All Outputs (354)

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).

Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study (2022)
Journal Article
Daniels, J. P., Dixon, E., Gill, A., Bishop, J., Wilks, M., Millar, M., …Collaboative Group, G. (2022). Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study. BMC Medicine, 20, Article 9. https://doi.org/10.1186/s12916-021-02202-2

Background: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test... Read More about Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study.

Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze) (2022)
Journal Article
Maheshwari, A., Bell, J. L., Bhide, P., Brison, D., Child, T., Chong, H. Y., …Bhattacharya, S. (2022). Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze). Human Reproduction, 37(3), 476-487. https://doi.org/10.1093/humrep/deab279

STUDY QUESTION: Does a policy of elective freezing of embryos, followed by frozen embryo transfer result in a higher healthy baby rate, after first embryo transfer, when compared with the current policy of transferring fresh embryos? SUMMARY ANSWER:... Read More about Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze).

Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT (2022)
Journal Article
Armstrong-Buisseret, L., Brittain, C., Kai, J., David, M., Anstey Watkins, J., Ozolins, M., …Ross, J. D. (2022). Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT. Health Technology Assessment, 26(2), 1-170. https://doi.org/10.3310/ZZKH4176

BACKGROUND: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. OBJECTIVES: The... Read More about Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT.

Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences (2022)
Journal Article
Nomikos, P. A., Hall, M. C., Fuller, A., Ogollah, R., Valdes, A. M., Doherty, M., …Abhishek, A. (2022). Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences. PLoS ONE, 17(1), Article e0262422. https://doi.org/10.1371/journal.pone.0262422

Objectives The overall purpose of this research programme is to develop and test the feasibility of a complex intervention for knee pain delivered by a nurse, and comprising both non-pharmacological and pharmacological interventions. In this first ph... Read More about Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences.

First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis (2022)
Journal Article
Karim, J. N., Bradburn, E., Roberts, N., Papageorghiou, A. T., Alfirevic, Z., Chudleigh, T., …Yaz, G. (2022). First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis. Ultrasound in Obstetrics and Gynaecology, 59(1), 11-25. https://doi.org/10.1002/uog.23740

Objectives: To determine the diagnostic accuracy of ultrasound at 11–14 weeks' gestation in the detection of fetal cardiac abnormalities and to evaluate factors that impact the detection rate. Methods: This was a systematic review of studies evaluati... Read More about First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis.

Long-term Effectiveness of Adjuvant Treatment with Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors Compared with Dopamine Agonists among Patients with Parkinson Disease Uncontrolled by Levodopa Therapy: The PD MED Randomized Clinical Trial (2021)
Journal Article
Gray, R., Patel, S., Ives, N., Rick, C., Woolley, R., Muzerengi, S., …Clarke, C. E. (2022). Long-term Effectiveness of Adjuvant Treatment with Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors Compared with Dopamine Agonists among Patients with Parkinson Disease Uncontrolled by Levodopa Therapy: The PD MED Randomized Clinical Trial. JAMA Neurology, 79(2), 131-140. https://doi.org/10.1001/jamaneurol.2021.4736

Importance: Many people with Parkinson disease (PD) develop motor complications that are uncontrolled by levodopa dose adjustment. Among these patients, it is uncertain which drug class is more effective as adjuvant therapy. Objective: To compare the... Read More about Long-term Effectiveness of Adjuvant Treatment with Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors Compared with Dopamine Agonists among Patients with Parkinson Disease Uncontrolled by Levodopa Therapy: The PD MED Randomized Clinical Trial.

The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis (2021)
Journal Article
Haydock, R., Hepburn, T., Ross, J., Daniels, J., Brittain, C., Jackson, L., …Wilson, J. (2021). The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis. Trials, 23(1), Article 1040. https://doi.org/10.1186/s13063-022-06954-x

Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour a... Read More about The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis.

Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial (2021)
Journal Article
Li, T., Li, J., Yuan, L., Wu, J., Jiang, C., Daniels, J., …RAGA Study Investigators. (2021). Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial. Journal of the American Medical Association, https://doi.org/10.1001/jama.2021.22647

Importance: In adults undergoing hip fracture surgery, regional anesthesia may reduce postoperative delirium, but there is uncertainty about its effectiveness. Objective: To investigate, in older adults undergoing surgical repair for hip fracture, th... Read More about Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA 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)
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.

Multifactorial falls prevention programme compared with usual care in UK care homes for older people: Multicentre cluster randomised controlled trial with economic evaluation (2021)
Journal Article
Logan, P. A., Horne, J. C., Gladman, J. R., Gordon, A. L., Robertson, K., Sach, T., …Sims, E. (2021). Multifactorial falls prevention programme compared with usual care in UK care homes for older people: Multicentre cluster randomised controlled trial with economic evaluation. BMJ, 375, Article e066991. https://doi.org/10.1136/bmj-2021-066991

Objectives To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes. Design Multicentre, parallel, cluster randomised controlled trial. Setting Long term care home... Read More about Multifactorial falls prevention programme compared with usual care in UK care homes for older people: Multicentre cluster randomised controlled trial with economic evaluation.

Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial (2021)
Journal Article
the TICH-2 Investigators, Law, Z. K., Appleton, J. P., Scutt, P., Roberts, I., Al-Shahi Salman, R., …Sprigg, N. (2021). Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial. Stroke, 53(4), 1141-1148. https://doi.org/10.1161/STROKEAHA.121.035191

Background: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) rand... Read More about Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial.

An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial (2021)
Journal Article
Rochat, T. J., Dube, S., Herbst, K., Hoegfeldt, C. A., Redinger, S., Khoza, T., …Stein, A. (2021). An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial. Trials, 22(1), Article 914. https://doi.org/10.1186/s13063-021-05672-0

Background: The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Peri... Read More about An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial.

Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial (2021)
Journal Article
Daniels, J., Middleton, L. J., Cheed, V., McKinnon, W., Sirkeci, F., Manyonda, I., …on behalf of the FEMME Trial Collaborative Group. (2022). Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial. European Journal of Obstetrics && Gynecology and Reproductive Biology: X, 13, Article 100139. https://doi.org/10.1016/j.eurox.2021.100139

Objective: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has b... Read More about Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial.

Theoretical Foundations to the Impact of Dog-Related Activities on Human Hedonic Well-Being, Life Satisfaction and Eudaimonic Well-Being (2021)
Journal Article
Barcelos, A. M., Kargas, N., Maltby, J., Hall, S., Assheton, P., & Mills, D. S. (2021). Theoretical Foundations to the Impact of Dog-Related Activities on Human Hedonic Well-Being, Life Satisfaction and Eudaimonic Well-Being. International Journal of Environmental Research and Public Health, 18(23), Article 12382. https://doi.org/10.3390/ijerph182312382

Cross-sectional comparisons of well-being between dog owners and non-owners commonly generate inconsistent results. Focusing on the uniqueness of the relationship might help address this issue and provide a stronger foundation for dog-related psychot... Read More about Theoretical Foundations to the Impact of Dog-Related Activities on Human Hedonic Well-Being, Life Satisfaction and Eudaimonic Well-Being.

Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Pessoa-Amorim, G., Staplin, N., Emberson, J. R., Campbell, M., …Landray, M. J. (2022). Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10320), 143-151. https://doi.org/10.1016/S0140-6736%2821%2901825-0

Background Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19. Methods In this randomised,... Read More about Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention (2021)
Journal Article
Berry, K., Wright, J., Sprange, K., Cooper, C., Courtney-Walker, R., & Mountain, G. (2021). The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention. Brain and Behavior, 11(12), Article e2436. https://doi.org/10.1002/brb3.2436

Objective: A key challenge in delivering pragmatic trials of complex interventions is effective implementation within the study period and beyond. We describe a trial of an intervention to improve quality of life in mild dementia (Journeying through... Read More about The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention.

Trends in hospital admissions for childhood fractures in England (2021)
Journal Article
Marson, B. A., Manning, J. C., James, M., Ikram, A., Bryson, D. J., & Ollivere, B. J. (2021). Trends in hospital admissions for childhood fractures in England. BMJ Paediatrics Open, 5(1), Article e001187. https://doi.org/10.1136/bmjpo-2021-001187

Purpose Fractures to the axial and appendicular skeleton are common in children causing loss of opportunities and disability. There are relatively few studies available to quantify the number of children who have their fractures diagnosed in the emer... Read More about Trends in hospital admissions for childhood fractures in England.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial (2021)
Journal Article
Subhani, M., Jones, K. A., Sprange, K., Rennick-Egglestone, S., Knight, H., Morling, J. R., …Ryder, S. D. (2021). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial. BMJ Open, 11(11), Article e054954. https://doi.org/10.1136/bmjopen-2021-054954

Introduction Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review su... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled 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.