Underlying data questioned: Error study focuses on primary care

The AAFP's quality improvement chief calls for more decision-support technology to lower errors in diagnosis.

By Andis Robeznieks — Posted May 3, 2004

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Recent evidence of the difficulty primary care physicians face in managing chronic conditions, keeping up with rapid medical advances and seeing more patients in less time has come from an unlikely source: a database of malpractice claims.

Using data from 15 years of malpractice claims, researchers at the Robert Graham Center in Washington, D.C., examined how the consequences of "seemingly trivial mistakes" can be multiplied by the high-volume and complex nature of today's practice environment and result in patient harm or even death. Because of the source of the information, however, some patient-safety experts suggest that the statistics be taken with a grain of salt.

Most previous medical-error studies have focused on hospital care, but since Americans annually make 820 million doctors' office visits compared with 38 million trips to the hospital, some experts feel a shift in focus is overdue. "The main value of the study is that it shows that the outpatient setting can be studied and errors occur there that can be categorized, and categorization helps us find systematic solutions," said American Academy of Family Physicians Director of Quality Improvement Bruce Bagley, MD.

Robert Gillette, MD, a "semi-retired" family physician and instructor at Northeastern Ohio Universities College of Medicine, agreed.

"The apparent rising incidence of true medical errors has many causes, but one of the most important is the constantly escalating complexity of medical science," he said. "The more balls one is expected to keep in the air at one time, the greater the probability that one of them will fall."

The report, published in the April edition of Quality and Safety in Health Care, examined a set of 49,345 malpractice claims made against primary care doctors between 1985 and 2000. Of those, 26,126 (53%) were peer reviewed and 5,921 were determined to be errors (23%). Diagnosis mistakes were the most common underlying cause for medical errors (2003, 34%), and problems with records were the highest single "contributing factor" in general (439 errors, 7%) and to errors linked to patient deaths (156).

"Frequent errors in primary care, often thought to be trivial, do contribute to very bad outcomes and should not be ignored," the report states. "These data reveal that many errors occur in primary care and the outpatient setting, and are a significant source of morbidity and mortality."

The level of patient harm examined in the study ranges from emotional distress and temporary injury to permanent injury and 2,148 deaths. In contrast, the study's lead author worked on a 2002 report that linked only one death to the 344 primary care errors that researchers studied.

"We can't say how many visits this is from and how many physicians were involved," said Robert L. Phillips, MD, assistant director of the Robert Graham Center. "But we should be working to make this safer."

Questions arise

Dennis O'Connor, DO, a Hemlock, Mich.-based family physician and self-described "country GP," said the report is "sobering," but he said it also raised more questions than it answered. Although all the claims were against primary care doctors, some were hospital-related, and he felt those should undergo a separate analysis.

"Claims filed from patients who were in hospital care are in a different world from office care," he said. "The patients are too ill to be in office care, there are multiple physicians involved -- often writing conflicting orders -- nursing staff is involved, and so are hospital labs, hospital rules and different care paths."

The cases studied came from the Physician Insurers Assn. of America's Data Sharing Project. Because of the source of the data, experts are warning that the report's numbers should not be extrapolated to create generalizations about primary care errors and patient harm.

Lucian L. Leape, MD, patient safety pioneer and adjunct professor of health policy at the Harvard School of Public Health in Boston, said he found the study interesting but raised concerns about drawing conclusions about its findings. "This is a study of malpractice claims, not of injuries or errors," he said. "You must not equate the two. Claims capture a very small fraction of incidents, and, most importantly, not a random or representative fraction.

"They are useful for identifying unsuspected problems, but they cannot be used for epidemiological analysis, since those who choose to file a claim do so for an incredible variety of reasons, of which having a serious injury is but one," Dr. Leape added.

Dr. Bagley said the data served as a "proxy" for a more representative sample of primary care errors and was useful in identifying problems.

"Malpractice claims are just a glimpse of what's going on out there, but there is enough data to examine the types of mistakes and why they might have happened," he said. "It's useful, but it's not generalizable."

Dr. Phillips agreed, saying that the study's purpose was "not about quantifying errors," but about looking at how errors are being made in the outpatient setting and trying to resolve the problems that lead up to them.

"A malpractice suit is about affixing blame to someone who can pay, it's not about figuring out what happened," he said, suggesting that more cases need to be peer reviewed and more data need to be collected. "We need to know why the wrong diagnosis was made."

Dr. Phillips speculated that some diagnosis errors could be tied to communication problems between physicians. "If I send you to a subspecialist, I'd like to have that information when I see you again," he said. "It's hard to attribute that to a breakdown in professional courtesy; it's a breakdown in communication in general."

Dr. Bagley said diagnosis errors emphasized the need for information-technology decision-support tools that tell physicians the probabilities that a person has a certain disease based on symptoms and lab results and could suggest the tests that could improve diagnostic certainty.

A call for tort reform

American Medical Association Immediate Past President Yank D. Coble Jr., MD, said the study again documents the complexity of caring for a population growing older and sicker, but what he found most interesting about it was that there were so many claims and so few documented errors.

"What it confirms is that the majority of closed claims are not related to negligence or liability," said the Neptune, Fla.-based endocrinologist. "It's pointing out very clearly that we need reform of the tort system. Being right is no protection. Quality is no protection."

He said the study shows how, in the current legal climate, candid discussion of medical errors is discouraged and the practice of "defensive medicine" is encouraged, which raises costs, which in turn create access barriers.

The study said patient harm often results from delayed treatment or hospital admission, but Dr. Coble said this is sometimes beyond the physician's control and is the result of patients' failures to have tests performed or to see specialists in a timely manner.

"They say: 'You should have been more persuasive,' " Dr. Coble said. "[Doctors] are highly intelligent, committed folks, but it's so easy to second-guess them in today's legal environment and say they didn't do the perfect thing when the perfect thing can be so difficult to determine."

How much impact this report will have remains to be seen, but just doing the research on how small systemic problems can add up to patient harm has had an effect on Dr. Phillips.

He left the clinic he was working at after receiving an incomplete chart for the fourth time in one day.

"I was doing error research at the time, and I said, 'I can't practice this way anymore,' " Dr. Phillips said. "I knew these things hurt people. The data were staring me in the face, and I just couldn't do it anymore."

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It all adds up

Small mistakes can pile up to create sometimes tragic results. In a study of 49,345 malpractice claims, researchers identified the underlying causes for the 5,921 errors that were documented.

Number of
Diagnosis error 2,003 34%
Failure to supervise or monitor case 972 16%
Improper performance 898 15%
Medication error 489 8%
Failure/delay in referral 248 4%
Failure to perform indicated treatment or procedure 229 4%
Performed unnecessary or unfavorable treatment or procedure 227 4%
No underlying cause 208 4%
Delay in performance 156 3%
Failure/delay in hospital admission 142 2%
Failure to recognize treatment complication 122 2%
Other 227 4%
Total 5,921 100%

Source: Quality and Safety in Health Care, April

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Nothing is trivial

Small problems can be contributing factors leading to errors and, in some cases, even deaths.

Errors leading
to deaths
Total errors
Problems with records 156 439
Consent issues, breach of contract 38 231
Premature discharge from institution 103 184
X-ray error 68 164
Communication between health care providers 72 131
Other (multiple factors) 1,485 4,103

Notes: Consent issues defined as cases in which patients claim they didn't formally grant consent for a procedure or risks weren't fully explained. Breach of contract defined as cases in which patients say they consented to a procedure and it wasn't done or something else was done instead.

Sources: Quality and Safety in Health Care, April; Robert L. Phillips Jr., MD.

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External links

"Learning from malpractice claims about negligent, adverse events in primary care in the United States," abstract, Quality & Safety in Health Care, April (link)

"Malpractice Claim Reports Can Help Direct Prevention of Medical Errors, Study Says," American Academy of Family Physicians news release (link)

"A preliminary taxonomy of medical errors in family practice," abstract, Quality & Safety in Health Care, September 2002 (link)

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