All Outputs (447)

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., Waheed, W., Bower, P., Bullock, P., Lovell, K., Gilbody, S., Bailey, D., Butler-Whalley, S., & 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, Article 172. https://doi.org/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 about A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: the NOTEPAD study Protocol.

Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations (2018)
Journal Article
McKeever, T., Mortimer, K., Wilson, A., Walker, S., Brightling, C., Skeggs, A., Pavord, I., Price, D., Duley, L., Thomas, M., Bradshaw, L., Higgins, B., Haydock, R., Mitchell, E., Devereux, G., & Harrison, T. (2018). Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations. New England Journal of Medicine, 378(10), 902-910. https://doi.org/10.1056/NEJMoa1714257

Copyright © 2018 Massachusetts Medical Society. 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 te... Read More about Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations.

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., Powell, L., Gossage-Worrall, R., Chater, T., Keetharuth, A., Lee, E., & Woods, B. (2018). Recruitment of older adults to three preventative lifestyle improvement studies. Trials, 19, Article 121. https://doi.org/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 about Recruitment of older adults to three preventative lifestyle improvement studies.

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, Article 59. https://doi.org/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 about Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial.

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., Montgomery, A. A., Pocock, S. J., & 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), 193-196. https://doi.org/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 about Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’.

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), https://doi.org/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 about How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods.

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), https://doi.org/10.1097/j.pain.0000000000001147

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 about Novel approach to characterising individuals with low back-related leg pain: cluster identification with latent class analysis and 12-month follow-up.

Hypocritical Blame, Fairness, and Standing (2018)
Journal Article
Roadevin, C. (2018). Hypocritical Blame, Fairness, and Standing. Metaphilosophy, 48(1-2), 137-152. https://doi.org/10.1111/meta.12281

This paper argues that hypocritical blame renders blame inappropriate. Someone should not express her blame if she is guilty of the same thing for which she is blaming others, in the absence of an admission of fault. In failing to blame herself for t... Read More about Hypocritical Blame, Fairness, and Standing.

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., Beridze, M., Thomsen, T. T., Christensen, H., Kruuse, C., Dineen, R. A., Jensen, H. H., Duley, L., Hansen, S. S., England, T. J., Petrovic, V., Flaherty, K., Beridze, N., Havard, D., Kakabadze, N., …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.

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., Beresford, L., Roberts, T. E., McLoughlin, C., Geoghegan, J., Daniels, J. P., Catling, S., Clark, V. A., Ayuk, P., Robson, S., Gao-Smith, F., Hogg, M., Lanz, D., & 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).

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., Williamson, P. R., Altman, D. G., Montgomery, A., Lim, P., Berlin, J., Senn, S., Day, S., Barbachano, Y., & 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.

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.

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.

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.

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., Macarthur, C., Moore, P., Nolan, M., Rivero-Arias, O., Sanders, J., Shennan, A., & 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., Mitchell, J., Rick, C., Singhal, R., Woolley, R., & 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.

Parent perceptions of the quality of life of pet dogs living with neuro-typically developing and neuro-atypically developing children: An exploratory study (2017)
Journal Article
Hall, S. S., Wright, H. F., & Mills, D. S. (2017). Parent perceptions of the quality of life of pet dogs living with neuro-typically developing and neuro-atypically developing children: An exploratory study. PLoS ONE, 12(9), Article e0185300. https://doi.org/10.1371/journal.pone.0185300

There is growing scientific and societal recognition of the role that pet dogs can play in healthy development of children; both those who are neuro-typically developing and those who live with a neuro-developmental disorder, such as autism or attent... Read More about Parent perceptions of the quality of life of pet dogs living with neuro-typically developing and neuro-atypically developing children: An exploratory study.

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.

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., Bradshaw, L., Mitchell, E. J., & 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.

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 (2017)
Journal Article
Markey, K. A., Ottridge, R., Mitchell, J. L., Rick, C., Woolley, R., Ives, N., Nightingale, P., & 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 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.