All Outputs (440)

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.

A multifaceted and standardized approach is needed to improve acne severity assessment in clinical practice: an online survey of UK health professionals (2024)
Journal Article
Masterson, N., Burden-Teh, E., Healy, E., Hepburn, T., Layfield, C., Layton, A., Leighton, P., Leng, S., Mitchell, E., Northover, G., Penzer-Hick, R., Price, W., Radley, K., Ramesh, G., Ravenscroft, J. C., Sach, T., Sadiq, S., Santer, M., Thomas, K. S., Thompson, A., …the Acne-ID Trial Development Team. (2025). A multifaceted and standardized approach is needed to improve acne severity assessment in clinical practice: an online survey of UK health professionals. Clinical and Experimental Dermatology, 50(1), 158-160. https://doi.org/10.1093/ced/llae180

Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial (2024)
Journal Article
Cooper, K. G., Bhattacharya, S., Daniels, J. P., Horne, A. W., Clark, T. J., Saridogan, E., Cheed, V., Pirie, D., Melyda, M., Monahan, M., Roberts, T. E., Cox, E., Stubbs, C., Middleton, L. J., & on behalf of the PRE-EMPT Collaborative Group. (in press). Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial. BMJ, 385, Article e079006. https://doi.org/10.1136/bmj-2023-079006

Objectives: To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design: The PRE-EMPT (preventing recurrence of endometriosis) pr... Read More about Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial.

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study (2024)
Journal Article
Mitchell, E. J., Aluvaala, J., Bradshaw, L., Daniels, J. P., Emadau, C., Muthumbi, B., Nabwera, H., Ojee, E., Opira, J., Pallotti, P., Qureshi, Z., Sigei, M., Su, Y., Swinden, R., Were, F., & Ojha, S. (2024). A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study. BMC Pediatrics, 24, Article 326. https://doi.org/10.1186/s12887-024-04778-z

Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whe... Read More about A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study.

Metformin for endometrial hyperplasia (2024)
Journal Article
Shiwani, H., Clement, N. S., Daniels, J. P., & Atiomo, W. (2024). Metformin for endometrial hyperplasia. Cochrane Database of Systematic Reviews, 2024(5), Article CD012214. https://doi.org/10.1002/14651858.cd012214.pub3

Background
Endometrial cancer is one of the most common gynaecological cancers in the world. Rates of endometrial cancer are rising, in part because of rising obesity rates. Endometrial hyperplasia is a precancerous condition in women that can lead... Read More about Metformin for endometrial hyperplasia.

Identifying the Optimum Strategy for Identifying Adults and Children With Celiac Disease: A Cost-Effectiveness and Value of Information Analysis (2024)
Journal Article
Keeney, E., Elwenspoek, M. M., Jackson, J., Roadevin, C., Jones, H. E., O’Donnell, R., Sheppard, A. L., Dawson, S., Lane, D., Stubbs, J., Everitt, H., Watson, J. C., Hay, A. D., Gillett, P., Robins, G., Mallett, S., Whiting, P. F., & Thom, H. (2024). Identifying the Optimum Strategy for Identifying Adults and Children With Celiac Disease: A Cost-Effectiveness and Value of Information Analysis. Value in Health, 27(3), 301-312. https://doi.org/10.1016/j.jval.2023.12.010

Objectives
Celiac disease (CD) is thought to affect around 1% of people in the United Kingdom, but only approximately 30% are diagnosed. The aim of this work was to assess the cost-effectiveness of strategies for identifying adults and children with... Read More about Identifying the Optimum Strategy for Identifying Adults and Children With Celiac Disease: A Cost-Effectiveness and Value of Information Analysis.

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK (2024)
Journal Article
Barber, V. S., Calvert, C., Appelbe, D., Sprange, K., Nollett, C., Tanner, S., & Richards, D. B. (2024). Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK. Trials, 25, Article 224. https://doi.org/10.1186/s13063-024-08060-6

Background
Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology... Read More about Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK.

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., Merry, S., Sayal, K., Sprange, K., Stasiak, K., Tench, C. R., Townsend, E., Stallard, P., & 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(1), 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 depressi... Read More about Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK.

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators (2024)
Journal Article
Papaioannou, D., Sprange, K., Hamer-Kiwacz, S., Mooney, C., Moody, G., & Cooper, C. (2024). Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators. Trials, 25(1), Article 163. https://doi.org/10.1186/s13063-024-07978-1

Background: Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); howe... Read More about Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators.

Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence (2024)
Journal Article
Papaioannou, D., Hamer-Kiwacz, S., Mooney, C., Cooper, C., O'Cathain, A., Sprange, K., & Moody, G. (2024). Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence. Journal of Clinical Epidemiology, 169, Article 111275. https://doi.org/10.1016/j.jclinepi.2024.111275

Objectives: Randomized controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behavior change interventions (BCIs) that aim to change a habit, belief, or attitude to improve h... Read More about Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence.

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., Munavvar, M., Warris, A., Wittes, J., Cradduck-Bamford, A., Barton, J., Basoglu, A., Brown, R., Brudlo, W., Denis, E., Fletcher, L., Howard, S., Taylor, K., Cui, G., Goodenough, B., …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., Johnson, S., Kelsall, W., Pepperell, J., Roberts, T., Sinha, S., Stanbury, K., Wyllie, J., Hardy, P., Juszczak, E., & Baby-OSCAR Collaborative Group, B.-O. 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., Jaki, T., Juszczak, E., Spata, E., Wan, M., Bamford, A., Dimitri, P., Finn, A., Furness, J., Ramanan, A. V., Gale, C., & 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.-W., Elbourne, D., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Juszczak, E., & 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., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Chan, A.-W., & 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., Linsell, L., Chiocchia, V., Bell, J. L., Stokes, C., Santhanadass, P., Nicoll, I., Adams, E., King, A., Murray, D., Bowler, U., Stanbury, K., & 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.