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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., …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.

An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge (2020)
Journal Article
Kelleher, M. M., Montgomery, A. A., Jay, N., Perkin, M. R., Haines, R. H., Batt, R., …Boyle, R. J. (2020). An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge. Clinical and Experimental Allergy, 50(3), 334-342. https://doi.org/10.1111/cea.13577

© 2020 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd. Background: Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time-consuming, carry some risk and may, therefore,... Read More about An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge.

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., …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

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., …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).

Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial (2019)
Journal Article
Bath, P. M., Scutt, P., Anderson, C. S., Appleton, J. P., Berge, E., Cala, L., Dixon, M., England, T. M., Godolphin, P. J., Havard, D., Haywood, L., Hepburn, T., Krishnan, K., Mair, G., Montgomery, A. A., Muir, K., Phillips, S. J., Pocock, S., Potter, J., Price, C., …Mir, R. (2019). Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial. Lancet, 393(10175), 1009-1020. https://doi.org/10.1016/S0140-6736%2819%2930194-1

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure... Read More about Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial.

Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial (2018)
Journal Article
Major, G., Bradshaw, L., Boota, N., Sprange, K., Diggle, M., Montgomery, A., Jawhari, A., & Spiller, R. (2018). Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial. Gut, https://doi.org/10.1136/gutjnl-2018-316794

Background Clostridium difficile infection (CDI) recurs after initial treatment in approximately one in four patients. A single-centre pilot study suggested that this could be reduced using ‘follow-on’ rifaximin treatment. We aimed to assess the effi... Read More about Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial.

Lamotrigine for people with borderline personality disorder: a RCT (2018)
Journal Article
Crawford, M. J., Sanatinia, R., Barrett, B., Cunningham, G., Dale, O., Ganguli, P., …Reilly, J. G. (2018). Lamotrigine for people with borderline personality disorder: a RCT. Health Technology Assessment, 22(17), 1-68. https://doi.org/10.3310/hta22170

Background: No drug treatments are currently licensed for the treatment of borderline personality disorder (BPD). Despite this, people with this condition are frequently prescribed psychotropic medications and often with considerable polypharmacy. Pr... Read More about Lamotrigine for people with borderline personality disorder: a RCT.

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., …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.

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., …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.

The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency (2016)
Journal Article
Sahota, O., Pulikottil-Jacob, R., Marshall, F., Montgomery, A., Tan, W., Sach, T., Logan, P., Kendrick, D., Watson, A., Walker, M., & Waring, J. (in press). The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency. Age and Ageing, 46(1), https://doi.org/10.1093/ageing/afw149

Objective: To compare the clinical and cost-effectiveness of a Community In-reach Rehabilitation and Care Transition (CIRACT) service with the traditional hospital-based rehabilitation (THB-Rehab) service.

Design: Pragmatic randomised controlled... Read More about The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency.

Experiences of patients and healthcare professionals of NHS cardiovascular health checks: a qualitative study (2016)
Journal Article
Riley, R., Coghill, N., Montgomery, A. A., Feder, G., & Horwood, J. (2016). Experiences of patients and healthcare professionals of NHS cardiovascular health checks: a qualitative study. Journal of Public Health, 38(3), https://doi.org/10.1093/pubmed/fdv121

Background

NHS Health Checks are a national cardiovascular risk assessment and management programme in England and Wales. We examined the experiences of patients attending and healthcare professionals (HCPs) conducting NHS Health Checks.
Methods... Read More about Experiences of patients and healthcare professionals of NHS cardiovascular health checks: a qualitative study.

Multicentre, randomised controlled trial of a low-cost smoking cessation text message intervention for pregnant smokers (MiQuit) (2016)
Presentation / Conference Contribution
Naughton, F., Foster, K., Emery, J., Cooper, S., Sutton, S., Leonardi-Bee, J., Jones, M., Ussher, M., Whitemore, R., Leighton, M., Montgomery, A., Parrott, S., & Coleman, T. (2016, August). Multicentre, randomised controlled trial of a low-cost smoking cessation text message intervention for pregnant smokers (MiQuit). Presented at European Health Psychology Society and British Psychological Society Division of Health Psychology Conference 2016 (EHPS/DHP 2016)

Background: Text message cessation programmes have potential to change smoking behaviour during pregnancy but their effectiveness is unknown. This study aimed to estimate key parameters, including effectiveness and cost-effectiveness, for delivering... Read More about Multicentre, randomised controlled trial of a low-cost smoking cessation text message intervention for pregnant smokers (MiQuit).

Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial (2016)
Journal Article
controlled trial. BMC Psychiatry, 16, Article 276. https://doi.org/10.1186/s12888-016-0985-4

Background: Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectivene... Read More about Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial.

Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial (2016)
Journal Article
Dixon, P., Hollingshurst, S., Edwards, L., Thomas, C., Gaunt, D., Foster, A., …Salisbury, C. (2016). Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial. BMJ Open, 6, Article e01235. https://doi.org/10.1136/bmjopen-2016-012352

Objectives: To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk.
Design: A prospective within-trial patient-level economic evaluation conducted alongside a rando... Read More about Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial.

Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents (2016)
Journal Article
Stapinski, L. A., Montgomery, A. A., & Araya, R. (2016). Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents. Drug and Alcohol Dependence, 166, 109-115. https://doi.org/10.1016/j.drugalcdep.2016.06.032

Background: Adolescents who experience internalising symptoms may be susceptible to the use of alcohol and other substances in an attempt to alleviate or cope with these symptoms. We examined the hypothesised internalising pathway from symptoms of d... Read More about Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents.