The Medical Internet
There are countless medical resources online. Dr. Harlan Weinberg, author of Best Health Resources on the Web, started with a list of 20,000 Web sites and took three-and-a-half years to whittle it down to 1,000 reliable and accurate sites. In addition to reference sites, there are also list-serves and blogs which can connect patients with their peers and other experts. With the abundance of information, Dr. Harland urges users to be skeptical and not believe everything they read.
Health-related resources on the Internet can be a powerful tool if used wisely.
FORBES.COM, Dec-Jan 2008/2009, by Rebecca Ruiz — The Internet has twice saved Jola Stettler’s life.
In November 2006, the 39-year-old mother of three was diagnosed with ocular melanoma that had spread to her liver.
“My oncologist flat out told me that there is no treatment,” remembers Stettler, who emigrated to the U.S. from Poland in 1994. “He said for me to go home and enjoy with my family whatever time I have left, which could be up to six months.”
Stettler’s husband, Marek, couldn’t fathom the oncologist’s terminal diagnosis and instead turned to the Internet. Hours of research led him to Dr. Charles Nutting, an interventional radiologist at the Swedish Medical Center in Denver. Dr. Nutting agreed to treat Stettler, also a Denver resident, with a cutting edge therapy that injects the tumors with radioactive beads to gradually shrink them. A year-and-a-half later her tumors began to grow again.
That’s when Marek returned to the Internet and discovered that the National Institutes of Health was in the midst of a clinical trial to treat cancer patients with a radical new therapy that uses six times the amount of chemotherapy while not allowing it to enter the body’s bloodstream. Dr. Nutting hadn’t yet heard of the trial, but agreed to help Stettler participate. Four treatments this year have shrunk the tumors by 75%.
Though Stettler’s case is an extreme example, it is a reminder that online medical resources and advice can be a powerful tool if used wisely. The most reliable and accurate Web sites, blogs and list-serves can lead users to information about prevention, diagnosis, treatment and experts, sometimes helping them to improve their quality of life dramatically.
But Internet users will have mixed results when searching the “medical Internet” if they don’t first establish which sites are most credible, says Dr. Harlan Weinberg, head of the critical care department at Northern Westchester Hospital in Mt. Kisco, N.Y.
Dr. Weinberg spent three-and-a-half years combing through 20,000 possible Web sites to include in a book on online medical resources. The final list contained just 1,000 sites, each of which met Dr. Weinberg’s standards for reliability and accuracy. They include Medline Plus, National Library of Medicine, the National Immunization Program, CDC and MyPyramid, USDA.
He gave greater weight to sites run by respected academic, government, medical and nonprofit organizations and institutions. He also evaluated the validity and timeliness of the information, trying to determine the source and when it had been last updated. These are key indicators of a site’s trustworthiness, and ones that users often overlook. A study conducted by the Pew Internet & American Life Project in 2007 found that while eight in 10 American adults have consulted the Web for health care information, 75% failed to check a source’s validity or relevance.
Many users begin their search by typing a few key words into a search engine, but they could be more effective by compiling a list of first-tier online resources. A Google search for diabetes, for example, offers Web sites for health care media publishing companies in its top three results. But perhaps more reliable is a site run by the National Institutes of Health, which contains basic research on the disease in addition to information about ongoing clinical trials and alternative therapies.
As in Jola Stettler’s case, Internet resources can help patients become more active advocates for their own interests. Her radiologist, Dr. Nutting, says Internet savvy patients often find experts and remedies that change the course of their treatment, but that the newfound knowledge should be parsed by a trained professional.
“It can be an overwhelming task for a non-medical person,” he says.
A physician’s opinion is particularly important since searching the medical Internet can sometimes lead to “cyberchondria,” or an increased anxiety caused by reviewing online content.
A Microsoft (nasdaq: MSFT – news – people ) study of Internet use and medical research released last month found that of more than 11,100 search sessions, 5.3% led to a “query escalation” during which the subject began associating a common symptom with a serious medical condition. When searching for the key word headache, for example, the subject then began querying “headache tumor” and “brain tumor treatment” instead of something more probable like “headache coffee” and “caffeine withdrawal symptoms.”
Instead of using the Internet to turn random aches and pains into the worst-case scenario, Dr. Weinberg recommends utilizing it for prevention. This means seeking out accurate information on a number of health issues, including exercise and diet recommendations, weight loss and smoking cessation.
But even when using the Internet for preventive purposes, it’s important to consult a physician who will know best how to diagnose and treat various ailments.
“It’s a tool,” he says, “but you still need to have someone doing the critical medical thinking. Your Internet is not going to provide you that.”
How to Surf the Web for Medical Advice
You could start out by typing a key word into a search engine, but don’t just click on the top results. A Google search for diabetes, for example, offers Web sites for health care media publishing companies in its top three results. But perhaps more reliable is a site run by the National Institutes of Health, which contains basic research on the disease in addition to information about ongoing clinical trials and alternative therapies.
Find Reliable Sources
Give greater weight to sites run by respected academic, government, medical and nonprofit organizations and institutions. Evaluate the validity and timeliness of the information, trying to determine the source and when it had been last updated. These are key indicators of a site’s trustworthiness, and ones that users often overlook.
Don’t let paranoia dominate your search habits when looking for medical information online. A recent Microsoft study of Internet use and medical research found that of more than 11,100 search sessions, 5.3% led to a “query escalation.” In such cases, the subject began associating a common symptom with a serious medical condition, like starting with “headache” then proceeding to “headache tumor” and “brain tumor treatment.” Caffeine withdrawal is far more likely the cause.
Involve Your Physician
Internet savvy patients can find experts and remedies that change the course of their treatment, but that the newfound knowledge should be parsed by a trained professional. “It’s a tool,” says Dr. Harlan Weinberg, head of the critical care department at Northern Westchester Hospital in Mt. Kisco, N.Y, “but you still need to have someone doing the critical medical thinking.”
Delegate Research Responsibilities
When Jola Stettler, a 39-year-old mother of three, was diagnosed with ocular melanoma that had spread to her liver, she relied on her husband to use the Internet as a research tool. “I was trying to occupy my mind with something else,” she says. So her husband began investigating treatments for the disease and eventually found a radiologist willing to treat her as well as a clinical trial being run by the National Institutes of Health.
Remember that You’re Unique
When discussing health issues and concerns through a list-serve, blog or other medium, remember that your case is unique. Despite shared symptoms and experiences, try to think about how your care and treatment might differ from that of online contacts. There are basic rules about treating certain ailments, but gender, age and lifestyle can make a huge difference when it comes to finding the right approach.
Preventative Health Care
Instead of using the Internet to turn random aches and pains into the worst-case scenario, Dr. Weingberg recommends utilizing it for prevention. This means seeking out accurate information on a number of health issues, including exercise and diet recommendations, weight loss and smoking cessation. There are a number of Web sites with up-to-date recommendations on these topics, including the American College of Sports Medicine and the Centers for Disease Control.
January 5, 2009
New Approaches to Cardiac Resuscitation
More focus on compressions (and less on ventilation) by bystanders in out-of-hospital cardiac arrest is associated with better outcomes.
Survival to hospital discharge after out-of-hospital cardiac arrest is very unlikely. To simplify cardiopulmonary resuscitation (CPR) protocols and, possibly, improve cardiac and cerebral perfusion, investigators studied a new approach, called minimally interrupted cardiac resuscitation (MICR), which places more emphasis on chest compressions and less on ventilation. The MICR protocol (Table 1) was implemented through 2 emergency medical services (EMS) in Arizona, and a separate comparative study was conducted through 60 Arizona fire departments.
In the EMS study (886 patients), survival to hospital discharge rose from 1.8% before the new protocol was implemented to 5.4% afterward. For 174 patients with witnessed arrests and ventricular fibrillation, the rate rose from 4.7% to 17.6%. In the comparative study (2460 patients), survival to discharge occurred in 9.1% of those who received MICR versus 3.8% of those who received CPR under old guidelines.
In a position paper from the American Heart Association (AHA), which was published at about the same time, the authors called for compression-only cardiac resuscitation by bystanders who witness out-of-hospital cardiac arrest. Based on results from the MICR studies above and others, the AHA proposed simplifying cardiac resuscitation for bystanders and addressed fears of contagion and concerns about proper technique for mouth-to-mouth ventilation. This AHA recommendation applies only to lay bystanders and not to skilled healthcare personnel who follow current cardiac life-support protocols (which I can confirm, having just recertified in Advanced Cardiac Life Support).
The results of the MICR studies are encouraging, but, because the studies were observational and uncontrolled, other factors could have contributed to the difference in survival to discharge. At the least, the findings suggest that a wide range of approaches to cardiac resuscitation likely will lead to comparable outcomes, that an emphasis on cardiac compression over ventilation is appropriate (especially in situations where mouth-to-mouth ventilation is problematic), and that a rigid prescriptive approach to tightly counted compressions and interpolated ventilations is unnecessary.
— Thomas L. Schwenk, MD
Published in Journal Watch General Medicine December 29, 2008
Prevention of Recurrent Ischemic Stroke
Cost and side effects, not effectiveness, might be the discriminators between aspirin plus dipyridamole and clopidogrel.
Aspirin, aspirin plus dipyridamole, or clopidogrel often is used to prevent recurrent stroke. In the double-blind randomized PRoFESS trial, more than 20,000 clinically stable patients (age, 50) with recent ischemic strokes received either a fixed combination of aspirin (25 mg) plus extended-release dipyridamole (200 mg) twice daily or clopidogrel (75 mg) once daily. The study was sponsored by the maker of the aspirin/dipyridamole combination (Aggrenox).
During a mean follow-up of 2.5 years, recurrent stroke occurred in 9.0% of combination recipients and in 8.8% of clopidogrel recipients — a nonsignificant difference. The incidence of a secondary composite outcome (stroke, myocardial infarction, or death from vascular causes) was 13.1% in both groups. A slight excess incidence of major hemorrhage that occurred with aspirin plus dipyridamole compared with clopidogrel (4.1% vs. 3.6%) was of borderline significance, but incidence of a composite endpoint of stroke or major hemorrhage was similar in the two groups. Combination recipients were significantly more likely than clopidogrel recipients to discontinue study medication.
Previously, the combination of aspirin plus dipyridamole was shown to be superior to aspirin alone, whereas clopidogrel had shown only a marginal benefit over aspirin alone. The PRoFESS trial (the first head-to-head comparison of the 2 regimens) was designed to establish superiority of aspirin plus dipyridamole over clopidogrel for prevention of recurrent stroke, but it failed to do so. Overall, the two regimens appear to be equally efficacious. However, this study complicates the issue of whether either of these regimens is substantially superior to aspirin alone. Using a technique called “network meta-analysis” (in which dissimilar trials are analyzed together), editorialists concluded that aspirin plus dipyridamole might be minimally superior to clopidogrel alone (although not significantly so), whereas clopidogrel might be minimally superior to aspirin alone (again, not significantly). As such, cost and side-effect profiles probably should factor into physicians’ choices among these treatments for individual patients.
— Jamaluddin Moloo, MD, MPH
Published in Journal Watch General Medicine December 29, 2008
The JUPITER Study: Statins for Primary Prevention of Cardiovascular Disease
Among patients with high CRP levels, rosuvastatin lowered risk for adverse cardiovascular events.
One of 2008’s most hotly debated studies has the potential to change prevention recommendations for millions of Americans. In the industry-sponsored JUPITER study, researchers investigated the role of statins in primary prevention when patients’ cholesterol levels were not markedly high but high-sensitivity C-reactive protein (hsCRP) was elevated. Nearly 18,000 subjects (ages: men, 50; women, 60) without known cardiovascular (CV) disease and with normal LDL-cholesterol levels (<130 mg/dL), but with high hsCRP levels (2 mg/L), were randomized to receive daily rosuvastatin (Crestor; 20 mg) or placebo. Extensive exclusion criteria eliminated many patients (e.g., those with diabetes, uncontrolled hypertension, or various other chronic diseases; those who used cholesterol-lowering drugs).
After a median follow-up of 1.9 years (the trial was stopped early, due to markedly positive results for rosuvastatin), rosuvastatin lowered LDL-cholesterol levels by a mean of 50% and hsCRP levels by 37%. Incidence of the primary endpoint (first major cardiovascular event, including unstable angina, myocardial infarction, stroke, arterial revascularization, or death from cardiovascular causes) was significantly lower in the rosuvastatin group than in the placebo group (hazard ratio, 0.56), as was overall mortality (HR, 0.8). For every 1000 patients who received rosuvastatin for 1 year, roughly six fewer primary-endpoint events and three fewer deaths occurred. Incidences of physician-reported diabetes and glycosylated hemoglobin levels were both significantly higher in the rosuvastatin group than in the placebo group.
So, where do we go from here? Statins lowered the rate of adverse CV events in this large study of apparently healthy subjects who were at CV risk because of high hsCRP levels; however, in an accompanying editorial, the author notes that the absolute effect size was relatively modest and that the higher incidence of diabetes and lack of long-term data on hazards of therapy are worrisome. Nonetheless, these data almost certainly will prompt review of current guidelines on use of statins in primary prevention, as well as generate a flurry of calls to physicians about hsCRP testing. Some media reports on JUPITER have couched the study results as supporting widespread use of hsCRP testing, but the editorialist reminds us that this is a randomized trial of statin therapy, not of hsCRP testing, and he advocates selective rather than routine CRP testing.
— Kirsten E. Fleischmann, MD, MPH
Published in Journal Watch General Medicine December 29, 2008
More Data on Medical Therapy vs. PCI in Patients with Stable Angina
Both medical therapy and PCI have a place in the management of patients with stable angina.
The COURAGE trial generated much discussion in 2007, when its investigators presented results suggesting that, in patients with stable angina — but without high-risk disease identified by angiograms — percutaneous coronary intervention (PCI) did not lower rates of myocardial infarction or death compared with best medical therapy. In 2008, the COURAGE investigators presented data on additional important outcomes — symptom relief and quality of life (QOL).
Among 2287 patients who were randomized to PCI plus optimal medical therapy or optimal medical therapy alone, the proportion of patients who were free of angina at 3-month follow-up was significantly higher in the PCI group (53% vs. 42%), and the PCI group also had generally better angina-specific QOL scores. Generally, this advantage persisted from 6 to 24 months depending on the measure. Patients with more-severe angina benefited more from PCI. By 36 months, health status and QOL did not differ significantly between the groups.
In another study, about selection of patients for PCI, investigators used Medicare data to determine how often patients who underwent elective PCI for stable coronary artery disease had undergone stress testing in the 90 days prior to their procedures, as current guidelines often call for documenting ischemia prior to elective PCI. Less than half the sample (44.5%) had undergone stress testing, and geographic variation in rates of stress testing before PCI was wide (22% to 71%). Lower rates were seen in women, older patients (85), and those with prior heart failure or catheterization. Patients treated by higher-volume interventionalists were less likely to have undergone stress testing prior to PCI.
What do these data tell us? In my opinion, both medical therapy and PCI have a place in management of patients with stable angina. Those who support intervention will rightly point out that prospectively evaluated participants in COURAGE underwent angiography to define their coronary artery disease and that those with left-main disease, 3-vessel disease with depressed ejection fraction, or disease unsuitable for PCI revascularization were excluded from randomization. But the data suggest that most patients can be managed successfully with medical therapy when high-risk features (e.g., significantly depressed left ventricular function, difficult-to-control heart failure, markedly positive stress test) are absent, and PCI can be reserved for those who do not respond symptomatically to optimal medical therapy. The Medicare study demonstrates the wide variation in practice for stress testing before elective PCI, but, unfortunately, these researchers could not look at linked outcomes data to tell us whether preprocedural stress testing was associated with better outcomes after PCI.
— Kirsten E. Fleischmann, MD, MPH
Published in Journal Watch General Medicine December 29, 2008
Preventing Adverse Cardiovascular Events in Patients with Type 2 Diabetes
In younger patients with newly diagnosed diabetes, intensive glucose-lowering therapy appears to prevent macrovascular events; in patients with established diabetes, the jury is still out.
Intensive glucose-lowering therapy is widely believed to prevent macrovascular complications in patients with type 2 diabetes. However, results from several recent trials have cast doubt on this assumption.
In the ACCORD trial, researchers randomized about 10,000 type 2 diabetic patients (mean age, 62) with known cardiovascular (CV) disease or at least two CV risk factors to either intensive glucose-lowering therapy or standard therapy. Glycemic control was significantly better in the intensive-treatment group (glycosylated hemoglobin [HbA1c], 6.4% vs. 7.5%). However, after a mean follow-up of 3.5 years, the intensive-treatment group had significantly higher mortality than the standard-treatment group did (5% vs. 4%; P=0.04). Furthermore, no differences were noted between the groups in CV death, myocardial infarction, or stroke.
In the ADVANCE trial, investigators randomized more than 11,000 type 2 diabetic patients (mean age, 66) with known microvascular or macrovascular disease or one risk factor for CV disease to either intensive glucose-lowering therapy or standard therapy. After a median follow-up of 5 years, the intensive-treatment group had significantly better glycemic control (HbA1c, 6.5% vs. 7.3%) and experienced fewer microvascular events (the main event in both groups was nephropathy). However, no differences were found between the groups in mortality or major adverse CV events.
Researchers from the United Kingdom Prospective Diabetes Study (UKPDS) randomized about 4000 patients (median age, 54) with new-onset type 2 diabetes to either intensive glucose-lowering therapy or standard therapy. After a median follow-up of 11 years, the intensive-treatment group had significantly better glycemic control (HbA1c, 7.0% vs. 7.9%) and experienced fewer microvascular events (mainly, requisite retinal photocoagulation). No differences were found between the groups in macrovascular events or mortality at the close of the randomized portion of the study. More than 3000 UKPDS patients were followed after trial completion, and their HbA1c levels became similar within 1 year. After 10 years, however, the patients who were initially in the intensive-therapy group experienced significantly fewer microvascular events, fewer MIs, and lower mortality.
The UKPDS involved younger patients with new-onset type 2 diabetes, whereas patients in ACCORD and ADVANCE had established diabetes and end-organ complications or CV risk factors. These observations suggest that intensive glucose-lowering therapy holds more promise for younger, newly diagnosed, type 2 diabetic patients; however, this hypothesis should be confirmed by additional trials. For older diabetic patients with end-organ complications or CV risk factors, perhaps the best approach is to achieve “reasonable” glycemic control (HbA1c, about 7.0%); avoid hypoglycemic events; and focus on diet, exercise, smoking cessation, weight loss, blood pressure control, and lipid lowering. Indeed, in a recent trial, investigators found that such a multifactorial approach lessened microvascular and macrovascular events and excess deaths in type 2 diabetic patients during 13 years of follow-up.
As we were going to press, another randomized controlled trial of intensive glucose control was published. In a study from U.S. Veterans Affairs hospitals, almost 1800 patients with type 2 diabetes who were at high risk for vascular events were randomized to conventional or tight glycemic control. At a median of 5.6 years of follow-up, tight control was not associated with longer time to reach the primary endpoint (a composite of MI, stroke, cardiovascular death, heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene).
— Paul S. Mueller, MD, MPH, FACP
Published in Journal Watch General Medicine December 29, 2008
PLoS Medicine, January 6, 2009, by Denise Grady — Six years ago, a relative of mine found out that she had rectal cancer and would need surgery, radiation and chemotherapy. She lives in a small town, and she consulted a local surgeon at a community hospital.
He was pleasant and kind, and clearly explained her condition and the operation he would perform. He was also painfully honest, and said that because the tumor was large, he doubted that he would be able to save the sphincter muscles that make bowel control possible. She would very likely need a colostomy, a procedure to divert wastes out through an opening cut in the abdomen, and would have to wear a colostomy bag for the rest of her life.
My relative thought it over. Being treated close to home had seemed so easy and convenient, and she dreaded the thought of shopping around for doctors when she was feeling sick, vulnerable and anxious. It was tempting to think that she would receive first-rate treatment no matter where she went.
But she also recognized that this was a small hospital, and a surgeon who probably spent more time fixing hernias and taking out gallbladders than he did operating on cancer patients. She decided that she wanted a doctor who operated on patients like her all the time, and that the two-hour trip to a cancer center would be worth the trouble.
And so it was: she found a surgeon who specialized in rectal cancer, and today she’s in good health, with no need for a bag. She might have done just as well with the local surgeon, but we both doubt it.
An article published online in October in the journal PLoS Medicine really hit home with me. Noting that the quality of cancer care is uneven, its authors argued that as part of the informed-consent process, doctors have an ethical obligation to tell patients if they are more likely to survive, be cured, live longer or avoid complications by going to Hospital A instead of Hospital B. And that obligation holds even if the doctor happens to work at Hospital B, and revealing the truth might mean patients will take their business someplace else.
“It’s only fair,” said Dr. Leonidas G. Koniaris, an author of the article and a cancer surgeon at the Miller School of Medicine at the University of Miami.
Studies have confirmed the common-sense notion that practice makes perfect, and the medical profession has known for at least 30 years that how well people fare after surgery often depends on where it was performed. For a given operation, outcomes are generally best at “high volume” hospitals, which perform it often. The difference between high- and low-volume centers is not just the surgeon’s skill, but also the level of expertise in other areas that are crucial after surgery, like nursing, intensive care, respiratory therapy and rehabilitation, Dr. Koniaris said. The same principles apply to treating cancer.
But patients are not often told during the informed-consent process that the results of cancer treatment can vary among hospitals, according to Dr. Koniaris and his co-author, Nadine Housri, a medical student.
“I think it’s sort of starting to happen but hasn’t really become a dialogue yet,” Dr. Koniaris said.
The strongest evidence that volume makes a difference comes from studies of surgery for pancreatic and esophageal cancer, but Dr. Koniaris said the experience of the surgeon and the whole medical team was important in any major cancer surgery.
He was not surprised to hear about my relative. He was an author of a study published in 2007 that found that people with rectal cancer survived longer and were more likely to have operations that saved the sphincter at teaching hospitals than at community ones — even though the university hospitals were more likely to take on difficult cases with large tumors. Another study in which he participated suggested that women with advanced breast cancer received more comprehensive therapy and survived somewhat longer when treated at teaching hospitals rather than at community ones.
Some medical experts say complicated treatments like surgery for cancer or heart problems should be regionalized — done strictly at specialized, high-volume centers, not at centers that don’t perform the operations often enough to become really good at them. But Dr. Koniaris and Ms. Housri suggested still another option.
“We brought up the idea that maybe it should just be up to the patient,” Dr. Koniaris said.
Studies have found that some people still prefer to be treated close to home even if the risks are higher there. Maybe they shouldn’t be forced to travel, especially if the difference is not large, Dr. Koniaris said.
Asked if he practiced what he preached, Dr. Koniaris said yes, that as a surgeon he sometimes sent patients to other doctors, especially for pancreatic cancer and liver tumors.
His article pointed out that in a few cases in the United States and Australia, courts have ruled that doctors who had operated on people with poor results should have informed the patients that more experienced surgeons were available.
PLoS Medicine framed the article by Dr. Koniaris and Ms. Housri as a debate, with two other researchers taking different views. Dr. Robert J. Weil, a neurosurgeon at the Cleveland Clinic, argued that although it might seem a good idea to inform patients of differences in outcomes among hospitals, there would be “a variety of hurdles.”
Which hospitals would be chosen for comparison? And as medicine advances and changes, Dr. Weil asked, “is it possible to compare hospitals or even recent time periods, especially when faced with disease courses that may extend over years?” He also suggested that if hospitals were forced to give patients comparative information, it might lead some to avoid difficult cases, to make their numbers look better. And he pointed out that patients might have no idea what to make of the information, because most people have a hard time gauging risk or understanding that statistics apply to a population but don’t predict the fate of an individual.
David I. Shalowitz, a bioethicist, said that expecting surgeons and hospitals to disclose information about other doctors and medical centers would create an untenable conflict of interest for them and should be avoided.
The question of what the doctor’s obligation is remains unresolved. People can ask doctors for comparative information, but many patients would fear giving offense. And judging by volume alone may have its pitfalls, because there are bound to be some hospitals that do lots of operations badly and some that perform few but do them well.
(For people who want to find out how a specific hospital performs in treating certain illnesses and performing operations, the government Web site www.hospitalcompare.hhs.gov provides information. In addition, some states require that hospitals publish their infection rates; that information is at www.hospitalinfection.org.)
Some people will try to sort out whatever information they can obtain or, as my relative did, simply figure that the odds will be most in their favor if they can find their way to a doctor or surgeon who takes care of a lot of people who are a lot like them. For now, many patients facing tough decisions are pretty much on their own.
The PLoS Medicine Debate discusses important but controversial issues in clinical practice, public health, or health in general.
Should Informed Consent for Cancer Treatment Include a Discussion about Hospital Outcome Disparities?
Nadine Housri, Robert J. Weil, David I. Shalowitz, Leonidas G. Koniaris
Background to the debate: Several studies have found disparities in the outcome of medical procedures across different hospitals—better outcomes have been associated with higher procedure volume. An Institute of Medicine workshop found such a “volume–outcome relationship” for two types of cancer surgery: resection of the pancreas and esophagus (http://www.iom.edu/?id=31508). This debate examines whether physicians have an ethical obligation to inform patients of hospital outcome disparities for these cancers.
Funding: NH and LGK are supported by an Arsht Research Grant from the Ethics Program at the University of Miami and The James and Esther King Tobacco Research Award from the state of Florida. None of the authors received any specific funding for this article.
Competing Interests: The authors have declared that no competing interests exist.
Citation: Housri N, Weil RJ, Shalowitz DI, Koniaris LG (2008) Should Informed Consent for Cancer Treatment Include a Discussion about Hospital Outcome Disparities? PLoS Med 5(10): e214 doi:10.1371/journal.pmed.0050214
Published: October 21, 2008
Copyright: © 2008 Housri et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Nadine Housri is with the University of Miami Miller School of Medicine, Miami, Florida, United States of America. E-mail: email@example.com. Robert J. Weil is with the Brain Tumor and Neuro-Oncology Center, the Department of Neurosurgery, and the Neurological Institute at the Cleveland Clinic, Cleveland, Ohio, United States of America. E-mail: firstname.lastname@example.org. David I. Shalowitz is with the Bioethics Program, University of Michigan Medical School, Ann Arbor, Michigan, United States of America. E-mail: email@example.com. Leonidas G. Koniaris is with the DeWitt Daughtry Family Department of Surgery, Division of Surgical Oncology, University of Miami Miller School of Medicine, Miami, Florida, United States of America. E-mail: firstname.lastname@example.org.
Provenance: The opening viewpoint by Nadine Housri and Leonidas G. Koniaris was not commissioned and was externally peer reviewed. The two other viewpoints were commissioned and not externally peer reviewed.
Nadine Housri and Leonidas Koniaris’ Viewpoint: Physicians Have an Ethical Duty to Inform Patients of Hospital Outcome Disparities for Select Cancers
Thirty years ago, Luft and colleagues published the mortality rates for 12 surgical procedures of varying complexity in 1,498 hospitals, finding the mortality of open-heart surgery, vascular surgery, transurethral prostatectomy, and coronary bypass to be inversely related to hospital volume Since then, further studies have found an association between improved outcome and high hospital procedure volume or teaching hospital status . Such reports have led to calls for regionalization of care and have served as the impetus leading consumer groups and policy makers to use hospital volume as a quality indicator and, in some cases, to direct patients to high-volume centers for select procedures
The results of outcomes studies, especially those for cancer, have generated significant interest among consumer groups and private organizations, some of which provide patients with hospital volume information on their Web sites In addition, a number of articles on volume–outcome studies have appeared in popular American newspapers and magazines These articles present a relatively simplistic view of volume–outcome data and may be subject to misinterpretation .
Since it is clear that patients are receiving information on hospital disparities in cancer treatment not only from their physicians but also from less informed sources, a crucial ethical question has arisen for the individual physician treating patients with cancer. Should primary care physicians, surgeons, and oncologists inform their patients of outcome disparities among hospitals? Should such information be disclosed as an element of informed consent? In response to one of the initial studies on volume–outcome relationships, Charles Culver and Bernard Gert argued in 1980 in favor of informing patients of volume–outcome disparities, where they exist . However, almost 30 years later, it is questionable whether this information is disclosed during the informed consent process. Based on the principles of informed consent and the prevailing standards of disclosure, we argue that physicians have an ethical obligation to inform patients of hospital outcome disparities for select cancers.
The Scope of Informed Consent in Cancer Care
Informed consent, which aims to protect the autonomous choice of the patient, is traditionally defined in terms of two components: (1) the disclosure of information on a procedure, leading to the patient’s comprehension of this information; and (2) authorization by the patient to proceed with treatment . Disclosure includes information on the nature of a procedure, potential risks and benefits, and alternative treatments. While patients are theoretically given adequate information to help them decide whether or not to be treated, they are given very little, if any, information to guide their decision on where to be treated. How often does the informed consent process include a discussion on the risks and benefits of treatment at a low-volume or nonteaching hospital or the possibility of an alternative treatment at a high-volume or academic center? Withholding outcome data where substantial differences in short- and long-term outcomes are observed potentially costs patients the ability to make an informed decision on where they should seek care.
The Case for Informed Consent
Informed consent is often seen as a right of a patient and a duty or obligation of a physician Does a physician have an ethical obligation to share volume–outcome data when consenting a patient for treatment? And is it the patient’s right to know this information when making a decision?
The necessity of disclosure can be assessed through two prevailing standards—the “professional practice” standard and the “reasonable person” standard. According to the “professional practice” standard, adequate disclosure is determined by the professional community’s customary practices . At the conclusion of the 2000 Institute of Medicine workshop examining evidence on the volume–outcome relationship, the National Cancer Policy Board determined that the volume–outcome relationship was strongest and most consistent for resections of the pancreas and esophagus While the volume–outcome relationship is gaining strength for a number of other cancers involving complex surgeries, the only cancer resections for which the Agency for Healthcare Research and Quality lists hospital volume in their Inpatient Quality Indicators are those of pancreatic and esophageal cancer. In addition, the Leapfrog coalition (http://www.leapfroggroup.org/), an alliance of large and small corporations that employs a total of over 20 million individuals, requires that employees who undergo one of five high-risk procedures must be cared for at high-volume centers. Two of the five procedures are pancreatic and esophageal cancer resections . Therefore, we feel that the professional practice standard would, at the very least, support the disclosure of volume–outcome differences for patients undergoing pancreatic or esophageal cancer treatment.
Conversely, the “reasonable person” standard holds that the relevance of information is not based on the professional community’s practices, but rather on the significance that a reasonable person would attach to it in making a decision What value would a reasonable woman with metastatic breast cancer place on the information that treatment at a teaching hospital is associated with a significantly higher chance of five- and ten-year survival? . Would knowing that a local low-volume hospital may provide a man with rectal cancer with a significantly higher risk of a postoperative colostomy or even death cause him to seek out care at a high-volume center? According to Finlayson’s study on patient preferences for location of care, nearly half of surveyed patients stated that they would rather travel four hours to a distant center for a Whipple procedure than be treated at a local hospital if care at the distant center was associated with half the risk of operative mortality . Interestingly, 45 out of 100 patients would not travel to a distant center if the risk was doubled at their local hospital, and almost one quarter of patients would rather face a six-times higher risk of operative mortality than travel for treatment. Thus while many patients may value outcome data in deciding where to have their surgeries, a similarly large number of patients will prefer local treatment, despite disparities in outcomes. The study makes no mention of the manner in which risks were framed when conveyed to the patient—“framing effects” during informed consent are known to influence patients’ decisions The value that a reasonable person would place on outcome data in selecting location of care remains uncertain.
The reasonable person standard is one that can be very challenging for a physician to assess. In order to accurately evaluate what a reasonable person would find significant in making an informed decision, a physician must engage in discussion with the patient. Such discussion is also essential in allowing treatment to be a result of “shared decision-making.” While informed consent and shared decision-making serve the same goal—to enhance a patient’s control over his or her own medical care—they are two distinct entities. Informed consent is a physician’s ethical and legal duty and mandates the two components outlined above: discussion of the procedure and explicit patient agreement or refusal. Shared decision-making, on the other hand, is a manner in which decisions may be made, involving an exchange of ideas between patient and doctor and collaboration on the decision itself . We believe that for any cancer in which a volume–outcome relationship has been defined, discussion of this relationship should be part of both processes. Additionally, disclosure of outcomes research should be a required component of informed consent for those cases in which the volume–outcome relationship is significant and consistent, and is supported by the professional practice standard of disclosure.
Consequences of Disclosure or Nondisclosure
Physicians may be hesitant in disclosing hospital outcome disparities for fear of migration of cancer patients from low-volume and nonteaching hospitals to high-volume and teaching hospitals. However, armed with knowledge of hospital-outcome data, patients will not necessarily choose to change hospitals—they may prefer to remain at a local hospital or they may simply lack access to high-volume centers In addition, patients may not wish to travel to a high-volume center for cases in which treatment at a high-volume center confers only a small, albeit significant, advantage.
It is an ethical duty, and not fear of litigation, that should motivate physicians to provide full disclosure to their patients. Nevertheless, the legal implications of inadequate disclosure cannot be ignored. In the United States, the courts continue to differ in their definitions of adequate disclosure, and the states are split evenly between the two standards . However, failures to inform patients of alternatives that may have otherwise yielded a better outcome have been met with legal action in recent years. In the case of Johnson v. Kokemoor, a neurosurgeon was successfully prosecuted for failure to accurately disclose risks of a basilar bifurcation aneurysm surgery performed by a surgeon at his level of experience. Furthermore, the Wisconsin Supreme Court decided that information on the availability of other centers and physicians better able to perform that procedure would have facilitated the plaintiff’s awareness of “all of the viable alternatives” and her ability to make an informed choice . A similar conclusion was reached in the Australian case of Chappel v. Hart, which sided with a patient plaintiff for failure of a treating physician to disclose the availability of a more experienced surgeon for a particular procedure . “Loss of chance of a better outcome” is a recent development in Australian law in which negligence may be claimed without the need to prove causation. The loss of chance concept has been rejected by British courts. Nonetheless, more claims based on loss of chance are expected in Australia and may be successfully prosecuted unless rejected by the High Court.
A Question of Trust and Honesty
Full disclosure of outcomes research, whether it is during the mandated process of informed consent or the recommended shared decision-making part of care, is essential to maintain trust and honesty in the physician–patient relationship. More importantly, it will protect the cancer patient’s autonomy and sense of control, a value of paramount importance for a patient battling a potentially lethal disease.
Robert J. Weil’s Viewpoint: Such a Discussion Faces Logistic Hurdles and Risks Unintended Consequences
In their thoughtful and provocative viewpoint, Nadine Housri and Leonidas Koniaris propose that hospital outcome studies should be a necessary and obligatory component of the informed consent process ahead of offering surgery for cancer. Reviewing a number of the salient papers published over the past 30 years, they re-emphasize that, for some cancers, hospitals with higher volumes and/or teaching-training facilities have statistically lower rates of postoperative mortality and increased rates of survival (both indicators of surgical quality). In the field of oncological surgery, this association is true only of resections for esophageal and pancreatic cancer.
Housri and Koniaris’ focus on both improving the delivery of health care and enhancing the shared decision-making process with patients is commendable. However, one must also consider carefully the broader effects of adding yet another requirement (and potential barrier) to the patient–physician relationship. Housri and Koniaris argue that surgeons have an “ethical obligation to inform patients of hospital outcome disparities for select cancers,” but their proposal faces a number of logistic hurdles. And, to quote Robert Merton, their proposal could have several “unanticipated consequences.” (In his seminal 1936 paper, “The Unanticipated Consequences of Purposive Social Action,” Merton outlined various types of unintended outcomes that may follow an organized, positive, and rational action.
There are a variety of hurdles to Housri and Koniaris’ proposal. For example, it is unclear who exactly should disclose the hospital outcomes data to the patient. Does the burden of disclosure fall upon the surgeon or the hospital? It is also unclear what exactly should be disclosed and which types of hospitals should be compared. For example, should local teaching or high-volume hospitals be compared with local community hospitals, across states, populations, nations, or all three? Given advances in devices, medicine, surgical approaches, and technology, is it possible to compare hospitals or even recent time periods, especially when faced with disease courses that may extend over years? Similarly, it remains unclear how to compare the rates of surgical complications or successful outcomes in patients of variable surgical risk. And there are major hurdles in understanding, computing, and then conveying to the patient the difficult concept that statistics apply to populations but not to an individual.
One possible unintended consequence of mandating that physicians disclose hospital outcomes data is that hospitals or physicians may engage (overtly or subconsciously) in practices that help boost their hospital’s rating. For example, in an effort to maintain good outcomes data, will community hospitals refer high-risk patients to the teaching hospital? Similarly, will surgeons do less radical or less morbid operations that may have little effect on cancer outcome but improve complication rates substantially? And what might happen in the event that a hospital is found to have poor surgical outcomes compared to other hospitals, and yet no specific causative factor is identified by careful audit, and the surgeon’s personal outcomes are better than average? Should the surgeon switch hospitals?
What is most worrisome, when considering unintended consequences, is that most patients do not fully grasp the strengths and limitations of outcomes measures. Indeed, Finlayson and colleagues found that many patients wish, for a variety of reasons and in spite of their physician’s advice, to obtain care at a facility with a worse than average outcome.
Weaknesses in Outcomes Studies
A universal desire among physicians is to enhance and promote a patient’s welfare through improved outcomes. However, at present, outcomes studies remain incomplete for most cancers, frequently lag behind evolving standards of care for many tumors, and remain difficult to apply to the individual. For example, Koniaris and colleagues recently found that in the treatment of breast cancer, teaching hospitals were superior to community hospitals in terms of five-year mortality (p < 0.001) . However, the disparity was only 3%–6% depending upon the type of community hospital, which may not represent a clinically meaningful difference, especially at the level of a single patient. Furthermore, as Pfister and colleagues noted , teaching hospitals tend to enroll more patients on clinical trials. In most of these trials, enrollment criteria require extensive evaluation to exclude metastatic disease, which may use technology available only at specialized centers (for example, PET imaging). In many of these cases, if patients do not qualify for the clinical trial due to previously unsuspected advanced or metastatic disease, they return to their community hospital and may be reported from that hospital, at their original stage, to the registry. This leads to a potential selection bias in favor of teaching hospitals in registries with respect to “initial stage” and overall outcome. Given the potential variety of unpredictable outcomes for a given patient, the time may not yet be ripe to insist upon incorporation of outcomes data into the informed consent process. Efforts should be focused on processes that assist and stimulate physicians to improve patient care and outcomes, and on more incisive studies that determine the individual and organizational actions that lead to positive outcomes, and that can be applied universally. The value of Housri and Koniaris' viewpoint is that it should help stimulate our efforts to continuously seek improvements and refinements in the quality and performance of our care, so as to attain optimal results. David Shalowitz's Viewpoint: More Work Is Needed before Outcomes Data Are Routinely Used in Clinical Decision-Making To what extent do volume–outcomes data matter in patients' decision-making? The National Cancer Policy Board of the Institute of Medicine concluded that “volume per se does not result in good outcomes in health care but is instead a proxy measure for other factors [potentially including] physician skill, experienced interdisciplinary teams, or well-organized care processes”. The volume–outcome relationship is therefore less likely to be valuable to patients selecting a cancer treatment site than the actual outcomes data from potential treating institutions. Put another way, outcomes data from multiple institutions are likely to be important to a patient's selection of a treatment center, but the causes of differences in outcomes, whether case volume, teaching status, or otherwise, are far less likely to matter. How, then, should outcomes data be communicated to patients? There are at least three possible strategies. The first is simply to ensure public access to hospital data, including outcomes data on different medical and surgical procedures, thus allowing the informed patient–consumer to select the best site for treatment. However, despite the current emphasis on patient-centered medicine, we often prefer information critical to patient care to be communicated directly by a physician. A second strategy, therefore, would be for the physician to communicate outcomes data. When a patient has an established relationship with a primary care physician or specialist, outcomes data may be included in the process of determining what treatment course, if any, will be selected and where treatment will take place. For example, Housri and Koniaris note that while some patients may opt for treatment at the institution with the best outcomes, others may base their decision on proximity. The shared decision-making interaction would likely best allow physicians to elicit patients' relevant preferences. However, this strategy would require physicians to obtain and interpret up-to-date outcomes data, which may be difficult and time-consuming. A third option, as proposed by Housri and Koniaris, would be to incorporate outcomes data, where appropriate, into the consent form that the patient signs ahead of a surgical procedure—specifically in the “Risks” and “Alternatives to Treatment” sections of the form. On the one hand, surgeons may be best informed to discuss the relative risks and benefits of having a procedure performed at their institution versus another, and may be best placed to answer patients' questions. On the other hand, consent for a surgical procedure is solicited after the treating institution has been selected, and patients may still have many questions. Revisiting the selection of treatment site may consequently take time away from other important aspects of the consent process. Furthermore, including outcomes data at this point would make surgeons responsible for interpreting other institutions' outcomes data as well as their own, which may be neither possible nor prudent. Despite their best intentions, treating surgeons and institutions would be placed in the somewhat awkward position of determining whether to recommend a patient to another—perhaps competing—institution. This conflict of interest must be avoided whenever possible. Housri and Koniaris' arguments do support a responsibility on the part of surgeons and hospitals to track their own complication rates and disclose these data accurately and understandably in the consent process for procedures. Competent adult patients may then decide whether the benefits and risks are compatible with pursuing the procedure. However, the ethical responsibility of hospitals to discuss other institutions' outcomes is still indeterminate. Selection of treatment site is, at this point, best done as part of a dynamic decision-making process in which all aspects of treatment can be evaluated in the context of the patient's preferences, including the importance of local treatment, differences in outcomes, existing relationships with surgeons, and other intangible considerations. Importantly, Housri and Koniaris have also drawn attention to the content of the “Alternatives to Treatment” section of informed consent documents. This section has traditionally focused on alternative approaches to treatment rather than alternative treating physicians or institutions. However, careful examination of relevant ethical principles and legal precedents may prompt reconsideration of this standard. The role of outcomes data may be important to patients' treatment decision-making, but more work must be done to clarify: (1) patients' desire for outcomes data; (2) the proper arena(s) for communicating such data; and (3) the ethical/legal underpinnings of using outcomes data in treatment decision-making. Only then can discussion of outcomes data be mandated in selection of an institution for surgical care.