“ProCESS” for Improvement or Reason for Caution

“There is no such thing as the world of letters apart from the world of men…The scholar without this vision is a pedant.  He mistakes learning for an end in itself, instead of seeing that it is only a weapon in a wise man’s hands.” (Seth Low, 1890 -quoted in NEJM 2014; 370: 1679).

While sepsis, “the syndrome of dysregulated inflammation that occurs with severe infection,” is not frequent among pediatric gastroenterology patients, it does occur. Pediatric GI patients at risk include patients receiving immunosuppression medications, patients with inflammatory bowel disease, and patients with central lines.  So, it is not simply an academic exercise to understand the efforts to improve sepsis treatment. A recent study and related editorials discuss the role for protocols in treating sepsis, and likely have broader implications [NEJM 2014; 370: 173-76 (editorial-http://nej.md/1hYoAXc ), 1683-93 (article-http://nej.md/1qvKwBc ), 1750-51 (editorial-http://nej.md/1gkt6D2 )].

Overall, sepsis was reported as the 11th leading cause of death in the U.S. in 2010 and was the single most expensive condition treated in hospitals.  Nevertheless, the diagnosis is in part subjective and these statistics rely on insurance claims.

Key points:

  • Policymakers in New York require hospitals to adopt sepsis protocols (“Rory’s regulations”) following the death of a 12 year-old boy who died from unrecognized sepsis.  Other agencies, like the National Quality Forum (NQF), have recommended this as well. The Centers for Medicare and Medicaid is considering whether to adopt the NQF metric.
  • The ProCESS (Protocolized Care for Early Septic Shock) study (31 centers) enrolled 1341 patients (average age 61 years) into 3 randomized separate arms: protocol-based goal-directed therapy bundle, protocol-based standard therapy, and usual care. Conclusion: protocol-based resuscitation did not improve outcomes.
  • Sepsis mandates are not without risks.  Overdiagnosis can lead to unwarranted antibiotics, excessive testing, excessive blood transfusions, diversion of scarce ICU resources, and complications from central line placement.
  • Two more multicenter studies are underway (ARISE and ProMISE) which will further determine the utility of protocoled sepsis care

While the ProCESS trial did not identify improvements in protocol-driven care, most patients (76%) in all three groups received antimicrobials by the time of randomization (mean of ~3 hours).  Thus, early recognition of sepsis with treatment, particularly antibiotics and volume resuscitation, remain critical.  The editorial (pg 1750) imparts some useful advice from Machiavelli: “the physicians say it happens in hectic fever, that in the beginning of the malady it is easy to cure but difficult to detect, but in the course of time, not having been either detected or treated in the beginning, it becomes easy to detect but difficult to cure.”

More Eloquently Stated Concerns Over MOC

Recently, I stated my concerns over the MOC process: After I Passed The Test | gutsandgrowth

The same issues I discussed are articulated more precisely in a recent editorial, titled “Maintenance of Certification: Beauty is in the Eyes of the Beholder:”

Ann Intern Med. Published online 13 May 2014 doi:10.7326/M14-1014

Here’s the link: http://bit.ly/Centor 

Copy Forward: What Could Go Wrong?

From GI & Hepatology News: “Copy and paste at your own risk”

Here’s an excerpt:

In medical negligence claims, the accuracy of the patient’s medical record and the credibility of the health care providers are often both at issue, and many times the two go hand in hand. Lawyers representing injured patients love to point out errors in the medical record, whether or not the error caused any patient harm, because – the argument goes – if the medical provider was careless in record-keeping, then chances are he/she was also careless in the treatment at issue…

When data from a prior note in the EHR are copied, little thought or focus is given to context or clarity, and the cobbled-together entry is frequently disorganized and unclear. Worse yet, such copying can result in entering outdated or inaccurate information into the patient’s chart. Even simple errors of this kind can be very damaging. Imagine trying to convince a jury that you are a careful and caring practitioner when it has been pointed out to them that, in your records, your patient’s blood pressure was exactly the same every time she was in your office over the last 5 years. Or that despite the fact that she was experiencing a precipitous, unexplained weight loss, you continued to describe her as morbidly obese. Or that even though her husband died 3 years ago, your records show her “accompanied by spouse” at every visit.

The Bigger Picture -Mammography as an Example

This week, a commentary makes a strong case for eliminating mammography (N Engl J Med 2014; 370:1965-1967):  “Abolishing Mammography Screening Programs? A View from the Swiss Medical Board”

Here’s a link from the NEJM: nej.md/1hV8q0L

What is fascinating is how ingrained mammography has become in our medical culture and how most individuals believe that mammography is so beneficial.  Take a look at the figure in the link to get a better perspective.  While women think that mammography may save 80 lives out of a thousand screened, according to the commentary, the data suggest that 1 woman may be saved.  The main problem: “for every breast-cancer death prevented in U.S. women over a 10-year course of annual screening beginning at 50 years of age, 490 to 670 women are likely to have a false positive mammogram with repeat examination; 70 to 100, an unnecessary biopsy; and 3 to 14, an overdiagnosed breast cancer that would never have become clinically apparent.”

If a well-established screening measure like mammography is not so beneficial, what else could be on the chopping block?  As noted in a previous blog post (Do you know about the “Choosing Wisely … – gutsandgrowth), even the annual physical exam has been deemed a low-value service.

Another related blog post:

“There is More to Life Than Death” | gutsandgrowth

 

A Leading Cause of Mortality in U.S….

Being uninsured.  A recent article in Annals of Intern Medicine (2014; 160: 585-93) explored the reduction in mortality associated with expansion of Medicaid.

Key result: “Reform in Massachusetts was associated with a significant decrease in all-cause mortality compared with the control group (−2.9%; P = 0.003, or an absolute decrease of 8.2 deaths per 100 000 adults).”  The control group consisted of similar patients from other states.

An editorial (advbd.co/1lWHfsu) on this subject (from Atul Gawande retweet), notes the following: “The takeaway: Every 830 additional people who got insurance under Massachusetts’ health reforms prevented roughly one death….

A 2012 Urban Institute report estimated that 15.1 million uninsured adults could gain coverage if every state expanded Medicaid. Using the 830 figure from the Massachusetts study, and acknowledging that the state’s coverage wasn’t exactly equivalent to Medicaid, that would translate to 18,193 deaths prevented per year.

For a sense of comparison—that would make the Medicaid coverage gap the number five leading cause of preventable death in the United States”

1 “Medicaid Coverage Gap” based on 2012 estimate; other causes based on 2010 data.

Bottomline: Not having health insurance can be very bad for your health.

Related blog post:

45,000 Unnecessary Deaths Per Year | gutsandgrowth

Questions and Answers about MERS

Recently two cases of Middle Eastern Respiratory Syndrome (MERS) have been reported in the U.S.  For more information -the following link (thx to Mike Hart) may be useful:  www.cdc.gov/coronavirus/MERS/index.html<http://www.cdc.gov/coronavirus/MERS/index.html

From the CDC: Middle East Respiratory Syndrome (MERS) is viral respiratory illness first reported in Saudi Arabia in 2012. It is caused by a coronavirus called MERS-CoV. Most people who have been confirmed to have MERS-CoV infection developed severe acute respiratory illness. They had fever, cough, and shortness of breath. About 30% of these people died.

So far, all the cases have been linked to countries in the Arabian Peninsula. This virus has spread from ill people to others through close contact, such as caring for or living with an infected person. However, there is no evidence of sustained spreading in community settings.

A Lack of $2.17 Can Cost Thousands More

An interesting article in the NY Times explains a couple situations in which patients reluctantly admit their lack of financial resources and how this impacts their care.  The article underscores the message that doctors need to find a careful way to find out if patients can afford their medications.

Here’s the link: http://nyti.ms/1fVPzDx  and here’s an excerpt:

His protuberant belly was actually a sign of serious liver disease that had quickly worsened…

“I know how to take the pills, but I can’t buy them,” he said, his eyes refusing to meet mine as he stared at a spot on the hospital’s beige floor…The medicines were crucial to helping him avoid landing in the hospital again, so I went down to the pharmacy to see what the problem might be. “The co-pay is $2.17,” the pharmacist told me matter-of-factly, referring to a white paper bag with a few pill-filled bottles inside…The medications cost less than a subway ticket, but were still more than my patient could afford. If he ended up in the hospital again because he couldn’t take them, the medical costs would be thousands of times greater than $2.17…

A recent report in The American Journal of Medicine that found that one-third of Americans suffering from a chronic illness such as diabetes or high blood pressure said they had trouble affording medications, food or both…

The standard co-payment was $20, the doctor told her, and then gently asked if it would be a problem to pay.  The mother shook her head, but tears were welling up in her eyes. “But we can’t come back in a few months,” she blurted out. “It’s just too expensive.”

Tears rolled down her cheeks, and she looked away as her cheeks flushed. Her daughters sat silently on the exam table, their thin legs swinging back and forth.

I felt the family’s shame and embarrassment, and in retrospect, it seems obvious they lacked enough to eat. Yet we wouldn’t have known they were pressed for funds if our patient hadn’t brought up the issue at the last minute. The pediatrician was able to waive the co-payment, but it was just another short-term fix to a longer-term problem.

Neither doctors nor medical students can solve a patient’s financial problems on the spot. Yet any one of us can be the first to detect a problem. If we’ve done the research, we can help patients get the assistance they need, or at least direct them to social workers, pharmacists and other members of the health care team who can. What we cannot do is fail to ask.

Quitting Smoking Associated with Better Mental Health

Given the amount of information about the negative consequences of smoking that is currently available, some might say that you would have to be mentally-ill to start smoking.  The good news is that stopping smoking has been associated with improvements in mental health (BMJ 2014; 348: g1151 dii 10.1136/bmj.g1151 -thanks to Mike Hart for this reference).  Free full-text BMJ article PDF

From Abstract:

Design Systematic review and meta-analysis of observational studies.

Eligibility criteria for selecting studies Longitudinal studies of adults that assessed mental health before smoking cessation and at least six weeks after cessation or baseline in healthy and clinical populations.

Results 26 studies that assessed mental health with questionnaires designed to measure anxiety, depression, mixed anxiety and depression, psychological quality of life, positive affect, and stress were included…. the standardised mean differences (95% confidence intervals) were anxiety −0.37 (95% confidence interval −0.70 to −0.03); depression −0.25 (−0.37 to −0.12); mixed anxiety and depression −0.31 (−0.47 to −0.14); stress −0.27 (−0.40 to −0.13). Both psychological quality of life and positive affect significantly increased between baseline and follow-up in quitters compared with continuing smokers 0.22 (0.09 to 0.36) and 0.40 (0.09 to 0.71), respectively). There was no evidence that the effect size differed between the general population and populations with physical or psychiatric disorders.

Conclusions Smoking cessation is associated with reduced depression, anxiety, and stress and improved positive mood and quality of life compared with continuing to smoke. The effect size seems as large for those with psychiatric disorders as those without. The effect sizes are equal or larger than those of antidepressant treatment for mood and anxiety disorders.

Figure 2 shows the relationship of the individual studies and the mental health outcomes.  In every study except one, there was improvement in those who quit smoking, though many of the studies had confidence limits that indicated that the results did not meet statistical significance.

Bottomline: This study indicates that quitting smoking can improve rather than worsen mental health.

Zip Code or Genetic Code -which is more important for longevity?

From NY Times: http://t.co/fNm0nFOUdK

An excerpt:

Fairfax County, Va., and McDowell County, W.Va., are separated by 350 miles, about a half-day’s drive. Traveling west from Fairfax County, the gated communities and bland architecture of military contractors give way to exurbs, then to farmland and eventually to McDowell’s coal mines and the forested slopes of the Appalachians. Perhaps the greatest distance between the two counties is this: Fairfax is a place of the haves, and McDowell of the have-nots. Just outside of Washington, fat government contracts and a growing technology sector buoy the median household income in Fairfax County up to $107,000, one of the highest in the nation. McDowell, with the decline of coal, has little in the way of industry. Unemployment is high. Drug abuse is rampant. Median household income is about one-fifth that of Fairfax.

One of the starkest consequences of that divide is seen in the life expectancies of the people there. Residents of Fairfax County are among the longest-lived in the country: Men have an average life expectancy of 82 years and women, 85, about the same as in Sweden. In McDowell, the averages are 64 and 73, about the same as in Iraq….           

There have long been stark economic differences between Fairfax County and McDowell. But as their fortunes have diverged even further over the past generation, their life expectancies have diverged, too. In McDowell, women’s life expectancy has actually fallen by two years since 1985; it grew five years in Fairfax.

“Poverty is a thief,” said Michael Reisch, a professor of social justice at the University of Maryland, testifying before a Senate panel on the issue. “Poverty not only diminishes a person’s life chances, it steals years from one’s life.”

That reality is playing out across the country. For the upper half of the income spectrum, men who reach the age of 65 are living about six years longer than they did in the late 1970s. Men in the lower half are living just 1.3 years longer.

This life-expectancy gap has started to surface in discussions among researchers, public health officials and Washington policy makers. The general trend is for Americans to live longer, and as lawmakers contemplate changes to government programs — like nudging up the Social Security retirement age or changing its cost-of-living adjustment — they are confronted with the potential unfairness to those who die considerably earlier.

The link between income and longevity has been clearly established. Poor people are likelier to smoke. They have less access to the health care system. They tend to weigh more. And their bodies suffer the debilitating effects of more intense and more constant stress. Everywhere, and across time, the poor tend to live shorter lives than the rich, whether researchers compare the Bangladeshis with the Dutch or minimum-wage workers with millionaires.

But is widening income inequality behind the divergence in longevity over the last three decades? …

Living in Fairfax is different than living in McDowell.

In Fairfax, there are ample doctors, hospitals, recreation centers, shops, restaurants, grocery stores, nursing homes and day care centers, with public and private entities providing cradle-to-grave services to prosperous communities…

The jobs tend to be good jobs, providing health insurance and pensions, even if there is a growing low-wage work force of health aides, janitors, fast-food workers and the like. “It’s a knowledge-based work force,” Mr. Fuller said. “And we have an economy built on services, technology-intensive services.”

…350 miles away, …

Coal miners still dig into and blast off the tops of steep Appalachian hills. But the industry that once provided thousands of jobs is slowly disappearing, and the region’s entrenched poverty has persisted. The unemployment rate is 8.8 percent, down from more than 13 percent in the worst of the recession. The current number would be even higher if more residents hadn’t simply given up looking for work.

Government assistance accounts for half of the income of county residents. Social workers described shortages of teachers, nurses, doctors, surgeons, mental health professionals and addiction-treatment workers. There is next to no public transportation…

Many people … have multiple woes: “Diabetes. Obesity. Congestive heart failure. Drug use. Kidney problems. Lung conditions from the mines.” Problems often start young and often result in shorter lives, she said. Earlier that day, she handed me a list of recent funerals with about half highlighted in yellow; they signified that the deceased was under 50…

But dollars in a bank account have never added a day to anyone’s life, researchers stress. Instead, those dollars are at work in a thousand daily-life decisions — about jobs, medical care, housing, food and exercise — with a cumulative effect on longevity…

As such, the health statistics for Fairfax and McDowell are as striking as their income data. In Fairfax, the adult obesity rate is about 24 percent and one in eight residents smokes. In McDowell, the adult obesity rate is more than 30 percent and one in three adults smokes. And the disability rate is about five times higher in McDowell.

In both counties, food availability matters. There are only two full-size grocery stores in McDowell; minimarts and fast-food restaurants are major sources of nutrition. “We don’t have gyms or fitness centers,” said Pamela McPeak, who grew up in McDowell getting creek water to flush her family’s toilet. “It’s cheaper to buy Cheetos rather than apples.” She now runs a nonprofit program that provides tutoring and helps high school students get into college.

Education is also correlated with longevity, as it is with income and employment. Educated individuals are much more likely to work, and much more likely to have higher incomes. In McDowell, about one in 18 adults has a college degree; in Fairfax, the share is 60 percent.

Finally, and perhaps most powerfully, researchers say that a life in poverty is a life of stress that accumulates in a person’s very cells. Being poor is hard in a way that can mean worse sleep, more cortisol in the blood, a greater risk of hypertension and, ultimately, a shorter life…

It is hard to prove causality with the available information. County-level data is the most detailed available, but it is not perfect. People move, and that is a confounding factor. McDowell’s population has dropped by more than half since the late 1970s, whereas Fairfax’s has roughly doubled. Perhaps more educated and healthier people have been relocating from places like McDowell to places like Fairfax. In that case, life expectancy would not have changed; how Americans arrange themselves geographically would have…

In particular, changes in smoking and obesity rates may help explain the connection between bigger bank accounts and longer lives. “Richer people and richer communities smoke less, and that gap is growing,” said Dr. Murray at the Institute for Health Metrics and Evaluation…

To some extent, the broad expansion of health insurance to low-income communities, as called for under Obamacare, may help to mitigate this stark divide, experts say. And it is encouraging that both Republicans and Democrats have recently elevated the issues of poverty, economic mobility and inequality, But the contrast between McDowell and Fairfax shows just how deeply entrenched these trends are, with consequences reaching all the way from people’s pocketbooks to their graves.

Related blog posts:

Checklists -Helpful? Overhyped? Hawthorne Effect?

Over the last few years, adoption of surgical safety checklists has taken hold due to the promise of improving outcomes with a simple intervention.  While the concept of checklists is sound, new data indicate that in practical experience these checklists may not result in any significant reductions in meaningful outcomes (NEJM 2014; 370: 1029-38).

The study of surgical safety checklists in Ontario (13 million people) examined the 3-month periods before and after adoption of a surgical safety checklist (around July 2010) at a total of 101 hospitals.  In the period prior to adoption, there were 109,341 procedures and afterwards 106,370.

Key findings:

  • Adjusted risk of death during a hospital stay or within 30 days of surgery was 0.71 prior and 0.65 afterwards.  This produced an odds ratio of 0.91 with 95% confidence limits of 0.80 to 1.03.
  • Adjusted risk of surgical complications was 3.86% and 3.82% respectively, yielding an odds ratio of 0.97 with 95% confidence limits of 0.90 to 1.03.
  • Checklists did not reduce emergency room visits or hospital readmissions within 30 days after discharge.

These findings contradict previous WHO estimates that at least 500,000 deaths per year could be prevented through worldwide implementation of checklists.  A previous meta-analysis of three other before-and-after checklist studies determined that the checklists were associated with a pooled relative risk of operative death of 0.57 (confidence intervals 0.42 to 0.76). Yet, this Ontario study had a similar implementation without this reduction.

So, how can this study show no significant reduction in operative mortality or complications?

Possible explanations:

  • Hawthorne effect could explain some of the previous results.  This effect refers to “the tendency for some people to perform better when they perceive that their work is under scrutiny.”
  • Publication bias.  Because these checklists are utilized in thousands of hospitals, “many will have improvements in the outcomes by chance alone.”

The authors note that there has never been a controlled trial with randomization to determine conclusively the effectiveness of checklists.  However, the current study is less susceptible to biases than single center studies and no other confounding variables were identified.

Take-home message: In this study, checklists did not result any striking improvements.  Nevertheless, “there may be value in the use of surgical safety checklists, such as enhanced communication and teamwork and the promotion of a hospital culture in which safety is a high priority.”

On a side note, this study reinforced my view that many quality initiatives are well-meaning but sometimes overhyped with regard to their effectiveness.

Related blog posts: