According to interviews with U.S. physicians, some Roman Catholic hospitals not only refuse to provide some women's health services like abortion, but may also prevent doctors from referring women to facilities that would provide them.
Performing high-sensitivity troponin (hs-TnT) tests, in the absence of an explicit management protocol incorporating the results, did not alter treatment or outcomes of patients with acute coronary syndrome in a prospective multi-center trial.
Patients who had serum troponin levels reported with the hs-TnT test were just as likely as their peers who underwent a standard assay to be admitted (57.7% versus 58.0%, P=0.069) and to have angiography (11.9% versus 10.9%, P=0.479), Derek P. Chew, MBBS, MPH, of Flinders Medical Centre in Australia, and colleagues reported online in Circulation: Cardiovascular Quality and Outcomes.
Clinical outcomes were no different at 12 months, either, with hs-TnT reporting versus standard reporting in terms of:
Death or acute coronary syndrome (5.86% versus 7.05%, HR 0.83, 95% CI 0.57 to 1.22)
MI (2.06% versus 2.18%, HR 0.94, 95% CI 0.64 to 1.40)
Readmission for chest pain (13.46% versus 13.28%, HR 0.98, 95% CI 0.78 to 1.25)
Any cardiovascular event (24.67% versus 24.07%, HR 1.04, 95% CI 0.87 to 1.25)
The exception was the group with troponin levels below 30 ng/L, which saw a modest reduction in the combination of mortality and acute coronary syndrome when the highly sensitive test was used (2.6% versus 4.4%, HR 0.58, 95% CI 0.34 to 1.00).
"We observed only modest impact on clinical practice considering the greater degree of information offered by the hs-TnT result, with only minor reduction in the rate of discharge from hospital, and a nonsignificant increases in hospital admissions and revascularization overall," Chew and co-authors wrote.
Thus, "hs-TnT reporting alone is associated with only modest changes in practice. Clinical effectiveness in the adoption of hs-TnT may require close coupling with protocols that guide interpretation and care," they continued, adding that a real shift towards a notable impact would require a change in clinical decision-making.
"High-sensitivity troponin provides useful risk information, but routine reporting without integration within protocols is associated with only modest changes in practice. Nevertheless, beyond the diagnostic process, routine use may improve late outcomes. Adoption of high-sensitivity troponin testing is likely to require coupling with management protocols that guide interpretation and care if the benefits of greater diagnostic discrimination are to be harnessed."
The multicenter trial included 1,937 patients presenting to emergency departments from 2011 through 2013 who had chest pain but no ST-segment elevation. They were randomized to hs-TnT reporting or a standard troponin T assay.
At the index hospitalization, 75.7% had a maximal troponin level below 30 ng/L within 24 hours.
The investigators noted a previous observational study had come up with different results, which they suggested could be attributable to "a greater difference in the information being provided to the clinician resulting from a much greater difference in assay performance between the two troponin I tests assessed; the post hoc exclusion of patients with an alternate noncardiac diagnosis; and the impact of secular changes in clinical practice that is difficult to control for when conducting a before and after comparisons of healthcare innovations."
"Of significance is that hs-TnT assays are yet to be approved by the Food and Drug Administration for routine use in the United States, whereas HealthPACT (Australian Health Technology Assessment Agency) and the Canadian Agency for Drug and Technologies in Heath currently recommend against routine use as recently as in 2011 and 2013, respectively," Chew's group commented.
In those other countries, they added, "The routine use of hs-TnT assays incorporated into protocols of care is currently advocated in acute coronary syndrome guidelines, particularly for identifying patients suitable to early discharge."
"This study highlights the inertia of clinical decision making in response to the adoption of new diagnostic and therapeutic innovations. Availability of troponin results with greater diagnostic precision alone did not substantially improve the effectiveness or efficiency of care, particularly among patients with low or no detectable troponin T," they concluded.
"The modest change in practice may reflect many factors, including a lack of clinical appreciation of the increased risk for future events associated with low-level elevations in troponin or the lack of mature decision making and established investigative/management pathways for the care of patients with and without evidence of low-grade myocardial injury."
There was no dearth of studies, columns, and think pieces exploring the slowdown in healthcare costs for the decade starting in 2004. But the slowdown didn't affect everyone equally, according to a report in the July issue of Health Affairs, and the result is a growing disparity in health expenditures.
The U.S. Preventive Services Task Force released an updated recommendation ("I" statement) this week citing insufficient evidence for universal screening for heterozygous familial hypercholesterolemia and multifactorial dyslipidemia in children and adolescents.
Liver transplantation might become more equitable under an allocation program being considered by the United Network for Organ Sharing (UNOS) and the Organ Procurement and Transplantation Network (OPTN).
In one of the first studies of its kind, tau imaging was able to distinguish patients with Alzheimer's disease from those without, researchers reported.
The revised model should "enable improved assessment of hospital quality and enhance research into best practices to further reduce mortality in patients with acute MI," researchers say. From MedPage Today.
This article first appeared August 1, 2016 on the Medpage Today website
by Salynn Boyles
The first time inclusion of cardiac arrest in the latest version of the ACTION Registry-Get With the Guidelines (GWTG) in-hospital mortality risk model following myocardial infarction, increases the efficacy of this tool for assessing death risk among hospitalized patients, researchers reported.
The updated model replaces an earlier version of the in-hospital mortality risk prediction tool, and it was based on data from MI patients hospitalized over a 2-year period from 2012 through 2013.
In an analysis, researcher Robert L. McNamara, MD, of Yale University School of Medicine, New Haven, Connecticut, and colleagues, wrote that the revised model should "enable improved assessment of hospital quality and enhance research into best practices to further reduce mortality in patients with acute MI." The new model and analysis were published online August 1 in the Journal of the American College of Cardiology.
"The addition of risk adjustment for patients presenting after cardiac arrest is critically important and enables a fairer assessment across hospitals with varied case mix," they wrote.
In addition to cardiac arrest, other independent predictors of outcome included in the risk assessment model are patient age, presenting systolic blood pressure, heart rate at presentation, cardiogenic shock or heart failure at presentation, type of heart attack, creatinine clearance, and troponin ratio.
The analysis of data on 243,440 MI patients treated at 655 hospitals across the nation between January of 2012 and December of 2013 revealed an in-hospital mortality rate of 4.6%.
Risk scores varied significantly based on patient characteristics and clinical presentation. Younger heart patients without many other risk factors who did not present with cardiac arrest had a less than 1% risk of dying while hospitalized, while the death risk was close to 50% among older patients presenting with cardiac arrest and other risk factors.
"Observed mortality rates varied substantially across risk groups, ranging from 0.4% in the lowest group (score <30) to 49.5% in the highest group (score >59%)," the researchers wrote.
The revised model was found to perform well in subgroups based on age, sex, race, and transfer status; as well as the presence of diabetes, renal dysfunction, cardiac arrest, cardiogenic shock, and ST-segment elevation MI.
The researchers wrote that the revised model "represents a robust, parsimonious approach to contemporary risk adjustment methodology for in-hospital mortality after acute MI." But they also cited several potential limitations, including the voluntary nature of the registry.
"The contributing hospitals tend to be larger referral centers and are more likely to have PCI capabilities than the average U.S. hospital," they wrote, adding that in-hospital outcomes may not be generalizable to smaller hospitals.
They noted that the inclusion of additional information on patient baseline health status, such as frailty or other noncardiac conditions, could increase the robustness of the model.
In an editorial published with the study, Peter Wilson, MD, of Emory University School of Medicine in Atlanta, Georgia and Ralph D'Agostino Sr., PhD, of Boston University, wrote that research is needed comparing the growing number of risk algorithms for in-hospital MI outcomes, which now include TIMI, GRACE, ACTION-GWTG, HEART, and DAPT.
"Until now, clinicians and researchers have generally used either the TIMI or GRACE score to guide therapeutic decisions," they wrote. "With the advent of the ACTION score, which appears to be more helpful for patients with moderate-to-severe disease, and the HEART score, which targets care for patients with minimal-to-mild disease, there are other options."
They noted that a comprehensive, cross validation and comparison of TIMI, GRACE, HEART, DAPT, AND ACTION could provide valuable information.
"It is likely that one score does not fit all," they wrote. "Each algorithm provides a useful summary of risk to help guide decision-making for patients with ischemic symptoms depending on the severity of the signs and symptoms at presentation and the duration of the follow-up interval. Consensus building would help to move this field forward for hospital-based management of patients evaluated for cardiac ischemia."
Physicians have been advised to avoid prescribing these agents for uncomplicated infections unless there were no other options. Now, that advice will be carried on the drugs' package inserts. From MedPage Today.
This article first appeared July 29, 2016 on the MedPage Today website.
"These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient," the FDA explained in a Drug Safety Communication.
In the agency's previous announcement, it advised physicians to avoid prescribing these agents for uncomplicated infections unless there were no other options. Now, that advice will be carried on the drugs' package inserts.
The labels will also state that these agents should be reserved for patients "who have no other treatment options" for treating acute bacterial sinusitis, bronchitis, or urinary tract infections, "because the risk ... generally outweighs the benefits in these patients.
Fluoroquinolones -- a category that includes such familiar brand names as Cipro, Levaquin, Avelox, and Factive, with the identifying generic suffix "-floxacin" -- previously carried a boxed warning about tendinitis and tendon rupture and worsening of myasthenia gravis. The revised warning will now note that these effects may be permanent and disabling and may involve multiple body systems. Labels will also list an expanded range of serious potential side effects, ranging from skin rashes to hallucinations.
The warning were based mainly on a review of 178 reports of persistent (mean duration 14 months) adverse effects in previously healthy patients who used fluoroquinolones for common, uncomplicated infections. Long-lasting pain was the most common effect described.
At a "satellite" briefing held during the Republican National Convention, the CEO of the Cleveland Clinic CEO says the nation needs to learn to live with healthcare reform; Rep. Tom Price, MD, (R, GA) says 'no way.' From MedPage Today.
This article first appeared July 22, 2016 on MedPage Today .
by Shannon Firth
"We have to figure out how we can provide high quality care, better quality care, make it accessible and make it affordable ... that's an enormous job," saidDelos "Toby" Cosgrove, MD, CEO of the Cleveland Clinic, at a Thursday breakfast briefing hosted by the Washington Post.
The briefing was one of several "satellite" events held here during the Republican National Convention.
"You have to make [providers] understand what the objective is and figure out how we all get there together," Cosgrove continued.
He said promoting wellness, specifically targeting risk factors like smoking and obesity, was critical to getting a handle on healthcare costs.
The Clinic, which is Cleveland's largest employer and the second largest employer in Ohio -- Walmart is number one -- has been very aggressive in its efforts to promote wellness among its employees. "[W]e don't hire smokers anymore," he said. The clinic also removed all sugar-sweetened beverages from its soda machines.
Also, employees are given specific wellness goals. Employees who meet the goals are rewarded with discounted insurance premiums.
Cosgrove addressed those incentives, or carrots, at a separate panel briefing earlier in the week.
"[W]e started giving [employees] a small financial benefit on their insurance for dealing with diabetes, hypertension, asthma, and hypercholesterolemia. We've seen our inflation rate in healthcare per-member-per-month going from 7.5%, to now going flat and starting down, and that's over the course of a decade."
As an organization, "we've [collectively] lost over 500,000 pounds ... So at the end of the day, you're getting lower costs for everybody, and better care."
Another aspect of the clinic's cost-cutting approach is its focus on innovation, relying on virtual visits, for things such as dermatological appointments -- "you send them a picture of your rash and they'll tell you what the problem is -- and "shared medical appointments" in specific instances, such as giving instructions on how to take diabetes medications.
"[Patients] like it a lot and it's obviously efficient for the doc," he said
Cosgrove does not anticipate the repeal of Obamacare, he expects "continuing modifications."
"It's going to evolve over time ... it's change, and change requires time and discussion and explanation and effort."
"One out of every four individuals believe they've been harmed by the current law," said Price who spoke on a separate panel at the same briefing.
Donald Trump understands the "regulatory oppression" imposed by Obamacare, Price told MedPage Today.
Asked whether he believed providers should employ cost-saving strategies such as shared medical appointments, Price was dubious. "[T]o force patients into a mode of treatment that the patient doesn't desire is wrong. And that's what the administration doesn't appreciate."
"I think the first thing [Trump] would do would be to address the regulatory overreach of the federal government in the area of healthcare."
"A lot of individuals get coverage ... but no care," because of narrowed networks and high deductibles, Price said.
Quality has also suffered. Doctors aren't allowed to offer the tests they think are needed or to keep patients in the hospital for the length of time they think is necessary, or choose the best setting for a patient's care, he added.
"All the things that ought to be decisions between patients and family and doctors are being made by the federal government."
Price said he believes in the "repeal and replace" approach and supports Speaker Paul Ryan's "patient-centered" alternative plan.