A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment.

UNLABELLED: This study compared a new transient sham transcutaneous electrical nerve stimulation (TENS) that delivers current for 45 seconds to an inactive sham and active TENS to determine the degree of blinding and influence on pain reduction. Pressure-pain thresholds (PPT), heat-pain thresholds (HPT), and pain intensities to tonic heat and pressure were measured in 69 healthy adults before and after randomization. Allocation investigators and subjects were asked to identify the treatment administered. The transient sham blinded investigators 100% of the time and 40% of subjects compared to the inactive sham that blinded investigators 0% of the time and 21% of subjects. Investigators and subjects were blinded only 7% and 13% of the time, respectively, with active TENS. Neither placebo treatment resulted in significant changes in PPT, HPT, or pain intensities. Subjects using higher active TENS amplitudes (> or =17 mAs) had significantly higher PPTs and lower pain intensities to tonic pressure than subjects using lower amplitudes (<17 mAs). HPTs and pain intensities to tonic heat were not significantly changed. The transient TENS completely blinds investigators to treatment and does not reduce pain, thereby providing a true placebo treatment. PERSPECTIVE: This article presents the benefits of a new transient sham TENS device for use in prospective, randomized, clinical trials. This device facilitates blinding of subjects and investigators to eliminate expectation bias and determine the true efficacy of TENS for use in clinical populations.

Management of high-order multiple births: application of lessons learned because of participation in Vermont Oxford Network collaboratives.

OBJECTIVES: The delivery and care of sextuplets is complex. Potentially better practices that were developed as part of the Vermont Oxford Network improvement collaboratives were used to prepare for a sextuplet delivery at Akron Children's Hospital. METHODS: The team used potentially better practices that were learned from the Neonatal Intensive Care Quality Improvement Collaborative 2002 using multidisciplinary teams. There was extensive media coverage of the delivery. RESULTS: The goal was to use nearly all potentially better practices that focused on the goals of reducing nosocomial infection, reducing chronic lung disease, reducing radiograph use, reducing length of stay, reducing blood gas use, promoting nutrition, reducing intraventricular hemorrhage, and enriching family-centered care. The center aimed to use these 97 potentially better practices. Of the 97 possible potential better practices as set by the Neonatal Intensive Care Quality Improvement Collaborative 2002, 96 (99%) were used. CONCLUSIONS: This is a blueprint that any center that is faced with high-order multiple births could use as a reference point to begin planning. The team created a benchmark to achieve in every birth of very low birth weight infants and not just a special situation of high-order multiple births.