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Patient safety in community-based healthcare: Understanding adverse events in massage therapy

CMTBC Education Day April 13, 2014. Patient safety in community-based healthcare: Understanding adverse events in massage therapy. Donelda Gowan-Moody, MT, MSc, PhD student Department of Community Health & Epidemiology University of Saskatchewan. Key Messages.

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Patient safety in community-based healthcare: Understanding adverse events in massage therapy

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  1. CMTBC Education Day April 13, 2014 Patient safety in community-based healthcare: Understanding adverse events in massage therapy Donelda Gowan-Moody, MT, MSc, PhD student Department of Community Health & Epidemiology University of Saskatchewan

  2. Key Messages There are gaps in what we know about the ‘adverse’ Clarity and consensus is needed

  3. Workshop Purpose • what we do know about adverse events (AEs) in MT • what relevant research others have done • what we need to do – explore views

  4. Background • Patient safety is an important domain of population health and a Canadian national priority (Baker, 2004) - do no harm • Few data on professions that use manual therapies – physiotherapy, osteopathy, MT • Few data on manual therapies –massage, mobilization and manipulation, acupuncture

  5. Conceptual Frameworks and Classification Schemas • WHO International Classification for Patient Safety – key concepts, conceptual framework, consensus • JCAHO Patient Safety Event Taxonomy – impact, type, domain, cause, prevention • Common Terminology Criteria for Adverse Events (v4.02) National Cancer Institute

  6. Definitions From Pharmacology • Adverse reaction: an unintended noxious response under normal dosage. • Adverse event/adverse experience: Any untoward medical occurrence ;does not necessarily have a causal relationship • Side effect: Any unintended effect related to the pharmacological properties of the drug.

  7. Definitions of Adverse Event • Adverse event: An event that results in unintended harm to the patient, and is related to the care and/or services provided to the patient rather than to the patient’s underlying medical condition (Canadian Patient Safety Institute) • Harm: An outcome that negatively affects the patient’s health and/or quality of life (CPSI)

  8. Literature Review Posadzki P, Ernst E. The safety of massage therapy: an update of a systematic review. Focus on Alternative and Complementary Therapies. 2013;18(1):27-32 17 case reports and 1 case series Updates Ernst (2003) - 16 case reports and 4 case series

  9. Sample Cases – Hospitalization Required Chen et al. Small bowel intramural hematoma secondary to abdominal massage. Am J Emerg Med. 2013 Apr;31(4):758 e3-4. PubMed PMID: 23380131. Jabr FI. Massive Pulmonary Emboli after Legs Massage. Am J Phys Med Rehabil. 2007; 86(8): 691. Chakrapani et al. Bilateral Carotid and Bilateral Vertebral Artery Dissection Following Facial Massage. Angiology. 2009;59(6):761-4.

  10. Sample Cases – Surgical Intervention Required • Lee et al. Cervical cord injury after massage. Am J Phys Med Rehabil. 2011;90(10):856-9. • Guo et al. Isolated unilateral vertebral pedicle fracture caused by a back massage in an elderly patient: a case report and literature review Eur J Orthop Surg Traumatol [Internet]. 2012.

  11. Sample Cases – Physician Treatment Required • Aksoy et al. Spinal accessory neuropathy associated with deep tissue massage: a case report. Archives of physical medicine and rehabilitation. 2009;90(11):1969-72.

  12. Literature Review - MT Grant KE. Massage safety: injuries reported in Medline relating to the practice of therapeutic massage-1965-2003. J Bodyw Mov Ther. 2003;7(4):207-12

  13. Claims Data • Average annual rate of claims per 1000 insured = 1.8 claims per 1000 massage therapists from 1993-1996 Studdert D, Eisenberg D, Miller F, Curto D, Kaptchuk T, Brennan T. Medical malpractice implications of alternative medicine/. The Journal of the American Medical Association. 1998;280:1610-5.

  14. Literature Review -MT Cambron JA, Dexheimer J, Coe P, Swenson R. Side-Effects of Massage Therapy: A Cross-Sectional Study of 100 Clients. J Altern Complement Med. 2007;13(8):793-96

  15. IJTMB • International Journal of Therapeutic Massage and Bodywork: Research, Education, and Practice http://www.ijtmb.org/index.php/ijtmb • Peer-reviewed, indexed in PubMed, Subscription-free open-access, Electronic

  16. Research in progress – your views • Patient safety in community-based healthcare: Understanding adverse events in massage therapy • Purpose: to develop a clear definition of adverse events (AEs) in massage therapy to facilitate understanding of patient safety issues and aid recording and prevention of AEs in MT

  17. Consent • This project was approved on ethical grounds by the University of Saskatchewan Behavioural Research Ethics Board. • Your participation is voluntary and you can answer only those questions that you are comfortable with. You may withdraw from participation for any reason, at any time without explanation or penalty of any sort.

  18. Your views • What are the gaps? • Does the evidence presented link in any way to practice? • What are the concepts for which we should seek clarity? • Other insights?

  19. Literature Review – Other Fields • How do patients receiving manual therapy through Ontario chiropractic, physiotherapy or osteopathic care define and interpret AEs associated with manual therapy techniques? • Manual tx = joint manipulation or mobilization NOT soft tissue • Carlesso et al, 2011

  20. Carlesso et al, 2011 • Functional impact • Changes in symptom location or quality • Neurologic-type symptoms

  21. Carlesso et al, 2013 • Patients with LBP will identify adverse responses 51% more • Patients with an expectation of posttreatment soreness are 9% less likely to identify an adverse response • Being advised about potential; or getting better overall are important

  22. Systematic Review - Canada Carlesso LC, Gross AR, Santaguida PL, Burnie S, Voth S, Sadi J. Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Manual Therapy. 2010 Oct;15(5):434-44

  23. Claims Data – PT - NZ Johnson et al (2012) demonstrated that "massage" as a physical therapy modality was in the top 5 treatments causing injury. Exercise Spinal manipulation or joint mobilization Taping Heat Massage and acupuncture

  24. Systematic Review - UK Carnes et al,2010 Adverse events and manual therapy: a systematic review. • Manual therapy: any techniques administered manually, using touch, by a trained practitioner for therapeutic purposes • Advice, through soft tissue massage and passive or active mobilisation, to manipulation • Statutory registered/ regulated professional

  25. SR Findings Meta-analysis of RCTs - major AE: 0.13% (0/2301 txs) Minor or moderate: 22% (11.1-36.2) From the cohort studies – Major AE: 0.007% (0/42 451) Minor or moderate: 41% 95% CI (17-68%)

  26. Carnes et al, 2010 – Focus Group & Delphi Constructs measured on a 6 point rating scale: For example: • Level of distress • Treatment alterations required or no • Expected or Unexpected • Acceptable or Unacceptable

  27. More from the UK – Rajendran et al, 2012 • Study aim: to investigate how osteopathic patients view post-treatment experiences and what meaning they ascribe to them • Conducted focus groups with patients from a teaching clinic

  28. Rajendran cont • Perceptions evolve; clinical change is evaluated within the context of their ‘global osteopathic experience’ • Non-clinical factors, such as feeling respected, understanding through education and service efficiency • Clinical factors – function and quality of life

  29. A Typology of Negative Responses Masunaga Shiatsu: a Japanese body-based life-energy therapy. Zen or Masunaga: a theoretical framework Holistic, mind-body approach Transition effects: healing crisis

  30. Long et al, Continued Type 1 – unrelated Type 2 – Transitional – client describes experience as initially (-) then (+) Type 3 – Transitional- consistent with modality theory (example feeling exhausted) Type 4 – Undesired event or effect but no risk to safety; distressing and interferes Type 5 - Potentially adverse events or effects – may represent a risk to client safety

  31. Your views • Is there anything useful here from what others have done? • Is MT in any way unique?

  32. Your views • What puts the adverse in 'adverse events'? • What are the potential negative consequences of massage therapy treatment? • What is the common terminology used in describing negative experiences in massage therapy? • What elements would be necessary in a classification system for adverse events?

  33. Your views • What are the important constructs for providing meaning for adverse events? • What are the important descriptors for categories of adverse events?

  34. Conclusion • scarce data, inconsistent aims, and disparate conceptualizations of adverse events • there are disparate conceptualizations of manual therapy and massage therapy. • There remains a gap in the understanding of patient safety in massage therapy.

  35. Next Steps- Project Plan & Research Objectives • To describe and define the attributes of the concept of AEs in MT as compared to other manual therapies and medicine • To develop a conceptual taxonomic framework • To develop and pilot a data collection tool to be used in gathering, evaluating and reporting AEs in MT.

  36. Acknowledgements I gratefully acknowledge the Department of Community Health & Epidemiology for scholarship support. The CMTBC and MTABC for their ongoing support of this work.

  37. References Baker G. R., Norton P. G., Flintoft V., Blais, R., Brown, A., Cox, J., Etchells, E., Ghali, W. A., Hébert, P., Majumdar, S. R., O’Beirne, M., Palacios-Derflingher, L., Reid, R. J., Sheps, S. & Tamblyn, R. (2004). The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CanadianMedical Association Journal, 170, 1678-1686 World Health Organization (2009). Final Technical Report for the Conceptual Framework for the International Classification for Patient Safety v.11. Geneva, Switzerland: Author. Retrieved from http://www.who.int/patientsafety/taxonomy/icps_full_report.pdf Andrew Chang et al. “The JCAHO patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events.” International Journal for Quality in Health Care17, no. 2 (2005): 95-105 Ernst E. The safety of massage therapy. Rheumatology. 2003;42:1101-6 Posadzki P, Ernst E. The safety of massage therapy: an update of a systematic review. Focus on Alternative and Complementary Therapies. 2013;18(1):27-32 Grant KE. Massage safety: injuries reported in Medline relating to the practice of therapeutic massage-1965-2003. J Bodyw Mov Ther. 2003;7(4):207-12

  38. References Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P. Towards an International Classification for Patient Safety: key concepts and terms. International Journal for Quality in Health Care. 2009 February 1, 2009;21(1):18-26. Carlesso LC, Cairney J, Dolovich L, Hoogenes J. Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Man Ther. 2011 Oct;16(5):440-6. Johnson GM, Skinner MA, Stephen RE. Lessons to be learned: a retrospective analysis of physiotherapy injury claims. Journal of Orthopaedic & Sports Physical Therapy. 2012;42(8):698-704. PubMed PMID: 22711215. Carlesso LC, MacDermid JC, Santaguida PL, Thabane L. A survey of patient's perceptions of what is "adverse" in manual physiotherapy and predicting who is likely to say so. J Clin Epidemiol. 2013 Oct;66(10):1184-91

  39. Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63 Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther. 2010 Feb;15(1):2-6 Rajendran D, Bright P, Bettles S, Carnes D, Mullinger B. What puts the adverse in 'adverse events'? Patients' perceptions of post-treatment experiences in osteopathy--a qualitative study using focus groups. Man Ther. 2012 Aug;17(4):305-11 Long AF, Esmonde L, Connolly S. A typology of negative responses: A case study of shiatsu. Complementary therapies in medicine. 2009 6//;17(3):168-75.

  40. Key Messages There are gaps in what we know Clarity and consensus is needed

  41. Questions?

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