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All Outputs (36)

It is unprecedented: trial management during the COVID-19 pandemic and beyond (2020)
Journal Article
Mitchell, E. J., Ahmed, K., Breeman, S., Cotton, S., Constable, L., Ferry, G., …McDonald, A. (2020). It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials, 21, Article 784. https://doi.org/10.1186/s13063-020-04711-6

The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pau... Read More about It is unprecedented: trial management during the COVID-19 pandemic and beyond.

Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda (2020)
Journal Article
Mitchell, E. J., Benjamin, S., Ononge, S., Ditai, J., Qureshi, Z., Masood, S. N., …Duley, L. (2020). Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda. BMC Pregnancy and Childbirth, 20(1), Article 439. https://doi.org/10.1186/s12884-020-03126-0

Background: Globally, 15 million infants are born preterm each year, and one million die due to complications of prematurity. Over 60% of preterm births occur in Sub-Saharan Africa and south Asia. Care at birth for premature infants may be critical f... Read More about Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda.

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials (2020)
Journal Article
Mitchell, E. J., Godolphin, P., Meakin, G., & Sprange, K. (2020). Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials. Trials, 21, Article 514. https://doi.org/10.1186/s13063-020-04465-1

© 2020 The Author(s). Background: Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the hosting of... Read More about Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials.

Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals (2020)
Journal Article
Mitchell, E., Goodman, K., Hartley, S., Hickey, H., McDonald, A. M., Meadows, H. M., …UK Trial Managers’ Network Executive Group. (2020). Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals. Trials, 21, Article 384. https://doi.org/10.1186/s13063-020-04316-z

Background Clinical trials commonly have a dedicated trial manager and effective trial management is essential to the successful delivery of high-quality trials. Trial managers have diverse experience and currently there is no standardised structure... Read More about Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals.

Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial (2020)
Journal Article
Armstrong-Buisseret, L., Godolphin, P. J., Bradshaw, L., Mitchell, E., Ratcliffe, S., Storey, C., & Heazell, A. E. P. (2020). Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial. Pilot and Feasibility Studies, 6, Article 23. https://doi.org/10.1186/s40814-020-0561-z

Background Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by... Read More about Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial.

Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study (2019)
Journal Article
Bradshaw, L., Sawyer, A., Mitchell, E., Armstrong-Buisseret, L., Ayers, S., & Duley, L. (2019). Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study. Trials, 20(1), Article 225. https://doi.org/10.1186/s13063-019-3325-4

Background The Cord Pilot Trial compared two alternative policies for cord-clamping at very preterm birth at eight UK tertiary maternity units: clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and n... Read More about Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study.

Randomised trial of cord clamping and initial stabilisation at very preterm birth (2017)
Journal Article
Duley, L., Dorling, J., Pushpa-Rajah, A., Oddie, S. J., Yoxall, C. W., Schoonakker, B., …Fawke, J. A. (2018). Randomised trial of cord clamping and initial stabilisation at very preterm birth. Archives of Disease in Childhood. Fetal and Neonatal Edition, 103(1), F6-F14. https://doi.org/10.1136/archdischild-2016-312567

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. OBJECTIVES: For very preterm births, to compare alternative po... Read More about Randomised trial of cord clamping and initial stabilisation at very preterm birth.

Ciclosporin compared to prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial (2017)
Journal Article
Mason, J., Thomas, K., Ormerod, A., Craig, F., Mitchell, E., Norrie, J., & Williams, H. (2017). Ciclosporin compared to prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial. British Journal of Dermatology, 177(6), 1527-1536. https://doi.org/10.1111/bjd.15561

Background Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomised controlled trial... Read More about Ciclosporin compared to prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial.

Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial) (2017)
Journal Article
Thomas, K. S., Bradshaw, L. E., Sach, T. H., Batchelor, J. M., Lawton, S., Harrison, E. F., …MacCallum, S. (2017). Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial). PLoS Medicine, 14(4), Article e1002280. https://doi.org/10.1371/journal.pmed.1002280

© 2017 Thomas et al. Background: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to st... Read More about Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study (2016)
Journal Article
Thomas, K. S., Ormerod, A. D., Craig, F. E., Greenlaw, N., Norrie, J., Mitchell, E., …Williams, H. C. (2016). Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study. Journal of The American Academy of Dermatology, 75(5), 940-949. https://doi.org/10.1016/j.jaad.2016.06.016

Background: pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. Objective: to estimate the effectiveness of topical therapies in the treatment of PG. Methods: prospective cohort study of UK secondary... Read More about Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study.

Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial (2015)
Journal Article
Ormerod, A. D., Thomas, K. S., Craig, F. E., Mitchell, E., Greenlaw, N., Norrie, J., …UK Dermatology Clinical Trials Network’s STOP GAP team. (2015). Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial. BMJ, 350, Article h2958. https://doi.org/10.1136/bmj.h2958

Objective: To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum, a painful, ulcerating skin disease with a poor evidence base for management. Design: Multicentre, parallel group, observer blind, ran... Read More about Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial.

UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial (2012)
Journal Article
Craig, F. F., Thomas, K. S., Mitchell, E. J., Williams, H. C., Norrie, J., Mason, J. M., & Ormerod, A. D. (2012). UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial. Trials, 13(1), Article 51. https://doi.org/10.1186/1745-6215-13-51

RCT of treatments for pyoderma gangrenosum: time to get involved (2010)
Journal Article
Mitchell, E. (2010). RCT of treatments for pyoderma gangrenosum: time to get involved. Wounds UK, 6(4), 27-32

Background: Pyoderma gangrenosum (PG) is a rare, painful ulcerating skin condition that is often associated with underlying systemic disease such as inflammatory bowel disease, rheumatoid arthritis and haematological malignancies. There has been litt... Read More about RCT of treatments for pyoderma gangrenosum: time to get involved.