Issue 7 / 3 March 2014

I LEARNED the hard way that the risk of an uncommon adverse event in clinical practice becomes quantifiable when it happens to someone you are treating.

It was a case of pregnancy loss after amniocentesis in a patient I had referred. Afterwards, as everyone involved faced their sadness, regret and individual feelings of responsibility, there was also a shared sense of disbelief that we had been the “one in a hundred” — the quoted statistic back then.

This was the meaning of risk.

In a comment written for MJA InSight this week, Professor Peter O’Leary, an Australian expert in prenatal diagnosis, discusses a test for fetal DNA in maternal serum that provides more accurate, less invasive, less risky testing for Down syndrome.

A US study of the impressive accuracy of maternal plasma cell-free DNA testing for detecting foetal aneuploidy is also reported in our News in brief.

With an expansion in the options for early pregnancy screening comes the challenge of integrating new knowledge into pregnancy care. O’Leary says questions about the cost of, and access to, the new test have exposed a need for better coordination of prenatal testing in Australia.

Communicating the risk of adverse events to patients is impossible without accurate information about what they might be. This is currently the situation for the Australian chiropractic profession, which has no adverse events reporting system.

A letter published in the MJA was the stimulus for MJA InSight to put the need for such a system to chiropractic and medical safety experts, for our lead news story.

Obtaining informed consent from participants in medical research is an ethical obligation, involving explicit recognition and discussion of any associated risks. But many studies involve very low risk indeed (arguably lower than individual practitioner decisions in clinical practice) and a robust discussion of simplified models for consent is underway both in Australia and internationally. This is the subject of another of our news stories.

One scenario in which opt-out consent (where consent is presumed after dissemination of information about the study unless a participant actively withdraws) seems reasonable is in the use of disease registries and large clinical databases to answer clinical and epidemiological research questions.

Most patients agree that the wealth of information in these datasets should be used to help others but, as Australian researchers increasingly do so, we need to be aware that public trust in our intentions and actions can be fragile, as recent experience in the UK with care.data, a project using anonymised British National Health Service data to better monitor patient care and outcomes, will attest. The project was suspended last week amid seemingly well founded public concerns about breaches of privacy and commercial use of information.

The risks associated with prescription medications are subject to a constant if imperfect cycle of scrutiny, but in the shadowy world of illicit use of banned or restricted substances, patterns of harm can be difficult to detect. Another of this week’s news stories reports on a study, published in the MJA, analysing calls to the NSW Poisons Information Centre about adverse reactions to the performance-enhancing drug, clenbuterol.

A quick scan of the “gym-junkie” web forums reveals that the β2-adrenergic drug is favoured as a “fat burner” and is easy to get hold of in Australia, with little mention of the severe reactions reported in the MJA study.

In another Australian study, based on autopsy findings from young men who were users of anabolic steroids, the pathological findings in these men, with a mean age of just under 32 years, included left ventricular hypertrophy and coronary artery atherosclerosis, as well as testicular atrophy and fibrosis, and arrested spermatogenesis.

These unappealing adverse effects, unsurprising to the medical eye, were graphically described in a lay media report of the study.

To my mind, this was a very good thing. In seeking to minimise, manage and communicate risk — in medicine and in life — we need all the help we can get!

 

Dr Ruth Armstrong is the medical editor of MJA InSight.

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