Neighbor Finds Man on Knees, Vomiting

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The correct interpretation of this ECG includes atrial fibrillation and ST- and T-wave changes consistent with a central nervous system hemorrhage, as well as a markedly prolonged QT interval.

The most common ECG alterations seen in cases of acute subarachnoid hemorrhage include repolarization abnormalities due to imbalance of autonomic cardiovascular control. While ST depression is more common in patients with poor outcomes, it is not predictive.

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Lyle W. Larson, PhD, PA-C, is clinical faculty in the Department of Medicine, Division of Cardiology, Cardiac Electro­physiology, at the University of Washington, ­Seattle.

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ANSWER

The correct interpretation of this ECG includes atrial fibrillation and ST- and T-wave changes consistent with a central nervous system hemorrhage, as well as a markedly prolonged QT interval.

The most common ECG alterations seen in cases of acute subarachnoid hemorrhage include repolarization abnormalities due to imbalance of autonomic cardiovascular control. While ST depression is more common in patients with poor outcomes, it is not predictive.

ANSWER

The correct interpretation of this ECG includes atrial fibrillation and ST- and T-wave changes consistent with a central nervous system hemorrhage, as well as a markedly prolonged QT interval.

The most common ECG alterations seen in cases of acute subarachnoid hemorrhage include repolarization abnormalities due to imbalance of autonomic cardiovascular control. While ST depression is more common in patients with poor outcomes, it is not predictive.

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Neighbor Finds Man on Knees, Vomiting
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What is your interpretation of this ECG?

 

 

A 68-year-old man was found on his knees, ­vomiting, in his backyard by a neighbor early this morning. When asked if he was OK, the ­patient responded that he suddenly felt nauseated and had a headache. The neighbor helped him to his feet and, noticing that his left leg and arm were weak, called 911. During that time, the neighbor observed slurred speech. As they waited for the ambulance to arrive, the patient was able to say that this was the worst headache he’d ever had. When the paramedics arrived, they recorded a blood pressure of 198/120 mm Hg, consistent in both arms. Medical history is remarkable for hypertension, paroxysmal atrial fibrillation, adult-onset diabetes, and nephrolithiasis. Surgical history is remarkable for appendectomy, cholecystectomy, and lithotripsy. The patient is a retired civil engineer who lives at home alone. His wife died three years ago of complications from uterine cancer. He has one adult son who is in excellent health but lives on the opposite coast. The patient has never smoked and drinks approximately one six-pack of beer per month. Current medications include hydrochlorothiazide, metformin, and rivaroxaban. He is allergic to sulfa-containing medications. A complete review of systems is not obtained, given the patient’s slurred speech and progressive aphasia. He is able to nod yes or no to specific questions, and no significant symptoms or findings are identified. At the hospital, the patient is agitated and in apparent distress, with severe headache and aphasia. Vital signs include a blood pressure of 180/110 mm Hg; pulse, 60 beats/min; respiratory rate, 14 breaths/min; and temperature, 98.4°F. The O2 saturation is 96.4% on room air. Pertinent physical findings include aphasia, oculomotor nerve palsy, nuchal rigidity, and findings of a left-sided (right hemispheric) progressive hemiparesis. The remainder of the physical examination is noncontributory. Samples are drawn for laboratory testing, and an ECG is obtained prior to the patient’s transfer to radiology for CT of the head. The ECG findings include a ventricular rate of 62 beats/min; QRS duration, 88 ms; QT/QTc interval, 718/728 ms; P axis, not measured; R axis, 35°; and T axis, 209°. What is your interpretation of this ECG?

 

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Healthcare Industry Agents of Change Promote Responsible Spending

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1 Caring Wisely Program

http://healthvalue.ucsf.edu/caring-wisely

  • Started in 2012 within the division of hospital medicine at the University of California, San Francisco (UCSF), the program sponsored or collaborated on six high-value care projects within its first year. “We don’t shy away from the fact that part of what we do is address cost, but it is about making sure that we’ve got the right mindset and right frame, which is that we’re going to improve quality while decreasing costs and keeping it really patient centered,” says Christopher Moriates, MD, program director and an assistant clinical professor.
  • Beyond its successful Nebs No More After 24 project, Caring Wisely helped hospital pharmacists and the UCSF Medication Outcomes Center develop and implement an evidence-based initiative to cut inappropriate stress ulcer prophylaxis in intensive care unit patients. After its first month, the program had cut unnecessary use of the medication from 19% to 6.6%.

2 Choosing Wisely Program

http://www.choosingwisely.org

  • Launched in 2012 as an initiative of the ABIM Foundation and based on a pilot project by the National Physicians Alliance, Choosing Wisely was designed to encourage more proactive conversations between providers and patients. The goal is to help patients choose care that is both evidence-based and necessary, while minimizing harm and avoiding duplication of tests or procedures.
  • Since its debut, the program has gathered nearly 60 specialty society lists of “Five Things Physicians and Patients Should Question,” including two lists compiled by SHM for adult and pediatric hospital medicine. As a complement, Consumer Reports and many of the specialty societies have collaborated on 75 patient-friendly reports that dispense advice about whether a test, treatment, or procedure is really needed.

3 Costs of Care

www.costsofcare.org

  • Founded in 2009 by Neel Shah, MD, an assistant professor at Harvard Medical School, the nonprofit got its start by collecting stories from patients and physicians about unnecessary or inflated healthcare costs. “It had a manifesto about what the role of physicians ought to be and thinking about healthcare costs, and that message actually really resonated with a lot of people,” Dr. Shah says. “That basic message that we decide what goes on the bill, patients have to pay for it, and yet we don’t know what it’s costing them—that just seemed crazy and we heard from a lot of people, both from patients with whom that message resonated and physicians who were like, ‘Yeah.’”
  • In 2010, the organizers hosted their first essay contest and ended up receiving more than 300 entries; several were subsequently included as case reports in a report on healthcare waste by the Institute of Medicine. The nonprofit, supported by the ABIM Foundation and other institutions, has since led to an educational venture called the Teaching Value Project, a textbook titled Understanding Value-Based Care (McGraw-Hill), and a “Costs of Care” iPhone app—all designed to help clinicians make high-value clinical decisions and increase price transparency.

4 The Do No Harm Project

http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/

GIM/education/DoNoHarmProject/Pages/Welcome.aspx

  • Launched in 2012 at the University of Colorado by Brandon Combs, MD, and Tanner Caverly, MD, MPH, the project is aimed at medical trainees. Starting with the internal medicine program, the physicians asked medical residents to reflect on a patient who had suffered an adverse consequence from medical overuse. “This was reasonable care that was nevertheless unneeded or unwanted by a fully informed patient,” Dr. Combs says. “So this isn’t errors or malpractice; this is the stuff that flies under the radar, the stuff that people might miss.”
  • The project uses clinical vignettes written by medical trainees (including those found in the “Teachable Moments” section of JAMA Internal Medicine) to improve the recognition of potential harm from overuse and to spur a culture change. In 2013, the Teaching Value and Choosing Wisely Competition, jointly sponsored by Costs of Care and the ABIM Foundation, recognized the project as one of its Innovations award winners; so far, five internal medicine and emergency medicine programs around the country have adopted the model.
 

 

5 I-CARE

http://wingofzock.org/2013/12/05/yales-i-care-engages-residents-faculty-on-costs-in-friendly-competition/

  • The Interactive Cost-Awareness Resident Exercise (I-CARE) was launched in 2011 by Yale hospitalist Robert Fogerty, MD, MPH, and colleagues. The friendly competition among medical students, interns, residents, and attending physicians uses a traditional morning report structure and charge data. At these conferences, the providers compete to come up with the correct diagnosis using the fewest resources possible. In 2013, the Teaching Value and Choosing Wisely competition, jointly sponsored by Costs of Care and the ABIM Foundation, recognized I-CARE as one of its Innovations award winners.
  • “Physicians tend not to have a lot of business training,” Dr. Fogerty says. “They don’t have a lot of financial training. They don’t have a lot of economics background, and when you tell them that healthcare expense is 18% of GDP [gross domestic product], they don’t really know what that means. When you tell them that that would be in the top 10 of world economies, now they’re starting to get a picture of it. And when you tell them that that CAT scan you just ordered is going to cost your patient $1,200, that’s an eye-opening number that they can understand. So I think the purpose behind I-CARE was to take this seemingly insurmountable problem and to begin to digest it into small enough bits of information that allowed this problem to be accessible to the trainees.”

6 Providers for Responsible Ordering (PRO)

www.providersforresponsibleordering.org

  • The organization launched in 2009 with a mission to “promote high-value care and create a culture that minimizes unnecessary or potentially-harmful diagnostic tests and interventions.” By the end of 2014, five chapters had been established and more than 150 providers had signed the PRO pledge that asks signatories, in part, “to provide my patients with all of the care that they need and none that they do not, thereby protecting them from unnecessary diagnostic tests and treatments.”
  • “Our model is simple and yet powerful. It’s a grass-roots effort that any interested provider can join, and it builds on a peer-to-peer approach of establishment of chapters that solve local problems and reporting of those solutions back to the national group,” says Anthony Accurso, MD, PRO faculty director at Johns Hopkins Bayview Medical Center in Baltimore.
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1 Caring Wisely Program

http://healthvalue.ucsf.edu/caring-wisely

  • Started in 2012 within the division of hospital medicine at the University of California, San Francisco (UCSF), the program sponsored or collaborated on six high-value care projects within its first year. “We don’t shy away from the fact that part of what we do is address cost, but it is about making sure that we’ve got the right mindset and right frame, which is that we’re going to improve quality while decreasing costs and keeping it really patient centered,” says Christopher Moriates, MD, program director and an assistant clinical professor.
  • Beyond its successful Nebs No More After 24 project, Caring Wisely helped hospital pharmacists and the UCSF Medication Outcomes Center develop and implement an evidence-based initiative to cut inappropriate stress ulcer prophylaxis in intensive care unit patients. After its first month, the program had cut unnecessary use of the medication from 19% to 6.6%.

2 Choosing Wisely Program

http://www.choosingwisely.org

  • Launched in 2012 as an initiative of the ABIM Foundation and based on a pilot project by the National Physicians Alliance, Choosing Wisely was designed to encourage more proactive conversations between providers and patients. The goal is to help patients choose care that is both evidence-based and necessary, while minimizing harm and avoiding duplication of tests or procedures.
  • Since its debut, the program has gathered nearly 60 specialty society lists of “Five Things Physicians and Patients Should Question,” including two lists compiled by SHM for adult and pediatric hospital medicine. As a complement, Consumer Reports and many of the specialty societies have collaborated on 75 patient-friendly reports that dispense advice about whether a test, treatment, or procedure is really needed.

3 Costs of Care

www.costsofcare.org

  • Founded in 2009 by Neel Shah, MD, an assistant professor at Harvard Medical School, the nonprofit got its start by collecting stories from patients and physicians about unnecessary or inflated healthcare costs. “It had a manifesto about what the role of physicians ought to be and thinking about healthcare costs, and that message actually really resonated with a lot of people,” Dr. Shah says. “That basic message that we decide what goes on the bill, patients have to pay for it, and yet we don’t know what it’s costing them—that just seemed crazy and we heard from a lot of people, both from patients with whom that message resonated and physicians who were like, ‘Yeah.’”
  • In 2010, the organizers hosted their first essay contest and ended up receiving more than 300 entries; several were subsequently included as case reports in a report on healthcare waste by the Institute of Medicine. The nonprofit, supported by the ABIM Foundation and other institutions, has since led to an educational venture called the Teaching Value Project, a textbook titled Understanding Value-Based Care (McGraw-Hill), and a “Costs of Care” iPhone app—all designed to help clinicians make high-value clinical decisions and increase price transparency.

4 The Do No Harm Project

http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/

GIM/education/DoNoHarmProject/Pages/Welcome.aspx

  • Launched in 2012 at the University of Colorado by Brandon Combs, MD, and Tanner Caverly, MD, MPH, the project is aimed at medical trainees. Starting with the internal medicine program, the physicians asked medical residents to reflect on a patient who had suffered an adverse consequence from medical overuse. “This was reasonable care that was nevertheless unneeded or unwanted by a fully informed patient,” Dr. Combs says. “So this isn’t errors or malpractice; this is the stuff that flies under the radar, the stuff that people might miss.”
  • The project uses clinical vignettes written by medical trainees (including those found in the “Teachable Moments” section of JAMA Internal Medicine) to improve the recognition of potential harm from overuse and to spur a culture change. In 2013, the Teaching Value and Choosing Wisely Competition, jointly sponsored by Costs of Care and the ABIM Foundation, recognized the project as one of its Innovations award winners; so far, five internal medicine and emergency medicine programs around the country have adopted the model.
 

 

5 I-CARE

http://wingofzock.org/2013/12/05/yales-i-care-engages-residents-faculty-on-costs-in-friendly-competition/

  • The Interactive Cost-Awareness Resident Exercise (I-CARE) was launched in 2011 by Yale hospitalist Robert Fogerty, MD, MPH, and colleagues. The friendly competition among medical students, interns, residents, and attending physicians uses a traditional morning report structure and charge data. At these conferences, the providers compete to come up with the correct diagnosis using the fewest resources possible. In 2013, the Teaching Value and Choosing Wisely competition, jointly sponsored by Costs of Care and the ABIM Foundation, recognized I-CARE as one of its Innovations award winners.
  • “Physicians tend not to have a lot of business training,” Dr. Fogerty says. “They don’t have a lot of financial training. They don’t have a lot of economics background, and when you tell them that healthcare expense is 18% of GDP [gross domestic product], they don’t really know what that means. When you tell them that that would be in the top 10 of world economies, now they’re starting to get a picture of it. And when you tell them that that CAT scan you just ordered is going to cost your patient $1,200, that’s an eye-opening number that they can understand. So I think the purpose behind I-CARE was to take this seemingly insurmountable problem and to begin to digest it into small enough bits of information that allowed this problem to be accessible to the trainees.”

6 Providers for Responsible Ordering (PRO)

www.providersforresponsibleordering.org

  • The organization launched in 2009 with a mission to “promote high-value care and create a culture that minimizes unnecessary or potentially-harmful diagnostic tests and interventions.” By the end of 2014, five chapters had been established and more than 150 providers had signed the PRO pledge that asks signatories, in part, “to provide my patients with all of the care that they need and none that they do not, thereby protecting them from unnecessary diagnostic tests and treatments.”
  • “Our model is simple and yet powerful. It’s a grass-roots effort that any interested provider can join, and it builds on a peer-to-peer approach of establishment of chapters that solve local problems and reporting of those solutions back to the national group,” says Anthony Accurso, MD, PRO faculty director at Johns Hopkins Bayview Medical Center in Baltimore.

1 Caring Wisely Program

http://healthvalue.ucsf.edu/caring-wisely

  • Started in 2012 within the division of hospital medicine at the University of California, San Francisco (UCSF), the program sponsored or collaborated on six high-value care projects within its first year. “We don’t shy away from the fact that part of what we do is address cost, but it is about making sure that we’ve got the right mindset and right frame, which is that we’re going to improve quality while decreasing costs and keeping it really patient centered,” says Christopher Moriates, MD, program director and an assistant clinical professor.
  • Beyond its successful Nebs No More After 24 project, Caring Wisely helped hospital pharmacists and the UCSF Medication Outcomes Center develop and implement an evidence-based initiative to cut inappropriate stress ulcer prophylaxis in intensive care unit patients. After its first month, the program had cut unnecessary use of the medication from 19% to 6.6%.

2 Choosing Wisely Program

http://www.choosingwisely.org

  • Launched in 2012 as an initiative of the ABIM Foundation and based on a pilot project by the National Physicians Alliance, Choosing Wisely was designed to encourage more proactive conversations between providers and patients. The goal is to help patients choose care that is both evidence-based and necessary, while minimizing harm and avoiding duplication of tests or procedures.
  • Since its debut, the program has gathered nearly 60 specialty society lists of “Five Things Physicians and Patients Should Question,” including two lists compiled by SHM for adult and pediatric hospital medicine. As a complement, Consumer Reports and many of the specialty societies have collaborated on 75 patient-friendly reports that dispense advice about whether a test, treatment, or procedure is really needed.

3 Costs of Care

www.costsofcare.org

  • Founded in 2009 by Neel Shah, MD, an assistant professor at Harvard Medical School, the nonprofit got its start by collecting stories from patients and physicians about unnecessary or inflated healthcare costs. “It had a manifesto about what the role of physicians ought to be and thinking about healthcare costs, and that message actually really resonated with a lot of people,” Dr. Shah says. “That basic message that we decide what goes on the bill, patients have to pay for it, and yet we don’t know what it’s costing them—that just seemed crazy and we heard from a lot of people, both from patients with whom that message resonated and physicians who were like, ‘Yeah.’”
  • In 2010, the organizers hosted their first essay contest and ended up receiving more than 300 entries; several were subsequently included as case reports in a report on healthcare waste by the Institute of Medicine. The nonprofit, supported by the ABIM Foundation and other institutions, has since led to an educational venture called the Teaching Value Project, a textbook titled Understanding Value-Based Care (McGraw-Hill), and a “Costs of Care” iPhone app—all designed to help clinicians make high-value clinical decisions and increase price transparency.

4 The Do No Harm Project

http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/

GIM/education/DoNoHarmProject/Pages/Welcome.aspx

  • Launched in 2012 at the University of Colorado by Brandon Combs, MD, and Tanner Caverly, MD, MPH, the project is aimed at medical trainees. Starting with the internal medicine program, the physicians asked medical residents to reflect on a patient who had suffered an adverse consequence from medical overuse. “This was reasonable care that was nevertheless unneeded or unwanted by a fully informed patient,” Dr. Combs says. “So this isn’t errors or malpractice; this is the stuff that flies under the radar, the stuff that people might miss.”
  • The project uses clinical vignettes written by medical trainees (including those found in the “Teachable Moments” section of JAMA Internal Medicine) to improve the recognition of potential harm from overuse and to spur a culture change. In 2013, the Teaching Value and Choosing Wisely Competition, jointly sponsored by Costs of Care and the ABIM Foundation, recognized the project as one of its Innovations award winners; so far, five internal medicine and emergency medicine programs around the country have adopted the model.
 

 

5 I-CARE

http://wingofzock.org/2013/12/05/yales-i-care-engages-residents-faculty-on-costs-in-friendly-competition/

  • The Interactive Cost-Awareness Resident Exercise (I-CARE) was launched in 2011 by Yale hospitalist Robert Fogerty, MD, MPH, and colleagues. The friendly competition among medical students, interns, residents, and attending physicians uses a traditional morning report structure and charge data. At these conferences, the providers compete to come up with the correct diagnosis using the fewest resources possible. In 2013, the Teaching Value and Choosing Wisely competition, jointly sponsored by Costs of Care and the ABIM Foundation, recognized I-CARE as one of its Innovations award winners.
  • “Physicians tend not to have a lot of business training,” Dr. Fogerty says. “They don’t have a lot of financial training. They don’t have a lot of economics background, and when you tell them that healthcare expense is 18% of GDP [gross domestic product], they don’t really know what that means. When you tell them that that would be in the top 10 of world economies, now they’re starting to get a picture of it. And when you tell them that that CAT scan you just ordered is going to cost your patient $1,200, that’s an eye-opening number that they can understand. So I think the purpose behind I-CARE was to take this seemingly insurmountable problem and to begin to digest it into small enough bits of information that allowed this problem to be accessible to the trainees.”

6 Providers for Responsible Ordering (PRO)

www.providersforresponsibleordering.org

  • The organization launched in 2009 with a mission to “promote high-value care and create a culture that minimizes unnecessary or potentially-harmful diagnostic tests and interventions.” By the end of 2014, five chapters had been established and more than 150 providers had signed the PRO pledge that asks signatories, in part, “to provide my patients with all of the care that they need and none that they do not, thereby protecting them from unnecessary diagnostic tests and treatments.”
  • “Our model is simple and yet powerful. It’s a grass-roots effort that any interested provider can join, and it builds on a peer-to-peer approach of establishment of chapters that solve local problems and reporting of those solutions back to the national group,” says Anthony Accurso, MD, PRO faculty director at Johns Hopkins Bayview Medical Center in Baltimore.
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Practical Approaches in the Management of Bipolar Depression: Overcoming Challenges and Avoiding Pitfalls

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In the past 2 decades, the burden of care for psychiatric complaints in primary care—including bipolar depression—has increased considerably. The prevalence of bipolar disorder (BPD) in primary care has been recently estimated to range up to 4.3%, and in studies with broader definitions of the disorder or in populations with higher-than-usual psychiatric disorders, the prevalence has been reported to be up to 11.4%. Even though BPD is seen commonly in primary care, there are still profound disparities in the delivery of care, including underdiagnosis, misdiagnosis, and inappropriate treatments. There is abundant evidence that BPD can be successfully managed in the primary care setting when adequate physician education, collaborative care teams, and patient education are employed. Efficacious and well-tolerated pharmacologic treatments for BPD are available, and evidence-based pharmacotherapy can be optimally managed by the primary care provider. In this supplement, experts in BPD discuss the recognition and management of bipolar depression and associated comorbidities in the primary care setting.

Click here to read the supplement.

After reading the supplement, click here to access the posttest and evaluation form to receive CME credit.

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In the past 2 decades, the burden of care for psychiatric complaints in primary care—including bipolar depression—has increased considerably. The prevalence of bipolar disorder (BPD) in primary care has been recently estimated to range up to 4.3%, and in studies with broader definitions of the disorder or in populations with higher-than-usual psychiatric disorders, the prevalence has been reported to be up to 11.4%. Even though BPD is seen commonly in primary care, there are still profound disparities in the delivery of care, including underdiagnosis, misdiagnosis, and inappropriate treatments. There is abundant evidence that BPD can be successfully managed in the primary care setting when adequate physician education, collaborative care teams, and patient education are employed. Efficacious and well-tolerated pharmacologic treatments for BPD are available, and evidence-based pharmacotherapy can be optimally managed by the primary care provider. In this supplement, experts in BPD discuss the recognition and management of bipolar depression and associated comorbidities in the primary care setting.

Click here to read the supplement.

After reading the supplement, click here to access the posttest and evaluation form to receive CME credit.

In the past 2 decades, the burden of care for psychiatric complaints in primary care—including bipolar depression—has increased considerably. The prevalence of bipolar disorder (BPD) in primary care has been recently estimated to range up to 4.3%, and in studies with broader definitions of the disorder or in populations with higher-than-usual psychiatric disorders, the prevalence has been reported to be up to 11.4%. Even though BPD is seen commonly in primary care, there are still profound disparities in the delivery of care, including underdiagnosis, misdiagnosis, and inappropriate treatments. There is abundant evidence that BPD can be successfully managed in the primary care setting when adequate physician education, collaborative care teams, and patient education are employed. Efficacious and well-tolerated pharmacologic treatments for BPD are available, and evidence-based pharmacotherapy can be optimally managed by the primary care provider. In this supplement, experts in BPD discuss the recognition and management of bipolar depression and associated comorbidities in the primary care setting.

Click here to read the supplement.

After reading the supplement, click here to access the posttest and evaluation form to receive CME credit.

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Standard Text Messaging for Smartphones Not HIPAA Compliant

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Image Credit: SHUTTERSTOCK.COM

Doctors were the first to begin using pagers and, along with drug dealers, appear to be the last to give them up. But we really need to get rid of them.

Sadly, for the foreseeable future, we will need a pager replacement, but, in the longer term, I’m hopeful that we can:

  1. Reduce the frequency of electronic interruptions—all forms of interruptions—and the adverse effects that reliably accompany them, and
  2. Ensure that each interruption has value—that is, reduce or eliminate the many low value and non-urgent messages we all get (e.g. the ones informing you of a lab result you’ve already seen).

Death to the Pager

I can’t imagine anyone who will be more pleased than I will if pagers go the way of now rare hospital-wide PA announcements. Some hospitals have eliminated these announcements entirely, and even critical messages like “code blue” announcements are sent directly to each responder via a pager or other personal device.

Around the time the first iPhone was born, hospital signs banning cell phones began coming down. It seems the fear that they would disrupt hospital electronics, such as telemetry and other monitoring devices, has proven largely unfounded (though, along with things like computer keyboards and stethoscopes, pagers and cell phones can serve as dangerous repositories of bacteria).

Now nearly everyone, from staff to patients, keeps a cell phone with them while in the hospital. I think that is the most important step toward getting rid of pagers. Many doctors already are using the standard text messaging apps that come with the phone to communicate with one another efficiently.

I would love to see a feature that I don’t think any vendor offers yet. It would be great if all messages the sender hasn’t marked “stat” or “urgent” first went to a queue in the EHR rather than immediately interrupting the recipient.

“Regular” Texting Won’t Cut It

Unfortunately, the standard text messaging that comes with every smartphone is not HIPAA compliant. Though I certainly don’t know how anyone would do it, it is apparently too easy for another person to intercept the message. So, if you’re texting information related to your clinical work, you need to make sure it doesn’t include anything that could be considered protected health information. It isn’t enough just to leave the patient’s name off the message. If you’re in the habit of regularly texting doctors, nurses, and other healthcare personnel about patient care, you are at high risk of violating HIPAA, even if you try hard to avoid it.

Another big drawback is that there isn’t a good way to turn off work-related texting when you’re off duty, while leaving your texting app open for communication with your friends and family. Hospital staff will sometimes fail to check whether you’re on duty before texting, and that will lead to your personal time being interrupted by work reminders.

I think these shortcomings mean that none of us should rely on the standard text messaging apps that come with our phones.

But in order for a different app or service to be of any value, we will need to ensure that most providers associated with our hospital are on the same messaging system. That is a tall order, but fortunately there are a lot of companies trying to produce an attractive product that makes it as easy as possible to attract a critical mass of users at your institution.

HIPAA-Compliant Texting Vendors

Many healthcare tech companies provide secure messaging, usually at no additional cost, as an add-on to their main products, such as charge capture software (e.g. IngeniousMed), or physician social networking (e.g. Doximity). Something like 30 companies now offer a dedicated HIPAA-compliant texting option, including IM Your Doc, Voalte, Telmediq, PerfectServe, Vocera, and TigerText. There are so many that it is awfully tough to understand all of their strengths and shortcomings in detail, but I’m having fun trying to do just that. And I anticipate there will be significant consolidation in vendors within the next two to three years.

 

 

The dedicated HIPAA-compliant texting services range in price from free for basic features to a monthly fee per user that varies depending on the features you choose to enable. Some offer integration with the hospital’s EHR, which can let a message sender who only knows the patient’s name to see which doctor, nurse, or other caregiver is currently responsible for the patient. Some offer integration with a call schedule and answering service, or even replace an answering service.

No pager replacement will be viable if there are sites in the hospital or elsewhere where it is out of contact; a solution that works on both cellular networks and Wi-Fi is essential. Some vendors offer the ability for messages not delivered to or acknowledged by the recipient to escalate to other forms of delivery after a specified period of time.

I would love to see a feature that I don’t think any vendor offers yet. It would be great if all messages the sender hasn’t marked “stat” or “urgent” first went to a queue in the EHR rather than immediately interrupting the recipient. That way a doctor or other caregiver could see messages while already working in the EHR, rather than glancing at each new message as it arrives, something that all too often needlessly interrupts another important task such as talking with a patient.

And, since most work in EHRs is done in front of a larger device with a full keyboard, it would be easier to type a quick reply message than it would be to rely on a smartphone keyboard for return messaging. Protocols could be established such that messages waiting in the EHR without a reply or dismissal after a specified time would then be sent to the recipient’s personal device.

A Texting Ecosystem

In nearly every case, the hospital will select the text messaging vendor, though hospitalists and nurses, who will typically be among the highest-volume users, should participate in the decision. But the real value of the system hinges on ensuring its wide adoption by most, or nearly all, hospital caregivers and affiliated ambulatory providers.

I would enjoy hearing from those who are already using a HIPAA-secure texting and pager replacement service now, as well as those still researching their options. This has the potential to meaningfully change the way hospitalists and others do their work.


Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at john.nelson@nelsonflores.com.

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Image Credit: SHUTTERSTOCK.COM

Doctors were the first to begin using pagers and, along with drug dealers, appear to be the last to give them up. But we really need to get rid of them.

Sadly, for the foreseeable future, we will need a pager replacement, but, in the longer term, I’m hopeful that we can:

  1. Reduce the frequency of electronic interruptions—all forms of interruptions—and the adverse effects that reliably accompany them, and
  2. Ensure that each interruption has value—that is, reduce or eliminate the many low value and non-urgent messages we all get (e.g. the ones informing you of a lab result you’ve already seen).

Death to the Pager

I can’t imagine anyone who will be more pleased than I will if pagers go the way of now rare hospital-wide PA announcements. Some hospitals have eliminated these announcements entirely, and even critical messages like “code blue” announcements are sent directly to each responder via a pager or other personal device.

Around the time the first iPhone was born, hospital signs banning cell phones began coming down. It seems the fear that they would disrupt hospital electronics, such as telemetry and other monitoring devices, has proven largely unfounded (though, along with things like computer keyboards and stethoscopes, pagers and cell phones can serve as dangerous repositories of bacteria).

Now nearly everyone, from staff to patients, keeps a cell phone with them while in the hospital. I think that is the most important step toward getting rid of pagers. Many doctors already are using the standard text messaging apps that come with the phone to communicate with one another efficiently.

I would love to see a feature that I don’t think any vendor offers yet. It would be great if all messages the sender hasn’t marked “stat” or “urgent” first went to a queue in the EHR rather than immediately interrupting the recipient.

“Regular” Texting Won’t Cut It

Unfortunately, the standard text messaging that comes with every smartphone is not HIPAA compliant. Though I certainly don’t know how anyone would do it, it is apparently too easy for another person to intercept the message. So, if you’re texting information related to your clinical work, you need to make sure it doesn’t include anything that could be considered protected health information. It isn’t enough just to leave the patient’s name off the message. If you’re in the habit of regularly texting doctors, nurses, and other healthcare personnel about patient care, you are at high risk of violating HIPAA, even if you try hard to avoid it.

Another big drawback is that there isn’t a good way to turn off work-related texting when you’re off duty, while leaving your texting app open for communication with your friends and family. Hospital staff will sometimes fail to check whether you’re on duty before texting, and that will lead to your personal time being interrupted by work reminders.

I think these shortcomings mean that none of us should rely on the standard text messaging apps that come with our phones.

But in order for a different app or service to be of any value, we will need to ensure that most providers associated with our hospital are on the same messaging system. That is a tall order, but fortunately there are a lot of companies trying to produce an attractive product that makes it as easy as possible to attract a critical mass of users at your institution.

HIPAA-Compliant Texting Vendors

Many healthcare tech companies provide secure messaging, usually at no additional cost, as an add-on to their main products, such as charge capture software (e.g. IngeniousMed), or physician social networking (e.g. Doximity). Something like 30 companies now offer a dedicated HIPAA-compliant texting option, including IM Your Doc, Voalte, Telmediq, PerfectServe, Vocera, and TigerText. There are so many that it is awfully tough to understand all of their strengths and shortcomings in detail, but I’m having fun trying to do just that. And I anticipate there will be significant consolidation in vendors within the next two to three years.

 

 

The dedicated HIPAA-compliant texting services range in price from free for basic features to a monthly fee per user that varies depending on the features you choose to enable. Some offer integration with the hospital’s EHR, which can let a message sender who only knows the patient’s name to see which doctor, nurse, or other caregiver is currently responsible for the patient. Some offer integration with a call schedule and answering service, or even replace an answering service.

No pager replacement will be viable if there are sites in the hospital or elsewhere where it is out of contact; a solution that works on both cellular networks and Wi-Fi is essential. Some vendors offer the ability for messages not delivered to or acknowledged by the recipient to escalate to other forms of delivery after a specified period of time.

I would love to see a feature that I don’t think any vendor offers yet. It would be great if all messages the sender hasn’t marked “stat” or “urgent” first went to a queue in the EHR rather than immediately interrupting the recipient. That way a doctor or other caregiver could see messages while already working in the EHR, rather than glancing at each new message as it arrives, something that all too often needlessly interrupts another important task such as talking with a patient.

And, since most work in EHRs is done in front of a larger device with a full keyboard, it would be easier to type a quick reply message than it would be to rely on a smartphone keyboard for return messaging. Protocols could be established such that messages waiting in the EHR without a reply or dismissal after a specified time would then be sent to the recipient’s personal device.

A Texting Ecosystem

In nearly every case, the hospital will select the text messaging vendor, though hospitalists and nurses, who will typically be among the highest-volume users, should participate in the decision. But the real value of the system hinges on ensuring its wide adoption by most, or nearly all, hospital caregivers and affiliated ambulatory providers.

I would enjoy hearing from those who are already using a HIPAA-secure texting and pager replacement service now, as well as those still researching their options. This has the potential to meaningfully change the way hospitalists and others do their work.


Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at john.nelson@nelsonflores.com.

Image Credit: SHUTTERSTOCK.COM

Doctors were the first to begin using pagers and, along with drug dealers, appear to be the last to give them up. But we really need to get rid of them.

Sadly, for the foreseeable future, we will need a pager replacement, but, in the longer term, I’m hopeful that we can:

  1. Reduce the frequency of electronic interruptions—all forms of interruptions—and the adverse effects that reliably accompany them, and
  2. Ensure that each interruption has value—that is, reduce or eliminate the many low value and non-urgent messages we all get (e.g. the ones informing you of a lab result you’ve already seen).

Death to the Pager

I can’t imagine anyone who will be more pleased than I will if pagers go the way of now rare hospital-wide PA announcements. Some hospitals have eliminated these announcements entirely, and even critical messages like “code blue” announcements are sent directly to each responder via a pager or other personal device.

Around the time the first iPhone was born, hospital signs banning cell phones began coming down. It seems the fear that they would disrupt hospital electronics, such as telemetry and other monitoring devices, has proven largely unfounded (though, along with things like computer keyboards and stethoscopes, pagers and cell phones can serve as dangerous repositories of bacteria).

Now nearly everyone, from staff to patients, keeps a cell phone with them while in the hospital. I think that is the most important step toward getting rid of pagers. Many doctors already are using the standard text messaging apps that come with the phone to communicate with one another efficiently.

I would love to see a feature that I don’t think any vendor offers yet. It would be great if all messages the sender hasn’t marked “stat” or “urgent” first went to a queue in the EHR rather than immediately interrupting the recipient.

“Regular” Texting Won’t Cut It

Unfortunately, the standard text messaging that comes with every smartphone is not HIPAA compliant. Though I certainly don’t know how anyone would do it, it is apparently too easy for another person to intercept the message. So, if you’re texting information related to your clinical work, you need to make sure it doesn’t include anything that could be considered protected health information. It isn’t enough just to leave the patient’s name off the message. If you’re in the habit of regularly texting doctors, nurses, and other healthcare personnel about patient care, you are at high risk of violating HIPAA, even if you try hard to avoid it.

Another big drawback is that there isn’t a good way to turn off work-related texting when you’re off duty, while leaving your texting app open for communication with your friends and family. Hospital staff will sometimes fail to check whether you’re on duty before texting, and that will lead to your personal time being interrupted by work reminders.

I think these shortcomings mean that none of us should rely on the standard text messaging apps that come with our phones.

But in order for a different app or service to be of any value, we will need to ensure that most providers associated with our hospital are on the same messaging system. That is a tall order, but fortunately there are a lot of companies trying to produce an attractive product that makes it as easy as possible to attract a critical mass of users at your institution.

HIPAA-Compliant Texting Vendors

Many healthcare tech companies provide secure messaging, usually at no additional cost, as an add-on to their main products, such as charge capture software (e.g. IngeniousMed), or physician social networking (e.g. Doximity). Something like 30 companies now offer a dedicated HIPAA-compliant texting option, including IM Your Doc, Voalte, Telmediq, PerfectServe, Vocera, and TigerText. There are so many that it is awfully tough to understand all of their strengths and shortcomings in detail, but I’m having fun trying to do just that. And I anticipate there will be significant consolidation in vendors within the next two to three years.

 

 

The dedicated HIPAA-compliant texting services range in price from free for basic features to a monthly fee per user that varies depending on the features you choose to enable. Some offer integration with the hospital’s EHR, which can let a message sender who only knows the patient’s name to see which doctor, nurse, or other caregiver is currently responsible for the patient. Some offer integration with a call schedule and answering service, or even replace an answering service.

No pager replacement will be viable if there are sites in the hospital or elsewhere where it is out of contact; a solution that works on both cellular networks and Wi-Fi is essential. Some vendors offer the ability for messages not delivered to or acknowledged by the recipient to escalate to other forms of delivery after a specified period of time.

I would love to see a feature that I don’t think any vendor offers yet. It would be great if all messages the sender hasn’t marked “stat” or “urgent” first went to a queue in the EHR rather than immediately interrupting the recipient. That way a doctor or other caregiver could see messages while already working in the EHR, rather than glancing at each new message as it arrives, something that all too often needlessly interrupts another important task such as talking with a patient.

And, since most work in EHRs is done in front of a larger device with a full keyboard, it would be easier to type a quick reply message than it would be to rely on a smartphone keyboard for return messaging. Protocols could be established such that messages waiting in the EHR without a reply or dismissal after a specified time would then be sent to the recipient’s personal device.

A Texting Ecosystem

In nearly every case, the hospital will select the text messaging vendor, though hospitalists and nurses, who will typically be among the highest-volume users, should participate in the decision. But the real value of the system hinges on ensuring its wide adoption by most, or nearly all, hospital caregivers and affiliated ambulatory providers.

I would enjoy hearing from those who are already using a HIPAA-secure texting and pager replacement service now, as well as those still researching their options. This has the potential to meaningfully change the way hospitalists and others do their work.


Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at john.nelson@nelsonflores.com.

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Consider ACO Participation As Medicare Weighs Changes to Shared Savings Program

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In December 2014, nearly three years since its launch, the Centers for Medicare and Medicaid Services (CMS) issued the first proposed rule changes to the Shared Savings Program. The changes, if approved, would take effect in the 2016 performance year and would focus on a host of alterations impacting participating accountable care organizations (ACOs), including reduced administrative burden, improved function and transparency, and enhanced incentives to participate in risk-based models.

Experts say the changes could address some of the biggest flaws in the program but also may not go far enough to incentivize more healthcare providers to participate—or protect them from the risk of financial loss. The rules are under review following a public comment period.

“Many features about the original rules weaken the incentives to participate in ACOs,” says Michael McWilliams, MD, PhD, associate professor of healthcare policy and medicine at Harvard Medical School and a practicing primary care physician at Brigham and Women’s Hospital in Boston.

The ACO model encourages providers to realize savings under fee-for-service Medicare through better-coordinated care and improvements in metrics related to utilization and quality. Any savings relative to a benchmark year are shared between the ACO and CMS.

This year, 424 ACOs are participating in the program nationwide, and while the number of Pioneer ACOs has fallen in recent years (Pioneer ACOs wager higher savings for participants at the risk of greater financial loss), a new independent report commissioned by CMS shows the program saved more than $300 annually per beneficiary in its first two years, achieving $384 million in savings.1 In a statement, CMS concluded this meets the criteria for expanding the Pioneer program; however, Dr. McWilliams says policy changes may still be needed to encourage participation in ACOs with downside risk.

In January, Dr. McWilliams and colleagues published a study in Health Affairs that demonstrated that existing benchmark rules may actually encourage higher Medicare spending as ACOs try to “fatten up” so they have more improvements to make and, therefore, more chance of success at realizing savings.2

Currently, providers’ performance is stacked against their performance and cost benchmarks established in the year prior to forming an ACO. As improvements are made, it becomes increasingly challenging for ACOs to do better. Dr. McWilliams says ACOs should instead be compared to other ACOs and providers.

It’s a “melting ice cube problem,” says Gregory Burke, MPA, director of innovation strategies for New York-based United Health Fund (UHF), a research and philanthropic organization focused on advancing healthcare.

For a hospital system, the bulk of the money comes from inpatient care. We’re saying: ‘You stomp on your own air hose today, and a year from now I’ll give you 50% oxygen—and you have to share with your buddy.’

—Gregory Burke, MPA, director of innovation Strategies, United Health Fund

“You are punishing the good, lean providers that are efficient,” he adds, “and rewarding people who are less efficient, in terms of cost of care and utilization of services.”

Burke and a colleague at UHF, health policy analyst Suzanne Brundage, recently completed qualitative and quantitative reports on ACOs in the state of New York, which currently make up 20% of Medicare fee-for-service beneficiaries.3,4

Through their analysis, which included structured interviews with 17 Pioneer ACO leaders, Burke and Brundage found ACO rules could change in the following ways to make the program sustainable and more attractive to providers:

  • Patients should be attributed to PCPs within the ACO;
  • Risk adjustment should be made for ACO providers serving a sicker population of patients; and
  • Benchmark rules should be altered.

Additionally, Dr. McWilliams says the shared savings rate realized by ACOs should be higher than 50%, which is especially true for hospitals within an ACO, since the goals of the program are to reduce hospital visits, extensive specialist services, and testing services.

 

 

“For a hospital system, the bulk of the money comes from inpatient care,” Burke says. “We’re saying: ‘You stomp on your own air hose today, and a year from now I’ll give you 50% oxygen—and you have to share with your buddy.’”

The 2014 State of Hospital Medicine report indicates that 36% of adult hospitalist medicine groups are in hospitals either already involved in or considering involvement in an ACO; however, respondents in that report also reflect no clear role for hospitalists in the ACO model.

This is a point disputed by Val Akopov, MD, vice president and chief of hospital medicine at WellStar Health System, a not-for-profit organization in northwestern Atlanta and a participating ACO. Dr. Akopov highlights ways in which hospitals and hospitalists could take advantage of the model.

“Five measures fall into the domain of care coordination that are directly, unequivocally related to what hospitalists do, and these metrics are part of, in my opinion, what any hospital medicine program should have as a value proposition,” Dr. Akopov says.

At WellStar, for example, hospitalists have become part of the ACO structure by serving as medical directors and attending physicians at skilled nursing facilities (SNFs). They are “solely responsible to attend to patients in SNFs, and we have seen a dramatic improvement in readmission rates and quality metrics in nursing homes, such as incidence of falls, use of antipsychotics, and 30-day unplanned readmissions to acute care hospitals,” Dr. Akopov explains.

Additionally, WellStar hospitalists work with each inpatient to ensure they have primary care follow-up scheduled before discharge, Dr. Akopov says, noting that the model is a good opportunity to explore changes to the way hospitals and providers deliver care.

“There are roughly 38,000 Medicare patients in [our] ACO; it’s much easier to work out the kinks with innovations on a limited patient population and then extrapolate findings on 1.5 million annually, rather than trying to bite too much,” he says.

Despite the challenges, experts are optimistic the ACO model can—and will—work. In their reporting, Burke and Brundage found healthcare leaders participating in ACOs remain optimistic.

“It’s a post-Copernican universe, where the world no longer revolves around the hospital, so balancing the equation is a little different,” Burke says. “But they’re staying in the game, because that’s where the puck is going to be.”


Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

  1. Affordable Care Act payment model saves more than $384 million in two years, meets criteria for first-ever expansion. Centers for Medicare & Medicaid Services website. Published May 4, 2015. Accessed May 11, 2015.
  2. Douven R, McGuire TG, McWilliams JM. Avoiding unintended incentives in ACO payment models. Health Aff. 2015;34(1):143-149.
  3. Burke, G, Brundage S. Accountable care in New York state: emerging themes and issues. United Hospital Fund. Accessed May 9, 2015.
  4. Burke, G and Brundage S. New York’s Medicare ACOs: participants and performance. United Hospital Fund. Accessed May 9, 2015.
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In December 2014, nearly three years since its launch, the Centers for Medicare and Medicaid Services (CMS) issued the first proposed rule changes to the Shared Savings Program. The changes, if approved, would take effect in the 2016 performance year and would focus on a host of alterations impacting participating accountable care organizations (ACOs), including reduced administrative burden, improved function and transparency, and enhanced incentives to participate in risk-based models.

Experts say the changes could address some of the biggest flaws in the program but also may not go far enough to incentivize more healthcare providers to participate—or protect them from the risk of financial loss. The rules are under review following a public comment period.

“Many features about the original rules weaken the incentives to participate in ACOs,” says Michael McWilliams, MD, PhD, associate professor of healthcare policy and medicine at Harvard Medical School and a practicing primary care physician at Brigham and Women’s Hospital in Boston.

The ACO model encourages providers to realize savings under fee-for-service Medicare through better-coordinated care and improvements in metrics related to utilization and quality. Any savings relative to a benchmark year are shared between the ACO and CMS.

This year, 424 ACOs are participating in the program nationwide, and while the number of Pioneer ACOs has fallen in recent years (Pioneer ACOs wager higher savings for participants at the risk of greater financial loss), a new independent report commissioned by CMS shows the program saved more than $300 annually per beneficiary in its first two years, achieving $384 million in savings.1 In a statement, CMS concluded this meets the criteria for expanding the Pioneer program; however, Dr. McWilliams says policy changes may still be needed to encourage participation in ACOs with downside risk.

In January, Dr. McWilliams and colleagues published a study in Health Affairs that demonstrated that existing benchmark rules may actually encourage higher Medicare spending as ACOs try to “fatten up” so they have more improvements to make and, therefore, more chance of success at realizing savings.2

Currently, providers’ performance is stacked against their performance and cost benchmarks established in the year prior to forming an ACO. As improvements are made, it becomes increasingly challenging for ACOs to do better. Dr. McWilliams says ACOs should instead be compared to other ACOs and providers.

It’s a “melting ice cube problem,” says Gregory Burke, MPA, director of innovation strategies for New York-based United Health Fund (UHF), a research and philanthropic organization focused on advancing healthcare.

For a hospital system, the bulk of the money comes from inpatient care. We’re saying: ‘You stomp on your own air hose today, and a year from now I’ll give you 50% oxygen—and you have to share with your buddy.’

—Gregory Burke, MPA, director of innovation Strategies, United Health Fund

“You are punishing the good, lean providers that are efficient,” he adds, “and rewarding people who are less efficient, in terms of cost of care and utilization of services.”

Burke and a colleague at UHF, health policy analyst Suzanne Brundage, recently completed qualitative and quantitative reports on ACOs in the state of New York, which currently make up 20% of Medicare fee-for-service beneficiaries.3,4

Through their analysis, which included structured interviews with 17 Pioneer ACO leaders, Burke and Brundage found ACO rules could change in the following ways to make the program sustainable and more attractive to providers:

  • Patients should be attributed to PCPs within the ACO;
  • Risk adjustment should be made for ACO providers serving a sicker population of patients; and
  • Benchmark rules should be altered.

Additionally, Dr. McWilliams says the shared savings rate realized by ACOs should be higher than 50%, which is especially true for hospitals within an ACO, since the goals of the program are to reduce hospital visits, extensive specialist services, and testing services.

 

 

“For a hospital system, the bulk of the money comes from inpatient care,” Burke says. “We’re saying: ‘You stomp on your own air hose today, and a year from now I’ll give you 50% oxygen—and you have to share with your buddy.’”

The 2014 State of Hospital Medicine report indicates that 36% of adult hospitalist medicine groups are in hospitals either already involved in or considering involvement in an ACO; however, respondents in that report also reflect no clear role for hospitalists in the ACO model.

This is a point disputed by Val Akopov, MD, vice president and chief of hospital medicine at WellStar Health System, a not-for-profit organization in northwestern Atlanta and a participating ACO. Dr. Akopov highlights ways in which hospitals and hospitalists could take advantage of the model.

“Five measures fall into the domain of care coordination that are directly, unequivocally related to what hospitalists do, and these metrics are part of, in my opinion, what any hospital medicine program should have as a value proposition,” Dr. Akopov says.

At WellStar, for example, hospitalists have become part of the ACO structure by serving as medical directors and attending physicians at skilled nursing facilities (SNFs). They are “solely responsible to attend to patients in SNFs, and we have seen a dramatic improvement in readmission rates and quality metrics in nursing homes, such as incidence of falls, use of antipsychotics, and 30-day unplanned readmissions to acute care hospitals,” Dr. Akopov explains.

Additionally, WellStar hospitalists work with each inpatient to ensure they have primary care follow-up scheduled before discharge, Dr. Akopov says, noting that the model is a good opportunity to explore changes to the way hospitals and providers deliver care.

“There are roughly 38,000 Medicare patients in [our] ACO; it’s much easier to work out the kinks with innovations on a limited patient population and then extrapolate findings on 1.5 million annually, rather than trying to bite too much,” he says.

Despite the challenges, experts are optimistic the ACO model can—and will—work. In their reporting, Burke and Brundage found healthcare leaders participating in ACOs remain optimistic.

“It’s a post-Copernican universe, where the world no longer revolves around the hospital, so balancing the equation is a little different,” Burke says. “But they’re staying in the game, because that’s where the puck is going to be.”


Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

  1. Affordable Care Act payment model saves more than $384 million in two years, meets criteria for first-ever expansion. Centers for Medicare & Medicaid Services website. Published May 4, 2015. Accessed May 11, 2015.
  2. Douven R, McGuire TG, McWilliams JM. Avoiding unintended incentives in ACO payment models. Health Aff. 2015;34(1):143-149.
  3. Burke, G, Brundage S. Accountable care in New York state: emerging themes and issues. United Hospital Fund. Accessed May 9, 2015.
  4. Burke, G and Brundage S. New York’s Medicare ACOs: participants and performance. United Hospital Fund. Accessed May 9, 2015.

In December 2014, nearly three years since its launch, the Centers for Medicare and Medicaid Services (CMS) issued the first proposed rule changes to the Shared Savings Program. The changes, if approved, would take effect in the 2016 performance year and would focus on a host of alterations impacting participating accountable care organizations (ACOs), including reduced administrative burden, improved function and transparency, and enhanced incentives to participate in risk-based models.

Experts say the changes could address some of the biggest flaws in the program but also may not go far enough to incentivize more healthcare providers to participate—or protect them from the risk of financial loss. The rules are under review following a public comment period.

“Many features about the original rules weaken the incentives to participate in ACOs,” says Michael McWilliams, MD, PhD, associate professor of healthcare policy and medicine at Harvard Medical School and a practicing primary care physician at Brigham and Women’s Hospital in Boston.

The ACO model encourages providers to realize savings under fee-for-service Medicare through better-coordinated care and improvements in metrics related to utilization and quality. Any savings relative to a benchmark year are shared between the ACO and CMS.

This year, 424 ACOs are participating in the program nationwide, and while the number of Pioneer ACOs has fallen in recent years (Pioneer ACOs wager higher savings for participants at the risk of greater financial loss), a new independent report commissioned by CMS shows the program saved more than $300 annually per beneficiary in its first two years, achieving $384 million in savings.1 In a statement, CMS concluded this meets the criteria for expanding the Pioneer program; however, Dr. McWilliams says policy changes may still be needed to encourage participation in ACOs with downside risk.

In January, Dr. McWilliams and colleagues published a study in Health Affairs that demonstrated that existing benchmark rules may actually encourage higher Medicare spending as ACOs try to “fatten up” so they have more improvements to make and, therefore, more chance of success at realizing savings.2

Currently, providers’ performance is stacked against their performance and cost benchmarks established in the year prior to forming an ACO. As improvements are made, it becomes increasingly challenging for ACOs to do better. Dr. McWilliams says ACOs should instead be compared to other ACOs and providers.

It’s a “melting ice cube problem,” says Gregory Burke, MPA, director of innovation strategies for New York-based United Health Fund (UHF), a research and philanthropic organization focused on advancing healthcare.

For a hospital system, the bulk of the money comes from inpatient care. We’re saying: ‘You stomp on your own air hose today, and a year from now I’ll give you 50% oxygen—and you have to share with your buddy.’

—Gregory Burke, MPA, director of innovation Strategies, United Health Fund

“You are punishing the good, lean providers that are efficient,” he adds, “and rewarding people who are less efficient, in terms of cost of care and utilization of services.”

Burke and a colleague at UHF, health policy analyst Suzanne Brundage, recently completed qualitative and quantitative reports on ACOs in the state of New York, which currently make up 20% of Medicare fee-for-service beneficiaries.3,4

Through their analysis, which included structured interviews with 17 Pioneer ACO leaders, Burke and Brundage found ACO rules could change in the following ways to make the program sustainable and more attractive to providers:

  • Patients should be attributed to PCPs within the ACO;
  • Risk adjustment should be made for ACO providers serving a sicker population of patients; and
  • Benchmark rules should be altered.

Additionally, Dr. McWilliams says the shared savings rate realized by ACOs should be higher than 50%, which is especially true for hospitals within an ACO, since the goals of the program are to reduce hospital visits, extensive specialist services, and testing services.

 

 

“For a hospital system, the bulk of the money comes from inpatient care,” Burke says. “We’re saying: ‘You stomp on your own air hose today, and a year from now I’ll give you 50% oxygen—and you have to share with your buddy.’”

The 2014 State of Hospital Medicine report indicates that 36% of adult hospitalist medicine groups are in hospitals either already involved in or considering involvement in an ACO; however, respondents in that report also reflect no clear role for hospitalists in the ACO model.

This is a point disputed by Val Akopov, MD, vice president and chief of hospital medicine at WellStar Health System, a not-for-profit organization in northwestern Atlanta and a participating ACO. Dr. Akopov highlights ways in which hospitals and hospitalists could take advantage of the model.

“Five measures fall into the domain of care coordination that are directly, unequivocally related to what hospitalists do, and these metrics are part of, in my opinion, what any hospital medicine program should have as a value proposition,” Dr. Akopov says.

At WellStar, for example, hospitalists have become part of the ACO structure by serving as medical directors and attending physicians at skilled nursing facilities (SNFs). They are “solely responsible to attend to patients in SNFs, and we have seen a dramatic improvement in readmission rates and quality metrics in nursing homes, such as incidence of falls, use of antipsychotics, and 30-day unplanned readmissions to acute care hospitals,” Dr. Akopov explains.

Additionally, WellStar hospitalists work with each inpatient to ensure they have primary care follow-up scheduled before discharge, Dr. Akopov says, noting that the model is a good opportunity to explore changes to the way hospitals and providers deliver care.

“There are roughly 38,000 Medicare patients in [our] ACO; it’s much easier to work out the kinks with innovations on a limited patient population and then extrapolate findings on 1.5 million annually, rather than trying to bite too much,” he says.

Despite the challenges, experts are optimistic the ACO model can—and will—work. In their reporting, Burke and Brundage found healthcare leaders participating in ACOs remain optimistic.

“It’s a post-Copernican universe, where the world no longer revolves around the hospital, so balancing the equation is a little different,” Burke says. “But they’re staying in the game, because that’s where the puck is going to be.”


Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

  1. Affordable Care Act payment model saves more than $384 million in two years, meets criteria for first-ever expansion. Centers for Medicare & Medicaid Services website. Published May 4, 2015. Accessed May 11, 2015.
  2. Douven R, McGuire TG, McWilliams JM. Avoiding unintended incentives in ACO payment models. Health Aff. 2015;34(1):143-149.
  3. Burke, G, Brundage S. Accountable care in New York state: emerging themes and issues. United Hospital Fund. Accessed May 9, 2015.
  4. Burke, G and Brundage S. New York’s Medicare ACOs: participants and performance. United Hospital Fund. Accessed May 9, 2015.
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Hospitals’ Uncompensated Costs Estimated at $27.3 Billion in 2014

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Hospitals’ Uncompensated Costs Estimated at $27.3 Billion in 2014

The estimated total amount of uncompensated costs incurred by hospitals in 2014 was $27.3 billion, which is $7.4 billion, or 21 percent, less than uncompensated hospital care would have been in 2014 at 2013 levels, before Accountable Care Act Medicaid coverage provisions took effect. Federal data reported by CNBC on March 23 indicate most of the reduction came in the 28 states and the District of Columbia that expanded their Medicare programs under the act to cover nearly all poor people in their states, while those that did not could have seen their revenues decline by an additional $1.4 billion.

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The estimated total amount of uncompensated costs incurred by hospitals in 2014 was $27.3 billion, which is $7.4 billion, or 21 percent, less than uncompensated hospital care would have been in 2014 at 2013 levels, before Accountable Care Act Medicaid coverage provisions took effect. Federal data reported by CNBC on March 23 indicate most of the reduction came in the 28 states and the District of Columbia that expanded their Medicare programs under the act to cover nearly all poor people in their states, while those that did not could have seen their revenues decline by an additional $1.4 billion.

The estimated total amount of uncompensated costs incurred by hospitals in 2014 was $27.3 billion, which is $7.4 billion, or 21 percent, less than uncompensated hospital care would have been in 2014 at 2013 levels, before Accountable Care Act Medicaid coverage provisions took effect. Federal data reported by CNBC on March 23 indicate most of the reduction came in the 28 states and the District of Columbia that expanded their Medicare programs under the act to cover nearly all poor people in their states, while those that did not could have seen their revenues decline by an additional $1.4 billion.

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Quality Data Dashboards Provide Performance Feedback to Physicians

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Quality Data Dashboards Provide Performance Feedback to Physicians

A best-of-research plenary presentation at HM15 in National Harbor, Md., described a project to link physicians’ schedules to the electronic health record (EHR) in order to provide real-time, individualized performance feedback on key quality improvement and value metrics.

The abstract’s lead author, Victoria Valencia, MPH, a research data and project manager at the University of California San Francisco (UCSF), explains that quality improvement priorities have driven feedback of quality metrics at the department level.

“Where I came in was to try to get the same quality metrics down to the level of the team,” she says. “We take data from our EPIC EHR, clean it up by removing outliers, merge it with our online scheduling program, and provide a robust visual presentation of individualized, real-time performance feedback to the clinical team.”

“We take data from our EPIC EHR, clean it up by removing outliers, merge it with our online scheduling program, and provide a robust visual presentation of individualized, real-time performance feedback to the clinical team.”

–Dr. Valencia

One example is counting the total number of phlebotomy “sticks” per day, per patient. Reporting this data helped to reduce the number of “sticks per day” by 20%, to 1.6 from 2.0. A similar approach is used for care transitions and the percentage of discharges with high-quality, after-visit summaries.

“The feedback is timely and actionable and allows the teams to address areas needing improvement,” Valencia says.

How have the doctors responded to this feedback?

“Our division is used to receiving quality feedback as part of an ongoing process that includes working meetings where the metrics are reviewed,” she says, adding that there hasn’t been pushback from the teams over these reports.

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A best-of-research plenary presentation at HM15 in National Harbor, Md., described a project to link physicians’ schedules to the electronic health record (EHR) in order to provide real-time, individualized performance feedback on key quality improvement and value metrics.

The abstract’s lead author, Victoria Valencia, MPH, a research data and project manager at the University of California San Francisco (UCSF), explains that quality improvement priorities have driven feedback of quality metrics at the department level.

“Where I came in was to try to get the same quality metrics down to the level of the team,” she says. “We take data from our EPIC EHR, clean it up by removing outliers, merge it with our online scheduling program, and provide a robust visual presentation of individualized, real-time performance feedback to the clinical team.”

“We take data from our EPIC EHR, clean it up by removing outliers, merge it with our online scheduling program, and provide a robust visual presentation of individualized, real-time performance feedback to the clinical team.”

–Dr. Valencia

One example is counting the total number of phlebotomy “sticks” per day, per patient. Reporting this data helped to reduce the number of “sticks per day” by 20%, to 1.6 from 2.0. A similar approach is used for care transitions and the percentage of discharges with high-quality, after-visit summaries.

“The feedback is timely and actionable and allows the teams to address areas needing improvement,” Valencia says.

How have the doctors responded to this feedback?

“Our division is used to receiving quality feedback as part of an ongoing process that includes working meetings where the metrics are reviewed,” she says, adding that there hasn’t been pushback from the teams over these reports.

A best-of-research plenary presentation at HM15 in National Harbor, Md., described a project to link physicians’ schedules to the electronic health record (EHR) in order to provide real-time, individualized performance feedback on key quality improvement and value metrics.

The abstract’s lead author, Victoria Valencia, MPH, a research data and project manager at the University of California San Francisco (UCSF), explains that quality improvement priorities have driven feedback of quality metrics at the department level.

“Where I came in was to try to get the same quality metrics down to the level of the team,” she says. “We take data from our EPIC EHR, clean it up by removing outliers, merge it with our online scheduling program, and provide a robust visual presentation of individualized, real-time performance feedback to the clinical team.”

“We take data from our EPIC EHR, clean it up by removing outliers, merge it with our online scheduling program, and provide a robust visual presentation of individualized, real-time performance feedback to the clinical team.”

–Dr. Valencia

One example is counting the total number of phlebotomy “sticks” per day, per patient. Reporting this data helped to reduce the number of “sticks per day” by 20%, to 1.6 from 2.0. A similar approach is used for care transitions and the percentage of discharges with high-quality, after-visit summaries.

“The feedback is timely and actionable and allows the teams to address areas needing improvement,” Valencia says.

How have the doctors responded to this feedback?

“Our division is used to receiving quality feedback as part of an ongoing process that includes working meetings where the metrics are reviewed,” she says, adding that there hasn’t been pushback from the teams over these reports.

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Why Physicians Override Best Practice Alerts

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Research published earlier this year in the Journal of Hospital Medicine finds that rationales offered by physicians for overriding interruptive, computerized best practice alerts (BPAs) regarding whether or not to give blood transfusions vary widely, including specialty service protocolized behaviors, anticipation of surgical or procedural interventions, and imminent hospital transfers.

The electronic health record at Stanford University Medical Center in Palo Alto, Calif., has an automated alert function to check reported hemoglobin level and trigger a pop-up reminder when a doctor orders a transfusion for a patient with a hemoglobin level of 9 or above—outside of the recognized guidelines—prompting the doctor to either abort the transfusion or provide a reason for the override, explains co-author Lisa Shieh, MD, PhD, FHM, medical director of quality in the department of medicine at Stanford.

“Our study was trying to understand why providers still transfuse, even when we provide just-in-time education on transfusion recommendations,” she says. “We can’t say that all of these orders are inappropriate. But, for many reasons, blood has harms and is costly.

“We want to convey an overall understanding about why this issue is important.”

Although a substantial number of transfusions continue outside of the recommended guidelines, Stanford has reduced its numbers significantly.

“I’m a big believer in clinical decision support … if it’s designed well and doesn’t add to alert fatigue,” Dr. Shieh says. “I think this BPA was effective in education and making people stop and think why they were ordering transfusions. Our next step will be to look at the outlier practices and maybe have a conversation with them, doctor to doctor.”

Stanford is looking at sepsis treatment as a next target.

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Research published earlier this year in the Journal of Hospital Medicine finds that rationales offered by physicians for overriding interruptive, computerized best practice alerts (BPAs) regarding whether or not to give blood transfusions vary widely, including specialty service protocolized behaviors, anticipation of surgical or procedural interventions, and imminent hospital transfers.

The electronic health record at Stanford University Medical Center in Palo Alto, Calif., has an automated alert function to check reported hemoglobin level and trigger a pop-up reminder when a doctor orders a transfusion for a patient with a hemoglobin level of 9 or above—outside of the recognized guidelines—prompting the doctor to either abort the transfusion or provide a reason for the override, explains co-author Lisa Shieh, MD, PhD, FHM, medical director of quality in the department of medicine at Stanford.

“Our study was trying to understand why providers still transfuse, even when we provide just-in-time education on transfusion recommendations,” she says. “We can’t say that all of these orders are inappropriate. But, for many reasons, blood has harms and is costly.

“We want to convey an overall understanding about why this issue is important.”

Although a substantial number of transfusions continue outside of the recommended guidelines, Stanford has reduced its numbers significantly.

“I’m a big believer in clinical decision support … if it’s designed well and doesn’t add to alert fatigue,” Dr. Shieh says. “I think this BPA was effective in education and making people stop and think why they were ordering transfusions. Our next step will be to look at the outlier practices and maybe have a conversation with them, doctor to doctor.”

Stanford is looking at sepsis treatment as a next target.

Research published earlier this year in the Journal of Hospital Medicine finds that rationales offered by physicians for overriding interruptive, computerized best practice alerts (BPAs) regarding whether or not to give blood transfusions vary widely, including specialty service protocolized behaviors, anticipation of surgical or procedural interventions, and imminent hospital transfers.

The electronic health record at Stanford University Medical Center in Palo Alto, Calif., has an automated alert function to check reported hemoglobin level and trigger a pop-up reminder when a doctor orders a transfusion for a patient with a hemoglobin level of 9 or above—outside of the recognized guidelines—prompting the doctor to either abort the transfusion or provide a reason for the override, explains co-author Lisa Shieh, MD, PhD, FHM, medical director of quality in the department of medicine at Stanford.

“Our study was trying to understand why providers still transfuse, even when we provide just-in-time education on transfusion recommendations,” she says. “We can’t say that all of these orders are inappropriate. But, for many reasons, blood has harms and is costly.

“We want to convey an overall understanding about why this issue is important.”

Although a substantial number of transfusions continue outside of the recommended guidelines, Stanford has reduced its numbers significantly.

“I’m a big believer in clinical decision support … if it’s designed well and doesn’t add to alert fatigue,” Dr. Shieh says. “I think this BPA was effective in education and making people stop and think why they were ordering transfusions. Our next step will be to look at the outlier practices and maybe have a conversation with them, doctor to doctor.”

Stanford is looking at sepsis treatment as a next target.

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Hospitals with Hotel-Like Amenities Don’t Improve Satisfaction Scores

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Hospital design may not contribute to patients’ satisfaction with the care given by their hospital professionals, according to new research from Johns Hopkins Hospital in Baltimore, published in the Journal of Hospital Medicine. Newly built hospitals often emphasize patient-centered features like reduced noise, natural light, visitor-friendly facilities, well-designed rooms, and hotel-like amenities, note the authors, led by Zishan Siddiqui, MD, attending physician and assistant professor of medicine at Johns Hopkins.

When Hopkins moved a number of its hospital units to the sleek new Sheikh Zayed Tower in 2012, researchers used a pre-post design experiment to compare patient satisfaction in the newer, more pleasing surroundings via Press Ganey and HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey scores. Patients responded positively to the new environment, with significant improvement in facility-related satisfaction, but were able to distinguish that satisfaction from their ratings of their doctors and nurses, which were not impacted by the new environment.

“It is more likely that provider-level interventions will have a greater impact on provider level and overall satisfaction,” the authors conclude. “Hospital administrators should not use outdated facilities as an excuse for suboptimal provider satisfaction scores.”

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Hospital design may not contribute to patients’ satisfaction with the care given by their hospital professionals, according to new research from Johns Hopkins Hospital in Baltimore, published in the Journal of Hospital Medicine. Newly built hospitals often emphasize patient-centered features like reduced noise, natural light, visitor-friendly facilities, well-designed rooms, and hotel-like amenities, note the authors, led by Zishan Siddiqui, MD, attending physician and assistant professor of medicine at Johns Hopkins.

When Hopkins moved a number of its hospital units to the sleek new Sheikh Zayed Tower in 2012, researchers used a pre-post design experiment to compare patient satisfaction in the newer, more pleasing surroundings via Press Ganey and HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey scores. Patients responded positively to the new environment, with significant improvement in facility-related satisfaction, but were able to distinguish that satisfaction from their ratings of their doctors and nurses, which were not impacted by the new environment.

“It is more likely that provider-level interventions will have a greater impact on provider level and overall satisfaction,” the authors conclude. “Hospital administrators should not use outdated facilities as an excuse for suboptimal provider satisfaction scores.”

Hospital design may not contribute to patients’ satisfaction with the care given by their hospital professionals, according to new research from Johns Hopkins Hospital in Baltimore, published in the Journal of Hospital Medicine. Newly built hospitals often emphasize patient-centered features like reduced noise, natural light, visitor-friendly facilities, well-designed rooms, and hotel-like amenities, note the authors, led by Zishan Siddiqui, MD, attending physician and assistant professor of medicine at Johns Hopkins.

When Hopkins moved a number of its hospital units to the sleek new Sheikh Zayed Tower in 2012, researchers used a pre-post design experiment to compare patient satisfaction in the newer, more pleasing surroundings via Press Ganey and HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey scores. Patients responded positively to the new environment, with significant improvement in facility-related satisfaction, but were able to distinguish that satisfaction from their ratings of their doctors and nurses, which were not impacted by the new environment.

“It is more likely that provider-level interventions will have a greater impact on provider level and overall satisfaction,” the authors conclude. “Hospital administrators should not use outdated facilities as an excuse for suboptimal provider satisfaction scores.”

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Managing dyspepsia

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Managing dyspepsia

PRACTICE RECOMMENDATIONS

› Review the medications taken by patients who suffer from dyspepsia, as many drugs—bisphosphonates, antibiotics, steroids, and nonsteroidal anti-inflammatory drugs, among others—are associated with this condition. B
› Order an esophagogastroduodenoscopy for patients ages 55 years or older with new-onset dyspepsia and those who have red flags for more serious conditions, eg, a history of upper gastrointestinal (GI) cancer, unintended weight loss, GI bleeding, dysphagia, or a palpable mass. C
› Prescribe acid suppression therapy as first-line treatment for patients who have dyspepsia but are at low risk or have tested negative for Helicobacter pylori infection. A

Strength of recommendation (SOR)

A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

Each year, an estimated 25% to 30% of the US population suffers from dyspepsia.1 Most self-treat with home remedies and over-the-counter products, but others seek medical care. Dyspepsia accounts for an estimated 2% to 5% of primary care visits annually,2 mostly by patients who are found to have no organic, or structural, cause for their symptoms.1,3

Compared with the general public, patients with functional dyspepsia have higher levels of anxiety, chronic tension, hostility, and hypochondriasis, and a tendency to be more pessimistic.

Such patients are said to have functional dyspepsia (FD), a category that applies to about two-thirds of those with dyspepsia.1 A small number of cases are categorized as organic dyspepsia, indicating the presence of a clear structural or anatomic cause, such as an ulcer or mass. The remainder are said to have undifferentiated dyspepsia, which simply means that their signs and symptoms do not rise to the level for which further investigation is warranted and thus it is not known whether it is functional or organic.

There are many possible causes of FD, ranging from medications3,4 to abnormal gastroduodenal motility5,6 to Helicobacter pylori infection,7 and a comprehensive differential diagnosis. The first step in an investigation is to rule out red flags suggestive of gastrointestinal (GI) cancer or other serious disorders.

Patients with FD, like the vast majority of those you’ll treat in a primary care setting, suffer significant morbidity. Most have chronic symptoms, with intermittent flare-ups interspersed with periods of remission.8 In the text and dyspepsia treatment ALGORITHM5,7-12 that follow, you’ll find an evidence-based patient management approach.

Symptoms and causes: What to look for

The primary symptoms of dyspepsia include bothersome postprandial fullness, early satiety, and epigastric pain and burning. To meet the Rome criteria for dyspepsia, these symptoms must have been present for the last 3 months and have had an onset ≥6 months prior to diagnosis.2 Recurrent belching and nausea are also common, but are not included in the Rome diagnostic criteria.

Symptom severity is a poor predictor of the seriousness of the condition, however, and more intense symptoms are no more likely than milder cases to have an organic cause.13,14 Indeed, anxiety is a common comorbidity in patients with FD and a risk factor for the diagnosis. Compared with the general public, patients with FD have been found to have higher levels of anxiety, chronic tension, hostility, and hypochondriasis, and a tendency to be more pessimistic.15

Possible causes of FD

While the etiology of organic dyspepsia is clear, the cause of FD is often far more difficult to determine.

Medication use should always be considered, as many types of drugs—including bisphosphonates, antibiotics, narcotics, steroids, iron, metformin, and nonsteroidal anti-inflammatory drugs (NSAIDs)—are associated with dyspepsia.3,4

Gastroduodenal motility and accommodation, which has been found in numerous studies of patients with FD, is a proposed etiology.5,6

Visceral hypersensitivity also appears to play a role. In one study of patients with severe dyspepsia, 87% of those with FD had a reduced or altered GI pain threshold, compared with 20% of those with organic dyspepsia.16

H pylori, commonly linked to peptic ulcer disease (PUD), is also associated with both organic dyspepsia and FD.17,18 The gram-negative rod-shaped bacterium is present in approximately half of the population worldwide, but is more common in developing nations.7H pylori immunoglobulin G (IgG) is more prevalent in patients with dyspepsia, particularly in those younger than 30 years of age. The exact mechanism by which H pylori causes non-ulcerative dyspepsia is not clear, but inflammation, dysmotility, visceral hypersensitivity, and alteration of acid secretion have all been proposed.17

Dysfunctional intestinal epithelium is increasingly being considered in the pathophysiology of dyspepsia, among other conditions. Researchers theorize that certain foods, toxins, infections, and/or other stressors lead to changes in the structure and function of tight junctions, resulting in increased intestinal permeability.19 This in turn is thought to allow the outflow of antigens through the leaky epithelium and to stimulate an immune response—a process that may play a role in the increased GI inflammation or hypersensitivity associated with dyspepsia. The “leaky gut” theory may eventually lead to new ways to treat dyspepsia, but thus far, highquality evidence of the efficacy of treatments aimed at this mechanism is lacking.

 

 

A range of disorders included in the differential

Symptom severity is a poor predictor of the seriousness of dyspepsia; more intense symptoms are no more likely than milder cases to have an organic cause.

The primary differential diagnosis for dyspepsia includes gastroesophageal reflux disease (GERD), esophagitis, chronic PUD (including both gastric and duodenal ulcers), and malignancy. The differential may also include biliary disorder, pancreatitis, hepatitis, or other liver disease; chronic abdominal wall pain, irritable bowel syndrome, motility disorders, or infiltrative diseases of the stomach (eosinophilic gastritis, Crohn’s disease, sarcoidosis); celiac disease and food sensitivities/allergies, including gluten, lactose, and other intolerances; cardiac disease, including acute coronary syndrome, myocardial infarction, and arrhythmias; intestinal angina; small intestine bacterial overgrowth; heavy metal toxicity; and hypercalcemia.8

Ulcers are found in approximately 10% of patients undergoing evaluation for dyspepsia.8 Previously, PUD was almost exclusively due to H pylori infection. In developed countries, however, chronic use of NSAIDs, including aspirin, has increased, and is now responsible for most ulcer diseases.20,21 The combination of H pylori infection and NSAID usage appears to be synergistic, with the risk of uncomplicated PUD estimated to be 17.5 times higher among those who test positive for H pylori and take NSAIDs vs a 3- to 4-fold increase in ulcer incidence among those with either of these risk factors alone.22

The work-up starts with a search for red flags

Symptom severity is a poor predictor of the seriousness of dyspepsia; more intense symptoms are no more likely than milder cases to have an organic cause.

Evaluation of a patient with dyspepsia begins with a thorough history. Start by determining whether the patient has any red flags, or alarm features, that may be associated with a more serious condition—particularly an underlying malignancy. One or more of the following is an indication for an esophagogastroduodenoscopy (EGD):5,8,12
• family and/or personal history of upper GI cancer
• unintended weight loss
• GI bleeding
• progressive dysphagia
• unexplained iron-deficiency anemia
• persistent vomiting
• palpable mass or lymphadenopathy
• jaundice.

The “leaky gut” theory may eventually lead to new ways to treat dyspepsia, but thus far, high-quality evidence of the efficacy of treatments aimed at this mechanism is lacking.

While it is important to rule out these red flags, they are poor predictors of malignancy.23,24 With the exception of a single study, their positive predictive value was a mere 1%.8 Their usefulness lies in their ability to exclude malignancy, however; when none of these features is present, the negative predictive value for malignancy is >97%.8

Age is also a risk factor. In addition to red flags, EGD is recommended by the American Gastroenterological Association (AGA) for patients with new-onset dyspepsia who are 55 years or older—an age at which upper GI malignancy becomes more common. A repeat EGD is rarely indicated, unless Barrett’s esophagus or severe erosive esophagitis is found on the initial EGD.25

Physical exam, H pylori evaluation follow

A physical examination of all patients presenting with symptoms suggestive of dyspepsia is crucial. While the exam is usually normal, it may reveal epigastric tenderness on abdominal palpation. Rebound tenderness, guarding, or evidence of other abnormalities should raise the prospect of alternative diagnoses. GERD, for example, has many symptoms in common with dyspepsia, but is a more likely diagnosis in a patient who has retrosternal burning discomfort and regurgitation and reports that symptoms worsen at night and when lying down.

Lab work has limited value. Although laboratory work is not specifically addressed in the AGA guidelines (except for H pylori testing), a complete blood count is a reasonable part of an initial evaluation of dyspepsia to check for anemia. Other routine blood work is not needed, but further lab testing may be warranted based on the history, exam, and differential diagnosis.

H pylori risk. Because of the association between dyspepsia and H pylori, evaluating the patient’s risk for infection with this bacterium, based primarily on his or her current and previous living conditions (TABLE 1),9 is the next step. Although a test for H pylori could be included in the initial work-up of all patients with dyspepsia, a better—and more cost-effective—strategy is to initially test only those at high risk. (More on testing and treating H pylori in a bit.)

Initiate acid suppression therapy for low-risk patients

First-line treatment for patients with dyspepsia who have no red flags for malignancy or other serious conditions and either are not at high risk for H pylori or are at high risk but have been tested for it and had negative results is a 4- to 8-week course of acid suppression therapy. Patients at low risk for H pylori should be tested for the bacterium only if therapy fails to alleviate their symptoms.9

 

 

H2RAs or PPIs? A look at the evidence

In a Cochrane review, both H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) were significantly more effective than placebo for treating FD.26 However, H2RAs can lead to tachyphylaxis—an acute decrease in response to a drug—within 2 to 6 weeks, thus limiting their long-term efficacy.27

Suspect gastroesophageal reflux disease, rather than dyspepsia, in a patient who has retrosternal burning and regurgitation that worsen when lying down.

PPIs appear to be more effective than H2RAs, and are the AGA’s acid suppression drug of choice.11 The CADET study, a randomized controlled trial comparing PPIs (omeprazole 20 mg/d) with an H2RA (ranitidine 150 mg BID) and a prokinetic agent (cisapride 20 mg BID) as well as placebo for dyspepsia, found the PPI to be superior to the H2RA at 6 months.28 In a systematic review, the number needed to treat with PPI therapy for improvement of dyspepsia symptoms was 9.29

There is no specified time limit for the use of PPIs. AGA guidelines recommend that patients who respond to initial therapy stop treatment after 4 to 8 weeks.11 If symptoms recur, another course of the same treatment is justified; if necessary, therapy can continue long term. However, patients should be made aware of the risk for vitamin deficiency, osteoporosis, and fracture, as well as arrhythmias, Clostridium difficile infection, and rebound upon abrupt discontinuation of PPIs.

When to test for H pylori ...

Empiric treatment for H pylori is not recommended. Thus, testing is indicated for patients who have risk factors for the bacterium or who fail to respond to acid suppression therapy. There are various ways to test for the presence of H pylori. Which test you choose depends, in part, on patient-specific factors.

Serology. IgG serology testing is extremely useful in patients who have never been diagnosed with H pylori. It is best suited for those who are currently taking proton pump inhibitors (PPIs) or who recently completed a course of antibiotics, since neither medication affects the results of the serology test.

Serology testing should not be used, however, for any patient who was previously diagnosed with or treated for H pylori, because this type of test cannot distinguish between an active or past infection. The IgG serology test has a sensitivity of 87% and a specificity of 67%.30

Stool antigen. Stool tests using monoclonal antibodies to detect the presence of H pylori have a sensitivity of 87% to 92% and a specificity of 70%. Stool antigen is also an excellent post-treatment test to confirm that H pylori has been eradicated.31

Stool testing has some drawbacks, however. PPIs can decrease the sensitivity and should be discontinued at least 2 weeks prior to stool testing.32 In addition, a stool test for H pylori is not accurate if the patient has an acute GI bleed.

Urea breath testing. This is the most sensitive and specific test for active H pylori infection (90%-96% sensitivity and 88%-96% specificity).33 PPIs can lower the sensitivity of the test, however, and are typically discontinued at least 2 weeks prior to testing. Urea breath testing, like stool testing, is an excellent way to confirm that H pylori has been eradicated after treatment. However, it is more expensive than other tests for H pylori and often inconvenient to obtain.13

An EGD is indicated for a patient who has failed to respond to acid suppression therapy and has a negative serology, stool antigen, or urea breath test for H pylori.

Biopsy-based testing for H pylori is performed with EGD and is therefore reserved for patients who have red flags or other indications of a need for invasive testing. There are 3 types of biopsy-based tests: urease (sensitivity, 70%-90%; specificity, 95%); histology (87%-92% and 70%, respectively); and culture (85%-88% and 69%, respectively). Overall, the specificity is slightly better than that of noninvasive testing, but the sensitivity can be lowered by recent use of PPIs, bismuth, or antibiotics.12,34

... and how to treat it

H pylori infection is associated with an increased risk of noncardiac gastric adenocarcinoma, but a decreased risk of cardiac gastric adenocarcinoma and esophageal adenocarcinoma.35,36 Thus, the potential to reduce the risk of gastric cancer is not considered an indication for H pylori treatment. The possibility of improving dyspepsia symptoms is a reason to treat H pylori infection, although eradicating it does not always do so.

IgG serology testing should not be used for any patient who was previously diagnosed with, or treated for, H pylori because this type of test can’t distinguish between an active or past infection.

 

 

In a 2006 Cochrane Review, treating H pylori had a small but statistically significant benefit for patients with FD (NNT=14).37 A 2011 study on the effects of H pylori eradication on symptoms and quality of life in primary care patients with FD revealed a 12.5% improvement in quality of life and a 10.6% improvement in symptoms.38

The triple therapy regimen (a PPI + amoxicillin + clarithromycin) is the most common first-line H pylori treatment in the United States, and a good initial choice in regions in which clarithromycin resistance is low (TABLE 2).39-44 The standard duration is 7 days. A 2013 Cochrane Review showed that a longer duration (14 days) increased the rate of eradication (82% vs 73%), but this remains controversial.39 The addition of bismuth subsalicylate to the triple therapy regimen has been shown to increase the eradication rate of H pylori by approximately 10%.45 Adding probiotics (saccharomyces or lactobacillus) appears to increase eradication rates, as well.40

Sequential therapy consists of a 5-day course of treatment in which a PPI and amoxicillin are taken twice a day, followed by another 5-day course of a PPI, clarithromycin, and metronidazole. A recent meta-analysis of sequential therapy showed that it is superior to 7-day triple therapy but equivalent to 14-day triple therapy.40

LOAD (levofloxacin, omeprazole, nitazoxanide, and doxycycline) therapy for 7 to 10 days can be used in place of triple therapy in areas of high resistance or for persistent H pylori. In one study, the H pylori eradication rate for a 7-day course of LOAD therapy—levofloxacin and doxycycline taken once a day, omeprazole before breakfast, and nitazoxanide twice daily—was 90% vs 73.3% for a 7-day course of triple therapy.41

Quadruple therapy has 2 variations: bismuth-based and non-bismuth (concomitant) therapy. The latter uses the base triple therapy and adds either metronidazole or tinidazole for 7 to 14 days. In a multicenter randomized trial, this concomitant therapy was found to have similar efficacy to sequential therapy.42

The possibility of improving dyspepsia symptoms is a reason to treat H pylori infection, although eradicating it does not always do so.

Bismuth-based quad therapy includes a PPI, bismuth, metronidazole, and tetracycline. A meta-analysis found it to have a higher rate of eradication than triple therapy for patients with antibiotic resistance.43,44

For persistent H pylori, a PPI, levofloxacin, and amoxicillin for 10 days has been shown to be more effective and better tolerated than quadruple therapy.12

Confirmation is indicated when symptoms persist

If dyspepsia symptoms persist after H pylori treatment, it is reasonable to retest to confirm that the infection has in fact been eradicated. Confirmation is also indicated if the patient has an H pylori-associated ulcer or a prior history of gastric cancer.

Retesting should be performed at least 4 to 6 weeks after treatment is completed. If H pylori has not been eradicated, you can try another regimen. If retesting confirms eradication and symptoms persist, EGD with biopsy is indicated. Although EGD typically has a very low yield, even for patients with red flags, this invasive test often provides reassurance and increased satisfaction for patients with persistent symptoms.46

More options for challenging cases

Managing FD is challenging when both initial acid suppression therapy and H pylori eradication fail. Unproven but low-risk treatments include modification of eating habits (eg, eating slower, not gulping food), reducing stress, discontinuing medications that may be related to symptoms, avoiding foods that seem to exacerbate symptoms, and cutting down or eliminating tobacco, caffeine, alcohol, and carbonated beverages.8 Bismuth salts have been shown to be superior to placebo for the treatment of dyspepsia.25 Small studies have also demonstrated a favorable risk–benefit ratio for peppermint oil and caraway oil for the treatment of FD.47 Prokinetics have shown efficacy compared with placebo, although a Cochrane review questioned their efficacy based on publication bias.26

There is no good evidence of efficacy for over-the-counter antacids, such as TUMS, or for GI “cocktails” (antacid, antispasmotic, and lidocaine), sucralfate, psychological interventions (eg, cognitive behavioral therapy, relaxation therapy, or hypnosis), or antidepressants.48,49 Several recent randomized controlled trials have shown the efficacy of acupuncture for the treatment of dyspepsia.49,50 Ginger may also be helpful; it has been found to help with nausea in other GI conditions, but it’s uncertain whether it can help patients with dyspepsia.51

CORRESPONDENCE 
Michael Malone, MD, 845 Fishburn Road, Hershey, PA 17053; mmalone@hmc.psu.edu

References

1. Shaib Y, El-Serag HB. The prevalence and risk factors of functional dyspepsia in a multiethnic population in the United States. Am J Gastroenterol. 2004;99:2210-2216.

2. Talley NJ. Dyspepsia: management guidelines for the millennium. Gut. 2002;50(suppl 4):iv72–iv78.

3. Harmon RC, Peura DA. Evaluation and management of dyspepsia. Therap Adv Gastroenterol. 2010;3:87–98.

4. Bazaldua OV, Schneider FD. Evaluation and management of dyspepsia. Am Fam Physician. 1999;60:1773-1784.

5. Tack J, Talley NJ, Camilleri M, et al. Functional gastroduodenal disorders. Gastroenterology. 2006;130:1466-1479.

6. Haag S, Talley NJ, Holtmann G. Symptom patterns in functional dyspepsia and irritable bowel syndrome: relationship to disturbances in gastric emptying and response to a nutrient challenge in consulters and non-consulters. Gut. 2004;53:1445-1451.

7. Malfertheiner P, Megraud F, O’Morain CA, et al; European Helicobacter Study Group. Management of Helicobacter pylori infection—the Maastricht IV/Florence Consensus Report. Gut. 2012;61:646-664.

8. Talley NJ, Vakil NB, Moayyedi P. American Gastroenterological Association technical review on the evaluation of dyspepsia. Gastroenterology. 2005;129:1756-1780.

9. Moayyedi P, Axon AT. The usefulness of the likelihood ratio in the diagnosis of dyspepsia and gastroesophageal reflux disease. Am J Gastroenterol. 1999;94:3122-3125.

10. McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010;362:1597-1604.

11. Kahrilas PJ, Shaheen NJ, Vaezi MF, et al; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135:1383-1391.

12. Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori Infection. Am J Gastroenterol. 2007;102:1808-1825.

13. Moayyedi P, Talley NJ, Fennerty MB, et al. Can the clinical history distinguish between organic and functional dyspepsia? JAMA. 2006;295:1566-1576.

14. Eslick GD, Howell SC, Hammer J, et al. Empirically derived symptom sub-groups correspond poorly with diagnostic criteria for functional dyspepsia and irritable bowel syndrome. A factor and cluster analysis of a patient sample. Aliment Pharmacol Ther. 2004;19:133-140.

15. Aro P, Talley NJ, Ronkainen J, et al. Anxiety is associated with uninvestigated and functional dyspepsia (Rome III criteria) in a Swedish population-based study. Gastroenterology. 2009;137:94-100.

16. Mertz H, Fullerton S, Naliboff B, et al. Symptoms and visceral perception in severe functional and organic dyspepsia. Gut. 1998;42:814-822.

17. O’Morain C. Role of Helicobacter pylori in functional dyspepsia. World J Gastroenterol. 2006;12:2677-2680.

18. Shmuely H, Obure S, Passaro DJ, et al. Dyspepsia symptoms and Helicobacter pylori infection, Nakuru, Kenya. Emerg Infect Dis. 2003;9:1103-1107.

19. Barbara G, Zecchi L, Barbaro R, et al. Mucosal permeability and immune activation as potential therapeutic targets of probiotics in irritable bowel syndrome. J Clin Gastroenterol. 2012;46(suppl):S52-S55.

20. Liu NJ, Lee CS, Tang JH, et al. Outcomes of bleeding peptic ulcers: a prospective study. J Gastroenterol Hepatol. 2008;23:e340-e347.

21. Ramsoekh D, van Leerdam ME, Rauws EA, et al. Outcome of peptic ulcer bleeding, nonsteroidal anti-inflammatory drug use, and Helicobacter pylori infection. Clin Gastroenterol Hepatol. 2005;3:859-864.

22. Papatheodoridis GV, Sougioultzis S, Archimandritis AJ. Effects of Helicobacter pylori and nonsteroidal anti-inflammatory drugs on peptic ulcer disease: a systematic review. Clin Gastroenterol Hepatol. 2006;4:130-142.

23. Bai Y, Li ZS, Zou DW, et al. Alarm features and age for predicting upper gastrointestinal malignancy in Chinese patients with dyspepsia with high background prevalence of Helicobacter pylori infection and upper gastrointestinal malignancy: an endoscopic database review of 102,665 patients from 1996 to 2006. Gut. 2010;59:722-728.

24. Vakil N. Dyspepsia, peptic ulcer, and H. pylori: a remembrance of things past. Am J Gastroenterol. 2010;105:572-574.

25. Shaheen NJ, Weinberg DS, Denberg TD, et al; Clinical Guidelines Committee of the American College of Physicians. Upper endoscopy for gastroesophageal reflux disease: best practice advice from the clinical guidelines committee of the American College of Physicians. Ann Intern Med. 2012;157:808-816.

26. Moayyedi P, Soo S, Deeks J, et al. Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2006;(4):CD001960.

27. Chiu CT, Hsu CM, Wang CC, et al. Randomised clinical trial: sodium alginate oral suspension is non-inferior to omeprazole in the treatment of patients with non-erosive gastroesophageal disease. Aliment Pharmacol Ther. 2013;38:1054-1064.

28. Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol. 2005;100:1477-1488.

29. Moayyedi P, Delaney BC, Vakil N, et al. The efficacy of proton pump inhibitors in nonulcer dyspepsia: a systematic review and economic analysis. Gastroenterology. 2004;127:1329-1337.

30. Garza-González E, Bosques-Padilla FJ, Tijerina-Menchaca R, et al. Comparison of endoscopy-based and serum-based methods for the diagnosis of Helicobacter pylori. Can J Gastroenterol. 2003;17:101-106.

31. Kodama M, Murakami K, Okimoto T, et al. Influence of proton pump inhibitor treatment on Helicobacter pylori stool antigen test. World J Gastroenterol. 2012;18:44-48.

32. Shimoyama T. Stool antigen tests for the management of Helicobacter pylori infection. World J Gastroenterol. 2013;19:8188-8191.

33. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. Am J Gastroenterol. 1998;93:2330-2338.

34. Gisbert J, Abraira V. Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis. Am J Gastroenterol. 2006;101:848-863.

35. Kamangar F, Dawsey SM, Blaser MJ, et al. Opposing risks of gastric cardiac and noncardia gastric adenocarcinomas associated with Helicobacter pylori seropositivity. J Natl Cancer Inst. 2006;98:1445-1452.

36. Islami F, Kamangar F. Helicobacter pylori and esophageal cancer risk: a meta-analysis. Cancer Prevent Res (Phila). 2008;1:329-338.

37. Moayyedi P, Soo S, Deeks J, et al. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2006;(2):CD002096.

38. Mazzoleni LE, Sander GB, Francesconi CF, et al. Helicobacter pylori eradication in functional dyspepsia: HEROES trial. Arch Intern Med. 2011;171:1929-1936.

39. Yuan Y, Ford AC, Khan KJ, et al. Optimum duration of regimens for Helicobacter pylori eradication. Cochrane Database Syst Rev. 2013;(12):CD008337.

40. Zou J, Dong J, Yu X. Meta-analysis: Lactobacillus containing quadruple therapy versus standard triple first-line therapy for Helicobacter pylori eradication. Helicobacter. 2009;14:97-107.

41. Basu PP, Rayapudi K, Pacana T, et al. A randomized study comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple therapy for the eradication of Helicobacter pylori. Am J Gastroenterol. 2011;106:1970-1975.

42. Wu DC, Hsu PI, Wu JY, et al. Sequential and concomitant therapy with 4 drugs are equally effective for eradication of H. pylori infection. Clin Gastroenterol Hepatol. 2010;8:36–41.

43. Osato R, Reddy R, Reddy SG, et al. Pattern of primary resistance of Helicobacter pylori to metronidazole or clarithromycin in the United States. Arch Intern Med. 2001;161:1217-1220.

44. Fischbach L, Evans EL. Meta-analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple firstline therapies for Helicobacter pylori. Aliment Pharmacol Ther. 2007;26:343-357.

45. Hinostroza Morales D, Díaz Ferrer J. Addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events. Rev Gastroenterol Peru. 2014;34:315-320.

46. Rabeneck L, Wristers K, Souchek J, et al. Impact of upper endoscopy on satisfaction in patients with previously uninvestigated dyspepsia. Gastrointest Endosc. 2003;57:295-299.

47. Hojo M, Miwa H, Yokoyama T, et al. Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review. J Gastroenterol. 2005;40:1036-1042.

48. Soo S, Moayyedi P, Deeks J, et al. Psychological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2005;(2):CD002301.

49. Lima FA, Ferreira LE, Pace FH. Acupuncture effectiveness as a complementary therapy in functional dyspepsia patients. Arq Gastroenterol. 2013;50:202-207.

50. Ma TT, Yu SY, Li Y, et al. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012;35:552-561.

51. Koretz RL, Rotblatt M. Complementary and alternative medicine in gastroenterology: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2004;2:957-967.

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PRACTICE RECOMMENDATIONS

› Review the medications taken by patients who suffer from dyspepsia, as many drugs—bisphosphonates, antibiotics, steroids, and nonsteroidal anti-inflammatory drugs, among others—are associated with this condition. B
› Order an esophagogastroduodenoscopy for patients ages 55 years or older with new-onset dyspepsia and those who have red flags for more serious conditions, eg, a history of upper gastrointestinal (GI) cancer, unintended weight loss, GI bleeding, dysphagia, or a palpable mass. C
› Prescribe acid suppression therapy as first-line treatment for patients who have dyspepsia but are at low risk or have tested negative for Helicobacter pylori infection. A

Strength of recommendation (SOR)

A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

Each year, an estimated 25% to 30% of the US population suffers from dyspepsia.1 Most self-treat with home remedies and over-the-counter products, but others seek medical care. Dyspepsia accounts for an estimated 2% to 5% of primary care visits annually,2 mostly by patients who are found to have no organic, or structural, cause for their symptoms.1,3

Compared with the general public, patients with functional dyspepsia have higher levels of anxiety, chronic tension, hostility, and hypochondriasis, and a tendency to be more pessimistic.

Such patients are said to have functional dyspepsia (FD), a category that applies to about two-thirds of those with dyspepsia.1 A small number of cases are categorized as organic dyspepsia, indicating the presence of a clear structural or anatomic cause, such as an ulcer or mass. The remainder are said to have undifferentiated dyspepsia, which simply means that their signs and symptoms do not rise to the level for which further investigation is warranted and thus it is not known whether it is functional or organic.

There are many possible causes of FD, ranging from medications3,4 to abnormal gastroduodenal motility5,6 to Helicobacter pylori infection,7 and a comprehensive differential diagnosis. The first step in an investigation is to rule out red flags suggestive of gastrointestinal (GI) cancer or other serious disorders.

Patients with FD, like the vast majority of those you’ll treat in a primary care setting, suffer significant morbidity. Most have chronic symptoms, with intermittent flare-ups interspersed with periods of remission.8 In the text and dyspepsia treatment ALGORITHM5,7-12 that follow, you’ll find an evidence-based patient management approach.

Symptoms and causes: What to look for

The primary symptoms of dyspepsia include bothersome postprandial fullness, early satiety, and epigastric pain and burning. To meet the Rome criteria for dyspepsia, these symptoms must have been present for the last 3 months and have had an onset ≥6 months prior to diagnosis.2 Recurrent belching and nausea are also common, but are not included in the Rome diagnostic criteria.

Symptom severity is a poor predictor of the seriousness of the condition, however, and more intense symptoms are no more likely than milder cases to have an organic cause.13,14 Indeed, anxiety is a common comorbidity in patients with FD and a risk factor for the diagnosis. Compared with the general public, patients with FD have been found to have higher levels of anxiety, chronic tension, hostility, and hypochondriasis, and a tendency to be more pessimistic.15

Possible causes of FD

While the etiology of organic dyspepsia is clear, the cause of FD is often far more difficult to determine.

Medication use should always be considered, as many types of drugs—including bisphosphonates, antibiotics, narcotics, steroids, iron, metformin, and nonsteroidal anti-inflammatory drugs (NSAIDs)—are associated with dyspepsia.3,4

Gastroduodenal motility and accommodation, which has been found in numerous studies of patients with FD, is a proposed etiology.5,6

Visceral hypersensitivity also appears to play a role. In one study of patients with severe dyspepsia, 87% of those with FD had a reduced or altered GI pain threshold, compared with 20% of those with organic dyspepsia.16

H pylori, commonly linked to peptic ulcer disease (PUD), is also associated with both organic dyspepsia and FD.17,18 The gram-negative rod-shaped bacterium is present in approximately half of the population worldwide, but is more common in developing nations.7H pylori immunoglobulin G (IgG) is more prevalent in patients with dyspepsia, particularly in those younger than 30 years of age. The exact mechanism by which H pylori causes non-ulcerative dyspepsia is not clear, but inflammation, dysmotility, visceral hypersensitivity, and alteration of acid secretion have all been proposed.17

Dysfunctional intestinal epithelium is increasingly being considered in the pathophysiology of dyspepsia, among other conditions. Researchers theorize that certain foods, toxins, infections, and/or other stressors lead to changes in the structure and function of tight junctions, resulting in increased intestinal permeability.19 This in turn is thought to allow the outflow of antigens through the leaky epithelium and to stimulate an immune response—a process that may play a role in the increased GI inflammation or hypersensitivity associated with dyspepsia. The “leaky gut” theory may eventually lead to new ways to treat dyspepsia, but thus far, highquality evidence of the efficacy of treatments aimed at this mechanism is lacking.

 

 

A range of disorders included in the differential

Symptom severity is a poor predictor of the seriousness of dyspepsia; more intense symptoms are no more likely than milder cases to have an organic cause.

The primary differential diagnosis for dyspepsia includes gastroesophageal reflux disease (GERD), esophagitis, chronic PUD (including both gastric and duodenal ulcers), and malignancy. The differential may also include biliary disorder, pancreatitis, hepatitis, or other liver disease; chronic abdominal wall pain, irritable bowel syndrome, motility disorders, or infiltrative diseases of the stomach (eosinophilic gastritis, Crohn’s disease, sarcoidosis); celiac disease and food sensitivities/allergies, including gluten, lactose, and other intolerances; cardiac disease, including acute coronary syndrome, myocardial infarction, and arrhythmias; intestinal angina; small intestine bacterial overgrowth; heavy metal toxicity; and hypercalcemia.8

Ulcers are found in approximately 10% of patients undergoing evaluation for dyspepsia.8 Previously, PUD was almost exclusively due to H pylori infection. In developed countries, however, chronic use of NSAIDs, including aspirin, has increased, and is now responsible for most ulcer diseases.20,21 The combination of H pylori infection and NSAID usage appears to be synergistic, with the risk of uncomplicated PUD estimated to be 17.5 times higher among those who test positive for H pylori and take NSAIDs vs a 3- to 4-fold increase in ulcer incidence among those with either of these risk factors alone.22

The work-up starts with a search for red flags

Symptom severity is a poor predictor of the seriousness of dyspepsia; more intense symptoms are no more likely than milder cases to have an organic cause.

Evaluation of a patient with dyspepsia begins with a thorough history. Start by determining whether the patient has any red flags, or alarm features, that may be associated with a more serious condition—particularly an underlying malignancy. One or more of the following is an indication for an esophagogastroduodenoscopy (EGD):5,8,12
• family and/or personal history of upper GI cancer
• unintended weight loss
• GI bleeding
• progressive dysphagia
• unexplained iron-deficiency anemia
• persistent vomiting
• palpable mass or lymphadenopathy
• jaundice.

The “leaky gut” theory may eventually lead to new ways to treat dyspepsia, but thus far, high-quality evidence of the efficacy of treatments aimed at this mechanism is lacking.

While it is important to rule out these red flags, they are poor predictors of malignancy.23,24 With the exception of a single study, their positive predictive value was a mere 1%.8 Their usefulness lies in their ability to exclude malignancy, however; when none of these features is present, the negative predictive value for malignancy is >97%.8

Age is also a risk factor. In addition to red flags, EGD is recommended by the American Gastroenterological Association (AGA) for patients with new-onset dyspepsia who are 55 years or older—an age at which upper GI malignancy becomes more common. A repeat EGD is rarely indicated, unless Barrett’s esophagus or severe erosive esophagitis is found on the initial EGD.25

Physical exam, H pylori evaluation follow

A physical examination of all patients presenting with symptoms suggestive of dyspepsia is crucial. While the exam is usually normal, it may reveal epigastric tenderness on abdominal palpation. Rebound tenderness, guarding, or evidence of other abnormalities should raise the prospect of alternative diagnoses. GERD, for example, has many symptoms in common with dyspepsia, but is a more likely diagnosis in a patient who has retrosternal burning discomfort and regurgitation and reports that symptoms worsen at night and when lying down.

Lab work has limited value. Although laboratory work is not specifically addressed in the AGA guidelines (except for H pylori testing), a complete blood count is a reasonable part of an initial evaluation of dyspepsia to check for anemia. Other routine blood work is not needed, but further lab testing may be warranted based on the history, exam, and differential diagnosis.

H pylori risk. Because of the association between dyspepsia and H pylori, evaluating the patient’s risk for infection with this bacterium, based primarily on his or her current and previous living conditions (TABLE 1),9 is the next step. Although a test for H pylori could be included in the initial work-up of all patients with dyspepsia, a better—and more cost-effective—strategy is to initially test only those at high risk. (More on testing and treating H pylori in a bit.)

Initiate acid suppression therapy for low-risk patients

First-line treatment for patients with dyspepsia who have no red flags for malignancy or other serious conditions and either are not at high risk for H pylori or are at high risk but have been tested for it and had negative results is a 4- to 8-week course of acid suppression therapy. Patients at low risk for H pylori should be tested for the bacterium only if therapy fails to alleviate their symptoms.9

 

 

H2RAs or PPIs? A look at the evidence

In a Cochrane review, both H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) were significantly more effective than placebo for treating FD.26 However, H2RAs can lead to tachyphylaxis—an acute decrease in response to a drug—within 2 to 6 weeks, thus limiting their long-term efficacy.27

Suspect gastroesophageal reflux disease, rather than dyspepsia, in a patient who has retrosternal burning and regurgitation that worsen when lying down.

PPIs appear to be more effective than H2RAs, and are the AGA’s acid suppression drug of choice.11 The CADET study, a randomized controlled trial comparing PPIs (omeprazole 20 mg/d) with an H2RA (ranitidine 150 mg BID) and a prokinetic agent (cisapride 20 mg BID) as well as placebo for dyspepsia, found the PPI to be superior to the H2RA at 6 months.28 In a systematic review, the number needed to treat with PPI therapy for improvement of dyspepsia symptoms was 9.29

There is no specified time limit for the use of PPIs. AGA guidelines recommend that patients who respond to initial therapy stop treatment after 4 to 8 weeks.11 If symptoms recur, another course of the same treatment is justified; if necessary, therapy can continue long term. However, patients should be made aware of the risk for vitamin deficiency, osteoporosis, and fracture, as well as arrhythmias, Clostridium difficile infection, and rebound upon abrupt discontinuation of PPIs.

When to test for H pylori ...

Empiric treatment for H pylori is not recommended. Thus, testing is indicated for patients who have risk factors for the bacterium or who fail to respond to acid suppression therapy. There are various ways to test for the presence of H pylori. Which test you choose depends, in part, on patient-specific factors.

Serology. IgG serology testing is extremely useful in patients who have never been diagnosed with H pylori. It is best suited for those who are currently taking proton pump inhibitors (PPIs) or who recently completed a course of antibiotics, since neither medication affects the results of the serology test.

Serology testing should not be used, however, for any patient who was previously diagnosed with or treated for H pylori, because this type of test cannot distinguish between an active or past infection. The IgG serology test has a sensitivity of 87% and a specificity of 67%.30

Stool antigen. Stool tests using monoclonal antibodies to detect the presence of H pylori have a sensitivity of 87% to 92% and a specificity of 70%. Stool antigen is also an excellent post-treatment test to confirm that H pylori has been eradicated.31

Stool testing has some drawbacks, however. PPIs can decrease the sensitivity and should be discontinued at least 2 weeks prior to stool testing.32 In addition, a stool test for H pylori is not accurate if the patient has an acute GI bleed.

Urea breath testing. This is the most sensitive and specific test for active H pylori infection (90%-96% sensitivity and 88%-96% specificity).33 PPIs can lower the sensitivity of the test, however, and are typically discontinued at least 2 weeks prior to testing. Urea breath testing, like stool testing, is an excellent way to confirm that H pylori has been eradicated after treatment. However, it is more expensive than other tests for H pylori and often inconvenient to obtain.13

An EGD is indicated for a patient who has failed to respond to acid suppression therapy and has a negative serology, stool antigen, or urea breath test for H pylori.

Biopsy-based testing for H pylori is performed with EGD and is therefore reserved for patients who have red flags or other indications of a need for invasive testing. There are 3 types of biopsy-based tests: urease (sensitivity, 70%-90%; specificity, 95%); histology (87%-92% and 70%, respectively); and culture (85%-88% and 69%, respectively). Overall, the specificity is slightly better than that of noninvasive testing, but the sensitivity can be lowered by recent use of PPIs, bismuth, or antibiotics.12,34

... and how to treat it

H pylori infection is associated with an increased risk of noncardiac gastric adenocarcinoma, but a decreased risk of cardiac gastric adenocarcinoma and esophageal adenocarcinoma.35,36 Thus, the potential to reduce the risk of gastric cancer is not considered an indication for H pylori treatment. The possibility of improving dyspepsia symptoms is a reason to treat H pylori infection, although eradicating it does not always do so.

IgG serology testing should not be used for any patient who was previously diagnosed with, or treated for, H pylori because this type of test can’t distinguish between an active or past infection.

 

 

In a 2006 Cochrane Review, treating H pylori had a small but statistically significant benefit for patients with FD (NNT=14).37 A 2011 study on the effects of H pylori eradication on symptoms and quality of life in primary care patients with FD revealed a 12.5% improvement in quality of life and a 10.6% improvement in symptoms.38

The triple therapy regimen (a PPI + amoxicillin + clarithromycin) is the most common first-line H pylori treatment in the United States, and a good initial choice in regions in which clarithromycin resistance is low (TABLE 2).39-44 The standard duration is 7 days. A 2013 Cochrane Review showed that a longer duration (14 days) increased the rate of eradication (82% vs 73%), but this remains controversial.39 The addition of bismuth subsalicylate to the triple therapy regimen has been shown to increase the eradication rate of H pylori by approximately 10%.45 Adding probiotics (saccharomyces or lactobacillus) appears to increase eradication rates, as well.40

Sequential therapy consists of a 5-day course of treatment in which a PPI and amoxicillin are taken twice a day, followed by another 5-day course of a PPI, clarithromycin, and metronidazole. A recent meta-analysis of sequential therapy showed that it is superior to 7-day triple therapy but equivalent to 14-day triple therapy.40

LOAD (levofloxacin, omeprazole, nitazoxanide, and doxycycline) therapy for 7 to 10 days can be used in place of triple therapy in areas of high resistance or for persistent H pylori. In one study, the H pylori eradication rate for a 7-day course of LOAD therapy—levofloxacin and doxycycline taken once a day, omeprazole before breakfast, and nitazoxanide twice daily—was 90% vs 73.3% for a 7-day course of triple therapy.41

Quadruple therapy has 2 variations: bismuth-based and non-bismuth (concomitant) therapy. The latter uses the base triple therapy and adds either metronidazole or tinidazole for 7 to 14 days. In a multicenter randomized trial, this concomitant therapy was found to have similar efficacy to sequential therapy.42

The possibility of improving dyspepsia symptoms is a reason to treat H pylori infection, although eradicating it does not always do so.

Bismuth-based quad therapy includes a PPI, bismuth, metronidazole, and tetracycline. A meta-analysis found it to have a higher rate of eradication than triple therapy for patients with antibiotic resistance.43,44

For persistent H pylori, a PPI, levofloxacin, and amoxicillin for 10 days has been shown to be more effective and better tolerated than quadruple therapy.12

Confirmation is indicated when symptoms persist

If dyspepsia symptoms persist after H pylori treatment, it is reasonable to retest to confirm that the infection has in fact been eradicated. Confirmation is also indicated if the patient has an H pylori-associated ulcer or a prior history of gastric cancer.

Retesting should be performed at least 4 to 6 weeks after treatment is completed. If H pylori has not been eradicated, you can try another regimen. If retesting confirms eradication and symptoms persist, EGD with biopsy is indicated. Although EGD typically has a very low yield, even for patients with red flags, this invasive test often provides reassurance and increased satisfaction for patients with persistent symptoms.46

More options for challenging cases

Managing FD is challenging when both initial acid suppression therapy and H pylori eradication fail. Unproven but low-risk treatments include modification of eating habits (eg, eating slower, not gulping food), reducing stress, discontinuing medications that may be related to symptoms, avoiding foods that seem to exacerbate symptoms, and cutting down or eliminating tobacco, caffeine, alcohol, and carbonated beverages.8 Bismuth salts have been shown to be superior to placebo for the treatment of dyspepsia.25 Small studies have also demonstrated a favorable risk–benefit ratio for peppermint oil and caraway oil for the treatment of FD.47 Prokinetics have shown efficacy compared with placebo, although a Cochrane review questioned their efficacy based on publication bias.26

There is no good evidence of efficacy for over-the-counter antacids, such as TUMS, or for GI “cocktails” (antacid, antispasmotic, and lidocaine), sucralfate, psychological interventions (eg, cognitive behavioral therapy, relaxation therapy, or hypnosis), or antidepressants.48,49 Several recent randomized controlled trials have shown the efficacy of acupuncture for the treatment of dyspepsia.49,50 Ginger may also be helpful; it has been found to help with nausea in other GI conditions, but it’s uncertain whether it can help patients with dyspepsia.51

CORRESPONDENCE 
Michael Malone, MD, 845 Fishburn Road, Hershey, PA 17053; mmalone@hmc.psu.edu

PRACTICE RECOMMENDATIONS

› Review the medications taken by patients who suffer from dyspepsia, as many drugs—bisphosphonates, antibiotics, steroids, and nonsteroidal anti-inflammatory drugs, among others—are associated with this condition. B
› Order an esophagogastroduodenoscopy for patients ages 55 years or older with new-onset dyspepsia and those who have red flags for more serious conditions, eg, a history of upper gastrointestinal (GI) cancer, unintended weight loss, GI bleeding, dysphagia, or a palpable mass. C
› Prescribe acid suppression therapy as first-line treatment for patients who have dyspepsia but are at low risk or have tested negative for Helicobacter pylori infection. A

Strength of recommendation (SOR)

A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

Each year, an estimated 25% to 30% of the US population suffers from dyspepsia.1 Most self-treat with home remedies and over-the-counter products, but others seek medical care. Dyspepsia accounts for an estimated 2% to 5% of primary care visits annually,2 mostly by patients who are found to have no organic, or structural, cause for their symptoms.1,3

Compared with the general public, patients with functional dyspepsia have higher levels of anxiety, chronic tension, hostility, and hypochondriasis, and a tendency to be more pessimistic.

Such patients are said to have functional dyspepsia (FD), a category that applies to about two-thirds of those with dyspepsia.1 A small number of cases are categorized as organic dyspepsia, indicating the presence of a clear structural or anatomic cause, such as an ulcer or mass. The remainder are said to have undifferentiated dyspepsia, which simply means that their signs and symptoms do not rise to the level for which further investigation is warranted and thus it is not known whether it is functional or organic.

There are many possible causes of FD, ranging from medications3,4 to abnormal gastroduodenal motility5,6 to Helicobacter pylori infection,7 and a comprehensive differential diagnosis. The first step in an investigation is to rule out red flags suggestive of gastrointestinal (GI) cancer or other serious disorders.

Patients with FD, like the vast majority of those you’ll treat in a primary care setting, suffer significant morbidity. Most have chronic symptoms, with intermittent flare-ups interspersed with periods of remission.8 In the text and dyspepsia treatment ALGORITHM5,7-12 that follow, you’ll find an evidence-based patient management approach.

Symptoms and causes: What to look for

The primary symptoms of dyspepsia include bothersome postprandial fullness, early satiety, and epigastric pain and burning. To meet the Rome criteria for dyspepsia, these symptoms must have been present for the last 3 months and have had an onset ≥6 months prior to diagnosis.2 Recurrent belching and nausea are also common, but are not included in the Rome diagnostic criteria.

Symptom severity is a poor predictor of the seriousness of the condition, however, and more intense symptoms are no more likely than milder cases to have an organic cause.13,14 Indeed, anxiety is a common comorbidity in patients with FD and a risk factor for the diagnosis. Compared with the general public, patients with FD have been found to have higher levels of anxiety, chronic tension, hostility, and hypochondriasis, and a tendency to be more pessimistic.15

Possible causes of FD

While the etiology of organic dyspepsia is clear, the cause of FD is often far more difficult to determine.

Medication use should always be considered, as many types of drugs—including bisphosphonates, antibiotics, narcotics, steroids, iron, metformin, and nonsteroidal anti-inflammatory drugs (NSAIDs)—are associated with dyspepsia.3,4

Gastroduodenal motility and accommodation, which has been found in numerous studies of patients with FD, is a proposed etiology.5,6

Visceral hypersensitivity also appears to play a role. In one study of patients with severe dyspepsia, 87% of those with FD had a reduced or altered GI pain threshold, compared with 20% of those with organic dyspepsia.16

H pylori, commonly linked to peptic ulcer disease (PUD), is also associated with both organic dyspepsia and FD.17,18 The gram-negative rod-shaped bacterium is present in approximately half of the population worldwide, but is more common in developing nations.7H pylori immunoglobulin G (IgG) is more prevalent in patients with dyspepsia, particularly in those younger than 30 years of age. The exact mechanism by which H pylori causes non-ulcerative dyspepsia is not clear, but inflammation, dysmotility, visceral hypersensitivity, and alteration of acid secretion have all been proposed.17

Dysfunctional intestinal epithelium is increasingly being considered in the pathophysiology of dyspepsia, among other conditions. Researchers theorize that certain foods, toxins, infections, and/or other stressors lead to changes in the structure and function of tight junctions, resulting in increased intestinal permeability.19 This in turn is thought to allow the outflow of antigens through the leaky epithelium and to stimulate an immune response—a process that may play a role in the increased GI inflammation or hypersensitivity associated with dyspepsia. The “leaky gut” theory may eventually lead to new ways to treat dyspepsia, but thus far, highquality evidence of the efficacy of treatments aimed at this mechanism is lacking.

 

 

A range of disorders included in the differential

Symptom severity is a poor predictor of the seriousness of dyspepsia; more intense symptoms are no more likely than milder cases to have an organic cause.

The primary differential diagnosis for dyspepsia includes gastroesophageal reflux disease (GERD), esophagitis, chronic PUD (including both gastric and duodenal ulcers), and malignancy. The differential may also include biliary disorder, pancreatitis, hepatitis, or other liver disease; chronic abdominal wall pain, irritable bowel syndrome, motility disorders, or infiltrative diseases of the stomach (eosinophilic gastritis, Crohn’s disease, sarcoidosis); celiac disease and food sensitivities/allergies, including gluten, lactose, and other intolerances; cardiac disease, including acute coronary syndrome, myocardial infarction, and arrhythmias; intestinal angina; small intestine bacterial overgrowth; heavy metal toxicity; and hypercalcemia.8

Ulcers are found in approximately 10% of patients undergoing evaluation for dyspepsia.8 Previously, PUD was almost exclusively due to H pylori infection. In developed countries, however, chronic use of NSAIDs, including aspirin, has increased, and is now responsible for most ulcer diseases.20,21 The combination of H pylori infection and NSAID usage appears to be synergistic, with the risk of uncomplicated PUD estimated to be 17.5 times higher among those who test positive for H pylori and take NSAIDs vs a 3- to 4-fold increase in ulcer incidence among those with either of these risk factors alone.22

The work-up starts with a search for red flags

Symptom severity is a poor predictor of the seriousness of dyspepsia; more intense symptoms are no more likely than milder cases to have an organic cause.

Evaluation of a patient with dyspepsia begins with a thorough history. Start by determining whether the patient has any red flags, or alarm features, that may be associated with a more serious condition—particularly an underlying malignancy. One or more of the following is an indication for an esophagogastroduodenoscopy (EGD):5,8,12
• family and/or personal history of upper GI cancer
• unintended weight loss
• GI bleeding
• progressive dysphagia
• unexplained iron-deficiency anemia
• persistent vomiting
• palpable mass or lymphadenopathy
• jaundice.

The “leaky gut” theory may eventually lead to new ways to treat dyspepsia, but thus far, high-quality evidence of the efficacy of treatments aimed at this mechanism is lacking.

While it is important to rule out these red flags, they are poor predictors of malignancy.23,24 With the exception of a single study, their positive predictive value was a mere 1%.8 Their usefulness lies in their ability to exclude malignancy, however; when none of these features is present, the negative predictive value for malignancy is >97%.8

Age is also a risk factor. In addition to red flags, EGD is recommended by the American Gastroenterological Association (AGA) for patients with new-onset dyspepsia who are 55 years or older—an age at which upper GI malignancy becomes more common. A repeat EGD is rarely indicated, unless Barrett’s esophagus or severe erosive esophagitis is found on the initial EGD.25

Physical exam, H pylori evaluation follow

A physical examination of all patients presenting with symptoms suggestive of dyspepsia is crucial. While the exam is usually normal, it may reveal epigastric tenderness on abdominal palpation. Rebound tenderness, guarding, or evidence of other abnormalities should raise the prospect of alternative diagnoses. GERD, for example, has many symptoms in common with dyspepsia, but is a more likely diagnosis in a patient who has retrosternal burning discomfort and regurgitation and reports that symptoms worsen at night and when lying down.

Lab work has limited value. Although laboratory work is not specifically addressed in the AGA guidelines (except for H pylori testing), a complete blood count is a reasonable part of an initial evaluation of dyspepsia to check for anemia. Other routine blood work is not needed, but further lab testing may be warranted based on the history, exam, and differential diagnosis.

H pylori risk. Because of the association between dyspepsia and H pylori, evaluating the patient’s risk for infection with this bacterium, based primarily on his or her current and previous living conditions (TABLE 1),9 is the next step. Although a test for H pylori could be included in the initial work-up of all patients with dyspepsia, a better—and more cost-effective—strategy is to initially test only those at high risk. (More on testing and treating H pylori in a bit.)

Initiate acid suppression therapy for low-risk patients

First-line treatment for patients with dyspepsia who have no red flags for malignancy or other serious conditions and either are not at high risk for H pylori or are at high risk but have been tested for it and had negative results is a 4- to 8-week course of acid suppression therapy. Patients at low risk for H pylori should be tested for the bacterium only if therapy fails to alleviate their symptoms.9

 

 

H2RAs or PPIs? A look at the evidence

In a Cochrane review, both H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) were significantly more effective than placebo for treating FD.26 However, H2RAs can lead to tachyphylaxis—an acute decrease in response to a drug—within 2 to 6 weeks, thus limiting their long-term efficacy.27

Suspect gastroesophageal reflux disease, rather than dyspepsia, in a patient who has retrosternal burning and regurgitation that worsen when lying down.

PPIs appear to be more effective than H2RAs, and are the AGA’s acid suppression drug of choice.11 The CADET study, a randomized controlled trial comparing PPIs (omeprazole 20 mg/d) with an H2RA (ranitidine 150 mg BID) and a prokinetic agent (cisapride 20 mg BID) as well as placebo for dyspepsia, found the PPI to be superior to the H2RA at 6 months.28 In a systematic review, the number needed to treat with PPI therapy for improvement of dyspepsia symptoms was 9.29

There is no specified time limit for the use of PPIs. AGA guidelines recommend that patients who respond to initial therapy stop treatment after 4 to 8 weeks.11 If symptoms recur, another course of the same treatment is justified; if necessary, therapy can continue long term. However, patients should be made aware of the risk for vitamin deficiency, osteoporosis, and fracture, as well as arrhythmias, Clostridium difficile infection, and rebound upon abrupt discontinuation of PPIs.

When to test for H pylori ...

Empiric treatment for H pylori is not recommended. Thus, testing is indicated for patients who have risk factors for the bacterium or who fail to respond to acid suppression therapy. There are various ways to test for the presence of H pylori. Which test you choose depends, in part, on patient-specific factors.

Serology. IgG serology testing is extremely useful in patients who have never been diagnosed with H pylori. It is best suited for those who are currently taking proton pump inhibitors (PPIs) or who recently completed a course of antibiotics, since neither medication affects the results of the serology test.

Serology testing should not be used, however, for any patient who was previously diagnosed with or treated for H pylori, because this type of test cannot distinguish between an active or past infection. The IgG serology test has a sensitivity of 87% and a specificity of 67%.30

Stool antigen. Stool tests using monoclonal antibodies to detect the presence of H pylori have a sensitivity of 87% to 92% and a specificity of 70%. Stool antigen is also an excellent post-treatment test to confirm that H pylori has been eradicated.31

Stool testing has some drawbacks, however. PPIs can decrease the sensitivity and should be discontinued at least 2 weeks prior to stool testing.32 In addition, a stool test for H pylori is not accurate if the patient has an acute GI bleed.

Urea breath testing. This is the most sensitive and specific test for active H pylori infection (90%-96% sensitivity and 88%-96% specificity).33 PPIs can lower the sensitivity of the test, however, and are typically discontinued at least 2 weeks prior to testing. Urea breath testing, like stool testing, is an excellent way to confirm that H pylori has been eradicated after treatment. However, it is more expensive than other tests for H pylori and often inconvenient to obtain.13

An EGD is indicated for a patient who has failed to respond to acid suppression therapy and has a negative serology, stool antigen, or urea breath test for H pylori.

Biopsy-based testing for H pylori is performed with EGD and is therefore reserved for patients who have red flags or other indications of a need for invasive testing. There are 3 types of biopsy-based tests: urease (sensitivity, 70%-90%; specificity, 95%); histology (87%-92% and 70%, respectively); and culture (85%-88% and 69%, respectively). Overall, the specificity is slightly better than that of noninvasive testing, but the sensitivity can be lowered by recent use of PPIs, bismuth, or antibiotics.12,34

... and how to treat it

H pylori infection is associated with an increased risk of noncardiac gastric adenocarcinoma, but a decreased risk of cardiac gastric adenocarcinoma and esophageal adenocarcinoma.35,36 Thus, the potential to reduce the risk of gastric cancer is not considered an indication for H pylori treatment. The possibility of improving dyspepsia symptoms is a reason to treat H pylori infection, although eradicating it does not always do so.

IgG serology testing should not be used for any patient who was previously diagnosed with, or treated for, H pylori because this type of test can’t distinguish between an active or past infection.

 

 

In a 2006 Cochrane Review, treating H pylori had a small but statistically significant benefit for patients with FD (NNT=14).37 A 2011 study on the effects of H pylori eradication on symptoms and quality of life in primary care patients with FD revealed a 12.5% improvement in quality of life and a 10.6% improvement in symptoms.38

The triple therapy regimen (a PPI + amoxicillin + clarithromycin) is the most common first-line H pylori treatment in the United States, and a good initial choice in regions in which clarithromycin resistance is low (TABLE 2).39-44 The standard duration is 7 days. A 2013 Cochrane Review showed that a longer duration (14 days) increased the rate of eradication (82% vs 73%), but this remains controversial.39 The addition of bismuth subsalicylate to the triple therapy regimen has been shown to increase the eradication rate of H pylori by approximately 10%.45 Adding probiotics (saccharomyces or lactobacillus) appears to increase eradication rates, as well.40

Sequential therapy consists of a 5-day course of treatment in which a PPI and amoxicillin are taken twice a day, followed by another 5-day course of a PPI, clarithromycin, and metronidazole. A recent meta-analysis of sequential therapy showed that it is superior to 7-day triple therapy but equivalent to 14-day triple therapy.40

LOAD (levofloxacin, omeprazole, nitazoxanide, and doxycycline) therapy for 7 to 10 days can be used in place of triple therapy in areas of high resistance or for persistent H pylori. In one study, the H pylori eradication rate for a 7-day course of LOAD therapy—levofloxacin and doxycycline taken once a day, omeprazole before breakfast, and nitazoxanide twice daily—was 90% vs 73.3% for a 7-day course of triple therapy.41

Quadruple therapy has 2 variations: bismuth-based and non-bismuth (concomitant) therapy. The latter uses the base triple therapy and adds either metronidazole or tinidazole for 7 to 14 days. In a multicenter randomized trial, this concomitant therapy was found to have similar efficacy to sequential therapy.42

The possibility of improving dyspepsia symptoms is a reason to treat H pylori infection, although eradicating it does not always do so.

Bismuth-based quad therapy includes a PPI, bismuth, metronidazole, and tetracycline. A meta-analysis found it to have a higher rate of eradication than triple therapy for patients with antibiotic resistance.43,44

For persistent H pylori, a PPI, levofloxacin, and amoxicillin for 10 days has been shown to be more effective and better tolerated than quadruple therapy.12

Confirmation is indicated when symptoms persist

If dyspepsia symptoms persist after H pylori treatment, it is reasonable to retest to confirm that the infection has in fact been eradicated. Confirmation is also indicated if the patient has an H pylori-associated ulcer or a prior history of gastric cancer.

Retesting should be performed at least 4 to 6 weeks after treatment is completed. If H pylori has not been eradicated, you can try another regimen. If retesting confirms eradication and symptoms persist, EGD with biopsy is indicated. Although EGD typically has a very low yield, even for patients with red flags, this invasive test often provides reassurance and increased satisfaction for patients with persistent symptoms.46

More options for challenging cases

Managing FD is challenging when both initial acid suppression therapy and H pylori eradication fail. Unproven but low-risk treatments include modification of eating habits (eg, eating slower, not gulping food), reducing stress, discontinuing medications that may be related to symptoms, avoiding foods that seem to exacerbate symptoms, and cutting down or eliminating tobacco, caffeine, alcohol, and carbonated beverages.8 Bismuth salts have been shown to be superior to placebo for the treatment of dyspepsia.25 Small studies have also demonstrated a favorable risk–benefit ratio for peppermint oil and caraway oil for the treatment of FD.47 Prokinetics have shown efficacy compared with placebo, although a Cochrane review questioned their efficacy based on publication bias.26

There is no good evidence of efficacy for over-the-counter antacids, such as TUMS, or for GI “cocktails” (antacid, antispasmotic, and lidocaine), sucralfate, psychological interventions (eg, cognitive behavioral therapy, relaxation therapy, or hypnosis), or antidepressants.48,49 Several recent randomized controlled trials have shown the efficacy of acupuncture for the treatment of dyspepsia.49,50 Ginger may also be helpful; it has been found to help with nausea in other GI conditions, but it’s uncertain whether it can help patients with dyspepsia.51

CORRESPONDENCE 
Michael Malone, MD, 845 Fishburn Road, Hershey, PA 17053; mmalone@hmc.psu.edu

References

1. Shaib Y, El-Serag HB. The prevalence and risk factors of functional dyspepsia in a multiethnic population in the United States. Am J Gastroenterol. 2004;99:2210-2216.

2. Talley NJ. Dyspepsia: management guidelines for the millennium. Gut. 2002;50(suppl 4):iv72–iv78.

3. Harmon RC, Peura DA. Evaluation and management of dyspepsia. Therap Adv Gastroenterol. 2010;3:87–98.

4. Bazaldua OV, Schneider FD. Evaluation and management of dyspepsia. Am Fam Physician. 1999;60:1773-1784.

5. Tack J, Talley NJ, Camilleri M, et al. Functional gastroduodenal disorders. Gastroenterology. 2006;130:1466-1479.

6. Haag S, Talley NJ, Holtmann G. Symptom patterns in functional dyspepsia and irritable bowel syndrome: relationship to disturbances in gastric emptying and response to a nutrient challenge in consulters and non-consulters. Gut. 2004;53:1445-1451.

7. Malfertheiner P, Megraud F, O’Morain CA, et al; European Helicobacter Study Group. Management of Helicobacter pylori infection—the Maastricht IV/Florence Consensus Report. Gut. 2012;61:646-664.

8. Talley NJ, Vakil NB, Moayyedi P. American Gastroenterological Association technical review on the evaluation of dyspepsia. Gastroenterology. 2005;129:1756-1780.

9. Moayyedi P, Axon AT. The usefulness of the likelihood ratio in the diagnosis of dyspepsia and gastroesophageal reflux disease. Am J Gastroenterol. 1999;94:3122-3125.

10. McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010;362:1597-1604.

11. Kahrilas PJ, Shaheen NJ, Vaezi MF, et al; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135:1383-1391.

12. Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori Infection. Am J Gastroenterol. 2007;102:1808-1825.

13. Moayyedi P, Talley NJ, Fennerty MB, et al. Can the clinical history distinguish between organic and functional dyspepsia? JAMA. 2006;295:1566-1576.

14. Eslick GD, Howell SC, Hammer J, et al. Empirically derived symptom sub-groups correspond poorly with diagnostic criteria for functional dyspepsia and irritable bowel syndrome. A factor and cluster analysis of a patient sample. Aliment Pharmacol Ther. 2004;19:133-140.

15. Aro P, Talley NJ, Ronkainen J, et al. Anxiety is associated with uninvestigated and functional dyspepsia (Rome III criteria) in a Swedish population-based study. Gastroenterology. 2009;137:94-100.

16. Mertz H, Fullerton S, Naliboff B, et al. Symptoms and visceral perception in severe functional and organic dyspepsia. Gut. 1998;42:814-822.

17. O’Morain C. Role of Helicobacter pylori in functional dyspepsia. World J Gastroenterol. 2006;12:2677-2680.

18. Shmuely H, Obure S, Passaro DJ, et al. Dyspepsia symptoms and Helicobacter pylori infection, Nakuru, Kenya. Emerg Infect Dis. 2003;9:1103-1107.

19. Barbara G, Zecchi L, Barbaro R, et al. Mucosal permeability and immune activation as potential therapeutic targets of probiotics in irritable bowel syndrome. J Clin Gastroenterol. 2012;46(suppl):S52-S55.

20. Liu NJ, Lee CS, Tang JH, et al. Outcomes of bleeding peptic ulcers: a prospective study. J Gastroenterol Hepatol. 2008;23:e340-e347.

21. Ramsoekh D, van Leerdam ME, Rauws EA, et al. Outcome of peptic ulcer bleeding, nonsteroidal anti-inflammatory drug use, and Helicobacter pylori infection. Clin Gastroenterol Hepatol. 2005;3:859-864.

22. Papatheodoridis GV, Sougioultzis S, Archimandritis AJ. Effects of Helicobacter pylori and nonsteroidal anti-inflammatory drugs on peptic ulcer disease: a systematic review. Clin Gastroenterol Hepatol. 2006;4:130-142.

23. Bai Y, Li ZS, Zou DW, et al. Alarm features and age for predicting upper gastrointestinal malignancy in Chinese patients with dyspepsia with high background prevalence of Helicobacter pylori infection and upper gastrointestinal malignancy: an endoscopic database review of 102,665 patients from 1996 to 2006. Gut. 2010;59:722-728.

24. Vakil N. Dyspepsia, peptic ulcer, and H. pylori: a remembrance of things past. Am J Gastroenterol. 2010;105:572-574.

25. Shaheen NJ, Weinberg DS, Denberg TD, et al; Clinical Guidelines Committee of the American College of Physicians. Upper endoscopy for gastroesophageal reflux disease: best practice advice from the clinical guidelines committee of the American College of Physicians. Ann Intern Med. 2012;157:808-816.

26. Moayyedi P, Soo S, Deeks J, et al. Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2006;(4):CD001960.

27. Chiu CT, Hsu CM, Wang CC, et al. Randomised clinical trial: sodium alginate oral suspension is non-inferior to omeprazole in the treatment of patients with non-erosive gastroesophageal disease. Aliment Pharmacol Ther. 2013;38:1054-1064.

28. Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol. 2005;100:1477-1488.

29. Moayyedi P, Delaney BC, Vakil N, et al. The efficacy of proton pump inhibitors in nonulcer dyspepsia: a systematic review and economic analysis. Gastroenterology. 2004;127:1329-1337.

30. Garza-González E, Bosques-Padilla FJ, Tijerina-Menchaca R, et al. Comparison of endoscopy-based and serum-based methods for the diagnosis of Helicobacter pylori. Can J Gastroenterol. 2003;17:101-106.

31. Kodama M, Murakami K, Okimoto T, et al. Influence of proton pump inhibitor treatment on Helicobacter pylori stool antigen test. World J Gastroenterol. 2012;18:44-48.

32. Shimoyama T. Stool antigen tests for the management of Helicobacter pylori infection. World J Gastroenterol. 2013;19:8188-8191.

33. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. Am J Gastroenterol. 1998;93:2330-2338.

34. Gisbert J, Abraira V. Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis. Am J Gastroenterol. 2006;101:848-863.

35. Kamangar F, Dawsey SM, Blaser MJ, et al. Opposing risks of gastric cardiac and noncardia gastric adenocarcinomas associated with Helicobacter pylori seropositivity. J Natl Cancer Inst. 2006;98:1445-1452.

36. Islami F, Kamangar F. Helicobacter pylori and esophageal cancer risk: a meta-analysis. Cancer Prevent Res (Phila). 2008;1:329-338.

37. Moayyedi P, Soo S, Deeks J, et al. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2006;(2):CD002096.

38. Mazzoleni LE, Sander GB, Francesconi CF, et al. Helicobacter pylori eradication in functional dyspepsia: HEROES trial. Arch Intern Med. 2011;171:1929-1936.

39. Yuan Y, Ford AC, Khan KJ, et al. Optimum duration of regimens for Helicobacter pylori eradication. Cochrane Database Syst Rev. 2013;(12):CD008337.

40. Zou J, Dong J, Yu X. Meta-analysis: Lactobacillus containing quadruple therapy versus standard triple first-line therapy for Helicobacter pylori eradication. Helicobacter. 2009;14:97-107.

41. Basu PP, Rayapudi K, Pacana T, et al. A randomized study comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple therapy for the eradication of Helicobacter pylori. Am J Gastroenterol. 2011;106:1970-1975.

42. Wu DC, Hsu PI, Wu JY, et al. Sequential and concomitant therapy with 4 drugs are equally effective for eradication of H. pylori infection. Clin Gastroenterol Hepatol. 2010;8:36–41.

43. Osato R, Reddy R, Reddy SG, et al. Pattern of primary resistance of Helicobacter pylori to metronidazole or clarithromycin in the United States. Arch Intern Med. 2001;161:1217-1220.

44. Fischbach L, Evans EL. Meta-analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple firstline therapies for Helicobacter pylori. Aliment Pharmacol Ther. 2007;26:343-357.

45. Hinostroza Morales D, Díaz Ferrer J. Addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events. Rev Gastroenterol Peru. 2014;34:315-320.

46. Rabeneck L, Wristers K, Souchek J, et al. Impact of upper endoscopy on satisfaction in patients with previously uninvestigated dyspepsia. Gastrointest Endosc. 2003;57:295-299.

47. Hojo M, Miwa H, Yokoyama T, et al. Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review. J Gastroenterol. 2005;40:1036-1042.

48. Soo S, Moayyedi P, Deeks J, et al. Psychological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2005;(2):CD002301.

49. Lima FA, Ferreira LE, Pace FH. Acupuncture effectiveness as a complementary therapy in functional dyspepsia patients. Arq Gastroenterol. 2013;50:202-207.

50. Ma TT, Yu SY, Li Y, et al. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012;35:552-561.

51. Koretz RL, Rotblatt M. Complementary and alternative medicine in gastroenterology: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2004;2:957-967.

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51. Koretz RL, Rotblatt M. Complementary and alternative medicine in gastroenterology: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2004;2:957-967.

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The Journal of Family Practice - 64(6)
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The Journal of Family Practice - 64(6)
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350-357
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350-357
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Managing dyspepsia
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Managing dyspepsia
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Michael Malone, MD; dyspepsia; Helicobacter pylori infection; H pylori; FD; functional dyspepsia; urea breath testing; gastrointestinal
Legacy Keywords
Michael Malone, MD; dyspepsia; Helicobacter pylori infection; H pylori; FD; functional dyspepsia; urea breath testing; gastrointestinal
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