Why Are So Many “Low Value” Endoscopies Performed?

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After reading a few commentaries regarding value in medicine (which I will summarize tomorrow), it made me think a little more about value in pediatric gastroenterology.

I recently observed that a pediatric gastroenterologist in another group had a pattern of scheduling a lot of procedures.  In pediatric gastroenterology, we are not doing endoscopies to screen for malignancy.  The majority of children evaluated in our offices do not have organic disease.  In addition, there are a number of variables that can be used to select patients who are most likely to benefit from evaluation. In fact, much of our value comes from this selection process, because non-physicians can be taught to be endoscopic technicians.

My reaction to this volume of cases was that I thought either this practitioner was seeing a ton of patients, had been away and had accumulated a number of cases, or that this was low value care.  Though, another possibility is that the physician may be influenced by the “illusion of control” or “therapeutic illusion.” (NEJM full text: The Science of Choosing Wisely –Overcoming the Therapeutic Illusion).  According to a recent editorial, “When physicians believe that their actions or tools are more effective than they actually are, the results can be unnecessary and costly care.”

“The therapeutic illusion is reinforced by a tendency to look selectively for evidence of impact — one manifestation of the “confirmation bias” that leads us to seek only evidence that supports what we already believe to be true.”

Whatever the circumstances with regard to endoscopy volume, my intent is not to single out an individual or specific group.  My impression is that there are a lot more pediatric endoscopies being done these days and many are not needed.  While I recognize that clinicians recommend endoscopy with a great deal of variation, my suspicion is that those who use endoscopy less frequently are likely to see similar outcomes.  So, why are there so many low value endoscopies performed?

  1. The entire system is incentivized to do more procedures.  Physicians and hospitals are compensated more for doing these procedures.
  2. Families and sometimes referring physicians think these procedures are necessary.  In fact, there are studies that generally indicate higher levels of patient satisfaction when more diagnostic tests are done even if they are unnecessary.
  3. Physicians have a great deal of knowledge asymmetry in healthcare compared with families and it is expected that they will use their knowledge to help families pursue appropriate care.  While all physicians may have some lapses, some physicians skirt this part of their job.  One physician described this type of pediatric GI practice to me: “Scope first, think second.”

This blog has highlighted numerous aspects of health care economics.  Pharmaceutical companies and hospitals have been criticized for gaming the system.  The blog has discussed efforts to improve value like the “Choosing Wisely” campaign.  Though, it is interesting to note that even with this campaign, most physician groups rarely identified areas that would affect their financial bottom-line.  Among pediatric gastroenterologists, a frequent concern that I hear regards the overuse of CT scans by emergency room physicians.

When I take my car for repairs, I don’t want them doing an expensive overhaul unless it is really needed.  If a car needs a muffler change, but the repairman recommended a few thousand dollars of repairs, that would be outrageous.  Yet, in many cases with children, who are more precious than cars, the main difference with excessive endoscopic procedures, is that health insurance covers the majority of the costs.

I wonder too whether the frequency of endoscopy procedures actually discourages some families from having endoscopic procedures when they are clearly needed (eg. suspected celiac disease, suspected inflammatory bowel disease).

My take: Financial resources are limited.  When physicians do not help utilize resources well, this results in poor care, whether families realize this or not.  Ultimately, this will result in increased regulatory burdens for all physicians to more carefully justify what they are doing and/or result in efforts to eliminate financial incentives for unnecessary care.  However, as noted previously (Do deductibles work to improve smart spending on health care?), financial incentives often affect both low value and high value care.

Any readers care to comment?

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ViK Muniz Art -done completely from chocolate syrup

ViK Muniz Art -done completely from chocolate syrup -see the picture below for comparison.

The Vik Muniz piece is modeled after this photograph of Jackson Pollack

The Vik Muniz piece above is modeled after this photograph of Jackson Pollack

Drug-Induced Liver and Skin Reactions

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A recent study (H Devarbhavi et al. Hepatology 2016; 63: 993-99 & associated editorial 700–2) provide insight into outcomes and causative agents in patients who had both drug-induced liver injury (DILI) along with severe skin reactions.

With regard to the skin reactions, the authors were specifically focused on Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).  SJS indicates an area of skin detachment of <10% and TEN involves >30%.  SJS/TEN overlap is 10-30%.

The study reviewed a single center DILI registry over 18 years with 748 patients.  There was prospective recruitment during the final 10 years of the study period (1997-2015). 36 (4.8%) had either SJS or TEN (mean age 32 years, 53% females).  9/36 (25%) were <18 years.

Causative agents:

  • Antiepileptics 47%
  • Sulfonamides 18%
  • Nevirapine 16%
  • Multiple agents 61%

Key points:

  • Median duration between drug initiation and onset of rash was 24 days
  • 13/36 (36%) died. 77% of those who died had jaundice.
  • 14/36 (39%) received steroids including 10 survivors and 4 who died.

While a mortality of 36% among those with both DILI and SJS/TEN is high, the discussion notes that the mortality is high even in those without DILI (~18% in ones study).  There were 8/36 in the study with HIV which is associated with a much higher risk of DILI.  There was a lower mortality in the pediatric age group (1 child 11%) and in those with HIV (1 patient 12.5%).

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Walnut Street Bridge

Walnut Street Bridge

Persistent Symptoms after Lyme Disease

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A new study has shown that long-term antibiotic therapy for Lyme disease is not helpful.

Here’s a link to a quick summary (1:37 min): Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease

In the associated editorial (MT Melia, PG Auwaeter, NEJM 2016; 374: 1277-8), it is noted that 10-20% of treated patients (after initial antibiotics) “may have lingering symptoms of fatigue, musculoskeletal pains…The plausible idea that additional antimicrobial therapy for potentially persistent bacterial infection would foster improvement has been a touchstone of hope in the 40 years since discovery of the disease in the mid-1970s.”

My take (from editorial): “Prolonged antibiotic therapy is not the answer” for lingering symptoms after Lyme disease. “We do not know what is truly helpful”

Related blog post: Facts and fiction with Lyme disease gutsandgrowth

 

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Liver Transplant Recipients Are Getting Older

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Data(F Su et. al. Gastroenterol 2016; 150: 441-53) from 2002 thru 2014 indicate that liver transplant recipients are getting older.

The researchers reviewed data from the United Network for Organ Sharing (UNOS), including 60,820 adults who underwent liver transplantation and 122,606 listed for transplantation. Key findings:

  • Mean age of those listed increased from 51.2 to 55.7 years.  This trend was more prominent among those with hepatitis C (50.9 –>57.9).
  • The proportion of listed patients ≥60 years increased from 19% to 41%.
  • There were no differences in 5-year transplant-related survival “benefit”

The topic of survival “benefit” is reviewed in the discussion and the associated editorial (pg 306).  The survival benefit is calculated as the difference between life expectancy with and without liver transplantation. So, even though older transplant recipients have worse post-transplantation survival, this is counterbalance by the increased risk of waitlist mortality.  It is quite likely, however, that with more time (>5 year followup) that the survival benefit for younger patients would be more apparent.  In addition, the idea that the survival benefit could be equivalent could be influenced by selection bias.  Many transplant centers may be more selective when deciding to place older patients (>70 years) on the waitlist.

My take: The steady increase in age in adult liver transplant recipients is a concern due to worse outcomes in older patients.  This trend could be reversed if hepatitis C becomes a less frequent indication for liver transplantation.

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Best Way to Quit Smoking

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According to a recent study (N Lindson-Hawley et al.
Ann Intern Med. Published online 15 March 2016 doi:10.7326/M14-2805), for patients interested in quitting smoking, the best way is to do this abruptly rather than gradually (25% more successful).  Apparently, the gradual approach adds work to the process.

From Abstract:

Results: At 4 weeks, 39.2% (95% CI, 34.0% to 44.4%) of the participants in the gradual-cessation group were abstinent compared with 49.0% (CI, 43.8% to 54.2%) in the abrupt-cessation group (relative risk, 0.80 [CI, 0.66 to 0.93]). At 6 months, 15.5% (CI, 12.0% to 19.7%) of the participants in the gradual-cessation group were abstinent compared with 22.0% (CI, 18.0% to 26.6%) in the abrupt-cessation group (relative risk, 0.71 [CI, 0.46 to 0.91]). Participants who preferred gradual cessation were significantly less likely to be abstinent at 4 weeks than those who preferred abrupt cessation (38.3% vs 52.2%; P = 0.007).

Here’s a link to a 4 minute summary: Gradual versus Abrupt Smoking Cessation

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Anti-TNF therapy and Pregnancy -More Data

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G Broms et al (Clin Gastroenterol Hepatol 2016; 14: 234-41) provide more data on the ‘low risk of birth defects for infants whose mothers are treated with anti-tumor necrosis factor agents during pregnancy.”

From a Danish/Swedish cohort of 1,272,424 live births (2004-2012), the authors found the following (in comparison to healthy infants):

  • Birth defects were increased in chronic inflammatory bowel disease: 4.8% vs. 4.2%
  • 43 (6.3%) of the infants born to women with IBD who received anti-TNF therapy (683) had birth defects.  The OR for any defect was 1.32 (CI 0.93-1.82).  The types of defects were generally similar, including VSD, ASD, hypospadias, and hydronephrosis

Limitations:

  • In infants of mothers with chronic diseases, it is possible that more careful screening identified some less apparent defects.
  • Study did not examine rates of stillborn or abortions

My take: Overall there is a slightly but not significantly increased risk in birth defects based on the use of anti-TNF therapy.  Stopping anti-TNF therapy is likely to be more detrimental.

Briefly noted: P Wils et al. Clin Gastroenterol Hepatol 2016; 14: 242-50.  This retrospective study of 122 patients showed that 65% had a clinical benefit within 3 months of receiving ustekinumab for Crohn’s disease refractory to anti-TNF therapy.  Concomitant immunosuppressant therapy was associated with an increased likelihood of benefit (OR 5.43)

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Which patients with asymptomatic gallstones need a cholecystectomy?

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Update: re: Yesterday’s post on tax inversion.  NPR report: Pfizer calls off Allergan Merger due to anti-inversion rules instituted by Treasury Dept

—-

“Generally, the clinical course for the majority of gallstones is asymptomatic…Overall, little knowledge exists about the development into symptomatic disease.”  This introduction from a recent study (DM Shabanzadeh et al. Gastroenterol 2016; 150: 156-67-thanks to Ben Gold for sharing his interest in this study) provides the rationale for their study which analyzed 3 randomly selected groups in Denmark (ages 30-70 years) and followed them for a median of 17.4 years.

Out of an initial 6037 participants, 664 had gallstones at baseline (after excluding 189 who had cholecystectomy and 5180 without gallstones). Only 10% were aware that they had gallstones.

Key findings: 

19.6% developed symptomatic disease (8% complicated, 11.6% uncomplicated)

Risks for symptomatic disease: Female sex, Younger age, Stone size >10 mm, Multiple stones

  • Male with small stone: 2/67 (HR 1.0)
  • Male with multiple stones: 4/97 (HR 1.83)
  • Male with large stone: 2/47 (HR 2.79)
  • Male with multiple and large stones: 3/29 (HR 5.12)
  • Female with small stone: 4/102 (HR 2.16)
  • Female with multiples stones (no large stones) 11/120 (HR 3.96)
  • Female with large stone: 12/67 (HR 6.02)
  • Highest risk: female with multiple stones and with largest stone >10 mm: 10/53(HR 11.05)

Interestingly, the 10% who knew that they had gallstones before randomly being selected  into the study had significantly higher rates of all outcomes, especially uncomplicated events.  “This finding may reflect a protopathic bias.” Patients who were aware were more likely to have suffered bilary colic attacks before study entry and thus had a higher risk of events.

My take: First of all, completion of this study over more than 17 years is an astonishing feat, particularly without informing the participants of their gallstone status.  In patients who are truly asymptomatic, my interpretation would be that only those at substantial risk would benefit from cholecystectomy.  This study does not account for other factors that could favor cholecystectomy (in asymptomatic patients) such as hemolytic diseases (e.g. sickle cell), cystic fibrosis, and other conditions in which symptomatic gallbladder disease is more likely to develop.

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Treachery or Sound Business Decision: Health Care Tax Inversions

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An insightful commentary (HJ Warraich, KA Schulman NEJM 2016; 374: 1005-7) provide some insight into “corporate inversion” or “tax inversion” and how they apply specifically to pharmaceutical companies.  This article was prompted by Pfizer’s plans to merge with Ireland-based Allergan which would create the largest pharmaceutical company in the world, worth ~$160 billion.

  • Inversions allow U.S. companies to lower their tax rate from as high as 35% (most never pay the full rate) to as low as Ireland’s corporate rate of 7.7%.  While this seems like a sound idea, there are reasons why U.S. tax payers should be outraged:
  • These firms “generate substantial revenue from purchases made by Medicare, Medicaid, and the Veterans Health Administration.  These programs are supported by revenue from federal taxes — precisely the taxes companies are trying to avoid by inverting.”
  • In fact, Medicare “parts B and D, received 76% and 80%, respectively of their funding from federal tax revenues in 2015.”
  • These companies charge U.S. consumers much more than anywhere else in the world for their products. For Pfizer, for example, in 2013, two of its leading drugs (Enbrel and Celebrex) were twice as expensive in the U.S. as in the U.K.
  • The U.S. government has pursued policies to protect these “domestic” industries in numerous trade agreements to secure intellectual-property rights.
  • The National Institutes of Health has provided funding that supports the development of new pharmaceuticals.

What should be done?

  • Policies to discourage inversion should be pursued.
  • This could mean that Medicare and Medicaid should be given a free hand to negotiate drug prices with inverted companies or to require additional reviews to qualify their products.
  • The FDA could withhold priority review from companies who have undergone inversion.
  • The IRS could be allowed to levy exit taxes on inverting companies.

My take: Pharmaceutical companies want to extract billions of dollars of benefits from the U.S. taxpayers and charge U.S. consumers higher costs than anywhere else. Avoiding paying U.S. taxes is not business as usual and should be met with consequences.

 

Gibbs Gardens, Ball Ground

Gibbs Gardens, Ball Ground

Goldilocks and Gluten

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A recent study (CA Aronsson et al. Clin Gastroenterol Hepatol 2016; 14: 403-09, editorial 410-12) suggests that how much gluten is given may be another important factor rather than looking at the timing with regard to the development of celiac disease (CD).

In this 1-to-3 nested case-control study with 146 cases of CD and 436 controls, the authors indicate that a larger intake of gluten than controls increased the likelihood of celiac disease.  Specifically, children receiving large amounts of gluten (>5 g/day) during their first 24 months had a 2.6-fold increased risk of CD compared to those who consumed lower quantities.

The associated editorial notes that the total amount of gluten intake was only marginally increased in CD cases versus all control patients (OR 1.05) and that the association was decreased when individuals with first-degree relatives with CD were excluded.  In addition, this high consumption increased the risk after the first 2 years of life, rather than during this period of high consumption.

Does this make sense? Not to me.  These findings need to be replicated in other studies to determine if gluten exposure is like Goldilocks: too little, too much –>just right.

My take: For now, I think sticking with the timing of gluten exposure (recommended at 4-6 months) rather than the quantity is worthwhile.

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