Outputs (139)

Choosing and evaluating randomisation methods in clinical trials: a qualitative study (2024)
Journal Article
Bruce, C. L., Iflaifel, M., Montgomery, A., Ogollah, R., Sprange, K., & Partlett, C. (2024). Choosing and evaluating randomisation methods in clinical trials: a qualitative study. Trials, 25(1), Article 199. https://doi.org/10.1186/s13063-024-08005-z

Background: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is... Read More about Choosing and evaluating randomisation methods in clinical trials: a qualitative study.

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
RECOVERY Collaborative Group, Sandercock, P., Darbyshire, J., DeMets, D., Fowler, R., Lalloo, D., …Local Clinical Centre staff (for the RECOVERY Collaborative Group). (in press). Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Nature Communications, 15, Article 924. https://doi.org/10.1038/s41467-023-43644-x

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOV... Read More about Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

[TEMPORARILY RENAMED] Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
Faust, S. N., Jones, C. E., Staplin, N., Whittaker, E., Jaki, T., Juszczak, E., …Haynes, R. (2024). [TEMPORARILY RENAMED] Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet Child & Adolescent Health,

Background Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS), also known as multisystem inflammatory syndrome in children (MIS-C) emerged in April, 2020. The paediatric comparisons within the RECOVERY tri... Read More about [TEMPORARILY RENAMED] Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial.

Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial (2024)
Journal Article
RECOVERY Collaborative Group, Faust, S. N., Haynes, R., Jones, C. E., Staplin, N., Whittaker, E., …Montgomery, A. (2024). Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet Child & Adolescent Health, 8(3), 190-200. https://doi.org/10.1016/S2352-4642%2823%2900316-4

Background: Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS), also known as multisystem inflammatory syndrome in children (MIS-C) emerged in April, 2020. The paediatric comparisons within the RECOVERY trial... Read More about Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial.

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Elbourne, D., Juszczak, E., …Montgomery, A. A. (2023). Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement. JAMA Network Open, 6(12), Article e2346121. https://doi.org/10.1001/jamanetworkopen.2023.46121

Importance Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates... Read More about Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Chan, A., Elbourne, D., …Montgomery, A. A. (2023). Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA Network Open, 330(21), 2106-2114. https://doi.org/10.1001/jama.2023.19793

Importance Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique method... Read More about Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial (2023)
Journal Article
Faust, S. N., Jones, C. E., Staplin, N., Whittaker, E., Jaki, T., Juszczak, E., …RECOVERY Collaborative Group, R. C. G. (in press). Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial. Lancet Child and Adolescent Health,

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs) (2023)
Journal Article
Madurasinghe, V. W., Knapp, P., Eldridge, S., Collier, D., Treweek, S., Rick, J., …Bower, P. (2023). Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs). BMC Medicine, 21(1), Article 425. https://doi.org/10.1186/s12916-023-03081-5

Background: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the... Read More about Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs).

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2023)
Journal Article
Horby, P. W., Staplin, N., Peto, L., Emberson, J. R., Mark Campbell, M., Pessoa-Amorim, G., …Landray, M. J. (2023). Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Diabetes and Endocrinology, 11(12), 905-914. https://doi.org/10.1016/s2213-8587%2823%2900253-x

Background Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COV... Read More about Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial (2023)
Journal Article
Sach, T. H., Lartey, S. T., Davies, C., Chalmers, J. R., Haines, R. H., Bradshaw, L. E., …Williams, H. C. (2023). Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial. Clinical & Experimental Allergy, 53(10), 1011-1019. https://doi.org/10.1111/cea.14381

Background Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. Objective To determine the cost‐effectiveness of daily all‐over‐body application of emollient during the firs... Read More about Emollients for preventing atopic eczema: Cost‐effectiveness analysis of the BEEP trial.

Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia (2023)
Journal Article
Woodhouse, L. J., Appleton, J. P., Christensen, H., Dineen, R. A., England, T. J., James, M., …Bath, P. M. (2023). Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia. Scientific Reports, 13, Article 11717. https://doi.org/10.1038/s41598-023-38474-2

Intensive antiplatelet therapy did not reduce recurrent stroke/transient ischaemic attack (TIA) events as compared with guideline treatment in the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial, but did increase th... Read More about Bleeding with intensive versus guideline antiplatelet therapy in acute cerebral ischaemia.

Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure (2023)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Pocock, S., James, M., Ranta, A., Bath, P. M., & TARDIS Investigators, T. I. (2023). Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure. Contemporary Clinical Trials Communications, 35, Article 101186. https://doi.org/10.1016/j.conctc.2023.101186

Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its p... Read More about Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure.

Emollient application from birth to prevent eczema in high-risk children: the BEEPRCT (2023)
Journal Article
Wyatt, L. A., Bradshaw, L. E., Brown, S. J., Haines, R. H., Montgomery, A. A., Perkin, M. R., …Williams, H. C. (in press). Emollient application from birth to prevent eczema in high-risk children: the BEEPRCT. Health Technology Assessment,

Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial (2023)
Journal Article
Wardlaw, J. M., Woodhouse, L. J., Mhlanga, I. I., Oatey, K., Heye, A. K., Bamford, J., …Bath, P. M. (2023). Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial. JAMA Neurology, 80(7), 682-692. https://doi.org/10.1001/jamaneurol.2023.1526

Importance Cerebral small vessel disease (cSVD) is a common cause of stroke (lacunar stroke), is the most common cause of vascular cognitive impairment, and impairs mobility and mood but has no specific treatment. Objective To test the feasibili... Read More about Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial.

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., …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., …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., …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., …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.

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., … 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., …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., …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., …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., …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., …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., …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., …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., …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., …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., …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., …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., …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.

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., …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., …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., …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, …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., …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., …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., …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., …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., …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., …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., …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., …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., …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)
Working Paper
Horby, P., Lim, W. S., Emberson, J., Mafham, M., Bell, J., Linsell, L., …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, 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.

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., …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., …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.

Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial (2020)
Journal Article
Chalmers, J. R., Haines, R. H., Bradshaw, L. E., Montgomery, A. A., Thomas, K. S., Brown, S. J., …Williams, H. C. (2020). Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet, 395(10228), 962-972. https://doi.org/10.1016/S0140-6736%2819%2932984-8

Background Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children. Methods We did a multicentre, pragmatic, parallel-group, randomised contr... Read More about Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial.

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.

A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures (2020)
Journal Article
the HAND-1 Study group, Davis, T. R. C., Tan, W., Harrison, E. F., Hollingworth, W., Karantana, A., …Montgomery, A. A. (2020). A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures. Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-019-0546-y

© 2020 The Author(s). Purpose: The purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures.... Read More about A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures.

Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT (2020)
Journal Article
Lincoln, N. B., Bradshaw, L. E., Constantinescu, C. S., Day, F., Drummond, A. E., Fitzsimmons, D., …CRAMMS Trial Collaborative Group. (2020). Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT. Health Technology Assessment, 24(4), 1-182. https://doi.org/10.3310/hta24040

Abstract Background People with multiple sclerosis have problems with memory and attention. The effectiveness of cognitive rehabilitation has not been established. Objectives The objectives were to assess the clinical effectiveness and cost-eff... Read More about Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT.

Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial (2019)
Journal Article
Shafayat, A., Csipke, E., Bradshaw, L., Charlesworth, G., Day, F., Leung, P., …Orrell, M. (2019). Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial. Trials, 20(1), Article 709. https://doi.org/10.1186/s13063-019-3838-x

Background: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management interventio... Read More about Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial.

Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis (2019)
Journal Article
Armstrong-Buisseret, L., Brittain, C., David, M., Dean, G., Griffiths, F., Hepburn, T., …Ross, J. D. (2019). Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis. Trials, 20, Article 648. https://doi.org/10.1186/s13063-019-3731-7

Background: Bacterial vaginosis (BV) affects 30 – 50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronid... Read More about Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis.

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., …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., …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., …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., …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., …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., …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

Full Milk Feeds from Day 1 (2019)
Journal Article
Ojha, S., Mitchell, E., Montgomery, A., & Dorling, J. (2019). Full Milk Feeds from Day 1. Neonatology, 116(1), https://doi.org/10.1159/000499676

Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial (2019)
Journal Article
Ross, J., Brittain, C., Cole, M., Dewsnap, C., Harding, J., Hepburn, T., …Duley, L. (2019). Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial. Lancet, 393(10190), 2511-2520. https://doi.org/10.1016/S0140-6736%2818%2932817-4

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Background: Gonorrhoea is a common sexually transmitted infection for which ceftriaxone is the current first-line treatment, but antimi... Read More about Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial.

Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT (2019)
Journal Article
Ross, J. D., Harding, J., Duley, L., Montgomery, A. A., Hepburn, T., Tan, W., …Lawrence, T. (2019). Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT. Health Technology Assessment, 23(20), 1-104. https://doi.org/10.3310/hta23200

Background: Gonorrhoea is a common sexually transmitted infection that can cause pain and discomfort, affect fertility in women and lead to epididymo-orchitis in men. Current treatment is with ceftriaxone, but there is increasing evidence of antimicr... Read More about Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT.

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., …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.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial (2019)
Journal Article
das Nair, R., Bradshaw, L. E., Day, F. E., Drummond, A., Harris, S. R., Fitzsimmons, D., …Lincoln, N. B. (2019). Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial. Clinical Rehabilitation, 33(7), 1171-1184. https://doi.org/10.1177/0269215519840069

Objective: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. Design: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. Sett... Read More about Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

Day of the week to tweet: a randomised controlled trial (2019)
Journal Article
Jayaram, M., Adams, C. E., Friedel, J. S., Mcclenaghan, E., Montgomery, A. A., Välimäki, M., …Zhao, S. (2019). Day of the week to tweet: a randomised controlled trial. BMJ Open, 9(4), Article e025380. https://doi.org/10.1136/bmjopen-2018-025380

Objective: To assess the effects of using health social media on different days of the working week on web activity. Design: Individually randomised controlled parallel group superiority trial. Setting: Twitter and Weibo. Participants: 194 Cochran... Read More about Day of the week to tweet: a randomised controlled trial.

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., …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.

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 adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial) (2018)
Journal Article
Godolphin, P., Montgomery, A., Woodhouse, L., Bereczki, D., Berge, E., Collins, R., …ENOS Investigators. (2018). Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial). PLoS ONE, 13(11), Article e0208142. https://doi.org/10.1371/journal.pone.0208142

Background and Purpose: Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudicat... Read More about Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial).

Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial (2018)
Journal Article
Hull, M. A., Sprange, K., Hepburn, T., Tan, W., Shafayat, A., Rees, C. J., …seAFOod Collaborative Group. (2018). Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial. Lancet, 392(10164), 2583-2594. https://doi.org/10.1016/S0140-6736%2818%2931775-6

© 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) and aspirin both have proof of concept for colorectal cancer... Read More about Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial 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., …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 QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation (2018)
Journal Article
L, R., LJ, S., JM, B., CA, R., KM, T., S, H., …Wheatley, T. (2019). The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. Journal of Clinical Epidemiology, 106, 108-120. https://doi.org/10.1016/j.jclinepi.2018.10.004

Objective To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implem... Read More about The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation.

Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study (2018)
Journal Article
Whitham, D., Turzanski, J., Bradshaw, L., Clarke, M., Culliford, L., Duley, L., …Wood, J. (2018). Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study. Trials, 19, Article 557. https://doi.org/10.1186/s13063-018-2940-9

Background Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution of potential problems, minim... Read More about Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study.

Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics (2018)
Journal Article
Walker, K. F., Turzanski, J., Whitham, D., Montgomery, A., & Duley, L. (2018). Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics. Trials, 19, Article 562. https://doi.org/10.1186/s13063-018-2941-8

© 2018 The Author(s). Background: Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collecting hi... Read More about Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics.

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., …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.

Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: The TARDIS RCT (2018)
Journal Article
Bath, P. M., Woodhouse, L. J., Appleton, J. P., Beridze, M., Christensen, H., Dineen, R. A., …Sprigg, N. (2018). Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: The TARDIS RCT. Health Technology Assessment, 22(48), 1-75. https://doi.org/10.3310/hta22480

© Queen’s Printer and Controller of HMSO 2018. Background: Two antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents... Read More about Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: The TARDIS RCT.

Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2): safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial (2018)
Conference Proceeding
Dixon, M., Appleton, J. P., Scutt, P., England, T., Havard, D., Howard, H., …Bath, P. M. (2018). Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2): safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke 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., …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., …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)’.

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial (2017)
Journal Article
McMurran, M., Day, F., Reilly, J., Delport, J., McCrone, P., Whitham, D., …Crawford, M. J. (2017). Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial. Journal of Personality Disorders, 31(6), 810-826. https://doi.org/10.1521/pedi_2017_31_286

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., …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.

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., …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., …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.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit): randomized controlled trial of MiQuit (2017)
Journal Article
Naughton, F., Cooper, S., Foster, K., Leonardi-Bee, J., Emery, J., Sutton, S., …Coleman, T. (2017). Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit): randomized controlled trial of MiQuit. Addiction, 112(7), 1238-1249. https://doi.org/10.1111/add.13802

Aims: To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Design: Multi‐centre, parallel‐group, single‐blinded, individual r... Read More about Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit): randomized controlled trial of MiQuit.

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., …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.

Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial) (2017)
Journal Article
Thomas, K. S., Bradshaw, L. E., Sach, T. H., Batchelor, J. M., Lawton, S., Harrison, E. F., …MacCallum, S. (2017). Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial). PLoS Medicine, 14(4), Article e1002280. https://doi.org/10.1371/journal.pmed.1002280

© 2017 Thomas et al. Background: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to st... Read More about Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial (2017)
Journal Article
Thomas, K. S., Bradshaw, L., Sach, T. H., Cowdell, F., Batchelor, J. M., Lawton, S., …Montgomery, A. A. (2017). Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial. Health Technology Assessment, 21(16), https://doi.org/10.3310/hta21160

Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. Objectives: To assess the... Read More about Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial.

Investigating the effect of independent blinded digital image assessment on the STOP GAP trial (2017)
Journal Article
Patsko, E., Godolphin, P. J., Thomas, K. S., Hepburn, T., Mitchell, E., Craig, F. E., …Montgomery, A. A. (2017). Investigating the effect of independent blinded digital image assessment on the STOP GAP trial. Trials, 18(1), Article 53. https://doi.org/10.1186/s13063-017-1779-9

Background Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low risk studies. In dermatology, one popu... Read More about Investigating the effect of independent blinded digital image assessment on the STOP GAP trial.

Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial (2016)
Journal Article
Brittain, C., Childs, M., Duley, L., Harding, J., Hepburn, T., Meakin, G., …Ross, J. D. (2016). Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial. Trials, 17, Article 558. https://doi.org/10.1186/s13063-016-1683-8

Background: Gonorrhoea is a common sexually transmitted infection which causes genital pain and discomfort; in women it can also lead to pelvic inflammatory disease and infertility, and in men to epididymo-orchitis. Current treatment is with ceftriax... Read More about Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial.

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., …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)
Conference Proceeding
Naughton, F., Foster, K., Emery, J., Cooper, S., Sutton, S., Leonardi-Bee, J., …Coleman, T. (2016). Multicentre, randomised controlled trial of a low-cost smoking cessation text message intervention for pregnant smokers (MiQuit).

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
Gaete, J., Martinez, V., Fritsch, R., Rojas, G., Montgomery, A. A., & Araya, R. (2016). Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized 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.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention (2016)
Journal Article
Salisbury, C., O'Cathain, A., Edwards, L., Thomas, C., Gaunt, D., Hollingshurst, S., …Montgomery, A. A. (2016). Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention. Lancet Psychiatry, 3(6), 515-525. https://doi.org/10.1016/S2215-0366%2816%2900083-3

Background Many countries are exploring the potential of telehealth interventions manage the rising number of people with chronic conditions. However, evidence of effectiveness of telehealth is equivocal. Based on an evidence-based conceptual framew... Read More about Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial (2016)
Journal Article
Salisbury, C., O'Cathain, A., Thomas, C., Edwards, L., Gaunt, D., Dixon, P., …Montgomery, A. A. (2016). Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial. BMJ, 353, Article i2647. https://doi.org/10.1136/bmj.i2647

Objective: To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design: Pragmatic, multicentre, randomised controlled trial. Setting: 42 general practices in th... Read More about Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial.

Tweeting links to Cochrane Schizophrenia Group reviews: a randomised controlled trial (2016)
Journal Article
Adams, C. E., Jayaram, M., Bodart, A., Sampson, S., Zhao, S., & Montgomery, A. A. (2016). Tweeting links to Cochrane Schizophrenia Group reviews: a randomised controlled trial. BMJ Open, 6(3), Article e010509. https://doi.org/10.1136/bmjopen-2015-010509

Objective: To assess the effects of using health social media on web activity. Design: Individually randomised controlled parallel group superiority trial. Setting: Twitter and Weibo. Participants: 170 Cochrane Schizophrenia Group full reviews wit... Read More about Tweeting links to Cochrane Schizophrenia Group reviews: a randomised controlled trial.

Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies (2016)
Journal Article
Edwards, L., Salisbury, C., Horspool, K., Foster, A., Garner, K., & Montgomery, A. A. (2016). Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies. Trials, 17, Article 107. https://doi.org/10.1186/s13063-016-1234-3

Background: Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression – three features of The Healthlines Study. Advance notification, including a photograph and using action-ori... Read More about Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies.

Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of Vitiligo treatment success (2016)
Journal Article
Batchelor, J., Tan, W., Tour, S., Yong, A., Montgomery, A. A., & Thomas, K. (2016). Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of Vitiligo treatment success. British Journal of Dermatology, 174(2), https://doi.org/10.1111/bjd.14208

Background: Patient-reported outcome measures are rarely used in vitiligo trials. The Vitiligo Noticeability Scale (VNS) is a new patient-reported outcome measure assessing how ‘noticeable’ the vitiligo patches are after treatment. The noticeabilit... Read More about Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of Vitiligo treatment success.

Comparing the cost-effectiveness and clinical effectiveness of a new community in-reach rehabilitation service with the cost-effectiveness and clinical effectiveness of an established hospital-based rehabilitation service for older people: a pragmatic randomised controlled trial with microcost and qualitative analysis – the Community In-reach Rehabilitation And Care Transition (CIRACT) study (2016)
Journal Article
Sahota, O., Pulikottil-Jacob, R., Marshall, F., Montgomery, A., Tan, W., Sach, T., …Waring, J. (2016). Comparing the cost-effectiveness and clinical effectiveness of a new community in-reach rehabilitation service with the cost-effectiveness and clinical effectiveness of an established hospital-based rehabilitation service for older people: a pragmatic randomised controlled trial with microcost and qualitative analysis – the Community In-reach Rehabilitation And Care Transition (CIRACT) study. Health Services and Delivery Research, 4(7), https://doi.org/10.3310/hsdr04070

Background: Older people represent a significant proportion of patients admitted to hospital as a medical emergency. Compared with the care of younger patients, their care is more challenging, their stay in hospital is much longer, their risk of ho... Read More about Comparing the cost-effectiveness and clinical effectiveness of a new community in-reach rehabilitation service with the cost-effectiveness and clinical effectiveness of an established hospital-based rehabilitation service for older people: a pragmatic randomised controlled trial with microcost and qualitative analysis – the Community In-reach Rehabilitation And Care Transition (CIRACT) study.

The provision of NHS health checks in a community setting: an ethnographic account (2015)
Journal Article
Riley, R., Coghill, N., Montgomery, A., Feder, G., & Horwood, J. (in press). The provision of NHS health checks in a community setting: an ethnographic account. BMC Health Services Research, 15, https://doi.org/10.1186/s12913-015-1209-1

Background: The UK National Health Service Health Checks programme aims to reduce avoidable cardiovascular deaths, disability and health inequalities in England. However, due to the reported lower uptake of screening in specific black and minority et... Read More about The provision of NHS health checks in a community setting: an ethnographic account.

Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS) (2015)
Journal Article
Lincoln, N. B., das Nair, R., Bradshaw, L., Constantinescu, C. S., Drummond, A. E. R., Erven, A., …Morgan, M. (2015). Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS). Trials, 16(1), Article 556. https://doi.org/10.1186/s13063-015-1016-3

Background People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual’s memory and other cognitive functions. Cognitive rehabili... Read More about Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS).

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial (2015)
Journal Article
Robling, M., Bekkers, M., Bell, K., Butler, C. C., Cannings-John, R., Channon, S., …Torgerson, D. (2016). Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial. Lancet, 2016(387), https://doi.org/10.1016/S0140-6736%2815%2900392-X

Background Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting int... Read More about Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial (2015)
Journal Article
Harrison, E. F., Haines, R. H., Cowdell, F., Sach, T. H., Dean, T., Pollock, I., …Thomas, K. S. (2015). A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial. Trials, 16(1), https://doi.org/10.1186/s13063-015-0921-9

Background Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that... Read More about A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

Lamotrigine versus inert placebo in the treatment of borderline personality disorder: study protocol for a randomized controlled trial and economic evaluation (2015)
Journal Article
Crawford, M. J., Sanatinia, R., Barrett, B., Byford, S., Cunningham, G., Gakhal, K., …Reilly, J. G. (2015). Lamotrigine versus inert placebo in the treatment of borderline personality disorder: study protocol for a randomized controlled trial and economic evaluation. Trials, 16, Article 308. https://doi.org/10.1186/s13063-015-0823-x

Background: People with borderline personality disorder (BPD) experience rapid and distressing changes in mood, poor social functioning and have high rates of suicidal behaviour. Several small scale studies suggest that mood stabilizers may produce s... Read More about Lamotrigine versus inert placebo in the treatment of borderline personality disorder: study protocol for a randomized controlled trial and economic evaluation.

To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial (2015)
Journal Article
Jayaram, M., Bodart, A. Y., Sampson, S., Zhao, S., Montgomery, A. A., & Adams, C. E. (in press). To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial. BMJ Open, 5, Article e00769. https://doi.org/10.1136/bmjopen-2015-007695

Introduction: The Cochrane Schizophrenia Group (CSzG) has produced and maintained systematic reviews of effects of interventions for schizophrenia and related illness. Each review has a Plain Language Summary (PLS), for those without specialised know... Read More about To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial.

Who does not participate in telehealth trials and why? A cross-sectional survey (2015)
Journal Article
Foster, A., Horspool, K., Edwards, L., Thomas, C., Salisbury, C., Montgomery, A. A., & O'Cathain, A. (2015). Who does not participate in telehealth trials and why? A cross-sectional survey. Trials, 16(258), https://doi.org/10.1186/s13063-015-0773-3

Background Telehealth interventions use information and communication technology to provide clinical support. Some randomised controlled trials of telehealth report high patient decline rates. A large study was undertaken to determine which patients... Read More about Who does not participate in telehealth trials and why? A cross-sectional survey.

A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria (2015)
Journal Article
Oladeji, A., Kola, L., Abiona, T., & Montgomery, A. A. (in press). A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria. BMC Psychiatry, 15(96), https://doi.org/10.1186/s12888-015-0483-0

Background Depression is common in primary care and is often unrecognized and untreated. Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers (PHCWs) in sub-Saharan... Read More about A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria.

A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) (2015)
Journal Article
Lam, C., Tan, W., Leighton, M., Hastings, M., Lingaya, M., Falcone, Y., …Spiller, R. C. (2015). A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D). Gut, 65(1), https://doi.org/10.1136/gutjnl-2015-309122

Introduction: Immune activation has been reported in the mucosa of irritable bowel syndrome patients with diarrhoea (IBS-D) and some small studies have suggested that Mesalazine may reduce symptoms. We performed a double blind, randomised placebo con... Read More about A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D).

Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation (2015)
Journal Article
Lim, W. S., Brittain, C., Duley, L., Edwards, S., Gordon, S., Montgomery, A., …Wootton, D. (2015). Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation. Health Technology Assessment, 19(16), https://doi.org/10.3310/hta19160

Background: There are no completed randomised trials of the use of corticosteroids in patients with severe influenza infection. Corticosteroid use in influenza is widespread, non-systematic and marked by controversy. A recent meta-analysis of observa... Read More about Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation.

Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial (2015)
Journal Article
Jago, R., Sebire, S., Davies, B., Wood, L., Banfield, K., Edwards, M. J., …Fox, K. (2015). Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial. BMC Public Health, 15(156), https://doi.org/10.1186/s12889-015-1501-3

Background Many children do not engage in recommended levels of physical activity (PA), highlighting the need to find ways to increase children’s PA. Process evaluations play an important role in improving the science of randomised controlled trials... Read More about Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial.

The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial (2015)
Journal Article
Watson, A., Charlesworth, L., Jacob, R., Kendrick, D., Logan, P., Marshall, F., …Sahota, O. (2015). The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial. Trials, 16(41), https://doi.org/10.1186/s13063-015-0551-2

Background Older people represent a significant proportion of patients admitted to hospital. Their care compared to younger patients is more challenging, length of stay is longer, risk of hospital-acquired problems higher and the risk of being re-... Read More about The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial.

TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation (2015)
Journal Article
Salisbury, C., Thomas, C., O'Cathain, A., Rogers, A. E., Pope, C., Yardley, L., …Montgomery, A. A. (in press). TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation. BMJ Open, 5(2), Article e006448. https://doi.org/10.1136/bmjopen-2014-006448

Objective To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease r... Read More about TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation.

Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial (2015)
Journal Article
Cooper, S., Foster, K., Naughton, F., Leonardi-Bee, J., Sutton, S., Ussher, M., …Coleman, T. (2015). Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial. Trials, 16, Article 29. https://doi.org/10.1186/S13063-014-0546-4

Background Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised... Read More about Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial.

Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial (2015)
Journal Article
das Nair, R., Lincoln, N., Ftizsimmons, D., Brain, N., Montgomery, A., Bradshaw, L., …Pink, A. (2015). Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial. Trials, 16(6), https://doi.org/10.1186/1745-6215-16-6

Background Impairments of memory are commonly reported by people with traumatic brain injuries (TBI). Such deficits are persistent, debilitating, and can severely impact quality of life. Currently, many do not routinely receive follow-up appointment... Read More about Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial.

Randomised trial of the fascia iliaca block versus the ‘3-in-1’ block for femoral neck fractures in the emergency department (2014)
Journal Article
Reavley, P., Montgomery, A. A., Smith, J. E., Binks, S., Elder, G., Benger, J., & Edwards, J. (in press). Randomised trial of the fascia iliaca block versus the ‘3-in-1’ block for femoral neck fractures in the emergency department. Emergency Medicine Journal, 32(9), https://doi.org/10.1136/emermed-2013-203407

Introduction: Femoral neck fractures are a common and painful injury. Femoral nerve blocks, and a variant of this technique termed the ‘3-in-1’ block, are often used in this patient group, but their effect is variable. The fascia iliaca compartment b... Read More about Randomised trial of the fascia iliaca block versus the ‘3-in-1’ block for femoral neck fractures in the emergency department.

Peer victimization during adolescence: concurrent and prospective impact on symptoms of depression and anxiety (2014)
Journal Article
Stapinski, L. A., Araya, R., Heron, J., Montgomery, A. A., & Stallard, P. (2014). Peer victimization during adolescence: concurrent and prospective impact on symptoms of depression and anxiety. Anxiety, Stress and Coping, 28(1), 105-120. https://doi.org/10.1080/10615806.2014.962023

© 2014 Taylor & Francis. Background: Peer victimization is ubiquitous across schools and cultures, and has the potential for long-lasting effects on the well-being of victims. To date, research has focused on the consequences of peer victimization... Read More about Peer victimization during adolescence: concurrent and prospective impact on symptoms of depression and anxiety.

Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30 (2014)
Journal Article
Jago, R., Sebire, S., Davies, B., Wood, L., Edwards, M. J., Banfield, K., …Montgomery, A. A. (2014). Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30. International Journal of Behavioral Nutrition and Physical Activity, 11, Article 114. https://doi.org/10.1186/s12966-014-0114-z

Background: Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by... Read More about Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30.

Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando) – a pilot study (2014)
Journal Article
Hamilton-Shield, J., Goodred, J., Powell, L., Thorn, J., Banks, J., Hollinghurst, S., …Turner, K. (2014). Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando) – a pilot study. Health Technology Assessment, 18(47), https://doi.org/10.3310/hta18470

Background Around one in five children in England is obese when they leave primary school. Thus far, it has not been demonstrated that primary care interventions to manage childhood obesity can achieve significant weight reduction. Training obese... Read More about Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando) – a pilot study.

Relationship between Expectation Management and Client Retention in Online Cognitive Behavioural Therapy (2014)
Journal Article
Ekberg, S., Barnes, R. K., Kessler, D. S., Mirza, S., Montgomery, A. A., Malpass, A., & Shaw, A. R. (2015). Relationship between Expectation Management and Client Retention in Online Cognitive Behavioural Therapy. Behavioural and Cognitive Psychotherapy, 43(6), 732-743. https://doi.org/10.1017/S1352465814000241

Background: Engaging clients from the outset of psychotherapy is important for therapeutic success. However, there is little research evaluating therapists’ initial attempts to engage clients in the therapeutic process. This article reports retrospec... Read More about Relationship between Expectation Management and Client Retention in Online Cognitive Behavioural Therapy.

Associations between Physical Activity Parenting Practices and Adolescent Girls’ Self-Perceptions and Physical Activity Intentions (2014)
Journal Article
Sebire, S., Haase, A. M., Montgomery, A. A., McNeil, J., & Jago, R. (2014). Associations between Physical Activity Parenting Practices and Adolescent Girls’ Self-Perceptions and Physical Activity Intentions. Journal of Physical Activity and Health, 11(4), 734-740. https://doi.org/10.1123/jpah.2012-0034

Background: The present study investigated cross-sectional associations between maternal and paternal logistic and modelling physical activity support and the self-efficacy, self-esteem and physical activity intentions of 11-12 year old girls. Met... Read More about Associations between Physical Activity Parenting Practices and Adolescent Girls’ Self-Perceptions and Physical Activity Intentions.

Cost-effectiveness of classroom-based cognitive behaviour therapy in reducing symptoms of depression in adolescents: a trial-based analysis (2014)
Journal Article
Anderson, R., Ukoumunne, O. C., Sayal, K., Phillips, R., Taylor, J. A., Spears, M., …Stallard, P. (2014). Cost-effectiveness of classroom-based cognitive behaviour therapy in reducing symptoms of depression in adolescents: a trial-based analysis. Journal of Child Psychology and Psychiatry, 55(12), 1390-1397. https://doi.org/10.1111/jcpp.12248

Background A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide, social and educational impairment, and mental health problems in adulthood. A recently conducted randomized controlled tri... Read More about Cost-effectiveness of classroom-based cognitive behaviour therapy in reducing symptoms of depression in adolescents: a trial-based analysis.

Are People With Chronic Diseases Interested in Using Telehealth? A Cross-Sectional Postal Survey (2014)
Journal Article
Edwards, L., Thomas, C., Gregory, A., Yardley, L., O'Cathain, A., Montgomery, A. A., & Salisbury, C. (2014). Are People With Chronic Diseases Interested in Using Telehealth? A Cross-Sectional Postal Survey. Journal of Medical Internet Research, 16(5), Article e123. https://doi.org/10.2196/jmir.3257

Background: There is growing interest in telehealth—the use of technology to support the remote delivery of health care and promote self-management—as a potential alternative to face-to-face care for patients with chronic diseases. However, little i... Read More about Are People With Chronic Diseases Interested in Using Telehealth? A Cross-Sectional Postal Survey.

Sedentary time and markers of inflammation in people with newly diagnosed type 2 diabetes (2014)
Journal Article
Falconer, C., Cooper, A., Walhin, J., Thompson, D., Page, A., Peters, T., …Andrews, R. (2014). Sedentary time and markers of inflammation in people with newly diagnosed type 2 diabetes. Nutrition, Metabolism and Cardiovascular Diseases, 2014(24(9)), https://doi.org/10.1016/j.numecd.2014.03.009

Background and aims: We investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type 2 diabetes. Methods and results: We studied 285 adults (184 men, 101 women, mean... Read More about Sedentary time and markers of inflammation in people with newly diagnosed type 2 diabetes.

School travel mode, parenting practices and physical activity among UK Year 5 and 6 children (2014)
Journal Article
Jago, R., Wood, L., Sebire, S., Edwards, M. J., Davies, B., Banfield, K., …Montgomery, A. A. (2014). School travel mode, parenting practices and physical activity among UK Year 5 and 6 children. BMC Public Health, 14, Article 370. https://doi.org/10.1186/1471-2458-14-370

Background: School travel mode and parenting practices have been associated with children’s physical activity (PA). The current study sought to examine whether PA parenting practices differ by school travel mode and whether school travel mode and... Read More about School travel mode, parenting practices and physical activity among UK Year 5 and 6 children.

Instrumental delivery and ultrasound: a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery (2014)
Journal Article
Ramphul, M., Ooi, P. V., Burke, G., Kennelly, M. M., Said, S. A., Montgomery, A. A., & Murphy, D. J. (2014). Instrumental delivery and ultrasound: a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery. BJOG: An International Journal of Obstetrics and Gynaecology, 121(8), https://doi.org/10.1111/1471-0528.12810

Objectives: To determine whether the use of ultrasound can reduce the incidence of incorrect diagnosis of the fetal head position at instrumental delivery and subsequent morbidity. Design: Two-arm, parallel, randomised trial, conducted from June 2... Read More about Instrumental delivery and ultrasound: a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

Health services changes: is a run-in period necessary before evaluation in randomised clinical trials? (2014)
Journal Article
Rathod, T., Belcher, J., Montgomery, A. A., Salisbury, C., & Foster, N. (2014). Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?. Trials, 15(41), https://doi.org/10.1186/1745-6215-15-41

Background Most randomised clinical trials (RCTs) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach. Consequently, health professionals involved may feel insufficiently familiar or confid... Read More about Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?.

Antibiotic prescribing in primary care and antimicrobial resistance in patients admitted to hospital with urinary tract infection: a controlled observational pilot study (2014)
Journal Article
Costelloe, C., Williams, O. M., Montgomery, A. A., Dayan, C., & Hay, A. D. (2014). Antibiotic prescribing in primary care and antimicrobial resistance in patients admitted to hospital with urinary tract infection: a controlled observational pilot study. Antibiotics, 3(1), https://doi.org/10.3390/antibiotics3010029

There is growing evidence that primary care prescribed antibiotics lead to antibiotic resistance in bacteria causing minor infections or being carried by asymptomatic adults, but little research to date has investigated links between primary care pre... Read More about Antibiotic prescribing in primary care and antimicrobial resistance in patients admitted to hospital with urinary tract infection: a controlled observational pilot study.