Ms ELEANOR MITCHELL's Outputs (63)

Clinical trial management: a profession in crisis? (2022)
Journal Article
Mitchell, E. J., Goodman, K., Wakefield, N., Cochran, C., Cockayne, S., Connolly, S., Desai, R., Hartley, S., Lawton, S. A., Oatey, K., Rhodes, S., Savage, J. S., Taylor, J., Youssouf, N. F. J., Fletcher, L., & Lee, R. (2022). Clinical trial management: a profession in crisis?. Trials, 23(1), Article 357. https://doi.org/10.1186/s13063-022-06315-8

Clinical trial managers play a vital role in the design and conduct of clinical trials in the UK. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to... Read More about Clinical trial management: a profession in crisis?.

Impacted fetal head during second stage Caesarean birth: A prospective observational study (2022)
Journal Article
Wyn Jones, N., Mitchell, E. J., Wakefield, N., Knight, M., Dorling, J., Thornton, J. G., & Walker, K. F. (2022). Impacted fetal head during second stage Caesarean birth: A prospective observational study. European Journal of Obstetrics and Gynecology and Reproductive Biology, 272, 77-81. https://doi.org/10.1016/j.ejogrb.2022.03.004

Objective: To determine the incidence of, and complication rates from, impacted fetal head at full dilatation Caesarean birth in the UK, and record what techniques were used. Design: Prospective observational study using the UK Obstetric Surveillance... Read More about Impacted fetal head during second stage Caesarean birth: A prospective observational study.

Managing an impacted fetal head at caesarean section: a UK survey of healthcare professionals and parents (2022)
Journal Article
Hanley, S. J., Walker, K. F., Wakefield, N., Plachcinski, R., Pallotti, P., Tempest, N., Pillai, A., Thornton, J., Jones, N., & Mitchell, E. J. (2022). Managing an impacted fetal head at caesarean section: a UK survey of healthcare professionals and parents. European Journal of Obstetrics and Gynecology and Reproductive Biology, 271, 88-92. https://doi.org/10.1016/j.ejogrb.2022.01.033

Objective(s)
To understand current practice, expertise and training requirements for management of an impacted fetal head (IFH) at caesarean section (CS) in the UK, and whether a clinical trial of techniques to manage an IFH is acceptable.

Study... Read More about Managing an impacted fetal head at caesarean section: a UK survey of healthcare professionals and parents.

The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age) (2022)
Journal Article
Mitchell, E. J., Meakin, G., Anderson, J., Dorling, J., Gale, C., Haines, R., Kenyan, C., Johnson, M. J., McGuire, W., Mistry, H., Montgomery, A., Oddie, S., Ogollah, R., Pallotti, P., Partlett, C., Walker, K. F., & Ojha, S. (2022). The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age). Trials, 23(1), Article 64. https://doi.org/10.1186/s13063-021-05994-z

Background: In the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonatologists are cautious in initi... Read More about The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age).

Implementing two-stage consent pathway in neonatal trials (2021)
Journal Article
Mitchell, E., Oddie, S. J., Dorling, J., Gale, C., Johnson, M. J., McGuire, W., & Ojha, S. (2023). Implementing two-stage consent pathway in neonatal trials. Archives of Disease in Childhood. Fetal and Neonatal Edition, 108(1), F79-F82. https://doi.org/10.1136/archdischild-2021-322960

Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway... Read More about Implementing two-stage consent pathway in neonatal trials.

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., Oliver, M., Pallotti, P., Qureshi, Z., Swinden, R., Were, F., & 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.

Timing of umbilical cord clamping for preterm infants in low-and-middle-income countries: A survey of current practice (2021)
Journal Article
Payne, L., Walker, K. F., & Mitchell, E. J. (2021). Timing of umbilical cord clamping for preterm infants in low-and-middle-income countries: A survey of current practice. European Journal of Obstetrics and Gynecology and Reproductive Biology, 264, 15-20. https://doi.org/10.1016/j.ejogrb.2021.06.041

Introduction
The optimal timing of umbilical cord clamping in preterm infants has been contested for years. Previously, it was common practice to clamp the cord immediately after birth. There is now high-quality evidence that delayed cord clamping (... Read More about Timing of umbilical cord clamping for preterm infants in low-and-middle-income countries: A survey of current practice.

Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya (2021)
Journal Article
Mitchell, E. J., Pallotti, P., Qureshi, Z., Daniels, J. P., Oliver, M., Were, F., Osoti, A., Gwako, G., Kimani, V., Opira, J., & Ojha, S. (2021). Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya. BMJ Open, 11(6), Article e043802. https://doi.org/10.1136/bmjopen-2020-043802

Objectives: Prematurity is the leading cause of global neonatal and infant mortality. Many babies could survive by the provision of essential newborn care. This qualitative study was conducted in order to understand, from a family and professional pe... Read More about Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya.

The acceptability to women of techniques for managing an impacted fetal head at caesarean section and of randomised trials evaluating those techniques: a qualitative study (2021)
Journal Article
Romano, G., Mitchell, E., Plachcinski, R., Wakefield, N., Walker, K., & Ayers, S. (2021). The acceptability to women of techniques for managing an impacted fetal head at caesarean section and of randomised trials evaluating those techniques: a qualitative study. BMC Pregnancy and Childbirth, 21, Article 103. https://doi.org/10.1186/s12884-021-03577-z

Background
This study aimed to explore women’s views on the acceptability of different techniques for managing an impacted fetal head at caesarean; and the feasibility and acceptability of conducting a trial in this area.

Methods
Qualitative sem... Read More about The acceptability to women of techniques for managing an impacted fetal head at caesarean section and of randomised trials evaluating those techniques: a qualitative study.

TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands (2020)
Journal Article
Foss, A. J. E., Haydock, R., Childs, M., Duley, L., Empeslidis, T., Dhar-Munshi, S., Montgomery, A., Ogollah, R., Ozolins, M., Tesha, P., & Mitchell, E. (2020). TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands. BMJ Open Ophthalmology, 5(1), Article e000588. https://doi.org/10.1136/bmjophth-2020-000588

Objective: Neovascular age-related macular degeneration (nAMD) causes damage to the macula and severe vision loss. Bevacizumab is the most cost-effective nAMD treatment. The TANDEM trial was designed to determine whether, in patients with nAMD, low-d... Read More about TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands.

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., Opira, J., Bradshaw, L., Oliver, M., Pallotti, P., & 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., Opira, J., Bradshaw, L., Oliver, M., Pallotti, P., & 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.

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., Goodman, K., Hickey, H., Meakin, G., Mironov, K., Quann, N., Wakefield, N., & McDonald, A. (2020). It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials, 21(1), Article 784. https://doi.org/10.1186/s13063-020-04711-6

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., Goodman, K., Hickey, H., Meakin, G., Mironov, K., Quann, N., Wakefield, N., & 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., Whitham, D., Godolphin, P., & 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., Rhodes, S., Taylor, J., Wakefield, N., Farrell, B., & 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., Ridd, M. J., Lawton, S., Simpson, E. L., Cork, M. J., Sach, T. H., Flohr, C., Mitchell, E. J., Swinden, R., Tarr, S., Davies-Jones, S., Jay, N., Kelleher, M., Perkin, M. R., Boyle, R. 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.