International Journal of Osteopathic Medicine
Volume 12, Issue 2 , Pages 47-48, June 2009

Clinical guidelines, adverse events and SQUID

School of Biomedical and Health Sciences, University of Western Sydney, Sydney, Australia

Department of Health Science, Unitec NZ, Auckland, New Zealand

published online 17 April 2009.

Article Outline

 

Hands up who likes being told what to do? We hazard a guess that there aren't many in the osteopathic profession who would raise their hands – ourselves included. Yet, we all find ourselves working in an environment of best practice and clinical guidelines that do tell us what to do. Or at least they appear do to so.

We're a little cautious about clinical guidelines for a number of reasons. First, average data from a typical population doesn't necessarily apply to individual patients who may not be representative of the narrow ‘patient’ criteria that is often a requirement of the trials upon which guidelines are typically based. Second, gaps in the literature in the area covered by a guideline means that some recommendations will be based on consensus agreement between panel members of the guideline committee rather than objective data, and it is possible (but hopefully not probable) that personal biases of committee members may come into play. Third, evidence is dynamic, not static, and the recommendations contained within a certain guideline may become outdated or reversed depending upon what new evidence comes to light.

It is for these reasons, however, that clinical guidelines are referred to as guidelines and not absolute rules. Their usefulness is most often apparent in terms of the big picture of patient management, and not the individual level of patient management where clinical judgement and patient preferences take precedence. Working within the recommendations of clinical guidelines helps to ensure that practice is evidence-based and justifiable yet at the same time is flexible in relation to the person you are trying to help.

In this issue of the journal, Nicholas Penney provides a discussion of the European and Australian clinical guidelines for the treatment of acute non-specific low back pain.1 He explains how each guideline is structured differently in terms of how the evidence for each recommendation is rated, and points out specific areas of agreement and disagreement between the two different guidelines. Penney also highlights those areas in which agreement between the two guidelines occurs and reminds us all about the key messages we can take home and apply in the clinic from guidelines such as these.

Also in this issue, Thomson and colleagues2 report on the effect of spinal high velocity low amplitude thrust technique (HVLAT) on the pressure pain thresholds of lumbar spinous processes. Comparing mobilisation with HVLAT is an obvious target for lumbar spine research, and its use in asymptomatic subjects sparked some debate between the editors, reviewers, and editorial board during the peer review of this article. The main debate centred around the definition of spinal manipulation and whether or not a technique could be called spinal manipulation if no specific osteopathic spinal lesion (somatic dysfunction) was identified and corrected by the manoeuvre.

For us, this again highlighted the fact that there is a broad range of different opinions as to what constitutes osteopathy and osteopathic manipulative therapy, and that the impact of this is potentially far more negative on the profession than it is positive.

The axiom “above all, do no harm” and its Latin equivalent, primum non nocere forms one of the fundamental principles for the ethical practice of medicine and healthcare. Most of us incorrectly attribute the phrase to Hippocrates, but according to a fascinating review by Smith3 the origins of the phrase lie not with Hippocrates, nor Galen, or Paré; but rather, with English physician Thomas Inman who, writing in 1860, attributes it to the prominent physician Thomas Sydenham.

Regardless of its origins, the principle of nonmaleficence is fundamental to ethical health practice and directly relates to risk benefit analysis. In terms of research in osteopathy, the focus has largely been in investigating the benefit side of the equation, with little attention on harms. Of course, we're all familiar with the potential for harms associated with high velocity low amplitude (HVLA) thrust manipulation and although more work is required, the topic of HVLA and adverse events receives at least some attention in the osteopathy literature.4, 5 Leaving aside HVLA, there is sparse literature about adverse events associated with other osteopathic techniques.6 Interestingly, one of the few exceptions to this is a single paper reporting adverse events arising from ‘cranial’ treatment.7

It's very apparent that good quality data about both benefit and harm associated with osteopathic treatment is necessary if well informed decisions are to be made about treatment. The notable absence of research in the area of adverse events has recently started to attract more attention by investigators in manual medicine. In the UK, the General Osteopathic Council is currently funding four projects investigating issues related to risk and adverse events. We're looking forward to the reading the findings from these studies as they start to emerge over the next year. As a ‘warm up’ to the findings that will emerge from the GOsC funded studies, we're particularly pleased to be able to publish a pilot study by Rejendran et al,8 who conducted a prospective pilot study into monitoring of adverse events occurring in a student teaching clinic. As Rajendran et al highlight, the study is of limited generalisability, however, it does provide valuable data in preparation for further work and other researchers interested in this area will find it useful in undertaking larger scale studies. The authors also point out the need for qualitative work to explore patient attitudes regarding post-treatment reactions. The combination of qualitative and quantitative approaches to health research problems is powerful, and it's encouraging to see that the GOsC funded projects include a substantial allocation of funding for investigating osteopaths' attitudes to managing and assessing risk as well as patient experiences and responses.9

Finally, in this issue, we publish a letter by Richard Blacklaw-Jones10 who contributes to the ongoing correspondence surrounding ‘cranial osteopathy’. We've published a number of articles11, 12 and letters on this topic in recent years.13, 14, 15, 16 What interested us in publishing yet another ‘cranial debate letter’ was that Blacklaw-Jones proposes some genuinely interesting and testable ideas about possible underlying mechanisms. Such knowledge would assist in explaining the experiences that are described by patients and practitioners using cranial therapy. Research in exotic fields such as human electro-magnetic research is attractive (think “computers and flashing lights”) and as Blacklaw-Jones writes “you only discover new things if you ask new questions”. But with the limited research resources we have in osteopathy we should be prioritising research that addressing cardinal questions such as ‘does this therapy work?’ before pursuing questions about ‘how does this therapy work?’.17 In this case, the generic ‘does this therapy work?’ question might be more formally phrased as “What is the effectiveness of cranial osteopathy for the treatment of condition x”, and could be approached using, in increasing order of rigour, a case study, a case series, an open pragmatic clinical trial, or a randomised controlled clinical trial.

In research, we need to constantly remind ourselves that developing a better understanding of mechanisms has almost no impact on an individual patient or a practitioner trying to decide if a series of osteopathy treatments might be clinically beneficial or harmful. The type of research that is most useful for clinical decision making has been described with the acronym POEM, or ‘Patient-Oriented Evidence that Matters’.18, 19 Knowledge about underlying biological mechanisms is largely inconsequential to clinical decision making if there is good quality data about effectiveness to inform our decision making. Having said that, we are quite curious to know what happens when a cranial practitioner does their thing near a SQUID.

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References 

  1. Penney JN. A comparison of Australian and European evidence-based guidelines for intervention in acute, non-specific low back pain. Int J Osteopath Med. 2009;12:63–68
  2. Thomson O, Haig L, Mansfield H. The effects of high-velocity low-amplitudethrust manipulation and mobilisation techniques on pressure pain thresholdin the lumbar spine. Int J Osteopath Med. 2009;12:56–62
  3. Smith CM. Origin and uses of primum non nocere – above all, do no harm!. J Clin Pharmacol. 2005;45:371–377
  4. Gibbons P, Tehan P. HVLA thrust techniques: what are the risks?. Int J Osteopath Med. 2006;9:4–12
  5. Snelling N. Spinal manipulation in patients with disc herniation: a critical review of risk and benefit. Int J Osteopath Med. 2006;9:77–84
  6. Kuchera M, Di Giovanna E, Greenman P. Efficacy and complications. In:  Ward R editors. Foundations of osteopathic medicine. Philadelphia: Lippincott Williams & Wilkins; 2003;p. 1143–1152
  7. McPartland J. Craniosacral iatrogenesis, side-effects from cranial-sacral treatment: case reports and commentary. J Bodyw Mov Ther. 1996;1:2–5
  8. Rajendran D, Mullinger B, Fossum C, Collins P, Froud R. Monitoring selfreportedadverse events: a prospective, pilot study in a UK osteopathicteaching clinic. Int J Osteopath Med. 2009;12:49–55
  9. National Council for Osteopathic Research . Retrieved on 2 March 2009. Available from: http://www.brighton.ac.uk/ncor/research_opps/index.htm
  10. Blacklaw-Jones RD. Comments on cranio-sacral method and efficacy. Int J OsteopathMed. 2009;12:72–74
  11. Moran RW. Osteopathy in the cranial field – moving towards evidence for causality and effectiveness. Int J Osteopath Med. 2005;8:79–80
  12. Milnes K, Moran RW. Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: a preliminary investigation. Int J Osteopath Med. 2007;10:8–17
  13. Hartman SE. Should osteopathic licensing examinations test for knowledge of cranial osteopathy?. Int J Osteopath Med. 2005;8:153–154
  14. Maddick AF, Korth SB. Response to Hartman's “Should osteopathic licensing examinations test for knowledge of cranial osteopathy?”. Int J Osteopath Med. 2006;9:108–109
  15. Hartman SE. Cranial osteopathy and licensing exams: rejoinder to Maddick and Korth. Int J Osteopath Med. 2006;9:143
  16. Maddick AF. The flawed cranial model. Int J Osteopath Med. 2007;10:80–82
  17. Lucas P, Moran RW. Evidence: uses and abuses. In: Advancing osteopathy 2008. London: Queen Elizabeth Conference Centre; 2008;
  18. Shaughnessy AF, Slawson DC, Bennett JH. Becoming an information master: a guidebook to the medical information jungle. J Fam Pract. 1994;39:489–499
  19. Slawson DC, Shaughnessy AF. Obtaining useful information from expert based sources. Br Med J. 1997;314:947–949

PII: S1746-0689(09)00026-1

doi:10.1016/j.ijosm.2009.03.004

International Journal of Osteopathic Medicine
Volume 12, Issue 2 , Pages 47-48, June 2009

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