Skip to main content

Klinische Studien zur multimodalen Schmerztherapie

Standardisierte Therapieeffektmessung mit einem „Core Outcome Set“

Clinical studies on multimodal pain therapy

Standardized measurement of therapy outcomes with a core outcome set

Zusammenfassung

Allokationsentscheidungen gründen sich auf Angaben zu den Effekten einer Intervention sowie zu deren Effektivität und Sicherheit in bestimmten Patientenpopulationen. Typischerweise gehen dabei Ergebnisse zu Therapieeffekten aus unterschiedlichen Studien ein. Eine wesentliche Hürde stellen in diesem Kontext Studien dar, die Therapieeffekte meist uneinheitlich messen und folglich eine Vergleichbarkeit nicht zulassen. Für sämtliche medizinische Versorgungsbereiche – so auch für die multimodale Schmerztherapie (MMST) – existieren solche methodischen Herausforderungen. Mithilfe eines „Core Outcome Sets“ (COS) soll eine notwendige Standardisierung der Effektivitätsmessung in der klinischen Forschung erreicht werden. Ein COS ist ein evidenzbasiertes und konsentiertes Minimumset, das in jeder klinischen Studie gemessen werden sollte. Es besteht aus Outcome-Domänen – d. h., Teilaspekten des zu untersuchenden Krankheitszustands, die gemessen werden sollten, um Therapieeffekte bestmöglich abbilden zu können – sowie aus dazugehörigen validen, reliablen und änderungssensitiven Messinstrumenten. Ein explizit für die MMST erarbeitetes COS für klinische Studien liegt derzeit nicht vor. Ein Ziel des Beitrags ist, zunächst einen Überblick über gegenwärtig empfohlene methodische Vorgehensweisen zur Entwicklung von COS zu geben. Darauf aufbauend wird anhand einer Bestandsaufnahme illustriert, welche diversen COS-Initiativen zu unterschiedlichen Schmerzsyndromen existieren. Zusätzlich werden die jeweiligen COS-Empfehlungen gegenübergestellt, um daran anknüpfend abzuleiten, ob die existierenden Empfehlungen für die MMST angewendet werden können. Abschließend wird anhand der Situation in Deutschland aufgezeigt, welchen Beitrag bisher die Versorgungsforschung zur einheitlichen Messung der Therapieeffekte der MMST leistet.

Abstract

Decision making in evidence-based medicine is based on general data on therapy outcomes as well as the effectiveness and safety in specific patient populations. Typically, findings concerning therapy outcomes from different studies are aggregated for a final conclusion. In this context a comparison of results is hampered by studies in which therapy outcomes are heterogeneously measured. Such methodological challenges exist for almost all areas of medical treatment, as well as for multimodal pain therapy (MMPT). Through establishing core outcome sets (COS) the required standardization of measurement of therapy outcomes in clinical research can be achieved. A COS is an evidence-based and consented minimum set consisting of outcome domains (i.e. partial aspects of the medical condition to be investigated, which have to be measured in order to give the best possible demonstration of therapy outcome of an intervention) accomplished by valid, reliable and sensitive measurement instruments which should be applied in each clinical trial. No such COS has so far been found for MMPT. The aim of this article is to give an overview about currently recommended methodological approaches to develop a COS accompanied by a brief introduction about existing COS initiatives focusing on chronic pain. The existing COS recommendations are discussed and conclusions are drawn on whether existing recommendations could also be applied for MMPT. Finally, the impact of healthcare research in Germany on a standardized assessment of therapy outcome in MMPT is outlined.

This is a preview of subscription content, access via your institution.

Abb. 1
Abb. 2

Literatur

  1. https://arzneimittel.aok.de/. Zugegriffen: 18. Febr. 2016

  2. Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L, Martin SA (2008) Patient perspectives on the impact of fibromyalgia. Patient Educ Couns 73(1):114–120

    PubMed  PubMed Central  Article  Google Scholar 

  3. Arnold B, Brinkschmidt T, Casser HR, Gralow I, Irnich D, Klimczyk K, Müller G, Nagel B, Pfingsten M, Schiltenwolf M, Sittl R, Söllner W (2009) Multimodale Schmerztherapie – Konzepte und Indikation. Schmerz 23(2):112–120

    CAS  PubMed  Article  Google Scholar 

  4. Ballantyne JC, Sullivan MD (2015) Intensity of chronic pain-the wrong metric? N Engl J Med 373(22):2098–2099

    CAS  PubMed  Article  Google Scholar 

  5. Boers M, Kirwan JR, Tugwell P, Beaton D, Bingham III CO, Conaghan PG D’Agostino M‑A, Gossec L, March L, Simon LS, Singh JA, Strand V, Wells G (2014) The OMERACT Handbook. OMERACT

  6. Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, D’Agostino MA, Conaghan PG, Bingham CO, Brooks P, Landewé R, March L, Simon LS, Singh JA, Strand V, Tugwell P (2014) Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 67(7):745–753

    PubMed  Article  Google Scholar 

  7. Bombardier C (2000) Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine 25(24):3100–3103

    CAS  PubMed  Article  Google Scholar 

  8. Borys C, Lutz J, Strauss B, Altmann U (2015) Effectiveness of a multimodal therapy for patients with chronic low back pain regarding pre-admission healthcare utilization. PLOS ONE 10(11):e0143139. doi:10.1371/journal.pone.0143139

    PubMed  PubMed Central  Article  Google Scholar 

  9. Brömme J, Mohokum M, Disch AC, Marnitz U (2015) Interdisziplinäre, multimodale Schmerztherapie vs. konventionelle Therapie. Eine Kostenanalyse bei Patienten mit chronischen Rückenschmerzen. Schmerz 29(2):195–202

    PubMed  Article  Google Scholar 

  10. Buchner M, Zahlten-Hinguranage A, Schiltenwolf M, Neubauer E (2006) Therapy outcome after multidisciplinary treatment for chronic neck and chronic low back pain: a prospective clinical study in 365 patients. Scand J Rheum 35(5):363–367

    CAS  PubMed  Article  Google Scholar 

  11. Casser HR, Hüppe M, Kohlmann T, Korb J, Lindena G, Maler C, Nagel B, Pfingsten M, Thoma R (2012) Deutscher Schmerzfragebogen (DSF) und standardisierte Dokumentation mit KEDOQ-Schmerz. Schmerz 26(2):168–175

    CAS  PubMed  Article  Google Scholar 

  12. http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/. Zugegriffen: 18. Febr. 2016

  13. Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, Costa LOP, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CWC, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, Tulder MW van, Ostelo RW (2015) Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J 24:1127–1142

    PubMed  Article  Google Scholar 

  14. Clarke M (2007) Standardising outcomes for clincal trials and systematic reviews. Trials 8:39

    PubMed  PubMed Central  Article  Google Scholar 

  15. Deckert S, Kaiser U, Kopkow C, Trautmann F, Sabatowski R, Schmitt J (2016) A systematic review of the outcomes reported in multimodal pain therapy for chronic pain. Eur J Pain 20(1):51–63

    CAS  PubMed  Article  Google Scholar 

  16. Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Korff M von, Waddell G (1998) Outcome measures for low back pain research. A proposal for standardized use. Spine 23:2003–2013

    CAS  PubMed  Article  Google Scholar 

  17. Dworkin RH, Laurie BB, Gewandter JS, Smith SM (2015) Reliability is necessary but far from sufficient: how might the validity of pain ratings be improved? Clin J Pain 31:599–602

    PubMed  Article  Google Scholar 

  18. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stuckig G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath PJ, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J (2005) Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 113:9–19

    PubMed  Article  Google Scholar 

  19. Gargon E, Gurung B, Medley N, Altmann DG, Blazeby JM, Clarke M, Williamson PR (2014) Choosing important health outcomes for comparative effectiveness research: A systematic review. PLOS ONE 9(6):e99111. doi:10.1371/journal.pone.0099111

    PubMed  PubMed Central  Article  Google Scholar 

  20. Gaul C, Doorn C van, Webering N, Dlugaj M, Katsarava Z, Diener HC, Fritsche G (2011) Clinical outcome of a headache-specific multidisciplinary treatment program and adherence to treatment recommendations in a tertiary headache center: an observational study. J Headache Pain 12(4):475–483

    PubMed  PubMed Central  Article  Google Scholar 

  21. Gockel HH, Maier C (2000) Quast-Auswertungsorientiertes EDV-System zur Dokumentation und Qualitätssicherung in der Schmerztherapie. Schmerz 14(6):401–415

    CAS  PubMed  Article  Google Scholar 

  22. Gossec L, Kirwan J, Wit M de (2013) Patient perspective in outcome measures developed by OMERACT. Indian J Rheumatol 8:S17–S22

    Article  Google Scholar 

  23. Hafenbrack K, Heinrich M, Müller G, Marnitz U, Mallwitz J, Klinger R (2013) Effekte eines interdisziplinären Functional-restoration-Behandlungsprogramms mit kognitiv-behavioraler Therapie beim chronischen Rückenschmerz. Schmerz 27(6):566–576

    CAS  PubMed  Article  Google Scholar 

  24. Häuser W, Bock F, Engeser P, Hege-Scheuing G, Hüppe M, Lindena G, Maier C, Norda H, Radbruch L, Sabatowski R, Schäfer M, Schiltenwolf M, Schuler M, Sorgatz H, Tölle T, Willweber-Strumpf A, Petzke F (2015) Empfehlungen der aktualisierten Leitlinie LONTS. Schmerz 29(1):109–130

    PubMed  Article  Google Scholar 

  25. Hechler T, Dobe M, Zernikow B (2013) Is it all worthwhile? Effectiveness of intensive interdisciplinary pain treatment. In: Dobe M, Zernikow B (Hrsg) Practical treatment options for chronic pain in children and adolescents. Springer, Heidelberg, S 215–228

    Chapter  Google Scholar 

  26. Hildebrandt J, Pfingsten M (2009) Vom GRIP zur multimodalen Schmerztherapie. Orthopade 38(10):885–895

    CAS  PubMed  Article  Google Scholar 

  27. http://www.comet-initiative.org. Zugegriffen: 18. Febr. 2016

  28. Huge V, Schloderer U, Steinberger M, Wuenschmann B, Schöps P, Beyer A, Azad SC (2006) Impact of a functional restoration program on pain and health-related quality of life in patients with chronic low back pain. Pain Med 7(6):501–508

    PubMed  Article  Google Scholar 

  29. Idzerda L, Radar T, Tugwell P, Boers M (2014) Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets. J Rheumatol 41(5):986–993

    PubMed  Article  Google Scholar 

  30. Kabisch M, Ruckes C, Seibert-Grafe M, Blettner M (2011) Randomisierte kontrollierte Studien. Teil 17 zur Bewertung wissenschaftlicher Publikationen. Dtsch Arztebl 108(39):663–668

    Google Scholar 

  31. Kaiser U, Deckert S, Kopkow C, Schmitt J, Sabatowski R (2014) Dose or content? Effectiveness of pain rehabilitation programs for patients with chronic low back pain: a systematic review. Waterschoot et al., Pain 155 (2014) 179–189. Pain 155(9):1903–1904

    PubMed  Article  Google Scholar 

  32. Kaiser U, Kopkow C, Deckert S, Sabatowski R, Schmitt J (2015) Validation and application of a core set of patient-relevant outcome domains to assess the effectiveness of multimodal pain therapy (VAPAIN) – a study protocol. BMJ Open 5:e008146. doi:10.1136/bmjopen-2015-008146

    PubMed  PubMed Central  Article  Google Scholar 

  33. Kaiser U, Sabatowski R, Azad SC (2015) Multimodale Schmerztherapie- eine Standortbestimmung. Schmerz 29(5):550–556

    CAS  PubMed  Article  Google Scholar 

  34. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, Tulder MW van (2014) Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev 2014(9):CD000963. doi:10.1002/14651858.CD000963.pub3

    Google Scholar 

  35. Macefield RC, Jacobs M, Korfage IJ, Nicklin J, Whistance RN, Brookes ST, Sprangers MAG, Blazeby JM (2014) Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials 15:49

    PubMed  PubMed Central  Article  Google Scholar 

  36. Mattenklodt P, Ingenhorst A, Wille C, Flatau B, Hafner C, Geiss C, Sittl R, Ulrich K, Griessinger N (2008) Multimodale Gruppentherapie bei Senioren mit chronischen Schmerzen. Schmerz 22:551–561

    CAS  PubMed  Article  Google Scholar 

  37. Mayer T, Gatchel RJ (1988) Functional restoration in spinal disorders: the sports medicine approach. Lea & Febiger, Philadelphia

    Google Scholar 

  38. McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, Baeyer CL von, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L (2008) Core outcome domains and measures for pediatric acute chronic/recurrent pain clinical trails: pedIMMPACT recommendations. J Pain 9(9):771–783

    PubMed  Article  Google Scholar 

  39. Mease P, Arnold LM, Choy EH, Clauw DJ, Crofford L, Glass JM, Martin SA, Morea J, Simon L, Strand V, Williams DA, OMERACT Fibromyalgia Working Group (2009) Fibromyalgia syndrome module at OMERACT 9. J Rheumatol 36(10):2318–2329

    PubMed  PubMed Central  Article  Google Scholar 

  40. Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russel IJ, Humphrey L, Abetz L, Martin SA (2008) Identifying the clinical domains of fibromyalgia: contributions from clinician and patient delphi excercises. Arthritis Rheum 59(7):952–960

    PubMed  Article  Google Scholar 

  41. Merle C, Brendle S, Wang H, Streit MR, Gotterbarm T, Schiltenwolf M (2014) Multidisciplinary treatment in patients with persistent pain following total hip and knee arthroplasty. J Arthroplasty 29(1):28–32

    PubMed  Article  Google Scholar 

  42. Moradi B, Hagmann S, Zahlten-Hinguranage A, Caldeira F, Putz C, Rosshirt N, Schonit E, Mesrian A, Schiltenwolf M, Neubauer E (2012) Efficacy of multidisciplinary treatment for patients with chronic low back pain: a prospective clinical study in 395 patients. J Clin Rheumatol 18(2):76–82

    PubMed  Article  Google Scholar 

  43. Nagel B (2009) Multimodale Therapie des Rückenschmerzes. Orthopade 38:907–912

    CAS  PubMed  Article  Google Scholar 

  44. Nagel B, Gerbershagen HU, Lindena G, Pfingsten M (2002) Entwicklung und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS. Schmerz 16(4):263–270

    CAS  PubMed  Article  Google Scholar 

  45. Nagel B, Pfingsten M, Brinkschmidt T, Casser HR, Gralow I, Irnich D, Klimczyk K, Sabatowski R, Schiltenwolf M, Sittl R (2012) Struktur- und Prozessqualität multimodaler Schmerztherapie. Schmerz 26(6):661–669

    CAS  PubMed  Article  Google Scholar 

  46. Pfaff H, Schrappe M (2011) Einführung in die Versorgungsforschung. In: Pfaff H, Neugebauer EAM, Glaeske G, Schrappe M (Hrsg) Lehrbuch Versorgungsforschung: Systematik–Methodik–Anwendung. Schattauer, Stuttgart, S 1–39

    Google Scholar 

  47. Pöhlmann K, Tonhauser T (2009) Die Multimodale Schmerztherapie Dachau (MSD). Schmerz 23(1):40–46

    PubMed  Article  Google Scholar 

  48. Prinsen CAC, Vohra S, Rose MR, King-Jones S, Ishaque S, Bhaloo Z, Adams D, Terwee CB (2014) Core outcome measures in effectiveness trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a „core outcome set“. Trials 15(1):247

    PubMed  PubMed Central  Article  Google Scholar 

  49. Reneman MF, Beemster TT, Edelaar MJA, Velzen JM van, Bennekom C van, Escorpizo R (2013) Towards an ICF-and IMMPACT-based pain vocational rehabilitation core set in the Netherlands. J Occup Rehabil 23(4):576–584

    CAS  PubMed  Article  Google Scholar 

  50. Scascighini L, Toma V, Dober-Spielmann S, Sprott H (2008) Multidisciplinary treatment for chronic pain: a systematic review of interventions and outcomes. Rheumatology 47:670–678

    CAS  PubMed  Article  Google Scholar 

  51. Schatman M (2012) Interdisciplinary chronic pain management: international perspectives. Pain Clin Updates 20(7):1–5

    Google Scholar 

  52. Schmitt J, Apfelbacher C, Spuls P, Thomas K, Simpson E, Masutaka F, Chalmers J, Wiliams H (2014) The harmonising outcomes for eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology. J Invest Dermatol 135(1):24–30

    PubMed  Article  Google Scholar 

  53. Schmitt J, Langan S, Stamm T, Williams HC (2011) Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Invest Dermatol 131(3):623–630

    CAS  PubMed  Article  Google Scholar 

  54. Schütze A, Kaiser U, Ettrich U, Große K, Goßrau G, Schiller M, Pöhlmann K, Brannasch K, Scharnagel R, Sabatowski R (2009) Evaluation einer multimodalen Schmerztherapie am UniversitätsSchmerzCentrum Dresden. Schmerz 23:609–617

    PubMed  Article  Google Scholar 

  55. Simang M, Schopper M, Mansmann U, Irnich D (2010) Evaluation of the Munich outpatient program in complementary and alternative medicine for chronic back pain (MOCAM BACK PAIN). Eur J Integr Med 2(4):241

    Article  Google Scholar 

  56. Sinha IP, Smyth RL, Williamson PR (2011) Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med 8(1):e1000393. doi:10.1371/journal.pmed.1000393

    PubMed  PubMed Central  Article  Google Scholar 

  57. Smelt AFH, Louter MA, Kies DA, Blom JW, Terwindt GM, Heijden GJMG van der, Gucht V de, Ferrari MD, Assendelft WJJ (2014) What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLOS ONE 9(6):e98933. doi:10.1371/journal.pone.0098933

    PubMed  PubMed Central  Article  Google Scholar 

  58. Smith SM, Hunsinger M, McKeown A, Parkhurst M, Allen R, Kopko S, Lu Y, Wilson HD, Burke LB, Desjardins P (2015) Quality of pain intensity assessment reporting: ACTTION systematic review and recommendations. J Pain 16(4):299–305

    PubMed  Article  Google Scholar 

  59. Terwee CB, Bot SD, Boer MR de, Windt DA van der, Knol DL, Dekker J, Bouter LM, Vet HC de (2007) Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60(1):34–42

    PubMed  Article  Google Scholar 

  60. Tugwell P, Bombardier C (1982) A Methodologic framework for developing and selecting endpoints in clinical trials. J Rheumatol 9(5):753–757

    PubMed  Google Scholar 

  61. Turk DC, Dworkin RH, Revicki D, Harding G, Burke LB, Cella D, Cleeland CS, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA (2008) Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain. Pain 137:276–285

    PubMed  Article  Google Scholar 

  62. Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J (2003) Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 106(3):337–345

    PubMed  Article  Google Scholar 

  63. Tulder MW van, Koes BW, Bouter LM (1997) Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine 22(18):2128–2156

    PubMed  Article  Google Scholar 

  64. Waterschoot FPC, Dijkstra PU, Hollack N, Vires HJ de, Geertzen JHB (2014) Dose or content? Effectiveness of pain rehabilitation programs for patients with chronic low back pain: a systematic review. Pain 155:179–189

    PubMed  Article  Google Scholar 

  65. Weiss AP, Guidi J, Fava M (2009) Closing the efficacy-effectiveness gap: translating both the what and the how from randomized controlled trials to clinical practice. J Clin Psychiatry 70(4):446–449

    PubMed  Article  Google Scholar 

  66. Williamson PR, Altmann DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P (2012) Developing core outcome sets for clinical trials: issues to consider. Trials 13:132

    PubMed  PubMed Central  Article  Google Scholar 

Download references

Danksagung

Bei der im Beitrag vorgestellten Studie VAPAIN handelt es sich um eine vom Bundesministerium für Bildung und Forschung geförderte Studie (01GY1326; Zeitraum 2013–2016).

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to U. Kaiser.

Ethics declarations

Interessenkonflikt

S. Deckert, R. Sabatowski, J. Schmitt und U. Kaiser geben an, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine von den Autoren durchgeführten Studien an Menschen oder Tieren.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Deckert, S., Sabatowski, R., Schmitt, J. et al. Klinische Studien zur multimodalen Schmerztherapie. Schmerz 30, 537–548 (2016). https://doi.org/10.1007/s00482-016-0123-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00482-016-0123-8

Schlüsselwörter

  • Chronischer Schmerz
  • Schmerztherapie
  • Therapieeffekt
  • Patientenbezogene Ergebnismessung
  • Versorgungsforschung

Keywords

  • Chronic pain
  • Pain management
  • Treatment outcome
  • Patient outcome assessment
  • Health services research