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All Outputs (47)

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.

Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial (2020)
Journal Article
Chalmers, J. R., Haines, R. H., Bradshaw, L. E., Montgomery, A. A., Thomas, K. S., Brown, S. J., …Williams, H. C. (2020). Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet, 395(10228), 962-972. https://doi.org/10.1016/S0140-6736%2819%2932984-8

Background Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children. Methods We did a multicentre, pragmatic, parallel-group, randomised contr... Read More about Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial.

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.

Randomised trial of cord clamping at very preterm birth: outcomes at 2 years (2019)
Journal Article
Armstrong-Buisseret, L., Powers, K., Dorling, J., Bradshaw, L., Johnson, S., Mitchell, E., & Duley, L. (2020). Randomised trial of cord clamping at very preterm birth: outcomes at 2 years. Archives of Disease in Childhood. Fetal and Neonatal Edition, 105(3), 292-298. https://doi.org/10.1136/archdischild-2019-316912

Objective: To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth. Design: Parallel group randomised (1:1... Read More about Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.

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.

Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year (2019)
Journal Article
Bradshaw, L., Sawyer, A., Armstrong-Buisseret, L., Mitchell, E., Ayers, S., & Duley, L. (2019). Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year. BMC Pregnancy and Childbirth, 19, Article 78. https://doi.org/10.1186/s12884-019-2223-9

Background The Cord Pilot Trial compared two alternative policies for cord clamping at very preterm birth at eight UK maternity units: clamping after at least 2 min and immediate neonatal care (if needed) with cord intact, or clamping within 20 s an... Read More about Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year.

Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation (2018)
Journal Article
Armstrong-Buisseret, L., Mitchell, E., Hepburn, T., Duley, L., Thornton, J. G., Roberts, T. E., …Heazell, A. E. P. (2018). Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation. Trials, 19, 1-13. https://doi.org/10.1186/s13063-018-2859-1

Background: Forty percent of babies who are stillborn born die after 36 weeks gestation and have no lethal structural abnormality. Maternal perception of reduced fetal movement (RFM) is associated with stillbirth and is related to abnormal placental... Read More about Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation.

Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial (2018)
Journal Article
Haines, R. H., Thomas, K. S., Montgomery, A. A., Ravenscroft, J. C., Akram, P., Chalmers, J., …Batchelor, J. M. (2018). Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial. BMJ Open, 8(4), Article e018649. https://doi.org/10.1136/bmjopen-2017-018649

Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high quality evide... Read More about Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial.

Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations (2018)
Journal Article
McKeever, T., Mortimer, K., Wilson, A., Walker, S., Brightling, C., Skeggs, A., …Harrison, T. (2018). Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations. New England Journal of Medicine, 378(10), 902-910. https://doi.org/10.1056/NEJMoa1714257

Copyright © 2018 Massachusetts Medical Society. BACKGROUND Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a te... Read More about Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations.

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.

Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial (2017)
Journal Article
Chalmers, J. R., Haines, R. H., Mitchell, E. J., Thomas, K. S., Brown, S. J., Ridd, M., …Williams, H. C. (2017). Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial. Trials, 18(1), Article 343. https://doi.org/10.1186/s13063-017-2031-3

Background: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for... Read More about Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial.

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).

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial (2017)
Journal Article
Thomas, K. S., Bradshaw, L., Sach, T. H., Cowdell, F., Batchelor, J. M., Lawton, S., …Montgomery, A. A. (2017). Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial. Health Technology Assessment, 21(16), https://doi.org/10.3310/hta21160

Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. Objectives: To assess the... Read More about Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial.

Investigating the effect of independent blinded digital image assessment on the STOP GAP trial (2017)
Journal Article
Patsko, E., Godolphin, P. J., Thomas, K. S., Hepburn, T., Mitchell, E., Craig, F. E., …Montgomery, A. A. (2017). Investigating the effect of independent blinded digital image assessment on the STOP GAP trial. Trials, 18(1), Article 53. https://doi.org/10.1186/s13063-017-1779-9

Background Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low risk studies. In dermatology, one popu... Read More about Investigating the effect of independent blinded digital image assessment on the STOP GAP trial.

A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease (2016)
Journal Article
Thomas, K. S., Batchelor, J. M., Bath-Hextall, F., Chalmers, J., Clarke, T., Crowe, S., …Williams, H. C. (2016). A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease. Programme Grants for Applied Research, 4(18), https://doi.org/10.3310/pgfar04180

Background Skin diseases are very common and can have a large impact on the quality of life of patients and caregivers. This programme addressed four diseases: (1) eczema, (2) vitiligo, (3) squamous cell skin cancer (SCC) and (4) pyoderma gangreno... Read More about A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease.

FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations (2016)
Journal Article
Skeggs, A., McKeever, T. M., Duley, L., Mitchell, E., Bradshaw, L., Mortimer, K., …Haydock, R. (2016). FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations. Trials, 17, https://doi.org/10.1186/s13063-016-1608-6

BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of ast... Read More about FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations.

Is speed of healing a good predictor of eventual healing of pyoderma gangrenosum? (2016)
Journal Article
Wilkes, S. R., Williams, H. C., Ormerod, A. D., Craig, F. E., Greenlaw, N., Norrie, J., …Thomas, K. S. (2016). Is speed of healing a good predictor of eventual healing of pyoderma gangrenosum?. Journal of The American Academy of Dermatology, 75(6), 1216-1220.e2. https://doi.org/10.1016/j.jaad.2016.07.049

Background: Pyoderma gangrenosum is a rare inflammatory skin condition. The STOPGAP studies compared treatments for pyoderma gangrenosum using a primary outcome of healing speed at 6 weeks. Objective: Using data from both studies we assessed the pre... Read More about Is speed of healing a good predictor of eventual healing of pyoderma gangrenosum?.