Patient Reported Outcome Measures, Nomenclature & Classifications in Clinical Research of Endoscopic Spine Surgery
Kai-Uwe Lewandrowski1, 2, 3, *, Álvaro Dowling4, 5, Said G Osman6, Jin-Sung Kim7, Stefan Hellinger8, Nimar Salari9, Rômulo Pedroza Pinheiro10, Ramon Torres11, Anthony Yeung12 1 Center for Advanced Spine Care of Southern Arizona and Surgical Institute of Tucson, Tucson AZ, USA
2 Associate Professor of Orthopaedic Surgery, Universidad Colsanitas, Bogota, Colombia, USA
3 Visiting Professor, Department Neurosurgery, UNIRIO, Rio de Janeiro, Brazil
4 Endoscopic Spine Clinic, Santiago, Chile
5 Department of Orthopaedic Surgery, USP, Ribeirão Preto, Brazil
6 Sky Spine Endoscopy Institute 1003 W 7th St, Frederick, MD 21701, USA
7 Professor, Spine Center, Department of Neurosurgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea 222 Banpo Daero, Seocho-gu, Seoul, 137-701, Korea
8 Department of Orthopedic Surgery, Isar Hospital, Munich, Germany
9 Desert Institute for Spine Care, Phoenix, AZ, USA
10 Orthopeadic Spine Surgery Department of Orthopedics and Anestesiology, Ribeirão Preto Medical School, University of São Paulo. Ribeirão Preto - SP, Brazil
11 Orthopedic Surgeon/ Spine Surgery Fellowship,, Universidad de Chile, Instituto Traumatologico, Santiago, Chile
12 Clinical Professor, University of New Mexico School of Medicine, Albuquerque, New Mexico Desert Institute for Spine Care, Phoenix, AZ, USA
Abstract
Uniform use of nomenclature and classification systems appears logical to anyone attempting to systematically study clinical outcomes with new emerging technology applications in spine surgery. At the introduction of spinal endoscopy into routine clinical practice, today's key opinion leaders introduced nomenclature conducive to the description of their innovations at the time. With endoscopy of the spine becoming more mainstream several authors have pushed classification systems
for clinical outcome studies. Others have introduced terminology in hopes of them being adopted to further research and health care policy agendas. These nomenclature and classification systems' practicality in routine clinical practice may be debatable and perhaps be considered by some an academic exercise. However, the need for some common language and categorization of descriptors of painful pathology, confounding factors, and their treatments are accepted by most. This chapter summarizes the literature on nomenclature, terminology, and classification systems relevant to clinical outcome research in spinal endoscopy. It was motivated by the desire to formalize its clinical outcome research, bring it up to par with traditional translaminar spine surgery techniques, and, ultimately, incorporate it into clinical treatment and coverage guidelines formulated by spine societies and payors.
Keywords: Classification, Clinical outcome research, Nomenclature, Spinal endoscopy, Terminology.
* Corresponding author Kai-Uwe Lewandrowski: Center for Advanced Spine Care of Southern Arizona and Surgical Institute of Tucson, Tucson, AZ, USA, Department of Orthopaedic Surgery, UNIRIO, Rio de Janeiro, Brazil and Department of Orthoapedic Surgery, Fundación Universitaria Sanitas, Bogotá, D.C., Colombia, USA; Tel: +1 520 204-1495; Fax: +1 623 218-1215; E-mail: [email protected] INTRODUCTION
The pioneers of endoscopic spine surgery techniques started reporting their clinical outcomes in the late 1980s and early 1990s. At the time, there was not much interest in the procedure, and it was carried out by a few who fought an uphill battle against the proponents of traditional open spinal surgery techniques, which at the time itself were relatively new. Pedicle screws had just been introduced, and their widespread application was challenged in a class-action lawsuit in the early 1990ies. Ultimately, one of the pioneering physicians and President of the North American Spine Society at the time, Dr. Hansen Yuan, recognized the overwhelming benefit of this technology for patients and spearheaded the defense against the trial lawyers. He orchestrated the formulation of clinical treatment guidelines, which ultimately formed the basis for modern spinal surgery, based on alleviating pain by surgical freeing-up of compressed neural elements and stabilizing instability and deformity. The media attention was horrendous and spinal endoscopy appeared to be the stepchild of the public debate of indications and clinical outcomes with modern spine surgery. That debate intensified in the early 2000s, highlighting the need for more formalized outcome research to make a case for selective endoscopic treatment of validated pain generators rather than image-based treatment guidelines focusing on stenosis, instability, and deformity. The senior authors of this chapter lived through these tumultuous times and argued the case for spinal endoscopy in many debates in his local community and on a national and international level. He published the up to date most widely cited article on selective endoscopic lumbar discectomy in 2003. Some 20 years later, many of today's spinal endoscopy proponents benefit from these earlier arguments. However, the debate on whether it is appropriate to replace traditional open, translaminar, and other forms of minimally invasive spine surgeries with endoscopy continues.
WIDELY USED CLINICAL OUTCOME TOOLS
Patient-reported outcome measures (PROM) frequently used in spine outcome research include the visual analog score (VAS) [1-12] and the Oswestry Disability Index (ODI) [13-18]. Understanding the ability of these PROM scores to detect improvements in health status resulting from an intervention meaningful to the patient is critical to support conclusions in favor of one treatment over another. The VAS is a ten-digit integer score from 0 (no pain) to 10 (worst pain imaginable) [12]. The ODI is a ten-item composite instrument. It assesses pain intensity, personal care, and function, including walking, lifting, personal care, sitting, standing, sleeping, social interaction, and traveling [19-22]. Each ODI item is scored from 0 (no impairment) to 5 (worst impairment). Then, the scores are summed up and then multiplied by two to obtain the ODI index ranging from 0 to 100. The Macnab criteria are commonly used in spinal endoscopy outcome studies [23, 24]. Briefly, follow-up outcome results are classified as Excellent when the patient experiences little pain, and can perform desired activities with few limitations. Good Macnab outcomes are defined when the patient complains of occasional pain or dysesthesia but can perform daily activities with minor restrictions and did not need pain medication. Fair Macnab outcomes are assigned when the pain level is somewhat improved but a continued to need pain medication exists. Poor Macnab outcomes describe a patient with worse function or in need of additional surgery to address symptoms. Another way to best stratify clinical improvements in clinical research is the anchor-based approach by calculating a pati...