Background/aimsUse of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative—a public–private partnership to improve clinical trials—launched a multi-stakeholder project.MethodsThe data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring committee recommendations.ResultsWe define the role of the data monitoring committee as an advisor to the research sponsor on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. Data monitoring committees should remain independent from the sponsor and be composed of members with no relevant conflicts of interest. Representation on a data monitoring committee generally should include at least one clinician with expertise in the therapeutic area being studied, a biostatistician, and a designated chairperson who has experience with clinical trials and data monitoring. Data monitoring committee meetings are held periodically to evaluate the unmasked data from ongoing trials, but the content and conduct of meetings may vary depending on specific goals or topics for deliberation. To guide data monitoring committee conduct and communication plans, a charter consistent with the protocol’s research design and statistical analysis plan should be developed and agreed upon by the sponsor and the data monitoring committee prior to patient enrollment. We recommend concise and flexible charters that explain roles, responsibilities, operational issues, and how data monitoring committee recommendations are generated and communicated. The demand for data monitoring committee members appears to exceed the current pool of qualified individuals. To prepare a new generation of trained data monitoring committee members, we encourage a combination of didactic educational programs, practical experience, and skill development through apprenticeships and mentoring by experienced data monitoring committee members.ConclusionOur recommendations address data monitoring committee use, conduct, communication practices, and member preparation and training. Furthermore recommendations form th...
This preliminary study supports the hypothesis that high-frequency stimulus pulse trains areeffective at detecting defects in the medial wall of pedicles in the thoracic spine during instrumentation, thereby improving on techniques using single-pulse stimulus protocols.
Object Reports of the accuracy of existing neuromonitoring methods for detecting or preventing medial malpositioning of thoracic pedicle screws have varied widely in their claimed effectiveness. The object of this study was to develop, test, and validate a novel neuromonitoring method for preventing medial malpositioning of pedicle screws in the thoracic spine during surgery. Methods This is a prospective, blinded and randomized study using a novel combination of input (4-pulse stimulus trains delivered within the pedicle track) and output (evoked electromyography from leg muscles) to detect pedicle track trajectories that—once implanted with a screw—would cause that screw to breach the pedicle's medial wall and encroach upon the spinal canal. For comparison, the authors also used screw stimulation as an input and evoked electromyogram from intercostal and abdominal muscles as output measures. Intraoperative electrophysiological findings were compared with postoperative CT scans by multiple reviewers blinded to patient identity or intraoperative findings. Results Data were collected from 71 patients, in whom 802 screws were implanted between the T-1 and L-1 vertebral levels. A total of 32 screws ended up with screw threads encroaching on the spinal canal by at least 2 mm. Pulse-train stimulation within the pedicle track using a ball-tipped probe and electromyography from lower limb muscles correctly predicted all 32 (100%) of these medially malpositioned screws. The combination of pedicle track stimulation and electromyogram response from leg muscles proved to be far more effective in predicting these medially malpositioned screws than was direct screw stimulation and any of the target muscles (intercostal, abdominal, or lower limb muscles) we monitored. Based on receiver operating characteristic analysis, the combination of 10-mA (lower alarm) and 15-mA stimulation intensities proved most effective for detection of pedicle tracks that ultimately gave rise to medially malpositioned screws. Additional results pertaining to the impact of feedback of these test results on surgical decision making are provided in the companion report. Conclusions This novel neuromonitoring approach accurately predicts medially malpositioned thoracic screws. The approach could be readily implemented within any surgical program that is already using contemporary neuromonitoring methods that include transcranial stimulation for monitoring motor evoked potentials.
Object The authors have reported in Part 1 of this study on a novel neuromonitoring test for the prevention of medial malpositioning of thoracic pedicle screws. In the present paper they examine the impact of providing the results of the test as intraoperative feedback to the surgical team. Methods This is the second part of a 2-part report of a prospective, blinded and randomized neuromonitoring study designed to lower the incidence of medially malpositioned thoracic pedicle screws. Details of the neuromonitoring technique and data supporting the alarm criteria used are contained in the companion article (Part 1). For the majority of pedicle screw placements, intraoperative test results were withheld from the study team (that is, the team members were blinded to the test results). However, for a limited number of pedicle sites the authors provided one of 2 forms of testing feedback to the surgical team: 1) “break the blind” feedback, if testing suggested that screw placement would result in direct contact between screw and the dura mater; and 2) “planned” feedback, beginning during the later stages of the study and provided for 50% of pedicle sites. Feedback gave the surgeon the opportunity to adjust the trajectory that the screw would ultimately take within the pedicle. The final screw position relative to the pedicle's medial wall for all sites in which feedback was withheld from the surgical team was compared with the screw position for those sites in which either form of feedback (“break the blind” or “planned”) was provided to and acted upon by the surgical team. Results Of the 820 pedicle tracks tested among the 71 surgical cases included in this study, a total of 684 were operated upon without any form of feedback. Planned feedback was provided for an additional 107 pedicle tracks, of which 15 triggered an intraoperative alarm (evoked electromyogram response in leg muscles to stimulus intensity ≤ 10 mA) leading to a warning to the surgical team of a medially biased pedicle track. Finally, the blind was broken 29 times, in each case when testing revealed a particularly low threshold (≤ 4 mA) for evoked responses in leg muscles when stimulating along the pedicle track with the ball-tipped probe. As detailed in the companion paper to this one, there were 32 screws with threads lying at least 2 mm medial to the pedicle wall. In all 32 instances (100%), either these screws were in the “no feedback” category (n = 29) or they were in a feedback category but the surgeon elected to not revise the pedicle-track trajectory. Two patients returned to the operating room for revision of screw placements because the screws were encroaching upon the central canal; the pedicle tracks for these screws had been in the “no feedback” category. Conclusions This is the first blinded and randomized study to prove that implementing a novel neuromonitoring strategy during placement of thoracic pedicle screws can significantly reduce the incidence of clinically relevant thoracic pedicle screw medial malpositioning.
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