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All Outputs (353)

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK (2024)
Journal Article
Khan, K., Hall, C. L., Babbage, C., Dodzo, S., Greenhalgh, C., Lucassen, M., …Hollis, C. (2024). Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK. Pilot and Feasibility Studies, 10, Article 53. https://doi.org/10.1186/s40814-024-01475-7

Background A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depressio... Read More about Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK.

Waiting-list interventions for children and young people using child and adolescent mental health services: a systematic review (2024)
Journal Article
Valentine, A. Z., Hall, S. S., Sayal, K., & Hall, C. L. (2024). Waiting-list interventions for children and young people using child and adolescent mental health services: a systematic review. BMJ Mental Health, 27(1), 1-6. https://doi.org/10.1136/bmjment-2023-300844

Question Children and young people experience delays in assessment and/or treatment within mental health services. The objective of this systematic review, funded by the Emerging Minds Network, was to explore the current evidence base for mental heal... Read More about Waiting-list interventions for children and young people using child and adolescent mental health services: a systematic review.

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
RECOVERY Collaborative Group, Sandercock, P., Darbyshire, J., DeMets, D., Fowler, R., Lalloo, D., …Local Clinical Centre staff (for the RECOVERY Collaborative Group). (in press). Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Nature Communications, 15, Article 924. https://doi.org/10.1038/s41467-023-43644-x

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOV... Read More about Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen (2024)
Journal Article
Gupta, S., Subhedar, N. V., Bell, J. L., Field, D., Bowler, U., Hutchison, E., …Baby-OSCAR Collaborative Group, B. C. G. (2024). Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. New England Journal of Medicine, 390(4), 314-325. https://doi.org/10.1056/NEJMoa2305582

BACKGROUND: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known. METHODS: We cond... Read More about Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
RECOVERY Collaborative Group, Faust, S. N., Haynes, R., Jones, C. E., Staplin, N., Whittaker, E., …Montgomery, A. (2024). Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet Child & Adolescent Health, 8(3), 190-200. https://doi.org/10.1016/S2352-4642%2823%2900316-4

Background: Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS), also known as multisystem inflammatory syndrome in children (MIS-C) emerged in April, 2020. The paediatric comparisons within the RECOVERY trial... Read More about Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial.

Dog owner mental health is associated with dog behavioural problems, dog care and dog-facilitated social interaction: a prospective cohort study (2023)
Journal Article
Barcelos, A. M., Kargas, N., Assheton, P., Maltby, J., Hall, S., & Mills, D. S. (2023). Dog owner mental health is associated with dog behavioural problems, dog care and dog-facilitated social interaction: a prospective cohort study. Scientific Reports, 13(1), Article 21734. https://doi.org/10.1038/s41598-023-48731-z

Despite numerous qualitative and cross-sectional studies investigating how dog-related factors may impact owners’ well-being, empirical studies to test these causal effects are lacking. This prospective cohort study examined the correlation and poten... Read More about Dog owner mental health is associated with dog behavioural problems, dog care and dog-facilitated social interaction: a prospective cohort study.

Pet ownership and grief - Exploring how pet ownership effects owners' mental wellbeing during times of grief, a qualitative pilot study (2023)
Journal Article
French, B., Anctil, Z., Brown, B., & Hall, S. (2023). Pet ownership and grief - Exploring how pet ownership effects owners' mental wellbeing during times of grief, a qualitative pilot study. Pet Behaviour Science, 15, 1-19

Animal-assisted interventions (AAIs) have exhibited encouraging outcomes in enhancing human mental health. However, research has investigated the potential benefits of untrained pets for human mental wellbeing, as training animals for AAI can be cost... Read More about Pet ownership and grief - Exploring how pet ownership effects owners' mental wellbeing during times of grief, a qualitative pilot study.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Chan, A., Elbourne, D., …Montgomery, A. A. (2023). Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA Network Open, 330(21), 2106-2114. https://doi.org/10.1001/jama.2023.19793

Importance Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique method... Read More about Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Elbourne, D., Juszczak, E., …Montgomery, A. A. (2023). Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement. JAMA Network Open, 6(12), Article e2346121. https://doi.org/10.1001/jamanetworkopen.2023.46121

Importance Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates... Read More about Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.

Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT (2023)
Journal Article
Roehr, C. C., Marshall, A. S., Scrivens, A., Sadarangani, M., Williams, R., Yong, J., …Juszczak, E. (2023). Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT. Health Technology Assessment, 27(33), 1-97. https://doi.org/10.3310/THJY0671

Background: Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet '... Read More about Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.

Eczema Bathing Study – how often should we bathe? (2023)
Dataset
Harrison, E., & Thomas, K. (2023). Eczema Bathing Study – how often should we bathe?. [Dataset]. 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?.

Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial (2023)
Journal Article
Faust, S. N., Jones, C. E., Staplin, N., Whittaker, E., Jaki, T., Juszczak, E., …RECOVERY Collaborative Group, R. C. G. (in press). Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial. Lancet Child and Adolescent Health,

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., …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., …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., …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), 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., …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.

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., …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 resea... Read More about Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study.