Table 1.
Impact of research on NAS at one academic medical center
| Category* | Indicator* | Description | Status |
|---|---|---|---|
| Evidence-base for pharmaceutical treatment | |||
| Clinical and medical | Guidelines | Published guidelines recommending longer-acting opioids (e.g., methadone) as first-line agent, rather than most often used prior to treatment [13] | Demonstrated |
| Therapeutic procedures | Findings influenced a shift from using morphine to using longer-acting opioids (e.g., methadone) [13] | Demonstrated | |
| Drugs | Ongoing testing of commercially available neonate-safer formulation of longer-acting opioid (buprenorphine)** | Potential (ongoing clinical trial expected to be completed in 2025) | |
| Community & Public Health | Health Care Quality | Treatment with longer-acting opioids (e.g., methadone) reduced length of pharmaceutical treatment [3] | Demonstrated |
| Economic | Cost Savings | Treatment with longer-acting opioids (e.g., methadone) reduced length of stay, which could reduce costs of NAS treatment [3] | Potential |
| Evidence-base for non-pharmacological treatments | |||
| Clinical and medical | Therapeutic procedures | Contributed to dissemination and implementation of the Eat, Sleep, Console (ESC) tool statewide and internationally [27] | Demonstrated |
| Community & Public Health | Health Care Quality | Use of the ESC tool reduced the need for pharmacological treatment of neonates with NAS [27] | Demonstrated |
| Economic | Cost Savings | Use of the ESC tool shortened length of stay, which could reduce costs of NAS treatment [27] | Potential |
| Culture of research with neonates, for NAS and beyond | |||
| Policy and legislative | Expert testimony and legislation | Legislation requiring research on prenatal opioid use and NAS [22] | Demonstrated |
| Legislation requiring neonatal expertise at the Food and Drug Administration (FDA) deliberations [30] | Demonstrated | ||
| Legislation to incentivize development of neonatal pharmaceuticals [24] | Demonstrated | ||
| Committee participation and policies | Broad stakeholder engagement of FDA’s Neonatal Advisory Committee to share knowledge and reduce inefficiencies | Demonstrated | |
| Broad international stakeholder engagement through Critical Path Institute’s International Neonatal Consortium to reduce inefficiencies | Demonstrated | ||
| Clinical and medical | Investigative procedures | Published guidelines for conducting clinical trials with neonates to provide a common roadmap for investigators and regulators to follow [23] | Demonstrated |
| Developing first international database of real-world neonatal data to facilitate evidence base for neonatal care | Potential (anticipated to be in use by 2025) | ||
*
Categories and indicators follow the Translational Science Benefits Model (TSBM) developed by the Institute of Clinical & Translational Sciences at Washington University School of Medicine. “Demonstrated benefits are those that have been observed and are verifiable. Potential benefits are those that are logically expected with moderate to high confidence” [19].
**
Source: JMD, personal communication.