Informed Consent for Spine Procedures: Best Practice Guideline from the American Society of Pain and Neuroscience (ASPN)

Abstract

Introduction

The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures.

Objective

The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology.

Methods

After a needs assessment, ASPN determined that best practice regarding proper informed consent for spinal procedures was needed and a process of selecting faculty was developed based on expertise, diversity, and knowledge of the subject matter. A comprehensive literature search was conducted and when appropriate, evidence grading was performed. Recommendations were based on evidence when available, and when limited, based on consensus opinion.

Results

Following a comprehensive review and analysis of the available evidence, the ASPN Informed Consent Guideline group rated the literature to assist with specification of best practice regarding patient consent during the management of spine disorders.

Conclusion

Careful attention to informed consent is critical in achieving an optimal outcome and properly educating patients. This process involves a discussion of risks, advantages, and alternatives to treatment. As the field of interventional pain and spine continues to grow, it is imperative that clinicians effectively educate patients and obtain comprehensive informed consent for invasive procedures. This consent should be tailored to the patient’s specific needs to ensure an essential recognition of patient autonomy and reasonable expectations of treatment.

Keywords:

• informed consent
• best practice
• clinical guideline
• pain medicine
• spine intervention
• spine surgery

Disclosure

Dr Timothy Deer reports personal fees for consulting, research and/or stock options from Abbott, Vertos, SpineThera, Saluda, Mainstay, Nalu, Cornerloc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTeq, Tissue Tech, Spinal Simplicity, Avanos, and Biotronik, outside the submitted work; In addition, Dr Timothy Deer has a pending patent to Abbott. Dr Ashley Bailey-Classen reports personal fees for consulting or speaker’s bureau from Nevro, Medtronic, Biotronik, and Spinal Simplicity, outside the submitted work. Ms Ashley Comer reports personal fees for consulting from Abbott, NALU, PainTEQ, Saluda, SPR Therapeutics, and Vertos, outside the submitted work. Ms Zohra Hussaini reports consulting fees from Nevro, SPR, PainTeq, Averitas; advisory board for Vertos, outside the submitted work. Dr Nasir Khatri reports personal fees for consulting from Saluda Medical; personal fees, non-financial support for advisory board from Vertos Inc., outside the submitted work. Dr Melissa Murphy reports personal fees for speaking, research and/or consulting from Medtronic and Relievant, outside the submitted work. Dr Morteza Rabii reports personal fees from InFormed consent, LLC, Abbott, Spinal Simplicity LLC, Flowonix Medical, and Southern Spine, outside the submitted work. Dr Douglas Beall reports personal fees from Medtronic, Spineology, Merit Medical, Johnson & Johnson, IZI, Techlamed, Peterson Enterprises, Medical Metrics, Avanos, Boston Scientific, Sollis Pharmaceuticals, Simplify Medical, Stryker, Lenoss Medical, Spine BioPharma, Piramal, ReGelTec, Nanofuse, Spinal Simplicity, Pain Theory, Spark Biomedical, Micron Medical Corp, Bronx Medical, Smart Soft, Tissue Tech, RayShield, Stayble, Thermaquil, Vivex, Stratus Medical, Genesys, Abbott, Eliquence, SetBone Medical, Amber Implants, Cerapedics, Neurovasis, Varian Medical Systems, Companion Spine, DiscGenics, Discure, SpinaFX, PainTEQ, outside the submitted work. Dr Michael E Schatman is a research consultant for Modoscript, Scientific Steering Committee for Collegium Pharma, and AdComm for Syneos Health, outside the submitted work. Dr Timothy Lubenow reports personal fees from Abbott Labs, Boston Scientific, Nevro, and Pain Teq, outside the submitted work. The authors report no other conflicts of interest in this work.