January 6th, 2014
A Cross-Section of CPR Training in U.S. Counties
Monique Anderson, MD
CardioExchange’s John Ryan interviews Monique L. Anderson about her research group’s study, published in JAMA Internal Medicine, of CPR training rates in the United States.
THE STUDY
In a cross-sectional ecologic study, researchers used CPR training data from the American Heart Association, the American Red Cross, and the Health & Safety Institute to analyze rates of CPR training in all U.S. counties from July 2010 through June 2011. County-based rates of CPR training were <1.29% of the population in the lowest tertile, 1.29% to 4.07% in the middle tertile, and >4.07% in the highest tertile. Compared with the two highest tertiles (combined), counties in the lowest tertile were significantly more to have a higher proportion of rural areas, black and Hispanic residents, a lower median household income, and a higher median age. Counties in the South, Midwest, and West were more likely to have rates of CPR training in the lowest tertile, compared with the Northeast.
THE INTERVIEW
Ryan: What are the causes of the lower rates of CPR training in the South, in low-income and rural areas, and in African American and Hispanic communities?
Anderson: CPR training may be occurring primarily in high-demand markets, related, for example, to healthcare- and job-related OSHA requirements. There may not be sufficient markets in rural, low-income, and high-density minority counties. For the community-based training, it may be some combination of (1) awareness of the need and value of CPR training, (2) expense, and (3) travel time for residents. As we note, this was a cross-sectional ecologic study, so we don’t know for sure who precisely is being trained in these counties.
Ryan: The highest tertile for CPR training was >4% of the population. To you, what is the ideal percentage of CPR-trained people in a community? Is it 100%?
Anderson: To start to answer this question, we would need a study to assess the association of CPR training with bystander CPR use and outcomes after out-of-hospital cardiac arrest (OHCA). If the higher rates of CPR training are correlated with bystander CPR use and outcomes, then I think there is an argument for consistent yearly CPR training in all U.S. counties (perhaps starting with a goal of >4%).
Ryan: How can CPR training rates be improved? And how will you measure the success of those efforts in altering CPR outcomes?
Anderson: We can start by following the Denmark example. A study recently highlighted the impact of a national initiative to improve cardiac arrest management and outcomes. Mandatory CPR training was implemented in elementary schools and for people who want to acquire a driver’s license, along with other efforts to increase the number of citizens available to perform CPR. The country experienced significant improvement in bystander CPR rates (from 22.1% to 44.9%) and survival from 2001 to 2010.
Implementation of two related requirements — CPR certification to qualify for a high school diploma and a driver’s license — can have a profound effect on the number of Americans with CPR training. Legislation is pending in some geographic areas — for example, North Carolina recently passed a law requiring CPR certification before high school graduation. In addition, dispatch-assisted CPR should be used by all emergency response systems in the United States. Finally, CPR training organizations should develop low-cost programs to improve training in geographic areas that have low overall rates of training.
Registries such as the Resuscitation Outcomes Registry, AED Registry, and CARES registry will be critical in measuring the success of efforts to increase CPR training, bystander CPR, and outcomes after OHCA. These registries collect comprehensive data on cardiac arrest characteristics, use of bystander CPR and AEDs, other treatments, and field and hospital outcomes.
The HeartRescue Initiative is a Medtronic-funded effort to improve outcomes after cardiac arrest. It involves seven academic centers with systems of care and/or OHCA expertise, has set a goal to increase survival after OHCA to more than 50% over a 5-year period. The mission is “developing and expanding SCA response systems by coordinating measurement, education, training and the application of evidence-based best practices among the general public, first responders, emergency medical services and hospitals.”
In short, the goal to improve survival after OHCA will require the collective and coordinated efforts of academic investigators, policy makers, CPR training organizations, and community leaders and citizens.
What insights do you gain from the study conducted by Dr. Anderson and her colleagues?
January 3rd, 2014
2013: The Year of the Guideline
John W McEvoy, MB BCh BAO
“I always pass on good advice. It is the only thing to do with it. It is never of any use to oneself.” — Oscar Wilde
This year culminated in an exciting flurry of academic activity. Long awaited guidelines for the treatment of cholesterol to reduce the risk of atherosclerotic cardiovascular disease and for the management of hypertension were finally released, both after agonizing delays.
While both guidelines have been mired in controversy, regrettably being undermined by some experts, they represent a sea-change for the field of preventive cardiology. Both place primary emphasis on evidence from randomized controlled clinical trials. This threshold means that the evidence base for clinical guidelines has never been stronger. The guideline writers should be commended for their efforts. Indeed, significant improvements in the health and well-being of our patients (and the population as a whole) are likely to result. For example, the use of evidence-based statin therapy should increase dramatically and reductions in atherosclerotic cardiovascular disease-related mortality are likely to
However, the guidelines have also inflicted significant collateral damage. The loss of LDL-Cholesterol targets and the increase of systolic blood pressure therapeutic thresholds (to 150mmHg for many patients) have shaken the very foundations on which many of us stand. One can only imagine what forefathers like Nikolaj N. Anitschkow would think of these new developments!
While full details of pros and cons of the new guidelines are outside the scope of this piece, it is disconcerting to realize that we appear, as a medical community, to have abandoned the idea of incorporating the full breadth of evidence-based medicine (including observation studies) into our decision-making armamentarium. When Francis Bacon first developed the scientific method, he proposed that causality can be approximated by interpreting the results of one’s observations. Thus, the very foundations of science were laid on the wide breadth of observation, not the narrow focus of randomization.
Admittedly, one must acknowledge that requiring randomized evidence as the basis for guidelines is the most robust strategy to deal with ever-present confounding and to ensure that recommendations are fully compatible with scientific truth. For example, no longer will physicians feel compelled to get patients to an arbitrary LDL-Cholesterol “target” with medicines that may have deleterious “off-target” effects.
However, multiple problems also arise with this thinking. For instance, at the most basic level, requiring results from randomized trials as the evidence base for guidelines is a problem when most clinical questions have no randomized evidence base in the first place. Thus, it appears that we will need many more randomized trials in the future. Indeed, the whole clinical research enterprise will need a major overhaul. Massively scalable mechanisms to conduct simple and varied randomized studies in “usual care” environments, as part of routine clinical workflow, are now urgently needed. This is the model of the learning health-care system.
For example, methods for embedding randomization within the clinical workflow of providers who use electronic health record systems are already being developed. However, besides cost, multiple hurdles obstruct progress in this field. These hurdles are significant and will require time and effort to overcome. Examples include difficulty acquiring streamlined consent given the current regulatory environment (which has not adapted to modern technology or comparative effectiveness research), poor physician motivation to sacrifice ever-precious time and effort to research as part of “usual care”, poor perception of research amongst patients, and a research hierarchy that does not engender inclusiveness (particularly with those non-academic providers who will be asked to contribute to this effort).
It is clear that new ideas and disruptive innovations will be necessary to make this learning health-care system a reality. However, once realized, it is possible that this reality could generate the volume of randomized evidence now necessary in the current era of cardiology guidelines. Of course, it would be folly to presume that we can perform randomized clinical trials for every single clinical scenario. No matter how much we think we can know, it is also unlikely we will ever have generate enough evidence such that there is no room left for different interpretations of this evidence. Disagreement will continue, indeed science depends on it. Such is the nature of inherently subjective human interpretations of data. Thus, randomization is not the panacea for our incomplete understanding of scientific truth, and we need to be careful not to become too inflexible to other (non-randomized) sources of data.
Personally, I think our current fixation on “hard facts” (evidence) from randomized clinical trials at times borders on utilitarian. I am reminded of Mr. Gradgrind, the headmaster from Charles Dickens’ Hard Times. In a famous passage, a visiting official asks Gradgrind’s students:
“Suppose you were going to carpet a room. Would you use a carpet having a representation of flowers upon it?”
The character Sissy Jupe replies, ingenuously, that she would because, “If you please, sir, I am very fond of flowers.”
“And is that why you would put tables and chairs upon them, and have people walking over them with heavy boots?” the official retorts.
“It wouldn’t hurt them, sir. They wouldn’t crush and wither, if you please, sir. They would be the pictures of what was very pretty and pleasant, and I would fancy -“
“Ay, ay, ay! But you mustn’t fancy,” cried the gentleman, quite elated by coming so happily to his point. “That’s it! You are never to fancy.”
“You are not, Cecilia Jupe,” Thomas Gradgrind solemnly repeated, “to do anything of that kind.”
“Fact, fact, fact!” said the gentleman. And “Fact, fact, fact!” repeated Thomas Gradgrind.
In conclusion, I hope that in 2014 we will not be consumed by the need for randomized “facts”, that the full breadth of evidence-based medicine will continue to be valued, and that guidelines can be seen as scientifically sound “advice.” And like all good advice, guidelines should be passed on and utilized wherever possible, as Mr. Wilde advises above. However, it is worth reminding ourselves that guidelines are not absolute rules. Thus, if the fully informed physician feels this “advice” does not apply to (or is of no use for) a specific patient, then they should continue to feel free to use clinical reasoning (inclusive of observational evidence, but with appropriate caution) to manage their patient.
January 3rd, 2014
FDA Plans New Safety Assessment of Dabigatran (Pradaxa)
Larry Husten, PHD
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin.
On December 30 the FDA posted a request for public comment on a proposed protocol of the study, which it describes as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.” The study will “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).”
The Mini-Sentinel project is a part of the FDA’s Sentinel active surveillance system. Mini-Sentinel, according to the FDA, uses pre-existing electronic healthcare data from multiple sources. The Mini-Sentinel database, the FDA notes, “is not so ‘mini’,” as it includes 17 data partners and uses data from nearly 100 million patients.
At this point there is no plan to assess the safety of the new oral anticoagulants that received approval after dabigatran — rivaroxaban (Xarelto, Johnson & Johnson) and Eliquis (Pfizer and BristolMysers Squibb).
A knowledgeable source said that the major purpose of the study will be to identify groups of patients who are at high risk for major bleeding events with dabigatran. Somewhat paradoxically, this might help bolster the drug, as it will then also identify groups more likely to benefit from treatment. On the other hand, the fact that similar studies are not being undertaken with the other new oral anticoagulants may well reinforce concerns about dabigatran.
December 27th, 2013
2013 In Review: Our Top 12 Posts
Harlan M. Krumholz, MD, SM and CardioExchange Editors, Staff
After an incredibly busy year we took a moment to reflect on our top stories. In no particular order, these are among the most viewed posts on CardioExchange over the past year. My personal favorite of the year was Victor Montori’s questioning of PRAMI. Take a look and let us know what was your favorite feature of the year. –Harlan Krumholz
Niacin Therapy in the Crossfire
- William E. Boden, lead investigator of the AIM-HIGH trial, and Harlan Krumholz debate the role of niacin.
Revisiting Novel Anticoagulants in Atrial Fibrillation
- Christian Thomas Ruff and Andrew E. Epstein answer questions about using these agents in patients with AF.
Renal Denervation: Delineating Its Uses, Misuses, and Possibilities
- Murray David Esler, Chief Investigator of Symplicity HTN-2, answers questions about renal denervation.
Persistent Chest Pain After Myopericarditis
- We asked five esteemed clinicians– James Fang, James de Lemos, Kamalendu Kanu Chatterjee,Thomas Ryan, and Rick Akira Nishimura– for their differing perspectives on a challenging condition.
The Mediterranean Diet in Clinical Practice: Three Experts Weigh In
- Walter Willett, Arthur Agatston, and Alice Lichtenstein comment on the influential PREDIMED study.
ACC.13: Is Cangrelor an Antiplatelet CHAMPION?
- Deepak Bhatt, lead author of the CHAMPION PHOENIX trial, answers questions from CardioExchange’s interventional cardiology editors, Rick Lange and David Hillis.
DIGging In: Three Reasons Why the Recent Digoxin Study Is Not Relevant to Readmission
- Harlan Krumholz digs in to a new analysis of an old study.
“Your Mortality Risk Is 11.827%”
- John Brush asks what exactly does an event’s numeric probability tell us?
Look Before Leaping to Conclusions About Bush’s Stent
- Ajay Kirtane writes about media overreaction to the Bush stent news.
Scrutinizing the PRAMI Trial of “Preventive Angioplasty”
- Victor Montori offers his analysis of the PRAMI trial.
The Benefits of Switching From Hydrochlorothiazide to Chlorthalidone: What’s Stopping Us?
- Medical student Nicholas Bergfeld raises an important but often overlooked question.
The TACT Investigators Respond to Questions
- The TACT investigators– Gervasio A. Lamas, Christine Goertz, Robin Boineau, Daniel Mark, Richard L. Nahin, and Kerry L. Lee– answered questions about their extremely controversial trial.
December 24th, 2013
The SGR Fix: Cost Versus Quality
Steven Spivack, MPH
The physician community might want to pay attention to what is going on with the sustainable growth rate (SGR).
Congress is finally on the verge of abolishing the SGR and, in an odd twist, it may not call for a joyous celebration. The crux of the disagreement centers on proposals in the House and Senate which would replace the SGR with pay-for-performance programs linking physician payments to quality. The most controversial aspect of these proposals lies in the Senate’s SGR Repeal and Medicare Beneficiary Access Improvement Act of 2013. Specifically, the plan would introduce a Value-Based Performance Incentive Program (VBP) starting in 2017 for fee-for-service (FFS) providers. The VBP would consolidate the Physician Quality Reporting System, Value-Based Modifier, and EHR Meaningful Use Program into a weighted, composite score. It would also include a new measure of physician engagement in “clinical practice improvement activities” [
However, what makes the VBP especially provocative is that it depends on a budget-neutral payment pool. In other words, there will be clear “winners” and “losers” with penalties for poor performers used to increase payments for high performers. While I laud Congress for seriously attempting to repeal the SGR, ensuring that the new proposal remains budget neutral seems unfair. If the real purpose of this program is to advance the quality of care, then providers should not be penalized for improving at slower rates than their peers. Even if every single provider in the country upgraded the quality of care they deliver, many would still be penalized.
The use of VBP as a carrot and stick is magnified by the fact that it will not apply to providers participating in “alternative payment models” (APMs). Clearly, Congress is encouraging providers to shift away from FFS by allowing them to eschew the potential penalties inherent in VBP. This should come as no surprise since the number of APMs has dramatically expanded with the enactment of the Affordable Care Act; an increasing number of providers are participating in accountable care organizations, bundled payment programs, and other pilot projects. Unlike the budget-neutral aspect of the VBP, I fully support Congress’ desire to transition away from the outdated FFS model. APMs, like the one employed by the California Public Employees’ Retirement System, have shown that they can drastically reduce the costs of care while maintaining or improving quality.
While I cheer on Congress’ attempt to repeal the SGR and transition the health system towards one that rewards providers based on quality and not quantity, I fear that they may be more concerned with curbing rising health care costs than improving quality. Akin to their approach in the Hospital Readmissions Reduction Program (HRRP), a large number of providers will be penalized despite improving performance. Instead of creating a budget-neutral payment policy, Congress should enact benchmarks for improvement so that providers have achievable targets to aim for. MedPAC has called for similar reforms and this would still allow Congress to recoup payment from providers who fail to reach the preset benchmarks [
I am interested in hearing what the CardioExchange community thinks.
December 23rd, 2013
Selections from Richard Lehman’s Literature Review: December 23rd
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint this selection from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
JAMA 18 Dec 2013 Vol 310
Three vs. Twelve Months of Dual Antiplatelet Therapy After Zotarolimus-Eluting Stents (pg. 2510): Ah, and now for some industry based research. The mechanistic model that industry loves is that coronary arteries are like blocked pipes. You put in a device to unblock them, and people get better. Then you add an agent to thin the blood and stop the stent blocking. Now consider all the different kinds of stent, and all the different kinds of blood thinning agents, and all the doses you can use them at, and all the different durations you can devise, and every comparison you could make between each. I doubt whether you could actually do all the possible trials before the sun burns itself up and the human race becomes extinct. Consider then the importance of the OPTIMIZE trial, comparing Three versus Twelve Months of Dual Antiplatelet Therapy After Zotarolimus-Eluting Stents. I would suggest that in the context of eternity (sub specie aeternitatis) this trial is not worth the time it takes you to read about it; but as a source of reprint income it may have some importance to JAMA.
Low-Dose Dopamine or Low-Dose Nesiritide in Acute HF With Renal Dysfunction (pg. 2533): The acutely failing heart is not much good at maintaining a circulation, but it is very good at pumping out large amounts of natriuretic peptides. That’s why I’ve always thought it a bizarre idea that adding extra natriuretic peptide analogues would make any difference to the treatment of acute heart failure; and in fact the BNP analogue nesiritide all but fell out of use when a properly conducted trial showed that it did nothing. But still they try. In this trial, nesiritide was compared with dopamine or placebo in patients admitted with acute HF and renal dysfunction, who were given diuretics as needed. Decongestion was measured by urine output and renal function by cystatin C. There was no difference between groups.
BMJ 21 Dec 2013 Vol 347
A Statin a Day Keeps the Doctor Away: The Christmas BMJ this year is a classic. Much publicity has attended the semi-serious article comparing an apple a day with a statin. The references are really helpful and I intend to use them in a decision tool.
December 23rd, 2013
Fellows: Want to Join the CardioExchange Case-Study Team?
Andrew M. Kates, MD
CardioExchange editor Andy Kates is looking for fellows who would like to regularly present cases for presentation on CardioExchange.
Each month we will feature an interesting patient vignette, submitted by a fellow, for open discussion. Cases can represent diagnostic dilemmas, management challenges, or just good, bread-and-butter cardiology. The goal is to engender lively discussion in the CardioExchange community.
If you are interested in participating, please contact us with a clinical vignette (100-300 words) describing pertinent information (deidentified, of course) including lab values and imaging studies (actual images are optional and can be submitted with follow-up correspondence). We will choose the best of these and ask those fellows to become regular contributors.
Thank you!
December 23rd, 2013
Statins: Targeting Risk, but Risking Diabetes?
Emma Morton-Eggleston, MD, MPH and Richard Lehman, BM, BCh, MRCGP
One of Richard Lehman’s recent blog posts lauding a BMJ editorial about targeting cardiovascular risk rather than cholesterol concentration from CardioExchange’s Editor, Harlan Krumholz, struck a chord with member Emma Morton-Eggleston. Emma, who is an endocrinologist at the Brigham and Women’s Hospital in Boston, wrote to Richard with her perspective, who responded, and they’ve agreed to share their debate with CardioExchange:
Dear Richard,
Hope all is well — and as always thanks for your weekly reviews. They are guaranteed to provoke a smile at your incisive (and instructive) skepticism. But I have to disagree with you on Dr. Krumholz’s editorial — which surprised me, as did your response to it, precisely because it was so optimistic.
While I completely agree with his primary points regarding the jettisoning of targets and the importance of grounding the translation of guidelines in shared decision-making with patients, the suggestion that we can let time and further studies fix the potential over-medicalization of millions of people (and if the global medical community follows suit, hundreds of millions) from a likely flawed risk calculator is puzzling to me. To my mind, the potential medicalization of low-risk populations for primary prevention is a fundamental problem that can’t be left to a promissory note on future work that accurately defines risk. Even if such work comes to pass, as noted in the JAMA Viewpoint you also referenced by John Ioannidis, risk prediction is an inherently tricky business even in the most thoughtful and rigorous of hands.
The diabetes experience made clear that once a guideline is in place, distracted following is the norm given the time pressures of modern medicine and the natural tendency towards inertia in critical thought that you have described so well. Why now is it statins and heart disease, not diabetes and anti-glycemic medications, do we do an about-face on decrying over-medicalization? And abandon prior attention to absolute risk of disease, and of benefit and harm of intervention, in the process?
You have howled (as have I across the Atlantic in agreement) about the potential creation of vast global pharma markets for quasi “diseases” including pre-diabetes. Why no howling now? The availability of generic statins may mean little profit is made for the time being, but it seems highly unlikely that opening the door to medical treatment for the prevention of arteriosclerotic cardiovascular disease (CVD) in low-risk populations will not herald targeting of these populations for new antilipidemic agents in the future.
The potential harms attributed to statins are no small thing and can impact quality of life in very real ways — I am not sure how this squares with patient-centered care in low-risk patients. Last — and you knew this one was coming as I am an eternal hammer when diabetes is the nail — the dismissal of potential diabetes risk with statin use in patients at low risk for CVD because of the absence of long-term data is baffling. It is an increased risk that two large studies — an RCT and a retrospective cohort analysis — have suggested may approximate 50% in women. The CV benefit of statins in high-risk groups is about as close as we can get to true evidence-based medicine, and benefit appears to far outweigh risk of diabetes in these patients. But it is not at all clear that small decrements in absolute risk of CVD outweigh harms in low-risk patients.
Muscle aches (at times profound), myopathy, and diabetes aside, overmedicalization is never a good thing. Okay, I’ll say rarely since nothing is never except immortality and nothing is always other than death, splendid gardens, friendship/family for the lucky, and good cheese with a ripe pear.
Looking forward to your thoughts,
Emma
Dear Emma,
Thank you so much for writing. I’m really glad you’ve raised these issues because they puzzle me. I am trying to draw up a simple option grid to help people discuss this with their doctors, since most people still need to see a doctor to get hold of a statin. This discussion might then proceed to a personal cardiovascular risk assessment using one of the current instruments — not the flawed one you mention, but either Victor Montori’s or James McCormack’s — to give people a ball-park idea of where they lie in the risk spectrum and what the absolute benefit might be from taking a statin.
I would leave guidelines aside here — this is not about health professionals but about a personal decision by a healthy person about how they want to play the odds of dying in a particular way. We can point people to fairly accurate information about that in relation to this class of drugs, though we could argue endlessly about the detail.
This doesn’t need to be done by a doctor — in fact it is probably best done by a web-based program, with the doctor merely signing the prescription according to what the person chooses. I don’t even see this as a domain of “shared decision making” because doctors really have no business telling asymptomatic people what to do. We can give our personal advice, but in the end it is the individual’s choice, based on full and accurate information — i.e., the kind that doctors rarely have the time and knowledge to provide. And as these are lifelong choices, they should be made at leisure and revoked at will — by the individual. In this way “overmedicalization” is not an issue — we simply accept the free choices of autonomous individuals. Some people may want an absolute risk reduction of 0.01% — that’s their affair. Others may have an irrational fear of all tablets and simply not take them whatever their risk — and there is nothing we can do to change that. Given such a free choice, “compliance” or “adherence” become meaningless terms.
That’s the way I see this issue. If a statin makes your muscles ache, you simply stop taking it. A recent study showed that most patients can be successfully started back on a different statin, though that is not my experience. I think — though I do not know for certain — that this applies to every adverse effect attributed to statins, including the rise in blood sugar which takes some people over the arbitrary threshold into “type 2 diabetes.” I would like to know more about the reversibility of this: I hope it is similar to the “diabetes” caused by thiazides, which stops when you stop the thiazide and has no prognostic importance anyway, since it is just a short-term biochemical effect of the agent and does not indicate beta-cell damage. If you are interested in the herd, rather than the individual, then the benefit of the statin in this borderline group outweighs any conceivable harm from a small rise in fasting blood sugar. But again, it’s up to the individual whether to carry on taking the stuff or not. You are not going to feel any different whether your fasting sugar is 6.5 or 7 and the odds are that you will live longer taking the statin, though not by much.
Does this make sense? I am sorry to find that my views on this differ from those of many friends who seem to think there is a pharma-led conspiracy to overmedicate the world. There is no money in this for anyone, and I just hope the whole saga will be one more nail in the coffin of target-driven “care”, where the quality of practice is measured by how many people you persuade to take a particular action. We are not here to increase the life expectancy of the adult general population by imposing interventions, but to help people live and die in the way that they choose, according to the skills we may possess. At least, that is my philosophy, and I still owe Harlan a book about it, which I hope to call “Sharing Medicine.”
I’d really value your thoughts about my option grid if you have time. And I hope you are enjoying/surviving the snow and obtaining a good supply of ripe pears and cheese.
All the very best,
Richard
Dear Richard,
Beautifully said! The framework for shared decision making you lay out is what we should all be working to ensure — and your reminder that the choice is entirely the patient’s to make is critical in informing how one views making clinical recommendations. I find it very helpful. But I still worry that the act of making the recommendation to start a statin is a form of medicalization. Even within the fluid bounds of shared decision-making, to start that conversation you have to invoke the specter of risk and lay a diagnosis of sorts on the patient. You are changing how they (and their insurance company) view themselves. Perhaps this perspective just shows my own medical paternalism (maternalism?). It is hard to shake.
Regarding glycemic thresholds, your point that the diagnosis of diabetes is but a number on a glucose continuum is well taken and, as you suggest, in the case of statins there may be little correlation between meaningful clinical outcomes and observed glycemic rise. But the metabolic and pancreatic reality underlying glycemic thresholds is often more complicated, and variable, than that and we simply don’t yet understand whether the “diabetes” of statin use is metabolically the same as the inflamed environment/beta-cell dance that is “diabetes” as we know it. Nor do we know whether statin-potentiated diabetes progresses or carries the same (or lower), risk of complications and all-cause mortality in low-risk patients. We do know that the large majority of observational studies demonstrate a strong relationship between glycemia and all-cause mortality – and at A1Cs well less than 7%. And we increasingly acknowledge that we can’t effectively decrease that risk with treatment in many people.
As far as I know (but please correct me if I’m wrong) there is little good evidence that statin therapy decreases all-cause mortality in low-risk patients. So are we saying that in groups at low risk for arteriosclerotic CVD we will recommend a drug for primary prevention that for most may modestly, but for some (women) may substantially, increase their risk of a disease that is itself a strong risk factor for mortality from any cause — not to mention a whole host of lesser, but no less relevant to patients, harms over time? And one that we can’t treat well once it develops? I’m open to the possibility, but will wait on the means to accurately identify risk — and the data demonstrating clear benefit that outweighs harms, before I do recommend it.
Best,
Emma
December 20th, 2013
Researching the Obvious: It Stinks to Have Cancer
Debra Lynne Sherman, BA
Editor’s note: Debra Sherman is an outstanding, exceptionally perceptive health reporter who asked me recently why it is that so many medical research findings seem so unimportant and obvious. She is facing a critical illness and needs research that is useful. Those of us who do research should be asking ourselves if there is real value in the knowledge we are producing. Debra wrote the following thoughtful blog for Reuters and gave us permission to rerun it here. Thanks Debra. –Harlan Krumholz
Being poor stinks. Having cancer really stinks. You probably can’t do worse than being poor and having cancer.
That seems so obvious, I’m not sure why anyone needs a study to confirm it. But researchers actually looked at this problem and found exactly what anyone might expect: Breast cancer patients with higher incomes were more likely to receive care that followed the guidelines set by the National Comprehensive Cancer Network (NCCN) than patients with lower incomes.
The NCCN is an alliance of 23 of the world’s leading cancer centers that has put together treatment guidelines that are widely recognized and used as the standard of care.
Specifically, researchers found that breast cancer patients with an annual family income of more than $90,000 were twice as likely to receive care that followed the NCCN guidelines for radiation, compared with those whose with incomes below $50,000.
The study looked into disparities in chemotherapy treatments, too. It found that lower income patients were almost five times as likely to receive care that did not follow NCCN guidelines for chemotherapy to treat their breast cancer. Again, not very surprising.
These and other findings came from a field of health research called disparity studies. They touch on an important topic — how poverty and other economic factors can make a difference in access to health care.
But at a time when there are so many vital questions to ask, and research budgets everywhere are under attack, I wonder why well-meaning researchers pick such obvious questions to ask.
Why are there so many obvious studies? Is it easier to get funding? Are they cheaper to execute? Is the bar lower? Or, am I just being too critical and harsh? After all, I am a stage 4 lung cancer patient who’s anxious for answers. I want someone to find a cure already!
I asked Dr. Harlan Krumholz, a Yale physician whose research focuses on improving patient outcomes and health system performance. He is a big wheel in the world of medical research: director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation and the director of the Robert Wood Johnson Clinical Scholars Program at the Yale University School of Medicine.
As far as I know, Krumholz is not sick and he agrees with me. He says that when it comes to medical studies, the pressure may be to produce volume over value.
“High value articles often take patience and resources, both of which may be in short supply by institutions that employ investigators,” Krumholz tells me.
“But the biggest problem may be a research culture that is not often enough asking itself whether the information it produces truly has value for others and will contribute to better lives for patients and the public,” he adds.
The breast cancer treatment study was presented recently at the American Association for Cancer Research Cancer Health Disparities special conference in Atlanta.
To be sure, there were some important studies presented in Atlanta that would seem to advance cancer care and address health disparities.
One such study looked at potential biological factors contributing to racial disparities in prostate cancer incidence and mortality between African American and non-Hispanic white men in the United States. Another examined the genetics of an inherited predisposition to breast cancer. A third looked at genetic alterations to a specific gene family that may be responsible for survival disparities seen between African-American and non-Latino white men with head and neck cancer.
These strike me as potentially useful to patients.
But there still are far too many obvious studies, in my view. And they are everywhere you turn.
Scientific American published a list of the 12 most obvious scientific findings in 2012. According to that list, someone actually spent time and money to determine that calling an ambulance improved heart attack survival. Someone else conducted a study that discovered, amazingly, that smoking pot can make your mind fuzzy.
With research dollars so hard to come by these days, it seems more important than ever that the medical research community take a critical look at what questions need to be asked and answered in order to best serve patients.
December 19th, 2013
More Walking and More Fiber: Good for the Heart
Larry Husten, PHD
It probably won’t come as a surprise, but walking more and eating more fiber are probably good for your heart. That’s the conclusion of two new studies, but because the studies relied on observational data it should be emphasized that they are incapable of demonstrating cause and effect. And it’s by no means clear that most people are willing to undertake the effort needed to achieve effective lifestyle changes like these.
Walking
In the first study, published in the Lancet, researchers analyzed data from 9,300 people with impaired glucose tolerance (and therefore at high risk for developing diabetes) and with existing cardiovascular disease or at high risk for CV disease. (The patients were participants in a trial, known as NAVIGATOR, that tested two different drugs.) Study participants were followed for 6 years. Walking was measured with a pedometer at the beginning of the study and at one year.
The amount of walking at baseline, and the change in walking at one year, were both inversely associated with the risk of having a cardiovascular event. For every 2000 steps per day at baseline — which is equivalent to about 20 minutes of walking — the risk of cardiovascular events was reduced by 10%. At one year, every additional 2000 steps per day was associated with a further 8% reduction in cardiovascular risk. The association persisted even after adjusting for a wide range of confounding factors, including weight, smoking status, diet, and use of other drugs.
In an accompany comment, Giuseppe Pugliese and Stefano Balducci write that the finding “adds compelling and reassuring evidence for the benefits of physical activity on cardiovascular health, although further observational and intervention studies with rigorous and objective assessment of physical activity and fitness are needed.”
Eating
In the second paper, published in BMJ, investigators performed a systematic review of studies examining the effect of dietary fiber on cardiovascular and coronary heart disease. They reported a significant 9% reduction for both CVD and CHD for every additional 7 grams of total fiber consumed each day. (Seven grams is the equivalent of 2-4 serving of fruit and vegetables or one portion of whole grains and one portion of beans or lentils.) The authors said that they only included studies of fiber contained in the diet and cautioned that their findings should not be applied to fiber supplements.
In an accompanying comment, Robert Baron writes that “clinicians should enthusiastically and skillfully recommend that patients consume more dietary fiber.” Current estimates are that most people in Western countries only consume about half of recommended amounts of dietary fiber.
But it’s one thing to show that walking more and eating more fiber are good for you. It’s another thing entirely to actually figure out how to get people to do these things. In his comment, Baron points out that “persuading patients to eat whole grains is particularly challenging.” Undoubtedly, getting people to exercise is even more difficult. Just earlier this year the Look Ahead trial found that an intensive lifestyle intervention was no better than standard care in reducing cardiovascular events in people with type 2 diabetes.
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