Implementing the SAFE Principles for the Development of Pain Medicine Therapeutic Algorithms That Include Neuromodulation Techniques
Elliot Krames MD
Pacific Pain Treatment Centers, San Francisco, CA, USA;
Search for more papers by this authorLawrence Poree MD, PhD
Pacific Pain Treatment Centers, San Francisco, CA, USA;
Pain Clinic of Monterey Bay, Aptos, CA, USA;
Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA;
Search for more papers by this authorTimothy Deer MD
Center for Pain Relief Inc., Charleston, WV, USA;
West Virginia University School of Medicine, Morgantown, WV, USA;
Search for more papers by this authorRobert Levy MD
Departments of Neurologic Surgery and Physiology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
Search for more papers by this authorElliot Krames MD
Pacific Pain Treatment Centers, San Francisco, CA, USA;
Search for more papers by this authorLawrence Poree MD, PhD
Pacific Pain Treatment Centers, San Francisco, CA, USA;
Pain Clinic of Monterey Bay, Aptos, CA, USA;
Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA;
Search for more papers by this authorTimothy Deer MD
Center for Pain Relief Inc., Charleston, WV, USA;
West Virginia University School of Medicine, Morgantown, WV, USA;
Search for more papers by this authorRobert Levy MD
Departments of Neurologic Surgery and Physiology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
Search for more papers by this authorABSTRACT
Currently accepted chronic pain treatment algorithms have positioned therapies according to levels of invasiveness and up-front costs. After reviewing updated literature on efficacy and cost outcomes of care for patients with chronic pain that include interventional implantable technologies, we offer a new model of thinking when formulating algorithms of care that might include more invasive and costly interventions such as spinal cord stimulation, the SAFE principles. These SAFE principles include “safety,”“appropriateness,”“fiscal neutrality,” and “efficacy.”
References
- 1 Danzon PM. Health Care Industry. In: RH David, ed. The Concise Encyclopedia of Economics. Indianapolis: Liberty Fund, Inc., 2002.
- 2 Catlin A, Cowan C, Heffler S, Washington B; National Health Expenditure Accounts Team. National health spending in 2005: the slowdown continues. Health Aff 2006; 26: 142–153.
- 3 Borger C, Smith S, Truffer C, et al. Health spending projections through 2015: changes on the horizon. Health Aff 2006; 25: W61–W73.
- 4 Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group. National Health Expenditure Data Overview [online]. Retrieved on April 2, 2008, from http://www.cms.hhs.gov/nationalhealthexpenddata/.
- 5 Review Panel on the Medicare Trustees Reports. Review of Assumptions and Methods of the Medicare Trustees’ Financial Projections (December 2000) [online]. Retrieved on April 2, 2008, from http://www.cms.hhs.gov/reportstrustfunds/02_technicalpanelreports.asp.
- 6 Di Matteo L. The macro determinants of health expenditure in the United States and Canada: assessing the impact of income, age distribution and time. Health Policy 2005; 71: 23–42.
- 7 Centers for Disease Control and Prevention. Cost of Chronic Disease [online]. Retrieved on April 2, 2008, from http://www.cdc.gov/nccdphp/overview.htm.
- 8 “The Research Paper”, Simple Interactive Statistical Analysis (SISA) . Retrieved on June 12, 2008, http://www.quantitativeskills.com/documents/paper6.htm.
- 9 Taken from Wikipedia: quality-adjusted life year (QALY) Retrieved on June 12, 2008, from http://en.wikipedia.org/wiki/qaly.
- 10 World Health Organization. Retrieved on June 12, 2008, from http://www.who.int/healthinfo/boddaly/en/.
- 11 Krames E. Interventional pain management. Appropriate when less invasive therapies fail to provide adequate analgesia. Med Clin North Am 1999; 83(3): 787–808.
- 12 North RB, Kidd D, Shipley J, Taylor R. SCS versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized controlled trial. Clinical studies. Neurosurgery 2007; 61: 361–369.
- 13 Kumar K, Malik S, Demeria D. Treatment of chronic pain with SCS versus alternative therapies: cost-effectiveness analysis. Neurosurgery 2002; 51: 106–116.
- 14 Kumar K, Taylor R, Jacques L et al. SCS versus conventional medical management for neuropathic pain: a multicenter, randomised controlled trial in patients with failed back surgery syndrome. Pain 2008; 132: 179–188.
- 15 Taylor RJ, Taylor RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis. Int J Technol Assess Health Care 2005; 21: 351–358.
- 16 Kemler MA, Furnee CA. Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology 2002; 59: 1203–1209.
- 17 Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for complex regional pain syndrome: a systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors. Eur J Pain 2006; 10: 91–101.
- 18 Waack KE, Ernst ME, Graber MA. Informational content of official pharmaceutical industry web sites about treatments for erectile dysfunction. Ann Pharmacother 2004; 38: 2029–2034.
- 19 Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998; 105: 31S–38S.
- 20 Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. N Engl J Med 1999; 340: 1888–1899.
- 21 Fennerty MB. NSAID-related gastrointestinal injury: evidence-based approach to a preventable complication. Postgrad Med 2001; 110: 87–89.
- 22 Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of SCS, suggestions to improve outcome, and financial impact. J Neurosurgery 2006; 5: 191–203.
- 23 Daniell HW. Opioid endocrinopathy in women consuming prescribed sustained-action opioids for control of nonmalignant pain. J Pain 2008; 9: 28–36.
- 24 Daniell HW. hypogonadism in men consuming sustained-action oral opioids. J Pain 2002; 3: 377–384.
- 25 Daniell HW. DHEAS: deficiency during consumption of sustained-action prescribed opioid-evidence for opioid-induced inhibition of adrenal androgen production. J Pain 2006; 7: 901–907.
- 26 Panchal SJ, Muller-Schweffe P, Wurzelmann JI. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract 2007; 61: 1181–1187.
- 27 Banning A, Sjogren P. Cerebral effects of long-term oral opioids in cancer patients measured by continuous reaction time. Clin J Pain 1990; 6: 91–95.
- 28 Bowen JD, Larson EB. Drug-induced cognitive impairment defining the problem and finding solutions. Drugs Aging 1993; 3: 349–357.
- 29 Chapman S. The effects of opioids on driving ability in patients with chronic pain. APS Bull 2001; 11: 1–5.
- 30 Galski T, Williams JB, Ehle HT. Effects of opioids on driving ability. J Pain Symptom Manage 2000; 19: 200–208.
- 31 McCrimmon DR, Alheid GF. On the opiate trail of respiratory depression. Am J Physiol Regul Integr Comp Physiol 2003; 285: R1274–R1275.
- 32 Osler W. Brainy Quotes [online]. Retrieved March 4, 2008, from http://www.brainyquote.com/quotes/authors/w/william_osler.html.
- 33 Cousins MJ. Foreword. In: WE Fordyce, ed. Back Pain in the Workplace: Management of Disability in Nonspecific Conditions Task Force Report. Seattle, WA: International Association for the Study of Pain Press, 1995.
- 34 Turk DC, Burwinkle TM. Clinical outcomes, cost-effectiveness, and the role of psychology in treatments for chronic pain sufferers. Prof Psychol Res Pr 2005; 36: 602–610.
- 35 Sealy CN, Mortimer JT, Reswick KB. Electrical inhibition of pain by stimulation of dorsal column: preliminary clinical reports. Anesthesia Analgesia 1967; 4: 489–491.
- 36 Long D, Erickson D, Campbell J, North R. Electrical stimulation of the spinal cord and peripheral nerves for pain control. Appl Neurophysiol 1981; 44: 207–217.
- 37 De La Porte C, Van de Kelfe E. SCS in failed back surgery syndrome. Pain 1993; 52: 55–61.
- 38 Gybels J, Erdine S, Maeyaert J et al. Neuromodulation of pain. A consensus statement prepared by a task force of the European Federation of IASP Chapters (EFIC). Eur J Pain 1998; 2: 203–209.
- 39 Beltrutti D, Lamberto A, Barolat G et al. The psychological assessment of candidates for SCS for chronic pain management. Pain Pract 2004; 4: 204–221.
- 40 Heckler DR, Gatchel RJ, Lou L, Whitwork T, Bernstein D, Stowell AW. Presurgical behavioral medicine evaluation (PBME) for implantable devices for pain management: a 1-year prospective study. Pain Pract 2007; 7: 110–122.
- 41 Iglehart JK. Opinion polls on health care. N Engl J Med 1984; 310: 1616–1620.
- 42 Blendon RJ, Altman DE. Public attitudes about health-care costs; a lesson in national schizophrenia. N Engl J Med 1984; 311: 613–616.
- 43 Bedder MD, Burchiel K, Larson A. Cost analysis of two implantable narcotic deliver systems. J Pain Symptom Manage 1991; 6: 368–373.
- 44 Mueller-Schweffe G, Hassenbusch SJ, Reig E. Cost effectiveness of intrathecal therapy for pain. Neuromodulation 1999; 2: 77–87.
- 45 Hassenbusch SJ, Paice JA, Patt RB, Bedder MD, Bell GK. Cost effectiveness of intrathecal therapy. J Pain Symp Manage 1997; 14(Suppl.): S36–S48.
- 46 Lissovoy G, Brown RE, Halpern M, Hassenbusch SJ, Ross E. Cost-effectiveness of long-term intrathecal morphine therapy for pain associated with failed back surgery syndrome. Clin Ther 1997; 19: 96–112.
- 47 Kumar K, Hunter G, Demeria DD. Treatment of chronic pain by using intrathecal drug therapy compared with conventional pain therapies: a cost-effectiveness analysis. J Neurosurg 2002; 97: 803–810.
- 48 North R, Shipley J, Taylor RS. SCS versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, control trial. Neurosurgery 2007; 61: 361–369.
- 49 Andrell P, Ekre O, Eliasson T et al. Cost-effectiveness of SCS versus coronary artery bypass grafting in patients with severe angina pectoris—long-term results from the ESBY study. Cardiology 2003; 99: 20–24.
- 50 Taylor RJ, Taylor RS. SCS for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis. Int J Technol Assess Health Care 2005; 21: 351–358.
- 51 Taylor RS, Taylor RJ, Van Buyten JP, Buschser E, North R, Bayliss S. The cost effectiveness of SCS in the treatment of pain: a systemic review of the literature. J Pain Symptom Manage 2004; 27: 370–378.
- 52 Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg 2004; 100: 254–267.
- 53 Rosenow JM, Stanton-Hicks M, Rezai AR, Henderson JM. Failure modes of spinal cord stimulation hardware. J Neurosurg Spine 2006; 5: 183–190.
- 54 Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain 2004; 108: 137–147.
- 55 Henderson JM, Schade CM, Sasaki J, Caraway DL, Oakley JC. Prevention of mechanical failures in implanted SCS systems. Neuromodulation 2006; 9: 183–191.
- 56 Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of SCS, suggestions to improve outcome, and financial impact. J Neurosurg Spine 2006; 5: 191–203.
- 57 North RB, Kidd DH, Petrucci L, Dorsi MJ. SCS electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes. Part II—clinical outcomes. Neurosurgery 2005; 57: 990–996.
- 58 Follett KA, Boortz-Marx R, Drako JM et al. Prevention and management of intrathecal drug delivery and SCS system infections. Anesthesiology 2004; 100: 1582–1594.
- 59 Hornberger J, Kumar K, Verhulst E, Clark MA, Hernandez J. Rechargeable SCS versus nonrechargeable system for patients with failed back surgery syndrome: a cost-consequences analysis. Clin J Pain 2008; 24: 244–252.
- 60 A quote from Peter Drucker. Retrieved March 4, 2008, from http://thinkexist.com/quotation/efficiency_is_doing_things_right-effectiveness_is/218648.html.
- 61 Namaka M, Gramlich CR, Ruhlen D, Melanson M, Sutton I, Major J. A treatment algorithm for neuropathic pain. Clin Ther 2004; 26: 951–959.
- 62 Finnerup NB, Otto M, McQuay HJ, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain 2005; 118: 289–305.
- 63 Finnerup NB, Otto M, Jensen TS, Sindrup SH. An evidence-based algorithm for the treatment of neuropathic pain. Medscape General Medicine 2007; 9: 36.
- 64 Diamond GA, Denton TA. Alternative perspectives on the biased foundations of medical technology assessment. Ann Intern Med 1993; 118: 455–464.
- 65 Rabin J, Steinhauer M. Handbook on Human Services Administration. Boca Raton, FL: CRC Press, 1988.
- 66 Knox RA. Heart transplants; to pay or not to pay. Science 1980; 209: 570–575.
- 67 Dworkin RH, Turk DC, Farrar JT et al. Core Outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005; 113: 9–19.
- 68 Ford PJ, Henderson JM. The clinical and research ethics of neuromodulation. Neuromodulation 2006; 9: 250–252.
- 69 World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000; 284: 3043–3045.
- 70 Zundert JV. Clinical research in intervenional pain management techniques: the clinician's point of view. Pain Pract 2007; 7: 221–229.
- 71 Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. Br Med J1996; 312: 71–72.
- 72 Smith TJ, Staats PS, Deer T et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol 2002; 20: 4040–4049.
- 73 Thimineur MA, Kravitz E, Vodapally MS. Intrathecal opioid treatment for chronic non-malignant pain: a 3-year prospective study. Pain 2004; 109: 242–249.
- 74 North RB, Kidd DH, Farrokhi F, Piantadosi SA. SCS versus repeated lumbosacral spine surgery for chronic pain: a randomized controlled trial. Neurosurgery 2005; 56: 98–107.
- 75 Cabana MD, Rand CS, Powe NR et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999; 282: 1458–1465.
- 76 McDonnell Norms Group. Enhancing the use of clinical guidelines: a social norms perspective. J Am Coll Surg 2006; 202: 826–836.