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All Outputs (354)

Do patient characteristics matter when calculating sample size for eczema clinical trials? (2021)
Journal Article
Howells, L., Gran, S., Chalmers, J. R., Stuart, B., Santer, M., Bradshaw, L., …Thomas, K. S. (2021). Do patient characteristics matter when calculating sample size for eczema clinical trials?. Skin Health and Disease, 1(3), Article e42. https://doi.org/10.1002/ski2.42

Background: The Patient-Oriented Eczema Measure (POEM) is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To ensure that the statistical significance of clinical trial results is meani... Read More about Do patient characteristics matter when calculating sample size for eczema clinical trials?.

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial (2021)
Journal Article
Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zyengi, S. (2021). Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet, 397(10289), 2049-2059. https://doi.org/10.1016/s0140-6736%2821%2900897-7

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This ran... Read More about Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.

Cost-Effectiveness of Dopamine Agonists and Monoamine Oxidase B Inhibitors in Early Parkinson's Disease (2021)
Journal Article
McIntosh, E., Kent, S., Gray, A., Clarke, C. E., Williams, A., Jenkinson, C., …PD MED Collaborative Group. (2021). Cost-Effectiveness of Dopamine Agonists and Monoamine Oxidase B Inhibitors in Early Parkinson's Disease. Movement Disorders, 36(9), 2136-2143. https://doi.org/10.1002/mds.28623

Background: The PD MED study reported small but persistent benefits in patient-rated mobility scores and quality of life from initiating therapy with levodopa compared with levodopa-sparing therapies in early Parkinson's disease (PD). Objectives: The... Read More about Cost-Effectiveness of Dopamine Agonists and Monoamine Oxidase B Inhibitors in Early Parkinson's Disease.

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zuriaga-Alvaro, A. (2021). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10285), 1637-1645. https://doi.org/10.1016/s0140-6736%2821%2900676-0

Background: We evaluated the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19... Read More about Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) (2021)
Journal Article
Imran, M., Kwakkenbos, L., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., …Thombs, B. D. (2021). Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). BMJ Open, 11(4), Article e049093. https://doi.org/10.1136/bmjopen-2021-049093

Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated St... Read More about Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration (2021)
Journal Article
Kwakkenbos, L., Imran, M., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., …Thombs, B. D. (2021). CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 373, Article n857. https://doi.org/10.1136/bmj.n857

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the t... Read More about CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.

Compression stockings for preventing deep vein thrombosis in airline passengers (2021)
Journal Article
Clarke, M. J., Broderick, C., Hopewell, S., Juszczak, E., & Eisinga, A. (2021). Compression stockings for preventing deep vein thrombosis in airline passengers. Cochrane Database of Systematic Reviews, 2021(4), https://doi.org/10.1002/14651858.cd004002.pub4

Background: Air travel might increase the risk of deep vein thrombosis (DVT). It has been suggested that wearing compression stockings might reduce this risk. This is an update of the review first published in 2006. Objectives: To assess the effects... Read More about Compression stockings for preventing deep vein thrombosis in airline passengers.

Incidence and risk factors for poor ankle functional recovery, and the development and progression of posttraumatic ankle osteoarthritis after significant ankle ligament injury (SALI): the SALI cohort study protocol (2021)
Journal Article
Bestwick-Stevenson, T., Wyatt, L. A., Palmer, D., Ching, A., Kerslake, R., Coffey, F., …Scammell, B. E. (2021). Incidence and risk factors for poor ankle functional recovery, and the development and progression of posttraumatic ankle osteoarthritis after significant ankle ligament injury (SALI): the SALI cohort study protocol. BMC Musculoskeletal Disorders, 22(1), Article 362. https://doi.org/10.1186/s12891-021-04230-8

Background: Ankle sprains are one of the most common musculoskeletal injuries, accounting for up to 5% of all Emergency Department visits in the United Kingdom. Ankle injury may be associated with future ankle osteoarthritis. Up to 70% of ankle osteo... Read More about Incidence and risk factors for poor ankle functional recovery, and the development and progression of posttraumatic ankle osteoarthritis after significant ankle ligament injury (SALI): the SALI cohort study protocol.

Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage (2021)
Journal Article
Pszczolkowski, S., Manzano-Patron, J. P., Law, Z. K., Krishnan, K., Ali, A., Bath, P. M., …Dineen, R. A. (2021). Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage. European Radiology, 31, 7945-7959. https://doi.org/10.1007/s00330-021-07826-9

Objectives To test radiomics-based features extracted from noncontrast CT of patients with spontaneous intracerebral haemorrhage for prediction of haematoma expansion and poor functional outcome and compare them with radiological signs and clinica... Read More about Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage.

Correction to: Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial (2021)
Journal Article
Williams, L., Hall, C. L., Brown, S., Guo, B., James, M., Franceschini, M., …Groom, M. J. (2021). Correction to: Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot and Feasibility Studies, 7, Article 94. https://doi.org/10.1186/s40814-021-00830-2

An Individual Cognitive Stimulation Therapy App for People With Dementia and Their Carers: Protocol for a Feasibility Randomized Controlled Trial (2021)
Journal Article
Rai, H. K., Schneider, J., & Orrell, M. (2021). An Individual Cognitive Stimulation Therapy App for People With Dementia and Their Carers: Protocol for a Feasibility Randomized Controlled Trial. JMIR Research Protocols, 10(4), Article e24628. https://doi.org/10.2196/24628

Background: There is a need for more resources to support the cognition and quality of life (QoL) of people with dementia. The individual Cognitive Stimulation Therapy application (iCST app) aims to provide cognitive stimulation and social interac... Read More about An Individual Cognitive Stimulation Therapy App for People With Dementia and Their Carers: Protocol for a Feasibility Randomized Controlled Trial.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial (2021)
Journal Article
Sprange, K., Mountain, G., & Craig, C. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial. BMJ Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478

Objectives: Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a det... Read More about Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial (2021)
Journal Article
Sprange, K., Mountain, G., & Craig, C. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial. BMJ Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478

Objectives: Robust research of complex interventions designed to promote mental wellbeing in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a deta... Read More about Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial.

Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial (2021)
Journal Article
Williams, L., Hall, C. L., Brown, S., Guo, B., James, M., Franceschini, M., …Groom, M. J. (2021). Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot and Feasibility Studies, 7, Article 68. https://doi.org/10.1186/s40814-021-00788-1

Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of t... Read More about Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial.

Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial (2021)
Journal Article
Gupta, S., Juszczak, E., Hardy, P., Subhedar, N., Wyllie, J., Kelsall, W., …on behalf of the ‘The Baby-OSCAR Collaborative Group. (2021). Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatrics, 21, Article 100. https://doi.org/10.1186/s12887-021-02558-7

Background The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks’ gestation are born in the... Read More about Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.

Promoting independence in Dementia (Pride): A feasibility randomized controlled trial (2021)
Journal Article
Csipke, E., Shafayat, A., Sprange, K., Bradshaw, L., Montgomery, A. A., Ogollah, R., …Orrell, M. (2021). Promoting independence in Dementia (Pride): A feasibility randomized controlled trial. Clinical Interventions in Aging, 16, 363-378. https://doi.org/10.2147/CIA.S281139

© 2021 Csipke et al. Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living we... Read More about Promoting independence in Dementia (Pride): A feasibility randomized controlled trial.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21, Article 119. https://doi.org/10.1186/s12877-021-02070-8

Background Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex... Read More about Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. L. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21(1), Article 119. https://doi.org/10.1186/s12877-021-02070-8

© 2021, The Author(s). Background: Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part... Read More about Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

Skin care interventions in infants for preventing eczema and food allergy (2021)
Journal Article
Kelleher, M. M., Cro, S., Cornelius, V., Lodrup Carlsen, K. C., Skjerven, H. O., Rehbinder, E. M., …Boyle, R. J. (2021). Skin care interventions in infants for preventing eczema and food allergy. Cochrane Library, 2021(2), Article CD013534. https://doi.org/10.1002/14651858.cd013534.pub2

Background Eczema and food allergy are common health conditions that usually begin in early childhood and often occur together in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying... Read More about Skin care interventions in infants for preventing eczema and food allergy.