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Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E. J., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., …Ojha, S. (2020). Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya. BMJ Open, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

© 2020 BMJ Publishing Group. All rights reserved. Introduction Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month o... Read More about Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya.

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.

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.

Pravastatin for early‐onset preeclampsia: a randomized, blinded, placebo‐controlled trial (2019)
Journal Article
Ahmed, A., Williams, D. J., Cheed, V., Middleton, L. J., Ahmad, S., Wang, K., …StAmP trial collaborative group. (2020). Pravastatin for early‐onset preeclampsia: a randomized, blinded, placebo‐controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology, 127(4), 478-488. https://doi.org/10.1111/1471-0528.16013

Objective Women with preeclampsia have elevated circulating levels of soluble fms‐like tyrosine kinase‐1 (sFlt‐1). Statins can reduce sFlt‐1 from cultured cells and improve pregnancy outcome in animals with a preeclampsia‐like syndrome. We investiga... Read More about Pravastatin for early‐onset preeclampsia: a randomized, blinded, placebo‐controlled trial.

Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial (2019)
Journal Article
Goranitis, I., Lissauer, D. M., Coomarasamy, A., Wilson, A., Daniels, J., Middleton, L., …Roberts, T. E. (2019). Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial. Lancet Global Health, 7(9), e1280-e1286. https://doi.org/10.1016/s2214-109x%2819%2930336-5

Background There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarria... Read More about Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial.

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy (2019)
Journal Article
Coomarasamy, A., Devall, A. J., Cheed, V., Harb, H., Middleton, L. J., Gallos, I. D., …Jurkovic, D. (2019). A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. New England Journal of Medicine, 380(19), 1815-1824. https://doi.org/10.1056/NEJMoa1813730

© 2019 Massachusetts Medical Society. BACKGROUND Bleeding in early pregnancy is strongly associated with pregnancy loss. Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone therapy may i... Read More about A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy.

Levothyroxine in women with thyroid peroxidase antibodies before conception (2019)
Journal Article
Dhillon-Smith, R. K., Middleton, L. J., Sunner, K. K., Cheed, V., Baker, K., Farrell-Carver, S., …Coomarasamy, A. (2019). Levothyroxine in women with thyroid peroxidase antibodies before conception. New England Journal of Medicine, 380(14), 1316-1325. https://doi.org/10.1056/nejmoa1812537

Background Thyroid peroxidase antibodies are associated with an increased risk of miscarriage and preterm birth, even when thyroid function is normal. Small trials indicate that the use of levothyroxine could reduce the incidence of such adverse out... Read More about Levothyroxine in women with thyroid peroxidase antibodies before conception.

A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery (2019)
Journal Article
Lissauer, D., Wilson, A., Hewitt, C. A., Middleton, L., Bishop, J. R., Daniels, J., …Coomarasamy, A. (2019). A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery. New England Journal of Medicine, 380(11), 1012-1021. https://doi.org/10.1056/NEJMoa1808817

© 2019 Massachusetts Medical Society. BACKGROUND Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important co... Read More about A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.

Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial (2018)
Journal Article
Wilson, M. J., MacArthur, C., Hewitt, . C. A., Handley, K., Gao, F., Beeson, L., & Daniels, J. (2018). Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial. Lancet, 392(10148), 662-672. doi:10.1016/S0140-6736(18)31613-1

Background: Approximately a third of women receiving pethidine for labour pain subsequently require an epidural, which provides effective pain relief but increases the risk of instrumental delivery. Remifentanil patient controlled analgesia (PCA) in... Read More about Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial.

Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO) (2017)
Journal Article
Khan, K. S., Moore, P. A., Wilson, M. J., Hooper, R., Allard, S., Wrench, I., …Dodds, J. (2017). Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO). PLoS Medicine, 14(12), Article e1002471. https://doi.org/10.1371/journal.pmed.1002471

Background: Excessive haemorrhage at caesarean section requires donor (allogeneic) blood transfusion. Cell 34 salvage may reduce this requirement. Methods and findings: We conducted a pragmatic randomised controlled trial (26 obstetric units; Jun... Read More about Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO).

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care (2016)
Journal Article
Kai, J., Middleton, L., Daniels, J., Pattison, H., Tryposkiadis, K., & Gupta, J. (in press). Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care. British Journal of General Practice, 66(653), Article e861-e870. https://doi.org/10.3399/bjgp16X687577

Background: Heavy menstrual bleeding (HMB) is a common, chronic problem burdening women and health services. However long-term evidence on treatment in primary care is lacking. Aim: To assess the effectiveness of commencing levonorgestrel intra-ut... Read More about Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care.

Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial (2016)
Journal Article
McIntosh, E., Gray, A., Daniels, J., Gill, S., Ives, N., Jenkinson, C., …on behalf of The PD SURG Collaborators Group. (2016). Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial. Movement Disorders, 31(8), 1173-1182. https://doi.org/10.1002/mds.26423

Introduction Williams and colleagues reported that DBS surgery for patients with advanced PD improves motor function and quality of life compared to best medical therapy alone at 1 year, but with surgery‐related side effects in a minority. This ar... Read More about Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial.

Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. (2015)
Journal Article
Cooper, N. A., Clark, T. J., Middleton, L., Diwakar, L., Smith, P., Denny, E., …Thornton, J. (2015). Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study. BMJ, 350, Article h1398. https://doi.org/10.1136/bmj.h1398

© BMJ Publishing Group Ltd 2015. To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy. Design Pragmatic multicentre randomised controlled noninferiority study. Setting Outpatient hysteroscopy clinics in... Read More about Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study..

Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial (2014)
Journal Article
Daniels, J., Gray, R., Ives, N., Rick, C., Patel, S., Gray, A., …Clarke, C. (2014). Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial. Lancet, 384(9949), 1196-1205. https://doi.org/10.1016/S0140-6736%2814%2960683-8

Background Whether initial treatment for Parkinson's disease should consist of levodopa, dopamine agonists, or monoamine oxidase type B inhibitors (MAOBI) is uncertain. We aimed to establish which of these three classes of drug, as initial treatment... Read More about Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial.

Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial (2014)
Journal Article
Sanghera, S., Roberts, T. E., Barton, P., Frew, E., Daniels, J., Middleton, L., …Gupta, J. K. (2014). Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial. PLoS ONE, 9(3), Article e91891. https://doi.org/10.1371/journal.pone.0091891

Objective: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device (‘LNG-IUS’) and usual medical treatment for women with menorrhagia in primary care; and compare th... Read More about Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial (2010)
Journal Article
Williams, A., Gill, S., Varma, T., Jenkinson, C., Quinn, N., Mitchell, R., …Wheatley, K. (2010). Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial. Lancet Neurology, 9(6), 581-591. https://doi.org/10.1016/s1474-4422%2810%2970093-4