Professor ALAN MONTGOMERY's Outputs (146)

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., Abbott, A., Abdallah, N., Abdelaziz, A., Abdelfattah, M., Abdelqader, B., Abdul, B., Abdul Rasheed, A., Abdulakeem, A., Abdul-Kadir, R., Abdulmumeen, A., Abdul-Raheem, R., Abdulshukkoor, N., Abdusamad, K., Abed El Khaleq, Y., …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.

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., Moniz-Cook, E., & 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.

Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abaleke, E., Abbas, M., Abbasi, S., Abbott, A., Abdelaziz, A., Abdelbadiee, S., Abdelfattah, M., Abdul, B., Abdul Rasheed, A., Abdul-Kadir, R., Abdulmumeen, A., Abdulshukkoor, N., Abdusamad, K., Abed El Khaleq, Y., Abedalla, M., Abeer Ul Amna, A. U., Aboaba, A., Abo-Leyah, H., Abou-Haggar, A., Abouibrahim, M., …Zuriaga-Alvaro, A. (2021). Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10274), 605-612. https://doi.org/10.1016/s0140-6736%2821%2900149-5

Summary
Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory
actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.

Methods In t... Read More about Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review (2021)
Journal Article
Deshmukh, S. R., Mousoulis, C., Marson, B. A., Grindlay, D., Karantana, A., the Core Outcome Set for Hand Fractures and Joint Injuries in Adults Group, Leighton, P., & Montgomery, A. A. (2021). Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review. Journal of Hand Surgery (European Volume), 46(5), 488-495. https://doi.org/10.1177/1753193420983719

© The Author(s) 2021. This study identifies the treatment outcome domains used in recently published studies on the treatment of hand fractures and joint injuries with the aim to inform development of a core outcome set. Seven databases were searched... Read More about Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review.

TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands (2020)
Journal Article
Foss, A. J. E., Haydock, R., Childs, M., Duley, L., Empeslidis, T., Dhar-Munshi, S., Montgomery, A., Ogollah, R., Ozolins, M., Tesha, P., & Mitchell, E. (2020). TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands. BMJ Open Ophthalmology, 5(1), Article e000588. https://doi.org/10.1136/bmjophth-2020-000588

Objective: Neovascular age-related macular degeneration (nAMD) causes damage to the macula and severe vision loss. Bevacizumab is the most cost-effective nAMD treatment. The TANDEM trial was designed to determine whether, in patients with nAMD, low-d... Read More about TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands.

A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults (2020)
Journal Article
Taha, R. H. M., Grindlay, D., Deshmukh, S., Montgomery, A., Davis, T. R. C., & Karanatana, A. (2022). A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults. Hand, 17(5), 869-878. https://doi.org/10.1177/1558944720974363

Metacarpal shaft fractures are common hand injuries that predominantly affect younger patients. There is wide variability in their treatment with no consensus on best practice. We performed a systematic review to assess the breadth and quality of ava... Read More about A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults.

Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-light vitiligo three-arm RCT (2020)
Journal Article
Batchelor, J. M., Thomas, K. S., Akram, P., Azad, J., Bewley, A., Chalmers, J. R., Cheung, S. T., Duley, L., Eleftheriadou, V., Ellis, R., Ferguson, A., Goulding, J. M., Haines, R. H., Hamad, H., Ingram, J. R., Laguda, B., Leighton, P., Levell, N., Makrygeorgou, A., Meakin, G. D., …Montgomery, A. A. (2020). Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-light vitiligo three-arm RCT. Health Technology Assessment, 24(64), 1-164. https://doi.org/10.3310/hta24640

Background: Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo. Objective: To explore the clinical effectiveness and cost-effecti... Read More about Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-light vitiligo three-arm RCT.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI) (2020)
Journal Article
Husbands, S., Elliott, D., Davis, T. R., Blazeby, J. M., Harrison, E. F., Montgomery, A. A., Sprange, K., Duley, L., Karantana, A., Hollingworth, W., & Mills, N. (2020). Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI). Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-020-00710-1

© 2020, The Author(s). Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome r... Read More about Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI).

An economic evaluation of the randomized controlled trial of topical corticosteroid and home-based narrowband ultraviolet B for active and limited vitiligo (the HI-Light Vitiligo Trial)* (2020)
Journal Article
Sach, T., Thomas, K., Batchelor, J., Akram, P., Chalmers, J., Haines, R., Meakin, G., Duley, L., Ravenscroft, J., Rogers, A., Santer, M., Tan, W., White, J., Whitton, M., Williams, H., Cheung, S., Hamad, H., Wright, A., Ingram, J., Levell, N., …The UK Dermatology Clinical Trials Network’s HI‐LIGHT Vitiligo Trial Team. (2021). An economic evaluation of the randomized controlled trial of topical corticosteroid and home-based narrowband ultraviolet B for active and limited vitiligo (the HI-Light Vitiligo Trial)*. British Journal of Dermatology, 184(5), 840-848. https://doi.org/10.1111/bjd.19554

Background: Economic evidence for vitiligo treatments is absent. Objectives: To determine the cost-effectiveness of (i) handheld narrowband ultraviolet B (NB-UVB) and (ii) a combination of topical corticosteroid (TCS) and NB-UVB compared with TCS alo... Read More about An economic evaluation of the randomized controlled trial of topical corticosteroid and home-based narrowband ultraviolet B for active and limited vitiligo (the HI-Light Vitiligo Trial)*.

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 (2020)
Journal Article
The RECOVERY Collaborative Group, Horby, P., Mafham, M., Linsell, L., Bell, J. L., Staplin, N., Emberson, J. R., Wiselka, M., Ustianowski, A., Elmahi, E., Prudon, B., Whitehouse, T., Felton, T., Williams, J., Faccenda, J., Underwood, J., Baillie, J. K., Chappell, L. C., Faust, S. N., Jaki, T., …Landray, M. J. (2020). Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. New England Journal of Medicine, 383(21), 2030-2040. https://doi.org/10.1056/NEJMoa2022926

BACKGROUND Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials. METHODS In this randomized, cont... Read More about Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.

Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2020)
Journal Article
The Recovery Collaborative Group, Horby, P. W., Mafham, M., Bell, J. L., Linsell, L., Staplin, N., Emberson, J., Palfreeman, A., Raw, J., Elmahi, E., Prudon, B., Green, C., Carley, S., Chadwick, D., Davies, M., Wise, M. P., Baillie, J. K., Chappell, L. C., Faust, S. N., Jaki, T., …Landray, M. J. (2020). Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 396(10259), 1345-1352. https://doi.org/10.1016/s0140-6736%2820%2932013-4

Summary
Background Lopinavir–ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity,
preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir–ri... Read More about Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Randomised controlled trial of topical corticosteroid and home‐based narrowband UVB for active and limited vitiligo: results of the HI‐Light Vitiligo trial (2020)
Journal Article
Thomas, K., Batchelor, J. M., Akram, P., Chalmers, J. R., Haines, R., Meakin, G. D., Duley, L., Ravenscroft, J. C., Rogers, A., Sach, T. H., Santer, M., Tan, W., White, J., Whitton, M. E., Williams, H. C., Cheung, S. T., Hamad, H., Wright, A., Ingram, J. R., Levell, N. J., …Montgomery, A. A. (2021). Randomised controlled trial of topical corticosteroid and home‐based narrowband UVB for active and limited vitiligo: results of the HI‐Light Vitiligo trial. British Journal of Dermatology, 184(5), 828-839. https://doi.org/10.1111/bjd.19592

Background
Evidence for the effectiveness of vitiligo treatments is limited.

Objectives
To determine effectiveness of (a) hand‐held narrowband‐UVB (NB‐UVB) and (b) combination of potent topical corticosteroid (TCS) and NB‐UVB compared to TCS, fo... Read More about Randomised controlled trial of topical corticosteroid and home‐based narrowband UVB for active and limited vitiligo: results of the HI‐Light Vitiligo trial.

Data sharing: experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine (2020)
Journal Article
Scutt, P., Woodhouse, L. J., Montgomery, A. A., & Bath, P. M. .. (2020). Data sharing: experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine. BMJ Open, 10(9), Article e038765. https://doi.org/10.1136/bmjopen-2020-038765

Objectives
Meta-analysis based on individual patient data (IPD) from randomised trials is superior to using published summary data since it facilitates subgroup and multiple variable analyses. Guidelines and funders expect that researchers share IPD... Read More about Data sharing: experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine.

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report (2020)
Journal Article
Horby, P., Lim, W. S., Emberson, J. R., Mafham, M., Bell, J. L., Linsell, L., Staplin, N., Brightling, C., Ustianowski, A., Elmahi, E., Prudon, B., Green, C., Felton, T., Chadwick, D., Rege, . K., Fegan, C., Chappell, L. C., Faust, S. N., Jaki, T., Jeffery, K., …Landray, M. J. (2021). Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. New England Journal of Medicine, 1-11. https://doi.org/10.1056/NEJMoa2021436

Background

Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

Methods

In this controlled... Read More about Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report.

Cost-benefit of outcome adjudication in nine randomised stroke trials (2020)
Journal Article
Godolphin, P. J., Bath, P. M., Algra, A., Berge, E., Chalmers, J., Eliasziw, M., Hankey, G. J., Hosomi, N., Ranta, A., Weimar, C., Woodhouse, L. J., & Montgomery, A. A. (2020). Cost-benefit of outcome adjudication in nine randomised stroke trials. Clinical Trials, 17(5), 576-580. https://doi.org/10.1177/1740774520939231

Background: Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process.
Methods: We estimated the cost of adjudicat... Read More about Cost-benefit of outcome adjudication in nine randomised stroke trials.

Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report (2020)
Preprint / Working Paper
Horby, P., Lim, W. S., Emberson, J., Mafham, M., Bell, J., Linsell, L., Staplin, N., Brightling, C., Ustianowski, A., Elmahi, E., Prudon, B., Green, C., Felton, T., Chadwick, D., Rege, K., Fegan, C., Chappell, L. C., Faust, S. N., Jaki, T., Jeffery, K., …RECOVERY Collaborative Group. Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report

Background Coronavirus disease 2019 (COVID-19) is associated with diffuse lung damage. Corticosteroids may modulate immune-mediated lung injury and reducing progression to respiratory failure and death.

Methods The Randomised Evaluation of COVID-1... Read More about Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report.

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial (2020)
Journal Article
Bradshaw, L., Montgomery, A. A., Williams, H. C., Chalmers, J., & Haines, R. (2020). Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial. Trials, 21, Article 529. https://doi.org/10.1186/s13063-020-04373-4

Background
Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in... Read More about Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial.

Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease (2020)
Journal Article
Wardlaw, J., Bath, P. M., Doubal, F., Heye, A., Sprigg, N., Woodhouse, L. J., Blair, G., Appleton, J., Cvoro, V., England, T., Hassan, A., John Werring, D., Montgomery, A., & The LACI-2 Trial Investigators. (2020). Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease. European Stroke Journal, 5(3), 297-308. https://doi.org/10.1177/2396987320920110

Background
Small vessel disease causes a quarter of ischaemic strokes (lacunar subtype), up to 45% of dementia either as vascular or mixed types, cognitive impairment and physical frailty. However, there is no specific treatment to prevent progressi... Read More about Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease.

Outcome assessment by central adjudicators in randomised stroke trials: Simulation of differential and non-differential misclassification (2020)
Journal Article
Godolphin, P. J., Bath, P. M., Partlett, C., Berge, E., Brown, M. M., Eliasziw, M., Sandset, P. M., Serena, J., & Montgomery, A. A. (2020). Outcome assessment by central adjudicators in randomised stroke trials: Simulation of differential and non-differential misclassification. European Stroke Journal, 5(2), 174-183. https://doi.org/10.1177/2396987320910047

Adding evidence of the effects of treatments into relevant Wikipedia pages: a randomised trial (2020)
Journal Article
Adams, C. E., Montgomery, A. A., Aburrow, T., Bloomfield, S., Briley, P. M., Carew, E., Chatterjee-Woolman, S., Feddah, G., Friedel, J., Gibbard, J., Haynes, E., Hussein, M., Jayaram, M., Naylor, S. D., Perry, L., Schmidt, L., Siddique, U., Tabaksert, A. S., Taylor, D., Velani, A., …Xia, J. (2020). Adding evidence of the effects of treatments into relevant Wikipedia pages: a randomised trial. BMJ Open, 10(2), Article e033655. https://doi.org/10.1136/bmjopen-2019-033655

Objectives

To investigate the effects of adding high-grade quantitative evidence of outcomes of treatments into relevant Wikipedia pages on further information-seeking behaviour by the use of routinely collected data.

Setting

Wikipedia, Co... Read More about Adding evidence of the effects of treatments into relevant Wikipedia pages: a randomised trial.