Category Archives: Gastroenterology

How Colonoscopy & Preps are Indicative of Patient Activation and Health Care Decision-Making

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I found two recent studies on bowel preps interesting primarily because of how they help us understand problems with utilization and problems with patient motivation.

The first study (Clin Gastroenterol Hepatol 2014; 12: 443-50) utilized a 5% random national sample of Medicare claims data.  The authors determined that among 57,597 Medicare beneficiaries 66 years and older that underwent screening colonoscopy (not therapeutic) 24.8% of these procedures were performed in individuals with a life expectancy <10 years.  Given the nature of the study (eg. relying on administrative data), there were several limitations.  However, the implication of the study is that there are a lot of unnecessary colonoscopies.  That is, screening colonoscopies are intended to interrupt a sequence of adenoma to adenocarcinoma that can take years; even when cancer is present, it can take several years before the onset of clinical symptoms.  Currently, the US Preventive Services Task Force (USPSTF) recommends against routine screening in those aged 75-84, precisely because the benefits of screening may be outweighed by the risks of screening.”  The authors note that “people with multiple comorbidities (and therefore lower life expectancy) are more likely to visit multiple providers, which increases the chances of receiving testing.”

The second study (Clin Gastroenterol Hepatol 2014; 12: 451-57) showed that patients with lower “patient activation” are much more likely to have a poor colonoscopy preparation.  Patient activation is defined as “an individual’s knowledge, skill, and confidence for managing his/her own health and health care.”  The author’s note that the “Patient Activation Measure (PAM) is a validated scale developed…to measure this construct.” This cross-sectional study took place in Chicago between 2008-2010 at either an academic practice or a ‘federally qualified health center.’ Key findings:

  • One-third of patients (n=134/462 adults) had suboptimal quality of bowel preparations. Of these, 15% (n=62) were fair quality and 17% (n=72) were poor quality.
  • After multivariable analysis and adjustments, patient activation (OR 2.12) and diabetes (OR 2.45) were independent predictors of suboptimal bowel preparation quality.
  • Health literacy (a measure of cognitive skill) was not correlated with patient activation (a measure of patient engagement).

Also noted in same journal issue: Clin Gastroenterol Hepatol 2014; 12: 470-77.  “In a supervised setting, nurse endoscopists perform colonoscopies (after a minimum of 100) according to quality and safety standards that are comparable with those of physician endoscopist and can substantially reduce costs.”

Take-home messages:

  1. Poor bowel preparations are common.  In studies of adult patients, split-dose preparations can help.  The associated editorial (pg 458-462) recommends delaying case and considering further oral prep or enemas for patients arriving with stool that is not clear or yellow.
  2. Colonoscopies are performed too frequently in some patients and not frequently enough in others.  Thus, something as simple as a colonoscopy is not so simple.

Related blog posts:

Probiotics For Fatty Liver Disease

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Probiotics and alterations in the microbiome are being examined for a range of ailments.  However, as noted in previous blog posts, the current evidence shows only a limited number of disorders where probiotics have been proven effective.  There is more evidence, now, that probiotics may be beneficial for nonalcoholic fatty liver disease (NAFLD).

  • Am J Clin Nutr 2014; 99: 425-6. editorial
  • Am J Clin Nutr 2014; 99: 535-42.

The referenced article examined 52 nondiabetic patients with fatty liver disease in a double-blind, randomized, placebo-controlled trial. Patients were considered to have NAFLD on the basis of an ultrasonography and an alanine aminotransferase value >60 U/L.  Those who received a probiotic were compared with a placebo group and followed for 28 weeks.

In this study, rather than a probiotic, technically, the treatment group received a synbiotic because it contained fructooligosaccharides (FOS) which are non digestible oligosaccharides in addition to a probiotic mixture.  FOS can stimulate the growth of intestinal bacteria.  The probiotic mixture included Lactobacillus case, Lactobacillus rhamnosus, Streptococcus thermopiles, Bificobacterium breve, Lactobacillus, acidophilus, B. longum, and Lactobacillus bulgaricus.

Key findings:

  • There were improvements in ALT values and in baseline mild fibrosis (estimated by Fibroscan).
  • There were decreased levels of circulating TNF-α and decreased nuclear transcription factor κβ in circulating mononuclear leukocytes –both consistent with decreased systemic inflammation

Limitations: 

  1. Study did not include liver histology (biopsy).  In addition, in nearly all subjects, the fibroscans were near normal, both before and after the intervention.  Thus, the reduction in liver stiffness is not clear cut.
  2. Small number of participants.
  3. Short study period.

Bottomline: This study along with several others points towards a potential role for modulating the microbiome to improve NAFLD along with metabolic syndrome more broadly.

Related blog posts:

 

 

 

What is Evidence-Based Medicine for Helicobacter Pylori?

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Full article (Clin Gastroenterol Hepatol 2014; 12: 177-86): http://ow.ly/sPKbi 

My take on the most important parts of this Helicobacter pylori (HP) article:

  • Success defined: curing HP ≥95% =excellent, curing HP ≥90% =good, acceptable ≥85%, and unsatisfactory <85%.
  • “Because clarithromycin-containing triple therapy and 10-day sequential therapy are now only effective in special populations, they are considered obsolete.”
  • The “preferred choices for Western countries” are the following
  1. 14-day concomitant therapy: PPI, amoxicillin 1 g, clarithromycin 500 mg, metronidazole -all twice daily
  2. 14-day bismuth quadruple therapy: PPI BID, bismuth BID, tetracycline 500 mg QID, metronidazole 500 mg TID
  3. 14-day hybrid sequential-concomitant therapy: 7 days of PPI-amoxicillin 1 g, followed by amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg for 7 days-all BID

Other useful points:

  • Tetracycline is not available in many parts of the world and generally doxycycline is not an adequate substitute for tetracycline.
  • Triple therapies are extremely sensitive to resistance of the third drug (eg. clarithromycin and metronidazole).  The increase in resistance is making these regimens ineffective
  • An online calculator can help predict which therapy to choose: https://hp-therapy.biomed.org/tw/ (need to know local resistance)
  • Poor compliance is the other factor besides resistance that can undermine a well-constructed treatment regimen. Spending ample time educating patients about the need to  take all of their medicines is crucial.
  • Figure 1 on page 178 outlines the recommended treatment approach.  Unfortunately, availability of susceptibility testing has been quite limited.

Take-home message: The authors emphasize using regimens that work locally and using the evidence that we have to choose the best treatments.  However, given the resistance patterns, working on collaborating with laboratories to culture HP for susceptibility/resistance would be worthwhile to increase the likelihood of excellent outcomes.

Related blog links:

Also noted:  full text article online (from Kipp Ellsworth twitter feed): http://goo.gl/dD2ooF “Intestinal Transplantation: An Unexpected Journey”  This is a succinct overview of intestinal transplantation’s progress and potential.

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Why an ERCP Study Matters to Pediatric Care

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While there are pediatric patients who undergo endoscopic retrograde cholangiopancreatography (ERCP), this is a relatively infrequent occurrence. Nevertheless, a recent study has a couple useful clinical pearls that may have broader application.

  1. Clin Gastroenterol Hepatol 2014; 12: 303-07.
  2. Clin Gastroenterol Hepatol 2014; 12: 308-10 Associated editorial
  3. Gastroenterol 2014; 146: 581-82. Associated summary

Key points/Implications:

  • Aggressive hydration may prevent post-ERCP pancreatitis. In the study, the treatment group received an average of 3290 mL over the 9-hour period compared with 945 mL in the standard infusion group.
  • Implication: The speculation from the study and the editorials is that improved pancreatic perfusion will result in better oxygenation and reduce the likelihood of  pancreatitis. In the 2nd reference, the author states that his practice is to administer “at least 3 L of crystalloid in recovery to young, healthy patients who have undergone high-risk ERCP and an additional 3 to 5 L within the first 12 hospital hours to those admitted with postprocedure pain”
  • The best fluid (for post-ERCP and acute pancreatitis) may be lactated Ringer’s (LR).
  • Implication: The lactate in LR may help reduce pancreatitis by avoiding acidosis which could promote zymogen activation and pancreatic inflammation. A previous small trial (n=40) of acute pancreatitits from any cause showed lesser degrees of systemic inflammatory response with LR in compared with normal saline (Clin Gastroenterol Hepatol 2011; 9: 710-17e1).
  • This study adds aggressive IVFs as another intervention to prevent ERCP.  Rectal indomethacin and prophylactic stent placement (in high-risk patients) are other accepted treatments.

Study details:

This pilot study randomly assigned 39 patients to aggressive hydration and 23 to standard hydration; all patients were inpatients who were not at risk for fluid overload. The aggressive group received 3 mL/kg/h during the procedure, a 20 mL/kg bolus after the procedure, and then continued on 3 mL/kg/hr for 8 hours.  In contrast, the standard group received LR at 1.5 mL/kg/h during and for 8 hours afterwards.

Demographics: The average age was 43 years in the aggressive hydration group and 45 years in the standard group. 78% were hispanic.  The ERCP procedures were mostly “average risk.”  74% had ERCP for choledocholithiasis.  Only 2 subjects needed precut sphinterotomy (3%).

Results:

  • No patients in the aggressive hydration group developed acute pancreatitis compared with 4 (17%) in the standard hydration group
  • Elevated amylase (23% vs. 39%) and epigastric pain (8% vs 22%) were also less frequent in the aggressive hydration group.

Numerous Limitations: This was a small pilot study with an atypical population; thus, the findings are difficult to generalize.  A false-positive (type 1 error) can easily occur due to the small numbers, especially as the standard hydration group had a rate of acute pancreatitis that was about double from previous studies. In addition, this study was not blinded and could have been susceptible to bias.  Furthermore, the authors defined acute pancreatitis differently than in previous studies.  In this study, the authors required enzyme increases 2 or 8 hours after ERCP with new abdominal pain; in previous studies, the definition of acute pancreatitis relied on enzyme increases for at least 24 hours after the ERCP.

Take-home message for those not doing ERCPs: Think about using lactated ringer’s and aggressive hydration in otherwise-well patients who present with acute pancreatitis.

Related blog entries:

What and When for ERCP with Gallstone Pancreatitis

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A recent case vignette highlights several key points regarding use and timing of ERCP (endoscopic retrograde cholangiopancreatography) for gallstone pancreatitis (NEJM 2014; 370: 150-7). Figure 1 provides a nice illustration of ERCP.

Indications:  Suspected bile-duct stones as the cause of pancreatitis AND one of the following:

  • cholangitis (fever, jaundice, sepsis)
  • persistent biliary obstruction (conjugated bilirubine level >5 mg/dL)
  • clinical deterioration (worsening pain, increasing white cell count, worsening vital signs)
  • stone evident in the common bile duct on imaging

AGA position paper (2007):

  • Urgent ERCP (within 24 hours of admission) was recommended in those with cholangitis
  • Early ERCP (within 72 hours of admission) was recommended if suspicion of persistent bile-duct stones remained high

Patient information/animated videos for pancreatic diseases from the National Pancreas Foundation: http://ow.ly/sF9vb 

Related post:

Indomethacin to prevent post-ERCP pancreatitis | gutsandgrowth

Variation in Practice -The Influence of Money

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A recent study highlights the problem of bundling and shows how financial incentives distort care in some gastroenterology practices (Clin Gastroenterol Hepatol 2014; 12: 58-63).

Background: When needed, patients can undergo both colonoscopy and esophagogastroduodenoscopy (EGD) at the same time; when combined, the procedures are considered bundled.  It is more convenient for patients and less costly to do the two procedures during the same sedation.  However, Medicare reimbursement to physicians for bundled procedures is less than the sum of the two procedures when charged separately. This creates an incentive for physicians to unbundle these procedures.

Study design: The authors examined Medicare claims from 2007-2009 in a national, random sample (patients ≥66 years) –part of the Surveillance Epidemiology and End Results Program.

Results:

  • 12,982 had colonoscopy and EGD within 180 days.  ~35% of these were not bundled.  This included 2359 (18%) unbundled procedures which were performed within 30 days of each other.
  • Geographic differences were noted: bundling occurred less often in the Northeast (55%) and most often in the West (68%)

What does this study indicate about bundling (& human nature)?  This study indicates that physicians respond to underlying financial incentives to separate these procedures.  In our pediatric practice, we do not unbundle procedures.  The additional facility costs, use of anesthesia, costs to families from missing work, and convenience are compelling reasons to combine procedures if feasible.  However, this data indicates that unless physicians are paid the same value for each EGD and colonoscopy, there will continue to be many patients who have their procedures scheduled on separate dates.

Bottomline: Medicare and other insurance companies will save money by not paying less for combined procedures.

Another example of financial incentive influencing care with regard to ambulance and EMS care:  How Perverse Incentives Drive Up Health Care Costs / ideastream …

Moving to All Oral Therapy for Hepatitis C

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Two more studies show the promise of all oral treatment for Hepatitis C virus:

  • NEJM 2014; 370: 211-21.
  • NEJM 2014; 370: 222-32.

A summary of these articles is available at the following link: http://t.co/Z8jMPKoLGz.

Here is an excerpt:

Hepatitis C treatment isn’t pretty, but the dark days of weekly injections, rough side effects and no guarantee of full recovery from the liver-damaging disease may soon be over, researchers report.

Two studies, both published in the Jan. 16 issue of the New England Journal of Medicine, involved giving various combinations of antiviral pill cocktails to patients with hepatitis C. Some had failed to respond to standard treatments, and some had not received treatment yet. Yet, the cocktails cleared the virus in both studies for between 93 percent and 98 percent of the patients…

The first study, conducted by Johns Hopkins researchers, included 211 men and women with hepatitis C who took two pill-form antiviral medications, daclatasvir and sofosbuvir. The patients were treated at 18 medical centers in the United States and Puerto Rico. They took 60 milligrams of daclatasvir and 400 milligrams of sofosbuvir for either 12 or 24 weeks, with or without a third drug, ribavirin….

98 percent of the 126 previously untreated patients and 98 percent of 41 patients whose infections had not cleared despite treatment with standard hepatitis C therapy, were considered cured. “There was no detectable virus in their blood three months after the treatment stopped,” he noted.

The second study, headed up by researchers at Virginia Mason Medical Center in Seattle, involved more than eight medical centers in the United States and internationally. It included 571 patients with hepatitis C, some of whom had not received treatment previously and others who had previously received standard treatments with interferon injections and ribavirin — an antiviral drug that when given reduces relapses — but had not responded to them.

The participants were randomly assigned to take any of three combinations of antiviral pills — medications called ABT-450, ABT-267, and ABT-333 — for eight, 12 or 24 weeks…

Almost all of the patients (more than 93 percent in both groups) saw the virus cleared from their systems within 24 weeks.

Bottomline: Once daily treatment with a combination of medicines will be an effective and safe cure for more than 90% of individuals with HCV. Whether these agents will be affordable remains in doubt.

Related blog posts:

 

AGA Guidelines for the Use of Thiopurines and Anti-TNF Agents for Crohn’s

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The link (from KT Park’s twitter feed): gastrojournal.org/article/S0016-5085(13)01521-7/fulltext …

Some of the key points/recommendations for adults with Crohn’s disease:

  • In clinical practice, CD of moderate severity is defined as disease requiring systemic corticosteroids for symptom control.

For Induction of Remission:

  • We Suggest Against Using Thiopurine Monotherapy to Induce Remission in Patients With Moderately Severe CD (Weak Recommendation, Moderate-Quality Evidence)
  • We Suggest Against Using Methotrexate to Induce Remission in Patients With Moderately Severe CD (Weak Recommendation, Low-Quality Evidence)
  • We Recommend Using Anti–TNF-α Drugs to Induce Remission in Patients With Moderately Severe CD (Strong Recommendation, Moderate-Quality Evidence)
  • We Suggest Using Anti–TNF-α Drugs in Combination With Thiopurines Over Anti–TNF-α Drug Monotherapy to Induce Remission in Patients Who Have Moderately Severe CD (Weak Recommendation, Moderate-Quality Evidence)

Maintenance of Remission:

  • We Recommend Using Thiopurines Over No Immunomodulator Therapy to Maintain a Corticosteroid-Induced Remission in Patients With CD (Strong Recommendation, Moderate-Quality Evidence)
  • We Suggest Using Methotrexate Over No Immunomodulator Therapy to Maintain Corticosteroid-Induced Remission in Patients With CD (Weak Recommendation, Low-Quality Evidence)
  • We Recommend Using Anti–TNF-α Drugs Over No Anti–TNF-α Drugs to Maintain Corticosteroid- or Anti–TNF-α—Induced Remission in Patients With CD (Strong Recommendation, High-Quality Evidence)
  • We Make No Recommendation for or Against the Combination of an Anti–TNF-α Drug and a Thiopurine Versus an Anti–TNF-α Drug Alone to Maintain Remission Induced by a Combination of These Drugs in Patients With CD (No Recommendation, Low-Quality Evidence)

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Predicting Severe Clostridium Difficile

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According to a recent publication (Clin Gastroenterol Hepatol 2013; 11: 1466-71), the most important risk factors for severe Clostridium difficile infection (CDI) are the following:

  • Peripheral leukocytosis (WBC >15,000)
  • Elevated serum creatinine >1.5 times baseline
  • Narcotic use
  • Acid-blocking medications
  • Older age

This study reviewed the records of inpatient cases at the Mayo clinic between 2007-2010. In total, 487 of 1446 patients had severe CDI, defined as ICU admssion (26.7%), colectomy (2.7%) or death (8.9%) within 30 days of diagnosis.

Patients with these risk factors may need to be treated more aggressively.

Also, noted: Am J Gastroenterol 2013; 108: 1794-1801. (Thanks to Ben Gold). Using electronic medical records, the authors identified 894  adult inpatients with a first-time CDI (2009-2012).  Receipt of PPIs concurrent with CDI treatment was not associated with CDI recurrence.

Related blog posts:

Intermittent Abdominal Pain and Intestinal Swelling –a Mystery?

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A recent “Think Like a Doctor”  -full link to the solved case: nyti.ms/1aJtxFK 

First an except from the challenge:

The Patient’s History

It started nearly two years earlier, the woman told Dr. Merai. She had been at work — she was a clerk in a bank then — and had suddenly started vomiting. As she made her way back to her desk, she felt weak and unsteady and fainted. Or that’s what everybody told her, because the next thing she knew, she was in an ambulance on the way to the hospital.

There, a CT scan showed that her small intestines were inflamed. The doctors said she might have Crohn’s disease. But after a couple of days, she started to feel better and went home. Because she felt O.K., she never followed up.

And then, it happened again — nine months later. Again she was rushed to the hospital. Again a CT scan showed an abnormality in the small intestines. This time the doctors were so worried they took her straight into the operating room.

“They thought my guts were tangled up in knots,” she told the doctor. But when she woke up, the surgeon told her that he was amazed to see that her insides were pristine. There was swelling and a lot of fluid in her belly, but no twisting, and no infection. And nothing to take out.

At that hospital she had an endoscopy so doctors could look at her stomach and upper G.I. tract and a colonoscopy to look at the other end. Those exams were normal.

And now the answer (an excerpt):

The correct diagnosis is…

Intestinal angioedema, triggered by lisinopril, the ACE inhibitor the patient took for her high blood pressure.

The Diagnosis:

Angioedema is a localized type of swelling usually involving the mouth, tongue or upper airways. It can be part of a typical allergic reaction, with hives and itching, or it can be isolated, with swelling as the only notable finding. While there is an inherited form of this disease, most cases are acquired. And medications are the most common cause of this form of the syndrome…

his patient had a rare form of the problem that arose not in the face but in the intestine. When swelling occurs in the gut, it can block off the intestinal lumen and bring digestion to a screeching halt, causing the terrible pain and vomiting this patient experienced.

Remarkably, no matter where in the body the swelling occurs, or how severe it gets, it always resolves quickly – often within hours – even if the patient continues to take the medication.

When the angioedema happens in the G.I. tract, the diagnosis can be delayed for months or years because so many doctors don’t know that this kind of reaction is even possible. When the medication is stopped, the episodic reaction also finally stops…

the resident on call that day at the University of Chicago Medical Center, and told her that he thought this was a reaction to the patient’s blood pressure medication.

He also recommended that the patient be tested for the inherited version of the disease.

Related blog post: 

Overlooking Important Detail$ in Hereditary Angioedema Treatment …