Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review

Martha Funabashi; Lindsay M. Gorrell; Katherine A. Pohlman; Andrea Bergna; Nicola R. Heneghan

doi:10.1371/journal.pone.0270671

Table 5

References cited by studies providing a direct adverse event definition and/or classification system (n = 78).

Cited by # studies Reference
Peer-reviewed articles (n = 55) Books, websites and other sources (n = 23)
17 Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther. 15:2–6.
10 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; 40:455–463
6 Carlesso L, Cairney J, Dolovich L, Hoogenes J (2011) Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Manual Therapy 16: 440–446
Senstad O, Leboeuf-Yde C, Borchgrevink C. Frequency and characteristics of side effects of spinal manipulative therapy. Spine. 1997; 22:435–441
4 Cagnie B, Vinck E, Beernaert A, et al.
How Common Are Side Effects of Spinal Manipulation
And Can These Side Effects Be Predicted?
Manual Therapy 2004 (Aug); 9 (3): 151�156
Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther 2010;15:355–63.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–9
Thiel HW, Bolton JE, Docherty S, Portlock JC: Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine 2007, 32(21):2375–8
Spilker B. Interpretation of adverse reactions. In: Guide to clinical trials. New York: Raven Press, Ltd; 1992:565–587 / Spilker B. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott Williams & Wilkins. 1995;1312.
3 Barrett AJ, Breen AC. Adverse effects of spinal manipulation. J R Soc Med 2000;93:258–9
Ernst E: Adverse effects of spinal manipulation: a systematic review. J R Soc Med 2007, 100(7):330–338
Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–58
Hurwitz E, Morgenstern H, Vassilaki M, Chiang L (2004) Adverse reactions to chiropractic treatment and their effects on satisfaction and outcomes among patients enrolled in the UCLA neck pain study. Journal of Manipulative and Physiological Therapeutics 27: 16–25.
Leboeuf-Yde C, Hennius B, Rudberg E, Leufvenmark P, Thunman M. Side effects of chiropractic treatment: a prospective study. J Manipulative Physiol Ther 1997;20:511–5.
Oliphant D: Safety of spinal manipulation in the treatment of lumbar disk herniations: a systematic review and risk assessment. J Manipulative Physiol Ther 2004, 27(3):197–210
Puentedura EJ, Landers MR, Cleland JA, Mintken PE, Huijbregts P, Fernandez-de-Las-Penas C. Thoracic spine thrust manipulation versus cervical spine thrust manipulation in patients with acute neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2011;41:208–20
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;17(August (4)):305–11
Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW.
The Benefits Outweigh the Risks for Patients Undergoing Chiropractic
Care for Neck Pain A Prospective, Multicenter, Cohort Study
J Manipulative Physiol Ther 2007 (Jul); 30 (6): 408�418
Senstad O, Leboeuf-Yde C, Borchgrevink C. Side-effects of chiropractic spinal manipulation: types, frequency, discomfort and course. Scand J Primary Health Care. 1996; 14:50–53
Good clinical practice; ICH-GCP (E6), glossary art. 1.2. Available from: http://ichgcp.net/1-glossary [Internet]
WHO Draft Guidelines for Adverse Event Reporting and Learning Systems. [http://www.who.int/patientsafety/events/05/Reporting_Guidelines. pdf]
2 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. Man Ther2010;15(October (5)):434–44
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
Pohlman K, O’Beirne M, Thiel H, et al. Development and validation of instruments to evaluate adverse events after spinal manipulation therapy. J Altern Complement Med. 2014;20(5). A49-A49
Puentedura EJ, March J, Anders J, Perez A, Landers MR, Wallmann HW, et al. Safety of cervical spine manipulation: are adverse events preventable and are manipulations being performed appropriately? A review of 134 case reports. J Man Manip Ther. 2012;20(2):66–74
Puentedura, E.J., O’Grady, W.H., 2015 Jul. Safety of thrust joint manipulation in the thoracic spine: a systematic review. J. Man. Manip. Ther. 23 (3), 154–161.
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(6):461–464
Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW: Predictors of Adverse Events Following Chiropractic Care for Patients with Neck Pain. J Manipulative Physiol Ther 2008, 31(2):94–103
Cancer therapy evaluation program, common terminology criteria for adverse events, version 4.0; 2009. Available from: http://ctep.cancer.gov/protocolDevelopment/electronicapplications/ctc.htm [Internet].
1 Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol 2006;7(11):903e9.
Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 2009; 101:1624e32
Bronfort et al. A randomized controlled clinical trial of rehabilitative exercise and chiropractic spinal manipulation for chronic neck pain. paper presented at: scientici symposium, World Chiropractic Congress; June 6–9, 1997; Tokyo, Japan.
Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH: Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med 2012, 156(1 Pt 1):1–10
Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S: Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Spine J 2008, 8(1):213–225
Carlesso LC, Macdermid JC, Santaguida PL, et al. 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;66(10):1184–1191.
Dvorak J, Orelli F. How dangerous is manipulation to the cervical spine? Case report and results of a survey. Manual Med 1985; 2:1–4.
Ernst, E., 2002 Apr 15, Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995–2001. Med. J. Aust. 176 (8), 376–380.
Gorrell LM, et al. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review. Spine J. 2016;16(9):1143–51.
Gouveia LO, Castanho P, Ferreira JJ. Safety of chiropractic interventions: a systematic review. Spine (Phila Pa 1976). 2009;34(11):E405-13.
Gross AR, Kay T, Hondras MA, Goldsmith CH, Haines T, Kennedy C, Peloso P 2002 Manual therapy for neck pain: A systematic review. Manual Therapy 7(3): 131–149.
Ioannidis J, Evans S, Gottzsche P, O’Neill R, Altman D, Schulz K. Moher D for the CONSORT group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141:781e8.
Kranenburg HA, Schmitt MA, Puentedura EJ, et al. Adverse events associated with the use of cervical spine manipulation or mobilization and patient characteristics: A systematic review. Musculoskeletal Sci Pract. 2017;28:32–38
Leboeuf-Yde C, Axén I, Ahlefeldt G, Lidefelt P, Rosenbaum A, Thurnherr T: The types and frequencies of improved nonmusculoskeletal symptoms reported after chiropractic spinal manipulative therapy. J Manipulative Physiol Ther 1999, 22(9):559–64
Lord J, Littlejohns P. Evaluating healthcare policies: the case for clinical audit. BMJ 1997; 315:668–71.
Malone D, Baldwin N, Tomecek F, Boxell C, Gaede S, Covington C, et al. Complications of cervical spine manipulation therapy: 5 year retrospective study in a single group practice. Neurol Focus 2002;13.
Nielsen SM, Tarp S, Christensen R, Bliddal H, Klokker L, Henriksen M. The risk associated with spinal manipulation: an overview of reviews. Syst Rev. 2017;6(1):64
Paanalahti K, Holm LW, Nordin M, Asker M, Lyander J, Skillgate E. Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2014; 15(1):77
Pohlman K, Carroll L, Tsuyuki R, Hartling L, Vohra S. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial. Trials. 2017;18(1):575.
Senstad O, Leboeuf-Yde C, Borchgrevink C. Predictors of side effects to spinal manipulative therapy. J Manipulative Physiol Ther. 1996; 19:441–445
Shafrir Y, Kaufman BA: Quadriplegia after chiropractic manipulation in an infant with congenital torticollis caused by a spinal cord astrocytoma. J Pediatr, 1992; 120:266–269
Skillgate E, Vingard E, Alfredsson L: Naprapathic manual therapy or evidence-based care for back and neck pain: a randomized, controlled trial. Clin J Pain 2007, 23(5):431–439.
Struewer J, Frangen TM, Ziring E, et al. Massive haemothorax after thoracic spinal manipulation for acute thoracolumbar pain. Orthop Rev (Pavia). 2013; 5:27
Terwee CB, Bot SDM, de Boer MR, van der Windt DA, Knol DL, DekkerJ, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007; 60(1):34–42
Thoomes-de Graaf M, Thoomes E, Carlesso L, et al. Adverse effects as a consequence of being the subject of orthopaedic manual therapy training, a worldwide retrospective survey. Musculoskelet Sci Pract. 2017; 29:20–27.
Walker BF, Hebert JJ, Stomski NJ. Outcomes of usual chiropractic. The OUCH randomized controlled trial of adverse events. Spine. 2013; 38:1723–9
Walshe K. Adverse events in health care: issues in measurement. Qual Health Care. 2000; 9(1):47–52.
White C. Doctors mistrust systems for reporting medical mistakes. BMJ 2004; 329:12–3.
Williams K. Patients will be able to report drugs’ side effects. BMJ 2004; 328:1095.
Woloshynowych M, Neale G, Vincent C. Case record review of adverse events: a new approach. Qual Saf Health Care 2003; 12:411–5.
AHRQ’s patient safety initiative: building foundations, reducing risk. Appendix 1. Patient safety terms and definitions; 2003. Avail-able from: http://www.ahrq.gov/research/findings/final-reports/pscongrpt/psiniapp1.html [Internet]
Davies JM, Hebert PC, Hoffman C. The Canadian patient safety dictionary. Edmonton: Canadian Patient Safety Institute; 2003. The National Patient Safety Agency (NPSA). Seven steps to patient safety for primary care. London, UK: NPSA; 2005
Department of Health. An organisation with a memory. London: Stationery Office; 2000.
Department of Health. Building a safer NHS for patients. London: Stationery Office; 2001.
Greenman PE: Principles of Manual Medicine, ed 2. Baltimore: Williams and Wilkins, 1996, pp 99–103
Griffin FA, Resar RK. IHI global trigger tool for measuring adverse events. IHI Innovation Series white paper, 2nd ed. Cambridge, MA: Institute for Healthcare Improvement; 2009
Kleynhans AM. Complications of and contraindications to spinal manipulative therapy. In: Haldeman S, ed. Modern Developments in the Practice and Principles of Chiropractic. Norwalk, CT: Appleton-Century-Crofts, 1980:359–82.
Livingston MC: Spinal manipulation causing injury. A three year study. Clin Orthop 81:82–86, 1971.
Maigne R. Orthopedic medicine: A new approach to vertebral manipulations. 3rd ed. Liberson WT, ed., trans. Springfield, IL: Charles C Thomas, 1972:153–5
MedWatch. The FDA safety information and adverse event reporting program. What is a serious adverse event? Available from: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm [Internet]
NPSA. Exploring incidents—improving safety. A guide to root cause analysis from the NPSA. In: www.npsa.uk/rcatoolkit/course/iindex.htm.
SafteyNet. Available from: http://care.ualberta.ca/SafetyNET.aspx [Internet]
Secker-Walker J, Taylor-Adams S. Clinical incident reporting. In: Vincent C, editor. Clinical risk management. Enhancing patient safety. London: BMJ Publishing Group; 2001. p. 419–38
The Texas Chiropractic Association: Texas Guidelines for Chiropractic Quality Assurance and Practice Parameters. Gaithersburg, MD: Aspen Publishers, 1994, pp 167–177
Van Liew D. Using information systems to support risk management. In: Wilson J, Tingle J, editors. Clinical risk modification. A route to clinical governance. Oxford: Butterworth Heinemann; 1999. p. 66–85.
World Health Organisation 2009. In: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Ed. by E. M. Agency), pp. 58e59. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004443.pdf. Accessed on 10 October, 2013.
WHO Patient Safety. Conceptual framework for the international classification for patient safety, version 1.1: technical annex 2. Geneva, Switzerland: World Health Organization (WHO); 2010
Zhao P. Spinal health handbook. Beijing: Popular Science Press; 2010. p. 63–6.
Zhao P. Personalized attention on lumbar disc herniation. Beijing: Popular Science Press; 2009. p. 40–5.

Cited by # studies	Reference
Cited by # studies	Peer-reviewed articles (n = 55)	Books, websites and other sources (n = 23)
17	Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther. 15:2–6.
10	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; 40:455–463
6	Carlesso L, Cairney J, Dolovich L, Hoogenes J (2011) Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Manual Therapy 16: 440–446
6	Senstad O, Leboeuf-Yde C, Borchgrevink C. Frequency and characteristics of side effects of spinal manipulative therapy. Spine. 1997; 22:435–441
4	Cagnie B, Vinck E, Beernaert A, et al. How Common Are Side Effects of Spinal Manipulation And Can These Side Effects Be Predicted? Manual Therapy 2004 (Aug); 9 (3): 151�156
	Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther 2010;15:355–63.
	Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–9
	Thiel HW, Bolton JE, Docherty S, Portlock JC: Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine 2007, 32(21):2375–8
		Spilker B. Interpretation of adverse reactions. In: Guide to clinical trials. New York: Raven Press, Ltd; 1992:565–587 / Spilker B. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott Williams & Wilkins. 1995;1312.
3	Barrett AJ, Breen AC. Adverse effects of spinal manipulation. J R Soc Med 2000;93:258–9
	Ernst E: Adverse effects of spinal manipulation: a systematic review. J R Soc Med 2007, 100(7):330–338
	Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–58
	Hurwitz E, Morgenstern H, Vassilaki M, Chiang L (2004) Adverse reactions to chiropractic treatment and their effects on satisfaction and outcomes among patients enrolled in the UCLA neck pain study. Journal of Manipulative and Physiological Therapeutics 27: 16–25.
	Leboeuf-Yde C, Hennius B, Rudberg E, Leufvenmark P, Thunman M. Side effects of chiropractic treatment: a prospective study. J Manipulative Physiol Ther 1997;20:511–5.
	Oliphant D: Safety of spinal manipulation in the treatment of lumbar disk herniations: a systematic review and risk assessment. J Manipulative Physiol Ther 2004, 27(3):197–210
	Puentedura EJ, Landers MR, Cleland JA, Mintken PE, Huijbregts P, Fernandez-de-Las-Penas C. Thoracic spine thrust manipulation versus cervical spine thrust manipulation in patients with acute neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2011;41:208–20
	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;17(August (4)):305–11
	Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW. The Benefits Outweigh the Risks for Patients Undergoing Chiropractic Care for Neck Pain A Prospective, Multicenter, Cohort Study J Manipulative Physiol Ther 2007 (Jul); 30 (6): 408�418
	Senstad O, Leboeuf-Yde C, Borchgrevink C. Side-effects of chiropractic spinal manipulation: types, frequency, discomfort and course. Scand J Primary Health Care. 1996; 14:50–53
		Good clinical practice; ICH-GCP (E6), glossary art. 1.2. Available from: http://ichgcp.net/1-glossary [Internet]
		WHO Draft Guidelines for Adverse Event Reporting and Learning Systems. [http://www.who.int/patientsafety/events/05/Reporting_Guidelines. pdf]
2	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. Man Ther2010;15(October (5)):434–44
	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
	Pohlman K, O’Beirne M, Thiel H, et al. Development and validation of instruments to evaluate adverse events after spinal manipulation therapy. J Altern Complement Med. 2014;20(5). A49-A49
	Puentedura EJ, March J, Anders J, Perez A, Landers MR, Wallmann HW, et al. Safety of cervical spine manipulation: are adverse events preventable and are manipulations being performed appropriately? A review of 134 case reports. J Man Manip Ther. 2012;20(2):66–74
	Puentedura, E.J., O’Grady, W.H., 2015 Jul. Safety of thrust joint manipulation in the thoracic spine: a systematic review. J. Man. Manip. Ther. 23 (3), 154–161.
	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(6):461–464
	Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW: Predictors of Adverse Events Following Chiropractic Care for Patients with Neck Pain. J Manipulative Physiol Ther 2008, 31(2):94–103
		Cancer therapy evaluation program, common terminology criteria for adverse events, version 4.0; 2009. Available from: http://ctep.cancer.gov/protocolDevelopment/electronicapplications/ctc.htm [Internet].
1	Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol 2006;7(11):903e9.
	Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 2009; 101:1624e32
	Bronfort et al. A randomized controlled clinical trial of rehabilitative exercise and chiropractic spinal manipulation for chronic neck pain. paper presented at: scientici symposium, World Chiropractic Congress; June 6–9, 1997; Tokyo, Japan.
	Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH: Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med 2012, 156(1 Pt 1):1–10
	Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S: Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Spine J 2008, 8(1):213–225
	Carlesso LC, Macdermid JC, Santaguida PL, et al. 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;66(10):1184–1191.
	Dvorak J, Orelli F. How dangerous is manipulation to the cervical spine? Case report and results of a survey. Manual Med 1985; 2:1–4.
	Ernst, E., 2002 Apr 15, Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995–2001. Med. J. Aust. 176 (8), 376–380.
	Gorrell LM, et al. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review. Spine J. 2016;16(9):1143–51.
	Gouveia LO, Castanho P, Ferreira JJ. Safety of chiropractic interventions: a systematic review. Spine (Phila Pa 1976). 2009;34(11):E405-13.
	Gross AR, Kay T, Hondras MA, Goldsmith CH, Haines T, Kennedy C, Peloso P 2002 Manual therapy for neck pain: A systematic review. Manual Therapy 7(3): 131–149.
	Ioannidis J, Evans S, Gottzsche P, O’Neill R, Altman D, Schulz K. Moher D for the CONSORT group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141:781e8.
	Kranenburg HA, Schmitt MA, Puentedura EJ, et al. Adverse events associated with the use of cervical spine manipulation or mobilization and patient characteristics: A systematic review. Musculoskeletal Sci Pract. 2017;28:32–38
	Leboeuf-Yde C, Axén I, Ahlefeldt G, Lidefelt P, Rosenbaum A, Thurnherr T: The types and frequencies of improved nonmusculoskeletal symptoms reported after chiropractic spinal manipulative therapy. J Manipulative Physiol Ther 1999, 22(9):559–64
	Lord J, Littlejohns P. Evaluating healthcare policies: the case for clinical audit. BMJ 1997; 315:668–71.
	Malone D, Baldwin N, Tomecek F, Boxell C, Gaede S, Covington C, et al. Complications of cervical spine manipulation therapy: 5 year retrospective study in a single group practice. Neurol Focus 2002;13.
	Nielsen SM, Tarp S, Christensen R, Bliddal H, Klokker L, Henriksen M. The risk associated with spinal manipulation: an overview of reviews. Syst Rev. 2017;6(1):64
	Paanalahti K, Holm LW, Nordin M, Asker M, Lyander J, Skillgate E. Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2014; 15(1):77
	Pohlman K, Carroll L, Tsuyuki R, Hartling L, Vohra S. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial. Trials. 2017;18(1):575.
	Senstad O, Leboeuf-Yde C, Borchgrevink C. Predictors of side effects to spinal manipulative therapy. J Manipulative Physiol Ther. 1996; 19:441–445
	Shafrir Y, Kaufman BA: Quadriplegia after chiropractic manipulation in an infant with congenital torticollis caused by a spinal cord astrocytoma. J Pediatr, 1992; 120:266–269
	Skillgate E, Vingard E, Alfredsson L: Naprapathic manual therapy or evidence-based care for back and neck pain: a randomized, controlled trial. Clin J Pain 2007, 23(5):431–439.
	Struewer J, Frangen TM, Ziring E, et al. Massive haemothorax after thoracic spinal manipulation for acute thoracolumbar pain. Orthop Rev (Pavia). 2013; 5:27
	Terwee CB, Bot SDM, de Boer MR, van der Windt DA, Knol DL, DekkerJ, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007; 60(1):34–42
	Thoomes-de Graaf M, Thoomes E, Carlesso L, et al. Adverse effects as a consequence of being the subject of orthopaedic manual therapy training, a worldwide retrospective survey. Musculoskelet Sci Pract. 2017; 29:20–27.
	Walker BF, Hebert JJ, Stomski NJ. Outcomes of usual chiropractic. The OUCH randomized controlled trial of adverse events. Spine. 2013; 38:1723–9
	Walshe K. Adverse events in health care: issues in measurement. Qual Health Care. 2000; 9(1):47–52.
	White C. Doctors mistrust systems for reporting medical mistakes. BMJ 2004; 329:12–3.
	Williams K. Patients will be able to report drugs’ side effects. BMJ 2004; 328:1095.
	Woloshynowych M, Neale G, Vincent C. Case record review of adverse events: a new approach. Qual Saf Health Care 2003; 12:411–5.
		AHRQ’s patient safety initiative: building foundations, reducing risk. Appendix 1. Patient safety terms and definitions; 2003. Avail-able from: http://www.ahrq.gov/research/findings/final-reports/pscongrpt/psiniapp1.html [Internet]
		Davies JM, Hebert PC, Hoffman C. The Canadian patient safety dictionary. Edmonton: Canadian Patient Safety Institute; 2003. The National Patient Safety Agency (NPSA). Seven steps to patient safety for primary care. London, UK: NPSA; 2005
		Department of Health. An organisation with a memory. London: Stationery Office; 2000.
		Department of Health. Building a safer NHS for patients. London: Stationery Office; 2001.
		Greenman PE: Principles of Manual Medicine, ed 2. Baltimore: Williams and Wilkins, 1996, pp 99–103
		Griffin FA, Resar RK. IHI global trigger tool for measuring adverse events. IHI Innovation Series white paper, 2nd ed. Cambridge, MA: Institute for Healthcare Improvement; 2009
		Kleynhans AM. Complications of and contraindications to spinal manipulative therapy. In: Haldeman S, ed. Modern Developments in the Practice and Principles of Chiropractic. Norwalk, CT: Appleton-Century-Crofts, 1980:359–82.
		Livingston MC: Spinal manipulation causing injury. A three year study. Clin Orthop 81:82–86, 1971.
		Maigne R. Orthopedic medicine: A new approach to vertebral manipulations. 3rd ed. Liberson WT, ed., trans. Springfield, IL: Charles C Thomas, 1972:153–5
		MedWatch. The FDA safety information and adverse event reporting program. What is a serious adverse event? Available from: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm [Internet]
		NPSA. Exploring incidents—improving safety. A guide to root cause analysis from the NPSA. In: www.npsa.uk/rcatoolkit/course/iindex.htm.
		SafteyNet. Available from: http://care.ualberta.ca/SafetyNET.aspx [Internet]
		Secker-Walker J, Taylor-Adams S. Clinical incident reporting. In: Vincent C, editor. Clinical risk management. Enhancing patient safety. London: BMJ Publishing Group; 2001. p. 419–38
		The Texas Chiropractic Association: Texas Guidelines for Chiropractic Quality Assurance and Practice Parameters. Gaithersburg, MD: Aspen Publishers, 1994, pp 167–177
		Van Liew D. Using information systems to support risk management. In: Wilson J, Tingle J, editors. Clinical risk modification. A route to clinical governance. Oxford: Butterworth Heinemann; 1999. p. 66–85.
		World Health Organisation 2009. In: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Ed. by E. M. Agency), pp. 58e59. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004443.pdf. Accessed on 10 October, 2013.
		WHO Patient Safety. Conceptual framework for the international classification for patient safety, version 1.1: technical annex 2. Geneva, Switzerland: World Health Organization (WHO); 2010
		Zhao P. Spinal health handbook. Beijing: Popular Science Press; 2010. p. 63–6.
		Zhao P. Personalized attention on lumbar disc herniation. Beijing: Popular Science Press; 2009. p. 40–5.