Overdiagnosis with the Internet: Cyberchondria

From USA Today: Always diagnosing your health online? You may have ‘cyberchondria

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“Data-free Zone” and mHealth

A recent study (J Kamgno et al. NEJM 2017; 377: 2044-52) used an innovative cell-phone-based device (the LoaScope) to improve treatment of onchocerciasis (river blindness).

Background (summarized in editorial: pg 2088-90): Ivermectin has been distributed in Africa since 1988 to treat onchocerciasis; in fact, the 2015, Nobel Prize in Medicine was shared by the discoverers of ivermectin.  However, in 1996, it was recognized that central nervous system adverse events were occurring in ivermectin-treated patients with coexistent Loa loa infection.

Kamgno et al show that not treating patients with L loa counts >20,000 microfilariae per mL helps target ivermectin to those who will benefit.  The LoaScope identified 340 persons who were at high risk for serious adverse events; the authors estimate that 62 serious central nervous system complications and 8 deaths were avoided with this approach.

Despite the apparent success of this mobile Health (mHealth) application, a separate editorial cautions that most mHealth has little data to support its use (A Roess.  NEJM 2017; 377: 2010-11). Key points:

  • To date, more than 1200 mHealth tools or apps have been catalogued
  • Determining which are effective is difficult  With breastfeeding, there are >340 apps, yet only “15 had any evidence supporting their use, and that was from pilot evaluations.:
  • Most apps involve data collection and delivering health education messages.  The latter are usually one-way messages. “The evidence to support their rapid and widespread use is limited.”
  • mHealth in remote areas may enhance collaboration; though, practical infrastructure problems like poor wireless networks and unreliable electricity hamper their utility.
  • mHealth could improve point-of-care diagnostics. Current products include blood-glucose monitors, blood-pressure monitors, and electrocardiography
  • While many have suggested these apps will be cost-effective, these analyses typically do not evaluate the costs of misinformation and the diverse workforce requirements needed for implementation

My take (with help from editorial): mHealth tools are here and increasing.  Advances like the LoaScope for treating river blindness has been shown to improve outcomes.  Before recommending other mHealth tools, we need to insist on adequate evaluation or we will “arrive in an increasingly fragmented mHealth landscaped littered with poor-quality, unproven apps.”

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Sunrise at the Grand Canyon’s South Rim

12 Year Data: Pros and Cons with Bariatric Surgery

A recent study (TD Adams et al. NEJM 2017; 377: 1143-55) examines outcomes of bariatric surgery after 12 years.  The ‘skinny’ on this study is that the weight loss/improved metabolic measures associated with bariatric surgery were very durable but there was a small increased risk of suicide among those undergoing bariatric surgery.

In this study, there were three cohorts:

  • Surgery group: 418 patients
  • Nonsurgery group 1: 417 patients. This group had sought surgery but did not receive surgery (often due to insurance coverage)  (147 underwent subsequent surgery)
  • Nonsurgery group 2: 321 patients. This group had not sought surgery (39 underwent subsequent surgery)

Key findings:

  • At 12 yrs, mean change from baseline body weight was -35 kg in surgery group, compared with -2.9 kg in nonsurgery group 1 and 0 kg in nonsurgery group 2
  • Of those with type 2 diabetes in the surgery group, type 2 diabetes remitted in 75% at 2 yrs and remained remitted in 51% at 12 yrs.
  • The surgery group had higher remission rates of hypertension and dyslipidemia as well.
  • 7 deaths by suicide were noted -5 in the surgery group, and 2 in the nonsurgery 1 group but only after the patients had undergone subsequent bariatric surgery

My take: Weight loss and improved metabolic changes at 6 yrs were maintained over the following 6 yrs.  It is troubling that the surgery and/or weight loss is associated with suicide in a small number of patients.

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Crisis Developing in Blood Supply

As noted in a previous blog, Business of Blood in Decline, the number of transfusions are declining.  While this is good news, there are a number of worrisome trends that indicate a crisis in the sustainability of the U.S. blood system (HG Klein et al. NEJM 2017; 1485-8).

Some background:

  • U.S. blood collectors draw 35,000 units a day
  • Blood transfusion is ordered in 10-15% of all hospitalizations
  • Less-invasive surgical techniques and other blood-management strategies have reduced demand for blood

So what is the problem?

The U.S. blood supply relies on nonprofit organizations which in turn have relied on blood as a major source of revenue.  With reduction in blood demand and increased screening (e.g. for more infections), the cost per unit has increased; yet, due to stiff competition, there has not been a commiserate increase in reimbursement.

  • 57.1% of America’s Blood Centers in December 2016 reported operating with negative margins
  • 90% of the blood supply is estimated to be provided below cost
  • Due to cost constraints, blood suppliers are less likely to adopt additional measures which could improve patient and donor safety

The authors argue that human blood should not be treated as “just another consumer good.”  Strict economic principles undervalues the need of having a safe, available blood supply. While there have not been clinical consequences thus far, the current model is not sustainable.

My take: The financial market of the blood supply is precarious. This needs to be addressed to ensure the availability of blood when we need it.

Briefly noted -related study: EA Gehrie et al. J Pediatr 2017; 189: 227-31. In this study, the authors tested 220 red blood cell units.  15 (6.8%) had detectable drugs:. opiates, benzodiazepines, stimulants, and barbituates. While none of these units would have been disallowed under current FDA regulations, it is possible that these levels could cause reactions in vulnerable populations, like neonates.  The authors note that allergens, like peanuts and fish, in blood donations can result in anaphylactic transfusion reactions

The MH Score: Separating primary Hemophagocytic Lymphohistiocytosis from Macrophage Activation Syndrome

“Sincerity is the key to success. Once you can fake that, you’ve got it made.”

–Groucho Marx

The above quote is not particularly related to this blog post –but I like it.

A recent study (F Minoia et al. J Pediatr 2017; 189: 72-8) provides data supporting a scoring system which helps distinguish primary hemophagocytic lymphohistiocytosis (HLH) from macrophage activation syndrome (MAS).

Background: “By convention, secondary HLH seen in rheumatic disorders is termed macrophage activation syndrome…occurs most commonly in systemic juvenile idiopathic arthritis (sJIA).”  Both HLH and MAS are life-threatening, though HLH tends to be more severe.  The treatment for the two disorders is much different.

HLH typically develops in the first year of life, though some remain asymptomatic until later.  Identification of pathologic mutations (primary HLH is not a single disease) is considered the gold standard, but this “takes weeks to complete and is not available in many resource-limited areas.”

In this study, the authors reviewed clinical features from 362 patients with MAS and 258 patients with HLH to develop a scoring system that more readily distinguished these conditions.The data from 80% of the patients was used to construct the scoring system and then this was validated with the remaining 20%.  MH Score:

  • Age of onset, years:                              0 points if >1.6 yr, 37 points if ≤1.6 yr
  • Neutrophil count, x 10 to the 9th/L:      0 points if >1.4, 37 points if ≤1.4
  • Fibrinogen, mg/dL:                               0 points if >131, 15 points if ≤131
  • Splenomegaly:                                      0 points if no, 12 points if yes
  • Platelet count, x 10 to the 9th/L:           0 points if >78, 11 points if ≤78
  • Hemoglobin, g/dL:                                0 points if >8.3, 11 points if ≤8.3

The age of onset and severe neutropenia are weighted the most heavily as they most heavily influence the odds ratio of having HLH; with multivariate analysis (Table 3), age of onset ≤1.6 yrs had an OR of 40.3, and neutrophil count ≤1.4 had an OR of 39.3.  All of the other parameters had OR between 2.9 and 4.4.  Hepatomegaly favored HLH as well but was not independently associated with the diagnosis.

How to use this scoring system:

  • In this cohort, the MH score ranged from 0 to 123.  The median value was 97 for HLH and 12 for MAS.
  • A cutoff of ≥60 yielded a sensitivity of 91% and specificity of 93% for the diagnosis of HLH.  Higher values increased the probability of HLH further.

Most laboratory studies were more abnormal with HLH; however, both ferritin elevation and LDH elevation were more pronounced with MAS.  Median ferritin was 5353 with MAS and 2910 with HLH.  Median LDH was 1230 with MAS compared with 696 with HLH.

This study validated the MH score for distinguishing HLH from MAS associated with sJIA; this can allow early introduction of aggressive treatment and appropriate genetic/immunologic evaluation.  The applicability of the MH score for distinguishing HLH from other conditions is unclear.  Further prospective evaluation of the MH score is needed.

My take: This is a very helpful study and is likely to influence diagnostic workup and management of these sick patients. Due to the liver and spleen abnormalities, pediatric gastroenterologists need to be able to recognize both HLH and MAS.

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What’s with $1040 -is a fine of $40 more going to make a difference?

FDA Postapproval Studies: ‘You can have pie as long as you do your homework later’

A recent commentary (S Woloshin et al. NEJM 2017; 377: 1114-7) examines the fate of FDA postapproval studies.

“Both Congress and the Food and Drug Administration (FDA) have sought to accelerate the “availability of new drugs by allowing sponsors to wait to resolve many questions about safety and benefit until after their drugs receive marketing approval.”

However, this commentary points out that many times these studies are never completed. The authors examined these studies since 2009.  Key finding:

  • “After 5 to 6 years, 20% of postapproval studies had not been started, 25% were delayed or ongoing, and 54% had been completed.”

The authors note ‘the slow irregular pace of postapproval studies contrasts starkly with the short, rigid deadlines and other shortcuts used to speed marketing approval.”  They suggest that the FDA impose fines and establish shorter deadlines.  They indicate that the current administrations stated view that the FDA is ‘slow and burdensome’ could necessitate even more reliance on postapproval studies by loosening the evidence for new medication approvals.

In the same issue, the FDA responds that there have been improvements and that since 2015, “88% of postmarketing requirements overall…were progressing according to their original schedules.”

My take: More rapid approvals will inevitably lead to more medications with unrecognized safety signals.  These postapproval studies are crucial in identifying infrequent but important adverse effects.

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America Needs Immigrant (Doctors)

While anti-immigrant sentiment has become more widespread among many, in medicine it is clear that immigrant physicians play an important role.  This is discussed in a recent NY Times article: Why America Needs Foreign Medical Graduates

The key points:

  1. Foreign medical graduates help fill residency training positions that would otherwise be left vacant.  Their availability helps many hospitals operate.
  2. Foreign medical graduates disproportionately take positions in primary care, accounting for approximately 40% of primary care physicians.
  3. There is evidence that the care of foreign medical graduates is at least as good as physicians who received their medical degrees in the U.S.

An excerpt:

The American system relies to a surprising extent on foreign medical graduates, most of whom are citizens of other countries when they arrive. By any objective standard, the United States trains far too few physicians to care for all the patients who need them. We rank toward the bottom of developed nations with respect to medical graduates per population…

A 2015 study found that almost a quarter of residents across all fields, and more than a third of residents in subspecialist programs, were foreign medical graduates…

 About a quarter of all doctors in the United States are foreign medical graduates.

My take: Physicians from other countries improve the health of our entire country.  In addition, many physicians who train in the U.S. return abroad and help improve health in their home countries.

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