Study details and key findings

In the 1980s, the Harvard Medical Practice Study was one of the first studies to record rates of patient harm from healthcare. The findings from this study would later become the basis of a 1999 report from the National Academies of Sciences called "To Err is Human," which spotlighted patient safety problems within healthcare settings.

For the new study, a team of researchers based at Harvard University replicated the methods of the original Harvard Medical Practice Study. The researchers analyzed data from 1,009 randomly selected patients who were admitted for surgery at 11 hospitals in Massachusetts in 2018.

According to the researchers, this was the most recent data they could analyze based on the time it took to get all the hospitals to agree to participate, collect the records they needed, have nurses review the records, and identify any potential adverse events. Doctors also spent four months verifying the events and determining whether they appeared to be preventable.

Among the patients, 383 (38%) experienced at least one adverse event, and around half of these events were determined to be serious or life-threatening. Over 250 patients, or nearly 25%, had at least one adverse event that was determined to be potentially preventable, while 103 patients, or roughly 10%, had events that were determined to be definitely preventable or the result of medical errors.

Based on the proportion of patients who had adverse events, 60% of these events were potentially preventable, and around 20% were definitely preventable. The most common complications were related to the surgeries themselves, followed by medication errors and healthcare-associated infections.

According to the study, the risk of a complication also increased with a patient's age, as well with the type of procedure they had. Operations involving the heart and lungs had the highest rates of complications, followed by those on the gut and digestive system, then the bones and joints.

Adverse events most commonly occurred outside the operating room, typically after a patient returned to their hospital rooms. Some of these adverse events include falls and pressure ulcers.

According to the researchers, the study had several limitations. To start, all the hospitals included in the study were in Massachusetts, so even though the researchers tried to include different-sized hospitals in various parts of the state, it's not clear whether the results would be the same in different states or regions of the country. In addition, the study only focused on patients admitted to the hospital for surgery, so the findings may not apply to other settings, such as outpatient surgery centers, which generally handle fewer complex procedures.

Commentary

Since the original Harvard Medical Practice Study, there have been several important changes in hospital operations designed to make surgery safer. For example, electronic medical records can send alerts if a patient is prescribed two medications that could have dangerous interactions. Surgeons also now routinely use presurgical checklists, and there are safety campaigns to make doctors and patients aware of how conditions like sepsis can quickly become deadly.

However, despite these changes, the new study shows that safety issues in surgical settings have persisted.

"It's clear that the problem has not gone away. If anything, it's even bigger than it was," said David Bates, a professor of health policy and management at Harvard's T.H. Chan School of Public Health, who led the study.

On the other hand, Bates noted that it's difficult to directly compare the findings of the older Harvard study to the current one since so much about healthcare delivery has changed over the last 40 years. In the original study, researchers examined paper charts, while this time, they used electronic medical records.

Patients are also different now than they were in the past. According to Kedar Mate, president and CEO of the Institute for Healthcare Improvement, people in hospitals are often sicker than they used to be, and procedures are now riskier and more complex.

Because of this higher degree of difficulty, "the fact that our overall adverse event rate is about the same as it was 20 years ago is in some ways an accomplishment, even though the rate of harm is still far too high and far too great," Mate said.

According to Akin Demehin, senior director of quality and patient safety at the American Hospital Association, hospitals and health systems are continuously working to improve patient safety and quality. He noted that recent data from CDC showed a decline in healthcare-associated infections.

In general, Bates said that reducing surgical complications is the job of hospitals and doctors, but patients can also do things to lower their risk of complications.

"It's useful, for example, to know what medications you're taking and to keep track of what the dosages are," he said.

It can also help to bring someone to the hospital with you if you're going in for surgery. "Often, people who are in the hospital are not that mentally alert," Bates said. "They're not their usual self or in pain. And so having someone else, either a friend or a loved one, there can be really helpful." (Goodman, CNN, 11/15; Duclos et al., BMJ, 11/13)

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