Impact of comprehensive quality improvement program on outcomes in very-low-birth-weight infants: A cluster-randomized controlled trial in Japan.

BACKGROUND: Differences in outcomes among neonatal intensive care units (NICUs) in Japan have been noted, prompting the need for quality improvement. AIM: To assess a comprehensive quality improvement program on outcomes in very-low-birth-weight (VLBW) infants. STUDY DESIGN: A cluster-randomized clinical trial. SUBJECTS: Forty hospitals and VLBW infants born in 2012-2014 and admitted to those hospitals were study subjects. OUTCOME MEASURES: The intervention group (IG) received a comprehensive quality improvement program involving clinical practice guidelines, educational outreach visits, workshops, opinion leader training, audits, and feedback. The control group (CG) was provided only with the guidelines. The primary outcome was survival without neurological impairment at three years of age. RESULTS: IG consisted of 19 hospitals and 1735 infants, while CG included 21 hospitals and 1700 infants. There were no significant differences in gestational weeks, 29.1(26.9-31.3) vs. 29.1(26.7-31.1) or birth weights (g), 1054(789-1298) vs. 1084(810-1309) between the two groups. Both groups showed survival rates without neurological impairment of 67.2 % (1166) and 66.9 % (1137), respectively, without a significant difference. There was no significant difference in mortalities at NICU discharge between the groups, with rates of 4.0 % (70) and 4.2 % (72) respectively. Several clinically relevant improvements were observed in IG, including reduced rates of sepsis, adrenal insufficiency, transfusion for anemia, and a shorter interval to achieve full enteral feeding. However, these did not lead to improvements in the primary outcome. CONCLUSION: The comprehensive quality improvement program to Japanese NICUs did not result in a significant improvement in survival without neurological impairment in VLBW infants.

The effect of professional-led guideline workshops on clinical practice for the management of patent ductus arteriosus in preterm neonates in Japan: a controlled before-and-after study.

BACKGROUND: Clinical guidelines assist physicians to make decisions about suitable healthcare. We conducted a controlled before-and-after study to investigate the impact of professional-led guideline workshops for patent ductus arteriosus (PDA) management on physicians' clinical practices, discharge mortality, and associated morbid conditions among preterm neonates. METHODS: We recruited physicians practicing at two neonatal intensive care units (NICUs) in Japan and used the data of all neonates weighing less than or equal to 1,500 g admitted to 90 NICUs (2 intervention NICUs and 88 control NICUs) in the Neonatal Research Network of Japan from April 2008 to March 2010. We held 1-day workshops for physicians on PDA clinical practice guidelines at the two intervention NICUs. Physicians' skills assessed by confidence rating (CR) scores and the Sheffield Peer Review Assessment Tool (SPRAT) were compared between pre- and post-workshop month at the intervention NICUs using Wilcoxon signed-rank tests. Neonatal discharge mortality and morbidity were compared between pre- and post-workshop year at both the intervention and control NICUs using multivariable regression analyses adjusting for potential confounders. RESULTS: Fifteen physicians were included in the study. Physicians' CR scores (2.14 vs. 2.47, p = 0.02) and SPRAT (4.14 vs. 4.50, p = 0.05) in PDA management improved after the workshops. The analyses of neonatal outcomes included 294 and 6,234 neonates in the intervention and control NICUs, respectively. Neonates' discharge mortality declined sharply at the intervention NICUs (from 15/146 to 5/148, relative risk reduction -0.67; adjusted odds ratio 0.30, 95% confidence interval 0.10 to 0.89) during the post-workshop period. The mortality reduction was much greater than that in the control NICUs (from 207/3,322 to 147/2,912, relative risk reduction -0.19; adjusted odds ratio 0.75, 95% confidence interval 0.59 to 0.95), although the difference between the intervention and control NICUs were not statistically significant. CONCLUSIONS: Overall, physicians' confidence in PDA management improved after attending guideline workshops. Face-to-face workshops by guideline developers can be a useful strategy to improve physicians' PDA management skills and, thereby, might reduce PDA-associated mortality in preterm neonates.