Abstract
This systematic review assessed design characteristics and reporting quality of published randomized clinical trials of spinal cord stimulation (SCS) for treatment of pain in adults and adolescents. The study protocol was registered with PROSPERO (CRD42018090412). Relevant articles were identified by searching the following databases through December 31, 2018: MEDLINE, Embase, WikiStim, The Cochrane Database of Systematic Reviews, and The Cochrane Central Register of Controlled Trials. Forty-six studies were included. Eighty-seven percent of articles identified a pain-related primary outcome. Secondary outcomes included physical functioning, health-related quality of life, and reductions in opioid use. Nineteen of the 46 studies prespecified adverse events as an outcome, with 4 assessing them as a primary outcome. Eleven studies stated that they blinded participants. Of these, only 5 were assessed as being adequately blinded. The number of participants enrolled was generally low (median 38) and study durations were short (median 12 weeks), particularly in studies of angina. Fifteen studies employed an intention-to-treat analysis, of which only seven specified a method to accommodate missing data. Review of these studies identified deficiencies in both reporting and methodology. The review's findings suggest areas for improving the design of future studies and increasing transparency of reporting. Perspective: This article presents a systematic review of research methods and reporting quality of randomized clinical trials of SCS for the treatment of various pain complaints. The review identifies deficiencies in both methodology and reporting, which may inform the design of future studies and improve reporting standards.
| Original language | English |
|---|---|
| Pages (from-to) | 127-142 |
| Number of pages | 16 |
| Journal | Journal of Pain |
| Volume | 22 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2021 |
Keywords
- Clinical trials systematic review/meta analysis
- Disc disease
- Neuromodulation
- Pain
- Peripheral neuropathy
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In: Journal of Pain, Vol. 22, No. 2, 02.2021, p. 127-142.
Research output: Contribution to journal › Review article › peer-review
TY - JOUR
T1 - Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation for Pain
AU - McNicol, Ewan
AU - Ferguson, McKenzie
AU - Bungay, Kathleen
AU - Rowe, Emily L.
AU - Eldabe, Sam
AU - Gewandter, Jennifer S.
AU - Hayek, Salim M.
AU - Katz, Nathaniel
AU - Kopell, Brian H.
AU - Markman, John
AU - Rezai, Ali
AU - Taylor, Rod S.
AU - Turk, Dennis C.
AU - Dworkin, Robert H.
AU - North, Richard B.
AU - Thomson, Simon
N1 - Funding Information: Conflicts of interest: The views expressed in this article are those of the authors, several of whom have received consulting fees, honoraria, or equity from one or more pharmaceutical or device companies: Sam Eldabe has received consultancy fees from Medtronic, Inc., Mainstay Medical, Boston Scientific Corp., Saluda Medical and Abbott. He has received Department Research funding from the National Institute of Health Research (NIHR), Medtronic, Inc., and Nevro Corp. Jennifer S. Gewandter has received consulting income in the past 36 months from MundiPharma, Disarm Therapeutics, Asahi Kasei Pharma, and SK Life Science. Salim M. Hayek is a member of the medical advisory board for Boston Scientific. Nathaniel Katz has been a paid consultant for Boston Scientific. Brian H. Kopell has received consulting income from Medtronic, Abbott and BlueRock Therapeutics. John Markman has participated in advisory boards or consulted with Flexion Therapeutics, Tremeau Pharmaceuticals, Sophren, Eliem Therapeutics, Vertiflex, Pfizer, Lilly, Teva, Quark, Pacira, Inspirion, Delivery Sciences, Quartet, Egalet, Biogen, Nektar, Endo, Immune Pharma, Chromocell, Collegium, Purdue, Novartis, Sanofi, Convergence, Aptinyx, Daiichi Sankyo, Allergan, Plasmasurgical, and Grunenthal). Dr. Markman has received research funding (Depomed, Pfizer), and served on Data Safety Monitoring Boards (Allergan, Novartis) over the past 7 years. Ali Rezai has served on the Board of Directors and had a potential equity position in Autonomic Technologies (ATI), Neurotechnology Innovation Translator (NIT), and Sollis Therapeutics in the last 12 months. Rod S. Taylor is a paid consultant for Medtronic, Nevro, and Saluda. Dennis C. Turk has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health, and Patient Centered Outcomes Research Institute (PCORI) and compensation for consulting on research methods from: AccelRx, Eli Lilly, Johnson & Johnson, GlaxoSmithKline, Novartis, Pfizer, and St. Jude. He is Editor-in-Chief of The Clinical Journal of Pain. Robert H. Dworkin, PhD, has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Celgene, Centrexion, Chromocell, Clexio, Concert, Coronado, Daiichi Sankyo, Decibel, Dong-A, Editas, Eli Lilly, Eupraxia, Glenmark, Grace, Hope, Hydra, Immune, Johnson & Johnson, Lotus Clinical Research, Mainstay, Medavante, Merck, Neumentum, Neurana, NeuroBo, Novaremed, Novartis, NSGene, Olatec, Periphagen, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy (also equity), Relmada, Sanifit, Scilex, Semnur, Sollis, Spinifex, Syntrix, Teva, Thar, Theranexus, Trevena, Vertex, and Vizuri. Richard B. North serves as an unpaid officer of the nonprofit Neuromodulation Foundation, Inc. to which (like his former employers Johns Hopkins University and Sinai Hospital) grants and support have been provided by Abbott, Boston Scientific Corp., Medtronic, Inc., Nevro Corp., Nuvectra, and Stimwave, Inc. He receives royalties from Abbott and consulting fees and royalties from Nuvectra. His wife holds shares in Stimwave, Inc. Simon Thomson, MBBS acts as a consultant to Boston Scientific Neuromodulation. Dr. McNicol, Dr. Ferguson, Dr. Bungay, and Dr. Rowe declare no conflicts of interest. Funding Information: Funding: ACTTION, IoN, and INS supported preparation of this review and have received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, and other sources. No official endorsement by the FDA or the companies that have provided unrestricted grants to support the activities of ACTTION, IoN, and INS should be inferred. Conflicts of interest: The views expressed in this article are those of the authors, several of whom have received consulting fees, honoraria, or equity from one or more pharmaceutical or device companies: Sam Eldabe has received consultancy fees from Medtronic, Inc., Mainstay Medical, Boston Scientific Corp., Saluda Medical and Abbott. He has received Department Research funding from the National Institute of Health Research (NIHR), Medtronic, Inc., and Nevro Corp. Jennifer S. Gewandter has received consulting income in the past 36 months from MundiPharma, Disarm Therapeutics, Asahi Kasei Pharma, and SK Life Science. Salim M. Hayek is a member of the medical advisory board for Boston Scientific. Nathaniel Katz has been a paid consultant for Boston Scientific. Brian H. Kopell has received consulting income from Medtronic, Abbott and BlueRock Therapeutics. John Markman has participated in advisory boards or consulted with Flexion Therapeutics, Tremeau Pharmaceuticals, Sophren, Eliem Therapeutics, Vertiflex, Pfizer, Lilly, Teva, Quark, Pacira, Inspirion, Delivery Sciences, Quartet, Egalet, Biogen, Nektar, Endo, Immune Pharma, Chromocell, Collegium, Purdue, Novartis, Sanofi, Convergence, Aptinyx, Daiichi Sankyo, Allergan, Plasmasurgical, and Grunenthal). Dr. Markman has received research funding (Depomed, Pfizer), and served on Data Safety Monitoring Boards (Allergan, Novartis) over the past 7 years. Ali Rezai has served on the Board of Directors and had a potential equity position in Autonomic Technologies (ATI), Neurotechnology Innovation Translator (NIT), and Sollis Therapeutics in the last 12 months. Rod S. Taylor is a paid consultant for Medtronic, Nevro, and Saluda. Dennis C. Turk has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health, and Patient Centered Outcomes Research Institute (PCORI) and compensation for consulting on research methods from: AccelRx, Eli Lilly, Johnson & Johnson, GlaxoSmithKline, Novartis, Pfizer, and St. Jude. He is Editor-in-Chief of The Clinical Journal of Pain. Robert H. Dworkin, PhD, has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Celgene, Centrexion, Chromocell, Clexio, Concert, Coronado, Daiichi Sankyo, Decibel, Dong-A, Editas, Eli Lilly, Eupraxia, Glenmark, Grace, Hope, Hydra, Immune, Johnson & Johnson, Lotus Clinical Research, Mainstay, Medavante, Merck, Neumentum, Neurana, NeuroBo, Novaremed, Novartis, NSGene, Olatec, Periphagen, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy (also equity), Relmada, Sanifit, Scilex, Semnur, Sollis, Spinifex, Syntrix, Teva, Thar, Theranexus, Trevena, Vertex, and Vizuri. Richard B. North serves as an unpaid officer of the nonprofit Neuromodulation Foundation, Inc. to which (like his former employers Johns Hopkins University and Sinai Hospital) grants and support have been provided by Abbott, Boston Scientific Corp., Medtronic, Inc., Nevro Corp., Nuvectra, and Stimwave, Inc. He receives royalties from Abbott and consulting fees and royalties from Nuvectra. His wife holds shares in Stimwave, Inc. Simon Thomson, MBBS acts as a consultant to Boston Scientific Neuromodulation. Dr. McNicol, Dr. Ferguson, Dr. Bungay, and Dr. Rowe declare no conflicts of interest. Publisher Copyright: © 2020 The Authors
PY - 2021/2
Y1 - 2021/2
N2 - This systematic review assessed design characteristics and reporting quality of published randomized clinical trials of spinal cord stimulation (SCS) for treatment of pain in adults and adolescents. The study protocol was registered with PROSPERO (CRD42018090412). Relevant articles were identified by searching the following databases through December 31, 2018: MEDLINE, Embase, WikiStim, The Cochrane Database of Systematic Reviews, and The Cochrane Central Register of Controlled Trials. Forty-six studies were included. Eighty-seven percent of articles identified a pain-related primary outcome. Secondary outcomes included physical functioning, health-related quality of life, and reductions in opioid use. Nineteen of the 46 studies prespecified adverse events as an outcome, with 4 assessing them as a primary outcome. Eleven studies stated that they blinded participants. Of these, only 5 were assessed as being adequately blinded. The number of participants enrolled was generally low (median 38) and study durations were short (median 12 weeks), particularly in studies of angina. Fifteen studies employed an intention-to-treat analysis, of which only seven specified a method to accommodate missing data. Review of these studies identified deficiencies in both reporting and methodology. The review's findings suggest areas for improving the design of future studies and increasing transparency of reporting. Perspective: This article presents a systematic review of research methods and reporting quality of randomized clinical trials of SCS for the treatment of various pain complaints. The review identifies deficiencies in both methodology and reporting, which may inform the design of future studies and improve reporting standards.
AB - This systematic review assessed design characteristics and reporting quality of published randomized clinical trials of spinal cord stimulation (SCS) for treatment of pain in adults and adolescents. The study protocol was registered with PROSPERO (CRD42018090412). Relevant articles were identified by searching the following databases through December 31, 2018: MEDLINE, Embase, WikiStim, The Cochrane Database of Systematic Reviews, and The Cochrane Central Register of Controlled Trials. Forty-six studies were included. Eighty-seven percent of articles identified a pain-related primary outcome. Secondary outcomes included physical functioning, health-related quality of life, and reductions in opioid use. Nineteen of the 46 studies prespecified adverse events as an outcome, with 4 assessing them as a primary outcome. Eleven studies stated that they blinded participants. Of these, only 5 were assessed as being adequately blinded. The number of participants enrolled was generally low (median 38) and study durations were short (median 12 weeks), particularly in studies of angina. Fifteen studies employed an intention-to-treat analysis, of which only seven specified a method to accommodate missing data. Review of these studies identified deficiencies in both reporting and methodology. The review's findings suggest areas for improving the design of future studies and increasing transparency of reporting. Perspective: This article presents a systematic review of research methods and reporting quality of randomized clinical trials of SCS for the treatment of various pain complaints. The review identifies deficiencies in both methodology and reporting, which may inform the design of future studies and improve reporting standards.
KW - Clinical trials systematic review/meta analysis
KW - Disc disease
KW - Neuromodulation
KW - Pain
KW - Peripheral neuropathy
UR - http://www.scopus.com/inward/record.url?scp=85087958934&partnerID=8YFLogxK
U2 - 10.1016/j.jpain.2020.05.001
DO - 10.1016/j.jpain.2020.05.001
M3 - Review article
C2 - 32574787
AN - SCOPUS:85087958934
SN - 1526-5900
VL - 22
SP - 127
EP - 142
JO - Journal of Pain
JF - Journal of Pain
IS - 2
ER -