Skip to main content

Research Repository

Advanced Search

All Outputs (51)

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.

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.

Do patient characteristics matter when calculating sample size for eczema clinical trials? (2021)
Journal Article
Howells, L., Gran, S., Chalmers, J. R., Stuart, B., Santer, M., Bradshaw, L., …Thomas, K. S. (2021). Do patient characteristics matter when calculating sample size for eczema clinical trials?. Skin Health and Disease, 1(3), Article e42. https://doi.org/10.1002/ski2.42

Background: The Patient-Oriented Eczema Measure (POEM) is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To ensure that the statistical significance of clinical trial results is meani... Read More about Do patient characteristics matter when calculating sample size for eczema clinical trials?.

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.

Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., …Ojha, S. (2020). Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya. BMJ Global Health, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

Introduction: Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month of life are due to prematurity and the neonatal mort... Read More about Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya.

Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E. J., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., …Ojha, S. (2020). Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya. BMJ Open, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

© 2020 BMJ Publishing Group. All rights reserved. Introduction Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month o... Read More about Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya.

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, 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.

Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement (2020)
Journal Article
Armstrong-Buisseret, L. K., Haslam, S., James, T., Bradshaw, L., & Heazell, A. E. (2020). Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement. Annals of Clinical Biochemistry, 57(3), 223-233. https://doi.org/10.1177/0004563220911993

Background: Placental growth factor (PlGF) and soluble-fms-like tyrosine kinase 1 (sFlt-1) are biomarkers of placental function used to aid the diagnosis and prediction of pregnancy complications. This work verified the analytical performance of both... Read More about Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement.

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.

An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge (2020)
Journal Article
Kelleher, M. M., Montgomery, A. A., Jay, N., Perkin, M. R., Haines, R. H., Batt, R., …Boyle, R. J. (2020). An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge. Clinical and Experimental Allergy, 50(3), 334-342. https://doi.org/10.1111/cea.13577

© 2020 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd. Background: Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time-consuming, carry some risk and may, therefore,... Read More about An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge.

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.

Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT (2020)
Journal Article
Lincoln, N. B., Bradshaw, L. E., Constantinescu, C. S., Day, F., Drummond, A. E., Fitzsimmons, D., …CRAMMS Trial Collaborative Group. (2020). Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT. Health Technology Assessment, 24(4), 1-182. https://doi.org/10.3310/hta24040

Abstract Background People with multiple sclerosis have problems with memory and attention. The effectiveness of cognitive rehabilitation has not been established. Objectives The objectives were to assess the clinical effectiveness and cost-eff... Read More about Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT.

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).

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.

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.