Medical Errors of Diagnosis Harm More Than Treatment Mistakes

Via: Healthy Skepticism (Facebook Page)

Source: ourhealthcaresucks

CGI image of rod piercing Phineas Gage's skull taken from NINDS public domain page at http://www.ninds.nih.gov/health_and_medical/pubs/tbi.htm (Photo credit: Wikipedia)

Another report on medical errors in America’s healthcare system cautions that these early-stage medical errors account for more medical harm – both preventable deaths and disability – than treatment errors.

In this study, Johns Hopkins researchers reviewed 25 years of medical errors – reflected in medical malpractice payouts – and found that diagnostic errors accounted for more payouts than surgical mistakes or medication overdoses.

Medical errors of improper diagnoses – missed, delayed and wrong diagnoses – accounted for the single largest proportion of such payouts at over a third. And twice as many occurred on an outpatient basis as among hospital inpatients, although the latter were more often lethal (48.4% vs. 36.9%).

The majority were missed diagnoses rather than delayed or wrong diagnoses – and the numbers are vastly understated because they only include those that led to malpractice claims. Most medical errors never reach the point of a malpractice claim.

15-40% Misdiagnoses?

Medical errors is a subject I address in-depth in Our Healthcare Sucks, including the following excerpts:

An estimated 15% of medical diagnoses are in error, with autopsy results showing diagnostic error rates in select areas up to 40%.[1]…

According to an article in The New England Journal of Medicine: [2]

 “125 million (Americans live) with chronic illness, disability, or functional limitation….

“The typical Medicare beneficiary saw two primary care physicians and five specialists (a) year…

“Patients with several chronic conditions may visit up to 16 physicians in a year.”

In a mostly seamless delivery system that emphasized and rewarded coordination of care and avoidance of redundant tests and procedures, maybe it would be possible to maintain quality despite such fragmentation of care.

But the U.S. medical delivery system is anything but “seamless” and, even if it were, it would still require a level of professional precision that’s sorely missing. Physician diagnostic error rates have been estimated as low as 5% (still 1 in 20) and as high as 40% based on autopsy results, with 15% the likely average ballpark.

That’s a huge margin of error that underscores the need to take what your doctor tells you with a grain of salt, at least until you’re able to get it confirmed by another opinion or by imaging or lab test results.

A special Supplement in The American Journal of Medicine [3] addressed this issue with a comprehensive review of the medical literature “Concerning teaching, learning, reasoning and decision making as they relate to diagnostic error and overconfidence”.[4]

According to the authors of this review:

“Being confident even when in error is an inherent human trait, and physicians are no exception. When directly questioned, many clinicians find it inconceivable that their own error rate could be as high as the literature demonstrates…

“This reflects both overconfidence and complacency (emphasis added).”

An article on this report makes this dismal observation:

“Medical practitioners really do not use systems designed to aid their diagnostic decision making…physicians have underutilized decision-support systems and misdiagnosis rates remain high.”

Say It Ain’t So, Doc

Many patients don’t want to believe their doctors are capable of such high rates of medical misdiagnoses – any more than they want to believe our higher rates of medical errors than other developed countries. These are very intelligent, well-educated people, after all – generally more so than the patients they treat. How can such smart people make so many diagnostic errors?

The obvious answer lay in our fee-for-service payment system that penalizes doctors for spending the time required for thoughtful assessments and diagnoses. These “cognitive” services are reimbursed at far lower levels than procedures – whether needed or not.

Medicare and other payers are partly to blame for perpetuating this skewed payment system, as are those in the medical profession who choose to maximize their incomes at their patients’ expense. No one’s forcing them to submit to these skewed incentives, after all. Some don’t, so it’s not impossible – but they’re generally considered either saints or fools by their peers.

Anchoring On First Impressions

But there’s more to our excess medical errors than that. Dr. Jerome Groopman helps us understand how doctors’ training perpetuates mental shortcuts and crutches that contribute greatly to medical errors – and to diagnostic errors specifically. Here’s another excerpt from Our Healthcare Sucks on the subject:

Enter Dr. Jerome Groopman and his New York Times best seller, How Doctors Think, in which he lays out many of the sources of medical error, misdiagnosis, and misjudgment.

He helps us understand how such smart people can make so many mistakes by explaining that it’s not a function of intellect.

Instead, it’s a type of cognitive dysfunction in which many physicians – who are trained and required by their business mandates to make snap judgments – can fall prey to all sorts of errors in thinking.

Here are a few sentences from Dr. Groopman’s book that bear on this discussion:

“Misdiagnosis is different (from medical errors)…experts studying misguided care have concluded the majority of errors are due to flaws in physician thinking, not technical mistakes…

“In one study of misdiagnoses…some 80% could be accounted for by a cascade of cognitive errors…ignoring information that contradicted a fixed notion….

“As many as 15% of all diagnoses are inaccurate…

“Physicians tend to go with their first impression…

“The cognitive mistakes that account for most misdiagnoses…largely reside below the level of conscious thinking (emphasis added).”[5]

Doctors, he explains, tend to get stuck on first impressions, something he calls “anchoring” because it anchors or fixates their diagnosis and often that of other doctors to whom you might be referred.

Or they just might not like certain patients, leading them to cut them off from fully describing their symptoms and settle for the most convenient or available treatment.

If they think the patient is a complainer or hypochondriac, they may assume a benign condition and minimize the likelihood of serious disease.

Now these cognitive flaws, as Dr. Groopman describes them, are all understandable as human failings – and Groopman quite understands them having labored with them himself – but are they professional?

Don’t patients have a right to expect more of their highly-paid doctors?

Why should patients have to worry about whether their doctor likes them or not and fear, quite correctly it seems, that it will bias their treatment?

This isn’t high school, after all.

Defensive Medicine is A Failed Response 

The medical profession has failed to address this crisis in patient safety with the urgency it deserves – opting instead for defensive medicine practices intended to insulate them from malpractice liability rather than address medical errors head-on.

This defensive mindset prevents the profession from engaging more meaningfully to correct both diagnostic and treatment failures.

And with more patients seeking medical care as Obamacare is implemented, doctors will have even less time to spend with patients. The risk of diagnostic errors – and medical errors generally – is likely to increase as a result.

A thorough diagnostic work-up takes time and thought – both of which are in increasingly short supply in America’s broken healthcare system.

All of which means patients will have to learn how to protect themselves and their loved ones when engaging with our fundamentally flawed medical system.

[1] The Autopsy as an Outcome and Performance Measure. Agency for Healthcare Research and Quality. Evidence Report/Technology Assessment. Number 58. Oct. 2002.

[2] Coordinating Care – A Perilous Journey through the Health Care System, The New England Journal of Medicine, Vol. 358:1064-1071, 3/6/08.

[3] The American Journal of Medicine, Volume 121, Issue 5A, May, 2008.

[4] Elsevier Health Sciences (2008, April 29). Will You Be Misdiagnosed? How Diagnostic Errors Happen. ScienceDaily.
[5] How Doctors Think. Dr. Jerome Groopman, Houghton Miflin Company.2007.

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Diabetic Patients with Uncontrolled Blood Pressure

Full Text 

Eve A. Kerr, MD, MPH; Brian J. Zikmund-Fisher, PhD; Mandi L. Klamerus, MPH; Usha Subramanian, MD, MS; Mary M. Hogan, PhD, RN; and Timothy P. Hofer, MD, MS

[+] Article and Author Information

Companion Article(s):

• It's Time to Overcome Clinical Inertia

Ann Intern Med. 2008;148(10):717-727. doi:10.7326/0003-4819-148-10-200805200-00004

Editors' Notes

Context

• Why do clinicians fail to intensify antihypertensive therapy when a patient's blood pressure is elevated?

Contribution

• This study involved 1169 diabetic patients seen by 92 primary care providers at 9 Veterans Affairs facilities. All had elevated triage blood pressures, but only half received antihypertensive treatment intensification by providers. Patient reports of home blood pressures or repeated blood pressures by providers within normal limits and discussion of medication issues decreased the likelihood of antihypertensive intensification at clinic visits.

Implication

• Uncertainty about true blood pressure values may underlie many reasons why physicians do not intensify antihypertensive therapy.

—The Editors

Despite some recent improvements in blood pressure control, the number of patients with inadequate control remains high and contributes to excess morbidity and mortality, especially among patients at high risk from complications of hypertension (1 - 8). Several studies have suggested that “clinical inertia”—the failure by providers to initiate or intensify therapy (medication intensification) in the face of apparent need to do so—is a main contributor to poor control of hypertension (9 - 12).

Although the failure to intensify treatment medications for patients with elevated blood pressures at visits has been well documented ((5 - 6), (12 - 18)), factors underlying what seems to be clinical inertia have been studied less systematically. When providers are queried after clinic visits about the lack of medication intensification for elevated blood pressure, they variously report that the patient's “true” blood pressure was lower than the clinic blood pressure reading, that other patient concerns precluded attention on blood pressure management, and that patient adherence should be improved before medication intensification ((6), (17)). Some studies have examined the role of various clinical and patient factors in intensification decisions ((6), (8), (17), (19 - 20)), but no study has used a detailed conceptual model to comprehensively examine the relative contribution of a broad array of potential patient, provider, organizational, and visit-specific contributors to a medication intensification decision. In addition, although a frequently cited reason for deferring medication changes is that the clinic blood pressure does not reflect the patient's “true” blood pressure (21 - 22), this clinical uncertainty and its effects have not been explored.

To better understand factors underlying apparent clinical inertia for hypertension, we designed the ABATe (Addressing Barriers to Treatment for Hypertension) study to examine treatment change decisions for diabetic primary care patients with elevated triage blood pressures before a primary care visit. We defined elevated blood pressure for this population to be 140/90 mm Hg, a value well above guideline targets for diabetic patients and one clearly requiring some type of action (4). Our goals were to assess how often patients presenting with an elevated triage blood pressure received medication intensification or were scheduled for close follow-up and the role that clinical uncertainty about blood pressure, competing demands and prioritization, medication-related factors, and care organization play in treatment change decisions.

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Statins, sepsis, and chronic kidney disease

Source: Bandolier (160)
Bandolier once came across a paper that claimed that at least half of all indications for drug use arose from observations made by perceptive clinicians, rather than from the original intentions for their use by pharmaceutical companies. It is interesting, therefore, to perhaps see one swim into our ken, and perhaps watch it develop. The case of the possible effect of statins in reducing sepsis may be one of these.

Study

A prospective observational study [1] has examined the use of statins and rate of sepsis in dialysis patients. Situated in the USA, the study began in 1995 to examine treatment choices and outcomes. Eligibility included long-term outpatient dialysis in the preceding three months in adults of at least 17 years, and it enrolled 1041 participants up to mid-1998, with observations continuing up to 2005.
Statin use was determined by review of clinic notes and computerised records. Data collected was extensive, including demographics, comorbidity, drug therapy, and laboratory values. The primary outcome was hospital admission for sepsis, where sepsis was defined using ICD codes. A number of different statistical analyses were performed, including multivariate regression and propensity score matching.

Results

The mean age of patients was 57 years, about half men, and about 80% white. Statin users were more likely to be white, and have higher cholesterol levels, cardiovascular disease, and a history of sepsis, but were less likely to have used street drugs, and consumed less alcohol.
In the 1041 patients there were 303 hospital admissions for sepsis over the mean follow up of 3.4 years. The crude incidence rate was 4% per year in statin users and 11% per year in non-users (Figure 1). In the main statistical analysis, the crude incidence rate ratio was 0.37 (95% confidence interval 0.22 to 0.61). Using multivariate analysis with more complex interaction models, or propensity scoring, did not reduce the effect, but if anything made it larger. Various sensitivity analyses did not change the findings.

Figure 1: Crude rate of hospital admission for sepsis with and without statin

Comment

This was an extremely detailed study, with a moderate number of events, and with extensive efforts to discover possible sources of confounding, especially confounding by indication. It found none of these, and the result, a 60% reduction in the risk of sepsis with statins in dialysis patients looks strong.
Several other observational studies in bacteraemia or bacterial infection have also found improved outcomes in statin users, and a study of hospital admission for cardiovascular events found a lower incidence of sepsis with statin use. Moreover, there appears to be a biological plausibility, as the first statin was originally identified from a penicillin fungus, where it is theorised that it may have benefited the fungus by preventing replication of microorganisms requiring cholesterol for growth.
All in all an intriguing story based on some good observation. It will be interesting to see where it leads.

Reference:

1. R Gupta et al. Statin use and hospitalization for sepsis in patients with chronic kidney disease. JAMA 2007 297: 1455-1464.

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Therapy with Omalizumab in Ireland

Omalizumab (Photo credit: Wikipedia)

  Via: Dr. Ivancevich.

A study into efficacy of omalizumab therapy in patients with severe persistent allergic asthma at a tertiary referral centre for asthma in Ireland

1. A. Subramaniam,
2. M. Al-Alawi,
3. S. Hamad,
4. J. O’Callaghan and
5. S.J. Lane

+ Author Affiliations

1. From the Department of Respiratory Medicine, The Adelaide and Meath Hospital, Belgard Road, Tallaght, Dublin 24, Ireland

1. Address correspondence to Dr A. Subramaniam, Department of Respiratory Medicine, The Adelaide and Meath Hospital, Belgard Road, Tallaght, Dublin 24, Ireland. email: dr.abisubra@gmail.com

• Received December 31, 2012.
• Revision received January 19, 2013.

Abstract

Background: Asthma is a chronic airway disease characterized by airway inflammation, bronchial hyperresponsiveness and airflow obstruction. Patients with persistent symptoms despite maximum standard treatment as per Global Initiative of Asthma guidelines are considered to have severe persistent asthma. Omalizumab is a recombinant humanized monoclonal antibody licenced for use as an add-on therapy in these patients. Aim: To assess the clinical benefit amongst responders to omalizumab therapy at a tertiary referral centre. Methods: This was a retrospective audit assessing the effect of omalizumab therapy on asthma control, frequency of exacerbation and hospitalization rates over 6 months before and after therapy. Results: The study included 30 responders (14 females). There was a reduction in exacerbation and hospitalization rates following initiation of omalizumab, 73 and 91%, respectively (P-value < 0.0001). The number of exacerbations decreased from 3.48 ± 2.20 to 0.93 ± 0.83 and the mean number of admissions decreased from 1.07 ± 1.1 to 0.1 ± 0.40 over the study duration (P < 0.001). There was 73% reduction in the weekly need for rescue salbutamol therapy with mean of 30.33 ± 6.49 puffs to 8.23 ± 1.51 puffs after omalizumab therapy (P < 0.0001). Seventy-nine per cent of patients were able to reduce their maintenance oral corticosteroid therapy. Conclusions: Overall, responders to omalizumab therapy are less likely to experience an asthma exacerbation and hospitalization. They were also more likely to reduce maintenance corticosteroid therapy and the need for rescue reliever therapy. These data suggest that omalizumab has proven effective in improving health outcomes for a cohort of carefully selected patients with severe allergic asthma in Ireland.

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The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

AUDIENCE: Pharmacy, Healthcare Professionals, Patients
ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.
BACKGROUND:  The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile drug products.
RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.

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