Monthly Archives: July 2017

Insurers Begin Denying Payment for ‘Unnecessary’ ED Care

Second-guessing patients, emergency workers
by Jesse Pines, MD July 26, 2017

In May 2017, Blue Cross Blue Shield (BCBS) of Georgia announced it will no longer cover “unnecessary” emergency department (ED) care, starting July 1. According to BCBS Georgia President Jeff Fusile, “…we have got to find a better way to do some of this stuff, taking some unnecessary spending out of the system.” Fusile would rather patients use urgent care, retail clinics, and their online app, instead of costly EDs for conditions treatable in those settings. The BCBS policy follows similar ones enacted by Anthem in New York, Kentucky, and Missouri.
To many, these policies seem well-intentioned for a fiscally responsible insurer in a country with out-of-control healthcare costs. The simple goal: drive low-acuity illness to cheaper settings, which will control costs and in turn, allow for lower premiums.
Insurers are partly right: inefficient setting selection is a real issue. It is not uncommon for emergency physicians to face situations where a panicky ED patient realizes their perceived health emergency was a false alarm. Some well known examples: a toddler with a fever and listlessness who perks up after a weight-appropriate dose of ibuprofen; a bout of severe, unrelenting abdominal pain that resolves spontaneously right after the patient is triaged and passes gas; the allergic reaction which initially felt like “throat closing” with not even a hive after some Benadryl.
Some ED patients could potentially be served elsewhere. Some patients come to the ED when they didn’t need any medical attention at all. But the reality is there is no systematic way for patients to reliably and safely determine whether their symptoms represent an emergency. Many patients are referred to the ED by their doctors, others have no easy access to physicians, and many do not know about or think they should use telemedicine during a potential health emergency.
Bottom line, it is playing with fire for BCBS and Anthem to systematically discourage ED use. Sometimes, fever and listlessness is meningitis, unrelenting abdominal pain can be a bursting appendix, and allergic reactions occasionally result in life-threatening anaphylaxis. All are potentially lethal if untreated. Insurers’ new ED deterrent policies create a new, unfair responsibility for patients: self-diagnose accurately, or else. Patients choosing incorrectly face steep financial penalties after seeking care in settings deemed “non-ideal,” decided after the fact by their insurer using their final diagnosis.
These policies will dissuade some patients from using the ED. They will also save insurers a boatload of money, allowing them to happily keep more of their members’ hard-earned premium dollars.
Yet for many, the perception of a potential health emergency will be too great to bear. The fact is most patients do not consider costs when they think they are having an emergency. No doubt, many patients in Georgia, New York, Kentucky, and Missouri will continue to pile into EDs at all hours for conditions that end up being nothing serious. But later, they will get punched in the gut by their insurer with a “surprise coverage gap”: a large out-of-pocket bill, despite already having responsibly paid their insurance premiums. Their insurers will recast this travesty as “surprise billing” by greedy physicians and hospitals.
Given the large numbers of people these policies affect, some hapless patients will err on the side of fiscal responsibility, risking their safety and well-being. They may initially think they need care, but will think twice and make the wrong decision. Deferring life-saving care will cause them to experience a poor outcome or even die.
These insurance policies ignore the realities and uncertainties that patients face during illness and injury. Patients with minor symptoms not uncommonly have serious illness, and many patients with symptoms that first seem serious end up being nothing. A 2013 JAMA article described this phenomenon: the 6% of ED patients with “primary care treatable” conditions had the same chief complaints as 89% of overall ED visits. Even for expert emergency physicians and nurses armed with advanced equipment, the art of accurate diagnosis can be deceivingly difficult. It sometimes takes an ED visit to figure out whether a condition is “primary-care treatable.”
For the American College of Emergency Physicians (ACEP), this is not its first rodeo with insurers over fair coverage. This came to a head in the late ’90s with repeated denials for ED visit claims: for example, crushing chest pain ultimately diagnosed as gastro-esophageal reflux. In the end, ACEP’s work along with patient outcry led to the “prudent layperson standard.” This requires insurers to pay for emergency conditions that, according to a person who “possesses an average knowledge of health and medicine,” potentially places someone in serious jeopardy from impairment of bodily function or dysfunction to bodily organs. The prudent layperson standard was written into federal law in the Patient Protection and Affordable Care Act of 2010. The intention of prudent layperson was to not allow insurers to make post-hoc coverage decisions. Specifically, by reviewing limited information (i.e., the discharge diagnosis), an insurer has no way of knowing what brought the patient to the ED or whether a prudent layperson would have considered their symptoms a medical emergency.
The trouble is that now BCBS Georgia thinks that it can read their beneficiaries’ minds, apply the prudent layperson standard fairly and reliably, and not pay for “non-emergencies.” Think again.
Take a 43-year-old female who whacks her foot into the door jam at 1 a.m., which is immediately painful and she can’t bear weight. The toes turn dark purple, and appear swollen and deformed. After ibuprofen, the pain becomes unbearable. She goes to the ED (the only place open), gets an x-ray and some pain control. She goes home comfortable, reassured there’s no fracture, with a surgical shoe and a prescription for painkillers. Weeks later, insurance staff reviews her claim and sees the ICD-10: “S90.1 Contusion of toe without damage to nail.” Nowhere in her insurance records did it say she had severe pain, ibuprofen was ineffective, or that she couldn’t walk. The conclusion: another “unnecessary” ED visit for a stubbed toe. She is left paying $1200 out of pocket. One night, several months later, she is awoken by chest pain. Still stinging from her “surprise coverage gap,” she goes back to sleep, hoping it’s nothing and dies from a heart attack. The only winner is her insurer, who got out of paying for not one, but two ED visits.
Where and when people should seek care when sick and injured is thorny business. The terms “inappropriate” and “unnecessary” are commonly invoked, yet never defined reliably. A recent study found that experienced emergency physicians only agreed on “ideal” settings for about half the time, even with detailed clinical information about the ED visit. Therefore, it is impossible for insurers to know with any reasonable certainty whether any particular case was “unnecessary” with the limited data they review or whether a prudent layperson would have sought medical care.
So where do we go from here? Like the many prior attempts to implement similar policies, the BCBS and Anthem coverage shell game will ultimately fail. Patients will not stand for it. ACEP and other hospital groups will fight it. However, along the way many patients who trusted their insurance company to cover their medical bills will experience a “surprise coverage gap.” For everyone who this happens to, the bill will certainly sting. Some will go bankrupt. And a few will experience avoidable medical complications or die off in the process.

Jesse Pines, MD, is a practicing emergency physician and professor of emergency medicine and health policy at George Washington University. A version of this article originally appeared at Emergency Physicians Monthly.

Amazon has a secret health care team called 1492 focused on medical records, virtual doc visits

CNBC 7/26/17

Amazon (AMZN) has started a secret skunkworks lab dedicated to opportunities in health care, including new areas such as electronic medical records and telemedicine. Amazon has dubbed this stealth team 1492, which appears to be a reference to the year Columbus first landed in the Americas.
The stealth team, which is headquartered in Seattle, is focused on both hardware and software projects, according to two people familiar. Amazon has become increasingly interested in exploring new business in healthcare. For example, Amazon has another unit exploring selling pharmaceuticals, CNBC reported in May.
The new team is currently looking at opportunities that involve pushing and pulling data from legacy electronic medical record systems. If successful, Amazon could make that information available to consumers and their doctors. It is also hoping to build a platform for telemedicine, which in turn could make it easier for people to have virtual consultations with doctors, one of the people said.
The group is also exploring health applications for existing Amazon hardware, including Echo and Dash Wand. Hospitals and doctor’s offices have already dabbled in developing skills for Amazon’s voice assistant Alexa, which presents a big opportunity for the e-commerce company.
It’s not clear whether Amazon is building any new health devices, but sources didn’t rule it out.
The company currently has a slew of roles available for its “stealth” operation, which are searchable on the jobs site under the keyword “a1.492.” Some job posts describe the position as “The Amazon Grand Challenge a.k.a. ‘Special Projects’ team.” The unit is currently hiring for a UX Design Manager for its “new vertical,” as well as a machine learning director with experience in healthcare IT and analytics and a knowledge of electronic medical records.
Some members of the team list their affiliation with a1.492 on LinkedIn. Those involved include two machine learning experts; a UX designer; and two strategic initiative leads that are running projects inside the group, Kristen Helton and Cameron Charles.
Amazon did not immediately respond to a request for comment.
1492 isn’t the only team inside Amazon that is working in health and life sciences.
Its cloud operation, Amazon Web Services, has also hired a slew of health experts to beat out Microsoft and Google for contracts with large hospitals and pharmaceutical vendors. The company has also invested in a health startup called Grail as a very special kind of future customer for its cloud business.
Its Amazon business team is also grabbing opportunities in the $3 trillion sector. It has been selling medical supplies for several years, which poses a big threat to the U.S. distribution business, and is looking to build out a pharmacy business.
The company is attempting to better coordinate these efforts through a series of meetings with senior leaders across these groups that kicked off this year, according to one of the people.
The market opportunity is enormous: Former White House CTO Aneesh Chopra, who has been highly involved in efforts to digitize health operations but had no prior knowledge of the Amazon effort, told CNBC “anyone who aspires to help consumers navigate our health system and is digitally capable should find the market conditions ripe for entry.”
Apple (AAPL)’s health unit is also working with partners in the industry to aggregate medical information, CNBC previously reported. Google and Microsoft have stumbled in similar efforts, known as Google Health and HealthVault

The dirty (and dangerous) truth about doctors’ stethoscopes

by Joanne Finnegan |FierceHealth Jul 19, 2017 12:13pm

While stethoscopes can transmit the same germs as unclean hands, none of the doctors in a recent study bothered to clean them between patients.
And that was the case even after an educational intervention about the importance of stethoscope hygiene in preventing infections: Zero doctors wiped off the stethoscope between patient encounters, according to a study published in the July issue of the American Journal of Infection Control, the journal of the Association for Professionals in Infection Control and Epidemiology (APIC).
The team of doctors from Yale University School of Medicine and the department of medicine at Veterans Affairs Connecticut Healthcare System in West Haven, Connecticut, anticipated a poor result based on the low rates of stethoscope hygiene reported in other studies, but were still surprised no one disinfected their stethoscope.
The bad results were especially confounding because the institution checks second-year medical students’ compliance in an evaluation that demonstrates competency in performing a complete history and physical.
Infection control guidelines from the Centers for Disease Control and Prevention also say reusable medical equipment, such as stethoscopes, must undergo disinfection between patients.
“Stethoscopes are used repeatedly throughout the day and become contaminated after each patient exposure, so they must be treated as potential vectors of transmission. Failing to disinfect stethoscopes could constitute a serious patient safety issue similar to ignoring hand hygiene,” said APIC President Linda Greene, RN, in an announcement.
The doctors undertook a quality improvement pilot project in which they observed stethoscope hygiene, using alcohol swabs or gel or disinfectant wipes, at the start of a 4-week rotation for medical students, resident physicians and attending physicians at a tertiary care academic teaching hospital. No one bothered with stethoscope hygiene. They also observed for hand hygiene, via alcohol gel or soap and water.
The team then educated clinicians about the importance of stethoscope hygiene between patient encounters, set the expectation that they follow the procedure and hinted they might monitor clinicians during a follow-up phase. Despite the effort, the physicians failed to clean their stethoscopes.
The study authors said the project demonstrates that standard education may not be the answer to the problem and consistent efforts may be necessary to change culture and habits.
Hand hygiene has traditionally received much more attention than stethoscope hygiene, but the authors said microbiology data show that contamination of a stethoscope after a single patient exam is comparable to that of a physician’s dominant hand. Potential pathogens cultured from stethoscopes include Staphylococcus aureus, Pseudomonas aeruginosa, Clostridium difficile and vancomycin-resistant enterococci. And a recent Swiss study found that stethoscopes were capable of transmitting potentially resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Certain Antibiotics in First Trimester Up Risk of Major Birth Defects

Largest cohort study to examine risk by antibiotic class and type
by Molly Walker, Staff Writer, MedPage Today July 19, 2017

Action Points
• Several common types of antibiotics were linked both to major congenital and to organ specific malformations in infants when taken during the first trimester of pregnancy.
• Note that exposure to clindamycin, doxycycline, quinolones, macrolides and phenoxymethylpenicillin, increased the risk of these birth defects, although there was no increased risk of major congenital malformations linked to exposure to amoxicillin, cephalosporins, or nitrofurantoin.

Several common types of antibiotics were linked both to major congenital and to organ specific malformations in infants when taken during the first trimester of pregnancy, a retrospective Canadian cohort study found.
Exposure to antibiotics, such as clindamycin, doxycycline, quinolones, macrolides and phenoxymethylpenicillin, increased the risk of these birth defects, reported Flory T. Muanda, MD, of the University of Montreal, and colleagues.
However, there was no increased risk of major congenital malformations linked to exposure to amoxicillin, cephalosporins, or nitrofurantoin, the authors wrote in the British Journal of Clinical Pharmacology.
They added that while animal studies showed a link between exposure to certain antibiotics, those results could not be extrapolated to humans, and characterized the evidence from human studies on the subject as “inconclusive,” with conflicting results about the link between major congenital malformations in the fetus and the safety of certain antibiotics.
But to their knowledge, they said, “this is the largest cohort study investigating the risk of [major congenital] … [and] organ specific malformations associated with the use of antibiotic classes and types during pregnancy.”
Researchers examined data from the Quebec pregnancy cohort, an ongoing population-based cohort with data on all pregnancies covered by Quebec Public Prescription Drug Insurance from 1998 to 2008, comprising about 140,000 infants.
Exposure to antibiotics was defined as having filled at least one prescription for any type of antibiotics within the first trimester or a prescription for antibiotics before pregnancy, which overlapped the early part of pregnancy. Major congenital malformations were defined according to ICD-9 and ICD-10 codes.
Overall, 15,469 pregnancies (11%) were exposed during the first trimester. Almost 60% of antibiotics users were exposed to penicillins only, followed by 15% exposed to macrolides only, and 6.5% to cephalosporins only.
The authors found that users of antibiotics were more likely to be welfare recipients, less educated, living alone, and have more comorbidities and infections than those not exposed to antibiotics.
Ofloxacin had more than an eight-fold increased risk of major congenital malformations (adjusted OR 8.30, 95% CI 1.60-43.00), although this was on the basis of just three cases, hence the wide confidence interval.
Clindamycin was linked with an increased risk in these malformations with 60 cases seen (adjusted OR 1.34, 95% CI 1.02-1.77).
Organ specific malformations varied by antibiotic exposure. Both clindamycin and doxycycline were linked with increased risk of ventricular/atrial septal defects (adjusted OR 1.67, 95% CI 1.12-2.48, 29 exposed cases and adjusted OR 3.19, 95% CI 1.57-6.48, eight exposed cases, respectively).
Doxycycline was linked with an increase in other cardiovascular malformations, such as circulatory system malformations (adjusted OR 2.38, 95% CI 1.21-4.67, nine exposed cases) and cardiac malformations (adjusted OR 2.46, 95% CI 1.21-4.99, eight exposed cases).
The authors noted that the findings for doxycycline were consistent with a previous study suggesting increased risk of heart defects associated with tetracyclines.
Their findings for clindamycin were novel, however, as no previous studies have investigated the risk of malformations with the use of this antibiotic, they said. But prior research found nitrosatable drugs, such as clindamycin, linked to an increased risk of many congenital malformations, including heart malformations.
The authors also found that phenoxymethylpenicillin was linked with an increased risk of nervous system malformations (adjusted OR 1.85, 95% CI 1.01-3.39, 11 exposed cases), while erythromycin exposure was linked to a higher risk of urinary system malformations (adjusted OR 2.12, 95% CI 1.08-4.17), and moxifloxacin was associated with an increased risk of respiratory system malformations (adjusted OR 5.48, 95% CI 1.32-22.76, two exposed cases).
Limitations include potential unmeasured confounders, such as smoking, folic acid and alcohol intake, as well as that the study was underpowered to detect associations between individual antibiotics and specific malformations due to the low number of cases.
They concluded that, despite the small absolute risks associated with these birth defects, “physicians should consider prescribing safer antibiotics for the treatment of maternal infections when possible.”

This study was supported in part by grants from the Canadian government.
Muanda disclosed financial support from the University of Montreal and the Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research.
One co-author disclosed being the endowment Research Chair of the Famille Louis Boivin on Medications, Pregnancy and Lactation at the Faculty of Pharmacy at the University of Montreal and being a consultant for plaintiffs in litigations involving antidepressants with birth defects.

Scientists Reverse Brain Damage in Drowned U.S. Toddler

Newsweek – Hannah Osborne,  July 19, 2017

Eden was submerged in 5 degree Celsius for 15 minutes and was unresponsive after being resuscitated.

In what is believed to be a world first, scientists have reversed brain damage in a toddler that drowned in a swimming pool. Using oxygen therapy, scientists were able to restore her ability to walk and talk just months after the accident, in which she spent 15 minutes submerged in a swimming pool and two hours where her heart did not beat on its own.
The accident took place in February 2016. Two-year-old Eden Carlson had managed to get through a baby gate and fall into the family swimming pool and was in the 5 degree Celsius water for up to 15 minutes before being discovered.
After being resuscitated and treated in hospital for just over a month, she was unresponsive to all stimuli. She was immobile and constantly squirmed and shook her head. MRI scans showed deep injury to the brain’s gray matter, as well as loss of white and gray matter.
In a bid to reverse the brain damage, researchers at the LSU Health New Orleans School of Medicine and the University of North Dakota School of Medicine began treating her with two types of oxygen therapy.
This includes normobaric oxygen therapy, where levels of oxygen given are the same as at sea level, and hyperbaric oxygen therapy (HBOT), where they are given pure oxygen at pressures higher than that of the atmosphere within a special chamber.
Fifty five days after the drowning accident, doctors started giving Eden normobaric oxygen for 45 minutes twice per day. This appeared to make her more alert and awake, and she stopped squirming. She started laughing more and was able to move her arms and hands, and grasp with her left. Scientists also noted eye-tracking movements and some speech.
After 78 days, Eden began HBOT therapy, with 45 minute sessions five days per week for four weeks. After 10 sessions, her mother said she was almost back to normal other than motor function. After 39 sessions—coupled with physical therapy—Eden was able to walk and her speech had returned to normal. Her cognitive abilities had improved and motor function was almost restored to pre-drowning levels.
An MRI scan a month after the 40th HBOT session showed almost complete reversal of the brain damage initially recorded. Researchers believe the oxygen therapy, coupled with Eden having the developing brain of a child, had activated genes that promote cell survival and reduce inflammation—allowing the brain to recover. The case report is published in the journal Medical Gas Research.
Paul Harch, who treated Eden, said in a statement: “The startling regrowth of tissue in this case occurred because we were able to intervene early in a growing child, before long-term tissue degeneration. Although it’s impossible to conclude from this single case if the sequential application of normobaric oxygen then HBOT would be more effective than HBOT alone, in the absence of HBOT therapy, short duration, repetitive normobaric oxygen therapy may be an option until HBOT is available.”
Concluding, the researchers say that to their knowledge, this is the first reported case of gray matter loss and white matter atrophy (types of brain damage) reversal with any therapy and that treatment with oxygen should be considered in similar cases. “Such low-risk medical treatment may have a profound effect on recovery of function in similar patients who are neurologically devastated by drowning.”

Artificial intelligence is transforming radiology, but it still can’t make human judgment calls

by Joanne Finnegan |FierceHealth Jul 18, 2017 11:53am

Automation is expected to replace millions of jobs in the coming years, but it’s not just blue-collar workers in the crossfire. Technology is changing the way some doctors work, and that could result in lower demand for some specialties.
As artificial intelligence expands into healthcare, radiologists will be among the first doctors who will have to adapt.
That’s because AI can help read the medical images that radiologists use to diagnose and treat patients, providing better services at lower costs by, for instance, improving the analysis of an MRI. “This is going to be transformational,” Keith Dreyer, D.O., vice chairman of radiology computing and information sciences at Massachusetts General Hospital, told CNN.
Massachusetts General Hospital is embracing the change, organizing data to train algorithms with a focus on 25 ways AI can respond to match the image interpretation that a radiologist does now.
Will radiologists someday be obsolete? Geoffrey Hinton, an expert in AI, suggested that medical schools should stop training doctors to be radiologists, according to CNN.
But others in the field won’t go that far. Radiologists will still be needed to make judgment calls, said Carla Leibowitz, head of strategy and marketing at Arterys, a company that has created a program to read MRIs of the heart.
With artificial intelligence poised to take over image-centric medical domains, some health experts are urging radiologists and pathologists to consider merging into a single specialty. They could take on a single role as “information specialists,” allowing computers to take over the menial tasks associated with reading images.

The One Universal Truth About Medicine

Communication is key, says Suneel Dhand
by Suneel Dhand, MD July 18, 2017

There are many different theories out there about the direction that healthcare should go and what we need to be doing in the future. Passions run high, and peoples’ opinions vary wildly. It’s frequently difficult to find agreement on anything. There is, however, one universal truth I’ve found about the everyday practice of medicine, and what constitutes great medical care for any individual in any healthcare system. Having worked in the United Kingdom, Australia, up and down the east coast here in America — and even had experience with medicine in a third world country, India, when relatives have been unwell — the same rule always applies. This is the following: Good communication is at the core of all good medical care, no matter where you are.
Here are three important examples:
1. The doctor-patient interaction. However advanced we become scientifically and technologically, humans will always be humans. We are emotional beings that crave one-on-one personal connection. That sacred doctor-patient interaction, centered around trust, is to be valued and promoted. Doctors frequently need to be good communicators above being highly skilled clinicians. The ability to communicate well with patients and have a deep understanding of human nature, is paramount for any competent physician. We’ve all seen everyday examples of physicians who could quote you any scientific paper from the last decade, yet have no idea how to talk to patients and their families. At the opposite end of the spectrum, is a physician who is terrible clinically (not that it’s ever something to aspire to), yet is highly personable — and their patients love them! While lots of traits that lead people to be good communicators may be innate, there are also many skills that can totally be taught and improved upon through deliberate practice.
2. Organizational and administrative communication. The reality of modern day healthcare is that organizations need to work with all their staff and be as collaborative and open as possible. As soon as mistrust and suspicion has taken hold between administrations and their frontline staff, it’s a very difficult situation to come back from without a major overhaul. It never ceases to surprise me how some very experienced and high-level people can be such poor communicators, and not have insight into the effect their poor choice of words and tone have.
3. Communication between doctors and healthcare facilities. There is a term I use, and have written about previously, called “Too Many Cooks in the Kitchen Syndrome.” This is an all too common occurrence in healthcare settings when a complex (typically elderly) patient with multiple comorbidities, is seen by a large number of different specialists. Communication is lacking between these different doctors, and everything ends up confused and muddled (most of all for the patients and their families). Along the same lines, communication within and between healthcare facilities during transitions of care also still sadly leaves much to be desired. In these situations, nothing beats a concise, good old fashioned face-to-face or telephone conversation between doctors.

We have so much we need to improve upon. As with many things in healthcare, lots of the answers are surprisingly straightforward. They basically rely on talking and communicating more with each other. They do not — as lots of people sadly believe — rely on more computer time, funky expensive apps, or more complex bureaucracy (ironically, many of the issues that doctors, nurses, and patients have right now with healthcare information technology, is the widespread perception that it actually impedes good communication). That’s not to say that technology doesn’t play a crucial role in communicating test results and messages, but where we fall short is often in other simpler ways.

Healthcare is a unique field. It is emotional and personal. For patients, who are being seen at a very low point in their lives, nothing could be more important than being able to communicate with their doctors, and also knowing that their doctors are communicating with each other. For physicians, those moments of one-on-one communication and personal connection are also the most meaningful as well. It’s a field where communication is literally, everything.

Suneel Dhand is an internal medicine physician and author of three books, including Thomas Jefferson: Lessons from a Secret Buddha. He is the founder and director, HealthITImprove, and blogs at his self-titled site, Suneel Dhand. This post appeared in

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.

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