Real-World Experience on Why Research Flatlines: A Review of Trials From the Coordinator's Perspective.

INTRODUCTION: Investigator-initiated research trial failure is a national concern that hinders the dissemination of information while wasting resources, time, and funding. The goal of this analysis was to provide an objective review of points to consider increasing an investigator's chances of success. METHODS: The included trials were divided into two groups based on whether they were successful or unsuccessful in meeting enrollment goals. Common issues were noted for each trial to identify prevalent issues and compare their quantity within each group. RESULTS: Unsuccessful trials averaged twice as many issues as trials in the successful group. The most common problems identified in unsuccessful studies involved study planning, whereas the most common problems identified in successful studies revolved around study staff. CONCLUSIONS: There is no single definitive indicator for trial failure; however, awareness of these issues in a trial's planning phase can help prevent their occurrence and aid in overall completion and publication.

Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study.

STUDY DESIGN: Historically controlled clinical trial. OBJECTIVES: Patients presenting for correction of adolescent idiopathic scoliosis (AIS) by posterior spinal fusion may benefit from structured clinical pathways. We studied the effects of implementing a published clinical pathway for the perioperative care of patients with AIS that required intraoperative use of methadone at our institution. METHODS: We performed a historically controlled clinical trial of patients undergoing posterior spinal fusion for AIS by comparing a retrospectively collected control group of 25 patients with a prospective experimental group of 14 patients receiving methadone, gabapentin, propofol, and remifentanil as part of a new clinical pathway. RESULTS: Use of the pathway decreased average pain scores evaluated by the Numeric Rating Scale in the 24 hours following surgery (4.8 [4-6] to 3.4 [2-4], P = .03 [-2.6 to -0.2; t = -2.3]) and postoperative opioid consumption by 76% (41 [29-51] mg to 10 [4-17] mg, P < .001 [-45 to -15; Welch's t = 4.9]) during the same period. Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days, P = .001 [-2 to -1; U = 67, Z = -3.3]). CONCLUSIONS: Multimodal analgesia and a clinical pathway add value in the perioperative care of patients undergoing posterior spinal fusion for AIS by improving analgesia and shortening hospitalization. The prospective arm of the trial was registered at clinicaltrials.gov under NCT02481570.

Impact of oral carbohydrate consumption prior to cesarean delivery on preoperative well-being: a randomized interventional study.

PURPOSE: Oral carbohydrate consumption before surgery improves insulin sensitivity, cardiac output and well-being, and shortens hospital stays without adverse effects. No work has compared higher-dose carbohydrate beverages made for preoperative consumption to common, commercial oral rehydration solutions with lower carbohydrate concentrations. METHODS: We recruited low-risk women undergoing scheduled cesarean deliveries with planned spinal anesthesia. Participants were randomized to one of three groups: those who consumed Clearfast® beverage, those who consumed Gatorade Thirst Quencher® beverage, or fasting control. Participants in the two beverage groups received 710 mL of the appropriate beverage the night before surgery and 355 mL 2 h before surgery. Participants in the control group fasted after midnight the night before surgery. Two hours before surgery, we recorded baseline patient well-being using visual analogue scales, followed by beverage consumption for subjects in the beverage groups. One hour later, we repeated the same assessment. Additional recorded measures included cord blood glucose level, intraoperative variables, breastfeeding success, and a quality of recovery assessment administered 1 day after surgery. RESULTS: Forty-seven patients were recruited: 15 received Clearfast®, 17 received Gatorade Thirst Quencher®, and 15 patients fasted after midnight. Group differences in change in patient well-being using visual analog scales were analyzed using linear regression. Both beverage-consuming groups showed significant improvements in patient well-being using visual analog scales while fasted patients showed no change. CONCLUSION: Either a common oral rehydration beverage or a higher-dose carbohydrate beverage consumed preoperatively resulted in superior well-being compared to fasting. No differences in other outcomes were noted. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov with clinical trial registration number: NCT02684513.