Sunday, August 4, 2019

PKD Patients: Brain Aneurysm Screening, Kidney Charity Lawsuit, VA and Google DeepMind AI: Predicting Acute Kidney Disease

Living with PKD

From MedicalXpress, by American Society of Nephrology

Should polycystic kidney disease patients be screened for brain aneurysms?

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive development of kidney cysts, as well as abnormalities outside the kidneys, including brain aneurysms—or weaknesses in blood vessels in the brain that balloon and fill with blood and may later rupture. A new study appearing in CJASNinvestigated whether patients with ADPKD should be routinely screened for brain aneurysms.

For the study, Vincente E. Torres, MD, Ph.D. (Mayo Clinic) and his colleagues examined the medical records of 812 patients with ADPKD who were evaluated between 1989 and 2017 and underwent brain imaging tests despite having no neurological symptoms.

Among the major findings:
  • 94 brain aneurysms were diagnosed in 75 of the 812 (9%) patients who underwent screening. None of the aneurysms ruptured over an average follow-up of 9 years.
  • Gender, age, race, and genetics related to ADPKD were similar in the groups with and without aneurysms, but hypertension and a history of smoking were more frequent in the aneurysm group.
  • 29% of patients with aneurysms vs. 11% of those without aneurysms had a family history of subarachnoid hemorrhage, a type of stroke caused by bleeding into the space surrounding the brain.
  • Among patients who had evidence of aneurysms at the initial screening, new brain aneurysms were detected in 5 patients during an average follow-up of 8 years, and none of the aneurysms ruptured.
  • Among 135 of the 737 patients with no brain aneurysms detected at the first screening who underwent additional screening, 3 patients developed aneurysms over an average follow-up of 7 years, and 2 patients had a brain aneurysm rupture. Both patients had significant risk factors for brain aneurysm development and rupture.
The investigators noted that their results do not allow a firm conclusion on whether widespread or selective screening for brain aneurysms is beneficial in ADPKD. A large prospective study would be necessary to determine the benefits and costs of such strategies.

"Our approach has been to recommend screening for patients with ADPKD who have a family history of aneurysm. We also recommend screening to patients with ADPKD before major elective surgeries (including transplantation), those with high risk occupations, and those who after being properly informed on the available data wish to be screened for reassurance," said Dr. Torres. "We educate our patients on the importance of correcting conditions that have been associated with aneurysmal development and/or rupture, particularly smoking and inadequately controlled hypertension. The results our study do not provide a reason for changing our current approach".

In an accompanying editorial, Ivana Kuo, Ph.D. (Loyola University School of Medicine) and Arlene Chapman, MD (University of Chicago) noted that "this report provides some incremental confirmatory information regarding the increased frequency of intracranial aneurysm, the traditional characteristics of intracranial aneurysm in ADPKD similar to the general population, and a significant need for more mechanistic studies to determine how central a role the ADPKD proteins play in intracranial aneurysm formation."

In an accompanying Patient Voice editorial, Kevin Fowler shared his first-hand experiences with ADPKD and his opinion of the study.




Kidney Dialysis

From New York Times, By Reed Abelson and Katie Thomas

Top Kidney Charity Directed Aid to Patients at DaVita and Fresenius Clinics, Lawsuit Claims

A whistle-blower said the leading charity favored patients from the major dialysis chains because the companies were its biggest donors.

One of the nation’s largest public charities steered financial aid to patients of its two biggest corporate donors — the dialysis chains DaVita and Fresenius — while denying help to people who used smaller, unrelated clinics, in violation of anti-kickback laws, according to a federal whistle-blower lawsuit unsealed this week in Boston.

The charity, the American Kidney Fund, helps patients who need dialysis by paying their health insurance premiums and other costs for treatment. But under a longstanding federal agreement intended to prevent illegal kickbacks, the charity is supposed to provide help based solely on a patient’s financial need, and not favor companies that donate to it.

The lawsuit, filed by David Gonzalez, who worked for 12 years at the kidney fund in its patient assistance program until he left in 2015, accused the charity of creating a so-called blocked list of dialysis clinics whose patients would not get financial assistance while making sure patients at clinics operated by DaVita and Fresenius would.

The Justice Department, which had earlier issued subpoenas regarding the accusations, said it would not join the case. But it requested that the court seek the department’s consent if a decision were reached to dismiss or settle the lawsuit. Some cases that did not involve federal prosecutors have still led to large settlements, including one in which Celgene agreed to pay $280 million to settle claims it had inappropriately marketed the cancer drugs Thalomid and Revlimid.

In a statement, LaVarne A. Burton, president of the American Kidney Fund, said the group was pleased that the Justice Department had declined to intervene and said it had cooperated fully in the case. “We now know that this suit was brought by a former employee who, prior to making this complaint, was terminated for cause,” she said. The fund adheres to the federal agreement that governs its charitable program, she added.

“The Department of Justice has looked at this matter and decided not to pursue any action against DaVita,” the company said in a statement.

Fresenius declined to comment. A lawyer for Mr. Gonzalez did not return a request for comment.

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Fresenius and DaVita control about 70 percent of the market. The accusations against the big dialysis chains have become public just a few weeks after the Trump administration called for a shift away from the care provided in dialysis clinics to kidney transplants or in-home dialysis.

The allegations in the lawsuit mirror the findings of a 2016 report in The New York Times about the fund. Representative Katie Porter, a California Democrat, recently requested that the Office of Inspector General for the Department of Health and Human Services, the federal agency that created the original guidelines for the charity, investigate the charity’s activities. A spokeswoman for the agency said it would not comment.

The lawsuit, filed in 2016, says the charity went to great lengths to ensure no aid was given to patients at clinics that were not donors. Mr. Gonzalez said in his lawsuit that the charity began formally tracking donors in 2009, labeling those clinics that did not contribute as “free riders.”

When the charity was criticized for its use of a “blocked list” of clinics, it changed the name to “training list,” according to the lawsuit. The charity would contact these clinics to request donations in specific amounts, calculated by looking at the payments made to patients at these clinics.

When one patient moved from a Fresenius clinic in Florida to a clinic in Indianapolis, the fund initially stopped paying the patient’s premiums, according to the lawsuit, because the new clinic had not donated. “She will definitely lose the policy without AKF assistance, so I just wanted to see what we are able to do,” the patient’s social worker wrote in an email quoted in the suit.

Similarly, Mr. Gonzalez described the “rough treatment” given to Kaiser Permanente, the California group, which he says was blocked in 2015.

With revenues of $299 million in 2018, the American Kidney Fund is one of the country’s largest charities and helped pay the insurance premiums of about 74,000 people in 2017, or about one in every five patients who underwent dialysis.

It continues to receive the vast majority of its support from DaVita and Fresenius. In 2018, the group’s external auditors said it had received $247 million from two corporations, which represented 82 percent of its total revenues.

Though the two companies were not named, the whistle-blower complaint identified the group’s primary contributors as DaVita and Fresenius, as have insurers and state regulators. The American Kidney Fund said it could not reveal the identities of the contributors.




Predicting Kidney Disease

From Business Insider, Zachary Hendrickson

Google's DeepMind is applying artificial intelligence to detect acute kidney disease

The health unit of Google's London-based AI powerhouse DeepMind published research that claims its machine learning (ML) AI can accurately predict 90% of acute kidney injuries (AKI) that would require dialysis and spot potentially fatal kidney injuries 48 hours before symptoms are recognized by doctors, per CNBC.

AKI refers to sudden impairment or failure of normal kidney functions, and it claims the lives of approximately 2 million people globally each year, according to research from the University of Pittsburgh School of Medicine.

Here's what it means: DeepMind's tech is a groundbreaking application of ML for clinical diagnostics, but false positives and a lack of diversity in the study's participants means this is just the start of its efforts.

  • This study is a breakthrough for the early detection of AKI — a notoriously difficult disease for physicians to identify. The disease is hard to detect given how little is known about its causes and the speed at which the kidney breakdown occurs. But by assessing insights gleaned from electronic health records (EHRs), DeepMind's ML algorithm outperformed current clinical models used for AKI risk assessment by 20%, per STAT.
  • Still, shortcomings in DeepMind's study suggest its algorithm is just the first step — not a final solution — for the detection of AKI. Because DeepMind trained its AI detection tool on anonymized data from 700,000 patients in US Veteran's Affairs (VA) hospitals across the country, the study suffered from a lack of patient diversity due to the demographics of the VA: Only about 6% of all patients used in the data set were female, for instance. When asked about how DeepMind Health addressed concerns around gender and racial diversity in its VA study a spokesperson for DeepMind Health informed Business Insider Intelligence that its model predicted 56% of AKI early in men, but only 44.8% overall for patients whose gender was known, indicating worse outcomes for female patients. Furthermore, they shared that the model actually performed 6% better among African American patients than all other ethnicities in aggregate, which can be critical given that recent studies have shown African Americans are 30-50%more likely to experience AKI.

The bigger picture: DeepMind's VA study marks the first US partnership for the London-based Google subsidiary — and it's likely the first of many as one of DeepMind Health's most prominent teams is soon to be absorbed into Google Health.

DeepMind is coming stateside with long-term plans to bring AI-informed decision making to " nurses and doctors everywhere." New information about the performance of DeepMind's clinical alert and patient management app, Streams, in UK hospitals was also announced alongside the VA study results.

A peer review revealed that Streams reduced cost of care by more than £ 2,000 ($2,400) per patient, according to Digital Health. Notably, Streams was designed in part to more efficiently notify caregivers of preventable, but difficult-to-detect conditions like sepsis and AKI via assessment tools already used by the UK's National Health System. And the new algorithm trained on data from the VA study will eventually be incorporated into the app.

This all comes less than a year after Google Health announced it would absorb the DeepMind Health team behind Streams. I (Zach) think it's highly likely we'll see an updated version of Streams released in the US very soon — which would be a major US healthcare play for Google Health.

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