Training Not Meeting Procedure Thresholds for Fellows

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With expanding numbers of pediatric GI trainees, it is even more concerning that training centers have had difficulty providing adequate experience for their trainees.  In a recent study (JPGN 2014; 58: 27-33), not one of 12 centers was able to meet the threshold for all of the procedures.

The authors provide NASPGHAN procedural competency guidelines in Table 2. The 2013 guidelines lowered the threshold for almost all procedures in comparison to the 1999 guidelines.  One notable exception was foreign bodies which was increased to 10. Then, the authors examined the frequency of procedures actually performed between 2009-2011.

Key findings (with the lower thresholds)

  • Polypectomy (threshold, n=10) 67% of programs meeting 2013 NASPGHAN guidelines
  • Control of nonvariceal bleeding/Sclerotherpy/Variceal band ligation (threshold, n=15) 17% of programs meeting 2013 NASPGHAN guidelines. Mean number per fellow of nonvariceal bleeding cases was 2 procedures. Mean number per fellow of banding/sclerotherapy was 7 procedures. With the 1999 guidelines, the threshold had been 35 for these procedures combined.
  • Esophageal, pyloric and duodenal stricture dilatation (threshold, n=15) 42% of programs meeting 2013 NASPGHAN guidelines
  • PEG (threshold, n=10) 42% of programs meeting 2013 NASPGHAN guidelines (training not available at 42% of these institutions)
  • Percutaneous liver biopsy (threshold, n=15) 67% of programs meeting 2013 NASPGHAN guidelines
  • Foreign-body removal (threshold, n=10) 58% of programs meeting 2013 NASPGHAN guidelines

It is noted that the 2013 guidelines “reclassified control of variceal and nonvariceal bleeding from a level 2 to a level 1 procedure, stressing that expertise in hemostasis should be achieved during fellowship.” “Without supplemental training, none of these programs, which are likely representative of most programs, were able to provide sufficient opportunities to meet the NASPGHAN guidelines.” Besides spending more time working with adult gastroenterologists, other potential ways to gain more experience includes simulators and hands-on training courses.

Take-home message: Pediatric gastroenterology training centers are not providing enough procedural experience and need to make rotating with adult gastroenterologists mandatory. It is unfair to trainees and vulnerable patients to consider their training complete with these obvious deficiencies.

When families ask the newly trained pediatric gastroenterologist how many cases like this that they have completed, how will they feel if the honest answer is two?

Related blog post:

Training for Tomorrow | gutsandgrowth

The Liver –Front and Center

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Before proceeding with today’s post, those who read yesterday’s post may be interested in Atul Gawande’s take on the NEJM checklist publication -here’s the link (from Atul Gawande’s twitter feed): bit.ly/1d6v31z. 

A recent review “Extrahepatic Complications of Nonalcoholic Fatty Liver Disease” (NAFLD)(Hepatology 2014; 59: 1174-97) seems to position the liver as the center of a multitude of problems rather than one of many associated problems.

It is known that NAFLD increases the risk of end-stage liver disease and hepatocellular carcinoma.  However, the majority of deaths among individuals with NAFLD are attributed to cardiovascular disease and malignancy.  This lengthy review describes in great detail the associations between NAFLD and the risk of developing cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM), chronic kidney disease (CKD), and colorectal neoplasm.  The presence of NAFLD appears to convey an independent increase in risk for these conditions.

Key points:

  • “The aggregated evidence provides strong evidence that individuals with NAFLD are at increased “independent” risk of developing CVD.  The risk of CVD mortality may be greater in subgroups of subjects with NASH and advanced fibrosis, compared to those with simple steatosis.”
  • “USS-defined NAFLD is associated with a 2- to 5-fold risk of developing T2DM after adjustment of several lifestyle and metabolic confounders.”
  • “NAFLD (in particular, biopsy-proven NASH) is associated with a greater prevalence of CKD (20% to 50% of patients). USS-defined NAFLD carries a 1.5- to 2-fold adjusted risk of incident CKD.”
  • “A true causal relationship between and NASH and colorectal cancer cannot be confirmed.”
  • Other potential extrahepatic manifestations: hypothyroidism, polycystic ovarian syndrome, obstructive sleep apnea syndrome, and osteoporosis.

Take-Home Message: NAFLD has independent associations for greater risk of CVD, hyperglycemia, and malignancy.  Whether these associations are simply an epiphenomenon  of more aggressive metabolic syndrome or whether the liver injury primarily causes these additional risks remains unclear.

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Checklists -Helpful? Overhyped? Hawthorne Effect?

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Over the last few years, adoption of surgical safety checklists has taken hold due to the promise of improving outcomes with a simple intervention.  While the concept of checklists is sound, new data indicate that in practical experience these checklists may not result in any significant reductions in meaningful outcomes (NEJM 2014; 370: 1029-38).

The study of surgical safety checklists in Ontario (13 million people) examined the 3-month periods before and after adoption of a surgical safety checklist (around July 2010) at a total of 101 hospitals.  In the period prior to adoption, there were 109,341 procedures and afterwards 106,370.

Key findings:

  • Adjusted risk of death during a hospital stay or within 30 days of surgery was 0.71 prior and 0.65 afterwards.  This produced an odds ratio of 0.91 with 95% confidence limits of 0.80 to 1.03.
  • Adjusted risk of surgical complications was 3.86% and 3.82% respectively, yielding an odds ratio of 0.97 with 95% confidence limits of 0.90 to 1.03.
  • Checklists did not reduce emergency room visits or hospital readmissions within 30 days after discharge.

These findings contradict previous WHO estimates that at least 500,000 deaths per year could be prevented through worldwide implementation of checklists.  A previous meta-analysis of three other before-and-after checklist studies determined that the checklists were associated with a pooled relative risk of operative death of 0.57 (confidence intervals 0.42 to 0.76). Yet, this Ontario study had a similar implementation without this reduction.

So, how can this study show no significant reduction in operative mortality or complications?

Possible explanations:

  • Hawthorne effect could explain some of the previous results.  This effect refers to “the tendency for some people to perform better when they perceive that their work is under scrutiny.”
  • Publication bias.  Because these checklists are utilized in thousands of hospitals, “many will have improvements in the outcomes by chance alone.”

The authors note that there has never been a controlled trial with randomization to determine conclusively the effectiveness of checklists.  However, the current study is less susceptible to biases than single center studies and no other confounding variables were identified.

Take-home message: In this study, checklists did not result any striking improvements.  Nevertheless, “there may be value in the use of surgical safety checklists, such as enhanced communication and teamwork and the promotion of a hospital culture in which safety is a high priority.”

On a side note, this study reinforced my view that many quality initiatives are well-meaning but sometimes overhyped with regard to their effectiveness.

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More on Gut Microbiome and Crohn Disease

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Earlier this week on NPR there was a story summarizing the altered microbiome in Crohn disease and a related recent paper; here’s the link: Mix Of Gut Microbes May Play Role In Crohn’s Disease.  Other media outlets covered the story too:

The graphical abstract (Cell Host & Microbe, Volume 15, Issue 3, 382-392, 12 March 2014) is noted below:

Graphical Abstract

The link to the full study is listed below if you want to see the source article.  The amount of data that is presented is impressive but easy to follow with the figures:

Full link to article (from Kipp Ellsworth twitter feed): http://goo.gl/603Rbz 

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Curing Iron Overload with Liver Transplantation

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The role of hepcidin in iron metabolism has been described in detail.  Yet, a new study provides another line of evidence that the liver has a primary role in regulating iron absorption (Hepatology 2014; 59: 839-47, editorial 749-50).

Background: Hereditary hemochomatosis (HH) is mainly due to defects in the gene encoding the human hemochromatosis protein (HFE), particularly the C282Y mutation.  Initially, HH was thought to be related to the role of HFE in regulation iron absorption at the intestinal crypt.  However, the discovery of hepcidin, which is mainly secreted by the liver, was shown to regulate iron absorption through its interaction with ferroportin, the cellular iron exporter. With HH, inappropriately low hepcidin was associated with excessive iron absorption.

Despite this understanding, many questions remain, especially regarding the fact that some C282Y homozygotes have a normal serum ferritin and transferrin saturation.  In addition, whether liver transplantation prevents further iron overload in patients transplanted for HH is not entirely certain.

Methods: This study evaluated 18 liver transplant (LT) patients with HH and who were homozygous for C282Y mutations.  16 of these patients had HCC.  All patients underwent iron evaluations (iron, hepcidin, hepatic iron concentrations) prior to LT and most (n=11) had evaluations following LT with a median followup of 57 months.

Key findings:

  • After LT, no patients received iron depletion therapy (eg. phlebotomy).  9 of 11 had no iron overload based on bloodwork (normal transferrin saturation) and MRI without iron overload.
  • One patient with hereditary spherocytosis continued to have iron overload, and one patient with metabolic syndrome had mild iron overload.
  • Hepcidin was normal (11.12 nmol/L) in 10 patients at the end of followup and low in one patient with iron deficiency anemia; prior to LT, serum hepcidin levels were low in all patients (mean 0.54 nmol/L)

Bottomline: This study shows that LT corrects hepcidin dysregulation caused by the HFE mutation and that post-LT HH patients do not require phlebotomy.  Thus, HH is clearly a liver disease and not an intestinal disease.

Related blog post: Help with hepcidin | gutsandgrowth (with annotated references)

“If You Never Give Up, You Cannot Possibly Lose”

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Recently I was reviewing the “Black Knight scene” from Monty Python’s Holy Grail.  This scene in which the Black Knight continues to insist on fighting King Arthur even after losing all of his limbs came to mind as I was reading a recent study (JPGN 2014; 58: 226-36).  The blog title comes from an explanation of the scene from John Cleese who intended the scene to mock this philosophy. (Wikipedia link: Black Knight (Monty Python) – Wikipedia, the free encyclopedia)

The study is another trial of a proton pump inhibitor (rabeprazole) for 1- to 11-month old infants with symptomatic GERD.  In the discussion the authors note that this is the “fourth DB randomized placebo-controlled study published in the last 4 years that fails to show the efficacy of PPIs to treat symptomatic GERD in infants younger than 1 year.”

If anything, the design of this study should have allowed a therapeutic effect to be witnessed if present.  Infants selected for participation (n=268 in the double-blind phase) had been responsive to a 10 mg open-label usage of rabeprazole before randomization.  Yet, those infants who continued to receive 5 mg or 10 mg daily fared no better than placebo-treated patients.

The good news: no new safety signals in those who were treated compared to placebo.

The findings of this study are in marked distinction to clinical practice which has embraced PPIs in all age groups. In the same issue of JPGN, using a national database, De Bruyne et al (JPGN 2014; 58: 220-25) show a huge increase in PPI usage over the past decade in the Netherlands, especially in children ages 2 years and younger.  From 2004 to 2008, use of PPIs nearly doubled in this population.

The rabeprazole study manuscript which had nearly as many pediatric GI investigators as enrolled patients discusses the potential drawbacks of PPI therapy in infants including enteric infections like Clostridium difficile, lower respiratory infections (e.g.. pneumonia), and “perhaps even an increased incidence of necrotizing enterocolitis in premature infants.”  Unlike the Black Knight, after four blows to the PPI cause, the authors recommend yielding on PPIs except under much more stringent criteria (1 of 3):

  • Nonimproving symptoms at 1 year of age & resistant to conservative measures
  • Presence of underlying conditions that predispose to a natural history of severe chronic unremitting reflux
  • Erosive reflux esophagitis proven on endoscopy

Take-home message: PPIs have not been shown to be effective in infants…again!

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Alan Alda (aka Hawkeye Pierce) on Communicating Science

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Link from Dr. Chris Simpson: http://t.co/f4etUVUiQr

Here’s an excerpt:

While Alda is best known for his role on  M.A.S.H  , the 78-year-old is also a science enthusiast who has spent more screentime hosting a PBS show called Scientific American Frontiers  than portraying Hawkeye Pierce. On that fateful day ten years ago, he was at a mountain observatory in Chile for Scientific American Frontiers, preparing to interview some astronomers, when he felt a sudden pain in his gut….

Alda recounted this [near-death] story…in Chicago, where hundreds of scientists from around the world crowded into a packed conference hall to hear him talk about science communication. Alda was one of       four plenary speakers     at the       2014 AAAS meeting     , the world’s largest annual general science conference.

His plenary speech was about communicating science, a subject Alda has become intensely passionate about over the years. He has described his stint at Scientific American Frontiers as “the best thing I ever did in front of a camera” — but it also showed him that many scientists have incredible stories but lack the tools to describe their work in a way that most people can understand.

This is a very real problem, one that journalists often struggle with when interviewing scientists. But for scientists, learning how to describe their work is not only a necessity, it is also a responsibility.

“Communication is essential to science,” Alda said. “It’s essential to the funding of science and even in the doing of it.”

So nowadays, Alda devotes himself to helping scientists discover their inner storytellers. He is a visiting professor at the Alan Alda Center for Communicating Science at Stony Brook University and has also created an improv class for scientists. A few years ago, he also started an annual competition challenging scientists to explain a scientific concept — for example, “what is a flame?” — in terms that would make sense to 11-year-olds, who actually judge the entries. This year’s challenge: “What is colour?”

(Last year’s winner, by the way, was a       PhD student from the University of Ottawa     who made this       video     to entertainingly answer the question “what is time?”).

On Saturday, Alda said he is often asked for tips on how to communicate science better. But there are no shortcuts, he said— becoming a storyteller is something that takes training, practice and commitment to improve.

But his speech left the audience with one general rule of thumb: storytelling is a powerful tool for helping people understand science.

“If you don’t begin with a story, or some kind of introduction to the hard words, we’re suffering from something awful that a couple of people have called the curse of knowledge,” Alda said. “It’s a curse when you know something in such depth, and with such a level of complexity, that you forget what it’s like not to know it at that depth. That’s a curse.”

Related blog post:

Why I have always liked Arthur Caplan… | gutsandgrowth

Even the Experts Agree: pH-MII is a “Flawed Test”

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A recent study (JPGN 2014; 58: 22-26) reports on the combination of a new technique of intraesophageal pressure recording (IEPR) along with multichannel intraluminal impedance with pH (pH-MII).  While this prospective study is small with only 20 children who had a history of chronic intractable cough, some of its observations are important, especially for those who have embraced pH-MII.

In determining whether the pH-MII studies were abnormal the authors relied on symptom index (SI) defined as the number of symptoms associated with reflux/total number of symptoms.  SI is considered positive if >50%.  In addition, the authors calculated the symptoms sensitivity index (SSI) which is defined as the total number of reflux episodes associated with symptoms/total number of reflux episodes; it is considered positive if it is >10%.  The authors note SAP and SI have a comparable positive predictive value and “our experience suggests that SAP calculation using software is unreliable.”

Key Results/Discussion:

  • IEPR changed the diagnosis in 15-20% of patients depending of scoring index used.  That is, IEPR assisted the detection of reflux-associated cough.
  • IEPR detected 106% more coughs than patient report alone.  Thus, this study, if accurate, indicates that “symptom reporting during pH or pH-MII testing is significantly flawed and, if possible, should not be used alone for clinical decision making.”
  • “We did not find a significant association between cough production and the height of the refluxate.”
  • The authors argue that since nonacid reflux can be associated with cough and is not always detected with pH-MII, that this could “explain why studies that have tried to use pH criteria to predict clinical outcome after acid suppression therapy have been negative.”  The two studies cited at that point by the authors were landmark studies (referenced below) showing that proton pump inhibitors are not effective in children or adults in improving asthma.  I think the authors’ comment misses the importance of these studies entirely.  There are no proven effective GERD (acid or nonacid) therapies that alter the course of asthma.

Take-home message from authors: “Studies are now needed to determine whether this increased detection improves therapeutic outcomes, but clearly, relying on symptom reporting by patients is flawed and clinical decision making based on patient report alone should be done with caution.”

Referenced studies:

  • JAMA 2012; 307: 373-81
  • NEJM 2009; 360: 1487-99

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Calprotectin: Part of diagnostic algorithm for IBD?

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Full text available at this link from Jeremy Adler: cghjournal.org/article/S1542-3565(13)01044-6/abstract#.Ut5vnV5z8Cw.twitter …

This article describes the use of fecal calprotectin (FC) levels as a screen for inflammatory bowel disease.  The false-negative rate for this assay is related to pre-test probability of having IBD.  Thus, in patients with a low probability of IBD, a normal calprotectin may allow avoidance of endoscopic evaluation and may be “particularly cost-effective when baseline clinical suspicion for IBD is low to moderate…the low FC cutoff value of 50 μg/g would substantially reduce the likelihood of false-negative FC, minimizing delayed diagnosis of true IBD.” In those with persistent symptoms, the article’s algorithm recommends proceeding with endoscopic evaluation.

Excerpt from abstract:

Conclusions

Screening adults and children to measure fecal levels of calprotectin is effective and cost-effective in identifying those with IBD on a per-case basis when the pre-test probability is ≤75% for adults and ≤65% for children. The utility of the test is greater for adults than children. Increasing the FC cutoff level to ≥50 μg/g increases diagnostic accuracy without substantially increasing total cost.

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