Reducing umbilical catheter migration rates by using a novel securement device.

OBJECTIVE: This study evaluates the effectiveness of a novel device, LifeBubble, in reducing umbilical cord catheter (UC) migration and associated complications in neonates. STUDY DESIGN: A retrospective review was performed at Oregon Health & Science University's NICU (2019-2021) to compare standard adhesive securement with LifeBubble. The primary outcomes were UC migration, discontinuation due to malposition, and CLABSI incidence. Differences between groups were statistically analyzed and logistic regression used to adjust for potential confounders. RESULTS: Among 118 neonates (57 LifeBubble, 61 adhesive), LifeBubble significantly reduced migration of any UC > 1 vertebral body (12.3% vs. 55.7%), including UVC migration (5.3% vs. 39.3%) and UAC migration (7.0% vs 23.0%), as well as UVC discontinuation due to malposition (5.6% vs 37.7%). The number needed to treat (NNT) to prevent one instance of UVC discontinuation is 4. CONCLUSION: LifeBubble effectively reduces UC migration and premature discontinuation, indicating its potential to enhance neonatal care and safety.

Determining Critical Topics for Undergraduate Surgical Education in Rwanda: Results of a Modified Delphi Process and a Consensus Conference.

Background Developing a contextually appropriate curriculum is critical to train physicians who can address surgical challenges in sub-Saharan Africa. An innovative modified Delphi process was used to identify contextually optimized curricular content to meet sub-Saharan Africa and Rwanda's surgical needs. Methods Participants were surgeons from East, Central, Southern, and West Africa and general practitioners with surgical experience. Delphi participants excluded or prioritized surgical topic areas generated from extensive grey and formal literature review. Surgical educators first screened and condensed identified topics. Round 1 screened and prioritized identified topics, with a 75% consensus cut-off based on the content validity index and a prioritization score. Topics that reached consensus were screened again in round 2 and re-prioritized, following controlled feedback. Frequencies for aggregate prioritization scores, experts in agreement, item-level content validity index, universal agreement and scale-level content validity index based on the average method (S-CVI/Ave) using proportion relevance, and intra-class correlation (ICC) (based on a mean-rating, consistency, two-way mixed-effects model) were performed. We also used arithmetic mean values and modal frequency. Cronbach's Alpha was also calculated to ascertain reliability. Results were validated through a multi-institution consensus conference attended by Rwanda-based surgical specialists, general practitioners, medical students, surgical educators, and surgical association representatives using an inclusive, participatory, collaborative, agreement-seeking, and cooperative, a priori consensus decision-making model. Results Two-hundred and sixty-seven broad surgical content areas were identified through the initial round and presented to experts. In round 2, a total of 247 (92%) content areas reached 75% consensus among 31 experts. Topics that did not achieve consensus consisted broadly of small intestinal malignancies, rare hepatobiliary pathologies, and transplantation. In the final round, 99.6% of content areas reached 75% consensus among 31 experts. The highest prioritization was on wound healing, fluid and electrolyte management, and appendicitis, followed by metabolic response, infection, preoperative preparation, antibiotics, small bowel obstruction and perforation, breast infection, acute urinary retention, testicular torsion, hemorrhoids, and surgical ethics. Overall, the consistency and average agreement between panel experts was strong. ICC was 0.856 (95% CI: 0.83-0.87). Cronbach's Alpha for round 2 was very strong (0.985, 95% CI: 0.976-0.991) and higher than round 1, demonstrating strong reliability. All 246 topics from round 4 were verbally accepted by 40 participants in open forum discussions during the consensus conference. Conclusions A modified Delphi process and consensus were able to identify essential topics to be included within a highly contextualized, locally driven surgical clerkship curriculum delivered in rural Rwanda. Other contexts can use similar processes to develop relevant curricula.

Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies.

Importance: A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies. Objective: To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway. Design, Setting, and Participants: In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. Main Outcome Measurement: Time from FDA authorization to the first coverage milestone. Results: Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40). Conclusions and Relevance: In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.

A Novel Method for Administering Epinephrine during Neonatal Resuscitation.

OBJECTIVE: This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation. STUDY DESIGN: Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone. For other emergency use drugs, prefilled medication syringes have decreased error and administration time. Twenty-one neonatal intensive care unit nurses were enrolled. Each subject engaged in four simulated neonatal resuscitation scenarios involving term or preterm manikins using conventional epinephrine or novel prefilled epinephrine syringes specified for patient weight and administration route. All scenarios were video-recorded. Two investigators analyzed video recordings for time to epinephrine preparation and administration. Differences between conventional and novel techniques were evaluated using the Wilcoxon Signed Rank Tests. RESULTS: Twenty-one subjects completed 42 scenarios with conventional epinephrine and 42 scenarios with novel prefilled syringes. Epinephrine preparation was faster using novel prefilled epinephrine syringes (median = 17.0 s, interquartile range [IQR] = 13.3-22.8) compared with conventional epinephrine (median = 48.0 s, IQR = 40.5-54.9, n = 42, z = 5.64, p < 0.001). Epinephrine administration was also faster using novel prefilled epinephrine syringes (median = 26.9 s, IQR = 22.1-33.2) compared with conventional epinephrine (median = 57.6 s, IQR = 48.8-66.8, n = 42, z = 5.63, p < 0.001). In a poststudy survey, all subjects supported the clinical adoption of prefilled epinephrine syringes. CONCLUSION: During simulated neonatal resuscitation, epinephrine preparation and administration are faster using novel prefilled epinephrine syringes, which may hasten return of spontaneous circulation and be lifesaving for bradycardic neonates in clinical practice. KEY POINTS: · Currently, epinephrine administration in neonatal resuscitation is inefficient and error prone.. · Prefilled epinephrine syringes hasten medication administration in simulated neonatal resuscitation.. · Clinical use of prefilled epinephrine syringes may be lifesaving for bradycardic neonates..