All Outputs (39)

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.

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.

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.

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., …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), 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., …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., …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.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial (2023)
Journal Article
Subhani, M., Enki, D. G., Knight, H., Jones, K. A., Sprange, K., Rennick-Egglestone, S., …Ryder, S. D. (2023). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial. eClinicalMedicine, 61, Article 102069. https://doi.org/10.1016/j.eclinm.2023.102069

Background: Early identification followed by effective behaviour interventions is pivotal to changing the natural history of alcohol-related liver disease. We examined the feasibility of using transient elastography based advice and alcohol recovery... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial.