Monthly Archives: July 2017

Behavioral Changes Effective for Most T2D Patients

But some patients in LOOK Ahead fared worse with intervention
by Kristen Monaco, Contributing Writer, MedPage Today July 17, 2017

Action Points
• Among a majority of patients with type 2 diabetes, intensive weight loss intervention reduced the risk of adverse cardiovascular outcomes.
• Note that 14% of the study participants reported significantly worse outcomes following such intensive lifestyle intervention.

Among a majority of patients with type 2 diabetes, intensive weight loss intervention reduced the risk of adverse cardiovascular outcomes, a post hoc analysis of the Look AHEAD (Action for Health in Diabetes) trial found.
In the study, led by Aaron Baum, PhD, lead economist at the Arnhold Institute for Global Health in New York City, and colleagues, 86% of the overall population (n=2,101 of 2,451) reduced the risk of composite cardiovascular outcomes via intensive lifestyle modification — 167 (16%) of 1,046 primary outcome events for intervention versus 205 (19%) of 1,055 for control; absolute risk reduction 3.46%, 95% CI 0.21-6.73%, P=0.038. This group included those with any HbA1c levels and self-reported good general health.
The findings were published online in The Lancet Diabetes & Endocrinology.
However, 14% of the study participants (n=350 of 2,451) reported significantly worse outcomes following such intensive lifestyle intervention (27 [16%] of 171 primary outcomes events for intervention versus 15 [8%] of 179 primary outcomes events for control; absolute risk increase 7.41%, 0.60-14.22, P=0.003). These patients were identified as having well-controlled diabetes at baseline (A1c <6.8%) and poor self-reported general health.
“We were surprised to find that weight loss interventions may not be beneficial for all patients,” Baum, who is also affiliated with the Icahn School of Medicine at Mount Sinai, told MedPage Today. “The intervention seems to lower the risk of cardiovascular events and mortality for the majority of patients, but it may have had a negative impact on a small subgroup patients, thus rendering the overall average effect neutral.”
The original analysis of the 2013 Look AHEAD trial, published in the New England Journal of Medicine, was stopped early after a median follow-up of nearly a decade due to the lack of significant findings between the primary outcomes of long-term cardiovascular disease morbidity and mortality with intensive weight loss intervention among people with type 2 diabetes.
The multicenter trial included 5,145 overweight or obese individuals with type 2 diabetes, who were randomized to undergo intensive lifestyle intervention, marked by diet and exercise to attain at least a 7% total weight loss, or a control group, which included diabetes education and support.
In the current analysis, Baum’s group used new machine learning techniques to re-address the original data by implementing a causal forest analysis, designed to identify heterogeneous treatment effects.
Baum said that after attending a talk on new machine learning techniques aimed at causal inference problems, Baum said, “it struck me that the newer [machine learning] methods would be well suited for increasing the quantity of knowledge we can learn from the clinical trial data we already have,” and that this new type of model was particularly well suited to analyze health disparities.
“From a technical point of view, the method was attractive, because it learns from half of the data — in this case, looking for combinations of characteristics of the patients who benefited the most from the weight loss intervention, and uses the rest of the data to test those hypotheses and look for complex interactions in the data, thus avoiding multiple hypothesis testing or p-hacking,” he added.
A total of 4,901 participants from the original trial were included and randomized into the training set (n=2,450) to identify the factors via the causal forest model, or to a testing set (n=2,451) used to validate the findings. Baum’s group employed the same primary outcome definition of composite cardiovascular (CV)-outcome: first occurrence of death from CV-causes, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for angina.
The causal forest analysis divided the testing set into subgroups based upon baseline HbA1c measures (A1c<6.8%: well-controlled; ≥6.8%: moderately or poorly controlled), and general health self-reported with the Short Form-36 survey (score≥48: good health; <48: poor). Self-reported mental health was also assessed using the SF-36 with a mental component summary.
In an accompanying editorial, Edward W. Gregg, PhD, of the Centers for Disease Control and Prevention, and Rena Wing, PhD, of Alpert Medical School of Brown University in Providence, R.I., called the study’s method a “novel approach to assessing such heterogeneity,” noting, however, that the findings are difficult to interpret.
Gregg and Wing suggested that good self-reported health may be indicative of improved lifestyle intervention adherence, thus rendering improved outcomes, although “the lack of any significant difference between these subgroups in compliance or metabolic risk factors in the supplemental analyses leaves this explanation unsatisfying.” Instead, the editorial posed the idea that it may be “simply a chance finding” in regard to the perplexing 14% of those in the study who had worse CV-outcomes with intervention.
“Computer science methods for causal inference will continue to improve,” Baum added. “We are working on applying them to targeting hypertension management goals, balancing risk and reward for cancer screenings, and understanding the impacts of insurance expansions.”

Non-Invasive Ventilation Reduces Death from COPD Breathing Failure

Also reduces need for intubation, Cochrane reviewers find
by Salynn Boyles, Contributing Writer, MedPage Today July 17, 2017

Action Points
• Non-invasive ventilation is an effective treatment strategy for chronic obstructive pulmonary disease (COPD) patients hospitalized for acute exacerbation and hypercapnic respiratory failure.
• Note that noninvasive positive pressure ventilation (NPPV) has been standard therapy for use in patients with COPD exacerbations who do not have a contraindication to its use, and the Cochrane findings support this.

Non-invasive ventilation is an effective treatment strategy for chronic obstructive pulmonary disease (COPD) patients hospitalized for acute exacerbation and hypercapnic respiratory failure, findings from a newly published Cochrane Review confirm.
The review of 17 clinical trials involving 1,264 patients found non-invasive ventilation to be associated with a 46% reduction in death risk and a 65% reduction in the risk of needing intubation.
The reviewers rated the quality of the evidence for both of these findings as “moderate,” according to GRADE (Grading of Recommendations, Assessment, Development and Evaluations) criteria.
Patients in the studies treated with non-invasive ventilation were hospitalized, on average, 3½ days less than COPD patients with respiratory failure due to exacerbation who did not receive the treatment, wrote Christian Osadnik, PhD, of Monash University in Melbourne, Australia, and colleagues.
Their analysis is now online in the Cochrane Database of Systematic Reviews 2017.
Asked for his opinion, Ray S. Peebles, MD, of Vanderbilt University Medical Center in Nashville, Tenn., who was not involved with the review, said that noninvasive positive pressure ventilation (NPPV) has been standard therapy for use in patients with COPD exacerbations who do not have a contraindication to its use, and the Cochrane findings support this.
Contraindications to NPPV include respiratory arrest, cardiovascular instability, impaired mental status, high aspiration risk, extreme obesity, and recent facial or gastrointestinal surgery, he said. “In patients who do not have these contraindications, it is clear that NPPV reduces the rate of endotracheal intubation, hospital mortality, ventilator associated pneumonia, and other nosocomial infections. This confirmation is important to help spread the word of the efficacy of NPPV in this patient population.”
The Cochrane review included randomized, controlled trials comparing usual care plus non-invasive ventilation with usual care alone in an acute hospital setting in patients with acute exacerbations of COPD due to acute hypercapnic respiratory failure (AHRF).
AHRF was defined by a mean admission pH of <7.35 and mean partial pressure of carbon dioxide (PaCO2) of >45 mmHg (6kPa).
Primary outcomes included death during hospital admission and the need for endotracheal intubation. Secondary outcomes included hospital length of stay, treatment intolerance, complications, changes in symptoms, and changes in atrial blood gases.
The mean age of the patients included in the analysis was 66.8 (range of 57.7 to 70.5), and 65% of the participants were male.
In 12 of the 17 studies, the reviewers found a risk of performance bias, and the risk of detection was found to be uncertain in 14 studies.
“These risks may have affected subjective patient-reported outcome measures (e.g., dyspnea) and secondary review outcomes, respectively,” Osadnik and colleagues wrote.
Use of non-invasive ventilation was found to decrease the risk of death by 46% — risk ratio, 0.54, 95% CI, 0.38-0.76; N= 12 studies; number needed to treat for an additional beneficial outcome (NNTB) 12, 95% CI 9-23.
The treatment also decreased the need for endotracheal intubation by 65% (RR 0.36, 95% CI, 0.28-0.46; N=17 studies; NNTB 5, 95% CI, 5-6).
The authors graded both outcomes as being of “moderate” quality — “owing to uncertainty regarding risk of bias for several studies.”
“Inspection of the funnel plot related to need for endotracheal intubation raised the possibility of some publication bias pertaining to this outcome,” the review team wrote.
Use of non-invasive ventilation was also associated with:
• Reduced length of hospital stay (mean difference (MD) -3.39 days, 95% CI, -5.93 to -0.85; N = 10 studies)
• Reduced incidence of complications (unrelated to non-invasive ventilation (RR 0.26, 95% CI, 0.13-0.53; N = 2 studies)
• Improvement in pH (MD 0.05, 95% CI, 0.02-0.07; N = 8 studies) and in partial pressure of oxygen (PaCO2) (MD 7.47 mmHg, 95% CI, 0.78-14.16 mmHg; N = 8 studies) at 1 hour
A trend toward improvement in PaCO2 was observed, but this finding was not statistically significant (MD -4.62 mmHg, 95% CI ,-11.05 to 1.80 mmHg; N = 8 studies).
“Post hoc analysis revealed that this lack of benefit was due to the fact that data from two studies at high risk of bias showed baseline imbalance for this outcome (worse in the non-invasive ventilation group than in the usual care group).”
Sensitivity analysis revealed that exclusion of these two studies resulted in a statistically significant positive effect of non-invasive ventilation on PaCO2.
Treatment intolerance was significantly greater in the non-invasive ventilation group than in the usual care group (risk difference [RD] 0.11, 95% CI, 0.04-0.17; N = 6 studies) and there was a nonsignificant trend towards reduction in dyspnea with non-invasive ventilation compared with usual care (standardized mean difference [SMD] -0.16, 95% CI, -0.34 to 0.02; N = 4 studies). Subgroup analyses revealed no significant between-group differences.
“Data from good-quality randomized controlled trials show that non-invasive ventilation is beneficial as a first-line intervention in conjunction with usual care for reducing the likelihood of mortality and endotracheal intubation in patients admitted with acute hypercapnic respiratory failure secondary to an acute exacerbation of chronic obstructive pulmonary disease (COPD),” the Cochrane authors concluded.
“The magnitude of benefit for these outcomes appears similar for patients with acidosis of a mild (pH 7.30 to 7.35) versus a more severe nature (pH < 7.30), and when non-invasive ventilation is applied within the intensive care unit or ward setting.”

iMedicalApps: Apple’s Secret Personal Health Records Project

Can they succeed where Google and Microsoft failed?
by Greg Von Portz July 17, 2017

After the high-profile failures of Google Health and Microsoft HealthVault, can tech titan Apple find a way to centralize personal health data, and could it solve medicine’s interoperability problem?
CNBC reports that Apple is working in secret to develop a way to store not just wellness info like step counts and emergency contacts, but clinical information on an iPhone — sort of like personal EHR in your pocket.
Some believe the company, which revolutionized the music industry, could do the same for healthcare. And Apple is confident with a slew of recent hires and has apparently been in talks with hospitals and industry groups. Details, however, are sparse and mostly rumors at this point, as is usually the case with Apple.
Many apps and devices hold a lot of information for specific conditions, Q Heart for hypertension and GKC’s Personal KinetiGraph for Parkinson’s, for example. And many of those types of medical apps have fared well.
What’s been more challenging is the development of a single, unified personal health record that can capture it all – medications, diagnosis history, lab results, and so on. There are many reasons for that, most notably the fragmentation of health IT in general. Many prior platforms have failed because they were cumbersome to use and could only capture pieces of health data.
Apple is reportedly working with partners focused on working around those barriers. And they may find some help with recent legislation mandating some degree of interoperability in EHRs and other health data systems. They also have an advantage with an existing health data management infrastructure on their devices with the Health app as well as HealthKit and CareKit.

This article originally appeared on iMedicalApps.com.

When it comes to healthcare, U.S. once again ranks last in quality care compared to other wealthy nations

by Ilene MacDonald |FierceHealth  Jul 14, 2017 2:03pm

The United States spends more on healthcare than other wealthy nations, yet ranks dead last on equity, access, efficiency, care delivery and healthcare costs.
Despite progress made in providing coverage to previously uninsured Americans via the Affordable Care Act, the latest report from The Commonwealth Fund finds that the United States offers its citizens the least financial protection among the 11 high-income countries surveyed. It is also the only one without universal health insurance coverage.
Indeed, the U.S. has the highest costs and lowest overall performance compared to Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland and the United Kingdom. The U.S. spent $9,364 per person on healthcare in 2016, compared to $4,094 in the U.K., which ranked first on performance overall.
Forty-four percent of lower income Americans and 26% of higher income U.S. citizens reported financial barriers to care. Remarkably, the report noted, someone with a high income in the U.S. was more likely to report financial barriers to healthcare than a low-income person in the U.K.
“What this report tells us is that despite the substantial gains in coverage and access to care due to the Affordable Care Act, our healthcare system is still not working as well as it could for Americans, and it works especially poorly for those with middle or lower incomes,” Commonwealth Fund President David Blumenthal, M.D., said in an announcement. “The healthcare policies currently being contemplated in Congress would certainly exacerbate these challenges as millions would lose access to health insurance and affordable healthcare.”
This isn’t the first time the U.S. has fared poorly compared to other nations. Since 2004, it has ranked last in every one of six similar reports. This year the Commonwealth Fund added new measures and refined the scoring to give each country an overall score, as well as a score on five specific areas of performance. The new approach ranked the U.K. Australia and the Netherlands as top performers. New Zealand, Norway, Switzerland, Sweden and Germany were in the middle of the pack. Canada and France were near the bottom but performed better than the U.S.
Another recent global report found massive inequity within the United States in terms of access to care and the quality of care provided.
But it’s not impossible for the U.S. to move from last place to first among wealthy countries if it heeds the lessons offered from top performing countries, notes Eric Schneider, M.D., the lead author of the study and senior vice president for policy and research at the Commonwealth Fund, and David Squires, former senior researcher to the president at the Commonwealth Fund, in a piece for The New England Journal of Medicine.
This would mean the U.S. must expand health insurance coverage, such as universal coverage that provides citizens with healthcare they need at little or no cost; invest more in primary care so that it is accessible on nights and weekends; cut down on the administrative paperwork that physicians must complete so they can spend time on providing care; and invest more in social services to reduce healthcare disparities.
“If we are going to be the best, we have to do better for patients,” Schneider said in the announcement. “We are not the U.K., Australia or the Netherlands, and we don’t have to be. Each of those countries follows a different path to top performance. A country that spends as much as we do could be the best in the world. We can adapt what works in other countries and build on our own strengths to achieve a healthcare system that provides affordable, high-quality healthcare for everyone.”

Zero Hospital-Acquired Infections? Believe It.

Philip Betbeze, July 13, 2017
Philip Betbeze is the senior leadership editor at HealthLeaders Media.

Convincing clinicians that getting to zero infections is possible, says one CQO. It requires a culture change, adherence to evidence-based practice, and leadership.
Danielle Scheurer, MD, believes that the plague of hospital-acquired infections and other patient harm is within clinicians’ power to cure. Infections, no matter how small the ratio to the number of surgical interventions, are not simply part and parcel of surgery, she contends.
If that belief does not permeate among clinicians involved in surgery, it’s tough to make headway on the national scourge of avoidable patient harm—a reality made frighteningly mainstream with the publication of the report, To Err Is Human, by the Institute of Medicine, way back in 1999.

Convincing is Half the Battle
Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina, where she is also an associate professor of medicine.
She says big progress can be made in infection control, especially where surgery is concerned, from convincing clinicians that getting to zero infections is possible.
“I’m not sure a lot of people even believed that was true as short as 10 years ago,” she says.
But now, there is at least proof of concept that if evidence-based practices are applied consistently, it is possible to achieve zero harm—or come extraordinarily close.
Among others, both Memorial Hermann and Cincinnati Children’s hospitals have both proven that near-zero harm is possible, but to achieve those results, the board and clinicians had to believe it was possible.
“Before you do anything else, make sure your care team members believe that’s true,” says Scheurer. “You can’t get rigorous practice without variability until everyone believes.”
On its face, that’s a strange concept—the idea that belief is a critical component of something being possible. But belief presages action, and action is certainly critical to limiting harm, from infection to surgical site errors—to near zero levels.
There are many ways to convince clinicians to believe in zero harm, says Scheurer.
At MUSC, they started by studying other healthcare organizations—such as Memorial Hermann or Cincinnati Children’s—where buy-in went well beyond bedside care and the OR—to frontline workers, the administration, and even board members.
Scheurer started by identifying high performing teams within her organization. At MUSC, one such team is in the pediatric cardiac ICU, which cares for some of the sickest, most vulnerable patients.
Patients go there there for complex cardiac surgeries, and they’re already in a weakened state when they arrive. Prior to surgery, they’re often in the ICU, and they often have, as Scheurer says, “a half-dozen portals of entry into their bodies—pacing wires, catheters, and central lines.”
“That team sort of just accepted as their mental model that ‘we’re here to save the baby’s life, there will be some infections, but that’s just the risky business we’re in,'” Scheurer says.
“I’m not sure anyone on that team believed zero harm was possible.”
But working diligently on compliance with a dashboard of known infection-reduction techniques, including building a culture of safety and reducing the time, even to the hour, that infection pathways are in the patient’s body, yielded payoffs that drastically changed that attitude.
“Some of our ICUs have gone up to two years [without an infection] as risk factors have been reduced,” Scheurer says. “Those are the best evangelists for other teams.”
She says that a single champion who can vouch for a proof of concept in a complex area makes culture change easier.
Her husband is a cardiac pediatric intensivist who once argued with Scheurer that eliminating infections in such settings was not possible. Thanks in part to the results in the pediatric cardiac ICU, “he has totally come around,” she says.
Chipping Away at Barriers
With infections, there’s often no way to prove when or where the inoculation occurred, which is one reason adherence to a bundle of evidence-based procedures is so important.

Double-Booked: When Surgeons Operate On Two Patients At Once

By Sandra G. Boodman  / Kaiser Health News, July 12, 2017

The controversial practice has been standard in many teaching hospitals for decades, its safety and ethics largely unquestioned and its existence unknown to those most affected: people undergoing surgery.
But over the past two years, the issue of overlapping surgery — in which a doctor operates on two patients in different rooms during the same time period — has ignited an impassioned debate in the medical community, attracted scrutiny by the powerful Senate Finance Committee that oversees Medicare and Medicaid, and prompted some hospitals, including the University of Virginia’s, to circumscribe the practice.
Known as “running two rooms” — or double-booked, simultaneous or concurrent surgery — the practice occurs in teaching hospitals where senior attending surgeons delegate trainees — usually residents or fellows — to perform parts of one surgery while the attending surgeon works on a second patient in another operating room. Sometimes senior surgeons aren’t even in the OR and are seeing patients elsewhere.
Hospitals decide whether to allow the practice and are primarily responsible for policing it. Medicare billing rules permit it as long as the attending surgeon is present during the critical portion of each operation — and that portion is defined by the surgeon. And while it occurs in many specialties, double-booking is believed to be most common in orthopedics, cardiac surgery and neurosurgery.
The issue was catapulted into public consciousness in October 2015 by an exhaustive investigation of concurrent surgery at Harvard’s famed Massachusetts General Hospital by The Boston Globe. The validity of the story has been vehemently disputed by hospital officials who defend their care as safe and appropriate.
The article detailed concerns by some doctors and other hospital staff about complications — including one patient who was paralyzed and two who died — possibly linked to double-booking over a 10-year period. It described patients waiting under anesthesia for prolonged periods and surgeons who could not be located, leaving residents or fellows to perform surgeries without supervision.
Patients who signed standard consent forms said they were not told their surgeries were double-booked; some said they would never have agreed had they known.
The practice has also figured prominently in cases in South Florida, Nashville and, most recently, Seattle.
Critics of the practice, who include some surgeons and patient-safety advocates, say that double-booking adds unnecessary risk, erodes trust and primarily enriches specialists. Surgery, they say, is not piecework and cannot be scheduled like trains: Unexpected complications are not uncommon.
All patients “deserve the sole and undivided attention of the surgeon, and that trumps all other considerations,” said Michael Mulholland, chair of surgery at the University of Michigan Health System, which halted ¬double-booking a decade ago. Surgeons might leave the room when a patient’s incision is being closed, Mulholland said. A computerized system records the doctor’s entry and exit.
“It doesn’t do any good to check out your surgeon if they’re not even going to be in the room,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “We all know about the dangers of multitasking. This adds a layer of danger if you have the most expert person coming in and out.”
Indiana orthopedic surgeon James Rickert regards double-booking as a form of bait-and-switch. “The only reason it has continued is that patients are asleep,” said Rickert, president of the Society for Patient-Centered Orthopedics, a doctor group.
“Having a fellow so you can run two rooms helps augment your income,” he added. “You can bill for six procedures: You do three and the fellow does three.” The critical portion of the operation required by Medicare and designated by the surgeon can mean “running in and checking two screws for 10 seconds.”
Defenders of the practice, which has been the subject of a handful of studies with mixed results, say it can be done safely and allows more patients to receive care.
“It’s extremely important for us to make sure [all surgeries are] done with the highest quality,” said Peter Dunn, Mass General’s executive medical director of perioperative administration. Officials at his hospital, Dunn said in a recent interview, have “never traced back a quality issue” to concurrent surgery, which involves a minority of procedures.
Mass General complies with all applicable guidelines and regulations, Dunn said. The hospital now explicitly requires doctors to inform patients if an operation will overlap as part of the consent process, which may occur just before the start of surgery.
In January, a Boston jury found that a Mass General spine surgeon who failed to inform a 45-year-old financial analyst that he was running two rooms was not responsible for the patient’s subsequent quadriplegia.
Divided Attention
No one knows how many of the nation’s 4,900 hospitals that receive Medicare payments — about 1,000 of which are teaching hospitals — allow the practice, the Senate Finance Committee noted in a recent report. The committee called on hospitals to adopt stronger policies and consent forms that go beyond opaque boilerplate statements that grant broad permission without specifying who is doing what. And the report noted that concurrent surgery may also occur in outpatient surgery centers and non-teaching hospitals and that it can involve patients who are not covered by Medicare.
The practice surprised some primary care doctors and a veteran medical ethicist.
“I certainly knew that for many procedures, residents might be involved,” said Arthur Caplan, a professor of bioethics at NYU School of Medicine. (NYU Langone Medical Center does not permit concurrent surgery.) “But I was a little taken aback that the attending surgeon was not in the room.”
Proponents say that overlapping operations can improve efficiency and better utilize a surgeon’s valuable time.
“Much of surgery is team-based,” said David Hoyt, executive director of the American College of Surgeons (ACS), which last year issued guidelines governing concurrent surgery. Largely similar to Medicare rules, the guidelines state that surgeons should inform patients of overlapping operations.
Robert Cima, a colorectal surgeon and medical director of surgical outcomes research at the Mayo Clinic, agrees. Overlapping surgery has been used safely since Mayo’s inception more than 100 years ago, he said. A recent study he co-authored found that 11,000 overlapping operations at Mayo did not have a higher death rate than non-overlapping surgeries.
Allowing qualified junior doctors to perform parts of an operation, Cima said, is vital in “training the next generation of surgeons.” Determining what portion of an operation is critical should be left to the individual surgeon, he said, not defined by Medicare or insurers, because it can vary from patient to patient.
But L.D. Britt, a past president of the ACS and chairman of surgery at Eastern Virginia Medical School in Norfolk, says that efficiency has little to do with concurrency. “Unless you’re closing, that surgeon should be there,” he said. “Most [surgeons] are doing it for lifestyle.”
Indiana’s Rickert and Britt say they are troubled by what they regard as a double standard: Very few surgeons would consent to the practice for themselves or a relative. “This happens to the Medicaid patient,” Rickert said, “not the partner’s wife.”
He advocates that Medicare and insurers define the critical portion requiring the presence of an attending surgeon as being everything between the making of an incision and the start of its closure, a task frequently performed by residents. “The critical components should not depend on whether the surgeon has opera tickets that night.”
Ghost Surgery?
Some surgeons say they are troubled by the resemblance of double-booking to a practice known as “ghost surgery,” in which patients learn, usually after something goes wrong, that someone other than the surgeon they hired performed their operation.
In April, a Seattle jury awarded an anesthesiologist and her husband $8.5 million for botched abdominal surgery that disfigured his penis. After his operation, the couple discovered that a crucial part of the procedure was performed by a fellow, not the senior surgeon to whom he had explicitly granted consent.
“I always prided myself in telling patients I would be there from the moment they went to sleep to the moment they woke up,” said Stanley Shapshay, a head and neck surgeon in Albany, N.Y., who co-authored a 2016 editorial opposing simultaneous surgery.
Many things can go wrong during “noncritical” portions of an operation, particularly if a resident or fellow is unsupervised, said Shapshay, a professor of otolaryngology at Albany Medical College. A major artery or nerve can be cut accidentally, he said. “By the time the surgeon [arrives, the damage] has already been done.”
Trainees, Shapshay observed, vary. “Some are very good, some are OK and some need more experience.”
His view was reinforced by his experience at a hospital in the Southeast several years ago. A senior surgeon he was visiting left in the middle of an operation, after telling a family that surgery had gone well. While he and Shapshay were having coffee, the surgeon received an urgent page and had to rush back to the OR to deal with a serious breathing problem. The family was later told only that an unexpected event had occurred, not that the attending had been out of the room.
“That illustrated to me very clearly that you don’t leave the OR until the patient has left the OR,” Shapshay said.
Adequate informed consent is essential, said Robin Diamond, senior vice president for patient safety and risk management at the Doctors Company, a California-based malpractice insurer that has begun tracking malpractice claims related to overlapping surgery. She expects such lawsuits will increase.
“I think it can be done safely and has been safe in many cases,” said Diamond, who has degrees in nursing and law. But surgeons who plan to run two rooms should obtain explicit consent from patients at least a week ahead of surgery, she said, not the day before or the day of, as is common, to allow time to reconsider.
“It’s a basic patient right to know” who is doing their operation, Diamond said.
Patients don’t seem enamored of overlapping surgery. A recent study based on an online survey by Harvard researchers found that fewer than 4 percent of 1,454 people had heard of concurrent surgery and that only 31 percent supported the practice; 95 percent said it should be disclosed in advance.
A Surprising Result
After the fallout at Mass General, officials at U.Va. decided it was time to largely eliminate concurrent surgery in all specialties; the practice had been most common in orthopedics.
In return for an end to simultaneous surgeries, hospital executives agreed that orthopedic surgeons would not be “disadvantaged,” said Richard Shannon, executive vice president for health affairs at U.Va. Part of the process involved overhauling the way surgeries were scheduled.
“It was an important wake-up call,” Shannon said of the controversy. “We wanted to redesign our system to eliminate the risk” as part of a larger patient-safety push.
Eliminating most concurrent procedures, Shannon said, actually resulted in an increase of 560 surgeries in 2016 over 2015, using the same number of operating rooms. “Concurrency was masking an efficiency problem,” said Shannon, who plans to publish the results of U.Va.’s efforts. “There was a lot of waste.”
“This debunks the urban legend” that overlapping surgery is more efficient, he said. “Like many things in health care, if you apply a rigorous disciplined approach, you may get an answer you didn’t expect.”
Rickert and others advise patients who want to avoid overlap to ask detailed questions well in advance and to put their request in writing and on the consent form.
“If you say, ‘I want only you to do the surgery,’ doctors will typically do it,’” Rickert said. “They want the business.”
He also recommends asking, “Are you going to be in the room the entire time during my surgery?” and then repeating that statement in front of the OR nurses the day of surgery. “If the doctor’s not willing to say yes, vote with your feet.”
If a surgeon says he or she will be “present” or “immediately available,” a patient should ask what that means. It may mean that the surgeon is somewhere on a sprawling hospital campus but not in — or even near — your operating room.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Bone Drug Lowers Risk for Hip Breaks in Seniors on Steroids

No cases of incident drug-induced osteonecrosis

by Kristen Monaco, Contributing Writer, MedPage Today July 11, 2017

Action Points
• Following moderate to high oral prednisolone use among older patients, alendronate (Fosamax) may be protective against fracture risk.
• Note that there were no reported cases of drug-induced osteonecrosis during the study, and alendronate usage was not linked to peptic ulcers among the study group.

Following moderate to high oral prednisolone use among older patients, alendronate (Fosamax) may be protective against fracture risk, a new study found.
In an adjusted model, oral alendronate use was associated with significantly lower risk of hip fractures (HR 0.35, 95% CI 0.22-0.54), reported Kristian F. Axelsson, MD, of Skaraborg Hospital in Skövde in Sweden, and colleagues.
In the study, there were hip fractures in patients receiving alendronate during a 1.32 year median follow-up (incidence rate 9.5, 95% CI 6.5-13.9 fractures per 1,000 person-years), compared with 73 hip fractures among the prednisolone-only group (IR 27.2, 95% CI 21.6-34.2 for an absolute rate difference of -17.6 (95% CI -24.8 to -10.4), they reported in JAMA.
“Alendronate is known to reduce the risk of vertebral fractures in patients taking prednisolone, but no studies were previously available regarding hip fracture, which is the most serious fracture, often leading to disability and increased risk of mortality,” co-author Mattias Lorentzon, MD, PhD, of Sahlgrenska University Hospital, in Mölndal, Sweden told MedPage Today.
“Since alendronate is now a generic compound (without patent) it is unlikely that there will be any large randomized trials, investigating the effect of alendronate on hip fracture risk in older patients taking prednisolone, in the future,” he added.
The authors collected participant information on adults, ages, 65 and older who were registered in Sweden’s Senior Alert database. A total of 1,802 individuals who were prescribed alendronate after a minimum of 3 months of 5 mg/d or higher of oral prednisolone were identified. They were then equally matched with individuals taking the same dosage of prednisolone without alendronate usage (n=3,604, 70% women). Individuals who were currently prescribed other treatments for osteoporosis, including risedronate, zoledronic acid, denosumab, testosterone, among others, were excluded from the analysis.
Findings were similar in an unadjusted Cox model, which reported alendronate treatment was still associated with a lowered hip fracture risk which was defined as a fractured femoral head, neck, trochanter, or subtrochanteric section of the femur (HR 0.35, 95% CI 0.23-0.55).
“Since previous studies have shown that several osteoporosis medications have the largest protective effect in the patients with the highest fracture risk, we were not surprised to see that alendronate was associated with a much lower hip fracture risk in the high-risk population we investigated — [elderly] patients using high doses of oral prednisolone,” Lorentzon explained.
Among secondary outcomes, alendronate treatment was also associated with reduced risk for major osteoporotic fracture in a multivariable Cox model (HR 0.53, 95% CI 0.38-0.73), any fracture (HR 0.58, 95% CI 0.46-0.73), and nonvertebral fracture (HR 0.55, 95% CI 0.43-0.71). Absolute risk reduction among these secondary outcomes for the alendronate group over a 30-month treatment period were as follows:
• Major osteoporotic fracture: 3.9% (95% CI 2.2-5.4%)
• Any fracture: 5.7% (95% CI 3.9-8.0%)
• Nonvertebral fracture: 5.5% (95% CI 3.6-7.5%)
The researchers noted these associated were only statistically significant among the postmenopausal female participants.
Axelsson’s group noted there were no reported cases of drug-induced osteonecrosis during the study. Alendronate usage was not linked to peptic ulcers among the study group: treatment versus no treatment: 10.9 (95% CI 7.7-15.5) versus 11.4 (95% CI 8.0-16.2) per 1,000 person-years (P=0.86). It also was not associated with an increased risk of mild upper gastrointestinal tract symptoms: 15.6 (95% CI 11.6-21.0) versus 12.9 (95% CI 9.3-18.0) per 1,000 person-years (P=0.40).
According to the American Association of Clinical Endocrinologists and the American College of Endocrinology’s clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis, the four approved agents — alendronate, risedronate, zoledronic acid (Zometa), and denosumab (Xgevia and Prolia) — are recommended as initial therapy for those at high risk for fracture. Oral agents, such as alendronate, are specifically recommended for patients with a lower or moderate fracture risk, including younger post-menopausal women without a prior history of fracture and moderately low T-Scores.
However, alendronate does not come without notable side effects, which have recently landed drug maker Merck in court for a “failure-to-warn” lawsuit specifically regarding the risk of thighbone fractures. In this analysis, there were only two reported incidents of femoral shaft fracture, one per study group.
For future studies,”we aim to continue to investigate osteoporosis medications and fracture outcomes in patients with other diseases and conditions, not studied in randomized trials before, using our national registers,” Lorentzon said.

CardioBrief: New Studies Reassure on Coffee Safety, Suggest Survival Bump

Benefits of coffee now apparent in non-white and European populations

by Larry Husten, CardioBrief July 10, 2017

Two large new observational studies appearing Monday in Annals of Internal Medicine strengthened the association between higher coffee consumption and longer life. In the wake of earlier studies pointing to the potential benefits of coffee, the two new papers extend those benefits to new populations, including 10 European countries and non-white people in the U.S.
Because the studies are observational they were unable to determine whether coffee itself is beneficial, but the studies do offer a measure of reassurance for coffee lovers.
“Drink some coffee!” said Salim Yusuf of McMaster University in Hamilton, Ontario, when asked what he would advise a physician to tell patients who ask about coffee. Yusuf said the studies were “intriguing” but that it is necessary to “explore confounders” before reaching any conclusion.
In the first paper, researchers from the International Agency for Research on Cancer and Imperial College London analyzed data from 520,000 people in 10 countries participating in EPIC (European Prospective Investigation into Cancer and Nutrition), a large prospective cohort study. They found that, with mean 16.4 years of follow-up, people who drank coffee had a lower risk of death, with the greatest benefit occurring in people who drank three or more cups of coffee per day. The reduced risk of death was most evident in a reduction of deaths from digestive and circulatory diseases. The results were broadly consistent across countries, men and women, and other major subgroups.
In the second paper, U.S.-based researchers analyzed data from more than 185,000 African Americans, Japanese Americans, Native Hawaiians, Latinos, and whites participating in the MEC (Multiethnic Cohort) study, also with mean follow-up of about 16 years. They, too, reported an inverse relationship between coffee consumption and all-cause mortality. There were no differences among the different ethnic groups. (The result in Native Hawaiians did not reach statistical significance, probably because of the small number of Native Hawaiians enrolled in the study, according to the authors.) There were statistically significant reductions in deaths due to heart disease, cancer, chronic lower respiratory disease, stroke, diabetes, and kidney disease.
In both studies smoking played a large confounding role, since smokers are more likely to drink coffee. But the researchers reported that the association was consistent for never smokers, former smokers, and current smokers.
In an accompanying editorial, Eliseo Guallar and colleagues at Johns Hopkins University wrote that “a protective effect of coffee is biologically plausible.” However, they warned that the studies do not prove that coffee reduces mortality, since the relationship may be “just a reflection of uncontrolled confounding.”
Further, the association of coffee and mortality “was modest,” Guallar and colleagues cautioned. They said it would be “premature” to recommend coffee for its beneficial effects but “it is increasingly evident that moderate coffee intake up to 3 to 5 cups per day or caffeine intake up to 400 mg/d is not associated with adverse health effects in adults and can be incorporated into a healthy diet.”

Heartburn Drugs May Increase Risk of Early Death

By NICHOLAS BAKALAR  JULY 5, 2017  NYTIMES-Well Section

Proton pump inhibitors, or P.P.I.s, the widely used heartburn medicines, may increase the risk of early death, a new study reports.
P.P.I.s, sold over the counter under such brand names as Nexium and Prevacid, have been associated with serious adverse side effects, including kidney disease, bone fractures and infections. This study found an association with death from any cause.
The study, in BMJ Open, compared people who used P.P.I.s with those who used H2 receptor antagonists (Zantac, for example) and with those who used neither. About 350,000 people in the Veterans Affairs health care system database were included and followed for an average of almost six years.
The researchers found that compared to the other groups, those taking P.P.I.s were at an increased risk of premature death, and the longer the use, the greater the risk.
“I don’t want people to panic,” said the lead author, Dr. Ziyad Al-Aly, an assistant professor of medicine at the Washington University School of Medicine. “The risk is not large, and with people who need P.P.I.s for a valid medical condition — a bleeding ulcer, for example — the benefit far outweighs the risk. But people are taking them when they don’t really need them and they’re getting no benefit, only the risk.”

Thousands of unresponsive patients might actually be conscious

By Susannah Cahalan
July 1, 2017 | 1:23pm   NYPost
They called him a dead man.
Last month New York-Presbyterian Hospital issued a death certificate for 68-year-old Yechezkel Nakar after he suffered a stroke that rendered him unconscious and unresponsive.
Trouble is Nakar wasn’t dead. His heart was still beating, and he remained on life support at Maimonides Medical Center while his family filed a lawsuit asking the court to withdraw his death certificate so they could be reimbursed for his continuing care. He survived for another 21 days after doctors had officially declared him deceased.
Nakar’s story not only raises the role of morality in medical care (his family objected to removing him from life support on religious grounds), but also highlights medicine’s limited understanding about this borderland between the dead and the living — an area the British-born neuroscientist Adrian Owen calls “the gray zone.”
Dr. Owen has spent the last 20 years using brain scans to try to communicate with people written off as brain-dead — as unreachable as heads of broccoli. And to the shock of the neurological community he has been successful. His studies estimate that upwards of 15 to 20 percent of patients in persistent vegetative states or “unresponsive wakefulness” may actually be conscious but locked in their bodies and unable to communicate. Some, he’s found, have “intact minds adrift deep within damaged bodies and brains.”
This has serious implications for the estimated 15,000 to 40,000 people on life support in the United States — a number that has nearly doubled in the last decade as medical advancements keep people alive longer. Some are warehoused in sub-acute units, derisively called “vent farms,” where hosts of people live out their last days, months or even years. If Owen’s data is correct, more than 7,000 of these people could be conscious — a realization that sounds more like a “Twin Peaks” plotline than real life.
In his book “Into the Gray Zone: A Neuroscientist Explores the Boundary between Life and Death” (S&S), out now, the Canada-based Dr. Owen introduces readers to patients who helped bring him closer to breaking through this gray zone. Here are four astounding cases that led to some of his most exciting breakthroughs.
KATE
Before Dr. Owen began his investigation, doctors believed that once you were vegetative for several months, there was zero chance of recovery. This led to some weird-but-true moments like the Venezuelan man Carlos Camejo, who lost consciousness 10 years earlier in a car accident but awoke during his own autopsy.
In 1997, Dr. Owen met a patient named Kate Bainbridge, who had developed encephalomyelitis, a brain and spinal-cord tissue inflammation. With this diseases, some recover, others die — and another group, including Kate, enter into a persistent vegetative state. Dr. Owen wanted to know: Are people like Kate completely lost?
He decided to track her visual processing system to see if her brain responded to images. Dr. Owen collected pictures of Kate’s favorite people and showed her the images while scanning her brain using Positron Emission Tomography (PET), which works by monitoring blood flow marked with radioactive tracers. When healthy people see familiar faces, blood flow tends to increase in a part of the brain called the fusiform face area. Would this happen with Kate?
To his surprise, whenever Kate was shown family photos, her visual cortex lit up but then “returned to relative inactivity when a cloth covered her face . . . Her brain responded just as if she was awake and aware, just as if she was a perfectly healthy person,” Dr. Owen writes.
Luckily, after six months in a vegetative state, Kate recovered well enough to share her side of the story. Though she didn’t recall seeing the faces she was shown, she did remember being conscious and being desperately thirsty and trying to call out. She said she was in so much psychic pain that she even tried to kill herself by holding her breath — a common occurrence among those locked in their bodies, Dr. Owen writes.
“Part of Kate was still there,” he writes, “and perhaps that’s what was reflected in our early scans.”
After Dr. Owen published Kate’s story in the medical journal The Lancet, responses ranged from excitement to incredulity. Some questioned his research methods and others suggested that Dr. Owen was fooled by an automatic response. Nevertheless, the idea of “the gray zone” was born.
KEVIN
Now that Dr. Owen knew the visual cortex could be activated by familiar images in some people in vegetative states, he wanted to know: Would speech cause a similar change?
In 2003, he tested Kevin, a 53-year-old bus driver who was unresponsive four months after suffering a massive stroke that devastated his brain stem and thalamus. Dr. Owen scanned Kevin while playing sentences — some clear and some layered in static noise. If Kevin understood the sentences, Dr. Owen expected to see a greater increase of activity in the temporal lobe.
Again, like the healthy controls, Kevin’s brain lit up in the exactly same way. “Surely this was key evidence that Kevin’s brain wasn’t just hearing speech — his brain understood it!” writes Dr. Owen. “There could be little doubt that Kevin’s brain was processing meaning.”
Dr. Owen and colleagues scanned Kevin again using an fMRI scanner that measures activity through oxygen in the blood (the more brain activity in one area, the more blood rushes to it with its stock of oxygen).
This time, Dr. Owen read Kevin ambiguous sentences containing words with multiple meanings like, “the shell was fired toward the tank” (shell, fired, and tank all have multiple meanings). Research shows sentences like these require more brain activity in the left temporal lobe and the lower part of both frontal lobes than clearer sentences like, “He wrote a poem.”
With this test, Kevin’s brain lit up in all the right spots, providing evidence that a nonresponsive person could glean meaning from spoken language.
SCOTT
Armed with the knowledge that some vegetative patients could comprehend language, Dr. Owen opened the lines of communication further. Now he had to test his tennis theory out on healthy and vegetative patients. Years later he felt prepared to open up a dialogue.
His “a-ha” moment came while watching Wimbledon in June 2006.
“What about tennis?” he suggested to his colleague, neuroscientist Melanie Boly. Although the thought of getting nonresponsive patients to pretend to play tennis seemed silly, it actually made neurological sense. Thinking of playing the sport — one that is particularly easy to imagine — activates a very specific part of the brain called the premotor cortex.
Now he had to test it out on healthy and vegetative patients until years later he felt prepared to open up a dialogue.
Scott was T-boned by a police cruiser in 1999 and spent the next 12 years in a minimally responsive vegetative state, though Scott’s family remained adamant he was there and making efforts to communicate. Dr. Owen explained the study to Scott and told him to picture playing tennis: bouncing the ball, swinging the racket and making contact with the ball. As hoped, Scott’s premotor cortex lit up on cue.
“Scott, are you in any pain? Do any of your body parts hurt right now? Please imagine playing tennis if the answer is no,” Dr. Owen continued.
Scott’s premotor cortex activated. He had given a “no” answer. He was communicating.
Dr. Owen followed up with other questions. Scott knew it was 2012, not 1999 (the year of his accident), which indicated he had new memories, a key component in full consciousness.
MARTIN
The most famous case of a person coming back from a perceived vegetative state is Martin Pistorius, a South African who chronicled the 12 years he spent “locked in” to his body in his harrowing memoir “Ghost Boy,” published in 2013. When Martin was 12 years old in 1988, he fell ill with a mysterious degenerative illness that slowly robbed him of his ability to walk or talk. Eighteen months later doctors believed that he had the intellect of a 3-month-old baby.
But Martin remembers waking up four years later completely cognizant — and entirely trapped in his body. “For so many years, I was like a ghost. I could hear and see everything, but it was like I wasn’t there. I was invisible,” he told NBC in 2015.
It all started in 2001, when one of Martin’s therapists, Virna Van Der Walt, began to suspect her patient was engaging with the world in a deeper way than he could communicate. She could see it, she would later say, in the sparkle in his eye. She convinced his parents to get him neurologically tested, which confirmed her suspicions.
Martin’s inert body, it turned out, was hiding a brilliant mind. He went through years of rehab, which strengthened both body and brain, and began communicating with the outside world with the help of a computer program. He regained the use of his hands, attended college, works as a website designer and married “the love of his life” in 2009.
Although his is a rare case, Pistorius is a symbol of hope for many who have unresponsive loved ones. Some patients, like Yechezkel Nakar who finally passed away on June 21, will die. But others will continue to live — and even if we can’t yet pluck them out of the gray zone, we can improve their quality of life.
Dr. Owen imagines a future — not too far from now — where we are able to implant sensors in the brains of these patients, allowing them to communicate and re-engage with the outside world.
Dr. Owen’s collaborator, Belgian neurologist Steven Laureys, confirmed that if we can reach them, these people often reveal they are living meaningful — even happy — lives. In one study of 91 people with “locked-in syndrome” like Pistorius, 72 percent reported that they were happy and only 7 percent expressed a wish for euthanasia.
“What began as a scientific journey more than 20 years ago, a quest to unlock the mysteries of the human brain, evolved over time into a different kind of journey altogether,” writes Dr. Owen, “a quest to pull people out of the void, to ferry them back from the gray zone, so they can once again take their place among us in the land of the living.”