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Consensus Statement: Systematic Reviews of Value-Based Surgical Spine CareWhat Do We Know? Where Are the Limitations?

Fehlings, Michael G., MD, PhD, FRCS(C)*; Nater, Anick, MD*; Chapman, Jens, MD; Harrop, James, MD; Mroz, Thomas, MD§

doi: 10.1097/BRS.0000000000000541
Introduction to Value Based Spine Care
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*Toronto Western Hospital, Toronto, Ontario, Canada

University of Washington, Seattle, WA

Thomas Jefferson University, Philadelphia, PA; and

§Cleveland Clinic, Cleveland, OH.

Address correspondence and reprint requests to Michael G. Fehlings, MD, PhD, FRCS(C), Toronto Western Hospital, West Wing, 4th Floor Room 4WW449, 399 Bathurst St, Toronto, Ontario, Canada M5T 2S8; E-mail: michael.fehlings@uhn.ca

Acknowledgment date: June 6, 2014. Acceptance date: July 23, 2014.

The manuscript submitted does not contain information about medical device(s)/drug(s).

Supported by AO Spine North America, Inc. Analytic support for this work was provided by Spectrum Research, Inc., with funding from the AO Spine North America.

Relevant financial activities outside the submitted work: board membership, consultancy, employment, stocks, payment for lecture, travel/accommodations/meeting expenses.

This section aimed to examine the current knowledge regarding cost-effectiveness of surgical intervention for 5 topics in spine care: minimal access spine surgery, biological substitutes or extenders, management of cervical degenerative disease, metastatic epidural spinal cord compression, and lumbar degenerative spondylolisthesis and spinal stenosis. These topics reflect a breadth of practice and areas of clinical importance or controversy. Strict inclusion and exclusion criteria were used for these systematic economic literature reviews to favor specificity to gather evidence that evaluated, compared, and synthesized the costs and consequences of alternative treatment options to answer predetermined key questions.

The “pearls,” limitations, and opportunities derived from these systematic reviews are summarized in Table 1. The first article searched for full economic studies evaluating whether minimal access spine surgery techniques were more cost-effective compared with conventional “open” surgical interventions in either the cervical spine or lumbar spine. The second study synthesized the evidence on cost-effectiveness regarding first surgical procedures compared with non-operative treatment for cervical myelopathy or radiculopathy. Then, it more specifically addressed whether anterior surgical procedures are more cost-effective than their posterior surgical counterparts in the context of either cervical myelopathy, radiculopathy, or both. Similarly, the third article presented the existing evidence assessing the cost-effectiveness for adult patients with lumbar degenerative spondylolisthesis or stenosis undergoing surgical treatment compared with those treated conservatively. It also examined whether fusion or instrumentation was more cost-effective than no fusion or instrumentation, respectively. The fourth article reported the current evidence comparing the cost-effectiveness of various agents (biological substitutes or extenders) in spinal arthrodesis procedures. The last study reviewed the evidence comparing whether surgery and radiotherapy (either alone or combined with chemotherapy) was more cost-effective than radiotherapy (alone or combined with chemotherapy) in patients experiencing metastatic epidural spinal cord compression. In addition, this article examined if there was evidence to suggest that surgical intervention for spinal instability resulting from spinal metastasis or its treatment was cost-effective compared with nonoperative treatment.

TABLE 1-a

TABLE 1-a

TABLE 1-b

TABLE 1-b

The techniques in spine surgery have evolved and been refined considerably during the past 2 decades. Although there are limitations regarding the number and quality of cost-effectiveness evaluations undertaken in the setting of spine surgery, many interventions have been shown to provide excellent value. In particular, based on data from the AOSpine North America cervical spondylotic myelopathy study1 and the landmark Spine Patient Outcomes Research Trial (SPORT) study,2,3 surgery for cervical spondylotic myelopathy and lumbar degenerative stenosis is highly cost-effective. Because value is intrinsically a multiperspective concept, it is clear that it cannot be fully appraised in just economic terms. Indeed, reduction in complications, shorter length of stay, easier and faster surgery, or improved clinical outcomes have obvious clinical “value,” even when they are associated with increased costs. This is particularly poignant when one considers the management of patients with metastatic spine pathology. Two high-quality economic evaluations, based on data from the landmark Patchell et al4 trial, showed that surgery for metastatic epidural spinal cord compression is not only clinically more effective, but also more expensive. The willingness of society to pay for a particular intervention cannot always be easily captured solely in economic terms.

It must be emphasized that additional costing studies have been performed but were not examined in these reviews because they failed to meet the inclusion criteria, mainly regarding appropriate cost or cost-effectiveness data related to intervention and corresponding comparison specified in the predetermined key questions. Nonetheless, these studies might provide valuable information when comparing the overall effectiveness of alternative treatments. Given the specificity of the inclusion and exclusion criteria employed in conducting the systematic economic literature reviews that follow, the yield was generally low; the largest included 6 full economic studies.

For the most part, the scarcity of full economic evaluations resulted from a paucity of data comparing concurrently therapeutic modalities in terms of clinical outcomes and their associated costs. Well-structured and high-quality full economic studies are typically time consuming and quite expensive to conduct. In addition, their results could potentially have an appreciably adverse impact on the industry. Indeed, surgical spine care has experienced a spectacular technological blooming in the last decade, with some key participants sharing in a period of lucrative market development.

Given the myriad of factors that must be taken into account and the fact that many studies draw data from retrospectively collected or indirectly obtained datasets, comprehensive full economic evaluations are left with inherent variability. To generate higher powered and more conclusive results, priority is placed on careful understanding of the specific challenges of the population under investigation to design a tailored economic evaluation. Furthermore, an a priori and clearly stated depiction of the economic model should be a reasonable expectation, together with detailed and transparent description of the methodology, and sensitivity analyses for validation. In addition, full economic evaluations often only consider charges or upfront surgical costs, dismissing indirect costs, such as those related to hospital costs or medical system costs, and opportunity costs such as loss of productivity for both the patient and/or their caregivers. A particularly elusive entity to grasp has been non-operative care costs, such as pharmaceutical treatments as well as inpatient and/or outpatient rehabilitation expenses. Furthermore, the observation windows chosen for economic evaluations have been very inconsistent, with short-term follow-up periods commonly not exceeding 3 months post-operatively and rarely extending beyond 1 year. This leaves most economic evaluations deficient to accurately assess long-term impacts of the different modalities being compared.

Although none of the 5 systematic economic literature reviews our author collectives performed seemed to provide sufficient evidence to draw definitive conclusions, they greatly enlightened future research endeavors by providing a critical appraisal of past studies and consequently delineating opportunities to improve the quality of upcoming full economic evaluations. The shift toward value-based spine care is a relatively new concept for which there is a marked growing interest. Indeed, the high costs and increasing number of spinal surgical procedures performed are strong motivators for health care systems to support further well-structured and designed full economic studies to optimize resource allocation. The information presented in this section hopefully sets the ground for future economic evaluations. Finally, as emphasized in the earlier text, value in spine care cannot always be measured in pure economic terms and the willingness of a society to pay for an intervention will vary on the basis of the pathology, the subjectively perceived impact of the disorder, and the value system of a given society and its resource availability. With the predicted continued increase for spinal procedures and globally strained health care budgets, the time is now to act and produce high-quality value-centered spine research.

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References

1. Fehlings MG, Barry S, Kopjar B, et al. Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: outcomes of the prospective multicenter AOSpine North America CSM study in 264 patients. Spine (Phila Pa 1976) 2013;38:2247–52.
2. Tosteson AN, Skinner JS, Tosteson TD, et al. The cost-effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976) 2008;33:2108–15.
3. Tosteson AN, Tosteson TD, Lurie JD, et al. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976) 2011;36:2061–8.
4. Patchell RA, Tibbs PA, Regine WF, et al. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet 2005;366:643–8.
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