Gastric Protection and Pneumonia Risk

Acid is bad. Acid eats through stuff like gastric mucosa and causes ulcers, bleeding, and death. Acute severe illness increases the risk of “stress ulcers” (stress-related mucosal disease) via a disruption of the normal protective gastric mucoprotein layer from bile acid reflux and/or decreased gastric perfusion from shock/sepsis (head trauma can cause increased acid production via gastrin stimulation and is one of very few examples of what is commonly thought of as the cause of ulcers i.e. increased acid).

Risk factors for the development of stress ulcers include mechanical ventilation for more than 48 hours (an indication of critical illness), coagulopathy, sepsis, severe head trauma, severe burns, and a history of gastric ulcer or bleeding within the prior 12 months. Critically ill patients who have one or more of these risk factors are usually given medications to decrease the acidity of the stomach and reduce the development of ulceration and bleeding. This and the improved treatment of the underlying cause has decreased the incidence of stress ulcers in hospitalized patients from 20-30% in the 1970s to 2-14% in the 1990s (Am J Gastroenterol. 1995; 90:708-12).

Two different medication classes have shown efficacy in raising gastric pH (decreasing acidity) and reducing the incidence of stress ulcers. H2 blockers including cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac) work by preventing histamine from binding to H2 receptors on the basal membrane of acid producing parietal cells. Proton pump inhibitors like omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium), pantoprazole (Protonix), and rabeprazole (Aciphex) are more effective than H2 blockers because they irreversibly bind to and inhibit the enzyme that pumps protons (acid) from inside the parietal cell through the apical membrane and into the stomach.

It has been known that the use of medications in the ICU to reduce stomach acid increases the risk of Clostridium difficile infections and hospital acquired pneumonia (reduced stomach acidity may allow gram negative bacteria from the duodenum to proliferate and enter the lungs after reflux and aspiration) but this evidence was not statistically significant in many studies. It has become very common for ICU patients to be on a gastric protective medication regardless of the risk factors.

This practice has extended outside the ICU so that up to 71% of hospitalized general medicine patients get some type of gastric protective medication and significant numbers go home on these medications even though there are no indications for their continued use. It’s not clear why. Maybe it’s because hospitalized patients might be at increased risk of reflux symptoms due to their recumbent position (hospital standard), the side effects of medications, and acute illness but this is far different and not at all indicative of the development of stress ulcers. And maybe because there is a wide spread belief that these medications are harmless.

A new retrospective study looked at almost 64,000 non-ICU hospitalized patients and found that hospital acquired pneumonia occurred in 4.9% of those who were placed on gastric protective therapy and only in 2.0% of those who were not. However, this risk only held for patients taking proton pump inhibitors and not those on H2 blockers. Likely this is because PPIs are more efficient at lowering gastric acid.

Unfortunately, the study didn’t look at other end points like death and longer hospital stays or increased costs associated with the more expensive PPIs. Although it is very likely that these pneumonias lead to increased costs and all-cause mortality. There is no such thing as a “harmless” medication. More attention needs to be paid to the appropriate indications to use these medications.

How to Measure Medical Safety

It’s even more important than quality. But how do we measure it? Safety metrics are easy when it comes to fields like transportation or infant formulas where the expected rates of death and injury are supposed to be zero. So we make this the expected benchmark and try to get these rates to be as low as possible.

But with medical care, the picture is far more complicated. In this case, the outcome as a result of an illness or condition in the absence of medical treatment is EXPECTED to be death and injury (i.e. permanent disability). This is your benchmark. Therefore, it’s often difficult to determine whether a death or injury in this context was the result of treatment failure or it was iatrogenic (as a result of treatment itself) or a combination the two and whether, in retrospect, things could have been done differently that may have improved the odds for the patient.

Notice, I didn’t use the term “preventable”. Medical care does not prevent anything. It maximizes the odds ratios for patient morbidity and mortality. In my practice I use terms like “this treatment will reduce the likelihood . . ” instead of “this treatment will prevent . . ” such and such. Treatment with bisphosphonates will reduce the likelihood of a fracture. The use of daily aspirin will reduce the chances of a heart attack or stroke.There is however, a remaining chance that a fracture or heart attack will occur despite these treatments.

And every single medical treatment has the potential for iatrogenic harm. The use of blood thinners to reduce the risk of clots in the lower extremities increases the risk of bleeding. The use of invasive monitoring equipment will improve that ability for physicians to make treatment decisions but at the risk of infections, bleeding, and other complications. Ideally, multiple complex treatments are applied in various combinations that try to maximize the odds for recovery while minimizing the likelihood of a poor outcome though this is never assured.

Decades ago, people understood these simple concepts. But through a combination of the success of medical care, the growth of the tort industry, and American obsession with safety, we have come to have unrealistic expectations regarding safety in medical care. One of the biggest reasons for this delusion is that far too many people have lumped medical errors, iatrogenic complications, poor outcomes, and non-medical (i.e. administrative or systemic) errors together into one big messy pile.

This was evident when the Institutes of Medicine (IOM) released a study in 1999 that found that up to 98,000 patients die each year as a result of medical errors (they even included “to err” in the title of the report). But this figure was significantly revised when the methodology of the IOM study was re-evaluated. The IOM study simply looked at hospital charts and depended on the conclusion of the reviewer to determine whether an error was present. However, the accuracy of such methodology was found to be highly variable on further evaluation. It’s like watching two Monday morning ESPN analysts slug it out. Was the interception a result of a bad throw, a bad decision, good defense, a mistake by the receiver, or bad luck, or a combination? Different “experts” can see it differently. This type of study is not helpful (except for lawyers who still quote the study on their websites).

Amazingly, few people make the distinction between systemic errors and poor outcomes as a result of medical treatment. Systemic errors are errors that should never happen due to things like poor equipment design or defects, improper equipment maintenance and usage, wrong site, wrong procedure, wrong patient errors, poor training, and mismatched blood typing. Unlike medical complications, these adverse outcomes are completely preventable and have little to do with actual medical practice and more to do with administrative problems. Yet, studies and the media continue to lump preventable systemic/administrative adverse events in with medical complications like infections, bleeding, and medication reactions that will occur even under the safest of situations.

The first step is to separate systemic errors from medical adverse outcomes because the expectations and approaches to each can be quite different. Systemic errors are approached much the same way the FAA approaches aircraft accidents. Based on a root cause analysis, equipment is redesigned and/or new or revised procedures are implemented to try and prevent future errors.

Complications as a result of medical treatment requires an understanding and acceptance that this the trade-off we make in order to aggressively treat illness and that a certain finite level of risk will exist even under the most ideal set of circumstances until and unless new technologies or practices are developed to reduce this risk. With this in mind it is more appropriate to measure rates of complications related to the best known techniques in order to set a benchmark.

But even the use of complications or mortality and morbidity rates can be misleading in that different hospitals tend to treat different subsets of patients who may be sicker or healthier than the general population.

Some suggest that better metrics might be how well care is coordinated, how closely evidence-based medical guidelines are adhered to and how short the wait times are. But no matter how we ultimately measure medical safety, we need to start by understanding that there is a significant difference between system/administrative errors and medical complications

The stone in the bottle

Gavin Yamey, the Senior Magazine Editor of PLoS Medicine, is currently on sabbatical from the journal after being awarded a “mini-fellowship” from the Kaiser Family Foundation to undertake a project as a reporter in East Africa and Sudan.

In his latest blog, Gavin writes from Southern Sudan, explaining the impact that basic medical training can have on a community, and the often frustrating ordeal of obtaining long-term funding for community-based educational projects.

In remote rural regions of Africa—where there is no doctor or nurse, no health system or infrastructure—can a village itself be mobilized to learn life-saving health skills? A non-governmental organization called the Malaria Consortium thinks that it can.

In Northern Bahr el Gazal state, in Southern Sudan, the NGO is implementing a child survival project that teaches illiterate women in the village how to diagnose and treat malaria, pneumonia, and diarrhoea—the three big causes of child death in the region.

When one of the women makes a diagnosis and treats a child, she marks the illness episode by putting a stone in a bottle. The stones are collected up and then sent to the local community health worker, who converts the “stone-based health reporting” into a paper-based health record.

At the Malaria Consortium’s office in Aweil, Northern Bahr el Gazal, I met with Tadesse Fesseha, the medical officer leading the project.

The NGO, he explained, has trained 13 volunteers—all women—in Aweil Center. The project is funded by Unicef, which is also supplying the medicines—antimalarials, amoxycillin for pneumonia, and oral rehydration salts and zinc for diarrhoea.

The training takes 12-13 days, after which each volunteer, who is known as a Community Drug Distributor (CDD), is responsible for 40 households.

I asked Tadesse why the project trained only women. “They deal with children,” he said, “and women are more responsible than men.”

The volunteers are trained to spot danger signs suggestive of serious illness, such as blood in the stool or a high respiratory rate (the women don’t have watches, but are given Unicef timers to count respiration). Children with danger signs are referred to the nearest health facility (although, as I’ve written before, many facilities lack medical supplies).

Is there any evidence, I asked, as to whether CDDs can save lives?

“The International Rescue Committee pioneered the CDD approach,” said Tadesse, “and they’ve trained three hundred to four hundred CDDs in Aweil East. The IRC says child morbidity and mortality is curtailed by thirty to fifty per cent.”

But the Malaria Consortium project only has funding for one year, so its future is uncertain. The short term funding, said Tadesse, “is frustrating.”

I’ve heard health workers across southern Sudan and East Africa express the same frustration over and over about the nightmare of short term funding. Funders, they’ve told me, often have short attention spans—they’ll fund the start-up phase of a project, but then they’ll get bored and will want to move on to the next new thing.

Sustainability is a massive challenge. Getting long term funding, I’ve been told repeatedly, is like getting blood out of a stone.

Nanotechnology: Human and Environmental Exposure Assessment of Nanomaterials Workshop

Determining whether a material or substance poses an occupational health risk depends on knowing not only the potential toxic characteristics of the material, but also the characteristics of exposure. To what concentrations are workers exposed, for how long, and in what ways? In research to answer the question of whether nanomaterials pose work-related health risks, exposure assessment is particularly vital. Because of the relative newness of nanotechnology, very little exposure data have been reported in the scientific literature. At this stage, measuring or determining risk becomes a little like trying to solve a mystery when major clues are missing. Scientists and engineers face this challenge even as the market for nanotechnology grows, and along with it, an increasing demand from diverse parties for guidance to underpin its responsible development.

As part of a national effort to stimulate new research and knowledge in this area, the National Institute for Occupational Safety and Health (NIOSH) collaborated with the U.S. Nanoscale Science, Engineering and Technology Subcommittee (NSET) to co-sponsor the workshop on Human and Environmental Exposure Assessment of Nanomaterials on Feb. 24-25, 2009, in Bethesda, Md. More than 165 scientists and other stakeholders from government, industry, labor and other segments participated in person. An additional 25 viewers joined from other locations through the webcast plenary session. The workshop focused on research needed for characterizing exposures to nanomaterials among workers, other populations, and environments by measuring and modeling exposure levels, and by monitoring indicators of biological responses through the product life of a nanomaterial. The objectives of NIOSH, NSET, and other partners were to review the state-of-the-science, identify critical gaps, and inform further development and adaptation of the interagency research strategy as appropriate.

Planning for the workshop began in February 2008 by the interagency Nanotechnology Environmental and Health Implications (NEHI) workgroup. The workgroup operates under the auspices of NSET and includes NIOSH as a member. It was established informally in 2003, and then formalized in 2005. One of the main tasks of the group was to develop strategy in close consultation with the public.The group released three documents for public review. The first NEHI document, released in 2006 and provides an evaluation of the science, groups research into five research categories (Instrumentation, Metrology and Analytical Methods; Nanomaterials and Human Health, Nanomaterials and the Environment, Human and Environmental Exposure Assessment of Nanomaterials, and Risk Management Methods) and describes research needs within each category. The second document, released in 2007, was intended to elicit comments from the public, the scientific community, and other stakeholders, on how the NSET was proposing to approach prioritization of environmental health and safety research needs. That input was incorporated into the third document, released in 2008. The strategy describes adaptive management approach for addressing implication of nanotechnology through inter-agency efforts including identification of priority needs, assessing existing research, analyzing strengths and weaknesses and periodically updating and revising it. The strategy provides information to agencies that conduct and fund research on nanotechnology. It informs those agencies on critical research needs, and facilitates collaborative research activities to address them.

The strategy focuses on research supporting risk assessment and risk management of nanomaterials to meet needs of agencies with regulatory and oversight responsibilities. As needs of regulator decision makers change and as we learn more though basic research, the strategy should be updated. Therefore, the inter-agency group conducts periodic progress reviews and updates research needs and priorities, taking into consideration advances from private sector and international entities. This is accomplished in part through workshops for each of the research categories. Organizing workshops to inform further development and adaptation of the inter-agency strategy as appropriate in their research categories is one of the coordinating agency roles. NIOSH, in recognition of its leadership in conducting research on exposure assessment, is a coordinating agency for the Exposure Assessment research category and played a leading role in organizing the Human and Environmental Exposure Assessment of Nanomaterials Workshop.

Five plenary presentations provided state-of-the-science overviews for five research needs in the exposure assessment category, including needs for closing critical gaps in information necessary to adequately manage risk of nanomaterials, and for identifying emerging trends. These presentations served as catalysts for general open-floor discussions by the workshop participants. The plenary presentations were as follows:

1. Characterize Exposure among workers – Dr. Robert Herrick, Harvard University;
2. Identify population groups and environments exposed to engineered nanoscale materials – Dr. David MacIntosh, Environmental Health & Engineering, Inc.;
3. Characterize exposure to the general population from industrial processes and industrial and consumer products containing nanomaterials – Dr. Paul Lioy, Rutgers;
4. Characterize health of exposed populations and environments – Dr. William Halperin, University of Medicine & Dentistry of New Jersey;
5. Understand workplace processes and factors that determine exposure to nanomaterials – Dr. Susan Woskie, University of Massachusetts, Lowell.

The rest of the workshop was organized around six concurrent breakout sessions for five research needs and emerging trends. During the first day, breakout sessions focused on collecting information about where we are in addressing research needs, where we need to be in 5 years, are the current research needs framed correctly? Specific technical questions for each of the breakout sessions helped focus discussions. Discussions on the second day of the workshop centered on identifying paths forward in addressing critical research gaps identified in the first-day breakout sessions.

The main output of the workshop will be a workshop report which will further development and adaptation of the strategy. All presentation slides and video recording will be made available on the workshop website.

The workshop also provided valuable information that NIOSH will use in its research planning and allowed NIOSH to update participants about NIOSH research. The Human and Environmental Exposure Assessment of Nanomaterials workshop is the first in the series of workshops for each of the five research categories which will follow later in 2009 and 2010. We would like to encourage all stakeholders from government, industry, labor, non-governmental organizations and the general public to actively participate in these workshops to help update the strategy for the U.S. government program addressing the environmental health and safety implications of nanotechnology.

As NIOSH moves forward with research in this area, we would like to hear what you think are the critical needs in exposure assessment for nanomaterials in the workplace. Additionally, we would welcome comment on the exposure assessment part of the NNI Strategy for Nanotechnology-Related Environmental, Health, and Safety Research. We are also seeking volunteers for exposure assessment studies at work sites where nanomaterials currently are being produced or used and volunteers for NIOSH nanotech field team visits.

Disclaimer: this blog is not intended to be an official workshop update, but simply represents NIOSH's informal reflections.

—Vladimir V. Murashov, Ph.D.

Dr. Murashov is a Special Assistant for Nanotechnology to the NIOSH Director. He was Chair of the Human and Environmental Exposure Assessment of Nanomaterials workshop committee and is a member of the U.S. Nanoscale Science, Engineering, and Technology subcommittee. Dr. Murashov also leads projects for the ISO Technical Committee 229 (Nanotechnologies) and the Organization for Economic Cooperation and Development's Working Party on Manufactured Nanomaterials.

H1N1: Protecting Healthcare Workers

As we brace for the flu season, concerns are rising about the full impact of Novel H1N1 Influenza Virus (H1N1) also known as "Swine Flu." As of July 31, 2009, there were 162,380 documented cases of human infection with H1N1 throughout the world, including the United States. As of August 6, 2009, there were 6,506 hospitalized cases and 436 deaths in the U.S. From the time of its emergence earlier this year, H1N1 has prompted a concerted response from health agencies here and abroad for the following reasons:

• It is a never-before seen combination of human, swine, and avian influenza viruses.
• It is being spread from human to human.
• The age group most affected is healthy, young adults (unlike seasonal flu).
• Like other influenza viruses, it continues to evolve.

Healthcare workers and emergency responders will face increased risk of exposure to H1N1 given their role in caring for sick patients. It is estimated that at lest 50% of ill people will seek medical care, and the number of hospitalizations and deaths will depend on the virulence of the pandemic virus. The National Institute for Occupational Safety and Health (NIOSH) is working to protect healthcare workers from exposure to H1N1 in the workplace. Examples of NIOSH initiatives related to H1N1 include communications strategies to emphasize the hierarchy of controls to reduce the risk of workers becoming ill, respirator research and enhanced respirator certification, laboratory and field research on the transmission of influenza, and plans for field evaluations and surveillance of healthcare worker and other populations.

This week, NIOSH researchers will participate in a workshop convened by an ad hoc committee of the Institute of Medicine. IOM describes the scope and purpose of the workshop in this way:

In response to a request from the Centers for Disease Control and Prevention and the Occupational Safety & Health Administration, an ad hoc committee of the Institute of Medicine (IOM) will conduct a study and issue a letter report to the CDC director and Assistant Secretary for Occupational Safety and Health by September 1, 2009. The committee will provide recommendations regarding the necessary personal protective equipment (PPE) for healthcare workers in their workplace against the novel influenza A (nH1N1) virus. Issues to be addressed to the extent feasible given available evidence and within the timeline for this letter report include: the potential for exposure to the nH1N1 virus among healthcare workers, which groups of workers are at risk, which patient care activities pose a risk of exposure and what degree of risk, and what is known and what is unknown about transmissibility, severity and virulence of the current virus and how transmissibility might change. The committee will base its recommendations on the available current state of scientific and empirical evidence about nH1N1 virus, as well its expert judgment. Economic and logistical considerations regarding PPE equipment will not be addressed in this letter report. In determining the appropriate PPE for the U.S. healthcare workforce, attention will be given to the current PPE guidance documents offered by the CDC and by the World Health Organization for novel H1N1 influenza and for seasonal influenza.

The IOM Workshop on Personal Protective Equipment for Healthcare Workers in the Workplace against Novel H1N1 Influenza A will be available via live audio webcast from 8 am to 5 pm on Wednesday, August 12th, and from 8 am to noon on Thursday, August 13th. The webcast can be accessed through the National Academies homepage. The full workshop agenda is available on the study's website.

NIOSH experts will participate in the panel discussion on what is known about the effectiveness of respirators and surgical masks with regard to influenza virus or particles of a similar size to provide worker protection. NIOSH also will provide an update on research related to cough dispersion and exposure measures of influenza transmission, with an emphasis on a recent urgent care air sampling study. NIOSH also conducted an emergency room air sampling study last year.

The overall workshop goals include:

• Examine the emerging science and clinical experience base associated with H1N1
• Discuss criteria used to delineate infection control guidelines
• Discuss criteria used to assess risk to the healthcare workforce
• Examine what's known about the effectiveness of medical masks, respirators, gowns, gloves, and eye protection in preventing H1N1 and seasonal influenza transmission

NIOSH would appreciate comments related to the workshop goals including peer-reviewed and published work on the topics mentioned above. We will forward comments received on this blog during the first week to the IOM to help inform their process. This is the first in a series of science blogs focusing on NIOSH initiatives related to H1N1. We welcome suggestions for future blogs on this topic.

—Maryann D'Alessandro, Ph.D., and Ed Fries

Dr. D'Alessandro is the NIOSH PPT Program Coordinator and Associate Director for Science in the NIOSH National Personal Protective Technology Laboratory.
Mr. Fries serves as the Assistant Coordinator for the NIOSH PPT Program in the NIOSH National Personal Protective Technology Laboratory.

Everyday Health care: studies leads to incredible snore treatment.

In what may have seen one of the most questionable ways to approach a final solution to the common snore disease, also called the "whirr throat" disease (a.k.a. grumble igsquizoihdea), in 2003 Dr. Sebastian Harrison (right photo), from Montreal, led a team of recently graduated high-profile doctors from the University of Montreal in Canada with close cooperation from the Boston University of Medicine in the U.S. in order to find a non-conventional and more effective way to treat the snoring sound emanated from the troats of his patients during sleep. (*)

With an original funding of U$S 3.450.000 coming from a newly formed society between Roche Laboratories and the Boston University, which will later rise to U$S 5.742.200, Doctor Harrison started his research on Inverse Trachea Extoll Release, which purpose is to find the connection between the trachea snoring sound being somehow reduced or "faded", as he describes it on the latest report, after practicing short periods of sexual intercourse throw the rectum of the patient.

The team, led by Dr. Harrison, Gynecologist, is composed by two Ph.D.'s on Chemistry, three General Practicians, two plastic surgeons and two Glaciologist, supported by a resident staff of six nurses and seven students / assistants. Currently the studies are being taken over the Saint Joseph General Hospital, with Dr. Harrison being the oldest of the team with thirty-eight years old (EN: the picture that the University of Montreal provided us of Dr. Harrison is not up to date and it belongs to his former resume).

Although Harrison's studies were taken with little consideration on the medical network, Boston University and Roche Laboratories from Germany had assured in the "23rd Senior Innovate" health care convention that took place in Chicago, U.S., that the results were more amazing that originally predicted.

Harrison declined to give any public statement and only when the final results came up from his studies, which may as well arise to a sum around U$S 7.000.000 next year, the medical community will have the information concerning this treatment and how the research was done.

However, Boston's University Dean Steven Gerrard has told briefly in his interview on the New York Times the basics of this new alternative and revolutionary method of treatment for the snore disease, based on preliminary results from the first fifty subjects:
" (...) The treatment involves an inverse traction of the jejdulum and the sigmold due to increase hormonal activity, creating a natural enzyme that uses the vitamin C2 allocate in the pudendum, with no need to ingest extra vitamins or any kind of drugs or serum. Primarily , this is created by the vacuum effect inside the system of the subjects, wich relaxes both deltoids and trachea and cord cartilage (...) after practicing it in short periods over time and in a specific strength, which has proven to be the hardest part of the procedure determining how much pace and thrust must be applied throw the rectum to obtain an effective response, causing the dilatation of both trachea, vocal cords and epiglottis (...) ."

Although Dr. Harrison suffered from a heavy drop on the medicine society after announcing his studies and be mistaken as an advertising action from some adult entertaining websites or networks and his research stands in the thin line between medicine and perversity, latest results have proven that this alternative method might be, if accepted and practiced, the ultimate way to avoid this commonly found disease, which until today has no standard treatment and affects over 47% of the inhabitants in the United Kingdom (statistics from The New York Times).

* This information is corroborated legally by The University of Sheffield, C.V.O.C.U., and must be taken professionally.

The consequences of doing everything in end-of-life-care

Fear-mongering about health care reform killing grandma really burns me: I have delivered “everything”, I know what “everything” looks like. I know its dark side. I also know that these deliberate and self-serving lies will ultimately hurt not only grandma, but the rest of us too. Here is what I mean.

When I was in practice I cared for critically ill patients. I loved the ICU for its complex physiology and its palpable human dimension. Unfortunately, my practice afforded me many opportunities to understand the pain and frequent futility of interventions to prolong life without regard to its quality.

Often the intensivist is first to address end-of-life issues. In a typical scenario, an elderly patient is hospitalized with pneumonia. The primary care physician, with a long and meaningful history with her, has never broached her wishes should she require heroic interventions. Nor has she shared them with her family. Possibly she has not thought about it herself, despite her chronic health problems and advanced age. So, now she is on a ward, deteriorating despite appropriate care. She is in extremis and will die without immediate help. The intensivist, with no prior relationship with her or her family, has seconds-to-minutes to decide on the best course of action. The family opts for “everything” without a clear understanding of what it entails.