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Photo: Len Bruzzese/AHCJWall Street Journal reporter John Carreyrou spoke about his award-winning investigation of Theranos at Health Journalism 2018.

One of the highlights of Health Journalism 2018 in Phoenix last month was John Carreyrou’s presentation about his work covering the much-troubled Theranos Inc., a Silicon Valley lab testing company that has been investigated by the Securities and Exchange Commission and the federal Centers for Medicare and Medicaid Services. In 2015, Carreyrou won first place in beat reporting in AHCJ’s Excellence in Health Care Journalism awards for his coverage of Theranos.

Last week, my colleague Rebecca Vesely covered his remarks for Covering Health. As she wrote, Carreyrou is a two-time Pulitzer Prize winning journalist at The Wall Street Journal who, in October 2015, started breaking stories about Theranos and its failed attempts to revolutionize blood testing.

Because today is the publication date for his book, “Bad Blood: Secrets and Lies in a Silicon Valley Startup,” I wanted to highlight the advice he gave about the need to have a lawyer on your side when doing investigative reporting.

Early in his work on Theranos, Carreyrou learned that the company’s legal counsel was David Boies, one of the nation’s best-known litigators. At the time, some of Carreyrou’s work was based on comments from a whistleblower, and he recognized that he would need the full support of his boss, Senior Editor Michael Siconolfi, and the newspaper’s lawyer, Jason Conti, who is now the general counsel and executive vice president of Dow Jones, the journal’s parent company.

Within weeks of making contact with the whistleblower, Carreyrou told Conti about the story and that attorneys from Bois’ firm, Bois Schiller Flexner, were threatening and harassing the whistleblower. Here’s his advice:

“I would recommend to all of you who are working on tough stories, that you know are going to be an uphill battle to publish in your paper or on your website, to bring the lawyers in at an early stage and make them feel like they’re part of the process.”

Doing so is much better than alerting them at the last moment because at that point lawyers may want to delay publication while they seek to understand the issues. “I found in this particular investigation, that bringing in lawyers very early was hugely beneficial,” he commented.

Later when he confronted Theranos with his findings, he got the runaround for about two months. “They had hired an outside PR guy and I kept asking for an interview and for a tour of the Theranos lab, and they kept putting me off,” he said. All the while, Theranos founder and CEO Elizabeth Holmes was frequently on television promoting her company, prompting Carreyrou to insist on a meeting.

“At that point a delegation of seven people came to the journal’s newsroom in midtown Manhattan, and of the seven people, four were attorneys, one was a PR person, one was an opposition researcher who co-founded Fusion GPS (the firm that commissioned the infamous Trump Dossier), and the seventh was a Theranos executive but not Elizabeth Holmes,” he said.

“We had a very heated and confrontational five-hour meeting in a conference room at the journal,” he added. Although he didn’t go into detail about the meeting, he was glad to have the support of Siconolfi and Conti. “I expected fireworks, and I was not disappointed,” he said, adding that we can read the details of that meeting in his book.

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Photo: Jen R via Flickr

Health and Human Services Secretary Alex Azar and Centers for Medicare & Medicaid Services Director Seems Verma are crisscrossing the country to tout the Trump administration’s plan to combat prescription drug prices. They promise that America’s Patients First, released by the president and HHS on May 11, will address significant roadblocks to lowering drug costs.

People age 65 and older account for 34 percent of all prescription medication use and 30 percent of all over-the-counter drugs purchased, according to this Medscape article. Azar, a former drug company executive, recently spoke with reporters and other stakeholders to promote the plan, saying that high prescription costs seriously threaten too many Americans’ health and wellbeing.

He called the administration’s proposed changes “more sweeping than any other drug pricing plan ever proposed.” (Here is a recording of the secretary’s remarks.)

Many of the ideas are part of an ongoing conversation between the government and the pharmaceutical industry, according to drug policy expert Adam Fein, Ph.D., CEO of the Drug Channels Institute. “They’re basically signaling to the industry they’re going to make a move and you better be prepared,” Fein said.

Rebates, discounts, generic drugs and pharmacy benefits manager (PBM) practices were among the issues highlighted in Azar’s talk. The proposal stops well short of allowing Medicare to negotiate directly with drug manufacturers for Part B drugs, those a patient would receive in a physician’s office (such as chemotherapy for cancer treatment). However, Part D – the pharmacy benefit – is managed by outside insurers. Medicare does have negotiating authority there, so moving some Part B drugs into Part D could be a way to lower prices of some of these high-ticket, often life-saving treatments.

Part D was created as part of the 2003 Medicare Modernization Act and has not been updated significantly since. Given the size of the aging population and the rising price of prescriptions something has to be done, Fein said in a phone interview. “There have been some unintended consequences that must be addressed, like warped benefit and incentive structures.” He pointed out that while the majority of the proposals under consideration will have significant impact on the industry, they are topics very hard for the average person to understand. Fein wrote this in-depth analysis of the new plan, which he mainly supports.

However, many elder advocates give the proposal mixed reviews, according to this Washington Examiner article. “It seems to signal that more will be done to scrutinize PBM arrangements, some additional transparency will be brought to bear on rebates and list prices, but I don’t see clear plans for making Medicare a more powerful negotiator – yet. Overall, the market is quite fractured and segmented, and that dynamic doesn’t look to change much,” wrote Anne Montgomery, deputy director, elder care and advanced illness, at the Altarum Institute, in an email.

Key points of the plan include:

  • Applying “a substantial portion” of Part D rebates at the point of sale, which could result in lower consumer costs if the rebates are passed
  • Establishing an out-of-pocket maximum for Part D’s catastrophic
  • Getting rid of cost-sharing for generic drugs for low-income beneficiaries
  • Requiring drug ads to include prices as a means of increasing transparency.
  • Bringing generic drugs to market faster and going after brand name companies blocking these efforts. The FDA is already working on this.

Azar was clear that he thought the popular notion of importing drugs from Canada was “a gimmick” and would not work. Canada is too small and doesn’t have enough drugs to export to the United States. “The last four FDA commissioners have said there’s no effective way to ensure drugs from Canada are coming from Canada,” rather than counterfeit factory overseas, he added.

Another issue Azar mentioned was the need for pharmacy benefit managers (PBMs) to lift the “gag clause” restriction on pharmacists. He said some PBMs prevent neighborhood pharmacies from telling customers they could get a better deal on a drug, or a similar one, by paying cash instead of using insurance.

Fein insisted this is a rare occurrence, and while the existence of these gag rules has been widely reported, it’s not something that journalists should necessarily take at face value. “While one PBM did have this gag clause, other PBMs have strenuously insisted they do not. I haven’t seen very many journalists dig into some of the stories they’ve been told.”

When you look at the data, the vast majority of people – 90 percent to 95 percent of people – have anywhere from $0 to $300 in out-of-pocket expenses right now, according to Fein. While out-of-pocket costs are perceived as a big problem, in reality that’s only true for a small number of people. However, the fear of going bankrupt should something serious happen is very real. “People want to know if they’ll get the benefit they’ve been paying for,” he said.

Ensuring the average consumer understands their benefits continues to be a major challenge. Many do not grasp basics such as co-insurance versus co-pay or the out-of-pocket maximum. Fein cited United Health Care’s 2017 survey on consumer sentiment, and “the numbers are scary.” There’s a low level of sophistication and lots of misunderstanding among beneficiaries, he said. He encouraged journalists to take the lead in helping people understand how prescription coverage works.

This analysis by Katie Thomas of The New York Times provides other important takeaways from the proposal.

For a more in-depth discussion, check out this “What the Health” podcast from Kaiser Health News.

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Please welcome these new professional and student members to AHCJ.

All new members are welcome to stop by this post’s comment section to introduce themselves.

  • Terry Ahern, independent journalist, Columbia, Ga.
  • Alicia Barney, independent journalist, Chicago
  • Maria Castellucci, reporter, Modern Healthcare, Chicago
  • Sarah DiGregorio, independent journalist, Brooklyn, N.Y. (@SarahDiGregorio)
  • Erin Durkin, health care correspondent, National Journal, Washington, D.C.
  • Vicki Gonzalez, reporter, KCRA-Sacramento, Calif. (@KCRAVicki)
  • Julie Halpert, independent journalist, Ann Arbor, Mich. (@julhalps)
  • Jennifer Kearney-Strouse, executive editor, American College of Physicians, Merion Station, Pa. (@jks_philly)
  • Nicole Knight, western regional reporter, Rewire News, Costa Mesa, Calif.
  • John Murawski, staff writer, The News & Observer, Raleigh, N.C. (@johnmurawski)
  • Jeremiah Murphy, student, UNC Chapel Hill, School of Media and Journalism, Chapel Hill, N.C. (@je7emiah)
  • Paul Myers, editor, The Sun-Gazette, Exeter, Calif.
  • Qui Nguyen, student, Foothills College, Mountain View, Calif.
  • Linda Peckel, independent journalist, Ansonia, Conn.
  • Benjamin Purper, reporter, KVCR, Yucaipa, Calif. (@benjaminpurper)
  • Michaela Ramm, health care reporter, The Gazette, Cedar Rapids, Iowa (@Michaela_Ramm)
  • Kevin Truong, multimedia producer and reporter, San Francisco Business Times, Oakland, Calif. (@kevinbtruong)
  • Laura Tsutsui, reporter, Valley Public Radio, Fresno, Calif. (@LauraTsutsui)
  • Mary Katherine Wildeman, health reporter, The Post and Courier, Charleston, S.C.

If you haven’t joined yet, see what member benefits you’re missing out on: Access to more than 50 journals and databases, tip sheets and articles from your colleagues on how they’ve reported stories, conferences, workshops, online training, reporting guides and more. Join AHCJ today to get a wealth of support and tools to help you.

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As you report on medical studies more and more, you probably start to notice patterns in the parts that you find confusing or difficult to parse. You start to realize where you need the most help in understanding a study, or perhaps you know you need to refine your skills but aren’t sure how.

Massive Online Open Courses (MOOCs) are a great way to sharpen some skills and learn some new ones. A variety of universities and companies offer MOOCs, an online course involving video lessons, reading assignments, message boards, tests and/or other aspects of a typical online course. The difference is that MOOCs are free (unless you want to pay extra for an official certificate showing you completed one), and many are self-paced or allow you take them even after the course has officially ended.

The two largest distributors of MOOCs are Coursera and EdX, both of which offers courses from universities such as Harvard, Johns Hopkins, Stanford and even overseas schools, such as the University of Cape Town. The instructors are actual instructors from those schools, either full professors, department heads, researchers or adjuncts. The lesson updates are emailed to you each week, and you can estimate the time you need each week (anywhere from an hour or two up to 15 hours) for that course.

Some require prerequisites or recommend certain base knowledge skills (such as calculus for more advanced biostatistics classes or “Epidemiology 1” before taking “Epidemiology II”). Many courses repeat a few times a year so you can catch it again if it’s not available now, and others allow you to take a course that’s already finished at your own pace. And of course, like Amazon and many other online shopping sites, pages featuring one course will usually show you similar or related courses you might also want to check out.

I skimmed through the offerings recently at Coursera and EdX for courses related in some form to medical studies and drug development. The list below is not comprehensive, and several of these are already in session or already completed, but they provide a sense of what kinds of courses are offered.

Epidemiology and medicine

Clinical trials and studies

Drugs

Biostatistics and terminology

Here is a list of even more MOOCs that might be relevant to your beat.

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The Medicare program has removed a page from Medicare.gov that explained what Medicare members need to know about the Affordable Care Act and made other changes to the website, according to a report today from the Web Integrity Project of the Sunlight Foundation.

The “Affordable Care Act and Medicare” page was removed and changes were made to the “Medicare and Marketplace” page, according to the report (PDF), “Removal of the ‘Affordable Care Act & Medicare’ webpage and corresponding links from the Medicare website.” The page that was removed included a link to the “Medicare and Marketplace” page and information related to Medicare coverage protected under the ACA, preventive services covered under Medicare and discounts on brand-name prescription drugs, the report explained. The page was removed and the changes were made in December without notice, the report said.

Note that under the ACA, all preventive services are covered for free without the need for individuals to pay deductibles or copayments.

A spokesman for the Centers for Medicare & Medicaid Services said the changes were made, “based on advice from career web staff who understand how beneficiaries and web users navigate the site” and were made as part of a regular review of content on Medicare.gov. As part of that review, CMS staff identified two similar pages, the one titled “The Affordable Care Act & Medicare” and one titled “Medicare & the Marketplace,” the spokesman said. “The removal of the ACA page is consistent with our curation of content and standard web practice around other laws that impact Medicare.”

In addition, the spokesman said, “We decided, based on outdated content and low usage, that the ‘Affordable Care Act & Medicare’ page was no longer relevant or needed and took action to remove the page on Dec. 21.”

Because the Medicare & the Marketplace page focuses on questions relevant to beneficiaries, the staff decided to leave that page in place and update it as needed, he said. The page is for those enrolled in a Marketplace plan who become eligible for Medicare and have questions about the transition. “The page also includes a very extensive ‘frequently asked questions’ document on the subject,” he said. “This page replaced the ‘Affordable Care Act and Medicare’ page as the one page on this issue.”

About the removed page, Rachel Bergman, the Web Integrity Project’s director of programs, said, “Now that the ‘Affordable Care Act and Medicare’ page, has been removed and the link along with it, access to the ‘Medicare and Marketplace’ page is greatly reduced.”

Also, she added, the staff at CMS could have edited the page to revise or remove inaccurate or outdated information.

In March, the Web Integrity Project reported that pages on other health care topics were removed, including content about lesbian and bisexual health and pages on breast cancer.

In the report on lesbian and bisexual health, Federal women’s health office obscures lesbian and bisexual fact sheet online, the project said, “The ‘Lesbian and bisexual health’ page is no longer linked from anywhere on the Office of Women’s Health website and the previous URL leads to a removed page.” In its report on the breast cancer page, Unexplained censorship of women’s health website renews questions about Trump administration commitment to public health, the project said, “The specificity of these removals adds more evidence to a growing concern: that public information for vulnerable populations is being targeted for removal or simply hidden.”

Following the project’s reports, the Office of Women’s Health added a page about breast cancer, the project reported.

After project staff asked HHS about the removal of the “Lesbian and bisexual health” fact sheet, the page was added back under a separate URL, said Bergman. “It remains live, but is not linked from any other pages on the OWH website, remaining inaccessible by navigating through the website,” she added. Members of the U.S. Congress have written to HHS Secretary Alex M. Azar condemning the removals and seeking answers about why the pages were removed, she said.

In March, Dan Diamond reported for Politico that multiple LGBT health resources were removed  between September and October 2017 from WomensHealth.gov. John Paul Brammer at NBC News and Amanda Michelle Gomez at ThinkProgress also reported on the changes to the website.

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A social autopsy.

That’s what West Virginia Health Commissioner Dr. Rahul Gupta called his efforts to examine opioid deaths in his state, one of the hardest hit by the drug epidemic.

In an interview with WBUR, Gupta said he was crunching the data on hundreds of those who die in hopes of seeing past the medical causes and into the social issues that may have contributed. Understanding that, and the stigma, may better help him and other officials tackle the scourge that is sweeping the state.

“One of the things that we wanted to find out is [how to] learn from those who have already passed away, and how can we learn just not about their medical diagnosis or what’s in their blood, but actually also find out, what were their social conditions like? What would a social autopsy of someone who dies from a drug overdose look like?” he said on its “Here and Now” program.

“For example, we found about 71 percent of the decedents actually had Medicaid, yet we found that there was a less likelihood of getting naloxone, which is an antidote for reversing overdose in the field, if EMS was called. What we’re saying is that stigma issues run wide and probably deeper than we actually estimate [them] to be,” Gupta told host Robin Young.

The effort is noteworthy in that it represents a systematic effort to collect and analyze data to see how social determinants of health could impact such drug use. Looking at some of those issues could help authorities better understand the health care system’s failings when it comes to such patients, Gupta said in the nearly 11-minute long segment, “Here’s What West Virginia Is Doing To Address The Opioid Crisis.”

Gupta likened the problem to that of addressing diabetes, noting the difficulties to tackling other factors at play such as community, jobs, education, the environment and food establishments

“This is an epidemic of so many different epidemics. Just addressing a particular substance of use or misuse isn’t enough.”

Listen to Young’s piece here.

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If you are familiar with  Drugs@FDA, you know that the website allows you to quickly look up a drug by its name (brand), the active ingredient (generic), or application number. But if you frequently work on the go or need to look up something quickly while away from your computer, you now can download the FDA’s new app, Drugs@FDA Express (iOS/Apple and Android/Google), to see much of the same information.

Released in late March, the app is pretty basic, but often that’s the best kind of app. It loads quickly, isn’t overly cluttered and has simpler user-friendly interface. The opening page is straightforward.

For journalists, the “Last 7 Days’ Approval,” organized in reverse date order, is particularly helpful, especially if you missed a press release or are not subscribed to all FDA press releases on new drug approvals.


When you click on the drug entry, you have the option to look at its approval history as well. It’s not super detailed, but there’s PDF link that gives the same PDF label you’d see on the website. From there you can download the files via your preferred PDF or document storage app (Evernote, Dropbox, Google Drive, etc.).

One thing a little non-intuitive about the interface is that its “Back” button is at the bottom instead of the top, so you have to scroll down to go back if there are multiple entries.

However, the upper right hamburger menu will take you to Home or one of the major sections.

Learning about this app led me to look for other FDA apps and I found five total. Most are designed for pharmacists or health care professionals, but I was pleasantly surprised to see an FDA Drug Shortages app, which can be very useful for a journalist covering shortages or checking whether a shortage might be occurring due to a recent outbreak or another event.

The app also loads very quickly and has a simple, clean opening interface.

You can look at drug shortages alphabetically or according to the clinical area.


Again, the entries are basic but provide the most important information: the clinical area the drug treats, how long there’s been a shortage, the reason for the shortage and manufacturer contact information.

The same information is provided for drug shortages that have been resolved, useful if you need to follow up on a past shortage (or, in the case of the screenshot below, point out that they either have a typo on their dates or have begun a new-fangled way of writing them).

For discontinued drugs, a brief (usually vague) reason is provided. If your Spidey sense tingles when skimming one of these, it may be worth finding out what’s meant by a “business decision.” While it may be a run-of-the-mill, business-as-usual reason, having the app on your phone enables you periodically skim through the list and note anything surprising or unusual that’s worth checking out.

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Eleanor Fleming

The good news: In recent years, tooth decay rates have significantly decreased for American children.

Overall, 43.1 percent of American children between the ages of 2 and 19 experienced decay in primary and permanent teeth in 2015-16, down from 50 percent reported in 2011-12.

Untreated tooth decay also declined among U.S. children during the most recent study period, according to the federal findings just published.

Working with data from the National Health and Nutrition Examination Survey, investigators found that 13 percent of US youths had untreated decay in 2015-2016, down from 16.1 percent in 2011–2012, according to findings published in April in a National Center for Health Statistics data brief.

Now for the bad news: Tooth decay remains the most common chronic disease of U.S. youths aged 6 to 19, researchers concluded. And the disease known as dental caries continues to place a disproportionate burden on minority and low-income youth.

Hispanic and black children remain more likely than white or Asian children to have decay and untreated decay, which can result in pain, worsening infection and tooth loss.

In 2015-16, the prevalence of dental disease was highest among Hispanic children (52 percent) compared with their black (44.3 percent), Asian (42.6 percent), and white (39 percent) peers. The prevalence of untreated decay was highest among black children (17.1 percent) followed by Hispanic (13.5 percent), white (11.7 percent) and Asian (10.5 percent) youth. Researchers also found that children from more affluent families experienced less decay and untreated decay than poorer children.

Slightly more than one third (34.2 percent) of youth from families with income levels greater than 300 percent of the federal poverty level had tooth decay while more than half (51.8 percent) of children living below the federal poverty level had decay. And while in 2015-2016, 7 percent of children from higher-income families had untreated decay, 18.6 percent of children living below the poverty level did.

Decay prevalence was lowest in the youngest cohort of children during the 2015-16 study period, investigators found. Among children aged 2-to-5, the decay rate stood at 17.7 percent; for 6- to 11-year-olds, the rate was 45.2 percent. Children in the 12-to-19 age group experienced decay at a rate of 53.5 percent.

Photo: Patrick via Flickr

“The take-home message from this report is that there are differences in untreated and total caries (tooth decay) by age group, race and Hispanic origin, and income,” noted the study’s lead author, dental epidemiologist Eleanor Fleming in a Q&A on the findings featured in a recent NCHStats blog.

“The trend analysis shows that the prevalence of untreated and total caries are decreasing,” Fleming said. “However, there are still disparities that exist. Because monitoring prevalence of untreated and total caries is key to preventing and controlling oral diseases, these disparities are important.”

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Alex Azar

Last week, President Trump spoke about his plans to lower prescription drug prices by increasing competition and creating incentives for them to lower prices.

His plan includes budget proposals to reform the Medicare Part D program, curbing abuse of FDA safety rules and  continuing generic drug approvals,

On Monday morning, HHS Secretary Alex Azar elaborated on the administration’s plans. The prepared remarks are available on the HHS website but AHCJ is making a recording available here.

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Photo: Brian Walker via Flickr

Caregivers seeking a long-term facility for their loved ones often have little idea about how to evaluate certain issues that can’t be easily quantified. Are the aides kind and attentive? Do residents easily make friends? Are calls and queries handled promptly and efficiently? Will Mom or Dad really be OK?

Enter crowdsourcing. Just as they would for restaurants, movies, or vacation spots, more consumers are turning to review sites such as Yelp for the skinny on many intangible aspects of nursing home care that government databases leave out. “Yelp for Nursing Homes” has been gaining in popularity over the past few years. However, there haven’t been any studies to examine what consumers say in these reviews.

These crowdsourced reviews tend to focus more on staff attitudes, staff responsiveness and the physical facility itself than government review sites do, according to a study by researchers at the University of Southern California’s Leonard Davis School of Gerontology. Analyzing themes addressed in these reviews could help improve patient-centered nursing home care.

“Yelp reviewers are looking at different aspects of care than the government reviews,” said Anna Rahman, an assistant research professor at the school. “People want to know: How homey is it? How nice is it inside?”

Accurately interpreting the various data from CMS’ Nursing Home Compare or Pro Publica’s Nursing Home Inspect can be difficult, and often overwhelming for the average caregiver. Also, measures such as nursing home star ratings can be unreliable because they don’t paint a full picture, as AHCJ previously reported. Families instead rely on word of mouth, clinician recommendations, or a “gut” feeling during an initial visit. That can leave lots of room for doubt, especially for those who are unfamiliar with the health system or its jargon. But Yelp? That’s a familiar and comfortable tool for millions.

Rahman and a team of researchers evaluated 264 Yelp reviews of California facilities, grouping reviews them into five categories: the quality of staff care and staffing, physical building and setting, resident safety and security, clinical care quality and financial issues. They used data collected in 2014 by the California Office of Statewide Health Planning and Development for a geographically diverse sample of 51 skilled nursing facilities, small and large, that had been rated on both the CMS site and Yelp. Small facilities averaged 58 beds while large ones had about 116 beds.

The analyses confirmed earlier research showing that Yelp reviewers tend to focus on subjective experiences of health care, such as the reviewer’s personal assessment of staff attitudes, physical setting and the cost of care. Yelp reviews of hospitals do a commendable job in ranking them by what matters to patients and families, as one STAT article found.

The USC gerontologists noted that such aspects of nursing homes are not rated on Nursing Home Compare. Instead, the federal site focuses on clinical issues such as infections and the use of restraints for some patients.

Overall, Yelp reviewers were less favorable towards many nursing homes than government sources. Just over 53 percent of the Yelp reviewers posted comments about staff attitude and caring. About 29 percent posted comments about staff responsiveness. Twenty-five percent discussed matters with cleanliness. Nearly 14 percent rated issues with meals.

“Yelp is not focused on the clinical aspects of care, such as how often are staff turning residents with pressure sores, and did patients get their pneumonia shot or the flu shot,” Rahman said. “We found that what is most important clinically to Yelp reviewers is whether their loved one got better.”

Nearly 15 percent of the Yelp reviews mentioned whether their loved one’s condition improved or worsened while at a particular facility.

This was a small study and focused only on facilities in California. But it points to how reliant family and patients are becoming on the collective wisdom of virtual strangers that address qualitative, but significant aspects of care for families and patients. It also confirms that when searching for nursing homes, hospitals or other care needs, crowdsourced data can be as influential for some people as more traditional data points. Researchers emphasized the importance of turning to multiple sources to make a well-informed decision about nursing home care.

For their own reporting, journalists may want to peruse Yelp or other crowdsourced sites for consumer feedback about local nursing homes. How do they compare with CMS ratings? Talk to some of the reviewers and find out what may be going on day-to-day.

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