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POST-IMPLEMENTATION SURVEILLANCE OF A NON-PHARMACOLOGICAL HEALTH TECHNOLOGY WITHIN A NATIONAL HEALTH SERVICE

Part of: Special Collection - Methods

Published online by Cambridge University Press:  07 May 2014

Carlos Campillo ,
Montserrat Casamitjana ,
Fernando Carrillo-Arias ,
Ana Royuela ,
Francisco M. Kovacs  and
Víctor Abraira
Carlos Campillo
Affiliation:
Ib-Salut
Montserrat Casamitjana
Affiliation:
Regió Sanitària de Barcelona. Consorci Sanitari de Barcelona; Servei Català de la Salut (CatSalut); Parc Sanitari Pere Virgili
Fernando Carrillo-Arias
Affiliation:
Servicio Madrileño de Salud (SERMAS); Consejería de Sanidad de Madrid
Ana Royuela
Affiliation:
CIBER Epidemiología y Salud Pública (CIBERESP); Unidad de Bioestadística Clínica. Hospital Ramón y Cajal. IRICYS; Spanish Back Pain Research Network
Francisco M. Kovacs
Affiliation:
Spanish Back Pain Research Network; Scientific Department, Kovacs Foundation
Víctor Abraira
Affiliation:
CIBER Epidemiología y Salud Pública (CIBERESP); Unidad de Bioestadística Clínica; Hospital Ramón y Cajal; IRICYS; Spanish Back Pain Research Network
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Abstract

Objectives: The aim of this study was to describe 8-year results from post-implementation surveillance of neuroreflexotherapy (NRT), a health technology proven effective for treating neck and back pain.

Methods: Post-implementation surveillance included all patients undergoing NRT across five regions within the Spanish National Health Service (SNHS). Validated methods were used to assess pain, disability, adverse events, use of health resources, and patient satisfaction. Logistic regression models were developed to identify the variables associated with the risk of a pain episode requiring more than one NRT intervention. The number of relapses among discharged patients during the 8-year period was calculated.

Results: Between January 1, 2004, and June 30, 2012, 9,023 patients (median age: 53 years), presenting 11,384 subacute (25.2 percent) and chronic (74.8 percent), neck or back pain episodes, were discharged after receiving NRT. Spinal pain improved in 89 percent of cases, 83 percent abandoned drugs, and 0.02 percent required spine surgery. The only adverse event was skin discomfort (8.0 percent of patients). Number of patient complaints was 0, and answers to a standardized questionnaire reflected a high degree of satisfaction (response rate: 76.7 percent). Of the pain episodes, 18.9 percent required more than one NRT intervention; logistic regression models identified the variables associated with this. Over the 8-year period, the proportion of discharged patients referred for treatment due to relapse at the same level for neck, thoracic, and low back pain, was 16.4 percent, 6.5 percent, and 14.5 percent respectively.

Conclusions: Post-marketing surveillance for a non-pharmacological technology is feasible within the SNHS. These results support generalizing NRT across the entire SNHS under the current validated application conditions.

Keywords

Post-implementation surveillanceRoutine practiceNeuroreflexotherapySpanish National Health ServiceNeck painBack pain
Type
Methods
Information
International Journal of Technology Assessment in Health Care , Volume 30 , Issue 2 , April 2014 , pp. 153 - 164
Copyright
Copyright © Cambridge University Press 2014 

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References

REFERENCES

1. Waddell, G. The back pain revolution. London: Churchill-Livingstone; 2004.Google Scholar
2. Andersson, G. The epidemiology of spinal disorders. In: Frymoyer, JW, ed. The adult spine: Principles and practice. Baltimore: Raven Press, Ltd; 1997:93–141.Google Scholar
3. Martin, BI, Deyo, RA, Mirza, SK, et al. Expenditures and health status among adults with back and neck problems. JAMA. 2008;299:656–664.Google Scholar
4. Dagenais, S, Caro, J, Haldeman, S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8:8–20.Google Scholar
5. Gore, M, Sadosky, A, Stacey, BR, Tai, KS, Leslie, D. The burden of chronic low back pain: Clinical comorbidities, treatment patterns, and healthcare costs in usual care settings. Spine (Phila Pa 1976). 2012;37:E668–677.CrossRefGoogle ScholarPubMed
6. Vos, T, Flaxman, AD, Naghavi, M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: A systematic analysis for the global burden of disease study 2010. Lancet. 2013;380:2163–2196.Google Scholar
7. Haldeman, S, Carroll, L, Cassidy, JD. Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010;52:424–427.Google Scholar
8. Airaksinen, O, Brox, JI, Cedraschi, C, et al. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006; 15(Suppl 2):S192–300.Google Scholar
9. Chou, R, Huffman, LH. Evaluation & management of low back pain: Evidence review for the American Pain Society. Portland: Oregon Evidence-based Practice Center; 2007 Google Scholar
10. Kovacs, FM, Abraira, V, Lopez-Abente, G, Pozo, F. [Neuro-reflexotherapy intervention in the treatment of non specified low back pain: A randomized, controlled, double-blind clinical trial]. Med Clin (Barc). 1993;101:570–575.Google Scholar
11. Kovacs, FM, Abraira, V, Pozo, F, et al. Local and remote sustained trigger point therapy for exacerbations of chronic low back pain. A randomized, double-blind, controlled, multicenter trial. Spine (Phila Pa 1976). 1997;22:786–797.Google Scholar
12. Kovacs, FM, Llobera, J, Abraira, V, et al. Effectiveness and cost-effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice: A cluster randomized, controlled trial. Spine (Phila Pa 1976). 2002;27:1149–1159.Google Scholar
13. Urrutia, G, Burton, K, Morral, A, Bonfill, X, Zanoli, G. Neuroreflexotherapy for nonspecific low back pain: A systematic review. Spine (Phila Pa 1976). 2011;30:E148–153.Google Scholar
14. Grupo, PINS. [Implementation of neuroreflexotherapy in the treatment of back pain. Results of a pilot trial]. Gac Sanit. 2004;18:275–286.Google Scholar
15. Corcoll, J, Orfila, J, Tobajas, P, Alegre, L. Implementation of neuroreflexotherapy for subacute and chronic neck and back pain within the Spanish public health system: Audit results after one year. Health Policy. 2006;79:345–357.Google Scholar
16. Pallicer, A, Corcoll, J, Orfila, J. Implementation and post-marketing surveillance of neuroreflexotherapy in the routine practice of the Spanish Public Health System. IX International Forum on Low Back Pain Research, Palma de Mallorca, October 2007, available at http://www.aemen.es/descargas/Implementationandpostmarketingsurveillanceofneuroreflexotherapy.pdf, accessed on April 15th, 2014Google Scholar
17. Kovacs, F, Abraira, V, Muriel, A, et al. Prognostic factors for neuroreflexotherapy in the treatment of subacute and chronic neck and back pain: A study of predictors of clinical outcome in routine practice of the Spanish National Health Service. Spine (Phila Pa 1976). 2007;32:1621–1628.Google Scholar
18. Campillo, C, Kovacs, F. The use of risk sharing tools for post adoption surveillance of a non pharmacological technology in routine practice: Results after one year. BMC Health Serv Res. 2013;13:181 doi:10.1186/1472-6963-13-181.Google Scholar
19. Kovacs, FM, Seco, J, Royuela, A, Corcoll, J, Abraria, V and the Spanish Back Pain Research Network. Predicting the evolution of low back pain patients in routine clinical practice. Results from a registry within the Spanish National Health Service. Spine J. 2012;12:1008–1020.Google Scholar
20. Instituto Nacional de Estadística [Spanish National Institute for Statistics]; [Population as of January 1st, 2010]. http://www.ine.es./ http://www.ine.es/jaxi/menu.do?type=pcaxis&path=%2Ft20%2Fe260%2Fa2010%2F&file=pcaxis&N=&L=0 (accesssed on January 30, 2013).Google Scholar
21. Huskisson, EC. Measurement of pain. Lancet. 1974;2:1127–1131.Google Scholar
22. AEMEN-Asociación Española de Médicos Neurorreflejoterapeutas [Spanish Association of Neuro-reflexotherapy Physicians]. [Certification standards]. http://aemen.es/criterios.html (accessed on January 24, 2013).Google Scholar
23. AEMEN-Asociación Española de Médicos Neurorreflejoterapeutas [Spanish Association of Neuro-reflexotherapy Physicians]. [Training standards] http://www.aemen.es/formacion.html (accessed January 24, 2013).Google Scholar
24. Deyo, RA, Battie, M, Beurskens, AJ, et al. Outcome measures for low back pain research. A proposal for standardized use. Spine (Phila Pa 1976). 1998;23:2003–2013.Google Scholar
25. Kovacs, FM, Llobera, J, Gil Del Real, MT, et al. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002;27:538–542.CrossRefGoogle ScholarPubMed
26. Kovacs, FM, Bago, J, Royuela, A, et al. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008;9:42.Google Scholar
27. Kovacs, FM, Abraira, V, Royuela, A, et al. Minimal clinically important change for pain intensity and disability in patients with nonspecific low back pain. Spine (Phila Pa 1976). 2007;32:2915–2920.Google Scholar
28. Kovacs, FM, Abraira, V, Royuela, A, et al. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. BMC Musculoskelet Disord. 2008;9:43.CrossRefGoogle ScholarPubMed
29. Pool, JJ, Ostelo, RW, Hoving, JL, Bouter, LM, de Vet, HC. Minimal clinically important change of the Neck Disability Index and the Numerical Rating Scale for patients with neck pain. Spine (Phila Pa 1976). 2007;32:3047–3051.Google Scholar
30. Kovacs, FM, Abraira, V, Zamora, J, Fernández, C and the Spanish Back Pain Research Network. The transition from acute to subacute and chronic low back pain. A study based on determinants of quality of life and prediction of chronic disability. Spine. 2005;30:1786–1792.Google Scholar
31. Merskey, H, Bogduk, N. Description of chronic pain syndromes and definitions of pain terms. In: Classification of chronic pain, 2nd ed. Seattle: IASP Press; 1994.Google Scholar
32. Kovacs, FM, Arana, E, Royuela, A, et al. Appropriateness of lumbar spine magnetic resonance imaging in Spain. Eur J Radiol. 2013;82:1008–1014.Google Scholar
33. Manchikanti, L, Singh, V, Datta, S, Cohen, SP, Hirsch, JA; American Society of Interventional Pain Physicians Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician. 2009;12:E35–70.Google Scholar
34. Mehling, WE, Gopisetty, V, Bartmess, E, et al. The prognosis of acute low back pain in primary care in the United States: A 2-year prospective cohort study. Spine (Phila Pa 1976). 2012;37:678–684.Google Scholar
35. Stanton, TR, Henschke, N, Maher, CG, et al. After an episode of acute low back pain, recurrence is unpredictable and not as common as previously thought. Spine. 2008;33:2923–2928.Google Scholar
36. Kovacs, FM, García, E, Royuela, A, González, L, Abraira, V, and the Spanish Back Pain Research Network. Prevalence and factors associated with low back pain and pelvic girdle pain during pregnancy. A multicenter study conducted in the Spanish National Health Service. Spine. 2012;37:1516–1533.CrossRefGoogle ScholarPubMed
37. Hayden, JA, Dunn, KM, van der Windt, DA, Shaw, WS. What is the prognosis of back pain? Best Pract Res Clin Rheumatol. 2010;24:167–179.Google Scholar
38. Itz, CJ, Geurts, JW, van Kleef, M, Nelemans, P. Clinical course of non-specific low back pain: A systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17:5–15.CrossRefGoogle ScholarPubMed
39. Karstens, S, Hermann, K, Froböse, I, Weiler, SW. Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: A prospective observational study. PLoS One. 2013;8:e61587. doi: 10.1371/journal.pone.0061587. Print 2013.Google Scholar
40. Scheele, J, Luijsterburg, PA, Bierma-Zeinstra, SM, Koes, BW. Course of back complaints in older adults: A systematic literature review. Eur J Phys Rehabil Med. 2012;48:379–86.Google Scholar
41. Verkerk, K, Luijsterburg, PA, Heymans, MW, et al. Prognosis and course of disability in patients with chronic nonspecific low back pain: A 5- and 12-month follow-up cohort study. Phys Ther. 2013;93:16503–1614.Google Scholar
42. Albadalejo, C, Kovacs, FM, Royuela, A, et al. The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care. A cluster randomized trial. Spine. 2010;35:483–496.Google Scholar
43. Kovacs, FM, Muriel, A, Abraira, V, et al. The influence of fear avoidance beliefs on disability and quality of life is sparse in Spanish low back pain patients. Spine. 2005;30:E676–682.Google Scholar
44. Kovacs, F, Abraira, V, Cano, A, et al. Fear Avoidance Beliefs do not influence disability and quality of life in Spanish elderly subjects with low back pain. Spine. 2007;32:2133–2138.Google Scholar
45. Kovacs, F, Abraira, V, Santos, S, et al. A comparison of two short education programs for improving low back pain-related disability in the elderly. A cluster randomized controlled trial. Spine. 2007;32:1053–1059.CrossRefGoogle ScholarPubMed
46. Kovacs, FM, Noguera, J, Abraira, V, et al. The influence of psychological factors on low back pain-related disability in community-dwelling older persons. Pain Med. 2008;9:871–880.Google Scholar
47. Kovacs, FM, Seco, J, Royuela, A, Corcoll, J, Peña, A, and the Spanish Back Pain Research Network. The prognostic value of catastrophizing for predicting the clinical evolution of low back pain patients. A study in routine clinical practice within the Spanish National Health Service [NCT00502333]. Spine J. 2012;12:545–555.Google Scholar
48. Kovacs, FM, Fernandez, C, Cordero, A, Muriel, A, González-Luján, L, and the Spanish Back Pain Research Network. Non-specific low back pain in primary care in the Spanish National Health Service: A prospective study on clinical outcomes and determinants of management. BMC Health Serv Res. 2006;6:57.Google Scholar
49. Heymans, MW, van Buuren, S, Knol, DL, et al. The prognosis of chronic low back pain is determined by changes in pain and disability in the initial period. Spine J. 2010;10:847–856.Google Scholar
50. Grupo de Variaciones de la Práctica Médica de la Red temática de Investigación en Resultados y Servicios de Salud (Grupo VPM-IRYS). [Variations in orthopedic surgery across the Spanish National Health Service]. Atlas de Variaciones en la Práctica Médica en el Sistema Nacional de Salud. Valencia: Fundación IISS; 2005:17–37.Google Scholar
51. Carragee, EJ, Deyo, RA, Kovacs, FM, et al. Clinical research. Is the spine field a mine field? Spine. 2009;34:423–430.CrossRefGoogle Scholar
52. Spanish Medical Association, Kovacs Foundation. [Recommendations for improving the adoption of medical innovations within the Spanish Health Service], www.adopcioninnovacionessanitarias.org (accessed March 3, 2013).Google Scholar
53. Serrano-Aguilar, P, Kovacs, FM, Cabrera-Hernández, JM, Ramos-Goñi, JM, García-Pérez, L. Avoidable costs of physical treatments for chronic back, neck and shoulder pain within the Spanish National Health Service: A cross-sectional study. BMC Musculoskel Disord. 2011;12:287. doi:10.1186/1471-2474-12-287.Google Scholar
54. Deyo, RA. Gaps, tensions, and conflicts in the FDA approval process: Implications for clinical practice. J Am Board Fam Pract. 2004;17:142–149.Google Scholar
55. Weiner, AK, Levi, BH. The profit motive and spine surgery. Spine. 2004;29:2588–2591 Google Scholar
56. Smith, R. Medical journals and pharmaceutical companies: Uneasy bedfellows. BMJ. 2003;326:1202–1205.Google Scholar
57. Smith, R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2005;2:e138.Google Scholar
58. Shah, RV, Todd, JA, Bruegel-Sanchez, V, et al. Industry support and correlation to study outcome for papers published in Spine. Spine. 2005;30:1099–1104.Google Scholar
59. Carragee, EJ, Hurwitz, EL, Weiner, BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: Emerging safety concerns and lessons learned. Spine J. 2011;11:471–491.Google Scholar
60. Kmietowicz, Z. Senators question Medtronic about unreported side effects of spinal protein. BMJ. 2011;343:d4284. doi: 10.1136 /bmj.d4284.CrossRefGoogle ScholarPubMed
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