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Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study (2021)
Journal Article
Bradshaw, L. E., Haines, R. H., Thomas, K. S., Chalmers, J. R., Irvine, A. D., Williams, H. C., & Brown, S. J. (2021). Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study. Clinical and Experimental Allergy, 51(11), 1421-1428. https://doi.org/10.1111/cea.14025

Background: Palmar hyperlinearity is a feature of ichthyosis vulgaris, the monogenic skin disorder caused by FLG loss-of-function mutations. Objective: To investigate how well the presence or absence of hyperlinear palms (HLP) detect FLG genotype in... Read More about Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study.

Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials (2021)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Mant, J., Davis, B. R., Algra, A., Mas, J., …Bath, P. M. (2021). Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials. BMC Medical Research Methodology, 21, Article 218. https://doi.org/10.1186/s12874-021-01388-6

Background: Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best ana... Read More about Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials.

Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial (2021)
Journal Article
Fleminger, J., Duhig, K., Seed, P. T., Brocklehurst, P., Green, M., Juszczak, E., …Chappell, L. (2021). Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial. Pregnancy Hypertension, 26, 91-93. https://doi.org/10.1016/j.preghy.2021.10.002

This secondary analysis of the PHOENIX trial (evaluating planned delivery against expectant management in late preterm preeclampsia) demonstrates that in women who started induction of labour, 63% of women delivered vaginally (56% at 34 weeks’ gestat... Read More about Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial.

Motivation and willingness to increase physical activity for dementia risk reduction: Cross-Sectional UK survey with people aged 50 and over (2021)
Journal Article
Oliveira, D., Knight, H., Jones, K. A., Ogollah, R., & Orrell, M. (2022). Motivation and willingness to increase physical activity for dementia risk reduction: Cross-Sectional UK survey with people aged 50 and over. Aging and Mental Health, 26(9), 1899-1908. https://doi.org/10.1080/13607863.2021.1984393

Objective:Tackling modifiable risk factors such as physical inactivity currently represents the only way to reduce the increasing prevalence of dementia worldwide. This study aimed to investigate attitudes to increasing physical activity to reduce ri... Read More about Motivation and willingness to increase physical activity for dementia risk reduction: Cross-Sectional UK survey with people aged 50 and over.

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results (2021)
Journal Article
Mc Cord, K. A., Imran, M., Rice, D. B., McCall, S. J., Kwakkenbos, L., Sampson, M., …Hemkens, L. G. (2022). Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. Journal of Clinical Epidemiology, 141, 175-186. https://doi.org/10.1016/j.jclinepi.2021.09.012

Objective: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries. Study Design and... Read More about Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results.

Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases (2021)
Journal Article
Langan, S. M., Imran, M., Mc Cord, K., McCall, S. J., Kwakkenbos, L., Sampson, M., …Thombs, B. D. (2022). Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases. Journal of Clinical Epidemiology, 141, 187-197. https://doi.org/10.1016/j.jclinepi.2021.09.010

Objective: We evaluated reporting completeness and transparency in randomized controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTIN... Read More about Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases.

Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (Trials, (2021), 22, 1, (368), 10.1186/s13063-021-05324-3) (2021)
Journal Article
Bell, J. L., Gupta, S., Juszczak, E., Hardy, P., & Linsell, L. (2021). Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (Trials, (2021), 22, 1, (368), 10.1186/s13063-021-05324-3). Trials, 22, Article 609. https://doi.org/10.1186/s13063-021-05409-z

Following the publication of the original article [1], It has come to the authors’ attention that some wording was changed prior to publication of the Statistical Analysis Plan from the original SAP which will be used in their analysis of data.

Obesity and Breast Cancer Risk in Men: A National Case-Control Study in England and Wales (2021)
Journal Article
Swerdlow, A. J., Bruce, C., Cooke, R., Coulson, P., Griffin, J., Butlin, A., …Jones, M. E. (2021). Obesity and Breast Cancer Risk in Men: A National Case-Control Study in England and Wales. JNCI Cancer Spectrum, 5(5), Article pkab078. https://doi.org/10.1093/jncics/pkab078

Background Breast cancer is rare in men, and information on its causes is very limited from studies that have generally been small. Adult obesity has been shown as a risk factor, but more detailed anthropometric relations have not been investigated.... Read More about Obesity and Breast Cancer Risk in Men: A National Case-Control Study in England and Wales.

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT (2021)
Journal Article
Juszczak, E., Hewer, O., Partlett, C., Hurd, M., Bari, V., Bowler, U., …Stenson, B. (2021). Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT. Trials, 22(1), Article 554. https://doi.org/10.1186/s13063-021-05515-y

Background: Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, leading to potentially biased and... Read More about Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT.

Identifying the psychological processes used by male and female students when learning about science technology engineering and mathematics: A linguistic inquiry (2021)
Journal Article
Hall, S. S., Puttick, S., & Maltby, J. (2021). Identifying the psychological processes used by male and female students when learning about science technology engineering and mathematics: A linguistic inquiry. Science Education, 105(6), 1151-1172. https://doi.org/10.1002/sce.21679

Learning in Science, Technology, Engineering, and Mathematics (STEM) is challenging, leaving many students to give up on these subjects. Specifically, females are underrepresented in STEM industries. Identifying how male and female students deal with... Read More about Identifying the psychological processes used by male and female students when learning about science technology engineering and mathematics: A linguistic inquiry.

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial (2021)
Journal Article
Scobie, S., Jowett, S., Lambe, T., Patel, S., Woolley, R., Ives, N., …Sackley, C. (2021). Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial. Pilot and Feasibility Studies, 7(1), Article 154. https://doi.org/10.1186/s40814-021-00888-y

Background: The PD COMM pilot randomised controlled trial compared Lee Silverman Voice Treatment (LSVT® LOUD) with standard NHS speech and language therapy (SLT) and a control arm in people with Parkinson’s disease (PwPD) with self-reported problems... Read More about Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial.

Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: A mixed methods study (2021)
Journal Article
Nomikos, P. A., Hall, M., Fuller, A., Millar, B., Ogollah, R., Valdes, A., …Abhishek, A. (2021). Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: A mixed methods study. BMJ Open, 11(7), Article e045242. https://doi.org/10.1136/bmjopen-2020-045242

Objectives To evaluate fidelity of delivery of a nurse-led non-pharmacological complex intervention for knee pain. Setting Secondary care. Single-centre study. Study design Mixed methods study. Participants Eighteen adults with chronic knee pain. Inc... Read More about Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: A mixed methods study.

A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: awaiting peer review] (2021)
Journal Article
McCarthy, E., O'Keeffe, L., Williamson, P. R., Sydes, M. R., Farrin, A., Lugg-Widger, F., …Kearney, P. M. (2021). A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: awaiting peer review]. HRB Open Research, 4, 1-7. https://doi.org/10.12688/hrbopenres.13314.1

Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study (2021)
Journal Article
Taha, R., Leighton, P., Bainbridge, C., Montgomery, A., Davis, T., & Karantana, A. (2021). Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study. BMJ Open, 11, Article 046913. https://doi.org/10.1136/bmjopen-2020-046913

Introduction Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society, however there is a lack of evidence to guide thei... Read More about Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study.

Learning from a successful process evaluation in care homes (2021)
Journal Article
Allen, F., Darby, J., Cook, M., Evley, R., Godfrey, M., Horne, J., …Robinson, K. (2021). Learning from a successful process evaluation in care homes. Age and Ageing, 50(5), 1850-1853. https://doi.org/10.1093/ageing/afab139

Introduction process evaluations (PE) are increasingly used in parallel with randomised controlled trials (RCT) to inform the implementation of complex health interventions. This paper explores the learning accrued from conducting a PE within the Fa... Read More about Learning from a successful process evaluation in care homes.

Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya (2021)
Journal Article
Mitchell, E. J., Pallotti, P., Qureshi, Z., Daniels, J. P., Oliver, M., Were, F., …Ojha, S. (2021). Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya. BMJ Open, 11(6), Article e043802. https://doi.org/10.1136/bmjopen-2020-043802

Objectives: Prematurity is the leading cause of global neonatal and infant mortality. Many babies could survive by the provision of essential newborn care. This qualitative study was conducted in order to understand, from a family and professional pe... Read More about Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya.

Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial (2021)
Journal Article
Rana, D., Wu, O., Cheed, V., Middleton, L. J., Moss, J., Ann Lumsden, M., …The FEMME Trial Collaborative Group. (2021). Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial. BJOG: An International Journal of Obstetrics and Gynaecology, 128(11), 1793-1802. https://doi.org/10.1111/1471-0528.16781

Objectives: To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. Design: Economic evaluation alongside the FEMME randomised controlled trial. S... Read More about Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial.

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes (2021)
Journal Article
Bell, J. L., Gupta, S., Juszczak, E., Hardy, P., & Linsell, L. (2021). Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes. Trials, 22, Article 368. https://doi.org/10.1186/s13063-021-05324-3

Background: The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analy... Read More about Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes.