Materials and Methods
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The CONSORT Statement. Accessed November 9, 2021. CONSORT. http://www.consort-statement.org.
- The CONSORT statement and its impact on quality of reporting of trials.Perspect Clin Res. 2019; 10: 145-147
SPIRIT. Accessed November 9, 2021. CONSORT. http://www.consort-statement.org/resources/spirit.
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- Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension.Nat Med. 2020; 26: 1364-1374
- Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.Nat Med. 2020; 26: 1351-1363
- Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness? (TRIAL-STIM study): study protocol for a randomised controlled trial.Trials. 2018; 19: 633
- Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol.Trials. 2020; 21: 111
- Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? A randomised controlled trial.Pain. 2020; 161: 2820-2829
- Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a doubleblind, randomised, controlled trial.Lancet Neurol. 2020; 19: 123-134
- Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial.Anesthesiology. 2015; 123: 851-860
- Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial.Pain. 2017; 158: 669-681
- Randomized placebo-/sham-controlled trials of spinal cord stimulation: a systematic review and methodological appraisal.Neuromodulation. 2020; 23: 10-18
- Systematic review of research methods and reporting quality of randomized clinical trials of spinal cord stimulation for pain.J Pain. 2021; 22: 127-142
- Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations.Pain. 2021; 162: 1935-1956
- Guidance for developers of health research reporting guidelines.PLoS Med. 2010; 7e1000217
- The COMET Handbook: version 1.0.Trials. 2017; 18: 280
Source(s) of financial support: The development of the guidelines was funded by Abbott, Boston Scientific Corp, Mainstay Medical, Medtronic Ltd, Nevro Corp, and Saluda Medical. Representatives from the research divisions of the companies supporting the study were invited to participate in the Delphi survey and to be part of the Consensus Group.
Conflict of Interest Statement: Rui V. Duarte has received consultancy fees from Boston Scientific Corp, Mainstay Medical, Medtronic Ltd, and Saluda Medical. Sam Eldabe has received consultancy fees from Abbott, Boston Scientific Corp, Mainstay Medical, and Medtronic Ltd. He has received Department Research funding from the National Institute of Health Research, Medtronic Ltd, and Nevro Corp. Simon Thomson has received consultancy fees from Boston Scientific Corp. He has received department research funding from the National Institute of Health Research, Boston Scientific Corp, and Mainstay Medical. 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. Ganesan Baranidharan has a consulting agreement and is on the advisory board for Nevro Corp, Nalu Medical Inc, Abbott, and Boston Scientific Corp. Rod S. Taylor has received consultancy fees from Medtronic Ltd, Nevro Corp, and Saluda Medical. The other authors report no conflict of interest.