Skip to main content

Research Repository

Advanced Search

All Outputs (440)

A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial (2020)
Journal Article
Sackley, C. M., Rick, C., Au, P., Brady, M. C., Beaton, G., Burton, C., Caulfield, M., Dickson, S., Dowling, F., Hughes, M., Ives, N., Jowett, S., Masterson-Algar, P., Nicoll, A., Patel, S., Smith, C. H., Woolley, R., Clarke, C. E., & on behalf of the PD COMM Collaborative Group. (2020). A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial. Trials, 21, Article 436. https://doi.org/10.1186/s13063-020-04354-7

Background
Parkinson’s disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, an... Read More about A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial.

Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals (2020)
Journal Article
Mitchell, E., Goodman, K., Hartley, S., Hickey, H., McDonald, A. M., Meadows, H. M., Rhodes, S., Taylor, J., Wakefield, N., Farrell, B., & UK Trial Managers’ Network Executive Group. (2020). Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals. Trials, 21, Article 384. https://doi.org/10.1186/s13063-020-04316-z

Background
Clinical trials commonly have a dedicated trial manager and effective trial management is essential to the successful delivery of high-quality trials. Trial managers have diverse experience and currently there is no standardised structure... Read More about Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals.

Providing patients with direct access to musculoskeletal physiotherapy: the impact on general practice musculoskeletal workload and resource use. The STEMS-2 study (2020)
Journal Article
Bishop, A., Chen, Y., Protheroe, J., Ogollah, R. O., Bailey, J., Lewis, M., Jordan, K., & Foster, N. E. (2021). Providing patients with direct access to musculoskeletal physiotherapy: the impact on general practice musculoskeletal workload and resource use. The STEMS-2 study. Physiotherapy, 111, 48-56. https://doi.org/10.1016/j.physio.2020.04.006

Objectives
This study examined the real-world impact of patient direct access to NHS physiotherapy (self-referral) on (a) general practice consultations for musculoskeletal (MSK) conditions and (b) specified clinical management for patients with MSK... Read More about Providing patients with direct access to musculoskeletal physiotherapy: the impact on general practice musculoskeletal workload and resource use. The STEMS-2 study.

Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT) (2020)
Journal Article
Tahir, W., Monahan, M., Dorling, J., Hewer, O., Bowler, U., Linsell, L., Partlett, C., Berrington, J. E., Boyle, E., Embleton, N., Johnson, S., Leaf, A., McCormick, K., McGuire, W., Stenson, B. J., Juszczak, E., & Roberts, T. E. (2020). Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT). Archives of Disease in Childhood. Fetal and Neonatal Edition, 105(6), 587-592. https://doi.org/10.1136/archdischild-2019-318346

Objective: To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants.
Design: Within-trial economic evaluation alongside a multicentre, two-arm parallel group,... Read More about Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).

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., Hall, D., & 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).

Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement (2020)
Journal Article
Armstrong-Buisseret, L. K., Haslam, S., James, T., Bradshaw, L., & Heazell, A. E. (2020). Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement. Annals of Clinical Biochemistry, 57(3), 223-233. https://doi.org/10.1177/0004563220911993

Background: Placental growth factor (PlGF) and soluble-fms-like tyrosine kinase 1 (sFlt-1) are biomarkers of placental function used to aid the diagnosis and prediction of pregnancy complications. This work verified the analytical performance of both... Read More about Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement.

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

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

Objectives

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

Setting

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

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., Ridd, M. J., Lawton, S., Simpson, E. L., Cork, M. J., Sach, T. H., Flohr, C., Mitchell, E. J., Swinden, R., Tarr, S., Davies-Jones, S., Jay, N., Kelleher, M., Perkin, M. R., Boyle, R. 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.

Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial (2020)
Journal Article
Armstrong-Buisseret, L., Godolphin, P. J., Bradshaw, L., Mitchell, E., Ratcliffe, S., Storey, C., & Heazell, A. E. P. (2020). Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial. Pilot and Feasibility Studies, 6, Article 23. https://doi.org/10.1186/s40814-020-0561-z

Background

Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by... Read More about Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot 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., Chalmers, J. R., Bradshaw, L. E., Williams, H. C., & 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., Mills, N., Hepburn, T., Sprange, K., Duley, L., Blazeby, J. M., Bainbridge, C. G., Murali, R., & 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), Article 7. 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., Harris, S., Montgomery, A. A., das Nair, R., & 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.

11β-Hydroxysteroid Dehydrogenase Type 1 Inhibition in Idiopathic Intracranial Hypertension: A Double-Blind Randomized Controlled Trial (2020)
Journal Article
Tomlinson, J. W., Markey, K., Mitchell, J., Botfield, H., Ottridge, R. S., Lavery, G. G., Mollan, S. P., Sinclair, A. J., Arlt, W., Matthews, T., Krishnan, A., Woolley, R., Westgate, C., Yiangou, A., Scotton, W., Fairclough, R., Singhal, R., Stewart, P. M., Taylor, A. E., Alimajstorovic, Z., …Jenkinson, C. (2020). 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibition in Idiopathic Intracranial Hypertension: A Double-Blind Randomized Controlled Trial. Brain Communications, 2(1), Article fcz050. https://doi.org/10.1093/braincomms/fcz050

Treatment options for idiopathic intracranial hypertension are limited. The enzyme 11β-hydroxysteroid dehydrogenase type 1 has been implicated in regulating cerebrospinal fluid secretion, and its activity is associated with alterations in intracrania... Read More about 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibition in Idiopathic Intracranial Hypertension: A Double-Blind Randomized Controlled Trial.

A core outcome set for future endometriosis research: an international consensus development study (2020)
Journal Article
Duffy, J. M., Hirsch, M., Vercoe, M., Abbott, J., Barker, C., Collura, B., Drake, R., Evers, J. L., Hickey, M., Horne, A. W., Hull, M. L., Kolekar, S., Lensen, S., Johnson, N. P., Mahajan, V., Mol, B. W., Otter, A. S., Puscasiu, L., Rodriguez, M. B., Rombauts, L., …Cook, L. A. (2020). A core outcome set for future endometriosis research: an international consensus development study. BJOG: An International Journal of Obstetrics and Gynaecology, 127(8), 967-974. https://doi.org/10.1111/1471-0528.16157

© 2020 Royal College of Obstetricians and Gynaecologists Objective: To develop a core outcome set for endometriosis. Design: Consensus development study. Setting: International. Population: One hundred and sixteen healthcare professionals, 31 researc... Read More about A core outcome set for future endometriosis research: an international consensus development study.

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., Jackson, L., Kai, J., Montgomery, A., Roberts, T., Thandi, S., & 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., Harris, S., Montgomery, A., & 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).

Acceptability of and treatment preferences for recurrent bacterial vaginosis—Topical lactic acid gel or oral metronidazole antibiotic: Qualitative findings from the VITA trial (2019)
Journal Article
Anstey Watkins, J., Ross, J. D. C., Thandi, S., Brittain, C., Kai, J., & Griffiths, F. (2019). Acceptability of and treatment preferences for recurrent bacterial vaginosis—Topical lactic acid gel or oral metronidazole antibiotic: Qualitative findings from the VITA trial. PLoS ONE, 14(11), Article e0224964. https://doi.org/10.1371/journal.pone.0224964

Background: Bacterial vaginosis (BV) is associated with an elevated vaginal pH and the presence of abnormal offensive discharge. It is common, often recurrent, and the most effective treatment regimen is unknown. ‘Metronidazole Versus lactic acId for... Read More about Acceptability of and treatment preferences for recurrent bacterial vaginosis—Topical lactic acid gel or oral metronidazole antibiotic: Qualitative findings from the VITA trial.