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The effectiveness of treatments for degenerative spine conditions, where the primary symptom is back pain, is typically determined using patient-reported quality of life (QoL) measures. However, patients may adjust their internal standards when scoring QoL based on factors other than their health. This response shift phenomenon could confound the interpretation of study data and impact effectiveness conclusions. In the current study, response shift was examined using structural equation modeling (SEM) and previously collected clinical trial data comparing 2 minimally invasive medical devices in lumbar spinal stenosis patients through 1 year postintervention. In subject QoL results, reprioritization shift between 3 months and 12 months that could confound standard analysis was identified. Treatment group did not influence response shift identified at 12 months. SEM provided an effective and practical tool for clinical investigators to assess response shift in available clinical study data. As response shift could lead to invalid conclusions when QoL measures are analyzed, clinical investigators should include response shift assessment in the design of clinical trials. This research into how response shift phenomenon can impact clinical trial results improves the ability of clinical investigators to interpret clinical trial data, potentially preventing erroneous conclusions. This research may also assist researchers and government regulators in the identification and reimbursement of beneficial, cost-effective medical treatments for patients worldwide. For clinical research designers, this study demonstrates a practical application of response shift assessment.
Carlson, Robin, "Clinical Significance of Response Shift in a Spine Interventional Clinical Trial" (2015). Walden Dissertations and Doctoral Studies. 231.