Cervical spine manipulation, a procedure with a rare but potentially serious adverse reaction: exploring the ethical dimensions in the new Zealand context.
The purpose of this paper was to undertake a review of literature
investigating the risks and benefits of Cervical Spine Manipulation
(CSM) and the ethical decision making involved with informed consent.
CSM is often used to treat neck pain. The technique carries the
infrequent yet serious risk of stroke. While the evidence for the
effectiveness of CSM is growing, some aspects of screening guidelines to
identify the risk have been found to be unreliable. This creates an
ethical dilemma for clinicians using CSM. As the first stage of the
analysis, key electronic databases were searched and relevant articles
were identified. An ethical framework, using a four principles approach
was applied to this issue with particular application of autonomy,
beneficence and non-maleficence. The results of the review indicate that
to uphold autonomy the therapist is required to ensure the patient has
all the relevant information regarding the potential benefits and
dangers of CSM. Beneficence emphasises that the therapist performs CSM
for the benefit of the client and non-maleficence encompasses outlining
the risks but also delivering CSM competently. This analysis explores
how CSM may be ethically performed given the current state of knowledge.
Culy R, Reid DA, Diesfeld K (2011): Cervical spine manipulation, a procedure with a rare but potentially serious adverse reaction: Exploring the ethical dimensions in the New Zealand context. New Zealand Journal of Physiotherapy 39(3) 116-123.
Therapeutics, Physiological (Health aspects)
Decision-making (Health aspects)
Pain (Care and treatment)
Pain (Health aspects)
Reid, Duncan A.
|Publication:||Name: New Zealand Journal of Physiotherapy Publisher: New Zealand Society of Physiotherapists Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 New Zealand Society of Physiotherapists ISSN: 0303-7193|
|Issue:||Date: Nov, 2011 Source Volume: 39 Source Issue: 3|
Mechanical neck pain is a prevalent and costly disorder (Cote et al 1998, Cote et al 2004, Linton 1998). Neck dysfunction can cause pain, cervicogenic headache, stiffness, limited function and decreased quality of life. One form of treatment for these conditions is Cervical Spine Manipulation (CSM), which involves passive, high velocity and low amplitude (HVLA) movements to the neck (Di Fabio 1999). CSM is used by complementary, alternative and traditional medicine practitioners including physiotherapists, chiropractors, osteopaths, medical practitioners (Di Fabio 1999) and traditional healers such as Maori bone setters (Hudson 2010). While the evidence for the effectiveness of this intervention is growing, (Bronfort et al 2004, Gross et al 2004, Hurwitz et al 1996), some authors comment that this evidence may not be enough to overcome the inherent dangers involved in CSM (Di Fabio 1999, Refshauge et al 2002a).
The major area of concern in treating the cervical spine is the close proximity of the vertebral artery to the joints of the cervical spine. More recently, research has indicated the importance of additionally considering the close association of the internal carotid arteries with the cervical spine (Taylor and Kerry 2010). Manual therapy techniques such as CSM and mobilisation can result in a small yet serious risk of injury to these arteries leading to stroke or even death (Ernst 2010).
The incidence for these serious events ranges from 1 in 163,371 manipulations (Rivett and Reid 1998) to less than 1 in 5,000,000 (Jaskoviak 1980), (see Table 1). These figures may not reflect the true incidence, due to under-reporting and a lack of a causal link with such events (Kerry et al 2008). The primary mechanism of cerebrovascular insult, occurring post-CSM, is cervical arterial dissection (Ernst 2007, Taylor and Kerry 2010). Cervical arterial dissection occurs due to a disruption or tear to the lining of the blood vessel (Taylor and Kerry 2010) causing blood to divide the outer and inner layer of the arterial wall leading to thrombus and stenosis (Haynes 2002). Factors such as trauma, smoking, ligament instability, high blood pressure and high cholesterol, among others are associated with damage or disease (e.g. atherosclerosis) to the vertebral artery (Taylor and Kerry 2010). Damage or disease to the artery can predispose a vessel to dissection and cause symptoms of vertebro-basilar insufficiency, a transient or permanent reduction in blood supply to the hindbrain (Taylor and Kerry 2010). Vertebro-basilar insufficiency symptoms include difficulty speaking, double vision, difficulty swallowing, dizziness, drop attacks, nausea, rapid alternating eye movements, ataxia and numbness of the face, lips, and tongue (Huijbregts and Oostendorp 2010, Taylor and Kerry 2010).
Different types of mechanical "trauma" may compromise the vertebral arteries or internal carotid arteries causing a cerebrovascular accident (CVA) including: sporting activities, activities of daily living, major trauma such as a road traffic accidents, a minor fall, sneezing, turning the head while backing a car, fair rides and CSM (Di Fabio 1999, Haldeman et al 2002, Kawchuk et al 2008).
As the current evidence base of CSM's efficacy does not provide unambiguous guidance for clinicians, ethical issues may arise when trying to achieve optimum outcomes based on conflicting or incomplete evidence. Modern consumers of health care are often knowledgeable and concerned about evidence-based justification for treatments. Evidence based healthcare is sometimes of limited utility when the literature provides an inconclusive, weak or contentious picture of the best way to manage the health issue. Therefore the practitioner may be placed in an ethical quandary when trying to provide evidence informed treatment options. On the one hand practitioners are ethically obliged to use the best evidence to justify CSM to the patient, but on the other hand where the evidence is weak or does not exist, they may find it difficult to convince both themselves and the patient that CSM is the best course of action. This ethical quandary is further exacerbated where CSM has a significant element of risk.
Within the New Zealand health care arena there has been a transition from a therapist-focused environment to a consumer-focused environment, and this transition is now reflected in the law (Haswell 1996, Sladden 2001). In New Zealand, a range of legislation provides protection for consumers of health and disability services, thereby promoting quality service (Paterson 2007). The Health Practitioners Competence Assurance Act (HPCAA) (2003) established a mechanism to promote competent practice by registered health practitioners. Under the HPCAA (2003), CSM is a restricted activity and may only be performed by registered health practitioners who have this procedure included in their scopes of practice. From a practical perspective this restricted activity of CSM is most often applied to physiotherapists, chiropractors, osteopaths and doctors specialising in musculoskeletal medicine.
The Health and Disability Commissioner Act (HDCA) (1994) promotes and protects the rights of those receiving a health or disability service (Sladden 2001) through the Code of Health and Disability Services Consumers' Rights (CHDSCR) (HDC 1996). The Code includes ten rights that offer comprehensible, accessible guidance on the rights of consumers and the corresponding responsibilities of providers (see Table 2) (Sladden 2001). CSM has featured in a range of complaints to the Health and Disability Commissioner (HDC) and most often those involved rights four through seven, specifically regarding standards of care and informed consent (HDC 1998, 2002, 2003, 2004, 2008a, 2008b). Consequently, these rights are integral to competent administration of CSM. More generally, the rights are relevant to all interventions of high risk and uncertain evidence bases. Thus, in New Zealand, there are not only ethical, but also enforceable legal, obligations that are applicable to CSM.
This analysis is founded on a literature review examining the risks and benefits of CSM and the application of the four principles ethical framework. In order to undertake this review, a search strategy was developed using the following electronic data bases in the AUT University library: Biomedical Reference Collection, CINAHL, Health Source, MEDLINE, SportsDiscus, Scopus, AMED, Cochrane Library, EBM Reviews, PEDro (physiotherapy evidence database), and Google Scholar. The following key words were used: "cervical manipulation", "spinal manipulation", "neck manipulation", "adverse event", "risk", "stroke", "vertebro basilar insufficiency", "vertebral artery dissection", "four principles approach", "ethics", "benefit" and "effect". Title and abstract searches were undertaken. Reference lists and relevant texts were also reviewed to gather any other relevant literature.
The four key ethical principles used were: autonomy (freedom of intentional choice), beneficence (creating good), nonmaleficence (do no harm), and justice (fair and equal rights). Additionally the review makes recommendations within the context of the New Zealand health system. Of these four principles, three are examined in detail below because they are of particular relevance to the current state of CSM practice. The fourth, justice, an important ethical value but is of limited relevance in this situation.
A FOUR PRINCIPLES APPROACH TO CERVICAL SPINE MANIPULATION
Principilism is an ethical framework which balances four principles that are significant in health care: these are: autonomy; non-maleficence; beneficence; and justice (Beauchamp and Childress 2009). This approach is designed for practical application and promotes reflective practice (Pierce and Randels 2010). A principle is a general guide or rule for conduct, with scope for interpretation between individuals (Pierce and Randels 2010). When conflict arises between principles, the practitioner must weigh and balance them against each other (Beauchamp and Childress 2009). The principles are not prioritised; the relative strength of the principles arises from particular case contexts (Pierce and Randels 2010). This analysis will consider whether the four principles approach offers a beneficial ethical framework for making CSM decisions.
Autonomy is liberty from controlling influences and the ability to take deliberate action (Beauchamp and Childress 2009). This concept is fundamental to Western medical ethics and the professional patient-practitioner relationship (Pierce and Randels 2010). The principle both respects individual choice and includes a positive obligation to provide sufficient information for a person to make an informed, and autonomous, choice (Pierce and Randels 2010). Thus, the foundation of informed consent is the promotion of autonomy. This principle is central to New Zealand's codified rights.
The CHDSCR (1996) incorporates the entitlement to effective communication that enables understanding under Right 5. Effective communication is necessarily the foundation of consent, which is elaborated in Rights 6 and 7. Both rights are relevant to a case analysis of CSM posed by Haswell (1996) in which both the therapist and observing therapist disagreed on the appropriate amount of disclosure. Haswell (1996) commented that the degree of disclosure is an integral feature when considering CSM; too much information may be confusing and too little information may compromise the person's decision-making.
Similarly, there is debate regarding whether discussion of relative risk between options is helpful or detrimental. For example, a practitioner may explain that other procedures such as non steroidal anti-inflammatory drugs (NSAIDs) or neck surgery (Dabbs and Lauretti 1995, Jull et al 2002) are claimed to have a much more frequent risk. However, some authors have suggested that comparing prolonged medication use to a single or limited number of CSMs may be inappropriate (Refshauge et al 2002b, Rubinstein 2008, Stevinson and Ernst 2002). Drugs and medical devices are subject to post market surveillance (Stevinson and Ernst 2002) whereas the safety profile of CSM is not formally surveyed (Gouveia et al 2007). A recent risk analysis showed the use of NSAIDs does not increase risk of death and using a surgery comparison may be a unrealistic alternative to CSM (Refshauge et al 2002a).This analysis relating to conflicting evidence demonstrates the issues that clinicians face. In short, consumers' autonomy and ability to make informed decisions are compromised when information regarding CSM and other procedures are withheld, manipulated or incomplete.
While informed consent is applicable in New Zealand under Rights 6 and 7 of the CHDSCR (1996) for many forms of assessment and treatment, it has particular relevance to CSM. In the context of CSM, it is essential for practitioners to obtain informed consent so consumers are aware of the existing evidence regarding its efficacy (HDC 1996). Autonomy is initially created by communicating sufficient information that a reasonable person in that person's circumstance would expect, as outlined within Right 6 (HDC 1996). Autonomy involves respect for the consumer's informed choice based upon his or her understanding of: risks, options, benefits, side effects, prices, time recommendations, and screening guidelines. Therefore informed consent is intricately linked with autonomy within the health care context. Autonomy-respecting practice includes full and informed disclosure, offered in clear language that a lay person is able to understand. Regarding potential side effects, disclosure for example may include; that following CSM it is common to have a minor adverse reaction of increased pain, stiffness or headache although it may not be prolonged. The patient's pain may also increase before it resolves (Cagnie et al 2004, Ernst 2004, Hurwitz et al 2004, Rubinstein et al 2007).
To enable consumers' to make autonomous, informed decisions, significant risks must be disclosed. The principles from the Australian case of Rogers v Whittaker (1992) are highly relevant to CSM administration in New Zealand. The patient consented to surgery on her blind eye but was not told of the potential for her healthy eye to be damaged due to an unusual complication. Subsequently the surgery caused blindness in her otherwise healthy eye. The defence relied on the Bolam Principle that due to the rarity of the complication, ophthalmic surgeons did not routinely disclose the risk. However, the court held that the surgeon was negligent in failing to inform his patient of this rare and unusual complication. In reflecting upon the administration of CSM and Right 6 of the Code, Manning (2007) asserted that stroke, permanent impairment or death are remote occurrences but the seriousness of each warrants disclosure as reasonable information a patient would expect. What may seem immaterial to practitioners due to its infrequent occurrence may be material, due to the seriousness or nature of the risk. This principle is embedded in New Zealand's consumer-orientated legislation; consumers have the right to know when there are "material" or "significant" risks involved with an intervention (HDC 1996, Manning 2007).
Another aspect of autonomy is to uphold the right to informed consent; practitioners may have to remind consumers of the potential risks and dangers of CSM on each occasion that it is performed. This may involve the practitioner checking the consumers' understanding by asking them to repeat the information.
For a consumer to be fully informed and in a position to make an autonomous choice, s/he must be told what is known, and what is not known, about a procedure such as CSM. This includes the degree to which the intervention is supported within the literature. Haldeman et al (2002) state it is difficult to give informed consent when the relevant information is merely based on the practitioner's personal or professional experience and bias rather than on accurate statistics regarding the risks and efficacy of CSM. Communicating current evidence and the limitations of existing evidence protects autonomy. Therefore, to protect autonomy the discussion should include what is certain, what is uncertain and the degree of that uncertainty. For example, the estimated incidence of post-CSM CVA is wideranging as portrayed in Table 1. Also, several biases arise in determining a factual occurrence rate, thereby causing estimates to be misleading and inaccurate. These include: inadequate sample sizes (Haynes 1994); short data collection periods; insufficient response rates; speculation of the frequency of applied CSM (Kerry et al 2008); under-reporting (Ernst 2001, Kerry et al 2008, Rivett et al 2005); over-reporting; and bias and reliability in recalling past events in retrospective surveys (Kerry et al 2008).
Similar ethical standards are seen across those registered health professionals restricted to perform CSM and all carry an ethical and professional responsibility to fully inform their patients (NZCB 2004, NZMA 2008, OCNZ, PBNZ 2006). A review of the websites of the New Zealand chiropractic and osteopathic registration boards and personal communication with the schools of training in New Zealand, indicate that neither of these professions have published guidelines on pre-screening for CSM. Physiotherapists in New Zealand and Australia have standardised the information and knowledge that can be communicated to patients potentially receiving CSM in the form of a screening guideline (Rivett et al 2006) and a "take-home" information sheet. This information is disseminated by the New Zealand Society of Physiotherapists, the New Zealand Manipulative Physiotherapists Association and Musculoskeletal Physiotherapy Australia. There are also significant differences in professional perspectives of the frequency of post-CSM complications with higher risk estimates of the frequency of CSM often seen in non-manual therapists surveys compared to manual therapists (Kerry et al 2008, Murphy 2010). Therefore it would be fair to assume that differences exist between individuals and professions regrading informed consent procedures.
Beneficence and non-maleficence
These twin principles are also relevant to administration of CSM. In the health care setting beneficence is the positive obligation to contribute to the welfare of patients (Beauchamp and Childress 2009). This places the duty on health professionals to provide specific benefits to their patients (Pierce and Randels 2010). Non-maleficence is an obligation of health professionals to not inflict harm (Beauchamp and Childress 2009). Nonmaleficence is preceded by, and integrally linked with, the Hippocratic Oath of medical tradition: "First, do no harm" (Beauchamp and Childress 2009). Harm is generally considered as physical or mental injury (Pierce and Randels 2010). Nonmaleficence includes the notion of not imposing a risk of harm (Pierce and Randels 2010).
The two principles may assist in analysing and determining whether there is a "net benefit" (Gillon 1994). For example, a risk-benefit analysis may guide a health professional to recommend CSM to a patient, when the technique is clinically indicated, while appreciating that what constitutes a "net benefit" for one patient may be a "net harm" for another (Gillon 1994).
Rubinstein (2008) states that the benefit of CSM to patients suffering mechanical neck dysfunction outweighs the relatively rare risk which may be considered negligible. Current literature suggest that the evidence of the efficacy of the technique is heading in a favourable direction (Bronfort et al 2010, Bronfort et al 2004, Gross et al 2004, Leaver et al 2010, Rubinstein et al 2007). There is also evidence that a "multimodal approach" (incorporating CSM and exercise) is the most efficacious way to treat mechanical neck dysfunction (Jull et al 2002). Chestnut (2004) proposes that until data are available, the ethical, scientific and logical analysis based on current understanding of risk factors, vertebral artery dissection must be considered a rare, unpredictable event associated with, however not 'caused' by, CSM. Two factors may indicate that the benefits outweigh the risks: first, there is growing support for the place of CSM in treating neck dysfunction; second, the risk of CVA is so small that some may consider the risk as negligible.
Another important ethical consideration is a lack of, or limit in, evidence does not necessarily mean that a treatment is not beneficial (Lawrence and Ernst 2004). This type of information should also be shared with patients. Even a lack of plausible effect does not rule out the potential use of an intervention. This is seen in the example of the symptom modifier for osteoarthritis, the supplement glucosamine sulphate, and the recent conclusion that its effect on pain was beneficial, although equal to that of a placebo (Rozendaal et al 2008). There are many new treatment interventions that are yet to have proven efficacy; however, for treatments to advance there needs to be an ability to apply these with the patient's consent and discussing with them the current lack of efficacy. Therefore withholding treatment until the efficacy has been proven may also be considered a form of harm (Harris 2001).
The counter-argument is that that due to the catastrophic potential consequences such as stroke or death from CSM, the risks although infrequent, are so serious that the application of CSM , based on current evidence, is not justified.(Di Fabio 1999, Refshauge et al 2002a). Again, patients must have full information to make a reasoned and autonomous decision. There is an uncertainty in the literature as to the incidence of the rare yet catastrophic adverse sequel to CSM (see Table 1) and current evidence does not entirely support the efficacy of screening protocol particularly with the physical tests related to cervical rotation (Thiel and Rix 2005).
There may be providers who have not undergone sufficient formal training in the recognised manipulative techniques to offer competent treatment. These might include non-registered providers and those practitioners who are registered but do not have the authority to administer CSM under their scopes of practice. Such providers may pose a risk because they may not understand the potential dangers and currently recommended screening and selection procedures. While all who provide health and disability services in New Zealand are governed by the CHDSCR, only registered practitioners are governed by the HPCAA (and subject to the Health Practitioners Disciplinary Tribunal). However, both registered practitioners and nonregistered providers (e.g. massage therapists) must "comply with legal, professional, ethical and other relevant standards" under Right 4 (and the remaining 9 rights) or potentially face proceedings before the Human Rights Review Tribunal for breach.
There is also debate regarding whether CSM should be restricted to practitioners who have completed postgraduate studies (Refshauge et al 2002a). The authors support the view because of the probable disparity in the level of knowledge, skill and clinical judgment between new graduates and experienced manipulative therapists, even though both groups are legally entitled to use CSM (Refshauge et al 2002a, Refshauge et al 2002b) . Likewise, there may be an ethical argument that beneficence and non-maleficence require that providers of CSM maintain and improve their skill and knowledge base to adequately protect consumers. This is particularly relevant when it comes to the assessment of the medical risk factors. Physiotherapists are trained to take measures such as blood pressure but will need to improve their assessment skills to include wider ranging questions around other vascular risk factors such as high blood pressure, cholesterol levels and diabetes. In doing so physiotherapists also need to consider their scope of practice and not endeavour to overstep the mark in this area. Onwards referral to the medical profession for further evaluation and blood tests may be required before the risks are sufficiently understood to reduce the risk of harm from CSM.
Not all practitioners who treat mechanical neck dysfunction choose to use CSM, suggesting there are alternative effective methods for treating neck dysfunction (Refshauge et al 2002a). Therefore, there is debate whether the benefit of treatments with serious risk is warranted given the contradictory or incomplete evidence regarding the efficacy of CSM and the existence of less risky alternatives. Alternatives include doing nothing, as often mechanical neck dysfunction is self-limiting. However this may seem unacceptable for a professional whose goal is to provide treatment for relief and unsatisfying for the patient who is in pain. CSM has been shown to be both superior (Hurwitz et al 1996) and equal (Gross et al 2010) to a mobilisation treatment (Leaver et al 2010). However, when weighing this option it is also important to consider that there has been documented similar serious adverse events with this intervention (Kanakamedala 2002). Exercise provides another effective alternative and does not have the same inherent risks, although it is more effective when combined with manual therapy (Jull 2002). HVLA to the thoracic spine is also another option in successfully treating mechanical neck dysfunction and is gaining increasing attention in the literature (Krauss et al 2008). In summary, it is important for practitioners to consider alternative treatments that will provide similar results without the risks posed by CSM.
There may be occasions when beneficence may conflict with autonomy. For example, some practitioners may believe that disclosure of potential risks will cause patients unnecessary anxiety and interfere with their decision to have CSM (Haswell 1996). The practitioners' perspective may be viewed as paternalistic and designed to achieve an outcome in what they consider to be, the patients' best interests. However, failure to disclose on paternalistic, beneficent grounds, conflicts with the principle of autonomy (Haswell 1996). Some authors suggest that having more detail is better than not having enough and an uninformed patient may ultimately suffer more distress or anxiety (Haswell 1996). Therefore, although a practitioner may be tempted to deceive a patient or withhold information on benevolent grounds, the patient's autonomous informed decision is paramount.
The final of the four principles is justice, meaning an entitlement to fairness and equality (Beauchamp and Childress 2009) administered in a consistent fashion included the following: equitable distribution of resources and respect for people's rights. As noted above, while New Zealand's CHDSCR provides 10 rights for health and disability consumers (including respect); these do not include the right to treatment. Also, while justice is a key concept in Beauchamp and Childress's framework, it does not offer practitioners who contemplate CSM with the more specific guidance offered by the concepts of autonomy, beneficence and non-maleficence.
The following rights are of particular relevance to New Zealand consumers who contemplate CSM. Under Right Four of the Code (HDC 1996) consumers are entitled to an appropriate standard of care and sub-section 5 includes the right to cooperation among providers to ensure quality and continuity of services. The Health and Disability Commissioner noted his concern with respect to differing CSM practices between chiropractors and physiotherapists in response to a complaint regarding the standard of care provided to a patient who suffered a post-CSM vertebral artery dissection (HDC 2008a). The Commissioner also noted it was not standard practice for chiropractors to carry out vertebro-basilar insufficiency testing prior to every CSM (HDC 2008a), indicating a further disparity in the standards of care.
Maori Health Ethics
Within the New Zealand health system there is also a requirement to consider Maori ethical principles. Te Tiriti o Waitangi (The Treaty of Waitangi) is the founding document between Maori Iwi (the indigenous people of New Zealand) and the British Crown (Hera 2011). The principles developed from Te Tiriti o Waitangi are pertinent to all law formed in New Zealand. In New Zealand there is an increased interest in traditional Maori healing (Ahuriri-Driscoll et al 2008). Traditional Maori healing involves a holistic system embodying spiritual as well as physical, emotional and mental aspects of health (Ahuriri-Driscoll et al 2008). Evidence based health care is challenging for many alternative health professions, including traditional Maori healers, because critique of, or challenge to, traditional healing may be considered inappropriate on cultural/ philosophical grounds (Hudson 2010). Universal ethical frameworks such as the four principles approach may often fail to recognise cultural impact on the application of those principles (Hudson 2004).
Recommendations for the future
Both clinical practice guidelines and protocols are increasingly prominent in evidence based health care (Manning 2007) and may offer ethical and legal frameworks. The highest numbers of CVAs have arisen from chiropractic CSM (Ernst 2010). Yet in New Zealand, the chiropractic and osteopathic professions do not have published guidelines. Consumers' rights and ethical standards might be protected through regularly updated, consistent guidelines across and within professions. New Zealand physiotherapists have adopted the cervical screening guidelines instigated by the Australian Physiotherapy Association (Rivett et al 2006). This could be applied more widely, and updated based on current evidence, to uphold New Zealand consumers' rights to make informed choices and obtain competent treatment. The notion of standardised, evidence-based guidelines is equally valuable to practitioners in and across relevant professions, regardless of whether they practise in New Zealand or abroad. A periodically updated, collaborative, screening guideline could help to ensure manual therapists maintain skill-levels according to current evidence. Further research also needs to be undertaken on the impact of the other health risks, particularly in the area of cardiovascular disease, which are not currently as well documented in the screening guidelines. This ethical analysis supports clear and complete explanations for consumers regarding techniques that involve limited research evidence and potentially high risks, such as CSM. Encouraging communication founded on evidence-based research will promote patients' interests and autonomy.
The four principles provided a helpful means to examine the challenging issues surrounding CSM and other procedures that involve potentially high risks and uncertain evidence bases. Consideration of autonomy, beneficence and nonmaleficence is helpful in the face of unknown or conflicting evidence. Of note, the concept of autonomy is particularly helpful and embedded in New Zealand's patients' rights scheme. Consumers have a right to choose what constitutes "net-benefit" or "net-harm" but must have relevant information to make that determination. Providers have a duty to fully inform consumers and this includes risks that may seem immaterial, due to their infrequency, but are material, due to their severity or nature. If evidence regarding the risks of an intervention is incomplete, limited or controversial, this should be disclosed. However, autonomy, beneficence and non-maleficence offer a starting point and reminder regarding providers' fundamental obligations to consumers who may not have access to current health information. CSM may be ethically justified if every reasonable effort to reduce the risk has been undertaken and the current knowledge of risks and benefits are fully explored with the patient.
* Cervical spine manipulation is a high risk procedure with the potential to cause serious harm including stroke.
* Guidelines and aspects of the physical testing procedures regarding risk are unreliable. Current evidence does not allow a definitive decision to be made with respect to efficacy and safety.
* An ethical framework using the four principles of autonomy, beneficence, non-maleficence and justice may aid clinicians in the process of offering and obtaining informed consent regarding CSM and other procedures with a limited evidence-base.
Rose Culy was supported by a Health Research Council Ethics summer studentship at AUT University in the development of this paper.
ADDRESS FOR CORRESPONDENCE
Duncan Reid, Health and Rehabilitation Research Institute, School of Rehabilitation and Occupation Studies, Auckland, University of Technology, Private Bag 92006, Auckland, New Zealand. Phone 0064 (9) 917-9999 ext 7806, Fax 0064 (9) 9179620. Email firstname.lastname@example.org
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Rose Culy (BHSc, Physiotherapy Yr 3 Student),
Duncan A Reid (DHSc)
Health and Rehabilitation Research Institute
School of Rehabilitation and Occupation Studies
Auckland University of Technology
Kate Diesfeld (JD)
Te Piringa, Faculty of Law, University of Waikato
Table 1: Estimates of frequency of CVA occurring with Cervical Spine Manipulation Case-control studies Incidence Rate (CVA/CSM) Jaskoviak (1980) <1 in 5,000,000 Gutmann (1981) 1 in 50,000 Dvorak and Orelli (1985) 1/383,750 Terrett (1987) 1/ 300,000- 500,000 Michaeli (1993) <1/75,500 Carey (1993) 1/ 3,846,153 Haynes (1994) 1/200,000 Lee et al (1995) 1/500, 000 Klougart et al (1996) 1/300,000 Rivett and Reid (1998) 1/163,371 Rothwell et al (2001) 1.3/100,000 in persons < 45 years Haldeman et al (2001) 1/5,850,000 Magarey et al (2004) 0/50,000 Case-control studies Profession Type of study Jaskoviak (1980) Chiropractic Case review Gutmann (1981) Medicine Questionnaire survey Dvorak and Orelli (1985) Medicine Retrospective survey Terrett (1987) Chiropractic Case review Michaeli (1993) Physiotherapy Retrospective survey Carey (1993) Chiropractic Case review Haynes (1994) Chiropractic Retrospective survey Lee et al (1995) Neurologists on Retrospective chiropractic survey manipulation Klougart et al (1996) Chiropractic Retrospective survey Rivett and Reid (1998) Physiotherapy Case review Rothwell et al (2001) Chiropractic Population based nested controlled study Haldeman et al (2001) Chiropractic Case review and survey questionnaire Magarey et al (2004) Physiotherapy Retrospective survey CVA: Cerebrovascular Accident, CSM: Cervical Spine Manipulation Table 2 Code of Health and Disability Service 10 Consumers' Rights (retrieved from http://www.hdc.org. nz/the-act--code/the-code-of-rights) Right 1: the right to be treated with respect Right 2: the right to freedom from discrimination, coercion, harassment, and exploitation Right 3: the right to dignity and independence Right 4: the right to services of an appropriate standard Right 5: the right to effective communication Right 6: the right to be fully informed Right 7: the right to make an informed choice and give informed consent Right 8: the right to support Right 9: rights in respect of teaching or research Right 10: the right to complain
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