Illinois medical malpractice

Stroke victims, their families and attorneys should be aware that Post-Traumatic Stress Disorder (PTSD) is a common disorder found after stroke or major traumas, and may play a significant role in impeding recovery. Frequently a consequence of acute life-threatening events, including acute coronary syndrome (ACS), cancer, and stroke, PTSD is estimated to affect up to 18% of stroke survivors. PTSD has been shown to impair stoke victims’ reliable adherence to medication regimens, according to new research.

Investigators at Columbia University Medical Center in New York found that 65% of stroke survivors with PTSD failed to adhere to treatment vs 33% of their counterparts without PTSD. They also found that concerns about medications were a primary barrier to treatment adherence.
Stroke survivors should be assessed for concerns about medications and PTSD symptoms, so that interventions may be introduced as early as possible to get patients back on track to avoid future stroke events. The study was published online on January 7th in the British Journal of Health Psychology.

In survivors of strokes and transient ischaemic attacks…adherence to risk-reducing medications, including antiplatelet agents, antihypertensive agents, and statins, is especially important for preventing subsequent strokes.

Veterans and Medicare beneficiaries can now enjoy new access to their own medical information and other data. In August, President Obama announced the creation of the “Blue Button”—a web-based feature through which patients may easily download their health information and share it with health care providers, caregivers, and others they trust. Since then, the Department of Veterans Affairs (VA) and the Centers for Medicare & Medicaid Services (CMS) in the Department of Health and Human Services (HHS) have beta-tested their respective systems—with great success. The Blue Button was formally launched today.

Veterans should log onto My HealtheVet at www.myhealth.va.gov and click the Blue Button can save or print information from their own health records. Medicare beneficiaries who are registered users of www.mymedicare.gov can log onto a secure site where they can save or print their Medicare claims and self-entered personal information with the Blue Button there. Data from of each site can be used to create portable medical histories that will facilitate dialog with Veterans’ and beneficiaries’ health care providers, caregivers, and other trusted individuals or entities.

The Blue Button option should help Veterans and Medicare beneficiaries save their information on individual computers and portable storage devices or print that information in hard copy. Having this ready access to personal health information from Medicare claims can help beneficiaries understand their medical history and work more easily and effectively with providers, as well as provide valuable assistance to their attorneys. The Blue Button feature will allow Medicare beneficiaries to view their claims and self-entered information—and be able to export that data onto their own computer. The information is downloaded as an “ASCII text file,” the easiest and simplest electronic text format. The files are easy to read by the individual, and helps organize a lot of information.

The My HealtheVet personal health record includes self-entered health data (including blood pressure, weight, and heart rate), emergency contact information, test results, family health history, military health history, and other health-related information. The ASCII text file that Veterans can download will include this information. As additional personal health information becomes available to VA patients through the My HealtheVet personal health record, this will also be added to the VA Blue Button download. In pre-launch testings, the VA’s Blue Button system has generated an overwhelmingly positive response, and many veterans have already used it to access their records.

For a long time, registered users of MyMedicare.gov have had the ability to view their Medicare claims information add their personal and health information, such as emergency contact information, names of pharmacies and providers, self-reported allergies, medical conditions, and prescription drugs. Now, with the Blue Button, CMS is making it convenient and safe for them to download and share this information in an easy-to-read and portable format. For people who are involved in personal injury or medical malpractice claims, the slow-moving administration of Medicare agencies has delayed their recoveries of settlement funds for months, and oftentimes, for more than a year!

The VA and CMS both stress the importance to users of protecting the electronic information on their personal computers with appropriate security measures. Once individuals download their data, they will need to ensure its safety—for example, by encryption or password protection.

The VA and CMS issued a challenge to software developers to develop apps to make the Blue Button even easier and more useful. The winner of that challenge is Adobe’s Blue Button Health Assistant. This new “app” provides a comfortable and familiar user layout and eases the linkage of consumer information—including immunizations, allergies, medications, family health history, lab test results, and military service histories—among patients, providers, and caregivers using My HealtheVet, or claims data for those using the CMS Button.

Soon, Blue Button users may be able to augment the downloaded information that is housed on their computers—or that they transferred to a commercial personal health record or other health application—through automated connections to, and downloads from, major pharmacies including Walgreens and CVS; lab systems such as Quest and LabCorp; and an increasing number of inpatient and outpatient electronic medical records systems.

The FDA has issued a “Warning Letter”, dated January 10, 2013, to St. Jude Medical, a company that manufactures many medical devices used throughout the world, including implantable cardiac devices. In the letter, St, Jude was advised that, during a 2012 inspection of St. Jude’s Sylmar, California facility, FDA investigators determined that St. Jude manufactured implantable cardiac leads which were “adulterated” under federal law, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. While St. Jude has responded to some of the concerns addressed by the investigators,the FDA has concluded that the responses were inadequate.

The FDA has asked St. Jude to provide written notice within fifteen business days from the date they received the warning letter of the specific steps St. Judey has taken to correct the noted violations, as well as an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again. They asked that St. Jude include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that the firm has taken. If St. Jude’s planned corrections and/or corrective actions will occur over time, they are to include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, St. Jude was asked to state the reason for the delay and the time within which these activities will be completed. Finally, the warning letter notes that St. Jude’s “response should be comprehensive and address all violations included in this Warning Letter.” We’ll see…but it looks like the FDA is finally running out of patience with St. Jude.

Unredacted Reports of Nursing Home Inspections Now Available!

From good buddy-nurse-paralegal Janabeth Taylor….’Feds Release Nursing Home Inspections, Free of Censor’s Marks’ – the government has released unredacted write-ups of problems found during nursing home inspections around the country. ProPublica is making them available today for anyone who wants to download the complete versions. http://www.propublica.org/article/feds-release-nursing-home-inspectionsWATCH “The Silent Epidemic – Nursing Home Care Abuse ”

The site contains real stories about real people who have been harmed by “tort reform.” And it demonstrates how site visitors could easily find themselves victims themselves. It engages people with a full-time social media commitment and blogs from outside organizations dedicated to civil justice. And it provides all the tools to motivate people to take action right from the site, from contacting their members of Congress to signing petitions.

Researchers have found that as many as 28% of adult patients in intensive care units die each year with a misdiagnosis,
and up to 8% die with a potentially fatal “major missed diagnosis,” such as pulmonary embolism or myocardial infarction.

These findings come from a meta-analysis of 31 autopsy-based studies (BMJ Qual Saf 2012; doi:10.1136/bmjqs-2012-000803), and might even understate the rate of missed diagnoses, said Bradford Winters, MD, PhD, associate professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine, in Baltimore, who led the research.

“Since we did not include non-autopsy-based studies in our analysis, we did not evaluate misdiagnoses that did not result in death, but that are likely associated with increased morbidity health care costs,” Dr. Winters told General Surgery News.

The 31 studies–which were observational, mostly retrospective studies and largely based in the United States–included information from 5,863 autopsied adults who had died in an intensive care unit (ICU). The papers were published between 1966 and 2011. The analysis excluded publications that examined the rate of disease-specific misdiagnoses and studies
that did not include original data. A median of 43% of ICU deaths that occurred during the study period were autopsied.

The investigators turned to the Goldman Classification, widely used for autopsy findings, to group the misdiagnoses they identified. The criteria define class I errors as “missed major misdiagnoses with potential adverse impact on survival and that would have changed management”; class II errors as missed major diagnoses that would not have affected survival or altered the course of care; and class III and class IV errors as misdiagnoses related to the terminal disease but not related to death or unrelated to both disease and death, respectively.

The rate of misdiagnoses detected during autopsy ranged from 5.5% to 100%, with a 28% overall rate (1,632 of 5,863), the researchers found. Class I and class II errors accounted for 8% and 15% of misdiagnoses, respectively; class III and class IV errors accounted for 15% and 21%, respectively. Dr. Winters noted that some studies reported only the total number
of misdiagnoses and class I or class II errors, leaving the specific misdiagnoses of the remaining 41% unclear.

The most common class I and class II misdiagnoses reported in the studies were vascular events and infections.

The 8% rate of major and potentially lethal ICU misdiagnoses is higher than the 5% rate of lethal misdiagnoses documented in the general hospital population in a previous study (JAMA 2003;289:2849-2856). The difference, Dr. Winters explained, can be attributed to ICU-specific factors such as the inability of patients to communicate their medical history during the workup process and limited staff resources leading to “competition for care.” Factors not specific to the ICU, including an overload of information and cognitive errors that lead to a biased interpretation of patient data, also may play a role.

Richard Dutton, MD, executive director of the Anesthesia Quality Institute, in Park Ridge, Ill., who specializes in trauma, said several limitations may undermine the generalizability of the findings. “Most autopsied patients have some level of diagnostic uncertainty to begin with, which makes the population in this meta-analysis not completely representative of the general ICU population,” said Dr. Dutton, who was not involved in the research.

Some of the studies included in the meta-analysis were conducted before the introduction of more accurate and advanced imaging-based diagnostics, Dr. Dutton noted. And he questioned the effect that missed class I or class II diagnoses would have had on patient outcomes had they been identified. “If a patient is dying of septic shock, secondary events like myocardial infarction and pulmonary embolism, which are common during the immediate premortem period, may not have affected their survival.”