rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.14412/1995-4484-2015-564-567rsp-2134Research ArticleРЕВМООРТОПЕДИЯ И РЕАБИЛИТАЦИЯORTHOPEDIC RHEUMATOLOGY AND REHABILITATIONПроблемы применения принципов доказательной медицины в медицинской реабилитации ревматических заболеванийPROBLEMS IN THE APPLICATION OF PRINCIPLES OF EVIDENCE-BASED MEDICINE TO THE MEDICAL REHABILITATION OF RHEUMATIC DISEASESСухареваМ. Л.SukharevaM. L.marina-su@mail.ruДубининаТ. В.DubininaT. V.ЭрдесШ. Ф.ErdesSh. F.АгасаровЛ. Г.AgasarovL. G.V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522Russian FederationФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой, Москва, Россия 121099 Москва, ул. Новый Арбат, 32РоссияV.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522Russian FederationФГБУ «Российский научный центр медицинской реабилитации и курортологии» Минздрава России, Москва, Россия 121099 Москва, ул. Новый Арбат, 32РоссияRussian Research Center for Medical Rehabilitation and Balneology, Ministry of Health of Russia, Moscow, Russia 32, Novyi Arbat St., Moscow 121099Russian Federation201514102015535564567Copyright © Сухарева М.Л., Дубинина Т.В., Эрдес Ш.Ф., Агасаров Л.Г., 20152015Сухарева М.Л., Дубинина Т.В., Эрдес Ш.Ф., Агасаров Л.Г.Sukhareva M.L., Dubinina T.V., Erdes S.F., Agasarov L.G.This work is licensed under a Creative Commons Attribution 4.0 License.https://rsp.mediar-press.net/rsp/article/view/2134

Проанализированы основные проблемы проведения рандомизированных контролируемых исследований в медицинской реабилитации: отбор пациентов, использование имитационных устройств в качестве плацебо, стандартизация методов, процедура «ослепления». Представлены методологические соображения по повышению качества исследований.

The paper analyzes the main problems associated with randomized controlled studies in medical rehabilitation: patient selection; use of simulation devices as placebo; standardization of methods; blinding procedure. It presents methodological considerations for improving the quality of studies.

медицинская реабилитацияревматические заболеваниядоказательная медицинарандомизированные контролируемые исследованияmedical rehabilitationrheumatic diseasesevidence-based medicinerandomized controlled studiesReferencesZhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–62. doi: 10.1016/j.joca.2007.12.013Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–62. doi: 10.1016/j.joca.2007.12.013Vliet Vlieland TP, van den Ende CH. Nonpharmacological treatment of rheumatoid arthritis. Cur Opin Rheumatol. 2001;23(3):259–64. doi: 10.1097/BOR.0b013e32834540fbVliet Vlieland TP, van den Ende CH. Nonpharmacological treatment of rheumatoid arthritis. Cur Opin Rheumatol. 2001;23(3):259–64. doi: 10.1097/BOR.0b013e32834540fbBraun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70:896–904. doi:10.1136/ard.2011.151027Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70:896–904. doi:10.1136/ard.2011.151027Villamar MF, Contreras VS, Kuntz RE, Fregni F. The reporting of blinding in physical medicine and rehabilitation randomized controlled trials: a systematic review. J Rehabil Med. 2013;45(1):6–13. doi: 10.2340/16501977-1071Villamar MF, Contreras VS, Kuntz RE, Fregni F. The reporting of blinding in physical medicine and rehabilitation randomized controlled trials: a systematic review. J Rehabil Med. 2013;45(1):6–13. doi: 10.2340/16501977-1071Mayo NE, Goldberg MS. When is a case-control study not a case-control study? J Rehabil Med. 2009;41(4):209–16. doi: 10.2340/16501977-0343Mayo NE, Goldberg MS. When is a case-control study not a case-control study? J Rehabil Med. 2009;41(4):209–16. doi: 10.2340/16501977-0343CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:869. doi: http://dx.doi.org/10.1136/bmjCONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:869. doi: http://dx.doi.org/10.1136/bmjFregni F, Imamura M, Chien HF, et al. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group. Am J Phys Med Rehabil. 2010;89:160–172. doi: 10.1097/PHM.0b013e3181bc0bbdFregni F, Imamura M, Chien HF, et al. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group. Am J Phys Med Rehabil. 2010;89:160–172. doi: 10.1097/PHM.0b013e3181bc0bbdWitt CM, Aichin M, Cherkin D, et al. Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document. Trials. 2014 May 13;15:169. doi: 10.1186/1745-6215-15-169Witt CM, Aichin M, Cherkin D, et al. Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document. Trials. 2014 May 13;15:169. doi: 10.1186/1745-6215-15-169MacPherson H, White A, Cummings M, et al. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture. Acupunct Med. 2002;20(1):22–5. doi: 10.1136/aim.20.1.22MacPherson H, White A, Cummings M, et al. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture. Acupunct Med. 2002;20(1):22–5. doi: 10.1136/aim.20.1.22Fregni F, Boggio PS, Lima MC, et al. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006;122:197–209. doi: 10.1016/j.pain.2006.02.023Fregni F, Boggio PS, Lima MC, et al. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006;122:197–209. doi: 10.1016/j.pain.2006.02.023Kaptchuk TJ, Stason WB, Davis RB. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006;332: 391–7. doi: 10.1136/bmj.38726.603310.55Kaptchuk TJ, Stason WB, Davis RB. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006;332: 391–7. doi: 10.1136/bmj.38726.603310.55Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006;117:845–50. doi: 10.1016/j.clinph.2005.12.003Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006;117:845–50. doi: 10.1016/j.clinph.2005.12.003Gerdesmeyer L, Frey C, Vester J, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008;36:2100–09. doi: 10.1177/0363546508324176Gerdesmeyer L, Frey C, Vester J, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008;36:2100–09. doi: 10.1177/0363546508324176Witt CM, Aickin M, Baca T, et al. Effectiveness guidance document (EGD) for acupuncture research – a consensus document for conducting trials. Trials. 2014;15:169. doi: 10.1186/1745-6215-15-169Witt CM, Aickin M, Baca T, et al. Effectiveness guidance document (EGD) for acupuncture research – a consensus document for conducting trials. Trials. 2014;15:169. doi: 10.1186/1745-6215-15-169Brosseau L, Casimiro L, Robinson V, et al. Therapeutic ultrasound for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2001;(4):CD003375. doi: 10.1002/14651858.cd003375Brosseau L, Casimiro L, Robinson V, et al. Therapeutic ultrasound for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2001;(4):CD003375. doi: 10.1002/14651858.cd003375Vickers AJ, de Craen AJ. Why use placebos in clinical trials? A narrative review of the methodological literature. J Clin Epidemiol. 2000;53:157–61. doi: 10.1016/S0895-4356(99)00139-0Vickers AJ, de Craen AJ. Why use placebos in clinical trials? A narrative review of the methodological literature. J Clin Epidemiol. 2000;53:157–61. doi: 10.1016/S0895-4356(99)00139-0Kaptchuk TJ, Goldman P, Stone DA, et al. Do medical devices have enhanced placebo effects? J Clin Epidemiol. 2000;53:786–92. doi: 10.1016/S0895-4356(00)00206-7Kaptchuk TJ, Goldman P, Stone DA, et al. Do medical devices have enhanced placebo effects? J Clin Epidemiol. 2000;53:786–92. doi: 10.1016/S0895-4356(00)00206-7Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002;136:817–25. doi: 10.7326/0003-4819-136-11-200206040-00011Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002;136:817–25. doi: 10.7326/0003-4819-136-11-200206040-00011Khan A, Warner HA, Brown WA. Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration database. Arch Gen Psychiatry. 2000;57:311–7. doi: 10.1001/archpsyc. 57.4.311Khan A, Warner HA, Brown WA. Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration database. Arch Gen Psychiatry. 2000;57:311–7. doi: 10.1001/archpsyc. 57.4.311Langevin HM, Wayne PM, MacPherson H, et al. Paradoxes in acupuncture research: strategies for moving forward. Evidence- Based Complem Alternat Med. 2011;2011:Article ID 180805, 11 p. doi: 10.1155/2011/180805Langevin HM, Wayne PM, MacPherson H, et al. Paradoxes in acupuncture research: strategies for moving forward. Evidence- Based Complem Alternat Med. 2011;2011:Article ID 180805, 11 p. doi: 10.1155/2011/180805Spadaro A, De Luca T, Massimiani MP, et al. Occupational therapy in ankylosing spondylitis: Short-term prospective study in patients treated with anti-TNF-alpha drugs. Joint Bone Spine. 2008;75(1):29–33. doi: 10.1016/j.jbspin.2007.07.006Spadaro A, De Luca T, Massimiani MP, et al. Occupational therapy in ankylosing spondylitis: Short-term prospective study in patients treated with anti-TNF-alpha drugs. Joint Bone Spine. 2008;75(1):29–33. doi: 10.1016/j.jbspin.2007.07.006Berezne A, Seror R, Morell-Dubois S, et al. Impact of systemic sclerosis on occupational and professional activity with attention to patients with digital ulcers. Arthritis Care Res (Hoboken). 2011;63(2):277–85. doi: 10.1002/acr.20342Berezne A, Seror R, Morell-Dubois S, et al. Impact of systemic sclerosis on occupational and professional activity with attention to patients with digital ulcers. Arthritis Care Res (Hoboken). 2011;63(2):277–85. doi: 10.1002/acr.20342Targino RA, Imamura M, Kaziyama HH, et al. A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia. J Rehabil Med. 2008;40: 582–8. doi: 10.2340/16501977-0216Targino RA, Imamura M, Kaziyama HH, et al. A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia. J Rehabil Med. 2008;40: 582–8. doi: 10.2340/16501977-0216Дубинина ТВ, Подряднова МВ, Красненко СО, Эрдес ШФ. Лечебная физкультура при анкилозирующем спондилите: рекомендации и реальность. Научно-практическая ревматология. 2014;52(2):187–91 [Dubinina TV, Podryadnova MV, Krasnenko SO, Erdes ShF. Therapeutic exercise for patients with ankylosing spondylitis: recommendations and reality. Nauchnoprakticheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(2):187–91 (In Russ.)]. doi: 10.14412/1995- 4484-2014-187-191Дубинина ТВ, Подряднова МВ, Красненко СО, Эрдес ШФ. Лечебная физкультура при анкилозирующем спондилите: рекомендации и реальность. Научно-практическая ревматология. 2014;52(2):187–91 [Dubinina TV, Podryadnova MV, Krasnenko SO, Erdes ShF. Therapeutic exercise for patients with ankylosing spondylitis: recommendations and reality. Nauchnoprakticheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(2):187–91 (In Russ.)]. doi: 10.14412/1995- 4484-2014-187-191

The authors declare that there are no conflicts of interest present.