The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis

New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were const...

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Autores principales:	Lisa Goudman, Geert Molenberghs, Rui V. Duarte, Maarten Moens
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	missing data mechanisms sensitivity analysis multiple imputations neuromodulation Medicine R
Acceso en línea:	https://doaj.org/article/0c977a707b67444da8755a828d9d4020
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spelling	oai:doaj.org-article:0c977a707b67444da8755a828d9d40202021-11-11T17:32:51ZThe Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis10.3390/jcm102148972077-0383https://doaj.org/article/0c977a707b67444da8755a828d9d40202021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/4897https://doaj.org/toc/2077-0383New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were constructed to evaluate how conclusions may be influenced by these assumptions. The aim is to perform a tipping point sensitivity analysis to evaluate the influence of missing data on the overall conclusion regarding the effectiveness of HD-SCS on disability. Data from the Discover study were used, in which 185 patients with Failed Back Surgery Syndrome were included. Disability was evaluated before SCS and after 1, 3 and 12 months of HD-SCS. During the second, third and fourth visit, data from 130, 114 and 90 patients were available, respectively. HD-SCS resulted in a significant decrease in disability scores based on the analysis of observed data and with multiple imputations. The tipping point sensitivity analysis revealed that the shift parameter was 17. Thus, the conclusion concerning the time effect under a “missing at random” mechanism is robust when the shift parameter for the disability score is 17. From a clinical point of view, a shift of 17 points on disability is not very plausible. Therefore we tend to consider the conclusions drawn under “missing at random” as being robust.Lisa GoudmanGeert MolenberghsRui V. DuarteMaarten MoensMDPI AGarticlemissing data mechanismssensitivity analysismultiple imputationsneuromodulationMedicineRENJournal of Clinical Medicine, Vol 10, Iss 4897, p 4897 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	missing data mechanisms sensitivity analysis multiple imputations neuromodulation Medicine R
spellingShingle	missing data mechanisms sensitivity analysis multiple imputations neuromodulation Medicine R Lisa Goudman Geert Molenberghs Rui V. Duarte Maarten Moens The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis
description	New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were constructed to evaluate how conclusions may be influenced by these assumptions. The aim is to perform a tipping point sensitivity analysis to evaluate the influence of missing data on the overall conclusion regarding the effectiveness of HD-SCS on disability. Data from the Discover study were used, in which 185 patients with Failed Back Surgery Syndrome were included. Disability was evaluated before SCS and after 1, 3 and 12 months of HD-SCS. During the second, third and fourth visit, data from 130, 114 and 90 patients were available, respectively. HD-SCS resulted in a significant decrease in disability scores based on the analysis of observed data and with multiple imputations. The tipping point sensitivity analysis revealed that the shift parameter was 17. Thus, the conclusion concerning the time effect under a “missing at random” mechanism is robust when the shift parameter for the disability score is 17. From a clinical point of view, a shift of 17 points on disability is not very plausible. Therefore we tend to consider the conclusions drawn under “missing at random” as being robust.
format	article
author	Lisa Goudman Geert Molenberghs Rui V. Duarte Maarten Moens
author_facet	Lisa Goudman Geert Molenberghs Rui V. Duarte Maarten Moens
author_sort	Lisa Goudman
title	The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis
title_short	The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis
title_full	The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis
title_fullStr	The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis
title_full_unstemmed	The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis
title_sort	influence of missing data on disabilities in patients treated with high-dose spinal cord stimulation: a tipping point sensitivity analysis
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/0c977a707b67444da8755a828d9d4020
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The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis

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