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Eczema Bathing Study – how often should we bathe? (2023)
Data
Harrison, E., & Thomas, K. (2023). Eczema Bathing Study – how often should we bathe?. [Data]. https://doi.org/10.1186/isrctn12016473

Background and study aims
The Eczema Bathing Study is part of the Rapid Eczema Trials project. The researchers hope to answer many questions about how to manage eczema through this project. People with eczema are helping to prioritise, design and ru... Read More about Eczema Bathing Study – how often should we bathe?.

Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data. (2023)
Journal Article
Seidler, A. L., Libesman, S., Hunter, K. E., Barba, A., Aberoumand, M., Williams, J. G., Shrestha, N., Aagerup, J., Sotiropoulos, J. X., Montgomery, A. A., Gyte, G. M. L., Duley, L., & Askie, L. M. (2023). Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data. Lancet, 402(10418), 2223-2234. https://doi.org/10.1016/S0140-6736%2823%2902469-8

Background:

Deferred (also known as delayed) cord clamping can improve survival of infants born preterm (before 37 weeks of gestation), but the optimal duration of deferral remains unclear. We conducted a systematic review and individual particip... Read More about Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data..

Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis. (2023)
Journal Article
Seidler, A. L., Aberoumand, M., Hunter, K. E., Barba, A., Libesman, S., Williams, J. G., Shrestha, N., Aagerup, J., Sotiropoulos, J. X., Montgomery, A. A., Gyte, G. M. L., Duley, L., & Askie, L. M. (2024). Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis. Lancet, 402(10418), 2209-2222. https://doi.org/10.1016/S0140-6736%2823%2902468-6

Background:

Umbilical cord clamping strategies at preterm birth have the potential to affect important health outcomes. The aim of this study was to compare the effectiveness of deferred cord clamping, umbilical cord milking, and immediate cord c... Read More about Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis..

Determining a risk-proportionate approach to the validation of statistical programming for clinical trials (2023)
Journal Article
Gamble, C., Lewis, S., Stocken, D., Juszczak, E., Bradburn, M., Doré, C., & Kean, S. (2024). Determining a risk-proportionate approach to the validation of statistical programming for clinical trials. Clinical Trials, 21(1), 85-94. https://doi.org/10.1177/17407745231204036

Background
The contribution of the statistician to the design and analysis of a clinical trial is acknowledged as essential. Ability to reconstruct the statistical contribution to a trial requires rigorous and transparent documentation as evidenced... Read More about Determining a risk-proportionate approach to the validation of statistical programming for clinical trials.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs) (2023)
Journal Article
Madurasinghe, V. W., Knapp, P., Eldridge, S., Collier, D., Treweek, S., Rick, J., Graffy, J., Parker, A., Salisbury, C., Torgerson, D., Jolly, K., Sidhu, M. S., Fife-Schaw, C., Hull, M. A., Sprange, K., Brettell, E., Bhandari, S., Montgomery, A., & Bower, P. (2023). Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs). BMC Medicine, 21(1), Article 425. https://doi.org/10.1186/s12916-023-03081-5

Background: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the... Read More about Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs).

2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial (2023)
Journal Article
Clarke, P., Soe, A., Nichols, A., Harizaj, H., Webber, M. A., Linsell, L., Bell, J. L., Tremlett, C., Muthukumar, P., Pattnayak, S., Partlett, C., King, A., Juszczak, E., & Heath, P. T. (2023). 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial. Archives of Disease in Childhood. Fetal and Neonatal Edition, https://doi.org/10.1136/archdischild-2023-325871

Objective: Catheter-related sepsis (CRS) is a major complication with significant morbidity and mortality. Evidence is lacking regarding the most appropriate antiseptic for skin disinfection before percutaneous central venous catheter (PCVC) insertio... Read More about 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial.

Alternative cascade-testing protocols for identifying and managing patients with familial hypercholesterolaemia: systematic reviews, qualitative study and cost-effectiveness analysis (2023)
Journal Article
Qureshi, N., Woods, B., Neves de Faria, R., Saramago Goncalves, P., Cox, E., Leonardi Bee, J., Condon, L., Weng, S., Akyea, R. K., Iyen, B., Roderick, P., Humphries, S. E., Rowlands, W., Watson, M., Haralambos, K., Kenny, R., Datta, D., Miedzybrodzka, Z., Byrne, C., & Kai, J. (2023). Alternative cascade-testing protocols for identifying and managing patients with familial hypercholesterolaemia: systematic reviews, qualitative study and cost-effectiveness analysis. Health Technology Assessment, 27(16), 1-140. https://doi.org/10.3310/CTMD0148

Background
Cascade testing the relatives of people with familial hypercholesterolaemia is an efficient approach to identifying familial hypercholesterolaemia. The cascade-testing protocol starts with identifying an index patient with familial hyperc... Read More about Alternative cascade-testing protocols for identifying and managing patients with familial hypercholesterolaemia: systematic reviews, qualitative study and cost-effectiveness analysis.

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2023)
Journal Article
Horby, P. W., Staplin, N., Peto, L., Emberson, J. R., Mark Campbell, M., Pessoa-Amorim, G., Basnyat, B., Thwaites, L., van Doorn, R., Hamers, R. L., Nel, J., Amuasi, J., Rawal, M., Ghosh, D., Douse, J., Hamilton, F., Kerry, A., Thu-Ta, P., Widdrington, J., Green, C. A., …Landray, M. J. (2023). Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Diabetes and Endocrinology, 11(12), 905-914. https://doi.org/10.1016/s2213-8587%2823%2900253-x

Background

Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COV... Read More about Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

The cost-effectiveness of risk-stratified breast cancer screening in the UK (2023)
Journal Article
Hill, H., Kearns, B., Pashayan, N., Roadevin, C., Sasieni, P., Offman, J., & Duffy, S. (2023). The cost-effectiveness of risk-stratified breast cancer screening in the UK. British Journal of Cancer, 129(11), 1801-1809. https://doi.org/10.1038/s41416-023-02461-1

There has been growing interest in the UK and internationally of risk-stratified breast screening whereby individualised risk assessment may inform screening frequency, starting age, screening instrument used, or even decisions not to screen. This st... Read More about The cost-effectiveness of risk-stratified breast cancer screening in the UK.

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., Gillies, K., Hood, K., Love, S. B., Sydes, M. R., Williamson, P. R., & 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.

Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial (2023)
Preprint / Working Paper
Khan, K., Hall, C. L., Babbage, C., Dodzo, S., Greenhalgh, C., Lucassen, M., Merry, S., Sayal, K., Sprange, K., Stasiak, K., Tench, C. R., Townsend, E., Stallard, P., & Hollis, C. Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial

Background:

A serious game (SPARX), developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression. Howev... Read More about Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial.

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study (2023)
Journal Article
Kai, J., Dutton, B., Vinogradova, Y., Hilken, N., Gupta, J., & Daniels, J. (2023). Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study. Health Technology Assessment, 27(17), https://doi.org/10.3310/jhsw0174

Background: Heavy menstrual bleeding is a common problem that can significantly affect women’s lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives... Read More about Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study.

Prognosis of patients with neuropathic low back-related leg pain: An exploratory study using prospective data from UK primary care (2023)
Journal Article
Harrisson, S. A., Ogollah, R., Dunn, K. M., Foster, N. E., & Konstantinou, K. (2024). Prognosis of patients with neuropathic low back-related leg pain: An exploratory study using prospective data from UK primary care. Journal of Pain, 25(2), 533-544. https://doi.org/10.1016/j.jpain.2023.09.016

This prospective cohort study investigates the prognosis of patients with neuropathic low back-related leg pain consulting in UK primary care. Data from 511 patients were collected using standardised baseline clinical examinations (including magnetic... Read More about Prognosis of patients with neuropathic low back-related leg pain: An exploratory study using prospective data from UK primary care.

Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study (2023)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2023). Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study. BMC Medical Research Methodology, 23(1), Article 211. https://doi.org/10.1186/s12874-023-02032-1

Background:

Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health r... Read More about Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study.

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., Montgomery, A. A., Thomas, K. S., Brown, S. J., Ridd, M. J., Lawton, S., Cork, M. J., Flohr, C., Mitchell, E., Swinden, R., Wyatt, L., Tarr, S., Davies‐Jones, S., Jay, N., Kelleher, M. M., …the BEEP Study Team. (2023). Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial. Clinical and 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.

Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT (2023)
Journal Article
Knight, M., Ramakrishnan, R., Ratushnyak, S., Rivero-Arias, O., Bell, J., Bowler, U., Buchanan, P., Carter, C., Cole, C., Hewer, O., Hurd, M., King, A., Juszczak, E., Linsell, L., Long, A. M., Mottram, L., Murray, D., Oddie, S., Quigley, M., Stalker, V., …Hardy, P. (2023). Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT. Health Technology Assessment, 27(11), 1-73. https://doi.org/10.3310/WBBW2302

Background
Tongue-tie can be diagnosed in 3–11% of babies, with some studies reporting almost universal breastfeeding difficulties, and others reporting very few feeding difficulties that relate to the tongue-tie itself, instead noting that incorrec... Read More about Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT.

Patients’ experience of accessing support for tics from primary care in the UK: an online mixed-methods survey (2023)
Journal Article
Marino, C., Khan, K., Groom, M. J., Hall, S. S., Anderson, S., Mcnally, E., Murphy, T., & Hall, C. L. (2023). Patients’ experience of accessing support for tics from primary care in the UK: an online mixed-methods survey. BMC Health Services Research, 23, Article 788. https://doi.org/10.1186/s12913-023-09753-5

Background
Tics are common in children and young people and may persist into adulthood. Tics can cause challenges with social, occupational, physical, and academic functioning. The current study explores the perceptions of adults with tics and paren... Read More about Patients’ experience of accessing support for tics from primary care in the UK: an online mixed-methods survey.

Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia (2023)
Journal Article
Woodhouse, L. J., Appleton, J. P., Christensen, H., Dineen, R. A., England, T. J., James, M., Krishnan, K., Montgomery, A. A., Ranta, A., Robinson, T. G., Sprigg, N., & Bath, P. M. (2023). Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia. Scientific Reports, 13, Article 11717. https://doi.org/10.1038/s41598-023-38474-2

Intensive antiplatelet therapy did not reduce recurrent stroke/transient ischaemic attack (TIA) events as compared with guideline treatment in the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial, but did increase th... Read More about Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia.

Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure (2023)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Pocock, S., James, M., Ranta, A., Bath, P. M., & TARDIS Investigators, T. I. (2023). Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure. Contemporary Clinical Trials Communications, 35, Article 101186. https://doi.org/10.1016/j.conctc.2023.101186

Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its p... Read More about Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure.