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Professor ALAN MONTGOMERY's Outputs (119)

Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS) (2019)
Journal Article
Lincoln, N., Bradshaw, L., Constantinescu, C., Day, F., Drummond, A., Fitzsimmons, D., Harris, S., Montgomery, A., & das Nair, R. (2020). Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS). Clinical Rehabilitation, 34(2), 229-241. https://doi.org/10.1177/0269215519890378

Objective: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. Design: Multicentre, pragmatic, randomized controlled trial. Setting: Community Participants: Pe... Read More about Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS).

Gentamicin, azithromycin and ceftriaxone in the treatment of gonorrhoea; the relationship between antibiotic minimum inhibitory concentration and clinical outcome (2019)
Journal Article
Cole, M., Tan, W., Fifer, H., Brittain, C., Duley, L., Hepburn, T., Lawrence, T., Montgomery, A., SPRANGE, K., Thandi, S., Churchward, C., Tripodo, F., Woodford, N., & Ross, J. (2020). Gentamicin, azithromycin and ceftriaxone in the treatment of gonorrhoea; the relationship between antibiotic minimum inhibitory concentration and clinical outcome. Journal of Antimicrobial Chemotherapy, 75(2), 449–457. https://doi.org/10.1093/jac/dkz436

© Crown copyright 2019. OBJECTIVES: To investigate the relationship between MIC and clinical outcome in a randomized controlled trial that compared gentamicin 240 mg plus azithromycin 1 g with ceftriaxone 500 mg plus azithromycin 1 g. MIC analysis wa... Read More about Gentamicin, azithromycin and ceftriaxone in the treatment of gonorrhoea; the relationship between antibiotic minimum inhibitory concentration and clinical outcome.

Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage (2019)
Journal Article
Bath, P. M., Woodhouse, L. J., Krishnan, K., Appleton, J. P., Anderson, C. S., Berge, E., Cala, L., Dixon, M., England, T. J., Godolphin, P. J., Hepburn, T., Mair, G., Montgomery, A. A., Phillips, S. J., Potter, J., Price, C. I., Randall, M., Robinson, T. G., Roffe, C., Rothwell, P. M., …Sprigg, N. (2019). Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage. Stroke, 50(11), 3064-3071. https://doi.org/10.1161/STROKEAHA.119.026389

Background and Purpose—
Pilot trials suggest that glyceryl trinitrate (GTN; nitroglycerin) may improve outcome when administered early after stroke onset.

Methods—
We undertook a multicentre, paramedic-delivered, ambulance-based, prospective ran... Read More about Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage.

Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT (2019)
Journal Article
Hull, M. A., Sprange, K., Hepburn, T., Tan, W., Shafayat, A., Rees, C. J., Clifford, G., Logan, R. F., Loadman, P. M., Williams, E. A., Whitham, D., & Montgomery, A. A. (2019). Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT. Efficacy and Mechanism Evaluation, 6(4), 1-154. https://doi.org/10.3310/eme06040

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis (2019)
Journal Article
Godolphin, P. J., Bath, P. M., Algra, A., Berge, E., Brown, M. M., Chalmers, J., Duley, L., Eliasziw, M., Gregson, J., Greving, J. P., Hankey, G. J., Hosomi, N., Johnston, S. C., Patsko, E., Ranta, A., Sandset, P. M., Serena, J., Weimar, C., Montgomery, A. A., Knipp, S., …on behalf of the Adjudicating Outcomes in Stroke Trials Collaboration*. (2019). Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis. Stroke, 50(8), 2187-2196. https://doi.org/10.1161/strokeaha.119.025019

© 2019 American Heart Association, Inc. Background and Purpose-In randomized stroke trials, central adjudication of a trial's primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in rando... Read More about Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials: A Systematic Review and Meta-Analysis.

Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster-randomised controlled trial (2019)
Journal Article
Gureje, O., Oladeji, B. D., Montgomery, A. A., Bello, T., Kola, L., Ojagbemi, A., Chisholm, D., & Araya, R. (2019). Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster-randomised controlled trial. Lancet Global Health, 7(7), e951-e960. https://doi.org/10.1016/s2214-109x%2819%2930148-2

A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT (2019)
Journal Article
das Nair, R., Bradshaw, L. E., Carpenter, H., Clarke, S., Day, F., Drummond, A., Fitzsimmons, D., Harris, S., Montgomery, A. A., Newby, G., Sackley, C., & Lincoln, N. B. (2019). A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT. Health Technology Assessment, 23(16), 1-193. https://doi.org/10.3310/hta23160

Main outcome measures: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire – patient version (EMQ-p) at 6 months’ follow-up. Secondary outcomes: Rivermead Behavioural Memory... Read More about A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT.

High- versus low-intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: cluster randomised controlled trial (the EXPONATE trial) (2019)
Journal Article
Gureje, O., Oladeji, B. D., Montgomery, A. A., Araya, R., Bello, T., Chisholm, D., Groleau, D., Kirmayer, L. J., Kola, L., Olley, L., Tan, W., & Zelkowitz, P. (2019). High- versus low-intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: cluster randomised controlled trial (the EXPONATE trial). British Journal of Psychiatry, 215(3), 528-535. https://doi.org/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 about High- versus low-intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: cluster randomised controlled trial (the EXPONATE trial).

Short email with attachment versus long email without attachment when contacting authors to request unpublished data for a systematic review: a nested randomised trial (2019)
Journal Article
Godolphin, P. J., Bath, P. M., & Montgomery, A. A. (2019). Short email with attachment versus long email without attachment when contacting authors to request unpublished data for a systematic review: a nested randomised trial. BMJ Open, 9(1), Article e25273. https://doi.org/10.1136/bmjopen-2018-025273

Objective: Systematic reviews often rely on the acquisition of unpublished analyses or data. We carried out a nested randomised trial comparing two different approaches for contacting authors to request additional data for a systematic review.
Part... Read More about Short email with attachment versus long email without attachment when contacting authors to request unpublished data for a systematic review: a nested randomised trial.

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., Gommans, J., Ntaios, G., Pocock, S., Prasad, K., Wardlaw, J., Bath, P., & Montgomery, A. (2018). 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, 12, 176-181. https://doi.org/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 about Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation.

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., Lawrence-Smith, G., Leeson, V., Lemonsky, F., Lykomitrou, G., Montgomery, A. A., Morriss, R. K., Munjiza, J., Paton, C., Skorodzien, I., Singh, V., Tan, W., Tyrer, P., & Reilly, J. G. (2018). The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial. American Journal of Psychiatry, 175(8), 756-764. https://doi.org/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 about The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial.

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, Article 238. https://doi.org/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 about NHS health checks: a cross- sectional observational study on equity of uptake and outcomes.

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., Whitman, D., Duley, L., Eleftheriadou, V., Meakin, G., Mitchell, E., White, J., Rogers, A., Sach, T., Santer, M., Tan, W., Hepburn, T., Williams, H. C., & 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), Article e018649. https://doi.org/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 about Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized 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)’.

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.

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.

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., Elliott, D., Blazeby, J. M., Hollingworth, W., Montgomery, A. A., & 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.

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., Lawton, S., Simpson, E. L., Cork, M. J., Sach, T. H., Bradshaw, L. E., Montgomery, A. A., Boyle, R. J., & 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.

Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial (2017)
Journal Article
Jeffcoate, W., Game, F., Turtle-Savage, V., Musgrove, A., Price, P., Tan, W., Bradshaw, L. E., Montgomery, A. A., Fitzsimmons, D., Farr, A., Winfield, T., & Phillips, C. (in press). Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial. Health Technology Assessment, 21(34), https://doi.org/10.3310/hta21340

Background
Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel.
Objective
To assess both the clinical effectiveness and the cost-... Read More about Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial.