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All Outputs (30)

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study (2024)
Journal Article
Mitchell, E. J., Aluvaala, J., Bradshaw, L., Daniels, J. P., Emadau, C., Muthumbi, B., …Ojha, S. (2024). A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study. BMC Pediatrics, 24, Article 326. https://doi.org/10.1186/s12887-024-04778-z

Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whe... Read More about A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study.

Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study (2023)
Journal Article
Walker, K. F., Mitchell, E. J., Ayers, S., Jones, N. W., Ogollah, R., Wakefield, N., …Thornton, J. G. (2023). Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study. Health Technology Assessment, 27(6), 1-87. https://doi.org/10.3310/KUYP6832

Background: Second-stage caesarean sections, of which there are around 34,000 per year in the United Kingdom, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis,... Read More about Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study.

Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial (2022)
Journal Article
Bradshaw, L. E., Wyatt, L. A., Brown, S. J., Haines, R. H., Montgomery, A. A., Perkin, M. R., …Williams, H. C. (2023). Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial. Allergy, 78(4), 995-1006. https://doi.org/10.1111/all.15555

Background: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and... Read More about Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial.

Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study (2021)
Preprint / Working Paper
Mitchell, E. J., Aluvaala, J., Bradshaw, L., Daniels, J., Kumar, A., Opira, J., …Ojha, S. Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global healt... Read More about Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study.

Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study (2021)
Journal Article
Bradshaw, L. E., Haines, R. H., Thomas, K. S., Chalmers, J. R., Irvine, A. D., Williams, H. C., & Brown, S. J. (2021). Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study. Clinical and Experimental Allergy, 51(11), 1421-1428. https://doi.org/10.1111/cea.14025

Background: Palmar hyperlinearity is a feature of ichthyosis vulgaris, the monogenic skin disorder caused by FLG loss-of-function mutations. Objective: To investigate how well the presence or absence of hyperlinear palms (HLP) detect FLG genotype in... Read More about Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study.

Promoting independence in Dementia (Pride): A feasibility randomized controlled trial (2021)
Journal Article
Csipke, E., Shafayat, A., Sprange, K., Bradshaw, L., Montgomery, A. A., Ogollah, R., …Orrell, M. (2021). Promoting independence in Dementia (Pride): A feasibility randomized controlled trial. Clinical Interventions in Aging, 16, 363-378. https://doi.org/10.2147/CIA.S281139

© 2021 Csipke et al. Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living we... Read More about Promoting independence in Dementia (Pride): A feasibility randomized controlled trial.

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial (2020)
Journal Article
Bradshaw, L., Montgomery, A. A., Williams, H. C., Chalmers, J., & Haines, R. (2020). Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial. Trials, 21, Article 529. https://doi.org/10.1186/s13063-020-04373-4

Background Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in... Read More about Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention 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.

Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial (2019)
Journal Article
Shafayat, A., Csipke, E., Bradshaw, L., Charlesworth, G., Day, F., Leung, P., …Orrell, M. (2019). Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial. Trials, 20(1), Article 709. https://doi.org/10.1186/s13063-019-3838-x

Background: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management interventio... Read More about Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial.

Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS) (2019)
Journal Article
Lincoln, N., Bradshaw, L., Constantinescu, C., Day, F., Drummond, A., Fitzsimmons, D., …das Nair, R. (2020). Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS). Clinical Rehabilitation, 34(2), 229-241. https://doi.org/10.1177/0269215519890378

Objective: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. Design: Multicentre, pragmatic, randomized controlled trial. Setting: Community Participants: Pe... Read More about Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS).

A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT (2019)
Journal Article
das Nair, R., Bradshaw, L. E., Carpenter, H., Clarke, S., Day, F., Drummond, A., …Lincoln, N. B. (2019). A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT. Health Technology Assessment, 23(16), 1-193. https://doi.org/10.3310/hta23160

Main outcome measures: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire – patient version (EMQ-p) at 6 months’ follow-up. Secondary outcomes: Rivermead Behavioural Memory... Read More about A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT.

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.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial (2019)
Journal Article
das Nair, R., Bradshaw, L. E., Day, F. E., Drummond, A., Harris, S. R., Fitzsimmons, D., …Lincoln, N. B. (2019). Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial. Clinical Rehabilitation, 33(7), 1171-1184. https://doi.org/10.1177/0269215519840069

Objective: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. Design: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. Sett... Read More about Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

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.

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.

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.

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.