Patient-Generated Data as a Novel Outcomes Instrument in Carpal Tunnel Syndrome
Heather A McMahon, MD, John T Heineman, MD, MPH and Brent R DeGeorge, MD, PhD, University of Virginia, Charlottesville, VA
Introduction
Currently, we lack objective measures to quantify outcomes in carpal tunnel syndrome (CTS). Instead, surgeons rely on patient-reported outcomes measures (PROMs) to assess the effect of carpal tunnel release (CTR). We assessed the validity and reliability of wearable activity monitors to objectively characterize the functional and sleep impact of CTR. We hypothesized that actigraphy could detect changes in sleep and activity and would demonstrate short-term impairment due the operative procedure.
Materials & Methods
This pilot, prospective, cohort study compared validated PROMS with actigraphy data obtained via wearable activity monitors (Actigraph Link). Subjects completed baseline questionnaires and wore their device for one week pre-operatively as a baseline. Subjects then underwent open CTR, wearing actigraphy devices for four weeks and completing questionnaires at two and four weeks post-operatively. Pre and post-intervention data were compared using paired-sample t-test. PROMIS questionnaire data were analyzed in accordance with published PROMIS scoring manuals and raw scores were converted to standardized T scores.
Results
Twenty subjects (4 males, 16 females) with moderate or severe CTS were enrolled. Mean age was 56.9 years. PROMIS 29 average cumulative T score was 42.9 with average change of -0.072 pre versus post-operatively. Average sleep disturbance T score was 38.9 pre-operatively and 41.4 post-operatively. There was no statistically significant difference in T score in any domain. Figure 1 demonstrates mean actigraphy step data, both absolute and normalized as a ratio to subject's preoperative steps. Figure 2 displays the actigraphy sleep data for all subjects.
Conclusions
Actigraphy data indicate a near immediate return to baseline activity. Sleep parameters demonstrated improvements in sleep fragmentation indices and duration of awakenings, but did not reach statistical significance. Overall, patient-generated data detected differences in sleep and activity pre versus post-operatively and demonstrated only a short period of activity disruption following CTR, which may be utilized when counseling patients. These data support actigraphy as a viable adjunct to traditional PROMS to evaluate the impact of surgical intervention and therefore may be useful in the study of other diseases affecting the upper extremity.
Figure 1:
Figure 2:
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