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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., Fröbert, O., Gale, C., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., Thombs, B. D., & 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., Fröbert, O., Gale, C., Hemkens, L. G., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., & 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., Smith, B., Swerdlow, M. J., & 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., Linsell, L., Dorling, J., Berrington, J., Boyle, E., Embleton, N., Hewer, O., Johnson, S., King, A., Leaf, A., Linsell, L., McCormick, K., McGuire, W., Murray, D., Roberts, T., & 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., Rick, C., Smith, C., Brady, M. C., Clarke, C., & 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.

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., Davies, G., Avery, K., Chan, A.-W., Kwakkenbos, L., Thombs, B. D., Watkins, A., Hemkens, L. G., Gale, C., Zwarenstein, M., Langan, S. M., Thabane, L., Juszczak, E., Moher, D., & 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

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., Doherty, M., Walsh, D. A., Das Nair, R., & 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.

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.