Clinical trials for common health conditions are constantly being designed and implemented in our institution, often with some urgency to meet funding deadlines. The scope and complexity of these trials has resulted in the need for databased computer management systems typically tailored to each project. Even with current advanced software resources, development, testing and implementation can take months for each new project. This presentation describes a new approach to this problem involving an adaptive table-driven software system using project-specific recruitment and screening data which we have developed using visual basic. The chief design criterion was that the software be reconfigurable by the user based on data tables that contain the parameters of the project design. Essentially, each new project would be implemented by generating new input to the tables, but without the need for reprogramming. The first system implemented was a branching phone screen application that presents questions in an interview format and records participant responses in a data table which can be judged against inclusion/exclusion criteria contained in another table as well as for status reports.Purpose
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The importance of interpreting clinical trial results in terms of the benefits a treatment may offer to individuals with chronic pain is becoming more widely recognized. The clinical meaningfulness of group differences can better be described by looking at the percentages of responders in each treatment group, rather than between group mean differences. We have reassessed the outcomes of a clinical trial for chronic low back pain (LBP) from this new perspective. The randomized clinical trial examined short- (12 weeks) and long-term (52 weeks) efficacy of high-dose, supervised trunk exercise (SET), spinal manipulative therapy (SMT), and a course of home exercise and self-care advice (HEA) for the treatment of LBP ≥ 6 weeks duration. We calculated response to care at 2 levels for 2 variables: numeric back pain scores (NRS) and Roland-Morris Disability (RMD), and at 3 timepoints (Weeks 12, 26 and 52). The 2 levels were calculated as percent improvement from baseline ≥ 30% and ≥75%. Finally, we calculated the relative proportion (± 95% confidence intervals) of the sample (∼100 per treatment group) that achieved each level of improvement.Purpose
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