Healthy Skepticism Library item: 2285

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Publication type: Journal Article

Sackett DL.
Why randomized controlled trials fail but needn't: 1. Failure to gain "coal-face" commitment and to use the uncertainty principle.
CMAJ 2000 May 2; 162:(9):1311-4
http://www.cmaj.ca/cgi/content/full/162/9/1311

Abstract:

From the undersideMy pager went off as I was half-dozing, half-reading the newspaper. Yuri Gagarin, born the same year as me, had just become the first man to orbit the earth; Nelson Mandela, not yet imprisoned, had gone underground; and John F. Kennedy had just signed the bill creating the Peace Corps. An hour later, back on the charity ward and feeling the effects of too much acrid coffee and too little sleep, achalasia hit me when I found the lancet-shaped diplococci in her sputum. It was 3 am and the research protocol, appearing unannounced on our workroom wall, declared that, as the front-line clinician (the British call this “working at the coal face”), I had to enter her into the trial.

From the undersideShe was single, poor, the sole supporter of 3 children and now so sick after 10 days of cough, fever and sputum that she’d risked losing her menial job by leaving it early to struggle through Chicago’s filthy March slush to our emergency room. My boss was testing one of the first synthetic penicillins against the then standard penicillin G in patients with pneumococcal pneumonia, and she fit the entry criteria. But she had classic signs of hepatization and already had suffered an episode of the euphoria and cyanosis we’d been taught was characteristic of bacteremia and interlobar spread. The last patient I’d seen this sick from pneumococcal pneumonia, a strapping 18-year-old basketball player, was also the first patient on whom I’d conducted fruitless open-chest cardiac massage.

From the undersideWith the fear, hopelessness and trust I’d come to expect from my patients, she consented at once to take part in the trial. But by the time I completed her entry form I knew what I had to do. Blocking the view of the ward nurse, I took the syringe containing the study drug from the refrigerator, loaded a second syringe with penicillin G and injected her with both.

From the undersideI have never discussed this decision with anyone, nor admitted it until now. I don’t know how many of my fellow house officers did the same thing for their sickest patients. I believe that my action was right in particular, wrong in general (I’ve never cheated since), and doubly preventable.

Keywords:
MeSH Terms: Attitude of Health Personnel Bias (Epidemiology) Canada Ethics, Medical Humans Outcome and Process Assessment (Health Care)/statistics & numerical data* Patient Care Team Randomized Controlled Trials/statistics & numerical data*