Extensive Evaluation via Blinded Testing of an UHPLC-MS/MS Method for Quantitation of Ten Ergot Alkaloids in Rye and Wheat Grains.

BACKGROUND: Ergot alkaloids are mycotoxins produced by the fungus Claviceps, which can contaminate grains and pose a health risk to humans and animals. Validation of an ergot alkaloid method in collaborative projects can be challenging due to instability of analytes, a lack of reliable reference materials, and a fully validated reference method. OBJECTIVE: To extensively evaluate performance of a quantitative UHPLC-MS/MS method to detect ten ergot alkaloids at concentrations between 16 and 500 ng/g in grains. METHOD: The method performance was evaluated in the Blinded Method Test (BMT) exercise, which allowed organizers to successfully address the challenges. Forty completely blinded test samples were prepared in an independent laboratory and shipped to a participating laboratory to analyze on two separate days. RESULTS: Precision, accuracy, and HorRatr values met or exceeded the U.S. Food and Drug Administration recommendations. The design of the BMT exercise provided a high degree of confidence in data and conclusions drawn. CONCLUSIONS: The method performed in a manner as expected, and the method can be used by the laboratory for routine testing of wheat and rye grains. HIGHLIGHTS: BMT of laboratory methods facilitate validation of tests by evaluating performance in an unbiased manner.

Effects of Connective Tissue Massage on Pain in Primiparous Women After Cesarean Birth.

OBJECTIVE: To evaluate the efficacy of connective tissue massage to reduce postoperative pain in primiparous women on Postoperative Day 1 after unplanned cesarean birth. DESIGN: A randomized controlled trial with three groups: intervention (Group 1), control or standard care (Group 2), and individualized attention (Group 3). SETTING: Family/newborn units of a large teaching hospital in the Northeastern United States. PARTICIPANTS: A total of 165 women who experienced unplanned cesarean births of singleton newborns at term gestation. METHODS: Participants were randomized to three groups: those in Group 1 received a 20-minute massage, those in Group 2 received the usual standard of care, and those in Group 3 received 20 minutes of individualized attention. On Postoperative Day 1, participants completed questionnaires to measure overall pain, stress, and relaxation at Time 1 and again 60 minutes later. Daily numeric pain ratings and medication consumption data were retrieved from the electronic health care records. Latent growth modeling and analysis of variance were used to analyze data, as appropriate. RESULTS: Participants in Group 1 had increased relaxation (p < .001), decreased pain (p < .001), decreased stress (p < .001), and decreased opioid use on Day 1 (p = .031) and Day 2 (p = .006) of the hospital stay after the intervention compared with the other groups. Additionally, opioid use in Group 1 decreased linearly, whereas the control groups had a nonlinear pattern of change. CONCLUSION: Using massage therapy during postoperative hospitalization improved relaxation and decreased pain, stress, and opioid use in this sample of women after unplanned cesarean births.