All Outputs (446)

Psychosocial Impacts of Infertility among Omani Women with Polycystic Ovarian Syndrome: A Qualitative Study (2023)
Journal Article
ALSumri, H., Szatkowski, L., Gibson, J., Fiaschi, L., & Bains, M. (2023). Psychosocial Impacts of Infertility among Omani Women with Polycystic Ovarian Syndrome: A Qualitative Study. International Journal of Fertility & Sterility, 17(2), 107-114. https://doi.org/10.22074/IJFS.2022.550111.1310

Background: To understand the psychosocial experience of infertility among women with polycystic ovarian syndrome in Oman.

Materials and Methods: In this qualitative study, semi-structured interviews were conducted with 20 Omani women diagnosed w... Read More about Psychosocial Impacts of Infertility among Omani Women with Polycystic Ovarian Syndrome: A Qualitative Study.

Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial. (2023)
Journal Article
Horne, A. W., Tong, S., Moakes, C. A., Middleton, L. J., Duncan, W. C., Mol, B. W., Whitaker, L. H., Jurkovic, D., Coomarasamy, A., Nunes, N., Holland, T., Clarke, F., Doust, A. M., & Daniels, J. P. (2023). Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet, 401(10377), 655-663. https://doi.org/10.1016/S0140-6736%2822%2902478-3

Background

Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, a... Read More about Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial..

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study (2023)
Journal Article
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., Juszczak, E., Linsell, L., Montgomery, A., & Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24, Article 71. https://doi.org/10.1186/s13063-022-06992-5

Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, ther... Read More about Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

Risk of liver fibrosis associated with long-term methotrexate therapy may be overestimated (2023)
Journal Article
Atallah, E., Grove, J., Crooks, C., Burden-Teh, E., Abhishek, A., Moreea, S., Jordan, K., Ala, A., Hutchinson, D., Aspinall, R. J., Murphy, R., & Aithal, G. (2023). Risk of liver fibrosis associated with long-term methotrexate therapy may be overestimated. Journal of Hepatology, 78(5), 989-997. https://doi.org/10.1016/j.jhep.2022.12.034

Background & Aims
The risk of significant liver fibrosis from prolonged methotrexate (MTX) exposure has been estimated at around 5%, prompting intensive monitoring strategies. However, the evidence is derived from retrospective studies that under-re... Read More about Risk of liver fibrosis associated with long-term methotrexate therapy may be overestimated.

Understanding the Impact of Home Confinement on Children and Young People with ADHD and ASD During the COVID-19 Pandemic (2023)
Journal Article
Hall, C. L., Partlett, C., Valentine, A. Z., Pearcey, S., & Sayal, K. (2023). Understanding the Impact of Home Confinement on Children and Young People with ADHD and ASD During the COVID-19 Pandemic. Child Psychiatry and Human Development, 55(5), 1279-1293. https://doi.org/10.1007/s10578-022-01490-w

To understand whether the mental health of children and young people (CYP) with and without attention-deficit/hyperactivity disorder (ADHD) and/or autism spectrum disorder (ASD) were differentially affected by COVID-19. We analysed data (n = 6507) fr... Read More about Understanding the Impact of Home Confinement on Children and Young People with ADHD and ASD During the COVID-19 Pandemic.

Mental health in clinically referred children and young people before and during the Covid-19 pandemic (2022)
Journal Article
Sayal, K., Partlett, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Ewart, C., James, M., Lang, A., Sprange, K., & Montgomery, A. (2023). Mental health in clinically referred children and young people before and during the Covid-19 pandemic. European Child and Adolescent Psychiatry, 32(12), 2657–2666. https://doi.org/10.1007/s00787-022-02115-2

The Covid-19 pandemic and mitigation approaches, including lockdowns and school closures, are thought to have negatively impacted children and young people’s (CYP) mental health. However, the impact for clinically referred CYP is less clear. We inves... Read More about Mental health in clinically referred children and young people before and during the Covid-19 pandemic.

Refining Anger: Summarizing the Self-Report Measurement of Anger (2022)
Journal Article
Maltby, J., Norton, W. H. J., McElroy, E., Cromby, J., Halliwell, M., & Hall, S. S. (2022). Refining Anger: Summarizing the Self-Report Measurement of Anger. Journal of Personality Assessment, https://doi.org/10.1080/00223891.2022.2152345

The current paper presents a five-factor measurement model of anger summarizing scores on public-domain self-report measures of anger. Exploratory and confirmatory factor analyses of self-report measures of anger (UK, n = 500; USA, n = 625) suggest f... Read More about Refining Anger: Summarizing the Self-Report Measurement of Anger.

A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection (2022)
Journal Article
Bruce, C. L., Juszczak, E., Ogollah, R., Partlett, C., & Montgomery, A. (2022). A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection. BMC Medical Research Methodology, 22(1), Article 314. https://doi.org/10.1186/s12874-022-01786-4

Background: When conducting a randomised controlled trial, there exist many different methods to allocate participants, and a vast array of evidence-based opinions on which methods are the most effective at doing this, leading to differing use of the... Read More about A systematic review of randomisation method use in RCTs and association of trial design characteristics with method selection.

Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT (2022)
Journal Article
Chappell, L. C., Brocklehurst, P., Green, M., Hardy, P., Hunter, R., Beardmore-Gray, A., Bowler, U., Brockbank, A., Chiocchia, V., Cox, A., Duhig, K., Fleminger, J., Gill, C., Greenland, M., Hendy, E., Kennedy, A., Leeson, P., Linsell, L., McCarthy, F. P., O’Driscoll, J., …Shennan, A. (2022). Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT. Health Technology Assessment, 27(28), 1-22. https://doi.org/10.3310/CWWH0622

In women with late preterm pre-eclampsia (i.e. at 34 to 36 weeks' gestation), the optimal delivery time is unclear because limitation of maternal-fetal disease progression needs to be balanced against infant complications. The aim of this trial was... Read More about Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT.

Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial (2022)
Journal Article
Marshall, A. S. J., Scrivens, A., Bell, J. L., Linsell, L., Hardy, P., Yong, J., Williams, R., Adams, E., Sadarangani, M., Juszczak, E., Roehr, C. C., & NeoCLEAR Collaborative Group. (2023). Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial. The Lancet Child & Adolescent Health, 7(2), 91-100. https://doi.org/10.1016/s2352-4642%2822%2900343-1

Background
Newborn infants are the highest-risk age group for bacterial meningitis. Lumbar punctures are therefore frequently performed in neonates, but success rates are low (50-60%). In Neonatal Champagne Lumbar punctures Every time-A Randomised C... Read More about Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial.

Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial (2022)
Journal Article
Kai, J., Dutton, B., Vinogradova, Y., Hilken, N., Gupta, J., & Daniels, J. (2022). Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial. British Journal of General Practice, 72(725), e857-e864. https://doi.org/10.3399/bjgp.2022.0260

Background Heavy menstrual bleeding (HMB) is a common problem that can significantly affect women's lives. There is a lack of evidence on long-term outcomes after seeking treatment. Aim To assess continuation rates of medical treatments and rates of... Read More about Medical treatment for heavy menstrual bleeding in primary care: 10-year data from the ECLIPSE trial.

Mechanisms affecting the gut of preterm infants in enteral feeding trials: A nested cohort within a randomised controlled trial of lactoferrin (2022)
Journal Article
Young, G. R., Berrington, J. E., Cummings, S., Dorling, J., Ewer, A. K., Frau, A., Lett, L., Probert, C., Juszczak, E., Kirby, J., Beck, L. C., Renwick, V. L., Lamb, C. A., Lanyon, C., McGuire, W., Stewart, C. J., & Embleton, N. D. (2023). Mechanisms affecting the gut of preterm infants in enteral feeding trials: A nested cohort within a randomised controlled trial of lactoferrin. Archives of Disease in Childhood. Fetal and Neonatal Edition, 108(3), 272-279. https://doi.org/10.1136/archdischild-2022-324477

Objective: To determine the impact of supplemental bovine lactoferrin on the gut microbiome and metabolome of preterm infants.

Design: Cohort study nested within a randomised controlled trial (RCT). Infants across different trial arms were matched... Read More about Mechanisms affecting the gut of preterm infants in enteral feeding trials: A nested cohort within a randomised controlled trial of lactoferrin.

Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial (2022)
Journal Article
Bath, P. M., Skinner, C. J. C., Bath, C. S., Woodhouse, L. J., Areti, A., Korovesi, K., Long, H., Havard, D., Coleman, C. M., England, T. J., Leyland, V., Lim, W. S., Montgomery, A. A., Royal, S., Avery, A., Webb, A. J., & Gordon, A. L. (2022). Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial. European Geriatric Medicine, 13, 1343-1355. https://doi.org/10.1007/s41999-022-00714-5

Purpose
Infections cause considerable care home morbidity and mortality. Nitric oxide (NO) has broad-spectrum anti-viral, bacterial and yeast activity in vitro. We assessed the feasibility of supplementing dietary nitrate (NO substrate) intake in ca... Read More about Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter)-a randomised placebo-controlled feasibility trial.

Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial (2022)
Journal Article
Bradshaw, L. E., Wyatt, L. A., Brown, S. J., Haines, R. H., Montgomery, A. A., Perkin, M. R., Lawton, S., Sach, T. H., Chalmers, J. R., Ridd, M. J., Flohr, C., Brooks, J., Swinden, R., Mitchell, E. J., Tarr, S., Jay, N., Thomas, K., Allen, H., Cork, M. J., Kelleher, M. M., …Williams, H. C. (2023). Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial. Allergy, 78(4), 995-1006. https://doi.org/10.1111/all.15555

Background: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and... Read More about Emollients for prevention of atopic dermatitis: 5‐year findings from the BEEP randomized trial.

Defining the optimum strategy for identifying adults and children with coeliac disease: systematic review and economic modelling (2022)
Journal Article
Elwenspoek, M. M., Thom, H., Sheppard, A. L., Keeney, E., O’Donnell, R., Jackson, J., Roadevin, C., Dawson, S., Lane, D., Stubbs, J., Everitt, H., Watson, J. C., Hay, A. D., Gillett, P., Robins, G., Jones, H. E., Mallett, S., & Whiting, P. F. (2022). Defining the optimum strategy for identifying adults and children with coeliac disease: systematic review and economic modelling. Health Technology Assessment, 26(44), https://doi.org/10.3310/ZUCE8371

Background
Coeliac disease is an autoimmune disorder triggered by ingesting gluten. It affects approximately 1% of the UK population, but only one in three people is thought to have a diagnosis. Untreated coeliac disease may lead to malnutrition, an... Read More about Defining the optimum strategy for identifying adults and children with coeliac disease: systematic review and economic modelling.

A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial (2022)
Journal Article
Baker, A., Mitchell, E. J., & Thomas, K. S. (2022). A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial. Trials, 23, Article 905. https://doi.org/10.1186/s13063-022-06839-z

Background: Participant recruitment into clinical trials remains challenging. The global increase in the number of social media users has accelerated the use of social media as a modality of recruitment, particularly during the COVID-19 pandemic when... Read More about A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial.

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial (2022)
Journal Article
Hodgetts Morton, V., Toozs-Hobson, P., Moakes, C. A., Middleton, L., Daniels, J., Simpson, N. A., Shennan, A., Israfil-Bayli, F., Ewer, A. K., Gray, J., Slack, M., Norman, J. E., Lees, C., Tryposkiadis, K., Hughes, M., Brocklehurst, P., & Morris, R. K. (2022). Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial. Lancet, 400(10361), 1426-1436. https://doi.org/10.1016/S0140-6736%2822%2901808-6

Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture th... Read More about Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

Understanding factors that could influence patient acceptability of the use of the PINCER intervention in primary care: A qualitative exploration using the Theoretical Framework of Acceptability (2022)
Journal Article
Laing, L., Salema, N.-E., Jeffries, M., Shamsuddin, A., Sheikh, A., Chuter, A., Waring, J., Avery, A., & Keers, R. N. (2022). Understanding factors that could influence patient acceptability of the use of the PINCER intervention in primary care: A qualitative exploration using the Theoretical Framework of Acceptability. PLoS ONE, 17(10), Article e0275633. https://doi.org/10.1371/journal.pone.0275633

Introduction Medication errors are an important cause of morbidity and mortality. The pharmacist-led IT-based intervention to reduce clinically important medication errors (PINCER) intervention was shown to reduce medication errors when tested in a c... Read More about Understanding factors that could influence patient acceptability of the use of the PINCER intervention in primary care: A qualitative exploration using the Theoretical Framework of Acceptability.

Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT (2022)
Journal Article
Jayne, D., Walsh, M., Merkel, P. A., Peh, C. A., Szpirt, W., Puéchal, X., Fujimoto, S., Hawley, C., Khalidi, N., Jones, R., Flossmann, O., Wald, R., Girard, L., Levin, A., Gregorini, G., Harper, L., Clark, W., Pagnoux, C., Specks, U., Smyth, L., …Pusey, C. D. (in press). Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT. Health Technology Assessment, 26(38), https://doi.org/10.3310/pnxb5040

Background
Anti-neutrophil cytoplasm antibody-associated vasculitis (AAV) is an inflammatory multisystem autoimmune disease that frequently involves the lungs and kidneys, resulting in end-stage renal disease and premature death. Treatment with high... Read More about Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT.

Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment (2022)
Journal Article
Hewson, D. W., Nightingale, J., Ogollah, R., Ollivere, B. J., Costa, M. L., Craxford, S., Bates, P., & Bedforth, N. M. (2022). Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment. BMJ Open, 12(9), Article e062935. https://doi.org/10.1136/bmjopen-2022-062935

Introduction Patients with rib fractures commonly experience significant acute pain and are at risk of hypoxia, retained secretions, respiratory failure and death. Effective analgesia improves these outcomes. There is widespread variation in analgesi... Read More about Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment.