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The Institute of Medicine has been an advocate for clinical guidelines for many years. Although the value of guidelines has never really been established, both clinicians and medical malpractice attorneys often want to ascribe greater credibility to them than they deserve.
A few years ago Dr. Robert Ewart discussed the ethics of using guidelines to screen patients for medical conditions in a review entitled “Primum Non Nocere and the Quality of Evidence: Rethinking the Ethics of Screening” (J Am Bd Fam Pract. 2000:13(3):188-196). Dr. Ewart concluded that many of the “guidelines” in use at that time had insufficient evidence to be used as a standard for clinical practice. He pointed out that there is a marked difference between “investigation” (seeking to better define a known problem) and “screening” (seeking to find if there is a problem) in terms of four ethical principles: beneficence, nonmaleficence, autonomy, and distributive justice. Since the healthy bear the harms of screening, nonmaleficence takes ethical precedence over beneficence in individual cases. Both the cost of and the consent for such screening programs for both the individual and society have ethical implications and differ for screening vs. investigation. This review/essay is worth the consideration of attorneys, especially, for example, those who may be involved in situations where “loss of chance” is an issue.
Now, Dr. Pierluigi Tricoci et al. have revisited the value of clinical practice guidelines in an article in JAMA, (JAMA. 2009; 301(8): 831-841). While guidelines published by the American College of Cardiology and the American Heart Association have become important benchmarks for quality of care, the vast majority are based on inadequate evidence or biased expert opinion. They find that the evidence from which clinical practice guidelines are derived as well as the process of writing guidelines needs improvement. A variety of print and online media provide more comprehensive analysis. Check out the articles in the Wall Street Journal, Bloomberg News, and USA Today.
In an accompanying editorial titled “Reassessment of Clinical Practice Guidelines: Go Gently Into That Good Night” (JAMA, February 25, 2009. 301(8):868-869), Dr. Terrence Shayneyfelt and Robert Centor find that:
- Guidelines have become marketing and opinion-based pieces with a widely recognized financial bias.
- Guidelines are being developed and used as “marketing tools for device and pharmaceutical manufacturers.”
- As many as “87% of guideline authors had some form of industry tie.”
In summary, they state that “clinical guidelines are supposed to be guides, not rules.” Because one size does not fit all patients, the authors suggest that “perhaps guidelines should be avoided completely,” and add that, given the present state of guidelines, “clinicians and policy makers must reject calls for adherence to guidelines. Physicians would be better off making clinical decisions based on valid primary data.”
They conclude that, because of the disarray found in guidelines, many clinicians (appropriately) do not use them.
Nor, in this editor’s opinion, should malpractice attorneys for either plaintiff or defense use them as a place to hang one’s hat.
He has 35 years or experience as an emergency physician, most of those years as Medical Director of a now 50,000 visit per year suburban Emergency Department. Board certified in both Emergency Medicine and Family Medicine, he has has helped both plaintiff and defense attorneys with malpractice litigation for over 25 years. He is proud that attorneys on both sides have found his assistance valuable, and is especially honored when he has been retained by opposing counsel in a subsequent case following a deposition or trial. His CV can be found here.
July 4, 2009
At 7 PM on July 4, in Fort Myers airport, Florida my family and I were walking toward the boarding gate of our JetBlue flight 138 heading back home to New York. As we approached the boarding gate, we saw a gate attendant kneeling on the floor next to an elderly man who was clearly unresponsive. The gate attendant had his finger on the man’s carotid artery, checking for a pulse. My son immediately dropped his laptop ran over to the man on the floor, announced that he was a first responder and a firefighter and also checked for a pulse. Having found no pulse and that he was not breathing, my son directed that they immediately begin CPR and advised the gate attendant to begin chest compressions.
A few moments later, a Port Authority policeman arrived and my son requested a mask to ventilate his lungs.
Together, the gate attendant and my son worked as a team to perform CPR on this cardiac arrest victim. If you’ve ever performed CPR it is physically taxing. Your adrenaline is pumping and you’re focused on reviving the patient.
Chest compressions and ventilation continued for minutes until the pilot of our plane and another Port Authority police officer arrived with an automatic external defibrillator. Two large electrodes strips were placed on this man’s body and the defibrilator was activated.
If you’ve never seen an automatic defibrillator in action, it’s fascinating to watch and to hear. It announces that it is evaluating the patient’s heart rate and once it has finished assessing heart rate, it immediately recommends action and whether or not to shock the patient in an attempt to restore the normal heart rhythm.
After the first assessment was made by the automatic defibrilator, it recommended that the patient be shocked immediately. Once you press the button to administer the shock, the automatic defibrilator advises that everyone should stand back away from the patient. If you’ve ever seen someone shocked using defibrillator paddles on TV, it is the same as watching it in real life. A tremendous jolt of electricity is sent throughout the patient’s body to try and restore the heart rhythm or to get the heart rhythm reverted back to normal.
In this case, after the shock had been administered, my son and the gate attendant continued CPR until the automatic defibrilator advised to momentarily stop so it could check for a heart rate. At this point, there was still no heart rate or respirations. The defibrillator again recommended shocking the patient, and after the patient was shocked for the second time, the patient regained a pulse and respirations. My son together with an EMS attendant and the gate attendant turned the patient onto his side in order to prevent him from inhaling any fluids into his lungs (known as aspiration), now that he was breathing again.
By this time, two other emergency medical crews arrived and took over where my son had left off.
My son is 17 years old and is a volunteer firefighter with the Vigilant Fire Department here in Great Neck. Watching my son take control of this medical emergency and selflessly run to help this man in distress gave me the greatest feeling I could ever have as a parent. All of his training with the fire department effortlessly kicked into gear and I’m proud to say that my son helped save a life on July 4, 2009, Independence Day.
On the plane ride home to New York, my son told me this was his 15th time performing CPR. Looking at him, I could see the sparkle in his eye knowing that he did something good for someone else. Even though we were unaware of this man’s fate, I couldn’t help but think what a great person my son turned out to be.