PATIENT SAFETY The Council on Chiropractic Practice
Chalpter 9. Patient SafetyRECOMMENDATION
Patient safety encompasses the entire spectrum of care offered by the chiropractor. Consequently, it is important to define at the onset, the nature of the practice as well as the limits of care to be offered. Minimally this should include a Terms of Acceptance document between the practitioner and the patient. Additionally, all aspects of clinical practice should be carefully chosen to offer the patient the greatest advantage with the minimum of risk.
Rating: Established
Evidence: E, L
Commentary
Patient safety is assured by more than the practitioner's causing no harm. Since every consumer of health care is ultimately responsible for his/her own health choices, patient safety is also a matter of the availability of accurate and adequate information with which the patient must make these choices. The patient's expectations should be consistent with the provider's goals. If the patient perceives those goals as anything different, proper and safe choices cannot be assured. Thus, it is important to recognize that chiropractic is a limited, primary profession which contributes to health by addressing the safe detection, location, and correction or stabilization of vertebral subluxation(s). It is important that the chiropractor take the steps necessary to foster proper patient perception and expectation of the practitioner's professional goals and responsibilities. It is within this context that patient safety is addressed in this chapter.
A Terms of Acceptance is the recorded written informed consent agreement between a chiropractor and the patient. This document provides the patient with disclosure of the responsibilities of the chiropractor and limits of chiropractic, and the reasonable benefit to be expected. This enables the patient to make an informed choice either to engage the services of the chiropractor, aware of the intended purpose of the care involved, or not to engage those services if the proposed goals are not acceptable or not desired. This embodies the responsibility of assuring patient safety by not providing false or misleading promises, claims or pretenses to the patient.(1-7)
Professional Referral: Professional referral requires authority and competence to acquire accurate information concerning matters within the scope and practice of the professional to whom a referral is made. There are two types of professional referrals made by chiropractors:
(A) Intraprofessional referral: Chiropractors, by virtue of their professional objective, education, and experience, have authority and competence to make direct referrals within the scope and practice of chiropractic. Such a referral may be made when the attending chiropractor is not able to address the specific chiropractic needs of a particular patient. Under these circumstances, the chiropractor may refer the patient directly to or consult with another chiropractor better suited by skill, experience or training to address the patient's chiropractic needs.
(B) Interprofessional referral: In the course of patient assessment and the delivery of chiropractic care, a practitioner may encounter findings which are outside his/her professional and/or legal scope, responsibility, or authority to address. The chiropractor has a responsibility to report such findings to the patient, and record their existence. Additionally, the patient should be advised that it is outside the responsibility and scope of chiropractic to offer advice, assessment or significance, diagnosis, prognosis, or treatment for said findings and that, if the patient chooses, he/she may consult with another provider, while continuing to have his/her chiropractic needs addressed.
Rare case reports of adverse events following spinal manipulation exist in the literature. However, scientific evidence of a causal relationship between such adverse events and the manipulation is lacking. Furthermore, spinal adjustment and spinal manipulation are not synonymous terms.
In the case of strokes purportedly associated with manipulation, the panel noted significant shortcomings in the literature. A summary of the relevant literature follows:
*Lee(8) attempted to obtain an estimate of how often practicing neurologists in California encountered unexpected strokes, myelopathies, or radiculopathies following chiropractic manipulation. Neurologists were asked the number of patients evaluated over the preceding two years who suffered a neurological complication within 24 hours of receiving chiropractic manipulation. Fifty-five strokes were reported. The author stated, Patients, physicians, and chiropractors should be aware of the risk of neurologic complications associated with chiropractic manipulation. No support was offered to substantiate the premise that a causal relationship existed between the stroke and the event(s) of the preceding 24 hours.
*In a letter to the editor of the Journal of Manipulative and Physiological Therapeutics, Myler(9) wrote, I was curious how the risk of fatal stroke after cervical manipulation, placed at 0.00025%(10) compared with the risk of (fatal) stroke in the general population of the United States. According to data obtained from the National Center for Health Statistics, the mortality rate from stroke in the general population was calculated to be 0.00057%. If these data are correct, the risk of a fatal stroke following cervical manipulation is less than half the risk of fatal stroke in the general population.
*Jaskoviak(11) reported that not a single case of vertebral artery stroke occurred in approximately five million cervical manipulations at the National College of Chiropractic Clinic from 1965 to 1980.
*Osteopathic authors Vick, et al.(12) reported that from 1923 to 1993, there were only 185 reports of injury associated with several million treatments.
*Pistolese(13) has constructed a risk assessment for pediatric chiropractic patients. His findings covering approximately the last 30 years indicate a risk of a neurological and/or vertebrobasilar accident during a chiropractic visit about one in every 250,000,000 visits.
*An article in the Back Letter(14) noted that In scientific terms, all these figures are rough guesses at best... There is currently no accurate data on the total number of cervical manipulations performed every year or the total number of complications. Both figures would be necessary to arrive at an accurate estimate. In addition, none of the studies in the medical literature adequately control for other risk factors and co-morbidities.
*Leboeuf-Yde et al.(15) suggested that there may be an over-reporting of spinal manipulative therapy related injuries. The authors reported cases involving two fatal strokes, a heart attack, a bleeding basilar aneurysm, paresis of an arm and a leg, and cauda equina syndrome which occurred in individuals who were considering chiropractic care, yet because of chance, did not receive it. Had these events been temporally related to a chiropractic office visit, they may have been inappropriately attributed to chiropractic care.
*In many cases of strokes attributed to chiropractic care, the operator was not a chiropractor at all. Terrett(16) observed that manipulations administered by Kung Fu practitioner, GPs, osteopaths, physiotherapists, a wife, a blind masseur, and an Indian barber were incorrectly attributed to chiropractors. As Terrett wrote, The words chiropractic and chiropractor have been incorrectly used in numerous publications dealing with SMT injury by medical authors, respected medical journals and medical organizations. In many cases, this is not accidental; the authors had access to original reports that identified the practitioner involved as a non-chiropractor. The true incidence of such reporting cannot be determined. Such reporting adversely affects the reader's opinion of chiropractic and chiropractors.
*Another error made in these reports was failure to differentiate cervical manipulation from specific chiropractic adjustment. Klougart et al.(17) published risk estimates which revealed differences which were dependent upon the type of technique used by the chiropractor.
The panel found no competent evidence that specific chiropractic adjustments cause strokes. Although vertebrobasilar screening procedures are taught in chiropractic colleges, no reliable screening tests were identified which enable a chiropractor to identify patients who are at risk for stroke.
After examining twelve patients with dizziness reproduced by extension rotation and twenty healthy controls with Doppler ultrasound of the vertebral arteries, Cote, et al.(18) concluded, We were unable to demonstrate that the extension-rotation test is a valid clinical screening procedure to detect decreased blood flow in the vertebral artery. The value of this test for screening patients at risk of stroke after cervical manipulation is questionable. Terrett(19) noted, There is no evidence which suggests that positive tests have any correlation to future VBS (vertebrobasilar stroke) and SMT (spinal manipulative therapy). Despite this lack of evidence, some have suggested that failure to employ such tests could place a chiropractor in a less defensible position should litigation ensue following a CVA.(20)
References
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2. Cary P. Informed consent - the new reality. J Can Chiro Assoc 1988; 32(2):91-94.
3. Gill KM. Efforts to prevent malpractice suits. Princeton Insurance Company, Princeton, NJ, May 4, 1989.
4. Gotlib A. The nature of the informed consent doctrine and the chiropractor. J Can Chiro Assoc 1984; 28(2):272-274.
5. Hug PR. General considerations of consent. J Chiro 1985; 22(12):52-53.
6. Jackson R, Schafer R. Basic chiropractic paraprofessional manual, Chapter XII. ACA, Des Moines, 1A. XII:3-4, 1978.
7. White B. Ethical issues surrounding informed consent. Part II. Components of a morally valid consent and conditions that impair its validity. Urol Nurs 1989; 9(4):4-9.
8. Lee K. Neurologic complications following chiropractic manipulation: a survey of California neurologists. Neurology 1995; 45:1213.
9. Myler L. Letter to the editor. J Manipulative Physiol Ther 1996;19:357.
10. Dabbs V, Lauretti WJ. A risk assessment of cervical manipulation vs. NSAIDS for the treatment of neck pain. J Manipulative Physiol Ther 1995; 18:530.
11. Jaskoviac P. Complications arising from manipulation of the cervical spine. J Manipulative Physiol Ther 1980; 3:213.
12. Vick D, McKay C, Zengerle C. The safety of manipulative treatment: review of the literature from 1925 to 1993. JAOA 1996; 96:113.
13. Pistolese RA. Risk assessment of neurological and/or vertebrobasilar complications in the pediatric chiropractic patients. Journal of Vertebral Subluxation Research 1998; 2(2): In Press.
14. What about the serious complications of cervical manipulation? The Back Letter 1996; 11:115.
15. Leboeuf-Yde C, Rasmussen LR, Klougart N. The risk of over-reporting spinal manipulative therapy-induced injuries; a description of some cases that failed to burden the statistics. J Manipulative Physiol Ther 1996; 19:536.
16. Terrett AGJ:
Misuse of the Literature by Medical Authors in Discussing Spinal Manipulative Therapy Injury
J Manipulative Physiol Ther 1995 (May); 18 (4): 203–21017. Klougart N, Leboeuf-Yde C, Rasmussen LR.
Safety in Chiropractic Practice, Part I; The Occurrence of Cerebrovascular Accidents After
Manipulation to the Neck in Denmark from 1978-1988
J Manipulative Physiol Ther 1996 (Jul); 19 (6): 371–37718. Cote, P., Kreitz, B.G., Cassidy, J.D., Thiel, H.,1996.
The Validity of the Extension-rotation Test as a Clinical Screening Procedure Before Neck Manipulation:
A Secondary Analysis
J Manipulative Physiol Ther 1996 (Mar); 19 (3): 159–16419. Terrett AGJ. Vertebrobasilar stroke following manipulation. NCMIC, Des Moines, 1996, page 32.
20. Ferezy JS. The Chiropractic Neurological examination. Aspen Publishers. Gaithersburg, MD 1992.