Skip to main content

Research Repository

Advanced Search

All Outputs (355)

Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial (2020)
Journal Article
Horne, A. W., Vincent, K., Hewitt, C. A., Middleton, L. J., Koscielniak, M., Szubert, W., …GaPP2 collaborative. (2020). Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet, 396(10255), 909-917. https://doi.org/10.1016/S0140-6736%2820%2931693-7

© 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Chronic pelvic pain affects 2–24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in tre... Read More about Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial.

It is unprecedented: trial management during the COVID-19 pandemic and beyond (2020)
Journal Article
Mitchell, E. J., Ahmed, K., Breeman, S., Cotton, S., Constable, L., Ferry, G., …McDonald, A. (2020). It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials, 21, Article 784. https://doi.org/10.1186/s13063-020-04711-6

The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pau... Read More about It is unprecedented: trial management during the COVID-19 pandemic and beyond.

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.

The East Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility study protocol (2020)
Journal Article
Hall, M. C., Fuller, A., Nomikos, P. A., Millar, B., Ogollah, R., Valdes, A., …Abhishek, A. (2020). The East Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility study protocol. BMJ Open, 10(9), Article e037760

Introduction: Knee pain and osteoarthritis (OA) are a common cause of disability. The UK National Institute of Health and Care Excellence (NICE) OA guidelines recommend education, exercise and weight-loss advice (if overweight) as core interventions... Read More about The East Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility study protocol.

East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol (2020)
Journal Article
Hall, M., Fuller, A., Nomikos, P. A., Millar, B., Ogollah, R., Valdes, A., …Abhishek, A. (2020). East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol. BMJ Open, 10(9), https://doi.org/10.1136/bmjopen-2020-037760

© 2020 BMJ Open Introduction Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core int... Read More about East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol.

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, 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, 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., …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).