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The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study (2024)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Walker, K. F., Downe, S., Jones, A.-M., Moore, S., & Daniels, J. P. (2024). The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study. Women and Birth, 37(6), Article 101832. https://doi.org/10.1016/j.wombi.2024.101832

Objective
To determine the acceptability of different methods of routine testing for group B Streptococcus (GBS) colonisation to pregnant women and health care professionals (HCPs), and to examine barriers and facilitators to their implementation.... Read More about The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study.

Expert opinion on characteristics of vulval LS: initial identification of important clinical features through an international electronic-Delphi consensus study (2024)
Journal Article
Simpson, R. C., Birchall, M., Daniels, J., Gran, S., Kirtschig, G., & Thomas, K. S. (2024). Expert opinion on characteristics of vulval LS: initial identification of important clinical features through an international electronic-Delphi consensus study. Clinical and Experimental Dermatology, Article llae393. https://doi.org/10.1093/ced/llae393

Background
Lichen sclerosus (LS) is a chronic inflammatory condition mainly affecting genital skin. It causes distressing symptoms that impact daily quality of life as well as progressive anatomical changes and potential risk of cancer. Vulval LS is... Read More about Expert opinion on characteristics of vulval LS: initial identification of important clinical features through an international electronic-Delphi consensus study.

Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT (2024)
Journal Article
Cooper, K. G., Bhattacharya, S., Daniels, J. P., Cheed, V., Gennard, L., Leighton, L., Pirie, D., Melyda, M., Monahan, M., Weckesser, A., Roberts, T., Denny, E., Ocansey, L., Stubbs, C., Cox, E., Jones, G., Clark, T. J., Saridogan, E., Gupta, J. K., Critchley, H. O., …Middleton, L. J. (2024). Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT. Health Technology Assessment, 28(55), 1-77. https://doi.org/10.3310/sqwy6998

Background Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option. Obje... Read More about Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT.

The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study (2024)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Moore, S., Jones, A.-M., Downe, S., Walker, K. F., & Daniels, J. (2024). The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study. Midwifery, 135, Article 104063. https://doi.org/10.1016/j.midw.2024.104063

Background: Group B streptococcus (GBS) is a bacterium carried by 20–25 % of pregnant women in the UK, which can be transmitted from pregnant women to their babies at the time of birth. Women can be tested for GBS in pregnancy using a vaginal-rectal... Read More about The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study.

Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial (2024)
Journal Article
Cooper, K. G., Bhattacharya, S., Daniels, J. P., Horne, A. W., Clark, T. J., Saridogan, E., Cheed, V., Pirie, D., Melyda, M., Monahan, M., Roberts, T. E., Cox, E., Stubbs, C., Middleton, L. J., & on behalf of the PRE-EMPT Collaborative Group. (in press). Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial. BMJ, 385, e079006. https://doi.org/10.1136/bmj-2023-079006

Objectives: To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design: The PRE-EMPT (preventing recurrence of endometriosis) pr... Read More about Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial.

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study (2024)
Journal Article
Mitchell, E. J., Aluvaala, J., Bradshaw, L., Daniels, J. P., Emadau, C., Muthumbi, B., Nabwera, H., Ojee, E., Opira, J., Pallotti, P., Qureshi, Z., Sigei, M., Su, Y., Swinden, R., Were, F., & Ojha, S. (2024). A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study. BMC Pediatrics, 24, Article 326. https://doi.org/10.1186/s12887-024-04778-z

Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whe... Read More about A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study.

Metformin for endometrial hyperplasia (2024)
Journal Article
Shiwani, H., Clement, N. S., Daniels, J. P., & Atiomo, W. (2024). Metformin for endometrial hyperplasia. Cochrane Database of Systematic Reviews, 2024(5), Article CD012214. https://doi.org/10.1002/14651858.cd012214.pub3

Background
Endometrial cancer is one of the most common gynaecological cancers in the world. Rates of endometrial cancer are rising, in part because of rising obesity rates. Endometrial hyperplasia is a precancerous condition in women that can lead... Read More about Metformin for endometrial hyperplasia.

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study (2023)
Journal Article
Kai, J., Dutton, B., Vinogradova, Y., Hilken, N., Gupta, J., & Daniels, J. (2023). Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study. Health Technology Assessment, 27(17), https://doi.org/10.3310/jhsw0174

Background: Heavy menstrual bleeding is a common problem that can significantly affect women’s lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives... Read More about Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study.

Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review (2023)
Journal Article
Odubamowo, K., Garcia, M., Muriithi, F., Ogollah, R., Daniels, J. P., & Walker, K. F. (2023). Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review. European Journal of Obstetrics and Gynecology and Reproductive Biology, 286, 95-101. https://doi.org/10.1016/j.ejogrb.2023.05.027

Background
Testing for group B streptococcus (GBS) requires a vaginal-rectal swab in late pregnancy.
Objective
A systematic review of the test accuracy of a self-collected swab compared with a health-care professional collected swab in the diagnos... Read More about Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review.

Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial (2023)
Journal Article
Whitaker, L. H. R., Middleton, L. J., Daniels, J. P., Williams, A. R. W., Priest, L., Odedra, S., …Critchley, H. O. D. (2023). Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial. eClinicalMedicine, 60, Article 101995. https://doi.org/10.1016/j.eclinm.2023.101995

Background: Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. Ulipristal acetate is prescribed to treat symptoms associated with uterine fibroids. We compared the effectiveness of ulipristal acetate and the le... Read More about Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial.

Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study (2023)
Journal Article
Constantinou, G., Ayers, S., Mitchell, E. J., Walker, K. F., Daniels, J., Moore, S., …Downe, S. (2023). Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study. BMC Pregnancy and Childbirth, 23, Article 339. https://doi.org/10.1186/s12884-023-05651-0

Background: 20–25% pregnant women in the UK carry group B streptococcus (GBS) which, if left undetected, is transmitted from pregnant mothers to their babies during birth in 36% of cases. This transmission leads to early onset GBS infection (EOGBS) i... Read More about Women’s knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study.

Systematic review of the effectiveness of remifentanil in term breech pregnancies undergoing external cephalic version (2023)
Journal Article
Lomas, S., Minton, Z., & Daniels, J. P. (2023). Systematic review of the effectiveness of remifentanil in term breech pregnancies undergoing external cephalic version. International Journal of Obstetric Anesthesia, 54, Article 103649. https://doi.org/10.1016/j.ijoa.2023.103649

Background: External cephalic version (ECV) is a moderately painful procedure used to turn a fetus from a non-vertex to cephalic position. This systematic review and meta-analysis compared intravenous remifentanil with other analgesia or no analgesia... Read More about Systematic review of the effectiveness of remifentanil in term breech pregnancies undergoing external cephalic version.

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., …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, an... Read More about Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-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.

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., …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.

A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert (2022)
Journal Article
Gupta, J. K., Maher, A., Stubbs, C., Brocklehurst, P., Daniels, J. P., & Hardy, P. (2022). A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert. American Journal of Obstetrics and Gynecology, 4(4), Article 100628. https://doi.org/10.1016/j.ajogmf.2022.100628

BACKGROUND: Induction of labor is a commonly performed obstetrical intervention. Vaginal prostaglandin E2 (dinoprostone) is a first-choice agent. Mechanical methods of induction are slower in achieving cervical ripening but have a lower risk of adver... Read More about A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert.

A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT (2022)
Journal Article
Daniels, J., Dixon, E. F., Gill, A., Bishop, J., D'Amico, M., Ahmed, K., …Thangaratinam, S. (2022). A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT. Health Technology Assessment, 26(12), 1-82. https://doi.org/10.3310/BICF1187

BACKGROUND: Mother-to-baby transmission of group B Streptococcus (Streptococcus agalactiae) is the main cause of early-onset infection. OBJECTIVES: We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces mat... Read More about A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT.

Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study (2022)
Journal Article
Daniels, J. P., Dixon, E., Gill, A., Bishop, J., Wilks, M., Millar, M., …Collaboative Group, G. (2022). Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study. BMC Medicine, 20, Article 9. https://doi.org/10.1186/s12916-021-02202-2

Background: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test... Read More about Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study.

Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT (2022)
Journal Article
Armstrong-Buisseret, L., Brittain, C., Kai, J., David, M., Anstey Watkins, J., Ozolins, M., …Ross, J. D. (2022). Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT. Health Technology Assessment, 26(2), 1-170. https://doi.org/10.3310/ZZKH4176

BACKGROUND: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. OBJECTIVES: The... Read More about Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT.

The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis (2021)
Journal Article
Haydock, R., Hepburn, T., Ross, J., Daniels, J., Brittain, C., Jackson, L., …Wilson, J. (2021). The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis. Trials, 23(1), Article 1040. https://doi.org/10.1186/s13063-022-06954-x

Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour a... Read More about The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis.