Hail, the one-eyed King: 30 years after the contested Harvard Medical Practice Study on Medical Errors

by Godfrey Onime

Scissors on Chest X-Ray
Scissors on Chest X-Ray

A few months ago, I walked into a patient’s hospital room, introduced myself, and sat on a chair next to her bed. After a quick review of her condition, I stood to examine her. The woman stopped me. 

“No offense, Doc,” she said, “but did you wash your hands?” 

I was shocked by the seemingly simple question. No patient had ever before challenged me in this direct manner. I explained that I had indeed used the disinfectant solution by her door before entering. But I proceeded to wash my hands at the sink in her room anyway, making a show of using ample soap and scrubbing as high up as my elbows. Then, I examined her. 

Concerning her challenge, the woman explained the source of her empowerment. She’d learned that according to a governmental report, medical errors kill nearly 100,000 Americans per year–perhaps a low estimate. She also understood that a large proportion of the deaths are related to hospital-acquired infections, which nurses and doctors can introduce by not washing their hands before touching patients. 

I was familiar with the report. It is the now-famous Institute of Medicine’s (IOM) 1999 publication, To Err is Human. It attributed the dismaying figures of 48,000 to 98,000 deaths per year to medical errors. That number would translate to a Titanic cruise ship crammed full of people crashing into an iceberg every one to two weeks, killing everyone on board. The press ran with the numbers—statistics that are still widely cited today. But the report also drew intense criticisms, notably concerning the research from which those figures were gleaned, particularly the estimate of 98,000 deaths.

In the study, Troyen Brennan and his colleagues at Harvard reviewed the medical records of 30,121 discharges from 51 New York hospitals in 1984. They found adverse events in 3.7 percent of the cases, of which one percent was due to negligence. Commonly called The Harvard Medical Practice Study, the research was published as a series of papers in the New England Journal of Medicine in 1991. 

The IOM report extrapolated this data to the number of yearly discharges in all American hospitals to arrive at the 98,000 figure. A July 2000 article in the Journal of the American Medical Association by investigators at the Indiana University Center for Aging Research exemplifies some of the criticisms of the research. Titled, “Deaths due to medical errors are exaggerated in Institute of Medicine report,” it challenged the way the investigators selected charts for the study. It argued that the criteria used, including deaths, were skewed towards finding adverse events. This bias, it contended, may have falsely led to the high rates of harm that the authors reported.

That Harvard study was 30 years old this February. All these years after it sounded the alarm on medical errors, it seems a good time to revisit and rethink both the study and its controversy. No study is perfect, but I am reminded of the words of my grandfather. When I was a boy in Nigeria, Grandpa often said “If he has substance, the one-eyed king illuminates history; if he lacks substance, the perfect-eyed king darkens history.” For all of its imperfections, the Harvard study sparked the flame of the modern patient safety movement. It was the first major study that employed a large number of cases and encompassed several hospitals. The study—and others that soon followed—fueled the IOM report which, when citing its findings, fanned the inferno of interest in the press and various governmental agencies.

Today, there is better recognition that the problem of medical errors exists, more research is being done, and even graduate programs are springing up, including at Harvard and Johns Hopkins Universities, to train patient safety experts. The increased discourse and spotlight have further recruited the most worthy of allies to the fight for safer healthcare: the patients themselves. 

My grandfather also often said the commonly uttered sage, time is the best judge. Concerning the Harvard Medical Practice patient safety study, the years have shown that rather than overstate the problem, it after all settled on a conservative estimate. In 2010, the Department of Health and Human Services found that one in seven Medicare beneficiaries suffers an “adverse event” during a hospital stay; half of these are preventable — and contribute to 15,000 deaths a month. A 2013 study, published in the Journal of Patient Safety, estimated deaths due to medical errors at 210,000 to 440,000 per year. John James, the author of the study, is no stranger to medical errors. His 19-year old son collapsed and died three weeks after he was evaluated by cardiologists. They failed to attend to a troubling heart rhythm on his electrocardiogram and a low potassium level.

A prescient judge perhaps, but time is yet to significantly impact the problem of preventable medical harm. In July 2014, Peter Pronovost, MD, Ph.D., then vice president for safety at Johns Hopkins University Hospital, testified before a Senate subcommittee on medical errors, in a hearing aptly titled, More Than 1,000 Preventable Deaths a Day Is Too Many: The Need to Improve Patient Safety. An engaging speaker, Pronovost lamented, “Medicine today has preventable harm as the third leading cause of death.” Dr. Pronovost is not just a patient-safety advocate but has also suffered a personal tragedy from medical errors–his father died at age 50 because his lymphoma was misdiagnosed as leukemia. During the Senate testimony, Pronovost also stated, “Stories are powerful forces for change. They can pin us to current preferences or they propel us to new pinnacles. The stories we tell influence how we act in the world and what we achieve.” 

When she challenged me, the woman who inquired if I washed my hands added to the story of the modern patient-safety movement. At the time of her discharge, she thanked me for my excellent care. Then, she apologized for what she called her “rudeness.” I told her no apologies were needed, told her that rather than being offensive, her willingness to walk the rocky road of challenging her doctors was quite admirable.

But it is the Harvard Medical Practice study 30 years ago that crafted the first major chapter in the contemporary story of the quest for safer healthcare. And it owes no apologies. Rather, it belongs to the annals of research on patient safety, and by extension, in the very heart of medicine.