Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial.

The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <280/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to "lack-of-physician-equipoise" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.

Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320).

OBJECTIVE: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks. METHODS: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants). RESULTS: Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05-5.01)), followed by ibuprofen = 2.03 (1.05-3.91), and acetaminophen = 1.33 (0.55-3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)). CONCLUSION: Indomethacin was more effective than acetaminophen in producing ductus constriction.

Nursing research across a large health care system: sparking nurses' clinical inquiry.

UNLABELLED: In our journey to achieve Magnet designation, we sought to increase staff nurses' research participation and teach them about the research process by conducting a corporate-wide study, a blind taste test, using potato chips. PURPOSE: To compare 3 varieties of the same-brand potato chips for overall preference and perception of healthiness. We hypothesized that the potato chip the nurses liked the best would not be the chip they perceived as the healthiest. METHODS: For this institutional review board-approved study, nurses were recruited via (1) randomly selected units and (2) a convenience sample during cafeteria lunch hours. After informed consent was obtained, nurses rated each potato chip in a blinded manner, based on appearance, crispiness, flavor, saltiness, and greasiness. They indicated which potato chip they perceived to be the healthiest and which they preferred overall, and they completed an anonymous demographic questionnaire. RESULTS: A total of 263 nurses participated, with 78% being staff nurses. Regular (full fat) was most preferred (37.6%), whereas fat free was least preferred (16%) and also considered the healthiest (45.2%) (P < .0001). CONCLUSIONS: Nurses preferred the regular chip and chose the fat-free chip as the healthiest, proving our hypothesis that the preferred chip would not be considered the healthiest. IMPLICATIONS: This study was easy, feasible, and helped promote systemwide nursing research.