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All Outputs (34)

The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study (2024)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Moore, S., Jones, A.-M., Downe, S., …Daniels, J. (2024). The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study. Midwifery, 135, Article 104063. https://doi.org/10.1016/j.midw.2024.104063

Background: Group B streptococcus (GBS) is a bacterium carried by 20–25 % of pregnant women in the UK, which can be transmitted from pregnant women to their babies at the time of birth. Women can be tested for GBS in pregnancy using a vaginal-rectal... Read More about The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study.

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.

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence (2023)
Journal Article
Mitchell, E. J., Appelbe, D., Bravery, A., Culliford, L., Evans, H., Farrin, A. J., …Wakefield, N. (2023). e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence. Trials, 24(1), Article 657. https://doi.org/10.1186/s13063-023-07656-8

Background: During the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although some clinical trials may have i... Read More about e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence.

Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial (2023)
Journal Article
Sach, T. H., Lartey, S. T., Davies, C., Chalmers, J. R., Haines, R. H., Bradshaw, L. E., …Williams, H. C. (2023). Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial. Clinical & Experimental Allergy, 53(10), 1011-1019. https://doi.org/10.1111/cea.14381

Background Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. Objective To determine the cost‐effectiveness of daily all‐over‐body application of emollient during the firs... Read More about Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial.

Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study (2023)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Walker, K. F., Daniels, J., Moore, S., …Downe, S. (2023). Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study. BMC Pregnancy and Childbirth, 23, Article 339. https://doi.org/10.1186/s12884-023-05651-0

Background: 20–25% pregnant women in the UK carry group B streptococcus (GBS) which, if left undetected, is transmitted from pregnant mothers to their babies during birth in 36% of cases. This transmission leads to early onset GBS infection (EOGBS) i... Read More about Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study.

Parents and healthcare professionals' attitudes to Kangaroo Care for preterm infants in the United Kingdom (2023)
Journal Article
Walker, S., Ojha, S., & Mitchell, E. J. (2023). Parents and healthcare professionals' attitudes to Kangaroo Care for preterm infants in the United Kingdom. Acta Paediatrica, https://doi.org/10.1111/apa.16795

Aim: To explore the attitudes of parents and healthcare professionals (HCPs), and facilitators and barrier to implementation of Kangaroo Care (KC) in the United Kingdom. Methods: Online cross-sectional survey; distributed via the British Association... Read More about Parents and healthcare professionals' attitudes to Kangaroo Care for preterm infants in the United Kingdom.

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.

The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study (2023)
Journal Article
Romano, G., Ayers, S., Constantinou, G., Mitchell, E. J., Plachcinski, R., Wakefield, N., & Walker, K. F. (2023). The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study. BMC Pregnancy and Childbirth, 23(1), Article 216. https://doi.org/10.1186/s12884-023-05444-5

Background: Caesarean sections (CS) account for 26% of all births in the UK, of which at least 5% are done at full dilatation, in the second stage of labour. Second stage CS may be complicated by the fetal head being deeply impacted in the maternal p... Read More about The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study.

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing? (2022)
Journal Article
Mitchell, E. J., Sprange, K., Treweek, S., & Nixon, E. (2022). Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?. Trials, 23, Article 457. https://doi.org/10.1186/s13063-022-06417-3

Marketing is a core business function in commercial companies but is also frequently used by not-for-profit organisations. Marketing focuses on understanding what people value to make choices about engaging with a product or service: a concept also k... Read More about Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?.

Clinical trial management: a profession in crisis? (2022)
Journal Article
Mitchell, E. J., Goodman, K., Wakefield, N., Cochran, C., Cockayne, S., Connolly, S., …Youssouf, N. F. J. (2022). Clinical trial management: a profession in crisis?. Trials, 23, 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.

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., …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., …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., …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.

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., …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.