Major government health directive monitored for efficacy and safety

Last year I was fortunate to become part of a team at Christchurch hospital led by emergency care physician, Dr Martin Than. About 7 years ago in response to some local issues with how patients presenting with chest pain were being evaluated for potential heart attacks, Dr Than began a research program that investigated what clinical, demographic, and biological (blood) factors could best be used to safely and efficiently rule-out a heart attack.

Someone turning up at the doors of the Emergency Department with chest pain desperately wants to hear those reassuring words “You are not having a heart attack.” Unfortunately, for the ED staff this a very difficult conclusion to come to rapidly. As a result, around the world, as many as 90% of patients being assessed for possible heart attack end up being admitted to hospital overnight or longer, although only 20% of them end up being diagnosed with a heart attack. Obviously this is not good for the patient or the hospital – especially given tight budgets and lack of bed space. Dr Than’s work addressed the problem with a large multi-national observational study which assessed if a decision making pathway (called an accelerated diagnostic pathway or ADP for short) could increase the proportion of patients who could potentially not be admitted to hospital instead referred for some outpatient testing(1). This was further refined in another observational study which reduced the number of blood biomarkers that needed testing(2). Finally, and uniquely a randomised controlled trial of the new ADP verse standard practice was run at Christchurch Hospital. This was very successful, nearly doubling the proportion of patients who could be discharged to outpatient care within 6 hours of arriving in the ED(3). More has been done since on refining the ADP … but that is for another post.

The Ministry of Health liked what they saw as did ED physicians and Cardiologists throughout the country. This has resulted in the MOH asking all EDs within New Zealand to implement an accelerated diagnostic protocol. In doing so they will join all of Queensland, and a sprinkling of hospitals throughout the world that have recently adopted an ADP. This kind of positive outcome to local research is what every scientist dreams of, and Dr Than and his team have a right to be proud. But wait, as they say, there is more. Thanks to a Health Innovation Partnership grant from the Health Research Committee we are able to put in place a mechanism to monitor the effect and safety of an ADP at eight hospitals around New Zealand. This is where I come in, as I am collecting, collating and analysing the data for this project.   It is very exciting to be involved not only in helping implement a change of practice, but to be able to assess if that change is effective across a range of New Zealand hospitals from major inner-city hospitals to small rural hospitals, each of which has to adapt an ADP to meet their own particular circumstances. As I write Middlemore, North Shore, Wellington, Hutt Valley, Nelson and Christchurch hospitals all have new ADPs in place. Most if not all EDs will have them by the end of the year.

Some of where accelerated diagnostic pathways have been implemented.

Some of where accelerated diagnostic pathways have been implemented.

The model of observational research -> randomised controlled trial -> local implementation with further research -> mandatory national implementation -> research the effect of that change on local and national levels -> refine processes etc, is I believe a very good one and one that should be standard practice for major health initiatives. The MOH, HRC, and various district health boards that have bought into this process should be commended. There are other similar initiatives happening around the country and a look forward to when as a health consumer I can have confidence in any procedure I may face as been similarly thoroughly assessed.

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Thanks to my Acute Care Fellowship sponsors: Sponsors

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and to the grant funding body:

HRC

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References

  1. Than, M. P., Cullen, L., Reid, C. M., Lim, S. H., Aldous, S., Ardagh, M. W., et al. (2011). A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet, 377(9771), 1077–1084. doi:10.1016/S0140-6736(11)60310-3
  2. Than, M. P., Cullen, L., Aldous, S., Parsonage, W. A., Reid, C. M., Greenslade, J., et al. (2012). 2-Hour accelerated diagnostic protocol to assess patients with chest pain symptoms using contemporary troponins as the only biomarker: the ADAPT trial. Journal of the American College of Cardiology, 59(23), 2091–2098. doi:10.1016/j.jacc.2012.02.035
  3. Than, M. P., Aldous, S., Lord, S. J., Goodacre, S., Frampton, C. M. A., Troughton, R., et al. (2014). A 2-hour diagnostic protocol for possible cardiac chest pain in the emergency department: a randomized clinical trial. JAMA Internal Medicine, 174(1), 51–58. doi:10.1001/jamainternmed.2013.11362

I’ve Got a Bad Feeling About This. . .

John Pickering:

My brother-in-law English lit professor shamelessly writing about a recent NZ sci fi book by his brother-in-law who’s not me…

Originally posted on Intelligently Artificial:

I’m not even going to pretend that there isn’t a conflict of interest here.  A better, more ethical person would take steps to maintain their objectivity and protect their sense of integrity.  But in a world where news anchor Brian Williams can singlehandedly drive the Taliban out of Afghanistan, and the US Supreme Court has declared that money is people, I will simply press on.  In the immortal words of Brian Williams, once more unto the breach!

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Hot oil baths and other things to do on World Kidney Day 2015

“In ancient times the Persian philosopher Avicenna [Ibn Sina] noted that urine may be retained in crisis of fever (s393) and prescribed hot oil baths (s413)(1). Unfortunately, apart from the supportive therapy of dialysis, there has been little progress since in the treatment of acute kidney injury (AKI).”(2)

Given that getting AKI at least doubles your chance of dying in hospital “no progress” is a major health issue.

Today is World Kidney Day and I get to post quite possibly the first blog post in the world on this day. I believe Avicenna would be thrilled with the attention paid to the organ which delivers urine. He may not be so thrilled that hot oil baths have been abandoned. Of course there is the obvious safety issues of scalding and drowning. Also, as Herod the Great found out, syncope (sudden loss of consciousness) is also a possible side effect (probably just because the heat constricted his blood flow [vasoconstriction] causing too little oxygen to reach his brain [cerebral anoxaemia].(3) Nevertheless, I think Avicenna is the type of person who would have welcomed a randomised controlled trial of hot oil baths verse today’s standard treatment.

91467137

The statue of Avicenna (Ibd Sina) to be found in Hamaden, Iran. http://www.panoramio.com/photo/91467137

If you don’t fancy a hot oil bath this World Kidney Day, then there are other things to do to minimise the possibility of Acute Kidney Injury. Have you got high blood pressure, diabetes or Chronic Kidney Disease? Be warned, ~10% of the adult population have Chronic Kidney Disease, many of whom are not aware, and many more are at risk of developing it. All add to your risk of multiple illnesses any one of which can trigger acute kidney injury. If you happen to have a heart attack or sepsis (very serious infection) you are more likely to get AKI and more likely to die because of these underlying conditions.

So, on the assumption that readers of this blog are smarter than the average bear, I shall give you some sound advice – for the sake of yourselves and your family LOOK AFTER YOURSELF (yes, I’m shouting and therefore sinning against the internet protocol police – but this is important). Cut the sugar intake, quit smoking, take a walk around the block. It ain’t rocket science (one of the simpler sciences that involves cylinders with fins and lots of explosives) – it’s easier than that.

Former World Kidney Day posts

2014 A day to celebrate https://100dialysis.wordpress.com/2014/03/13/a-day-to-celebrate/

2013 Happy WKD https://100dialysis.wordpress.com/2013/03/14/happy-wkd/

2012 I am a pee scientist https://100dialysis.wordpress.com/2012/03/07/i-am-a-pee-scientist/

References

  1. Avicenna: The Canon of Medicine [Internet]. 2nd ed. New Yourk: AMS Press; 1973. Available from: http://archive.org/stream/AvicennasCanonOfMedicine/9670940-Canon-of-Medicine_djvu.txt
  2. Pickering JW, Endre ZH: The definition and detection of acute kidney injury. Journal of Renal Injury Prevention 2014; 3:19–23 http://www.journalrip.com/Archive/3/1
  3. Retief FP, Cilliers JFG: Illnesses of Herod the Great. S Afr Med J 2003; 93:300–303

Cantabrians, this is your life

There is little more precious than our health and that of those we love. “Research saves lives” is  Canterbury Medical Research Foundation’s (CMRF) proudly held motto. The CMRF has been supporting the people of Canterbury for 55 years thanks to the generosity of Cantabrians. In that time they have funded more than $22 million in grants.  Yesterday I attended the launch of their new logo and branding.  The logo depicts a medical cross and the four avenues of Christchurch.  This new logo is intended to signal CMRF’s intention to be fresh and more external facing with a broader appeal to the Canterbury donating community and a bigger emphasis on  partnerships with other funding organisations to leverage money to best effect.  My own fellowship, jointly funded by the CMRF, the Emergency Care Foundation, and the Canterbury District Health Board is an example of that.  CMRF are also expanding the breadth of research they will fund and are now working to expand their influence in the translational, population health and health education spaces. Their vision is to be giving $2 million in grants per annum within 5 years.  What a great boost that will be to Canterbury. A key partner largely funded through CMRF is the NZ Brain Research Institute – their logo has also changed to mirror that of CMRF.

CMRF_launch

Acute Kidney Injury Following Cardiac Surgery: A Well-studied Cohort of AKI

Originally posted on AJKD Blog:

Dr. John Pickering Dr. John Pickering

Acute kidney injury (AKI) following cardiothoracic surgery has been well reported in the nephrology literature with numerous studies published in the last decade, although the definition of AKI was variable in many of these studies.  In a recent article published in AJKD, Pickering et al perform a systematic review and meta-analysis of the literature to assess the different definitions of AKI in these studies.  Dr. John Pickering (JP), the first and corresponding author of the study, discusses this topic with Dr. Kenar Jhaveri (eAJKD), eAJKD Editor.

eAJKD:Can you explain why your team felt this topic was important to study?

JP: There is a long history of studies evaluating AKI after cardiopulmonary bypass surgery, but the information is heterogeneous and cannot be easily used to understand the extent of the problem.  We thought it was important to quantify the association and its consistency across several global…

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beyond reasonable doubt: a significant improvement

For the second time in a week I have removed the word “significant” from a draft manuscript written by a colleague of mine in clinical medicine. In a significantly p’d I wrote about the myth of significance – that is about the ubiquitous use of the term “significant” in the medical literature to mean a specific probability  incorrectly rejecting the hypothesis that two things (eg two treatments) are the same (you may need to read that twice).  What I pointed out was the “significant” does not mean “meaningful.”   Here I want to propose an alternative.  But first, I need to discuss two major problems with the term.

Where common is not specific

In my experience the common usage of “significant” to mean important is the normal interpretation of the word in the science literature even by many medically trained people and sometimes the authors of articles themselves.

The tyranny of p<0.05

When the maths wiz Ronald Fisher talked about significance (in an agricultural journal not a medical one!) he used 0ne in 20 (p<0.05) as an acceptable error rate in agricultural field trials so that trials did not have to be repeated many times.  That p<0.05 has taken on almost magical proportions (‘scuse the pun) in the medical literature is scary and shameful.  I don’t want to delve into all that now.  If you want to, a starting point maybe the Nature article here.

My proposal

I propose that in all scientific literature that authors replace the term “significant” with the phrase “beyond reasonable doubt” and that they only be allowed to publish the article if in the methods section they define what p value they choose to represent “beyond reasonable doubt” and they defend why they have chosen this value and not another.  “Beyond reasonable doubt” is a term used in the New Zealand judicial system where those charged with a crime are presumed innocent (Null hypothesis) until proven otherwise.  Perhaps those of us in science could learn something from our lawyer friends.

Fat Mate: Fat chance lost

I expect New Zealand tax dollars science spending to be better than what I read in the media this morning. Headlined in the Press was “Blenheim ‘fat mate’ loses 13.5kg in 8 weeks.”  The story was of someone on a trial of a locally produced diet supplement having lost weight.  So far nothing to peak my interest, but then I came across the statements “Satisfax was the result of $12 million research over four years with support from Crown Research Institute Plant & Food Research.” (Satisfax is the trademark)  and “Huge demand for the trial saw it expanded from 100 “fat mates” to 200.”  The second of the links goes to an October article in the Marlborough express which includes the statement that “The trial had been approved by the Health Ministry’s health and disability ethics committee and was partially funded by Callaghan Innovation.

So, your and my taxes are being spent by Callaghan Innovation on a trial of a diet pill the development of which received other tax dollars through Plant & Food. Worth a little more investigation.  The trial went through an ethics committee – big tick.  It was also (a little late) registered on the Australia New Zealand Clinical Trials network (here) – tick.

BUT, it fails miserably as an efficacy trial.

There is no control group.  ie the pill is not compared against a placebo. I can think of no practical reason why there was not a control group taking a placebo (randomised and blinded of course).  Instead, the trial just looks at the average change in weight change over eight weeks and tries to establish if this is non-zero.  Given that these people are doing something hoping to loose weight, there may well be an average loss of weight that has nothing to do with the pill. The press article suggests a biostatistician is going to somehow “account” for the placebo affect (something not mentioned on the trial registration).  I pity the biostatistician as this is involves trying to convince someone that a study run elsewhere with a placebo group, at a different time, under different circumstances could actually serve as a control for this study.

Incredibly, that is not the only major issue.  I read that part way through the trial the publicity was such that there was a demand from people to enter the trial and so they doubled the number of participants from 100 to 200.  Ahhhhhh….. this is classic introduction of bias and should never have been allowed.  Those extra 100 people are not the same as the first group… they have elevated expectations that may well bias the results.  Furthermore, it is always dangerous to talk about the trial efficacy part way through as this may influence the behaviour of those already in the trial.   Grrrrr….

In short – a chance lost and waste of Plant and Food & Callaghan Innovation funding.  There is hope though – a proper randomised controlled trial could be conducted.  But, I won’t be holding my breath.

ps.  The Marlborough Express and Press should be ashamed of such blatant product placement – diet pills on January 2nd are so cliche.  I wonder if it was the reporter or the company who initiated this piece?