Skip to main content

Research Repository

Advanced Search

All Outputs (32)

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., Christensen, L. M., Woodhouse, L. J., Bentsen, L., Appleton, J. P., Krarup Hansen, C., …Farren, P. (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), 850-859. https://doi.org/10.1016/S0140-6736%2817%2932849-0

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 about 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.

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials (2017)
Journal Article
Gamble, C., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Doré, C., …Loder, E. (2017). Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Journal of the American Medical Association, 318(23), 2337-2343. https://doi.org/10.1001/jama.2017.18556

© 2017 American Medical Association. All rights reserved. IMPORTANCE While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support tr... Read More about Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.

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), Article e1002471. https://doi.org/10.1371/journal.pmed.1002471

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 about Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO).

Prognosis of sciatica and back-related leg pain in primary care: the ATLAS cohort (2017)
Journal Article
Konstantinou, K., Dunn, K. M., Ogollah, R. O., Lewis, M., Windt, D. V. D., & Hay, E. M. H. (2018). Prognosis of sciatica and back-related leg pain in primary care: the ATLAS cohort. Spine Journal, 18(6), https://doi.org/10.1016/j.spinee.2017.10.071

BACKGROUND CONTEXT: Evidence is lacking on the prognosis and prognostic factors of back-related leg pain and sciatica in patients seeing their primary care physicians. This evidence could guide timely appropriate treatment and referral decisions. PU... Read More about Prognosis of sciatica and back-related leg pain in primary care: the ATLAS cohort.

Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial (2017)
Journal Article
Lim, W. S., Meakin, G., Brittain, C., Bewick, T., & Duley, L. (2017). Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial. Trials, 18, 1-7. https://doi.org/10.1186/s13063-017-2290-z

Background: Research in public health emergencies requires trials to be set up in readiness for activation at short notice and in anticipation of limited timelines for patient recruitment. We conducted a simulated activation of a hibernating pandemic... Read More about Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial.

Robustness of crossover trials against subject drop-out – Examples of perpetually connected designs (2017)
Journal Article
Godolphin, P., & Godolphin, E. (2019). Robustness of crossover trials against subject drop-out – Examples of perpetually connected designs. Statistical Methods in Medical Research, 28(3), 788-800. https://doi.org/10.1177/0962280217736541

When performing a repeated measures experiment, such as a clinical trial, there is a risk of subject drop-out during the experiment. If one or more subjects leave the study prematurely, a situation could arise where the eventual design is disconnecte... Read More about Robustness of crossover trials against subject drop-out – Examples of perpetually connected designs.

A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES) (2017)
Journal Article
Bick, D., Briley, A., Brocklehurst, P., Hardy, P., Juszczak, E., Lynch, L., …Wilson, M. (2017). A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES). Health Technology Assessment, 21(65), 1-175. https://doi.org/10.3310/hta21650

Background: Epidural analgesia leads to increased risk of instrumental vaginal delivery (IVD). There is debate about whether or not posture in second-stage labour influences the incidence of spontaneous vaginal birth (SVB). Objectives: In nulliparous... Read More about A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES).

Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol (2017)
Journal Article
Ottridge, R., Mollan, S. P., Botfield, H., Frew, E., Ives, N. J., Matthews, T., …Sinclair, A. J. (2017). Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol. BMJ Open, 7(9), 1-8. https://doi.org/10.1136/bmjopen-2017-017426

Introduction: Effective treatments are lacking for idiopathic intracranial hypertension (IIH), a condition characterised by raised intracranial pressure (ICP) and papilloedema, and found primarily in obese women. Weight loss and lowering body mass in... Read More about Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol.

The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study (2017)
Journal Article
Chatters, R., Roberts, J., Mountain, G., Cook, S., Windle, G., Craig, C., & Sprange, K. (2017). The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study. BMJ Open, 7(9), Article e016711. https://doi.org/10.1136/bmjopen-2017-016711

Objectives To assess the long-term effect on health and well-being of the Lifestyle Matters programme. Design Qualitative study of a subset of intervention arm participants who participated in the Lifestyle Matters randomised controlled... Read More about The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study.

Assessing the Efficacy and Safety of an 11?-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial (2017)
Journal Article
Markey, K. A., Ottridge, R., Mitchell, J. L., Rick, C., Woolley, R., Ives, N., …Sinclair, A. J. (2017). Assessing the Efficacy and Safety of an 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial. JMIR Research Protocols, 6(9), 1-10. https://doi.org/10.2196/resprot.7806

Background: Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. Objectives: The purpose of this paper is to outl... Read More about Assessing the Efficacy and Safety of an 11?-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial.

Randomised trial of cord clamping and initial stabilisation at very preterm birth (2017)
Journal Article
Duley, L., Dorling, J., Pushpa-Rajah, A., Oddie, S. J., Yoxall, C. W., Schoonakker, B., …Fawke, J. A. (2018). Randomised trial of cord clamping and initial stabilisation at very preterm birth. Archives of Disease in Childhood. Fetal and Neonatal Edition, 103(1), F6-F14. https://doi.org/10.1136/archdischild-2016-312567

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. OBJECTIVES: For very preterm births, to compare alternative po... Read More about Randomised trial of cord clamping and initial stabilisation at very preterm birth.

Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study (2017)
Journal Article
Sawyer, A., Chhoa, C., Ayers, S., Pushpa-Rajah, A., & Duley, L. (in press). Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials, 18, https://doi.org/10.1186/s13063-017-2149-3

Background The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The... Read More about Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

The views of children and young people on the use of silk garments for the treatment of eczema: a nested qualitative study within the CLOTHES randomised controlled trial (2017)
Journal Article
Wake, E., Batchelor, J. M., Lawton, S., Thomas, K., Harrison, E. F., & Cowdell, F. (2018). The views of children and young people on the use of silk garments for the treatment of eczema: a nested qualitative study within the CLOTHES randomised controlled trial. British Journal of Dermatology, 178(1), 183-190. https://doi.org/10.1111/bjd.15909

Background: Many children suffer with skin diseases, but to date, most dermatological research has been done ‘on’ rather than ‘with’ children; in this study we actively sought the experiences of children and young people. Atopic eczema (AE) is a chro... Read More about The views of children and young people on the use of silk garments for the treatment of eczema: a nested qualitative study within the CLOTHES randomised controlled trial.

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson’s disease (2017)
Journal Article
Masterson-Algar, P., Burton, C. R., Brady, M. C., Nicoll, A., Clarke, C. E., Rick, C., …Sackley, C. M. (2017). The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson’s disease. Trials, 18(1), 78. https://doi.org/10.1186/s13063-017-2130-1

Background The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control)... Read More about The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson’s disease.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial (2017)
Journal Article
Harrison, E., Tan, W., Mills, N., Karantana, A., Sprange, K., Duley, L., …Davis, T. (2017). A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial. Trials, 18(1), Article 392. https://doi.org/10.1186/s13063-017-2127-9

© 2017 The Author(s). Background: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment... Read More about A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial.

Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053) (2017)
Journal Article
Appleton, J. P., Scutt, P., Dixon, M., Howard, H., Haywood, L., Havard, D., …Bath, P. M. (in press). Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053). International Journal of Stroke, https://doi.org/10.1177/1747493017724627

Rationale: Vascular nitric oxide levels are low in acute stroke and donors such as glyceryl trinitrate have shown promise when administered very early after stroke. Potential mechanisms of action include augmentation of cerebral reperfusion, thrombol... Read More about Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053).

Relationship Between Attitudes and Beliefs and Physical Activity in Older Adults With Knee Pain: Secondary Analysis of a Randomized Controlled Trial: Attitudes About Physical Activity in Older Adults With Knee Pain (2017)
Journal Article
Quicke, J. G., Foster, N. E., Ogollah, R. O., Croft, P. R., & Holden, M. A. (2017). Relationship Between Attitudes and Beliefs and Physical Activity in Older Adults With Knee Pain: Secondary Analysis of a Randomized Controlled Trial: Attitudes About Physical Activity in Older Adults With Knee Pain. Arthritis Care and Research, 69(8), 1192-1200. https://doi.org/10.1002/acr.23104

OBJECTIVE: To investigate how attitudes and beliefs about exercise relate to physical activity behavior in older adults with knee pain attributable to osteoarthritis (OA). METHODS: We conducted secondary data analyses of a randomized controlled... Read More about Relationship Between Attitudes and Beliefs and Physical Activity in Older Adults With Knee Pain: Secondary Analysis of a Randomized Controlled Trial: Attitudes About Physical Activity in Older Adults With Knee Pain.

Fifteen minute consultation: stabilisaton of the high risk newborn infant beside the mother (2017)
Journal Article
Batey, N., Yoxall, B., Fawke, J., Duley, L., & Dorling, J. (2017). Fifteen minute consultation: stabilisaton of the high risk newborn infant beside the mother. Archives of Disease in Childhood, 102, https://doi.org/10.1136/archdischild-2016-312276

Paediatric and adult resuscitation is often performed with family present. Current guidelines recommend deferred umbilical cord clamping as part of immediate neonatal care, requiring neonatal assessment next to the mother. This paper describes strate... Read More about Fifteen minute consultation: stabilisaton of the high risk newborn infant beside the mother.

Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial (2017)
Journal Article
Hammond, A., O’Brien, R., Woodbridge, S., Bradshaw, L., Prior, Y., Radford, K. A., …Pulikottil-Jacob, R. (2017). Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial. BMC Musculoskeletal Disorders, 18, Article 315. https://doi.org/10.1186/s12891-017-1671-5

Background Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United Sta... Read More about Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial.

Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial (2017)
Journal Article
Chalmers, J. R., Haines, R. H., Mitchell, E. J., Thomas, K. S., Brown, S. J., Ridd, M., …Williams, H. C. (2017). Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial. Trials, 18(1), Article 343. https://doi.org/10.1186/s13063-017-2031-3

Background: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for... Read More about Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial.