The lede:

A patient safety project that helped more than 100 Michigan hospital intensive care units cut their average catheter-related bloodstream infection rate by 66% can start collecting outcomes data again. That was the ruling last month from the Dept. of Health and Human Services’ Office for Human Research Protections.

The move was viewed widely as a reversal of OHRP’s controversial decision last fall to order the hospitals to suspend data collection. OHRP acted then because researchers had misclassified the project as being exempt from federal human research subject regulations and did not obtain informed consent from ICU patients.

More broadly, the decision seemed to signal a new willingness by the agency to re-evaluate whether rules designed to protect patients involved in high-risk biomedical experiments should also be applied to minimal-risk, evidence-based quality improvement research activities.

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Hospitals that do fewer than 14 heart transplants a year see significantly more patients die within 30 days than do higher-volume transplant centers, according to a study of United Network for Organ Sharing data.

Researchers argued that physicians and policymakers should steer patients toward high-volume transplant centers to get better outcomes.

But other experts said transplant volume is not the only factor that should be considered when aiming for quality.

“This is not a new concept,” said study co-investigator John V. Conte, MD, director of heart and lung transplantation at Johns Hopkins Hospital in Baltimore, which handles 20 to 30 heart transplants annually. “The evidence shows that the more you do of any complex procedure, the better that people are going to be at it.”

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Twenty-one states have mandated hospital infection reporting in the last four years, and 221 health care quality report cards are listed on a Health and Human Services Web site.

Last month alone saw new quality reports released in New Jersey, Minnesota and the Seattle area.

The premise behind this wave of public reporting is that transparency will spur doctors and hospitals to improve quality and safety while giving patients valuable data to help them decide where to seek care. The concept has widespread
acceptance, yet it is also largely untested and unproven.

Since 1986, 45 studies have examined the impact of public reports on quality and safety. But while such reports appear to stimulate quality activity in hospitals, there is little evidence to show they improve the effectiveness, safety or patient-centeredness of care. They also can have unintended consequences, such as discouraging doctors from treating sicker patients.

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Buried in clinical guidelines and buffeted by the latest published research findings, what’s a physician to do when faced with a patient and a 15-minute treatment window? Begin to sort through the conflicting guidelines or analyze the latest research studies?

A Jan. 24 Institute of Medicine report suggests a way to bring order from the chaos that surrounds conflicting clinical guidelines and questions about how to choose the best available diagnostic, treatment or preventive service — but Congress would have to create a federal program to make it happen.

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The Washington, D.C., city council last month became the first legislative body in the nation to approve the licensing of drug reps. At press time, the bill was awaiting the signature of Mayor Adrian M. Fenty, who supports the legislation.

The measure, dubbed SafeRx, would require detailers to pay a licensure fee, adhere to an ethics code, receive continuing education and refrain from misleading doctors about drugs. Sales reps could be fined up to $10,000 for operating without a license.

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The lede:

More than 100 Michigan intensive-care units cut their average catheter-related bloodstream infection rate 66% by implementing a simple checklist of proven infection-control practices such as hand washing and removing unnecessary catheters.

But the Dept. of Health and Human Services’ Office for Human Research Protections last fall ordered the hospitals to suspend collecting data documenting the research project’s success because researchers did not properly comply with federal regulations aimed at safeguarding patients.

Now each participating hospital must seek institutional review board approval for the project, which was organized by the Johns Hopkins University School of Medicine in Baltimore and whose results were published in the Dec. 28, 2006, New England Journal of Medicine.

The study already has been cited more than 20 times in other medical journals, with experts in one patient safety publication dubbing it an “instant classic.” The safety effort reduced the median infection rate to zero per 1,000 catheter days, compared with national rates as high as 5.2 per 1,000 catheter days.

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Since their rise more than three decades ago, hospital ethics committees have sought to help physicians, patients and their families resolve ethical disagreements and navigate the treacherous terrain that so often accompanies medical care at the end of life.

The role of these committees was cemented in 1992 when the Joint Commission mandated that health care organizations come up with some way of addressing ethical concerns. Ninety-five percent of general hospitals surveyed in 1999 and 2000 offered ethics consultation or were starting up a consult service.

Yet at the median, these services handled only three cases in the previous year, according to the survey of more than 500 general hospitals whose results were published in February 2007 in The American Journal of Bioethics.

The use of ethics consultation services varies widely from hospital to hospital, but physician experts and ethicists agree that they frequently are underused. That leads, they say, to increased medical costs and ugly disputes among physicians, patients and families.

Physicians’ reluctance to seek aid when dilemmas arise is partly grounded in the notion that a call for help is equivalent to hauling in the “ethics police.” But the problem, experts say, goes far deeper.

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Nearly half of physicians use placebos in clinical care, and only 4% tell their patients the truth about it, according to a survey of Chicago academic physicians that was published this month in the Journal of General Internal Medicine.

Only 8% of the 231 physicians surveyed used placebos more than 10 times during the last year, but experts were alarmed by doctors’ self-reported, less-than-straightforward conversations with patients about placebos.

The study is troubling because deceptive use of placebos is “inconsistent with what we now understand as the rights of patients to decide on treatment in a knowledgeable way and the duties of physicians to disclose to patients the treatments that they are providing,” said Paul S. Appelbaum, MD, director of the
division of psychiatry, law and ethics in the psychiatry department of Columbia University College of Surgeons.

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Nearly 100,000 Americans are waiting for an organ transplant. Every day, the wait for 17 of those people ends in death.

It is a wait that could be drastically shortened or even eliminated if a market for live and cadaveric organs were allowed to operate, according to a paper co-authored by Nobel Prize-winning economist Gary S. Becker, PhD, and published last year in the Journal of Economic Perspectives.

The study comes on the heels of what observers say is slow but steady progress in breaking down opposition to testing the idea of financial incentives in an effort to combat an organ shortage growing by 5% each year. But resistance among many in the transplant community is still fierce, as other efforts such as paired donation exchanges begin to take off.

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A recent American College of Obstetricians and Gynecologists’ position statement outlining the limits of conscientious refusal in reproductive medicine is drawing fire from physicians who oppose abortion.

The ACOG Committee on Ethics opinion says doctors whose personal beliefs may require them to “deviate from standard practices” such as providing abortion, sterilization or contraceptives should:

• Give patients prior notice of their moral commitments and provide accurate and unbiased information about reproductive services.
• Refer patients in a timely manner to another doctor who can provide the requested service.
• Provide medically indicated services in an emergency when referral is impossible or might affect a patient’s physical or emotional health.
• Practice close to physicians who will provide legal services or ensure that referral processes are in place so that patient access is not impeded.

The opinion, published in November 2007, comes in response to heated debate over some pharmacists’ refusal to fill patient prescriptions for Plan B, known as the morning-after pill. The Food and Drug Administration in September 2006 approved Plan B for over-the-counter status, but the debate over the right to refuse certain procedures or medication has not disappeared.

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The movement to align patient safety and payment seems to be picking up a full head of steam. Hospitals and payers are coalescing around the idea that no one should get paid for so-called never events — serious reportable events, such as wrong-site surgery, that kill or maim patients.

Perhaps most significantly, the BlueCross BlueShield Assn. announced in November 2007 that its plans will work toward ending payment for never events. The change will be phased in over several years as the Blues alters its coding and claims processes. A spokesman said adoption will vary among the 39 Blues plans, which insure more than 100 million people, because the change requires renegotiating contracts and securing agreements from local physicians and hospitals.

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A recent study estimates that between 1.5% and 2% of all cancers can be attributed to radiation from the 62 million computed tomography scans Americans get each year. The finding comes on the heels of earlier, similar risk estimates, and it has some experts saying physicians should think twice about ordering the test.

The review article in the Nov. 29, 2007, New England Journal of Medicine arrives at its estimate by examining the cancer effects on the 25,000 Japanese who survived the 1945 atomic bombs and received radiation doses equivalent to the x-rays emitted by several CT scans.

The authors, David J. Brenner, PhD, and Eric J. Hall, PhD, are professors at the Columbia University Center for Radiological Research and have studied the cancer-causing effects of imaging for years. They write that the evidence of cancer risk from CTs is “reasonably convincing” for adults and “very convincing for children.”

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Doctors agree on the basic tenets of medical professionalism, but they frequently fail to live up to those ideals in practice, according to a survey of more than 1,600 physicians in the Dec. 4 Annals of Internal Medicine.

Nearly all of the physicians surveyed agreed doctors should use medical resources appropriately, tell patients the truth, minimize disparities, see patients regardless of their ability to pay, maintain board certifications, evaluate peers’ care, avoid sex with patients, work on quality initiatives, disclose conflicts of interest, report impaired or incompetent physicians, and report medical errors.

But more than half of doctors told investigators that they failed to report a serious medical error they observed, or a colleague who was impaired or incompetent, to authorities in the last three years. And more than a third of the doctors said they would order an unnecessary magnetic resonance imaging scan to mollify an insistent patient.

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