All Outputs (32)

Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study) (2024)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2024). Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study). Trials, 25(1), Article 832. https://doi.org/10.1186/s13063-024-08665-x

Background: Lower than expected recruitment continues to be one of the major causes of trial delays, and trials to improve mental health are no exception. Indeed, recruitment challenges in trials of vulnerable populations, such as those living with m... Read More about Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study).

Lessons from the PROTECT-CH COVID-19 platform trial in care homes (2024)
Journal Article
Bath, P. M., Ball, J., Boyd, M., Gage, H., Glover, M., Godfrey, M., Guthrie, B., Hewitt, J., Howard, R., Jaki, T., Juszczak, E., Lasserson, D., Leighton, P., Leyland, V., Shen Lim, W., Logan, P., Meakin, G., Montgomery, A., Ogollah, R., Passmore, P., …Gordon, A. L. (in press). Lessons from the PROTECT-CH COVID-19 platform trial in care homes. Health Technology Assessment,

Umbilical cord management in newborn resuscitation (2024)
Journal Article
Dorling, J. S., Roehr, C. C., Katheria, A. C., & Mitchell, E. J. (2024). Umbilical cord management in newborn resuscitation. Pediatric Research, https://doi.org/10.1038/s41390-024-03711-5

At birth, blood continues to flow from the mother to baby through the intact umbilical cord. This continuum of fetal-placental circulation, now taking place between the placenta and the newborn infant has been termed ‘placental transfusion’, and it e... Read More about Umbilical cord management in newborn resuscitation.

The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study (2024)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Walker, K. F., Downe, S., Jones, A.-M., Moore, S., & Daniels, J. P. (2024). The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study. Women and Birth, 37(6), Article 101832. https://doi.org/10.1016/j.wombi.2024.101832

Objective: To determine the acceptability of different methods of routine testing for group B Streptococcus (GBS) colonisation to pregnant women and health care professionals (HCPs), and to examine barriers and facilitators to their implementation. D... Read More about The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study.

How professional development can be supported for health and care research methodologists: results of the PROfesSionnal develoPmEnt for Research methodologists (PROSPER) e-Delphi and consensus study (2024)
Journal Article
Iflaifel, M., Williamson, P. R., & Mitchell, E. J. (2024). How professional development can be supported for health and care research methodologists: results of the PROfesSionnal develoPmEnt for Research methodologists (PROSPER) e-Delphi and consensus study. BMJ Open, 14(10), Article e085656. https://doi.org/10.1136/bmjopen-2024-085656

Objective: Research methodologists play a pivotal role in health and care research, yet they face many challenges relating to their professional development. The PROfessional development for Research methodologists (PROSPER) study was designed to und... Read More about How professional development can be supported for health and care research methodologists: results of the PROfesSionnal develoPmEnt for Research methodologists (PROSPER) e-Delphi and consensus study.

Practicality, Validity, and Responsiveness of Using the Proxy Version of the Child Health Utility–9 Dimensions With Children Aged 2 to 5 Years (2024)
Journal Article
Sach, T. H., Williams, H. C., Allen, H., Boyle, R., Kelleher, M., Brown, S., Cork, M., Flohr, C., Jay, N., Lartey, S., Davies, C., Lawton, S., Perkin, M., Ridd, M., Brooks, J., Tarr, S., Wyatt, L., & Thomas, K. (2024). Practicality, Validity, and Responsiveness of Using the Proxy Version of the Child Health Utility–9 Dimensions With Children Aged 2 to 5 Years. Value in Health, https://doi.org/10.1016/j.jval.2024.08.010

Objectives
To assess the practicality, validity and responsiveness of proxy CHU-9D in children aged 2-5 years.

Methods
We used data from BEEP, a UK randomised co... Read More about Practicality, Validity, and Responsiveness of Using the Proxy Version of the Child Health Utility–9 Dimensions With Children Aged 2 to 5 Years.

A national evaluation of QbTest to support ADHD assessment: a real-world, mixed methods approach (2024)
Journal Article
Hall, S. S., McKenzie, C., Thomson, L., Ingall, B.-R., Groom, M. J., McGlennon, N., Dines-Allen, M., & Hall, C. L. (2024). A national evaluation of QbTest to support ADHD assessment: a real-world, mixed methods approach. BMC Health Services Research, 24(1), Article 1201. https://doi.org/10.1186/s12913-024-11693-7

Background: QbTest is a commercially available, computerised test of attention, impulsivity, and activity designed to assist with the diagnosis of attention deficit hyperactivity disorder (ADHD). Health Innovation East Midlands (formerly East Midland... Read More about A national evaluation of QbTest to support ADHD assessment: a real-world, mixed methods approach.

Development of a Vocational Rehabilitation Intervention to support Return to Work and Wellbeing following Major Trauma: A Person-Based Approach (2024)
Journal Article
Radford, K., Kettlewell, J., das Nair, R., Morriss, R., Holmes, J., Kellezi, B., Timmons, S., Jones, T., Tressider, H., Andrews, I., Bridger, K., Patel, P., Lindley, R., De Dios Perez, B., Statham, A., Jones, T., Hoffman, K., James, M., Kendrick, D., & ROWTATE study team. (2024). Development of a Vocational Rehabilitation Intervention to support Return to Work and Wellbeing following Major Trauma: A Person-Based Approach. BMJ Open, 14(10), Article e085724. https://doi.org/10.1136/bmjopen-2024-085724

Objectives: Major trauma centres save lives but rehabilitation to support return-to-work (RTW) is lacking. This paper describes development of a vocational rehabilitation intervention (the ROWTATE intervention) to support RTW following traumatic inju... Read More about Development of a Vocational Rehabilitation Intervention to support Return to Work and Wellbeing following Major Trauma: A Person-Based Approach.

Expert opinion on characteristics of vulval LS: initial identification of important clinical features through an international electronic-Delphi consensus study (2024)
Journal Article
Simpson, R. C., Birchall, M., Daniels, J., Gran, S., Kirtschig, G., & Thomas, K. S. (2024). Expert opinion on characteristics of vulval LS: initial identification of important clinical features through an international electronic-Delphi consensus study. Clinical and Experimental Dermatology, Article llae393. https://doi.org/10.1093/ced/llae393

Background
Lichen sclerosus (LS) is a chronic inflammatory condition mainly affecting genital skin. It causes distressing symptoms that impact daily quality of life as well as progressive anatomical changes and potential risk of cancer. Vulval LS is... Read More about Expert opinion on characteristics of vulval LS: initial identification of important clinical features through an international electronic-Delphi consensus study.

Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT (2024)
Journal Article
Cooper, K. G., Bhattacharya, S., Daniels, J. P., Cheed, V., Gennard, L., Leighton, L., Pirie, D., Melyda, M., Monahan, M., Weckesser, A., Roberts, T., Denny, E., Ocansey, L., Stubbs, C., Cox, E., Jones, G., Clark, T. J., Saridogan, E., Gupta, J. K., Critchley, H. O., …Middleton, L. J. (2024). Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT. Health Technology Assessment, 28(55), 1-77. https://doi.org/10.3310/sqwy6998

Background Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option. Obje... Read More about Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT.

Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study (2024)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2024). Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study. Trials, 25, Article 596. https://doi.org/10.1186/s13063-024-08435-9

Background: Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, re... Read More about Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study.

Challenges and opportunities for identifying people with Familial hypercholesterolaemia in the UK: Evidence from the National FH PASS database (2024)
Journal Article
Cox, E., Faria, R., Saramago, P., Haralambos, K., Watson, M., Humphries, S. E., Qureshi, N., & Woods, B. (2024). Challenges and opportunities for identifying people with Familial hypercholesterolaemia in the UK: Evidence from the National FH PASS database. Journal of Clinical Lipidology, https://doi.org/10.1016/j.jacl.2024.08.007

Background
Familial Hypercholesterolaemia (FH) is a monogenic disorder that causes high levels of low-density lipoprotein (LDL) cholesterol. Cascade testing, where relatives of known individuals with FH (‘index’) are genetically tested, is effective... Read More about Challenges and opportunities for identifying people with Familial hypercholesterolaemia in the UK: Evidence from the National FH PASS database.

Detection of non-cardiac fetal abnormalities on ultrasound at 11–14 weeks: systematic review and meta-analysis (2024)
Journal Article
Karim, J. N., Di Mascio, D., Roberts, N., Papageorghiou, A. T., Alfirevic, Z., Chudleigh, T., Goodman, H., Ioannou, C., Longworth, H., Karim, J., Nicolaides, K., Pandya, P., Smith, G., Thilaganathan, B., Thornton, J., Rivero-Arias, O., Campbell, H., Juszczak, E., Linsell, L., Wilson, E., …Yaz, G. (2024). Detection of non-cardiac fetal abnormalities on ultrasound at 11–14 weeks: systematic review and meta-analysis. Ultrasound in Obstetrics and Gynaecology, 64(1), 15-27. https://doi.org/10.1002/uog.27649

Objectives: To assess the diagnostic accuracy of two-dimensional ultrasound at 11–14 weeks' gestation as a screening test for individual fetal anomalies and to identify factors impacting on screening performance. Methods: This was a systematic review... Read More about Detection of non-cardiac fetal abnormalities on ultrasound at 11–14 weeks: systematic review and meta-analysis.

Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial (2024)
Journal Article
Afolabi, B. B., Adaramoye, V. O., Adeyemo, T. A., Balogun, M., Mitchell, E. J., Walker, K., Akinajo, O. R., Abioye, I. A., Banke-Thomas, A., Babah, O. A., Chieme, C. F., Oshodi, Y., Quao, R., Eboreime, E. A., & Ogunsola, F. (2024). Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial. BMJ Open, 14(8), Article e086553. https://doi.org/10.1136/bmjopen-2024-086553

Introduction Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80% in low-income and middle-income countries. It po... Read More about Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial.

Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT (2024)
Journal Article
Wyatt, L. A., Bradshaw, L. E., Brown, S. J., Haines, R. H., Montgomery, A. A., Perkin, M. R., Sach, T. H., Lawton, S., Flohr, C., Ridd, M. J., Chalmers, J. R., Brooks, J., Swinden, R., Mitchell, E. J., Tarr, S., Jay, N., Thomas, K. S., Allen, H., Cork, M. J., Kelleher, M. M., …Williams, H. C. (2024). Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT. Health Technology Assessment, 28(29), 1-116. https://doi.org/10.3310/rhdn9613

Background

Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.

Objectives

To determine whether advising parents to apply daily emollients in the first year can... Read More about Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.

Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial (2024)
Journal Article
Kendrick, D., Lindley, R., Blackburn, L., Roadevin, C., Thompson, E., Andrews, I., Anwar, F., Brooks, A., Carlton, E., Crouch, R., Day, F., Fallon, S., Farrin, A., Graham, L., Hoffman, K., Howell, R., Holmes, J., James, M., Jones, T., Kellezi, B., …Radford, K. (2024). Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial. Trials, 25(1), Article 439. https://doi.org/10.1186/s13063-024-08183-w

Background
Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to w... Read More about Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial.

Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort (2024)
Journal Article
Allen, H. I., Wing, O., Milkova, D., Jackson, E., Li, K., Bradshaw, L. E., Wyatt, L., Haines, R., Santer, M., Murphy, A. W., Brown, S. J., Kelleher, M., Perkin, M. R., Jay, N., Smith, T. D. H., Moriarty, F., Montgomery, A. A., Williams, H. C., & Boyle, R. J. (2025). Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort. Allergy, 80(1), 148-160. https://doi.org/10.1111/all.16203

Background: Cow's milk allergy (CMA) overdiagnosis in young children appears to be increasing and has not been well characterised. We used a clinical trial population to characterise CMA overdiagnosis and identify individual‐level and primary care pr... Read More about Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort.

Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial (2024)
Journal Article
Harrison, S., Ogollah, R., Hollingworth, W., Mills, N., Karantana, A., Blazeby, J., Montgomery, A., Shafayat, A., Jarrett, H., & Davis, T. (2024). Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial. Trials, 25(1), Article 398. https://doi.org/10.1186/s13063-024-08003-1

Background: Dupuytren’s contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function.... Read More about Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial.

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., Walker, K. F., & 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.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy (2024)
Journal Article
Clark, M. M., Cooper, S., Naughton, F., Ussher, M., Emery, J., McDaid, L., Thomson, R., Phillips, L., Bauld, L., Aveyard, P., Torgerson, D., Berlin, I., Lewis, S., Parrott, S., Hewitt, C., Welch, C., Parkinson, G., Dickinson, A., Sutton, S., Brimicombe, J., …Coleman, T. (2024). Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy. BMJ Open, 14(5), Article e087175. https://doi.org/10.1136/bmjopen-2024-087175

IntroductionSmoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for t... Read More about Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.