Stratification of patients based on the neuropathic pain symptom inventory (NPSI): development and validation of a new algorithm.
The personalization of neuropathic pain treatment could be improved by identifying specific sensory phenotypes (i.e. specific combinations of symptoms and signs) predictive of the response to different classes of drugs. A simple and reliable phenotyping method is required for such a strategy. We investigated the utility of an algorithm for stratifying patients into clusters corresponding to specific combinations of neuropathic symptoms assessed with the Neuropathic Pain Symptom Inventory (NPSI). Consistent with previous results, we first confirmed, in a cohort of 628 patients, the existence of a structure consisting of three clusters of patients characterized by higher NPSI scores for: pinpointed pain (cluster 1), evoked pain (cluster 2) or deep pain (cluster 3). From these analyses, we derived a specific algorithm for assigning each patient to one of these three clusters. We then assessed the clinical relevance of this algorithm for predicting treatment response, through post hoc analyses of two previous controlled trials of the effects of subcutaneous injections of botulinum toxin A (BTX-A). Each of the 97 patients with neuropathic pain included in these studies was individually allocated to one cluster, by applying the algorithm to their baseline NPSI responses. We found significant effects of BTX-A relative to placebo in clusters 2 and 3, but not in cluster 1, suggesting that this approach was, indeed, relevant. Finally, we developed and performed a preliminary validation of a web-based version of the NPSI and algorithm for the stratification of patients in both research and daily practice.