Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study

Martha Funabashi, Katherine A Pohlman, Lindsay M Gorrell, Stacie A Salsbury, Andrea Bergna, Nicola R Heneghan, Martha Funabashi, Katherine A Pohlman, Lindsay M Gorrell, Stacie A Salsbury, Andrea Bergna, Nicola R Heneghan

Abstract

Introduction: Spinal and peripheral joint manipulation (SMT) and mobilisation (MOB) are widely used and recommended in the best practice guidelines for managing musculoskeletal conditions. Although adverse events (AEs) have been reported following these interventions, a clear definition and classification system for AEs remains unsettled. With many professionals using SMT and MOB, establishing consensus on a definition and classification system is needed to assist with the assimilation of AEs data across professions and to inform research priorities to optimise safety in clinical practice.

Methods and analysis: This international multidisciplinary electronic Delphi study protocol is informed by a scoping review and in accordance with the 'Guidance on Conduction and Reporting Delphi Studies'. With oversight from an expert steering committee, the study comprises three rounds using online questionnaires. Experts in manual therapy and patient safety meeting strict eligibility criteria from the following fields will be invited to participate: clinical, medical and legal practice, health records, regulatory bodies, researchers and patients. Round 1 will include open-ended questions on participants' working definition and/or understanding of AEs following SMT and MOB and their severity classification. In round 2, participants will rate their level of agreement with statements generated from round 1 and our scoping review. In round 3, participants will rerate their agreement with statements achieving consensus in round 2. Statements reaching consensus must meet the a priori criteria, as determined by descriptive analysis. Inferential statistics will be used to evaluate agreement between participants and stability of responses between rounds. Statements achieving consensus in round 3 will provide an expert-derived definition and classification system for AEs following SMT and MOB.

Ethics and dissemination: This study was approved by the Canadian Memorial Chiropractic College Research Ethics Board and deemed exempt by Parker University's Institutional Review Board. Results will be disseminated through scientific, professional and educational reports, publications and presentations.

Keywords: adverse events; complementary medicine; health & safety.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Delphi study procedures.

References

    1. Hurwitz EL. Epidemiology: spinal manipulation utilization. J Electromyogr Kinesiol 2012;22:648–54. 10.1016/j.jelekin.2012.01.006
    1. Beliveau PJH, Wong JJ, Sutton DA, et al. . The chiropractic profession: a scoping review of utilization rates, reasons for seeking care, patient profiles, and care provided. Chiropr Man Therap 2017;25:35. 10.1186/s12998-017-0165-8
    1. Rushton K, Ronel B, Jordaan JL. Educational standards in orthopaedic manipulative therapy, 2016. Available:
    1. Coulter ID, Crawford C, Hurwitz EL, et al. . Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J 2018;18:866–79. 10.1016/j.spinee.2018.01.013
    1. Paige NM, Miake-Lye IM, Booth MS, et al. . Association of spinal manipulative therapy with clinical benefit and harm for acute low back pain: systematic review and meta-analysis. JAMA 2017;317:1451–60. 10.1001/jama.2017.3086
    1. Clar C, Tsertsvadze A, Court R, et al. . Clinical effectiveness of manual therapy for the management of musculoskeletal and non-musculoskeletal conditions: systematic review and update of UK evidence report. Chiropr Man Therap 2014;22:12. 10.1186/2045-709X-22-12
    1. Kohn L, Corrigan J, Donaldson M. To err is human: building a safer health system. Washington DC: National Academy Press, 2000.
    1. WHO . Towards eliminating avoidable harm in health care - Draft Global Patient Safety Action Plan 2021-2030, 2021. Available:
    1. Landrigan CP, Parry GJ, Bones CB, et al. . Temporal trends in rates of patient harm resulting from medical care. N Engl J Med 2010;363:2124–34. 10.1056/NEJMsa1004404
    1. Swait G, Finch R. What are the risks of manual treatment of the spine? A scoping review for clinicians. Chiropr Man Therap 2017;25:37. 10.1186/s12998-017-0168-5
    1. Vohra S, Kawchuk GN, Boon H, et al. . SafetyNET: an interdisciplinary research program to support a safety culture for spinal manipulation therapy. Eur J Integr Med 2014;6:473–7. 10.1016/j.eujim.2014.06.005
    1. Foundation NPS . Free from harm: accelerating patient safety improvement fifteen years after to err is human 2015.
    1. Statistics NC for H . FastStats A to Z, 2015. Available:
    1. Marra AR, Algwizani A, Alzunitan M, et al. . Descriptive epidemiology of safety events at an academic medical center. Int J Environ Res Public Health 2020;17:353. 10.3390/ijerph17010353
    1. Kuriakose R, Aggarwal A, Sohi RK, et al. . Patient safety in primary and outpatient health care. J Family Med Prim Care 2020;9:7–11. 10.4103/jfmpc.jfmpc_837_19
    1. Funabashi M, Pohlman KA, Goldsworthy R, et al. . Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. Chiropr Man Therap 2020;28:46. 10.1186/s12998-020-00336-3
    1. Carnes D, Mars TS, Mullinger B, et al. . Adverse events and manual therapy: a systematic review. Man Ther 2010;15:355–63. 10.1016/j.math.2009.12.006
    1. Hebert JJ, Stomski NJ, French SD, et al. . Serious adverse events and spinal manipulative therapy of the low back region: a systematic review of cases. J Manipulative Physiol Ther 2015;38:677–91. 10.1016/j.jmpt.2013.05.009
    1. Pohlman KA, Funabashi M, Ndetan H, et al. . Assessing adverse events after chiropractic care at a chiropractic teaching clinic: an Active-Surveillance pilot study. J Manipulative Physiol Ther 2020;43:845–54. 10.1016/j.jmpt.2020.05.007
    1. Senstad O, Leboeuf-Yde C, Borchgrevink CF. Side-Effects of chiropractic spinal manipulation: types frequency, discomfort and course. Scand J Prim Health Care 1996;14:50–3. 10.3109/02813439608997068
    1. Walker BF, Hebert JJ, Stomski NJ, et al. . Outcomes of usual chiropractic. The OUCH randomized controlled trial of adverse events. Spine 2013;38:1723–9. 10.1097/BRS.0b013e31829fefe4
    1. Rubinstein SM. Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? J Manipulative Physiol Ther 2008;31:461–4. 10.1016/j.jmpt.2008.06.001
    1. Carlesso LC, Macdermid JC, Santaguida LP. Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. J Orthop Sports Phys Ther 2010;40:455–63. 10.2519/jospt.2010.3229
    1. Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther 2010;15:2–6. 10.1016/j.math.2009.02.003
    1. Pohlman KA, O’Beirne M, Thiel H, et al. . Development and validation of providers’ and patients’ measurement instruments to evaluate adverse events after spinal manipulation therapy. Eur J Integr Med 2014;6:451–66. 10.1016/j.eujim.2014.01.002
    1. Eriksen K, Rochester RP, Hurwitz EL. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: a prospective, multicenter, cohort study. BMC Musculoskelet Disord 2011;12:219. 10.1186/1471-2474-12-219
    1. Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Wiley-Blackwell, 2010.
    1. Jünger S, Payne SA, Brine J, et al. . Guidance on conducting and reporting Delphi studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliat Med 2017;31:684–706. 10.1177/0269216317690685
    1. Delbecq A, Van de Ven A, Gustafson D. Group techniques for program planning; a guide to nominal group and Delphi processes. Glenview, IL: Scott Foresman and Company, 1975.
    1. Cantrill JA, Sibbald B, Buetow S. The Delphi and nominal group techniques in health services research. Int J Pharm Pract 2011;4:67–74. 10.1111/j.2042-7174.1996.tb00844.x
    1. Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther 2010;15:94–8. 10.1016/j.ijosm.2010.03.001
    1. Kranenburg HA, Lakke SE, Schmitt MA, et al. . Adverse events following cervical manipulative therapy: consensus on classification among Dutch medical specialists, manual therapists, and patients. J Man Manip Ther 2017;25:279–87. 10.1080/10669817.2017.1332556
    1. Rosenthal R, Hoffmann H, Clavien P-A, et al. . Definition and classification of intraoperative complications (classic): Delphi study and pilot evaluation. World J Surg 2015;39:1663–71. 10.1007/s00268-015-3003-y
    1. Audigé L, Schwyzer H-K, et al. , Shoulder Arthroplasty Core Event Set (SA CES) Consensus Panel . Core set of unfavorable events of shoulder arthroplasty: an international Delphi consensus process. J Shoulder Elbow Surg 2019;28:2061–71. 10.1016/j.jse.2019.07.021
    1. Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Manage Sci 1963;9:458–67. 10.1287/mnsc.9.3.458
    1. Goodman CM. The Delphi technique: a critique. J Adv Nurs 1987;12:729–34. 10.1111/j.1365-2648.1987.tb01376.x
    1. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:1008–15.
    1. Zambaldi M, Beasley I, Rushton A. Return to play criteria after hamstring muscle injury in professional football: a Delphi consensus study. Br J Sports Med 2017;51:1221–6. 10.1136/bjsports-2016-097131
    1. Preston CC, Colman AM. Optimal number of response categories in rating scales: reliability, validity, discriminating power, and respondent preferences. Acta Psychol 2000;104:1–15. 10.1016/S0001-6918(99)00050-5
    1. de Loë RC, Melnychuk N, Murray D, et al. . Advancing the state of policy Delphi practice: a systematic review evaluating methodological evolution, innovation, and opportunities. Technol Forecast Soc Change 2016;104:78–88. 10.1016/j.techfore.2015.12.009
    1. Braun V, Clarke V. Successful qualitative research: a practical guide for beginners. SAGE Publications, 2013.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. Boulkedid R, Abdoul H, Loustau M, et al. . Using and reporting the Delphi method for selecting healthcare quality indicators: a systematic review. PLoS One 2011;6:e20476. 10.1371/journal.pone.0020476
    1. Diamond IR, Grant RC, Feldman BM, et al. . Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol 2014;67:401–9. 10.1016/j.jclinepi.2013.12.002
    1. von der Gracht HA. Consensus measurement in Delphi studies: review and implications for future quality assurance. Technol Forecast Soc Change 2012;79:1525–36.
    1. Meijering JV, Kampen JK, Tobi H. Quantifying the development of agreement among experts in Delphi studies. Technol Forecast Soc Change 2013;80:1607–14. 10.1016/j.techfore.2013.01.003
    1. Price J, Rushton A, Tyros V, et al. . Consensus on the exercise and dosage variables of an exercise training programme for chronic non-specific neck pain: protocol for an international e-Delphi study. BMJ Open 2020;10:e037656. 10.1136/bmjopen-2020-037656
    1. Schmidt RC. Managing Delphi surveys using nonparametric statistical techniques. Decision Sciences 1997;28:763–74. 10.1111/j.1540-5915.1997.tb01330.x
    1. Wiangkham T, Duda J, Haque MS, et al. . Development of an active behavioural physiotherapy intervention (ABPI) for acute whiplash-associated disorder (WAD) II management: a modified Delphi study. BMJ Open 2016;6:e011764. 10.1136/bmjopen-2016-011764
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Staniszewska S, Brett J, Simera I, et al. . GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ 2017;358:j3453. 10.1136/bmj.j3453

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