Archive for July, 2011

Guest Blog: The Confusing Morass of Medical Evidence

Ken Covinsky
Thursday, July 28th, 2011

Ken Covinsky, M.D., MPH, is a Professor of Medicine in the Division of Geriatrics at University of California, San Francisco. Dr. Covinsky leads the division’s research training and mentoring programs, conducts his own research program funded by the National Institute on Aging, and cares for patients in the San Francisco VAMC Geriatrics Clinic and inpatient medical service. He contributes regularly to GeriPal, a geriatrics and palliative care blog, where this post was originally published. You can follow him on Twitter @geri_doc.

Practitioners of evidence-based medicine use published evidence from the medical literature to guide them as they try to provide the best care for each patient. But sometimes the medical literature just feels like a big morass.

The difficulty applying the medical literature to patient care is illustrated by two studies published in the past few months in the very best medical journals. The studies give precisely opposite answers to an important clinical question.

The studies focus on the management of COPD (sometimes called emphysema or chronic bronchitis). COPD, which causes very distressing symptoms such as shortness of breath, is very common, especially in Geriatric patients. It is one of the most common causes of hospitalization, and costs Medicare billions of dollars. One of the studies, published in the NEJM, was recently reviewed on GeriPal. The other study was published in the Annals of Internal Medicine this month.

Patients with COPD are often treated with long acting inhaler medicines to control symptoms, and hopefully prevent exacerbations that lead to hospitalization. However, there are two types of long acting medicines that are available: Beta agonists (such as salmererol) and anticholinergics (such as tiotropium). It is has been a guess as to which of these medicines are better, and there has been little to guide clinicians as to which medicine to use.

Well, after these two studies, it is still a guess. It is worth briefly reviewing each of these studies, since they provide a useful allegory about the limitations of evidence-based medicine. One could teach a entire class on evidence based medicine or epidemiology focused on these two papers. And if you have a good understanding of the strengths and limitations of both studies, you can have a feeling of confidence in your skill critically evaluating the medical literature.

The more recent study published in the Annals of Internal Medicine leveraged an administrative database in Ontario that had information on nearly all patients in the Province over the age of 65 with diagnoses of COPD. They used billing codes from patient encounters to identify patients with COPD. Then they determined whether these patients were first prescribed a Beta agonist or an anticholinergic. Since Ontario provided these patient prescription coverage, use of these drugs was recorded in the database. The study then compared rates of death and hospitalization in elders prescribed Beta agonists and anticholinergics. The study suggested patients given B-agonists did better. Patients given anticholinergics had 14% higher risk of death and a 13% higher risk of hospitalization for COPD than patients given Beta Agonists.

But, this study does not prove B-agonists are better. This study was not randomized. It compared patients who happened to be given a B-agonist against those who happened to be given an anticholinergic. It is possible patients given anticholinergics were sicker than patients given Beta agonists and that higher levels of illness severity, not drug choice explain outcome differences. The authors did a lot of analyses to address this possibility that seem to suggest that differences in illness severity do not explain their results. However, with this type of study design, there is simply no way to know for certain are due to the drug choice rather than other patient characteristics.

The other study, published in NEJM was recently discussed in detail on GeriPal, so we will only discuss it briefly here. This study was a randomized trial comparing a B-agonist and anticholinergic. It showed that patients who were treated with the anticholinergic did better—they were less likely to be hospitalized for COPD.

Those who know guidelines for medical evidence might instinctively say “duh—what’s the problem?? Randomized studies are the gold standard, so I am going to believe the NEJM randomized study. Bring out the anticholinergics.” After all, randomization (when successful) assures the groups are virtually identical except for the choice of drug. As a result, outcome differences can be attributed to the drug.

Unfortunately, it is not so simple. As we discussed, the subjects in the NEJM study do not look like most patients with COPD. They were much younger than the typical patient. (Average age of 62). Also, there was an absurd set of enrollment restrictions. Most patients with COPD would probably not qualify for the study. Even though the vast majority of patients with COPD have several other medical problems, the study excluded patients with many co-existing illnesses. So, while the ideal study design of randomization was used, the nature of the patients in the study markedly limit the ability to generalize the findings to real world COPD patients. (In contrast, the patients in the Annals study closely resemble real world patients with COPD).

So, what should one do? If you have a patient with COPD, should you use a long acting Beta-Agonist or an anticholinergic?

My first answer would be that I have no idea.

But of course, we have real patients to treat, and we have to make a decision. So my vote would be for the B-agonist, especially for the older patients I see. I slightly favor the results of the Annals study because the patients were much more like the patients I see with COPD and outcome of mortality examined in this study is more important than the hospitalization outcome assessed in the NEJM study. The stronger study design of the NEJM study does not make up for focus on patients that bear limited resemble to the typical patient.

But, in the end the choice of drug remains an educated guess. As is often the case, the application of evidence based medicine to a common clinical question yields as much confusion as clarification.

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Our Preference in Health News: Uncertainty or Naked Ladies?

Jessie Gruman
Wednesday, July 27th, 2011

News of the World wasn’t read by 15 percent of the British public because it told people what they should know. It got there by giving them what they wanted: stories about the peccadilloes of the rich and famous, accounts of the gross incompetence of government and of course, pictures of naked ladies.

Setting aside the fact that News of the World is no more, its publishers and editors knew how to sell the “news.”  As free online news replaces print, every click, every page view, every second of viewing per page is tracked in the fierce competition for ad dollars, and so the selling of news increasingly influences its reporting.  Titles, format and content are tweaked by editors to “optimize the metrics.” Reporters succeed and fail based on their ability to write articles that attract eyeballs, not Pulitzer prizes.

In the health domain, the effects of these demands were described in a series of conversations the Center for Advancing Health hosted with health care journalists over the past month.*  The themes that emerged were that journalists are often encouraged to:

  1. Avoid ambiguity.  Write short, definite pieces.  Don’t qualify the findings or describe limitations of studies.  Stay away from “We don’t know what works” and “More research is needed.”
  2. Make things simple.  Present “The Top Five Things You Need to Know (or Do) About X.”
  3. Write to get clicks.  “We are successful based on how many people open our articles.” “I write articles based on questions readers submit.”

Shocked?  Nah. The news business has historically maintained a delicate balance between offering stories people want versus providing “citizens with the accurate and reliable information they need to function in a free society.”  These comments merely indicate that technology now allows for sharper calibration of content to increase the former.

Concerned?  Yes.  These observations suggest that health care journalists are under pressure to excise the uncertainty inherent in scientific inquiry and medical practice from their coverage.  Learning about the uncertainty is what we need but not what many of us want.

Most of us prefer yes-or-no answers to questions about our health: Should I stop smoking? Yes. Should I take antibiotics for a viral infection? No.  Ambiguity about health matters makes us uncomfortable.  We don’t fully understand how to apply information about the risks and benefits of treatment options. We are not confident about our ability to master the technical language and complicated concepts some health decisions now require.  And many of us don’t have the time or the interest — or we are too sick — to do so.  We want to believe that there is a single solution to our problem: a cure for our illness, relief from our suffering.  We just want our clinician to recommend or prescribe or refer or schedule whatever it will takes to make us feel better.

And so, of course, we want our health news to confirm that this is true.

But we need accurate health news.  And coverage is inaccurate when it omits discussion of the limitations of a finding, for example, or when it stretches to personalize the conclusions of a study in the interest of satisfying our appetite for certainty about the effectiveness of a drug.

Further, as increased responsibilities fall to us to make decisions about our health care, the illusion of certainty supports our passivity.  If there is no difference in the quality of care delivered by different doctors or in different hospitals, my choices of both can be based on convenience alone.  If questions about the risks of a drug I take are glossed over, why should I inquire about alternatives?  The illusion of certainty in health care also perpetuates public attitudes that skew against policies to improve the quality of care and contain its costs.  For example, if the news stories of women who have successfully taken expensive but unproven cancer drugs are not accompanied by discussion of the limitations of their effectiveness and their dangerous side effects, why shouldn’t I expect that such a drug would be available to me if I needed it?

The observations of these journalists make sense: The business model of online news organizations supplies strong incentives for reporters to present scientific findings both as simpler and more definite than the research supports because that’s what most of us prefer to read.  Of course, this trend is not completely pervasive — yet.

It is still possible to find thoughtful and lengthy discussions of evidence on specific questions in mainstream publications.  The lively Association of Health Care Journalists provides a range of services and activities to uphold the quality of reporting.  Gary Schwitzer and his cadre of fellow critics at HealthNewsReview.org publicly ding the most egregious laggards.  And there is considerable interest among journalists in improving, not weakening, the quality of their health care coverage.

But the money is on the side of giving people what they want, not what they need, providing incentives for journalists to cover health science news as certain…and of course, naked ladies.

* CFAH is the home of the Health Behavior News Service, which since 1994 has identified new findings relevant to people making decisions about their health and health care, written news stories about them and disseminated them pre-embargo to journalists around the world at no cost.  HBNS focuses particularly on Cochrane Collaboration systematic reviews and large randomized controlled trials that meet this criterion.  The aim is to ensure that the public has easy access to well-written, accurate accounts of new, useful findings.  CFAH periodically interviews journalists who subscribe to HBNS and a few who do not in an effort to improve the service and the product.

Better Health’s Grand Rounds Volume 7, Number 44

CFAH Staff
Tuesday, July 26th, 2011

Welcome to Better Health’s Grand Rounds Volume 7, Number 44! This is our second time hosting Grand Rounds and we’re excited about sharing the posts we received.  The theme of this week’s collection came from a recent Health Affairs blog post by CFAH president, Jessie Gruman, Patient Advocates: Flies In The Ointment Of Evidence-Based Care, which addresses a few of the many challenges of basing health care practices, policies, and decisions on evidence of effectiveness.

We have posts that wrestle with conflicts of interest in reporting on evidence, obstacles to the delivery of evidence-based care, using evidence in practice and care decisions, and providing patient-centered care.  We believe this topic is important to all those involved in health care, from patients and doctors to hospital administrators and policy makers.  Thank you to everyone who submitted a post.  We hope you enjoy this week’s collection.

Consider the Source

Evidence of clinical effectiveness/harm is revealed over time by additional “white-coat” research and via the real-life experiences of patients and clinicians.  Identifying how and by whom evidence is revealed is an important part of evaluating its reliability and accuracy…and towards following the winding path towards effectively applying evidence to practice.

Elaine Schattner, in her post on Medical Lessons, Patients Words, Unfiltered, Medical Journalism and Evidence, shares her concerns that:  1) journalists often select patients’ voices to support pre-determined points of view;  2) making rational decisions based on data is often more complicated than surface appearances; and while 3) evidence should be the foundation of care…we also must acknowledge that outliers exist.

In Direct-to-Consumer Advertising and the Role of Advocacy Organizations: Two Threats to Evidence Based Testing, Josh Freeman, from Medicine and Social Justice, reviews two recent JAMA “commentaries” that addressed challenges to the implementation of evidence-based practice guidelines from two very different but very powerful forces. The marketing of health care technology and treatment directly to consumers and patient activists present both obstacles and opportunities to advance the delivery of evidence-based care.

How did this Heart Drug get Approved in the First Place?, asks Carolyn Thomas, in her post on The Ethical Nag: Marketing Ethics for the Easily Swayed, referring to the drug Nesiritide.  A heart attack survivor, Carolyn “figured the purpose of the drug approval process is to ensure that testing the effects of new drugs on patient outcomes has already been done before approval is granted.”  Pat Salber, of The Doctor Weighs In, also tackles this in her post: Niseritide, the “Lost Decade”, and the Pinto.

Obstacles to Delivering Evidence-based Care

One challenge to the delivery of evidence-based care is the interpretation and application of evidence by individual clinicians.  A Country Doctor, in his post, Patient Centered or Evidence Based Medicine – Can we really have both?, notes that every physician has to evaluate the evidence and determine how to apply it to each patient’s unique situation.

From Joel M. Topf, of Precious Body Fluids, comes, The Problem with Numbers, the Curse of Intermediate End-points, expressing his concern that medical interventions are increasingly oriented around improving the “numbers” – what he defines as intermediate endpoints – rather than real goals of preventing morbidity and mortality in addition to effectively addressing patient concerns and symptoms.  He worries that medications “are pursued and approved only for their ability to fix the numbers.”

The frenzied pace of many medical practices can also be a barrier to providing optimal care, says Steve Wilkins, of Mind the Gap, in Lack of Time and Reimbursement—Is That Why Physicians Don’t Do a Better Job Communicating With Patients? Steve points out that although doctors claim that there is not enough time for patient education, evidence shows that such conversations improve patient outcomes.

InsureBlog‘s Kelley Beloff makes a similar argument in Wait Times in the Medical Office, proposing that patients should consider why doctors run late before making judgments or feeling frustrated.  Kelley writes, “The standard patient appointment time is 15 minutes.  How many of us could do our entire job in 15 minute increments, 25 to 28 times a day?”

Are We Using Evidence Effectively?

Val Jones of Better Health tells us Why She’s Afraid For Anyone to Enter the Healthcare System…Ever.  Val’s post offers resources for patients, caregivers and health care professionals to ensure they are “on the right diagnostic pathway, getting the most appropriate care that suits their needs and preferences, and protecting them from errors and missteps.”

Rheumatologist Irwin Lim, in One Fracture, Two Fracture, Three Fracture…Enough! writes about the need for targeted interventions for high-risk groups…especially patients with osteoporotic fractures that “are getting a surgical fix or a cast, but not assessed and therefore, not treated for osteoporosis…this causes pain, suffering, disability and loss of independence. It also costs….a lot of…money.”

Harold Pollack at Kaiser Health News says in, It’s Not Just About the Money: Cost Control in Cancer Care, that providing evidence-based care is greatly impacted by incentives promoting aggressive care.  He writes that “We all must face these issues to control costs…We can treat our loved ones, and ultimately ourselves, more effectively, more efficiently, and more decently than we often do.”

Family physician Ed Pullen at DrPullen.com struggles with how to best reduce morbidity risks when facing contradictory recommendations for care.  For example, he wonders how to weigh concerns about PSA screening asking “Is there more morbidity related to treating cancer long before symptoms develop, or is there more morbidity from treating cancer after symptoms appear?”

On Pizaazz, Glenn Laffel argues that while no one would dispute screening and prevention as potentially useful tools in the effort to improve the quality of care and reduce unnecessary costs, not all such programs actually work.  Screening for prostate cancer, spiral CT screening for lung cancer, colonoscopies, and ECG screening for high school students, to name a few.  He says, “Some screening and prevention programs are not effective at all.  Others are effective, but prohibitively expensive.”

Gary Schwitzer, of HealthNewsReview, in two posts about using robotics for surgical procedures, raises questions about its use despite many questions about its benefits, harms, and increased costs.  Gary asks, “How are patients to make informed health care decisions and weigh evidence fairly if the information presented is not whole?”

Alexander Friedman adds in his post, My Patient Needed to be Delivered, that cesarean section rates are on the rise due to standard use of fetal heart monitors.  Friedman says that although it’s an “appallingly poor test,” nearly all American mothers are monitored during labor.  Yet, in his experience, almost every time he performs a C-section based on the warnings of distress from the monitor, the baby is delivered “pink, healthy, and a little bit angry…our medical culture prizes technology and tests, even if they don’t work and can cause harm.”

With several recent deaths in Oregon from attempting at-home breech deliveries, Jonie Dawning, an experienced midwife, believes that too many midwives are unaware of the potential risks involved.  In her letter to the Oregon State Legislature, she makes the case for an evidence-based care and policy approach.

Wilderness medicine expert Paul S. Auerbach acknowledges that antibiotics are overused to treat childhood ear infections. But when in an outdoor or wilderness setting, where there is no medical professional to help make the decision, he advises that it is certainly reasonable to administer antibiotics.

Using Evidence for End of Life Care Decisions

In response to a recent NYTimes piece on rising Medicare hospice costs and the role of fraud in the phenomenon, Chris Langston, of The John A. Hartford Foundation HealthAGEnda blog, offers a primer on hospice in the first of a two-part series. With the current budget-cutting environment, Langston “worries that we will make a mistake that will deprive people at the end of their lives of valuable services and that we could even unintentionally increase total health care costs while trying to lower them.”

On GeriPal, Eric Widera shares that “despite a lack of evidence to show any benefits to prevent aspiration pneumonias or pressure ulcers, improving comfort, or prolonging life, feeding tubes are still inserted in patients with advanced dementia.” Widera wonders if family members have unreasonable expectations about the benefits of feeding tubes and specifically if they know that “40 percent of tube fed individuals must be restrained to keep feeding tubes in place.”

Ryan DuBosar, on ACP Hospitalist blog, highlights a recent report from the Center to Advance Palliative Care, noting that nearly two-thirds of all hospitals now have a palliative care program and larger hospitals have even more access. These palliative care teams can help patients and their caregivers when facing a serious illness and making difficult choices.

Receiving Patient-Centered Care…Not Always as Expected

Clinicians, family members and sometimes even strangers can all play a role in providing patient-centered care.  Sometimes you get the support you need…at other times, there is a gap between what you need and what you receive.

Amy Berman, of the John A Hartford Foundation HealthAGEnda blog, shares her experience with what she believes was an overly aggressive treatment recommendation in Can Good Care Produce Bad Health?.  She says, “It doesn’t matter if care is cutting-edge and technologically advanced; if it doesn’t take the patient’s goals into account, it may not be worth doing.”

Posting a sick kid’s photo on Facebook led to the swift diagnosis of a dangerous, fast-moving illness. David E. Williams, in the Health Business Blog, explores the role of social media and crowd-sourcing in his post, Diagnosing an Illness with Facebook.

Beth L. Gainer, of Calling the Shots, recognizes the compassion and support she received from unexpected sources after she received her breast cancer diagnosis and during her treatment in her post, Heroic Moments.

We hope you enjoyed this week’s Grand Rounds.  It was wonderful to read so many posts related to such an important and lasting issue.  Thank you to everyone who submitted a post and to those whose posts we happened upon and included above.  Please be sure to check out next week’s host, James Logan, MD at http://jamesloganmd.com.

Accommodations for Chronic Conditions

Patient Perspectives
Monday, July 25th, 2011

Patient Perspectives roundup recent post from patient blogs and are part of the Center for Advancing Health’s portfolio of free, evidence-based coverage of what it takes to find good care and make the most of it.  Written by Monica Kriete, CFAH Communications Associate, and Goldie Pyka, CFAH Communications Manager.

While the Americans with Disabilities Act, Equal Employment Opportunities Act, and similar legislation outside the USA are meant to protect people with disabilities from discrimination, the language can be confusing, leaving patients to wonder: “Is what I’m experiencing really discrimination?” and “What is a reasonable accommodation?”

Here to help is Kriss Halpern, a lawyer who offers advice on what is and isn’t legal for an employer to ask.  He should know…he’s managed a career and diabetes since college.  Though having diabetes can influence one’s career choices (and in the past some jobs simply may not have been feasible), a combination of technological advances and determined creativity have made it possible for diabetics to do most jobs.

But what happens when the symptoms of your illness are invisible to those around you?  Kelly Young has experienced the discrimination that occurs from the illusion of appearing well – the effects of her rheumatoid arthritis aren’t visible to others.  “I couldn’t hold an iron or a soap bottle any more – and at times even a cup of coffee.  Even if I asked them not to, people handed me heavy things and looked incredulous if I said I can’t hold that.  It’s just hard for the mind to overcome what their eyes see.” 

Lene Andersen of The Seated View uses a wheelchair due to limited mobility from lifelong rheumatoid arthritis.  Recently, when trying to purchase a new outfit with a debit card, the store’s PIN pad couldn’t reach her in her wheelchair.  How was she to enter her PIN number?  After a number of failed work-arounds, Lene had to put her items on hold and leave.  Frustrated and humiliated, she writes, “Claiming that it was a mistake or a goof or that they ‘just didn’t think’ about accessibility for people with disabilities is not an excuse.  Not in this day and age where said people with disabilities are independent, contributing members of the community.”

Taking a different perspective is Sandra Beasley on accommodating what seems to be a growing cacophony of food allergies.   Sandra herself has multiple severe allergies, but she wonders if we’ve “gone too far in trying to create a bubble around those of us with food allergies.”  From classrooms to baseball games, she says, “Manipulating shared adult environments with bans and ‘free’ zones does not help those with allergies learn to fend for themselves in the real world…There will be mistakes. There will be both allergic reactions and reactions avoided. These moments…will be scary, exhilarating, precarious—and essential…Dodging death is a daily mission for those of us with food allergies.”

What do you think…do accommodations go too far or not far enough?  Is more legislation the answer?

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