You are here: Home / Archives for Research

Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Andrew Wakefield and Cognitive Dissonance.

Thu, 04 Feb 2010 06:30:32 -0500 by
He made up a syndrome.

He performed unnecessary and risky medical procedures on children.

He received hundreds of thousands of pounds from lawyers for a study to look for that imaginary syndrome, because the imaginary syndrome could make the lawyers a lot of money.

He was horribly incompetent in his research methods.

He lied about what he did.

He sued Brian Deer, the investigative reporter who uncovered most of the fraud. He had to withdraw the law suit and pay the expenses of Brian Deer.

In 2004, when they became aware of the fraud, 10 of the 13 authors of the study had their names removed from that study.

On January 28, 2010, a little over a week ago, The General Medical Council released its verdict.

The Fitness to Practise Panel has heard this case under The General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules Order of Council 1988. It has considered which, if any of the facts not admitted by Dr Andrew Wakefield, Professor John Walker-Smith and Dr (now Professor) Simon Murch have been found proved and then went on to consider whether such facts found proved together with those admitted, would be insufficient to support a finding of serious professional misconduct.[1]

The Panel has accepted in full the advice of the Legal Assessor as to the approach to be taken. The three doctors have nothing to prove, the burden of proof is on the GMC throughout. If the Panel were not sure beyond reasonable doubt, the sub-head of charge was found not proved in favour of the doctor, in accordance with the criminal, as opposed to the civil, standard of proof.[1]

A lot of findings of Admitted and found proved.

A lot of findings of Found proved.

The occasional finding of Found not proved.

A lot of irresponsible – Found proved.

A lot of dishonest – Found proved.

Some crazy people are still defending Andrew Wakefield.

You would have to be crazy to defend that fraud.

Or dishonest and irresponsible.

These people have convinced themselves that vaccines cause autism, even though research has repeatedly shown no connection.

So, in order to protect themselves from having to admit that they endangered their children and other children, they need to defend this, even though Andrew Wakefield has admitted some of the fraud and a court has determined that he is guilty of a lot more.

When people should admit that they made a mistake, some will actually become even more defensive of their clearly mistaken position.

A clear case of cognitive dissonance.[2]

If you wish to read about the research that has been done on autism and vaccines, there are scores of studies.[3] Studies paid for by many different organizations – governments, universities, non-profit groups, and even drug companies. They don’t find any connection between vaccines and autism.

Andrew Wakefield was receiving hundreds of thousands of pounds from lawyers to show a connection. Is it surprising that he did?

Andrew Wakefield was working on a vaccine to compete with the MMR vaccine, so he has another reason he might benefit financially from making false accusations about the MMR.

Andrew Wakefield has shown that he is willing to subject children to risky procedures for no benefit to the children, as long as he makes his money.

There has been a lot written by others on the topic. In the comments the anti-vaccinationists will try all sorts of misleading approaches. Some will claim that they are not anti-vaccinationists, but that they only want safe vaccines.

Vaccines are safe.

How much safer could vaccines be?

There are a some examples in response to Dear Jenny McCarthy . . . at A Day In The Life Of An Ambulance Driver. Another is at Asshole doctor responsible for false MMR/autism claim gets his at Cranky Epistles.

In The martyrdom of St. Andy at Respectful Insolence, there is far more detail about the dishonest and irresponsible conspiracy to link autism and vaccines. A listing of a lot of posts on this topic, even some defending the fraud, can be found in On The Lancet’s Retraction of Wakefield’s 1998 Paper Alleging A Connection Between the MMR Vaccine and Autism at I Speak of Dreams.

The unfortunate thing is that Andrew Wakefield is still making over a quarter of a million dollars a year to spread his lies for Thoughtful House, an anti-vaccination organization in Texas. When it comes to Andrew Wakefield, follow the money – he does. He came to the US, but he is not a doctor in the US.

If you know of Andrew Wakefield pretending to be a doctor, call the police.

And vaccinate your children for their sake.

More information is available at Brian Deer’s website.

Footnotes:

^ 1 Fitness to Practice Panel Hearing
UK General Medical Council
January 28, 2010
Free Full Text

^ 2 Cognitive dissonance
Wikipedia
Article

^ 3 Vaccines and Autism
Science-Based Medicine
Article

.

Filed Under: Ethics, Fraud, Heresy, Malpractice, Mythology, Research, Vaccines Tagged With: , , , , ,

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

Thu, 21 Jan 2010 21:11:04 -0500 by
ResearchBlogging.org

–

Also posted over at Paramedicine 101. Go check out the rest of what is there.

–

Correction posted 3/15/2011 in Correction to Spine Immobilization in Penetrating Trauma: More Harm Than Good.

–

A recent study points out some of the problems with EMS (Emergency Medical Services) treatment in some places. Each medical director, or state medical director, is permitted to ignore the evidence that some treatments are harmful. They can use ignorance as an excuse for continuing harmful practices. Rather than ignorance, those familiar with the research will claim that somebody might benefit. Their battle cry is What if . . . ?

If we take that approach, there is no limit to how much we can do to a patient, and I do mean to a patient, not for a patient. This is not patient care. This is alternative medicine. Since alternative medicine is not medicine, but an alternative to medicine, this EMS treatment qualifies as alternative medicine. When our patients need care, they do not need an alternative to medicine that works, they need medicine that works.

Spine immobilization in penetrating trauma: more harm than good?[1] shows that What if . . . ? medicine can double or triple the death rate of our patients.

What if . . . ? we act as if our patients matter enough to be treated as human beings.

What if . . . ? we try to help our patients survive.

The reason for the continued use of What if . . . ? practices seems to be more of a fear of lawyers, than any kind of understanding of medicine. The medical directors appear to presume that they will never get in trouble for doing too much, as long as we are not using pain medicine. They seem to think that anything they recommend is good, or at worst, not harmful. We’ve got to do something! That is the theme in EMS these days.

We need to continue to harm our patients right up until there is inescapable proof that we are causing harm.

What does the study say?

This study seeks to measure the effect of prehospital spine immobilization on mortality in a large national sample of penetrating trauma patients drawn from the NTDB (National Trauma Data Bank). We hypothesized that penetrating trauma patients who underwent prehospital spine immobilization would have higher mortality than penetrating trauma patients who did not undergo spine immobilization. In addition, we expected that a very small proportion of penetrating trauma patients potentially benefited from prehospital spine immobilization.[2]

Patients were considered to have potentially benefited from prehospital spine immobilization if they had an incomplete spine injury and required an operative spine procedure (including vertebral spine repair, spine fusion, laminectomy, and/or halo placement).[2]

This seems as if it should be the way to determine which patients might have been best treated with immobilization, but there remains a big problem. There is no research to show that without prehospital spinal immobilization, outcomes would be any worse, even for patients with unstable spinal fractures. We presume that this is an effective treatment, but we are only hoping that we are doing the right thing.[3]

On subset analysis of specific patient populations, no group of penetrating trauma patients had any survival benefit with prehospital spine immobilization (Fig. 1) Even for patients with the least severe injuries (ISS <15), spine immobilization was independently associated with significantly decreased survival (OR of death 3.40, 95% CI 1.48–7.81). The OR of death was significantly elevated for GSW patients (OR 2.12; 95% CI 1.33–3.37) and for hypotensive patients (OR of death 2.42, 95% CI 1.37–4.27).[2]

The fatality rate appears to be multiplied, not just increased, by this treatment. Maybe it is time to stop killing so many of our patients. Fortunately, most places stopped this dangerous treatment long ago. This comes from Johns Hopkins. It appears to have been motivated by the continuing attempts by MIEMSS (Maryland Institute for Emergency Medical Services Systems) to stick to the What if . . . ? method of treatment, in spite of evidence of harm. MIEMSS protocols do not appear to differentiate between blunt and penetrating trauma, when determining if immobilization is necessary[4].

Of these 116 patients, 86 (74%) had complete spinal cord injury and would not have benefitted from spine immobilization. Only 30 (0.01%) of the 30,956 patients had incomplete spinal cord injury and underwent operative spine stabilization. The number needed to treat (NNT) with spine immobilization to potentially benefit one penetrating trauma patient was 1,032. The NNH (Number Needed to Harm) with spine immobilization to potentially contribute to one death was 66.[2]

The NNT is not at all clear. They are using a potential benefit of spinal immobilization that has only been presumed. That benefit has not been demonstrated. Where is the research to show that prehospital spinal immobilization in any way improves outcomes for patients with unstable spinal injuries even due to blunt trauma?

In this case, the NNH is not the Number Needed to Harm. What is reported is the Number Needed to Kill, because they are only looking at fatal harm in calculating NNH. When looking at benefit, if they were to look for lives saved by spinal immobilization for penetrating injuries, they would still be looking. If they had a unicorn to guide them, they might find something.

According to one study of the harm due to spinal immobilization, the NNH is less than 2.

Conclusion

In this population of alert and cooperative patients with no obvious distracting injuries or clinical signs of intoxication, 52% had no complaints of neck pain or back pain yet were transported to the ED using FSI (Full Spinal Immobilization), which increased both their level of discomfort and their EMS charges.[5]

The number needed to treat is 1,032 – assuming there is any benefit from prehospital spinal immobilization. Only 1 study has looked at this. It found no evidence of any benefit. Even those with unstable spinal fractures did worse with spinal immobilization. Unfortunately the study was too small to be statistically significant.[6]

The number needed to harm is less than 2.

The number needed to kill is 66.

The extremely optimistic number needed to treat is 1,032.

Although the intention behind conservative prehospital spine immobilization protocols is to protect the minority of patients who suffer spine injuries, this study demonstrates that spine immobilization is associated with higher mortality in penetrating trauma patients and may harm more penetrating trauma patients than it helps. Prehospital spine immobilization was associated with higher odds of death in all penetrating trauma patients, and this association was qualitatively robust across all subsets of penetrating trauma patients.[2]

The merits of IV fluid administration, endotracheal intubation, and now spine immobilization (in penetrating trauma patients) have been called into question, because their clinical benefit may not be worth the extra time on scene.[2]

This is an excellent example of narrative fallacy.

We know that spinal immobilization leads to worse outcomes for patients with penetrating injuries. That is the part that is important to know. Then there is an attempt at an explanation – because their clinical benefit may not be worth the extra time on scene. This explanation is where we make a mistake. I have written quite a bit about narrative fallacy. The posts are linked below, in chronological order, just above the footnotes.

In the limitations, they do acknowledge this to some extent.

Our conservative estimate of the benefit is possibly exaggerated as not all patients with an incomplete spinal cord injury who underwent surgery truly benefitted from spinal immobilization.[2]

Elsewhere in the limitations, they write this.

This retrospective study suffers some significant limitations, mainly because of the data available. The NTDB does not report prehospital scene or transport times or differentiate urban versus rural care. Thus, we could not demonstrate that the excess mortality in patients who underwent spine immobilization was associated with delays in transport to definitive care.[2]

There is not really a good reason to presume that extra time on scene is the reason for the dramatic increase in death among those immobilized. While it is possible that time does contribute to the result, it is a mistake to claim that a study that does not have the ability to examine prehospital times at all is capable of providing evidence that extra time on scene is the cause.

Another recent study showed that there is no reason to believe that prehospital times significantly affect outcomes even for the most unstable trauma patients.[7]

Where research is not being used, we need to find ways to get the medical directors to understand research. Then we need to get them to apply the research.

Narrative Fallacy –

Narrative Fallacy I

How did this happen? – Research

Narrative Fallacy II

CAST and Narrative Fallacy

C A S T and Narrative Fallacy comment from Shaggy

Some Research Podcasting Comments

Shaggy Comments on Some Research Podcasting Comments.

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

EMS EdUCast – Journal Club 2: Episode 43

Education Problems, Autism, and Vaccines

–

Footnotes:

–

[1] Spine immobilization in penetrating trauma: more harm than good?
Haut ER, Kalish BT, Efron DT, Haider AH, Stevens KA, Kieninger AN, Cornwell EE 3rd, Chang DC.
J Trauma. 2010 Jan;68(1):115-20; discussion 120-1.
PMID: 20065766 [PubMed – in process]

–

[2] Spine immobilization in penetrating trauma: more harm than good?
Haut ER, Kalish BT, Efron DT, Haider AH, Stevens KA, Kieninger AN, Cornwell EE 3rd, Chang DC.
J Trauma. 2010 Jan;68(1):115-20; discussion 120-1.
PMID: 20065766 [PubMed – in process]

This is the same as footnote [1]

–

[3] Out-of-hospital spinal immobilization: its effect on neurologic injury.
Hauswald M, Ong G, Tandberg D, Omar Z.
Acad Emerg Med. 1998 Mar;5(3):214-9.
PMID: 9523928 [PubMed – indexed for MEDLINE]

I wrote about this study in Spinal Immobilization Harm.

–

[4] MIEMSS Maryland Medical Protocols
Effective July 1, 2008
348 pages of trying to predict everything that might go wrong.
Free large PDF

–

[5] Unnecessary out-of-hospital use of full spinal immobilization.
McHugh TP, Taylor JP.
Acad Emerg Med. 1998 Mar;5(3):278-80. No abstract available.
PMID: 9523943 [PubMed – indexed for MEDLINE]

–

[6] Out-of-hospital spinal immobilization: its effect on neurologic injury.
Hauswald M, Ong G, Tandberg D, Omar Z.
Acad Emerg Med. 1998 Mar;5(3):214-9.
PMID: 9523928 [PubMed – indexed for MEDLINE]

This is the same study as footnote [3].

–

[7] Emergency Medical Services Intervals and Survival in Trauma: Assessment of the “Golden Hour” in a North American Prospective Cohort.
Newgard CD, Schmicker RH, Hedges JR, Trickett JP, Davis DP, Bulger EM, Aufderheide TP, Minei JP, Hata JS, Gubler KD, Brown TB, Yelle JD, Bardarson B, Nichol G; Resuscitation Outcomes Consortium Investigators.
Ann Emerg Med. 2009 Sep 22. [Epub ahead of print]
PMID: 19783323 [PubMed – as supplied by publisher]

I wrote about this study in Emergency Medical Services Intervals and Survival in Trauma: Assessment of the “Golden Hour” in a North American Prospective Cohort.

–

Haut, E., Kalish, B., Efron, D., Haider, A., Stevens, K., Kieninger, A., Cornwell, E., & Chang, D. (2010). Spine Immobilization in Penetrating Trauma: More Harm Than Good? The Journal of Trauma: Injury, Infection, and Critical Care, 68 (1), 115-121 DOI: 10.1097/TA.0b013e3181c9ee58

.

Filed Under: 'Alternative' Medicine, Critical Judgment, EMS EduCast, Heresy, Paramedicine 101, Research, Research Blogging, Spinal Immobilization Tagged With: , , , ,

Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial.

Thu, 24 Dec 2009 18:59:33 -0500 by

ResearchBlogging.org
Also posted over at Paramedicine 101. Go check out the rest of what is there.

This study has received a lot of attention. I will interchangeably use the terms the IV (IntraVenous) group and the epinephrine group depending on the terminology I think is more relevant at the time. The distinction is not one that I believe is important. This is a study of IV medication in cardiac arrest. Epinephrine is the stated focus of the study.

There has never been any evidence to suggest that medication leads improved resuscitation outcomes. Unless your idea of an improved resuscitation outcome has nothing to do with quality of life.

Beneficial short-term effects of epinephrine have been shown in animal studies,3-5 but there is increasing concern for increased myocardial dysfunction6,7 and disturbed cerebral microcirculation after cardiac arrest.8[1]

Some people argue that the short-term effects are important. If we do not get a pulse back, we will not resuscitate anyone. This is true, but the problem is how much long-term damage do we inflict just to obtain that short-term improvement?

High-dose epinephrine is no longer recommended, even though it was better than standard-dose epinephrine at producing ROSC (Return Of Spontaneous Circulation). The current recommendation for epinephrine is based on this same misconception. More ROSC = better outcomes – except that the dogma is not supported by any evidence.

CONCLUSIONS–High-dose epinephrine (HDE) significantly improves the rate of return of spontaneous circulation and hospital admission in patients who are in prehospital cardiac arrest without increasing complications. However, the increase in hospital discharge rate is not statistically significant, and no significant trend could be determined for neurological outcome. No benefit of NE compared with HDE was identified. Further study is needed to determine the optimal role of epinephrine in prehospital cardiac arrest.[2]

That study was 17 years ago. That was far from the first study of epinephrine. There has been many studies of epinephrine in cardiac arrest since then.

We still do not have any research to show improved outcomes with any dose of epinephrine to treat cardiac arrest, but rather than admit that epinephrine should only be used in well controlled studies, we continue to make excuses. We are practicing alternative medicine, not real medicine.

Absence of evidence of benefit does not mean an absence of benefit, but when does it become enough evidence to insist that we stop using this ineffective and potentially harmful drug as the standard treatment?

Back to the current study.

Because there are no randomized controlled studies showing improved survival to hospital discharge with any drugs routinely administered during CPR, we concluded such a study was warranted.[1]

This study is possible because these researchers are outside of the US. In the US, the IRBs (Institutional Review Boards) seem to have concluded that it is unethical to deviate from the standard treatment, even if the standard treatment is harmful. Of course, we can never learn if the standard treatment is harmful, or even if it is beneficial, if we are prohibited from studying the treatment. However, the IRBs’ definition of ethics seems to have been arrived at while consuming hallucinogens and reading Lewis Carroll.

Epinephrine in cardiac arrest is also firmly established outside of the US. Here is a part of their explanation of the study design.

In this prospective, randomized controlled trial of intravenous drug administration during out-of-hospital cardiac arrest, we compared outcomes for patients receiving standard ACLS with intravenous drug administration (control) and patients receiving ACLS without intravenous drug administration (intervention).[1]

ACLS is Advanced Cardiac Life Support – almost all of the treatments that would be given in the ED (Emergency Department). Not giving the drug is the intervention. Giving the drug is considered the non-intervention – the control against the effects of the treatment, which is the non-treatment.

Defibrillation was attempted in more patients in the intravenous group compared with the no intravenous group (47% vs 37%, respectively; OR, 1.16 [95% CI, 0.74-1.82]). More defibrillation shocks were delivered to those who received defibrillation in the intravenous group compared with the no intravenous group (median, 3 [range, 1-22] vs 2 [range, 1-26], respectively; P = .008). Both groups had adequate and similar CPR quality with few chest compression pauses (median hands-off ratio, 0.15 for the intravenous group and 0.14 for the no intravenous group) and the compression and ventilation rates were within the guideline recommendations (Table1).[1]

While there were no apparent differences in the quality of CPR, the more frequent defibrillations might be worth looking at. One of the important aspects of this study, as opposed to most prehospital research, is the recognition of a need to control for quality.

The explanation for the more frequent defibrillations that seems most likely is that the epinephrine produced a shockable rhythm more often than CPR alone produced a shockable rhythm. Since a shockable rhythm appears to be the next best thing to ROSC, this would not be a surprise. Many patients will change from a shockable rhythm to asystole when defibrillated. Defibrillation is a profound vagal stimulus and asystole is the ultimate vagal state. Even with similar initial rates of shockable rhythms, some of both groups would be expected to be shocked into asystole. The epinephrine, being a huge cardiac stimulus, would be expected to lead to a return of a shockable rhythm more often than just CPR. In other words, if the epinephrine is expected to produce ROSC more often, it should also produce a shockable rhythm more often. The authors came to a similar conclusion.

Without differences in the predefined primary outcome, patients in the intravenous group received more defibrillations, were resuscitated for a longer period, and more frequently had ROSC. With similar and adequate CPR quality, this is likely due to the pharmacological effects of the drugs used (epinephrine, atropine, and/or amiodarone). This finding is consistent with previous animal studies with epinephrine,6,7 and clinical studies evaluating the effects of amiodarone,23 atropine,24 and even high-dose epinephrine,25 all of which documented improved short-term effects without improving long-term outcomes.[1]

One major criticism of the methods is that they did not have a placebo to be given to keep the EMS crews blinded to the actual treatment. The authors do admit that this is a limitation. Of course, this placebo would probably not be called a placebo, since the epinephrine arm is the placebo arm, while the non-treatment arm is the active intervention arm, but that is really only an amusing problem of terminology and attitude. When the epinephrine group is the group with an IV line in place during resuscitation and the no epinephrine group is the one that does not have an IV until after return of pulses, there is not even an attempt at blinding. Did this lead to any detectable difference in the way patients were treated by EMS, other than other than the differences intended by the study design?

Our study has several limitations. First, ambulance personnel could not be blinded to the randomization. Closely related to this, only patients who were randomized to the no intravenous group could be monitored with regard to protocol compliance. If intravenous drugs were administered to a patient in the no intravenous group, violation of the study protocol could be documented. If intravenous drugs were not administered to a patient in the intravenous group, several valid reasons could exist, such as rapid ROSC. We have no reason to believe that personnel refrained from establishing intravenous access under the pretense that the procedure was unsuccessful. The ambulance personnel involved were strongly committed to testing the hypothesis presented, but we cannot totally rule out possible bias toward procedures such as intravenous access and administration of drugs, which have been important in Norwegian culture for decades.[1]

This is a reason for creating a sham drug to use for the study. Without knowledge of the contents of the syringes being used, any bias of the treating medics should not affect the results. That is the purpose of blinding.

Analysis was performed on an intention-to-treat basis regardless of which treatment was actually given.[1]

In the No IV group, 10% received IV drugs. 9% of patients received epinephrine.

In the IV group, 82% received IV drugs. 79% of patients received epinephrine.

Why did some of the No IV patients receive epinephrine, or any drug? Clearly a protocol violation. I tripped and the IV landed in the patient, is not a valid explanation.

Why did 21% of the IV group not receive epinephrine? That is not clearly explained by the authors. Were these patients resuscitated prior to initiation of an IV and administration of epinephrine?

CPR and defibrillation are indicated before drugs. Since both CPR and defibrillation have research showing that they improve the long-term outcome from cardiac arrest, it is not unreasonable to expect that cases of ROSC with only CPR and defibrillation will be the reason for some patients not receiving epinephrine.

One of the perversions of a requirement that epinephrine be given in cardiac arrest is that the 1 mg bolus dose of epinephrine, repeated every 3 to 5 minutes, is never to be given to a patient with a pulse – Never. The reason is that epinephrine is so toxic to the heart, that it could be expected to produce cardiac arrest.

There are people criticizing this study because not all of the patients in the IV group received epinephrine. They see this as a bias. Contrariwise, I see their objection as just looking for any excuse to complain about research results they do not like, even though the study’s results are consistent with all of the other research that has been done. The critics fail to consider that some patients will be resuscitated prior to the point in the algorithms where drug administration is indicated. Their apparent demand that patients resuscitated prior to epinephrine administration be given epinephrine, even though the patient is no longer in cardiac arrest, is silly.

This would also not be likely to do anything to improve outcomes in the epinephrine group. The patients resuscitated prior to epinephrine administration are likely to be the patients with the briefest periods of cardiac arrest and therefore maybe the patients with the best potential for good outcomes. Returning them to a cardiac arrest, by means of epinephrine, just to follow an algorithm, would not be a good thing and it would probably have a dramatic negative effect on the survival of the patients in the epinephrine group.

The standard dose of epinephrine for a patient with a pulse, but not in cardiac arrest, is 2 mcg/minute to 10 mcg/minute. The standard dose of epinephrine for a patient without a pulse, but in cardiac arrest, is 1,000 mcg fast push every 3 to 5 minutes. I do not know of any medical professional, or any medical organization, or any medical reference, that recommends giving a living human being the dose of epinephrine that we only give to dead patients, and repeating it every 3 to 5 minutes. I would not be surprised at murder charges if the patient were to die soon after receiving this treatment that is given indiscriminately to dead patients.

Unless we can predict which patients, if any, will benefit from epinephrine, we need to find a better way to prevent giving epinephrine to the patients who will be harmed by epinephrine. If we cannot do that, we need to admit that we do not have any basis for using epinephrine in cardiac arrest.

Until there is research to show any benefit from epinephrine in cardiac arrest, we should eliminate epinephrine from all cardiac arrest treatment algorithms that are not part of well controlled studies.

–

Correction posted 3/07/2010 in Correction on Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial.

–

Footnotes:

–

^ 1 Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial.
Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L.
JAMA. 2009 Nov 25;302(20):2222-9.
PMID: 19934423 [PubMed – in process]

If you want to read the entire study, this link opens it in PDF.

–

^ 2 A randomized clinical trial of high-dose epinephrine and norepinephrine vs standard-dose epinephrine in prehospital cardiac arrest.
Callaham M, Madsen CD, Barton CW, Saunders CE, Pointer J.
JAMA. 1992 Nov 18;268(19):2667-72.
PMID: 1433686 [PubMed – indexed for MEDLINE]

–

Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, & Wik L (2009). Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial. JAMA : the journal of the American Medical Association, 302 (20), 2222-9 PMID: 19934423

.

Filed Under: ACLS, Critical Judgment, Epinephrine, Ethics, Heresy, Research, Research Blogging, Surrogate End Points Tagged With: , , , ,

Emergency Medical Services Intervals and Survival in Trauma – Assessment of the “Golden Hour”

Fri, 20 Nov 2009 09:52:04 -0500 by
ResearchBlogging.orgThere is a very important paper due to be published in the Annals of Emergency Medicine.[1] I expect that there will be a lot of criticism of this paper. There will be many reasons for being cautious in implementing the suggestions of the authors, but bad research is not one of them.

One of the difficult things about this paper is that the authors are very good about identifying potential confounding influences. They explain that there are many factors that may have affected the results. They are thorough in pointing out the many different ways they analyzed the data to try to minimize any potential confounding influences. While many may look at this study, see the amount of doubt the authors express throughout the study, and conclude that there is too much uncertainty to pay any attention to this study, they would be wrong to do so.

Trusting in the certainty of those promoting the Golden Hour is the true error. Anxious exhortations to Panic! and Faster! and Panic faster! are not substitutes for good patient care.

The Golden Hour has been around for decades. This is the idea that seriously injured patients need to receive definitive care within 60 minutes of that serious injury.

The amount of information used by Dr. R Adams Cowley to concoct the Golden Hour could fit onto a cocktail napkin. According to legend, it was dreamed up in a bar, so maybe it did fit onto a cocktail napkin. The Golden Hour is not science. The Golden Hour is marketing, and very successful marketing. There are still plenty of people citing the Golden Hour as their excuse for all sorts of mistreatment of patients – But we have to get them to the trauma center inside the Golden Hour. A more appropriate term is the Bogus Hour.

The commonly used 8 minute response time (or 8 minutes 59 second response time in some places) limit (in at least 90% of responses) is based on the AHA’s (American Heart Association’s) Chain of Survival. The interesting thing is that cardiac arrest survival appears to be the only condition that has good science supporting a short response time.

To date, patients with out-of-hospital cardiac arrest remain the only field-based patient population with a consistent association between time (response interval) and survival.18,19[2]

The authors of this study probably looked at far more data on trauma time intervals than any other study. They evaluated the data in as many different ways as they could think of, to see if there were any ways that there could be a connection between prehospital time and survival. In spite of all of these different ways of evaluating the data, the conclusion based on all of the evidence is – time does not make a significant difference in survival for unstable trauma patients.

This was not a study just looking at all trauma patients, the patients meeting only anatomic criteria were not included. The same is true for patients only meeting mechanism criteria. In other words, they excluded most of the patients transported to trauma centers.

Why?

Because these patients do not have serious enough injuries to expect time to make a difference. Even though these patients are rushed to trauma centers, their injuries have not resulted in unstable vital signs/level of consciousness. Therefore, they are not considered to have significant injuries for the purposes of this study.

Here are some representative anatomic criteria and mechanism criteria for trauma triage –

Anatomic Criteria:
• Penetrating injury to head, neck, torso and extremities proximal to elbow or knee (unless obviously superficial)
• Chest injuries with respiratory distress (for example, flail chest)
• Two or more proximal long-bone (humerus or femur) fractures
• Pelvic fractures
• Limb paralysis (spinal cord injury)
• Amputation proximal to wrist or ankle[3]

None of these qualify to get the patient into the study – shooting, stabbing, nibbled at by a lion, – unless the patient has signs of being unstable.

Mechanism of Injury:
• Death of another occupant in same vehicle
• Auto vs. pedestrian (bicycle) injury with significant impact
• Pedestrian thrown or run over
• Extrication time > 20 minutes
• Falls from > 20 feet
• Ejection from vehicle
• Vehicle rollover
• High-energy vehicle crash (e.g. significant intrusion into
passenger compartment)
• Motorcycle crash with separation of rider from motorcycle
Other factors combined with traumatic injuries:
• Age 55 years
• Combination of trauma with burns
• Known heart disease, CHF, or COPD
• Known bleeding disorder or taking coumadin/ heparin
• Pregnancy (>20 weeks)
• Rigid or diffusely tender abdomen
• Amputation of fingers with possibility of reattachment[3]

These are the kind of criteria that Maryland was using to fly patients. When they had their fatal crash last year, these mechanism criteria required permission from medical command to fly patients. Flights dropped by about two thirds and outcomes do not appear to have changed. Few of these criteria are useful for predicting instability. This study was only concerned with patients who really are unstable, not those with significant damage to their cars or trucks.

So, what is unstable in the study?

The criteria from the study –

Injured patients with one or more of the following criteria were included: systolic blood pressure (SBP) less than or equal to 90 mmHg, Glasgow Coma Scale (GCS) score less than or equal to 12, respiratory rate less than 10 or greater than 29 breaths/min, or advanced airway intervention (tracheal intubation, supraglottic airway, or cricothyrotomy). “Injury” was broadly defined as any blunt, penetrating, or burn mechanism for which the EMS provider(s) believed trauma to be the primary clinical insult.[2]

And still they have 10 physiologically unstable patients per day, if averaged over a year – with a few left over. Remember, this is after excluding most of the patients who would automatically be flown to trauma centers, because the authors do not believe that those patients are injured enough for time to make a difference in their outcomes.

Editor’s Capsule Summary

What is already known on this topic

The “golden hour” concept in trauma is pervasive despite little evidence to support it.

What question this study addressed

Is there an association between various emergency medical services (EMS) intervals and in hospital mortality in seriously injured adults?

What this study adds to our knowledge

In 3,656 injured patients with substantial perturbations of vital signs or mental status, transported by 146 EMS agencies to 51 trauma centers across North America, no association was found among any EMS interval and mortality.

How this might change clinical practice

This study suggests that in our current out-of-hospital and emergency care system time may be less crucial than once thought. Routine lights-and-sirens transport for trauma patients, with its inherent risks, may not be warranted.[2]

So, if time is not making a difference in survival, maybe we should stop killing people just to get patients to the hospital a little bit faster.

Some more details from the paper –

. . . total EMS time was not associated with mortality . . . for every minute of total time . . . When the sample was assessed with 10-minute increments for total EMS time, there was no evidence of increased mortality with increasing field times . . . Similar results were obtained when total times were grouped by quartile . . . We were also unable to demonstrate independent associations between mortality and any other EMS interval for the overall sample . . . [2]

No matter how they broke down the time intervals, there was no detectable change in outcome.

For categorized response interval, there was no association with mortality for patients with a 4- to 8-minute interval . . . or greater than 8-minute interval . . . compared with patients with a response less than 4 minutes.[2]

The same for response times.

In multivariable logistic regression models, there was no demonstrable association between time and mortality for any subgroup.[2]

Although some seriously injured individuals may require time-dependent EMS interventions to survive (eg, airway obstruction, respiratory arrest, external hemorrhage at a compressible site), faster application of such interventions may not have a measureable effect on outcomes for most trauma patients.[2]

There may be isolated patients, who benefit from less prehospital time, but there are not enough to make any detectable difference in the outcomes of these unstable patients. No difference in the cumulative outcomes. No difference in any of the subgroup analyses. No difference in any of the time subgroups. How many people are being injured and killed, just to get EMS crews there faster, because in EMS we just know that faster is better. Are we killing more people trying to get to the occasional patient who might benefit from a more rapid response, or a more rapid transport, than we are helping?

That little bit faster is insignificant, except psychologically. Perhaps we should refer those in need of lights, sirens, speed, and helicopters for CISM (Critical Incident Stress Management) in stead. Oops, that is also a treatment that lacks evidence to support it.[4]

The authors conclude with this bit of common sense –

In the setting of a perceived “emergency,” the public may not necessarily value whether faster EMS time and expeditious care have been shown to save lives for the majority of clinical conditions. However, meeting these expectations costs money (eg, establishment of fire houses and positioning of EMS crews to achieve predefined response intervals), can place EMS providers, patients, and the nearby public at risk,20-22 and is a common reason (ie, emergency vehicle crashes) for tort claims against EMS agencies.58[2]

The big questions are –

Will more than a handful of people in EMS pay any attention to this?

Will we wait until lawyers force us to do what is right?

Why do we continue to choose mythology and expert opinion over science?

Dr. Bledsoe provides his own commentary on this trauma paper.[5] Peter Canning also writes about this.[6]

–

Footnotes –

–

[1] Emergency Medical Services Intervals and Survival in Trauma: Assessment of the “Golden Hour” in a North American Prospective Cohort.
Newgard CD, Schmicker RH, Hedges JR. at al.
Ann Emerg Med. 2009;(in press, may end up with a 2010 publication date)
PMID: 19783323 [PubMed – as supplied by publisher]

–

[2] This is the same as footnote [1].

–

[3] Statewide BLS Protocols Effective November 2008
Pennsylvania
Page with link to the full text PDF of the protocols.

–

[4] Critical Incident Stress Debriefing and Mythology
Rogue Medic
November 10, 2009
Article

–

[5] Speed and Time in Prehospital Trauma Care
The EMS Contrarian
by Bryan E. Bledsoe
EMS1.com
Article

–

[6] The Golden Hour
Street Watch
Article

–

Newgard CD, Schmicker RH, Hedges JR, Trickett JP, Davis DP, Bulger EM, Aufderheide TP, Minei JP, Hata JS, Gubler KD, Brown TB, Yelle JD, Bardarson B, Nichol G, & Resuscitation Outcomes Consortium Investigators (2009). Emergency Medical Services Intervals and Survival in Trauma: Assessment of the “Golden Hour” in a North American Prospective Cohort. Annals of emergency medicine PMID: 19783323

.

Filed Under: Ethics, Fraud, Golden Hour, Helicopters, Heresy Tagged With: , , , , ,

Research and EMS What are We Missing: EMS Garage Episode 53

Fri, 25 Sep 2009 06:07:04 -0400 by

Also posted over at Paramedicine 101. Go check out the rest of what is there.

I write a lot about research. EMS research, medical research, and non-medical research. The reason is simple. If we want to know how the world works, research is the way to find out. The scientific method is the formula to tell us what works. What worked yesterday, what works today, and what will work tomorrow.

Some people become confused when there are changes in the science. They see this as science being unreliable. Just the opposite. This is science responding to new information. Science is correcting itself.

An analogy is driving a car down a road. If you do not turn, when there is a bend in the road, you will crash. The car is not defective, just because it has a steering wheel, because occasionally the wheel is used to change direction. The car is effective because it has a steering wheel.

In science, the research is the way we learn what works. We then create hypotheses about the ways that new information (the latest research) may be used to learn more about things we want to know about. Science does not progress in a straight line. Science needs to respond to new information.

Science is about making mistakes. A lot of mistakes. A few will not be mistakes. these non-mistakes, or not complete mistakes, will lead to more opportunities to make mistakes. This is what we need to encourage. It is by making mistakes that we learn.

Expert opinion is a hunch that is used by someone with experience, but it isn’t specific research. Expert opinion should include all of the relevant research, but in many areas, the research is vague, or non-existent. In EMS we have had all sorts of expert opinions inflicted on our patients. Spinal immobilization. Epinephrine for cardiac arrest. Antiarrhythmics for cardiac arrest. Antiarrhythmics for chest pain patients. Furosemide for CHF. 50% dextrose for hypoglycemia. High flow oxygen for everything. Helicopter transport for almost everything. Lights and sirens. CISM/CISD. Et cetera.

We have learned that many of these treatments are not just ineffective, but harmful. Some claim that this is evidence that science does not work. No. When an expert makes a guess, and later that guess turns out to be wrong, the guess can be a part of the scientific process. The correction of the incorrect idea is the science.

Learning from our mistakes is science. Ignoring our mistakes is something that defines itself. Ignoring our mistakes is ignorant.

Some of the things I mentioned have been removed from our protocols (almost everywhere), and some are still in the protocols (almost everywhere).

These were, some still are, based on expert opinion.

All of them.

Every single one.

Expert opinion. There may have been some research that suggested that there might be some benefit from using these treatments. As those initial studies, vaguely related to the specific treatments, have been followed up with specific studies; We have learned that the expected benefit; The hoped for benefit; The wouldn’t it be great idea that led to the treatment; Was not what we had hoped for. Maybe the treatment had side effects that cancelled out any benefit. Maybe the side effects were much worse than the benefits. Maybe there were no benefits.

Unfortunately, in spite of abundant evidence of lack of benefit, some of these treatments are still used. Epinephrine, antiarrhythmics, and other ALS (Advanced Life Support) treatments for cardiac arrest. In stead, we have learned that the percentage of patients we have been resuscitating is a just small fraction of those we should be resuscitating. If only we would ignore the ALS and focus on compressions and defibrillation. In many places, the resuscitation rates have tripled with the focus on continuous compressions.

Tripled.

There is not any research to support the use of these ALS treatments in cardiac arrest, but we insist that we must use them. Why? Because we do not understand science. We have more faith in old discredited hunches, that have not worked out, than we have understanding of the current science.

Spinal immobilization.

The evidence for it? What if? What about the lawyers? But we were taught . . . .

Given that solid basis, somebody must be doing research to determine if there actually is a benefit to the patient. Or to find out what the rate of side effects is.

Not a chance.

Everybody is afraid of the harm of depriving patients of this essential treatment – this Gold Standard. The IRBs (Institutional Research Boards/Institutional Review Boards) consider it unethical to deprive patients of the standard of care. In their eyes, it is much better to force an untested treatment based on expert opinion on patients. The lack of ability to provide accurate information to the patient, so that actual informed consent would be possible – this ignorant consent is essential (according to the behavior of the IRBs). This is unethical behavior.

We are required to provide information to the patient, so that the patient may make an informed decision, when possible. The IRBs are against informed consent.

The IRBs prevent us from having accurate information to provide to patients. The EMS Yahoo screaming, Do you want to be a quad?! is not really providing less information than is available from the best research in these areas. We make King Lear look like a man with vision.

However, the IRBs say that the research is unethical, and the IRBs are the ones who are there to protect patients from unethical treatment.

So, if we learn later on, from studies carried out in other countries, that the treatment itself is more harmful than beneficial, and therefore unethical to use; When you learn this remember that the IRBs are there requiring these harmful treatments, because they are protecting the patients from progress.

It is not the job of the IRB to protect the patient from progress. It is not the job of the IRB to force harmful treatments on patients. But that is what IRBs do. Rather than know more about the safety of treatments, we are forcing experimental treatments on the patients, because the IRBs will not allow the research to find out if the treatments are effective, or even safe. If there is not research to show that a treatment is effective or safe, then the treatment is by definition experimental.

Part of the role of the IRB is to protect patients from unauthorized research, but here they are forcing everyone treated to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment. The IRBs have abandoned the patients they are supposed to be protecting.

The IRBs seem less concerned with making mistakes, than with appearing to make mistakes. If we are afraid of making mistakes, then we are afraid of learning. If we are afraid of appearing to make mistakes, then we take that ignorance to a much more dangerous level.

I was on the EMS Garage episode that is the title of this post. You didn’t forget about the title already? So, now it is time to get to the point of the title. The topic of the show is research. There were many important research points brought up in the show. There was a lot of frustration among the participants – frustration with the obstacles to research in EMS. This was the topic I ranted about for a little bit.

We need to educate the IRBs about ethics. Their superficial understanding of what is good for patients is harmful and unethical. They turn down far too many studies. There needs to be more coordination among IRBs, rather than having IRB approval be a scavenger hunt for the researchers to participate in.

We need to oppose ignorant consent.

Well, that is an expanded version of my little rant from the broadcast. I will write more about this episode, but I needed to cover this rant, first.

Listen to the whole episode. It is longer than average, but the material is very important.

Science alone of all the subjects contains within itself the lesson of the danger of belief in the infallibility of the greatest teachers in the preceding generation … Learn from science that you must doubt the experts. As a matter of fact, I can also define science another way:

Science is the belief in the ignorance of experts. Richard Feynman.

Science works differently from the way most people think. Science shows that hypotheses are valid when we cannot prove them wrong, no matter how hard we try. Most people approach hypotheses with the goal of protecting them. This hypothesis is my pet idea. I must protect it. That is the wrong approach. If we never test hypotheses to the point of failure, we never learn if the hypotheses are failures. Then we end up protecting these failures. In medicine, and EMS is a part of medicine, untested hypotheses (probable failures) kill patients.

Or we could go back to bleeding patients. If it makes you feel that bad, and even kills some patients, it has to be strong medicine. We could do that. But even the IRBs are not that unethical.

Research and EMS What are We Missing: EMS Garage Episode 53
Sep.19, 2009
Links to broadcast and downloads.

.

Filed Under: Critical Judgment, EMS Garage, Ethics, Heresy, Paramedicine 101, Research Tagged With: , , , ,

Correlation vs. Causation – repost for the Handover

Wed, 23 Sep 2009 18:22:41 -0400 by

This is a repost to fit in with the theme of the Handover over at Life Under the lights. Some coverage of research in comics by xkcd:

One of the amusing parts of xkcd is the mouse over text. It does not transfer to my blog (the text doesn’t transfer, the humor increases tremendously, or maybe not), but this is what pops up at the xkcd site:

Correlation doesn’t imply causation, but it does waggle its eyebrows suggestively and gesture furtively while mouthing ‘look over there’

Correlation is when things happen together. The whole purpose of the scientific method is to try to differentiate among the different correlations. Some will be purely coincidences. Some will be related, but some will not be the causes of what comes after them. And some will be causes.

All of the links in this are from the original article. The author trying to make his point, not me criticizing his points.

Cows with Names Make More Milk
By Robert Roy Britt, Editorial Director
posted: 27 January 2009 09:05 pm ET

Researchers in the UK say cows with names make 3.4 percent more milk in a year than cows that just feel, well, like cows.

There seems to be more than just names involved, however.

This sounds as if it is common sense. Call a cow by name and the cow will be more productive. People seem to prefer to be called by name, so why not cows?

Is this an example of anthropomorphic fallacy? Anthropomorphic fallacy is attributing human qualities to other creatures without any evidence to support these traits. Do cows feel happy? Do they feel sad? Do they feel unique? If they do, which is a big If, how do we recognize that the cow is feeling that feeling? What about an appearance that resembles a human expression of happiness, or sadness, or uniqueness (which would almost always be wrong)? Does that appearance mean the same on a cow as on a human?

The study, involving 516 dairy farmers and published online Tuesday by the journal Anthrozoos, found that “on farms where each cow was called by her name the overall milk yield was higher than on farms where the cattle were herded as a group,” write researchers Catherine Douglas and Peter Rowlinson of Newcastle University.

Nobody likes to be herded. Even a cow, one might presume. Indeed, the findings in fact point to an overall personal touch that — just a guess here — might say as much about the farmers as it does about the cows.

Precisely. There does not seem to be any attempt to control for variables in this study. Is the only difference between the farms that, some farmers called their cows by name, while other farmers did not? I called up Jimmy The Greek and he would not give me any odds on that bet. It seems that Jimmy The Greek, with no scientific research training, is able to recognize a major flaw in this research. And Jimmy The Greek has been dead for a dozen years.

Nobody likes to be herded?

I think that the economy is demonstrating exactly the opposite. There are a lot of people just begging to be herded. Tell us what to do! Save us! Is that not herd mentality? Nobody likes to be herded is what we would like to believe about ourselves, but a lot of people sure do seem as if they like to be herded. That freedom from the responsibility of having to think. They do seem to love it. Even the link provided does not support the claim that nobody likes to be herded.

“Just as people respond better to the personal touch, cows also feel happier and more relaxed if they are given a bit more one-to-one attention,” Douglas said. “By placing more importance on the individual, such as calling a cow by her name or interacting with the animal more as it grows up, we can not only improve the animal’s welfare and her perception of humans, but also increase milk production.”

Improve … her perception of humans?

This is not doing much for my perception of this human they call Douglas. Excuse me for taking a bit of a speciesist view of this, but what evidence do we have that cows’ perception of humans has anything to do with life as a cow on a farm? Do they view us as benevolent creatures, more so if we call them by name? Do they view us as soft touches, to be manipulated as much as possible? How would we know?

Happy cows. Okay. Well, if you are a farmer (especially one with a small farm that struggles to be profitable by milking only a handful of cows) you probably would not argue with success. Cows, after all (and in case you thinking of judging them as dumb animals) are known to have a magnetic sixth sense and are not as prone to cow-tipping as you might have heard. Who knows what else they are capable of?

A magnetic sixth sense?

Birds have a similar ability to sense magnetic north. Comparing a cow brain to a bird brain is not making a case for intelligent cows.

Not as prone (a pun?) to cow tipping?

Again, this has nothing to do with intelligence. Cows do not sleep standing up. If the cow is standing, the cow is awake. Not being completely oblivious to one’s surroundings correlates with intelligence. Awareness is not the same as intelligence. A Venus Flytrap has enough awareness to catch flies, but that does not make it intelligent.

Dairy farmer Dennis Gibb, who co-owns Eachwick Red House Farm outside Newcastle with his brother Richard,

The Brothers Gibb?

Milkin’ the Cows sung to the tune of Stayin’ Alive. You know, the CPR song.

Well, you can tell by the way I name my cows,
I’m an udder man: no time to talk.
Bowels are loud and teats are warm, I’ve been excreted on
Since I was born.
And now it’s all right. It’s OK.
And you may milk another way.
We can try to understand
Callin’ their name’s effect on cows.

Whether you’re a twister or whether you’re a squeezer,
You’re milkin’ the cows, milkin’ the cows.
Feel methane breakin’ and everybody shakin’,
And were milkin’ the cows, milkin’ the cows.
Ah, ha, ha, ha, milkin’ the cows, milkin’ the cows.
Ah, ha, ha, ha, milkin’ the cows.

Naming cows is one thing, but do they teach them karaoke? Do they teach them to dance? How can you have a proper control group without these groups?

Sorry. I get just a little bit silly at times. Just a little bit.

Dairy farmer Dennis Gibb, who co-owns Eachwick Red House Farm outside Newcastle with his brother Richard, says he believes treating every cow as an individual is vitally important. “They aren’t just our livelihood — they’re part of the family,” Gibb said in a statement released by the university. “We love our cows here at Eachwick and every one of them has a name. Collectively we refer to them as ‘our ladies’ but we know every one of them and each one has her own personality.”

See?

The findings:

* 46 percent said the cows on their farm were called by name.
* 66 percent said they “knew all the cows in the herd.”
* 48 percent said positive human contact was more likely to produce cows with a good milking temperament.
* Less than 10 percent said that a fear of humans resulted in a poor milking temperament.

* 66 percent said they “knew all the cows in the herd.”

Isn’t that shepherds. . .

Have I mentioned that you should try the veal? Badump bump.

* Less than 10 percent said that a fear of humans resulted in a poor milking temperament.

Are they claiming that fear results in poor milking temperament?

Or are they claiming that fear of humans results in poor milking temperament?

I don’t have a big problem with categorizing certain responses as indications of fear. We cannot ask the cow what she is feeling, but we can guess. All that this would be is a great big guess. OK, I guess I do have a problem with this. Now, if you take that great big guess, not only take it for granted, but attribute a specific cause to the presumed fear, that’s just silly. Even sillier than my little rewrite of Stayin’ Alive.

Unless you have John Edwards reading the minds of these cows for you:

John Edwards – I sense something from over here. Something that begins with an M. Is it Moo?

Cow – Yes. That is what my mother, an unnamed cow, always used to say to me.

After all, the lack of continuing success for his show isn’t because John Edwards is a fraud. He’s just misunderstood by the cows in the audience. Yeah. That’s the ticket. He’s just misunderstood. By the cows.

“Our data suggests that on the whole UK dairy farmers regard their cows as intelligent beings capable of experiencing a range of emotions,” Douglass said. “Placing more importance on knowing the individual animals and calling them by name can — at no extra cost to the farmer –— also significantly increase milk production.”

The cows are intelligent beings?

Compared to what? Bacteria?

Maybe these intelligent beings should be allowed to vote.

This is at no extra cost to the farmer?

Clearly, these farmers do not understand cows. You call a cow by the wrong name and no milk for a week.

* Amazing Animal Abilities
* My Big Beef with Cloned Cattle
* Love of Milk Dated Back to 6000 B.C.

Robert Roy Britt is the Editorial Director of Imaginova. In this column, The Water Cooler, he takes a daily look at what people are talking about in the world of science and beyond.

Correlation:

Cows called by name.

AND

Cows produce more milk.

This is a correlation.

Does this equal causation?

Does calling the cow by name mean that the cow will produce more milk, than if you do not call the cow by name?

To quote from the xkcd comic – Well, maybe.

Just because the research does not exclude the obvious, and even less obvious, variables, does not mean that one does not cause the other. It is possible.

However, because of the lack of control of variables, and other flaws, it would be a huge mistake to suggest that there is evidence to support that conclusion. For all we know, it could be an error of measurement – there may not be any real difference.

This isn’t research. This is comedy.

.

Filed Under: Critical Judgment, Heresy, Research, Science Tagged With: , , ,

Eureka – Conventional Treatment Plus Placebo Beats Conventional Treatment Alone – comment from RavenBlack

Fri, 18 Sep 2009 18:40:03 -0400 by

Also posted as part of the Skeptics’ Circle over at Pro-science. Go check out the rest of what is there.
 

In response to Eureka – Conventional Treatment Plus Placebo Beats Conventional Treatment Alone, there is a comment by RavenBlack.
 

You are mistaken, or at least the study (and other studies) doesn’t support what you say.

 

This study,[1] and other studies, make it clear that benefits of acupuncture are nothing more than the placebo effect. In the 2008 study,[2] the fake acupuncture was significantly more effective than real acupuncture.

How bad is a treatment, when faking the treatment is more effective than the real treatment?

At least, with real medicine, treatments that are demonstrated to be no more effective than placebo, are not adopted, or are discarded if they ever had been mistakenly adopted. To keep using these treatments would endanger patients. With alternative medicine, they just come up with excuses for continuing to use the failure. Alternative medicine is both a medical failure and an ethical failure.

Suppose the patient had subcutaneous emphysema, cysts in need of drainage, boils needing to be lanced, . . . there would be a medical benefit from the treatment? 😉

Back to the comment:
 

“Maybe, but it won’t make any more difference than any other placebo. Placebos can be helpful in treating pain. Why not go with something equally effective, but less expensive, less potentially infectious, and less involved?”

Different placebos have different levels of effect; in fact, between sugar pill A ($2, generic box) and identical sugar pill B ($10, posh-looking box) pill B is statistically significantly more effective. The cost (financial and otherwise) of your placebo makes it more effective, so you can’t just go with something equally effective, less expensive and less involved. The effectiveness is (to a point) proportional to the expense and involvement – which is why acupuncture is one of the better placebos!

 

It is true, that the perceived cost of the placebo influences the placebo effect. If you know that it is all placebo, the pill should not have any effect. The same is true for the acupuncture, since it is all in the mind, or changes produced by the mind. However, this is not true for some of the side effects of acupuncture, such as infection.

Why do proponents of alternative medicine continually defend telling lies to patients?

Look at the wonderful placebo effect!

Ooh! Ahh!

The study did not address cost, or at least did not mention it. I was just editorializing. I stick to generic medicines, because the added cost of name brand medicine is only an effective placebo if you believe that the more expensive it is, the better it is. I do not.

I have bills to pay, so there is no reason for me to waste money on something that is just an attempt to influence my perception of treatment.

There is already too much waste in health care. We should get rid of treatments that are nothing but placebo, or at least encourage lawyers to sue the practitioners for malpractice fraud. Malpractice would suggest that there was some medicine involved. Fraud is just an alternative name for alternative medicine.

Perhaps, people should buy expensive placebos from trusted family members.

Then there is the problem of whether treating with placebos is ethical. Of course, ethics is something that is a part of real medicine, but not a part of alternative medicine fraud. After all, treatment with alternative medicine is fraud.
 

(Also it has added “lying there and relaxing” over most placebos, which calls for a separate study since it may be the “lying there and relaxing” effect at play in this study, rather than [or in addition to] the placebo effect.)

 

The fake acupuncture had the same conditions as the real acupuncture, except that no needles were placed and in the first study. but not the second[2*] different sites were used for the imitation needles. The patients were not able to tell which treatment they were getting. Therefore, I do not see any reason to conclude that the fake acupuncture is anything other than an excellent imitation of real acupuncture. The real acupuncture, and even the super duper individualized acupuncture, did not do any better than imitation acupuncture.

Any untrained person was just as effective as the most highly trained acupuncturist. It is all about putting on a good show. Otherwise, there should have been some difference between the expert individualized acupuncture and the fake (intentionally wrong) acupuncture.

The older study showed that the real acupuncture did not even do as well as the fake acupuncture.

They could add in all sorts of treatments (such as relaxation) to compare them with acupuncture, but if real acupuncture is not as effective as an indistinguishable placebo, these studies would just be a waste of time, money, and opportunity. All of these could go toward treatments that might actually do some good – other than just doing good for the acupuncturists’ bank accounts.

This kind of rationalization only encourages the acupuncturists to keep trying, hoping that random variation in study participants will lead to them studying a very suggestible group that disproportionately falls into the treatment group.

The only reason to continue to study acupuncture would be the possibility that it does have a replicatable effect on some specific condition, but where is the evidence of that? And why keep trying with such a blatant failure? Time to give up and work on real medicine.
 

You seem to support the use of placebo, as long as it is expensive enough to bleed the patient, but not expensive enough to kill off the golden goose.

If the treatment becomes more effective as the price goes up, for some people, does that mean that we should raise the prices of all treatments, to get the most out of them.

You seem to suggest that an effect is all the justification needed for a cost, or even raising the cost. A treatment may be effective, but not worth the cost. An ineffective treatment is just not worth the cost, no matter how much you like alternative placebo medicine.

Patients with too much money, and not enough sense, may eventually find an equilibrium. With the health care reform proposals and the whining from Dr. Sen. Tom Harkin, that science us unfair to his alternative medicine nonsense, there will probably be more money wasted on this fraud. That deprives patients of effective treatments.

Of course, science is unfair to nonsense. Science is a way of identifying nonsense. The only surprise is that so many people are too gullible to understand that acupuncture is pure nonsense. The individualized acupuncture, which is the higher quality treatment from the acupuncture specialist, is also pure nonsense, just nonsense with better publicity.

The whole purpose of science is to be a nonsense detector (or a BS detector). Alternative medicine has been repeatedly failing its attempts to be categorized as anything other than nonsense, because alternative medicine is nonsense.

Science discriminates against nonsense.

Nonsense should be discriminated against.

Alternative medicine discriminates against patients.
 

Placebo Acupuncture = Acupuncture = Placebo

Placebo Acupuncture = Expert Acupuncture = Placebo
 

Remember, if alternative medicine worked, it would be able to get rid of the name alternative and just call itself medicine. Just the same as all of the other traditional treatments that have been able to show that they are better than placebo – more effective, fewer side effects, et cetera.

Alternative medicine is just another way of saying failure.

Alternative medicine practitioners are the Bernie Madoffs[3] of medicine – all fraud, all the time.

Acupuncture – It isn’t medicine, but the cost is real.

–

Footnotes:

–

[1] A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.
Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA.
Arch Intern Med. 2009 May 11;169(9):858-66.
PMID: 19433697

Free Full Text from PubMed Central.
 

In conclusion, acupuncture-like treatments significantly improved function in persons with chronic low back pain. However, the finding that benefits of real acupuncture needling were no greater than those of non-insertive stimulation raises questions about acupuncture’s purported mechanism of action.

 

–

[2] Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.
Goldman RH, Stason WB, Park SK, Kim R, Schnyer RN, Davis RB, Legedza AT, Kaptchuk TJ.
Clin J Pain. 2008 Mar-Apr;24(3):211-8.
PMID: 18287826

[2*] Correction 01-07-2019 and 01-08-2019 – In this study real acupuncture sites were used, but not real needles, so this only examined the justification for using needles, not the effect of the locations. The other study[1] did use fake acupuncture locations and did show that the location also does not matter.

In a twist that the acupuncturist cannot explain, the patients outcomes were significantly better in the group that did not use real needles.
 

The sham group improved significantly more than the true acupuncture group during the treatment period, but this advantage was not sustained 1 month after treatment ended. The difference in pain between sham and true acupuncture groups at the end of treatment (0.75 points on 10-point scale), although statistically significant, probably does not represent a clinically discernible difference.

–

[3] Bernard Madoff
Wikipedia
Article

–

Added 01-10-2019 – In going through some old sources, I have been making a few corrections and occasionally adding updated information, such as this more recent study showing that acupuncture is just a placebo –
 

Acupuncture for Menopausal Hot Flashes: A Randomized Trial.
Ee C, Xue C, Chondros P, Myers SP, French SD, Teede H, Pirotta M.
Ann Intern Med. 2016 Feb 2;164(3):146-54. doi: 10.7326/M15-1380. Epub 2016 Jan 19.
PMID: 26784863

Free Full Text in PDF format from carolinashealthcare.org
 

CONCLUSION: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. (Hot Flashes)

 

.

Filed Under: Correction, Fraud, Heresy, Mythology, Research Tagged With: , ,

Early Warning For Atypical Chest Pain

Thu, 17 Sep 2009 07:09:54 -0400 by
There is an article[1] in yesterday’s newspaper about an early warning for chest pain. There is also a video with better explanations of the device.[2]

Why would anyone need an early warning for chest pain?

Not all chest pain is the typical crushing feeling over the middle of the chest. Actually, the chest pain considered to be typical may be the atypical presentation.

We may be doing people a disservice by convincing them that the atypical presentation is unusual. Typical chest pain is the kind of experience that is almost impossible to ignore. Anything that feels as if your chest is being crushed, is going to be difficult to ignore . . .

Difficult to ignore?

OK. It is impossible to ignore, but it is difficult to rationalize as something other than cardiac chest pain. Maybe this should be described as Typical Male Chest Pain. This isn’t about being politically correct, but women are much more likely to experience heart attacks without the typical crushing chest pain, than men.

However, the other presentations of an Acute Coronary Syndrome (ACS), or what people generally call a heart attack, can be much easier to explain as something that is not a heart attack.

I’m only 80. It can’t be a heart attack!

That is true. It does not matter what the age is. 60, 50, 40, 30, or anything else. I have worked teen-aged cardiac arrest patients that had cardiac causes for their cardiac arrest. While the lower you go in age, the less likely that you are dealing with a heart attack, there is no age at which we are immune from heart attacks.

What are the so-called atypical presentations of chest pain?

Indigestion. If there is one thing that is easy to excuse as something other than chest pain, indigestion is that thing. I just ate too much; or I ate something that didn’t agree with me; or I’m upset about whatever; or My reflux is acting up; or any of a dozen other explanations.

Difficulty breathing. Clearly difficulty breathing is a breathing problem, right? Wrong. If the heart is not working effectively to deliver blood to a part of the heart having a heart attack, the heart may be perceiving the problem as a lack of air – difficulty breathing.

Maybe if I just skip to the sidebar of the article:

Symptoms for men:

Chest discomfort lasting for more than a few minutes, or goes away and comes back. The discomfort can feel like uncomfortable pressure, squeezing, fullness, or pain.

Discomfort in other areas of the upper body, such as one or both arms, the back, neck, jaw, or stomach.

Shortness of breath.

Other symptoms may include breaking out in a cold sweat, nausea or light-headedness.

Symptoms for women:

Unusual fatigue.

Weakness.

Pain in either arm.

Nausea.

Vomiting.[3]

They don’t even include chest pain in the symptoms for women. There is a bunch of research on prodromal symptoms of heart attack. Perhaps this device will be able to pick up on some of what is otherwise dismissed as not feeling up to par. If these prodromal symptoms are reflected in the ECG, and th device, the Guardian System, is able to pick up on those ECG changes, that could make a big difference in outcomes from heart attacks. Those are some pretty big If’s, but this is definitely worth investigating.

In the video, Nick Nudell shows the device and explains the way it works. Nick is frequently on the EMS Garage and one of the founders of the EKG Club (along with Tom B. of Prehospital 12 Lead ECG). There is a doctor explaining things, too, but they did focus on Nick.

AngelMed has a page with some links to further information, here.

Footnotes:

^ 1 Device to warn of heart problems tested at Memorial
By Phillip Zonkel, Staff Writer
Posted: 09/16/2009 08:53:34 PM PDT
Press-Telegram
Article

^ 2 Long Beach Memorial Successfully Implants Cutting-Edge Heart Attack Detection Device
YouTube video of the news broadcast

From the more information section at YouTube:

MemorialCare Heart and Vascular Institute at Long Beach Memorial Medical Center (LBMMC) successfully implanted a new, cutting-edge heart attack detection device in two heart attack survivors. With the danger of a second heart attack occurring in the first year for 35 percent of female survivors and 20 percent of male survivors, the device is designed to monitor and analyze data about a patients heart, reducing the time it takes to get to the emergency room.

^ 3 Device to warn of heart problems tested at Memorial
By Phillip Zonkel, Staff Writer
Posted: 09/16/2009 08:53:34 PM PDT
Press-Telegram
Article
This is the same as footnote [1].

.

Filed Under: Assessment, Chest Pain, Critical Judgment, EMS Garage, Heresy, Research Tagged With: ,
« Previous Page
Next Page »