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Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year (2019)
Journal Article
Bradshaw, L., Sawyer, A., Armstrong-Buisseret, L., Mitchell, E., Ayers, S., & Duley, L. (2019). Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year. BMC Pregnancy and Childbirth, 19, doi:10.1186/s12884-019-2223-9

Background The Cord Pilot Trial compared two alternative policies for cord clamping at very preterm birth at eight UK maternity units: clamping after at least 2 min and immediate neonatal care (if needed) with cord intact, or clamping within 20 s an... Read More

High versus low intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: a cluster randomized controlledtrial (The EXPONATE Trial) (2019)
Journal Article
Gureje, O., Oladeji, B. D., Montgomery, A. A., Araya, R., Bello, T., Chisholm, D., …Zelkowitz, P. (2019). High versus low intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: a cluster randomized controlledtrial (The EXPONATE Trial). British Journal of Psychology, doi:10.1192/bjp.2019.4

Background: Contextually appropriate interventions delivered by primary maternal care providers might be effective in reducing the treatment gap for perinatal depression. Aim: To compare a high intensity psychological intervention with a low intensi... Read More

Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation (2018)
Journal Article
Godolphin, P., Hepburn, T., Sprigg, N., Walker, L., Berge, E., Collins, R., …Montgomery, A. (in press). Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation. Contemporary Clinical Trials Communications, doi:10.1016/j.conctc.2018.11.002

Background Central adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (E... Read More

Postpartum evaluation of cardiovascular disease risk for women with pregnancies complicated by hypertension (2018)
Journal Article
Escouto, D. C., Green, A., & Kurlak, L. (2018). Postpartum evaluation of cardiovascular disease risk for women with pregnancies complicated by hypertension. Pregnancy Hypertension, 13, 218-224. doi:10.1016/j.preghy.2018.06.019

Objectives: Postpartum stratification of cardiovascular risk for women with pregnancies complicated by pre-eclampsia is challenging. Our aim was to identify potential clinical and biomarker predictors of future cardiovascular risk at six weeks postpa... Read More

Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial (2018)
Journal Article
Sprigg, N., Flaherty, K., Appleton, J. P., Al-Shahi Salman, R., Bereczki, D., Beridze, M., …Bath, P. M. (in press). Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial. Lancet, doi:10.1016/S0140-6736(18)31033-X. ISSN 0140-6736

Background Tranexamic acid (TXA) reduces death due to bleeding after trauma and post-partum haemorrhage. The aim was to assess if tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral 6 haemorrha... Read More

The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial (2018)
Journal Article
Crawford, M. J., Sanatinia, R., Barrett, B., Cunningham, G., Dale, O., Ganguli, P., …Reilly, J. G. (in press). The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial. American Journal of Psychiatry, doi:10.1176/appi.ajp.2018.17091006

Objectives: To examine whether lamotrigine is a clinically effective and cost-effective treatment for people with borderline personality disorder. Method: Multicentre, double-blind, placebo-controlled randomized trial. Between July 2013 to Novembe... Read More

Clinical diagnostic model for sciatica developed in primary care patients with low back-related leg pain (2018)
Journal Article
Stynes, S., Konstantinou, K., Ogollah, R. O., Hay, E. M., & Dunn, K. M. (2018). Clinical diagnostic model for sciatica developed in primary care patients with low back-related leg pain. PLoS ONE, 13(4), doi:10.1371/journal.pone.0191852

Background Identification of sciatica may assist timely management but can be challenging in clinical practice. Diagnostic models to identify sciatica have mainly been developed in secondary care settings with conflicting reference standard select... Read More

NHS health checks: a cross- sectional observational study on equity of uptake and outcomes (2018)
Journal Article
Coghill, N., Garside, L., Montgomery, A. A., Feder, G., & Horwood, J. (2018). NHS health checks: a cross- sectional observational study on equity of uptake and outcomes. BMC Health Services Research, 18, doi:10.1186/s12913-018-3027-8

Background The National Health Checks programme aims to reduce the incidence of cardiovascular diseases and health inequalities in England. We assessed equity of uptake and outcomes from NHS Health Checks in general practices in Bristol, UK. Me... Read More

Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial (2018)
Journal Article
Haines, R. H., Thomas, K. S., Montgomery, A. A., Ravenscroft, J. C., Akram, P., Chalmers, J., …Batchelor, J. M. (2018). Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial. BMJ Open, 8(4), doi:10.1136/bmjopen-2017-018649

Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high quality evide... Read More

Determining one-year trajectories of low back related leg pain in primary care patients: growth mixture modelling of a prospective cohort study (2018)
Journal Article
Ogollah, R. O., Konstantinou, K., Stynes, S., & Dunn, K. M. (2018). Determining one-year trajectories of low back related leg pain in primary care patients: growth mixture modelling of a prospective cohort study. Arthritis Care and Research, doi:10.1002/acr.23556. ISSN 2151-464X

Objective The clinical presentation and outcome of patients with back and leg pain in primary care are heterogeneous and may be better understood by identification of homogeneous and clinically meaningful subgroups. Subgroups of patients with diff... Read More

A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: the NOTEPAD study Protocol (2018)
Journal Article
Burroughs, H., Bartlam, B., Kingstone, T., Shepherd, T., Ogollah, R. O., Proctor, J., …Chew-Graham, C. (2018). A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: the NOTEPAD study Protocol. Trials, 19, doi:10.1186/s13063-018-2550-6

BACKGROUND: Anxiety and depression are common among older people, with up to 20% reporting such symptoms, and the prevalence increases with co-morbid chronic physical health problems. Access to treatment for anxiety and depression in this population... Read More

Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations (2018)
Journal Article
McKeever, T., Mortimer, K., Wilson, A., Walker, S., Brightling, C., Skeggs, A., …Harrison, T. (2018). Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations. New England Journal of Medicine, 378(10), doi:10.1056/NEJMoa1714257

BACKGROUND Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled gluc... Read More

Recruitment of older adults to three preventative lifestyle improvement studies (2018)
Journal Article
Chatters, R., Newbold, L., Sprange, K., Hind, D., Mountain, G., Shortland, K., …Woods, B. (2018). Recruitment of older adults to three preventative lifestyle improvement studies. Trials, 19, doi:10.1186/s13063-018-2482-1

Background: Recruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment tech... Read More

Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial (2018)
Journal Article
Quicke, J. G., Foster, N. E., Croft, P. R., Ogollah, R. O., & Holden, M. A. (2018). Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial. BMC Musculoskeletal Disorders, 19, doi:10.1186/s12891-018-1968-z

BACKGROUND: Exercise interventions improve clinical outcomes of pain and function in adults with knee pain due to osteoarthritis and higher levels of physical activity are associated with lower severity of pain and higher levels of physical function... Read More

Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ (2018)
Journal Article
Scutt, P., Appleton, J. P., Dixon, M., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., …Bath, P. M. (2018). Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’. European Stroke Journal, 3(2), doi:10.1177/2396987318756696

Rationale: Glyceryl trinitrate, a nitric oxide donor, is a candidate treatment for acute stroke; it lowers blood pressure, does not alter cerebral blood flow or platelet function and is neuroprotective in experimental stroke. The ongoing rapid interv... Read More

How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods (2018)
Journal Article
Howells, L., Ratib, S., Chalmers, J., Bradshaw, L., & Thomas, K. (2018). How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods. British Journal of Dermatology, 178(5), doi:10.1111/bjd.16367

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the... Read More

Novel approach to characterising individuals with low back-related leg pain: cluster identification with latent class analysis and 12-month follow-up (2018)
Journal Article
Stynes, S., Konstantinou, K., Ogollah, R. O., Hay, E. M. H., & Dunn, K. M. (2018). Novel approach to characterising individuals with low back-related leg pain: cluster identification with latent class analysis and 12-month follow-up. PAIN, 159(4), doi:10.1097/j.pain.0000000000001147. ISSN 0304-3959

Traditionally, low back-related leg pain (LBLP) is diagnosed clinically as referred leg pain or sciatica (nerve root involvement). However, within the spectrum of LBLP, we hypothesised that there may be other unrecognised patient subgroups. This stud... Read More

The clinical and cost-effectiveness of rehabilitation of memory in brain injury: the ReMemBrIn RCT (2017)
Journal Article
das Nair, R., Bradshaw, L. E., Carpenter, H., Clarke, S., Day, F., Drummond, A., …Lincoln, N. B. (in press). The clinical and cost-effectiveness of rehabilitation of memory in brain injury: the ReMemBrIn RCT. Health Technology Assessment,

Background People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating, and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital. Ob... Read More

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial (2017)
Journal Article
Bath, P. M., Woodhouse, L. J., Appleton, J. P., Beridze, M., Christensen, H., Dineen, R. A., …Sprigg, N. (2018). Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial. Lancet, 391(10123), doi:10.1016/S0140-6736(17)32849-0

Background: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplat... Read More

Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO) (2017)
Journal Article
Khan, K. S., Moore, P. A., Wilson, M. J., Hooper, R., Allard, S., Wrench, I., …Dodds, J. (2017). Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO). PLoS Medicine, 14(12), doi:10.1371/journal.pmed.1002471. ISSN 1549-1277

Background: Excessive haemorrhage at caesarean section requires donor (allogeneic) blood transfusion. Cell 34 salvage may reduce this requirement. Methods and findings: We conducted a pragmatic randomised controlled trial (26 obstetric units; Jun... Read More