Research design considerations for randomized controlled trials of spinal cord stimulation for pain: IMMPACT/ION/INS recommendations

Spinal cord stimulation (SCS) is an interventional non-pharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). While randomization overcomes certain types of bias, additional challenges to the validity of RCTs of SCS include blinding, choice of control groups, non-specific effects of treatment variables (e.g., paresthesia, device programming and recharging, psychological support, and rehabilitative techniques), and safety considerations. In order to address these challenges, three professional societies (IMMPACT, ION, INS) convened a meeting to develop consensus recommendations on the design, conduct, analysis, and interpretation of RCTs of SCS for chronic pain. This paper summarizes the results of this meeting. Highlights of our recommendations include disclosing all funding source and potential conflicts; incorporating mechanistic objectives when possible; avoiding non-inferiority designs without internal demonstration of assay sensitivity; achieving and documenting double-blinding whenever possible; documenting investigator and site experience; keeping all information provided to patients balanced with respect to expectation of benefit; disclosing all information provided to patients, including verbal scripts; using placebo/sham controls when possible; capturing a complete set of outcome assessments; accounting for ancillary pharmacologic and non-pharmacologic treatments in a clear manner; providing a complete description of intended and actual programming interactions; making a prospective ascertainment of SCS-specific safety outcomes; training patients and researchers on appropriate expectations, outcome assessments, and other key aspects of study performance; and providing transparent and complete reporting of results according to applicable reporting guidelines

Indiana Traffic Signal Hi Resolution Data Logger Enumerations

This document defines the enumerations used to encode events that occur on a traffic signal controllers with high resolution data loggers. The time resolution is to the nearest 100 milliseconds. Background information on the development of high resolution controller data in Indiana can be found at: Smaglik E.J., A. Sharma, D.M. Bullock, J.R. Sturdevant, and G. Duncan, “Event-Based Data Collection for Generating Actuated Controller Performance Measures, Transportation Research Record, #2035, TRB, National Research Council, Washington, DC, pp.97-106, 2007.http://dx.doi.org/10.3141/2035-11 Recent applications of high resolution data to develop traffic signal performance measures in Indiana can be found at: Outcome-Oriented Performance Measures for Management of Signalized Arterial Capacity http://dx.doi.org/10.3141/2192-03 Track Clearance Performance Measures for Railroad-Preempted Intersections http://dx.doi.org/10.3141/2192-06 Reliability, Flexibility, and Environmental Impact of Alternative Objective Functions for Arterial Offset Optimization http://dx.doi.org/10.3141/2259-02 Visual Education Tools to Illustrate Coordinated System Operation http://dx.doi.org/10.3141/2259 -0