September 1, 2007
By Mark Taylor Post-Tribune correspondent
Northwest Indiana hospitals accounted for 14 of the 79 medical errors reported by state hospitals in a first-ever report issued by the Indiana State Department of Health.
"The Indiana Medical Error Reporting System (MERS) Final Report for 2006," partly a national trend to improve healthcare quality and patient safety, was mandated by Gov. Mitch Daniels in 2005.
The 54-page MERS report adopted 27 kinds of medical error standards identified by the National Quality Forum and required Indiana hospitals and ambulatory surgery centers to report errors within those categories.
Those so-called "never events" include operating on the wrong body part; performing the wrong surgery on a patient; leaving foreign objects in patients after surgeries; death or disability because of medication errors, contaminated or misused medical devices, drugs or biologics; and severe pressure ulcers (bedsores) acquired after hospital admissions.
Four acute-care hospitals, a surgical hospital and a long-term care "hospitals within a hospital" reported medical errors in Lake, LaPorte and Porter counties.
The number of medical errors is minimal compared to the total number of surgical procedures performed and patients admitted.
Saint Margaret Mercy Healthcare Centers in Hammond reported four errors, all serious bedsores acquired after admission.
Porter hospital in Valparaiso, also reported four errors: two surgeries on the wrong body part and two bedsores.
The Methodist Hospitals in Gary reported a surgery on the wrong body part; a wrong surgical procedure performed on a patient and a death or serious disability related to a contaminated medical device, drug or biologic.
Heartland Hospital, which was then owned by physicians and was acquired recently by the Sisters of St. Francis Health Services, which owns Saint Margaret's, reported a single incident of leaving a foreign object in the body after a surgery, as did Saint Anthony Memorial Health Centers in Michigan City.
Regency Hospital in East Chicago, a long-term acute care hospital within a hospital at St. Catherine Hospital, reported a single incident of a serious bedsore acquired after admission.
Indiana's largest healthcare system, Indianapolis-based Clarian Health, reported the largest number of medical errors, 15, while Fort Wayne-based Parkview Health reported seven errors.
Officials at the Indiana Hospital & Health Association, Methodist Hospitals, Porter hospital and Regency Hospital of Northwest Indiana could not be reached for comment at deadline.
The report was released Friday afternoon on a holiday weekend.
But Gene Diamond, regional president of the Sisters of Saint Francis Health Services, said Saint Margaret's has adopted programs and protocols to prevent future recurrences of bedsores.
"Those incidents did occur and the hospital has put into place a very elaborate mechanism to address and resolve those issues," Diamond said. "Those patients left the hospital in good condition. We quickly corrected those problems and adopted preventive measures."
State Health Commissioner Judy Monroe said the MERS report is a valuable tool to improve patient safety.
"The data we get from this report will help reduce the frequency of medical errors by revealing causes and identifying statewide trends," Monroe said.
Monday, September 3, 2007
Sunday, September 2, 2007
A Mother’s Letter to a Hospital CEO
Our son died in your hospital 7 days ago. He caught an infection there as a result of his medical care while being treated for something else that put so much pressure on his brain that it caused part of it to be pushed into his spinal column, leaving him a helpless ventilator-dependent quadriplegic and ending his short but unforgettable life among us all.
In the week since his death, the days I live have small worth to me. I am numb now. I bring my husband coffee in the morning but he doesn’t smile or speak when I do; he doesn’t even look at me. He sits, hands in lap, shoulders rounded, wearing a mask of pain that I have never seen before; it is not a face I recognize when he is wearing it. I wish it would go away.
His voice is low and quiet and I am uncomfortable with its somber tone. We speak infrequently lately because it feels like no good words remain for us. Our son is dead. What good thing can be spoken now?
Gentle words that others have for us fall inadequately upon deaf ears. Angry words I rehearse in my head won’t help anything at all; spoken aloud they would change nothing for the better, they just sound mean, even to me. Explanations I seek out and find, full of swaggering, inflated medical terms come far, far - so ridiculously far too late.
Here, now my husband and I sit. We have too many questions and they are all useless. “Why?” is the most impossible one of them all. How I wish he would just stop asking me that. I have no proper answer to comfort him. I am momentarily lost.
So what then? And is it really, “What then?” or should it rather be, “How then?” How then might we prevent this from happening again to anyone, ever?
I wonder.
When our son was ill, I watched your nurses come in and out of his room by the hour and rather than just noticing random women with a regular job to do, I instead saw what angels looked like, masquerading in scrubs with name tags and stethoscopes to complete the disguise, caring for him generously and genuinely with real humanity integrated into their sense and deed of significant duty. I heard endearing compassion in their voices and saw true concern in their eyes that made me want to be like them somehow. Their gestures were warm and their care was competent. To them, my son was their own personal mission. They cared for him well; I would tell anyone – I believe they did their best. I know so.
• I got to know your nurses. They are devastated by our son’s death ... So that it doesn’t happen again, I want you to empower them to save their patients with appropriate procedures and whatever rock-solid rules that they see fit to execute in the name of safer, better healthcare so
they and you, may forego the sadness and futility you all must feel when a patient dies on your shared watch.
• I spoke at length with your doctors who treated my son. I felt their frustration when their prescribed treatment did not work. I heard the disappointment in their voices when they spoke of how they did not succeed with their plan for his recovery; the failure they felt was noticeable. It hurt them to lose a patient ... So it doesn’t happen again, I want you to help your doctors to achieve good, quality care with expected medical outcomes they can be proud of, even if it costs you another $10 per patient or surgical procedure for a preventive measure or device you didn’t want to pay for. In the end, the ounce of prevention costs so little in comparison to the loss of
another life.
• I’ve listened to your administrators who seem ashamed and afraid and go blah, blah, blah, shrinking back at the issue of the death of my son. Shamelessly, instead of offering right words of authenticity and community, I hear cheap words of faked rationalization globbed in paralyzing fear. You do your hospital no good thing to allow them to act in this manner ... So it doesn’t happen again, I want you to teach them to sincerely speak kind, genuine words that suggest shared knowledge of loss. Let them acknowledge fragility; perhaps even responsibility. Do not allow them to suggest that the status quo at your hospital is sufficient when our son is dead from his care. Empower your people to offer hope for a better future of proactive participation with a board of directors willing to improve care on every floor, in every room, for every patient. Demonstrate your honor and regret in appropriate amounts. Leave a significant mark in your community and make a deep imprint of high reputation and of real character that all great men and women do, as you take responsibility for deeds done under your own roof. It’s called stepping
up to the plate.
• I’ve been a patient as well as a caregiver, an advocate and family member. I’ve felt both trusting and helpless; I’ve acted as a participant as well as a bystander. I’ve had times when I was educated with full knowledge of an issue and I have been ignorant in my lacking of medical understanding ... So it doesn’t happen again, I want you to show my family and me how we can
contribute as important members of our own personal medical team so that we all, together with your staff, can effect our own best good, expected outcome. If you are unable to show us how to do that, then identify, invest in and empower those who can and do it as part of your chosen service to the practice of medicine. Respect that we can be capable, thinking, proactive partners in our own medical care instead of unsavvy outsiders who never went to medical school.
Healthcare needs teamwork to work. We need to know how to “Prepare for Care” and we look to you for direction in doing that.
Dear CEO, I hope you read this letter, this PLEA FROM A MOTHER aloud. Tell your board that my husband and I do not want anything for the loss of our dear son but a dramatic and effective plan for change that will make a difference for others who trust healthcare in general and your hospital specifically. We look to you to partner with us as patients and caregivers so that we may all be safe and well, both now, and in the future.
Sincerely,
Victoria Nahum
SAFE CARE CAMPAIGN, INC.
http://www.safecarecampaign.org
770-819-8787 (office) 678-472-9972 (mobile)
vnahum@safecarecampaign.org
We're Not Your Enemy
Reprinted from Patient Safety & Quality Healthcare July / August 2007
An Appeal from a Consumer to
Re-imagine Tort Reform
By Susan S. Sheridan, MIM, MBA, and Martin J. Hatlie, JD
If there is evidence for anything in the medico-legal research, it is that the tort system under-compensates the majority of patients and families who have experienced medical error (Brennan et al., 1991; Localio et al., 1991; Studdert et al., 2006). Yet many professional societies, liability insurers and other organizations that ardently champion evidence-based solutions continue to support a tort reform agenda that, at its core, seeks to reduce the amount of compensation paid to those injured by medical error or systems failure.
True, the evidence also indicates that many litigants are not the victims of reasonably foreseeable and preventable harm (Brennan et al., 1991; Localio et al., 1991; Studdert et al., 2006). Tort reform advocates also argue that many plaintiffs who have valid claims appear to get excessive "lottery ticket" awards from angry juries, although these are often reduced on appeal or in post-trial settlements to much-reduced values. In any case, it is a crude fix to address these concerns with a poorly performing litigation system by imposing monetary caps on damages and limitations on joint liability that apply across the board to meritorious and unfounded claims alike.
If patients and families are under-compensated by the medico-legal system, their damage is born by other social bodies, including the family and government. The social cost of medical error has not been well studied, and we suspect that costs of medical error would be much increased if correlations between medical error and subsequent medical care, lost productivity, depression, divorce, dysfunction, and suicide were more accurately measured. Indeed, a frequent presumption in patient safety advocacy is that initiatives like full disclosure and apology are socially desirable because they deflect malpractice claims. We respectfully suggest that the patient safety research agenda should be expanded to include the impact of medical care on family well being, Medicaid expenditures, and other costs before further efforts to limit compensation to patients are implemented via traditional tort reform.
Tragically, traditional tort reform advocacy pits consumers and providers against each other as if we were enemies. Surely, we can do better than bandaging up a poorly functioning legal dispute resolution system that serves neither of us well and continues to perpetuate a culture of culpability focused on professional negligence. We must do better than that if we are to achieve sustainable cultures in healthcare that are perceived to be just.
We have previously suggested an alternative tort reform agenda that would substitute a reasonable schedule of damages for arbitrary caps, modify or abrogate the National Practitioner Data Bank, and encourage the availability of alternatives to litigation for parties that wanted to use them, among other provisions (Hatlie, 2003). We have developed similar themes in testimony before the U.S. Senate Finance Committee. Our ideas were reiterated in the context of an appeal by Susan Sheridan to attendees of the 2007 National Patient Safety Foundation Congress. That statement is reproduced here:
"Thank you, National Patient Safety Foundation, for your courage to invite me here today and for valuing the contribution of real life experience in the tort system from a plaintiff's point of view.
"One might say that I have witnessed it from the trenches. I have been a plaintiff — twice. The first time we sued because we naively trusted the tort system. The second time, we litigated extremely reluctantly and only because we were given no other choice by the providers who harmed us. I have the desire — and more importantly — the duty to speak with complete candor to you today, not to shock or blame but to illuminate, to teach, and to inspire you as leaders to challenge the long-standing stalemate on tort reform between consumers and providers in this country. The very nature of our tort system polarizes us as enemies. Can we commit to moving our worlds closer together?
"I invite you to join me in envisioning a future where patients and healthcare workers, professional organizations, insurance companies, accreditors, attorneys, judges, and risk managers can combine our hard-won knowledge, our wisdom, and our courage to do what is right. By that I mean recreating and co-creating a tort system that is just.
"My family has experienced two medical errors with devastating impact. One resulted in the death of my husband, Patrick, due to the failure to communicate malignant spinal cancer pathology. This systems error resulted in a delay in treatment for six months and the subsequent penetration of the tumor into his spinal cord. The other error caused the permanent brain damage of our newborn son, Cal, in 1995 from the failure to test and treat his newborn jaundice. His condition is known as kernicterus, and today Cal has cerebral palsy, cannot walk independently, and is hearing and speech impaired. Although his cognitive abilities were spared and he is a smart little boy, he has uncontrollable movements of his body that present enormous challenges every day of his life.
"Unfortunately in media and tort conversations, patients are often characterized as greedy, angry, and eager to sue when medical error occurs. We sued in Cal's case because we faced enormous medical expenses and honestly believed a lawsuit was the path to justice. Cal's life care plan is projected to cost several million dollars, and as parents we had the responsibility to provide for him.
"By the time Pat's injury occurred, we had spent years in litigation over Cal's treatment including a trial that was then on appeal. We made it very clear to the hospital and the surgeon who had treated Pat that we did not want to sue because we had come to believe it was a dishonorable system. Initially we met together and had sincere conversations. We were told to track our out-of-pocket expenses for Pat's treatment and submit them to the hospital. However, we were later told that the surgeon's group and the hospital had different insurance companies, that legal counsel was involved, and that we were NOT to have any communication at all with the hospital or doctor's group. Basically, they were preparing to point the finger at each other and so neither was comfortable with the other talking to us. We were stuck in the middle, and communication came to a screeching halt. After a futile attempt to find legal counsel who would take our case on the condition that we not sue, we filed a lawsuit just before the statute of limitations would have terminated our rights. A four-year litigation process ensued.
"My family has learned from these experiences that the legal system does not serve the needs of many families who have been harmed, and I say that even though in the end many would say we 'won' our malpractice cases. What is justice? As we tried to do what was right for our son, to Pat, and me it meant:
prompt and fair financial compensation,
change in the practices in our healthcare community to assure that the error Cal experiences that was never supposed to happen couldn't happen to another baby, and
honesty, integrity, and honor in the judicial process.
"I think we also hoped that our healthcare providers would hold themselves accountable for what happened to Cal, and make some expression of compassion for our son. Instead, our litigation process in Cal's case took over eight years and included:
two-and-a-half years of discovery,
a seven-week trial, ending in a jury verdict for the defense,
a post-trial motion by the defense seeking to collect $114,000 from Pat and me for their court costs, which would have forced us into bankruptcy,
The judge's decision to reject the verdict as not substantiated by the evidence and order a new trial,
a subsequent appeal of the judge's order by defense,
an Idaho Supreme Court hearing, and subsequent decision upholding the trial judge's order for a new trial,
two more years of discovery,
three extensive mediation sessions,
hundreds of depositions,
hundreds of thousands of dollars in discovery and trial costs, and finally
settlements that amounted to a fraction of the total amount spent in the process.
"During those eight years I secretly pursued every credit card offer I could get my hands on, and got a home equity line to cover the expenses to get Cal and Pat necessary treatments that they needed. During those eight years, Pat died never knowing if his son's case would ever result in justice or if Cal would be financially secure. He also died feeling betrayed by a surgeon who was once his hero, but who disappeared instead of sitting down and talking with us about what had happened to Pat and why.
"Now as a widow and a mom to a disabled little boy and a nine-year-old little girl, I have gained insight into the reality of the tort system that I would never have imagined going into it. What I have learned from my experience and my activity as chair of the World Health Organization's Patients for Patient Safety program, where we work with patients all over the world, and as president of Consumers Advancing Patient Safety, is that medical error is a common phenomenon regardless of geographic location, economic condition, or language. It is also a human phenomenon that is profoundly challenging to us all. But while we acknowledge now that 'to err is human,' sadly when it happens it still is treated in a tragically inhumane manner. Medical errors or systems failures cause tremendous sadness, loss, and life experiences that I would never have imagined as a woman, a wife, or a mom.
"The errors that occurred in my family were unintentional mistakes, and Pat and I knew that. But what happened after the medical errors and how my family was treated through the litigation process was deliberate, calculated to harm us, and by far the most disturbing experience in my life. Initially we trusted the wisdom of the jury, the integrity of healthcare professionals involved as defendants and experts, the lawyers and the long history of our judicial system. Instead we witnessed a system where fairness had shockingly deteriorated; a system that cannot be trusted by patients or doctors alike; and a system that we naively believed would be based on truth, that would contribute to safer care in the future, and that would deliver fair compensation.
"We learned with great alarm and extreme disappointment that litigation is a 'win-at-all-costs blame game,' that it is wildly inconsistent and deviously strategic, and which rarely makes our healthcare system safer. We learned that expert testimony could be bought, that medical records could disappear, and that patients and family members were often pressured to keep quiet in the settlement process. We witnessed a culture of collusion and cover up. We learned that this was a system where patients who file lawsuits are often perversely blamed. In Cal's trial, Pat and I were portrayed as negligent parents, and relatives who were nurses were accused of not living up to their professional oath. Defense experts characterized my son's medical condition as idiopathic and concluded with testimony by a very prestigious physician who, based on a single entry of a headache in my prenatal chart during my last week of pregnancy, stated it was more likely than not that I passed an unspecified viral inflammation to Cal than that he was injured by elevated bilirubin levels that were well documented.
"I also have learned with great pain that the vilification of patients who sue continues after trial. Because we sued, healthcare providers in our hometown refused to treat us in a manner that I was surprised to learn was legal. There is one pediatric neurologist in the state of Idaho, and he informed us by registered letter that he would not treat Cal even in the event of an emergency. When Pat experienced a leakage in spinal fluid while recovering from spinal surgery, we were informed that the hospital where Cal had been injured would not admit him. We were forced to airlift Pat out of state at a cost of $13,000. He needed six stitches, which a resident performed.
"Does our jury system work? Has anyone asked the jurors? We witnessed a system where a jury is given the daunting and impossible task of muddling through dueling expert witness testimony and of determining medical diagnosis. After Cal's trial, I met with some of the jurors who shared their difficulties with being away from families and their jobs. One elderly man slept through much of the trial, one was sick and brought his blankie and pillow, and some said that it was over their head because they weren't medically trained.
"So, what were the biggest lessons learned and opportunities for the future? First, we must do better at ensuring the integrity of expert witnesses. We witnessed a defense strategy infested with expert witnesses willing to offer unscientific and fictional testimony known as junk science either to help a colleague or for handsome fees. One defense expert in Cal's case charged $34,000 for preparation and a half-day of testimony. As the trial judge stated in the memorandum decision accompanying his order to set aside the jury verdict, 'the expert witness testimony was offered for the mere purpose of obscuring the actual circumstances or misleading the court or the jury.' He went on to say, 'I have great difficulty when the expert appears to be straining an opinion to meet the requirement of advocacy. Unfortunately in my experience, this latter spectre occurs far too frequently in medical malpractice cases, where it appears to me that medical witnesses are willing to bend their testimony.' He concluded by observing, 'All of the experts, on both sides, viewed this case as a competition ‚ a verbal jousting match between lawyer and witnesses.' (Sheridan v. Jambura et al., 1999)
"I filed a grievance against the expert witnesses with their professional societies, another eye-opening experience for us. I learned that one national medical specialty society had no grievance mechanism consumers could initiate at all. Another accepted my complaint and conducted a "fair hearing" of the doctor before three of his peers. I was told this was a non-adversarial process, and that I could observe but not say a word. At the same time, the expert being reviewed was allowed to bring counsel, and that counsel was the hospital lawyer who had hired him to offer the suspect testimony in Cal's case. Counsel did not argue the facts about whether or not Cal had kernicterus. Rather, his defense was that our motivation in bringing a grievance was to eliminate the participation of the expert in the new trial that was pending, an allegation I was not permitted to even address. In truth, we knew from the discovery process that the hospital had no plans to call this expert again. One-sided advocacy is not a fair hearing, nor is it non-adversarial. In fact, it's a mockery.
"Expert witness oversight is patchy at best, and apparently extremely one-sided. We have researched the question and cannot find a single reported instance where a professional society has disciplined an expert testifying on behalf of a defendant. This is wrong and needs to be investigated. Is anyone accountable for policing expert witness testimony?
"Let's also look at confidentiality agreements upon settlement, the so-called 'gag clauses' claimants are so often pressured to sign so we cannot speak openly about the case. These are contrary to the call for transparency in medicine, and have the effect of burying learning that could prevent future injuries. Kernicterus cases were so effectively gagged that its re-emergence in the health system was hidden for at least six years. Gag clauses are nothing short of bribes and intimidation. I ask myself often if Cal would have kernicterus now if some of the cases before his injury had been made public before his birth. We must incentivize transparency. Finding a way to declare confidentiality agreements contrary to the public interest is an excellent place to start.
"Third, we must look at the tremendous variation between awards for patients and families with similar needs. I believe this result of the jury system is very troubling. There has been a kernicterus verdict in this country for close to $90 million dollars. We know of another for over $30 million, even though the child lived less than a month after the injury. Cal got a small fraction of that, and I know families who got a fraction of what Cal was awarded. Their children will inevitably become a burden to the Medicaid system, and most, including Cal, already are. Doesn't justice demand equitability? Our case-by-case system does not work that way, and I believe we must commit to creating some other mechanism or guidelines for juries and judges. This fairness gap needs to be addressed.
"As an American citizen, I was taught that our legal system was created for powerful, honorable, reasons. It was designed to be just, and to protect the rights of people who were unfairly harmed. When did it deteriorate into a win-at-all-costs game, where it is permissible for a party to prosecute or defend regardless of the merits of their case? I ask all of you to recognize that we have a common interest in reshaping the tort system.
"To the CEOs, Boards of Trustees members, and other healthcare organization leaders in the audience, I ask you, " Do you know what is happening behind closed doors when there is an event in your hospital that causes harm? Would you instruct your risk manager, your general counsel, or your outside counsel to fight to win every case, regardless of harm? Would you tolerate the use of expert witnesses to mislead the jury? Are you going to insist that patients who have been harmed be silenced by gag clauses? Remember, you are in charge — not your counsel — and you are our trusted leaders. We call to you to lead by example.
"To the leaders of professional societies, I ask you, "Do you really believe that greedy plaintiffs are to blame for the 'malpractice crisis?' In the future can we work together to establish new ways of assuring honest and scientific expert witness testimony?
"To the liability insurers in the audience, I realize that you are a powerful industry. Can we bring the patient perspective and the collective patient wisdom into your world? Can we be your partner? It may be provocative to suggest that we can help you achieve your goals of reduced malpractice payouts, but it is starting to happen already. I know of two medical malpractice companies, Northwest Physicians Mutual Insurance Company and Colorado Physicians Insurance Company, that already have begun implementing new jaundice management protocols to prevent what happened to my son. I hope that your industry will have the courage to use the power you have to invest in prevention.
"To the attorneys in the audience, can we structure a tort system that along with equitable compensation looks at creative resolutions that result in hospital policy changes and new protocols to prevent future harm? In both Cal and Pat's cases, I would not settle without meeting with the CEOs of the hospitals to assure that policy changes had taken place. This was perceived as an unusual request, but it is important to many families who suffer harm. Can we normalize this? Dare we believe that we can work together on this issue and discover common ground that we could nourish and grow together? It is a radical thought, but doable if we so chose.
"For those of you who believe the current tort system works, I ask you to reflect on my comments today. I have seen an underbelly of the tort system close up, and I would not wish that on any one of you. If we are serious about patient safety, we should not tolerate or encourage behaviors that hide lessons learned, convert patients and their providers into enemies, and that reduce trials into jousting matches between exorbitantly paid medical experts. Traditional tort reform, with its reliance on caps on noneconomic damages, remedies none of the concerns I've shared with you today. Caps on damages are not consistent with your compassion for your patients. They are based in fear and they do not drill down to the real problems.
"In closing, I invite you and I challenge you to discard your old beliefs about tort reform and to dismantle the paralyzing gridlock that prevents us all from going forward. I ask you to use your power, courage, and resolve to shape an innovative tort system in partnership with healthcare consumers that marks a return to integrity and honor.
"Remember that people who experience medical errors are not just dollar figures. We are your loved ones. We are you. I appeal to you; please serve the people who are relying on you — daddies like Pat, babies like Cal.
Thank you."
------------------------------------------------------------------------
Susan Sheridan's introduction to safety issues — and her motivation to make a difference — came through grave medical errors, which led to her son's permanent disability from kernicterus in 1995 and her husband's death in 2002 from failure to communicate a diagnosis of cancer. She is co-founder of Parents of Infants and Children with Kernicterus (PICK), a nonprofit devoted to preventing kernicterus and realizing the full potential of people who have it, and co-founder of Consumers Advancing Patient Safety (CAPS), a 501(c)(3) organization dedicated to fostering the role of consumer as proactive partner. She also chairs the Patients for Patient Safety track of the World Alliance for Patient Safety, launched by the World Health Organization (WHO) in 2004. Sheridan is a member of PSQH's Editorial Advisory Board and may be contacted at ssheridan@patientsafety.org.
Martin Hatlie is president of Partnership for Patient Safety (p4ps), a patient-centered initiative dedicated to advancing the reliability of healthcare systems worldwide, and co-editor of The Patient Safety Handbook (Jones & Bartlett 2003). Previously, Hatlie was a lobbyist for the American Medical Association (AMA) focusing on tort reform. In 1997, he coordinated the AMA's launch of the National Patient Safety Foundation and served as its founding executive director, and in 2003, Hatlie co-founded CAPS and serves on its board. He also serves on the Sentinel Event Advisory Group of the Joint Commission on Accreditation of Healthcare Organizations, the Steering Group of the Patients for Patient Safety work strand of the WHO World Alliance for Patient Safety, and the Advisory Board of Parents of Infants and Children with Kernicterus. Formerly, he has served on the governing boards of the Anesthesia Patient Safety Foundation and the American Tort Reform Association. Hatlie is a member of the Editorial Advisory Board for PSQH. Hatlie may be contacted at mhatlie@p4ps.org.
Most Angioplasties Unneeded, Study Finds
Boston Globe
By Marilynn Marchione, AP Medical Writer | March 26, 2007
NEW ORLEANS --More than half a million people a year with chest pain are getting an unnecessary or premature procedure to unclog their arteries because drugs are just as effective, suggests a landmark study that challenges one of the most common practices in heart care.
The stunning results found that angioplasty did not save lives or prevent heart attacks in non-emergency heart patients.
An even bigger surprise: Angioplasty gave only slight and temporary relief from chest pain, the main reason it is done.
"By five years, there was really no significant difference" in symptoms, said Dr. William Boden of Buffalo General Hospital in New York. "Few would have expected such results."
He led the study and gave results Monday at a meeting of the American College of Cardiology. They also were published online by the New England Journal of Medicine and will be in the April 12 issue.
Angioplasty remains the top treatment for people having a heart attack or hospitalized with worsening symptoms. But most angioplasties are done on a non-emergency basis, to relieve chest pain caused by clogged arteries crimping the heart's blood supply.
Those patients now should try drugs first, experts say. If that does not help, they can consider angioplasty or bypass surgery, which unlike angioplasty, does save lives, prevent heart attacks and give lasting chest pain relief.
In the study, only one-third of the people treated with drugs ultimately needed angioplasty or a bypass.
"You are not putting yourself at risk of death or heart attack if you defer," and considering the safety worries about heart stents used to keep arteries open after angioplasty, it may be wise to wait, said Dr. Steven Nissen, a Cleveland Clinic heart specialist and president of the College of Cardiology.
Why did angioplasty not help more?
It fixes only one blockage at a time whereas drugs affect all the arteries, experts said. Also, the clogs treated with angioplasty are not the really dangerous kind.
"Even though it goes against intuition, the blockages that are severe that cause chest pain are less likely to be the source of a heart attack than segments in the artery that are not severely blocked," said Dr. David Maron, a Vanderbilt University cardiologist who helped lead the new study.
Drugs are better today than they used to be, and do a surprisingly good job, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.
"It may not be as bad as we thought" to leave the artery alone, she said.
About 1.2 million angioplasties are done in the United States each year. Through a blood vessel in the groin, doctors snake a tube to a blocked heart artery. A tiny balloon is inflated to flatten the clog and a mesh scaffold stent is usually placed.
The procedure already has lost some popularity because of emerging evidence that popular drug-coated stents can raise the risk of blood clots months later. The new study shifts the argument from which type of stent to use to whether to do the procedure at all.
It involved 2,287 patients throughout the U.S. and Canada who had substantial blockages, typically in two arteries, but were medically stable. They had an average of 10 chest pain episodes a week -- moderately severe. About 40 percent had a prior heart attack.
"We deliberately chose to enroll a sicker, more symptomatic group" to give angioplasty a good chance to prove itself, Boden said.
All were treated with medicines that improve chest pain and heart and artery health such as aspirin, cholesterol-lowering statins, nitrates, ACE inhibitors, beta-blockers and calcium channel blockers. All also were counseled on healthy lifestyles -- diet, exercise and smoking cessation.
Half of the participants also were assigned to get angioplasty.
After an average of 4 1/2 years, the groups had similar rates of death and heart attack: 211 in the angioplasty group and 202 in the medication group -- about 19 percent of each.
Heart-related hospitalization rates were similar, too.
Neither treatment proved better for any subgroups like smokers, diabetics, or older or sicker people.
At the start of the study, 80 percent had chest pain. Three years into it, 72 percent of the angioplasty group was free of this symptom as was 67 percent of the drug group.
That means you would have to give angioplasties to 20 people for every one whose chest pain was better after three years -- an unacceptably high ratio, Nissen said.
After five years, 74 percent of the angioplasty group and 72 percent of the medication group were free of chest pain - "no significant difference," Boden said.
The study was funded by the U.S. Department of Veterans Affairs, the Medical Research Council of Canada and a host of drug companies. Stent makers refused to help pay for the research, said scientists who led the study.
The study renewed a heated animosity between doctors who perform angioplasty and other heart specialists.
In fact, one who does the procedures and who spoke at a meeting in New Orleans sponsored by stent maker Boston Scientific Corp. was responsible for the early release of the study's results, which were not due out until Tuesday.
The study "was rigged to fail, and it did," the Wall Street Journal quoted Dr. Martin B. Leon of Columbia University telling several hundred of his colleagues Sunday night.
"A lot of people have been taking shots at us, and we need to go on the offense for awhile," the Journal reported Leon said.
He claimed to have inside knowledge of the results because he reviewed the study for the New England Journal. The journal would not comment, saying the identity of its reviewers is confidential.
The cardiology college issued a statement saying it was "extremely disappointed" results were released prematurely, "betraying the confidentiality of the scholarly process and the professional integrity of the scientific community."
The college "will be considering strong sanctions against the individual or individuals involved," the statement said.
Boston Scientific shares fell $1.05, or 6.6 percent, to close at $14.22 on the New York Stock Exchange at double their average volume.
Dr. Spencer King of Piedmont Hospital in Atlanta, a leading cardiologist who does many angioplasties, said he was disappointed in the study results.
"How many patients have interventions in which the only expectation is to reduce the use of nitroglycerin or to walk a bit faster? Most patients anticipate a better prognosis and might opt for an extended course of medical therapy if they believe they are not putting their life at excess risk," he wrote in a recent editorial in an American Heart Association journal.
In an interview at the cardiology meeting, King said he recently had surgery for back pain and did not expect permanent relief but added, "If it only held up for five years, I wouldn't be happy about it."
The new study "should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial health care savings," Dr. Judith Hochman of New York University wrote in an editorial in the journal.
An angioplasty costs roughly $40,000. The drugs used in the study are almost all available in generic form.
Maron, the Vanderbilt doctor who helped lead the study, said people should give the drugs a chance.
"Often I think that patients are under the impression that unless they have that procedure done, they're not getting the best of care and are at increased risk of having a heart attack and die," he said.
Dr. Raymond Gibbons, a Mayo Clinic cardiologist and American Heart Association president, agreed: "This trial shows convincingly that that assumption is incorrect."
By Marilynn Marchione, AP Medical Writer | March 26, 2007
NEW ORLEANS --More than half a million people a year with chest pain are getting an unnecessary or premature procedure to unclog their arteries because drugs are just as effective, suggests a landmark study that challenges one of the most common practices in heart care.
The stunning results found that angioplasty did not save lives or prevent heart attacks in non-emergency heart patients.
An even bigger surprise: Angioplasty gave only slight and temporary relief from chest pain, the main reason it is done.
"By five years, there was really no significant difference" in symptoms, said Dr. William Boden of Buffalo General Hospital in New York. "Few would have expected such results."
He led the study and gave results Monday at a meeting of the American College of Cardiology. They also were published online by the New England Journal of Medicine and will be in the April 12 issue.
Angioplasty remains the top treatment for people having a heart attack or hospitalized with worsening symptoms. But most angioplasties are done on a non-emergency basis, to relieve chest pain caused by clogged arteries crimping the heart's blood supply.
Those patients now should try drugs first, experts say. If that does not help, they can consider angioplasty or bypass surgery, which unlike angioplasty, does save lives, prevent heart attacks and give lasting chest pain relief.
In the study, only one-third of the people treated with drugs ultimately needed angioplasty or a bypass.
"You are not putting yourself at risk of death or heart attack if you defer," and considering the safety worries about heart stents used to keep arteries open after angioplasty, it may be wise to wait, said Dr. Steven Nissen, a Cleveland Clinic heart specialist and president of the College of Cardiology.
Why did angioplasty not help more?
It fixes only one blockage at a time whereas drugs affect all the arteries, experts said. Also, the clogs treated with angioplasty are not the really dangerous kind.
"Even though it goes against intuition, the blockages that are severe that cause chest pain are less likely to be the source of a heart attack than segments in the artery that are not severely blocked," said Dr. David Maron, a Vanderbilt University cardiologist who helped lead the new study.
Drugs are better today than they used to be, and do a surprisingly good job, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.
"It may not be as bad as we thought" to leave the artery alone, she said.
About 1.2 million angioplasties are done in the United States each year. Through a blood vessel in the groin, doctors snake a tube to a blocked heart artery. A tiny balloon is inflated to flatten the clog and a mesh scaffold stent is usually placed.
The procedure already has lost some popularity because of emerging evidence that popular drug-coated stents can raise the risk of blood clots months later. The new study shifts the argument from which type of stent to use to whether to do the procedure at all.
It involved 2,287 patients throughout the U.S. and Canada who had substantial blockages, typically in two arteries, but were medically stable. They had an average of 10 chest pain episodes a week -- moderately severe. About 40 percent had a prior heart attack.
"We deliberately chose to enroll a sicker, more symptomatic group" to give angioplasty a good chance to prove itself, Boden said.
All were treated with medicines that improve chest pain and heart and artery health such as aspirin, cholesterol-lowering statins, nitrates, ACE inhibitors, beta-blockers and calcium channel blockers. All also were counseled on healthy lifestyles -- diet, exercise and smoking cessation.
Half of the participants also were assigned to get angioplasty.
After an average of 4 1/2 years, the groups had similar rates of death and heart attack: 211 in the angioplasty group and 202 in the medication group -- about 19 percent of each.
Heart-related hospitalization rates were similar, too.
Neither treatment proved better for any subgroups like smokers, diabetics, or older or sicker people.
At the start of the study, 80 percent had chest pain. Three years into it, 72 percent of the angioplasty group was free of this symptom as was 67 percent of the drug group.
That means you would have to give angioplasties to 20 people for every one whose chest pain was better after three years -- an unacceptably high ratio, Nissen said.
After five years, 74 percent of the angioplasty group and 72 percent of the medication group were free of chest pain - "no significant difference," Boden said.
The study was funded by the U.S. Department of Veterans Affairs, the Medical Research Council of Canada and a host of drug companies. Stent makers refused to help pay for the research, said scientists who led the study.
The study renewed a heated animosity between doctors who perform angioplasty and other heart specialists.
In fact, one who does the procedures and who spoke at a meeting in New Orleans sponsored by stent maker Boston Scientific Corp. was responsible for the early release of the study's results, which were not due out until Tuesday.
The study "was rigged to fail, and it did," the Wall Street Journal quoted Dr. Martin B. Leon of Columbia University telling several hundred of his colleagues Sunday night.
"A lot of people have been taking shots at us, and we need to go on the offense for awhile," the Journal reported Leon said.
He claimed to have inside knowledge of the results because he reviewed the study for the New England Journal. The journal would not comment, saying the identity of its reviewers is confidential.
The cardiology college issued a statement saying it was "extremely disappointed" results were released prematurely, "betraying the confidentiality of the scholarly process and the professional integrity of the scientific community."
The college "will be considering strong sanctions against the individual or individuals involved," the statement said.
Boston Scientific shares fell $1.05, or 6.6 percent, to close at $14.22 on the New York Stock Exchange at double their average volume.
Dr. Spencer King of Piedmont Hospital in Atlanta, a leading cardiologist who does many angioplasties, said he was disappointed in the study results.
"How many patients have interventions in which the only expectation is to reduce the use of nitroglycerin or to walk a bit faster? Most patients anticipate a better prognosis and might opt for an extended course of medical therapy if they believe they are not putting their life at excess risk," he wrote in a recent editorial in an American Heart Association journal.
In an interview at the cardiology meeting, King said he recently had surgery for back pain and did not expect permanent relief but added, "If it only held up for five years, I wouldn't be happy about it."
The new study "should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial health care savings," Dr. Judith Hochman of New York University wrote in an editorial in the journal.
An angioplasty costs roughly $40,000. The drugs used in the study are almost all available in generic form.
Maron, the Vanderbilt doctor who helped lead the study, said people should give the drugs a chance.
"Often I think that patients are under the impression that unless they have that procedure done, they're not getting the best of care and are at increased risk of having a heart attack and die," he said.
Dr. Raymond Gibbons, a Mayo Clinic cardiologist and American Heart Association president, agreed: "This trial shows convincingly that that assumption is incorrect."
Larry Smith Has Had Enough
DENVER – Smith plans to take his medical records and his medical payments from Medicare and insurance for his on-going care to a doctor that supports universal health care. No more feeding the beast of for-profit medical groups determined to push more patients – and therefore more revenue – through the door every hour rather than offer the level of care being paid for by millions of Americans.
“No more apologizing for getting sick after a lifetime of working and paying for health insurance only to watch everything be lost in an instant to high premiums, deductibles, co-pays and out-of-pocket costs -- and then still have doctor groups deny my care because I cannot pay them more. My father always said you can’t get blood out of a turnip, but in this system, my father has been proven wrong,” Smith said.
As a patient of numerous specialty groups and specialists over the past 20 years, Larry has seen the system which benefited wildly from his business as a patient morph into one in which he must now beg for adequate care. The 63-year-old Denver man is taking the first steps aimed at organizing his fellow patients to demand the quality of care for which they are paying and to demand meaningful health care reform.
Smith is walking away from the largest cardiology practice in his area – and the same practice that treated his father all the way through a heart transplant, death and income in the hundreds of thousands of dollars from Smith family insurance and savings – and Larry is transferring his care to a Denver cardiologist that supports universal health care.
“Ask your doctor if they support universal health care,” Larry said. “Look around that waiting room at the signage. If the first thing you see is the reminder that payment is expected BEFORE your doctor’s visit, consider checking out this group a bit more before you turn over your life or the life of someone you love to them. What assurances have they given to you about your satisfaction or your well-being based on pre-payment for service?”
Additionally, Smith urges physicians and providers who are serious about supporting universal health care to prominently post that support where patients can note that philosophy. “Does your physician value every human life? Or does your doctor value only those with the right coverage or checking account balance or credit rating? The answer fundamentally changes your focus and your doctor’s focus. You have a right to know these things before the doctor lays a hand on you or someone you love.”
Smith adds that if the doctor’s primary goal is to help him feel better and get well, that is to be rewarded with his business as a patient.
“I have no objection to my doctor earning money – even very good money – for good performance. But right now, the system rewards my doctor for keeping me sick and in need of more tests and more referrals and more follow-up appointments and more spending. The focus is not on my health but on his wealth.”
Smith will also ask the national organization Physicians for a National Health Program to encourage its physician-members to post their membership status for all patients and patient families to see.
At the end of September in Washington, D.C., Larry will formally launch his patients’ union organizing efforts following a vigil on the steps of the Lincoln Memorial at sundown on Friday, Sept. 28. The vigil is in memory of Tracy Pierce, a young Kansas City area husband and father who died after his insurance company denied him treatment, and the vigil also honors those still fighting for care now.
Several of the people who appear in Michael Moore’s film, SiCKO, are attending the vigil, including Tracy’s widow Julie Pierce, Adrian Campbell, Dr. Linda Peeno, Dawnelle Keys – along with Larry and Donna Smith. They have recently organized a patient advocacy group, American Patients for Universal Health Care, apuhc.com.
Patients who wish to reach Larry or Donna Smith to find out more about how to find doctors and providers who support universal health care may contact them through the apuhc.com website.
“No more apologizing for getting sick after a lifetime of working and paying for health insurance only to watch everything be lost in an instant to high premiums, deductibles, co-pays and out-of-pocket costs -- and then still have doctor groups deny my care because I cannot pay them more. My father always said you can’t get blood out of a turnip, but in this system, my father has been proven wrong,” Smith said.
As a patient of numerous specialty groups and specialists over the past 20 years, Larry has seen the system which benefited wildly from his business as a patient morph into one in which he must now beg for adequate care. The 63-year-old Denver man is taking the first steps aimed at organizing his fellow patients to demand the quality of care for which they are paying and to demand meaningful health care reform.
Smith is walking away from the largest cardiology practice in his area – and the same practice that treated his father all the way through a heart transplant, death and income in the hundreds of thousands of dollars from Smith family insurance and savings – and Larry is transferring his care to a Denver cardiologist that supports universal health care.
“Ask your doctor if they support universal health care,” Larry said. “Look around that waiting room at the signage. If the first thing you see is the reminder that payment is expected BEFORE your doctor’s visit, consider checking out this group a bit more before you turn over your life or the life of someone you love to them. What assurances have they given to you about your satisfaction or your well-being based on pre-payment for service?”
Additionally, Smith urges physicians and providers who are serious about supporting universal health care to prominently post that support where patients can note that philosophy. “Does your physician value every human life? Or does your doctor value only those with the right coverage or checking account balance or credit rating? The answer fundamentally changes your focus and your doctor’s focus. You have a right to know these things before the doctor lays a hand on you or someone you love.”
Smith adds that if the doctor’s primary goal is to help him feel better and get well, that is to be rewarded with his business as a patient.
“I have no objection to my doctor earning money – even very good money – for good performance. But right now, the system rewards my doctor for keeping me sick and in need of more tests and more referrals and more follow-up appointments and more spending. The focus is not on my health but on his wealth.”
Smith will also ask the national organization Physicians for a National Health Program to encourage its physician-members to post their membership status for all patients and patient families to see.
At the end of September in Washington, D.C., Larry will formally launch his patients’ union organizing efforts following a vigil on the steps of the Lincoln Memorial at sundown on Friday, Sept. 28. The vigil is in memory of Tracy Pierce, a young Kansas City area husband and father who died after his insurance company denied him treatment, and the vigil also honors those still fighting for care now.
Several of the people who appear in Michael Moore’s film, SiCKO, are attending the vigil, including Tracy’s widow Julie Pierce, Adrian Campbell, Dr. Linda Peeno, Dawnelle Keys – along with Larry and Donna Smith. They have recently organized a patient advocacy group, American Patients for Universal Health Care, apuhc.com.
Patients who wish to reach Larry or Donna Smith to find out more about how to find doctors and providers who support universal health care may contact them through the apuhc.com website.
N.Y. Hospitals Among Worst for Errors
By James T. Mulder, Staff writer
New York ranks as one of the worst states in the nation for hospital patient safety, according to a study released today that found high rates of medical errors at hospitals here.
New Jersey was the only state that fared worse in the study by HealthGrades, which analyzed the prevalence of patient safety incidents at every U.S. hospital.
The risk of experiencing one or more of 13 patient safety incidents, such as post-surgical infections, was nearly 24 percent higher in New York than in Minnesota, the top-ranked state, according to the study.
Medical errors continue to be a leading cause of death and injury nationwide and hospitals are not moving fast enough to improve patient safety, according to the study. "Progress is too slow and should be cause for great alarm," it said.
The study is based on an analysis of Medicare patients at nearly 5,000 hospitals nationwide from 2002 through 2004. HealthGrades used 13 patient safety indicators developed by the federal government to evaluate hospital admissions. HealthGrades is a publicly traded company that rates hospitals, nursing homes and doctors, and sells its ratings reports to the public.
William VanSlyke, speaking for the Healthcare Association of New York, which represents hospitals, called the report "misleading."
He said New York reports hospital patient safety incidents more aggressively than other states, which could be why it ranks so low in the study. He also questioned the accuracy of the report because it is based on data culled from billing information, not clinical data.
VanSlyke said his group will closely analyze the report to determine if there are patient care issues that need to be addressed.
Art Levin of the Center for Medical Consumers in New York City was surprised by the findings and said the study should be taken seriously.
"Hospital reputations tend to be built on superstar physicians and superstar departments, and it's not based on empirical evidence," he said. "This study tells us maybe that's not the way to do it."
Levin said the state Health Department should be using the same data to compare patient safety performance of New York hospitals.
The study did not explain why New York performed so poorly. "Significant state-to-state variations in overall patient safety indicator performance exist," it said. "The gap between the best possible care and actual care remains large."
Minnesota, Wisconsin, Iowa, Michigan and Kansas ranked as the best states for patient safety.
Joining New Jersey and New York at the bottom of the list are Nevada, Tennessee and the District of Columbia.
In the study, HealthGrades identified 238 U.S. hospitals with the best patient safety records. Only one New York hospital made the list - St. Peter's Hospital, in Albany.
The most prevalent patient safety incidents nationwide were: failure to save a patient's life who has acquired a complication in the hospital ("failure to rescue"), bedsores and bloodstream infections.
New York had 162.8 failure-to-rescue incidents per 1,000 patients between 2002 and 2004. Only Hawaii had more - 175.3 incidents per 1,000 patients. By comparison, Minnesota had 95.8 failure-to-rescue incidents per 1,000 patients.
The prevalence of bedsores in New York was 46.3 per 1,000 patients, the highest of any state. That rate was nearly three times higher than Minnesota's.
New York had 11.6 bloodstream infections per 1,000 patients compared to 6.9 per 1,000 in Minnesota.
Between 2002 and 2004, about one in four hospitalized Medicare patients who experienced a patient safety incident died, according to the study. About 82 percent of those deaths were potentially preventable, the study said.
The complete report can be found at www.healthgrades.com.
You can contact James T. Mulder at 470-2245 or jmulder@syracuse.com.
Read the Healthgrades report at http://www.healthgrades.com/media/dms/pdf/PatientSafetyInAmericanHospitalsStudy2006.pdf
New York ranks as one of the worst states in the nation for hospital patient safety, according to a study released today that found high rates of medical errors at hospitals here.
New Jersey was the only state that fared worse in the study by HealthGrades, which analyzed the prevalence of patient safety incidents at every U.S. hospital.
The risk of experiencing one or more of 13 patient safety incidents, such as post-surgical infections, was nearly 24 percent higher in New York than in Minnesota, the top-ranked state, according to the study.
Medical errors continue to be a leading cause of death and injury nationwide and hospitals are not moving fast enough to improve patient safety, according to the study. "Progress is too slow and should be cause for great alarm," it said.
The study is based on an analysis of Medicare patients at nearly 5,000 hospitals nationwide from 2002 through 2004. HealthGrades used 13 patient safety indicators developed by the federal government to evaluate hospital admissions. HealthGrades is a publicly traded company that rates hospitals, nursing homes and doctors, and sells its ratings reports to the public.
William VanSlyke, speaking for the Healthcare Association of New York, which represents hospitals, called the report "misleading."
He said New York reports hospital patient safety incidents more aggressively than other states, which could be why it ranks so low in the study. He also questioned the accuracy of the report because it is based on data culled from billing information, not clinical data.
VanSlyke said his group will closely analyze the report to determine if there are patient care issues that need to be addressed.
Art Levin of the Center for Medical Consumers in New York City was surprised by the findings and said the study should be taken seriously.
"Hospital reputations tend to be built on superstar physicians and superstar departments, and it's not based on empirical evidence," he said. "This study tells us maybe that's not the way to do it."
Levin said the state Health Department should be using the same data to compare patient safety performance of New York hospitals.
The study did not explain why New York performed so poorly. "Significant state-to-state variations in overall patient safety indicator performance exist," it said. "The gap between the best possible care and actual care remains large."
Minnesota, Wisconsin, Iowa, Michigan and Kansas ranked as the best states for patient safety.
Joining New Jersey and New York at the bottom of the list are Nevada, Tennessee and the District of Columbia.
In the study, HealthGrades identified 238 U.S. hospitals with the best patient safety records. Only one New York hospital made the list - St. Peter's Hospital, in Albany.
The most prevalent patient safety incidents nationwide were: failure to save a patient's life who has acquired a complication in the hospital ("failure to rescue"), bedsores and bloodstream infections.
New York had 162.8 failure-to-rescue incidents per 1,000 patients between 2002 and 2004. Only Hawaii had more - 175.3 incidents per 1,000 patients. By comparison, Minnesota had 95.8 failure-to-rescue incidents per 1,000 patients.
The prevalence of bedsores in New York was 46.3 per 1,000 patients, the highest of any state. That rate was nearly three times higher than Minnesota's.
New York had 11.6 bloodstream infections per 1,000 patients compared to 6.9 per 1,000 in Minnesota.
Between 2002 and 2004, about one in four hospitalized Medicare patients who experienced a patient safety incident died, according to the study. About 82 percent of those deaths were potentially preventable, the study said.
The complete report can be found at www.healthgrades.com.
You can contact James T. Mulder at 470-2245 or jmulder@syracuse.com.
Read the Healthgrades report at http://www.healthgrades.com/media/dms/pdf/PatientSafetyInAmericanHospitalsStudy2006.pdf
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