Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial

Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use.

Social media is essential for research engagement

Engagement underlies research success. Whether it is engagement with existing or new collaborators, the media, governing and funding bodies, or government, and last but not least consumers (formerly called patients), effective communication and dissemination of research findings is essential. The days of pure, unadulterated science, without the need to justify a disease cure are over. With scientific literature written in a style that is virtually impossible for the layperson to read and interpret, social media provides an alternative broadcasting strategy…

RCT evidence should drive clinical practice : A day without randomisation is a day without progress

Doctors should never be obliged to invite patients to join trials. Instead, we need a self‐improving health system that embeds randomised trials in routine care. ‘We must change community culture so that one of the first questions asked by pregnant women and their families is, “Are there any randomised trials we can join?”’ Melinda Cruz

Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia

Admission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant's care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge.

Dealing with the Unknown: Reducing the Proportion of Unvalidated Treatments Offered to Children

When, on the basis of up-to-date, well-conducted systematic reviews of relevant evidence, we know we do not know and yet we fail to act, people have suffered and died unnecessarily. For example, the consequence of decade-long delays in addressing uncertainties about the long-term effects of fetal exposure to antibiotics given to women in preterm labour is that many individuals are living today with cerebral palsy that could have been avoided.

The “Research Misconception” and the SUPPORT Trial: Toward Evidence-Based Consens

Critics of SUPPORT, including Macklin and Shepherd in this issue (2013), argue that its consent forms encouraged the “therapeutic misconception.” They allege that SUPPORT investigators blurred the distinction between research and clinical care by referring to different treatment options as “standard of care.” They contend that information statements ignored or downplayed the risks of participating in the research. 

Strategies to accelerate recruitment to NHMRC multi-centre clinical trials

All these trials are likely to have significant impact on clinical practice, because they were reported in the world's most highly cited medical journal. They illustrate the need to invest considerable resources and time, often well beyond 5 years, to address important study questions, rather than curtailing recruitment, diminishing power and scientific validity.


Evidence-based neonatal medicine in Latin America: what can we learn from the International Neonatal Immunotherapy Study and trials of IVIg?

Although reliable randomized trials are essential to guide policy and avoid unnecessary expenditure on ineffective treatments, very few babies or pregnant women in Latin America, and in the rest of the world, are recruited into multicenter perinatal trials.

Evaluating therapeutic hypothermia: parental perspectives should be explicitly represented in future research

THE SYSTEMATIC REVIEW OF RANDOMIZED controlled trials by Tagin et al in this issue of the Archives1 confirms therapeutic hypothermia, or cooling, as a major advance for infants with hypoxic ischemic encephalopathy (HIE). The evidence, achieved during 2 decades of international collaboration, reflects great credit on the neonatal community, parents, researchers, funding agencies, and providers of health care.