The week in review, July 8-14, 2012
MedWire News: This week's stories include a new initiative to teach penny-pinching practices to medical residents, government grants to boost disaster preparedness, a review of patient-centered medical homes, an iPhone/iPad app that helps physicians keep adult vaccinations up-to-date, and the Food and Drug Administration (FDA) considering whether it should regulate such apps.
Is the FDA apt to regulate apps?
Jeffery Shuren, Head of the FDA's Center for Devices and Radiological Health, thinks that some mobile applications (apps) on the market are actually medical devices and should be subject to FDA approval, according to a report broadcast on National Public Radio (NPR)'s All Things Considered and published online in an NPR health blog.
In July 2011, the FDA invited public comment on a proposal to oversee mobile medical apps that are used as an accessory to an FDA-regulated medical device, such as an app that would allow clinicians to view medical images on, say, an Android smart phone or tablet. In addition, the FDA is considering regulating devices or programs that transform a mobile platform into a regulated medical device, such as a snap-on case that turns an Apple iPhone 4 into a mobile cardiac event recorder.
The FDA does not, however, plan to regulate apps such as exercise logs, pedometers, diet reminders, or similar programs that promote a healthy lifestyle, Shuren told NPR.
The agency's concern is that some apps intended for professional use could result in inadvertent harm or unnecessary care, such as a visit to the cardiologist and a full cardiac workup from a phone-generated electrocardiogram (ECG) recommendation.
App IDs adult vaccine needs
And while we're on the subject, The American College of Physicians (ACP) has released a free app for the Apple iPhone and iPad that furnishes clinicians on the move with information about the most up-to-date vaccine indications for adult patients.
The ACP Immunization Advisor app allows the user to search for vaccine indications by age or by underlying medical conditions. Alternatively, users can browse a vaccine library to determine which vaccines are appropriate and indicated for their adult patients.
The app also gives users access to information and updates about immunizations from the ACP and from the Centers for Disease Control and Prevention (CDC).
"ACP's goal is to improve healthcare quality by disseminating clinical guidance and practice support through innovative web and mobile applications," said Michael Barr, ACP senior vice president, in a statement.
The app is intended to give clinicians easy access to adult vaccination guidelines developed by the CDC, and to assist with clinical decision-making at the point of care.
The ACP also provides a free, downloadable guide to adult immunization, designed to provide practical information for both clinicians and support staff, including administrators and office staff, physicians, physician assistants, residents, nurse practitioners, and nurses.
Home sweet (medical) home
The US Agency for Healthcare Research and Quality (AHRQ) has issued a progress report on attempts to improve the quality of patient care through the patient-centered medical home (PCMH) model.
As part of a series of evidence-based reviews, AHRQ investigators reviewed studies that evaluated the effects of PCMH interventions, assessing the effects of the PCMH on patient and staff experiences, process of care, clinical outcomes, and economic outcomes. They also looked at specific PCMH components to determine whether any were associated with either improvements or unintended harms to patient and clinical staff experiences, process of care, and clinical and economic outcomes.
The report authors found that in 17 studies with comparison groups, "PCMH interventions had a small positive impact on patient experiences (including patient-perceived care coordination) and small to moderate positive effects on preventive care services."
They also found that clinical staff reported small to moderate improvements in their experiences, but did not have sufficient evidence to estimate the effects of interventions on either clinical outcomes or most economic outcomes.
Teaching residents about medicine and the value of a dollar
The ACP and the Alliance for Academic Internal Medicine (AAIM) have jointly developed what they describe in a statement as "a high-value, cost-conscious care curriculum."
The goal of the curriculum is to train internal medicine residents how to avoid unnecessary care that does not improve outcomes, and may cause harm.
The curriculum uses actual patient cases to involve both residents and faculty in ten 1-hour interactive exercises centered on the use of shared, evidence-based decision-making. The sessions are intended to help novice physicians arrive at decisions that take into account benefits, harms, and costs of therapeutic choices.
"Physicians receive little specific training about identifying and eliminating wasteful diagnostic and treatment options," said study author Cynthia Smith (ACP, Philadelphia, Pennsylvania) in a statement. "Residency training is an excellent time to introduce the concept of high-value, cost-conscious care because the habits that residents learn during training have been shown to stay with them throughout their professional careers."
Writing with colleagues on behalf of the curriculum developers in the Annals of Internal Medicine, Smith notes that US healthcare expenditures are expected to reach nearly 20% of the nation's gross domestic product by the year 2020.
HHS awards almost $ 1 billion to emergency preparedness
The Department of Health and Human Services (HHS) is contributing $ 971 million in grants to hospital-based and public health disaster preparedness services throughout the USA and its territories.
The grants include approximately $ 352 million awarded to the Hospital Preparedness Program (HPP) cooperative agreement and about $ 619 million awarded to the Public Health Emergency Preparedness (PHEP) cooperative agreement.
The HPP supports healthcare system planning and emergency response through funding of programs at the state, local, and territorial levels; preparedness, response and surge capacity of healthcare facilities by assisting with private and public sector medical planning; and state, local, and territorial infrastructure improvements to enhance emergency response.
The PHEP, administered by the CDC, provides grants to state, local, tribal, and territorial public health departments for more effective response to myriad public health threats, including infectious diseases, natural disasters, and biological, chemical, nuclear, and radiological events.
To encourage cooperation between public and private healthcare systems, HHS is, for the first time, awarding HPP and PHEP funds jointly.
By Neil Osterweil