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All Outputs (354)

Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Thomas, B., Wright, J., Mason, C., & Cooper, C. L. (2021). Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists. Clinical Interventions in Aging, 16, 231-244. https://doi.org/10.2147/cia.s293921

Objectives: To identify the barriers and facilitators to the implementation of a complex psychosocial intervention though a study exploring the experiences of participants, carers and interventionists during a trial Methods: Individual semi-struct... Read More about Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists.

The acceptability to women of techniques for managing an impacted fetal head at caesarean section and of randomised trials evaluating those techniques: a qualitative study (2021)
Journal Article
Romano, G., Mitchell, E., Plachcinski, R., Wakefield, N., Walker, K., & Ayers, S. (2021). The acceptability to women of techniques for managing an impacted fetal head at caesarean section and of randomised trials evaluating those techniques: a qualitative study. BMC Pregnancy and Childbirth, 21, Article 103. https://doi.org/10.1186/s12884-021-03577-z

Background This study aimed to explore women’s views on the acceptability of different techniques for managing an impacted fetal head at caesarean; and the feasibility and acceptability of conducting a trial in this area. Methods Qualitative sem... Read More about The acceptability to women of techniques for managing an impacted fetal head at caesarean section and of randomised trials evaluating those techniques: a qualitative study.

Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021)
Journal Article
Abaleke, E., Abbas, M., Abbasi, S., Abbott, A., Abdelaziz, A., Abdelbadiee, S., …Zuriaga-Alvaro, A. (2021). Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 397(10274), 605-612. https://doi.org/10.1016/s0140-6736%2821%2900149-5

Summary Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In t... Read More about Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review (2021)
Journal Article
Deshmukh, S. R., Mousoulis, C., Marson, B. A., Grindlay, D., Karantana, A., the Core Outcome Set for Hand Fractures and Joint Injuries in Adults Group, …Montgomery, A. A. (2021). Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review. Journal of Hand Surgery (European Volume), 46(5), 488-495. https://doi.org/10.1177/1753193420983719

© The Author(s) 2021. This study identifies the treatment outcome domains used in recently published studies on the treatment of hand fractures and joint injuries with the aim to inform development of a core outcome set. Seven databases were searched... Read More about Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review.

Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1) (2021)
Journal Article
Whitaker, L. H., Doust, A., Stephen, J., Norrie, J., Cooper, K., Daniels, J., …Horne, A. W. (2021). Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1). Pilot and Feasibility Studies, 7(1), Article 19. https://doi.org/10.1186/s40814-020-00740-9

Background: Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial perito... Read More about Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1).

TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands (2020)
Journal Article
Foss, A. J. E., Haydock, R., Childs, M., Duley, L., Empeslidis, T., Dhar-Munshi, S., …Mitchell, E. (2020). TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands. BMJ Open Ophthalmology, 5(1), Article e000588. https://doi.org/10.1136/bmjophth-2020-000588

Objective: Neovascular age-related macular degeneration (nAMD) causes damage to the macula and severe vision loss. Bevacizumab is the most cost-effective nAMD treatment. The TANDEM trial was designed to determine whether, in patients with nAMD, low-d... Read More about TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (Avastin) for neovascular macular degeneration in the East Midlands.

A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults (2020)
Journal Article
Taha, R. H. M., Grindlay, D., Deshmukh, S., Montgomery, A., Davis, T. R. C., & Karanatana, A. (2022). A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults. Hand, 17(5), 869-878. https://doi.org/10.1177/1558944720974363

Metacarpal shaft fractures are common hand injuries that predominantly affect younger patients. There is wide variability in their treatment with no consensus on best practice. We performed a systematic review to assess the breadth and quality of ava... Read More about A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults.

Test evaluation trials present different challenges for trial managers compared to intervention trials (2020)
Journal Article
Rick, C., Mallett, S., Brown, J., Ottridge, R., Palmer, A., Parker, V., …Deeks, J. J. (2020). Test evaluation trials present different challenges for trial managers compared to intervention trials. Trials, 21(1), Article 987. https://doi.org/10.1186/s13063-020-04861-7

Introduction: Test evaluation trials present different challenges for trial managers compared to intervention trials. There has been very little research on the management of test evaluation trials and how this impacts on trial success, in comparison... Read More about Test evaluation trials present different challenges for trial managers compared to intervention trials.

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.

Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial (2020)
Journal Article
Desborough, M. J., Al-Shahi Salman, R., Stanworth, S. J., Havard, D., Brennan, P. M., Dineen, R. A., …DASH trial investigators. (2020). Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial. BMJ Open, 10(11), Article e037555. https://doi.org/10.1136/bmjopen-2020-037555

Introduction Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not usin... Read More about Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI) (2020)
Journal Article
Husbands, S., Elliott, D., Davis, T. R., Blazeby, J. M., Harrison, E. F., Montgomery, A. A., …Mills, N. (2020). Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI). Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-020-00710-1

© 2020, The Author(s). Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome r... Read More about Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI).

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)*.

Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., …Ojha, S. (2020). Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya. BMJ Global Health, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

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 of life are due to prematurity and the neonatal mort... Read More about Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya.

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.

Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial (2020)
Journal Article
Fleminger, J., Seed, P., Smith, A., Dixon, P., Juszczak, E., Chambers, J., …Chappell, L. (2021). Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial. BJOG: An International Journal of Obstetrics and Gynaecology, 128(6), 1066-1075. https://doi.org/10.1111/1471-0528.16567

Objective: To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA). Design: Secondary analysis of the P... Read More about Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT (2020)
Journal Article
Foster, N. E., Konstantinou, K., Lewis, M., Ogollah, R., Saunders, B., Kigozi, J., …Dunn, K. M. (2020). Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT. Health Technology Assessment, 24(49), 1-130. https://doi.org/10.3310/hta24490

Background Sciatica has a substantial impact on patients and society. Current care is ‘stepped’, comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensi... Read More about Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 (2020)
Journal Article
The RECOVERY Collaborative Group, Horby, P., Mafham, M., Linsell, L., Bell, J. L., Staplin, N., …Landray, M. J. (2020). Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. New England Journal of Medicine, 383(21), 2030-2040. https://doi.org/10.1056/NEJMoa2022926

BACKGROUND Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials. METHODS In this randomized, cont... Read More about Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.

Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2020)
Journal Article
The Recovery Collaborative Group, Horby, P. W., Mafham, M., Bell, J. L., Linsell, L., Staplin, N., …Landray, M. J. (2020). Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet, 396(10259), 1345-1352. https://doi.org/10.1016/s0140-6736%2820%2932013-4

Summary Background Lopinavir–ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity, preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir–ri... Read More about Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

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.