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All Outputs (15)

Online Remote Behavioural Intervention for Tics in 9 to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation (2023)
Journal Article
Hollis, C., Hall, C. L., Khan, K., Le Novere, M., Marston, L., Jones, R., …Murphy, T. (2023). Online Remote Behavioural Intervention for Tics in 9 to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation. Health Technology Assessment, 27(18), 1-120. https://doi.org/10.3310/cpms3211

Background: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online. Objective: To investigate the clinical and cost-effectiveness of an online-delivered, therapist and parent-... Read More about Online Remote Behavioural Intervention for Tics in 9 to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation.

Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement (2021)
Journal Article
McCall, S. J., Imran, M., Hemkens, L. G., Mc Cord, K., Kwakkenbos, L., Sampson, M., …Juszczak, E. (2022). Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement. Journal of Clinical Epidemiology, 141, 198-209. https://doi.org/10.1016/j.jclinepi.2021.09.011

Objective To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using... Read More about Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement.

Paediatric research in the times of COVID-19 (2021)
Journal Article
Fleming, P. F., Gale, C., Molloy, E. J., Faust, S. N., Costeloe, K., Juszczak, E., & Roehr, C. C. (2021). Paediatric research in the times of COVID-19. Pediatric Research, 90, 267–271. https://doi.org/10.1038/s41390-021-01479-6

The COVID-19 pandemic poses many direct and indirect consequences for children's health and associated research. Direct consequences include participation of children in COVID-19 research trials, pausing other research in children and the potential i... Read More about Paediatric research in the times of COVID-19.

Maternal transmission of SARS?COV?2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis (2020)
Journal Article
Walker, K., O'Donoghue, K., Grace, N., Dorling, J., Comeau, J. L., Li, W., & Thornton, J. (2020). Maternal transmission of SARS?COV?2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis. BJOG: An International Journal of Obstetrics and Gynaecology, 127(11), 1324-1336. https://doi.org/10.1111/1471-0528.16362

Challenges in the design, planning and implementation of trials evaluating group interventions (2020)
Journal Article
Biggs, K., Hind, D., Gossage-Worrall, R., Sprange, K., White, D., Wright, J., …Cooper, C. (2020). Challenges in the design, planning and implementation of trials evaluating group interventions. Trials, 21(1), Article 116. https://doi.org/10.1186/s13063-019-3807-4

BACKGROUND: Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or health education. Evaluating grou... Read More about Challenges in the design, planning and implementation of trials evaluating group interventions.

Investigating multisite pain as a predictor of self-reported falls and falls requiring health care use in an older population: A prospective cohort study (2019)
Journal Article
Welsh, V. K., Mallen, C. D., Ogollah, R., Wilkie, R., & McBeth, J. (2019). Investigating multisite pain as a predictor of self-reported falls and falls requiring health care use in an older population: A prospective cohort study. PLoS ONE, 14(12), https://doi.org/10.1371/journal.pone.0226268

Older people are continuing to fall despite fall prevention guidelines targeting known falls' risk factors. Multisite pain is a potential novel falls' risk factor requiring further exploration. This study hypothesises that: (1) an increasing number o... Read More about Investigating multisite pain as a predictor of self-reported falls and falls requiring health care use in an older population: A prospective cohort study.

Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial (2019)
Journal Article
Shafayat, A., Csipke, E., Bradshaw, L., Charlesworth, G., Day, F., Leung, P., …Orrell, M. (2019). Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial. Trials, 20(1), Article 709. https://doi.org/10.1186/s13063-019-3838-x

Background: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management interventio... Read More about Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial.

Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial (2019)
Journal Article
Ross, J., Brittain, C., Cole, M., Dewsnap, C., Harding, J., Hepburn, T., …Duley, L. (2019). Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial. Lancet, 393(10190), 2511-2520. https://doi.org/10.1016/S0140-6736%2818%2932817-4

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Background: Gonorrhoea is a common sexually transmitted infection for which ceftriaxone is the current first-line treatment, but antimi... Read More about Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial.

Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT (2019)
Journal Article
Ross, J. D., Harding, J., Duley, L., Montgomery, A. A., Hepburn, T., Tan, W., …Lawrence, T. (2019). Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT. Health Technology Assessment, 23(20), 1-104. https://doi.org/10.3310/hta23200

Background: Gonorrhoea is a common sexually transmitted infection that can cause pain and discomfort, affect fertility in women and lead to epididymo-orchitis in men. Current treatment is with ceftriaxone, but there is increasing evidence of antimicr... Read More about Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial (2019)
Journal Article
das Nair, R., Bradshaw, L. E., Day, F. E., Drummond, A., Harris, S. R., Fitzsimmons, D., …Lincoln, N. B. (2019). Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial. Clinical Rehabilitation, 33(7), 1171-1184. https://doi.org/10.1177/0269215519840069

Objective: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. Design: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. Sett... Read More about Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

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.

Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial (2019)
Journal Article
Bath, P. M., Scutt, P., Anderson, C. S., Appleton, J. P., Berge, E., Cala, L., …Mir, R. (2019). Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial. Lancet, 393(10175), 1009-1020. https://doi.org/10.1016/S0140-6736%2819%2930194-1

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure... Read More about Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial.

Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial) (2018)
Journal Article
Godolphin, P., Montgomery, A., Woodhouse, L., Bereczki, D., Berge, E., Collins, R., …ENOS Investigators. (2018). Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial). PLoS ONE, 13(11), Article e0208142. https://doi.org/10.1371/journal.pone.0208142

Background and Purpose: Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudicat... Read More about Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial).

Efficacy and cost-effectiveness of nurse-lead care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial (2018)
Journal Article
Doherty, M., Jenkins, W., Richardson, H., Sarmanova, A., Abhishek, A., Ashton, D., …Zhang, W. (2018). Efficacy and cost-effectiveness of nurse-lead care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet, 392(10156), 1403-1412. https://doi.org/10.1016/S0140-6736%2818%2932158-5

Background: In the UK gout management is suboptimal, only 40% of patients receiving urate-lowering therapy (ULT), usually without titration to a target serum urate (SU) level. Nurses successfully manage many diseases in primary care. This trial compa... Read More about Efficacy and cost-effectiveness of nurse-lead care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial.

Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation (2018)
Journal Article
Armstrong-Buisseret, L., Mitchell, E., Hepburn, T., Duley, L., Thornton, J. G., Roberts, T. E., …Heazell, A. E. P. (2018). Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation. Trials, 19, 1-13. https://doi.org/10.1186/s13063-018-2859-1

Background: Forty percent of babies who are stillborn born die after 36 weeks gestation and have no lethal structural abnormality. Maternal perception of reduced fetal movement (RFM) is associated with stillbirth and is related to abnormal placental... Read More about Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation.