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Evaluation of the Responsiveness of the Cold Intolerance Symptom Severity Questionnaire in Patients with Carpal Tunnel Syndrome
Moaath Saggaf, MD1; Christine B Novak, PT, PhD2; Brian M Feldman, MD, MSc1; Dimitri J Anastakis, MD3
1University of Toronto, Toronto, ON, Canada; 2Toronto Western Hospital Hand Program, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada; 3Division of Plastic and Reconstructive Surgery, University of Toronto, Toronto, ON, Canada

Introduction: A prerequisite of using a measurement tool in treatment assessment is establishing its responsiveness to change. The study hypothesis was that the standardized response mean (SRM) of the cold intolerance symptom severity (CISS) questionnaire is larger than 0.8 following a carpal tunnel release (CTR) at the three-month follow-up visit compared to the baseline preoperative scores in patients with carpal tunnel syndrome (CTS).
Methods: Data from a recent prospective cohort study was used where participants were assessed at the consultation and the three-month postoperative visits following surgery at two large academic hand units. The study enrolled adult patients with CTS and cold sensitivity and excluded patients with polyneuropathy, insulin-dependent diabetes mellitus, previous upper extremity surgeries and traumatic peripheral nerve injuries. Patients were treated with either nighttime splinting or surgery. Before and three months after the intervention, CTS severity was assessed using the Boston Carpal Tunnel Questionnaire (BCTQ), and cold sensitivity was assessed using the CISS scale. To establish responsiveness, we calculated the SRM as a signal-to-noise ratio method for each intervention. We then measured the Pearson correlation between the change in CISS and BCTQ scores. The use of nighttime splinting was perceived to have little to no effect overtime on CISS scores, and it was added as a comparison.
Results: The study included 49 participants; 23 in the surgical cohort and 26 patients in the splinting cohort. The mean age was 56 years (SD=12.4), and 36 participants were females (75%). The SRM following CTR was 1.15, and the SRM following nighttime splinting was 0.06. There was a positive correlation between the change in CISS scores and the change in BCTQ scores (r=0.64, 95% CI: 0.44 to 0.78, P<0.0001).
Conclusion: CISS demonstrated longitudinal validity (responsiveness) following CTR in patients with CTS, and it can be used as a patient-reported outcome tool in evaluating cold sensitivity longitudinally in patients with CTS.
Disclosure: The study was supported by the American Foundation for Surgery of the Hand (AFSH), the Plastic Surgery Foundation and the American Society for Peripheral Nerve.


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