M. J. (2021). Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. New England Journal of Medicine, 1-11. https://doi.org/10.1056/NEJMoa2021436

Background

Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

Methods

In this controlled... Read More about Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report.