The Research Cycle: Improving Care and Outcomes for Newborn Infants

Abstract

Ensuring that policies and practice in perinatal care are informed by evidence from high-quality research is fundamental to improving outcomes for newborn infants and their families. Effective interventions in the perinatal period can have a life-long impact disproportionate to their costs. Many of the major advances in care that have transformed outcomes for preterm and sick newborn infants have been informed by empirical and applied health research. Conversely, there are examples of life-long adverse consequences for infants and families that are a legacy of practices based on poor-quality evidence. The challenge in the 21st century is to maintain the trajectory of improvements in care and outcomes. This will most likely be achieved via marginal gains from new or improved care practices underpinned by a range of research approaches, from preclinical and laboratory-based empirical studies that uncover pathogenic pathways or therapeutic mechanisms, to large-scale, applied research such as multicentre, randomised controlled trials. This will involve the coordination and collaboration of research efforts globally. Strategies to develop and prioritise research questions need to involve parents and families. Given the context in which much perinatal research is conducted, particularly in emergency situations around the time of birth, robust and transparent ethics and governance frameworks are essential to maintain the trust and engagement of communities. An ethical imperative exists to ensure that research output is disseminated effectively, and that effective and cost-effective interventions are implemented and integrated within a cycle that audits and benchmarks good practice and outcomes, and informs research evidence-based continuous quality improvement. This is the first in a series of articles on research methodology in neonatal medicine to be published in Neonatology, in response to a request from trainee researchers. We introduce the series by describing the research cycle, in particular how it is applied in neonatal medicine. Subsequent articles will cover translational research, clinical trials, diagnostic tests, global challenges, and the ethical issues relating to neonatal/perinatal research.

Validity and Utility of Experimental Animal Models in Perinatal Research

“…Other, related initiatives include the "PROSPERO international database of pro-spectively registered systematic reviews of animal studies relevant to human health," developed and maintained by the SYRCLE-CAMARADES team and the Centre for Reviews and Dissemination at the University of York, UK [22]. Ultimately, these efforts to integrate ethical, valid, and reliable studies using animal models within the research cycle aim to drive innovation in care and improvements in outcomes for sick or preterm infants and their families [23].…”

Evaluation of the Quality of Perinatal Trials: Making the GRADE

“…Using evidence to inform policy and practice in health care, for example, in producing guidelines, requires an understanding of the quality of the underpinning research and the certainty of its findings [1]. As well as considering the size of the effects of interventions on important outcomes, practice recommendations should explicitly describe the validity, applicability, certainty, and strength of the evidence base [2, 3].…”

Editorial: Research Methods in Neonatal Medicine

“…The topics to be covered in the series include: the research cycle (published in this issue) [2], early-stage translational research in perinatal medicine, clinical trials for informing care practices for newborn infants, understanding and improving diagnostic tests, integrating parents and families in research initiatives, evidence-into-policy and practice, global challenges in perinatal health research, and ethics of perinatal research participation.…”