Playing by the rules – and getting it wrong

Cite this article as:
Tony Long. Playing by the rules – and getting it wrong, Don't Forget the Bubbles, 2020. Available at:
https://doi.org/10.31440/DFTB.29840

Ethics is based in philosophy – the critical evaluation of arguments and assumptions – and therefore is the activity of philosophical reflection about norms and values; right and wrong; good and bad; what ought and ought not to be done. Bluffer’s Guide tip: ethics is Greek and moral is Latin. Talking about ethics and morals is like referring to renal kidneys or cardiac hearts.

Theoretical positions

Two main theories guide ethical behaviour. The most commonly espoused is that of deontology: a principles – or rules-based approach. This has nothing to do with gods (Latin “deus”). It is from the Greek “deon” for duty. Immanuel Kant (1724-1804)not-a-recent-reference defined the Categorical Imperative, a supreme over-riding principle that is never context-dependent, which rules humans absolutely, and which is felt even when defied. It’s like Pinocchio’s Jiminy Cricket. For Kant, the foundation of morality was duty. Acts should be considered good or bad of their own right, regardless of the outcome.

Following the rules

The Beauchamp and Childress schema of respect for autonomy, beneficence, non-maleficence and justice is often adopted. Patients should not smoke (no-one should): it’s hazardous to their health and 50% of smokers will die from a smoking-related illnessinsert-reference-of-your-choice. (This includes the fictitious lady who smoked only 19 a day.) Beneficence requires that we act in patients’ best interests and stop them smoking: confiscating cigarettes and frisking visitors for contraband. At the same time, non-maleficence requires us to prevent the effects of withdrawal that we enforce. If patients refuse to use them, we might have to sneak nicotine patches in under the dressings. Justice requires that we treat all patients equally, not spending too much time stopping the smoking because obese patients need to get on the treadmills and time must be allocated to preventing cake-smuggling. Then respect for autonomy requires that patients decide for themselves whether or not to smoke (or eat too much). There’s the rub.Hamlet, nd.

Rules-based approaches are difficult because the rules or principles conflict. Increasingly more conditions (formally known as “ifs and buts”) have to be introduced to make it work. Ifs and buts bring with judgements based on circumstances, so the rules are no longer universal and rigid. Judging what action to take based on guidance (rules that have to be interpreted) and on circumstances is more often known as a consequentialist stance. Discworld fans might recognise this as Commander Vimes’ “dealing with what is in front of you” approach:try “Night Watch” something that will be familiar to all senior clinicians.

Considering the outcome

An alternative, also not without its critics, justifies actions by expected outcomes. Jeremy Bentham (1748-1832) and John Stuart Mill (1806-1873) were the classic sources of consequentialist or utilitarian theory: that to act morally, we should try to bring about the best consequences. Sometimes, telling lies is right (“Is this spot really noticeable?”), and sometimes, judgement is needed to decide between opposing actions. In health care, possible outcomes are often not clear-cut. Complexity and differing viewpoints make judgements difficult.


Ethical decisions in research

Ethical decision-making in research is just as difficult. When to stop a trial because of side effects or because the results are obviously fabulous, whether we can deceive participants for the greater good, and how informed participants need to be can all be problematic. The opt-out article is a discussion of a decision made about informing potential participants and ensuring that they have given valid consent for data to be collected in a research study in paediatric urgent care departments. 

Since the bureaucracy never retreats, the content of participant information sheets (PIS) continues to grow. Required items are added, but nothing is ever removed. A 20-page PIS is perfectly normal for a drug trial. Four pages will often be required even for an innocuous survey. GDPR regulations have added one or two pages of the densest and opaque text for those of standard (ie: low) reading age. You don’t read two pages of small print before signing a new mobile phone contract.No-you-don’t! There is evidence that participants don’t read PIS, either, so they are not informed before signing up. There is something odd, too, about requiring the person who is to be protected to sign the researcher’s consent form. The participant’s signature actually protects the researcher by evidencing that consent was sought.

In the study, we adopted opt-out consent in which brief information (one side of A4 in large print and low reading age) was provided, and parents or young people would sign only to indicate a refusal to participate. (This last sentence has a Gunning-Fog readability index of 21.5. Anything above 12 is hard for most people to read!)Years of experience in research with young people has taught us that they will not read more than a paragraph before making a decision, and they will decide immediately, refusing a cooling-off period.

Since that study, incorporation of GDPR into English law has led (in good faith and with appropriate professional concern) to the banning of opt-out consent in NHS research by the Health Research Authority and therefore by the National Institute for Health Research, applying the rule that “active consent” is compulsory. We argue that this is based on the false assumption that opt-out consent implies a lack of information and lack of a decision by participants. The brief information that we supplied had a better chance of being read than a standard PIS, so participants may have been better informed than usual. Parents made a decision for their child’s clinical data to be included and did so by not completing the contact details on the reverse of the form. 


Applying a blanket rule like this can damage recruitment to very large studies, may lead to participation without effective information, and places a greater burden of time on participants which is not commensurate with the risks of participation. The law must be obeyed, but what if the law has been misinterpreted? What if the rule brings about worse outcomes? See what you think.

The 7th Bubble Wrap

Cite this article as:
Grace Leo. The 7th Bubble Wrap, Don't Forget the Bubbles, 2017. Available at:
https://doi.org/10.31440/DFTB.11992

With millions upon millions of journal articles being published every year it is impossible to keep up.  Every month we ask some of our friends from PERUKI (Paediatric Emergency Research in UK and Ireland) to point out something that has caught their eye.

Crack the back?

Cite this article as:
Andrew Tagg. Crack the back?, Don't Forget the Bubbles, 2016. Available at:
https://doi.org/10.31440/DFTB.8591

A recent article in the Australian press has once again shone a spotlight on the practice of neonatal spinal manipulation by chiropractors.

Infantile colic can be hard on parents. As Ben points out here there is very little that we can do about it. It occurs in up to 30% of infants and peaks at around 6-8 weeks of age. It can severely impact the ability of both parents to bond with their child as they become progressively more deprived of sleep. Chiropractic therapy has been around since 1895 when Daniel David Palmer performed a manipulation on a partially deaf janitor and reportedly cured him of his affliction.

 

Is there any evidence that manipulation is of benefit in infantile colic?

A number of studies including this randomised controlled trial, suggest it is of no benefit though a small study by Wiberg et al compared spinal manipulation with dimethicone and noted a statistically significant reduction in hours spent crying in children that had seen the chiropractor. The same has been said to be true of occipital-sacral decompression -another manipulative technique. However, if you look more closely, the trials that show benefits are unblinded and thus open to bias.

The long term follow-up of these children suggested that they are much better two months after the treatment, but one must also consider the natural history of the disease. Colic disappears with time and so parents, who often subjectively report on their child’s symptoms using a crying diary, will always notice a reduction in colic and may falsely attribute it to the therapy. A short cut review by Hughes and Bolton (2002), agreed to the lack of efficacy when compared to placebo in the treatment of infantile colic, but suggested that parents might benefit from the time spent with the chiropractor. In a time-poor traditional health care system, private practitioners with more time to spend may exert a more powerful placebo effect.

Manipulation has also been suggested to be of benefit in a number of other gastrointestinal conditions such as reflux, constipation and inflammatory bowel disease, as well as unrelated disorders such as autism and ADHD.

Commentary in the chiropractic press suggests that given the lack of evidence of benefit for any standard treatment, that manipulation should be also be considered. The evidence there relies on small, single randomized trials coupled with case series and reports.

 

We often seem to do a lot of things in medicine with no clear evidence of benefit. Is there any evidence of harm with spinal manipulation?

It has been suggested that lack of benefit in some trials may be related to a dosing effect – the negative trial of Olafsdottir used up to three treatments only, whereas the positive trials extended the course of treatment. The theory being that just three treatments was not enough to make a difference but when the ‘dose’ of manipulation was increased to a full course then the benefit becomes more apparent. An audit of practice at a teaching practice in the UK suggested reactions occurred in 1 in 100 children with no serious adverse events reported. A recent literature review by the Journal of Manipulative and Physiological Therapeutics (the journal of the American Chiropractic Association) reported three deaths caused by high-velocity extension and rotational spinal movements. As well as death, a number of other adverse events have been reported including subarachnoid haemorrhage and paraplegia.

A recent article by a medical ethicist suggested that:

Any attempt to manipulate the immature, cartilaginous spine of a neonate or a small child to correct a putative chiropractic subluxation should be regarded as dangerous and unnecessary. Homola S. Pediatric Chiropractic Care: The Subluxation Question And Referral Risk. Bioethics. 2016 Feb 1;30(2):63-8.

With no clear evidence of benefit and certainly evidence of potential harm one wonders what the official bodies think about the manipulation of infant’s spines.

The Chiropractic Board of Australia has the following position statement on its website:

Current research indicates that the incidence of serious adverse events, either directly from manual therapy or indirectly by delayed or misdiagnosis, is rare but real. Given the lack of good quality evidence about chiropractic care of children, more research is required to better understand this issue.

However, this goes against the recommendations of the Chiropractic and Osteopathic College of Australia:-

…COCA expresses concern with respect to chiropractors, osteopaths and others, who employ spinal manipulation when providing care for children with non-musculoskeletal conditions. These non-musculoskeletal conditions include conditions such as colic, asthma, bed wetting and otitis media.

The best available evidence is either inconclusive or does not support the use of manual therapy for the treatment of non-musculoskeletal conditions in children [1,2]. In COCA’s view it is inappropriate to provide treatment that has been shown to be ineffective or where there is insufficient evidence to support its use when other available treatment options have been demonstrated to be beneficial.

And the president of the Australian Medical Association in 2013, Steve Hambleton, stated:-

We know there’s more and more chiropractors treating children for all sorts of things like infantile colic, like bed-wetting, like middle ear infections, all sorts of things for which it’s simply biologically implausible that manipulation…or doing anything with the spine is going to make any difference…You shouldn’t be doing anything with a young person…without significant levels of quality evidence.

 

Please read some of the literature and draw your own conclusions.

 

 

Selected references

Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Archives of disease in childhood. 2001 Feb 1;84(2):138-41. Full text here

Hughes S, Bolton J. Is chiropractic an effective treatment in infantile colic?. Archives of disease in childhood. 2002 May 1;86(5):382-4. Full text here

Ernst E. Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials. International journal of clinical practice. 2009 Sep 1;63(9):1351-3. Full text here

Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. Journal of manipulative and physiological therapeutics. 1999 Oct 31;22(8):517-22.

Vohra S, Johnston BC, Cramer K, Humphreys K. Adverse events associated with pediatric spinal manipulation: a systematic review. Pediatrics. 2007 Jan 1;119(1):e275-83.