Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

KNL Avery, PR Williamson, C Gamble… - BMJ open, 2017 - bmjopen.bmj.com
Objectives Designing studies with an internal pilot phase may optimise the use of pilot work
to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed …

[HTML][HTML] Adaptive designs in clinical trials: why use them, and how to run and report them

P Pallmann, AW Bedding, B Choodari-Oskooei… - BMC medicine, 2018 - Springer
Adaptive designs can make clinical trials more flexible by utilising results accumulating in
the trial to modify the trial's course in accordance with pre-specified rules. Trials with an …

Early stopping of randomized clinical trials for overt efficacy is problematic

D Bassler, VM Montori, M Briel, P Glasziou… - Journal of clinical …, 2008 - Elsevier
OBJECTIVE: To illustrate controversial issues associated with stopping randomized
controlled trials (RCTs) early for apparent benefit. STUDY DESIGN AND SETTING: The …

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

AW Chan, JM Tetzlaff, PC Gøtzsche, DG Altman… - Bmj, 2013 - bmj.com
High quality protocols facilitate proper conduct, reporting, and external review of clinical
trials. However, the completeness of trial protocols is often inadequate. To help improve the …

[HTML][HTML] Delayed versus immediate cord clamping in preterm infants

W Tarnow-Mordi, J Morris, A Kirby… - … England Journal of …, 2017 - Mass Medical Soc
Background The preferred timing of umbilical-cord clamping in preterm infants is unclear.
Methods We randomly assigned fetuses from women who were expected to deliver before …

[HTML][HTML] Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial

LC Chappell, P Brocklehurst, ME Green, R Hunter… - The Lancet, 2019 - thelancet.com
Background In women with late preterm pre-eclampsia, the optimal time to initiate delivery is
unclear because limitation of maternal disease progression needs to be balanced against …

[HTML][HTML] Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial

J Griffiths, P Jenkins, M Vargova, U Bowler, E Juszczak… - The Lancet, 2019 - thelancet.com
Background Infections acquired in hospital are an important cause of morbidity and mortality
in very preterm infants. Several small trials have suggested that supplementing the enteral …

Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation …

J Layland, KG Oldroyd, N Curzen, A Sood… - European heart …, 2015 - academic.oup.com
Aim We assessed the management and outcomes of non-ST segment elevation myocardial
infarction (NSTEMI) patients randomly assigned to fractional flow reserve (FFR)-guided …

[HTML][HTML] The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double …

H Shakur, D Elbourne, M Gülmezoglu, Z Alfirevic… - Trials, 2010 - Springer
Background Each year, worldwide about 530,000 women die from causes related to
pregnancy and childbirth. Of the deaths 99% are in low and middle income countries …

[HTML][HTML] Effect of women's groups and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers and children in rural Malawi …

S Lewycka, C Mwansambo, M Rosato, P Kazembe… - The Lancet, 2013 - thelancet.com
Background Women's groups and health education by peer counsellors can improve the
health of mothers and children. We assessed their effects on mortality and breastfeeding …