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All Outputs (27)

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.

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.

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)*.

Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial) (2020)
Journal Article
Haines, R., White, J., Meakin, G., Tan, W., Hepburn, T., Leighton, P., …Sereda, M. (2020). Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial). Pilot and Feasibility Studies, 6, Article 41. https://doi.org/10.1186/s40814-020-00582-5

Background: The most common management strategy for tinnitus provided in UK audiology clinics is education and advice. This may also be combined with some form of sound therapy (e.g. digital hearing aids). While education and advice is generally prov... Read More about Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial).

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.

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.

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

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.

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).

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.

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.

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.

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.

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.

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.

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.