Professor ALAN MONTGOMERY's Outputs (146)

Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial (2023)
Journal Article
Horby, P. W., Emberson, J. R., Basnyat, B., Campbell, M., Peto, L., Pessoa-Amorim, G., Staplin, N., Hamers, R. L., Amuasi, J., Nel, J., Kestelyn, E., Rawal, M., Kumar Jha, R., Thanh Phong, N., Sumardi, U., Paudel, D., Ngoc Thach, P., Nasronudin, N., Stratton, E., Mew, L., …RECOVERY Collaborative Group, R. C. G. (2023). Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 401(10387), 1499-1507. https://doi.org/10.1016/S0140-6736%2823%2900510-X

Background: Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation)... Read More about Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial.

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study (2023)
Journal Article
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., Juszczak, E., Linsell, L., Montgomery, A., & Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24, Article 71. https://doi.org/10.1186/s13063-022-06992-5

Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, ther... Read More about Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

Mental health in clinically referred children and young people before and during the Covid-19 pandemic (2022)
Journal Article
Sayal, K., Partlett, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Ewart, C., James, M., Lang, A., Sprange, K., & Montgomery, A. (2023). Mental health in clinically referred children and young people before and during the Covid-19 pandemic. European Child and Adolescent Psychiatry, 32(12), 2657–2666. https://doi.org/10.1007/s00787-022-02115-2

The Covid-19 pandemic and mitigation approaches, including lockdowns and school closures, are thought to have negatively impacted children and young people’s (CYP) mental health. However, the impact for clinically referred CYP is less clear. We inves... Read More about Mental health in clinically referred children and young people before and during the Covid-19 pandemic.

A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection (2022)
Journal Article
Bruce, C. L., Juszczak, E., Ogollah, R., Partlett, C., & Montgomery, A. (2022). A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection. BMC Medical Research Methodology, 22(1), Article 314. https://doi.org/10.1186/s12874-022-01786-4

Background: When conducting a randomised controlled trial, there exist many different methods to allocate participants, and a vast array of evidence-based opinions on which methods are the most effective at doing this, leading to differing use of the... Read More about A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection.

Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial (2022)
Journal Article
Bath, P. M., Skinner, C. J. C., Bath, C. S., Woodhouse, L. J., Areti, A., Korovesi, K., Long, H., Havard, D., Coleman, C. M., England, T. J., Leyland, V., Lim, W. S., Montgomery, A. A., Royal, S., Avery, A., Webb, A. J., & Gordon, A. L. (2022). Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial. European Geriatric Medicine, 13, 1343-1355. https://doi.org/10.1007/s41999-022-00714-5

Purpose
Infections cause considerable care home morbidity and mortality. Nitric oxide (NO) has broad-spectrum anti-viral, bacterial and yeast activity in vitro. We assessed the feasibility of supplementing dietary nitrate (NO substrate) intake in ca... Read More about Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial.

Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial (2022)
Journal Article
Bradshaw, L. E., Wyatt, L. A., Brown, S. J., Haines, R. H., Montgomery, A. A., Perkin, M. R., Lawton, S., Sach, T. H., Chalmers, J. R., Ridd, M. J., Flohr, C., Brooks, J., Swinden, R., Mitchell, E. J., Tarr, S., Jay, N., Thomas, K., Allen, H., Cork, M. J., Kelleher, M. M., …Williams, H. C. (2023). Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial. Allergy, 78(4), 995-1006. https://doi.org/10.1111/all.15555

Background: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and... Read More about Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial.

Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850) (2022)
Journal Article
Bath, P. M., Mhlanga, I., Woodhouse, L. J., Doubal, F., Oatey, K., Montgomery, A. A., Wardlaw, J. M., & LACI-2 Trial Investigators. (2023). Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850). Stroke and Vascular Neurology, 8, Article e001816. https://doi.org/10.1136/svn-2022-001816

Background: Cerebral small vessel disease (SVD) causes lacunar strokes (25% of all ischaemic strokes), physical frailty and cognitive impairment and vascular and mixed dementia. There is no specific treatment to prevent progression of SVD. Methods: T... Read More about Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850).

Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis (2022)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Emberson, J. R., Mafham, M., Campbell, M., Peto, L., Pessoa-Amorim, G., Spata, E., Staplin, N., Lowe, C., Chadwick, D. R., Brightling, C., Stewart, R., Collini, P., Ashish, A., Green, C. A., Prudon, B., Felton, T., Kerry, A., Baillie, J. K., …Landray, M. J. (2022). Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet, 400(10349), 359-368. https://doi.org/10.1016/S0140-6736%2822%2901109-6

Background: We aimed to evaluate the use of baricitinib, a Janus kinase (JAK) 1–2 inhibitor, for the treatment of patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of... Read More about Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis.

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units (2022)
Journal Article
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., Juszczak, E., Linsell, L., Montgomery, A., & Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. Trials, 23(1), Article 535. https://doi.org/10.1186/s13063-022-06481-9

Background: Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statistic... Read More about Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units.

Using the Vitiligo Noticeability Scale in clinical trials: construct validity, interpretability, reliability and acceptability (2022)
Journal Article
Batchelor, J. M., Gran, S., Leighton, P., Howells, L., Montgomery, A. A., Tan, W., Ahmed, I., & Thomas, K. S. (2022). Using the Vitiligo Noticeability Scale in clinical trials: construct validity, interpretability, reliability and acceptability. British Journal of Dermatology, 187(4), 548-556. https://doi.org/10.1111/bjd.21671

Background: Validated outcome measures are needed for vitiligo trials. Objectives: To assess construct validity, interpretability, reliability and acceptability of the Vitiligo Noticeability Scale (VNS). Methods: We used images of vitiligo before and... Read More about Using the Vitiligo Noticeability Scale in clinical trials: construct validity, interpretability, reliability and acceptability.

STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial (2022)
Journal Article
Day, F., Wyatt, L., Bhardwaj, A., Dubicka, B., Ewart, C., Gledhill, J., James, M., Lang, A., Marshall, T., Montgomery, A., Reynolds, S., Sprange, K., Thomson, L., Bradley, E., Lathe, J., Newman, K., Partlett, C., Starr, K., & Sayal, K. (2022). STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial. BMJ Open, 12(5), Article e053043. https://doi.org/10.1136/bmjopen-2021-053043

INTRODUCTION: Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions a... Read More about STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial.

The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure (2022)
Journal Article
Gordon, A. L., Rick, C., Juszczak, E., Montgomery, A., Howard, R., Guthrie, B., Lim, W. S., Shenkin, S., Leighton, P., Bath, P. M., Ball, J., Gage, H., Glover, M., Godfrey, M., Hewitt, J., Jaki, T., Lasserson, D., Logan, P., Passmore, P., Quinlan, P., …Tate, V. (2022). The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure. Age and Ageing, 51(3), Article afac052. https://doi.org/10.1093/ageing/afac052

The COVID-19 pandemic resulted in catastrophic levels of morbidity and mortality for care home residents. Despite this, research platforms for COVID-19 in care homes arrived late in the pandemic compared with other care settings. The Prophylactic The... Read More about The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure.

Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2022)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Mafham, M., Peto, L., Campbell, M., Pessoa-Amorim, G., Spata, E., Staplin, N., Emberson, J. R., Prudon, B., Hine, P., Brown, T., Green, C. A., Sarkar, R., Desai, P., Yates, B., Bewick, T., Tiberi, S., Felton, T., Baillie, J. K., …Landray, M. J. (2022). Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10325), 665-676. https://doi.org/10.1016/S0140-6736%2822%2900163-5

Background: Casirivimab and imdevimab are non-competing monoclonal antibodies that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike glycoprotein, blocking viral entry into host cells. We aimed to evaluate the efficac... Read More about Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age) (2022)
Journal Article
Mitchell, E. J., Meakin, G., Anderson, J., Dorling, J., Gale, C., Haines, R., Kenyan, C., Johnson, M. J., McGuire, W., Mistry, H., Montgomery, A., Oddie, S., Ogollah, R., Pallotti, P., Partlett, C., Walker, K. F., & Ojha, S. (2022). The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age). Trials, 23(1), Article 64. https://doi.org/10.1186/s13063-021-05994-z

Background: In the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonatologists are cautious in initi... Read More about The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age).

Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT (2022)
Journal Article
Armstrong-Buisseret, L., Brittain, C., Kai, J., David, M., Anstey Watkins, J., Ozolins, M., Jackson, L., Abdali, Z., Hepburn, T., Griffiths, F., Montgomery, A., Daniels, J., Manley, A., Dean, G., & Ross, J. D. (2022). Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT. Health Technology Assessment, 26(2), 1-170. https://doi.org/10.3310/ZZKH4176

BACKGROUND: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. OBJECTIVES: The... Read More about Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT.

Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
RECOVERY Collaborative Group, Horby, P. W., Pessoa-Amorim, G., Staplin, N., Emberson, J. R., Campbell, M., Spata, E., Peto, L., Brunskill, N. J., Tiberi, S., Chew, V., Brown, T., Tahir, H., Ebert, B., Chadwick, D., Whitehouse, T., Sarkar, R., Graham, C., Baillie, J. K., Basnyat, B., …Landray, M. J. (2022). Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 399(10320), 143-151. https://doi.org/10.1016/S0140-6736%2821%2901825-0

Background
Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19.

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

Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Horby, P. W., Campbell, M., Spata, E., Emberson, J. R., Staplin, N., Pessoa-Amorim, G., Peto, L., Wiselka, M., Wiffen, L., Tiberi, S., Caplin, B., Wroe, C., Green, C., Hine, P., Prudon, B., George, T., Wight, A., Baillie, J. K., Basnyat, B., Buch, M., …Landray, M. J. (2021). Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Respiratory Medicine, 9(12), 1419-1426. https://doi.org/10.1016/s2213-2600%2821%2900435-5

Background: Colchicine has been proposed as a treatment for COVID-19 based on its anti-inflammatory actions. We aimed to evaluate the efficacy and safety of colchicine in patients admitted to hospital with COVID-19. Methods: In this streamlined, rand... Read More about Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials (2021)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Mant, J., Davis, B. R., Algra, A., Mas, J.-L., Staessen, J. A., Thijs, L., Tonkin, A., Kirby, A., Pocock, S. J., Chalmers, J., Hankey, G. J., Spence, J. D., Sandercock, P., Diener, H.-C., Uchiyama, S., Sprigg, N., & Bath, P. M. (2021). Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials. BMC Medical Research Methodology, 21, Article 218. https://doi.org/10.1186/s12874-021-01388-6

Background: Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best ana... Read More about Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials.

Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study (2021)
Journal Article
Taha, R., Leighton, P., Bainbridge, C., Montgomery, A., Davis, T., & Karantana, A. (2021). Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study. BMJ Open, 11, Article 046913. https://doi.org/10.1136/bmjopen-2020-046913

Introduction
Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society, however there is a lack of evidence to guide thei... Read More about Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study.

Convalescent plasma 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., Abdo, D., Abdul, B., Abdul Rasheed, A., Abdulakeem, A., Abdul-Kadir, R., Abdulle, A., Abdulmumeen, A., Abdul-Raheem, R., Abdulshukkoor, N., …Zyengi, S. (2021). Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet, 397(10289), 2049-2059. https://doi.org/10.1016/s0140-6736%2821%2900897-7

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This ran... Read More about Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.