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Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone.
Neuromodulation. 2020 Jun 27 [Online ahead of print]N

Abstract

OBJECTIVE

The pain Numeric Rating Scale (NRS) score became standard when pain was introduced as the fifth vital sign in the 1990s. Although plagued with issues, it remains the basis for primary outcome measures in clinical trials for chronic pain therapies. Multidimensional composite scoring that considers all aspects of the chronic pain experience may provide a more meaningful response measure. Herein we propose a multidimensional responder index.

MATERIALS AND METHODS

Data were extracted from an ongoing prospective, multicenter study on DeRidder Burst spinal cord stimulation (B-SCS) for chronic back and/or leg pain (NCT03082261). The analysis cohort consisted of subjects who completed the NRS, Pain Catastrophizing Scale (PCS), EuroQol-5D (EQ-5D), and eight-item Patient-Reported Outcomes Measurement Information System Physical Function preoperatively and at 12 months after implant.

RESULTS

A principal component analysis showed that each of the four measures contributed equally to the variance in the data set, confirming that pain score should not be used alone. Subjects who failed to respond on NRS responded on both PCS and EQ-5D. Eighty-one percent of subjects responded on at least two measures. The responder algorithm yielded an 84% success rate at both 6- and 12-month time points.

CONCLUSIONS

Our study suggests that therapeutic response, similar to the chronic pain experience, is multidimensional. Careful consideration should be made to incorporate composite endpoints in future SCS clinical trials.

Authors+Show Affiliations

Department of Neurosurgery, Albany Medical Center, Albany, NY, USA. Department of Neuroscience and Experimental Therapeutics, Albany Medical College, Albany, NY, USA.Neuromodulation Division, Abbott, Austin, TX, USA.Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.Department of Anesthesiology and Pain Medicine, University of California San Diego Health Sciences, La Jolla, CA, USA. Department of Anesthesiology and Pain Medicine, VA San Diego Healthcare System, San Diego, CA, USA.Neuromodulation Division, Abbott, Austin, TX, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32592618

Citation

Pilitsis, Julie G., et al. "Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone." Neuromodulation : Journal of the International Neuromodulation Society, 2020.
Pilitsis JG, Fahey M, Custozzo A, et al. Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone. Neuromodulation. 2020.
Pilitsis, J. G., Fahey, M., Custozzo, A., Chakravarthy, K., & Capobianco, R. (2020). Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone. Neuromodulation : Journal of the International Neuromodulation Society. https://doi.org/10.1111/ner.13212
Pilitsis JG, et al. Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone. Neuromodulation. 2020 Jun 27; PubMed PMID: 32592618.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone. AU - Pilitsis,Julie G, AU - Fahey,Marie, AU - Custozzo,Amanda, AU - Chakravarthy,Krishnan, AU - Capobianco,Robyn, Y1 - 2020/06/27/ PY - 2020/02/14/received PY - 2020/04/29/revised PY - 2020/05/06/accepted PY - 2020/6/28/entrez PY - 2020/6/28/pubmed PY - 2020/6/28/medline KW - chronic pain KW - composite score KW - medial pain pathways KW - outcome measures KW - responder score KW - spinal cord stimulation JF - Neuromodulation : journal of the International Neuromodulation Society JO - Neuromodulation N2 - OBJECTIVE: The pain Numeric Rating Scale (NRS) score became standard when pain was introduced as the fifth vital sign in the 1990s. Although plagued with issues, it remains the basis for primary outcome measures in clinical trials for chronic pain therapies. Multidimensional composite scoring that considers all aspects of the chronic pain experience may provide a more meaningful response measure. Herein we propose a multidimensional responder index. MATERIALS AND METHODS: Data were extracted from an ongoing prospective, multicenter study on DeRidder Burst spinal cord stimulation (B-SCS) for chronic back and/or leg pain (NCT03082261). The analysis cohort consisted of subjects who completed the NRS, Pain Catastrophizing Scale (PCS), EuroQol-5D (EQ-5D), and eight-item Patient-Reported Outcomes Measurement Information System Physical Function preoperatively and at 12 months after implant. RESULTS: A principal component analysis showed that each of the four measures contributed equally to the variance in the data set, confirming that pain score should not be used alone. Subjects who failed to respond on NRS responded on both PCS and EQ-5D. Eighty-one percent of subjects responded on at least two measures. The responder algorithm yielded an 84% success rate at both 6- and 12-month time points. CONCLUSIONS: Our study suggests that therapeutic response, similar to the chronic pain experience, is multidimensional. Careful consideration should be made to incorporate composite endpoints in future SCS clinical trials. SN - 1525-1403 UR - https://www.unboundmedicine.com/medline/citation/32592618/Composite_Score_Is_a_Better_Reflection_of_Patient_Response_to_Chronic_Pain_Therapy_Compared_With_Pain_Intensity_Alone L2 - https://doi.org/10.1111/ner.13212 DB - PRIME DP - Unbound Medicine ER -
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