Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials

Authors: Karla Hemming, Jacqueline Y. Thompson, Richard L. Hooper, Obioha C. Ukoumunne, Fan Li, Agnes Caille, Brennan C. Kahan, Clemence Leyrat, Michael J. Grayling, Nuredin I. Mohammed, Jennifer A. Thompson, Bruno Giraudeau, Elizabeth L. Turner, Samuel I. Watson, Beatriz Goulão, Jessica Kasza, Andrew B. Forbes, Andrew J. Copas, Monica Taljaard

Source: Trials, Vol 26, Iss 1, Pp 1-14 (2025)

Subject Terms: Cluster randomized trials, Group randomization, Statistical analysis plans, Analysis plans, Guidelines, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/719149989f9a49fdb0e1722509e037c4

Estimating relative risks and risk differences in randomised controlled trials: a systematic review of current practice

Authors: Jacqueline Thompson, Samuel I. Watson, Lee Middleton, Karla Hemming

Source: Trials, Vol 26, Iss 1, Pp 1-14 (2025)

Subject Terms: Binary outcomes, Relative risk, Risk difference, Covariate adjustment, Statistical efficiency, Statistical practice, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/502d81beb7cf43c9ba0962bdaa966828

Re-analysis of data from cluster randomised trials to explore the impact of model choice on estimates of odds ratios: study protocol

Authors: Karla Hemming, Jacqueline Y. Thompson, Monica Taljaard, Samuel I. Watson, Jessica Kasza, Jennifer A. Thompson, Brennan C. Kahan, Andrew J. Copas

Source: Trials, Vol 25, Iss 1, Pp 1-15 (2024)

Subject Terms: Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/2f2fff824871415d8e9bc762e6330ce5

Interpretation of statistical findings in randomised trials: a survey of statisticians using thematic analysis of open-ended questions

Authors: Karla Hemming, Laura Kudrna, Sam Watson, Monica Taljaard, Sheila Greenfield, Beatriz Goulao, Richard Lilford

Source: BMC Medical Research Methodology, Vol 24, Iss 1, Pp 1-13 (2024)

Subject Terms: Confidence intervals, P-values, Misinterpretation, RCTs, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1471-2288

Access URL: https://doaj.org/article/0f9aac66bb5344c7a7a063ffdeca1add

Extending a parallel cluster randomised trial into a stepped-wedge cluster randomised trial: implications for interpretation

Authors: Karla Hemming, Monica Taljaard

Source: BMJ Global Health, Vol 10, Iss 2 (2025)

Subject Terms: Medicine (General), R5-920, Infectious and parasitic diseases, RC109-216

File Description: electronic resource

Relation: https://gh.bmj.com/content/10/2/e018087.full; https://doaj.org/toc/2059-7908

Access URL: https://doaj.org/article/566dd39675f84d60a80ac7dd7781f0f6

Antenatal pelvic floor muscle exercise intervention led by midwives in England to reduce postnatal urinary incontinence: APPEAL feasibility and pilot randomised controlled cluster trial

Authors: Karla Hemming, Jonathan Bishop, Sarah Dean, Jean Hay-Smith, Tim Coleman, Elizabeth Edwards, Christine MacArthur, Debra Bick, Mark Pearson, Rohini Terry, Eivor Oborn, Sara Webb, Eleni Gkini, Victoria Salmon, Ellie Jones, Helena Frawley

Source: BMJ Open, Vol 15, Iss 1 (2025)

Subject Terms: Medicine

File Description: electronic resource

Relation: https://bmjopen.bmj.com/content/15/1/e091248.full; https://doaj.org/toc/2044-6055

Access URL: https://doaj.org/article/fdccddc03a0347aa88202386924c5aa5

Statistical analysis plan for cluster randomised trial to evaluate a community-level complementary food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study

Authors: Laura Quinn, James Martin, Evans Asamane, Semira Manaseki-Holland, Richard J. Lilford, Lacina Traore, Jacqueline Thompson, Samuel I. Watson, Karla Hemming

Source: Trials, Vol 25, Iss 1, Pp 1-10 (2024)

Subject Terms: Statistical analysis plan, Cluster randomised controlled trial, Food safety and hygiene, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/08da3d4587a3476d9d2d104b950be152

Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT

Authors: Christine MacArthur, Debra Bick, Victoria Salmon, Ellie Jones, Jean Hay-Smith, Jon Bishop, Eleni Gkini, Karla Hemming, Sara Webb, Mark Pearson, Tim Coleman, Rohini Terry, Libby Edwards, Helena Frawley, Eivor Oborn, Sarah Dean

Source: Programme Grants for Applied Research, Vol 12, Iss 09 (2024)

Subject Terms: urinary incontinence, pelvic floor muscle exercises, antenatal, postnatal, midwives, feasibility and pilot cluster randomised controlled trial, prevention and treatment, behaviour change, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://doaj.org/toc/2050-4330

Access URL: https://doaj.org/article/57a262ee74fb4c24a2563ef548c31f95

Improving Air Quality and Childhood Respiratory Health in Mongolia: The Impact of the Raw Coal Ban and COVID-19 Restrictions—An Interrupted Time-Series Analysis

Authors: Emma Dickinson-Craig, Terkhen Turbat, Karla Hemming, Francis D. Pope, Suzanne E. Bartington, Suvdaa Anjaa, Sumiya Davaa, Rosie Day, Damdindorj Boldbaatar, Chimedsuren Ochir, David Warburton, Graham Neil Thomas, Jargalsaikhan Badarch, Semira Manaseki-Holland

Source: Atmosphere, Vol 16, Iss 1, p 46 (2025)

Subject Terms: air quality, air pollution intervention, child health, respiratory health, COVID-19, Meteorology. Climatology, QC851-999

File Description: electronic resource

Relation: https://www.mdpi.com/2073-4433/16/1/46; https://doaj.org/toc/2073-4433

Access URL: https://doaj.org/article/bbbee051295340138a0183648addad9e

Systematic scoping review of cluster randomised trials conducted exclusively in low-income and middle-income countries between 2017 and 2022

Authors: Shaun Treweek, Karla Hemming, Monica Taljaard, Lawrence Mbuagbaw, Charles Weijer, Cory E Goldstein, Fernando Althabe, Mira Johri, Vivian A Welch, Rieke van der Graaf, Rashida A Ferrand, Stuart G Nicholls, Yacine Marouf, Julia F Shaw, Anand Sergeant

Source: BMJ Open, Vol 14, Iss 9 (2024)

Subject Terms: Medicine

File Description: electronic resource

Relation: https://bmjopen.bmj.com/content/14/9/e087724.full; https://doaj.org/toc/2044-6055

Access URL: https://doaj.org/article/320494ed571f496ea18cefa8913058b6

Protocol for a parallel group, two-arm, superiority cluster randomised trial to evaluate a community-level complementary-food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study (version 1.3; 10 November 2022)

Authors: Evans A. Asamane, Laura Quinn, Samuel I. Watson, Richard J. Lilford, Karla Hemming, Cheick Sidibe, Ryan T. Rego, Sami Bensassi, Youssouf Diarra, Samba Diop, Om Prasad Gautam, Mohammad Sirajul Islam, Louise Jackson, Kate Jolly, Kassoum Kayentao, Ousmane Koita, Buba Manjang, Susan Tebbs, Nicola Gale, Paula Griffiths, Sandy Cairncross, Ousmane Toure, Semira Manaseki-Holland

Source: Trials, Vol 24, Iss 1, Pp 1-17 (2023)

Subject Terms: Diarrhoeal disease, Hygiene, Cluster randomised controlled trial, Behaviour change, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/2acb0c6aba9a4d0aa22344dc95b0f72d

Intensified screening for SARS-CoV-2 in 18 emergency departments in the Paris metropolitan area, France (DEPIST-COVID): A cluster-randomized, two-period, crossover trial.

Authors: Judith Leblanc, Lisbeth Dusserre-Telmon, Anthony Chauvin, Tabassome Simon, Chiara E Sabbatini, Karla Hemming, Vittoria Colizza, Laurence Bérard, Jérome Convert, Sonia Lazazga, Carole Jegou, Nabila Taibi, Sandrine Dautheville, Damien Zaghia, Camille Gerlier, Muriel Domergue, Florine Larrouturou, Florence Bonnet, Arnaud Fontanet, Sarah Salhi, Jérome LeGoff, Anne-Claude Crémieux, DEPIST-COVID group, FHU IMPEC (Improving Emergency Care) group

Source: PLoS Medicine, Vol 20, Iss 12, p e1004317 (2023)

Subject Terms: Medicine

File Description: electronic resource

Relation: https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004317&type=printable; https://doaj.org/toc/1549-1277; https://doaj.org/toc/1549-1676

Access URL: https://doaj.org/article/9e3d79d862a6479896358e5f0e7bd87a

Randomized controlled trials in patients with COVID-19: a systematic review and critical appraisal

Authors: Kavina Kudhail, Jacqueline Thompson, Vivek Mathews, Breanna Morrison, Karla Hemming

Source: International Journal of Infectious Diseases, Vol 122, Iss , Pp 72-80 (2022)

Subject Terms: COVID-19 treatments, LMICs, Randomized trials, Risk of bias, Infectious and parasitic diseases, RC109-216

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S1201971222002995; https://doaj.org/toc/1201-9712

Access URL: https://doaj.org/article/5b55bdbc7ae84b9bb88ab8b2ebb9eb93

Mind the gap: covariate constrained randomisation can protect against substantial power loss in parallel cluster randomised trials

Authors: Caroline Kristunas, Michael Grayling, Laura J. Gray, Karla Hemming

Source: BMC Medical Research Methodology, Vol 22, Iss 1, Pp 1-12 (2022)

Subject Terms: Group-randomised trial, Restricted randomisation, Candidate set size, Covariate adjusted analysis, Small sample, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1471-2288

Access URL: https://doaj.org/article/196d0b7b9a3e4829a369aa92cb277ce6

Impact assessment of a raw coal ban on maternal and child health outcomes in Ulaanbaatar: a protocol for an interrupted time series study

Authors: Karla Hemming, Chimedsuren Ochir, Semira Manaseki-Holland, Rasiah Thayakaran, Suzanne Bartington, Graham Neil Thomas, David Warburton, Emma Dickinson-Craig, Jargalsaikhan Badarch, Rosie Day, Francis Pope, Bataa Chuluunbaatar, Damdindorj Boldbaatar

Source: BMJ Open, Vol 13, Iss 4 (2023)

Subject Terms: Medicine

File Description: electronic resource

Relation: https://bmjopen.bmj.com/content/13/4/e061723.full; https://doaj.org/toc/2044-6055

Access URL: https://doaj.org/article/8c96c7564e9347089ef7732b7406b988

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

Authors: Jane P. Daniels, Emily Dixon, Alicia Gill, Jon Bishop, Mark Wilks, Michael Millar, Jim Gray, Tracy E. Roberts, Jane Plumb, Jonathan J. Deeks, Karla Hemming, Khalid S. Khan, Shakila Thangaratinam, on behalf of the GBS2 Collaborative Group

Source: BMC Medicine, Vol 20, Iss 1, Pp 1-13 (2022)

Subject Terms: Group B Streptococcus, Colonisation, Randomised controlled trial, Accuracy, Labour, Pregnancy, Medicine

File Description: electronic resource

Relation: https://doaj.org/toc/1741-7015

Access URL: https://doaj.org/article/941e14e793904ae08a5dd0643fdb3e8b

Evaluation of an organisational-level monetary incentive to promote the health and wellbeing of workers in small and medium-sized enterprises: A mixed-methods cluster randomised controlled trial.

Authors: Lena Al-Khudairy, Yasmin Akram, Samuel I Watson, Laura Kudrna, Joanna Hofman, Madeline Nightingale, Lailah Alidu, Andrew Rudge, Clare Rawdin, Iman Ghosh, Frances Mason, Chinthana Perera, Jane Wright, Joseph Boachie, Karla Hemming, Ivo Vlaev, Sean Russell, Richard J Lilford

Source: PLOS Global Public Health, Vol 3, Iss 7, p e0001381 (2023)

Subject Terms: Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://doaj.org/toc/2767-3375

Access URL: https://doaj.org/article/9956a54c6306448a8b09d1c8c53f05e6

Protocol for a cluster randomised waitlist-controlled trial of a goal-based behaviour change intervention for employees in workplaces enrolled in health and wellbeing initiatives

Authors: Lailah Alidu, Lena Al-Khudairy, Ila Bharatan, Paul Bird, Niyah Campbell, Graeme Currie, Karla Hemming, Kate Jolly, Laura Kudrna, Richard Lilford, James Martin, Laura Quinn, Kelly Ann Schmidtke, James Yates

Source: PLoS ONE, Vol 18, Iss 9 (2023)

Subject Terms: Medicine, Science

File Description: electronic resource

Relation: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10538707/?tool=EBI; https://doaj.org/toc/1932-6203

Access URL: https://doaj.org/article/d4b3e341e8ad42e3ace6b07afa041e4d

Reporting of and explanations for under-recruitment and over-recruitment in pragmatic trials: a secondary analysis of a database of primary trial reports published from 2014 to 2019

Authors: Karla Hemming, Monica Taljaard, Charles Weijer, Kelly Carroll, Stuart G Nicholls, Pascale Nevins, Yongdong Ouyang

Source: BMJ Open, Vol 12, Iss 12 (2022)

Subject Terms: Medicine

File Description: electronic resource

Relation: https://bmjopen.bmj.com/content/12/12/e067656.full; https://doaj.org/toc/2044-6055

Access URL: https://doaj.org/article/f5394652646a4990bb486e7249c1b25a

An opportunistic evaluation of a routine service improvement project to reduce falls in hospital

Authors: Diane Sheppard, Elaine Clarke, Karla Hemming, James Martin, Richard Lilford

Source: BMC Health Services Research, Vol 21, Iss 1, Pp 1-11 (2021)

Subject Terms: Patient safety, Falls, Time series, Implementation, Rapid response evaluation, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://doaj.org/toc/1472-6963

Access URL: https://doaj.org/article/e40dc696b5e64ab3bdf9e8e22aae3a8e