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All Outputs (51)

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.

Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study (2018)
Journal Article
Whitham, D., Turzanski, J., Bradshaw, L., Clarke, M., Culliford, L., Duley, L., …Wood, J. (2018). Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study. Trials, 19, Article 557. https://doi.org/10.1186/s13063-018-2940-9

Background Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution of potential problems, minim... Read More about Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study.

Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial (2018)
Journal Article
Major, G., Bradshaw, L., Boota, N., Sprange, K., Diggle, M., Montgomery, A., …Spiller, R. (2018). Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial. Gut, https://doi.org/10.1136/gutjnl-2018-316794

Background Clostridium difficile infection (CDI) recurs after initial treatment in approximately one in four patients. A single-centre pilot study suggested that this could be reduced using ‘follow-on’ rifaximin treatment. We aimed to assess the effi... Read More about Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo 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.

How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods (2018)
Journal Article
Howells, L., Ratib, S., Chalmers, J., Bradshaw, L., & Thomas, K. (2018). How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods. British Journal of Dermatology, 178(5), https://doi.org/10.1111/bjd.16367

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the... Read More about How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods.

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.

Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial (2017)
Journal Article
Hammond, A., O’Brien, R., Woodbridge, S., Bradshaw, L., Prior, Y., Radford, K. A., …Pulikottil-Jacob, R. (2017). Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial. BMC Musculoskeletal Disorders, 18, Article 315. https://doi.org/10.1186/s12891-017-1671-5

Background Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United Sta... Read More about Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial.

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.

Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial (2017)
Journal Article
Jeffcoate, W., Game, F., Turtle-Savage, V., Musgrove, A., Price, P., Tan, W., …Phillips, C. (in press). Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial. Health Technology Assessment, 21(34), https://doi.org/10.3310/hta21340

Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-... Read More about Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial.

Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks (2017)
Journal Article
Langan, S. M., Stuart, B., Bradshaw, L., Schmitt, J., Williams, H. C., & Thomas, K. S. (2017). Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks. Journal of Allergy and Clinical Immunology, 140(6), 1580-1586. https://doi.org/10.1016/j.jaci.2017.02.043

Background:Because atopic dermatitis (AD) is a relapsing, remitting disease, assessing long?term control is important. Well controlled weeks (WCWs) have been used to assess asthma long?term control, but never validated for AD. Objectives: To assess... Read More about Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks.

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.

Labour induction near term for women aged 35 or over: an economic evaluation (2017)
Journal Article
Walker, K. F., Dritsaki, M., Bugg, G., Macpherson, M., McCormick, C., Grace, N., …Thornton, J. (2017). Labour induction near term for women aged 35 or over: an economic evaluation. BJOG: An International Journal of Obstetrics and Gynaecology, 124(6), 929-934. https://doi.org/10.1111/1471-0528.14557

Objective Induction of labour at 39 weeks for nulliparous women aged 35 years and over may prevent stillbirths and does not increase caesarean births, so it may be popular. But the overall costs and benefits of such a policy have not been compared.... Read More about Labour induction near term for women aged 35 or over: an economic evaluation.

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.

Randomized trial of labor induction in women 35 years of age or older (2016)
Journal Article
Walker, K. F., Bugg, G. J., Macpherson, M., McCormick, C., Grace, N., Wildsmith, C., …Thornton, J. (2016). Randomized trial of labor induction in women 35 years of age or older. New England Journal of Medicine, 374(9), https://doi.org/10.1056/NEJMoa1509117

BACKGROUND The risk of antepartum stillbirth at term is higher among women 35 years of age or older than among younger women. Labor induction may reduce the risk of stillbirth, but it also may increase the risk of cesarean delivery, which already is... Read More about Randomized trial of labor induction in women 35 years of age or older.

Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial) (2015)
Journal Article
Bradshaw, L. E., Tanajewski, L., Franklin, M., Gkountouras, G., Berdunov, V., Harwood, R. H., …Elliott, R. A. (2015). Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial). PLoS ONE, 10(12), e0140662. https://doi.org/10.1371/journal.pone.0140662

Background One in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delir... Read More about Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial).

Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS) (2015)
Journal Article
Lincoln, N. B., das Nair, R., Bradshaw, L., Constantinescu, C. S., Drummond, A. E. R., Erven, A., …Morgan, M. (2015). Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS). Trials, 16(1), Article 556. https://doi.org/10.1186/s13063-015-1016-3

Background People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual’s memory and other cognitive functions. Cognitive rehabili... Read More about Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS).

Cord pilot trial: update to randomised trial protocol (2015)
Journal Article
on behalf of the Cord Pilot Trial Collaborative Group, , Bradshaw, L. E., Pushpa-Rajah, A., Dorling, J., Mitchell, E. J., & Duley, L. (2015). Cord pilot trial: update to randomised trial protocol. Trials, 16(1), 1-3. https://doi.org/10.1186/s13063-015-0936-2

Background: The Cord Pilot Trial aimed to assess the feasibility of conducting a large UK randomised trial to compare the effects of alternative polices for timing of cord clamping (immediate within 20 seconds or deferred after at least 2 minutes) fo... Read More about Cord pilot trial: update to randomised trial protocol.

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial (2015)
Journal Article
Harrison, E. F., Haines, R. H., Cowdell, F., Sach, T. H., Dean, T., Pollock, I., …Thomas, K. S. (2015). A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial. Trials, 16(1), https://doi.org/10.1186/s13063-015-0921-9

Background Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that... Read More about A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.