ABSTRACT
Background: COVID-19 trials took <1 year to identify therapies reducing death in >30,000 patients but the Australian Placental Transfusion Study took >12 years to show that delaying cord clamping reduced death or major disability (cerebral palsy, severe visual loss, deafness, or cognitive delay) in 1,531 preterm infants. What can this teach us? Further, as composite outcomes of death or major disability can be inconclusive if each is unequally affected (as in the NeOProM Collaboration1) 2 important aims are (i) global co-operation (https://www.alphacollaboration.com/) to identify core Participant-Intervention-Comparator-Outcome questions for trials assessing mortality, a key outcome, and (ii) to answer those questions in much larger, faster trials. Such trials will also yield much more precise estimates of disability in survivors than was previously typical - a major benefit. Method: To inform these aims we compared enrolment in 2 COVID-19 trials and in 10 trials by IMPACT collaborators with samples >1,500 in high- or low-or-middle-income countries (HIC/LMIC). Results: The COVID-19 trials took 3-9 months, enrolling 13 - 219 per-site-per-year. Perinatal trials took 16-86 months, enrolling 5 - 1,700 per site per year. Trials in pregnant women or LMIC (n = 53,092) enrolled 5 times more than trials in newborns or restricted to HIC (n = 9,014). (Table) Conclusions: Greater international collaboration could resolve questions of shared relevance and priority more rapidly. Megatrials addressing mortality may benefit from highly streamlined processes for enrolment and minimal data collection, e.g., RECOVERY's one-page outcome form.
ABSTRACT
Background: The use of electronic consent to recruit eligible women to the LEAP1 Study contributed greatly to the study reaching its target sample size of 900 women with, or who were likely to develop, mild to moderate iron deficiency in pregnancy. The COVID-19 pandemic in Australia between 2020-2021 greatly reduced the capacity for recruiting centres to provide in-person informed consent to potential study participants, and as such several centres adopted some form of electronic consent. Recruitment to LEAP1 was completed on the 27th of Oct 2021, when the 907th participant was enrolled. Methods: Adobe Sign was implemented at 1 recruiting centre (Epworth Freemasons), whilst 4 other centres (Monash Medical Centre, Angliss Hospital, Royal Brisbane and Women's Hospital, St George Hospital) adopted fillable PDF consent forms to obtain consent from eligible study participants. Electronic methods of consent were approved by the lead HREC and local RGOs prior to implementation. The remaining 9 participating sites in Australia continued using traditional paper informed consent. Results: A total of 5 recruiting centres implemented at least 1 form of electronic consent. These centres were able to continue study recruitment through the pandemic in 2020 and 2021. Conclusions: Electronic informed consent has shown to be a useful tool in supporting study recruitment in a perinatal context, particularly during the COVID-19 pandemic in Australia between 2020 and 2021. Future trials may benefit from adopting similar methods of informed consent for their participants.
ABSTRACT
Supply chains (SCs) are exposed to multiple risks and vulnerable to disruption propagation (i.e. the ripple effect). Despite established literature, quantitative analysis of the ripple effect in SCs considering simultaneous, long-term disruptions (i.e. induced by the COVID-19 pandemic) remains limited. This study defines, applies and demonstrates the capability of system dynamics modelling to recognise and visualise the ripple effect subject to supply, demand, and logistics disruptions as well as a combined, simultaneous disruption of supply, demand and logistics. Simulation results for these four risk scenarios indicate that disruption propagation and its impacts vary based on risk type, combination of risks and the impacting node. The bi-directional, increasing effect is significant for disruptions of longer duration. Retailers and manufacturers are most fragile to multiple disruptions due to broader risk exposure points. In generalised terms, systems theory-based study provides insights into the complex behaviour of simultaneous risks and associated disruptions occurring at a node and across the SC. The outcomes derived can help practitioners visualise and recognise the dynamic nature of the ripple effect cascading across the SC network. In addition, some novel insights on the systemic nature and delayed impact of disruption propagations are uncovered and discussed.