International Journal of Osteopathic Medicine
Volume 9, Issue 1 , Pages 1-3, March 2006

Risk and negligence: A minefield or an opportunity?

School of Health Professions, University of Brighton, East Sussex, UK

Article Outline

 

We are fortunate to have in this issue a review of the evidence on the safety of HVLA thrust techniques. The review by Gibbons and Tehan1 is timely as health professionals worldwide face mounting legal pressure to inform patients of the risk and benefit of the treatment we recommend. The pressure was raised dramatically in the UK by a single court case in October 2004.2 The case changed medical malpractice law, extending the definition of negligence to include failure to warn patients of the risks associated with a procedure. Confusion and consternation have been voiced by many UK osteopaths in 2005. Similar cases changed Australian law,3 and Canadian law4 some years ago, and maybe the UK can learn from their experience.

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1. The legal position 

The case of Chester vs Afshar which reached the House of Lords in 20042 was brought by Ms Chester who suffered very rare and serious neurological damage, cauda equina contusion, following routine spinal disc surgery. The surgeon Mr Afshar was found not guilty of surgical incompetence, but guilty of negligence for failing to warn his patient of the 1–2% risk of the operation. The House of Lords decided that the patient had the rights to be informed of a small risk of a serious adverse result. The rationale is to “enable adult patients of sound mind to make for themselves decisions intimately affecting their own lives and bodies”.5

This court case happened at a time when the General Osteopathic Council was in the process of revising the Code of Practice for UK osteopaths. When released in May 2005, a new clause 20 stated: “You should not only explain the usual inherent risks associated with the particular treatment but also any low risks of serious debilitating outcomes”.6 The guidance in the accompanying leaflet on Obtaining Consent stated: “There will always be an element of clinical judgement in determining what information you should give to your patients but this should always include: the usual risks; all risks of serious debility, no matter how remote”. The document does not define what is meant by usual risks.

The wording was consistent with the General Medical Council's older guidance that patients must be warned of “serious or frequent risks”.7 The only exception is when “disclosure… would cause the patient serious harm. In this context serious harm does not mean the patient would become upset, or decide to refuse treatment”. Back in 1999, a special issue of BMJ embraced this as a new spirit of partnership rather than paternalism in the doctor–patient relationship.8 As osteopaths, we strive to treat mind, body and spirit, and this surely includes achieving partnership in patient decision-making. Kluge4 reassures us that the need to warn patients of risks has not increased litigation in Canada, and claims it has improved the physician–patient relationship.

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2. Implications for practice 

There are many questions to be answered before practitioners can implement these laws in practice effectively:

1.What are the risks? And do we have any information on how large the risks are?

2.How should they be expressed and debated, so the osteopathic profession can reach a consensus view?

3.What are the benefits and how do they compare with the risks?

4.How best are the risks expressed so that patients understand them, and are able to reach a decision balanced against the benefits as they see them?

5.How do we present these risks at the same time as promoting a positive attitude in patients prone to anxiety or catastrophising?

6.How should consent be recorded in practice in order to be valid in the eyes of the law?

The paper by Gibbons and Tehan1 provides an excellent overview of the evidence we currently have on the first and third questions. Firstly, osteopathic research is sorely needed as the body of evidence comes from studies of the risk of manipulative practice by chiropractors, medical doctors and physiotherapists. The studies to date have been mainly surveys, case reports and case series, which provide widely varying estimates of the risks. However, several strong messages emerge. HVLA thrust techniques are considered more dangerous than non-impulse techniques. The two serious complications considered are stroke/vertebrobasilar accidents (VBA) following neck manipulation and cauda equina after lumbar manipulation. The risk of stroke appears to be about 1 in 500,000 (or 0.00002%) and may be even lower. This can be compared with the risk of serious gastric complications from prolonged use of NSAIDS, which may be as high as 1in 1000.9 However, the average age of patients with a VBA complication following manipulation is very young, only 38 years10 and while complications such as cauda equina can be treated, VBAs are difficult to prevent and treat. The reason why prevention is difficult is that there is no good test for vertebrobasilar insufficiency (VBI), as Gibbons and Tehan explain. The traditional VBI provocation test is now proven to be uninformative and should be dropped from use.

So, are we justified in continuing to perform cervical HVLA thrusts? As osteopaths with many techniques at our fingertips, plus our ability to address the bio-psychosocial factors in pain, do we need to use HVLA thrust techniques when treating the neck? Do the benefits really outweigh the risks? How does the risk benefit equation stack up depending on host factors such as age, smoking habits, migraine, and heart disease risk factors such as blood pressure, cholesterol and family history? How is the risk affected by medication such as anticoagulants? Clinical judgement will always be required. The evidence of benefit is not cast iron by any means, but supports the continued cautious use of HVLA thrust techniques for neck pain and headache in patients without contra-indications, provided practitioners have appropriate training, take a thorough case history, and conduct a detailed physical assessment before treatment.

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3. Implementing the evidence in practice 

The Australian manipulative physiotherapists have gone a long way in attempting to implement this evidence on safety. They have recently produced revised guidelines on pre-manipulative testing of the cervical spine3 following a survey to evaluate members' views on the previous (1988) protocol. The survey also collected information on the use of HVLA thrusts and other techniques, the frequency of adverse effects, and implementation of informed consent requirements. The results of the survey showed wide use of cervical HVLA thrusts (84.5%) and passive mobilisation (99.8%). Mild (VBI type) adverse effects such as dizziness occurred at a rate of about 1 per 50,000 HVLA thrust procedures and, surprisingly, were equally frequent with passive techniques. The revised guideline reflects members' feedback and is supported by several extensive literature reviews. The recommendation, like that of Gibbons and Tehan, is to screen patients using both history and physical tests. The history should include specific questions to check for possible symptoms of VBI (including dizziness, nausea, visual disturbance, dysphagia). The one physical test recommended is sustained end-range rotation, performed either sitting or supine, to left and to right, with follow-up questioning during active movements and during treatment. The osteopathic recommendation is a little more cautious, suggesting careful active and passive rotation, not beyond provocation of symptoms. All authors agree that cervical manipulation/HVLA thrust and end-range rotation techniques should NOT be undertaken if there is evidence of symptoms potentially associated with VBI.

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4. Informed consent 

In the Australian survey,3 only 37% of respondents always warned their patients of the dangers of cervical manipulation, and only 33% sought consent on every occasion. This result was a cause for concern, not only because informed consent is a legal requirement but also because the emphasis of good practice, and one factor in good outcomes, includes the patient in decision-making. The authors sought medico-legal opinion on good practice in this area. The advice was highly consistent with Lord Bingham's view that a person is entitled to make decisions about his or her own life. The key feature was that a health practitioner was required to provide adequate information to the patient to enable the patient to make a judgement about the choices offered. Such information must include the benefits and the risks associated with the procedure offered and alternative procedures. The risks of cervical manipulation should include dizziness, nausea, radiculopathy, and stroke. The risk of death need not be included: their legal advisors considered the risk to be lower than those taken as part of daily life. The information must be in a form the patient can understand, and appropriate to their needs. The information can be presented in brochure format, but a brochure alone without face to face discussion does NOT fulfil the legal requirement. The time spent on discussion may be balanced against the benefits to prognosis of shared decision-making, and the prevention of litigation. The legal terms “Express Consent” (explicit, recorded oral or written agreement made by the individual or their legally appointed representative or guardian) was considered essential for any techniques over which the patient has no control, such as cervical manipulation/HVLA thrust, and the paper suggests a short way to record such consent, which could form a useful basis for working towards a format for the osteopathic profession. “Implied consent” or “tacit consent”, in which the patient implies agreement by actions such as following instructions or by not dissenting, were considered adequate for non-thrust procedures for which no serious risks have been reported. Some members of the Australian association were still resentful of the informed consent requirement, but as the authors point out “the imposition has come from the changing perception of the individual's place and rights in society… and the guidelines have been developed to protect physiotherapists in addition to their patients”. A smaller survey of UK chiropractors also found poor implementation of valid consent procedures.11

General practitioners have a similar dilemma. Primary care consultations about the menopause and hormone replacement therapy (HRT) involve decision making in the face of clinical uncertainty.12 Their study found that women felt that risk communication would be optimised by the provision of unbiased, truthful and summarised information, and also by the personalisation of both this risk information and subsequent management. Some patients wished for a more directive approach, and practitioners need to develop skills to evaluate each patient's needs at each consultation. In genetic screening, Grande et al.13 found that women's understanding of heredity and disease was often idiosyncratic and might differ from biomedical models. A main task for clinicians appeared to be appropriate reassurance. Various risk communication aids for ‘shared decision making’ have been developed14 to facilitate this.

At present, the information about risks comes from other professions and the osteopathic profession urgently needs to conduct its own, rigorous research in this area. The evidence we have, suggests that cervical HVLA thrust techniques pose an extremely small but serious risk. Assessment of the risk for an individual patient requires knowledge, skill and clinical judgement. The legal framework supports each individual's rights over their own body and life, making it essential that osteopaths explain in clear and simple terms to patients the potential risks and benefits of cervical manipulation, both in specific terms and in a reassuring way. They can then engage the patient in shared decision making about whether or not they wish to proceed with this particular procedure. To do otherwise is to place yourself on the wrong side of the law. To embrace this process is an opportunity to enhance patient outcomes and satisfaction.

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References 

  1. Gibbons P, Tehan P. HVLA thrust techniques: what are the risks?. Int J Osteopath Med. 2006;9:4–12
  2. Dyer C. Surgeon found liable for not warning of partial paralysis risk. Br Med J. 2004;329:938
  3. Magarey ME, Rebbeck T, Coughlan B, Grimmer K, Rivett DA, Refshauge K. Pre-manipulative testing of the cervical spine review, revision and new clinical guidelines. Man Ther. 2004;9:95–108
  4. Kluge EW. Chester in perspective: suggestions from abroad (rapid response). bmj.com. 2005, 31 Jan;
  5. Lord Bingham of Cornhill . House of Lords Judgements – Chester (respondent) v Afshar (Appellant). The United Kingdom Parliament UKHL41 on. <http://www.parliament.the-stationery-office.co.uk/pa/ld200304/ldjudgmt/jd041014/cheste-1.htm>2004;
  6. General Osteopathic Council . Code of practice. <http://www.osteopathy.org.uk/about_gosc/about_standards.php>2004;
  7. General Medical Council . Seeking patients consent: the ethical considerations. <http://www.gmc-uk.org/guidance/library/consent.asp>1998;
  8. Coulter A. Paternalism or partnership? Patients have grown up-and there's no going back. Br Med J. 1999;319(7212):719–720
  9. Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med. 2002;112:566–571
  10. Assendelft WJ, Bouter LM, Knipschild PG. Complications of spinal manipulation: a comprehensive review of the literature. J Fam Pract. 1996;42:475–480
  11. Langworthy JM, le Fleming C. Consent or submission? The practice of consent within UK chiropractic. J Manipulative Physiol Ther. 2005;28:15–24
  12. Walter FM, Emery JD, Rogers M, Britten N. Women's views of optimal risk communication and decision making in general practice consultations about the menopause and hormone replacement therapy. Patient Educ Couns. 2004;53:121–128
  13. Grande GE, Hyland F, Walter FM, Kinmonth AL. Women's views of consultations about familial risk of breast cancer in primary care. Patient Educ Couns. 2002;48:275–282
  14. Elwyn G, Edwards A, Gwyn R, Grol R. Towards a feasible model for shared decision making: focus group study with general practice registrars. Br Med J. 1999;319:753–756

PII: S1746-0689(06)00030-7

doi:10.1016/j.ijosm.2006.02.004

International Journal of Osteopathic Medicine
Volume 9, Issue 1 , Pages 1-3, March 2006

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