A randomized trial of telemedicine efficacy and safety for nonacute headaches

Kai I Müller, Karl B Alstadhaug, Svein I Bekkelund, Kai I Müller, Karl B Alstadhaug, Svein I Bekkelund

Abstract

Objective: To evaluate long-term treatment efficacy and safety of one-time telemedicine consultations for nonacute headaches.

Methods: We randomized, allocated, and consulted nonacute headache patients via telemedicine (n = 200) or in a traditional manner (n = 202) in a noninferiority trial. Efficacy endpoints, assessed by questionnaires at 3 and 12 months, included change from baseline in Headache Impact Test-6 (HIT-6) (primary endpoint) and pain intensity (visual analogue scale [VAS]) (secondary endpoint). The primary safety endpoint, assessed via patient records, was presence of secondary headache within 12 months after consultation.

Results: We found no differences between telemedicine and traditional consultations in HIT-6 (p = 0.84) or VAS (p = 0.64) over 3 periods. The absolute difference in HIT-6 from baseline was 0.3 (95% confidence interval [CI] -1.26 to 1.82, p = 0.72) at 3 months and 0.2 (95% CI -1.98 to 1.58, p = 0.83) at 12 months. The absolute change in VAS was 0.4 (95% CI -0.93 to 0.22, p = 0.23) after 3 months and 0.3 (95% CI -0.94 to 0.29, p = 0.30) at 12 months. We found one secondary headache in each group at 12 months. The estimated number of consultations needed to miss one secondary headache with the use of telemedicine was 20,200.

Conclusion: Telemedicine consultation for nonacute headache is as efficient and safe as a traditional consultation.

Clinicaltrialsgov identifier: NCT02270177.

Classification of evidence: This study provides Class III evidence that a one-time telemedicine consultation for nonacute headache is noninferior to a one-time traditional consultation regarding long-term treatment outcome and safety.

Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Figures

Figure 1. Flow of participants through the…
Figure 1. Flow of participants through the study
ITT = intention-to-treat.
Figure 2. Prespecified Headache Impact Test–6 (HIT-6)…
Figure 2. Prespecified Headache Impact Test–6 (HIT-6) and visual analogue scale (VAS) from baseline to 12 months after consultation
(A) HIT-6 (p = 0.84) and (B) VAS (p = 0.64) from baseline to 12 months after consultation.

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Source: PubMed

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