Improving capacity to conduct observational studies in Australian and New Zealand ICUs

To the Editor: The Australian and New Zealand intensive care community is world renowned for conducting high quality intensive care unit (ICU) research. However, research capacity in Australia and New Zealand appears to have peaked due to increased research coordinator workload, competition for funding, and relative shortfalls of funded studies.

Multicentre observational studies are fundamental to the design and conduct of phase 2 and phase 3 trials, as well as translation of research into practice studies. Given the current restraint in research capacity, there is a need to find strategies to work alongside research coordinators, and in parallel with the three main research methods centres in Australia and New Zealand.

In 2018, we completed a one-year prospective observational study of in-hospital cardiac arrests in seven Australian hospitals, the ANZ-CODE study.¹ In several sites, there was relatively little need to use research coordinator time, and instead the study engaged novice researchers for data collection. Using this as an example, Table 1 outlines principles that may be adopted to increase capacity for conducting future multicentre observational studies, with the additional benefit of engaging consultants, registrars, residents and nurses in ICU research. ANZ-CODE study documents are available on request.

Table 1.

Principles for conducting multicentre observational research in Australian and New Zealand intensive care units

Governance •Senior and experienced investigators should be involved to provide research mentorship • The principal investigator is responsible for: ► development of the protocol, data dictionary, and case report form; ► coordination of meetings and video conferences; ► ethics approval and liaison with ethics committees; and ► formation and oversight of the management committee •The protocol should have management committee and site investigator protocol authorisation pages •The management committee should include an investigator with statistics experience •Consider including a higher degree student (eg, Masters, PhD) •Utilisation of methods centres should be kept to a minimum (eg, consider use for project management and oversight)

Study-specific issues •A data dictionary defines and standardises data collected •Data collected should ideally be pragmatic, kept to a minimum, not overly complex, available from electronic sources, and part of routine care

Site-specific issues •There should ideally be an investigator with research experience to provide oversight of ethics processes and supervise novice investigators • Novice investigators should receive: ► orientation and training regarding good clinical practice training with a focus on the importance of privacy; and ► regular meetings with their mentor to track progress and guidance on documentation of screening, consent, and case report form completion •The research coordinator time use should be targeted and specific (eg, assistance with ethics application, and screening to identify potential cases)

Competing interests

All authors declare that they do not have any potential conflict of interest in relation to this manuscript.