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All Outputs (44)

Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial (2020)
Journal Article
Roddy, E., Ogollah, R. O., Oppong, R., Zwierska, I., Datta, P., Hall, A., …Foster, N. E. (2020). Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial. British Journal of Sports Medicine, 1-11. https://doi.org/10.1136/bjsports-2019-101268

Objectives: To compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (form... Read More about Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial.

Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda (2020)
Journal Article
Mitchell, E. J., Benjamin, S., Ononge, S., Ditai, J., Qureshi, Z., Masood, S. N., …Duley, L. (2020). Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda. BMC Pregnancy and Childbirth, 20(1), Article 439. https://doi.org/10.1186/s12884-020-03126-0

Background: Globally, 15 million infants are born preterm each year, and one million die due to complications of prematurity. Over 60% of preterm births occur in Sub-Saharan Africa and south Asia. Care at birth for premature infants may be critical f... Read More about Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda.

Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT) (2020)
Journal Article
Richards, J., Rankin, J., Juszczak, E., Dorling, J., McGuire, W., & Embleton, N. D. (2021). Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT). Archives of Disease in Childhood. Fetal and Neonatal Edition, 106(1), 84-87. https://doi.org/10.1136/archdischild-2020-319031

Objective To explore parents’ perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study. Design A qualitative study involving 17 in-depth semistructured interviews, with parents who ha... Read More about Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT).

Uterine-Artery Embolization or Myomectomy for Uterine Fibroids (2020)
Journal Article
Manyonda, I., Belli, A. M., Lumsden, M. A., Moss, J., McKinnon, W., Middleton, L. J., …McPherson, K. (2020). Uterine-Artery Embolization or Myomectomy for Uterine Fibroids. New England Journal of Medicine, 383(5), 440-451. https://doi.org/10.1056/NEJMoa1914735

Copyright © 2020 Massachusetts Medical Society. BACKGROUND: Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of li... Read More about Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.

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.

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial (2020)
Journal Article
Konstantinou, K., Lewis, M., Dunn, K. M., Ogollah, R., Artus, M., Hill, J. C., …Foster, N. E. (2020). Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial. The Lancet Rheumatology, 2(7), e401-e411. https://doi.org/10.1016/S2665-9913%2820%2930099-0

Background: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the c... Read More about Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan (2020)
Journal Article
Bell, J. L., Hardy, P., Greenland, M., Juszczak, E., Cole, C., Maheshwari, A., …Linsell, L. (2020). E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan. Trials, 21(1), Article 596. https://doi.org/10.1186/s13063-020-04441-9

Background: The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial. Methods and de... Read More about E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials (2020)
Journal Article
Mitchell, E. J., Godolphin, P., Meakin, G., & Sprange, K. (2020). Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials. Trials, 21, Article 514. https://doi.org/10.1186/s13063-020-04465-1

© 2020 The Author(s). Background: Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the hosting of... Read More about Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials.

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial (2020)
Journal Article
Bradshaw, L., Montgomery, A. A., Williams, H. C., Chalmers, J., & Haines, R. (2020). Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial. Trials, 21, Article 529. https://doi.org/10.1186/s13063-020-04373-4

Background Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in... Read More about Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial.

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., …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.

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., …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., …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.

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.